ISO 9001:2015 Clause 5.1 Leadership and commitment

ISO 9001:2015 Requirements

5.1.1 General

Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization’s business processes;
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality management system requirements;
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
NOTE Reference to “business” in ISO 9001:2015 can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.

1) Top management shall demonstrate leadership and commitment with respect to the quality management system

Top management must ensure that the requirements of the management system, including the policies and objectives, are consistent with the strategic context and direction of your organization, and that the policies and objectives are established whilst ensuring that the human and financial resources needed for implementing the management system are available. Demonstrating leadership and commitment to the quality management system (QMS) is crucial for top management in an organization. Their actions set the tone for the entire organization and influence how seriously employees take the QMS. Here are some ways top management can demonstrate their commitment to the QMS:

  1. Communication and Policy: Top management should clearly communicate their commitment to quality through a formal quality policy statement. This policy should outline the organization’s dedication to meeting customer requirements, complying with regulations, and continuously improving the QMS.
  2. Leading by Example: Top leaders should actively participate in quality initiatives, follow QMS processes themselves, and adhere to quality standards. When employees see top management valuing the QMS, they are more likely to follow suit.
  3. Resource Allocation: Allocating sufficient resources for the QMS, including personnel, tools, technology, and training, shows a commitment to ensuring its effectiveness.
  4. Setting Objectives: Establishing quality objectives that are aligned with the organization’s overall goals and strategies demonstrates a commitment to improving the QMS and its impact on business outcomes.
  5. Regular Reviews: Participate in regular management reviews of the QMS. These reviews assess the performance of the QMS, identify areas for improvement, and ensure its continued alignment with business goals.
  6. Involvement in Decision-Making: Top management should be actively involved in decisions related to the QMS, such as major process changes, investments in quality improvement projects, and strategic shifts.
  7. Customer Focus: Demonstrating a strong focus on customer satisfaction and engagement shows commitment to delivering products or services that meet or exceed customer expectations.
  8. Support for Training: Encourage ongoing training and development for employees to enhance their understanding of the QMS and quality principles.
  9. Risk Management: Show an interest in identifying and managing risks that could impact the QMS and the organization’s ability to deliver quality products or services.
  10. Recognition and Rewards: Acknowledge and reward employees and teams that contribute to quality improvement efforts. This sends a clear message about the importance of quality to the organization.
  11. Continuous Improvement: Emphasize the value of continuous improvement by encouraging employees to seek out opportunities for innovation and efficiency gains within the QMS.
  12. Open Communication: Create an environment where employees feel comfortable reporting quality issues and suggesting improvements without fear of retribution.
  13. Supplier Relationships: Demonstrate the importance of quality throughout the supply chain by fostering strong relationships with suppliers and holding them to high quality standards.
  14. Ethical Behavior: Model ethical behavior and integrity, as these are integral to maintaining a strong QMS and building trust with stakeholders.
  15. Long-Term Perspective: Show commitment by taking a long-term perspective on quality, even if short-term trade-offs are required. This instills confidence in stakeholders that quality is not sacrificed for immediate gains.

Ultimately, top management’s consistent commitment to the QMS and quality principles will create a culture of quality throughout the organization and lead to improved customer satisfaction, operational efficiency, and overall business success.

2) Taking accountability for the effectiveness of the quality management system

Taking accountability for the effectiveness of the quality management system (QMS) is a fundamental responsibility of top management. Their ownership of the QMS’s success not only sets the tone for the entire organization but also reinforces the importance of quality throughout all levels. Here’s how top management can demonstrate accountability for the QMS’s effectiveness:

  1. Ownership of QMS Objectives: Top management should actively participate in defining and setting quality objectives that align with the organization’s strategic goals. They must take ownership of these objectives and track progress toward achieving them.
  2. Regular Review and Analysis: Conduct thorough and periodic reviews of the QMS’s performance. This involves analyzing data, metrics, and trends to assess whether the QMS is delivering the desired results and driving improvement.
  3. Decision-Making Involvement: Top management should be directly involved in key decisions related to the QMS, such as allocating resources, approving process changes, and addressing major quality issues.
  4. Resource Allocation: Ensure that the QMS receives adequate resources, including budget, personnel, training, and technology. Insufficient resources can hinder the QMS’s effectiveness.
  5. Risk Management: Identify potential risks and challenges that could affect the QMS’s performance and take proactive measures to address them. Mitigating risks demonstrates a commitment to ensuring the QMS’s success.
  6. Performance Monitoring: Continuously monitor key performance indicators (KPIs) related to quality, customer satisfaction, process efficiency, and other relevant metrics. Address any deviations promptly.
  7. Leading Continuous Improvement: Encourage and lead a culture of continuous improvement within the organization. Top management should actively support and participate in improvement initiatives that enhance the QMS.
  8. Communication and Transparency: Communicate openly with employees about the QMS’s goals, progress, challenges, and successes. Transparency fosters trust and a shared commitment to quality.
  9. Accountability for Non-Conformances: When non-conformances or quality issues arise, top management should take responsibility for addressing them promptly and effectively. This demonstrates a commitment to learning from mistakes and preventing recurrence.
  10. Personal Commitment to Quality: Lead by example and adhere to QMS processes and standards themselves. This sends a powerful message that everyone, including top management, is accountable for upholding quality.
  11. Representation with Stakeholders: Represent the organization’s commitment to quality when interacting with customers, suppliers, regulatory bodies, and other stakeholders. This reinforces the seriousness with which the organization treats its QMS.
  12. Long-Term Vision: Emphasize the long-term impact of the QMS on the organization’s reputation, customer loyalty, and overall success. This underscores the importance of sustained commitment.
  13. Recognition and Rewards: Recognize and reward employees who contribute to the QMS’s effectiveness. This demonstrates appreciation for efforts that align with the organization’s quality goals.

By taking accountability for the effectiveness of the QMS, top management not only ensures its success but also creates an environment where quality becomes a core value and an integral part of the organization’s culture.

3) Ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization

Ensuring that the quality policy and quality objectives are established in alignment with the context and strategic direction of the organization is a critical aspect of effective quality management. Here’s how top management can achieve this alignment:

  1. Understand the Organization’s Context: Top management should have a clear understanding of the organization’s internal and external context. This includes factors such as industry trends, market demands, regulatory requirements, competitive landscape, and the organization’s strengths and weaknesses.
  2. Strategic Direction: The quality policy and objectives should be directly linked to the organization’s strategic goals and objectives. They should contribute to the realization of the organization’s mission and vision.
  3. Quality Policy: Develop a quality policy that reflects the organization’s commitment to quality and customer satisfaction. The policy should be concise, easy to understand, and applicable to all levels of the organization. It should also align with the organization’s overall values and culture.
  4. Quality Objectives: Establish quality objectives that are specific, measurable, achievable, relevant, and time-bound (SMART). These objectives should be designed to drive improvement and contribute to the overall success of the organization.
  5. Alignment with Stakeholder Expectations: Consider the expectations and needs of customers, employees, suppliers, regulatory authorities, and other stakeholders when formulating the quality policy and objectives. Alignment with stakeholder expectations enhances the credibility of the organization and its commitment to quality.
  6. Leadership Involvement: Top management should actively participate in defining the quality policy and objectives. Their involvement reinforces the importance of these statements and sets an example for the rest of the organization.
  7. Review and Reassessment: Regularly review the quality policy and objectives to ensure they remain relevant and aligned with the organization’s context and strategic direction. Adjust them as necessary based on changes in the business environment.
  8. Communication: Effectively communicate the quality policy and objectives to all levels of the organization. Ensure that employees understand how their work contributes to achieving these objectives.
  9. Integration into QMS Processes: Integrate the quality policy and objectives into the various processes of the quality management system. This includes incorporating them into planning, execution, monitoring, and improvement activities.
  10. Measurement and Tracking: Implement a system for measuring and tracking progress toward achieving the quality objectives. Regularly review performance data to assess whether objectives are being met and to identify areas for improvement.
  11. Alignment with Continuous Improvement: Ensure that the quality policy and objectives support the organization’s culture of continuous improvement. They should encourage employees to seek out opportunities for enhancing processes and delivering higher quality products or services.
  12. Senior Management Endorsement: Obtain senior management’s endorsement of the quality policy and objectives. This shows commitment and provides a clear signal that these statements are a priority for the organization.

By establishing a quality policy and objectives that are closely aligned with the organization’s context and strategic direction, top management creates a strong foundation for a successful quality management system that contributes to the organization’s overall success.

4) Ensuring the integration of the quality management system requirements into the organization’s business processes

Integrating the requirements of the quality management system (QMS) into the organization’s business processes is crucial for achieving consistent and effective quality outcomes. Here’s how top management can ensure this integration:

  1. Understanding of QMS Requirements: Top management should have a comprehensive understanding of the QMS requirements of ISO 9001 and any specific industry regulations that apply.
  2. Cross-Functional Collaboration: Collaborate with different departments and teams to ensure that QMS requirements are incorporated seamlessly into various business processes. Quality is not just the responsibility of a single department; it should be embedded throughout the organization.
  3. Process Mapping: Map out the organization’s key business processes to identify points where QMS requirements can be integrated. This helps visualize how quality processes fit into the broader operational framework.
  4. Quality Objectives Alignment: Ensure that the organization’s quality objectives are embedded within relevant business processes. This alignment helps drive improvement and ensures that quality is a priority at every stage.
  5. Documentation and Procedures: Develop clear documentation and procedures that outline how QMS requirements are integrated into each process. These documents should serve as guidelines for employees to follow.
  6. Training and Awareness: Provide training to employees across different functions to ensure they understand the QMS requirements relevant to their roles. This promotes consistent adherence to quality standards.
  7. Performance Metrics: Integrate key performance indicators (KPIs) related to quality into regular performance tracking and reporting mechanisms. This ensures that quality performance is monitored alongside other business metrics.
  8. Risk Management: Integrate risk assessment and management practices into business processes to identify and address potential quality risks and issues before they escalate.
  9. Change Management: When making changes to business processes, ensure that QMS requirements are considered and incorporated. This prevents unintended deviations from quality standards.
  10. Auditing and Review: Regularly audit and review the integration of QMS requirements into business processes. This helps identify areas of improvement and corrective actions.
  11. Leadership Support: Demonstrate leadership support for QMS integration by encouraging and recognizing efforts to align processes with quality requirements.
  12. Continuous Improvement: Foster a culture of continuous improvement where employees are encouraged to identify opportunities for enhancing the integration of QMS requirements and business processes.
  13. Communication: Communicate the importance of QMS integration to all levels of the organization. This ensures that employees understand why it matters and how it contributes to overall success.
  14. Supplier Relationships: Extend QMS integration to supplier relationships by ensuring that suppliers adhere to quality requirements and contribute to the organization’s overall quality goals.
  15. Feedback Mechanisms: Establish feedback loops from employees and customers to identify areas where QMS integration can be enhanced or where adjustments are needed.

By integrating QMS requirements into the organization’s business processes, top management ensures that quality becomes an inherent part of day-to-day operations. This integration not only improves the organization’s ability to meet customer expectations but also enhances efficiency, reduces errors, and drives continuous improvement.

5) promoting the use of the process approach and risk-based thinking;

Promoting the use of the process approach and risk-based thinking is essential for effective quality management and continuous improvement within an organization. Here’s how top management can encourage and support these principles:

  1. Educate and Train: Provide training and education to employees at all levels about the process approach and risk-based thinking. Help them understand the benefits and how these concepts align with the organization’s goals.
  2. Lead by Example: Top management should demonstrate the use of the process approach and risk-based thinking in their own decision-making and problem-solving. This sets a precedent for others to follow.
  3. Process Mapping: Encourage the organization to map out its key processes, including inputs, outputs, activities, and interactions. This helps identify opportunities for improvement and ensures a clear understanding of how processes work.
  4. Cross-Functional Collaboration: Promote collaboration between different departments to ensure that processes are well-defined, integrated, and aligned with the organization’s objectives.
  5. Emphasize Customer Focus: Use the process approach to identify critical points of interaction with customers and ensure that these processes are designed to meet or exceed customer expectations.
  6. Identify and Manage Risks: Incorporate risk assessment and management into key processes. Encourage teams to identify potential risks, assess their impact, and develop mitigation strategies.
  7. Continuous Improvement: Encourage employees to continually evaluate and refine processes to enhance efficiency, effectiveness, and quality. Risk-based thinking can drive the identification of improvement opportunities.
  8. Feedback Mechanisms: Establish mechanisms for collecting feedback from employees and customers about processes and potential risks. This information can guide improvements.
  9. Incorporate Risk in Decision-Making: Encourage decision-makers to consider risks and opportunities when making strategic and operational decisions. This ensures a more holistic view of potential outcomes.
  10. Risk Registers: Develop risk registers or similar tools to document identified risks, their potential impacts, and the actions taken to mitigate them. This helps track and manage risks over time.
  11. Regular Reviews: Incorporate risk assessments and process evaluations into regular management reviews. This ensures that top management is informed about the state of processes and the associated risks.
  12. Communication: Communicate the importance of the process approach and risk-based thinking throughout the organization. Explain how these concepts contribute to better quality, customer satisfaction, and overall success.
  13. Recognition and Rewards: Recognize and reward employees and teams that demonstrate effective use of the process approach and risk-based thinking in their work. This reinforces their importance.
  14. Continuous Learning: Promote a culture of continuous learning by encouraging employees to stay updated on industry best practices related to processes and risk management.
  15. Integration into QMS: Ensure that the process approach and risk-based thinking are integrated into the organization’s quality management system (QMS) processes and documentation.

By promoting the process approach and risk-based thinking, top management can foster a culture of proactive problem-solving, continuous improvement, and effective risk management. This approach contributes to better decision-making, enhanced quality, and a more resilient organization.

6) Ensuring that the resources needed for the quality management system are available

Ensuring the availability of necessary resources is a crucial responsibility of top management to support the effective implementation and maintenance of the quality management system (QMS). Here’s how top management can fulfill this requirement:

  1. Resource Assessment: Begin by identifying the specific resources required for the QMS, including personnel, finances, technology, infrastructure, tools, and training.
  2. Budget Allocation: Allocate a sufficient budget to support the QMS activities and initiatives. Quality initiatives often require investments in training, technology, process improvement, and compliance efforts.
  3. Personnel: Assign qualified personnel to manage and oversee various aspects of the QMS, including quality assurance, quality control, and continuous improvement efforts.
  4. Training and Development: Ensure that employees receive appropriate training to understand their roles within the QMS and to perform their tasks in accordance with established quality standards.
  5. Technological Infrastructure: Provide the necessary technology, software, and tools required to support QMS activities, data collection, analysis, and reporting.
  6. Infrastructure and Facilities: Ensure that the physical facilities and infrastructure are conducive to maintaining quality standards. This could involve providing adequate workspace, storage, and equipment.
  7. Expertise: If necessary, bring in external consultants or experts to provide guidance and assistance in implementing and improving the QMS.
  8. Time Allocation: Allow employees the time required to participate in QMS activities, such as training, audits, process reviews, and improvement projects.
  9. Measurement and Monitoring: Invest in systems to measure and monitor the performance of the QMS and its processes. This could include software for data collection, analysis, and reporting.
  10. Continuous Improvement Initiatives: Allocate resources for continuous improvement projects aimed at enhancing the QMS, optimizing processes, and achieving better quality outcomes.
  11. Risk Management: Provide resources to identify, assess, and mitigate risks that could impact the QMS’s effectiveness and the organization’s ability to meet quality goals.
  12. Support for Documentation: Ensure that employees have the tools and support necessary to maintain accurate and up-to-date documentation related to the QMS, including policies, procedures, and work instructions.
  13. Stakeholder Engagement: Allocate resources for engaging with stakeholders, including customers, suppliers, and regulatory bodies, to ensure alignment with quality goals and requirements.
  14. Management Review: Allocate time and resources for regular management reviews of the QMS’s performance, outcomes, and opportunities for improvement.
  15. Recognition and Rewards: Consider implementing a recognition and rewards program to acknowledge and appreciate employees who contribute significantly to the successful implementation and maintenance of the QMS.

By providing the necessary resources, top management not only demonstrates their commitment to quality but also ensures that employees have the means to effectively carry out their roles within the QMS. Adequate resources are essential for achieving consistent quality outcomes and maintaining compliance with standards and regulations.

7) Communicating the importance of effective quality management and of conforming to the quality management system requirements

Communicating the importance of effective quality management and conforming to quality management system (QMS) requirements is a crucial role for top management. Here are several effective ways they can communicate this importance throughout the organization:

  1. Clear Communication Channels: Establish clear and open lines of communication between top management and all levels of the organization. This promotes transparency and ensures that the message reaches everyone.
  2. Regular Communication: Regularly communicate the importance of quality management through various channels such as company-wide meetings, newsletters, emails, and internal messaging platforms.
  3. Leading by Example: Demonstrate commitment to quality by adhering to QMS requirements and showing that it is a priority for top management.
  4. Quality Policy: Develop a concise quality policy statement that outlines the organization’s commitment to quality and conformity to QMS requirements. Communicate this policy widely and ensure that employees understand it.
  5. Strategic Alignment: Connect the importance of effective quality management to the organization’s strategic goals and objectives. Show how quality directly impacts the organization’s success.
  6. Case Studies and Examples: Share success stories and case studies that highlight the positive impact of effective quality management. Real-world examples can inspire and emphasize the significance of conforming to the QMS.
  7. Training and Workshops: Provide training sessions and workshops that educate employees about the importance of quality management, the benefits it brings, and how to conform to QMS requirements.
  8. Feedback and Recognition: Establish a system for employees to provide feedback and suggestions related to quality management. Recognize and reward individuals or teams that consistently conform to QMS requirements and contribute to quality improvement.
  9. Internal Quality Audits: Conduct internal audits to evaluate how well different departments adhere to QMS requirements. Share audit results and use them as opportunities for improvement.
  10. Town Hall Meetings: Hold town hall meetings where top management discusses the importance of quality management and the organization’s commitment to maintaining a strong QMS.
  11. Visual Aids: Use visual aids, such as posters, infographics, and digital displays, to remind employees about the importance of quality and QMS requirements in their daily work.
  12. Communication from Senior Leaders: Have senior leaders communicate directly with employees about the organization’s commitment to quality. This demonstrates a top-down commitment.
  13. Continuous Improvement Culture: Promote a culture of continuous improvement and emphasize how conforming to QMS requirements contributes to ongoing growth and enhancement.
  14. Feedback Loop: Create a mechanism for employees to provide input on quality-related issues and challenges. This fosters a sense of involvement and ownership.
  15. Collaborative Forums: Facilitate discussions and forums where employees can share their experiences, challenges, and best practices related to quality management.

Remember that effective communication should be consistent, clear, and tailored to the audience. By employing a variety of communication methods and involving employees at all levels, top management can effectively convey the importance of quality management and the significance of conforming to QMS requirements.

8) Ensuring that the quality management system achieves its intended results

Top management plays a crucial role in ensuring that the quality management system (QMS) achieves its intended results. Here are several key actions top management can take to ensure the effectiveness of the QMS:

  1. Clear Objectives: Define clear and measurable quality objectives that align with the organization’s strategic goals. These objectives should be communicated throughout the organization and serve as a guide for QMS implementation.
  2. Leadership Commitment: Demonstrate unwavering commitment to the QMS by actively participating in QMS-related activities, supporting improvement initiatives, and leading by example.
  3. Resource Allocation: Ensure that adequate resources, including personnel, technology, training, and budget, are allocated to support the QMS implementation and ongoing maintenance.
  4. Communication: Establish effective communication channels to regularly share information about the QMS, quality goals, progress, and performance throughout the organization.
  5. Monitoring and Measurement: Implement a system for monitoring and measuring QMS performance against established objectives and key performance indicators (KPIs).
  6. Regular Reviews: Conduct regular management reviews of the QMS to evaluate its performance, identify opportunities for improvement, and address any issues.
  7. Risk-Based Approach: Apply risk-based thinking to identify and address potential risks and opportunities that could impact the QMS’s effectiveness and the organization’s ability to meet quality goals.
  8. Continuous Improvement: Foster a culture of continuous improvement by encouraging employees to identify areas for enhancement and implement initiatives to drive incremental changes.
  9. Employee Involvement: Involve employees at all levels in QMS activities, encourage their participation in improvement projects, and value their input in achieving intended results.
  10. Alignment with Strategy: Ensure that the QMS is aligned with the organization’s overall strategy, mission, and vision. Quality should be an integral part of the organizational culture.
  11. Training and Competence: Provide necessary training to employees to ensure they understand their roles within the QMS and have the required skills to contribute to its success.
  12. Documentation and Records: Establish clear documentation and record-keeping procedures to track QMS processes, changes, and outcomes.
  13. Customer Focus: Maintain a strong customer focus by regularly seeking customer feedback, understanding their needs, and using this information to drive improvements.
  14. Supplier Collaboration: Collaborate closely with suppliers to ensure that their processes align with the QMS and contribute to the organization’s quality goals.
  15. Feedback and Lessons Learned: Encourage a culture where feedback, suggestions, and lessons learned are actively collected, shared, and used to enhance the QMS.
  16. External and Internal Audits: Conduct regular internal audits and consider external audits to verify compliance with QMS requirements and identify areas for improvement.
  17. Recognition and Rewards: Recognize and reward employees and teams that consistently contribute to the successful implementation and achievement of QMS goals.

By taking these actions, top management creates an environment where the QMS is well-supported, continuously improved, and effectively aligned with the organization’s objectives. This not only ensures that the QMS achieves its intended results but also contributes to overall business success and customer satisfaction.

9) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system

Top management plays a vital role in engaging, directing, and supporting individuals to contribute effectively to the success of the quality management system (QMS). Here’s how top management can fulfill this responsibility:

  1. Clear Communication: Communicate the importance of the QMS and its alignment with the organization’s goals. Ensure that employees understand their role in maintaining and improving the QMS.
  2. Supportive Leadership: Be approachable and encourage open dialogue with employees regarding quality concerns, suggestions for improvement, and any challenges they may face.
  3. Empowerment: Empower employees by giving them the authority and autonomy to make decisions related to quality improvement within their areas of responsibility.
  4. Setting Expectations: Clearly define expectations for employees regarding their roles in maintaining and enhancing the QMS. Provide guidance on how their work contributes to the organization’s overall quality objectives.
  5. Training and Development: Ensure that employees have the necessary skills and knowledge to effectively contribute to the QMS. Provide training opportunities to enhance their understanding of quality principles.
  6. Providing Resources: Allocate resources (financial, technological, personnel) required for employees to carry out their quality-related tasks effectively.
  7. Feedback Mechanisms: Establish mechanisms for employees to provide feedback, suggestions, and reports of quality-related issues. Respond promptly to their input.
  8. Recognition and Rewards: Recognize and reward employees who consistently contribute to the effectiveness of the QMS. This could include both individual and team accomplishments.
  9. Continuous Improvement Culture: Foster a culture of continuous improvement where employees are encouraged to identify areas for enhancement and implement solutions.
  10. Leading by Example: Model the behavior expected from employees by actively participating in quality-related activities, following QMS processes, and adhering to quality standards.
  11. Performance Reviews: Incorporate QMS-related performance indicators and goals into employee performance evaluations. This highlights the significance of quality contributions.
  12. Problem-Solving Support: Offer guidance and support to employees when they encounter quality-related challenges or issues that require problem-solving.
  13. Sharing Best Practices: Encourage the sharing of best practices among employees to facilitate cross-functional learning and the adoption of successful quality approaches.
  14. Participation in Improvement Projects: Involve employees in improvement projects or quality circles that allow them to collaborate on enhancing processes and addressing quality concerns.
  15. Transparency: Be transparent about the organization’s quality goals, progress, and results. Share information on QMS performance with employees to keep them informed.
  16. Removing Barriers: Identify and address any obstacles that prevent employees from effectively contributing to the QMS. This could involve addressing resource constraints or process bottlenecks.

By engaging, directing, and supporting employees to contribute to the effectiveness of the QMS, top management not only reinforces the importance of quality but also empowers employees to actively participate in achieving quality goals. This collaborative approach enhances the organization’s ability to deliver high-quality products or services and continuously improve its processes.

10) promoting improvement

Promoting improvement is a critical role for top management in fostering a culture of continuous enhancement within the organization. Here are ways top management can effectively promote improvement:

  1. Lead by Example: Demonstrate a personal commitment to improvement by actively participating in improvement initiatives, adhering to quality standards, and continuously seeking ways to enhance processes.
  2. Set Expectations: Clearly communicate to employees that continuous improvement is an organizational priority and is expected from every level and department.
  3. Provide Resources: Allocate the necessary resources—financial, human, technological—to support improvement projects and initiatives.
  4. Establish Goals: Define improvement goals and objectives that are aligned with the organization’s strategic direction and quality policy.
  5. Support Innovation: Encourage employees to think creatively and innovate in order to identify new ways of doing things that can lead to better outcomes.
  6. Recognize Improvement Efforts: Acknowledge and appreciate employees and teams that actively engage in improvement projects. Provide recognition and rewards for their contributions.
  7. Regularly Review Performance: Conduct regular reviews of performance metrics, key performance indicators (KPIs), and outcomes to identify areas for improvement.
  8. Feedback Mechanisms: Create a mechanism for employees to provide feedback and suggestions for improvement. Act on their input and keep them informed about outcomes.
  9. Encourage Collaboration: Promote cross-functional collaboration to address complex challenges and leverage diverse perspectives for improvement.
  10. Benchmarking: Encourage the organization to benchmark against industry best practices to identify areas where improvements can be made.
  11. Support Process Changes: Be receptive to changes in processes that can lead to improved quality, efficiency, or customer satisfaction.
  12. Remove Barriers: Identify and eliminate obstacles that hinder improvement efforts, whether they are related to resources, policies, or processes.
  13. Invest in Training: Provide training and development opportunities that empower employees with skills to identify, implement, and sustain improvements.
  14. Capture and Share Lessons Learned: Encourage teams to document and share their improvement experiences and lessons learned. This can facilitate knowledge transfer across the organization.
  15. Communication: Regularly communicate the results of improvement initiatives to all employees, highlighting the positive impact they have on the organization.
  16. Celebrate Successes: Celebrate and communicate the successes and positive outcomes resulting from improvement projects. This reinforces the value of improvement efforts.
  17. Provide Support for Problem-Solving: Offer guidance and support to teams and individuals working on improvement projects, including problem-solving techniques and tools.
  18. Long-Term Perspective: Stress the importance of sustained improvement efforts rather than quick fixes. Cultivate a culture where continuous enhancement is a way of doing business.

By actively promoting improvement, top management creates an environment where innovation, learning, and growth are encouraged. This leads to better processes, enhanced quality, increased customer satisfaction, and ultimately, organizational success.

11) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Top management plays a crucial role in supporting and empowering other relevant management roles to demonstrate effective leadership within their respective areas of responsibility. This collaborative approach strengthens the organization’s overall leadership and promotes alignment with its quality and strategic goals. Here’s how top management can provide support:

  1. Clear Expectations: Clearly communicate the organization’s expectations for leadership behaviors and actions within each management role.
  2. Alignment with Vision: Ensure that the goals and strategies of each management role are aligned with the organization’s overall vision and mission.
  3. Collaborative Planning: Collaborate with other relevant managers to develop cohesive plans that consider the organization’s holistic objectives.
  4. Resource Allocation: Allocate resources and support necessary for each management role to fulfill their responsibilities effectively.
  5. Communication: Foster open and transparent communication between top management and other relevant managers to ensure alignment and effective execution of strategies.
  6. Feedback and Coaching: Provide regular feedback and coaching to help other managers enhance their leadership skills and overcome challenges.
  7. Performance Evaluation: Incorporate leadership competencies into the evaluation process for other managers to ensure alignment with organizational values.
  8. Professional Development: Support the professional growth of other managers through training, mentorship, and exposure to leadership best practices.
  9. Encourage Innovation: Encourage other managers to innovate and adopt best practices in their areas of responsibility.
  10. Conflict Resolution: Provide guidance on handling conflicts and challenges effectively within their respective departments.
  11. Empowerment: Empower other managers to make decisions within their areas of responsibility, fostering a sense of ownership and accountability.
  12. Risk Management: Assist in identifying and managing risks associated with their areas of responsibility.
  13. Recognition and Rewards: Recognize and reward the efforts and successes of other managers, promoting a positive leadership culture.
  14. Promote Collaboration: Encourage collaboration and knowledge sharing among different management roles to leverage collective expertise.
  15. Continuous Improvement: Advocate for a culture of continuous improvement within other management roles and support their efforts in this direction.
  16. Leading by Example: Set an example by exhibiting the desired leadership behaviors and actions in your own role.
  17. Crisis Management: Offer guidance and support during times of crisis or unexpected challenges.
  18. Liaison with Top Management: Act as a liaison between other management roles and top management, facilitating effective communication and alignment.

By supporting other relevant management roles to demonstrate effective leadership, top management fosters a cohesive and empowered leadership team that collectively drives the organization toward its goals. This collaborative approach enhances decision-making, problem-solving, and innovation across the organization.

12 Reference to “business” in ISO 9001:2015 can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.

In ISO 9001:2015, the term “business” is used broadly to encompass the core activities and functions of an organization, regardless of its nature (public, private, for-profit, or nonprofit). The standard recognizes that the primary focus of an organization’s quality management system (QMS) is to ensure that its processes and activities consistently meet customer requirements and enhance customer satisfaction.ISO 9001:2015 defines “business” in Clause 3.2.2 as follows:

“3.2.2 business organization that engages in one or more activities that an organization undertakes to pursue its objectives”**

The key takeaway from this definition is that “business” refers to the various activities and processes an organization undertakes to achieve its objectives, whether those objectives are related to profit, mission fulfillment, customer satisfaction, or any other relevant purpose.This broad interpretation acknowledges that organizations have diverse missions and goals, and the ISO 9001 standard aims to provide a flexible framework that can be applied to organizations of various types and sizes. The emphasis is on achieving consistent quality and continuous improvement across the organization’s core activities, regardless of whether the organization operates in the public or private sector, or whether it operates for-profit or not-for-profit.

Documented Information Required

Though there is no mandatory requirement for Documented information for this clause ,it sets the tone for top management’s responsibilities in demonstrating leadership and commitment to the QMS. The specific documents and records that may be related to Clause 5.1 include:

  1. Quality Policy: The organization’s quality policy, which is a statement of the organization’s commitment to quality and its intent to meet customer requirements and enhance customer satisfaction.
  2. Quality Objectives: Documentation of the quality objectives that have been established to drive improvement and align with the organization’s strategic direction.
  3. Organizational Structure and Responsibilities: Records outlining the organizational structure, roles, responsibilities, and authorities within the QMS, showing how leadership and commitment are distributed throughout the organization.
  4. Management Review Records: Documentation of management review meetings that discuss the performance of the QMS, its effectiveness, the allocation of resources, and opportunities for improvement.
  5. Communications: Records of internal and external communications related to the QMS, including any communication that demonstrates leadership’s commitment to quality.
  6. Evidence of Resource Allocation: Documentation showing that top management is allocating appropriate resources (financial, human, technological) to support the QMS.
  7. Training and Development Plans: Records of training and development plans for leadership and employees, demonstrating the commitment to enhancing competence.
  8. Decision-Making Processes: Records of decision-making processes that involve top management’s input, particularly those related to QMS planning, objectives, and resource allocation.
  9. Minutes of Meetings: Minutes or records of meetings where leadership discusses QMS matters, sets objectives, and evaluates progress.
  10. Communication of Quality Policy: Records of how the quality policy is communicated throughout the organization to ensure everyone is aware of the commitment to quality.

It’s important to note that while these documents and records can demonstrate compliance with Clause 5.1, ISO 9001:2015 emphasizes a risk-based approach and flexibility in documentation requirements. Organizations are encouraged to determine the necessary level of documentation based on factors such as the size of the organization, the complexity of processes, and the potential risks.As always, organizations seeking ISO 9001 certification should work with their chosen certification body and follow their guidance on documentation requirements to ensure compliance.

ISO 9001:2015 Clause 4.4 Quality management system and its processes

ISO 9001:2015 Requirements

4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of ISO 9001:2015 Standard.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

  1. determine the inputs required and the outputs expected from these processes;
  2. determine the sequence and interaction of these processes;
  3. determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
  4. determine the resources needed for these processes and ensure their availability;
  5. assign the responsibilities and authorities for these processes;
  6. address the risks and opportunities as determined in accordance with the requirements of 6.1;
  7. evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
  8. improve the processes and the quality management system

4.4.2 To the extent necessary, the organization shall:

  1. maintain documented information to support the operation of its processes;
  2. retain documented information to have confidence that the processes are being carried out as planned.

1) The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of ISO 9001:2015 Standard.

This requirement emphasizes the establishment, implementation, maintenance, and continuous improvement of a Quality Management System (QMS) that complies with the ISO 9001:2015 standard. Let’s break down the key components of this requirement:

  1. Establishing a QMS: The organization must create a structured and documented Quality Management System that outlines the processes, procedures, and controls for managing quality.
  2. Implementing the QMS: The QMS should be put into practice across the organization, involving all relevant personnel in following the established processes and procedures.
  3. Maintaining the QMS: Regularly review and update the QMS to ensure its accuracy, relevance, and effectiveness. This includes adapting to changes within the organization and external factors.
  4. Continuous Improvement: Strive for ongoing improvement in the QMS and its associated processes. This involves identifying areas for enhancement and implementing corrective and preventive actions.
  5. Processes and Their Interactions: The QMS should include all necessary processes for effectively managing quality, from product design and development to customer feedback and support. These processes must be interconnected and well-coordinated to ensure seamless quality management.
  6. ISO 9001:2015 Requirements: The organization must align its QMS with the requirements specified in the ISO 9001:2015 standard. This involves understanding and implementing the standard’s principles, clauses, and guidance.
  7. Compliance and Conformance: The QMS should help the organization comply with ISO 9001:2015 requirements and demonstrate conformance through audits and assessments.
  8. Monitoring and Measurement: Regularly monitor and measure the performance of the QMS processes to ensure they are achieving their intended results and meeting quality objectives.
  9. Documented Information: The QMS processes and their interactions, along with quality policies, procedures, and records, should be documented to provide clear guidance and evidence of compliance.
  10. Leadership Involvement: – Organizational leadership plays a vital role in promoting and supporting the establishment, implementation, maintenance, and improvement of the QMS.
  11. Employee Involvement: – All employees should be engaged in following the QMS processes and contributing to its continuous improvement.
  12. Customer Focus: – The QMS should be designed to enhance customer satisfaction by consistently delivering products and services that meet or exceed customer expectations

.By adhering to this requirement, organizations ensure that they have a robust framework in place for managing quality effectively, meeting customer needs, and driving continuous improvement. The QMS serves as the foundation for a culture of quality within the organization and contributes to its long-term success. The processes needed for a Quality Management System (QMS) can vary depending on the organization’s industry, size, and specific operations. However, the ISO 9001:2015 standard provides a framework for identifying and defining these processes. The standard does not prescribe specific processes but outlines requirements for establishing, implementing, and maintaining a QMS. Below are some key processes commonly found in a QMS, along with their application throughout the organization:

1. Risk-Based Thinking and Context Analysis:

  • Identify and analyze internal and external factors that could affect the QMS.
  • Determine risks and opportunities to ensure proactive management.

2. Leadership and Management Responsibility:

  • Define quality policy and objectives.
  • Allocate resources, assign responsibilities, and demonstrate commitment to quality.

3. Customer Requirements Management:

  • Understand and document customer needs and expectations.
  • Translate these into product or service requirements.

4. Design and Development (if applicable):

  • Create a systematic approach to designing and developing products or services.
  • Ensure designs meet customer requirements and regulatory standards.

5. Supplier and External Provider Management:

  • Select and monitor suppliers based on their ability to meet quality requirements.
  • Maintain effective communication with external partners.

6. Document and Record Control:

  • Establish procedures for creating, updating, and managing documents and records.
  • Ensure access to accurate and up-to-date information.

7. Process Control and Monitoring:

  • Establish control measures for each critical process.
  • Monitor process performance, identify deviations, and take corrective actions.

8. Nonconformity and Corrective Action:

  • Establish a procedure to identify, assess, and address nonconformities.
  • Implement corrective actions to prevent recurrence.

9. Internal Auditing:

  • Conduct systematic audits of processes and the QMS to ensure compliance.
  • Identify areas for improvement and follow up on corrective actions.

10. Management Review:

  • Regularly assess the performance of the QMS and its alignment with organizational goals.
  • Use the results to drive improvements and make informed decisions.

11. Measurement and Analysis:

  • Establish methods for collecting and analyzing data related to product quality and process performance.
  • Use data to track trends, set targets, and drive improvement efforts.

12. Continuous Improvement:

  • Encourage a culture of continuous improvement.
  • Use data-driven insights to identify opportunities for enhancing processes and products.

13. Customer Feedback and Satisfaction:

  • Collect customer feedback and assess satisfaction levels.
  • Use feedback to make necessary improvements and address customer concerns.

14. Training and Competence Development:

  • Identify training needs for employees.
  • Provide necessary training to ensure competence in performing tasks.

15. Communication and Internal Reporting:

  • Establish effective communication channels to share quality-related information.
  • Encourage transparency and prompt reporting of quality-related issues.

These processes should be tailored to the organization’s specific context, objectives, and industry requirements. They work together to create a structured and systematic approach to quality management that permeates all levels and functions within the organization.

2) The organization shall determine the processes needed for the quality management system and their application throughout the organization

Determining the processes needed for the Quality Management System (QMS) and their application throughout the organization involves a systematic approach that aligns with the organization’s goals, products, services, and context. The ISO 9001:2015 standard emphasizes a process-based approach to quality management. Here’s a step-by-step guide on how the organization can determine the processes needed for the QMS and apply them throughout the organization:

  • Understand Organizational Context: Begin by understanding the organization’s internal and external context, including its size, industry, products, services, and stakeholders.
  • Identify Interested Parties and Requirements: Identify relevant interested parties, such as customers, suppliers, employees, and regulators. Determine their requirements and expectations related to products, services, and quality.
  • Define QMS Objectives: Establish quality objectives aligned with the organization’s strategic goals and customer needs.
  • Map Out Core Processes: Identify the key processes involved in delivering products and services. Map out the sequence of activities for each process.
  • Determine Process Interactions: Understand how processes interact with each other. Identify inputs, outputs, and dependencies between processes.
  • Assess Risks and Opportunities: Evaluate the risks and opportunities associated with each process. Consider potential impacts on product quality, customer satisfaction, and organizational goals.
  • Consider Compliance Requirements: Identify legal, regulatory, and industry-specific requirements that impact processes. Ensure processes adhere to these requirements.
  • Define Process Objectives and Measures: Define specific objectives for each process that align with QMS objectives. Develop measurable performance indicators for monitoring process effectiveness.
  • Allocate Responsibilities: Assign roles and responsibilities for managing and executing each process. Ensure clear ownership and accountability.
  • Develop Process Documentation: Create documented procedures, work instructions, and process flowcharts for each process. Ensure these documents are clear, accessible, and regularly updated.
  • Establish Performance Measurement: Set up mechanisms to collect and analyze data related to process performance. Monitor process metrics and identify trends.
  • Implement Continuous Improvement: Encourage a culture of continuous improvement within the organization. Regularly review process performance data and identify areas for enhancement.
  • Training and Competence Development: Ensure employees are trained and competent in executing their assigned processes. Provide necessary training and development opportunities.
  • Communication and Awareness: Communicate process objectives, expectations, and changes to relevant personnel. Foster awareness of the importance of each process in achieving overall quality goals.
  • Review and Validation: Periodically review and validate the effectiveness of each process. Use results to identify improvement opportunities.

By following these steps, the organization can systematically identify, define, implement, and continually improve the processes needed for its QMS. This approach ensures that quality management is integrated throughout the organization and aligned with its strategic objectives and customer expectations.

3) Determine the inputs required and the outputs expected from these processes;

The organization should determine the inputs and outputs for processes within the quality management system by first understanding the process requirements, identifying stakeholders, and defining clear process objectives. Through process mapping, the organization can then identify necessary inputs, including materials, data, resources, and specifications, while also defining desired outputs such as products, reports, documentation, and improvements. Regulatory compliance, risk assessment, and continuous improvement considerations should guide this determination. Effective communication, training, monitoring, and alignment with organizational goals are essential for ensuring consistent application of these inputs and outputs across the organization, fostering quality, efficiency, and stakeholder satisfaction.

4) Determine the sequence and interaction of these processes

Determining the sequence and interaction of processes within a quality management system (QMS) is essential to ensure a smooth and efficient flow of activities. The organization should determine the sequence and interaction of processes within the QMS by considering the logical order of activities, dependencies, and relationships. Begin by mapping out the flow of activities for each process, identifying where inputs from one process are required as inputs for another. Pay attention to process dependencies and potential bottlenecks. Ensure that outputs from one process align with the inputs of subsequent processes, maintaining a coherent and value-adding chain of activities. Regular cross-functional collaboration and feedback loops can help refine and optimize the process sequence over time. Additionally, utilize process flowcharts or diagrams to visualize and communicate the interconnections effectively, fostering a shared understanding across the organization and promoting seamless collaboration.

5) Determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

To determine and apply the criteria and methods for ensuring effective operation and control of processes within a quality management system (QMS), the organization should identify the critical criteria and methods that are essential for measuring and controlling the effectiveness of each process. This includes defining specific quality standards, requirements, specifications, and guidelines that need to be met. Define relevant performance indicators that allow you to quantitatively or qualitatively measure the success and efficiency of each process. These indicators should align with the process objectives and organizational goals. Implement a system for monitoring and measuring the process performance indicators. This involves collecting data and information related to the process activities, outputs, and outcomes. Use a combination of qualitative and quantitative data to gain a comprehensive view. Establish acceptable limits and tolerances for each performance indicator. This helps you determine whether the process is operating within acceptable parameters and producing the desired outcomes. Periodically review and analyze the collected data to assess process performance. Compare the actual results against the established criteria and limits. This analysis can uncover trends, anomalies, and opportunities for improvement. If discrepancies or deviations are identified during the review, implement appropriate corrective actions. These actions could involve adjusting processes, reallocating resources, or refining methodologies to bring the process back into compliance and alignment with the desired outcomes. Utilize the data and insights gathered from the monitoring and measurement activities to drive continuous improvement. Identify areas where processes can be optimized, streamlined, or enhanced to achieve better results. Document the criteria, methods, indicators, monitoring activities, and measurement results as part of your QMS documentation. This information provides a historical record and supports transparency and accountability. Ensure that employees involved in executing and controlling processes are adequately trained and competent in using the chosen methods and tools for measurement and monitoring. Foster collaboration between different departments and teams to ensure that the criteria and methods applied align with the organization’s overall goals and objectives. This can lead to a more comprehensive and holistic approach. Leverage appropriate technology, such as software systems and automation tools, to facilitate efficient monitoring, data collection, analysis, and reporting. Establish feedback loops where process owners, stakeholders, and relevant parties can provide insights and suggestions for improving the criteria, methods, and performance indicators over time.

6) Determine the resources needed for these processes and ensure their availability

The organization should determine the resources needed for its processes within the quality management system by conducting a comprehensive assessment of the requirements specific to each process, including personnel, equipment, facilities, materials, and technology. This assessment should consider factors such as process complexity, volume, and criticality. Once identified, the organization should establish resource allocation plans that outline the necessary resources and ensure their availability through effective resource management practices, such as workforce planning, procurement strategies, maintenance schedules, and technology investments. Regular monitoring, performance evaluations, and alignment with organizational goals are essential to maintaining the availability of resources required for smooth and efficient process operations within the QMS.

7) Assign the responsibilities and authorities for these processes

The organization assigns responsibilities and authorities for processes within the quality management system by first designating process owners who oversee the entire process. Clear roles and responsibilities are defined for individuals involved, considering their expertise and position within the organizational structure. These roles are documented in the quality management system documentation to ensure clarity and communication. Training and competence requirements are established to ensure individuals can perform their tasks effectively. Cross-functional collaboration ensures seamless process interactions, while performance evaluations and regular reviews maintain accountability and support adaptation to changing organizational needs.

8) Address the risks and opportunities

To address the risks and opportunities associated with processes within the quality management system, the organization should undertake a systematic risk assessment and opportunity identification process. This involves evaluating potential risks that could impact process performance, product/service quality, and customer satisfaction, as well as recognizing opportunities for process improvement and innovation. Utilizing tools such as risk matrices, SWOT analyses, and scenario planning, the organization can prioritize and develop mitigation strategies for identified risks, while also capitalizing on opportunities to enhance efficiency and achieve better outcomes. Regular reviews, adjustments to risk mitigation plans, and a proactive approach to seizing opportunities contribute to a resilient and adaptable quality management system that aligns with organizational objectives.

9) Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results

The organization should evaluate these processes within the quality management system by measuring key performance indicators, comparing results against predefined criteria and objectives, and analyzing trends and deviations. Regular reviews, audits, and assessments allow for identifying areas of improvement or non-conformities. When changes are needed, a systematic approach is taken: the organization reviews root causes, develops corrective or preventive actions, and implements changes through documented procedures. The effectiveness of these changes is monitored, and adjustments are made as necessary. This cycle of evaluation, change implementation, and monitoring is repeated to ensure that processes consistently achieve their intended results, align with quality standards, and contribute to continuous improvement.

10) Improve the processes and the quality management system

The organization can continuously improve processes and the quality management system by fostering a culture of innovation and learning. This involves regularly analyzing process performance data, customer feedback, and market trends to identify areas for enhancement. Encouraging employee engagement and involvement in suggesting improvements, and utilizing methodologies like Lean, Six Sigma, or Total Quality Management can streamline processes and eliminate waste. Periodic management reviews assess the effectiveness of the quality management system, leading to strategic adjustments. Embracing emerging technologies, benchmarking against industry best practices, and seeking certifications like ISO standards can further drive system-wide improvements, ensuring that the organization remains adaptable, customer-focused, and competitive.

11) Maintain documented information to support the operation of its processes

The organization should maintain documented information to support the operation of its processes through a structured and systematic approach. This involves:

  1. Identify Information Needs: Determine what types of information are required to support each process within the quality management system. This could include procedures, work instructions, specifications, guidelines, forms, templates, and records.
  2. Document Creation: Develop clear and concise documented information for each process. Ensure that it accurately reflects the steps, requirements, and expectations for executing the process effectively.
  3. Version Control: Establish version control mechanisms to track changes to documented information over time. This prevents confusion and ensures that employees are using the most up-to-date and accurate information.
  4. Centralized Repository: Create a centralized repository or document management system where all relevant documented information is stored. This makes it easily accessible to authorized personnel and reduces the risk of using outdated documents.
  5. Access and Distribution: Control access to the documented information based on roles and responsibilities. Ensure that employees who need the information can access it, while maintaining security and confidentiality.
  6. Training and Awareness: Provide training to employees on how to use and interpret the documented information. Ensure that employees are aware of where to find the information they need to perform their tasks.
  7. Regular Review: Establish a schedule for reviewing and updating documented information. This ensures that the information remains accurate and relevant as processes evolve.
  8. Change Management: Implement a formal change management process for making updates to documented information. Changes should be reviewed, approved, and communicated effectively to relevant stakeholders.
  9. Retention and Disposal: Define retention periods for different types of documented information based on regulatory requirements and organizational needs. Dispose of outdated or unnecessary documents in a secure and compliant manner.
  10. Searchability and Usability: Ensure that documented information is organized in a way that makes it easy to search and retrieve. Use consistent naming conventions, categorization, and indexing.
  11. Linkages: Establish linkages between different documents, processes, and relevant information. This helps users navigate through interconnected information effectively.
  12. Audit and Compliance: Maintain documented information in a manner that supports internal and external audits. Ensure that the documented information provides a clear audit trail of process execution and compliance.

By following these steps, the organization can establish a well-organized, accessible, and up-to-date repository of documented information that supports the operation of its processes within the quality management system.

12) Retain documented information to have confidence that the processes are being carried out as planned.

The organization can retain documented information to have confidence that processes are being carried out as planned by adhering to a systematic approach. This involves securely storing records, procedures, and other relevant documents in a centralized repository with clear version control and access restrictions. Regularly reviewing and updating documented information ensures its accuracy and relevance. Implementing audit trails and maintaining historical records of process execution, outcomes, and changes fosters transparency and accountability. By aligning documented information with the organization’s quality management system, adhering to retention policies, and utilizing technology for efficient information management, the organization can confidently verify that processes are being executed in accordance with established plans and procedures.

Document Information Required

There is no mandatory requirement for any document Information but it does emphasize the need for documented information to effectively operate and control processes. Here’s a general overview of the documents and records that are typically associated with this clause:

  1. Quality Manual (Optional): While ISO 9001:2015 no longer requires a formal quality manual, some organizations still choose to have one. A quality manual provides an overview of the organization’s QMS, including its processes and how they interact.
  2. Scope of the QMS: Document that defines the boundaries and application of the QMS, specifying what processes are included and excluded.
  3. Process Documentation: Documents that outline the processes within the QMS, including their objectives, scope, inputs, outputs, sequence, and interactions. This could include process maps, flowcharts, and written procedures.
  4. Work Instructions: Detailed instructions for executing specific tasks within processes, providing step-by-step guidance to ensure consistency and quality.
  5. Process Performance Criteria and Indicators: Documents that establish the criteria for measuring the performance of processes, including key performance indicators (KPIs) used to monitor their effectiveness.
  6. Risk and Opportunity Assessments: Documentation related to risk and opportunity assessments for each process, including identification, analysis, and mitigation strategies.
  7. Training Records: Documentation of employee training, competencies, and qualifications relevant to carrying out specific processes effectively.
  8. Documented Information Control: Procedures for controlling the creation, revision, approval, distribution, and archiving of documented information within the QMS.
  9. Monitoring and Measurement Records: Records of monitoring and measurement activities conducted to assess process performance, including data collected and analysis results.
  10. Corrective and Preventive Action Records: Records of actions taken to address non-conformities, deviations, and opportunities for improvement identified during process execution.
  11. Management Review Records: Records of management review meetings that assess the overall performance of the QMS and its processes, including decisions and actions taken.
  12. Internal Audit Records: Records of internal audits conducted to verify compliance with processes and identify areas for improvement.
  13. Supplier and Contractor Documentation: Documentation related to the evaluation, selection, monitoring, and performance of suppliers and contractors involved in processes.

Remember, the specific documents and records required can vary based on the organization’s size, complexity, industry, and the nature of its processes. It’s important to tailor the documentation to meet your organization’s needs and to ensure compliance with ISO 9001:2015 requirements.

ISO 9001:2015 Clause 4.3 Determining the scope of the quality management system

ISO 9001:2015 Requirements

The organization shall determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of 9001:2015 Standard if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of 9001:2015 Standard that the organization determines is not applicable to the scope of its quality management system.
Conformity to 9001:2015 Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

1) The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

Defining the scope of your management system is a key step when developing any management system. The scope should concisely describe the activities, regulatory requirements, facilities, and remote locations that are to be covered under, and supported by the management system. The scope of registration and certification will need to reflect precisely and clearly the activities covered by your organization’s management system; any exclusion to non-applicable requirements of the standards should be documented and justified in the manual. No single business-related activity should exist outside of the scope. You should discuss the scope of registration very early in your contact with the registrar, prior to or during the selection process.From a review of the nature of your business’s operations, products and services, the scope of the management system should be apparent by the extent of the processes and controls that your organization has already established.The scope of your management system may include the whole of the organization, specific and identified functions within the organization, specific sections of the organization, or one or more functions across a group of organizations Consideration of the boundaries and applicability of the management system can include:

  1. The range of products and services;
  2. Different sites and activities;
  3. External provision of processes, products and services;
  4. Common support provided by centralised functions;
  5. Processes, procedures, instructions, or site-specific requirements.

Here’s how an organization can go about determining the scope of its QMS:

  1. Identify Key Processes and Activities:
    • List all the processes, activities, and functions within the organization that are related to delivering products or services to customers.
    • Consider areas such as design, production, customer support, procurement, and distribution.
  2. Consider Stakeholder Expectations:
    • Understand the expectations and requirements of interested parties, including customers, regulatory authorities, and industry standards.
    • Evaluate which processes directly impact meeting these expectations.
  3. Define Product or Service Offerings:
    • Clearly define the products or services offered by the organization that fall under the QMS.
    • Include variations or specific types of products or services.
  4. Evaluate Organizational Boundaries:
    • Determine if there are any subsidiary companies or separate divisions that should be included or excluded from the QMS scope.
    • Consider the extent to which these entities impact product quality and customer requirements.
  5. Identify Exclusions:
    • Identify any processes, activities, products, or services that will be excluded from the QMS scope.
    • Clearly document the reasons for these exclusions.
  6. Consider Interfaces and Interactions:
    • Evaluate how processes and activities interact with each other, both internally and externally.
    • Include processes that impact the delivery of quality products or services.
  7. Compliance with Regulations:
    • Identify which regulatory requirements apply to the organization and the QMS processes.
    • Ensure that the QMS scope includes the processes necessary for regulatory compliance.
  8. Review Organizational Goals and Objectives:
    • Consider the organization’s strategic goals and objectives related to quality and customer satisfaction.
    • Align the QMS scope with these goals to ensure a focused approach.
  9. Stakeholder Communication:
    • Clearly communicate the determined scope to relevant stakeholders, including employees, customers, and regulatory authorities.
  10. Document the QMS Scope:
    • Document the determined scope of the QMS in a scope statement.
    • The scope statement should clearly outline the boundaries, applicability, exclusions, and reasons for exclusions.
  11. Regular Review and Updates:
    • Periodically review and reassess the QMS scope to ensure it remains aligned with organizational changes, stakeholder expectations, and industry trends.
  12. Get Leadership Buy-In:
    • Ensure that organizational leadership approves and supports the determined QMS scope.
    • Their endorsement is essential for effective implementation.

By thoroughly defining the boundaries and applicability of the QMS, an organization can establish a clear framework for quality management efforts. This scope ensures that the QMS focuses on areas that directly impact product or service quality and customer satisfaction, leading to more efficient processes, improved performance, and enhanced customer trust.

2) When determining this scope, the organization shall consider the external and internal issues

When determining the scope of the Quality Management System (QMS), considering both external and internal issues is crucial because they provide valuable context that influences the organization’s operations, processes, and overall approach to quality management. Here’s why these factors should be taken into account:

1. Alignment with Purpose and Strategy:

  • External issues, such as market trends, competition, and regulatory changes, impact the organization’s strategic direction.
  • Internal issues, including culture, values, and organizational structure, shape how the organization operates.
  • Aligning the QMS scope with these issues ensures that quality efforts are in line with the organization’s purpose and strategy.

2. Comprehensive Understanding:

  • Analyzing external factors helps the organization understand customer needs, market demands, and industry trends.
  • Internal issues provide insights into the organization’s strengths, weaknesses, and internal capabilities.
  • A comprehensive understanding of both sets of issues allows the organization to make informed decisions about the QMS scope.

3. Risk Management:

  • Identifying external risks, such as changes in regulations or competitive landscape, helps the organization proactively manage potential disruptions.
  • Internal issues like resource constraints or process inefficiencies can also pose risks to quality.
  • Integrating risk considerations into the QMS scope ensures that risk management is embedded in quality practices.

4. Effective Stakeholder Management:

  • Understanding external stakeholders’ needs and expectations helps tailor the QMS to meet customer and regulatory requirements.
  • Addressing internal issues like employee satisfaction and engagement contributes to a positive organizational culture that supports quality.

5. Compliance and Regulatory Requirements:

  • External issues include legal and regulatory requirements that may impact the organization’s products and services.
  • Aligning the QMS scope with these requirements ensures that the organization meets relevant standards and regulations.

6. Resource Allocation:

  • Internal issues like resource availability and capacity affect the organization’s ability to implement and maintain the QMS.
  • Considering these factors helps allocate resources effectively to support quality initiatives.

7. Continuous Improvement:

  • Analyzing internal issues related to process inefficiencies or gaps helps identify areas for improvement.
  • External issues may highlight emerging trends or customer expectations that can drive innovation and enhancement.

8. Transparent Communication:

  • Addressing external and internal issues demonstrates transparency and accountability to stakeholders.
  • Clearly defining the scope based on these issues helps in effective communication with employees, customers, and regulatory bodies.

9. Tailored Approach:

  • A QMS scope informed by external and internal issues allows the organization to focus on areas that matter most for quality improvement.
  • It prevents unnecessary efforts in areas with limited impact on quality.

Incorporating external and internal issues into the determination of the QMS scope ensures that quality management efforts are well-informed, strategically aligned, and relevant to the organization’s broader context. This approach enhances the organization’s ability to provide products and services that meet customer requirements and regulatory obligations effectively.

3) When determining this scope, the organization shall consider the requirements of relevant interested parties

When determining the scope of the Quality Management System (QMS), considering the requirements of relevant interested parties is essential for several reasons:

1. Meeting Stakeholder Expectations:

  • Interested parties such as customers, regulatory authorities, suppliers, and employees have specific expectations regarding product quality, safety, and compliance.
  • Incorporating these requirements into the QMS scope ensures that the organization’s quality efforts align with stakeholder expectations.

2. Enhancing Customer Satisfaction:

  • Customers are a primary group of interested parties with expectations related to product performance, delivery, and support.
  • Addressing customer requirements within the QMS scope leads to improved customer satisfaction and loyalty.

3. Regulatory Compliance:

  • Regulatory authorities set standards and requirements that organizations must meet.
  • Including regulatory requirements in the QMS scope ensures that the organization remains compliant with legal obligations.

4. Risk Management:

  • Some interested parties might raise concerns about potential risks associated with product safety, data security, or ethical practices.
  • Addressing these concerns in the QMS scope allows the organization to mitigate risks and prevent issues.

5. Reputation and Trust:

  • Meeting the requirements of interested parties, such as industry standards or ethical expectations, contributes to building a positive reputation and trust.
  • A good reputation enhances the organization’s market position and customer trust.

6. Effective Communication:

  • Clearly defining the QMS scope based on interested parties’ requirements enables transparent communication with stakeholders.
  • It shows a commitment to meeting their needs and addressing their concerns.

7. Supplier Relationships:

  • Suppliers are important stakeholders with expectations regarding quality, delivery, and collaboration.
  • Considering supplier requirements in the QMS scope fosters effective supplier relationships and a reliable supply chain.

8. Employee Engagement:

  • Employees are internal stakeholders with expectations related to working conditions, training, and opportunities for improvement.
  • Addressing employee requirements in the QMS scope contributes to a positive workplace culture and higher engagement.

9. Continuous Improvement:

  • Feedback from interested parties can highlight areas for improvement in processes, products, or services.
  • Incorporating these improvement areas in the QMS scope promotes ongoing enhancement.

10. Holistic Quality Approach: – Including requirements from a range of interested parties ensures a comprehensive quality approach that considers diverse perspectives.

11. Legal and Ethical Considerations: – Some interested parties, such as industry associations or ethical advocacy groups, may have specific requirements related to sustainability, social responsibility, or ethical practices. – Adhering to these requirements demonstrates the organization’s commitment to ethical behavior.

Incorporating the requirements of relevant interested parties into the QMS scope helps the organization create a holistic and customer-centric quality management approach. It ensures that the QMS focuses on areas that matter most to stakeholders, resulting in improved product quality, customer satisfaction, and overall organizational success.

4) When determining this scope, the organization shall consider the products and services of the organization

Considering the products and services of the organization is crucial when determining the scope of the Quality Management System (QMS). The scope should reflect the organization’s focus on delivering high-quality products and services that meet customer requirements and align with its strategic objectives. Here’s why the organization should consider its products and services when defining the QMS scope:

1. Alignment with Core Business Activities:

  • The primary purpose of the organization is to design, produce, and deliver products or services to customers.
  • The QMS scope should encompass all processes and activities directly related to the creation, delivery, and support of these offerings.

2. Customer Requirements:

  • The organization’s products and services must meet customer expectations and specifications.
  • The QMS scope should include processes that ensure consistent adherence to these customer requirements.

3. Product and Service Quality:

  • Ensuring the quality of products and services is at the heart of the QMS.
  • The scope should cover all aspects of quality control, assurance, and improvement throughout the product or service lifecycle.

4. Regulatory Compliance:

  • Products and services often need to adhere to industry-specific regulations and standards.
  • Including these compliance requirements in the QMS scope ensures that the organization meets legal and regulatory obligations.

5. Continuous Improvement:

  • A well-defined QMS scope supports the organization’s commitment to continuous improvement in product design, production, and customer satisfaction.

6. Risk Management:

  • The QMS should address risks related to the development, production, and delivery of products and services.
  • Risk mitigation strategies should be included within the scope to ensure product safety and customer satisfaction.

7. Supply Chain Considerations:

  • The scope should include processes that manage suppliers and their impact on the quality of inputs used in products or services.

8. Customer Experience:

  • The scope should cover processes related to customer interactions, feedback, and support.
  • This ensures a positive customer experience throughout the product or service lifecycle.

9. Strategic Focus:

  • Products and services are integral to the organization’s strategic goals and objectives.
  • The QMS scope should be aligned with these strategic priorities to drive growth and competitiveness.

10. Brand Reputation: – The quality of products and services directly influences the organization’s brand reputation. – The QMS scope should encompass processes that contribute to maintaining and enhancing the brand’s image.

11. Resource Allocation: – Focusing on products and services in the QMS scope allows the organization to allocate resources effectively to areas that impact customer satisfaction.In summary, the products and services offered by the organization form the core of its business activities.

Defining the QMS scope to include these offerings ensures that quality efforts are centered on meeting customer requirements, delivering compliant products and services, and driving continuous improvement. This approach helps the organization achieve its quality objectives and maintain a competitive edge in the market.

5) The organization must provide justification for any requirement of 9001:2015 Standard that the organization determines is not applicable to the scope of its quality management system.

When defining the scope of the Quality Management System (QMS), the organization needs to provide justification for any requirement of the ISO 9001 Standard that it determines is not applicable to the scope of its QMS. This requirement ensures transparency, accountability, and a clear understanding of the organization’s decisions regarding the applicability of certain ISO 9001 requirements. Here’s why this justification is necessary:

  1. Clarity and Transparency: Providing justifications for exclusions ensures that stakeholders, including customers, employees, and auditors, understand why certain ISO 9001 requirements have not been included in the QMS scope.
  2. Regulatory Compliance: If the organization excludes a requirement due to its inapplicability, the justification ensures that there’s a legitimate reason for this decision and that no regulatory obligations are overlooked.
  3. Accountability to Stakeholders: By offering clear explanations for exclusions, the organization demonstrates its accountability to stakeholders, particularly those who may have concerns about omitted requirements.
  4. Preventing Misinterpretation: Justifications prevent any misinterpretation or miscommunication regarding the organization’s intention to exclude certain requirements from the QMS scope.
  5. Preventing Inconsistencies: Providing clear justifications helps prevent inconsistencies between the organization’s QMS scope and the expectations of interested parties.
  6. Audit and Certification: During audits or certification assessments, auditors will examine the organization’s justifications to ensure they are valid and aligned with the ISO 9001 requirements.
  7. Process Improvement: Evaluating and justifying exclusions encourages the organization to critically assess its processes and align the QMS with its business needs.
  8. Documentation of Decision-Making: Justifications provide documented evidence of the organization’s decision-making process, adding a layer of formality and thoroughness to the QMS establishment.
  9. Organizational Context: Justifications may relate to the organization’s unique context, such as its industry, size, and complexity. Explaining these contextual factors helps stakeholders understand the reasoning.
  10. Avoiding Misrepresentation: – By explaining why certain ISO 9001 requirements are not applicable, the organization avoids misrepresenting its adherence to those requirements when they don’t apply.

Incorporating clear justifications for exclusions aligns with the principle of “Applicability” within ISO 9001 and ensures that the QMS scope accurately reflects the organization’s processes, products, and services. This approach supports effective communication and transparency, and it ensures that the organization’s QMS remains focused on areas that are relevant and impactful for quality management.

6) The organization shall apply all the requirements of 9001:2015 Standard if they are applicable within the determined scope of its quality management system.

This clause emphasizes that an organization should apply all the requirements outlined in the standard if they are applicable within the determined scope of its Quality Management System (QMS). This means that whenever a requirement is relevant to the organization’s operations and aligns with the QMS scope, the organization should fully implement and comply with that requirement. Here’s why adhering to applicable requirements is important:

  1. Consistency and Uniformity: Applying all applicable ISO 9001 requirements ensures consistency and uniformity in the organization’s quality management practices.
  2. Meeting Stakeholder Expectations: Stakeholders, including customers and regulatory authorities, expect the organization to follow industry standards and requirements.
  3. Quality Assurance: Implementing all applicable requirements contributes to a robust QMS that focuses on quality assurance and meeting customer needs.
  4. Risk Management: The ISO 9001 requirements include provisions for risk-based thinking. By adhering to these requirements, the organization can effectively identify and mitigate risks that could impact product quality and customer satisfaction.
  5. Demonstrating Compliance: Following applicable ISO 9001 requirements demonstrates the organization’s commitment to quality and its willingness to comply with internationally recognized standards.
  6. Enhanced Competitiveness: Organizations that fully implement ISO 9001 requirements are often seen as more reliable, consistent, and credible in the eyes of customers and partners.
  7. Continuous Improvement: ISO 9001 requirements provide a framework for continuous improvement. Applying these requirements helps the organization identify areas for enhancement and innovation.
  8. Audits and Assessments: During internal audits and external assessments, the organization’s adherence to applicable ISO 9001 requirements will be evaluated.
  9. Risk Mitigation: ISO 9001 requirements cover various aspects of risk management, including risk identification, analysis, and mitigation. By implementing these requirements, the organization enhances its ability to prevent quality-related risks.
  10. Legal and Regulatory Compliance: – Some ISO 9001 requirements relate to legal and regulatory compliance. – Adhering to these requirements helps the organization stay compliant with relevant laws and regulations.
  11. Improved Customer Satisfaction: – Applying ISO 9001 requirements ensures that the organization focuses on processes that directly impact customer satisfaction and product quality.

In summary, the organization’s commitment to implementing applicable ISO 9001:2015 requirements within the determined scope of the QMS demonstrates a dedication to quality, customer satisfaction, and continuous improvement. This approach aligns with the standard’s principles and helps the organization create a strong foundation for effective quality management practices.

7) The scope of the organization’s quality management system shall be available and be maintained as documented information.

The scope of the organization’s Quality Management System (QMS) must be documented and available as “documented information.” This documentation ensures clarity, transparency, and consistency in communicating the boundaries and applicability of the QMS.

  • Documenting the QMS scope allows for clear communication within the organization, ensuring that all employees understand the extent of the QMS.
  • Having the scope as documented information ensures that there’s a consistent and agreed-upon understanding of the organization’s QMS boundaries.
  • Making the scope available as documented information promotes transparency among stakeholders, including customers, suppliers, and auditors.
  • Auditors and certification bodies can review the documented scope to verify that it aligns with the organization’s practices and compliance with ISO 9001.
  • A documented scope provides a reference point for the organization to ensure that all relevant processes are within the QMS.
  • A well-documented scope helps the organization align its QMS with its strategic goals and objectives.
  • Management can use the documented scope to make informed decisions about the QMS and its alignment with the organization’s context.
  • If the scope needs to be revised due to organizational changes or shifts in strategy, having it documented makes updates more systematic.
  • The documented scope serves as a training and awareness tool for new employees, ensuring they understand the organization’s quality boundaries.
  • Customers and other external stakeholders can reference the documented scope to understand the organization’s commitment to quality.
  • The requirement for documenting the scope is in line with ISO 9001’s emphasis on documented information to support the QMS.
  • The documented scope can be used as a reference point to identify areas for improvement and expansion of the QMS in the future.

In summary, maintaining the scope of the organization’s QMS as documented information is a crucial practice that supports effective communication, compliance, decision-making, and transparency. It ensures that the QMS scope remains accurate, aligned with organizational context, and supportive of the organization’s quality objectives.

8) Conformity to 9001:2015 Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

an organization can claim conformity to the standard even if certain requirements are determined to be not applicable within the scope of its Quality Management System (QMS). However, there’s an important condition attached to this claim. The requirements that are determined as not applicable should not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. In other words, the exclusion of certain requirements should not compromise the organization’s commitment to quality and customer satisfaction. Here’s why this condition is significant:

1. Ensuring Quality Assurance:

  • The primary goal of the ISO 9001 standard is to ensure consistent quality and customer satisfaction.
  • The condition prevents organizations from excluding requirements that are crucial for maintaining product quality and customer trust.

2. Accountability to Customers:

  • Organizations must demonstrate that their products and services conform to customer requirements.
  • Excluding requirements that impact product quality or customer satisfaction could erode trust and credibility.

3. Balancing Customization and Standardization:

  • Organizations often need to tailor their QMS to their unique context.
  • However, this customization should not compromise adherence to essential quality requirements.

4. Meeting Legal and Regulatory Obligations:

  • Some requirements within the ISO 9001 standard are related to legal and regulatory compliance.
  • Excluding these requirements could lead to non-compliance and legal risks.

5. Upholding Customer Expectations:

  • Customers expect organizations to follow industry standards and deliver products and services that meet their needs.
  • Excluding requirements that impact quality could result in dissatisfied customers.

6. Holistic Quality Approach:

  • The condition encourages organizations to take a comprehensive approach to quality management that addresses all aspects of customer satisfaction.

7. Maintaining a Competitive Edge:

  • Organizations that consistently meet customer requirements and deliver high-quality products and services often have a competitive advantage.

8. Building and Sustaining Reputation:

  • The organization’s reputation is built on its ability to consistently provide quality products and services.
  • Excluding critical requirements could damage this reputation.

In summary, while the ISO 9001 standard allows for the exclusion of certain requirements under specific circumstances, it’s important to ensure that such exclusions do not compromise the organization’s commitment to quality and customer satisfaction. The condition helps strike a balance between customization and adherence to essential quality requirements, ultimately contributing to the organization’s success in delivering value to its customers and stakeholders.

Documented Information Requirement

The scope of the Quality Management System (QMS) should be documented in a clear and concise manner to ensure that all relevant stakeholders understand the boundaries and applicability of the QMS. Here’s a step-by-step guide on how to document the scope of the QMS:

  1. Scope Statement: Start by preparing a scope statement that provides a brief and accurate description of the scope of the QMS. This statement should outline the key products, services, processes, and activities that fall within the scope.
  2. Inclusions and Exclusions: Clearly specify what is included and excluded from the QMS scope. This can help manage expectations and prevent misunderstandings.
  3. Applicability Criteria: Describe the criteria used to determine whether a particular process or activity is within the QMS scope. This could include factors like relevance to product quality, customer requirements, regulatory compliance, etc.
  4. Industry Context: Provide a brief overview of the industry or sector in which the organization operates. This context helps stakeholders understand the external environment that influences the QMS scope.
  5. Organizational Context: Describe the organization’s structure, size, locations, and any relevant internal factors that impact the QMS scope. This provides a clear picture of the internal context.
  6. Stakeholder Considerations: Mention how the requirements of relevant interested parties have been considered in defining the QMS scope. This shows alignment with stakeholder expectations.
  7. Product and Service Description: Briefly describe the main products and services offered by the organization that are covered by the QMS scope. This helps stakeholders understand the organization’s core activities.
  8. Regulatory and Legal Considerations: Mention any relevant regulations, standards, or legal requirements that influence the QMS scope. This demonstrates a commitment to compliance.
  9. Process Overview: Provide a high-level overview of the key processes that are within the QMS scope. This helps stakeholders understand how the organization operates.
  10. Leadership Approval: – Include a section indicating that the QMS scope has been reviewed and approved by organizational leadership.
  11. Document Control: – Clearly indicate the version number, date, and any revision history associated with the scope document.
  12. Distribution and Access: – Specify how the scope document will be distributed and accessed within the organization. This ensures that relevant parties can easily refer to it.
  13. Document Format: – The scope document can be prepared in various formats, such as a formal document, presentation, or infographic, depending on the organization’s communication preferences.
  14. Regular Review: – Mention that the QMS scope will be periodically reviewed and updated as needed to ensure its accuracy and alignment with organizational changes.
  15. Document Signatures (if applicable): – If required by organizational policies, include signatures of authorized personnel to validate the document.The scope document should be easily understandable and accessible to all relevant stakeholders, both internal and external. It serves as a foundational document that guides the organization’s quality management efforts and ensures alignment with the organization’s strategic direction, customer expectations, and regulatory requirements.

Example of Scope of QMS

Here’s an example of a scope statement for a Quality Management System (QMS) based on a fictional manufacturing company that produces electronic devices:

Scope of Quality Management System (QMS) – ABC ElectronicsABC Electronics is committed to delivering high-quality electronic devices to our customers. Our QMS encompasses all processes and activities related to the design, production, and distribution of our electronic devices. This scope covers our main product lines, which include smartphones, tablets, and smart home devices.

Inclusions:

  • Design and development of electronic devices
  • Procurement of components and materials
  • Manufacturing and assembly processes
  • Quality control and testing of finished products
  • Packaging and labeling of products
  • Distribution and delivery to customers
  • Customer support and service related to our products

Exclusions:

  • Internal administrative processes unrelated to product quality
  • Activities related to subsidiaries not engaged in electronics manufacturing
  • Services provided by third-party vendors not directly related to our products

Applicability Criteria: Our QMS scope applies to all electronic devices manufactured at our main facility. The scope is determined based on the importance of the processes to product quality, customer satisfaction, and regulatory compliance.

Industry Context: ABC Electronics operates in the consumer electronics industry, which is characterized by rapid technological advancements and evolving customer preferences.

Organizational Context: Our organization comprises a single manufacturing facility with a workforce of approximately 500 employees. We are focused on producing innovative and reliable electronic devices that meet customer needs.

Stakeholder Considerations: The requirements of our customers, regulatory authorities, and industry standards have been considered when defining our QMS scope. We are committed to meeting customer expectations and delivering products that comply with relevant regulations.

Regulatory and Legal Considerations: Our QMS aligns with ISO 9001:2015 standards and relevant industry regulations. Compliance with these standards is essential for maintaining product quality and customer trust.

Process Overview: Our key processes include product design, component procurement, assembly, testing, and distribution. Each process is designed to ensure product quality, safety, and performance.

Leadership Approval: This scope document has been reviewed and approved by [Name], [Title], on [Date].

Document Control: Version: 1.0 Date: [Date]

Distribution and Access: This document is accessible to all employees through our document management system.

Regular Review: This scope will be reviewed annually and updated as needed to ensure its accuracy and alignment with organizational changes.

[Signature]

[Name]

[Title]

[Date]

Please note that this example is fictional and meant for illustrative purposes. The actual scope statement should be tailored to reflect the unique characteristics and context of your organization.

ISO 9001:2015 Clause 4.2 Understanding the needs and expectations of interested parties

The ISO 9001:2015 Requirements

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their relevant requirements.

1) Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine the interested parties that are relevant to the quality management system;

Stakeholder’s effect or potential effect on the organization’s ability to consistently provide products and services that meet Customer Requirement requirements

Stakeholders can have a significant effect, both direct and indirect, on an organization’s ability to consistently provide products and services that meet customer requirements. Understanding and engaging with stakeholders is essential for aligning the organization’s efforts with customer expectations and ensuring high-quality products and services. Here’s how stakeholders can influence the organization in this context:

  1. Customers: Customers are primary stakeholders whose needs, preferences, and feedback directly impact the organization’s ability to meet customer requirements. Understanding and fulfilling customer expectations are key to maintaining customer satisfaction and loyalty.
  2. Suppliers and Partners: The performance of suppliers and partners can affect the quality and consistency of inputs used in producing products or delivering services. Reliable suppliers contribute to meeting customer requirements.
  3. Regulatory Authorities: Regulatory bodies often establish quality and safety standards that products and services must meet. Complying with regulatory requirements ensures that the organization’s offerings align with customer expectations and legal obligations.
  4. Shareholders and Investors: Shareholders and investors have an interest in the organization’s financial performance. Meeting customer requirements contributes to positive financial results and shareholder value.
  5. Competitors: Monitoring competitors can help the organization understand market trends and customer preferences. Staying competitive involves delivering products and services that meet or exceed customer expectations.
  6. Media and Public Perception: Positive media coverage about the organization’s products and services can enhance its reputation, attracting more customers. Negative coverage can lead to reputational damage, affecting customer trust.
  7. Government and Society: Adhering to ethical and social norms aligns the organization’s offerings with societal expectations, positively influencing customer perception.
  8. Industry Associations and Standards Bodies: Aligning with industry standards and best practices ensures that the organization’s products and services meet industry norms, which can enhance customer trust.
  9. Local Communities: Organizations often serve local communities. Ensuring that products and services meet local needs and preferences strengthens community relationships.
  10. Employees: Employee satisfaction and engagement influence the quality of customer interactions and the delivery of services. Engaged employees are more likely to provide superior customer service.
  11. Consumer Advocacy Groups: These groups advocate for consumer rights and quality products. Engaging with them and addressing their concerns can improve the organization’s reputation among customers.
  12. Online Reviews and Social Media: Customers share their experiences through online reviews and social media. Positive reviews enhance the organization’s reputation, while negative reviews can lead to customer dissatisfaction.

Considering the effect of stakeholders on the organization’s ability to meet customer requirements involves:

  • Customer Engagement: Actively engage with customers to understand their needs and expectations, gather feedback, and address concerns.
  • Supplier Collaboration: Work closely with suppliers to ensure the consistent quality of inputs used in products and services.
  • Regulatory Compliance: Adhere to relevant regulations and standards to ensure the safety and quality of products and services.
  • Market Research: Monitor market trends, competitors, and consumer preferences to adjust offerings to meet customer demands.
  • Employee Training: Train employees to provide excellent customer service and ensure they understand the importance of meeting customer requirements.
  • Transparency: Communicate openly with stakeholders about the organization’s efforts to meet customer requirements and improve quality.

By effectively managing stakeholder relationships and aligning with their expectations, organizations can enhance their ability to consistently provide products and services that meet customer requirements, resulting in increased customer satisfaction and loyalty.

Stakeholder’s effect or potential effect on the organization’s ability to consistently provide products and services that meet applicable statutory and regulatory requirements

Stakeholders can have a significant effect, both direct and indirect, on an organization’s ability to consistently provide products and services that meet applicable statutory and regulatory requirements. Here’s how stakeholders can influence the organization in this context:

  1. Customers: Customer expectations and requirements often go beyond product features to include compliance with regulations and standards. Meeting customer demands for quality and regulatory compliance is essential for retaining customer trust and loyalty.
  2. Regulatory Authorities: Regulatory bodies set standards and requirements that organizations must adhere to. Non-compliance with these regulations can lead to legal penalties, product recalls, and reputational damage, affecting the organization’s ability to provide compliant products and services.
  3. Suppliers and Partners: The compliance of suppliers and partners with relevant regulations impacts the organization’s own compliance efforts. Non-compliance by suppliers can disrupt the supply chain, affecting the organization’s ability to provide compliant products and services.
  4. Shareholders and Investors: Shareholders and investors are concerned about legal and regulatory risks that could impact the organization’s financial stability. Non-compliance with regulations can lead to financial losses, reducing shareholder value.
  5. Government and Society: Organizations operate within the framework of society’s values and expectations. Demonstrating compliance with regulations and ethical standards ensures that the organization maintains its social license to operate.
  6. Competitors: Competitors that consistently adhere to regulations can set market standards. Failing to meet regulatory requirements may put the organization at a competitive disadvantage and harm its reputation.
  7. Media and Public Perception: Negative media coverage related to regulatory non-compliance can damage the organization’s reputation and erode public trust. Positive media coverage about the organization’s commitment to compliance enhances its image.
  8. Industry Associations and Standards Bodies: Participation in industry associations and adherence to industry standards can signal the organization’s commitment to quality and compliance, positively impacting its reputation and market position.
  9. Local Communities: Demonstrating adherence to environmental regulations and responsible practices can foster goodwill in local communities where the organization operates.
  10. Unions and Labor Organizations: Labor organizations may advocate for safe and compliant working conditions. Non-compliance with labor regulations can lead to labor disputes, affecting operations and product/service delivery.
  11. Legal and Compliance Professionals: Internal or external legal and compliance experts help ensure that the organization’s products and services align with applicable regulations. Their guidance is essential for maintaining compliance.

The potential effects of stakeholders on an organization’s ability to provide products and services that meet applicable statutory and regulatory requirements are multifaceted. Engaging with stakeholders, understanding their concerns, and integrating their input into compliance strategies are crucial to ensure that the organization consistently meets regulatory obligations and maintains its reputation in the market. This holistic approach helps safeguard against legal risks and enhances the organization’s long-term sustainability.

Determining the interested parties that are relevant to the quality management system

Determining the interested parties that are relevant to the Quality Management System (QMS) involves a systematic approach to identify stakeholders who have an interest in the organization’s products, services, and quality-related activities. You should allow time to develop an understanding of your business’s internal and external stakeholder interests that might impact upon your management system’s ability to deliver its intended results, or those that influence your organization’s operational purpose.This information should be gathered, reviewed and regularly monitored through formal channels, such as management review meetings. You can undertake analysis of your stakeholders to determine the relevance of the interested parties and their requirements as they relate to your business activities, and those which impact the management system. In order to determine the relevance of an interested party and their requirements, your organization needs to answer: ‘does this interested party, or their requirements, affect our organization’s ability to achieve the intended outcomes of its management system?’. If the answer is ‘yes’, then the interested parties’ requirements should be captured and considered when planning your management system. There are many ways to capture this information, your approach could include: Information summarised as an input to the quality risk and opportunity registers;

  • Information summarised as an input to the identification of environmental aspect and impact registers;
  • Information summarised as an input to the identification of health & safety hazard and risk registers;
  • Recorded in a simple spreadsheets with version control;
  • Logged and maintained in a database to allow tracking and reporting;
  • Captured, recorded, and disseminated through key meetings.

Here’s a step-by-step guide on how an organization can determine its relevant interested parties:

  1. Identify Internal and External Stakeholders:
    • Start by creating a list of internal stakeholders, including employees, managers, and departments involved in quality processes.
    • Identify external stakeholders, such as customers, suppliers, regulatory authorities, investors, and partners.
  2. Brainstorm Potential Interested Parties:
    • Conduct brainstorming sessions with key employees, managers, and representatives from different departments.
    • Encourage participants to think broadly and consider all parties that might be impacted by or have an interest in the organization’s products and services.
  3. Review Documentation:
    • Examine existing documents, such as contracts, agreements, and customer feedback, to identify parties mentioned or affected by the organization’s quality-related activities.
  4. Analyze Processes and Activities:
    • Evaluate the organization’s processes and activities to identify touchpoints where stakeholders interact or are impacted.
    • Consider each stage of the value chain, from procurement to production, distribution, and customer support.
  5. Segment Stakeholders:
    • Group identified stakeholders based on their relevance to the QMS. Prioritize those who have a direct influence on product quality, regulatory compliance, or customer satisfaction.
  6. Map Stakeholder Interactions:
    • Create a visual map illustrating how each stakeholder interacts with the organization and the QMS.
    • Identify potential positive or negative impacts of these interactions on product quality and customer requirements.
  7. Prioritize and Validate:
    • Prioritize the stakeholders based on their influence and potential impact on the organization’s ability to meet quality requirements.
    • Validate your list with key stakeholders to ensure accuracy and completeness.
  8. Regular Review and Updates:
    • Continuously monitor and review the list of interested parties.
    • Update the list as the organization evolves and new stakeholders emerge.
  9. Feedback and Input:
    • Encourage stakeholders to provide input on the QMS, quality objectives, and improvement initiatives.
    • Collect feedback to ensure that their interests and concerns are considered.
  10. Document the List:
    • Create a document or a register that lists the relevant interested parties, their roles, and their potential impact on the QMS and product quality.
  11. Integrate into the QMS:
    • Incorporate the needs, expectations, and requirements of relevant interested parties into the QMS.
    • Develop strategies to address the concerns and expectations of these stakeholders.

By systematically identifying and understanding the interested parties relevant to the QMS, organizations can better address their needs, maintain compliance, and ensure that quality-related processes align with stakeholder expectations. This approach supports effective stakeholder management and contributes to the success of the QMS and the organization as a whole.

The requirements of interested parties relevant to the Quality Management System

The requirements of interested parties relevant to the Quality Management System (QMS) can vary widely based on the nature of the organization, its industry, and the specific stakeholders involved. Here are some common types of requirements that different interested parties might have in relation to the QMS:

  1. Customers:
    • Product or service quality that meets specifications and expectations.
    • Timely delivery and reliable lead times.
    • Effective and responsive customer service and support.
    • Clear and accurate product information, labeling, and documentation.
  2. Regulatory Authorities:
    • Compliance with relevant laws, regulations, and industry standards.
    • Submission of accurate and timely regulatory documentation and reports.
    • Implementation of safety measures to protect consumers and the environment.
  3. Suppliers and Partners:
    • Consistency in product or service requirements for effective collaboration.
    • Clear communication of expectations, specifications, and delivery schedules.
    • Ethical business practices and adherence to contractual agreements.
  4. Shareholders and Investors:
    • Financial performance that reflects stability and growth.
    • Assurance of risk management and adherence to legal and regulatory requirements.
    • Transparency in reporting quality-related metrics and performance.
  5. Government and Society:
    • Environmental sustainability efforts, waste reduction, and responsible practices.
    • Contribution to the welfare and development of local communities.
    • Adherence to ethical and socially responsible business practices.
  6. Competitors:
    • Adherence to industry norms, standards, and fair competition practices.
    • Respect for intellectual property rights and fair trade practices.
  7. Media and Public Perception:
    • Positive public perception through quality-related achievements and responsible behavior.
    • Transparency in addressing quality-related issues and recalls.
  8. Employees:
    • Safe working conditions and adherence to occupational health and safety standards.
    • Opportunities for skill development and continuous learning.
    • Involvement in decision-making processes related to quality improvement.
  9. Industry Associations and Standards Bodies:
    • Participation and adherence to industry-specific standards and best practices.
    • Contribution to the advancement and improvement of industry quality standards.
  10. Local Communities:
    • Minimization of negative impacts on the local environment.
    • Contribution to local employment and economic development.
  11. Consumer Advocacy Groups:
    • Compliance with consumer protection laws and quality standards.
    • Responsiveness to concerns and issues raised by consumer advocates.

It’s important to note that the requirements of interested parties can evolve over time based on changes in the external environment, industry trends, and stakeholder expectations. Therefore, organizations should establish mechanisms to continuously monitor and assess these requirements, and then integrate them into their QMS processes and strategies. By doing so, organizations can effectively manage stakeholder relationships and enhance their ability to consistently provide products and services that meet a broad range of stakeholder expectations.

2) The organization shall determine the requirements of these interested parties that are relevant to the quality management system.

Determining the requirements of interested parties relevant to the Quality Management System (QMS) involves a thorough process of gathering, analyzing, and prioritizing the expectations, needs, and concerns of these stakeholders. Here’s a structured approach to help organizations determine the requirements of interested parties for their QMS:

  1. Identify Relevant Interested Parties:
    • Refer to the list of interested parties that you’ve identified as relevant to your QMS.
    • Ensure that the list is comprehensive and includes both internal and external stakeholders.
  2. Gather Information:
    • Engage in direct interactions, surveys, interviews, and feedback sessions with the identified interested parties.
    • Review existing contracts, agreements, customer feedback, and communication channels for insights.
  3. Analyze Stakeholder Expectations:
    • Identify the specific expectations, needs, and requirements expressed by each interested party.
    • Categorize the requirements into quality-related aspects, such as product performance, safety, compliance, communication, and support.
  4. Prioritize Requirements:
    • Rank the requirements based on their importance and impact on the QMS, product quality, and customer satisfaction.
    • Consider factors such as legal and regulatory compliance, customer preferences, and potential risks.
  5. Segmentation and Grouping:
    • Group similar requirements from multiple interested parties to identify common themes.
    • This can help streamline efforts in addressing shared concerns and expectations.
  6. Validation and Verification:
    • Share the compiled requirements with the interested parties to ensure accuracy and completeness.
    • Seek their validation and address any feedback or corrections.
  7. Incorporate into the QMS:
    • Integrate the requirements of interested parties into the relevant sections of your QMS documentation.
    • Update quality objectives, policies, and procedures to reflect the organization’s commitment to meeting these requirements.
  8. Develop Action Plans:
    • Create action plans to address each requirement. Assign responsibilities and set timelines for implementation.
    • Consider resource allocation, process adjustments, and communication strategies.
  9. Regular Review and Monitoring:
    • Continuously monitor changes in stakeholder expectations, regulatory requirements, and industry trends.
    • Review the requirements periodically and update the QMS accordingly.
  10. Communication and Transparency:
    • Communicate with interested parties about the organization’s commitment to meeting their requirements.
    • Maintain transparency regarding progress in addressing their expectations.
  11. Continuous Improvement:
    • Use feedback from interested parties to drive continuous improvement initiatives within the QMS.
    • Addressing their requirements can result in enhanced product quality and customer satisfaction.
  12. Feedback Loop:
    • Establish a mechanism for interested parties to provide ongoing feedback on their requirements.
    • This feedback loop helps the organization stay responsive to evolving needs.

By systematically determining and addressing the requirements of interested parties, organizations can enhance their QMS, improve product and service quality, and strengthen relationships with stakeholders. This approach not only supports compliance but also contributes to the organization’s overall success and reputation in the market

c) The organization shall monitor and review information about these interested parties and their relevant requirements.

Monitoring and reviewing information about interested parties and their relevant requirements is a vital aspect of effective Quality Management System (QMS) implementation. This process ensures that the organization remains responsive to stakeholder needs and aligned with their expectations. Here’s how the organization can monitor and review this information:

  1. Establish a Data Collection Process:
    • Designate responsible individuals or teams for collecting and updating information about interested parties.
    • Determine sources for obtaining information, such as customer feedback, surveys, regulatory updates, and industry publications.
  2. Regularly Update Information:
    • Set a schedule for updating information about interested parties and their requirements. This could be quarterly, semi-annually, or annually, depending on the organization’s industry and pace of change.
  3. Use Technology and Tools:
    • Implement customer relationship management (CRM) software, surveys, and feedback forms to gather insights from customers and other stakeholders.
    • Use social media monitoring tools to track public sentiment and concerns.
  4. Engage with Stakeholders:
    • Maintain open channels of communication with stakeholders to stay informed about their changing needs and expectations.
    • Encourage feedback through surveys, focus groups, and direct interactions.
  5. Analyze and Prioritize Requirements:
    • Review collected information to identify common themes and trends among stakeholder requirements.
    • Prioritize requirements based on their impact on the QMS and the organization’s ability to meet customer needs.
  6. Incorporate into QMS Documentation:
    • Document the identified requirements of interested parties in your QMS documentation, such as quality policies, objectives, and procedures.
  7. Regular Review Meetings:
    • Conduct regular meetings involving key stakeholders and relevant departments to discuss and validate requirements.
    • Use these meetings to address emerging issues and concerns.
  8. Monitor Industry Trends:
    • Stay updated on industry trends, market changes, and new regulations that could impact stakeholder expectations.
    • Adjust your QMS strategies accordingly to address these shifts.
  9. Performance Metrics:
    • Establish key performance indicators (KPIs) related to stakeholder satisfaction, compliance, and other relevant aspects.
    • Monitor these KPIs to track the organization’s performance in meeting stakeholder requirements.
  10. Internal Audits and Reviews:
    • Include the review of stakeholder requirements as part of your internal audit and management review processes.
    • Ensure that the QMS remains aligned with these requirements.
  11. Continuous Improvement:
    • Use feedback from stakeholders to identify opportunities for continuous improvement in the QMS.
    • Implement corrective and preventive actions to address any deviations from stakeholder requirements.
  12. Feedback Loop:
    • Establish a feedback loop with stakeholders to provide updates on how their requirements are being addressed.
    • This fosters transparency and builds trust with stakeholders.

By implementing a systematic process for monitoring and reviewing information about interested parties and their relevant requirements, the organization can adapt its QMS to changing stakeholder expectations and enhance its ability to consistently provide products and services that meet stakeholder needs. This approach supports the organization’s commitment to quality and customer satisfaction.

Documented Information Required

There is no requirement of any mandatory documented information, but the following types of documentation would help to evidence this:

  1. Minutes of meetings (from meetings from each group of interested party);
  2. Requirement spreadsheets and databases (CRM & ERM type applications);
  3. External communications and documentation;
  4. Quality manual;
  5. Flow down and capture of requirements relevant to the management system defined in contracts, orders, statements of work, terms of business etc;
  6. Records of meetings where interested parties and their requirements are routinely discussed and monitored.
  7. Stakeholder mapping to determine importance;
  8. Records of surveys, networking, face-to-face meetings, association membership, attending conferences, lobbying, participation in benchmarking.
  9. Customer Feedback and Surveys:
    • Records of customer feedback received through surveys, feedback forms, complaint registers, and customer service interactions.
    • Summaries of customer satisfaction surveys and feedback analysis reports.
  10. Stakeholder Communication Records:
    • Records of communication with stakeholders, including meeting minutes, email correspondence, and notes from feedback sessions.
  11. Customer Complaints and Resolutions:
    • Records of customer complaints, their investigation, resolution process, and the actions taken to address the concerns.
  12. Market Research Reports:
    • Reports from market research activities indicating changing customer preferences, trends, and emerging requirements.
  13. Regulatory Updates and Compliance Reports:
    • Documentation of changes in regulatory requirements, industry standards, and how the organization has adapted to meet them.
  14. Competitor Analysis:
    • Reports on competitive analysis highlighting how competitors are addressing similar stakeholder requirements.
  15. Quality Objectives and KPIs:
    • Documentation of quality objectives related to stakeholder satisfaction, along with performance metrics and KPIs used to monitor and measure progress.
  16. Management Review Records:
    • Documentation of discussions and decisions made during management review meetings regarding stakeholder requirements and their alignment with the QMS.
  17. Stakeholder Engagement Plans:
    • Plans outlining the organization’s strategies for engaging with different stakeholders, including how their requirements will be monitored and addressed.
  18. Internal Audit Reports:
    • Audit reports that evaluate the organization’s adherence to stakeholder requirements and the effectiveness of related processes.
  19. Continuous Improvement Initiatives:
    • Records of improvement projects or initiatives launched as a result of stakeholder feedback and requirements.
  20. Documentation of Changes and Actions Taken:
    • Records of actions taken to address specific stakeholder requirements, including changes made to procedures, policies, and processes.
  21. Feedback Loop Records:
    • Records of communication and feedback provided to stakeholders about how their requirements have been addressed.

It’s important to note that while documentation is essential, the organization should also focus on actively engaging with stakeholders and incorporating their input into the QMS processes. Documentation serves as evidence of the organization’s commitment to meeting stakeholder requirements and continuous improvement. Organizing and maintaining these documents systematically ensures transparency, accountability, and the ability to track changes over time.

ISO 9001:2015 clause 4.1 Understanding the organization and its context

The ISO 9001:2015 Requirements

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

Strategic Direction

“Strategic direction” refers to the actions you are taking to achieve the goals of your organizational strategy. Your strategic direction includes the plans and actions you have put in place to work toward this vision of the future for your company. The strategic direction of the company comes up four times in the ISO 9001:2015 requirements in relation to understanding the organization’s context, ensuring the quality policy & quality objectives are compatible with the strategic direction, verifying that the quality policy supports the strategic direction, and confirming that the management review checks that the QMS is in alignment with the strategic direction. The strategic direction of an organization within the context of a Quality Management System (QMS) refers to the long-term vision, goals, objectives, and plans that guide the organization’s efforts to consistently deliver high-quality products or services while meeting the needs of its stakeholders. “Strategic direction” refers to the actions you are taking to achieve the goals of your organizational strategy. Some companies use a “vision statement” or “mission statement” to define where the company wants to be, but in short, this statement is a way for the company to set the direction that the company wants to go, and define what it wants to be in the future. Your strategic direction includes the plans and actions you have put in place to work toward this vision of the future for your company.This strategic direction is aligned with the organization’s mission and values and is aimed at achieving sustainable success and continuous improvement.In the context of a QMS, the strategic direction typically includes the following elements:

  1. Quality Objectives: These are specific, measurable goals related to quality that the organization aims to achieve. Quality objectives should be aligned with the organization’s overall strategic goals and provide a clear direction for quality improvement efforts.
  2. Customer Focus: The strategic direction of the organization’s QMS should emphasize a strong commitment to understanding and meeting customer requirements and expectations. Customer satisfaction and loyalty are essential components of this focus.
  3. Continuous Improvement: An organization’s strategic direction should highlight its commitment to ongoing improvement in all aspects of its QMS. This can include processes, products, services, and the overall quality culture within the organization.
  4. Risk Management: Addressing risks and opportunities is an important part of strategic planning within a QMS. The organization should identify potential risks that could impact quality and devise strategies to mitigate or manage them.
  5. Resource Allocation: The strategic direction should allocate necessary resources, including personnel, technology, and infrastructure, to support the QMS and its goals effectively.
  6. Compliance and Regulatory Considerations: The organization’s strategic direction should include a commitment to complying with relevant industry standards, regulations, and legal requirements that impact quality and safety.
  7. Innovation: Emphasizing innovation in products, processes, and approaches to quality management can be an essential part of an organization’s strategic direction.
  8. Measurement and Analysis: The strategic direction should emphasize the importance of collecting data, analyzing performance metrics, and making data-driven decisions to support quality improvement efforts.
  9. Leadership and Culture: Effective leadership and fostering a culture of quality are integral to the strategic direction of a QMS. This includes promoting a quality mindset throughout the organization, encouraging employee engagement, and ensuring that quality is a shared responsibility.
  10. Stakeholder Engagement: Recognizing the importance of engaging and communicating with stakeholders, including customers, suppliers, employees, and regulatory bodies, is a key element of the strategic direction.

Ultimately, the strategic direction of an organization’s QMS provides a roadmap for achieving quality-related goals and aligning quality management efforts with the organization’s overall mission and business strategy. It guides decision-making, resource allocation, and continuous improvement efforts in the pursuit of excellence and customer satisfaction.

1) The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

It states that an organization must determine the external and internal issues that are relevant to its purpose and strategic direction, and that may affect its ability to achieve the intended results of its quality management system (QMS). In simpler terms, this clause emphasizes the importance of identifying and understanding the factors both within and outside the organization that could impact its ability to deliver quality products or services. These factors can include:

  1. External Issues: These are conditions, situations, and events that occur outside the organization and might affect its operations. They can include things like market trends, customer expectations, regulatory changes, technological advancements, economic conditions, and competition.
  2. Internal Issues: These are factors within the organization that could influence its ability to achieve quality objectives. They might include organizational culture, resources (such as personnel, facilities, technology), processes, management practices, and financial stability.

By identifying and analyzing these external and internal issues, an organization can better understand its environment, anticipate challenges, and make informed decisions to ensure its QMS is effective in achieving its intended results. This knowledge should be used to develop strategies, set objectives, and make improvements that align with the organization’s quality goals.In essence, the purpose of this requirement is to encourage organizations to take a proactive approach to quality management by understanding the broader context in which they operate.

External issues

In ISO 9001:2015, the standard doesn’t provide an exhaustive list of specific external issues that organizations must determine. Instead, it emphasizes that organizations need to identify the external issues that are relevant to their purpose and strategic direction and that could affect their ability to achieve the intended results of their quality management system (QMS).External issues can vary widely depending on the nature of the organization, its industry, and its operating environment.  External issues might typically be influenced by Cultural, social, political and regulatory; Innovation, technology, industry requirements, market requirements, suppliers and partners; Financial, economic, natural and competitive issues, whether international, national, regional or local; Quality, safety and environmental conditions capable of affecting or being affected by your organization. Sources of information relating to external issues might include:

  1. Reports relating to market environment, economic conditions, new technology, new markets, customer expectations;
  2. Reports relating to supplier intelligence, political considerations, investment opportunities, social factors etc.;
  3. Identification of factors relating to changes in legislation and regulation, including environmental and H&S impact;
  4. Feedback relating to product/service performance and lessons learned;
  5. Register of identified external risks and their treatment.

Some examples of external issues that organizations might consider include:

  1. Market Trends: Understanding shifts in customer preferences, market demand, and industry trends that could impact the organization’s products or services.
  2. Competitive Landscape: Analyzing the actions and strategies of competitors that might affect the organization’s market share or competitive position.
  3. Regulatory Changes: Staying updated on changes in laws, regulations, and industry standards that could influence how the organization operates and delivers its products or services.
  4. Economic Factors: Considering economic conditions such as inflation, interest rates, and currency fluctuations that might impact the organization’s financial stability and customer purchasing power.
  5. Technological Advancements: Monitoring developments in technology that could affect the organization’s processes, products, or services.
  6. Social and Cultural Factors: Recognizing shifts in societal values, cultural norms, and consumer expectations that could influence how the organization interacts with its stakeholders.
  7. Environmental Factors: Identifying environmental concerns and sustainability initiatives that might affect the organization’s operations and reputation.
  8. Political Factors: Considering political stability, government policies, and geopolitical events that could have implications for the organization’s operations and markets.
  9. Supplier and Partner Relationships: Assessing the performance and reliability of suppliers, partners, and collaborators that contribute to the organization’s value chain.
  10. Customer Expectations: Understanding evolving customer needs, preferences, and feedback to ensure that the organization’s products or services remain relevant and competitive.
  11. Demographic Changes: Recognizing shifts in demographics that could impact the organization’s target audience and customer base.

It’s important for each organization to conduct a thorough analysis of its unique external environment to determine which issues are most relevant and could have the greatest impact on its quality management system and overall success. This analysis helps organizations make informed decisions and establish strategies that align with their quality objectives and strategic direction.

Internal issue

In ISO 9001:2015, the standard doesn’t provide a specific list of internal issues that organizations must determine. However, it emphasizes the importance of identifying internal issues that are relevant to the organization’s purpose and strategic direction, and that could affect its ability to achieve the intended results of its quality management system (QMS).Internal issues can vary widely depending on the nature of the organization, its industry, and its internal environment. Internal issues might typically be influenced by Organizational activities; Types of product and service; Strategic direction; Capabilities (people, knowledge, processes, systems); Working practices; Employment practices; Location and conditions; Worker knowledge; Organizational structure; Policy and objectives; Values; Strategy; Competence; Culture; Knowledge; Performance; Quality, safety and environmental conditions capable of affecting or being affected by your organization. Sources of information relating to internal issues might include:

  1. Organizational structure, including the identification of roles and responsibilities and governance arrangements;
  2. External reports showing how well your business is performing;
  3. Statements relating to your organization’s mission, vision and core values;
  4. Emphasis placed upon business ethics and organizational codes of conduct;
  5. Feedback obtained from employees through opinion surveys;
  6. Information management systems and processes for capturing and deploying knowledge and lessons learned;
  7. Organizational capability studies, identification of load/capacity and resource requirements to achieve demand;
  8. Register of identified internal risks and their treatment.

Some examples of internal issues that organizations might consider include:

  1. Organizational Culture: Understanding the values, beliefs, and norms that shape the organization’s culture and how they might impact the organization’s quality management efforts.
  2. Resource Availability: Assessing the availability of human resources, facilities, technology, and other assets needed to support the QMS and deliver quality products or services.
  3. Processes and Workflows: Evaluating the efficiency and effectiveness of internal processes, workflows, and procedures that contribute to the production or delivery of products or services.
  4. Leadership and Management Practices: Examining the leadership and management practices within the organization to ensure they align with the goals of the QMS and promote a culture of quality.
  5. Employee Competence and Training: Assessing the skills, knowledge, and training needs of employees to ensure they are equipped to perform their roles effectively and contribute to quality outcomes.
  6. Communication: Evaluating the effectiveness of communication channels within the organization to ensure that information related to quality is effectively shared among different departments and levels.
  7. Change Management: Considering how changes in the organization, such as organizational restructuring or process changes, could impact the QMS and the ability to maintain quality.
  8. Performance Metrics: Establishing relevant key performance indicators (KPIs) to monitor and measure the performance of the QMS and the organization’s ability to meet quality objectives.
  9. Quality Culture: Assessing the level of commitment to quality across the organization and ensuring that all employees understand and embrace their role in achieving quality objectives.
  10. Risk Management: Identifying potential risks within the organization’s processes, operations, and systems that could negatively impact quality outcomes.
  11. Supplier Relationships: Evaluating the performance of suppliers and subcontractors that contribute to the organization’s products or services and assessing their impact on quality.
  12. Innovation and Improvement: Encouraging a culture of innovation and continuous improvement to drive enhancements in processes, products, and services.

It’s essential for each organization to conduct a thorough internal analysis to determine which issues are most relevant to their QMS and overall business objectives. This analysis helps organizations make informed decisions, allocate resources effectively, and establish strategies that align with their quality goals and strategic direction.

Relevant to the organization’s purpose and strategic direction

Ensuring that the determined external and internal issues are relevant to the organization’s purpose and strategic direction and that affect its ability to achieve the intended result(s) of its quality management system is a critical aspect of aligning the Quality Management System (QMS) with the organization’s overall goals. Here’s how the organization can achieve this:

  1. Strategic Planning: The organization should engage in strategic planning processes that define its long-term vision, mission, and goals. During this process, leaders can identify the key factors, both internal and external, that are critical to achieving the organization’s strategic objectives.
  2. Stakeholder Analysis: Understanding the needs and expectations of stakeholders, including customers, employees, suppliers, and regulatory bodies, can provide insights into the issues that are most relevant to the organization’s purpose and strategic direction.
  3. SWOT Analysis: Conducting a SWOT analysis (Strengths, Weaknesses, Opportunities, Threats) can help the organization identify internal strengths and weaknesses, as well as external opportunities and threats, that align with its strategic direction.
  4. Market Research: Regularly monitoring market trends, customer preferences, and industry developments can help the organization identify external issues that impact its strategic direction.
  5. Risk Assessment: Conducting risk assessments can help identify both internal and external risks that could affect the organization’s ability to achieve its strategic objectives. Risks that align with the organization’s purpose and direction should be prioritized.
  6. Leadership Involvement: The organization’s leadership team should actively participate in the identification and assessment of external and internal issues. Their insights and strategic perspective are valuable in ensuring alignment.
  7. Cross-Functional Collaboration: Collaborating across different departments and functions within the organization can help ensure that a comprehensive range of internal issues are considered and that they align with the overall strategic direction.
  8. Regular Review and Update: The organization should regularly review and update its understanding of external and internal issues. Changes in the business environment, market conditions, and other factors can impact the relevance of these issues over time.
  9. Communication: Effective communication across the organization is key to ensuring that everyone understands the importance of the identified issues and how they relate to the organization’s purpose and strategic direction.
  10. Alignment with Quality Objectives: The identified issues should directly contribute to the establishment of quality objectives. These objectives, in turn, should be aligned with the organization’s strategic direction.
  11. Feedback and Data: Collecting feedback from customers, employees, and other stakeholders and analyzing relevant data can provide insights into whether the identified issues are indeed impacting the organization’s purpose and strategic direction.
  12. Integration into Improvement Initiatives: The issues identified should inform improvement initiatives and projects. This ensures that efforts to address these issues are in line with the organization’s strategic priorities.

By integrating these practices into their quality management approach, organizations can effectively ensure that the determined external and internal issues remain relevant to their purpose and strategic direction. This alignment enhances the organization’s ability to achieve its intended results and continuously improve its quality management efforts.

2) The organization shall monitor and review information about these external and internal issues.

Monitoring and reviewing information about external and internal issues is a crucial ongoing process to ensure that an organization remains informed and responsive to factors that could impact its quality management system (QMS) and its ability to achieve intended results. Here’s how the organization can effectively monitor and review this information:

  1. Designate Responsibility: Assign specific individuals or teams within the organization to be responsible for monitoring and reviewing external and internal issues. This helps ensure accountability for staying updated on relevant information.
  2. Establish Information Sources: Identify key sources of information for both external and internal issues. This might include industry publications, market research reports, customer feedback, regulatory updates, internal performance metrics, and employee insights.
  3. Regular Data Collection:a. External Issues: Set up mechanisms to regularly gather information about external factors. This could involve subscribing to industry newsletters, monitoring news outlets, attending conferences, and engaging with industry associations.b. Internal Issues: Continuously collect data from various departments and stakeholders within the organization. This can include regular check-ins, performance reviews, feedback sessions, and surveys.
  4. Document and Organize: Create a centralized repository to store the collected information. This could be a digital platform, document management system, or a designated physical location for relevant materials.
  5. Scheduled Reviews: Establish a regular schedule for reviewing the collected information. Depending on the nature of the issues and the pace of change in the industry, reviews could be conducted monthly, quarterly, semi-annually, or annually.
  6. Cross-Functional Collaboration: Encourage collaboration between different departments and teams during the review process. This ensures that a diverse range of perspectives is considered when assessing the impact of external and internal issues.
  7. Analysis and Evaluation:a. External Issues: Analyze the collected external information to identify trends, emerging challenges, and opportunities. Consider how these factors could impact the organization’s strategic direction and quality objectives.b. Internal Issues: Evaluate internal data to identify areas where improvements are needed. Look for patterns in performance metrics, employee feedback, and process inefficiencies.
  8. Risk Assessment: For both external and internal issues, assess their potential impact on the organization’s QMS and quality objectives. Prioritize issues based on their severity and likelihood.
  9. Update Documentation: Regularly update the documentation that outlines the identified issues, their impact, and any changes made to address them. This documentation can serve as a reference for decision-making and strategy development.
  10. Continuous Improvement: Use the insights gained from monitoring and reviewing issues to drive continuous improvement initiatives. Develop action plans to address identified issues and capitalize on opportunities.
  11. Communication: Ensure that relevant information about external and internal issues is communicated effectively across the organization. This could involve sharing insights through reports, presentations, meetings, and internal communication channels.
  12. Feedback Loop: Encourage employees to provide feedback and insights based on their observations. Create an environment where employees feel empowered to contribute to discussions about issues that could impact the QMS.

A review of organizational context could include interviews with senior management, questionnaires, surveys and research. Cross-functional input is essential for the specific expertise required to identify the full breadth of issues, such as finance, training, human resources, commercial, engineering and design, etc. Not only will this ensure a broader appreciation of organizational context but also wider engagement, particularly with those functions not previously involved with the management system. You will need to determine and understand the various quality, safety and environmental conditions that could become inputs to internal and external issues, which are typically experienced in your type of organization that can have positive or negative impacts. By implementing a systematic approach to monitoring and reviewing information about external and internal issues, the organization can remain agile, responsive, and proactive in adapting its QMS to changing circumstances. This continuous monitoring and review process supports informed decision-making and contributes to the organization’s overall quality improvement efforts.

3) Issues can include positive and negative factors or conditions for consideration.

External and internal issues for a Quality Management System (QMS) can indeed include both positive and negative factors or conditions. These factors play a crucial role in shaping an organization’s approach to quality management and its ability to achieve its intended results. Here’s how positive and negative factors can be considered for both external and internal issues:

External Issues:

  1. Positive Factors:
    • Emerging market opportunities that align with the organization’s strengths.
    • Positive shifts in customer preferences that could boost demand for the organization’s products or services.
    • Technological advancements that enable more efficient production processes.
    • Favorable regulatory changes that reduce compliance burdens.
  2. Negative Factors:
    • Economic downturns that could lead to reduced consumer spending.
    • Stringent new regulations that could require significant adjustments to operations.
    • Increased competition from new entrants in the market.
    • Adverse weather conditions that affect supply chain operations.

Internal Issues:

  1. Positive Factors:
    • High employee morale and engagement that contribute to a positive quality culture.
    • Efficient and streamlined processes that enhance productivity and reduce waste.
    • Strong leadership commitment to quality improvement initiatives.
    • Well-trained and skilled workforce that consistently delivers quality results.
  2. Negative Factors:
    • Inefficient internal processes that lead to delays and errors.
    • Lack of proper resources, including skilled personnel and technological tools.
    • Inconsistent communication between departments, leading to misunderstandings.
    • Quality control issues that result in defects and customer complaints.

Incorporating both positive and negative factors into the consideration of external and internal issues ensures a balanced view of the organization’s environment and capabilities. It allows the organization to capitalize on strengths and opportunities while also proactively addressing weaknesses and potential threats.When identifying, monitoring, and reviewing these factors, it’s important to approach them with a clear understanding of their potential impact on the organization’s QMS and overall performance. This holistic approach helps the organization make well-informed decisions, set appropriate quality objectives, and take actions that align with its strategic direction.

4) Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.

Understanding the external context is a fundamental step in developing and maintaining an effective Quality Management System (QMS). Considering the various issues arising from legal, technological, competitive, market, cultural, social, and economic environments provides a comprehensive view of the organization’s external landscape. This understanding helps organizations anticipate challenges, identify opportunities, and align their quality management efforts with the broader context. Here’s a breakdown of how each of these factors contributes to understanding the external context:

  1. Legal Environment: Staying aware of relevant laws, regulations, and compliance requirements that impact the organization’s industry and operations. This includes understanding potential changes in regulations that might affect product safety, quality standards, and processes.
  2. Technological Environment: Monitoring technological advancements and innovations that could influence the organization’s processes, products, and services. This can help the organization adopt new technologies to enhance efficiency and maintain competitiveness.
  3. Competitive Environment: Analyzing the competitive landscape to identify strengths and weaknesses of competitors, market trends, and shifts in consumer preferences. This understanding guides the organization in positioning its products or services effectively.
  4. Market Environment: Keeping track of market trends, demand patterns, and customer expectations. This information helps the organization align its offerings with customer needs and preferences.
  5. Cultural and Social Environment: Recognizing shifts in societal values, cultural norms, and social expectations that could impact the organization’s reputation and relationship with stakeholders. This is particularly important for industries with strong consumer-driven brands.
  6. Economic Environment: Understanding economic conditions such as inflation rates, interest rates, and consumer purchasing power. Economic fluctuations can impact customer spending and demand for products or services.
  7. International, National, Regional, or Local Factors: Considering the geographical scope of the organization’s operations and how various external factors might differ based on location. This includes adapting strategies to suit different markets and regulatory environments.

By considering all these aspects, organizations can develop a comprehensive understanding of their external context. This understanding informs decision-making, risk assessment, and the establishment of quality objectives. It also helps organizations proactively respond to changes and challenges, enhancing their ability to achieve the intended results of their QMS while staying aligned with their purpose and strategic direction.

5) Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

Understanding the internal context within a Quality Management System (QMS) is crucial for effective quality management and achieving desired results. Considering issues related to values, culture, knowledge, and performance of the organization provides insights into the organization’s internal environment and helps shape its approach to quality. Here’s how each of these aspects contributes to facilitating understanding of the internal context:

  1. Values:
    • Mission and Vision: Review the organization’s mission and vision statements. These statements often encapsulate the core values and purpose of the organization, providing a foundation for quality-related goals.
    • Ethical Framework: Assess the organization’s ethical principles and values. These values guide decision-making and behavior, including those related to quality and customer satisfaction.
    • Quality Commitment: Examine the extent to which quality is a core value for the organization. A strong commitment to quality can influence organizational behavior and priorities.
  2. Culture:
    • Organizational Culture: Evaluate the prevailing culture within the organization. A culture that promotes collaboration, accountability, and continuous improvement is conducive to effective quality management.
    • Quality Culture: Consider the degree to which a quality-oriented culture is cultivated. A culture that prioritizes quality empowers employees to take ownership of quality-related responsibilities.
  3. Knowledge:
    • Competence and Training: Assess the organization’s approach to employee competence and training. Investing in training ensures that employees have the necessary knowledge and skills to contribute to quality.
    • Knowledge Sharing: Evaluate how knowledge is shared across the organization. Encouraging the sharing of best practices and lessons learned supports continuous improvement.
  4. Performance:
    • Key Performance Indicators (KPIs): Review KPIs related to quality, process efficiency, and customer satisfaction. KPIs provide a measurable way to assess the organization’s performance in line with its quality goals.
    • Process Improvement: Consider the organization’s approach to process improvement. A commitment to identifying and addressing inefficiencies contributes to overall performance and quality.

Facilitating understanding of the internal context using these factors involves several steps:

  • Assessment: Assess the organization’s current state with regards to values, culture, knowledge, and performance. This could involve surveys, interviews, and data analysis.
  • Leadership Involvement: Involve leadership in discussions and decisions related to these factors. Leadership plays a pivotal role in shaping organizational values and culture.
  • Documentation: Document the organization’s values, culture statements, training plans, and performance goals. This documentation serves as a reference point for alignment with the QMS.
  • Regular Review: Continuously review and monitor these internal aspects. As the organization evolves, these factors may change, and regular review ensures that the QMS remains aligned.
  • Communication: Ensure effective communication of the organization’s values, culture, and performance goals. This helps reinforce a consistent understanding throughout the organization.

By considering values, culture, knowledge, and performance, the organization can create a comprehensive picture of its internal context. This understanding forms the basis for setting quality objectives, implementing improvement initiatives, and fostering a culture of quality within the QMS.

Documented Information Required

 There is no requirement for any documented information to defining organizational context, it is helpful to retain the following types of documented information to help justify compliance:

  • Procedure for context of Organization
  • Policy statement(s) regarding your organization’s purpose and strategic direction;
  • Individual strategy documents underpinning your organization’s policies that provide a road map to achieve its goals;
  • Records of meetings where context is routinely discussed and monitored;
  • Structured risk assessments of external and internal issues;
  • Business plans and strategy reviews;
  • Competitor analysis;
  • Economic reports from business sectors or consultant’s reports;
  • SWOT template analysis output;
  • PESTLE template analysis output;
  • Risk and opportunity assessments;
  • Statement contained within a Management System Manual;
  • Minutes of management review meetings (that show decisions and actions relating organizational context);
  • Process maps, tables, spreadsheets, mind mapping diagrams.

AIAG & VDA FMEA For Monitoring And System Response (FMEA-MSR)

In a Supplemental FMEA for Monitoring and System Response, potential Failure Causes which might occur under customer operating conditions are analyzed with respect to their technical effects on the system, vehicle, people, and regulatory compliance. The method considers whether or not Failure Causes or Failure Modes are detected by the system, or Failure Effects are detected by the driver. Customer operation is to be understood as end-user operation or in-service operation and maintenance operations.
FMEA-MSR includes the following elements of risk:

  1. Severity of harm regulatory noncompliance. loss or degraded functionality. and unacceptable quality; represented by (S)
  2. Estimated frequency of a Failure Cause in the context of an operational situation; represented by (F)
  3. Technical possibilities to avoid or limit the Failure Effect via diagnostic detection and automated response, combined with human possibilities to avoid or limit the Failure Effect via sensory perception and physical reaction; represented by (M)

The combination of F and M is an estimate of the probability of occurrence of the Failure Effect due to the Fault (Failure Cause), and resulting malfunctioning behavior (Failure Mode).
NOTE: The overall probability of a Failure Effect to occur may be higher, because different Failure Causes may lead to the same Failure Effect.
FMEA-MSR adds value by assessing risk reduction as a result of monitoring and response. FMEA-MSR evaluates the current state of risk of failure and derives the necessity for additional monitoring by comparison with the conditions for acceptable residual risk.
The analysis can be part of a Design FMEA in which the aspects of Development are supplemented by aspects of Customer Operation. However. it is usually only applied when diagnostic detection is necessary to maintain safety or compliance. Detection in DFMEA Is not the same as Monitoring in Supplemental FMEA- MSR. In DFMEA Detection controls document the ability of testing to demonstrate the fulfillment of requirements in development and validation. For monitoring that is already part of the system design, validation is intended to demonstrate that diagnostic monitoring and system response works as intended. Conversely, Monitoring in FMEA-MSR assesses the effectiveness of fault detection performance in customer operation, assuming that specifications are fulfilled. The Monitoring rating also comprehends the safe performance and reliability of system reactions to monitored faults. It contributes to the assessment of the fulfillment of Safety Goals and may be used for deriving the Safety Concept. Supplemental FMEA-MSR addresses risks that in DFMEA would otherwise be assessed as High, by considering more factors which accurately reflect lower assessed risk according to the diagnostic functions of the vehicle operating system. These additional factors contribute to an improved depiction of risk of failure (including risk of harm, risk of noncompliance, and risk of not fulfilling specifications). FMEA-MSR contributes to the provision of evidence of the ability of the diagnostic, logical, and actuation mechanisms to achieve and maintain a safe or compliant state (in particular, appropriate failure mitigation ability within the maximum fault handling time interval and within the fault tolerant time interval). FMEA—MSR evaluates the current state of risk of failure under and user conditions (not just risk of harm to persons). The detection of faults/failures during customer operation can be used to avoid the original failure effect by switching to a degraded operational state (including disabling the vehicle), informing the driver and/or writing a diagnostic trouble code (DTC) into the control unit for service purposes. In terms of FMEA, the result of RELIABLE diagnostic detection and response is to eliminate (prevent) the original effect and replace it with a new, less severe effect. FMEA—MSR is useful in deciding whether the system design fulfills the performance requirements with respect to safety and compliance. The results may include items such as:

  • additional sensor(s) may be needed for monitoring purposes
  • redundancy in processing may be needed
  • plausibility checks may reveal sensor malfunctions

Step 1: Planning and Preparation

1.1 Purpose

The main objectives of Planning and- Preparation in FMEA-MSR are:

  • Project identification
  • Project plan (lnTent, Timing, Team, Tasks, Tools (5T)
  • Analysis boundaries: What is included and excluded from the analysis
  • Identification of baseline FMEA
  • Basis for the Structure Analysis step

1.2 FMEA-MSR Project Identification and Boundaries

FMEA—MSR project identification includes a clear understanding of what needs to be evaluated. This involves a decision-making process to define the FMEA—MSRs that are needed for a customer program. What to exclude can be just as important as what to include in the analysis. The following may assist the team. in defining FMEA-MSR projects, as applicable:

  • Hazard Analysis and Risk Assessment.
  • Legal Requirements
  • Technical Requirements
  • Customer wants/needs/expectation (external and internal customers)
  • Requirements specification
  • Diagrams (Block/Boundary/System)
  • Schematics, Drawings. and/or 3D Models.
  • Bill of Materials (BOM), Risk Assessment
  • Previous FMEA for similar products

Answers to these questions and others defined by the company help create the list of FMEA-MSR projects needed. The FMEA- MSR project list assures consistent direction, commitment and
focus. Below are some basic questions that help identify FMEA-MSR boundaries:

  1. After completing a DFMEA on an Electrical/Electronic/Prograrnmable Electronic System, are there effects that may be harmful to persons or involve regulatory noncompliance?
  2. Did the DFMEA indicate that all of the causes which lead to harm or noncompliance can be detected by direct sensing. and/or plausibility algorithms?
  3. Did the DFMEA indicate that the intended system response to any and all of the detected causes is to switch to a degraded operational state (including disabling the vehicle]. inform the driver and/or write a Diagnostic Trouble Code (DTC) into the control unit for service purposes?

FMEA for Monitoring and System Response may be used to examine systems which have integrated fault monitoring and response mechanisms during operation. Typically, these are more complex systems composed of sensors. actuators and logical processing units. The diagnosis and monitoring in such systems, may be achieved through hardware and, or software. Systems that may be considered in a Supplemental FMEA for Monitoring and System Response consist in general of at least a sensor, a control unit, and an actuator or a subset of them and are called mechatronic systems. Systems in-scope may also consist of mechanical hardware components (e.g., pneumatic and hydraulics).

Generic-block diagram of an Electrical / Electronic / Programmable Electronic system

The scope of a Supplemental FMEA for Monitoring and System Response may be established in consultation between customer and supplier. Applicable scoping criteria may include, but are not limited to:

  • System Safety relevance
  • ISO Standards, i.e., Safety Goals according to ISO 26262
  • Documentation requirements from legislative bodies e.g., UN/ECE Regulations, FMVSS/CMVSS, NHTSA, and On Board Diagnostic Requirements (OBD) Compliance.

1.3 FMEA-MSR Project Plan

A plan for the execution of the FMEA-MSR should be developed once the FMEA-MSR project is known. It is recommended that the 5T method (Intent, Timing, Team, Tasks. Tool) be used. The plan for the FMEA-MSR helps the company be proactive in starting the FMEA-MSR early. The FMEA-MSR activities (5-step process) should be incorporated into the overall design project plan.

Step 2 : Structure Analysis

2.1 Purpose

The main objectives of Structure Analysis in FMEA—MSR are:

  • Visualization of the analysis scope
  • Structure tree or equivalent: block diagram, boundary diagram, digital model, physical parts
  • Identification of design interfaces, interactions
  • Collaboration between customer and supplier engineering teams (interface responsibilities)
  • Basis for the Function Analysis step

Depending on the scope of analysis, the structure may consist of hardware elements and software elements. Complex structures may be split into several structures (work packages) or different layers of block diagrams and analyzed separately for organizational reasons or to ensure sufficient clarity. The scope of the FMEA—MSR is limited to the elements of the system for which the baseline DFMEA showed that there are causes of failure which can result in hazardous or non-compliant effects. The scope may be expanded to include signals received by the control unit. In order to visualize a system structure, two methods are commonly used:

  • Block (Boundary) Diagrams
  • Structure Trees

2.2 Structure Trees

In a Supplemental FMEA for Monitoring and System Response, the root element of a structure tree can be at vehicle level, i.e. for OEMs which analyze the overall system or at the system level, i.e. for suppliers which analyze a subsystem or component .

Example of a structure tree of a window lift system for investigating erroneous signals, monitoring, and system response

The sensor element and the control unit may also be part of one component (smart sensor). Diagnostics and monitoring in such systems may be realized by hardware and/or software elements.

Example of a structure tree of a smart sensor with an Internal sensing element and output to an interface

In case there is no sensor within the scope of analysis, an Interface Element is used to describe the data/current/voltage received by the ECU. One function of any ECU is to receive signals via a connector. These signals can be missing or erroneous. With no monitoring, you get erroneous output. In case there is no actuator within the scope of analysis, an Interface Element is used to describe the data/current/voltage sent by the ECU. Another function of any ECU is to send signals. i.e. via a connector. These signals can also be missing or erroneous. It can also be “no output” or “failure information.” The causes of erroneous signals may be within a component which is outside the scope of responsibility of the engineer or organization. These erroneous signals may have an effect on the performance of a component which is within the scope of responsibility of the engineer or organization. It is therefore necessary to include such causes in the FMEA-MSR analysis.
NOTE: Ensure that the structure is consistent with the Safety Concept (as applicable).

STRUCTURE ANALYSIS (STEP 2)
1. Next Higher Level2 Focus Element3. Next lower level or characteristic Type
Window Lift SystemECU Window LifterConnector ECU Window Lifter
Example of Structure Analysis in the FMEA-MSR Form Sheet

Step 3 : Function Analysis

The main objectives of Function Analysis in FMEA-MSR are:

  • Visualization of functions and relationships between functions in Function tree/ function net, or equivalent parameter diagram (P—diagram)
  • Cascade of customer (external and internal) functions with associated requirements
  • Association of requirements or characteristics to functions
  • Collaboration between engineering teams (systems, safety, and components)
  • Basis for the Failure Analysis step

In a Supplemental FMEA for Monitoring and System Response, monitoring for failure detection and failure responses are considered as functions. Hardware and software functions may include monitoring of system states. Functions for monitoring and detection of faults/failures may consist of, for example: out of range detection, cyclic redundancy checks, plausibility checks and sequence counter checks. Functions for failure reactions may consist of, for example, provision of default values, switching to a limp home mode, switching off the corresponding function and/or display of a warning. Such functions are modeled for these structural elements that are carriers of these functions, i.e., control units or components with computational abilities like smart sensors. Additionally, sensor signals can be considered which are received by control units. Therefore, functions of signals may be described as well. Finally, functions of actuators can be added, which describe the way the actuator or vehicle reacts on demand. Performance requirements are assumed to be the maintenance of a safe or compliant state. Fulfillment of requirements is assessed through the risk assessment. in case sensors and/or actuators are not within the scope of analysis, functions are assigned to the corresponding interface- elernents (consistent with the Safety Concept-as applicable).

Example of a Structure Tree with functions
FUNCTION ANALYSIS (STEP 3)
1. Next Higher Level Function and Requirement2 Focus Element Function and Requirement3. Next lower level Function and Requirement  or characteristic Type
Provide anti-pinch protection for comfort closing modeProvide signal to stop and reverse window lifter motor in case of pinch situationTransmit signal from Hall effect sensor to ECU
Example of Function Analysis in FMEA-MSR Form Sheet.

Step 4: Failure Analysis

4.1 Purpose

The purpose of Failure Analysis in FMEA-MSR is to-describe the chain of events which lead up to the end effect, in the context of a relevant scenario. The main objectives of Failure Analysis in FMEA-MSR are:

  • Establishment of the failure chain
  • Potential Failure Cause, Monitoring, System Response,Reduced Failure Effect.
  • Identification of product Failure Causes using a parameter diagram or failure network
  • Collaboration between customer and supplier (Failure Effects)
  • Basis for the documentation of failures in the FMEA form sheet and the Risk Analysis step

4.2 Failure Scenario

A Failure Scenario is comprised of a description of relevant operating conditions in which a fault results in malfunctioning behavior and possible sequences of events (system states) that lead to an and system state (Failure Effect). It starts from defined Failure Causes and leads to the Failure Effects.

Theoretical failure chain model DFMEA and FMEA-MSR

The focus of the analysis is a component with diagnostic capabilities, e.g., an ECU. If the component is not capable of detecting the fault/failure, the Failure Mode will occur which leads to the end effect with a corresponding degree of Severity. However, if the component can detect the failure, this leads to a system response with a Failure Effect with a lower Severity compared to the original Failure Effect. Details are described in the following scenarios (1) to (3).

Failure Scenario (1) – Non-Hazardous

Failure Scenario (1) describes the malfunctioning behavior from the occurrence of the fault to the Failure Effect, which in this example is not hazardous but may reach a non-compliant end system state.

Failure Scenario (2) – Hazardous

Failure Scenario (2) describes the malfunctioning behavior from the occurrence of the fault to the Failure Effect, which in this example leads to a hazardous event. As an aspect of the Failure Scenario, it is necessary to estimate the magnitude of the Fault Handling Time Interval (time between the occurrence of the fault, and the occurrence of the hazard/non-compliant Failure Effect). The Fault Handling Time Interval is the maximum time span of malfunctioning behavior before a hazardous event occurs, if the safety mechanisms are not activated.

Failure Scenario (3) – mitigated (Effect)

Failure Scenario (3) describes the malfunctioning behavior from the occurrence of the fault to the mitigated Failure Effect, which in this example leads to a loss or degradation of a function instead of the hazardous event.

4.3 Failure Cause

The description of the Failure Cause is the starting point of the Failure Analysis in a Supplemental FMEA for Monitoring and System Response. The Failure Cause is assumed to have occurred and is not the true Failure Cause (root cause). Typical Failure Causes are electrical/electronic faults (E/E faults). Root causes may be insufficient robustness when exposed to various factors such as the external environment, vehicle dynamics, wear, service, stress cycling, data bus overloading, and erroneous signal states etc. Failure Causes can be derived from the DFMEA, catalogues for failures of E/E components, and network communication data descriptions.

NOTE: In FMEA-MSR, diagnostic monitoring is assumed to function as intended. (However, it may not be effective.) Therefore, Failure Causes of diagnostics are not part of FMEA—MSR but can be added to the DFMEA section of the form sheet. These include Failed to detect fault; Falsely detected fault (nuisance); Unreliable fault response (variation in response capability).

Teams may decide not to include failures of diagnostic monitoring in DFMEA because Occurrence ratings are most often very low (including “latent faults” Ref. ISO 26262). Therefore. this analysis may be of limited value. However, the correct implementation of diagnostic monitoring should be part of the test protocol. Prevention Controls of diagnostics in a DFMEA describe how reliable a mechanism is estimated to detect the Failure Cause and reacts on time with respect to the performance requirements. Detection Controls of diagnostics in a DFMEA would relate back to development tests which verify the correct implementation and the effectiveness of the monitoring mechanism.

4.4 Failure Mode

A Failure Mode is the consequence of the fault (Failure Cause). In FMEA-MSR two possibilities are considered:

  1. In case of failure scenarios (1) and (2) the fault is not detected or the system reaction is too late. Therefore, the Failure Mode in FMEA-MSR is the same as in DFMEA.
  2. Different is failure scenario (3), where the fault is detected and the system response leads to a mitigated Failure Effect. In this case a description for the diagnostic monitoring and system response is added to the analysis. Because the failure chain in this specific possibility consists of a fault/failure and a description of an intended behavior, this is called a hybrid failure chain or hybrid failure network

4.5 Failure Effect

A Failure Effect is defined as the consequence of a Failure Mode. Failure Effects in FMEA-MSR are either a malfunctioning behavior of the system or an intended behavior after detection of a Failure Cause. The end effect may be a “hazard” or “non-compliant state” or, in case of detection and timely system response, a “safe state” or”compliant state” with loss or degradation of a function. The severity of Failure Effects is evaluated on a ten-point scale

FAILURE ANALYSIS (STEP 4)
Failure Effect (FE) to the  Next Higher Level Element and/ or End User2 Failure Mode (FM) of the Focus Element3. Failure Cause (FC) of theNext lower level Element  or characteristic
No anti-pinch protection in comfort closing mode. {Hand or neck may be pinched between window glass and frame]No signal to stop and reverse window lifter motor in case of pinch situationSignal of Hall effect sensor is not transmitted to ECU due to  poor connection of Hail effect Sensor
Example of Failure Analysis In FMEA-HSR Form Sheet.

Step 5: Risk Analysis

5.1 Purpose

The purpose of Risk Analysis in FMEA-MSR is to estimate risk of failure by evaluating Severity, Frequency, and Monitoring. and prioritize the need for actions to reduce risk. The main objectives of the FMEA-MSR Risk Analysis are:

  • Assignment of existing and/or planned controls and rating of failures
  • Assignment of Prevention Controls to the Failure Causes
  • Assignment of Detection Controls to the Failure Causes and/or Failure Modes
  • Rating of Severity, Frequency and Monitoring for each failure chain.
  • Evaluation of Action Priority
  • Collaboration between customer and supplier (Severity).
  • Basis for the Optimization step.

5.2 Evaluations

Each Failure Mode, Cause and Effect relationship (failure chain or hybrid network) is assessed by the following three criteria:

  • Severity (S): represents the Severity of the Failure Effect
  • Frequency (F): represents the Frequency of Occurrence of the Cause in a given operational situation, during the intended service life of the vehicle
  • Monitoring (M): represents the Detection potential of the Diagnostic Monitoring functions (detection of Failure Cause, Failure Mode and/or Failure Effect)

Evaluation numbers from 1 to 10 are used for S, F, and M respectively. where 10 stands for the highest risk contribution. By examining these ratings individually and in combinations of the three factors the need for risk-reducing actions may be prioritized.

5.3 Severity (S)

The Severity rating (S) is a measure associated with the most serious Failure Effect for a given Failure Mode of the function being evaluated and is identical for DFMEA and FMEA-MSR. Severity should be estimated using the criteria in the Severity Table . The table may be augmented to include product- specific examples. The FMEA project team should agree on an evaluation criteria and rating system, which is consistent even if modified for individual design analysis. The Severity evaluations of the Failure Effects should be transferred by the customer to the supplier, as needed.

Product General Evaluation Criteria Severity (S)
Potential Failure Effects rated according to the criteria below.Blank until filled in by user
SEffectSeverity criteriaCorporate or Product Line  Examples
10Very HighAffects safe operation of the vehicle and/or other vehicles, the health of driver or passengers or road users or pedestrians. 
9Noncompliance with regulations. 
8HighLoss of primary vehicle function necessary for normal driving during expected service life. 
7Degradation of primary vehicle function necessary for normal driving during expected service life. 
6ModerateLoss of secondary vehicle function. 
5Degradation of secondary vehicle function. 
4Very objectionable appearance, sound, vibration, harshness, or haptics. 
3LowModerately objectionable appearance, sound, vibration, harshness, or haptics. 
2Slightly objectionable appearance, sound, vibration, harshness, or haptics. 
1Very lowNo discernible effect 
Supplemental FMEA-MSR SEVERITY (S)

5.4 Rationale for Frequency Rating

In a Supplemental FMEA for Monitoring and System Response, the likelihood of a failure to occur in the field under customer operating conditions during service life is relevant. Analysis of end user operation requires assumptions that the manufacturing process is adequately controlled in order to assess the sufficiency of the design. Examples on which a rationale may be. based on:

  • Evaluation based on the results of Design FMEAs
  • Evaluation based on the results of Process FMEAs
  • Field data of returns and rejected parts
  • Customer complaints
  • Customer complaints
  • Warranty databases
  • Data handbooks

The rationale is documented in the column “Rationale for Frequency Rating“ of the FMEA-MSR form sheet.

5.5 Frequency (F)

The Frequency rating (F) is a- measure of the likelihood of occurrence of the cause in relevant operating situations during the intended service life of the vehicle or the system using the criteria in Table below. If the Failure Cause does not always lead to the associated Failure Effect, the rating may be adapted. taking into account the probability of exposure to the relevant operating condition. In such cases the operational situation and the rationale are to be stated in the column “Rationale for Frequency Rating.”
Example: From field data it is known how often a control unit is defective in ppm/year. This may lead to F=3. The system under investigation is a parking system which is used only a very limited
time in comparison to the overall operating time. So harm to persons is only possible when the defect occurs during the parking maneuver. Therefore, Frequency may be lowered to F=2.

Frequency Potential (F) for the Product
Frequency criteria (F) for the estimated occurrence of the Failure Cause in relevant operating situations during the intended service life of the vehicleBlank until filled in by user
FEstimated FrequencyFrequency criteria — FMEA-MSRCorporate or Product Line  Examples
10Extremely High or cannot be determinedFrequency of occurrence of the Failure Cause is unknown or known to be unacceptably high during the intended  service life of the vehicle 
9HighFailure Cause is likely to occur during the intended service  life of the vehicle 
8Failure Cause may occur often in the field during the  intended service life of the vehicle 
7MediumFailure Cause may occur frequently in the field during the intended service life of the vehicle 
6Failure Cause may occur somewhat frequently in the field during the intended service life of the vehicle 
5Failure Cause may occur Occasionally  in the field during the intended service life of the vehicle 
4lowFailure Cause is predicted to occur rarely in the field during the intended service life of the vehicle. At least ten occurrences in the field are predicted. 
3Very LowFailure Cause is predicted to occur in isolated cases in the field during the intended service life of the vehicle. At least one occurrence in the field is predicted. 
2Extreme LowFailure Cause is predicted not to occur in the field during the intended service life of the vehicle based on prevention and detection controls and field experience with similar parts. Isolated cases cannot be ruled out. No proof it will not happen. 
1Cannot occurFailure Cause cannot occur during the intended service life of the vehicle or is virtually eliminated. Evidence that Failure Cause cannot occur. Rationale is documented. 
Percentage of relevant operating condition in comparison to overall operating timeValue by which F may be lowered
< 10%1
< 1%2
supplemental FMEA-MSR FREQUENCY (F)

Note:

  1. Probability increases as number of vehicles are increased
  2. Reference value for estimation is one. million vehicles in a the field

5.6 Current Monitoring Controls

All controls that are planned or already implemented and lead to a detection of the Failure Cause, the Failure Mode or the Failure Effect by the system or by the driver are entered into the “Current Monitoring Controls” column. In addition, the fault reaction after-detection should be described. i.e. provision of default values, (if not already sufficiently described by the Failure Effect). Monitoring evaluates the potential that the Failure Cause, the Failure Mode or the Failure Effect can be detected early enough, so that the initial Failure Effect can be mitigated before a hazard occurs or a non-compliant state is reached. The result is an end state effect with a lower severity.

5.7 Monitoring (M)

The Monitoring rating (M) is a measure of the ability of detecting a fault/failure during customer operation and applying the fault reaction in order to maintain a safe or compliant state. The Monitoring Rating relates to the combined ability of all sensors, logic, and human sensory perception to detect the fault/failure; and react by modifying the vehicle behavior by means of mechanical actuation and physical reaction (controllability). In order to maintain a safe or compliant state of operation, the sequence of fault detection and reaction need to take place before the hazardous or non-compliant effect occurs. The resulting rating describes the ability to maintain a safe or compliant state of operation. Monitoring is a relative rating within the scope of the individual FMEA and is determined without regard. for severity or frequency. Monitoring should be estimated using the criteria in Table below. This table may be augmented with examples of common monitoring. The FMEA project team should agree on an evaluation criteria and rating system which is consistent, even if modified for individual product analysis. The assumption is that Monitoring is implemented and tested as designed. The effectiveness of Monitoring depends on the design of the sensor hardware. sensor redundancy, and diagnostic algorithms that are implemented. Plausibility metrics alone are not considered to be effective. Implementation of monitoring and the verification of effectiveness should be part of the development process and therefore may be analyzed in the corresponding DFMEA of the product. The effectiveness of diagnostic monitoring and response, the fault monitoring response time. and the Fault Tolerant Time Interval need to be determined prior to rating. Determination of the effectiveness of diagnostic monitoring is addressed in detail in ISO 26262-5:2018 Annex D.
In practice. three different monitoring/response cases may be distinguished:

If there is no monitoring control. or if monitoring and response do not occur within the Fault Handling Time Interval, then Monitoring should be rated as Not Effective (M=10).

The original Failure Effect is virtually eliminated. Only the mitigated Failure Effect remains relevant for the risk estimation of the product or system in this instance only. the mitigated FE is
relevant for the Action Priority rating, not the original FE. The assignment of Monitoring Ratings to Failure Causes and their corresponding Monitoring Controls can vary depending on:

  • Variations in the Failure Cause or Failure Mode
  • Variations in the hardware implemented for diagnostic monitoring
  • The execution timing of the safety mechanism. i.e., failure is detected during “power up” only
  • Variations in system response
  • Variations in human perception and reaction
  • Knowledge of implementation and effectiveness from other projects (newness)

Depending on these Variations or execution timing, Monitoring Controls may not be considered to be RELIABLE in the sense of M=1.

The original Failure Effect occurs less often. Most of the failures are detected and the system response leads to a mitigated Failure Effect. The reduced risk is represented by the Monitoring rating. The most serious Failure Effect remains S=10.

Supplemental FMEA for Monitoring and System Response (M)
Monitoring Criteria (M) for Failure Causes, Failure Modes and Failure Effects by Monitoring during Customer Operation. Use the rating number that corresponds with the least effective of either criteria for Monitoring or System ResponseBlank until filled in by user
MEffectiveness of Monitoring Control and system responseDiagnostic Monitoring/ Sensory Perception criteriaSystem Response /Human Reaction CriteriaCorporate or Product Line  Examples
10Not effectiveThe fault/failure cannot be detected at all or not during the Fault Handling Time Interval; by the system, the driver, passenger, or service technician.No response during the Fault Handling Time Interval 
9Very lowThe fault/failure can almost never be detected in relevant operating conditions. Monitoring control with low effectiveness, high variance, or high uncertainty. Minimal diagnostic coverage.The reaction to the fault/failure by the system or the driver may not reliably occur during the Fault Handling Time Interval 
8LowThe fault/failure can be detected in very few relevant operating conditions. Monitoring control with low effectiveness, high variance, or high uncertainty. Diagnostic coverage estimated <60%.The reaction to the fault/failure by the system or the driver may not always occur during the Fault Handling Time Interval 
7Moderately LowLow probability of detecting the fault/failure during the Fault Handling Time Interval by the system or the driver. Monitoring control with low effectiveness, high variance, or high uncertainty. Diagnostic coverage estimated >60%.Low probability of reacting to the detected fault/failure during the Fault Handling Time Interval by the system or the driver 
6ModerateThe fault/failure will be automatically detected by the system or the driver only during power-up, with medium variance in detection time. Diagnostic coverage estimated >90%.The automated system or the driver will be able to react to the detected fault/failure in many operating conditions.     
5The fault/failure will be automatically detected by the system during the Fault Handling Time Interval, with medium variance in detection time or detected by the driver in very many operating conditions. Diagnostic coverage estimated between 90% – 97%.The automated system or the driver will be able to react to the detected fault/failure during the Fault Handling Time Interval in a very many operating conditions 
4Moderately HighThe fault/failure will be automatically detected by the system during the Fault Handling Time Interval, with medium variance in detection time or detected by the driver in most operating conditions. Diagnostic coverage estimated > 97%.The automated system or the driver will be able to react to the detected fault/failure during the Fault Handling Time Interval in a most operating conditions 
3HighThe fault/failure will be automatically detected by the system during the Fault Handling Time Interval, with very low variance in detection time and with high Probability. Diagnostic coverage estimated > 99%.The system will automatically react to the detected fault/failure during the Fault Handling Time Interval in a most operating conditions with very low variance in system response time, and with a high probability. 
2Very HighThe fault/failure will be automatically detected by the system during the Fault Handling Time Interval, with very low variance in detection time and with very high Probability. Diagnostic coverage estimated > 99.9%.The system will automatically react to the detected fault/failure during the Fault Handling Time Interval in a most operating conditions with very low variance in system response time, and with a very high probability. 
1Reliable and acceptable for elimination of original failure effectThe fault/failure will always be automatically detected by the system. Diagnostic coverage estimated to be significantly greater then 99.9%.The system will always automatically react to the detected fault/failure during the Fault Handling Time Interval 
Supplemental F’MEA-MSR- MONITORING (M)

5.8 Action Priority (AP) for FMEA-MSR

The Action Priority is a methodology which allows for the prioritization of the need for action, considering Severity, Frequency, and Monitoring (SFM). This is done by the assignment of SFM ratings which provide a basis for the estimation of risk.

  • Priority High (H): Highest priority for review and action. The team needs to either identify an appropriate action to lower frequency and/or to improve monitoring controls or justify and document why current controls are adequate.
  • Priority Medium (M): Medium priority for review and action. The team should identify appropriate actions to lower frequency and/or to improve monitoring controls, or, at the discretion of the company, justify and document why controls are adequate.
  • Priority Low (L): Low priority for review and action. The team could identify actions to lower
  • frequency and/or to improve monitoring controls.

It is recommended that potential Severity 9-10 failure effects with Action Priority High and Medium, at a minimum, be reviewed by management including any recommended actions that were taken. This is not the prioritization of High, Medium, or Low risk, It. is the prioritization of the need for actions to reduce risk.
Note: it may be helpful to include a statement such as “No further action is needed” in the Remarks field as appropriate.

Auction Priority is based on combinations of Severity, Frequency, and monitoring ratings- in order to prioritize actions for risk reduction.
EffectSPrediction of Failure Cause occurring during service life of vehicleFEffectiveness of MonitoringMAction Priority (AP)
Product or Plant Effect Very high10Medium-Extremely High5-10Reliable – Not effective1-10H
Low4Moderately high – Not effective4-10H
Very high – High2-3H
Reliable1M
Very low3Moderately high – Not effective4-10H
Very high – High2-3M
Reliable1L
Extremely low2Moderately high – Not effective4-10M
Reliable- high1-3L
Cannot occur1Reliable – Not effective1-10L
Product Effect high9Low – Extremely high4-10Reliable – Not effective1-10H
Extremely low –Very low2-3Very High – Not effective2-10H
Reliable- high1-3L
Cannot occur1Reliable – Not effective1-10L
Product Effect Moderately high7-8Medium-Extremely High6-10Reliable – Not effective1-10H
Medium5Moderately high – Not effective5-10H
Reliable- Moderately high1-4M
low4Moderately low – Not effective7-10H
Moderately High- Moderate4-6M
Reliable -High1-3L
Very low3Very low – Not effective9-10H
Moderately low-Low7-8M
Reliable -Moderate1-6L
Extreme Low2Moderately low – Not effective7-10M
Reliable -Moderate1-6L
Cannot occur1Reliable – Not effective1-10L
Product or  Effect Moderately low4-6High-Extremely High7-10Reliable – Not effective1-10H
Medium5-6Moderate – Not effective6-10H
Reliable –Moderately High1-5M
Extremely low- Low2-4Very low – Not effective9-10M
Moderately High- Moderate7-8M
Reliable -Moderate1-6L
Cannot occur1Reliable – Not effective1-10L
Product  Effect low2-3High-Extremely High7-10Reliable – Not effective1-10H
Medium  5-6  Moderately low – Not effective7-10M
Reliable -Moderate1-6L
Extremely low- Low2-4Reliable -Moderate1-6L
Cannot occur1Reliable – Not effective1-10L
Product effect very low1Very low- Very high1-10Reliable – Not effective1-10L
ACTION PRIORITY FOR FMEA-MSR
  • NOTE 1: If M=1, the Severity rating of the Failure Effect after Monitoring and System Response is to be used for determining MSR Action Priority. If M is not equal to 1, then the Severity Rating of the original Failure Effect is to be used for determining MSR Action Priority.
  • NOTE 2: When FMEA—MSR is used. and M=1, then DFMEA Action Prioritization replaces the severity rating of the original Failure Effect with the Severity rating of the mitigated Failure Effect.
Example of FMEA-MSR Risk Analysis – Evaluation of Current Risk Form Sheet

Step 6: Optimization

6.1 Purpose

The primary objective of Optimization in FMEA-MSR is to develop actions that reduce risk and improve safety. In this step, the team reviews the results of the risk analysis and evaluates action priorities. The main objectives of FMEA-MSR Optimization are:

  • Identification of the actions necessary to reduce risks
  • Assignment of responsibilities and target completion dates for action implementation
  • Implementation and documentation of actions taken including confirmation of the effectiveness of the implemented actions and assessment of risk after actions taken.
  • Collaboration between the FMEA team, management, customers, and suppliers regarding potential failures
  • Basis for refinement of the product requirements and prevention/detection controls

High and medium action priorities may indicate a need for technical improvement. Improvements may be achieved by introducing more reliable components which reduce the occurrence potential of the Failure Cause in the field or introduce additional monitoring which improve the detection capabilities of the system. Introduction of monitoring is similar to design change. Frequency of the Failure Cause is not changed. It may also be possible to eliminate the Failure Effect by introducing redundancy. If the team decides that no further actions are necessary. “No further action is needed” is written in the Remarks field to show the risk analysis was completed. The optimization is most effective in the following order:

  • Component design modifications in order to reduce the Frequency (F) of the Failure Cause (FC)
  • Increase the Monitoring (M) ability for the Failure Cause (FC) or Failure Mode (FM).

In the case of design modifications. all impacted design elements are evaluated again.
In the case of concept modifications. all steps of the FMEA are reviewed for the affected sections. This is necessary because, the original analysis is no longer valid since it was based upon a different design concept.

6.2 Assignment of Responsibilities

Each action should have a responsible individual and a Target Completion Date (TCD) associated with it. The responsible person ensures’the action status is updated, if the action is confirmed this person is also responsible for the action implementation. The Actual Completion Date is documented including the date the actions are implemented. Target Completion Dates should be, realistic (i.e., in accordance with the product development plan, Prior to process validation,
prior to start of production).

6.3 Status of the Actions

Suggested levels for Status of: Actions:

  • Open: No Action defined.
  • Decision pending (optional): The action has been defined but has not yet decided on. A decision paper is being created.
  • Implementation pending (optional): The action has been decided on but not yet implemented.
  • Completed: Completed actions have been implemented and their effectiveness has been demonstrated and documented. A final evaluation has been done.
  • Not Implemented: Not Implemented status .is assigned when a decision is made not to implement an action. This may occur when risks related to practical and technical limitations are beyond current capabilities

The FMEA is not considered “complete” until the team assesses each item’s Action Priority and either accepts the level of risk or documents closure of all actions. Closure of all actions should be documented before the FMEA is released at Start of Production (SOP). If “No Action Taken”, then Action Priority is not reduced and the risk of failure is carried forward into the product design.

6.4 Assessment of Action Effectiveness

When an action has been completed, Frequency, and Monitoring values are reassessed, and a new Action Priority may be determined. The new action receives a preliminary Action Priority rating as a prediction of effectiveness. However. the status of the action remains “implementation pending” until the effectiveness has been tested. After the tests are finalized the preliminary rating has to be confirmed or adapted, when indicated. The status of the action is then changed from “implementation pending” to “completed.” The reassessment should be based on the effectiveness of the MSR Preventive and Diagnostic Monitoring Actions taken and the new values are based on the definitions in the FMEA-MSR Frequency and Monitoring rating tables.

6.5 Continuous Improvement

FMEA—MSR serves as an historical record for the design. Therefore. the original Severity. Frequency, and Monitoring (S, F, M) numbers are not modified once actions have been taken. The completed analysis becomes a repository to capture the progression of design decisions and design refinements. However, original S, F, M ratings may be modified for basis, family or generic DFMEAs because the information is used as a starting point for an application-specific analysis.

Example of FMEA-MSR Optimization with new Risk Evaluation Form Sheet

Step 7: Results Documentation

7.1 Purpose

The purpose of the results documentation step is to summarize. and communicate the results of the Failure Mode and Effects Analysis activity. The main objectives of FMEA – MSR Results Documentation are:

  • Communication of results and conclusions of the analysis.
  • Establishment of the content of the documentation
  • Documentation of actions taken including confirmation of the effectiveness of the implemented actions and assessment of risk after actions taken
  • Communication of actions taken to reduce risks.- including within the organization. and with customers and/or suppliers as appropriate
  • Record of risk analysis and reduction to acceptable levels

7.2 FMEA Report

The scope and results of an FMEA should be summarized in a report. The report can be used for communication purposes within a company, or between companies. The report is not meant to replace reviews of the FMEA-MSR details when requested by management, customers, or suppliers. It is meant to be a summary for the FMEA-MSR team and others to confirm completion of each of the tasks and review the results of the analysis. It is important that the content of the documentation fulfills the requirements of the organization, the intended reader. and relevant stakeholders. Details may be agreed upon between the parties. In this way, it is also ensured that all details of the analysis and the intellectual property remain at the developing company. The layout of the document may be company specific. However, the report should indicate the technical risk of failure as a part of the development plan and project milestones. The content may include the following:

  1. A statement of final status compared to original goals established in Project Plan
    • FMEA Intent – Purpose of this FMEA‘?
    • FMEA Timing – FMEA due date?
    • FMEA Team – List of participants?
    • FMEA Task – Scope of this FMEA?
    • FMEA Tool – How do we conduct the analysis Method used?
  2. A summary of- the scope of the analysis and identify what is new.
  3. A summary of how the functions were developed.
  4. A summary of at least the high-risk failures as determined by the team and provide a copy of the specific S/F/M rating tables and method of action prioritization (e.g. Action Priority table).
  5. . A summary of the actions taken and/or planned to address the high-risk failures including status of those actions.
  6. . A plan and commitment of timing for ongoing FMEA improvement actions.
    • Commitment and timing to close open actions.
    • Commitment to review and revise the FMEA-MSR during mass production to ensure the accuracy and completeness of the analysis as compared with the original production design (e.g. revisions triggered from design changes, corrective actions, etc., based on company procedures).
    • Commitment to capture “things gone wrong” in foundation FMEA-MSRs for the benefit of future analysis reuse, when applicable.
Standard FMEA-MSR Farm Sheet
FMEA-MSR Software View

AIAG & VDA Process Failure Mode and Effect Analysis

Step 1 : Planning and Preparation

1.1 Purpose

The purpose of the Process Planning and Preparation Step is to describe what product/ processes are to be included or excluded for review in the PFMEA project. The process takes into account that all processes within the facility can be analyzed or reanalyzed using PFMEA. This process allows an organization to review all processes at a high level and to make a final determination for which processes will be analyzed. The overall advantage of Preparation is to focus resources on processes with the highest priority. The main objectives of the Process Planning and Preparation
Step are:

  • Project identification
  • Project plan: lnTent, Timing, Team, Tasks. Tools (5T)
  • Analysis boundaries: What is included and excluded from the analysis
  • Identification of baseline FMEA with lessons learned
  • Basis for the Structure Analysis step

1.2 PFMEA Project Identification and Boundaries

PFMEA Project identification includes a clear understanding of what needs to be evaluated. This involves a decision-making process to define the PFMEAs that are needed for a customer program. What to exclude can be just as important as what to include in the analysis. Below are some basic questions that help identify PFMEA projects.

  • What is the customer buying from us?
  • Are there new requirements?
  • What specific process/elements cause a risk in imparting the requirement/characteristic?
  • Does the customer or company require a PFMEA?
  • Do we make the product and have design control?
  • Do we buy the product and still have design control?
  • Do we buy the product and do not have design control?
  • Who is responsible for the interface design?
  • Do we need a system, subsystem, component, or other level of analysis?

Answers to these questions and others defined by the company help create the list of DFMEA projects needed. The PFMEA project list assures consistent direction, commitment and focus. The following may assist the team in defining PFMEA boundaries, as available:

Legal requirements

  • Technical requirements
  • Customer wants/needs/expectation (external and internal customers)
  • Requirements specification
  • Diagrams (Block/boundary/System)
  • Schematics, drawings, and/or 3D models
  • Bill of Materials (BOM), Risk Assessment
  • Previous FMEA for similar products
  • Error proofing requirements, Design for Manufacturability and Assembly (DFM/DFA)
  • QFD Quality Function Deployment

Preparation needs to be established at the start of the process to assure consistent direction and focus, e.g., an entire process line, process item / process element. Processes within the plant that can impact the product quality and can be considered for PFMEA analysis include: receiving processes, part and material storage, product and material delivery, manufacturing, assembly, packaging, labeling, completed product transportation, storage, maintenance processes, detection processes and rework and repair processes, etc.

Demonstration of the process for narrowing the Preparation

The following may be considered in defining the scope of the PFMEA as appropriate:

  • Novelty of technology /degree of innovation
  • Quality/Reliability History (In-house. zero mileage, field failures, warranty and policy claims for similar products)
  • Complexity of Design
  • Safety of people and systems
  • Cyber-Physical System (including cybersecurity)
  • Legal Compliance
  • Catalog and standard parts

Items that may assist in determining whether an existing PFMEA should be included in the final scope:

  • New development of products and processes.
  • Changes to products or processes
  • Changes to the operating conditions
  • Changed requirements (laws/regulations, standards/norms, customers, state of the art)
  • Manufacturing experience, 0 km issues, or field issues/Warranty
  • Process failures that may result in hazards
  • Findings due to internal product monitoring
  • Ergonomic issues
  • Continuous Improvement

1.3 PFMEA Project Plan

A plan for the execution of the PFMEA should be developed once the DFMEA project is known. It is recommended that the 5T method (InTent. Timing, Team, Tasks. Tool) be used. The organization also needs to factor in development of the applicable Customer Specific Requirements) (CSRs) methods and/or deliverables into the project plan. The plan for the PFMEA
helps the company be proactive in starting the PFMEA early. The DFMEA activities (5-Step process) should be incorporated into the overall project plan.

1.4 Identification of the Baseline PFMEA

Part of the preparation for conducting the PFMEA is knowing what information is already available that can help the cross-functional team. This includes use of a foundation PFMEA, similar product PFMEA, or product foundation PFMEA. The foundation PFMEA is a specialized foundation process FMEA for products that generally contain common or consistent product boundaries and related functions. For a new product in the foundation, added to this foundation PFMEA would be the new project specific components and functions to complete the new product’s PFMEA. The additions for the new product may be in the foundation PFMEA itself, or in a new document with reference to the original family or foundation PFMEA. If no baseline is available. then the team will develop a new PFMEA.

1.5 Process FMEA Header

During Preparation, the header of the PFMEA document should be filled out. The header may be modified to meet the needs of the organization and includes some of the basic PFMEA Preparation information as follows:

  • Company Name: Name of Company Responsible of PFMEA
  • Manufacturing Location: Geographical Location
  • Customer Name: Name of Customer(s) or Product Family
  • Model Year / Program[s): Customer Application or Company Model /Style .
  • Subject: Name of PFMEA project
  • PFMEA Start Date: Start Date
  • PFMEA Revision Date: Latest Revision Date
  • Cross-Functional Team: Team: Team Roster needed
  • PFMEA ID Number: Determined by Company
  • Process Responsibility: Name of PFMEA owner
  • Confidentiality Level: Business Use, Proprietary, Confidential
Example of Completed PFMEA Header Preparation (Step 1)

Step 2 : Structure Analysis

2.1 Purpose

The purpose of Process Structure Analysis is to identify and breakdown the manufacturing system into Process items, Process steps, and Process Work Elements. The main objectives of a Process Structure Analysis are:

  • Visualization of the analysis scope
  • Structure tree or equivalent: process flow diagram
  • Identification of process steps and sub-steps
  • Collaboration between customer and supplier engineering teams (interface responsibilities)
  • Basis for the Function Analysis step

A Process Flow Diagram or a Structure Tree helps define the process and provide the basis for Structure Analysis. Formats may vary by company including the use of symbols, symbol type and their meaning. A Process FMEA is intended to represent the process flow as it physically exists when “walking the process” describing the flow of the product through the process. Function Analysis (Step 3) should not begin until Structure Analysis {Step 2) is complete.

2.2 Process Flow Diagram

A Process Flow Diagram is a tool that can be used as an input to the Structure Analysis.

Process Flow Diagram

2.3 Structure Tree

The structure tree arranges system elements hierarchically and illustrates the dependency via the structural connections. This pictorial structure, allows for an understanding of the relationships between Process Items, Process Steps and Process Work Elements. Each of these is a building block that will later have functions .and failures added.

Example of Structure Analysis Structure Tree (Electrical Meter Assembly line)

The Process Item of the PFMEA is the highest level of the structure tree or process flow diagram and PFMEA. This can also be considered the end result of all of the successfully completed Process Steps.

Process Item

The Process Step is the focus of the analysis. Process Step. is a manufacturing operation or station.

Process Steps

The Process Work Element is the lowest level of the process flow or structure tree. Each work element is the name of a main category of potential causes that could impact the process step. The number of categories may vary by company. ( e.g., 4M, 5M, 6M. etc. and is commonly called the lshikawa Approach.) A process step may have one or more categories with each analyzed separately.
4M Categories: Machine, Man, Material (Indirect) EnvironMent (Milieu)

Additional Categories could be Method, Measurement

STRUCTURE ANALYSIS (STEP 2)
1. Process Item, System, Subsystem, Part Element or Name of Process2.Process Step Station No. and Name of Focus Elements3.Process Work Element 4M Type
Electrical Motor Assy Line[OP 30] Sintered Bearing Press-In ProcessOperator
Electrical Motor Assy Line[OP 30] Sintered Bearing Press-In ProcessPress Machine
Example of Structure Analysis Form Sheet
  1. Process Item: The highest level of integration within the scope of analysis.
  2. Process Step: The element in focus. This is the item that is topic of consideration of the failure chain.
  3. Process Work Element: The element that is the next level down the structure from the focus element.

2.4 Collaboration between Customer and Supplier engineering teams (interface responsibilities):

The output of the Structure Analysis (visualization of the process flow) provides a tool for collaboration between customers and suppliers (including machine suppliers) during technical reviews-of- the process design and/or PFMEA project.

2.5 Basis for Function Analysis

The information defined during Step 2 Structure Analysis will be used to develop Step 3 Function Analysis. If process elements (operations) are missing from the Structure Analysis they will also
be missing from the Function Analysis.

Step 3 Function Analysis

3.1 Purpose

The purpose of the Process Function Analysis is to ensure that the intended functions/requirements of the product/process are appropriately allocated. The main objectives of a Process Function Analysis are:

  • Visualization of product or process functions
  • Function tree/net or equivalent process flow diagram
  • Association of requirements or characteristics to functions
  • Collaboration between engineering teams (systems, safety, and components)
  • Basis for the Failure Analysis step

3.2 Function

A function describes what the process item or process step is intended to do. There may be more than one function for each process item or process step. Prior to beginning the Function Analysis, information to be gathered could include but is not limited to; product and process functions, product/process requirements. manufacturing environment conditions, cycle time, occupational or operator safety requirements, environmental impact. etc. This information is important in defining the “positive” functions and requirements needed for the Functional Analysis. The description of a Function needs to be clear. The recommended phrase format is to use an action verb followed by a l to describe the measurable process function (“DO THIS“ “TO THIS”). A Function should be in the PRESENT TENSE; it uses the verb‘s base form (e.g., deliver, contain, control, assemble, transfer).

Examples: Drill hole, apply glue, insert pin, weld bracket

The Function of the Process Item begins at a high level and references the Process Item in the Structure Analysis. As a high-level description, it can take into account functions such as: internal function. external function, customer related function and/or end user function.

Example: Assemble components
The Function of the Process Step describes the resulting product features produced at the station.

Example: Press in sintered bearing to pole housing

The Function of the Process Work Element reflects the contribution to the Process Step to create the process / product features.

Note: The negative of these examples will be the Failure Effects.

Example: Get sintered bearing from chute manually

Example: Press force to press sintered bearing into pole housing

For the logical linking of a function and structure, questions are asked as:
“What does it do?”
How to achieve the product 1/ process requirements – from right to left
(Process Item → Process Step → Process Work Element)

“How?”

Why implement the product /process requirements from left to right
(Process Work Element →Process Step →Process Item)

3.3 Requirements (Characteristics)

A Characteristic is a distinguishing feature (or quantifiable attribute) of a product. For example, a diameter or surface finishes. For PFMEA. Requirements are described in terms of Product Characteristics and Process Characteristics.
Note: The negative of these will be the Failure Mode and the Failure Cause.
A Product Characteristic (Requirement) is related to the performance of a process function and can be judged or measured. A product characteristic is shown on a product drawing or specification document e.g., Geometry, Material, Surface Finish, Coatings. etc. Process functions create product characteristics. The design documents comprehend legal requirements (e.g. lead-free material), industry requirements (e.g., thread class), customer requirements (e.g., quantity), and internal requirements (e.g. part cleanliness). Product characteristics can be measured after the product has been made (e.g., gap), Product Characteristics can come from performance requirements, e.g., legal (performance of windshield wipers). In these cases, the measurable Product Characteristic should be listed, followed by the Performance Requirement, e.g., Spline Over-pin Diameter (Government Windshield Wiper Regulation XYZ). The specific quantitative value is optional for the PFMEA form sheet.

  • Product Characteristics: May be derived from various sources, external and internal.
  • Legal requirements: Compliance with designated health & safety-and environmental protection regulations
  • Industry Norms and Standards: ISO 9001, VDA Volume 6 Part 3, Process Audit, SAE J1739
  • Customer Requirements: According to customer specifications, e.g. adherence to
    required quality, manufacture and provision of products in time x and quantity y (output z/hour)
  • Internal Requirements: Manufacture of the product, in process cycle, compliance with expected production costs (e.g.,. facilities availability. limited rejects. no corrective work), production system principles, process quality and cleanliness instructions
  • Process Characteristics: A Process Characteristic is the process control that ensures the Product Characteristic is achieved by the process. It may be shown on manufacturing drawings or specifications (including operator work instructions, set-up instructions, error-proofing verification procedures, etc.). Process characteristics can be measured while the product is being made (e.g., press force). The specific quantitative value is optional for the PFMEA form sheet.
Example of Parameter Diagram of Press in Sintered Bearing

3.4 Visualization of functional relationships

The interaction of process item functions, process step functions and process work element functions may be visualized as function network, function structure, function tree, and/or function analysis depending on the software tool used to perform the PFMEA. For example, Function Analysis is contained in the Form Sheet to perform the PFMEA.

Example of Function Analysis Structure Tree
1. Function of the Process Item Function of System, Subsystem, Part Element or Process2. Function at the Process Step, and Product Characteristic (Quantitative value is optional)3.  Function at the Process Work Element and Process Characteristic
Your Plant: Assembly of shaft into pole housing assembly
Ship to Plant: Assembly of motor to vehicle door
End User: Window raises and lowers
Press in sintered bearing to achieve axial position in pole housing to max gap per printMachine presses sintered bearing into the pole housing seat until the defined axial position
Example of Function Analysis Form Sheet

The column header numbering (1, 2, 3) coding are included to help show alignment between the Structure Analysis and associated content of the Function Analysis. You work from left to right answering the question: “How is the higher level function enabled by lower level functions?”

3.5 Collaboration between Engineering Teams (Systems, Safety, and Components)

Engineering teams within the company need to collaborate to make sure information is consistent fer a project or customer program especially when multiple PFMEA teams are simultaneously conducting the technical risk analysis. For example, design information from systems, safety. and/or component groups helps the PFMEA team understand the functions of the product they manufacture. This collaboration, may be verbal (program meetings) or written as a summary.

3.6 Basis for Failure Analysis

Complete definition of process functions (in positive words) will lead to a comprehensive Step 4 Failure Analysis because the potential failures are ways the functions could fail (in negative words).

Step 4 Failure Analysis

4.1 Purpose

The purpose of the Process Failure Analysis is to identify failure causes, modes, and effects, and show their relationships to enable risk assessment. The main objectives of a Process Failure Analysis are:

  • Establishment of the Failure Chain
  • Potential Failure Effects. Failure Modes. Failure Causes for each process function.
  • Identification of process failure causes using a fishbone diagram (4M) or failure network
  • Collaboration between customer and supplier (Failure Effects)
  • Basis for the documentation of failures in the FMEA form sheet and the Risk Analysis step.

A failure analysis is performed for each element/step in the process description (Structure Analysis/Step 2 and Function Analysis/Step 3}.

4.2 Failures

Failures of a process step are. deduced from product. and process characteristics. Examples include:

  • Non-conformities
  • Inconsistently or partially executed tasks
  • Unintentional activity
  • Unnecessary activity

4.3 The Failure Chain

For a specific failure, there are three-aspects to be considered:
Failure Effect (FE), Failure Mode (FM), Failure Cause (FC)

Theoretical failure chain model

4.4 Failure Effects

Failure Effects are related to functions of the process item (System, Subsystem. Part Element or Name of Process). Failure Effects are described in terms of what the customer might notice or experience. Failures that could impact safety or cause noncompliance to regulations should be clearly identified in the PFMEA. Customers could be:

  • Internal customer (next operation/subsequent operation/operation targets)
  • External customer (Next Tier Level/OEM/dealer)
  • Legislative bodies
  • Product or Product and user/operator .

Failure Effects are given a Severity rating according to:

  1. Your Plant: the effect of the failure mode assuming the| defect is detected in the plant (what action will the plant take, e.g. scrap)
  2. Ship-to plant: the effect of the failure mode assuming the defect is not detected before shipping to the next plant (what action will the next plant take. e.g.. sort)
  3. End user: the effect of the process item effect (what will the end user notice, feel, hear, smell etc., e.g. window raises too slow)

The following questions should be asked to help determine the potential impact of failure effects:

1. Does the failure mode physically impact downstream processing or cause potential harm to equipment or operators? This includes an inability to assemble or join to a mating component at any subsequent customer‘s facility. Iif so, then identify the manufacturing impact “Your Plant“ and/or “ship-to plant“ in the PFMEA. If not, then go to question 2. Examples could include:

  • Unable to assemble at operation at operation x
  • Unable to attach at customer facility
  • Unable to connect at customer facility
  • Cannot bore at operation X
  • Causes excessive tool wear at operation X
  • Damages equipment at operation X
  • Endangers operator at customer facility

Note; When parts cannot be assembled there is no impact to the End User and question 2 does not apply.

2.What is the potential impact on the End User? Independent of any controls planned or implemented including error or mistake-proofing, consider what happens to the process item that leads to what the End User would notice or experience. This information may be available within the DFMEA. If an effect is carried from the DFMEA, the description of the product effects in the PFMEA should be consistent with those in the corresponding DFMEA.
NOTE: In some cases, the team conducting the analysis may not know the end user effect (e.g.. catalogue parts. off- the-shelf products. Tier 3 components). When this information is not known. the effects should be defined in terms of the part function and/or process specification.

Examples could include:

  • Noise
  • High effort
  • Unpleasant odor
  • Intermittent operation
  • Water leak
  • Rough idle
  • Unable to adjust
  • Difficult to control
  • Poor appearance
  • Regulatory System Function reduced or failed
  • End user lack of vehicle control
  • Safety effect on end user

3. What would happen if a failure effect was detected prior to reaching the end user? The failure effect at the current or receiving locations also needs to be considered. Identify the manufacturing impact “Your Plant” and/or “ship-to plant” in the PFMEA.
Examples could include:

  • Line shutdown
  • Stop shipment
  • Yard hold
  • 100% of product scrapped
  • Decreased line speed
  • Added manpower to maintain required line rate
  • Rework and repair

4.5 Failure Mode

A (Process) Failure Mode is defined as the manner in which the process could cause the product not to deliver or provide the intended function. The team should assume that the basic design of the product is correct; however, if there are design issues which result in process concerns. those issues should be communicated to the design team for resolution. Assume that the failure mode could occur but may not necessary occur. Failure modes should be described in technical terms, not as a symptom noticeable by the customer. Verification of completeness of the failure modes can be made through a review of past thing‘s gone wrong, reject or scrap reports, and group brainstorming. Sources for this should also include a comparison of similar processes and a review of customer (end user and subsequent operation) claims relating to similar components. There are several categories of potential failure modes including:

  • Loss of process function/operation not performed
  • Partial function – incomplete operation
  • Degradation of process function
  • Overachieving process function – Too much too high.
  • Intermittent process function – operation not consistent
  • Unstable operation .
  • Unintended process function – wrong operation
  • Wrong part installed
  • Delayed process function – operation too late

Typical failure modes could be, but are not limited to:

  • Hole too shallow, too deep. missing or off location.
  • Dirty surface
  • Surface finish too smooth
  • Misaligned connector pins
  • Connector not fully seated
  • Pass a bad part, or reject a good part, bypass inspection operation
  • Label missing
  • Barcode not readable
  • ECU flashed with wrong software.

4.6 Failure Cause:

A failure cause is an indication of why a failure mode could occur.The consequence of a cause is the failure mode. Identify, to the extent possible, every potential manufacturing or assembly cause for each failure mode. The cause should be listed as concise and complete as possible so that efforts (controls and actions) can be aimed at appropriate causes. Typical failure causes may include the classic lshikawa‘s 4M, but are not limited to:

  • Man: set-up worker, machine operator/ associate, material associate, maintenance technician etc.
  • Machine/Equipment: Robot, hopper reservoir tank. injection molding machine, spiral conveyor, inspection devices, fixtures, etc.
  • Material (Indirect): machining oil, installation grease. washer concentration, (aid for operation), etc.
  • EnvironMent (Milieu): ambient conditions such as heat, dust, contamination, lighting, noise, etc.

Note: In preparing the FMEA. assume that the incoming parts/materials are correct. Exceptions can be made by the FMEA team where historical data indicate deficiencies in incoming part quality.

One method to help reveal/uncover failure causes is to have a facilitator that leads the team through “Thought Provoking Stimulation /Questions.“ These questions can be broad category
questions, enough to stimulate the process experts thought process, while keeping the number of questions to a manageable level. Questions can be process specific and broken down into the
4M categories. Initial list of questions can be formed by reviewing the Failure Causes in previous PFMEA’s.
Example – Assembly Process:

4.6.1 Man

  • From parts available within the process, can wrong part be applied?
  • Can no part be applied?
  • Can the parts be loaded incorrectly?
  • Can parts be damaged – From pickup to application?
  • Can wrong material be used?

4.6.2 Machine

  • Can automated process be interrupted?
  • Can inputted data be entered incorrectly?
  • Can machine be run in manual mode, bypassing automated controls?
  • Is there a schedule to confirm prevention and detection controls?

4.6.3 Material (indirect)

  • Can too much/ too little / no material be used?
  • Can material be applied to a wrong location?

4.6.4- EnvironMent (Milieu)

  • Is lighting adequate for task?
  • Can parts used within the process, be considered foreign material?

The description of the failure. cause needs to be clear. Terms such as “defective, broken.” “operator failure,” “non-fulfillment or “not OK” and so on are insufficient to comprehensively assign the failure cause and mode and to determine actions.

4.7 Failure Analysis

Based on the process steps, the failures are derived and failure chains (i.e., Failure structure/failure trees/failure network) are created from the function analysis. The focus element of the failure structure is the Failure Mode, with its associated Failure Effects and potential Failure Causes. Depending on the focus, a failure can be viewed as a Failure Effect, a Failure Mode, or a Failure Cause. To link failure cause to a Failure Mode, the question should be “Why is the Failure Mode occurring?”
To link failure effects to a Failure Mode, the question should be “What happens in the event of a Failure Mode?“

Example of Failure Analysis Structure Tree
FAILURE ANALYSIS (STEP 4)
1. Failure Effects (FE) to the Next Higher Level Element and/or End User2. Failure Mode (FM) of the Focus Element3. Failure Cause (FC) of the Work Element
Your Plant: Clearance too small to assemble shaft without potential damage
Ship to Plant: Assembly of motor to vehicle door requires additional insertion force with potential damage
End user: Comfort closing time too long.
Axial position of sintered bearing is not reachedMachine stops before reaching final position
Example of Failure Analysis Form Sheet

Begin building the failure chain by using the information in the Function Analysis. When using a customer specific form sheet or software. follow the methodology as defined by your customer.
1.Failure Effects (FE): The effect of failure associated with “Next Higher Level Element and/or End User” in the Function Analysis.
Note for spreadsheet users: A potential failure mode may have more than one failure effect. Failure effects are grouped in the spreadsheet in order to avoid excessive duplication of the same failure modes and causes.

2.Failure Mode (FM): The mode (or type) of failure associated with the “Focus Element” in the Function Analysis.
Note for spreadsheet users: It is recommended that users start with the failure mode and then identify related failure effects using the information in the #1 Function of the Process Item column of the Function Analysis section because some or all categories may apply.

3. Failure Cause (FC): The cause of failure associated with the “Work Element and Process Characteristics in the Function Analysis.

4.8 Relationship between PFMEA and DFMEA

A design failure of a feature (product characteristic) can cause a failure fer one or more product functions. The corresponding process failure is the inability of the process to manufacture the same feature as designed. The failure to conform to a product characteristic alone leads to the Failure Effect. Only in this case is the Failure Effect in the Design FMEA the same as in the Process
FMEA. All Failure Effects which are caused by a failure of the processes and which are not identified in Design FMEA have to be newly defined and assessed in the Process FMEA. The Failure Effects related to the product, system, and/or end user and their associated seventies should be documented when known, but not assumed. The key to the identification of Failure Effects and associated severity is the communication of the involved parties and the understanding of differences and similarities of the analyzed failures in DFMEA and PFMEA. Figure below shows a potential interrelation of product-related Failure Effects, Failure Modes and Failure Causes from the “End User” level to the level of production (PFMEA level).
Note: The expectation of the relative time of and the flow of information from the DFMEA to the PFMEA is different in non-standard development flows, such as where development of a “standard” process precedes development of the products that will be manufactured using it. In such cases, the appropriate timing and flow of information between these FMEAs should be defined by the organization.

Relationship between PFMEA and DFMEA

4.9 Failure Analysis Documentation

After the Structure Analysis, Function Analysis and Failure Analysis are complete a structure tree or spreadsheet can have multiple views.

4.10 Collaboration between Customer and Supplier (Failure Effects)

The output of the Failure Analysis may be reviewed by customers and suppliers prior to the Risk Analysis step or after to the Risk Analysis step based on agreements with the customer and need
for sharing with the supplier.

4.11 Basis for Risk Analysis

Complete definition of potential failures will lead to a complete Step 5 Risk Analysis because the rating of Severity, Occurrence, and Detection are based on the failure descriptions. The Risk Analysis may be incomplete if potential failures are too vague or missing.

Step 5 Risk Analysis

5.1 Purpose:

The purpose of Process Risk Analysis is to estimate risk by evaluating Severity, Occurrence and Detection, in order to prioritize the need for actions. The main objectives of the Process Risk Analysis are:

  • Assignment of existing and/or planned controls and rating of failures
  • Assignment of Prevention Controls to the Failure Causes
  • Assignment of Detection Controls to the Failure Causes and/or Failure Modes
  • Rating of Severity, Occurrence and Detection for each failure chain
  • Evaluation of Action Priority
  • Collaboration between customer and supplier (Severity)
  • Basis for the Optimization step

There are two different Control Groups: Current Prevention Controls, and Current Detection Controls.

5.2 Current Prevention Controls (PC)

5.2.1 Process planning

Definition: Current Prevention Controls facilitate optimal process planning to minimize the possibility of failure occurrence.
Prevention of possible layout deficiencies of the production facility:

  • Test runs according to start-up regulation AV 17/3b

5.2.2 Production process

Definition: Eliminate (prevent) the failure cause or reduce its rate of occurrence.
Prevention of defectively produced parts in the production facility:

  • Two-handed operation of machines
  • Subsequent part cannot be attached (Poke-Yoke)
  • Form-dependent position
  • Equipment maintenance
  • Operator maintenance
  • Work instructions /Visual aids
  • Machine controls
  • First part release

Failure Causes are rated for occurrence, taking into account the effectiveness of the current prevention control. Current Prevention Controls describe measures which should be implemented in the design process and verified during prototype, machine qualifications (run-off), and process verification prior to start of regular production. Prevention Controls may also include standard work instructions, set-up procedures, preventive maintenance, calibration procedures, error-proofing verification procedures, etc.

5.3 Current Detection Controls- (DC)

Definition: Current Detection controls detect the existence of a failure cause or the failure mode, either by automated or manual methods, before the item leaves the process or is shipped to the
customer.

Examples of Current Detection controls:

  • Visual inspection
  • Visual inspection with sample checklist
  • Optical inspection with camera system
  • Optical test with limit sample
  • Attributive test with mandrel
  • Dimensional check with a caliper gauge
  • Random inspection
  • Torque monitoring
  • Press load monitoring
  • End of line function check
Prevention and Detection In the Process FMEA
Road-map of process understanding

5.4 Current Prevention and Detection Controls

Current Prevention and Detection Controls should be confirmed to be implemented and effective. This can be done during an in-station review (e.g. Line Side Review, Line walks and Regular audits). If the control is not effective, additional action may be needed. The Occurrence and Detection ratings should be reviewed when using data from previous processes, due to the possibility of different conditions for the new process.

5.5 Evaluations

Each Failure Mode, Cause and Effect relationship (failure-chain or net) is assessed for its independent risk. There are three rating criteria for the evaluation of risk:

  • Severity (S): stands for the Severity of the Failure Effect
  • Occurrence (O): stands for the Occurrence of the Failure Cause
  • Detection (D): stands for the Detection of the occurred Failure Cause and/or Failure Mode.

Evaluation numbers from 1 to 10 are used for S, O, and D respectively, in which 10 stands for the highest risk contribution.
NOTE: It is not appropriate to compare the ratings of one team’s FMEA with the ratings of another team’s FMEA, even if the product/process appear to be identical, since each team’s environment is unique and thus their respective individual ratings will be unique (i.e., the ratings are subjective)

5.6 Severity (S)

Severity is a rating number associated with the most serious effect for a given failure mode for the process step being evaluated. it is a relative rating within the scope of the individual FMEA and is determined without regard for Occurrence or Detection. Fer process-specific effects, the Severity rating should be determined using the criteria in evaluation Table given. The table may be augmented to include corporate or product line specific examples. The evaluations of the Failure Effects should be mutually agreed to by the customer and the organization.
NOTE: If the customer impacted by a Failure Mode is the next manufacturing or assembly plant or the product user, assessing the severity may lie outside the immediate process engineer’s team’s field of experience or knowledge. In these cases, the Design FMEA, design engineer, and/or subsequent manufacturing or assembly plant process engineer, should be consulted in order to comprehend the propagation of effects.

Process General Evaluation Criteria Severity (S)
Potential Failure Effects rated according to the criteria below.Blank until filled in by user
SEffectImpact to Your PlantImpact to Ship-to Plant  (when known)Impact to End User (when known)Corporate or Product Line  Examples
10Very HighFailure may result In an acute health and/or safety risk for the  manufacturing or assembly workerFailure may result in an acute health and/or  safety risk for the manufacturing or assembly workerAffects safe operation of the vehicles and / or other vehicles, the health of the drivers or passengers or road users or pedestrians. 
9Failure may result in in- plant regulatory noncomplianceFailure may result in in- plant regulatory noncomplianceNoncompliance with regulations 
8High100% of production run affected may have to be scrapped. Failure may result in in-plant regulatory noncompliance or may have a chronic health and/or safety risk for the manufacturing or assembly workerLine shutdown greater than full production shift; stop shipment possible; field repair or replacement required (Assembly to end users) other than regulatory noncompliance or may have a chronic health and/or safety risk for the manufacturing or assembly workerLoss of primary vehicle function necessary for normal driving during expected service life. 
7Product may have to be sorted and a portion (Less than 100%) scrapped; deviation form primary process ; decreased line speed or added manpowerLine shutdown from 1 hour up to full production shift; stop shipment possible; field repair or replacement required (Assembly to End User) other than for regulatory noncomplianceDegradation of primary vehicle function necessary for normal driving during expected service life. 
6Moderate100% of production run may have to be reworked off line and acceptedLine shutdown up to one hourLoss of secondary vehicle function. 
5A portion of the production run may have to be reworked off line and acceptedLess than 100% of product affected; strong possibility for additional defective product: sort required: no line  shutdownDegradation of secondary vehicle function 
4100% of production run may have to be reworked in station before it is processedDefective product triggers significant reaction plan; additional defective products not likely; sort not requiredVery objectionable, appearance, sound, vibration, harshness. Or haptics. 
3LowA portion of production run may have to be reworked in station before it is processedDefective product triggers minor reaction plan; additional defective products not likely; sort not requiredModerately objectionable, appearance, sound, vibration, harshness, or haptics. 
2Slight inconvenience to process operation or operatorDefective product triggers no reaction plan; additional defective products not likely; sort not required; requires feedback to supplierSlightly objectionable, appearance, sound, vibration, harshness, or haptics. 
1Very lowNo discernible effectNo discernible effectNo discernible effect 
PFMEA SEVERITY (s)

5.7 Occurrence (O)

The Occurrence rating (O) describes the occurrence of Failure Cause in the process, taking into account the associated current prevention controls. The occurrence rating number is a relative rating within the scope of the FMEA and may not reflect the actual occurrence. The Occurrence rating describes the potential of the failure cause to occur. according to the rating table. without regard to the detection controls. Expertise or other experiences with comparable processes. for example, can be. considered in the assessment of the rating numbers. In determining this rating, questions such as the following should be considered:

  • What is the equipment history with similar processes and process steps?
  • What is the field experience with similar processes?
  • Is the process a carryover or similar to a previous process?
  • How significant are changes from a current production process?
  • Is the process completely new?
  • What are the environmental changes?
  • Are best practices already implemented?
  • Do standard instructions exist? (e.g.. work instructions. set-up and calibration procedures, preventive maintenance, error-proofing verification procedures, and process monitoring
    verification checklists)
  • Are technical error-proofing solutions implemented? (e.g.,product or process design, fixture and tool design,established process sequence. production control tracking/traceability, machine capability, and SPC charting)
Occurrence Potential (O) for process
Potential Failure Causes rated according to the-criteria below. Consider Prevention Controls when determining the best Occurrence estimate. Occurrence is a predictive qualitative rating made at the time of evaluation and may not reflect the actual occurrence. The occurrence rating number is a relative rating within the scope of the in by FMEA (process being evaluated). For Prevention Controls with multiple Occurrence Ratings, use the rating that best reflects the robustness of the control.Blank until filled in by user
OPrediction of Failure Cause OccurringType of controlsOccurrence criteria – DFMEACorporate or Product Line  Examples
10Extremely HighNoneNo prevention controls 
9Very HighBehaviouralPrevention controls will have little effect in preventing failure cause. 
8 
7HighBehavioural or TechnicalPrevention controls somewhat effective in preventing failure cause. 
6 
5ModeratePrevention controls are effective in preventing failure cause. 
4 
3LowBest practices: Behavioural or TechnicalPrevention controls are highly effective in preventing failure cause. 
2Very low 
1Extremely lowTechnicalPrevention controls are extremely effective in preventing failure cause from occurring due to design (e.g., part geometry) or process (e.g.  fixture or tooling design}. Intent of prevention controls – Failure Mode cannot be physically produced due to the Failure Cause. 
Prevention Control Effectiveness: Consider if prevention controls are technical (rely on machines, tool life, tool material, etc), or use bast practices (fixtures, tool design, calibration procedures, error- proofing verification, preventive maintenance. work instructions, statistical process control charting,  process monitoring, product design, etc.) or behavioural (rely on certified or non-certified operators,  skilled trades, team leaders, etc.) when determining how effective the prevention controls will be.
PFMEA OCCURRENCE (0)

5.8 Detection (D)

Detection is the rating associated with a prediction of the most effective process control from the listed detection-type process controls. Detection is a relative rating, within the scope of the individual FMEA and is determined without regard for Severity or Occurrence. Detection should be estimated using the criteria in Table given. This table may be augmented with examples of
common detection methods used by the company. The intent of the term “control discrepant product” Ranks 3 and 4 is to have controls/systems/procedures in place that controls the discrepant-product in such a manner, that the probability of the product escaping the facility is very low. The controls start from when the product is identified as discrepant to the point of final disposition. These controls usually exceed controls that are used for discrepant products with higher Detection Ranks. After implementation of any unproven control. the effectiveness can be verified and re-evaluated, in determining this estimate, questions such as the following should be considered:

  • Which test is most effective in detecting the Failure Cause or the Failure Mode?
  • What is the usage Profile! Duty Cycle required detecting the failure?
  • What sample size is required to detect the failure?
  • Is the test procedure proven for detecting this Cause-Failure Mode?
Detection Potential (D) for tile Validation of the Process Design
Detection Controls rated according to Detection Method Maturity and Opportunity for Detection.Blank until filled in by user
DAbility to DetectDetection Method MaturityOpportunity for DetectionCorporate or Product Line  Examples
10Very LowNo testing or inspection method has been established or is knownThe failure mode will not or cannot be detected 
9It is unlikely that the testing or inspection method will detect the failure mode.The failure mode is not easily detected through random or sporadic audits. 
8LowTest or inspection method has not been proven to be effective and reliable ( e.g., plant has little or no experience with method, gauge R & R results marginal on comparable process or this application etc.Human inspection (visual, tactile, audible) or use of manual gauging (attribute or variable) that should detect the failure mode or failure cause 
7Machine-based detection (automated or semi-automated with notification by light, buzzer, etc}. or use of inspection equipment such as a coordinate measuring machine that should detect failure mode or failure Cause 
6ModerateTest or inspection Method has been proven to be effective and reliable (e.g. plant has experienced with method; gauge R & R results are acceptable on comparable process or this application, etc.)Human inspection (visual, tactile, audible), or use of manual gauging (attribute or variable) that will detect the failure mode or failure cause (including product sample checks). 
5Machine-based detection (semi-automated with notification by light, buzzer, etc), or use of Inspection equipment such as a coordinate measuring machine that will detect failure mode or failure cause {including product sample checks). 
4HighSystem has been proven to be effective and reliable (e.g. plant has experience with method on identical process or this application), gauge R&R results are acceptable.Machine-based automated detection method that will detect the failure mode downstream, prevent further processing or system will identify the product as discrepant and allow it to automatically move forward in the process until the designated reject unload area. Discrepant product will be controlled by a robust system that will prevent outflow of the product from the facility. 
3Machine-based automated detection method that will detect the failure mode in-station, prevent further processing or system will identify the product as discrepant and allow it to automatically move forward in the process until the designated reject unload area. Discrepant product will be controlled by a robust system that will prevent outflow of the product from the facility. 
2Detection method has been proven to be effective and reliable (e.g. plant has experience with method, error-proofing verifications, etc}.Machine-based detection method that will detect the cause and prevent the failure mode (discrepant part} from being produced. 
1Very HighFailure mode cannot be physically produced as-designed or processed, or detection methods proven to always detect the failure mode or failure cause. 
PFMEA DETECTION (D)

5.9 Action Priority (AP)

Once the team has completed the initial identification of failure modes and effects, causes and controls, including ratings fer severity, occurrence. and detection, they must decide if further efforts are needed to reduce the risk. Due to the inherent limitations on resources, time, technology. and other factors, they must choose how to best prioritize these efforts. It accounts for all 1000 possible combinations of S,O, and D. it was created to give more emphasis on severity first, then occurrence,then detection. This logic follows the failure-prevention intent of FMEA. The AP table offers a suggested high-medium-low priority for action. Companies can use a single system to evaluate action priorities instead of multiple systems required from multiple customers. Risk Priority Numbers are the product of S x O x D and range from 1 to 1000. The RPN distribution can provide some information about the range of ratings, but RPN alone is not an adequate method to determine the need for more actions since RPN gives equal weight to S, O, and D. For this reason, RPN could result in similar risk numbers for very different combinations of S, O, and D leaving the team uncertain about how to prioritize. When using RPN it is recommended to use an additional method to prioritize like RPN results such as S x O. The use of a Risk Priority Number (RPN) threshold is not a recommended practice for determining the need for actions. Risk matrices can represent combinations of S and O, S and D, and O and D. These matrices provide a visual representation of the results of the analysis and can be used as an input to prioritization of actions based on company-established criteria, not included in this publication. Since the AP Table was designed to work with the Severity, Occurrence, and Detection tables provided in this handbook. if the organization chooses to modify the S,O,D. tables for specific products, processes, or projects, the AP table should also be carefully reviewed. Note: Action Priority rating tables are the same for DFMEA and PFMEA, but different for FMEA—MSR.

Priority High (H): Highest priority for review and action. The team needs to either identify an appropriate action to improve prevention and/or detection controls or justify and document why current controls are adequate.

Priority Medium (M): Medium priority for review and action. The team should identify appropriate actions to improve prevention and for detection controls, or, at the discretion of the company, justify and document why controls are adequate.
Priority Low (L): Low priority for review and action. The team could identify actions to improve prevention or detection controls, it is recommended that potential Severity 9-10 failure effects with Action Priority High and Medium, at a minimum, be reviewed by management including any recommended actions that were taken.
This is not the prioritization of High, Medium, or Low risk, it is the prioritization of the need for actions to reduce risk.
Note: It may be helpful to include a statement such as “No further action is needed” in the Remarks field as appropriate.

Action Priority (AP) for DFMEA and PFMEA
Action Priority is based on combinations of Severity, Occurrence, and Detection ratings in order to prioritize actions for risk reduction.Blank until filled in by user
EffectSPrediction of Failure Cause occurringOAbility to detectDAction Priority (AP)Comments
Product or Plant Effect Very high9-10Very high8-10Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1H 
High6-7Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1H 
Moderate4-5Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1M 
Low2-3Low – Very low7-10H 
Moderate5-6M 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
Product or Plant Effect high7-8Very high8-10Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1H 
High6-7Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1M 
Moderate4-5Low – Very low7-10H 
Moderate5-6M 
High2-4M 
Very high1M 
Low2-3Low – Very low7-10M 
Moderate5-6M 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
Product or Plant Effect Moderate4-6Very high8-10Low – Very low7-10H 
Moderate5-6H 
High2-4M 
Very high1M 
High6-7Low – Very low7-10M 
Moderate5-6M 
High2-4M 
Very high1L 
Moderate4-5Low – Very low7-10M 
Moderate5-6L 
High2-4L 
Very high1L 
Low2-3Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
Product or Plant Effect low2-3Very high8-10Low – Very low7-10M 
Moderate5-6M 
High2-4L 
Very high1L 
High6-7Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Moderate4-5Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Low2-3Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
No discemible effect1Very low- Very high1-10Very high – Very low1-10L 
Table AP – ACTION PRIORITY FOR DFMEA and PFMEA
Example of PFMEA with Risk Analysis Form Sheet

5.10 Collaboration between Customer and Supplier (Severity)

The output of the Risk Analysis creates the mutual understanding of technical risk between customers and suppliers. Methods of collaboration range from verbal to formal reports. The amount of information shared is based on the needs of a project, company policy, contractual agreements. and so on. The information shared depends on the placement of the company in the supply chain. Some examples are listed below.

  1. The OEM may compare design functions, failure effects, and severity from a vehicle-level DFMEA with the Tier 1 supplier PFMEA.
  2. The Tier 1 supplier communicates necessary information about product characteristics on product drawings and/or specifications, or other means, including designation of standard or special characteristics and severity. This information is used as an input to the Tier 2 supplier PFMEA as well as the Tier 1‘s internal PFMEA. When the design team communicates the associated risk of making product characteristics out of specification the process team can build in the appropriate level of prevention and detection controls in manufacturing.

5.11 Basis for Optimization

The output of Steps 1, 2, 3, 4, and 5 of the 7-Step FMEA process is used to determine if additional design or testing action is needed. The process reviews, customer reviews, management reviews, and cross-functional team meetings lead to Step 6 Optimization.

Step 6: Optimization.

6.1 Purpose

The purpose of the Process Optimization Step is to determine actions to mitigate risk and assess the effectiveness of these actions. The end result is a process which minimizes the risk of producing and delivering products that do not meet the customer and stakeholder expectations. The main objectives of a Process Optimization are:

  • Identification of the actions necessary to reduce risks
  • Assignment of responsibilities and deadlines for action I implementation
  • Implementation and documentation of actions taken including confirmation of the effectiveness of the implemented actions and assessment of risk after actions taken.
  • Collaboration between the FMEA team, management, customers, and suppliers regarding potential failures.
  • Basis for refinement of the product and/or process requirements and prevention and detection controls

The primary objective of optimization is to develop actions that reduce risk by improving the process. In this step, the team reviews the results of the risk analysis and assigns actions to lower the occurrence of the failure cause or increase the ability to detect the failure cause or failure mode. Actions may also be assigned which improve the process but do not necessarily lower the risk assessment rating. Actions represent a commitment to take a specific, measurable, and achievable action, not potential actions which may never be implemented. Actions are not intended to be used for activities that are already planned as these are documented in the Prevention or Detection Controls, and are already considered in the initial risk analysis. All actions
should have a responsible individual and a target completion time associated with the action. If the team decides that no further actions are necessary, “No further action is needed“ is written in the Remarks field to show the risk analysis was completed. The PFMEA can be used as the basis for continuous improvement of the process. The optimization is most effective in the following order:

  • Process modifications to eliminate or mitigate a Failure Effect (FE)
  • Process modifications to reduce the Occurrence (O) of the Failure Cause (FC).
  • Increase the Detection (D) ability fer the Failure Cause (FC) or Failure Mode (FM).
  • In the case of process modifications, all impacted process steps are evaluated again.

In the case of concept modifications. all steps of the FMEA are reviewed for the affected sections. This is necessary because the original analysis is no longer valid since it was based upon a different manufacturing concept. The PFMEA can be used as the basis for continuous improvement of the process.

6.2 Assignment of Responsibilities

Each action should have a responsible individual and a Target Completion Date (TCD) associated with it. The responsible person ensures the action status is updated. If the action is confirmed this person is also responsible for the action implementation. The Actual Completion Date for Preventive and Detection Actions is documented including the date the actions are implemented.
Target Completion Dates should be realistic (i.e., in accordance with the product development plan. prior to process validation prior to start of production).

6.3 Status of the Actions

Suggested levels for Status of Actions:

  • Open: No action defined.
  • Decision pending (optional): The action has been defined but has not yet decided on. A
    decision paper is being created.
  • Implementation pending (optional): The action has been decided on but not yet implemented.
  • Completed: Completed actions have been implemented and their effectiveness has been demonstrated and documented. A final evaluation has been done.
  • Not Implemented: Not Implemented status is assigned when a decision is made not to implement an action. This may occur when risks related to practical and technical limitations are beyond current capabilities.

The FMEA is not considered “complete” until the team assesses. each item’s Action Priority and either accepts the level of risk or documents closure of all actions. If “No Action Taken,” then Action Priority is not reduced, and the risk of failure is carried forward into the product. Actions are open loops that need to be closed in writing.

6.4 Assessment of Action Effectiveness

When an action has been completed, Occurrence. and Detection values are reassessed. and a new Action Priority may be determined. The new action receives a preliminary Action Priority rating as a prediction of effectiveness. However. the status of the action remains “implementation pending” until the effectiveness has been tested. After the tests are finalized the preliminary rating has to be confirmed or adapted, when indicated. The status of the action is then changed from “implementation pending” to “completed.” The reassessment should be based on the effectiveness of the Preventive and Detection Actions taken and the new values are based on the definitions in the Process FMEA Occurrence and Detection rating tables.

6.5 Continual Improvement

The PFMEA serves as a historical record for the process. Therefore, the original Severity, Occurrence, and Detection (S, O, D) numbers need to be visible or at a minimum available and accessible as part of version history. The completed analysis becomes a repository to capture the progression of process decisions and design refinements. However, original S, O, D ratings may be. modified for foundation, family or generic PFMEA’s because the information is used as a starting point for an process specific analysis.

6.6 Collaboration between the FMEA team, Management, Customers, and Suppliers regarding Potential Failures:

Communication between the FMEA team, management, customers and suppliers during the development of the technical risk analysis and/or when the PFMEA is initially complete brings people together to improve their understanding of product and process functions and failures. In this way, there is a transfer of knowledge that promotes risk reduction.

Example of PFMEA Optimization with new Risk Evaluation Form Sheet

Step 7: Results Documentation

7.1 Purpose

The purpose of the results documentation step is to summarize and communicate the results of the Failure Mode and Effects analysis activity. The main objectives of Process Results Documentation are:

  • Communication of results and conclusions of the analysis
  • Establishment of the content of the documentation
  • Documentation of actions taken including confirmation of the effectiveness of the implemented actions and assessment of risk after actions taken
  • Communication of actions taken to reduce risks, including within the organization. and with customers and/or suppliers as appropriate
  • Record of risk analysis and risk reduction to acceptable levels.

7.2 FMEA Report

The-scope and results of an FMEA should be summarized in a report. The report can he used for communication purposes within a company, or between companies. The report is not meant to replace reviews of the PFMEA details when requested by management, customers, or suppliers. It is meant to be a summary for the PFMEA team and others to confirm completion of each of the tasks and review the results of the analysis. It is important that the content of the documentation fulfills the requirements of the organization, the intended reader, and relevant stakeholders. Details may be agreed upon between the parties. In this way. it is also ensured that all details of the analysis and the intellectual property remain at the developing company. The layout of the document may be company specific. However, the report should indicate the technical risk of failure as a part of the development plan and project milestones. The content may include the following:

  1. A-statement of final status compared to original goals established in the Project Plan
    • FMEA Intent-Purpose of this FMEA?‘
    • FMEA Timing- FMEA due date?
    • FMEA Team- List of participants?
    • FMEA Task- Scope of this FMEA?
    • FMEA Tool- How do we conduct the analysis Method used?
  2. A summary of_the scope of the analysis and identify what is new.
  3. A summary of how the functions were developed.
  4. A summary of at least the high-risk failures as determined by the team and provide a copy of the specific S/O/D rating tables and method of action prioritization (i.e., Action Priority table).
  5. A summary of the actions taken and/or planned to address the high-risk failures including status of those actions.
  6. A plan and commitment of timing for ongoing FMEA improvement actions.
    • Commitment and timing to close open actions.
    • Commitment to review and revise the PFMEA during mass production to ensure the accuracy and completeness of the analysis as compared with the production design (e.g. revisions triggered from design changes, corrective actions. etc., based on company procedures).
    • Commitment to capture “things gone wrong” in foundation PFMEA’s for the benefit of future analysis reuse, when applicable.
Standard PFMEA Form Sheet
Alternate PFMEA Form Sheet
Alternate PFMEA Form Sheet
Alternate PFMEA Form Sheet
Alternate PFMEA Form Sheet
PFMEA -Software View

PFMEA Form Sheet Hints: Step 7

PFMEA Step 7 is independently handled by each organization and is not recorded on the PFMEA form sheet.

AIAG & VDA Design Failure Mode and Effect Analysis

Step 1 : Planning and Preparation

1.1 Purpose

The purpose of the Design FMEA Planning and Preparation Step is to define which FMEAs will be done for a project, and to define what is included and excluded in each FMEA based on the type of analysis being developed. i.e.. system, subsystem or component. The main objectives of Design FMEA Planning and Preparation are:

  • Project identification
  • Project plan: lnTent, Timing, Team, Tasks, Tools (5T)
  • Analysis boundaries: What is included and excluded from the analysis
  • Identification of baseline FMEA with lessons learned
  • Basis for the Structure Analysis step

1.2 DFMEA Project Identification and Boundaries

DFMEA Project identification includes a clear understanding of what needs to be evaluated. This involves a decision-making process to define the DFMEAs that are needed for a customer program. What to exclude can be just as important as what to include in the analysis. Below are some basic questions that help identify DFMEA projects.

  • What is the customer buying from us?
  • Are there new requirements?
  • Does the customer or company require a DFMEA?
  • Do we make the product and have design control?
  • Do we buy the product and still have design control?
  • Do we buy the product and do not have design control?
  • Who is responsible for the interface design?
  • Do we need a system. subsystem. component. or other level of analysis?

Answers to these questions and others defined by the company help create the list of DFMEA projects needed. The DFMEA project list assures consistent direction, commitment and focus. The following may assist the team in defining DFMEA boundaries as applicable:

  • Legal requirements
  • Technical requirements
  • Customer wants/needs/expectation (external and internal customers)
  • Requirements specification
  • Diagrams (Block/Boundary) from similar project
  • Schematics. drawings, and/or 3D models
  • Bill of materials (BOM). risk assessment
  • Previous FMEA for similar products
  • Error proofing requirements, Design for Manufacturability and Assembly (DFMEA)
  • QFD Quality Function Deployment

The following may be considered in defining the scope of the DFMEA as appropriate:

  • Novelty of technology/ degree of innovation
  • Quality/reliability history (in-house. zero mileage, field failures, warranty and policy claims for similar product)
  • Complexity of design
  • Safety of people and systems
  • Cyber-physical system (including Cyber security)
  • Legal compliance
  • Catalog & standard parts

1.3 DFMEA Project Plan
A plan for the execution of the DFMEA should be developed once the DFMEA project is known. It is recommended that the 5T method (lnTent, Timing, Team,Tasks, Tool) be used. The plan for the DFMEA helps the company be proactive in starting the DFMEA early. The DFMEA activities (5-Step process) should be incorporated into the overall project plan.

1.4 Identification of the Baseline DFMEA
Part of the preparation for conducting the DFMEA is knowing what information is already available that can help the cross-functional team. This includes use of a foundation DFMEA , similar product DFMEA, or product family DFMEA. The family DFMEA is a specialized foundation design FMEA for products that generally contain common or consistent product boundaries and related functions. For a new product in the family, the new project specific components and functions to complete the new product’s DFMEA would be added to the family FMEA. The additions for the new product may be in the family DFMEA itself, or in a new document with reference to the original family or foundation DFMEA If no baseline. is available, then, the team will develop a new DFMEA.

1.5 DFMEA Header
During the Planning and Preparation Step, the header of the DFMEA document should be filled out. The header may be modified to meet the needs of the organization. The header includes some of the basic DFMEA scope information as follows:

  • Company Name: Name of Company Responsible for DFMEA
  • Engineering Location: Geographical Location
  • Customer Name: Name of Customer(s) or Product
  • Model Year / Program(s): Customer Application or Company Model /Style
  • Subject: Name of DFMEA Project (System, Subsystem and/or Component)
  • DFMEA Start Date: Start Date
  • DFMEA Revision Date: Latest Revision Date.
  • Cross-Functional Team: Team Roster needed
  • DFMEA ID Number: Determined by Company.
  • Design Responsibility: Name of DFMEA owner
  • Confidentiality Level: Business Use, Proprietary, Confidential
Example of Completed DFMEA Header Planning and Preparation

1.6 Basis for Structure Analysis
The information gathered during Step 1 Planning and. Preparation will be used to develop Step 2 Structure Analysis.

Step 2 : Structure Analysis

2.1 Purpose
The purpose of Design Structure Analysis is to identify and breakdown the FMEA scope into system, subsystem, and component parts for technical risk analysis. The main objectives of a Design Structure Analysis are:

  • Visualization of the analysis scope
  • Structure tree or equivalent: block diagram, boundary diagram, digital model, physical parts
  • Identification of design interfaces, interactions, close clearances
  • Collaboration between customer and supplier engineering teams (interface responsibilities)
  • Basis for the Function Analysis step

2.2 System Structure
A system structure is comprised of system elements. Depending on the scope of analysis, the system elements of a design structure can consist of a system, subsystems, assemblies. and components. Complex structures may be split into several structures (work packages) or different layers of block diagrams and analyzed separately for organizational reasons or to ensure sufficient clarity. A system has a boundary separating it from other systems and the environment. Its relationship with the environment is defined by inputs and outputs. A system element is a distinct component of a functional item. not a function, a requirement or a feature.

2.3 Define the Customer
There are two-major customers to be considered in the FMEA analysis:

  • END USER: The individual who uses a product after it has been fully developed and marketed.
  • ASSEMBLY and MANUFACTURING: the locations where manufacturing operations (e.g., powertrain, stamping and fabricating) and vehicle! product assembly and production material processing takes place. Addressing the interfaces between the product and its assembly process is critical to an effective FMEA analysis. This may be any subsequent or downstream operation or a next Tier manufacturing process.

Knowledge of these customers can help to define the functions, requirements and specifications more robustly as well as aid in determining the effects of related failure modes.

2..4 Visualize System Structure
A visualization of the system structure helps the DFMEA team develop the structural analysis. There are various tools which may be used by the team to accomplish this. Two methods commonly used

  • Block/Boundary Diagrams
  • Structure Tree

2.4.1 Block/Boundary Diagram
Block/Boundary Diagrams are useful tools that depict the system under consideration and its interfaces with adjacent systems, the environment and the customer. The diagram is a graphic
representation that provides guidelines for structured brainstorming and facilitates the analysis of system interfaces as a foundation for a Design FMEA. The diagram below shows the physical and logical relationships between the components of the product. It indicates the interaction of components and subsystems within the scope of the design as well as those interfaces to the product Customer, Manufacturing, Service,Shipping. etc. The diagram identifies persons and things that the design interacts with during its useful life. The Boundary Diagram can be used to identify the Focus Elements to be assessed in the Structure Analysis and Function Analysis. The diagram may be in the form of boxes connected by lines, with each box corresponding to a major component of the product. The lines correspond with how the product components are related to, or interface with each other, with arrows at the end point(s) to indicate the direction of flow. Interfaces between elements in the Boundary Diagram can be included as Focus Elements in the Structure and Function Analysis Structure Tree. There are different approaches and formats to the construction of a Block/Boundary Diagram, which are determined by the organization. The terms “Block Diagram” and “Boundary Diagram” are used interchangeably. However. the Boundary Diagram tends to be more comprehensive due to the inclusion of external influences and system interactions. In the context of the DFMEA, Block/boundary Diagrams define the analysis scope and responsibility and provides guidelines for structured brainstorming. The scope of analysis is defined by the boundaries of the system; however. interfaces with external factors/systems are to be addressed.

  • Defines scope of analysis (helps to identify potential team members)
  • Identifies internal and external interfaces
  • Enables application of system, sub-system. and component hierarchy

When correctly constructed, Block/Boundary Diagrams provide detailed information to the P-Diagram and the FMEA. Although Block/Boundary diagrams can be constructed to any level of
detail, it is important to identify the major elements, understand how they interact with each other, and how they may interact with outside systems. Block/boundary Diagrams are steadily refined as the design matures. The steps involved in completing a Block/boundary Diagram may be described as follows:

  1. Describe components and features
    • Naming the parts and features helps alignment within the team, particularly when features have ‘“nicknames’
    • All system components and interfacing components shown
  2. Reorganize blocks to show linkages :
    • Solid line for direct contact
    • Dashed line for indirect interfaces. e.g. clearances or relative motion
    • Arrows indicate direction
    • All energy flows /signal or force transfers identified.
  3. Describe connections
    • Consider all types of interfaces, both desired and undesired:
      • P – Physically touching (welded. bolted. clamped, etc.)
      • E – Energy transfer (Torque (Nm), heat. etc.)
      • I-information transfer (ECU, sensors, signals, etc.)
      • M-Material exchange (Cooling fluid, exhaust gases,etc.)
  4. Add interfacing systems and inputs (persons and things). The following should be included:
    • Adjacent systems— including systems that are not physically touching your system but may interact with it. require clearance, involve motion. or thermal exposure.
    • The customer/or end user
    • Arrows indicate direction
  5. Define the boundary (What parts are within “the span of control of the team? What is new or modified?). Only parts designed or controlled by the team are inside the boundary. The blocks within the boundary diagram are one level lower than the level being analyzed. Blocks within the boundary may be marked to indicate items that are not part of the analysis.
  6. Add relevant details to identify the diagram.
    • System, program and team identification
    • Key to any colors or line styles used to identify different types of interactions
    • Date and revision level
Example of Block/Boundary Diagram

2.4.2 Interface Analysis
An interface analysis describes the. interactions between elements of a system. There are five primary types of interfaces:

  • Physical connection (e.g., brackets, belts, clamps and various, types of connectors)
  • Material exchange (e.g., compressed air, hydraulic fluids or any other fluid or material exchange)
  • Energy transfer (e.g., heat transfer, friction or motion transfer such as chain links or gears)
  • Data exchange (e.g., computer inputs or outputs, wiring- harnesses, electrical signals or any other types of information exchange, cyber security items)
  • Human-Machine (e.g., controls, switches, mirrors, displays, warnings, seating, entry/exit)

Another type of interface may be described as a physical clearance between parts, where there is no physical connection. Clearances may be static and/or dynamic. Consider the interfaces between subsystems and components in addition to the content of the sub-systems and components themselves. An interface analysis documents the nature (strong/weak/none/beneficial/harmful) and type of relationships (Physical, Energy, Information or Material Exchange) that occur at all internal and external interfaces graphically displayed in the Block/Boundary Diagram. Information from an interface analysis provides valuable input to a Design FMEA, such as the primary functions or interface functions to be analyzed with potential causes/mechanisms of failure due to effects from neighboring systems and environments. Interface analysis also provides input to the P-Diagram on ideal functions. and noise factors.

2.4.3 Structure Trees
The structure tree arranges system elements hierarchically and illustrates the dependency via the structural connections. The clearly structured illustration of the complete system is thereby guaranteed by the fact that each system element exists only once to prevent redundancy. The structures arranged under each System Element are independent sub-structures. The interactions between System elements may be described as functions and represented by function nets. There is always a system element present even if it is only derived from the function and cannot yet be specified more clearly.

Example of Structure Analysis Structure Tree
Structural Analysis (Step 2)
1. Next Higher Level2. Focus Elements3. Next Lower Level or Characteristic Type
Window Lifter MotorCommutation SystemBrush Card Base Body
Example of Structure Analysis Form Sheet
  1. Next Higher Level: The highest level of integration. within the scope of analysis.
  2. Focus Element: The element in focus. This is the item that is topic of Consideration of the failure chain.
  3. Next Lower Level or Characteristic Type:The element that is the next level down the structure from the focus element.

2.5 Collaboration between Customer and Supplier
The output of the Structure Analysis (visualization of the design and its interfaces) provides a tool for collaboration between customers and suppliers during technical reviews of the design and/or DFMEA project.

2.6 Basis for Function Analysis.
The information defined during Step 2 Structure Analysis will be used to develop Step 3 Function Analysis. If design elements (items) are missing from the Structure Analysis they will also be missing from the Function Analysis.

Step 3: Function Analysis

3.1 Purpose

The purpose of the Design Function Analysis is to ensure that the functions specified by requirements/specifications are appropriately allocated to the system elements. Regardless of the
tool used to generate the DFMEA, it is critical that the analysis is written in functional terms. The main objectives of a Design Function Analysis are:

  • Visualization of product or process functions
  • Function tree/net or function analysis form sheet and parameter diagram (P-diagram)
  • Cascade of customer (external and internal) functions with associated requirements
  • Association of requirements or characteristics to functions
  • Collaboration between engineering teams (systems, safety, and components)
  • Basis for the Failure Analysis step

The structure provides the basis so that each System Element may be individually analyzed with regard to its functions and requirements. For this, comprehensive knowledge of the system and the operating conditions and environmental conditions of the system are necessary, for example, heat, cold, dust, splash water, salt, icing, vibrations. electrical failures. etc.

3.2 Function
A function describes what the item/system element is intended to do. A function is to be assigned to a system element. Also, a system element can contain multiple functions. The description of a function needs to be clear. The recommended phrase format is to use an “action verb“ followed by a “noun” to describe a measurable function. A Function should be in the “PRESENT TENSE”; it uses the verb’s base form (e.g., deliver, contain, control, assemble, transfer).
Examples: deliver power, contain fluid, control speed, transfer heat, color black. Functions describe the relationship between the input and output of an item system element with the aim of fulfilling a task.
Note: A component (i.e., a part or item in a part list) may have a purpose/ function where there is no input/output. Examples such as a seal, grease, clip, bracket, housing, connector, flux etc. have functions and requirements including material, shape, thickness, etc. In addition to the primary functions of an item, other functions that may be evaluated include secondary functions such as interface functions, diagnostic functions, and serviceability functions

Input/Interface/Output Flow

3.3 Requirements
Requirements are divided into two groups: functional requirements and non-functional requirements. A functional requirement is a criterion by which the intended performance of the function is judged or measured (e.g., material stiffness). A non-functional requirement is a limitation on the freedom for design decision (e.g., temperature range). Requirements may be derived from various sources, external and internal, these could be:
Legal requirements: for eg Environmentally friendly product design, suitable for recycling, safe in the event of potential misuse by the operator. non-flammable, etc.
Industry Norms and Standards: for eg ISO 9001, VDA Volume 6 Part 3, Process audit, SAE J1739, ISO 26262 Functional Safety.
Customer Requirements:Explicit (i.e., in customer specification) and implicit (i.e., freedom from prohibited materials) – under all specified conditions

Internal Requirements:Product Specific (i.e., Requirements Specifications, manufacturability, suitability for testing, compatibility with other existing products, reusability, cleanliness, generation, entry and spreading of particles)
Product Characteristics: A distinguishing feature (or quantifiable attribute) of a product such as a journal diameter or surface finish.

3.4 Parameter Diagram (P-Diagram)
Parameters are considered to be attributes of the behavior of a function. A Parameter (P) Diagram is a graphical representation of the environment in which an item exists. A P-Diagram includes factors which influence the transfer function between inputs and outputs, focusing on design decisions necessary to optimize output. A P-Diagram is used to characterize the behavior of a system or component in the context of a single function. P-Diagram-s are not required for all functions. Teams should focus on a few key functions affected by new conditions and those with history of robustness issues in previous applications. More than one P- Diagram may be needed in order to illustrate the function(s) of the system or component that are of concern to the FMEA Team.

The complete functional description forms the basis for subsequent failure analysis and risk mitigation. A P-Diagram focuses on achievement of function. It clearly identifies all influences on that function including what can be controlled (Control Factors), and what cannot reasonably be controlled (Noise Factors). The P-Diagram. completed for specific Ideal Functions. assists in the identification of:

  • Factors, levels. responses and signals necessary for system optimization
  • Functions which are inputs to the DFMEA
  • Control and Noise factors which could affect functional performance
  • Unintended system outputs (Diverted Outputs)
  • Information gained through developing a P-Diagram provides input to the test plan.

Referring to Figure below, the output (grey area) of the item/ System Element often deviates/varies from the desired behavior (straight line). The control factors act on the design to achieve as close as practical to the desired behavior.

Example of system behavior

A Parameter Diagram consists of dynamic inputs (including signals), factors that could affect system performance (control and noise), sources of variation, and outputs (intended outputs and
unintended/diverted outputs). The following is an example of a Parameter Diagram which is used to assess the influences on a function of a product including:

  • Input (What you want to put in to get the desired result) is a description of the sou fees required for fulfilling the system functionality.
  • Function (What you want to happen) is described in a Parameter Diagram with an active verb followed by a measurable noun in the present tense and associated with requirements.
  • Functional Requirements (What you need to make the function happen) are related to the performance of a function
  • Control Factors (What you can do to make it happen) which can be adjusted to make the design more insensitive to noise (more robust) are identified. One type of Control Factor is a Signal Factor. Signal Factors are adjustment factors, set directly or indirectly by a user of a system, that proportionally change the system response (e.g., brake pedal movement changes stopping distance). Only dynamic systems utilize signal factors. Systems without signal factors are called static systems.
  • Non-Functional Requirements (What you need beside the functional requirements) which limit the design option.
  • Intended Output (What you want from the system) are ideal, intended functional outputs whose magnitude may (dynamic system) or may not (static system) be linearly proportional to a signal factor (e.g., low beam activation for a headlamp. stopping distance as a function of brake pedal movement).
  • Unintended Output (What you don’t want from the system) are malfunctioning behaviors or unintended system outputs that divert system performance from the ideal intended function. For example, energy associated with a brake system is ideally transformed into friction. Heat, noise and vibration are examples of brake energy diverted outputs. Diverted Outputs may be losses to thermal radiation, vibration, electrical resistance, flow restriction. etc.
  • Noise Factors (What interferes with achieving the desired output) are parameters which represent potentially significant sources of variation for the system response and cannot be controlled or are not practical to control from the perspective of the engineer. Noises are described in physical units. Noise factors are categorized as follows:
    • Piece to Piece Variation (in a component and interference between components)
    • Change Over Time (aging over life time. e.g.. mileage, aging, wear)
    • Customer Usage (use out of desired specifications)
    • External Environment (conditions during customer usage.e.g. road type. weather)
    • System Interactions(interference from other systems)
Example of Parameter Diagram with Electrical Motor

3.5 Function Analysis

The interactions of the functions of several System elements are to be demonstrated. for example as a function tree/network or using the DFMEA form sheet. The focus of the analysis cascades from OEM to Tier 1 supplier to Tier N supplier. The purpose of creating a function tree/network or function analysis on the DFMEA form sheet is to incorporate the technical dependency between the functions. Therefore. it subsequently supports the visualization of the failure dependencies. When there is a functional relationship between hierarchically linked functions. Then there is a potential relationship between the associated failures. Otherwise. if there is no functional relationship between hierarchically linked functions, there will also be no potential relationship between the associated failures. For the preparation of the function tree/network. the functions that are involved need to be examined. Sub-functions enable the performance of an overall function. All sub-functions are linked logically with each other in the function structure (Boolean & relationships). A function structure becomes more detailed from top down. The lower level function describes how the higher level function is to be fulfilled. For the logical linking of a function structure, it is helpful to ask:

  • “How is the higher level function enabled by lower level functions?” (Top-Down) and
  • “Why is the lower level function needed?” (Bottom-Up).
Example of Function Analysts Structure Tree

The function structure can be created in the Function Analysis section:

FUNCTION Analysis (Step 3)
1.Next Higher Level Function and Requirement2. Focus Elements Function and Requirement3. Next Lower Level Function and Requirement or Characteristic
Convert electrical energy into mechanical energy according to parameterizationCommutation System transport the electrical current between coil pairs of the electromagnetic convertorsBrush card body transports forces between spring and motor body to hold the brush spring system in x. y, z position (support commutating contact points)
Example of Function Analysis Form Sheet

How is the higher level function enabled by lower level functions?

  1. Next Higher Level Function and Requirement: The function in scope of the Analysis.
  2. Focus Element Function and Requirement: The function of the associated System Element (item in focus) identified in the Structure Analysis.
  3. Next Lower Level Function and Requirement of Characteristic:The function of the associated Component Element identified in the Structure Analysis.

3.6 Collaboration between Engineering Teams (Systems, Safety, and Components)
Engineering teams within the company need to collaborate to make sure information is consistent for a project or customer program especially when multiple DFMEA teams are simultaneously conducting the technical risk analysis. For example, a systems group might be developing the design architecture (structure) and this information would be helpful to the DFMEA to avoid duplication of work. A safety team may be working with the customer to understand the safety goals and hazards. This information would be helpful to the DFMEA to ensure consistent severity ratings for failure effects.

3.7 Basis for Failure Analysis
Complete definition of functions (in positive words) will lead to a comprehensive Step 4 Failure Analysis because the potential failures are ways the functions could fail (in negative words).

Step 4 Failure Analysis

4.1 Purpose
The purpose of the Design Failure Analysis is to identify failure causes, modes, and effects, and show their relationships to enable risk assessment. The main objectives of a Design Failure Analysis are:

  • Establishment of the Failure Chain
  • Potential Failure Effects, Failure Modes. Failure Causes for each product function.
  • Collaboration between customer and supplier (Failure Effects)
  • Basis for the documentation of-failures in the FMEA form sheet and the Risk Analysis step

4.2 Failures

Failures of a function are derived from the function descriptions. There are several types of- potential failure modes including, but not limited to:

  • Loss of function (e.g. inoperable, fails suddenly)
  • Degradation of function (e.g. performance loss overtime)
  • Intermittent function (e.g. operation randomly starts/stops/starts)
  • Partial function (e.g. performance loss)
  • Unintended function (e.g. operation at the wrong time, unintended direction, unequal performance)
  • Exceeding function (e.g. operation above acceptable threshold)
  • Delayed function (e.g. operation after unintended time interval)
Types of Failure Modes

The description of a system and subsystem failure mode is described in terms of functional loss or degradation e.g., steering turns right when the hand wheel is moved left. as an example of an unintended function. When necessary, the operating condition of the vehicle should be included e.g. loss of steering assist during start up or shut down. A component/part failure mode is comprised of a noun and a failure description e.g., seal twisted. It is critical that the description of the failure is clear and understandable for the person who is intended to read it. A statement “not fulfilled,” “not OK,” “defective.” “broken“ and so on is not sufficient. More than one failure may be associated with a function. Therefore. the team should not stop as soon as one failure is
identified. They should ask “how else can this fail?“

Definition of Failure

4.3 The Failure Chain

There are three different aspects of a Failure analyzed in an FMEA:

  • Failure Effect (FE)
  • Failure Mode (FM)
  • Failure Cause (FC)
Theoretical failure chain model

4.4 Failure Effects

A Failure Effect is defined as the consequence of a failure mode. Describe effects on the next level of product integration (internal or external), the end user who is the vehicle operator (external), and government regulations (regulatory) as applicable. Customer effects should state what the user might notice or experience including those effects that could impact safety. The intent is to forecast the failure effects consistent with the team’s level of knowledge. A failure mode can have multiple effects relating to internal and external customers. Effects may be shared by OEMs with suppliers and suppliers with sub-suppliers as part of design collaboration. The severity of failure effects is evaluated on a ten-point scale. Examples of failure effects on the end user:

  • No discernible effect
  • Poor appearance e.g.. unsightly close-out. color fade, cosmetic corrosion.
  • Noise e.g.. misalignment/rub. fluid-borne noise. squeak/rattle, chirp, and squawk
  • Unpleasant odor, rough feel, increased efforts
  • Operation impaired. intermittent. unable to operate. electromagnetic incompatibility (EMC)
  • External leak resulting in performance loss. erratic operation,unstable
  • Unable to drive vehicle (walk home)
  • Noncompliance with government regulations
  • Loss of steering or braking

NOTE: In some cases. the team conducting the analysis may not know the end user effect, e.g.. catalogue parts. off- the-shelf products. Tier 3 components. When this information is not known, the effects should be defined in terms of the part function and specification. In these cases. the system integrator is responsible for ensuring the correct part for the application is selected. e.g.. auto,truck, marine, agriculture.

4.5 Failure Mode
A Failure Mode is defined as the manner in which an item could fail to meet or deliver the intended function. The Failure Modes are derived from the Functions. Failure Modes should be described in technical terms and not necessarily as symptoms noticeable by the customer. In preparing the DFMEA, assume that the design will be manufactured and assembled to the design intent. Exceptions can be made at the team‘s discretion where historical data indicates deficiencies exist in the manufacturing process. Examples of component-level failure modes include, but are not limited to:

Examples of system-level failure modes include, but are not limited to:

  • Complete fluid loss
  • Disengages too fast
  • Does not disengage
  • Does not transmit torque
  • Does not hold full torque
  • Inadequate structural support
  • Loss of structural support
  • No signal
  • Intermittent signal
  • Provides too much pressure/signal/voltage
  • Provides insufficient pressurefsignal/voltage
  • Unable to withstand load/temperature/vibration

4.6 Failure Cause
A Failure Cause is an indication of why the failure mode could occur. The consequence of a cause is the failure mode. Identify, to the extent possible, every potential cause for each failure mode. The consequences of not being robust to noise factors (found on a P-Diagram) may also be Failure Causes. The cause should be listed as concise and complete as possible so that remedial
efforts (controls and actions) can be aimed at appropriate causes. The Failure Causes can be derived from the Failure modes, of the next lower level function and requirement and the potential noise factors (e. g, from a Parameter Diagram). Types of potential failure causes could be, but are not limited to:

  • Inadequate design for functional performance (e.g., incorrect material specified, incorrect geometry, incorrect part selected for application, incorrect surface finish specified, inadequate travel specification, improper friction material specified, insufficient lubrication capability, inadequate design life assumption, incorrect algorithm, improper maintenance instructions, etc.)
  • System interactions (e.g., mechanical interfaces, fluid flow, heat sources. controller feedback, etc.)
  • Changes overtime (e.g., yield, fatigue, material instability, creep, wear, corrosion, chemical oxidation, electromigration, over-stressing, etc.)
  • Design inadequate for external environment (e.g., heat, cold, moisture, vibration, road debris, road salt, etc.)
  • End user error or behavior (e.g., wrong gear used, wrong pedal used, excessive speeds, towing, wrong fuel type, service damage, etc.)
  • Lack of robust design for manufacturing (e.g., part geometry allows part installation backwards or upside down, part lacks distinguishing design features, shipping container design
  • causes parts to scratch or stick together, part handling causes damage, etc.)
  • Software Issues (e.g., Undefined state, corrupted ccde/data)

4.7 Failure Analysis
Depending on whether the analysis is being done at the system, sub-system or component level, a failure can be viewed as a failure effect, failure mode, or failure cause. Failure Modes, Failure
Causes, and Failure Effects should correspond with the respective column in the FMEA form sheet. Figure below shows a cascade of design-related failure modes, causes, and effects from the vehicle level to the characteristic level. The focus element (Failure Mode), Causes, and Effects are different depending on the level of design integration. Consequently, a Failure Cause at the OEM becomes a Failure Mode at a next (Tier 1) level. However, Failure Effects at the vehicle level (as perceived by the end user) should be documented when known, but not assumed. Failure Networks may be created by the organization that owns multiple levels of the design. When multiple organizations are responsible for different levels of the design they are responsible to communicate failure effects to the next higher or next lower level as appropriate.

Failure Structure at different levels

To link Failure Cause(s) to a Failure Mode. the question. should be “Why is the Failure Mode happening?“. To link Failure Effects to a Failure Mode, the question should be “What happens in the event of a Failure Mode?”

Example of Failure Analysis Structure Tree

The failure structure can be created in the Failure Analysis section.

FAILURE ANALYSIS (STEP 4)
1.Failure Effect(FE) to the Next Higher Level Element and/or End User2.Failure Mode(FM) of the focus element3 Failure Cause (FC) of the next lower element or characteristics
Torque and rotating velocity of the window lifter motor too lowAngle deviation by commutation system intermittently connects the wrong coils (L1, L3 and L2 instead of L1, L2 and L3)Brush card body bends in contact area of the carbon brush
Example of Failure Analysis Form sheet

Following once again the header numbering (1, 2, 3) and color coding, by inspecting the items in the Function Analysis begin building the Failure Chain.

  1. Failure Effects (FE): The effect of failure associated with the “Next Higher Level Element and/or End User” in the Function Analysis.
  2. Failure Mode (FM): The mode (or type) of failure associated with the “Focus Element” in the Function Analysis.
  3. Failure Cause (FC): The cause of failure associated with the “Next Lower Element or Characteristic” in the Function Analysis..

4.8 Failure Analysis Documentation
The DFMEA Form Sheet can have multiple views once the Structure Analysis. Function Analysis and Failure Analysis are complete.

4.9 Collaboration between Customer and Supplier (Failure Effects)

The output of the Failure Analysis may be reviewed by customers and suppliers prior to the Risk Analysis step or after to the Risk Analysis step based on agreements with the customer and need
for sharing with the supplier.

4.10 Basis fer Risk Analysis
Complete definition of potential failures will lead to a complete Step 5 Risk Analysis because the rating of Severity. Occurrence, and Detection are based on the failure descriptions. The Risk Analysis may be incomplete if potential failures are too vague or missing.

Step 5: Risk Analysis

5.1 Purpose
The purpose of Design Risk Analysis is to estimate risk by evaluating Severity, Occurrence and Detection, and prioritize the need for actions. The main objectives of the Design Risk Analysis are:

  • Assignment of existing and/or planned controls and rating of failures
  • Assignment of Prevention Controls to the Failure Causes
  • Assignment of Detection Controls to the Failure Causes and/or Failure Modes
  • Rating of Severity. Occurrence and Detection for each failure chain
  • Evaluation of Action Priority
  • Collaboration between customer and supplier (Severity)
  • Basis for the Optimization step

5.2 Design Controls
Current design controls are proven considerations that have been established for similar. previous designs. Design control documents are a basis for the robustness of the design. Prevention-type controls and detection-type controls are part of the current library of verification and validation methods. Prevention controls provide information or guidance that is used as an input to the design. Detection controls describe established verification and validation procedures that have been previously demonstrated to detect the failure, should it occur. Specific
references to design features that act to prevent a failure or line items in published test procedures will establish a credible link between the failure and the design control. These prevention and/or detection methods that are necessary, but not part of a current library of defined procedures should be written as actions in the DFMEA.

5.3 Current Prevention Controls (PC)
Current Prevention Controls describe how a potential cause which results in the Failure Mode is mitigated using existing and planned activities. They describe the basis for determining the occurrence rating. Prevention Controls relate back to the performance requirement. For items which have been designed out-of-context and are purchased as stock or catalog items from a supplier, the prevention control should document a specific reference to how the item fulfills the requirement. This may be a reference to a specification sheet in a catalog. Current Prevention controls need to be clearly and comprehensively described, with references cited. if necessary, this can be done by reference to an additional document. Listing a control such as “proven material” or “lessons learned” is not a clear enough indication. The DFMEA team should also consider margin of safety in design as a prevention control. Examples of Current Prevention Controls:

  • EMC Directives adhered to, Directive 89/336/EEC
  • System design according to simulation, tolerance calculation, and Procedure – analysis of concepts to establish design requirements
  • Published design standard for a thread class
  • Heat treat specification on drawing
  • Sensor performance specifications.
  • Mechanical redundancy (fail-safe)
  • Design for test-ability
  • In Design and Material standards (internal and external)
  • Documentation (e.g., records of best practices. lessons learned, etc.) from similar designs
  • Error-proofing (Poke-Yoke design i.e., part geometry prevents wrong orientation)
  • Substantially identical to a design which was validated for a previous application, with documented performance history. (However, if there is a change to the duty cycle or operating conditions, then the carry-ever item requires re-validation in order for the detection control to be relevant.)
  • Shielding or guards which mitigate potential mechanical wear, thermal exposure, or EMC.
  • Conformance to best practices

After completion of the preventive actions the occurrence is verified by the Detection Control(s).

5.4 Current Detection Controls (DC)
Current Detection Controls detect the existence of a failure cause or the failure mode before the item is released for production. Current Detection Controls that are listed in the FMEA represent planned activities (or activities already completed), not potential activities which may never actually be conducted. Current Detection controls need to be clearly and comprehensively described. Listing a control such as “Test” or “Lab Test” is not a clear enough indication of a detection control. References to specific tests, test plans or procedures should be cited as applicable, to indicate that the FMEA team has determined that the test will actually detect the failure mode or cause, if it occurs (e.g.. Test No. 1234 Burst Pressure Test, Paragraph 6.1). Examples of Current Detection controls:

  • Function check
  • Burst test
  • Environmental test
  • Driving test a Endurance test
  • Range of motion studies
  • Hardware in-the-loop
  • Software in-the-Ioop
  • Design of experiments
  • Voltage output lab measurements
    All controls that lead to a detection of the failure cause. or the failure mode are entered into the “Current Detection Controls” column.
Prevention and Detection in the Design FMEA

5.5 Confirmation of Currant Prevention and Detection Controls

The effectiveness of the current prevention and detection controls should be confirmed. This can be done during validation tear down reviews. Such confirmation can be documented within the DFMEA, or within other project documents, as appropriate, according to the team’s normal product development procedure. Additional action may be needed if the controls are proven not to be effective. The occurrence and detection evaluations should be reviewed when using FMEA entries from previous products, due to the possibility of different conditions for the new product.

Roadmap of design under-standing

5.6 Evaluations
Each failure mode, cause and effect relationship is assessed to estimate risk. There are rating criteria for the evaluation of risk:

  • Severity (S): stands for the severity of the failure effect
  • Occurrence (O): stands for the occurrence of the failure cause
  • Detection (D): stands for the detection of the occurred failure cause and/or failure mode.

Evaluation numbers from 1 to 10 are used for S, O and D respectively, where 10 stands for the highest risk contribution.
NOTE: It is not appropriate to compare the ratings of one team’s FMEA with the ratings of another team’s FMEA, even if the product/process appear to be identical, since each team’s environment is unique and thus their respective individual ratings will be unique (i.e., the ratings are subjective).

5.7 Severity (S)
The Severity rating (S) is a measure associated with the most serious failure effect for a given failure mode of the function being evaluated. The rating is used to identify priorities relative to the scope of an individual FMEA and is determined without regard for occurrence or detection. Severity should be estimated using the criteria in the Severity Table. The table may be augmented to include product-specific examples. The FMEA project team should agree on an evaluation criteria and rating system. which is consistent even if modified for individual design analysis. The Severity evaluations of the failure effects should be transferred by the customer to. the supplier. as needed.

Product General Evaluation Criteria Severity (S)
Potential Failure Effects rated according to the criteria below.Blank until filled in by user
SEffectSeverity criteriaCorporate or Product Line  Examples
10Very HighAffects safe operation of the vehicle and/or other vehicles, the health of driver or passengers or road users or pedestrians. 
9Noncompliance with regulations. 
8HighLoss of primary vehicle function necessary for normal driving during expected service life. 
7Degradation of primary vehicle function necessary for normal driving during expected service life. 
6ModerateLoss of secondary vehicle function. 
5Degradation of secondary vehicle function. 
4Very objectionable appearance, sound, vibration, harshness, or haptics. 
3LowModerately objectionable appearance, sound, vibration, harshness, or haptics. 
2Slightly objectionable appearance, sound, vibration, harshness, or haptics. 
1Very lowNo discernible effect 
DFMEA SEVERITY (S} TABLE

5.3 Occurrence (O)
The Occurrence rating (O) is a measure of the effectiveness of the prevention control, taking into account the rating criteria. Occurrence ratings should be estimated using the criteria in the Occurrence Table . The table may be augmented to include product-specific examples. The FMEA project team should agree on an evaluation criteria and rating system. which is consistent, even if modified for individual design analysis (e.g., passenger car, truck, motorcycle, etc). The Occurrence rating number is a relative rating within the scope of the FMEA and may not reflect the actual occurrence. The Occurrence rating describes the potential of the failure cause to occur in customer operation, according to the rating table, considering results of already completed detection controls. Expertise, data handbooks, warranty databases or other experiences in the field of comparable products, for example, can be consulted for the analysis of the evaluation numbers. When failure causes are rated for occurrence, it is done taking into account an estimation of the effectiveness of the current prevention control. The accuracy of this rating depends on how well the prevention control has been described. Questions such as the following may be helpful for a team when trying to determine the appropriate Occurrence rating:

  • What is the service history and field experience with similar components, subsystems, or systems?
  • Is the item a carryover product or similar to a previous level item?
  • How significant are changes from a previous level item?
  • Is the item completely new?
  • What is the application or what are the environmental changes?
  • Has an engineering analysis (e.g. reliability) been used to estimate the expected comparable occurrence rate for the application?
  • Have prevention controls been put in place?
  • Has the robustness of the product been proven during the product development process?
Occurrence Potential (O) for the Product
Potential Failure Causes rated according to the criteria below. Consider Product Experience and Prevention Controls when determining the best Occurrence estimate (Qualitative rating).Blank until filled in by user
OPrediction of Failure Cause OccurringOccurrence criteria – DFMEACorporate or Product Line  Examples
10Extremely HighFirst application of new technology anywhere without operating experience and/or under uncontrolled operating conditions. No product verification and/or validation experience. Standards do not exist and best practices have not yet been determined. Prevention controls not able to predict field performance or do not exist. 
9Very HighFirst use of design with technical innovations or materials within the company. New application or change in duty cycle / operating conditions. No product verification and/or validation experience. Prevention controls not targeted to identify performance to specific requirements. 
8First use of design with technical innovations or materials on a new application. New application or change in duty cycle/operating conditions. No product verification and/or validation experience.   Few existing standards and best practices, not directly applicable for this design. Prevention controls not a reliable indicator of field performance. 
7HighNew design based on similar technology and materials. New application or change in duty cycle /operating conditions. No product verification and/or validation experience. Standards, best practices, and design rules apply to the baseline design, but not the innovations. Prevention controls provide  limited indication of performance 
6Similar to previous designs, using existing technology and materials. Similar application, with changes in duty cycle or operating conditions, Previous testing or field experience. Standards and design rules exist but are insufficient to ensure that the failure cause will not occur. Prevention controls provide some ability to prevent a failure cause. 
5ModerateDetail changes to previous design, using proven technology and materials. Similar application, duty cycle or operating conditions. Previous testing or field experience, or new design with some test experience related to the failure. Design addresses lessons learned from previous designs. Best Practices re-evaluated for this design but have not yet been proven. Prevention controls capable of finding deficiencies in the product related to the failure cause and provide some indication of performance. 
4Almost identical design with short-term field exposure. Similar application with minor change in duty cycle or operating conditions. Previous testing or field experience.   Predecessor design and changes for new design conform to best- practices, standards, and specifications. Prevention controls capable of finding deficiencies in the product related to the failure cause and indicate likely design conformance. 
3LowDetail changes to known design (same application, with minor change in duty cycle or operating conditions) and testing or field experience under comparable operating conditions or new design with successfully completed test procedure. Design expected to conform to Standards and Best Practices, considering Lessons Learned from previous designs. Prevention controls capable of finding deficiencies in the product related to the failure cause and predict conformance of production design. 
2Very lowAlmost identical mature design with long term field exposure. Same application, with comparable duty cycle and operating conditions. Testing or field experience under comparable operating conditions. Design expected to conform to standards and best practices, considering Lessons Learned from previous designs, with  significant margin of confidence. Prevention controls capable of finding deficiencies in the product related to the failure cause and indicate confidence in design conformance. 
1Extremely lowFailure eliminated through prevention control and failure cause is not possible by design 
Product Experience: History of product usage within the company [Novelty of design, application or use case). Results of already completed detection controls provide experience with the design.
Prevention Controls: Use of Best Practices for product design, Design Rules, Company Standards. Lessons Learned, industry Standards, Material Specifications, Government Regulations and effectiveness of prevention oriented analytical tools including Computer Aided Engineering, Math Modelling, Simulation Studies. Tolerance Stacks and Design/Safety Margins
Note: 10,9,8,7 can drop based on product validation activities
DFMEA Occurrence (O)

5.9 Detection (D)
The Detection rating (D) is an estimated measure of the effectiveness of the detection control to reliably demonstrate the failure cause or failure made before the item is released for production. The detection rating is the rating associated with the most effective detection control. Detection is a relative rating, within the scope of the individual FMEA and is determined without regard for severity or occurrence. Detection should be estimated using the criteria in Detection Table.The FMEA project team should agree on an evaluation criteria and rating system, which is consistent. even if modified for individual product analysis. The detection rating is initially a prediction of the effectiveness of any yet unproven control. The effectiveness can be verified and re-evaluated after the detection control is completed. However, the completion or cancellation of a detection control (such as a test) may also affect the estimation of occurrence. In determining this estimate, questions such as the following should be considered:

  • Which test is most effective in detecting the Failure Cause or the Failure Mode?
  • What is the usage Profile/ Duty Cycle required detecting the failure?
  • What sample size is required to detect the failure?
  • Is the test procedure proven for detecting this Cause / Failure Mode?
Detection Potential (D) for tile Validation of the Product Design
Detection Controls rated according to Detection Method Maturity and Opportunity for Detection.Blank until filled in by user
DAbility to DetectDetection Method MaturityOpportunity for DetectionCorporate or Product Line  Examples
10Very LowTest procedure yet to be developed.Test method not defined 
9Test method not designed specifically to detect failure mode or cause.Pass-Fail, Test-to-Fail, Degradation Testing 
8LowNew test method; not proven.Pass-Fail, Test-to-Fail, Degradation Testing 
7ModerateProven test method for verification of functionality or validation of performance, quality, reliability and durability; planned timing is later in the product development cycle such that test failures may result in production delays for re-design andi/r re-tooling.Pass-Fail 
6Test-to-Fail 
5Degradation Testing 
4HighProven test method for verification of functionality or validation of performance, quality, reliability and durability; planned timing is sufficient to modify production tools before release for production.Pass-Fail 
3Test-to-Fail 
2Degradation Testing 
1Very HighPrior testing confirmed that failure mode or cause cannot occur. or detection methods proven to always detect the failure mode or failure cause. 
DFMEA DETECTION (D)

5.10 Action Priority (AP)
Once the learn has completed the initial identification of Failure Modes, Failure Effects, Failure Causes and controls, including ratings for severity. occurrence, and detection. they must decide if
further efforts are needed to reduce the risk. Due to the inherent limitations on resources, time, technology, and other factors, they must choose how to best prioritize these efforts. The Action Priority (AP) method was created to give more emphasis on severity first, then occurrence, then detection. This logic follows the failure-prevention intent of FMEA. The AP table offers a suggested high-medium-low priority for action. Companies can use a single system to evaluate action priorities instead of multiple systems required from multiple customers. Risk Priority Numbers are the product of S x O x D and range from 1 to 1000. The RPN distribution can provide some information about the range of ratings. but RPN alone is not an adequate method to determine the need for more actions since RPN gives equal weight to S. O, and D. For this reason. RPN could result in similar risk numbers for very different combinations of S, O. and D leaving the team uncertain about how to prioritize. When using RPN it is recommended to use an additional method to prioritize like RPN results such as S x 0. The use of a Risk Priority Number(RPN) threshold is not a recommended practice for determining the need for actions. Risk matrices can represent combinations of S and 0, S and D, and 0 and D. These matrices provide a visual representation of the results of the analysis and can be used as an input to prioritization of actions based on company-established .Since the AP Table was designed to work with the Severity, Occurrence, and Detection tables , if the organization chooses to modify the S,0, D tables for specific products, processes, or projects, the AP table should also be carefully reviewed.
Note: Action Priority rating tables are the same for DFMEA and PFMEA, but different for FMEA-MSR.

Priority High (H): Highest priority for review and action. The team needs to either identify an appropriate action to improve Prevention and/or Detection Controls or justify and document why current controls are adequate.

Priority Medium (M): Medium priority for review and action. The team should identify appropriate actions to improve prevention and / or detection controls, or. at the discretion of the company, justify and document Why controls are adequate.

Priority Low (L): Low priority for review and action. The team could identify actions to improve
prevention or detection controls.

It is recommended that potential Severity 9-10 Failure Effects with Action Priority High and Medium, at a minimum, be reviewed by management including any recommended actions that were taken. This is not the prioritization of High, Medium, or Low risk, it is the prioritization of the actions to reduce risk.
Note: It may be helpful to include a statement such as “No further action is needed” in the Remarks field as appropriate.

Action Priority (AP) for DFMEA and PFMEA
Action Priority is based on combinations of Severity, Occurrence, and Detection ratings in order to prioritize actions for risk reduction.Blank until filled in by user
EffectSPrediction of Failure Cause occurringOAbility to detectDAction Priority (AP)Comments
Product or Plant Effect Very high9-10Very high8-10Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1H 
High6-7Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1H 
Moderate4-5Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1M 
Low2-3Low – Very low7-10H 
Moderate5-6M 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
Product or Plant Effect high7-8Very high8-10Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1H 
High6-7Low – Very low7-10H 
Moderate5-6H 
High2-4H 
Very high1M 
Moderate4-5Low – Very low7-10H 
Moderate5-6M 
High2-4M 
Very high1M 
Low2-3Low – Very low7-10M 
Moderate5-6M 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
Product or Plant Effect Moderate4-6Very high8-10Low – Very low7-10H 
Moderate5-6H 
High2-4M 
Very high1M 
High6-7Low – Very low7-10M 
Moderate5-6M 
High2-4M 
Very high1L 
Moderate4-5Low – Very low7-10M 
Moderate5-6L 
High2-4L 
Very high1L 
Low2-3Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
Product or Plant Effect low2-3Very high8-10Low – Very low7-10M 
Moderate5-6M 
High2-4L 
Very high1L 
High6-7Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Moderate4-5Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Low2-3Low – Very low7-10L 
Moderate5-6L 
High2-4L 
Very high1L 
Very low1Very high – Very low1-10L 
No discemible effect1Very low- Very high1-10Very high – Very low1-10L 
Table AP — ACTION PRIORITY FOR DFMEA and. PFMEA
Example of DFMEA. Risk Analysis Form Sheet

5.11 Collaboration between Customer and Supplier (Severity)
The output of the Risk Analysis creates the mutual understanding of technical risk between customers and suppliers. Methods of collaboration range from verbal to formal reports. The amount of information shared is based on the needs of a project, company policy, contractual agreements, and so on. The information shared depends on the placement of the company in the supply chain.Some examples are listed below.

  • The OEM may compare design functions, failure effects, and severity from a vehicle-level DFMEA with the Tier 1 supplier DFMEA.
  • The Tier 1 supplier may compare design functions, failure effects, and severity from a subsystem DFMEA with the Tier 2 supplier who has design responsibility.
  • The Tier 1 supplier communicates necessary information about product characteristics on product drawings and/or specifications, or other means. including designation of standard or special characteristics and severity. This information is used as an input to the Tier 2 supplier PFMEA as well as the Tier 1’s internal PFMEA. When the design team communicates the associated risk of making product characteristics out of specification the process team can build in the appropriate level of prevention and detection controls in manufacturing.

5.12 Basis for Optimization
The output of Steps 1, 2. 3, 4. and 5 of the 7-step FMEA process is used to determine if additional design or testing action is needed. The design reviews, customer reviews, management reviews, and cross-functional team meetings lead to Step 6 Optimization.

Step 6: Optimization

6.1 Purpose
The purpose of the Design Optimization is to determine actions to mitigate risk and assess the effectiveness of those actions. The main objectives of a Design Optimization are:

  • I Identification of the actions necessary to reduce risks
  • Assignment of responsibilities and deadlines for action implementation
  • Implementation and documentation of actions taken including confirmation of the effectiveness of the implemented actions and assessment of risk after actions taken
  • Collaboration between the FMEA team, management, customers, and suppliers regarding potential failures
  • Basis for refinement of the product requirements and prevention and detection controls

The primary objective of Design Optimization is to develop actions that reduce risk and increase customer satisfaction by improving the design. In this step, the team reviews the results of the risk analysis and assigns actions to lower the likelihood of occurrence of the Failure Cause or increase the robustness of the Detection Control to detect the Failure Cause or Failure Mode. Actions may also be assigned which improve the design but do not necessarily lower the risk assessment rating. Actions represent a commitment to take a specific, measurable, and achievable action, not potential actions which may never be implemented. Actions are not intended to be used for activities that are already planned as these are documented in the Prevention or Detection Controls and are already considered in the initial risk analysis. If the team decides that no further actions are. necessary. “No further action is needed” is written in the Remarks field to show the risk analysis was completed. The DFMEA should be used to assess technical risks related to continuous improvement of the design. The optimization is most effective in the following order.

  • Design modifications to eliminate or mitigate a Failure Effect (FE).
  • Design modifications to reduce the Occurrence (O) of the Failure Cause (FC)
  • Increase the Detection (D) ability for the Failure Cause (FC) or Failure Mode (FM).
  • In the case of design modifications, all impacted design elements are evaluated again.

In the case of concept modifications. all steps of the FMEA are reviewed for the affected sections. This is necessary because the original analysis is no longer valid since it was based upon a different design concept.

6.2 Assignment of Responsibilities
Each action should have a responsible individual and a Target Completion Date (TCD) associated with it. The responsible person ensures the action status is updated. If the action is confirmed this person is also responsible for the action implementation. The Actual Completion Date for Preventive and Detection Actions is documented including the date the actions are implemented.
Target Completion Dates should be realistic (i.e., in accordance with the product development plan, prior to process validation, prior to start of production).

.6.3 Status of the Actions
Suggested levels for Status of Actions:

  • Open: No action defined.
  • Decision pending (optional): The action has been defined but has not yet been decided on. A decision paper is being created.
  • Implementation pending (optional): The action has been decided on but not yet implemented.
  • Completed:Completed actions have been implemented and their effectiveness has been demonstrated and documented. A final evaluation has been done.
  • Not Implemented: Not implemented status is assigned when a decision is made not to implement an action. This may occur when risks related to practical and technical limitations are beyond current capabilities.

The FMEA is not considered “complete“ until the team assesses each item’s Action Priority and either accepts the level of risk or documents closure of all actions. If “No Action Taken,” then Action Priority is not reduced. and the risk of failure is carried forward into the product design. Actions are open loops that need to be closed in writing.

6.4 Assessment of Action Effectiveness
When an action has been completed, Occurrence and Detection values are reassessed, and a new Action Priority may be determined. The new action receives a preliminary Action Priority rating as a prediction of effectiveness. However, the status of the action remains “implementation pending” until the effectiveness has been tested. After the tests are finalized the preliminary rating has to be confirmed or adapted when indicated. The status of the action is then changed from “implementation pending” to “completed.” The reassessment should be based on the effectiveness of the Preventive and Detection Actions taken and the new values are based on the definitions in the Design FMEA Occurrence and Detection rating tables.

6.5 Continual Improvement
The DFMEA serves as an historical record for the design. Therefore, the original Severity, Occurrence, and Detection (S,O,D) numbers need to be visible or at a minimum available and accessible as part of version history. The completed analysis becomes a repository to capture the progression of design decisions and design refinements. However, originalS, O, D ratings may be modified for foundation. family or generic DFMEA’s because the information is used as a starting point for an application-specific analysis.

Example of DFMEA Optimization with new Risk Evaluation Form Sheet

6.6 Collaboration between the FMEA team, Management, Customers and Suppliers regarding Potential Failures

Communication between the FllA team, management, customers and suppliers during the development of the technical risk analysis and/or when the DFMEA is initially complete brings people together to improve their understanding of product functions and failures. In this way, there is a transfer of knowledge that promotes risk reduction.

Step 7: Results Documentation

7.1 Purpose
The purpose of the Results Documentation step is to summarize and communicate the results of the FMEA activity. The main objectives of Design Results Documentation are:

  • Communication of results and conclusions of the analysis
  • Establishment of the content of the documentation
  • Documentation of actions taken. including confirmation of the effectiveness of the implemented actions and assessment of risk after actions taken
  • Communication of actions taken to reduce risks, including within the organization, and with customers and/or suppliers as appropriate
  • Record of risk analysis and risk reduction to acceptable levels

7.2 FMEA Report
The report may be used for communication purposes within a company. or between companies. The report is not meant to replace reviews of the DFMEA details when requested by management, customers, or suppliers. It is meant to be a summary for the DFMEA team and others to confirm completion of each of the tasks and review the results of the analysis. It is important that the content of the documentation fulfills the requirements of the organization, the intended reader, and relevant stakeholders. Details may be agreed upon between the parties. In this way, it is also ensured that all details of the analysis and the intellectual property remain at the developing company. The layout of the document may be company specific. However, the report should indicate the technical risk of failure as a part of the development plan and project milestones. The content may include the following:

  1. A statement of final status compared to original goals established in Project Plan
    • FMEA lntent— Purpose of this FMEA?
    • FMEA Timing — FMEA due date?
    • FMEA Team — List of participants?
    • FMEA Task — Scope of this FMEA?
    • FMEA Tool – How do we conduct the analysis Method used?
  2. A summary of the scope of the analysis and identify what is new.
  3. A summary of how the functions were developed.
  4. A summary of at least the high—risk failures as determined by the team and provide a copy of the specific S/O/D rating tables and method of action prioritization (e.g. Action Priority table).
  5. A summary of the actions taken and/or planned to address the high-risk failures including status of those actions.
  6. A plan and commitment of timing for ongoing FMEA improvement actions.
    • Commitment and timing to close open actions.
    • Commitment to review and revise the DFMEA during mass production to ensure the accuracy and completeness of the analysis as compared with the production design (e.g. revisions triggered from design changes, corrective actions, etc.. based on company procedures).
    • Commitment to capture “things gone wrong” in foundation DFMEAs for the benefit of future analysis reuse, when applicable.
Standard DFMEA Farm Sheet
Alternate DFMEA Form Sheet
DFMEA Software View

AIAG & VDA Failure Mode and Effect Analysis

Failure Mode and Effects Analysis (FMEA) is a team-oriented, systematic. qualitative, analytical method intended to:

  • evaluate the potential technical risks of failure of’a product or process
  • analyze the causes and effects of those failures
  • document preventive and detection actions
  • recommend actions to reduce risk

Manufacturers consider different types of risk including technical risks. financial risks, time risks and strategy risks. The FMEA is used for analyzing the technical risks to reduce failures and improve safety in the products and processes.

The objective of FMEA is to identify the functions of a product or steps of a process and the associated potential failure modes, effects, and causes. Furthermore, it is used to evaluate whether prevention and detection controls already planned are enough, and to recommend additional actions. The FMEA documents and tracks actions that are taken to reduce risk. The FMEA methodology helps engineers prioritize and focus on preventing product and/or process problems from occurring. Business objectives exist that are supported by the FMEA and other activities. such as:

  • Increasing the quality, reliability, manufacturability, serviceability. and safety of automotive products
  • Ensuring the hierarchy. linkage, interface. and cascading and alignment of requirements between components, systems and vehicles are captured
  • Reducing warranty and goodwill costs
  • increasing customer satisfaction in a highly competitive market
  • Proving product and process risk analysis in the case of product liability
  • Reducing late changes in development
  • Maintaining defect-free product launches
  • Targeting communication in internal and external customer and supplier relationships
  • Building up a knowledge base in the company. i.e document lessons—learned
  • Complying with regulations in the registration approval of the components, systems, and vehicles

Limitations of the FMEA include the following:

  • It is qualitative (subjective). not quantitative (measurable)
  • It is a single-point failure analysis not a multi-point failure analysis
  • It relies on the team’ 5 level of knowledge which may or may not predict future performance.
  • It is a summary of the team’ s discussions and decisions, therefore, the quality of the FMEA report is subject to the recording skills of the team which may reflect the discussion points in whole, or in part (it is not a transcript of a meeting)

For quantitative analysis and multi-point failure analysis other methods such as FTA (Fault Tree Analysis) and FMEDA (Failure Modes Effects, and Diagnostic Analysis) are used. These are the methods which can calculate and analyze the relevant metrics (e.g. single-point failure analysis. multi—point faults latent faults) to reach a quantified analysis result.

Integration of FMEA in the Company

FMEA is a multi-disciplined activity affecting the entire product realization process. The implementation of FMEA needs to be well planned to be fully effective. The FMEA method is an integral element of Product Development and Process Development activities. The FMEA can reduce product redevelopment timing and cost. It supports the development of comprehensive specifications, test plans, and Control Plans.

1 Potential Considerations of the FMEA
The competent performance of the FMEA and the implementation of its results are among the responsibilities of companies that design,manufacture, and/or assemble products for the automotive industry. It is critical that the analysis take into consideration the product’s operating conditions during its useful life. particularly with regard to safety risks and foreseeable (but unintentional) misuse. When the FMEA is performed, the following norms are observed:

  • Clear: potential failure modes are described in technically precise, specific terms. enabling a specialist to assess failure causes and possible effects. Descriptions are free from possible misunderstanding. Emotion-laden terms, (e.g. dangerous, intolerable, irresponsible, etc.) are not appropriate.
  • True: the consequences of potential failures are described accurately (e.g.. potential for odor, smoke, fire, etc.).
  • Realistic: failure causes are reasonable. Extreme events are not considered (e.g.. falling rock on road, no power to manufacturing plant. etc.). Failures resulting from misuse relative to perception, judgement, or action are considered foreseeable when documented by systematic methods (including brainstorming, expert judgement, field reports. use case analysis, etc.). Failures resulting from intentional misuse (e.g. deliberate manipulation and sabotage) are not considered.
  • Complete: foreseeable potential failures are not concealed. Concern about revealing too much know-how by creating a correct and competent FMEA is not a valid reason for an incomplete FMEA. Completeness refers to the entirety of the product/process under analysis (e.g., system elements and functions). However. the depth of detail depends on the risks involved.

Technical risks of failure identified in the FMEA are either assessed as acceptable. or actions are assigned to further reduce risk. The closure status of actions to reduce the risk is documented.

2 Senior Management Commitment

The FMEA process can take considerable time to complete. A commitment of the required resources is vital. Active participation of the product and process owners and commitment from senior management are important to successful FMEA development. Senior management carries the responsibility for the application of FMEA. Ultimately. senior management is responsible for acceptance of the risks and risk minimization actions identified in the FMEA.

3 Know-How Protection of the Design FMEA/ Process FMEA

The sharing of intellectual property found in the Design FMEA and for Process FMEA between suppliers and customers is governed by contractual agreements between suppliers and customers .

4 Agreements between Customers and Suppliers
The Customer Specific Requirements regarding FMEA should be coordinated with the parties involved and for the suppliers. An agreement made about the execution of FMEAs may include but is not limited to items such as system boundaries, necessary work documents, analysis methods, and evaluation tables.

5 Foundation and Family FMEAs
Foundation and family FMEAs are recommended to be created and used as a basis for new analyses. These optional practices provide the greatest opportunity to leverage past experience and knowledge and ensure that knowledge is accumulated over product lifecycles and that prior performance issues are not repeated (lessons learned). Furthermore. such reuse also reduces effort and expenditures. Foundation FMEAs (also known as generic. baseline, template, core, master, or best practice FMEAs. etc.) are FMEAs that contain knowledge of the organization from prior developments which make them useful as a starting point for new FMEAs. The foundation FMEA is not program specific, therefore the generalization of requirements, functions, and measures is allowed. Family FMEAs are specialized foundation FMEAs. It is common to develop products that generally contain common or consistent product boundaries and related functions (a Product Family) or processes which contain a series of operations that produce multiple products or part numbers. In these cases, it is appropriate to develop Family FMEAs which cover the commonalities for these Families. When using the family or foundation FMEA approach for the new product or process under development, the team should identify and focus the analysis on the differences between the existing and the new product, process or application. The information and. ratings carried over from the family or foundation are to be criticality- examined. with regard to the respective use case, and experiences from the known application.

FMEA for Products and Processes

There are three basic cases fer which the FMEA is to be applied, each with a different scope or focus.
Case 1: New designs. new technology, or new process. The scope of the FMEA is the complete design. technology. or process.

Case 2: New application of existing design or process. The scope of the FMEA is an existing design or process in a new environment, location, application, or usage profile (including duty cycle, regulatory requirements, etc.). The scope of the FMEA should focus on the impact of the new environment, location, or application usage on the existing design or process.
Case 3: Engineering changes to an existing design or process. New technical developments, new requirements, product recalls, and reports of failures in the field may drive the need for design and/or process changes. In these cases, a review or revision of the FMEA may be necessary.
The FMEA contains a collection of knowledge about a design or process and may be revised after start of production if at least, one of the following points applies:

  • Changes to designs or processes
  • Changes to the operating conditions
  • Changed requirements (e.g.. law. norms. customer. state of the art)
  • Quality Issues, ( e.g.. Plant experience. zero mileage, or field issues. internal / external complaints)
  • Changes to the Hazard Analysis and Risk Assessment (HARA)
  • Changes to the Threat Analysis and Risk Assessment (TARA)
  • Findings due to product monitoring
  • Lessons learned
    There are two main approaches to FMEA: the analysis according to product functions (Design FMEA) or according to process steps (Process FMEA).

1 Design FMEA
A Design FMEA (DFMEA) is an analytical technique utilized primarily by a design responsible engineer/team as a means to assure that, to the extent possible. potential Failure Modes and their associated Causes or mechanisms of failure have been considered and addressed prior to releasing the part to production. The Design FMEA analyzes the functions of a system, subsystem, or component of interest as defined by the boundary shown on the Block/Boundary Diagram, the relationship between its underlying elements, and to external elements outside the system boundary. This enables the identification of possible design weaknesses to minimize potential risks of failure. A System DFMEA is comprised of various subsystems and components which are represented as system elements (items). System and subsystem analyses are dependent on the viewpoint or responsibility. Systems provide functions at the vehicle level. These functions cascade through subsystems and components. For purpose of analysis, a sub-system is considered the same way as a system. Interfaces and interactions among systems, subsystems, the environment and the customers (e.g. Tier N, OEM, and end user) may be analyzed in System FMEAs. Within a system there may be software, electronic, and mechanical elements. Examples of systems include: Vehicle, Transmission System, Steering System, Brake System or Electronic Stability Control System, etc. A component DFMEA is a subset of a system or subsystem DFMEA. For example. an Electrical Motor is a component of the Window Lifter, which is a subsystem of Window Lifter System. A Housing for the Electrical Motor may also be a component or part. For this reason, the terms “system element” or “item” are used regardless of the level of analysis. Design FMEA may also be used to assess the risks of failure of non-automotive products such as machines, and tooling. The actions resulting from the analysis may be used to recommend design changes, additional testing, and other actions which reduce the risk of failure or increase the ability of a test to detect failures prior to delivery of the design for production.

2 Process FMEA
In contrast to the Design FMEA (DFMEA). which analyzes the failure possibilities that may be created during the design phase of the product, the Process FMEA (PFMEA) analyzes the potential failures of manufacturing, assembly and logistical processes to produce products which conform to design intent. Process-related failures are different than the failures analyzed in the Design FMEA. The Process FMEA analyzes processes by considering the potential failure modes which may result from process variation, to establish priority of actions for prevention, and as needed, improve controls. The overall purpose is to analyze processes and take action prior to production start. to avoid unwanted defects related to manufacturing and assembly and the consequences of those defects.

3 Collaboration between FMEAs
There are opportunities for collaboration between both Design and Process FMEAs in the same company and outside of the company. To help communicate effects and severity, a joined and agreed to severity evaluation can be reviewed between organizations (different companies in the supply chain starting with Tier 1. Tier 2. Tier 3. etc.)

A good starting point for a manufacturer is to make sure the severity in the DFMEA and PFMEA are the same when the failure effects are the same. If the “product“ failure effects to the end user
(vehicle-level) are not included in the PFMEA then the correlation between the DFMEA and PFMEA is not possible. A correlation needs to be made so that a failure of a feature in design that leads to a certain failure effect is also captured in the PFMEA for the same feature (product characteristic).

Project Planning
The Five T’s are five topics that should be discussed at the beginning of a DFMEA or PFMEA. In order to achieve the best results on time and avoid FMEA rework. These topics can be used as part of a project kick- off.

  • FMEA lnTent – Why are we doing FMEA?
  • FMEA Timing- When is this due?
  • FMEA Team – Who needs to be on the team?
  • FMEA Task – What work needs to be done?
  • FMEA Tools- How do we conduct the analysis?

1 FMEA lnTent

It is recommended that members of the FMEA team are competent in the method, based on their role on the team. When team members understand the purpose and intent of FMEA. they will be more prepared to contribute to the goals and objectives of the project.

2 FMEA Timing

FMEA is meant to be a “before-the-event” action. not an “after-the- fact” exercise. To achieve the greatest value, the FMEA is conducted before the implementation of a product or process in which the failure mode potential exists. One of the most important factors for the successful implementation of an FMEA program is timeliness. Up-front time spent properly completing an FMEA, when product/process changes can be most easily and inexpensively implemented, will minimize late change crises. The FMEA as a method for system analysis and failure prevention is best initiated at an early stage of the product development process. It is used to evaluate the risks, valid at that time, in order to initiate actions to minimize them. In addition. the FMEA can support the compilation of requirements. The. FMEA should be carried out according to the project plan and evaluated at the project milestones according to the state of the analysis, it is recommended that a company defines the desired maturity levels for their FMEAs according to overall company-specific development project milestones.

Advanced Product Quality Planning (APQP) PhasesPlan and Define programProduct Design and Development  VerificationProcess Design and Development VerificationProduct and Production ValidationFeedback Assessment and Corrective action
DFMEAStart FMEA planning in concept phase before product development begins information flow from DFMEA and PFMEA The DFMEA and PFMEA should be executed during the same time period to allow optimization of both the product and process design  Start DFMEA when the design concept is well understoodComplete DFMEA analysis prior to release of design specification for QuotationComplete DFMEA action prior to start of production ToolingStart again with DFMEA and PFMEA planning if there are changes to an existing Design or process
PFMEAStart PFMEA when the production concept is well understoodComplete PFMEA analysis prior to final Process decisionComplete PFMEA action prior to PPAP/PPA
FMEA Timing Aligned with APQP Phases
VDA maturity level Assurance level for new partsML0ML1ML2ML3ML4ML5ML6ML7
Innovation Approval for serial DevelopmentRequirement Management for procurement ExtensiveDefinition of the supply chain and placing of ExtensiveApproval of Technical SpecificationProduction planning doneSerial tools, spare parts and Serial Machines availableProduct and Process approvalProject End, Responsibilities transfer to serial production, start ,Requalification
DFMEA Start FMEA planning in concept phase before product development begins information flow from DFMEA and PFMEA The DFMEA and PFMEA should be executed during the same time period to allow optimization of both the product and process design  Start DFMEA when the design concept is well understoodComplete DFMEA analysis prior to release of design specification for Quotation Complete DFMEA action prior to start of production Tooling Start again with DFMEA and PFMEA planning if there are changes to an existing Design or process
PFMEA Start PFMEA when the production concept is well understood Complete PFMEA analysis prior to final Process decision Complete PFMEA action prior to PPAP/PPA
FMEA Timing Aligned to MLA Phases

NOTE: Exceptions to this FMEA timing include non-traditional development flows such as where development of a “standard” process precedes the development of products that will be manufactured using the process.

3 FMEA Team

The FMEA team consists of multi-disciplinary (cross-functional) members who encompass the necessary subject matter knowledge. This should include facilitation expertise and knowledge of the FMEA process. The success of the FMEA depends on active participation of the cross-functional team as necessary to focus on the topics of discussion.

The Design FMEA Team
The Core Team may consist of the following people:-

  • facilitator
  • design engineer
  • system engineer .
  • component engineers
  • test engineer
  • quality/reliability engineer
  • others responsible for the development of the product

The Core Team members prepare the FMEA System Analysis. (Steps 1-3) and participate in the FMEA meetings. The Extended Team may participate on demand (coordinated by the FMEA facilitator or meeting organizer). The Extended Team may consist of the following people:

  • technical experts
  • process/manufacturing engineer
  • service engineer
  • project manager
  • functional safety engineer
  • purchasing
  • supplier
  • customer representative
  • others that may have specialized knowledge which will help the core team analyze specific aspects of the product

The Process FMEA Team
The Core Team may consist of the following people:

  • facilitator
  • prccess/manufacturing engineer
  • ergonomic engineer
  • process validation engineer
  • quality/reliability engineer
  • others responsible for the development of the process

The Core Team members prepare the FMEA System Analysis (Steps 1 – 3) and participate in the FMEA meetings. The Extended Team may participate on demand (coordinated by the FMEA facilitator or meeting organizer). The Extended Team may consist of the following people:

  • design engineer
  • technical experts
  • service engineer
  • project manager
  • maintenance staff
  • line worker
  • purchasing
  • supplier
  • others (as necessary)

FMEA Team Roles and Responsibilities
Within the organization’s product development process. the following roles and responsibilities for FMEA participation should be assigned. Responsibilities of a given role can be shared amongst different persons and/or multiple roles may be assigned to the same person.
a) Management, (Project Manager)

  • Authority to make decisions about the acceptability of identified risks and the execution of actions
  • Defines the persons responsible for pre-work activities, FMEA facilitation, and the design/process engineer responsible for implementation of actions resulting from the analysis
  • Responsible for selecting and applying resources and ensuring an effective risk management process is implemented within scheduled project timing
  • Responsibility and ownership for development and maintenance of the FMEAs.
  • Management responsibility also includes providing direct support to the team(s) through on-going reviews and eliminating roadblocks.
  • Responsible for budget.

b) Lead Design/Process Engineer (Technical Lead)

  • Technical responsibility for the FMEA contents
  • Preparation of the Business Case for technical and/or financial decisions
  • Definition of elements, functions, requirements, and interfaces
  • Focusing on the topics
  • Procurement of the necessary documents and information
  • Incorporating lessons learned

c) FMEA Facilitator

  • Coordination and organization of the workflows in the FMEA
  • Mitigation of conflicts
  • Participation in the team formation
  • Participation in the Preparation of the rough schedule
  • Participation in the invitation to the 1st team meeting for the analysis phase
  • Participation in the Preparation of the decision guidelines/criteria
  • Development of Corporate or Product Line Examples for Rating Tables (Optional) with support from Design/Process Engineer
  • Method competence (FMEA) and familiarization of participants in the FMEA method
  • FMEA Software documentation competence (as necessary)
  • Social skills. able to work in a team
  • Competent moderator, ability to convince, organization and, presentation skills
  • Managing execution of the 7 steps of FMEA method
  • If necessary, Preparation or wrap-up of FMEA meetings
  • Moderation of the FMEA workgroup
  • NOTE: Any team member with the relevant competence and training may fulfill the role of facilitator,

d Core Team Members.

  • Contribute knowledge from relevant product and process experience
  • Contribute necessary information about the product or process that is the focus of the FMEA
  • Contribution of existing experiences from previous FMEAs already known
  • Participation in the execution of the 7 steps of FMEA
  • Involvement in the Preparation of the Business Case
  • Incorporating lessons learned

e Extended Team Members/Experts

  • Contribution of additional information about special topics
  • Contribution of necessary information about the product or process that is the focus of the FMEA
  • Involvement in the Preparation of the Business Case

4 FMEA Task
The 7-Step Overview provides the framework for the tasks and deliverables of the FMEA. In addition, the FMEA team should be prepared to review the results of their analysis with management and the customer. upon request.The FMEA may also be audited by an internal auditor, customer auditor, or third-party registrar to ensure each task has been fulfilled.

5 FMEA Tools

There are numerous FMEA Tools, i.e.. software packages that an be used to develop a DFMEA and PFMEA as well as follow up on actions. This software ranges from dedicated FMEA software to standard spreadsheets customized to develop the FlEA. Companies may develop their own in-house database solution or purchase commercial software. In any case. the FMEA team needs to have knowledge of how to use the FMEA tool selected for their project as required by the company. The Software View depicts what the user sees when developing a FMEA using specialized software that utilizes system element structure, function net, failure net, etc. The Form View depicts what the user sees when developing a FMEA in a spreadsheet.

FMEA METHODOLOGY

The FMEA process is carried cut in seven steps. These seven steps provide a systematic approach to perforrn a Failure Made and Effects Analysis and serve as a record of the The FMEA process is carried cut in seven steps. technical risk analysis.

AIAG- Advance Product Quality Planning and Control Plan (APQP)

Product Quality Planning is a structured method of defining and establishing the steps necessary to assure that a product satisfies the customer. The goal of product quality planning is to facilitate communication with everyone involved to assure that all required steps are completed on time. Effective product quality planning depends on a company’s top management commitment to the effort required in achieving customer satisfaction. Some of the benefits of product quality planning are:

  • To direct resources to satisfy the customer.
  • To promote early identification of required changes.
  • To avoid late changes.
  • To provide a quality product on time at the lowest cost.

The work practices, tools, and analytical techniques described in this manual are listed in a logical sequence to make it easy to follow. Each Product Quality Plan is unique. The actual timing and sequence of execution is dependent on customer needs and expectations and/or other practical matters. The earlier a work practice, tool, and/or analytical technique can be implemented in the Product Quality Planning Cycle, the better.

Organize the Team:The organization’s first step in product quality planning is to assign a process owner for the APQP project. In addition, a cross functional team should be established to assure effective product quality planning. The team should include representatives from multiple functions such as engineering, manufacturing, material control, purchasing, quality, human resources, sales, field service, suppliers, and customers, as appropriate.

Define the Scope: It is important for the organization’s product quality planning team in the earliest stage of the product program to identify customer needs, expectations, and requirements. At a minimum, the team must meet to:

  • Select a project team leader responsible for overseeing the planning process. (In some cases it may be advantageous to rotate the team leader during the planning cycle.)
  • Define the roles and responsibilities of each area represented.
  • Identify the customers – internal and external.
  • Define customer requirements. (Use QFD if applicable.)
  • Select the disciplines, individuals, and/or suppliers that must be added to the team, and those not required
  • Understand customer expectations, i.e., design, number of tests.
  • Assess   the    feasibility   of   the    proposed   design,   performance requirements and manufacturing process.
  • Identify costs, timing, and constraints that must be considered.Determine assistance required from the customer.
  • Identify documentation process or method.

Team-to-Team: The organization’s product quality planning team must establish lines of communication with other customer and organization teams. This may include regular meetings with other teams. The extent of team-to-team contact is dependent upon the number of issues requiring resolution.

Training: The success of a Product Quality Plan is dependent upon an effective training program that communicates all the requirements and development skills to fulfill customer needs and expectations.

Customer and Organization Involvement: The primary customer may initiate the quality planning process with an organization. However, the organization has an obligation to establish a cross functional team to manage the product quality planning process. Organizations must expect the same performance from their suppliers.

Simultaneous Engineering: Simultaneous Engineering is a process where cross functional teams strive for a common goal. It replaces the sequential series of phases where results are transmitted to the next area for execution. The purpose is to expedite the introduction of quality products sooner. The organization’s product quality planning team assures that other areas/teams plan and execute activities that support the common goal or goals

Control Plans: Control plans are written descriptions of the systems for controlling parts and processes. Separate control plans cover three distinct phases:

  • Prototype – A description of the dimensional measurements and material and performance tests that will occur during Prototype build
  • Pre-launch – A description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production.
  • Production – A comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production.

Concern Resolution:  During the planning process, the team will encounter product design and/or processing concerns. These concerns should be documented on a matrix with assigned responsibility and timing. Disciplined problem- solving methods are recommended in difficult situations. Analytical techniques described in Appendix B should be used as appropriate.

Product Quality Timing Plan: The organization’s product quality planning team’s first order of business following organizational activities should be the development of a Timing Plan. The type of product, complexity and customer expectations should be considered in selecting the timing elements that must be planned and charted. All team members should agree with each event, action, and timing.   A well-organized timing chart should list tasks, assignments, and/or other events. (The Critical Path Method may be appropriate;) Also, the chart provides the planning team with a consistent format for tracking progress and setting meeting agendas. To facilitate status reporting, each event must have a “start” and a “completion” date with the actual point of progress recorded. Effective status reporting supports program monitoring with a focus on identifying items that require special attention.  

Plans Relative to the Timing Chart: The success of any program depends on meeting customer needs and expectations in a timely manner at a cost that represents value. The Product Quality Planning Timing Chart below and the Product Quality Planning Cycle described previously require a planning team to concentrate its efforts on problem prevention. Problem prevention is driven by Simultaneous Engineering performed by product and manufacturing engineering activities working concurrently. Planning teams must be prepared to modify product quality plans to meet customer expectations. The organization’s product quality planning team is responsible for assuring that timing meets or exceeds the customer timing plan.

1.0 Plan and Define Program

IT describes how customer needs and expectations are linked to planning and defining a quality program. The goal of any product program is meeting customer needs while providing competitive value. The initial step of the product quality planning process is to ensure that customer needs and expectations are clearly understood.The inputs and outputs applicable to the planning process may vary according to the product development process, and customer needs and expectations.

INPUTS

  • Voice of the Customer
    • Market Research (including OEM Vehicle Build Timing and OEM Volume Expectations)
    • Historical Warranty and Quality Information
    • Team Experience
  • Business Plan/Marketing Strategy
  • Product/Process Benchmark Data
  • Product/Process Assumptions
  • Product Reliability Studies
  • Customer Inputs

OUTPUTS

  • Design Goals
  • Reliability and Quality Goals
  • Preliminary Bill of Material
  • Preliminary Process Flow Chart
  • Preliminary Listing of Special Product and Process Characteristics
  • Product Assurance Plan
  • Management Support (including program timing and planning for resources and staffing to support required capacity)

1.1 Voice of the Customer
The “Voice of the Customer” encompasses complaints, recommendations, data and information obtained from internal and/or external customers. Some methods for gathering this information are as follows.

1.1.1 Market Research

The organization’s product quality planning team may need to obtain market research data and information reflecting the Voice of the Customer. The following sources can assist in identifying customer concerns and wants and translating those concerns into product and process characteristics:

  • Customer interviews
  • Customer questionnaires and surveys
  • Market test and positioning reports
  • New product quality and reliability studies
  • Competitive product quality studies
  • Best Practices
  • Lessons Learned

1.1.2 Historical Warranty and Quality Information

A list of historical customer concerns and wants should be prepared to assess the potential for recurrence during the design, manufacture, installation and use of the product. These should be considered as an extension of the other design requirements and included in the analysis of customer needs. Many of the following items can assist the team in identifying customer concerns and wants and prioritizing appropriate resolutions.

  • Best Practices
  • Lessons Learned
  • Warranty reports
  • Capability indicators
  • Supplier plant internal quality reports
  • Problem resolution reports
  • Customer plant returns and rejections
  • Field return product analysis

1.1.3 Team Experience

The team may use any source of any information as appropriate, including the following:

  • Input from higher system level or past Quality Function Deployment (QFD) projects
  • Media commentary and analysis: magazine and newspaper reports, etc
  • Customer letters and suggestions
  • Best Practices
  • Lessons Learned
  • Dealer comments
  • Fleet Operator’s comments
  • Field service reports
  • Internal evaluations using surrogate customers
  • Road trips
  • Management comments or direction
  • Problems and issues reported from internal customers
  • Government requirements and regulations
  • Contract review

1.2 Business Plan and Marketing Strategy

The customer business plan and marketing strategy will set the framework for the product quality plan. The business plan may place constraints (e.g., timing, cost, investment, product positioning, research and development (R&D) resources) on the team that affect the direction taken. The marketing strategy will define the target customer, the key sales points, and key competitors.

1.3 Product/Process Benchmark Data

The use of bench-marking will provide input to establishing product/process performance targets. Research and development may also provide benchmarks and concept ideas. One method to successful bench-marking is:

  • Identify the appropriate benchmarks.
  • Understand the reason for the gap between your current status and the benchmark.
  • Develop a plan to close the gap, match the benchmark, or exceed the benchmark.

1.4 Product/Process Assumptions

  There will be assumptions that the product has certain features, design, or process concepts. These include technical innovations, advanced materials, reliability assessments, and new technology. All should be utilized as inputs.

1.5 Product Reliability Studies

This type of data considers frequency of repair or replacement of components within designated periods of time and the results of long-term reliability/durability tests. 

1.6 Customer Inputs

 The next users of the product can provide valuable information relating to their needs and expectations. In addition, the next product users may have already conducted some or all of the aforementioned reviews and studies. These inputs should be used by the customer and/or organization to develop agreed upon measures of customer satisfaction.

1.7 Design Goals

 Design goals are a translation of the Voice of the Customer into measurable design objectives. The proper selection of design goals assures that the Voice of the Customer is not lost in subsequent design activity. The Voice of the Customer also includes regulatory requirements such as materials composition reporting and polymeric part marking.

1.8 Reliability and Quality Goals

Reliability goals are established based on customer wants and expectations, program objectives, and reliability benchmarks. An example of customer wants and expectations could include no safety failures. Some reliability benchmarks could be competitor product reliability, warranty data, or frequency of repair over a set time period. Quality goals should be based on metrics such as parts per million, problem levels, or scrap reduction.  

1.9 Preliminary Bill of Material

The team should establish a preliminary bill of material based on product/process assumptions and include a potential supplier list.   In order to identify the preliminary special product/process characteristics it is necessary to have selected the appropriate design and manufacturing process.

1.10 Preliminary Process Flow Chart
The anticipated manufacturing process should be described using a process flow chart developed from the preliminary bill of material and product/process assumptions.

1.11 Preliminary Identification of Special Product and Process Characteristics
Special product and process characteristics are identified by the customer in addition to those selected by the organization through knowledge of the product and process. Examples of input to identification of special characteristics include:

  • Product assumptions based on the analysis of customer needs and expectations.
  • Identification of reliability goals and requirements.
  • Identification of special process characteristics from the anticipated manufacturing process.
  • Similar part FMEAs.

1.12 Product Assurance Plan
The Product Assurance Plan translates design goals into design requirements and is based on customer needs and expectations. This manual does not require a specific method for preparing a Product Assurance Plan. The Product Assurance Plan can be developed in any format understood by the organization and should include:

  • Outlining of program requirements.
  • Identification of reliability, durability, and apportionment/allocation goals and/or requirements.
  • Assessment of new technology, complexity, materials, application, environment, packaging, service, and manufacturing requirements, or any other factor that may place the program at risk.
  • Use of Failure Mode and Effects Analysis (FMEA).
  • Development of preliminary engineering requirements.

1.13 Management Support

One of the keys to the success of Advanced Product Quality Planning is the interest, commitment and support of upper management. Participation by management in product quality planning meetings is vital to ensuring the success of the program. Management should be updated at the conclusion of every product quality planning phase to reinforce their commitment and support. Updates and/or requests for assistance can occur more frequently as required. A primary goal of Advanced Product Quality Planning is to maintain management support by demonstrating that all planning requirements have been met and/or concerns documented and scheduled for resolution, including program timing and planning for resources and staffing to support required capacity

2.0 Product Design and Development

It discusses the elements of the planning process during which design features and characteristics are developed into a near final form. All design factors should be considered by the organization in the Advanced Product Quality Planning process even if the design is owned by the customer or shared. The steps include prototype build to verify that the product or service meets the objectives of the Voice of the Customer. A feasible design must permit meeting production volumes and schedules, and be consistent with the ability to meet engineering requirements, along with quality, reliability, investment cost, weight, unit cost and timing objectives. Although feasibility studies and control plans are primarily based on engineering drawings and specification requirements, valuable information can be derived from the analytical tools described in this chapter to further define and prioritize the characteristics that may need special product and process controls.In this chapter, the Product Quality Planning Process is designed to assure a comprehensive and critical review of engineering requirements and other related technical information. At this stage of the process, a preliminary feasibility analysis will be made to assess the potential problems that could occur during manufacturing.

DESIGN INPUTS

  • Design Goals
  • Reliability and Quality Goals
  • Preliminary Bill of Material
  • Preliminary Process Flow Chart
  • Preliminary Listing of Special Product and Process Characteristics
  • Product Assurance Plan
  • Management Support

DESIGN OUTPUTS

  • Design Failure Mode and Effects Analysis (DFMEA)
  • Design for Manufacturability and Assembly
  • Design Verification
  • Design Reviews
  • Prototype Build – Control Plan
  • Engineering Drawings (Including Math Data)
  • Engineering Specifications
  • Material Specifications
  • Drawing and Specification Changes

APQP OUTPUTS

  • New Equipment, Tooling and Facilities Requirements
  • Special Product and Process Characteristics
  • Gages/Testing Equipment Requirements
  • Team Feasibility Commitment and Management Support

2.1 Design Failure Mode and Effects Analysis (DFMEA)

The DFMEA is a disciplined analytical technique that assesses the probability of failure as well as the effect of such failure. A DFMEA is a living document continually updated as customer needs and expectations require. The DFMEA is an important input to the APQP process that may include previously selected product and process characteristics. The Design FMEA Checklist should also be reviewed to assure that the appropriate design characteristics have been considered.

2.2   Design for Manufacturability and Assembly

   Design for Manufacturability and Assembly is a Simultaneous Engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly. The scope of customer needs and expectations defined will determine the extent of the organization’s product quality planning team involvement in this activity. This manual does not include or refer to a formal method of preparing a Design for Manufacturability and Assembly Plan. At a minimum, the items listed here should be considered by the organization’s product quality planning team:

  • Design, concept, function, and sensitivity to manufacturing variation
  • Manufacturing and/or assembly process
  • Dimensional tolerances
  • Performance requirements
  • Number of components
  • Process adjustments
  • Material handling

The above list may be augmented based on the organization’s product quality planning team’s knowledge, experience, the product/process, government regulations, and service requirements. 

2.3 Design Verification

 Design verification verifies that the product design meets the customer requirements derived from the activities.

2.4 Design Reviews

 Design reviews are regularly scheduled meetings led by the organization’s design engineering activity and must include other affected areas. The design review is an effective method to prevent problems and misunderstandings; it also provides a mechanism to monitor progress, report to management, and obtain customer approval as required.Design reviews are a series of verification activities that are more than an engineering inspection. At a minimum, design reviews should include evaluation of:

  • Design/Functional requirement(s) considerations
  • Formal reliability and confidence goals
  • Component/subsystem/system duty cycles
  • Computer simulation and bench test results
  • DFMEA(s)
  • Review of the Design for Manufacturability and Assembly effort
  • Design of Experiments (DOE) and assembly build variation results
  • Test failures
  • Design verification progress

A major function of design reviews is the tracking of design verification progress. The organization should track design verification progress through the use of a plan and report format, referred to as Design Verification Plan and Report (DVP&R) by some customers. The plan and report is a formal method to assure:

  • Design verification
  • Product and process validation of components and assemblies through the application of a comprehensive test plan and report.

The organization’s product quality planning team is not limited to the items listed. The team should consider and use as appropriate, the analytical techniques.

2.5 Prototype Build – Control Plan

Prototype control plans are a description of the dimensional measurements and material and functional tests that will occur during prototype build. The organization’s product quality planning team should ensure that a prototype control plan is prepared. A Control Plan Checklist is provided to assist in the preparation of the prototype control plan.The manufacture of prototype parts provides an excellent opportunity for the team and the customer to evaluate how well the product or service meets the Voice of the Customer objectives. It is the organization’s product quality planning team’s responsibility to review prototypes for the following:

  • Assure that the product or service meets specification and report data as required.
  • Ensure that particular attention has been given to special product and process characteristics.
  • Use data and experience to establish preliminary process parameters and packaging requirements.
  • Communicate any concerns, deviations, and/or cost impact to the customer.

2.6 Engineering Drawings (Including Math Data)

Customer designs do not preclude the organization’s product quality planning team’s responsibility to review engineering drawings in the following manner. Engineering drawings may include special (governmental regulatory and safety) characteristics that must be shown on the control plan. When customer engineering drawings are nonexistent, the controlling drawings should be reviewed by the team to determine which characteristics affect fit, function, durability and/or governmental regulatory safety requirements.Drawings should be reviewed to determine if there is sufficient information for a dimensional layout of the individual parts. Control or datum surfaces/locators should be clearly identified so that appropriate functional gages and equipment can be designed for ongoing controls. Dimensions should be evaluated to assure feasibility and compatibility with industry manufacturing and measuring standards. If appropriate, the team should assure that math data is compatible with the customer’s system for effective two-way communications.

2.7 Engineering Specifications

A detailed review and understanding of the controlling specifications will help the organization’s product quality planning team to identify the functional, durability and appearance requirements of the subject component or assembly. Sample size, frequency, and acceptance criteria of these parameters are generally defined in the in-process test section of the Engineering Specification. Otherwise, the sample size and frequency are to be determined by the organization and listed in the control plan. In either case, the organization should determine which characteristics affect meeting functional, durability, and appearance requirements.  

2.8 Material Specifications

In addition to drawings and performance specifications, material specifications should be reviewed for special characteristics relating to physical properties, performance, environmental, handling, and storage requirements. These characteristics should also be included in the control plan.  

2.9 Drawing and Specification Changes

Where drawing and specification changes are required, the team must ensure that the changes are promptly communicated and properly documented to all affected areas.  

2.10  New Equipment, Tooling and Facilities Requirements

The DFMEA, Product Assurance Plan and/or design reviews may identify new equipment and facilities including meeting capacity requirements. The organization’s product quality planning team should address these requirements by adding the items to the Timing Chart. The team should assure that there is a process to determine that new equipment and tooling is capable and delivered on time. Facilities progress should be monitored to assure completion prior to planned production tryout.

2.11 Special Product and Process Characteristics

In the Plan and Define Program stage, the team identified preliminary special product and process characteristics. The organization’s product quality planning team should build on this listing and reach consensus through the evaluation of the technical information. The organization should refer to the appropriate customer-specific requirements

2.12  Gages/Testing Equipment Requirements

Gages/testing equipment requirements may also be identified at this time. The organization’s product quality planning team should add these requirements to the Timing Chart. Progress should be monitored to assure that required timing is met. 

2.13 Team Feasibility Commitment and Management Support

The organization’s product quality planning team must assess the feasibility of the proposed design at this time. Customer design ownership does not preclude the organization’s obligation to assess design feasibility. The team must be satisfied that the proposed design can be manufactured, assembled, tested, packaged, and delivered in sufficient quantity on schedule at an acceptable cost to the customer. The Design Information Checklist allows the team to review its efforts in this section and make an evaluation of effectiveness. This checklist will also serve as a basis for the open issues discussed in the Team Feasibility Commitment. The team consensus that the proposed design is feasible should be documented along with all open issues that require resolution and presented to management for their support.

3.0 Process Design and Development

It discusses the major features of developing a manufacturing system and its related control plans to achieve quality products.   The tasks to be accomplished at this step of the product quality planning process depend upon the successful completion of the prior stages contained in the first two sections. This next step is designed to ensure the comprehensive development of an effective manufacturing system. The manufacturing system must assure that customer requirements, needs and expectations are met. The inputs and outputs applicable to the process step in this chapter are as follows:

INPUTS

  • Design Failure Mode and Effects Analysis (DFMEA)
  • Design for Manufacturability and Assembly
  • Design Verification
  • Design Reviews
  • Prototype Build – Control Plan
  • Engineering Drawings (Including Math Data)
  • Engineering Specifications
  • Material Specifications
  • Drawing and Specification Changes
  • New Equipment, Tooling and Facilities Requirements
  • Special Product and Process Characteristics
  • Gages/Testing Equipment Requirements
  • Team Feasibility Commitment and Management Support

OUTPUTS

  • Packaging Standards & Specifications
  • Product/Process Quality System Review
  • Process Flow Chart
  • Floor Plan Layout
  • Characteristics Matrix
  • Process Failure Mode and Effects Analysis (PFMEA)
  • Pre-Launch Control Plan (including Error-Proofing Devices)
  • Process Instructions
  • Measurement Systems Analysis Plan
  • Preliminary Process Capability Study Plan
  • Management Support (including operator staffing and training plan)

3.1  Packaging Standards and Specifications

The customer will usually have packaging requirements that should be incorporated into any packaging specifications for the product. If none are provided, the packaging design should ensure product integrity at point of use. The organization’s product quality planning team should ensure that individual product packaging (including interior partitions) is designed and developed. Customer packaging standards or generic packaging requirements should be used when appropriate. In all cases the packaging design should assure that the product performance and characteristics will remain unchanged during packing, transit, and unpacking. The packaging should have compatibility with all identified material handling equipment including robots. 

3.2 Product/Process Quality System Review

The organization’s product quality planning team should review the manufacturing site(s) Quality Management System. Any additional controls and/or procedural changes required to produce the product should be updated, documented and included in the manufacturing control plan. This is an opportunity for the organization’s product quality planning team to improve the existing quality system based on customer input, team expertise, and previous experience. The Product/Process Quality Checklist can be used by the organization’s product quality planning team to verify completeness. 

3.3  Process Flow Chart

The process flow chart is a schematic representation of the current or proposed process flow. It can be used to analyze sources of variations of machines, materials, methods, and manpower from the beginning to end of a manufacturing or assembly process. It is used to emphasize the impact of sources of variation on the process. The flow chart helps to analyze the total process rather than individual steps in the process.   The flow chart assists the organization’s product quality planning team to focus on the process when conducting the PFMEA and designing the Control Plan. The Process Flow Chart Checklist can be used by the organization’s product quality planning team to verify completeness. 

3.4   Floor Plan Layout

 The floor plan should be developed and reviewed to determine the acceptability of important control items, such as inspection points, control chart location, applicability of visual aids, interim repair stations, and storage areas to contain non-conforming material. All material flow should be keyed to the process flow chart and control plan. The Floor Plan Checklist can be used by the organization’s product quality planning team to verify completeness. The floor plan layout should be developed in such a manner to optimize the material travel, handling and value-added use of floor space and should facilitate the synchronous flow of materials through the process.  

3.5 Characteristics Matrix

A characteristics matrix is a recommended analytical technique for displaying the relationship between process parameters and manufacturing stations.

3.6 Process Failure Mode and Effects Analysis (PFMEA)

A PFMEA should be conducted during product quality planning and before beginning production. It is a disciplined review and analysis of a new or revised process and is conducted to anticipate, resolve, or monitor potential process problems for a new or revised product program. The Process FMEA Checklist i can be used by the organization’s product quality planning team to verify completeness. 

3.7  Pre-Launch Control Plan

Pre-launch control plans are a description of the dimensional measurements and material and functional tests that will occur after prototype and before full production. The pre-launch control plan should include additional product/process controls to be implemented until the production process is validated. The purpose of the pre-launch control plan is to contain potential non-conformities during or prior to initial production runs. Examples of enhancements in the pre-launch control plan are:

  • More frequent inspection
  • More in-process and final check points
  • Robust statistical evaluations
  • Enhanced audits
  • Identification of error-proofing devices

 The Control Plan can be used by the organization’s product quality planning team to verify completeness.

3.8 Process Instructions

The organization’s product quality planning team should ensure that process instructions provide sufficient understanding and detail for all personnel who have direct responsibility for the operation of the processes. These instructions should be developed from the following sources:

  • FMEAs
  • Control plan(s)
  • Engineering      drawings,      performance     specifications,     material specifications, visual standards and industry standards
  • Process flow chart
  • Floor plan layout
  • Characteristics matrix
  • Packaging Standards and Specifications
  • Process parameters
  • Organization expertise and knowledge of the processes and products
  • Handling requirements
  • Operators of the process

 The process instructions for standard operating procedures should be posted and should include set-up parameters such as: machine speeds, feeds, cycle times, and tooling, and should be accessible to the operators and supervisors. Additional information for process instruction preparation may be found in appropriate customer-specific requirements. 

3.9 Measurement Systems Analysis Plan

The organization’s product quality planning team should ensure that a plan to accomplish the required measurement systems analysis is developed, including checking aids. This plan should include, at a minimum, a laboratory scope appropriate for the required measurements and tests, the responsibility to ensure gage linearity, accuracy, repeatability, reproducibility, and correlation for duplicate gages.

3.10 Preliminary Process Capability Study Plan

The organization’s product quality planning team should ensure the development of a preliminary process capability plan. The characteristics identified in the control plan will serve as the basis for the preliminary process capability study plan. . 

3.11 Management Support

The organization’s product quality planning team should schedule a formal review designed to reinforce management commitment at the conclusion of the process design and development phase. This review is critical to keeping upper management informed as well as gaining assistance to assist in resolution of any open issues. Management support includes the confirmation of the planning and providing the resources and staffing to meet the required capacity.

4.0 Product and Process Validation

IT discusses the major features of validating the manufacturing process through an evaluation of a significant production run. During a significant production run, the organization’s product quality planning team should validate that the control plan and process flow chart are being followed and the products meet customer requirements. Additional concerns should be identified for investigation and resolution prior to regular production runs.The inputs and outputs applicable to the process steps in this chapter are as follows:

INPUTS

  • Packaging Standards & Specifications
  • Product/Process Quality System Review
  • Process Flow Chart
  • Floor Plan Layout
  • Characteristics Matrix
  • Process Failure Mode and Effects Analysis (PFMEA)
  • Pre-Launch Control Plan
  • Process Instructions
  • Measurement Systems Analysis Plan
  • Preliminary Process Capability Study Plan
  • Management Support

OUTPUTS

  • Significant Production Run
  • Measurement Systems Evaluation
  • Preliminary Process Capability Study
  • Production Part Approval
  • Production Validation Testing
  • Packaging Evaluation
  • Production Control Plan
  • Quality Planning Sign-Off and Management Support

4.1 Significant Production Run

The significant production run must be conducted using production tooling, production equipment, production environment (including production operators), facility, production gages and production rate. The validation of the effectiveness of the manufacturing process begins with the significant production run . The minimum quantity for a significant production run is usually set by the customer, but can be exceeded by the organization’s product quality planning team. Output of the significant production run (product) is used for:

  • Preliminary process capability study
  • Measurement systems analysis
  • Production rate demonstration
  • Process review
  • Production validation testing
  • Production part approval
  • Packaging evaluation
  • First time capability (FTC)
  • Quality planning sign-off
  • Sample production parts
  • Master sample (as required)

4.2 Measurement Systems Analysis

The specified monitoring and measuring devices and methods should be used to check the control plan identified characteristics to engineering specification and be subjected to measurement system evaluation during or prior to the significant production run. Refer to the Chrysler, Ford, and General Motors Measurement Systems Analysis (MSA) reference manual. 

4.3 Preliminary Process Capability Study

The preliminary process capability study should be performed on characteristics identified in the control plan. The study provides an assessment of the readiness of the process for production. Refer to customer-specific requirements for unique requirements.

4.4  Production Part Approval

PPAP’s purpose is to provide the evidence that all customer engineering design record and specification requirements are properly understood by the organization and that the manufacturing process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate.

4.5 Production Validation Testing

Production validation testing refers to engineering tests that validate that products made from production tools and processes meet customer engineering standards including appearance requirements.  

4.6 Packaging Evaluation

All test shipments (when required) and test methods must assess the protection of the product from normal transportation damage and adverse environmental factors. Customer-specified packaging does not preclude the organization’s product quality planning team involvement in evaluating the effectiveness of the packaging.  

4.7 Production Control Plan

The production control plan is a written description of the systems for controlling production parts and processes. The production control plan is a living document and should be updated to reflect the addition or deletion of controls based on experience gained by producing parts. (Approval of the authorized customer representative may be required.) The production control plan is a logical extension of the pre-launch control plan. Mass production provides the organization the opportunity to evaluate output, review the control plan and make appropriate changes.

4.8 Quality Planning Sign-Off and Management Support

The organization’s product quality planning team should perform a review at the manufacturing location(s) and coordinate a formal sign-off. The product quality sign-off indicates to management that the appropriate APQP activities have been completed. The sign-off occurs prior to first product shipment and includes a review of the following:

  • Process Flow Charts. Verify that process flow charts exist and are being followed.
  • Control Plans. Verify that control plans exist, are available and are followed at all times for all affected operations.
  • Process Instructions. Verify that these documents contain all the special characteristics specified in the control plan and that all PFMEA recommendations have been addressed. Compare the process instructions, PFMEA and process flow chart to the control plan.
  • Monitoring and Measuring Devices. Where special gages, fixtures, test equipment or devices are required per the control plan, verify gage repeatability and reproducibility (GR&R) and proper usage.
  • Demonstration of Required Capacity. Using production processes, equipment, and personnel.

Upon completion of the sign-off, a review with management should be scheduled to inform management of the program status and gain their support with any open issues.

5.0 Feedback, Assessment and Corrective Action

Quality planning does not end with process validation and installation. It is the component manufacturing stage where output can be evaluated when all special and common causes of variation are present. This is also the time to evaluate the effectiveness of the product quality planning effort. The production control plan is the basis for evaluating product or service at this stage. Variable and attribute data must be evaluated. Organizations that fully implement an effective APQP process will be in a better position to meet customer requirements including any special characteristics specified by the customer.

INPUTS

  • Significant Production Run
  • Measurement Systems Evaluation
  • Preliminary Process Capability Study
  • Production Part Approval
  • Production Validation Testing
  • Packaging Evaluation
  • Production Control Plan
  • Quality Planning Sign-Off and Management Support

OUTPUTS

  • Reduced Variation
  • Improved Customer Satisfaction
  • Improved Delivery and Service
  • Effective use of Lessons Learned/Best Practices

5.1 Reduced Variation

  Control charts and other statistical techniques should be used as tools to identify process variation. Analysis and corrective actions should be used to reduce variation. Continual improvement requires attention not only to the special causes of variation but understanding common causes and seeking ways to reduce these sources of variation. Proposals should be developed including costs, timing, and anticipated improvement for customer review. The reduction or elimination of a common cause may provide the additional benefit of lower costs. Organizations should be using tools such as value analysis and reduction of variation to improve quality and reduce cost.

5.2  Improved Customer Satisfaction

Detailed planning activities and demonstrated process capability of a product or service are important components to customer satisfaction. However, the product or service still has to perform in the customer environment. This product usage stage requires organization participation. In this stage much can be learned by the organization and customer. The effectiveness of the product quality planning efforts can also be evaluated at this stage.The organization and customer become partners in making the changes necessary to correct any deficiencies and to improve customer satisfaction. 

5.3  Improved Delivery and Service

The delivery and service stage of quality planning continues the organization and customer partnership in solving problems and continual improvement. The customer’s replacement parts and service operations must also meet requirements for quality, cost, and delivery.   The goal is first time quality. However, where problems or deficiencies occur in the field it is essential that the organization and customer form an effective partnership to correct the problem and satisfy the end-user customer.The experience gained in this stage provides the customer and organization with the necessary knowledge to reduce process, inventory, and quality costs and to provide the right component or system for the next product. 

5.4 Effective Use of Lessons Learned/Best Practices

  A Lessons Learned or Best Practices portfolio is beneficial for capturing, retaining and applying knowledge. Input to Lessons Learned and Best Practices can be obtained through a variety of methods including:

  • Review of Things Gone Right/Things Gone Wrong (TGR/TGW)
  • Data from warranty and other performance metrics
  • Corrective action plans”Read-across” with similar products and processes
  • DFMEA and PFMEA studies

PRODUCT QUALITY PLANNING CHECKLISTS

The following checklists are provided to assist the organization’s product quality planning team in order to verify that the APQP process is both complete and accurate. These checklists are not intended to fully define or represent all elements of the APQP process. The use of the checklists is one of the last steps of the process and not intended as a “check the box” activity or exercise to circumvent full application of the APQP process. In reviewing the questions in the checklist, where “No” is identified as the appropriate response, the column “Comment/Action Required” is used to identify the action required to close the gap, including the impact on the APQP process. The follow up action should include identification of an individual responsible and schedule. Use the “Person Responsible” and “Due Date” columns.

ANALYTICAL TECHNIQUES

Assembly Build Variation Analysis: An assembly build variation analysis is an analysis that simulates the buildup of an assembly and examines tolerance accumulation, statistical parameters, sensitivity, and “what if” investigation. 

Benchmarking:  Benchmarking is a systematic approach to identifying standards for comparison. It provides input to the establishment of measurable performance targets, as well as ideas for product design and process design. It can also provide ideas for improving business processes and work procedures.Product and process benchmarking should include the identification of world class or best-in-class based on customer and internal objective performance measures and research into how this performance was achieved. Benchmarking should provide a stepping stone for developing new designs and processes that exceed the capabilities of the benchmark companies.

Cause and Effect Diagram: The “cause and effect” diagram is an analytical tool to indicate the relationship between an “effect” and all possible “causes” influencing it. This is sometimes referred to as fishbone diagram, Ishikawa diagram, or feather diagram.

Characteristics Matrix

   A characteristics matrix is a display of the relationship between process parameters and manufacturing stations. A method of developing the characteristics matrix is to number the dimensions and/or features on the part print and each manufacturing operation. All manufacturing operations and stations appear across the top, and the process parameters are listed down the left-hand column. The more manufacturing relationships there are, the more important the control of a characteristic becomes. Regardless of matrix size, the upstream relationships of characteristics are evident. A typical matrix is shown below

CHARACTERISTICS MATRIX

 

(EXAMPLE)

 

      TOLERANCEOPERATION NOS.
DIM.DESCRIPTION05102030
NO.     
1IDXC X
2FACE XCC
3  XLL
4   X 
5   X 
6OD  X 
  • C = Characteristic at an operation used for clamping
  • L = Characteristic at an operation used for locating
  • x = Characteristic created or changed by this operation should match the process flow diagram form

Critical Path Method

  The critical path method can be a Pert or Gantt Chart that shows the chronological sequence of tasks that require the greatest expected time to accomplish. It can provide valuable information as to:

  • Interrelationships
  • Early Forecast of Problems
  • Identification of Responsibility
  • Resource Identification, Allocation and Leveling

Design of Experiments (DOE)

A design experiment is a test or sequence of tests where potential influential process variables are systematically changed according to a prescribed design matrix. The response of interest is evaluated under the various conditions to: (1) identify the influential variables among the ones tested, (2) quantify the effects across the range represented by the levels of the variables, (3) gain a better understanding of the nature of the causal system at work in the process, and (4) compare the effects and interactions. Application early in the product/process development cycle can result in: (1) improved process yields, (2) reduced variability around a nominal or target value, (3) reduced development time, and (4) reduced overall costs.

Design for Manufacturability and Assembly

Design for Manufacturability and Assembly is a Simultaneous Engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly. The enhancement of designs for assembly and manufacturing is an important step. Plant representatives should be consulted early in the design process to review components or systems and provide input on specific assembly and manufacturing requirements. Specific dimensional tolerances should be determined based on the like process. This will assist in identifying the equipment required and any process changes necessary.

Design Verification Plan and Report (DVP&R)

The Design Verification Plan and Report (DVP&R) is a method to plan and document testing activity through each phase of product/process development from inception to ongoing refinement. An effective DVP&R provides a concise working document that aids engineering personnel in the following areas:

  • Facilitates the development of a logical testing sequence by requiring the responsible areas to thoroughly plan the tests needed to assure that the component or system meets all engineering requirements.
  • Assures product reliability meets customer-driven objectives.
  • Highlights situations where customer timing requires an accelerated test plan.
  • Serves as a working tool for responsible area(s) by:
    • Summarizing functional, durability, and reliability testing requirements and results in one document for ease of reference.
    • Providing the ability to easily prepare test status and progress reports for design reviews.

Mistake Proofing/Error- Proofing

Mistake proofing is a technique to identify errors after they occur. Mistake proofing should be used as a technique to control repetitive tasks or actions and prevent non-conformances from being passed on to the subsequent operation and ultimately the customer. Error-proofing is a technique used to identify potential process errors and either design them out of the product or process, or eliminate the possibility that the error could produce a non- conformance.

Process Flow Charting

  Process flow charting is a visual approach to describing and developing sequential or related work activities. It provides both a means of communication and analysis for planning, development activities, and manufacturing processes.Since one goal of quality assurance is to eliminate non-conformities and improve the efficiency of manufacturing and assembly processes, advanced product quality plans should include illustrations of the controls and resources involved. These process flow charts should be used to identify improvements and to locate significant or critical product and process characteristics that will be addressed in control plans to be developed later.


Quality Function Deployment (QFD)

QFD is a systematic procedure for translating customer requirements into technical and operational terms, displaying and documenting the translated information in matrix form. QFD focuses on the most important items and provides the mechanism to target selected areas to enhance competitive advantages.Depending upon the specific product, the technique of QFD may be used as a structure for the quality planning process. In particular, QFD Phase I – Product Planning translates customer requirements into counterpart control characteristics or design requirements. QFD provides a means of converting general customer requirements into specified final product and process control characteristics.  

A.  ASPECTS OF QFD

The two dimensions of QFD are:

  • Quality Deployment: Translation of Customer Requirements into Product Design Requirements.
  • Function   Deployment:  Translation   of   Design   Requirements   into appropriate Part, Process and Production Requirements.

B.  BENEFITS OF QFD

  • Increases the assurance of meeting the customer requirements.
  • Reduces number of changes due to increased engineering understanding of customer requirements.
  • Identifies potentially conflicting design requirements.
  • Focuses various company activities on customer-oriented objectives.
  • Reduces product development cycle time.
  • Reduces costs of engineering, manufacturing, and service.
  • Improves quality of product and services.
TEAM FEASIBILITY COMMITMENT

Customer:                                                                                          Date:                                                                                               

Part Number:                                                                 

Part Name:                                                                                                                  

Revision Level                                                      

Feasibility Considerations

Our product quality planning team has considered the following questions.

The drawings and/or specifications provided have been used as a basis for analyzing the organizations ability to meet all specified requirements. All “no” answers are supported with attached comments identifying our concerns and/or proposed changes to enable the organization to meet the specified requirements.  

YESNOCONSIDERATION
  Is product adequately defined (application requirements, etc. to enable feasibility evaluation?
  Can Engineering Performance Specifications be met as written?
  Can product be manufactured to tolerances specified on drawing?
  Can product be manufactured with process capability that meet requirements?
  Is there adequate capacity to produce product?
  Does the design allow the use of efficient material handling techniques?
  Can the product be manufactured within normal cost parameters? Abnormal cost considerations may include:
  – Costs for capital equipment?
  – Costs for tooling?
  – Alternative manufacturing methods?
  Is statistical process control required on the product?
  Is statistical process control presently used on similar products?
  Where statistical process control is used on similar products:
  – Are the processes in control and stable?
  – Does process capability meet customer requirements?

Conclusion 

         

Feasible            Product can be produced as specified with no revisions.

Feasible            Changes recommended (see attached).

Not Feasible     Design revision required to produce product within the specified requirements.   Approval 

Team Member/Title/Date  Team Member/Title/Date  Team Member/Title/Date  

Team Member/Title/Date  Team Member/Title/Date  Team Member/Title/Date  
  1. Under “required,” for each item indicate the number of characteristics required. Under “acceptable,” for each item, indicate the quantity that was accepted per customer requirements. Under “pending,” for each item, indicate the quantity not accepted. Attach action plan for each item.
  2. Indicate if control plan has been approved by the customer (if required) by circling yes or no. If yes, indicate date approved. If no, attach action plan.
  3. Under “samples,” indicate the quantity of samples inspected for each item. Under “characteristics per sample,” for each item indicate the number of characteristics inspected on each sample for each category.Under “acceptable,” for each item indicate the quantity of characteristics acceptable on all samples.Under “pending,” for each item indicate the quantity of characteristics not accepted. Attach action plan for each item.
  4. Under “required,” for each item indicate the number of characteristics required. Under “acceptable,” for each item indicate the quantity acceptable per Chrysler, Ford and General Motors Measurement Systems Analysis Reference Manual.Under “pending,” for each item, indicate quantity not accepted. Attach action plan for each item.
  5. Under “required,” for each item indicate the quantity required. Under “acceptable,” for each item, indicate the quantity accepted. Under “pending,” for each time, indicate quantity not accepted. Attach action plan for each item.
  6. Under “required,” for each item indicate yes or no to indicate if item is required. Under “acceptable,” for each item indicate yes or no to indicate acceptance. Under “pending,” if answer under “acceptable” is no – attach action plan.
  7. Each team member should sign form and indicate title and date of signature.

For Control plan click here