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.

ISO 9001:2015/Amd 1:2024(en) Quality management systems — Requirements — AMENDMENT 1: Climate action changes

NOTE Relevant interested parties can have requirements related to climate change.

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:

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.
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.
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.
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.
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.
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.
Government and Society: Adhering to ethical and social norms aligns the organization’s offerings with societal expectations, positively influencing customer perception.
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.
Local Communities: Organizations often serve local communities. Ensuring that products and services meet local needs and preferences strengthens community relationships.
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.
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.
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:

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.
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.
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.
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.
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.
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.
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.
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.
Local Communities: Demonstrating adherence to environmental regulations and responsible practices can foster goodwill in local communities where the organization operates.
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.
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:

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.
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.
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.
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.
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.
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.
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.
Regular Review and Updates:
- Continuously monitor and review the list of interested parties.
- Update the list as the organization evolves and new stakeholders emerge.
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.
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.
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:

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.
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.
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.
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.
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.
Competitors:
- Adherence to industry norms, standards, and fair competition practices.
- Respect for intellectual property rights and fair trade practices.
Media and Public Perception:
- Positive public perception through quality-related achievements and responsible behavior.
- Transparency in addressing quality-related issues and recalls.
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.
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.
Local Communities:
- Minimization of negative impacts on the local environment.
- Contribution to local employment and economic development.
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:

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.
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.
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.
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.
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.
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.
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.
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.
Regular Review and Monitoring:
- Continuously monitor changes in stakeholder expectations, regulatory requirements, and industry trends.
- Review the requirements periodically and update the QMS accordingly.
Communication and Transparency:
- Communicate with interested parties about the organization’s commitment to meeting their requirements.
- Maintain transparency regarding progress in addressing their expectations.
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.
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

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:

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.
Regularly updated 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.
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.
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.
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.
Incorporate into QMS Documentation:
- Document the identified requirements of interested parties in your QMS documentation, such as quality policies, objectives, and procedures.
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.
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.
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.
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.
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.
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.

Relevant interested parties can have requirements related to climate change.

Relevant interested parties in the context of a Quality Management System (QMS) can indeed have requirements related to climate change. Here are some examples of interested parties whose needs and expectations might involve climate change considerations:

Customers: Customers may increasingly prioritize environmentally sustainable products and services. They may expect the organization to demonstrate environmental responsibility by minimizing greenhouse gas emissions, reducing energy consumption, using renewable resources, and implementing eco-friendly practices throughout the product lifecycle. Climate change concerns could influence their purchasing decisions, making it essential for organizations to address these expectations to maintain customer satisfaction.
Regulators and Government Agencies: Regulatory bodies may impose requirements related to climate change mitigation, adaptation, and reporting. These requirements could include regulations aimed at reducing greenhouse gas emissions, improving energy efficiency, promoting renewable energy sources, managing waste and emissions, or disclosing environmental performance metrics. Organizations must ensure compliance with relevant regulations and anticipate future regulatory developments related to climate change.
Investors and Shareholders: Investors and shareholders may consider climate change risks and opportunities when evaluating the organization’s financial performance and sustainability practices. They may expect transparency and disclosure regarding the organization’s exposure to climate-related risks, its resilience strategies, and its commitment to environmental stewardship. Addressing climate change concerns can enhance investor confidence and support long-term financial sustainability.
Suppliers and Business Partners: Suppliers and business partners may be subject to climate-related risks and regulatory requirements that could impact their ability to fulfill contractual obligations. Organizations may need to assess the climate resilience of their supply chain, collaborate with suppliers to mitigate shared risks, and incorporate climate considerations into procurement practices and supplier selection criteria.
Employees and Labor Organizations: Employees and labor organizations may have concerns about the organization’s environmental impact, workplace safety, and job security in the context of climate change. They may expect the organization to provide a safe and healthy work environment, support sustainable practices, offer training on climate-related issues, and engage in meaningful dialogue and collaboration on environmental initiatives.
Local Communities and Non-Governmental Organizations (NGOs): Local communities and NGOs may advocate for climate action and environmental protection initiatives that affect the organization’s operations and reputation. They may expect the organization to be a responsible corporate citizen, engage in community outreach and partnerships, address environmental concerns, and contribute positively to local sustainability efforts.

In summary, understanding the needs and expectations of interested parties in the context of a QMS requires recognizing the relevance of climate change considerations. Organizations must engage with relevant stakeholders, assess their climate-related requirements, and integrate climate change considerations into their quality objectives, processes, and performance measurement mechanisms to effectively address stakeholder expectations and ensure long-term sustainability.

Documented Information Required

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

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

ISO 9001:2015/Amd 1:2024(en) Quality management systems — Requirements — AMENDMENT 1: Climate action changes

“The organization shall determine whether climate change is a relevant issue.“

Climate change can relate to a Quality Management System (QMS) in several ways, impacting both internal processes and external factors that influence product and service quality. Here are some key ways in which climate change can intersect with a QMS:

Climate change can affect the availability and quality of resources used in production processes, such as water, energy, and raw materials. A QMS can incorporate measures to monitor and optimize resource usage to mitigate the impact of climate-related resource constraints or fluctuations.
Climate change can disrupt supply chains through extreme weather events, changes in agricultural productivity, transportation disruptions, and shifts in demand patterns. A robust QMS can include risk management processes to identify, assess, and address climate-related risks in the supply chain, ensuring continuity of supply and minimizing disruptions to product quality and delivery schedules.
Climate change considerations can be integrated into product lifecycle assessments within the QMS, evaluating the environmental impacts of products from raw material extraction to end-of-life disposal or recycling. This can involve assessing carbon footprints, energy consumption, emissions, and waste generation associated with products and identifying opportunities for reducing environmental impacts throughout their lifecycle.
Climate change-related regulations, standards, and reporting requirements can impact product design, manufacturing processes, and business operations. A QMS can ensure compliance with relevant environmental regulations and standards, such as emissions limits, energy efficiency requirements, waste management regulations, and carbon reporting obligations.
Increasingly, customers are demanding environmentally sustainable products and services, driving businesses to adopt greener practices. A QMS can help organizations understand and meet customer expectations related to climate change by incorporating environmental criteria into product specifications, quality criteria, and customer satisfaction metrics.
Climate change poses various risks to organizations, including physical risks (e.g., extreme weather events, supply chain disruptions), regulatory risks (e.g., compliance obligations, carbon pricing), reputational risks (e.g., negative public perception, brand damage), and financial risks (e.g., increased costs, market volatility). A QMS can include risk assessment and mitigation processes to proactively identify, evaluate, and manage climate-related risks to ensure business continuity and protect product quality and brand reputation.
Climate change adaptation and mitigation efforts require ongoing monitoring, evaluation, and improvement. A QMS facilitates continuous improvement by establishing processes for setting environmental objectives, monitoring performance indicators, conducting audits and reviews, and implementing corrective and preventive actions to enhance environmental sustainability and resilience in response to climate change.

In summary, climate change can significantly impact the effectiveness of a Quality Management System by influencing resource availability, supply chain resilience, regulatory compliance, customer expectations, risk management, and continuous improvement efforts. Integrating climate change considerations into a QMS helps organizations adapt to environmental challenges, enhance product quality, and ensure long-term business sustainability. Determining whether climate change is a relevant issue for an organization is essential for several reasons:

Climate change poses various risks to businesses, including physical risks (e.g., extreme weather events, sea level rise), regulatory risks (e.g., new environmental regulations), market risks (e.g., shifts in consumer preferences toward sustainable products), and reputational risks (e.g., negative public perception of environmentally unsustainable practices). By identifying climate change as a relevant issue, organizations can proactively assess and manage these risks to minimize potential adverse impacts on operations, finances, and reputation.
Climate change-related disruptions, such as extreme weather events, supply chain disruptions, or regulatory changes, can disrupt business operations and threaten continuity. Understanding the relevance of climate change allows organizations to develop strategies to enhance resilience, ensure business continuity, and maintain the quality and availability of products and services, even in the face of environmental challenges.
Climate change can also create opportunities for businesses, such as the growing demand for environmentally sustainable products and services, renewable energy technologies, carbon-neutral solutions, and climate resilience services. By recognizing climate change as a relevant issue, organizations can capitalize on these market opportunities, innovate to meet evolving customer needs, and gain a competitive advantage in a changing business landscape.
Governments worldwide are increasingly implementing regulations and policies to address climate change, such as emissions reduction targets, carbon pricing mechanisms, energy efficiency standards, and environmental reporting requirements. Organizations that fail to consider climate change as a relevant issue may risk non-compliance with existing and future regulations, leading to legal liabilities, fines, reputational damage, and other consequences.
Stakeholders, including customers, investors, employees, regulators, and communities, increasingly expect businesses to demonstrate environmental responsibility and sustainability leadership. Ignoring climate change as a relevant issue can lead to dissatisfaction among stakeholders, erosion of trust, and negative impacts on brand reputation, employee morale, investor confidence, and customer loyalty.
Climate change poses systemic risks to global ecosystems, economies, and societies. Addressing climate change as a relevant issue is not only essential for short-term risk management and business continuity but also for ensuring long-term organizational sustainability and resilience. By integrating climate change considerations into strategic planning, decision-making processes, and operations, organizations can contribute to building a more sustainable and resilient future for themselves and society as a whole.

In summary, determining whether climate change is a relevant issue is crucial for organizations to manage risks, seize opportunities, ensure regulatory compliance, meet stakeholder expectations, and foster long-term sustainability and resilience in a changing world.

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:

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.
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.
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.
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.
Resource Allocation: The strategic direction should allocate necessary resources, including personnel, technology, and infrastructure, to support the QMS and its goals effectively.
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.
Innovation: Emphasizing innovation in products, processes, and approaches to quality management can be an essential part of an organization’s strategic direction.
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.
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.
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:

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.
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:

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

Some examples of external issues that organizations might consider include:

Market Trends: Understanding shifts in customer preferences, market demand, and industry trends that could impact the organization’s products or services.
Competitive Landscape: Analyzing the actions and strategies of competitors that might affect the organization’s market share or competitive position.
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.
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.
Technological Advancements: Monitoring developments in technology that could affect the organization’s processes, products, or services.
Social and Cultural Factors: Recognizing shifts in societal values, cultural norms, and consumer expectations that could influence how the organization interacts with its stakeholders.
Environmental Factors: Identifying environmental concerns and sustainability initiatives that might affect the organization’s operations and reputation.
Political Factors: Considering political stability, government policies, and geopolitical events that could have implications for the organization’s operations and markets.
Supplier and Partner Relationships: Assessing the performance and reliability of suppliers, partners, and collaborators that contribute to the organization’s value chain.
Customer Expectations: Understanding evolving customer needs, preferences, and feedback to ensure that the organization’s products or services remain relevant and competitive.
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:

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

Some examples of internal issues that organizations might consider include:

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.
Resource Availability: Assessing the availability of human resources, facilities, technology, and other assets needed to support the QMS and deliver quality products or services.
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.
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.
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.
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.
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.
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.
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.
Risk Management: Identifying potential risks within the organization’s processes, operations, and systems that could negatively impact quality outcomes.
Supplier Relationships: Evaluating the performance of suppliers and subcontractors that contribute to the organization’s products or services and assessing their impact on quality.
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:

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.
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.
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.
Market Research: Regularly monitoring market trends, customer preferences, and industry developments can help the organization identify external issues that impact its strategic direction.
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.
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.
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.
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.
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.
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.
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.
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:

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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:

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.
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:

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.
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:

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.
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.
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.
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.
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.
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.
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:

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.
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.
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.
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.

IATF 16949:2016 Clause 9.1.3.1 Prioritization

Organisations are required to analyse and evaluate appropriate data and information arising from monitoring and measurement activities.The results of the analysis must be used to evaluate the following:

The conformity to requirements of products and services provided,
Customer satisfaction,
The performance and effectiveness of the organisations management system,
If planning activities have been implemented effectively,
If actions taken to address risks and opportunities have been effective,
The performance of external providers (EG: suppliers / subcontractors),
The need for any improvements required to the management system,

It is also noted that methods used for the analyse of data could include statistical techniques.Data collection systems exist to provide data to the function/department responsible for analyzing and reporting issues related to the effectiveness of the Quality Management System and overall quality improvement. You should expect to see that the organization has developed a process (method, techniques, format, etc.) to identify, collect and analyze and evaluate data and information from both internal and external sources (i.e. quality records, monitoring and measuring results, process performance results, objectives, internal audit findings, customer surveys and feedback, 2nd or 3rd-party audit results, competitor and benchmarking information, product test results, complaints, supplier performance information, etc.).This ‘input’ (information and data) should reflect upon the adequacy, suitability and effectiveness of the quality management system and its processes. The ‘output’ (result of the analysis) must provide information (understanding, insight, awareness, confidence, knowledge of, etc.). The analysis output must provide insight to:

Achievement of Quality objectives
Customer satisfaction and perception;
Product conformance;
Process performance;
Product and process characteristics;
Trends in products and processes;
Opportunities for preventive action;
Suppliers and subcontractors.
Need for corrective action;
Opportunity for improvement;
Competition.

9.1.3.1 Prioritization

Quality and operational performance trends will be analyzed alongside progress towards objectives, guiding actions aimed at enhancing customer satisfaction by prioritizing improvement measures.

The analysis and evaluation of quality objectives are closely linked to improving customer satisfaction. When organizations effectively assess their quality objectives and align them with customer needs, they can drive continuous improvement initiatives that lead to enhanced customer satisfaction. During the process of defining quality objectives, organizations take into account customer requirements and expectations. This helps ensure that the objectives are aligned with what customers value most. Quality objectives are often associated with specific KPIs that measure different aspects of product or service quality. Regular monitoring and analysis of these KPIs provide insights into the organization’s performance and its impact on customer satisfaction. The analysis of quality objective data allows organizations to make data-driven decisions. They can identify trends, patterns, and areas for improvement based on factual evidence rather than assumptions. If there are deviations from quality objectives or customer satisfaction metrics, root cause analysis helps identify underlying issues. Addressing root causes leads to more effective corrective actions and long-term improvements. The evaluation of quality objectives drives continuous improvement efforts. Organizations use the analysis results to prioritize improvement initiatives that directly impact customer satisfaction. Customer feedback, complaints, and suggestions are valuable inputs during the evaluation process. Integrating customer feedback into the analysis helps identify specific pain points and opportunities for better customer experience. Organizations compare their performance against industry benchmarks and best practices during the evaluation process. This allows them to identify areas where they can excel and learn from industry leaders to enhance customer satisfaction. Analyzing quality objectives through the lens of customer satisfaction encourages a customer-centric approach to quality management. It fosters a culture where meeting customer needs and expectations is the primary focus. The analysis and evaluation results are communicated across the organization. This helps align all employees with customer-centric goals and reinforces the importance of customer satisfaction. Quality objectives that are well-aligned with customer satisfaction goals contribute to overall business success. Higher customer satisfaction often leads to increased loyalty, repeat business, and positive word-of-mouth referrals. Leaders play a crucial role in the evaluation process by setting the tone for customer focus and driving improvement initiatives. Their involvement demonstrates the organization’s commitment to enhancing customer satisfaction. By conducting a comprehensive analysis and evaluation of quality objectives, organizations can identify opportunities for improvement and prioritize actions that directly impact customer satisfaction. A continuous focus on customer needs, data-driven decision-making, and a culture of improvement contribute to creating a positive customer experience and building lasting customer relationships.

The process of comparing trends in quality and operational performance with progress toward objectives is crucial for driving continuous improvement and enhancing customer satisfaction in any industry, including the automotive sector. By conducting this comparison, organizations can identify areas that require attention and prioritize actions to address potential gaps or opportunities for improvement. Here’s how this process works:

Establishing Objectives: The organization sets specific and measurable objectives related to quality and operational performance. These objectives align with the organization’s overall goals and customer requirements.
Monitoring Quality and Operational Performance: The organization regularly monitors key performance indicators (KPIs) related to quality and operational performance. These KPIs may include product defect rates, process capability, on-time delivery, customer complaints, lead times, and other relevant metrics.
Data Analysis: Statistical tools and data analysis techniques are used to analyze the collected data and identify trends and patterns over time. This analysis helps in understanding performance trajectories and potential areas of concern.
Comparing with Objectives: The trends observed in quality and operational performance are compared with the established objectives. This comparison helps assess whether the organization is making progress toward achieving its goals.
Action Planning: Based on the comparison results, the organization identifies any gaps between actual performance and the desired objectives. Action plans are developed to address these gaps and improve performance in areas where targets are not being met.
Prioritization of Actions: The organization prioritizes actions based on the significance of the gaps and the potential impact on customer satisfaction. Critical areas that directly affect customer experience are given priority.
Continuous Improvement: The action plans are implemented as part of the organization’s continuous improvement initiatives. Teams work collaboratively to implement corrective actions and make the necessary improvements.
Performance Review and Feedback: Regular reviews of performance data and progress toward objectives are conducted. The organization seeks feedback from customers to gauge their satisfaction and identify areas for further improvement.
Customer-Centric Approach: The organization keeps customer needs and expectations at the forefront of its improvement efforts. Customer feedback is used to fine-tune processes and enhance customer experience.
Adjustment of Objectives: As the organization progresses in its improvement journey, objectives may need to be adjusted or refined based on new insights and changing customer requirements.

By continually comparing quality and operational performance with objectives, organizations can identify early warning signs, address challenges, and proactively take corrective actions. This data-driven approach empowers organizations to improve customer satisfaction, deliver consistent quality products and services, and maintain a competitive advantage in the market.

IATF 16949:2016 Clause 9.1.2.1 Customer satisfaction

Customers are primarily the end users of your product, but also include intermediaries such as assemblers (internal or external) who integrate your product into theirs, and dealers and distributors who market and sell your product or the integrated product. You need to consider feedback from all these customers to determine whether or not you have met their specified and perceived requirements. Customer requirements may relate to the design, manufacture, delivery, servicing, and customer and technical support of product, QMS,communication and financial requirements; etc. you must have controls to identify and meet these requirements. Customer satisfaction is the customer’s perception of the degree to which the customer’s requirements have been fulfilled. The phrase ‘the degree’ implies the use of a qualitative or quantitative measure that customers can use to rate to what extent or degree your performance met their expectations and requirements, e.g. supplier score cards; alpha or numeric rating scales on survey forms; etc. There are many other ways to monitor customer satisfaction feedback (positive and negative). These may include – customer complaints; direct communications with customers; questionnaires and surveys; subcontracted collection and analysis of performance data ; reports from consumer organizations; reports in various media; sector and industry studies. You must continually gather information (about these requirements), capable of being analyzed and evaluated to determine how well you performed them. There are all kinds of performance indicators for design, manufacture, delivery, etc. Gather information on these indicators from both the customer as well from internal processes. You are expected to have a process that defines your customer satisfaction indicators; frequency and method of data collection; summarization, review and evaluation of data; actions to improve, timeline, responsibility and follow-up You must continuously review this customer feedback to ensure you maintain and improve your customer satisfaction rating. ‘Delivered part delivery performance’ relates to reduction in PPM defect rates. ‘Customer disruptions’ relate to temporary interruption or shutdown of your customers production or service operations that was caused by product quality or delivery problems from your organization. ‘Delivery schedule performance’ relates to product or service delivery that is not early or late, but just in time based on customer scheduling requirements. Premium freight whether paid by you or the customer to expedite on-time delivery is a non-value added cost that must be prevented. You are required to track premium freight costs and take corrective action if it is a significant cost or occurs frequently. Automotive OEM’s may impose a temporary halt on shipments from a supplier experiencing poor quality or delivery performance. You must take corrective action to eliminate the problems and their causes, following customer prescribed controls and measures, before you are allowed to resume production and delivery of the customer’s product. In many cases, third party audit and customer approvals are required to remove the ‘halt’. You must also consider performance indicators that improve the efficiency of your manufacturing processes. These may relate to lean manufacturing tools such as – ANDON process; direct run first time quality results; lead time reduction; level scheduling; number of error-proofing opportunities implemented; planned maintenance; standardized work; workplace organization and visual controls deployed. You must monitor trends in customer satisfaction indicators and use these as a baseline for continual improvement. You should consider both external as well as internal customer satisfaction. Note that every internal process is either a customer or supplier of another process. If any or all of your customer satisfaction process activities are done off-site, you must still identify this as a QMS process and show the interaction with the offsite organization (head office perhaps) in addressing these requirements and show how customer feedback information from Head office is used by you for continual improvement and enhancing customer satisfaction. Performance indicators (to measure the effectiveness of processes that control customer satisfaction may include – improvement in customer feedback ratings; reduction in customer complaints; increase in the number of customers providing feedback; increase in feedback that leads to QMS and product improvement opportunities.

Clause 9.1.2.1 Customer satisfaction

In addition to the requirement given in ISO 9001:2015 Clause 9.1.2 Customer satisfaction, Clause 9.1.2.1 necessitates ongoing monitoring of customer satisfaction by assessing both internal and external performance indicators. These indicators must be based on objective evidence and encompass factors like delivered part quality, customer disruptions, field returns, recalls, warranty claims, delivery schedule adherence, incidents of premium freight, customer notifications regarding quality or delivery issues, and any special status updates. The organization is tasked with monitoring manufacturing process performance to ensure alignment with customer requirements for product quality and process efficiency. This monitoring involves reviewing customer performance data, including online customer portals and customer scorecards where available.

Please click here for ISO 9001:2015 Clause 9.1.2

The integrity of your process for determining customer satisfaction is paramount, otherwise you could be misled by the data and believe customers are satisfied when they are not. The process therefore needs to be free from bias, prejudice, and political inﬂuence. A way of determining customer satisfaction is to:

Seek the opinions of customers about your organization’s products and services provided through questionnaires or interview checklists.
Seek opinions from the people within the customer’s organization, such as Marketing, Design, Purchasing, Quality Assurance, Manufacturing, etc.
Target key product features as well as delivery, price, and relationships.
Collect and analyze customer feedback, particularly complaints to target areas for improvement.
Conduct customer focus meetings to gather opinion and recommendations for action, using data gathered from questionnaires and periodic customer feedback.
Report back the findings to particular customers to secure understanding.
Summarize the data to identify trends and conditions that indicate improvement opportunities.
Compute customer satisfaction indices as an aid to measuring change.
Use the data to derive the business, product development, and quality plans for current and future products and services.

To document this process you should develop a customer satisfaction procedure that details:

The sources from which information is to be gathered and the forms, questionnaires, and interview checklists to be used
The actions and decisions to be taken and those responsible for the actions and decisions
The methods to be used for computing the customer satisfaction index
The records to be created and maintained The reports to be issued and to whom they should be issued

Frequency of measurement
Frequency also needs to be adjusted following changes in models and major changes in organization structure, such as mergers, downsizing, and plant closures. Changes in fashion and public opinion should also not be discounted. Repeating the survey after the launch of new technology, new legislation, or changes in world economics affecting the automotive industry may also affect customer perception and hence satisfaction.

Trends
To determine trends in customer satisfaction and dissatisfaction you will need to make regular surveys and plot the results, preferably by particular attributes or variables. The factors will need to include quality characteristics of the product or service as well as delivery performance and price. The surveys could be linked to your improvement programs so that following a change, and allowing sufficient time for the effect to be observed by the customer, customer feedback data could be secured to indicate the effect of the improvement. Customer dissatisfaction will be noticeable from the number and nature of customer complaints collected and analyzed as part of your corrective action process. This data provides objective documentation or evidence and again can be reduced to indices to indicate trends.

Performance indicators

Performance indicators play a crucial role in assessing the effectiveness of a company’s processes and their ability to meet customer requirements. In the context of the automotive industry, performance indicators should be based on objective evidence and cover various aspects related to product quality, delivery performance, and customer satisfaction. This KPI measures the percentage of delivered parts that meet customer specifications and quality requirements. It provides insights into the organization’s ability to consistently produce high-quality products. This indicator tracks the number and impact of disruptions experienced by customers due to issues with products or services. It helps identify areas for improvement to reduce customer disruptions and enhance customer satisfaction. This KPI monitors the number of products returned by customers, instances of recalls, and warranty claims. It reflects the reliability of products and highlights potential issues that need to be addressed to reduce warranty costs. This indicator assesses how well the organization adheres to delivery schedules and commitments. It measures the percentage of orders delivered on time and helps identify opportunities for improving supply chain efficiency. This KPI tracks the frequency and cost of premium freight, which is incurred when products need to be shipped urgently due to delivery delays or other issues. Reducing premium freight incidents can lead to cost savings and improved delivery performance. This indicator measures the number of notifications or complaints received from customers related to quality or delivery problems. It provides valuable feedback for identifying and resolving customer concerns promptly. This KPI tracks orders that have been assigned a special status due to quality or delivery issues. Monitoring special status orders helps prioritize corrective actions and ensures timely resolution of critical issues. This metric calculates the percentage of orders delivered to customers within the agreed-upon timeframe. It indicates the organization’s ability to meet customer delivery expectations. Regularly conducting customer satisfaction surveys provides valuable feedback on overall satisfaction with products, services, and support. It helps identify areas for improvement and gauges customer loyalty.This KPI measures the average time taken to resolve quality-related incidents or non-conformances. It reflects the organization’s responsiveness to quality issues. By tracking these performance indicators and analyzing the objective evidence, automotive companies can identify areas for improvement, implement corrective actions, and enhance their overall performance and customer satisfaction. These indicators are essential for measuring progress towards organizational goals and driving continuous improvement efforts.

Monitor the performance of manufacturing processes

Monitoring the performance of manufacturing processes is a critical aspect of quality management in the automotive industry, and it is essential to demonstrate compliance with customer requirements for product quality and process efficiency. By monitoring processes effectively, organizations can identify variations, detect potential issues, and implement timely corrective actions to ensure consistent product quality and customer satisfaction. Here’s how the organization can achieve this:

Establish Key Performance Indicators (KPIs): Define specific KPIs that align with customer requirements and process efficiency. These KPIs could include metrics related to product quality, defect rates, process capability, on-time delivery, customer complaints, and more.
Data Collection and Analysis: Implement a systematic data collection process to gather relevant information about process performance. Use statistical tools and techniques to analyze the data and identify trends or patterns.
Control Charts and SPC: Use control charts and Statistical Process Control (SPC) methods to monitor process stability and identify any out-of-control situations. Control charts help distinguish between common cause variation (inherent to the process) and special cause variation (due to specific factors).
Process Capability Analysis: Conduct process capability studies to assess the ability of the manufacturing processes to meet customer requirements. Use indices such as Cp, Cpk, Pp, and Ppk to quantify process performance.
Root Cause Analysis: Implement root cause analysis techniques to identify the underlying causes of process deviations or quality issues. Addressing root causes helps prevent recurrence and improves overall process efficiency.
Continuous Improvement: Emphasize a culture of continuous improvement by regularly reviewing process performance and seeking opportunities for enhancement. Encourage employee involvement in suggesting improvements.
Customer Feedback and Complaints: Actively gather and analyze customer feedback and complaints to understand their expectations and concerns. Addressing customer feedback is essential for meeting customer requirements and maintaining strong relationships.
Audit and Review Mechanisms: Conduct internal audits and management reviews to evaluate the effectiveness of the monitoring process and ensure alignment with customer requirements and quality objectives.
Process Validation: Validate manufacturing processes, especially for critical or new products, to ensure they consistently meet customer requirements and specifications.
Training and Skill Development: Provide training and skill development programs to employees involved in monitoring processes. Ensure they have the necessary knowledge and expertise to carry out their roles effectively.
Documentation and Record Keeping: Maintain comprehensive documentation and records of process monitoring activities, data analysis, corrective actions, and improvements implemented.

By monitoring the performance of manufacturing processes and demonstrating compliance with customer requirements, automotive organizations can drive process excellence, achieve consistent product quality, and enhance customer satisfaction. Effective monitoring and continual improvement efforts are vital for staying competitive in the dynamic automotive industry and meeting the ever-changing expectations of customers.

Review of customer performance data

The review of customer performance data, including online customer portals and customer scorecards, is an essential practice in the automotive industry and other sectors. This process allows organizations to assess their performance from the customer’s perspective, identify areas for improvement, and strengthen the customer-supplier relationship. The organization should regularly collect customer performance data, which may include metrics related to product quality, delivery performance, on-time delivery, lead times, customer complaints, responsiveness, and other key performance indicators (KPIs) specified by the customer. Many customers provide access to online portals or scorecards where they share performance data with their suppliers. These portals often offer real-time visibility into KPIs and performance trends. The organization should actively utilize and analyze data from these sources. Use statistical tools and data analysis techniques to identify trends, patterns, and areas of concern in the customer performance data. Compare performance against agreed-upon targets and benchmarks to assess the organization’s adherence to customer requirements. In case of customer complaints or issues, conduct root cause analysis to understand the underlying reasons for the problems. Addressing root causes helps prevent recurrence and demonstrates a commitment to continuous improvement. Engage with customers to discuss performance data, gain insights into their expectations, and gather feedback on areas for improvement. Customer feedback is valuable for enhancing processes and overall performance. Utilize customer performance data as inputs for continuous improvement initiatives. Prioritize actions based on the most significant opportunities for enhancing customer satisfaction and meeting customer requirements. Compare the organization’s performance against industry benchmarks and best practices to identify areas where it can excel and gain a competitive edge. Include the review of customer performance data in management review meetings. This ensures that top management is aware of the organization’s performance from the customer’s perspective and can take strategic actions to address any issues. Identify potential risks or challenges related to customer performance data and develop mitigation strategies to minimize their impact. Maintain open communication with customers regarding performance data and improvement initiatives. Transparency fosters trust and strengthens the customer-supplier relationship. By regularly reviewing customer performance data, the organization can demonstrate its commitment to meeting customer requirements, enhancing product and service quality, and achieving customer satisfaction. Utilizing customer feedback and data-driven insights, the organization can continuously improve its processes, products, and services to meet and exceed customer expectations.

IATF 16949:2016 Clause 8.5.5.2 Service agreement with customer

Servicing is an activity that primarily applies to manufactured products. However, servicing, which is a post-delivery activity, can also include after—sales service, product support, help lines,
customer service, and inquiry desks, etc. Servicing is a specified requirement when the contract requires you to service the products provided. Where servicing is a Customer requirement the customer must establish process for performing servicing to cover the following:

Design and validation of special-purpose tools and equipment
Control of measuring and test equipment
Supply and verification of installation instructions
Supply and verification of assembly instructions
Supply and verification of commissioning instructions
Supply and verification of operating instructions
Supply and verification of spare parts lists
Supply and verification of servicing instructions
Logistics support service covering technical assistance, supply of spares, servicing

Clause 8.5.5.2 Service agreement with customer

If a service agreement exists with the customer, the organization must confirm that the pertinent service centers meet applicable standards, evaluate the efficiency of any specialized tools or measuring equipment, and guarantee that all service personnel are adequately trained in relevant requirements.

The standard requires that when there is a servicing agreement with the customer, the supplier verifies the effectiveness of any supplier service centers, special-purpose tools, and training of servicing personnel. If you have a service agreement with an OEM customer either to service product under warranty or even past warranty, then you must make available appropriate resources for such services. These services may be performed at your customer or your own facilities. Appropriate resources include space; transportation; special purpose tools; diagnostic and measurement equipment; replacement parts and components; availability and use of competent personnel.This requirement is fairly straightforward. What you need to do is establish the conditions of the servicing agreement and Check that they have been conveyed to those affected by them, and that these personnel are in fact adhering to the requirements. However, meeting such requirements may require the setting up of a service organization, designing the necessary processes and equipping them with the relevant resources.

Service center complying with applicable requirements

When a service agreement is in place with a customer, the organization has the responsibility to ensure that the relevant service centers comply with all applicable requirements. This ensures that the services provided meet the agreed-upon standards, customer expectations, and any regulatory or industry-specific requirements. Here’s how the organization can verify compliance:

Documentation Review: The organization should review the service centers’ documentation, including policies, procedures, and quality management system documentation. This review helps ensure that the service centers have established processes to comply with the requirements.
Audit and Inspection: Conduct audits or inspections of the service centers to assess their adherence to applicable requirements. These audits may be conducted by internal auditors or third-party auditors, depending on the agreement and the organization’s policies.
Training and Competence: Verify that the service center staff are adequately trained and competent to perform their tasks. This includes ensuring that technicians and service personnel have the necessary skills and knowledge to carry out the services to the required standards.
Equipment and Tooling: Ensure that the service centers have the appropriate equipment, tools, and resources to perform the services effectively and in compliance with requirements.
Records and Traceability: Verify that the service centers maintain records of the services provided and have a system in place for traceability and tracking of service activities.
Customer Feedback and Complaints: Monitor customer feedback and complaints related to services provided by the service centers. This helps identify any potential issues or non-compliance and allows the organization to take corrective actions as needed.
Continuous Improvement: Encourage continuous improvement efforts in the service centers by reviewing their improvement plans, analyzing performance data, and sharing best practices.
Risk Assessment: Conduct a risk assessment of the service centers’ operations to identify potential risks and opportunities for improvement.
Communication and Collaboration: Maintain open lines of communication with the service centers and collaborate on resolving any compliance-related issues or challenges.
Contractual Obligations: Ensure that the service agreement explicitly states the applicable requirements and compliance expectations for the service centers. This helps set clear expectations and responsibilities.
Performance Monitoring: Continuously monitor the performance of the service centers and track key performance indicators (KPIs) to assess their compliance with applicable requirements.

By verifying compliance with applicable requirements in the service centers, the organization can ensure that the services provided are of high quality, consistent, and meet the customer’s expectations. It also helps build trust and confidence with the customer, leading to better long-term relationships and customer satisfaction.

Effectiveness of any special purpose tools or measurement equipment

When a service agreement is in place with a customer, the organization has the responsibility to verify the effectiveness of any special purpose tools or measurement equipment used in providing the services. This verification is crucial to ensure that the tools and equipment used for servicing meet the required standards, are accurate and reliable, and do not compromise the quality of the services delivered. Here’s how the organization can verify the effectiveness of such tools and measurement equipment:

Calibration and Certification: Ensure that all special purpose tools and measurement equipment used in the service centers are calibrated and certified according to applicable standards. Regular calibration ensures that the equipment provides accurate and reliable measurements.
Documentation Review: Review the documentation related to the special purpose tools and measurement equipment, including calibration certificates and records. Verify that the equipment’s calibration is up to date and within acceptable tolerances.
Training and Competence: Ensure that the service center personnel using the special purpose tools and measurement equipment are adequately trained and competent in their operation. Proper training ensures that the equipment is used correctly and optimally.
Measurement System Analysis (MSA): Perform MSA studies on critical measurement equipment to determine its accuracy, precision, and stability. This helps identify any potential issues with the measurement system and allows for corrective actions to be taken.
Equipment Maintenance: Regularly inspect and maintain the special purpose tools and measurement equipment to ensure their proper functioning and longevity.
Records and Traceability: Maintain detailed records of the special purpose tools and measurement equipment, including their identification, calibration history, and usage. This provides traceability and aids in identifying any non-compliant equipment.
Risk Assessment: Conduct a risk assessment of the special purpose tools and measurement equipment to identify potential risks associated with their usage and any impact on the service delivery process.
Supplier Evaluation: If the special purpose tools and measurement equipment are sourced from external suppliers, evaluate the suppliers’ capabilities, quality systems, and compliance with relevant standards.
Customer Feedback and Complaints: Monitor customer feedback and complaints related to the service delivery process to identify any issues that could be attributed to the tools or measurement equipment used.
Continuous Improvement: Encourage continuous improvement efforts in the service centers by reviewing the effectiveness of the special purpose tools and measurement equipment and addressing any identified areas for improvement.

By verifying the effectiveness of special purpose tools and measurement equipment, the organization can ensure the accuracy and reliability of the services provided. This helps meet customer expectations, comply with contractual requirements, and maintain high-quality service delivery standards.

Service personnel are trained in applicable requirements

Ensuring that all service personnel are trained in applicable requirements is a crucial aspect of providing high-quality services in the automotive industry. Training helps employees understand and comply with the standards, processes, and regulations necessary for their specific roles. Here’s how the organization can achieve this:

Training Needs Assessment: Conduct a thorough assessment to identify the specific training needs of each service personnel. This assessment should consider job roles, responsibilities, and the applicable requirements that apply to their tasks.
Training Plan Development: Based on the training needs assessment, develop a comprehensive training plan that outlines the required training topics, objectives, and the frequency of training.
Internal Training Programs: Organize internal training programs that cover the relevant applicable requirements. These programs can be conducted by experienced in-house trainers or subject matter experts from various departments.
External Training Resources: Utilize external training resources such as professional trainers, industry experts, or training courses provided by certification bodies or industry associations.
On-the-Job Training (OJT): Supplement formal training with on-the-job training, where experienced personnel guide and mentor new employees, helping them apply their knowledge in real-world situations.
Certification and Qualification: Encourage employees to attain relevant certifications or qualifications related to their roles and responsibilities. Certifications can demonstrate competence and dedication to professional growth.
Documentation and Records: Maintain comprehensive training records for each service personnel, including details of the training completed, dates, and certifications achieved. This helps in tracking compliance and demonstrating evidence during audits.
Regular Refresher Training: Schedule regular refresher training sessions to reinforce knowledge and keep employees updated on any changes in applicable requirements or best practices.
E-Learning and Online Resources: Utilize e-learning platforms and online resources to deliver training modules conveniently and provide self-paced learning opportunities.
Incorporate Quality Management System (QMS) Training: Integrate training on the organization’s Quality Management System, ensuring that service personnel understand their role in maintaining quality and customer satisfaction.
Feedback and Assessment: Gather feedback from service personnel about the effectiveness of the training programs and use assessments or quizzes to gauge knowledge retention.
Continuous Improvement: Continuously evaluate the training effectiveness and make necessary improvements to the training programs based on feedback and performance evaluations.

By ensuring that all service personnel are trained in applicable requirements, the organization can enhance service quality, minimize errors, and maintain compliance with industry standards. Well-trained personnel are better equipped to deliver excellent service, leading to higher customer satisfaction and improved business performance.

IATF 16949:2016 Clause 8.4.2.4 Supplier monitoring

Supplier performance monitoring is a systematic process of evaluating and assessing the performance of suppliers to ensure they consistently meet the required standards, contractual obligations, and customer expectations. It involves tracking and measuring various key performance indicators (KPIs) to gauge the supplier’s performance over time. On top of the initial evaluation and approval of suppliers, you are required to carry out ongoing monitoring of their performance. Use supplier monitoring indicators to evaluate the consistency, capability and reliability of their performance for quality, delivery, support, etc. Various tools are available to do this.On-time delivery is very important and disruptions (due to waiting for materials) at your customers or even your own facility must be avoided. You must track and evaluate all occurrences of premium freight on incoming deliveries, whether caused by you or your supplier. You must take corrective action where there a significant premium freight problem. If you have the misfortune to be put on hold, special alert or notification status by any of your OEM customers, the process for getting out of it can be very time-consuming and costly. Therefore, besides controlling your own product and delivery performance , make sure that you are on top of your supplier’s product quality and delivery using effective evaluation and monitoring controls as well as an effective problem resolution process when problems do arise. You must encourage your suppliers to monitor their own manufacturing performance. Motivate them to use lean manufacturing tools such as – ANDON procedures; direct run first time quality results; lead time reduction; level scheduling; number of error-proofing opportunities implemented; planned maintenance; standardized work; workplace organization and visual controls deployed.

Supplier performance monitoring is a crucial aspect of supplier management and helps in maintaining a reliable and efficient supply chain. Here’s how it works:

Establishing Performance Metrics: Define specific performance metrics and KPIs that align with your organization’s objectives and requirements. These metrics may include on-time delivery, product quality, responsiveness, lead times, cost-effectiveness, and adherence to contractual terms.
Data Collection and Tracking: Gather data on supplier performance regularly, based on the established metrics. This data may come from various sources, such as purchase orders, invoices, quality inspection reports, customer feedback, and delivery schedules.
Performance Evaluation: Analyze the collected data to evaluate the supplier’s performance against the defined metrics. This evaluation provides insights into how well the supplier is meeting the agreed-upon criteria.
Rating or Scoring System: Implement a rating or scoring system to quantify the supplier’s performance. This system helps in comparing suppliers objectively and identifying top-performing and underperforming suppliers.
Periodic Reviews: Conduct regular reviews or performance meetings with suppliers to discuss their performance, address any concerns, and collaborate on improvement initiatives.
Action Plans for Improvement: Work with suppliers to develop action plans to address any identified performance issues or non-conformities. These action plans should be measurable and time-bound.
Continuous Improvement: Encourage a culture of continuous improvement among suppliers. Offer support, share best practices, and provide resources to help suppliers enhance their performance.
Risk Assessment: Identify potential risks associated with supplier performance and take proactive measures to mitigate these risks.
Supplier Relationship Management: Use performance monitoring as part of a broader supplier relationship management strategy to build strong, collaborative relationships with suppliers.
Supplier Development: Leverage performance monitoring data to identify suppliers with growth potential and collaborate with them on supplier development initiatives.
Compliance and Audits: Ensure that suppliers comply with the required standards, regulations, and contractual agreements. Conduct periodic audits to verify compliance.

By implementing a robust supplier performance monitoring process, organizations can make data-driven decisions, identify opportunities for improvement, and foster a reliable and high-performing supplier base. This approach contributes to a more efficient supply chain and ultimately benefits the organization and its customers.

Clause 8.4.2.4 Supplier monitoring

The organization needs a documented procedure and criteria to assess supplier performance, ensuring that externally provided products, processes, and services meet both internal and external customer needs. Key indicators to monitor include the conformity of delivered products to requirements, any disruptions experienced by customers at receiving plants such as delays or stoppages, adherence to delivery schedules, and the frequency of premium freight incidents. Additionally, if the customer provides specific details, the organization should also incorporate special notifications regarding quality or delivery issues, as well as information on dealer returns, warranties, field actions, and recalls into their supplier monitoring process.

The organization needs a written process and criteria to judge how well suppliers are doing. This helps make sure the products, services, and processes from suppliers meet both internal and external customer requirements. They should keep an eye on certain signs of supplier performance, like whether the delivered products match the requirements, if there are any problems at the customer’s end like delays or stoppages, how well deliveries stick to the schedule, and how often expensive rush deliveries are needed. If the customer gives extra details, the organization should also watch out for special notifications about quality or delivery issues, along with returns, warranties, field actions, and recalls from dealers. Supplier performance monitoring is the process of assessing supplier performance on an ongoing basis in order to identify areas of improvement. It involves tracking supplier performance against specific metrics and standards, and using that information to make decisions about how to improve supplier performance. There are many benefits to supplier performance monitoring, including improved quality of products and services, reduced costs, and improved communication between suppliers and buyers. Additionally, supplier performance monitoring can help to build and maintain relationships with key suppliers. There are a number of ways to collect data for supplier performance monitoring. One common method is to use surveys. Surveys can be used to collect data on a variety of factors, including quality, delivery times, communication, and overall satisfaction. Another method is to track metrics such as error rates, scrap rates, or customer complaints. Supplier performance monitoring should be an ongoing process, not a one-time event. Monitoring should be done on a regular basis, such as monthly or quarterly. It is also important to involve all stakeholders in the process, from senior management to front-line employees.

The benefits of supplier performance monitoring
As a business, it is important to ensure that your suppliers are meeting your standards in terms of quality and delivery. This is where supplier performance monitoring comes in. By tracking the performance of your suppliers, you can identify any issues early on and take corrective action if necessary. This helps to ensure that your business is getting the best possible value from its suppliers. There are many benefits to supplier performance monitoring, including:

Improved quality of products and services: By tracking supplier performance, you can identify any areas where they are not meeting your standards. This allows you to take corrective action to improve the quality of their products or services.
Reduced costs: By identifying issues early on, you can avoid costly mistakes further down the line. For example, if a supplier is consistently late with deliveries, you can look for alternative suppliers who can meet your deadlines more effectively.
Greater transparency: Supplier performance monitoring helps to create a more transparent relationship between you and your suppliers. This allows for better communication and collaboration when problems arise.
Increased customer satisfaction: Ultimately, by ensuring that your suppliers are meeting your standards, you can help to improve customer satisfaction levels. This is because customers will receive products or services that meet their expectations in terms of quality and delivery timescales.

The different types of supplier performance monitoring
There are four different types of supplier performance monitoring: financial, quality, delivery, and compliance. Financial performance monitoring looks at things like a supplier’s financial stability, their ability to meet payment terms, and their overall cost-effectiveness. Quality performance monitoring assesses things like the quality of the products or services a supplier provides, their ability to meet specifications, and levels of customer satisfaction. Delivery performance monitoring focuses on a supplier’s ability to meet delivery deadlines, their order fill rates, and their on-time delivery rates. Compliance performance monitoring covers a supplier’s adherence to regulations and standards, as well as their compliance with internal policies and procedures.

How to implement supplier performance monitoring
Supplier performance monitoring is the practice of assessing supplier performance on a regular basis in order to identify areas of improvement. There are a number of ways to implement supplier performance monitoring, but the most important thing is to establish clear objectives and metrics that will be used to assess performance. Once you have established these, you can begin collecting data and conducting regular reviews. One way to collect data on supplier performance is to use a supplier scorecard. This scorecard should include metrics such as on-time delivery, quality, cost, and responsiveness. You can also use surveys or interviews to gather feedback from customers or internal stakeholders about their experiences with suppliers. Once you have collected this data, you can start to trend it over time to get a better understanding of how suppliers are performing. Conducting regular reviews is crucial to effective supplier performance monitoring. These reviews should be conducted at least quarterly, but more frequently if there are issues that need to be addressed. During the review, you should discuss the data that has been collected and identify any areas of improvement. You should also set expectations for future performance and agree on any actions that need to be taken in order to improve supplier performance.

Documented Process to evaluate supplier performance

Having a documented process and criteria to evaluate supplier performance is crucial for ensuring the conformity of externally provided products, processes, and services to internal and external customer requirements. This documented process provides a structured approach to measure and monitor supplier performance, enabling the organization to make informed decisions and maintain a reliable supply chain. Here’s how to establish such a process:

Defining Evaluation Criteria: Determine the specific criteria and metrics that will be used to assess supplier performance. These criteria should align with the organization’s objectives and customer requirements. Common evaluation criteria include quality, on-time delivery, responsiveness, cost, and compliance with relevant standards.
Setting Performance Targets: Establish clear performance targets for each evaluation criterion. These targets should be measurable and achievable, reflecting the desired level of supplier performance.
Data Collection and Documentation: Develop a systematic method for collecting and documenting data related to supplier performance. This data may come from various sources, such as purchase orders, delivery records, inspection reports, customer feedback, and non-conformance reports.
Performance Evaluation Process: Define the process for evaluating supplier performance based on the established criteria and targets. Determine the frequency of evaluations, such as monthly, quarterly, or annually.
Scoring or Rating System: Implement a scoring or rating system to quantify supplier performance. This system may involve assigning scores or ratings to different evaluation criteria and calculating an overall performance score for each supplier.
Performance Review Meetings: Conduct regular performance review meetings with suppliers to discuss their performance, share evaluation results, and collaborate on improvement opportunities.
Corrective Actions and Improvement Plans: Work with suppliers to develop corrective actions and improvement plans if performance falls below the established targets. Monitor the implementation and effectiveness of these actions.
Performance Feedback: Provide timely and constructive feedback to suppliers on their performance, including both strengths and areas for improvement.
Continuous Improvement: Continuously review and refine the supplier performance evaluation process to enhance its effectiveness. Seek feedback from stakeholders and incorporate lessons learned from past evaluations.
Supplier Development: Use performance evaluation data to identify opportunities for supplier development. Collaborate with suppliers to enhance their capabilities and align with the organization’s requirements.
Supplier Segmentation: Consider segmenting suppliers based on their performance levels. This segmentation can help allocate resources more effectively and tailor the organization’s engagement with suppliers accordingly.
Integration with Supplier Management: Integrate the supplier performance evaluation process with the broader supplier management strategy, including supplier selection, qualification, and relationship management.

By having a well-documented process and criteria for supplier performance evaluation, the organization can maintain high-quality externally provided products, processes, and services. This approach ensures that suppliers consistently meet internal and external customer requirements, contributing to a more reliable and customer-focused supply chain.

Monitoring of Delivered product conformity to requirements

Monitoring the supplier performance indicator “delivered product conformity to requirements” is a critical aspect of supplier performance evaluation. It ensures that the products provided by the supplier meet the specified requirements and standards, contributing to the overall quality and reliability of the organization’s products or services. Here’s how to effectively monitor this performance indicator:

Clearly Define Product Requirements: Work with the supplier to establish clear and detailed product requirements, specifications, and quality standards. These requirements should be documented and communicated to the supplier in a well-defined manner.
Inspection and Quality Checks: Implement inspection and quality checks on the delivered products to verify their conformity to the specified requirements. This may involve using sampling plans, statistical process control, or other quality assurance techniques.
Non-Conformance Reporting: Establish a process for reporting non-conformances if any delivered product fails to meet the specified requirements. Ensure that non-conformances are documented, communicated to the supplier, and addressed promptly.
Performance Data Collection: Regularly collect data on the conformity of delivered products to requirements. This data may include acceptance rates, rejection rates, defect counts, and any relevant customer feedback or complaints.
Performance Evaluation: Analyze the collected data to evaluate the supplier’s performance regarding delivered product conformity. Calculate metrics such as the percentage of conforming products or the number of non-conformances.
Performance Targets: Set performance targets for delivered product conformity based on the organization’s quality objectives and customer expectations. These targets should be realistic and aligned with industry standards.
Regular Performance Reviews: Conduct periodic performance reviews with the supplier to discuss their performance in terms of product conformity to requirements. Share the evaluation results and collaborate on improvement actions if needed.
Root Cause Analysis: In cases of non-conformance, work with the supplier to perform root cause analysis to identify the underlying reasons for the discrepancies. This analysis helps in implementing corrective and preventive actions.
Continuous Improvement: Encourage a culture of continuous improvement with the supplier. Collaborate on initiatives to enhance product quality and ensure better conformity to requirements over time.
Supplier Development: Use the performance data to identify opportunities for supplier development. Provide support, resources, and guidance to help the supplier improve their processes and deliver conforming products consistently.
Communication and Transparency: Maintain open communication with the supplier regarding their performance. Be transparent about the evaluation process and the organization’s expectations.

By monitoring the supplier performance indicator “delivered product conformity to requirements,” the organization can ensure that the products received from suppliers consistently meet the desired quality standards. This focus on conformity enhances customer satisfaction, reduces the risk of product failures, and strengthens the overall reliability of the supply chain.

Monitoring of Customer disruption

Monitoring the supplier performance indicator “customer disruptions at the receiving plant, including yard holds and stop ships” is crucial for understanding the impact of the supplier’s performance on the smooth operation of the customer’s receiving plant. This indicator reflects the ability of the supplier to provide products that meet the required quality, quantity, and delivery schedule. Here’s how to effectively monitor this performance indicator:

Define Customer Disruptions: Clearly define what constitutes customer disruptions at the receiving plant, including specific events such as shipment delays, damaged products, incorrect quantities, or any issues that lead to operational disruptions.
Data Collection: Set up a system to collect data on customer disruptions caused by the supplier. This data may come from various sources, including receiving plant records, customer feedback, and communication with the customer.
Root Cause Analysis: If disruptions occur, conduct a root cause analysis to understand the reasons behind them. Identify any issues in the supplier’s processes, logistics, or communication that contribute to the disruptions.
Performance Metrics: Establish performance metrics to quantify the frequency and severity of customer disruptions. This could be measured in terms of the number of disruptions, the duration of disruptions, or the impact on the customer’s production.
Performance Targets: Set specific performance targets for the supplier to minimize customer disruptions. These targets should align with the customer’s expectations and the organization’s overall supply chain goals.
Regular Performance Reviews: Conduct periodic performance reviews with the supplier to discuss customer disruptions and their impact. Share the evaluation results and collaborate on improvement actions.
Corrective and Preventive Actions: Work with the supplier to implement corrective actions to address any identified issues leading to customer disruptions. Additionally, implement preventive measures to avoid similar disruptions in the future.
Performance Improvement Plan: Develop a performance improvement plan in collaboration with the supplier to address recurring issues related to customer disruptions. Set milestones and timelines for achieving the desired improvements.
Continuous Monitoring: Continuously monitor the supplier’s performance regarding customer disruptions. Regularly track progress towards meeting the established targets and evaluate the effectiveness of improvement actions.
Supplier Collaboration: Foster a collaborative relationship with the supplier to improve communication and address issues promptly. Encourage the supplier to share any potential challenges or concerns that could impact product deliveries.
Supplier Development: Provide support and resources to help the supplier improve their processes and avoid disruptions at the customer’s receiving plant. Collaborate on initiatives to enhance the supplier’s capabilities and performance.

By monitoring the supplier performance indicator “customer disruptions at the receiving plant, including yard holds and stop ships,” the organization can proactively address issues that affect the customer’s operations. This focus on customer satisfaction and supply chain reliability contributes to a strong and mutually beneficial partnership between the supplier and the customer.

Monitoring of delivery schedule performance and number of occurrences of premium freight

Monitoring the supplier performance indicators “delivery schedule performance” and “number of occurrences of premium freight” is crucial for assessing the supplier’s reliability, adherence to delivery commitments, and impact on logistics costs. These indicators directly affect the smooth operation of the supply chain and customer satisfaction. Here’s how to effectively monitor these performance indicators:

Delivery Schedule Performance:
- Define Criteria: Clearly define the criteria for delivery schedule performance, such as on-time delivery percentage, early or late deliveries, and the allowed margin for deviations.
- Data Collection: Collect data on actual delivery dates compared to the scheduled delivery dates for each shipment or order.
- Performance Metrics: Calculate the on-time delivery rate and other relevant metrics based on the defined criteria.
- Performance Targets: Set specific performance targets for on-time delivery that align with customer requirements and overall supply chain goals.
- Periodic Review: Conduct regular performance reviews with the supplier to discuss delivery schedule performance, share evaluation results, and collaborate on improvement actions.
- Root Cause Analysis: If there are deviations from the delivery schedule, work with the supplier to perform a root cause analysis to identify the reasons and address the underlying issues.
- Performance Improvement: Collaborate with the supplier on a performance improvement plan to enhance delivery schedule reliability and meet the established targets.
Number of Occurrences of Premium Freight:
- Definition: Clearly define what constitutes premium freight, such as shipments that require expedited shipping methods due to missed or delayed deliveries.
- Data Collection: Record instances where premium freight is required and the associated costs.
- Performance Metrics: Calculate the number of occurrences of premium freight and the associated expenses over a specific period.
- Cost Analysis: Analyze the costs incurred due to premium freight and assess their impact on the overall supply chain expenses.
- Performance Targets: Set targets to reduce the number of occurrences of premium freight, aiming to minimize additional shipping costs.
- Collaboration and Improvement: Work with the supplier to identify root causes for premium freight incidents and implement corrective actions to prevent such occurrences in the future.
- Communication: Ensure open communication with the supplier to promptly address any potential disruptions that could lead to premium freight requirements.
Continuous Monitoring and Improvement:
- Continuously monitor the supplier’s performance related to delivery schedule and premium freight incidents.
- Regularly review progress and improvement efforts, supporting the supplier in meeting performance targets.
- Foster a culture of continuous improvement, encouraging collaborative problem-solving between the organization and the supplier.

By monitoring delivery schedule performance and the number of occurrences of premium freight, the organization can ensure a reliable supply chain, reduce logistics costs, and enhance customer satisfaction. These performance indicators contribute to a smooth and efficient flow of goods, benefiting both the organization and its customers.

Monitoring of special status customer notifications related to quality or delivery issues

Monitoring the supplier performance indicator “special status customer notifications related to quality or delivery issues” is essential for assessing the supplier’s ability to promptly address and resolve quality or delivery-related concerns that may impact the customer. Special status notifications are typically issued when there are exceptional situations that require immediate attention and action. Here’s how to effectively monitor this performance indicator:

Define Special Status Customer Notifications: Clearly define what constitutes special status customer notifications related to quality or delivery issues. These notifications may include customer complaints, non-conformances, quality escapes, missed deliveries, or any other significant concerns raised by the customer.
Data Collection and Documentation: Set up a system to collect data on special status customer notifications. Document the details of each notification, including the nature of the issue, the customer’s feedback, the response time, and the resolution provided.
Performance Metrics: Establish performance metrics to quantify the frequency and severity of special status customer notifications. Measure key indicators such as the number of notifications, average response time, and the time taken to resolve issues.
Performance Targets: Set specific performance targets for handling special status customer notifications. These targets should aim to minimize the number of notifications and ensure timely and effective responses.
Root Cause Analysis: For each special status notification, work with the supplier to conduct a root cause analysis to identify the underlying reasons for the issue. This analysis helps in implementing corrective and preventive actions.
Communication and Collaboration: Foster open and transparent communication with the supplier regarding special status customer notifications. Collaborate on resolving issues and preventing similar incidents in the future.
Corrective and Preventive Actions: Implement corrective actions to address immediate concerns raised by special status notifications. Additionally, work with the supplier to implement preventive measures to avoid similar issues in the future.
Continuous Improvement: Encourage a culture of continuous improvement with the supplier. Regularly review and refine processes based on lessons learned from handling special status notifications.
Performance Reviews: Conduct periodic performance reviews with the supplier to discuss special status notifications and the effectiveness of the responses. Share evaluation results and collaborate on improvement actions.
Supplier Development: Provide support and resources to help the supplier improve their processes and responsiveness in handling special status notifications. Collaborate on initiatives to enhance the supplier’s capabilities and performance.
Customer Feedback: Seek feedback from customers regarding the supplier’s handling of special status notifications. Incorporate this feedback into the evaluation process and improvement efforts.

By monitoring special status customer notifications related to quality or delivery issues, the organization can proactively address customer concerns and ensure prompt resolutions. This focus on customer satisfaction and issue resolution contributes to a stronger and more reliable relationship between the supplier and the customer.

Monitoring of dealer returns, warranty, field actions, and recalls

onitoring the supplier performance indicators “dealer returns, warranty, field actions, and recalls” is essential for assessing the quality and reliability of the products provided by the supplier. These indicators directly impact customer satisfaction, brand reputation, and the overall performance of the organization. Here’s how to effectively monitor these performance indicators:

Dealer Returns:
- Data Collection: Collect data on the number of products returned by dealers due to quality issues, defects, or customer dissatisfaction.
- Root Cause Analysis: Work with the supplier to conduct a root cause analysis for each return to identify the reasons behind the returns.
- Performance Metrics: Calculate the dealer return rate and analyze trends over time to identify improvement opportunities.
- Performance Targets: Set specific targets for reducing the dealer return rate, reflecting the organization’s quality objectives.
Warranty Claims:
- Data Collection: Record data on warranty claims made by customers for products supplied by the supplier.
- Root Cause Analysis: Analyze warranty claims to determine the underlying reasons for defects or failures.
- Performance Metrics: Measure the warranty claim rate and analyze trends to identify areas for improvement.
- Performance Targets: Set targets for reducing warranty claims, aiming to improve product quality and reliability.
Field Actions:
- Data Collection: Monitor the number of field actions taken to address product issues or defects identified after delivery to customers.
- Root Cause Analysis: Collaborate with the supplier to conduct root cause analysis for each field action to prevent recurrence.
- Performance Metrics: Calculate the field action rate and evaluate the effectiveness of actions taken.
- Performance Targets: Set targets to minimize the need for field actions, demonstrating improved product quality.
Recalls:
- Data Collection: Track the number of product recalls initiated due to safety issues or severe defects.
- Root Cause Analysis: Work with the supplier to perform a comprehensive root cause analysis for each recall.
- Performance Metrics: Evaluate the recall rate and assess its impact on the organization and customers.
- Performance Targets: Set targets to reduce the likelihood of product recalls, emphasizing product safety and quality.
Corrective and Preventive Actions:
- Collaborate with the supplier to develop and implement corrective and preventive actions based on the root cause analysis.
- Monitor the effectiveness of these actions in reducing the incidence of dealer returns, warranty claims, field actions, and recalls.
Continuous Improvement:
- Foster a culture of continuous improvement with the supplier, promoting a proactive approach to quality enhancement.
- Regularly review performance data, identify improvement opportunities, and collaborate on initiatives to address them.
Supplier Collaboration:
- Maintain open communication with the supplier to promptly address any quality issues and implement improvement measures.

By monitoring dealer returns, warranty, field actions, and recalls, the organization can take proactive steps to improve product quality, safety, and customer satisfaction. These performance indicators directly influence the organization’s reputation and market competitiveness. Effective monitoring and collaboration with the supplier lead to a more reliable and customer-centric supply chain.

IATF 16949:2016 Clause 8.4.2.3.1 Automotive product-related software or automotive products with embedded software

Automotive product-related software refers to any software or computer programs that are used in or integrated with automotive products or systems. These software applications are designed to enhance the functionality, performance, and safety of vehicles and automotive systems. There are two main categories of automotive product-related software:

Embedded Software in Automotive Products: Embedded software refers to software programs that are permanently stored and executed on microcontrollers or microprocessors within automotive products or components. These products include:
- Engine Control Units (ECUs): Embedded software controls various aspects of the engine, such as fuel injection, ignition timing, and emission control, to optimize performance and efficiency.
- Transmission Control Units (TCUs): Embedded software manages the operation of automatic or semi-automatic transmissions to ensure smooth shifting and improved fuel efficiency.
- Anti-lock Braking Systems (ABS): Embedded software controls the ABS system to prevent wheel lock-up during hard braking, enhancing vehicle stability and control.
- Infotainment Systems: Embedded software powers the multimedia, navigation, and communication features in modern infotainment systems.
- Advanced Driver Assistance Systems (ADAS): Embedded software enables features like lane departure warning, adaptive cruise control, and collision avoidance systems.
Automotive Product-Related Software Applications: This category includes software applications that are not embedded in the vehicle’s hardware but are used in the automotive industry for design, simulation, diagnostics, testing, and other purposes. Examples include:
- Computer-Aided Design (CAD) and Computer-Aided Engineering (CAE) software: Used for designing and simulating automotive components and systems before physical prototypes are built.
- Vehicle Diagnostics Software: Used by technicians to identify and troubleshoot issues in vehicles by communicating with the vehicle’s onboard diagnostics system.
- Vehicle Testing Software: Utilized for conducting various tests and simulations on vehicles to evaluate performance, safety, and emissions.
- Fleet Management Software: Helps manage and monitor vehicle fleets, including tracking vehicle locations, maintenance schedules, and fuel consumption.

The integration of software in modern automobiles has become increasingly complex, as vehicles are becoming more technologically advanced and connected. Automotive product-related software plays a vital role in ensuring vehicle performance, safety, and user experience, making it a critical focus area for automotive manufacturers and suppliers.

Clause 8.4.2.3.1 Automotive product-related software or automotive products with embedded software

The organization needs their suppliers of automotive products with software or products containing embedded software to have a process for ensuring the quality of their software. They should use a method to check how well their software is developed. Based on how risky it is and how much it could affect customers, the organization should ask the supplier to keep records showing how good their software development process is.

Supplier’s software quality assurance process

Requiring suppliers of automotive product-related software or automotive products with embedded software to implement and maintain a process for software quality assurance is essential to ensure the reliability, safety, and performance of their products. Here are the key steps to achieve this:

Software Quality Assurance Policy: Suppliers should establish a clear and comprehensive software quality assurance policy that outlines their commitment to delivering high-quality software products. The policy should align with industry standards and customer requirements.
Software Development Process: Develop a well-defined software development process that includes all the necessary stages from requirements gathering and design to coding, testing, and validation. Ensure that the process adheres to recognized software development standards such as Automotive SPICE (Software Process Improvement and Capability Determination) or ISO 26262 (Functional Safety for Road Vehicles).
Risk Management: Implement risk management practices specific to software development. Identify potential risks associated with software errors, safety hazards, or performance issues and devise mitigation strategies.
Software Testing and Validation: Establish robust testing procedures for software components and systems. This includes unit testing, integration testing, system testing, and validation against user requirements and safety standards.
Version Control and Configuration Management: Implement version control and configuration management to keep track of software changes, ensuring traceability and easy rollback to previous versions if necessary.
Change Management: Have a well-documented change management process to handle software changes, updates, and patches, ensuring that changes are thoroughly reviewed, approved, and tested before implementation.
Software Documentation: Maintain detailed documentation for all software components, including design documents, code comments, test cases, and user manuals. Clear documentation enhances maintainability and allows for better collaboration among teams.
Software Tool Validation: Validate and qualify the software development tools used in the process to ensure they are appropriate for their intended use and do not introduce errors or inconsistencies.
Training and Competence: Ensure that the software development team receives proper training and has the necessary skills and expertise to perform their roles effectively.
Continuous Improvement: Establish a culture of continuous improvement by regularly reviewing the software development process and performance metrics. Use feedback and lessons learned to identify areas for enhancement and implement corrective actions.
Compliance and Audits: Conduct internal audits to assess compliance with the established software quality assurance process. Additionally, prepare for external audits or assessments, especially if required by customers or regulatory bodies.

By implementing a robust software quality assurance process, suppliers can enhance the reliability, safety, and performance of their automotive product-related software or products with embedded software. This not only benefits the suppliers but also contributes to a more reliable and trustworthy supply chain for the automotive industry as a whole.

Software development assessment methodology to assess the supplier’s software development process

Using a software development assessment methodology to assess the supplier’s software development process is a proactive and systematic approach to ensure the quality, reliability, and compliance of their software products. This assessment helps identify strengths and areas for improvement, enabling the supplier to enhance their software development practices. Here’s how to conduct a software development assessment:

Select an Assessment Methodology: Choose a recognized and appropriate software development assessment methodology. Common methodologies include CMMI (Capability Maturity Model Integration), Automotive SPICE (Software Process Improvement and Capability Determination), or ISO/IEC 15504 (also known as SPICE).
Define Assessment Scope: Clearly define the scope of the assessment, specifying the software products or projects to be assessed, the relevant development processes, and the assessment objectives.
Gather Documentation: Request the supplier to provide relevant documentation related to their software development process, such as process descriptions, design documents, test plans, and quality records.
On-Site or Remote Assessment: Decide whether the assessment will be conducted on-site at the supplier’s location or remotely, depending on the practicality and nature of the assessment.
Conduct Interviews: Engage with key personnel involved in the software development process, including developers, testers, project managers, and quality assurance personnel. Conduct interviews to understand their roles, responsibilities, and process adherence.
Review Artifacts: Analyze the provided documentation and artifacts to evaluate the implementation of the software development process. Ensure that the documented processes align with the actual practices.
Assessment Criteria: Use the chosen methodology’s assessment criteria to evaluate the supplier’s software development process. Assess the maturity level, capability, and compliance with industry standards and best practices.
Identify Strengths and Weaknesses: Identify the strengths and best practices observed during the assessment, as well as areas where improvement is needed. Document the findings and provide actionable feedback.
Provide Recommendations: Based on the assessment results, provide specific and practical recommendations to the supplier to enhance their software development process. These recommendations should prioritize critical areas and support continuous improvement.
Follow-up and Monitoring: After the assessment, follow up with the supplier to monitor their progress in implementing the recommended improvements. Offer guidance and support as needed.
Repeat Assessments: Conduct periodic follow-up assessments to track the supplier’s progress and verify the effectiveness of the implemented improvements.

By utilizing a software development assessment methodology, the organization can gain insights into the supplier’s software development capabilities and ensure that the supplier is capable of delivering high-quality software products that meet the required standards and customer expectations. The assessment contributes to a more reliable and robust supply chain for the automotive industry.

Prioritizing based on risk and potential impact to the customer

Prioritizing based on risk and potential impact to the customer is a prudent approach for suppliers of automotive product-related software or automotive products with embedded software. By focusing on high-risk areas, suppliers can effectively allocate their resources and efforts to ensure that critical aspects of their software development process receive the necessary attention. Here’s how to prioritize based on risk and potential impact:

Risk Identification: Conduct a comprehensive risk assessment of the software development process, considering factors like safety-critical functionalities, regulatory requirements, complexity, and past performance. Identify potential risks that could impact the quality, safety, or reliability of the software.
Risk Categorization: Categorize the identified risks based on their severity and potential impact on the customer, product performance, and compliance. Classify risks as high, medium, or low based on their criticality.
Impact Analysis: Analyze the potential consequences of each high and medium-risk identified. Consider the impact on product functionality, safety, customer satisfaction, and compliance with relevant standards.
Customer-Centric Approach: Prioritize risks and development efforts with a customer-centric approach. Focus on risks that have the most significant potential impact on customers’ safety, experience, or business operations.
Regulatory Compliance: Address risks related to non-compliance with industry-specific regulations and standards. Prioritize the resolution of issues that could lead to non-compliance with safety standards or regulations governing the automotive industry.
Safety-Critical Functions: Give priority to risks associated with safety-critical functions or features of the software. Ensure that these aspects meet the highest quality standards and undergo rigorous testing and validation.
Resource Allocation: Allocate resources and efforts based on the prioritized risks. Devote more attention, testing, and verification activities to high-risk areas to minimize the likelihood of critical failures.
Continuous Monitoring: Continuously monitor the risks throughout the software development process. As new risks emerge or existing risks change, adjust the prioritization and development efforts accordingly.
Collaboration with Customers: Engage in open communication with customers to understand their specific concerns, expectations, and priorities related to software quality and safety. Incorporate customer feedback into the risk assessment process.
Traceability and Documentation: Maintain proper traceability and documentation of the risk assessment process, including the rationale behind prioritization decisions. This documentation helps support decision-making and audits.

By prioritizing based on risk and potential impact to the customer, suppliers can proactively address critical aspects of their software development process and ensure the delivery of high-quality, safe, and reliable automotive product-related software or products with embedded software. This approach also demonstrates the supplier’s commitment to customer satisfaction and compliance with industry standards.

Software development capability self-assessment.

Requiring suppliers to retain documented information of a software development capability self-assessment is essential for transparency, accountability, and continuous improvement. This documentation serves as evidence of the supplier’s self-assessment process, its findings, and the actions taken to enhance their software development capability. Here’s what the supplier’s documented information should include:

Self-Assessment Scope and Objectives: Clearly define the scope and objectives of the self-assessment. This includes specifying the software development processes, projects, or products covered by the assessment and the intended outcomes.
Assessment Methodology: Describe the methodology used for the self-assessment, including any industry-standard models or frameworks followed, such as CMMI, Automotive SPICE, ISO/IEC 15504, or other relevant standards.
Assessment Criteria: Outline the criteria used to evaluate the software development capability. This may include process maturity levels, capability levels, compliance with standards, and best practices.
Assessment Activities: Document the specific activities carried out during the self-assessment, such as interviews with key personnel, review of documentation, and analysis of artifacts.
Assessment Findings: Record the findings of the self-assessment, including strengths and weaknesses identified in the software development processes, areas for improvement, and potential risks.
Action Plans and Improvement Initiatives: Detail the action plans and improvement initiatives developed based on the assessment findings. This should include specific measures to address identified weaknesses and enhance the software development capability.
Responsibility and Accountability: Specify the individuals or teams responsible for implementing the improvement initiatives and their associated timelines.
Monitoring and Follow-up: Outline the approach for monitoring the progress of the improvement initiatives and conducting follow-up assessments to assess the effectiveness of the implemented changes.
Lessons Learned: Include any lessons learned during the self-assessment process, including insights gained, challenges faced, and best practices discovered.
Document Control: Ensure proper version control and document management for the self-assessment documentation, so that it remains up-to-date and accessible when needed.
Retention Period: Define the retention period for the self-assessment documentation, considering any regulatory or contractual requirements.

By retaining documented information of the software development capability self-assessment, the supplier demonstrates their commitment to quality, continuous improvement, and meeting industry standards. It also provides transparency to customers and other stakeholders, helping to build trust in the supplier’s software development processes and capabilities.

IATF 16949:2016 Clause 8.3.6.1 Design and development changes

Design changes are simply changes to the design and can occur at any stage in the design process from the stage at which the requirement is agreed to the final certification that the design is proven. Modifications are changes made to products to incorporate design changes and occur only after the first prototype is built. During development, design changes that affect the prototype are usually incorporated by rework or rebuild and are not classified as modifications. Following design certification, i.e. when all design verification has been completed and the product launched into production, changes to the product to incorporate design changes are classed as “modifications”. You need to control design changes to permit desirable changes to be made and to prohibit undesirable changes from being made. Change control during the design process is a good method of controlling costs and time-scales because once the design process has commenced every change will cost time and effort to address. This will cause delays while the necessary changes are implemented and provides an opportunity for additional errors to creep into the design. “If it’s not broke don’t fix it!” is a good maxim to adopt during design. In other words, don’t change the design unless it already fails to meet the requirements. Designers are creative people who love to add the latest devices and the latest technologies, to stretch performance, and to go on enhancing the design regardless of the time-scales or costs. One reason for controlling design changes is to restrain the otherwise limitless creativity of designers in order to keep the design within the budget and time-scale. The imposition of change control is often a difficult concept for designers to accept. They would prefer change control to commence after they have completed their design rather than before they have started. They may argue that until they have finished there is no design to control. They would be mistaken. Designs proceed through a number of stages (as described previously under Design reviews). Once the design requirements have been agreed, any changes in the requirements should be subject to formal procedures. When a particular design solution is complete and has been found to meet the requirements at a design review, it should be brought under change control. Between the design reviews the designers should be given complete freedom to derive solutions to the requirements. Between the design reviews there should be no change control on incomplete solutions. Design changes will result in changes to documentation but not all design documentation changes are design changes. This is why design change control should be treated separately from document control. You may need to correct errors in the design documentation and none of these may materially affect the product. The mechanisms you employ for such changes should be different from those you employ to make changes that do affect the design. By keeping the two types of change separate you avoid bottlenecks in the design change loop and only present the design authorities with changes that require their expert judgement. Make sure your process for design and development changes follow appropriate steps of define plan, have inputs and outputs, verify and validate to the extent necessary to meet customer requirements and control product, quality and business risks. Changes may come from internal, customer or regulatory sources. Get all requests for product or manufacturing process design changes in writing from your customer. Impact of the change must be evaluated on – materials used; design process; manufacturing process; characteristics and use of developed product; regulatory compliance; cost; etc.

Clause 8.3.6.1 Design and development changes

In addition to the requirement given in ISO 9001:2015 clause 8.3.6 Design and Development changes, Clause 8.3.6.1 necessitates the organization to assess all design modifications following the initial approval of the product, regardless of whether they are suggested by the organization itself or its suppliers, to determine their potential impact on fit, form, function, performance, and/or durability. These alterations need to be validated against customer requirements and internally approved before being implemented in production. If requested by the customer, documented approval or a documented waiver must be obtained from them before production implementation. For products incorporating embedded software, the organization must document the revision levels of both the software and hardware as part of the change control process.

Please click here for ISO 9001:2015 clause 8.3.6 Design and Development changes

This clause pertains to the control and management of changes that occur during the design and development stages of automotive products and processes. Compliance with Clause 8.3.6.1 aimed to ensure that any design and development changes in the automotive industry were well-controlled, properly assessed, and did not compromise product safety, quality, or customer requirements. It helped automotive companies maintain consistency and integrity throughout the product development lifecycle. Let’s explore the key aspects of this clause:

Change Control Process: Automotive companies were required to have a formal change control process in place to manage design and development changes effectively. This process needed to be documented and established to ensure that any modifications made during the design and development stages were carefully evaluated and controlled.
Impact Assessment: When a change was proposed, the organization had to conduct a comprehensive impact assessment to understand the potential consequences of the change. This assessment involved evaluating the impact on product functionality, safety, quality, compliance with requirements, and customer-specific requirements.
Authorization and Approval: The change control process needed to define the appropriate level of authorization and approval required for various types of changes. Depending on the nature and magnitude of the change, relevant personnel, including engineering, quality, and management representatives, needed to approve and authorize the change.
Verification and Validation: Before implementing the change, the organization was required to verify and validate the changes. This step involved testing and validating the changes to ensure they did not adversely affect the product’s performance, safety, or quality.
Documentation: All design and development changes, along with their associated impact assessments, authorizations, and verifications, needed to be thoroughly documented. Proper documentation allowed for traceability, transparency, and effective communication across the organization.
Communication: The change control process required clear and effective communication throughout the organization. Relevant stakeholders needed to be informed of the change, its implications, and any actions they needed to take as a result.
Risk Management: The change control process should incorporate risk management principles. Potential risks arising from the changes should be identified, evaluated, and appropriate actions taken to mitigate or control these risks.
Training: If the design and development changes impacted the skills or knowledge required by employees, the organization had to ensure that affected personnel received the necessary training to adapt to the changes.

Identification of design changes
All design changes are to be identified before their implementation including changes to proprietary designs. At each design review a design baseline should be established which identifies the design documentation that has been approved. The baseline should be recorded and change control procedures employed to deal with any changes. These change processs should provide a means for formally requesting or proposing changes to the design. The most effective method is by use of a Design Change Form constructed to collect all the data needed by the approval authorities. For complex designs you may prefer to separate proposals from instructions and have one form for proposing design changes and another form for promulgating design changes after approval. You will need a central registry to collect all proposed changes and provide a means for screening those that are not suitable to go before the review board (either because they duplicate proposals already made or because they may not satisfy certain acceptance criteria which you have prescribed). On receipt, the change proposals should be identified with a unique number that can be used on all related documentation that is subsequently produced. The change proposal needs to:

Identify the product of which the design is to be changed.
State the nature of the proposed change.
Identify the principal requirements, specifications, drawings, or other design documents that are affected by the change.
State the reasons for the change either directly or by reference to failure reports, nonconformity reports, customer requests, or other sources.
Provide for the results of the evaluation, review, and decision to be recorded.

Documenting design changes
All design changes to be documented before their implementation including changes to proprietary designs. The documentation for design changes should comprise the change proposal, the results of the evaluation, the instructions for change and traceability in the changed documents to the source and nature of the change. You will therefore need:

A Change Request Form, which contains the reason for change and the results of the evaluation. This was described previously as it is used to initiate the change and obtain approval before being implemented.
A Change Notice, which provides instructions defining what has to be changed. This is issued following approval of the change as instructions to the owners of the various documents that are affected by the change.
A Change Record, which describes what has been changed. This usually forms part of the document that has been changed and can be either in the form of a box at the side of the sheet (as with drawings) or in the form of a table on a separate sheet (as with specifications).

Where the evaluation of the change requires further design work and possibly experimentation and testing, the results for such activities should be documented to form part of the change documentation.

Review and approval of design changes

All design changes to be reviewed and approved by authorized personnel before their implementation including changes to proprietary designs. The organization are to address the impact of a design change on the systems in which the product is used, the customer assembly process, and other related products and systems. Following the commencement of design you will need to set up a change control board or panel comprising those personnel responsible for funding the design, administering the contract, and accepting the product. All change proposals should be submitted to such a body for evaluation and subsequent approval or disapproval before the changes are implemented. Such a mechanism will give you control of all design changes. By providing a two-tier system you can also submit all design documentation changes through such a body. They can filter the alterations from the modifications, the minor changes from the major changes. Remember that by controlling change you control cost so it is a vital organ of the business and should be run efficiently. The requirement for changes to be approved before their implementation emphasizes the importance of this control mechanism. The change proposals need to be evaluated:

To validate the reason for change
To determine whether the proposed change is feasible
To judge whether the change is desirable
To determine the effects on performance, costs, and time-scales
To determine the impact of the change on other designs with which it interfaces and in which it is used
To examine the documentation affected by the change and consequently program their revision
To determine the stage at which the change should be embodied

The evaluation may need to be carried out by a review team, by subcontractors, or by the original proposer; however, regardless of who carries out the evaluation, the results should be presented to the change control board for a decision. During development there are two decisions the board will need to make:

Whether to accept or reject the change
When to implement the change in the design documentation

If the board accepts the change, the changes to the design documentation can either be submitted to the change control board or processed through your document control process. During development it is a common practice to accumulate design changes for incorporation into the design when design proving has been completed. If there are many of these changes a two or three stage process of incorporation may be desirable. In the event that the development model is deliverable to the customer or, as in the case of one-off systems, the changes need to be incorporated into the design before delivery, acceptance may take place against drawings and specifications extended by change notes. However, unless the change notes accurately reﬂect the final design configuration, the integrity of any certification of the product against a proven design cannot be assured. There is also a temptation to cut costs by not incorporating latent design changes. This may well avert delayed delivery but will have severe consequences should modifications be necessary later or should the changes affect the integrity of the supporting handbooks and manuals. So, deciding when to incorporate the changes is a very important consideration.

Evaluating all design changes

Evaluating all design changes after initial product approval is a crucial practice in the automotive industry to ensure that any modifications or updates made to the product design do not compromise its fit, form, function, performance, and durability. This evaluation process helps to maintain the integrity and quality of the product throughout its lifecycle. Let’s explore the key aspects of this practice:

Post-Approval Design Change Evaluation: After the initial product approval, the organization establishes a systematic process to review and evaluate all proposed design changes. This evaluation includes changes proposed by the organization itself or by its suppliers.
Impact Assessment: The primary purpose of this evaluation is to assess the potential impact of the design changes on various aspects of the product, such as fit (how components and parts come together), form (the physical appearance and layout), function (how the product operates and performs its intended tasks), performance (the product’s ability to meet specifications and requirements), and durability (the product’s lifespan and resistance to wear and tear).
Cross-Functional Review: The evaluation process involves a cross-functional team that includes representatives from engineering, quality assurance, manufacturing, and other relevant departments. This team collectively reviews and analyzes the proposed changes to gain a comprehensive understanding of their implications.
Risk Analysis: The team identifies potential risks associated with the design changes. These risks can include safety concerns, negative impacts on performance or reliability, non-compliance with regulatory requirements, and adverse effects on customer satisfaction.
Validation and Testing: Depending on the complexity and significance of the design changes, the organization may conduct validation and testing to verify the impact on fit, form, function, performance, and durability. Testing may involve simulations, prototypes, or actual product testing, as appropriate.
Supplier Involvement: If the design changes are proposed by suppliers, the organization collaborates closely with them during the evaluation process. The organization may require suppliers to provide relevant data, testing results, and other supporting information to assess the changes adequately.
Documentation and Traceability: The entire evaluation process is thoroughly documented, providing a clear record of the design change assessments and the actions taken. Proper documentation ensures traceability and transparency in case of future reference or audits.
Continuous Improvement: The evaluation process is not a one-time activity but a part of the organization’s continuous improvement efforts. Feedback from the evaluation process is used to enhance design, development, and change management processes for the future.

By conducting thorough evaluations of design changes after initial product approval, automotive organizations can ensure that any modifications are well-controlled and do not compromise the product’s performance, safety, and customer satisfaction.

Validated against customer requirements

Validating design and development changes against customer requirements and obtaining internal approval before implementing them into production is a fundamental practice in the automotive industry. This process ensures that any modifications made to the product design are in line with customer expectations and internal quality standards. Let’s delve into the key steps involved in this validation and approval process:

Customer Requirement Validation: Before proceeding with any design and development changes, the automotive organization must thoroughly validate the changes against the specific requirements and expectations of their customers. This involves a detailed analysis of customer feedback, specifications, and any other relevant inputs to ensure that the proposed changes align with customer needs.
Design Verification: Once the design changes have been proposed, the organization conducts design verification activities to confirm that the modified design meets the established requirements. This can include simulations, testing, prototyping, and other validation methods to ensure that the proposed changes will function as intended.
Internal Review and Approval: After successful validation against customer requirements and design verification, the proposed changes are subjected to an internal review process. This review involves cross-functional teams, including engineering, quality assurance, manufacturing, and other relevant stakeholders. The purpose is to ensure that the changes are feasible, compliant with standards, and align with the organization’s strategic objectives.
Risk Assessment: During the internal review, the organization also performs a comprehensive risk assessment. This helps identify potential risks associated with the design and development changes. Risks related to safety, quality, compliance, and customer satisfaction are considered, and appropriate actions are taken to mitigate or control these risks.
Approval and Authorization: Once the design changes have successfully passed the internal review and risk assessment, they require formal approval and authorization. The designated personnel, which may include engineering managers, quality managers, and senior leadership, provide the necessary approvals to move forward with the changes.
Documentation and Record Keeping: Throughout the entire process, the organization maintains meticulous documentation of all activities related to the design and development changes. This includes customer requirement validation results, design verification reports, internal review records, and approval documentation. Proper documentation ensures traceability and compliance with quality standards.
Communication: Effective communication is essential during this process. The outcome of the validation and approval process, as well as any necessary changes or instructions, is communicated to all relevant departments and stakeholders involved in the production process.

By validating design and development changes against customer requirements and gaining internal approval, automotive organizations ensure that only authorized and well-vetted modifications are implemented into production. This helps maintain product quality, customer satisfaction, and adherence to i IATF 16949:2016.

Document approval by the customer

When required by the customer, the organization must obtain documented approval or a documented waiver before implementing any changes in the production of the product. This process ensures that the customer is aware of and agrees to the proposed changes, whether they are related to design, materials, processes, or any other aspect of the product. This practice is vital for maintaining transparency, customer satisfaction, and adherence to customer-specific requirements. Let’s delve into the key aspects of this requirement:

Customer Requirements and Agreements: The organization must thoroughly understand the customer’s specific requirements and agreements related to the production of the product. These requirements may include specifications, quality standards, delivery schedules, and any other conditions that the organization must fulfill.
Proposed Changes: If the organization identifies the need for changes in the production process, product design, materials, or any other aspect that could affect the final product, they must document these proposed changes.
Impact Assessment: Before seeking customer approval, the organization should conduct a comprehensive impact assessment of the proposed changes. This assessment evaluates how the changes may affect the product’s quality, functionality, performance, safety, and compliance with customer requirements.
Documented Approval or Waiver: Depending on the nature of the changes and the customer’s requirements, the organization must either obtain documented approval or a documented waiver from the customer. The customer’s approval confirms that they are aware of the changes and agree to them. A waiver, on the other hand, indicates that the customer has been informed of the changes but has chosen not to approve them.
Effective Communication: Effective communication is key throughout this process. The organization should clearly explain the proposed changes to the customer, along with the potential impacts and benefits. Any concerns or questions raised by the customer should be addressed promptly.
Record Keeping: The organization should maintain meticulous records of all communications with the customer regarding the proposed changes. This includes the documentation of customer approval, waivers, or any other relevant correspondence.
Timely Actions: It’s essential for the organization to obtain customer approval or waivers in a timely manner. Delays in seeking approval could lead to production bottlenecks or disruptions.
Regulatory Compliance: In some cases, the organization may need to consider regulatory requirements that govern changes to specific products or industries. Compliance with such regulations is critical and may also require customer approval.

By obtaining documented approval or waivers from the customer prior to production implementation, the organization demonstrates its commitment to meeting customer requirements and ensures a clear understanding between both parties. This practice helps build trust, maintain customer satisfaction, and fosters a positive relationship with the customer, which is essential for long-term business success.

Embedded software

or products with embedded software, documenting the revision level of both the software and hardware is a critical part of design change control in the automotive industry. This documentation ensures that the software and hardware versions used in the design and development process are accurately tracked and controlled. It helps maintain consistency, traceability, and quality throughout the product lifecycle. Let’s explore the key aspects of this practice:

Embedded Software and Hardware Identification: The organization must establish a systematic method for identifying and labeling the embedded software and hardware used in the product’s design. This identification should include unique version numbers or revision codes that distinguish one version from another.
Change Management Process: The organization should have a well-defined change management process that covers both software and hardware revisions. This process outlines how changes to the software and hardware are proposed, reviewed, and implemented throughout the design and development stages.
Version Control: The software and hardware versions must be carefully managed using version control mechanisms. Version control systems help track changes, maintain historical records, and prevent conflicting revisions.
Traceability: Documentation should provide full traceability between the design changes, the associated software and hardware revisions, and the reasons for these changes. This traceability allows for a clear understanding of how different versions of the software and hardware evolve over time.
Impact Assessment: Before implementing any design changes that involve software or hardware revisions, the organization should conduct a thorough impact assessment. This assessment evaluates the potential implications of the changes on the product’s performance, safety, and compliance with customer requirements.
Validation and Testing: For products with embedded software, validating the changes is critical. The organization must ensure that any changes to the software or hardware do not introduce defects or negatively impact the product’s functionality. Validation may involve testing the software, performing regression tests, and ensuring that the new hardware functions as intended.
Configuration Management: Configuration management is essential for products with embedded software. It ensures that the correct software and hardware versions are deployed during production and that any updates or changes are controlled and well-documented.
Approval and Authorization: Similar to other design changes, software and hardware revisions require proper approval and authorization before implementation. The designated personnel responsible for managing changes in the organization must review and approve the changes.

By documenting the revision level of embedded software and hardware as part of the design change control process, automotive organizations can effectively manage the complexities associated with software-driven products. This practice aligns with industry standards and best practices, ensuring that the product’s quality and compliance are upheld.

Example of documentation template for Production and Maintenance

The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Production and Maintenance. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1.0 Consolidated Timesheet for the month

2. Daily Work Control and Time sheet

SN.

Empl. No.

NAME

DESIGNATION

Working Time

Time allocation

JO / /

Maintainance/ Other Works

Out

HRS

HRS/OT OT

3 Production Planning and Control

S.No

Job No

Client

Description

QTY

Date

Allocation

Review

Delivery

Material

Production

INSP & TEST

Men

Machine

Completion

Performance

Client Req.

In Shop

Start

End

Final

Prepared by

Approved by:

4. Customer /Supplier Property Record

S. No.	Receipt / Delivery Order No.	Date	J.O / W.O. No.	Customer / Supplier Name	Type of Property		Description	Qty. / Copy No.	Disposition details & date	Receipt By
S. No.	Receipt / Delivery Order No.	Date	J.O / W.O. No.	Customer / Supplier Name	Product / Instrument Identification No.	Document Ref No. (with current Rev No. and Date)	Description	Qty. / Copy No.	Disposition details & date	Receipt By














Prepared By:							Approved By:
Name:							Name:
Sign:							Sign:
Date:							Date:
Issue No / Date : xx/xx.xx.xxxx Rev No / Rev Date: xx/xx.xx.xxxx

5.0 Operation and Execution Plan

Product / Service Details

Asset Owner / Client
Job description
Purchase order		Location
JOB NO		Country

Section I: General

Synopsis:

1.1 Scope of Work:

1.2 Location (Suitable work environment):

1.3 Codes and Specifications:

Section II: Initial Information about the Job

2.1 Product / Customer Specified requirements:
S. No	Product Description	Quantity	Customer requirement

2.2 Legal and Other applicable requirements:
2.3: Design and Development Requirements:

Section III: Activities and Responsibilities

S. No	Activities (Operational, inspection and testing activities)	Responsibilities	Target Date
1
2
3
4
5
6
7
8
9
10
11

Section IV: Risk Assessment, Contingency & MOC

Scope:

Risk:

Action taken:

Conclusions from the risk assessment:

Section V: Method Statement

S. No	Activities (Operational, inspection and testing activities)	Reference Standard / Procedures / Work Instruction
1
2
3
4
5
6
7
8

Section VI: Required Resources and Records

6.1 Resources (Machines / Equipment / Manpower)

6.2 Records

6. Breakdown Maintenance Report

EQUIPMENT Details		M/C No.
Manufacturer		Serial No.
Breakdown reported by		Date

TOTAL BREAKDOWN HOURS
PROBLEM DESCRIPTION
PROBLEM DIAGNOSED
REMEDIAL ACTION TAKEN
PARTS REPAIRED & REPLACED
ADDITIONAL REMARK
*Maintenance Engineer* (Name & Signature & Date)	*Operationa Manager* (Name & Signature & Date)

7. Breakdown Maintenance Register

Sr. No.	Date	Machine No.	Reason for breakdown	Damaged parts	Down time	Re-start	Spare used	Sign of Mechanic	Remarks


















Total Breakdown Hours :
Prepared by			Reviewed by				Approved by
Name			Name				Name
Signature			Signature				Signature
Date			Date				Date
Issue No / Date : xx/xx.xx.xxxx Rev No / Rev Date: xx/xx.xx.xxxx

8. Complete Overhauling / Reconditioning Plan

EQUIPMENT DETAILS				SOS M/C NO.
MANUFACTURER				SERIAL NO.
START DATE				COMPLETION DATE
MECHANICAL				ELECTRICAL
A	HYDRAULIC SYSTEM		YES/ No	A	POWER SUPPLY		YES / NO
	1)Pump				1)Incoming Power Supply
	2)Valves				2)Earthing
	3)Hydraulic Lines			B	CONTROL WIRING(Control panel)
	4)Lubrication System				1)MCB’S & Contractors
	5)Filtering System				2)Fuses & Terminal Blocks
	6)Clutch System (If any)				3)Relays & Timers
B	GUIDS & MOVEMENT				4)Push Buttons & Lights
	1)Scrapping (If needed)				5)Wiring
	2)Polishing of Guide & Bed			C	POWER WIRING(Control Panel)
C	MAINDRIVE				1) MCCB
	1)Gears & Shafts				2)MCB’S & Contractors
	2)Bearings				3)Fuses & Terminal Blocks
	3)All Moving & Engaging Parts				4)Wiring
D	FEED SYSTEM			D	MACHINE SIDE
	1)Gears & Shafts				1)Motors
	2)Beams				2)Coolant pump
	3)Head Screw				3)Lights
	4)screw Nut / Sleeve				4)Wiring
Remarks:
Prepared by		Reviewed by				Approved by
Name		Name				Name
Signature		Signature				Signature
Date		Date				Date
Iss No / Date : 01/20.07.2020 Rev No / Rev Date: 00/–

9. Annual Preventive maintenance plan

SRL#	MACHINE NAME	ASSET #	DAILY	WEEKLY	MONTHLY	QUARTERLY	YEARLY
1	AIR COMPRESSOR		Daily	_	_	Mar,Jun,spt,dec	25-Dec
2	RADIAL DRILLING M/C		Daily	_	_	Mar,Jun,spt,dec	23-Dec
3	LATHE M/C		Daily	Thursday	_	Mar,Jun,spt,dec	26-Dec
4	VTL M/C		Daily	Thursday	11th	_	24-Dec
5	MILLING M/C		Daily	Thursday	10th	_	21-Dec
6	BORING M/C		Daily	Thursday	10th	_	21-Dec
7	PIPE THREADING M/C		_	Monday	12th	_	23-Dec
8	FURNACE		_	Tuesday	13th		21-Dec
9	ELECTRODE OVEN		Daily	Tuesday	5th	_	17-Dec
10	WELDING M/C		_	Saturday	15th	_	30-Dec
11	SA WELDING M/C		Daily	_	_	Mar,Jun,spt,dec	21-Dec
12	OVERHEAD CRANE		_	Wednesday	5th	_	22-Dec
13	BENCH GRINDER		_	Tuesday	10th	_	27-Dec
14	ELECTRODE QUIVER		Daily	Saturday	15th	_	30-Dec
15	BANDSAW CUTTING M/C		Daily	Monday	10 th	_	20-Dec
16	PIPE BEVELING M/C		_	Sunday	11th	_	27-Dec
17	HYDROSTATIC TEST PUMP		Daily	Wednesday	5th	_	20-Dec
18	Air PRESSURE PUMP		Daily	Wednesday	5th	_	20-Dec
19	WATER PRESSURE PUMP		Daily	Wednesday	5th	_	20-Dec
20	TORQUE WRENCH PUMP		Daily	_	_	Mar,Jun,spt,dec	20-Dec
21	SAND BLASTING MACHINE		Daily	Monday	20th	_	19-Dec
22	PORTABLE AIR COMPRESSOR		Daily	_	_	Mar,Jun,spt,dec	25-Dec
23	HIGH PRESSURE PAINT SPRAYER M/C		Daily	_	20th	_	19-Dec
24	ELECTRODE OVEN		Daily	Tuesday	5th	_	17-Dec
Prepared by		Reviewed by			Approved by
Name		Name			Name
Signature		Signature			Signature
Date		Date			Date
Issue No / Date :xx/xx.xx.xxxx Rev No / Rev Date: xx/xx.xx.xxxx

10. Preventive Maintenance Checklist

Month/Year:			Machine Name:																					Machine ID / No –
Frequency	Sl.No	Activity	Days
Frequency	Sl.No	Activity	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24	25	26	27	28	29	30	31
Daily	1
	2
	3
	4

Quarterly	1
	2
	3

Yearly	1
	2
	3
	4
Last PM Month:			Quarterly:									Half Yearly:										Yearly:
Remarks:

11 Preventive Maintenance Checking Parameters

Preventive Maintenance For Air Compressor
- Daily:
  - a) Clean the compressor
  - b) Check the oil level
  - c) Check the coolers & Clean if required
  - d) Check for any oil leakage
- Quarterly:
  - a) Check the section coolers
  - b) Remove air filter and clean
  - c) Check all the flexible hoses
- Yearly:
  - a) Replace Oil filters
  - b) Change Oil
  - c) Change Oil separator
  - d) Check all electrical and safety controls
Preventive Maintenance for Drilling Machine
- Daily:
  - a) Clean the machine
  - b) Lubricate all moving parts
  - c) Check hydraulic oil level
  - d) Check for any oil leakage
- Quarterly:
  - a) Check all the electrical controllers
  - b) Apply grease on greasing points
- Yearly:
  - a) Check all functions of machine
  - b) Check all the electrical and safety controls
  - c) Change spares as required
Preventive Maintenance For Lathe Machine
- Daily:
  - a) Clean the machine
  - b) Lubricate all moving parts
  - c) Check the oil level
  - d) Check for any oil leakage
- Weekly:
  - a) Check the coolant tank
  - b) Apply grease on greasing ports
  - c) Check the spindle unit
- Quarterly:
  - a) Check all the electrical and safety controls
  - b) Clean the coolant tank and Top up the coolant
  - c) Check the hydraulic unit
- Yearly:
- a) Overall cleaning of the machine
- b) Check the overall conditions of machine c) clean & change the parts as required
Preventive Maintenance for VTL Machine
- Daily:
  - a) Clean the machine
  - b) Lubricate all moving parts
  - c) Check the oil level
  - d) Check for any oil leakage
- Weekly:
  - a) Check lead screws & feed shaft
  - b) Apply grease on greasing ports
- Monthly:
  - a) Check main spindle unit
  - b) Clean the coolant tank and Top up the coolant
  - c) Check & adjust lead screw nuts
  - d) Check the cross bar leveling & Adjust if required
- Yearly:
  - a) Overall cleaning of the machine
  - b) Check the overall conditions of machine c) clean & change the parts as required d) Check all the electrical devices
Preventive Maintenance for Milling Machine
- Daily:
  - a) Clean the machine
  - b) Lubricate all moving parts
  - c) Check the oil level
  - d) Check for any oil leakage
- Weekly:
  - a) Check lead screws & feed shaft
  - b) Apply grease on greasing ports
- Monthly:
  - a) Check main spindle unit
  - b) Clean the coolent tank and Top up the coolent
  - c) Check & adjust leadscrew nuts
- Yearly:
  - a) Overall cleaning of the machine
  - b) Check the overall conditions of machine
  - c) Clean & change the parts as required
  - d) Check all the electrical devices
Preventive Maintenance for Boring Machine
- Daily:
  - a) Clean the machine
  - b) Lubricate all moving parts
  - c) Check the oil level
  - d) Check for any oil leakage
- Weekly:
  - a) Check lead screws & feed shaft
  - b) Apply grease on greasing ports
- Monthly:
  - a) Check main spindle unit
  - b) Clean the coolent tank and Top up the coolent
  - c) Check & adjust leadscrew nuts
  - d) Check main drive belt
- Yearly:
  - a) Overall cleaning of the machine
  - b) Check the overall conditions of machine
  - c) clean & change the parts as required
  - d) Check all the electrical devices
Preventive Maintenance for Pipe Threading M/C
- Weekly:
  - a) Clean the machine
  - b) Lubricate all moving parts
  - c) Check the foot switch
  - d) Check the emergency stop
- Monthly:
  - a) Check the electrical devices
  - b) Check & lubricate the gear box
  - c) Check & stop oil leakage
- Yearly:
  - a) Overall cleaning of the machine
  - b) Check the overall conditions of the machine
  - c) Check all the electrical devices
  - d) Clean & change parts as required
Preventive Maintenance for furnace
- Weekly:
  - a) Clean the machine
  - b) Lubricate all moving parts
  - c) Check the foot switch
  - d) Check the emergency stop
- Monthly:
  - a) Check the electrical devices
  - b) Check & lubricate the gear box
  - c) Check & stop oil leakage
- Yearly:
  - a) Overall cleaning of the machine
  - b) Check the overall conditions of the machine
  - c) Check all the electrical devices
  - d) Clean & change parts as required
Preventive Maintenance for Electrode oven
- Daily:
  - a) Check the A/C cables
  - b) Check the A/C plug
- Weekly:
  - a) Check the thermostat
  - b) Check the temperature
- Monthly:
  - a) Overall function checking of the oven
  - b) Overall cleaning of the oven
  - c) Clean the thermostat
- Yearly:
  - a) Overall cleaning of the oven
  - b) Overall functional checking of the oven
  - c) Change the parts if required
Preventive Maintenance for Welding Machine
- Daily:
  - a)Clean the machine
  - b) Check the cables
  - c) Check the cooling system
- Quarterly:
  - a)Check the flow meter/regulator
  - b)check the cables
  - c)Check the electrode holder
- Yearly:
  - a)Check the electrode holder
  - b)Check wear & tear on cables
  - c) Check the isolation switch
  - d)Change the parts as required
Preventive Maintenance for SA Welding Machine
- Daily:
  - a)Clean the machine
  - b)Lubricate All Moving Parts
  - c)Check for any oil leakage
- Quarterly:
  - a)Check the limit switches
  - b)Check & fill Lubricating Oil
  - c)Check & clean Job Holder
- Yearly:
  - a)Overall cleaning of the machine
  - b)Check all electrical connections
  - c) Check all the functions
  - d)Check and change parts if required
Preventive Maintenance for Overhead crane
- Weekly:
  - a)Check cables
  - b)Check the safety switches
  - c)Check for the propper functioning of remote control
- Monthly:
  - a)Check lifting slings
  - b)Check the lifting hook condition
  - c)Check the oil level in gear motor
- Yearly:
  - a)Overall cleaning
  - b)Check all electrical parts
  - c) Change the parts if required
Preventive Maintenance for Bench Grinder
- Weekly:
  - a) Clean & remove grinding stone particles
  - b) Check the grinding wheel
  - c) Dress the wheel
- Monthly:
  - a) Check the machine guards
  - b) Check the electrical connections
  - c) Apply grease on greasing points
- Yearly:
  - a) Check the main power supply
  - b)Check the spindle bearing
Preventive Maintenance for Electrode Quiver
- Daily:
  - a)Check the A/C cables
  - b)Check the A/C plug
- Weekly:
  - a)Check the thermostat
  - b)Check the temperature
  - Monthly:
    - a)Overall function checking of the oven
    - b)Overall cleaning of the oven
    - c)Clean the thermostat
- Yearly:
  - a)Overall function checking of the oven
  - b)Overall cleaning of the oven
  - c) Change the parts if required
Preventive Maintenance for Band saw Cutting Machine
- Daily:
  - a) Clean the machine
  - b)Check blade for wear
  - c)Check functionality of shield & emergency stop
- Weekly:
  - a)Remove shavings from coolant tank
  - b)Clean pump suction filter & suction zone
- Monthly:
  - a)Check the tightening of the drive wheel screw
  - b)Check the blade guide bearings
- Yearly:
  - a)Check the tightening of the screws of the motor, pump, & accident protection guard
  - b)Changing gear oil
  - c)Check the tightening of the drive wheel screws
Preventive Maintenance for Pipe Beveling Machine
- Weekly:
  - a)Clean the machine
  - b)Lubricate all moving parts
  - c)Check for any physical damage
- Monthly:
  - a)Overall cleaning of the machine
  - b)Check the overall conditions of the machine
  - c)Check the electric & pneumatic
  - motors
- Yearly:
  - a)Overall cleaning of the machine
  - b)Check the overall conditions of the machine
  - c)Check the electric & pneumatic motors
  - d)Clean & change the parts as required
Preventive Maintenance for Hydrostatic Test Pump
- Daily:
  - a) Clean the Pump
  - b)Check for any leakage
- Weekly:
  - a)Check the Valves
  - b)Check the Hoses
- Monthly:
  - a)Check & Clean the Air filter
  - b)Check the safety Valve
  - c)Check the NRV
- Yearly:
  - a)Overall cleaning of the pump
  - b)Do the functional test
  - c)Change the parts if required
Preventive Maintenance for Air Pressure Pump
- Daily:
  - a) Clean the Pump
  - b) Check for any leakage
- Weekly:
  - a) Check the Valves
  - b) Check the Hoses
  - c) Lubricate the parts
- Monthly:
  - a) Check & Clean the Air filter
  - b) Check the safety Valve
- Yearly:
  - a) Overall cleaning of the pump
  - b) Electrical motor inspection
  - c) Replaced damaged seals & hoses
Preventive Maintenance for Water Pressure Pump
- Daily:
  - a) Clean the Pump
  - b)Check for any leakage
- Weekly:
  - a)Check the Valves & hoses
  - b)Check the tightening of the fittings
  - c)Check for any damage in power codes
- Monthly:
  - a)Check & Clean the filters & nozzles
  - b)Check the correct oil level
- Yearly:
  - a)Pump oil & filters replaced
  - b)Filters & nozzles replaced
  - c)All valves are checked & cleaned
Preventive Maintenance for Torque Wrench Pump
- Daily:
  - a) Check couplings,lock pins & safety cables
  - b) Inspect blast hose, couplings & nozzle holders for leaks
  - c) Check all external piping, control hoses & valves for leaks
- Weekly:
  - a) Inspect the blast hose for wear & worn
  - b) Check the nozzle & washer condition
  - c) Check & clean the filter
- Monthly:
  - a) Check for wear pop-up valves urethane coating
  - b) Inspect the rubber pop-up seal,replace at first sight of wear or cracking
- Yearly:
  - a) Overall cleaning of the machine
  - b) Inspect the whole machine & replace any parts if required
Preventive Maintenance for Sand Blasting Machine
- Daily:
  - a)Check couplings,lock pins & safety cables
  - b)Inspect blast hose, couplings & nozzle holders for leaks
  - c)Check all external piping, control hoses & valves for leaks
- Weekly:
  - a)Inspect the blast hose for wear & worn
  - b)Check the nozzle & washer condition
  - c)Check & clean the filter
- Monthly:
  - a)Check for wear pop-up valves urethane coating
  - b)Inspect the rubber pop-up seal,replace at first sight of wear or cracking
- Yearly:
  - a)Overall cleaning of the machine
  - b)Inspect the whole machine & replace any parts if required
Preventive Maintenance for Portable Air Compressor
- Daily:
  - a)Clean the compressor
  - b)Check the oil level
  - c)Check the coolers & Clean if required
  - d)Check for any oil leakage
- Quarterly:
  - a)Check the section coolers
  - b)Remove air filter and clean
  - c)Check all the flexible hoses
- Yearly:
  - a)Replace Oil filters
  - b)Change Oil
  - c)Change Oil separator
  - d)Check all electrical and safety controls
Preventive Maintenance for High Pressure Paint Sprayer Machine
- Daily:
  - a) Flush hose & gun
  - b) Drain water from air filter
  - c) Clean the suction tube
- Monthly:
  - a) Check & tighten all fluid connections
  - b) Check for any leakage
  - c) Clean fluid line filter
- Yearly:
  - a) Overall cleaning of the machine
  - b) Check hoses,tubes & couplings replace if required
Preventive Maintenance for Electorde Oven
- Daily:
  - a) Check the A/C cables
  - b)Check the A/C plug
- Weekly:
  - a)Check the thermostat
  - b)Check the temperature
- Monthly:
  - a)Overall function checking of the oven
  - b)Overall cleaning of the oven
  - c)Clean the thermostat
- Yearly:
  - a)Overall function checking of the oven
  - b)Overall cleaning of the oven
  - c) Change the parts if required

Prepared by :	Approved by :
Signature :	Signature :
Designation :	Designation :

Example of documentation template for QA

The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Quality Assurance. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.

1.0 Quality Plan

Description
Customer			Client Supplied Material
Date of Receiving			Client Supplied Tools and Equipments
Job No..			Client Witness
Plan No.			Rig no.			Serial No.
S.No	Activity/ Work Package	QA/QC Release	Procedure/ Drawing/ ATP	Equipment Required	Performed	Date		Signature
Work break down to be set process wise						Plan	Actual	Operator	Operation Engineer	QA/QC Engineer
01
02
03
04
05
06
07
08
09
10
11
12
13
NOTE: NO PROCESS HAVE BEEN OUTSOURCED.
LEGEND : H -Hold, W- Witness, I-Inspect, R-Review, S-Surveillance
PREPARED BY:			REVIEWED BY:			APPROVED BY:
SIGNATURE:			SIGNATURE:			SIGNATURE:
DATE:			DATE:			DATE:

2.0 Dimensional Inspection Report

Client:	Inspection Stage: As received / In process Inspection/ Final Inspection
Job No:	MI Traceability:
Report No.:	Rig No:

#	Item	Location	Dimensions Required	Visual Condition	Recommendation	Remark

Inspected by:
Name:

Sign:
Date

Witnessed or Verified by:
Name:

Sign:
Date

Recommendation Approved by:
Name:

Sign:
Date

3.0 Eye Test Report

Candidate Name:

Date of Birth:

Tested on:

Near Vision
Method:

Acuity:

Colour Vision
Method:

Colours Involved
Green – Capable/Not Capable
Yellow – Capable/Not Capable
White – Capable/Not Capable
Red – Capable/Not Capable
Black – Capable/Not Capable
Shades of Grey – Capable/Not Capable

Test Carried-out by: ( Signature) Company Stamp

Name:
Designation:
Registration No:
Company Name:
Place:

4.0 Welder Qualification Review

5.0 Customer Complaint Record

Sl.No	Date	Customer PO No. & Date	Customer Name	Description of Product	Qty. Supplied	Qty. Rejected / Returned	Complaint Details	Root Cause	NCR/NCP No.	Remarks

6.0 Annual Calibration Plan

Date:

Year:

Equipement type

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

(P)

(A)

(P)

(A)

(P)

(A)

(P)

(A)

(P)

(A)

(P)

(A)

(P)

(A)

(P)

(A)

(P)

(A)

(P)

(A)

7.0 In-House Calibration Certificate

CERT. NO. ——————- DATE ——————-
Equipment I.D.:		Made/Make:
Manufacturer:		Model No :
Type of Machine:		Serial No.:
Drive:		Physical Condition:
Referance Procedure:		Revision Status:
CALIBRATION DATA
Regulator Scale Marking	Measured marking		Variation	Remarks







MASTER EQUIPMENT TRACEBILITY
Equipment Type
Equipment I.D. No.
Calibration By.
Calibration Certificate No.

Calibrated By:		Certified by:
Name:		Name:
Signature:		Signature:
Date		Date:
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

7A) In-House Calibration Certificate For Pressure Equipment

				CERT. NO.
				CAL. DT :
				DUE DATE
Equipment I.D.:			Made/Make:
Manufacturer:			Model No :
Type of Machine:			Serial No.:
Drive:			Physical Condition:
Referance Procedure:			Revision Status:
CALIBRATION DATA
UPSCALE READINGS:
Input (% Pressure)		DWT Pressure Applied (psi)	Test Gauge Pressure	Errors	Result






Input (% Pressure)		DWT Pressure Applied (psi)	Test Gauge Pressure	Errors	Result





Acceptance criteria :				Ambient Temperature :
MASTER EQUIPMENT TRACEBILITY
Equipment I.D. No.	Description		Range	Calibration Date	Cal. Certificate No.



Calibrated By:			Reviewed by:
Name:			Name:
Signature:			Signature:
Date:			Date:
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

8.0 API – Gauge Engagement Record

Note: Gauge to be calibrated after every 1000 engagements
Gauge ID:
Form ID/Ref:
Sl.No.	Date	Number of Engagements	Accumulated Engagements	Signature
































Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

9.0 API – Monogram Issue Register (LOG)

DATE	API SPEC No.	JOB #	CLIENT	DESCRIPTION OF PRODUCT	TRACEABILITY





































Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

10.0 API Monogram Control Logbook

Sl.No.	Media	Purchase Order (PO) Date	Quantity	Inspection Status – Sign and Date
				Remarks	Prior to sending PO	After receiving Printed Material
				Remarks	Certification Eng.	Certification Eng.













Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

11.0 API Working Gauge Usage Record

Gauge Description
Gauge ID
FIRST CALIBRATION
APPLICABLE SPEC
FIRST TIME RECALIB
SECOND TIME RECALIB
USAGE DETAILS
DATE	DESCRIPTION / JOB NUMBER	ACCUM USAGE	REQUIRE CALIB NOW


























TOTAL
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

12.0 Document Transmittal

Ref no:			Transmittal No:
Doc:			Date
Rev Status:			Project/Contract:
Rev Date:			Job No/ Order No.
Doc Transmitted to:


For information			As Requested

For Record			For Construction
For Approval			Others
Doc or Drawing No.	Rev Status	Doc Title			No. of Copies	No. of Pages











Remarks:	Proceed the Works / Construction

Doc: Issued By:				Doc Received By:
Name:				Name:
Signature:				Signature:
Please send the original back to the issuer
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

13 CERTIFICATE OF CONFORMANCE

Cert. No. :

CUSTOMER NAME
JOB NUMBER
CUSTOMER PO NO.
PRODUCT DESCRIPTION
SERIAL NUMBER
PART NUMBER
DATE OF MANUFACTURING
CODES, STANDARDS APPLIED

This is to certify that the product identified above is manufactured in accordance with the API – xx requirements based on the traceability records maintained. The scope covered by this certificate is limited to the extent covered within the respective inspection procedure. XXX retains supporting documentation for a period of time as specified in the applicable standards.

“This document and conclusions within, as on the date of manufacturing do not alter any terms or conditions between the parties. Any historical or present deviation from traceability and equipment operation is at the sole risk of the customer.

FOR XXX

14.0 Welder training specification

TRAINING MATERIAL
1
2
3
TRAINING SCORES, ORAL EXAMINATION-Effectiveness
S.No.	Names	Scores	Welding – score Criticality



























Notes:
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

15.0 Visual Inspection Report

REFERENCE:

Client:

Report No:

Part:

Test date:

Sr. No:

Job No:

PO No:

Client’s Ref:

Email/Verbal

Procedure Ref.

Test Details:

Sr. No:

Description of Item

Serial Number

Observation

Remarks

NOTE:

Inspection Stage:

Incoming

In- Process

Final

Equipment Detail:

Light Source:

Light meter

Cal. Cert.

Light Level:

Cal Due Date:

Inspected By:

STAMP

Witnessed & Certified By:

Name:

Date:

Signature:

16.0 Good Receiving And Inspection Document

CLIENT NAME:				REPORT NO :
CLIENT REF NO. /JOB NO.				DATE :
ITEM EQUIPMENT:
Detail of the item/equipment :
SIZE / CONNECTION
PRESSURE RATING
ID NUMBER/TAG NUMBER
DATE OF MANUFACTURE
ACCESSORIES IF ANY
INITIAL PHOTO TAKEN
VISUAL CONDITION
OBSERVATIONS :

REMARKS, IF ANY

INSPECTED BY				REVIEWED BY
NAME:-				NAME:-
DATE:-				DATE:-
SIGNATURE:-				SIGNATURE:-
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

17.0 Calibration History Card

Equipment I.D.:			Made/Make:
Manufacturer:			Model No :
Type of Machine:			Serial No.:
Drive / Range:			Physical Condition:
Calibration Frequency
CALIBRATION DETAILS
Calibration Date	Calibration Agency	Certificate No		Calibration Due Date	QC Remarks



















Acceptance Criteria :

Prepaired By:			Approved by:
Name:			Name:
Signature:			Signature:
Date			Date
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

17.0 Material Verification Certificate

Customer/Supplier					Customer Purchase Order/Supplier Purchase order
Description					Specification reference
Part Number					Material
Job Number					Heat Number
Quantity					Heat Code

Chemical Composition %
Element	C	Mn	Si	P	S	Cr	Ni	Mo	Cu	H(ppm)
Min
Max
Actual
Grain Size				Forging Ratio
Heat Treatment Cycle with Batch Number



Mechanical Properties
Requirements		Yield Strength		Tensile Strength		%Elongation		%Reduction		Hardness
		Psi		Psi		GL:50MM		In area		BHN
Minimum
Maximum
Actual
Charpy Impact 10x10x55mm CVN 2mm IN 45°			Temperature		Required Value(J)		1(J)	2(J)	3(J)	Av(J)


Inspected By:				Stamp			Approved By:
Sign:							Sign:
Name:							Name:
Designation:							Designation:
Date:							Date:

18.0 Process Validation Record

NAME OF PROCESS: DATE OF ASSESSMENT :
If In-house Responsible Person: Location:	If Outsourced Supplier Code: Supplier Name and Location:
VALIDATION REPORT
Qualification of Personnel performing the process: Welders Name: Position: Process: Specification:
Qualification of equipments used for the process:
Evidence of adherence of special process parameters / characteristic when process is performed:
Validation of process carried out by Accredited Third Party if any:
Report by the process validating official:
*Validation conducted by Reviewed by*
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

19.0 Equipment / Product Specification Record

20.0 Inspection Release Note (Final Inspection Status)

Customer				Report No.
Description				Job / WO #
Product/Unit ID				Date
Scope of Work:
#	Activity Performed	Inspection Status	Ref. Std/Doc.		Record
1.
2.
3.
4.
5.
6.

Release Status:

All found acceptable and released Released based on client requirement

Released based on urgency Non-conforming/Returned

Final Release Statement: The above detailed products has been fabricated, inspected as per client Purchase Order requirements, applicable manufacturing specification requirements and released.
Organization Rep.	Client/TPI/Owner Rep.

21.0 Non Conforming Product Report

SPECIALIST OILFIELD SERVICES K. S. C.
NON CONFORMING PRODUCT REPORT				SOS / QA / 42
Originator		NCP Number
Job No.		NCP Date
Product details		Acceptance Std.
Process/Activity		Process owner
N. C Findings :

Signature of Orignator: Date			Process owner
			Sign & Date
Root Cause of the Non-Conforming product:

Name/ Title Signature & Date:
Disposition method/Rework recommendation
Concession – Accept as is Repair/Rework Reject/Scrap Returned to customer
Recommended by: Sign & Date		Approved By: Sign & Date
Description of actions taken

Reviewed By Sign & Date	Approved By: Sign & Date
Action complete By:

Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx

22. Non-Calibrated / Scrap Equipment Record

S. No	Date	Instrument / Equipment ID		Description	Location	Reason for scrap	Status





































Prepared by: Calibration and Inspection Engineer			Reviwed by: QA/QC Engineer		Approved by: MR
Name:			Name:		Name:
Sign:			Sign:		Sign:
Date: xx.xx.xxxx			Date: xx.xx.xxxx		Date: xx.xx.xxxx
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx

23. Preservation Report

Client :		Date
Part :		Job No.:
Part Ser.:		OEM Procedure No.
Sr. No.	Inspection Items	Comment
1	Perservation Performed
2	Perservation Label fixed
3	Corrosion Inhibitor installed
4	Storage Protection implemented
5	Transport Protection Implemented
6	Ship Loose Material Marking and Preserved
7	Periodical Preservation Carried out

Verified By:

Name :
Date :
Signature :
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx

24 Pre-Dispatch checklist

Client :		Date
Part :		Job No.:
Part Ser.:		Report Number

Sr. No.	Description	Observation/Remark
1	Final Inspection Carried out and product released for dispatch(As per Production and Quality Plan)
2	Visual check ? Surface condition Critical parts
3	Critical area protection ?
4	Delivery note with details (i.e PO, JO, SRV, etc) ?
5	Inspection Reports or Certificates ?
6	Preservation Done? If aplicable
7	Any accessories or spares to be delivered?
8	…………………………………………………………………………
9	…………………………………………………………………………
10	…………………………………………………………………………

Checked By:		Verified By:
Name :		Name :
Date :		Date :
Signature :		Signature :
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx

25 Ultrasonic Examination Report

CUSTOMER:							PROCEDURE REF :
PRODUCT NAME :							ANY IDENTIFICATION OR MARKING
EQUIPMENT DETAILS :			DRAWING :				SURFACE CONDITION
MAKE :			COUPLANT BRAND / TYPE :				AS CAST AS FORGED
MODEL :			BASIC CALIBRATION REF.BLOCK :				AS ROLLED AS WELDED
SPECIAL EQUIPMENT USED :			IDENTIFICATION & LOCATION OF WELD :				AS MACHINED
COMPUTER PROGRAMMER ID & Rev			TIME OF EXAMINATION:				AS MACHINED MACHINED
SIMULATOR BLOCK IF USED ID			DATA CORRELATING SIMULATOR :				ACCEPTANCE STANDARD:
SEARCH UNIT CABLE TYPE:						LENGTH:
PROBE DETAILS:
		0	45°	60°	70°
PROBE USED
PROBE MAKE
Sr.No
DIA /FREQUENCY
DAC(PRL) db
SCANNING db
DETAILS OF INDICATION(Above 50%PRL)
LOCATION	RESPONSE LEVEL	TYPE OF INDICATION		DEPTH		DIMENSION (SIZE/SHAPE)		RESULT




TEST RESULTS :
		TESTED BY			EVALUATED BY			ACCEPTED BY
SIGNATURE
NAME
DATE
DESIGNATION		NDT Level I / II			NDT Level II / III			CLIENT REP/AI/TPI
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx

26 Product Recall

CLIENT :		REPORT NO :
JOB NO :		REPORT DATE :
ITEM DESCRIPTION :		CLIENT REFERENCE / PO :
SERIAL NUMBER :		PART NUMBER :

Re-Call Notification

Reason For Re-Call

Disposition / Replacement
Internal (NCR)
Client
Recommended by: Sign & Date	Approved By: Sign & Date
Status of API Monogram and Action :

NOTE : If the product is API monogramed, the monogram shall be removed with an immediate effect.
Action Taken By : Sign & Date
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx

27. Material Compliance Checklist

SUPPLIER DETAIL :		PO NUMBER :
MTC REFERENCE :		MRIR #
SRV #		DATE OF INSPECTION :
SR#	CHECK POINTS	COMPLIANCE		REMARKS
		YES	NO
1	MATERIAL TYPE
2	SIZE
3	SPECIFICATION
4	MECHANICAL PROPERTIES (Please refer material specification and confirm the compliance on reuirement by the specfications)
5	CHEMICAL COMPOSITION (Please refer material specification and confirm the compliance on reuirement by the specfications)
6	MANUFACTURING PROCESS REQUIREMENTS
7	HEAT TREATMENT REQUIREMENTS
8	NDE REQUIREMENTS
9	NO WELD REPAIR
10	MARKING & TRACEABILITY OF THE MATERIAL
11	SUPPLIED PRODUCT
12	CERTIFICATION
13	…………………………………………………………………………
14	…………………………………………………………………………
15	…………………………………………………………………………
The material is complying to the requirements as verified above.
Inspected and verified by		Reviewed by
Name		Name
Date		Date
Sign		Sign
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx

28. Discrepancy Report

Job No.		Report Number
Client Name		DR Date
Product		Traceability
Product Requirements / Scope of work :
Discrepancy identified:
Disposition recommendation / Clarification Note :
Clarification Note : NOTE:
Recommended by: Sign & Date		Approved By: Sign & Date
Description of actions taken

Reviewed By Sign & Date	Approved By: Sign & Date
Action complete By:
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx

29. Load Test Certificate

Contract/Job No.: JO-			Report No.: JO-			Date:-
Customer: M/s.
Item/Component:-			Serial No.:-
Total Assembly Weight (WT)	Number of Lifting Eyes (Nos)		Lifting Time 1-Set of Lifting Eyes Minutes		Lifting Time 2-Set of Lifting Eyes Minutes
Tons	04		2 Min		2 Min
LOAD TEST (SELF) WAS CARRIED OUT ON THE SUBJECT ITEM IN ACCORDANCE WITH ABOVE HYDRIL SPECIFICATION AFTER REPAIR, ASSEMBLY AND HYDROSTATIC PRESSURE TEST. PROCEDURE FIRST LIFT WAS CARRIED OUT ON 2 OF THE FOUR PAD EYES, THE ASSEMBLY WAS THEN HELD FOR 2 MINUTES AND THE TEST WAS REPEATED ON THE ADJACENT PAD EYES AND ALSO HELD FOR 2 MINUTES, FOLLOWING THE LOAD TEST AN MPI WAS CARRIED OUT ON ACCESSIBLE SURFACES OF ALL THE FOUR PAD EYES AND ADJACENT AREAS ½” FROM THE CAST IN ACCORDANCE WITH THE HEMPS 10.202 AND FOUND NO SIGNIFICANT INDICATIONS. RESULTS PROOF LOAD TEST – ACCEPTABLE @ TON PER PAD EYE. MPI : ACCEPTABLE NOTE: IF THE PAD EYES ON THE UNIT ARE USED TO LIFT UP MORE THAN THE WEIGHT OF THE ASSEMBLY (E.G. SUPPORT THE WEIGHT OF STACK), CONTACT HYDRIL ENGINEERING FOR REVIEW OF THE REQUIREMENTS.
NDT Technician: (Level II) Sign : Date :		Verified By : (Level II) Sign : Date :		Client witness : Sign : Date :

30 Phosphating Inspection Report

REFERENCE:

Client:

Report No:

Product detail:

Test date:

Sr. No:

Job No:

PO No:

Client’s Ref:

Procedure Ref.

Test Details:

Sr. No:

Inspection

Instrument used

Observation

Remarks

Visual inspection

Inspection lamp

Adhesion test

Pencil eraser

Thickness check

Ultrasonic thickness gauge

Bath Control:

NOTE:

Bath Temperature:

Total Acid:

Free Acid:

Ferrous Iron Titration:

Equipment Detail:

Thickness gauge ID:

Cal. Cert.

Cal Due Date:

Inspected By:

STAMP

Witnessed & Certified By:

Name:

Date:

Signature:

31 Hardness Test Report

32 Pressure Test Report

Reference:

Client:

Report No:

Part:

Test date:

Sr. No.:

SOS Job No:

PO No:

Client’s Ref:

Email / Verbal

Proce. Ref:

Test Details:

Sr. No:

Item Description

Serial No.

Chart No.

Test Pressure (psi)

Test Duration

Hydro test performed on above items and no visible leak observed during holding period, hence test accepted.

Test Media:

Test Temperature:

Potable Water with anti Rust

Metal Temperature: °C

Test Equipments:

Test Pump: High pressure positive displacement pump

Pressure Gauge / Recorder Details:

Range:

Gauge Id:

Used for

Calibrated On:

Calibration Ref:

Observation :

Test Result :

Accepted / Rejected

Remarks :

Witnessed By:

Stamp

Witnessed & Certified By:

Name:

Date:

Signature:

33. Liquid Penetrant Examination (PT) Report

Contract/Job No.:

Report No.:

Date:

Customer:

Item/Component:

Part:

Thickness:

Materials:

Ambient Temperature: ٭C

Procedure No.:

Surface temperature: ٭C

Acceptance Standard:

Light level: >1000 lx

Penetrant Type:

Lighting Equipment:

Type/Designation:

Light Equipment: Equipment ID: Calibration Due Date:

Penetration Time:

Development Time:

Inspection Time:

EXAMINED PRODUCT CONDITION:

PLATE

TUBE / PIPE

FORGING

CASTING

WELDS

OTHER:

As rolled

As Drawn

As Forged

As Cast

As Welded

As Received

Machined

PWHT / Stress relieved

Heat treated

Machined

COVERAGE / AREA EXAMINED:

EXAMINATION STAGE:

CONSUMABLES DETAIL

100%

Initial

Penetrate Batch No.-

All Accessible area

Intermediate

Developer Batch No: –

Ring Groove(s)

Final

Cleaner Batch No: –

Specific Location (Detail) –

NOTE:

Item

Sl. No.

Location

Indication Type

Size (mm)

Result

Remark

Examined & Evaluated By:

(Level I / II)

Signature :_________________

Name :

Date :

STAMP

Witnessed By:

(Level II)

Signature    :___________

Name        :

Date          :

34 Magnetic Particle Examination (MT) Report

Contract/Job No.:

Report No.:

Date:

Customer:

Item/Component:

Part:

Material:

Thickness:

Procedure No & Rev.: –

MT Equipment: Yoke machine (AC)

Acceptance Standard:

Model :
Make: Magnaflux

Consumable Manufacturer:

Lifting Capacity & Current Type: Kg & AC

Technique / Method

Wet Non-Fluorescent

Pole Separation (3 to 8”): Actual: mm

Wet Fluorescent

Light Equipment: Inspection lamp-

Surface enhancement contrast: – 2 thin coats

Light level: > Lux

MT Yoke:
Equipment ID.:
Calibration Due date:

Light Equipment:
Equipment ID:
Calibration Due Date:

Demagnetization: Yes

Drawing No. (if applicable): N/A

EXAMINED PRODUCT CONDITION:

PLATE

TUBE / PIPE

FORGING

CASTING

WELDS

OTHER:

As rolled

As Drawn

As Forged

As Cast

As Welded

As Received

Machined

PWHT / Stress relieved

Heat treated

Grit Blasted

COVERAGE / AREA EXAMINED:

EXAMINATION STAGE:

CONSUMABLES DETAIL

100%

Initial

White Contrast Paint Batch No.-

All Accessible area

Intermediate

MPI Ink Batch No: –

Weld Joint (s)

Final

Cleaner Batch No: –

Specific Location (Detail) –

NOTE:

Item

Sl. No.

Location

Indication Type

Size in MM

Result

Remark

Examined and Evaluated By:

(Level- I / II)

Signature :   _________________

Name         :

Date           :

Witnessed/Reviewed By :

(Level- II)

Signature    :   _________________

Name        :

Date             :

35 Radiography Examination Report

Report No.:					Date:

JOB/Contract No:		ITEM NO.:			IQI Type:		CUSTOMER:
BASE MATERIAL:		STAGE:			PROCEDURE:		ACCEPTANCE STD:
FILM MAKE:		TYPE/CLASS:			FILM/CASSETTE:		NO OF EXPOSURES:
SOURCE:		STRENGTH:			X-RAY VOLTS:		SOURCE TO OBJECT DISTANCE:
SOURCE SIDE OF OBJECT TO FILM DISTANCE:		EXPOSURE TYPE:			REINFORCEMENT:		SHIMS:
SL. #	PART/WELD NO.		SIZE	Segment		OBSERVATION	RESULTS	REMARKS






Performed by:				Interpreted & Evaluated by:
SIGN				SIGN
NAME:				NAME
DATE				DATE

36 Ultrasonic Thickness Report


Customer							Report Number
Item Description							Date
Serial/ID Number							Instrument ID
Job Number							Procedure ref.
PO Number							Specifications

ITEM S/N :	POINTS	THICKNESS POSITIONS								MIN. THICK	MAX. THICK	REMARKS
ITEM S/N :	POINTS	A	B	C	D	E	F	G	H	MIN. THICK	MAX. THICK	REMARKS

	1
	2
	3
	4
	5
	6
	7
	8
	9
	10
	11
	12
	13
	14
	15
	16
	17
	18
	19
	20
	21
	22
	23
NOTE : Readings are in inches.
Sketch

Inspected & Evaluated By: Name : Date : Signature :								Witnessed & Evaluated By:- Name : Date : Signature :

37. Blasting and Coating Report

Job No.

Report No:

Client Name:

Date:

Part Description

Drawing No.

Part / ID No.

Ref. Procedure

SURFACE PREPARATION DETAILS

Type of Abrasive & Size

TIME

Abrasive Batch

Ambient (C°)

Surface Cleanliness Std

Dew Point (C°)

Surface Profile

Relative Humidity (%)

Bloter Test

Surface Temperature (C°)

Blasting Machine ID No.:

Location

Blasting Operator

Coating Applicator

COATING DETAILS

Date

Time

A.T(C°)

D.P(C°)

RH %

S.T(C°)

Paint Details

Primer

Intermediate

Top Coat

08.05.2019

Product Name&No

Color / Shade No.

09.05.2019

Base Batch No. Exp Dt.

Curing Batch No. Exp Dt.

11.05.2019

Mixing Ratio

Coating Method

Airless Spray

ITEM DESCRIPTION

WFT(microns)

Visual Insp.

Primer

Intermediate

Top Coat

ITEM DESCRIPTION

DFT(microns)

Visual Insp.

Primer

Intermediate

Top Coat

Remarks:

Visual, Surface Profile, Dust Level, Chloride level of blasted surface inspected and found acceptable.

Surface Preparation

Dust Level

Date

Rating 2

Total Dry Film Thickness (microns) :

Result:

Dew Point meter Gauge Sl.No :

Calibration Due Date:

Surfcae profile Gauge Sl. No.:

Calibration Due Date:

Conductivity meter Sl. No.:

Calibration Due Date:

DFT Gauge Sl.No :

Calibration Due Date:

Adhesion Test :

Result:

Inspected By:

Reviewed By:

Reviewed By: (NACE LEVEL II)

NAME

SIGNATURE

DATE

Abbreviations:
AT-Ambient Temperature,
D.P-Dew Point,
RH-Relative Humidity,
ST-Surface Temperature,
ACC-Accepted,
REJ-Rejected Preparation

38. Heat Treatment Report

CLIENT:
JOB NUMBER:			CHART REF. :
REPORT NUMBER:			PROCEDURE :
DATE:			WPS NO.
ITEM NUMBER:			PWHT TEMP. :
MATERIAL THICKNESS:			SOAKING TIME :
APPLICABLE CODE:			HEATING RATE:
TEMP. PROGRAMMER:			COOLING RATE:
CAL. DATE :			NO. OF THERMOCOUPLES:
TEMP. RECORDER :			THERMOCOUPLE TYPE
CAL. DATE :

#	Item Description			SN / PN





NOTES : The thermocouples are attached as per API 6A requirements.

CARRIED OUT BY: NAME SIGN. DATE		STAMP		REVIEWED BY: NAME SIGN. DATE