The organization’s policy for its commitment to quality shall be defined, documented, reviewed, and approved by top management. The quality policy shall: a) be appropriate to the organization and support its strategic direction, b) be the basis for the development of quality objectives, c) be communicated, understood, implemented, and maintained within the organization, d) be available to relevant interested parties, as specified by the organization, and e) include a commitment to conform to requirements and continually improve the effectiveness of the quality management system.
A quality policy is an essential element of the Quality Management System (QMS) according to API Specification Q1. This policy is crucial for several reasons, reflecting the organization’s commitment to quality and its operational and strategic objectives. Here are the main reasons why organizations should have a quality policy according to API Spec Q1:
Foundation for Quality Management Central Guideline: The quality policy serves as the central guideline for all activities within the QMS. It provides a clear direction and framework for establishing and reviewing quality objectives, ensuring that all efforts align with the policy’s principles. Strategic Alignment: It aligns the QMS with the strategic direction of the organization, ensuring that quality management is integrated into core business processes and decisions.
Commitment to Compliance and Continuous Improvement Regulatory Compliance: API Spec Q1 requires organizations to comply with specific quality standards tailored for the oil and gas industry. The quality policy demonstrates an organization’s commitment to meeting these standards and other regulatory requirements. Continuous Improvement: The policy underlines a commitment to continuous improvement. It is not just about maintaining quality standards but continuously enhancing the effectiveness of the QMS, leading to improved processes, products, and customer satisfaction.
Customer Satisfaction Meeting Customer Requirements: A central tenet of the quality policy is to meet or exceed customer requirements consistently. This focus helps in building customer trust and loyalty, which are critical in the competitive oil and gas industry. Enhanced Reputation: By adhering to a robust quality policy, organizations can enhance their reputation and credibility in the market, which is essential for sustaining long-term business relationships and expanding market opportunities.
Organizational Culture and Employee Engagement Quality Culture: The quality policy helps in fostering a culture of quality throughout the organization. When top management actively promotes this policy, it encourages employees at all levels to focus on quality in their daily work. Employee Morale and Engagement: Clearly articulated quality goals and values can enhance employee morale and engagement. Employees understand their role within the broader objectives of the organization, leading to increased productivity and job satisfaction.
Communication Tool Internal Communication: The quality policy acts as a vital communication tool within the organization, ensuring that everyone is on the same page regarding quality standards and expectations. External Communication: Externally, the quality policy can be communicated to customers, suppliers, and other stakeholders to assure them of the organization’s commitment to quality standards and excellence.
Basis for Quality Objectives and Planning Setting Objectives: The policy provides a basis for setting specific, measurable quality objectives at relevant functions and levels within the organization. Quality Planning: These objectives drive the planning process in the QMS, ensuring that resources and efforts are adequately directed toward critical areas for quality and performance enhancement.
Having a quality policy as mandated by API Spec Q1 is crucial not only for compliance but also for driving the organization towards excellence in quality management practices. It encapsulates the organization’s vision for quality, laying a foundational pathway for operational practices and strategic decisions that lead to sustained business success and growth in the demanding and regulated environments of the petroleum, oil, and gas industries.
The organization’s policy for its commitment to quality shall be defined, documented, reviewed, and approved by top management.
Ensuring that an organization’s policy for its commitment to quality is properly defined, documented, reviewed, and approved by top management is a critical aspect of a successful Quality Management System (QMS), especially in the context of API Specification Q1 for the petroleum, oil, and gas industry. Here are the steps and processes organizations should follow to ensure the quality policy meets these requirements:
Defining the Quality Policy Alignment with Organizational Goals: Ensure that the quality policy aligns with the broader goals and strategic direction of the organization. It should support the organization’s overall mission and be relevant to the context and scale of its operations. Inclusion of Commitments: The policy should include commitments to comply with applicable requirements and to continually improve the effectiveness of the QMS. It should be concise, easily understood, and applicable to all organizational activities.
Documentation Clear and Accessible: Document the quality policy in a manner that is clear and accessible to all stakeholders, including employees at all levels. This documentation acts as a formal declaration of the organization’s commitment to quality. Integration into QMS Documentation: Include the quality policy in the QMS documentation system, such as the quality manual or similar strategic documents, ensuring it is centrally available and can be referenced easily.
Review by Top Management Initial Approval: Before implementation, the quality policy should be reviewed and approved by top management to ensure it meets the strategic needs of the organization and reflects the commitments to quality and continuous improvement. Regular Reviews: Schedule regular reviews of the quality policy by top management as part of the management review process. This ensures the policy remains appropriate as the organization evolves and as external and internal factors change.
Communication Internal Communication: Communicate the quality policy to all employees through multiple channels such as onboarding training, regular meetings, internal communications, and posting in prominent locations within the workplace. Understanding and Engagement: Ensure that all personnel understand and are engaged with the quality policy. This may involve training sessions or discussions led by managers or the quality team to explain how the policy affects each employee’s work.
Making the Policy Available to Relevant Interested Parties External Communication: Make the quality policy available to relevant external parties, such as customers, suppliers, and other stakeholders, through the organization’s website, marketing materials, or upon request. This transparency builds trust and reinforces the organization’s commitment to quality.
Ensuring Continual Suitability Feedback and Performance Monitoring: Utilize feedback from employees, customers, audits, and process performance monitoring to assess whether the quality policy continues to be effective and suitable for the organization’s needs. Adaptation to Changes: Be prepared to make necessary changes to the quality policy when significant changes occur within the organization or in its external environment, including changes in market conditions, customer requirements, or regulatory updates.
By following these structured steps, an organization ensures that its commitment to quality is not only articulated in a meaningful and compliant way but is also embedded into the culture and operations of the organization. Top management’s involvement in approving and regularly reviewing the quality policy is crucial to its effectiveness and the overall success of the QMS. This active leadership role reinforces the importance of quality throughout the organization and helps to maintain a continual focus on meeting and exceeding the established quality standards.
The quality policy should be appropriate to the organization and support its strategic direction
The quality policy is a cornerstone of any Quality Management System (QMS), including those developed under standards like API Specification Q1 for the petroleum, oil, and gas industry. For the quality policy to be effective, it must be appropriately tailored to fit the specific characteristics and strategic direction of the organization. Here’s a closer look at how to ensure that the quality policy aligns with and supports an organization’s strategic direction:
1) Aligning with the Organization’s Nature and Scope Reflect Core Business Goals: The quality policy should echo the primary goals and objectives of the business. For an organization in the oil and gas industry, this might focus on operational excellence, safety, environmental stewardship, and reliability. Industry-Specific Considerations: The policy should also address specific quality issues relevant to the petroleum, oil, and gas sectors, such as adherence to environmental regulations, managing operational risks, and maintaining the integrity of supply chain operations. 2) Supporting the Strategic Direction Strategic Integration: The quality policy must integrate seamlessly with the strategic plans of the organization. It should support long-term goals, such as market expansion, technological advancements, or sustainability initiatives. Scalability and Flexibility: As strategic goals evolve, the quality policy should be adaptable enough to accommodate new directions or shifts in focus. It should not be so rigid that it becomes obsolete as the organization grows or shifts its strategy. 3) Development and Implementation Involvement of Leadership: Top management must take a leading role in developing and endorsing the quality policy. Their involvement ensures that the policy is aligned with the strategic vision and that it has the necessary authority and visibility. Stakeholder Input: Consider input from various stakeholders, including customers, employees, suppliers, and shareholders, to ensure that the policy reflects broader expectations and requirements. Communication: Effectively communicate the quality policy across all levels of the organization. Ensure that every employee understands how their actions contribute to the objectives outlined in the policy. Training and Resources: Provide training and resources to help employees implement the quality policy in their daily work processes. This might include specific training on quality standards, continuous improvement processes, and customer service excellence. 4) Review and Adaptation Regular Reviews: The quality policy should be reviewed regularly to ensure it remains relevant and effective in supporting the organization’s objectives and strategic direction. These reviews can coincide with management review meetings or strategic planning sessions. Metrics and Feedback: Use performance metrics and feedback mechanisms to assess how well the quality policy is supporting the strategic goals. Adjustments should be made based on this feedback to enhance alignment. Document Changes: Any changes to the quality policy following reviews should be well-documented and communicated throughout the organization. Updating the workforce on these changes is crucial for continued alignment and engagement.
The quality policy is not just a statement of intent but a functional and dynamic part of the organization’s strategic framework. It should guide quality initiatives that align with and support the organization’s long-term strategic goals. By ensuring the quality policy is appropriate to the organization and aligned with its strategic direction, companies can effectively drive continuous improvement, compliance, and competitiveness in their markets. This strategic alignment is essential for fostering a culture of quality that permeates every level of the organization and guides decision-making processes.
The quality policy should be the basis for the development of quality objectives
The quality policy of an organization should indeed serve as the fundamental basis for the development of specific quality objectives. This ensures that all quality initiatives are strategically aligned and contribute effectively to the organization’s overarching goals. Here’s how the quality policy can be effectively utilized to develop quality objectives within the framework of a Quality Management System (QMS), such as those outlined in API Specification Q1 for the petroleum, oil, and gas industry:
1.)Alignment of Quality Policy and Quality Objectives Direct Linkage: Quality objectives should be directly derived from the quality policy to ensure that they are fully aligned with the intentions and strategic direction outlined in the policy. This ensures that all efforts in quality management contribute towards the same end goals, enhancing the coherence and effectiveness of the QMS. Measurable Targets: The quality policy provides a broad direction and commitment, and the quality objectives translate this into specific, measurable targets that can be systematically pursued and evaluated. These objectives should be SMART (Specific, Measurable, Achievable, Relevant, Time-bound) to facilitate effective implementation and monitoring. 2) Development Process for Quality Objectives Break Down the Quality Policy: Analyze the quality policy to identify key themes and commitments, such as customer satisfaction, compliance with regulations, continuous improvement, and innovation. Each element of the policy can serve as a foundation for a corresponding quality objective. Engage Stakeholders: Involve various stakeholders, including management, employees, and customers, in the process of setting objectives. This engagement helps ensure that the objectives are realistic, achievable, and aligned with both internal expectations and external requirements. Departmental Objectives: Translate broad organizational quality objectives into specific departmental goals. This helps in cascading the overall quality policy down to actionable levels, where individual teams and departments understand their contributions to the quality goals. 3) Examples of Quality Objectives Derived from a Quality Policy If the Quality Policy emphasizes customer satisfaction, an objective might be to reduce customer complaints by a certain percentage annually or improve customer service response times. If the Quality Policy stresses compliance and safety, objectives could include achieving zero non-compliance incidents or enhancing safety training for employees, aiming for a reduction in workplace accidents. If the policy highlights continuous improvement, an objective might involve implementing specific numbers of process improvement projects per year or introducing innovative practices that reduce waste or enhance efficiency. 4) Monitoring and Review Performance Indicators: Establish clear performance indicators for each quality objective to monitor progress and effectiveness. These indicators should provide quantifiable data that can be analyzed regularly. Regular Reviews: Conduct regular reviews of both the quality objectives and the overarching quality policy. This ensures they remain suitable, adequate, and effective in light of changing internal and external circumstances. Feedback Mechanisms: Implement mechanisms to gather feedback on the attainment of quality objectives from employees, customers, and other stakeholders. Use this feedback to refine objectives and develop new goals as necessary.
The quality policy should act as the cornerstone for all quality-related activities in an organization. By ensuring that quality objectives are directly derived from and aligned with the quality policy, an organization can create a focused and effective QMS that not only meets the current requirements outlined in standards like API Spec Q1 but also drives continual improvement and sustainable success.
The quality policy should be communicated, understood, implemented, and maintained within the organization
Ensuring that the quality policy is communicated, understood, implemented, and maintained throughout an organization is crucial for the effective functioning of a Quality Management System (QMS). This approach not only enhances overall quality across the organization but also aligns every employee with the strategic quality goals, fostering a cohesive and proactive quality culture. Here are key steps organizations should take to achieve this:
Effective Communication Visibility: Display the quality policy prominently within all work locations. It can be posted in common areas such as break rooms, on company intranets, and in key operational areas to ensure employees see and can refer to it regularly. Orientation and Training: Include the quality policy in onboarding materials for new hires. Provide training sessions that explain the policy and its implications for daily work activities and organizational goals. Regular Discussions: Incorporate discussions of the quality policy into regular team meetings and management reviews to reinforce its importance and applicability.
Ensuring Understanding Simplify Language: Ensure the language used in the quality policy is clear and easily understandable for all employees, avoiding technical jargon that may be confusing to non-specialists. Training Sessions: Conduct training sessions that break down the quality policy into actionable parts specific to different departments or roles. This helps employees understand how they can contribute to the policy’s objectives. Feedback Mechanism: Establish a feedback mechanism where employees can ask questions or express concerns about the quality policy. This not only clarifies doubts but also encourages active engagement with the policy.
Implementation Integration into Daily Operations: Integrate the principles of the quality policy into standard operating procedures and daily work routines. This could include quality checks, compliance measures, and continuous improvement processes. Leadership Example: Leaders and managers should model behaviours that reflect the quality policy. This includes decision-making processes, how they manage projects, and how they interact with team members and stakeholders. Resources Allocation: Provide the necessary resources, such as training, tools, and time, to implement the quality policy effectively. Employees should have access to resources that enable them to uphold quality standards.
Maintenance and Continual Improvement Regular Reviews: Regularly review the quality policy to ensure it remains relevant and effective in meeting the organization’s needs and external requirements. This should be part of the management review process. Audit and Monitoring: Use internal audits and other monitoring techniques to check how well the quality policy is being implemented and maintained. Audits can identify areas where the policy may not be fully effective or understood. Continuous Training: Offer ongoing training and development opportunities related to quality management to keep all employees up-to-date with the latest practices and to reinforce the importance of the quality policy.
Recognition and Incentives Reward Compliance: Recognize and reward departments or individuals who excel in implementing the quality policy. This can motivate others to follow suit and reinforces the importance of quality within the corporate culture. Incentive Programs: Develop incentive programs that align with the achievement of quality objectives, making adherence to the quality policy part of the organizational rewards system.
A quality policy is not merely a statement of intent; it is a directive that influences every action and decision within the organization. By ensuring that it is communicated effectively, understood clearly, implemented thoroughly, and maintained diligently, an organization embeds quality into the fabric of its operations, leading to improved performance, enhanced customer satisfaction, and sustained business growth. These efforts are essential for meeting the standards of a robust QMS like those specified in API Specification Q1 and other industry-specific standards.
The quality policy should be available to relevant interested parties, as specified by the organization
Making the quality policy available to relevant interested parties is an important aspect of a robust Quality Management System (QMS). This transparency helps to reinforce the organization’s commitment to quality and ensures that all stakeholders understand the company’s quality goals and how they align with broader business objectives. Here are key steps and considerations for making the quality policy accessible to relevant interested parties, as outlined in standards like API Specification Q1:
Identifying Relevant Interested Parties Stakeholder Analysis: Start by identifying who the relevant interested parties are. This could include customers, suppliers, contractors, regulators, investors, and local communities. Understanding the needs and expectations of these different groups is crucial in determining how to effectively communicate the quality policy. Prioritize Communication: Depending on the nature of the business and its stakeholders, prioritize how and to whom the quality policy will be communicated, focusing on those who have a direct impact on or are directly impacted by the quality of the organization’s products and services.
Making the Quality Policy Accessible Public Platforms: Use the company’s website to publish the quality policy, ensuring it is easy to find and download. This is one of the most effective ways to reach a wide audience, including customers, potential clients, and other external parties. Customer Communications: Include a reference or link to the quality policy in communications with customers, such as on contracts, product documentation, and during bidding processes. Supplier and Partner Communications: Share the quality policy with suppliers and partners, especially during onboarding and contract negotiations, to ensure they are aware of your quality expectations. Investor Relations: Include the quality policy in annual reports and investor relations materials to communicate the organization’s commitment to quality to current and potential investors. Community Engagement: For local communities and other stakeholders, consider community newsletters, local meetings, or open house days where the quality policy and its implications for local engagement and environmental stewardship can be discussed.
Ensuring Understanding Tailored Communications: Adjust the communication of the quality policy based on the stakeholder group. For instance, what is shared with regulators may differ in form and detail compared to what is shared with local communities. Language and Accessibility: Ensure the policy is available in languages and formats accessible to all relevant stakeholders. This may include translations or adaptations for people with disabilities.
Feedback Mechanisms Soliciting Feedback: Establish mechanisms through which stakeholders can provide feedback on the quality policy. This can be via online forms, email addresses, or during stakeholder meetings. Address Concerns: Be responsive to feedback regarding the quality policy, addressing concerns and making adjustments as necessary to accommodate stakeholder needs and expectations.
Regular Updates and Reviews Policy Review: Regularly review the quality policy to ensure it remains relevant and effective. Stakeholder feedback and changes in the business environment or regulatory landscape should trigger reviews and potential updates. Communication of Changes: Notify all relevant interested parties of any significant changes to the quality policy through the established communication channels.
Making the quality policy available to relevant interested parties not only meets the requirements of standards like API Specification Q1 but also builds trust and strengthens relationships with all stakeholders. This transparency helps ensure that everyone involved or affected by the organization understands the commitment to quality and how they play a role in achieving quality objectives. Such clarity can significantly enhance collaborative efforts and contribute to the overall success and reputation of the organization in its industry.
The quality policy should include a commitment to conform to requirements and continually improve the effectiveness of the quality management system.
A well-crafted quality policy is essential for establishing the foundation of an organization’s Quality Management System (QMS). According to standards like API Specification Q1, which is particularly relevant to the petroleum, oil, and gas industries, the quality policy should explicitly state the organization’s commitment to two key aspects: conforming to specified requirements and continually improving the effectiveness of the QMS. Here’s a deeper insight into each of these commitments and how they can be effectively integrated into the quality policy:
1) Commitment to Conform to Requirements Understanding Requirements: The quality policy must reflect an understanding of all relevant requirements. These include customer requirements, statutory and regulatory requirements related to the product, and any additional standards the organization subscribes to, such as environmental or safety standards. Explicit Commitment: The policy should clearly state the organization’s commitment to meeting these requirements consistently. This demonstrates to all stakeholders, including customers and regulatory bodies, that the organization prioritizes compliance and quality in all aspects of its operations. Implementation: Effective mechanisms should be established within the QMS to ensure that these requirements are understood and met. This includes training employees, setting up robust process controls, and implementing effective monitoring and measurement systems. 2) Commitment to Continual Improvement Cultural Integration: Continual improvement should be integrated into the organizational culture. The quality policy should encourage a proactive approach to making ongoing enhancements to processes, products, and services. Regular Review and Improvement: The policy should support regular reviews of the QMS to assess its effectiveness and identify areas for improvement. This involves analyzing process performance, customer feedback, audit results, and other relevant data. Setting Objectives: The policy should guide the setting of measurable quality objectives at relevant functions and levels within the organization. These objectives should be aimed at specific areas of improvement and should be regularly reviewed and updated. Innovation Encouragement: Encourage innovation as a means to drive improvement. By fostering an environment where creative ideas are welcomed and tested, organizations can find more effective and efficient ways to meet customer needs and enhance product quality. 3) Implementing the Commitments in the Quality Policy Communication: Communicate the quality policy throughout the organization and ensure that all employees understand how their activities contribute to these commitments. Regular training sessions and team meetings can help reinforce the policy’s key points. Leadership Involvement: Leadership should actively demonstrate their commitment to the quality policy by being involved in QMS activities, such as participating in audits, reviewing the QMS performance, and leading by example. Resources: Allocate necessary resources for training, tools, and systems that help achieve these commitments. Ensuring that employees have what they need to meet quality standards and improve processes is crucial. Feedback Loops: Set up mechanisms to gather feedback from employees, customers, and other stakeholders. Use this feedback to make informed decisions about where improvements are needed and how best to achieve them.
The quality policy is more than just a document—it is a central doctrine that guides an organization’s approach to quality. By committing to meeting all relevant requirements and continually seeking ways to improve the QMS, the policy lays a strong foundation for achieving operational excellence and enhancing customer satisfaction. This commitment not only supports compliance with API Specification Q1 but also drives competitive advantage and sustainable business success.
Examples of Quality policy
Customer Focus and Compliance
“At [Company Name], we are committed to achieving and maintaining the highest levels of customer satisfaction and regulatory compliance. We strive to meet or exceed customer requirements and industry standards through a culture of continuous improvement, teamwork, and integrity. Our dedication is to deliver defect-free products on time, every time while ensuring the safety and reliability of our operations. We will continually improve the effectiveness of our quality management system to ensure compliance with API Specification Q1 and other applicable standards.”
Safety and Quality
“The cornerstone of [Company Name]’s policy is our commitment to the highest standards of safety and quality in the design, manufacture, and service of our products. We pledge to maintain a safe working environment, to prevent any adverse impact on the environment, and to continually improve our processes to meet the technical and safety criteria required by our clients and regulatory bodies. Compliance with API Spec Q1 and ongoing improvement of our quality management system is fundamental to our business strategy.”
Innovation and Efficiency
“[Company Name] is dedicated to leading the industry in innovation and efficiency. Our quality policy is to develop and provide innovative and effective solutions that not only meet but exceed our customers’ expectations. We commit to a process of continuous improvement, leveraging cutting-edge technologies and methodologies to enhance our quality management system, reduce waste, and increase efficiency. Our goal is to ensure robust compliance with API Spec Q1 and to drive industry standards forward.”
Integrity and Transparency
“At [Company Name], integrity and transparency guide our operations. We are committed to producing high-quality products while adhering strictly to ethical standards and compliance with all regulatory requirements, including API Spec Q1. We vow to maintain openness in our quality management processes, engage stakeholders directly, and foster a culture where every employee is empowered to uphold our high standards. Continuous improvement of our QMS and maintaining an unyielding integrity are at the heart of our mission to serve our customers with excellence.”
Employee Development and Engagement
“[Company Name] believes that the quality of our products and services begins with the quality of our people. Our policy is to continuously invest in our employees’ development and engage them actively in our quality management efforts. We are committed to fostering a collaborative environment where every team member is involved in achieving the goals outlined in API Spec Q1. By empowering our employees, we enhance our company’s ability to meet customer needs with excellence and integrity, ensuring ongoing improvement and compliance in all we do.”
Examples of Quality Objectives Derived from a Quality Policy
Quality Policy Focused on Customer Satisfaction
Quality Policy: “We commit to exceeding customer expectations through continuous improvement and responsive service.”
Quality Objective: Improve customer satisfaction score by 15% by the end of the fiscal year through enhanced service delivery and product customization.
Quality Policy Emphasizing Safety and Compliance
Quality Policy: “Safety and compliance with industry standards are paramount in every aspect of our operations.”
Quality Objective: Achieve zero non-compliance incidents and reduce safety incidents by 20% in the next 12 months through rigorous training and upgraded safety protocols.
Quality Policy Centered on Product Quality
Quality Policy: “Our goal is to deliver high-quality, defect-free products by adhering to the highest standards of manufacturing excellence.”
Quality Objective: Reduce product defect rates by 10% annually through improved quality control measures and enhanced manufacturing processes.
Quality Policy Targeting Operational Efficiency
Quality Policy: “We strive for operational excellence and efficiency in all our processes.”
Quality Objective: Increase production efficiency by 25% within the next two years by implementing lean manufacturing techniques and optimizing workflow.
Quality Policy Focused on Employee Engagement and Training
Quality Policy: “We believe in empowering our employees through continuous training and development to uphold our quality standards.”
Quality Objective: Ensure 100% of employees receive specialized training in quality management and control techniques by Q3 next year, aiming to increase overall employee involvement in quality initiatives by 40%.
Quality Policy with a Focus on Innovation
Quality Policy: “Innovation is at the core of our strategy to lead and redefine industry standards.”
Quality Objective: Launch three new innovative products by the end of next year, each meeting stringent quality benchmarks, thereby contributing to a 15% growth in market share.
Quality Policy: “Commitment to environmental sustainability is integral to our business ethics and practices.”
Quality Objective: Reduce waste generated from manufacturing processes by 30% and increase recycling efforts by 50% over the next 18 months.
Quality Policy Centered on Supply Chain Reliability
Quality Policy: “We ensure the reliability and integrity of our supply chain to enhance product quality and customer trust.”
Quality Objective: Improve supplier delivery on-time rates to 95% and enhance material quality acceptance rate to 98% within one year through stricter supplier quality management practices.
The organization shall plan, establish, document, implement, and maintain at all times a quality management system in accordance with the requirements of this specification for product provided within the scope defined by the organization. The organization shall measure and improve the effectiveness of the quality management system.
Section 4.1.1 of API Specification Q1 outlines the foundational requirements for establishing a quality management system (QMS) within an organization involved in the petroleum, oil, and gas industries. This section is pivotal as it sets the stage for the comprehensive framework that organizations must adopt to ensure quality management and compliance with the standard. Below are the detailed requirements specified in section 4.1.1:
Organizations are required to define, document, and implement a QMS that is appropriate to the scope of their operations. The QMS should be tailored to ensure the quality of products and services and to meet or exceed customer expectations alongside complying with legal and regulatory requirements.
The QMS must be structured in such a way that it not only ensures the effective implementation of necessary processes but also supports the continual improvement and effectiveness of these processes.
The QMS should be suitable for the organization, must reflect the complexities of the organization’s processes and interactions, and should be continually improved upon to ensure ongoing suitability and effectiveness.
The QMS must ensure that the products and services conform to specified requirements established by customers and regulatory bodies.
Although not explicitly detailed in every rendition of API Q1, integrating a risk-based approach to the QMS processes is essential to anticipate and address potential risks and opportunities, aligning with more recent perspectives on quality management systems.
This section essentially ensures that an organization’s QMS is comprehensively defined and documented. The emphasis is on a system that is not only compliant with specified standards but also effective in meeting customer and regulatory requirements, with mechanisms for continual assessment and improvement. The criteria laid out in Section 4.1.1 are crucial because they form the basis for all further specifications and requirements in API Spec Q1. This section ensures that organizations have a solid foundation upon which to build more specific procedures and controls related to product quality, safety, and reliability in the oil and gas industry.
The organization shall plan, establish, document, implement, and maintain at all times a quality management system in accordance with the requirements of this specification for product provided within the scope defined by the organization.
Planning a Quality Management System in accordance with the requirements of API specification Q1 for products provided within the scope defined by the organization.
Planning a Quality Management System (QMS) in accordance with API Specification Q1 involves a structured approach tailored to ensure the products and services provided meet the quality standards required in the oil and gas industry. This process involves several key steps, from defining the scope of the QMS to ensuring that it is adequately resourced and capable of achieving its intended outcomes. Here’s how an organization can plan a QMS in line with API Spec Q1:
Identify Products and Services: Clearly delineate which products and services are included within the QMS and outline the operations related to their design, development, production, delivery, and servicing.
Consider Regulatory Requirements: Understand and integrate all applicable statutory, regulatory, and customer requirements that are relevant to the products and services being offered.
Internal and External Context: Evaluate both the internal and external factors that can impact the effectiveness of the QMS. This includes market conditions, customer requirements, technological advances, and competitive realities.
Risk and Opportunity Assessment: Analyze risks and opportunities associated with product quality and compliance. This step is crucial for anticipating potential challenges and planning mitigative actions.
Quality Objectives: Set clear, measurable quality objectives that align with the business strategy. These should be designed to meet customer and regulatory requirements and to drive continuous improvement.
Quality Policy: Formulate a quality policy that reflects the organization’s commitment to quality and its objectives. This policy should be communicated across the organization and understood by all employees.
Identify Key Processes: Identify and map out all key processes needed to achieve quality objectives, including procurement, production, quality control, and customer service.
Process Interactions: Understand how these processes interact and impact each other. A well-defined process interaction map can help in visualizing and managing process flows.
Human Resources: Determine the competencies required for staff involved in key quality-related roles and plan for training, development, and recruitment accordingly.
Infrastructure and Environment: Assess the infrastructure and work environment needed to achieve conformity to product requirements and plan improvements if necessary.
Technology and Information Systems: Evaluate the need for technological upgrades or new information systems that can enhance quality and process efficiency.
Document Control Systems: Plan for a robust document control system that ensures all necessary documents are up-to-date, accessible, and secure.
Record Keeping: Define procedures for maintaining records that demonstrate the QMS meets quality requirements and regulatory compliance.
Performance Indicators: Develop key performance indicators to monitor process effectiveness and product quality.
Audit and Review: Plan for regular internal and external audits to assess the QMS’s effectiveness and compliance with API Spec Q1. Also, include periodic management reviews to ensure continual improvement.
Integration into Business Practices: Integrate quality management processes into the broader business practices to ensure that quality is maintained as a core business focus.
By following these steps, an organization can plan a robust and effective Quality Management System that not only complies with API Specification Q1 but also enhances overall operational efficiency and product quality. This strategic approach ensures that the QMS is not merely a compliance exercise but a vital component of the organization’s success in the competitive oil and gas industry.
Establishing a Quality Management System in accordance with the requirements of API specification Q1 for products provided within the scope defined by the organization.
Establishing a Quality Management System (QMS) in accordance with API Specification Q1 involves a methodical approach to ensure that the products and services provided by an organization in the oil and gas industry meet strict quality standards and customer requirements. Here is a comprehensive guide on how to establish a QMS based on API Spec Q1:
Identify Products and Services: Clearly define which products and services are covered by the QMS. Include aspects such as design, manufacturing, procurement, testing, and delivery.
Establish Boundaries: Determine the physical and organizational boundaries of the QMS, specifying which departments and processes are included.
Management Commitment: Secure commitment from top management for developing, implementing, and continuously improving the QMS. This involves the allocation of necessary resources and leadership support.
Quality Policy: Draft and implement a quality policy that reflects the organization’s commitment to quality and meets the requirements of API Spec Q1. The policy should be communicated to and understood by all employees.
Quality Manual: Create a quality manual outlining the QMS’s structure and compliance with API Spec Q1. It should detail the scope of the QMS, policies, process interactions, and document control procedures.
Documented Procedures and Work Instructions: Develop documented procedures required by API Spec Q1, which typically include handling non-conformances, corrective actions, and risk assessment methodologies. Ensure all documentation supports the operational needs and compliance requirements.
Risk Identification: Identify risks associated with each process and product conformity. Use tools such as SWOT analysis, Failure Mode and Effects Analysis (FMEA), or other industry-specific methodologies.
Risk Management: Develop strategies to mitigate identified risks, including preventive controls, to ensure product quality and compliance.
Process Mapping: Outline and map all critical processes that affect product quality. Define how these processes interact and establish clear input and output requirements.
Control Plans: Develop control plans for critical processes that detail monitoring, verification, and process controls. This ensures each process is capable of achieving its intended results.
Human Resources: Define roles, responsibilities, and competencies for personnel involved in the QMS. Implement training programs to enhance skills and awareness of quality standards.
Infrastructure and Work Environment: Ensure the work environment supports product requirements. This includes facilities, equipment, and support services necessary for the QMS.
Employee Engagement: Foster a quality culture where all employees are engaged and motivated to achieve quality objectives. Promote open communication and feedback on process improvement.
Continuous Training: Regularly conduct training and competency evaluations to ensure employees are proficient in quality management practices and understand their role within the QMS.
Performance Indicators: Set up key performance indicators (KPIs) to track the effectiveness of each QMS process. Monitor these indicators to identify areas for improvement.
Audits and Reviews: Schedule regular internal audits to assess compliance with API Spec Q1 and the effectiveness of the QMS. Use audit results to drive management reviews and continuous improvement efforts.
Management Review: Conduct periodic management reviews of the QMS to ensure its continuing suitability, adequacy, and effectiveness. Address any changes in external and internal issues that affect the QMS.
Continuous Improvement: Implement continuous improvement mechanisms based on performance data, audit outcomes, corrective actions, and management reviews.
Establishing a QMS as per API Spec Q1 requires thorough planning, dedicated resources, and ongoing commitment from all levels of the organization. It is a dynamic system that evolves with the organization and its operational environment, striving always to enhance customer satisfaction and comply with industry regulations.
Documenting a Quality Management System in accordance with the requirements of API specification Q1 for products provided within the scope defined by the organization.
Documenting a Quality Management System (QMS) according to API Specification Q1 is a critical component for organizations in the oil and gas industry, ensuring that all aspects of the QMS are clearly defined, controlled, and executed consistently. Effective documentation not only supports compliance and operational efficiency but also facilitates communication, training, and continuous improvement. Here’s a step-by-step guide on how to document a QMS in accordance with API Spec Q1:
Develop a Quality Manual Scope of the QMS: Clearly define the scope of the QMS, outlining the products and processes it covers. Exclusions: Justify any exclusion from the QMS requirements and explain how these exclusions do not affect the organization’s ability or responsibility to ensure the quality of its products. Documented Procedures and Process Interactions: Describe the sequence and interaction between the processes of the QMS.
Document Control Procedures Control of Documents: Establish procedures for approving, reviewing, updating, and retracting documents. Ensure all changes and revisions are logged and traceable. Documents must be readily available to those who need access and protected from unintended use. Control of Records: Define how records are identified, stored, protected, retrieved, retained, and disposed of. Ensure records provide evidence of conformity to requirements and the effective operation of the QMS.
Create Documented Procedures Critical Procedures: Depending on the nature of the business, typical procedures documented might include handling of customer requirements, design and development, procurement, production, non-conformance, corrective actions, risk assessment and management, and internal audits. Work Instructions: For each critical process, especially in areas like manufacturing or testing, develop detailed work instructions that describe how specific tasks should be performed to meet quality standards.
Define Quality Objectives and Policies Quality Policy: Document a quality policy that reflects the organization’s commitment to quality and its objectives. The policy should be communicated and accessible to all employees. Quality Objectives: Establish specific, measurable quality objectives at relevant functions and levels. Document how these objectives contribute to achieving the quality policy.
Process Documentation Process Maps and Flowcharts: Use visual tools like flowcharts and diagrams to document process flows. These tools help in understanding process inputs, outputs, controls, and interactions. Risk Management Documentation: Document how risks are identified, evaluated, and controlled. This includes methodologies, tools, and data used in risk assessments.
Operational Documentation Specifications and Standards: Document all technical specifications and standards that apply to the products and services, detailing how these are incorporated into design and production processes. Change Management: Document procedures for managing changes in processes, products, or the QMS itself, ensuring that all changes are controlled and verified.
Training Records Employee Competence: Document procedures for assessing, maintaining, and improving employee competence. Keep records of training sessions, skills assessments, and qualifications relevant to employees’ roles.
Audit and Review Documentation Internal Audits: Document procedures for conducting, reporting, and following up on internal audits. This should include audit frequency, methods, responsibilities, and information on how audit results are used for improvement. Management Reviews: Document procedures for management reviews, including scheduling, agenda, review inputs, expected outcomes, and follow-up actions.
Performance Monitoring and Improvement Documentation Performance Data: Document how performance data is collected, analyzed, and used for decision-making. Include details on key performance indicators, data analysis techniques, and reporting formats.
Effective documentation ensures that every aspect of the QMS is transparent, traceable, and transferable. It is a foundational component that supports consistent implementation of quality practices and enhances the organization’s ability to achieve and maintain compliance with API Spec Q1.
Implementing a Quality Management System in accordance with the requirements of API specification Q1 for products provided within the scope defined by the organization.
Implementing a Quality Management System (QMS) by API Specification Q1 involves several critical steps to ensure that the system not only complies with the standard but also effectively enhances product quality and organizational efficiency. Here is a detailed guide on how to implement a QMS as per API Spec Q1, tailored for organizations in the petroleum, oil, and gas industries:
1. Management Commitment and Leadership
Secure Commitment: Begin by securing a strong commitment from top management. This involves management defining and promoting the organization’s quality policy, ensuring it aligns with the business objectives and committing necessary resources for the QMS implementation.
Leadership Engagement: Ensure leaders at all levels are engaged and take accountability for their role within the QMS, fostering a culture that promotes meeting customer requirements and continuous improvement.
2. Define Organizational Roles, Responsibilities, and Authorities
Clear Definitions: Clearly define roles, responsibilities, and authorities for personnel involved in managing, performing, and verifying work that affects quality performance.
Communication: Establish effective internal communication processes to ensure QMS processes are understood, implemented, and maintained across all levels of the organization.
3. Develop and Document the QMS
Documentation: As per API Spec Q1, document all core processes of the QMS including scope of the system, procedures, and interactions between processes. This documentation should include the quality manual, process maps, work instructions, and procedures for addressing non-conformances and corrective actions.
Control of Documents: Implement a process for document control that ensures all necessary documents are appropriately approved, communicated, and regularly reviewed.
4. Process Design and Implementation
Identify Processes: Identify and outline all key processes that impact the quality of products and services. This includes design, purchasing, manufacturing, inspection, and testing processes.
Process Management: For each process, establish detailed instructions and criteria, assign responsibilities, and determine necessary resources. Define how these processes interact with each other.
5. Resource Management
Provide Resources: Allocate suitable resources, including human resources, infrastructure, and work environment, needed to maintain the integrity of the QMS and achieve product conformity.
Employee Competence: Ensure all personnel are competent based on education, training, skills, and experience. Provide training and keep records of competence.
6. Product Realization and Planning
Customer Requirements: Clearly define and understand customer requirements and product specifications. This includes establishing criteria for acceptance and delivery.
Design and Development: Plan and control design and development stages, if applicable, ensuring validation, verification, and monitoring of design changes.
7. Risk Assessment and Management
Risk Analysis: Conduct risk assessments for each critical process to identify potential risks to quality and compliance. Implement appropriate measures to manage and mitigate these risks.
Continual Risk Evaluation: Regularly review risk management strategies and effectiveness in the context of changes in processes, technologies, or market conditions.
8. Monitoring and Measurement
Inspection and Testing: Implement monitoring and measuring activities required for the verification of compliance with specified requirements, including raw materials, in-process materials, and final products.
Data Analysis: Analyze data obtained from monitoring activities to identify opportunities for improvement.
9. Internal Audit and Management Review
Conduct Audits: Schedule and conduct internal audits to assess the effectiveness of the QMS and compliance with API Spec Q1.
Management Review: Regularly review the performance of the QMS by top management to ensure its continuing suitability, adequacy, and effectiveness. Address potential changes and improvements.
10. Continual Improvement
Improvement Initiatives: Use the outcomes of data analysis, internal audits, corrective actions, and management reviews to drive continual improvement of the QMS. Implement changes necessary to meet customer requirements and enhance overall performance.
11. Handling Non-Conformities and Corrective Actions
Non-Conformance Processes: Develop procedures to identify, document, and handle non-conformities, including implementing corrective actions to prevent recurrence.
By following these steps and adhering to the principles and requirements of API Spec Q1, organizations can ensure their QMS is robust, compliant, and effective in delivering high-quality products and services in the petroleum, oil, and gas industries. This systematic approach helps not only in maintaining product quality and safety but also in fostering a culture of continuous improvement and customer satisfaction.
Maintaining a Quality Management System in accordance with the requirements of API specification Q1 for products provided within the scope defined by the organization.
Maintaining a Quality Management System (QMS) in accordance with API Specification Q1 requires ongoing effort to ensure the system remains effective and continues to improve over time. This involves regular monitoring, evaluation, and updating of the QMS to address changes in technology, business environment, customer requirements, and regulatory standards. Here’s how an organization can maintain a QMS as per API Spec Q1:
1. Management Commitment
Continued Support: Secure continued commitment from top management for the maintenance and improvement of the QMS. Management should regularly review the QMS to ensure its alignment with the strategic goals of the organization and compliance with API Spec Q1.
Provide Resources: Ensure that sufficient resources are allocated for the operation, monitoring, and improvement of the QMS. This includes staffing, training, tools, and financial resources.
2. Regular Monitoring and Measurement
Performance Indicators: Utilize key performance indicators (KPIs) to assess the effectiveness and efficiency of QMS processes. These should include metrics related to product quality, customer satisfaction, process performance, and compliance.
Process Audits: Conduct regular internal audits to check the conformity of processes to the established QMS requirements. Audits also help in identifying areas for improvement.
3. Management Review
Scheduled Reviews: Organize periodic management reviews of the QMS to assess its continuing suitability, adequacy, effectiveness, and alignment with the strategic objectives of the organization.
Review Inputs: Include the status of actions from previous management reviews, changes in external and internal issues that affect the QMS, and feedback from customers.
Review Outputs: Decisions and actions related to improvements in the QMS, resource needs, and opportunities to change the QMS, including adjustments to quality objectives.
4. Employee Training and Competence
Ongoing Training: Regularly evaluate and update training programs to ensure that all employees understand their role in the QMS and are competent to perform their duties. This is crucial for maintaining the integrity of the QMS.
Skill Updates: As technologies and methods evolve, update the required skills and competencies accordingly. Provide training and cross-training to fill any gaps.
5. Document Control
Document Updates: Ensure that all QMS documentation is periodically reviewed and updated to reflect current practices and compliance requirements. This includes the quality manual, process documentation, and standard operating procedures.
Control of Records: Maintain comprehensive records to demonstrate conformity to requirements and the effective operation of the QMS. Ensure that records are readily available for analysis and review.
6. Risk Management
Continuous Risk Assessment: Continuously identify and assess risks associated with processes and quality objectives. Update risk mitigation measures based on findings from performance data and audits.
Proactive Measures: Implement proactive measures to address potential risks before they impact the QMS or product quality.
7. Corrective and Preventive Actions
Nonconformity Handling: Implement and maintain procedures for dealing with nonconformities, including investigation, actions to prevent recurrence, and evaluation of the effectiveness of those actions.
Improvement Actions: Use data from audits, nonconformities, and management reviews to drive continual improvement initiatives across the organization.
8. Customer Feedback
Feedback System: Maintain a robust system for gathering and analyzing customer feedback. Use this information to improve product quality and customer service.
Customer Satisfaction: Regularly assess customer satisfaction to identify areas where the QMS can be enhanced to better meet customer needs and expectations.
9. Continuous Improvement
Improvement Projects: Initiate continuous improvement projects to enhance the effectiveness of the QMS and increase efficiency across processes. Use lessons learned to foster a culture of improvement.
By following these steps, an organization can maintain a robust QMS that not only complies with API Specification Q1 but also drives continual improvement and sustained customer satisfaction. Regular evaluation, coupled with a proactive approach to addressing potential issues, ensures that the QMS remains effective and relevant to the organization’s needs and objectives.
The organization shall measure and improve the effectiveness of the quality management system.
Measuring and improving the effectiveness of a Quality Management System (QMS) are crucial aspects of maintaining compliance with standards such as API Specification Q1 and ensuring the organization continually meets customer and regulatory requirements. Here are the key strategies and methods that organizations should implement to measure and enhance their QMS effectively:
Define Measurable Objectives Quality Objectives: Establish clear, measurable objectives at relevant functions and levels throughout the organization. These objectives should align with the quality policy and be designed to enhance customer satisfaction and product quality. Specific Metrics: Develop specific metrics that reflect performance relative to those objectives. These might include product defect rates, customer satisfaction scores, on-time delivery rates, or internal audit results.
Regular Monitoring and Measuring Process Performance: Regularly monitor and measure the performance of various processes within the QMS. This could involve checking the efficiency of production processes, the accuracy of product testing, and the effectiveness of service delivery. Product Quality: Use quality control tools and techniques, such as statistical process control, to monitor and ensure product quality continuously. This data helps in identifying trends and potential areas of improvement.
Internal Audits Scheduled Audits: Conduct regular internal audits to assess the QMS against the set quality objectives and compliance with API Spec Q1. These audits help identify inconsistencies, areas of non-conformance, and opportunities for improvement. Audit Results: Utilize audit findings to initiate corrective actions and refine QMS processes. This proactive approach helps in maintaining compliance and enhancing system effectiveness.
Management Review Regular Reviews: Hold management reviews at planned intervals to ensure the continuing suitability, adequacy, and effectiveness of the QMS. Review Inputs: Include data on process performance, outcomes of audits, customer feedback, the performance of external providers, the status of preventive and corrective actions, follow-up actions from previous management reviews, changes that could affect the QMS, and recommendations for improvement. Actionable Outcomes: Decisions and actions coming out of these reviews should focus on resource needs, changes to policies or objectives, and improvement strategies.
Customer Feedback and Satisfaction Feedback Collection: Implement a system for collecting and analyzing customer feedback. This could include surveys, customer service logs, and direct customer communications. Customer Satisfaction: Analyze feedback to gauge customer satisfaction levels and identify areas needing improvement. Responsive actions should aim to address any issues raised by customers.
Corrective and Preventive Actions Systematic Approach: Establish a systematic approach to handling nonconformities, including investigating the root causes, implementing corrective actions to prevent recurrence, and monitoring the effectiveness of those actions. Preventive Measures: Analyze data and trends to identify potential issues before they occur and take preventive measures to mitigate risks.
Continuous Improvement Improvement Initiatives: Encourage a culture of continuous improvement within the organization. Use tools like Six Sigma, lean methodologies, or Kaizen to enhance process efficiency and effectiveness. Innovation and Updates: Stay abreast of technological advancements or changes in industry standards that could improve the QMS. Implement these changes where applicable to maintain competitive advantage and compliance.
Training and Development Ongoing Training: Provide ongoing training and development to ensure employees are competent and knowledgeable about QMS requirements and improvements. Skill Enhancement: Regularly assess and enhance the skills of employees to keep pace with changes in technology, processes, and standards.
Implementing these practices ensures that the QMS remains effective, compliant, and aligned with business goals. Through regular assessment and adaptation, organizations can achieve higher levels of product quality and customer satisfaction, thereby maintaining their competitive edge in the market.
This is the official quality management system manual of XXX. It describes the approach, structured to comply with the ISO 29001:2020 Quality management system (QMS). This system applies to all activities and operations performed at XXX. Through this Quality management system XXX,
Demonstrates the ability to provide consistently products and services that meet customer and applicable statutory and regulatory requirements
Aims to enhance customer satisfaction through the effective application of system, including processes for improvement of the system and assurance of conformity to customer and applicable statutory and regulatory requirements
To have a systematic approach to environmental management that will provide information to build success over the long term and create options for contributing to sustainable development, the organization and interested parties.
2. NORMATIVE REFERENCES
Documents related to this integrated management system manual include:
ISO 29001:2022, Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations
Annex 001 of QMS manual Quality policy statement
Annex 002 of QMS manual Process interaction chart
Annex 003 of QMS manual Organization chart,
Annex 004 of QMS manual QMS Objectives (A, B and C)
Annex 005 of QMS manual Scope document
3 TERMS AND DEFINITIONS
Quality management system: a set of interrelated and coordinated activities to direct and control an organization with respect to quality. The advantages of conducting an quality management system approach are:
Providing a framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties.
Ensuring that the service level provided by the company satisfies customers’ stated and implied needs.
The implementation of such system will lead to minimizing non-conformity level and eliminating their causes.
Increasing the potential for improvement of the organization.
Note: A Management system is a set of interrelated elements used to establish policy and objectives and to achieve those objectives. A management system includes organizational structure, planning activities (including for example, risk assessment and the setting of objectives) responsibilities, practices procedures, processes and resources.
Integrated management system manual: a document specifying the quality, health, safety and environmental management system of an organization. The integrated management system manual is an overall controlling document that contains full reference to all supporting operational procedures that describe the routine functioning of each department within QBC.
QHSE policy: the overall intentions, objectives, and directions of an organization related to quality, health, safety and environmental management system.
Quality plan: specification of the procedures and associated resources to be applied when and by whom to a specific object.
Resources: all needed requirements that enable the organization to fulfil all the client’s requirements. Resources could be one of 4 M’s: Material, Manpower, Machines, and Money.
Procedure: documentary instructions to the operation of the related integrated management system of the standards and defining responsibilities and activities for the operations.
Internal Audit: Systematic, interdependent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the environmental management system audit criteria set by the Organization are fulfilled
Infrastructure: Organization (system) of facilities, equipment and services needed for the operation of an organization
Incident: Work related event(s) in which an injury or ill health ( regardless of severity ) or fatality occurred or could have occurred
Improvement: Activity to enhance performance
Non Conformity: Non fulfilment of requirement
Performances: Measurable results of an organization’s management of Risk (in terms of all applied standards)
Risk : Effect of uncertainty
Validation: Conformation, through the provision of objectives that the requirements for the specific intended use or application have been fulfilled
4.0 CONTEXT OF THE ORGANIZATION
4.1 Understanding the organization and its context
XXX reviews and analyses the key aspects of itself and its stakeholders to determine the strategic direction of the organization. Internal and external issues that make impact on the XXX’s core business process and its stakeholder’s interest are taken into consideration, monitored and implemented. Changes in the market, technologies, laws, regulations, economy, government policies competitors, cultural and social responsibilities, are also being taken into consideration while carrying out business operation, by:
Understanding our core products and services, and scope of management system
Maintaining a Register for the internal and external issues determined by XXX which is reviewed annually.
Identifying “interested parties” (stakeholders) who receive our (Products or Services), or who may be impacted by them, or those parties who may otherwise have a significant interest in our organization’s business. These interested parties are identified during the management system risk assessment process
Note: Outsourcing of activities are strictly controlled and ensured that the requirements of the product and QA/QC requirements of the XXX are maintained throughout the product manufacturing lifecycle.
Ref: Risk assessment (PR 002)
4.2 Understanding the needs and expectations of the interested parties
Understanding needs and expectations of the interested parties are of key concern to XXX and have ensured through regular meeting with relevant section managers to clearly understand who they are and how they can affect the organizational ability to consistently perform. For this XXX,
Maintains a register for determining who are the relevant interested parties and are monitored in regular frequency (annex to the risk assessment procedure)
Regularly updates the needs and expectations of the interested parties so that they are clearly understood and met
Where applicable to be added as legal and other requirements the respective process owners shall inform the management and update it.
This information is then used by the top management (General Manager) to determine the XXX’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.
Ref: Risk assessment (PR 002)
4.3 Determining the scope of the QMS
Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, XXX has determined the scope of the management system. The QMS is structured to provide a robust, comprehensive, and a continuously improving management system in a manner that ensures customer satisfaction, an improved Quality performance. For determining the scope the organization, has considered
the external and internal issues
the requirements relevant to the interested parties
the products and services of the organization,
the works related activities performed
organizational functions and physical boundaries
the compliance obligations
Its authority and ability to exercise control and influence
All the requirements given in the standards ISO 29001:2022 are applicable to the scope of XXX and same is advised to the interested parties as determine in 4.2 when requested by them.
4.4 Quality management system and its processes
The QMS has been established in line with the ISO 29001:2020 standard to implement, maintain and continually improve the effectiveness of the system as well as the business processes of XXX. For effective implementation the following has been:
Identified and determined:
Process flow and their sequence, major processes through process flow which are identified in document master list;
All the key processes, its applications and its interactions through process interaction chart (Annex 002);
Aspects which have significant impact on the environment, achievable programs for continual improvement;
Assessed risks which have been rated as extremely high and control measures and supporting action plans as and when required.
Management system risk identification, determination of risk treatment and opportunities for improvement for all critical management system activities within the organization
Processes and documented information required to meet the requirement of interested parties.
Defined:
Operational criteria;
Policy statement, objectives and targets for quality processes;
Measuring and monitoring of aspects from various activities/process which have significant impact on the risk control activities, management system risk assessment and risk treatment, through various clauses of this manual, established procedures, work instructions and job descriptions;
Details of activities of the company through procedures, work instruction, process flows and various clauses of this manual;
Method of control through established documents which are listed in document master list (QMSF002);
Method for periodically reviewing and evaluating the quality management system, as well as to identify the opportunities for improvement;
Outsource processes and their controls which affect the product conformity are identified through purchasing procedure (Controls applied to externally provided services PR-008).
All the above mentioned processes are established, documented, implemented, monitored and analyzed for the performance to achieve the planned results and continual improvement of these processes as per analysis of data and management review as detailed later in this manual. The system is applicable to all the activities, product, processes and services of XXX. For adapting to changing circumstances, XXX shall be periodically reviewing and evaluating its management system in order to identify the opportunities for improvement and their implementation.
5.0 LEADERSHIP
5.1 Leadership and commitment
5.1.1 General
The XXX’s top management which includes the General Manager is committed to the implementation and development of the documented QMS and to continually improve the effectiveness of the system by:
Taking accountability for the effectiveness of the Quality management system, including prevention of work-related injury and ill health, as well as the provision of safe and health workplaces and activities.
Ensuring that the Quality policy statements and objectives are established for the QMS is compactable with the context of the organization and strategic direction of the organization.
Ensuring that the integration of the QMS requirements into the business processes
Promoting risk based thinking and process based approach
Communicating to the company the importance of meeting the customers as well as statutory and regulatory requirements.
Establishing and communicating the company policy to all employees in the company and explaining that satisfying the requirements of the Quality management system will lead to effective implementation of the company policy.
Ensuring that all necessary resources whether human, financial, equipment, or material are available for efficiently conducting Quality management system tasks.
Providing the proper training for newly hired employees as well as the available employees in order to be able to perform all job requirements and duties each in his position.
Assuring that, where necessary, personnel have the authority to identify and record quality problems requiring resolution and analysis, or improve the applied systems and procedures after communicating them to the related department head and the management representative.
Ensuring that there is active participation of workers in QMS system and removing any barriers or obstacles to participation.
Initiating, recommending, and providing solutions to prevent the occurrence of non-conformance.
Ensuring that the QMS achieves its intended results.
Engaging, directing and supporting persons to contribute to the effectiveness of the QMS.
Promoting and ensuring continual improvement in all the processes.
Promoting and leading a positive culture with regards to the Quality management system.
Protecting workers from reprisals when reporting risks and opportunities.
Supporting all the relevant process owners and managers in their roles to demonstrate leadership and to achieve the indented result of the QMS.
5.1.2 Customer focus
XXX ensures that all the customer requirements are determined and fulfilled to meet their expectations and thereby achieving customer satisfaction. The management system is established and maintained keeping in view the further enhancement of the same by:
Determining requirements stated and implied by customer
Identifying, establishing, maintaining and updating the legal and statutory requirements those which are applicable to the activities, products or services provided.
Ensuring that the customers are aware of the requirements related delivery and post-delivery activities
Identifying the environmental aspects of its activities, which have significant impact on the environment, and informing the customer, employees and interested parties them about the significance, where required.
Implementation of necessary control measures to ensure that customers have a risk free product or service.
Providing information related to products and services through company profile.
Ensuring that the risks and opportunities that can affect the conformity of products and services are and the ability to enhance customer satisfaction are determined and addressed
Ensuring that the focus on enhancing customer satisfaction is maintained.
5.1 Policy
5.2.1 Establishing the QUALITY policy
In XXX, the QUALITY policy has been made in line with the requirements of ISO 29001:2020. The QUALITY policy statement has been defined and published and can be found with the General Manager endorsement in the QMS manual. The top management shall establish, maintain and implement the policy based on the discussion and agreement with the process owners in considerations of the interested parties. The strategy to achieve the company policy is through the implementation and maintenance of very well established objectives, which provides a framework for implementing the Quality management system described in this manual, compliance to applicable legal and other requirements and the associated procedures. The policy statement shall be reviewed (and revised as needed) during management review to ensure the continuing suitability to the established QMS and the changing needs of the customer.
5.2.2 Communicating the QUALITY policy
Employees at all levels of the organization are expected to understand and fulfil the requirements of this policy in all of their works, related efforts and decisions. The top management shall ensure that the commitment to workers participation and consultations are documented and demonstrated. The QUALITY policy is considered as a major part of the Quality management system; accordingly it shall be reviewed for continuous suitability and its support in the strategic direction of the company. The top management have ensured that the policy is
Available and maintained as documented information
Communicated, understood and applied within the organization through effective communication, training and supervision
Available for relevant interested parties as applicable through brochures, manuals, websites, etc.
QUALITY policy statement is also included in the induction training of the new employees as well as in the QMS training, contractor’s training and process trainings conducted periodically
Ref: QUALITY policy statement (Annex 001)
5.3 Organizational roles, responsibilities and authorities
The organizational chart (in Annex 03) provides the positions of all that manage, perform and verify works affecting quality. All relevant roles are well defined in each procedure. The responsibilities, accountability and the authorities of all relevant affecting QMS, facilities and processes are defined through the
Employment offer
Contract agreement (Recruitment phase)
Organization chart,
Job descriptions
Induction training, On job training
Internal memos/tool box meetings
Trainings – refreshment and development
The top management ensures that all the assigned roles have their responsibilities and authorities defined and communicated effectively. The steps taken shall ensure that the requirements of the established Quality management system are well understood by the process owners and employees to confirm to the ISO 29001:2020 standard as well as the desired outputs from the team. The top management shall ensure that the performance of the Quality management system and opportunities for improvement are identified and communicated to them by the process owners. The process owners shall ensure that the objectives and performance indicators of the intended outputs are reported to the Top Management. The job descriptions of the individual are communicated through training (induction/on job), regular meetings, notice boards and work instruction. Apart from the defined responsibilities, accountabilities and authorities, respective process linkages and the interrelation of the all the organizational processes are defined in process interaction chart (Annex 02).
6.0 PLANNING
6.1 Actions to address risks and opportunities
XXX shall ensure that the risk assessment is done for the critical processes, products and services within the Quality management system. While performing the risk assessment and opportunity identification, XXX shall ensure that
The relevant internal and external issues related to the products and services are considered
The needs and expectations of the external interested parties which affects the products and services are incorporated
The techniques, tools and their application for identification and assessment of risks and opportunities, and prevention and mitigation of risks are determined;
The sources of risk and opportunity, areas of impacts, events and their causes, and their potential consequences are determined.
The potential risk and opportunity by determining consequences and their likelihood are analysed ;
The risk and opportunity and develop controls for them are evaluated;
Appropriate risk treatments and opportunity realization plans are applied.
The details of the methodologies used for identification of risks and opportunities are documented in the procedure for management system Risk assessment (PR 002). Formal risk management may not be utilized in all instances; instead, the level of risk assessment, analysis, treatment and record keeping will be performed to the level deemed appropriate for each circumstance or application. XXX considers risks and opportunities when taking actions within the management system, as well as when implementing or improving the management system; likewise, these are considered relative to products and services.
Ref: Risk Assessment (PR 002).
6.2 Objectives and planning to achieve them
Objectives (Annex 04) shall be in line with the stated quality policy, measurable and monitored. The General Manager in co-ordination with the respective section manager(s) reviews and recommends, where needed, to process owners to revise the objectives in the management review meeting to ensure that the objectives are relevant to the conformity of products and services provided to the customers and serves to enhance customer satisfaction. The top management worked on establishing objectives that are extracted from XXX’s company policy. The management made sure that the objectives are:
Consistent with the QUALITY policy statement
Established after taking into account the applicable legal and other requirements
SMART: Specific, Measurable, Achievable, Realistic and Timely.
Established risks including the commitments to the prevention of injury and ill health, legal and other requirement, technological options, financial, operations and business and the views of interested parties
Established at relevant functions and levels within the organization for achieving conformity to products and service requirements and to enhancement of customer satisfaction and are monitored through objective measurement charts.
Planning taking into account, the applicable requirements, results of the risks and opportunities, results of consultation with workers and QUALITY representative
These objectives shall be reviewed continuously through the management review meetings and internal audits as described in the management review procedure for suitability and updating.
While planning for achieving the objectives are met, the process owners shall determine;
What will be done
What resources will be required
Who will be responsible
When it will be completed
How the results will be evaluated
Ref: Functional quality objectives (Appendix 04),
6.3 Planning of changes
When the organization determines the need for changing the Quality management system, the changes shall be carried out in a planned manner. When there are changes required in the existing service requirements, management ensures through management review that the suitability & integrity of the management system is maintained during the planning and the implementation to the smooth transition of the system. When changes are required existing objectives, the Management Representative shall ensure through review the purpose and potential consequences of the change and its suitability and integrity with the existing QMS. In case of need for availability of resources or need for the allocation or reallocation of responsibilities and authorities for the changes in the objectives, it shall be duly addressed prior to formalizing the objectives. Management programs, identified risk control measures and Action Plans are amended, if required. If necessary, planning is also carried out through review meetings. Any risk and opportunities arising out of the changes are managed as per the procedure of Risk assessment.
Regarding management of change (MOC) the organization shall identify the risks associated with changes in the organization, Quality management system, or its activities, prior to the introduction of the changes. The organization also ensures that the results of these assessments are considered for determining the appropriate controls. Documented Information for the management of changes are maintained. The relevant process owners along with the Management Representative shall plan to take actions to address its changes to the management system processes.
The Management Representative along with the process owners shall review and determine how to integrate and implement the relevant actions into the Quality management system and shall evaluate the effectiveness of these actions and shall consider
The purpose of the changes and its potential consequences
The integrity of the QMS
Availability of resources
Allocation of re-allocation of responsibilities and authorities
The requirements for quality requirements are met by the establishment and implementation of Quality management system which allows effective planning prior to the changes in the system.
The Quality management system has been assembled and documented in a format to suit this method of operation.
XXX will give timely consideration to conduct revision of the Quality management system through management review meetings, and interactions with the process owners.
While planning its actions XXX shall ensure the best practices, technological options, financial, operational and business requirements are met.
Ref: Management of change (PR 021)
7.0 SUPPORT
7.1 Resources
7.1.1 General
XXX’s Top management has assured the availability of resources needed for the effective implementation and the maintenance of the QMS and enhance the effectiveness of the system by providing resources on time. The General Manager shall consider the capabilities of, and constraints on, existing internal resources and what it needs from the external providers. By providing resources on time, the management ensures that there is:
Continual improvement in the QMS.
Enhances customer satisfaction by meeting and exceeding the requirements of the customer
7.1.2 People
XXX’s Top management has ensured that there are adequate personals available for the services provided and to enhance the quality performance of the Quality management system. Personnel performing work affecting service are competent on the basis of appropriate education, training, skills and experience. The top management ensures this through proper recruitment of the most appropriate personnel for the required jobs. Competence requirements are determined through job descriptions. Where additional training is required to enhance the competence of personnel, this is handled in accordance with Procedure for Training(PR 007).
The Admin/HR Representative ensures that the process of requirement of competent people is being arranged for the respective department either through recruitment or through outsourced activities.
Ref: Training (PR 007)
7.1.3 Infrastructure
The infrastructure facilities required to achieve planned results (as per the scope of service) are identified and maintained as per procedure for Maintenance (PR 022), this includes,
All equipment required for provision of services (is identified and made available).
Risk based Maintenance activities are carried out which includes preventive and predictive maintenance, reliability centred maintenance, mean time between failures, system, design and process failure mode and effects analysis, failure mode and criticality effects analysis, process control plans and others that are in context of the organization and its risks.
Software and hardware (information systems) (used are controlled and maintained to ensure the availability of licensed and updated versions as required).
Equipment and supporting services (are identified and maintained as per the established preventive maintenance system).
Preservation – (Incoming materials and finished products are maintained as per the required conditions by providing adequate storage and protection).
The availability of the process equipment and supporting services such as communication and transport are reviewed by top management during the management review meeting and internal meetings, for the capability to meet to the requirements of customers (both internal and external) and interested parties. XXX ensures the availability of latest versions of software that may be needed for carrying out the activities as required. Arrangements are made with the relevant suppliers for updates.
Ref: Maintenance (PR 022)
7.1.4 Environment for the operation of processes
The present work environment is determined to be suitable for the range and scopes of services carried out. The process owners ensure that the environment for operational process are defined and complied to.
The respective managers along with the QA/QC representative reviews the suitability of the work environment needed to achieve the conformity of the product requirements and to enhance the organization in achieving the quality requirements on a regular basis.
A work environment suitable for achieving conformance to product requirements are maintained. Data from the QMS system is also evaluated to determine if the work environment is sufficient for achieving conformance to the requirements, or if corrective action related to the work environment is to be taken. The present work environment is determined to be suitable to the range and scopes of the service carried out by XXX:
Work instructions are available for all general safety rules.
Safety rules and protective equipment – To create awareness, respective safety instructions are displayed and provided with the necessary protective equipment.
Other welfare facilities are also provided to the employees like drinking water facility, transport from the accommodation to the work place, free accommodation facilities and food.
Proper housekeeping is maintained taking safety into consideration.
Dust free atmosphere for critical processes
Maintaining the environment by planting trees and promoting greenery in the camp areas. Providing adequate breaks for staff to ensure that they are not over stressed
Motivating employees through performance appraisal, incentives, and real involvement of employees.
Note: The term “environment for the operations of processes” relates to those conditions under which work is performed including physical, environmental and other factors (such as Social, Psychological, physical)
Top management reviews the suitability of the work environment needed to achieve the conformity of the product requirements and to enhance the organization in achieving the QUALITY policy, objectives, targets and system performance etc. through management review meeting.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
XXX’s Top management considers providing resources as one of its top priorities in having an effective Quality management system, so when it comes to monitoring and measuring resources, the management ensures that it provides those resources which will give valid and reliable results for its products and services. The management shall ensure that these resources are suitable for the specific type of monitoring and measurement activities of XXX and are maintained by the authorized person for continuing fitness for their purpose.
Ref: Measurement and Monitoring (PR 025)
7.5.5.2 Measurement traceability
All inspection, measuring, and test equipment used for demonstrating the conformity of the product is controlled and maintained on a regular basis. A list of measuring equipment shall be established to define accuracy needed and frequency of calibration. Such measuring and test equipment is subject to either external calibration by independent bodies or in house by qualified personnel (where applicable). Results of calibration, indicating calibration status, shall be recorded and maintained. Calibration data or results will be afforded to customer on request. Calibration certificates shall provide traceability to national or international standards. Defective equipment shall be taken out of service for repair or disposal. If defective equipment was used to verify product acceptance the effect upon product quality shall be re-assessed. If calibration is carried out in-house, it will be done under suitable environmental conditions by qualified personnel. Master instruments traceability will be to the international or national standards. All master instruments will be maintained, protected from damage or loss to sustain accuracy needed. The calibration and control of monitoring and measuring devices is explained in the calibration procedure
Ref: Calibration procedures (PR018)
7.1.6 Organizational knowledge
XXX’s top management values the knowledge and skills of the employees that it has recruited and shall strive towards maintaining them within the organizations for growth and effectiveness of the processes. XXX’s top management shall determine knowledge necessary to perform process/operations to meet customer expectations and subsequently, plan the methods to achieve the identified knowledge goals by means of training, learning on the job etc.
XXX shall exchange in-house and maintain this knowledge through internal knowledge sharing sessions which ensure dedicated exchange of knowledge and sharing of lessons learned from projects and specific external training programmes.
The respective process owners and top management shall evaluate knowledge and identify opportunities for improvement in line with changes in the market or in technology and analyzing the extent to which they influence the knowledge that XXX requires.
7.2 Competence
Competence requirements are determined through job descriptions. Where additional training is required to enhance the competence of personnel, this is handled in accordance with Training procedure (PR 007).
The HR department ensures that the process of recruitment of competent people is being arranged for the respective process either through recruitment. It is the responsibility of the respective manager to ensure that all personnel carrying out activities are made aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives and the importance of conformance to XXX’s QUALITY policy, Quality procedures. Company objectives are deployed at the functional levels and all relevant personnel made aware of their roles.
In terms of QMS, the management shall ensure that actions taken to ensure competence, shall take into account
The Risk and Opportunity assessed by the organization
Preventive and control measures resulting from the risk assessment process
Assigned roles and responsibilities
Individual capabilities, including experience, language skills and literacy
The relevant updating of competencies made necessary to the context of the work changes
The evaluation of the competence or workers according to the determined necessary competence
Ref: Training procedures (PR 007)
7.3 Awareness
XXX’s top management understands and maintains that it is the responsibility of the respective manager to ensure that all personnel carrying out activities are
Made aware of the QUALITY Policy statement, relevant objectives, customer & regulatory requirements, risk mitigation and conformity assessment requirements.
how they contribute to the achievement of the Quality management system and the benefits of the enhanced performance
the implications of not conforming with the Quality management system, including consequences, actual or potential to their work activities
Information and lessons learned concerning Quality issues
Awareness sessions shall be carried out through the established training procedure and the by the procedure for communication, participation and consultation.
Ref: Training procedures (PR 007)
7.4 Information and communication
The internal communication among XXX’s staff is ensured by the well-established reporting system, which is covered by the application of the ISO 29001:2020 Quality management system. Records and information flow are available through two kinds of media: soft copies through the active networks and through hard copies. The process sequence, linkage/interrelation, interactions, method of operation and control and process criteria of monitoring and measurement are carried out as stated in general requirement and are communicated across all levels of the organization through the QMS. As a part of this QMS, effective communication is established throughout organization via:
Internal memo
Intranet
Verbal instructions
Display of quality policy statements and objectives
Circulars
Monitoring and measurement reports
Method for receiving, documenting and response to relevant communication from external interested parties of has been defined in the procedure for communication, participation and consultation (PR 012).
XXX’s top management has decided to communicate externally about its significant environmental aspects to interested parties if they ask or enquire about it. It will be the responsibility of the management representative on how to give a report to the interested parties on any Quality matters. Change of decision to communicate would be discussed during MRM and method for the same will be finalized.
A clear method of communication internal and external has been identified and defined in procedure for communication(PR012). Method for internal communication among the various levels and functions of XXX has been defined in the same procedure. With respect to information to external or interested parties, XXX shall ensure that they
Define the intent to be achieved by informing and communicating and shall evaluate whether the objectives have been met
Take into account diversity aspects, where they exist, when considering its information and communication needs
Ref: Communication (PR 012).
7.5 Documented information
XXX has established a documented procedure to maintain control of all documents and data relating to the requirements of ISO 29001:2020 standard. This also includes, if applicable, documents of external origin determined by XXX to be necessary for the planning and operation of the quality management system, such as standards and/or customer supplied documents.
The documented procedure covers the following issues:
The management representative is responsible for the issuance, amendment and recall of the entire documented Quality management system.
Amendments to the documented system may arise at any time as a result of but not limited to the following:
Changes to the Quality management system standard,
Internal and external audits.
Changes in technical standards.
System reviews.
Requests for amendments from Concerns.
Business expansion, development and improvement.
Amendments to the Quality management system might be requested by any employee and are forwarded to the management representative using the appropriate document as stated in the documents control procedure (PR 001)
The management representative shall review and approve any amended/new document for adequacy prior to issue.
To ensure that documents remain legible and readily identifiable, the management representative holds a copy of the current version of the Quality management system documents as a master reference in the system master file.
The document controller is responsible for issuing all manuals and maintaining a log of all issues. The Quality management system, which includes all approved documents, is distributed to all locations/departments where operations essential to the effective functioning of the QMS management system are performed.
Quality manual, procedures, and support documentation are issued as “controlled” documents.
When a change to the documented system has been agreed, the management representative advise all the internal document holders of the new revisions by changing the revision in the documentation master list and distributes this new version to all the holders.
All obsolete and/or invalid documents shall be taken from the holders and disposed.
The document controller retains copies of the superseded documents for a stated period of time.
Documents of external origin determined by XXX to be necessary for the planning and operation of the Quality management system shall be identified and their distribution shall be controlled.
Practices employed by XXX to integrate into its operating process any external specification requirements, including addenda, errata, and updates, used in the design or manufacture of a product or service,
XXX has established documented procedures for records control (PR 001) whereby the records are retained for defined periods, identified, filed/stored, maintained, and are always accessible and retrievable. Records may be in hard copies, electronic copies or other media formats. Where information is stored in a computer system, appropriate methods are taken to preserve data including data back-up copies.
The documented procedure includes controls for:
Records identification: this is covered in the documentation procedure (PR 001) where each record has a unique identification number and revision number.
Records storage and protection: all records shall remain legible by using appropriate storage methods to guarantee that they are readily retrievable. They are stored in a manner that prevents loss, damage, or deterioration.
Retention and disposition of records: retention period is stated for each record after which records are disposed. The retention period is specified according to the importance and the need of the document for a specific period of time.
Retained records demonstrate conformance to the ISO 29001:2020 and requirements and provide evidence of the effective operation of the Quality management system. Also, these records are considered as the basic input for the analysis of data used for measuring and improving the applied activities and processes.
Ref: Documented information procedure (PR 001)
8.0 OPERATION
8.1 Operational planning and control
8.1.1 General
Planning and realization of service is an on-going process. The controls needed to achieve service conformity are established and maintained through various process flow diagrams or procedures. Procedures and process flows diagrams for the key processes are documented. During planning the following are determined:
The requirements of the customer’s scope and product characteristics
The need to establish criteria for processes and acceptance of the products and services
The needs of resources to achieve conformity to the product and service.
Required verification, validation, monitoring, inspection and test activities specific to the requirement and the criteria for service acceptance. (Calibration of key equipment, validation, inspection and test activities as per quality plan/requirement)
Implementation of controls for the criteria
Records needed to provide evidence that the realization process (planning, review, production, delivery, etc) and resulting outputs meets contractual and product requirements.
The output of this planning process is the product itself and the records to prove its acceptance/service requirements by the customer shall be maintained.
Where required the respective section managers shall control planned changes and review the consequences of unintended changes taking action to mitigate any adverse effects as necessary. The outsourced processes shall be controlled and records maintained for conformity. Where there is a requirement by the client for Quality / Service plan or Inspection and test plan, the QA/QC representative and the respective section manager shall prepare a quality plan or Inspection and test plan and submit for approval.
Changes to operational processes are done in accordance with the procedure for Management of change(PR 021).
Contingency plans are established as a risk treatment in accordance with the Procedure for Contingency plan (PR 023).
Ref: Management of change (PR 021),Contingency plan (PR 023).
8.2 Requirements for products and services
8.2.1 Customer communication
For the effective implementation to meet the requirements of customer, appropriate channels of communication are established in relation to product information, enquiries, contracts, order handling, amendments, contract information, enquiries, and feedback including customer complaints etc.
The various modes of communication used are:
E- mail through Internet
Fax/Letters
Telephone
Displays
Personal meetings with clients
Brochures
Visits of clients to facilities
The complaints received from the customers are reported in Customer Complaint Register where required. Customer communication records are also retained throughout the project, or until the project is declined. The method for handling complaints is identified in the procedure for communication, participation and consultation (PR-012).
Ref: Communication, participation and consultation (PR 012).
8.2.2 Determining the requirements for products and services
The requirements related to the services (stated/implied) as below, but not limited to:
Customer/Market needs
Cost involved
Statutory & regulatory requirements
Reference to the international standard
Organizational codes of Practice
Organizational policies & Objectives
Organizational capability
Relevant similar past experience in new product/service launching
Source of purchase
Mode of transportation
Present storage, handling & delivery methods,
Present over heads
Storage reliability
Suppliers reliability
Product/Service reliability
Competitors Product/Service
Competency of personnel
Inspection requirements
Anticipated market requirements
Inventory cost
Identification & Traceability
Product specifications
Stages of inspection and requirement
Reports of qualification tests
Transport requirement
Post-delivery activities
8.2.3 Review of the requirements for product and services
XXX shall review the requirements related to the contract and service prior to the commitment to supply to the client by reviewing the requirements from the client. The review is carried out by the respective section manager(s) and the relevant engineers who determines if the service can be provided or not. In case of tenders the “Estimation department” ensures that all the requirements are adequately reviewed.
Requirements related to the client are also identified clearly at the tendering process itself. The scope of work and the project deliverables clearly indicates the needs of the client. The specifications and instructions that accompany the tender documents are clear in identifying the requirements of the client related to the contract.
Clarifications and further information is received through the pre-tender meetings, or discussions and meetings with the client, visits to the site or proposed site areas, etc. Document and records which are controlled during the contract period are as follows:
Tender documents
Authorisation for pricing
Order transfer note
Progress report
Supplier quotation
Quotation to customer
Job card
QA/QC documents
Estimation sheets
Order receipt
Customer and contract document
Intermediate completion of services
Customer product / data sheet
Contract review comments and communicate the same
The review requirements of the products are done as per the following table
S. No
Requirement
Responsibility
1
Market feasibility
G.M. / Section Manager
2
Statutory and regulatory requirements
G.M./PRO
3
Raw material quality
QC Manager
4
Design mix
QC Manager
5
Equipment & Maintenance
G.M./Section Manager
6
Road signage
Section manager
The Procedure for contract Review (PR 024) is maintained which describes the process in details.
Ref: Contract Review (PR 024)
8.2.4 Changes to requirements for products and services
In situations where the client is not providing any documented statement of their requirement, the standard specification of the product is confirmed before making final commitment. Where contract requirements are changed, it is ensured that the relevant documentation is amended and relevant personnel are made aware of the changed requirements. Records of review are maintained by the sections.
When changes are required existing QMS, the management representative shall ensure through review the purpose and potential consequences of the change and its suitability and integrity with the existing management system. In case of need for availability of resources or need for the allocation or reallocation of responsibilities and authorities for the changes in the Objectives, it shall be duly addressed prior to formalizing the objectives. Management programs, identified risk control measures and action plans are amended, if required. If necessary, planning is also carried out through management review meetings. Regarding management of change (MOC) the organization shall identify the Risks associated with changes in the organization, Quality management system, or its activities, prior to the introduction of the changes. The organization also ensures that the results of these assessments are considered for determining the appropriate controls. These activities are further defined in the procedure Management of Change (PR 021)
Ref: Management of change (PR 021)
8.3 Design and development of products and services
8.3.1 General
XXX shall determine all the requirements of design of the products and services to fulfil products requirements and meet the entire satisfaction of customer. Required processes have been established and carried out the design and development as per the design and development procedure (PR 017). Although, the development shall not be restricted to this procedures because development and research always looks for better improvement of products in order to exceed the customer satisfaction.
8.3.2 Design and development planning
XXX prepare the plan and control the design for the development of products and services. The design engineer verifies the customer requirements prepare the effective plan for the proper designing. The design and development stages are clearly defined. The design and development stages are reviewed, verified and validated to ensure the requirements of the products have been meet with the requirements. The design engineer shall be responsible for the planning of design processes. The process owner shall review, verify and approval the design and development stages. Any risk and opportunities arising out of the design and development are managed as per the procedure of Risk assessment (PR 002).
These activities are further defined in the procedure Contract Review (PR 024)
Ref: Contract Review (PR 024)
8.3.3 Design and development inputs
The inputs of design and development of the products requirements are determined by the design engineer. The inputs are maintained as per the documentation requirements including the functional and performance requirements, environment and safety condition and output of the risk and Opportunity Process. Also XXX determines the information of previous design of delivered products and takes as a feedback to develop forthcoming products in the better way.
8.3.4 Design and development controls
Design and development review:
While designing the products and services, at suitable stages systematic reviews of design and development are performed in accordance with planned arrangements. Reviews status and comments are clearly marked and documented to give feedback and proposal to take necessary actions to meet the products requirements.
Design and development verification
Design verifications are carried out according to the plans and records of the verifications are maintained. It has been ensured that design and development outputs have met the design and development input requirements.
Design and development validation
The production engineer shall do validation of design and development as per the planned arrangements to ensure that resulting products are qualified and capable of meeting the requirements for the specified application and intended use. Validation is done prior to final use or delivers to customer. As necessary the customer also can validate the design and development.
8.3.5 Design and development outputs
The output of design and development is verified against the design and development input and approved prior to release. The output of design and development shall meet the input requirements. Instructions for the productions, information required for the purchasing of materials required for the products, as well as storage and handling information are also provided. Design outputs are in a format that will furnish all information required for the end user.
8.3.6 Design and development changes
The products and services designed and developed on the basis requirements and ready for the intended use. If the changes are required by the client, clear information for the required changes is received, and design engineer reviews and verifies the changes. Prior to implementation the changes are reviewed, verified, validated and approved. The changes records are documented and will be part of the contractual documents. Where required, design and development stages are detailed in the project quality plans and procedures issued by XXX. Various forms are design for the entire design and development process to keep as quality records.
Ref: Design and development procedure (PR 017).
8.4 Control of externally provided products and services
8.4.1 General
XXX has established a system to demonstrate its commitment and method through following section on its commitment and method for purchasing process, purchasing information and verification of purchased products.
8.4.2 Type and extend of control
Purchasing documents clearly and completely describe ordered products, including quality requirements. Purchasing documents are reviewed and approved prior to release. Purchased products are verified before they are used or delivered to end users. Details of purchasing process are documented in the procedure for control of externally provided services (PR 008). All new suppliers are evaluated with regard to their quality and process capability. All potential suppliers are evaluated based on the criteria of Quality and process as documented in the (PR 008). Supplier evaluation & re-evaluation is done in order to introduce them in the approved supplier list. The General Manager and the Management Representative establish the criteria for selection of suppliers, and purchasing staffs conduct supplier evaluation.
All potential suppliers are evaluated at least once in a year based on the criteria of Quality and process are documented in the procedure for Purchasing (PR 008) and once approved records are maintained in Approved supplier list.
XXX extend the control over supplier and outsourced processes and to the purchased products through the procedure for control of externally provided services (PR 008). The type and extent of controls will depend on the risk and opportunity associated with the product or service purchase. Quality performance of suppliers are monitored. Suppliers showing inadequate performance may be asked to implement corrective actions, and be downgraded or discontinued. In case there are identified risks of goods, equipment and services purchased, the controls are identified and if required communicated to the supplier or sub-contractor. Purchased products are inspected by requestor or the relevant managers. This includes verification of product identity and quantity, visual inspection and, where applicable, verification that all requested certificates and quality records are available. Record of the inspection are maintained.
Review also ensures that the purchased product meets the specified requirements. When deviations are identified, the supplier is contacted to discuss the corrective action. Where specialized services are required and have to be outsourced, the suppliers of such services are also identified, selected and approved in a manner similar to that mentioned above. Same controls are established for such activities.
Ref: Control of externally provided services procedure (PR 008).
8.4.3 Information for external providers
Purchasing documents are prepared by the purchasing in charge. The documents clearly and completely describe ordered products, including precise product identification and quality requirements. The General Manager or his appointed deputy reviews and approves all purchasing documents prior to release. Purchasing documents may be in the form of fax, e-mail, or other documented communication sent to the supplier, these clearly specify the requirements, specifications, terms and conditions. The document also includes the requirements for approval of product, procedures to follow (if applicable), requirements for qualification of personnel (where applicable) and Quality management system requirements. The documents are reviewed for adequacy of specified requirements and approved before sending to the supplier. The requirements to be followed by the suppliers/contractors are communicated by purchasing section at the time of signing the contract or along with purchase orders.
The procurement in charge shall ensure that procurement process have adequately defined and applied criteria for the selection of contractors. The procurement in charge shall ensure that outsourced functions and processes are controlled. The procurement in charge shall ensure that its outsourcing arrangements are consistent with legal requirements and other requirements and with achieving the intended outcomes of the Quality management system. The type and degree of control to be applied to these functions and processes shall be defined within the Quality management system as per the nature of work outsourced.
Ref: Control of externally provided services procedure (PR 008).
8.5 Production and service provision
8.5.1 Control of production and service provision
XXX establish control procedures covering all areas of company like general working areas, project sites, contract/project management, manufacturing, installation etc. to make sure its activities are carried out under controlled conditions. Controlled conditions include the following (where applicable):
The availability of information that describes the characteristics of the products and services offered,
The availability of work instructions as necessary,
The availability of information that describes the characteristics of the project through timing plan and method statement,
The use of suitable equipment identified through resource planning,
The availability and use of monitoring and measuring equipment,
The implementation of monitoring and measurement, and
The implementation of product release, delivery, and post-delivery activities.
To ensure this, XXX have developed method statements/Work instructions as per relevant national and international standards to be followed by the clients or the projects. A standard method statement contains the details on how to ensure quality of the products, Quality services, resource requirements, safety for the safe working conditions, measurement and control of process in line with the requirements of the customer. The method of statement of works is prepared and submitted to the client, consultant or contractors for their approval prior to execute the production/projects.
However, these can be modified and customized in accordance with project specification. XXX can function as prime, joint venture, or subcontractor, according to clients’ preferences. The final customization is approved by the process owners and relevant engineers prior to sending out to the client for approval. XXX also has own production facility to manufacture. These are produced as per standard specifications and project requirements. The products are designed as per the standards , special needs of clients are determined & are built as per specifications of products.
QA/QC requirements
The project manager has the full authority to run the project according to the plan drawn up with the General Manager. Working procedures are laid down taking into consideration of the customer’s requirement and quality aspects. Coordination, follow up and checking is duties assigned to the site staff, and are assured by regular meetings at suitable intervals.
Plant & equipment maintenance:
Plants are regularly maintained as per manufacturer’s maintenance schedule and manual. Maintenance is done by the respective sections. Moving vehicles, equipment, machines & etc. are maintained by mechanical engineering workshop regularly as well as the respective foreman in the department. Other hardware and software are regularly checked & maintained by IT department. Section heads are responsible to ensure the adequacy of all plant and equipment under their possession. The equipment are listed and included in the service/maintenance schedule as per type of equipment and its requirements. Outsource requirements for the maintenance (for specialized equipment) are requested and done as per purchasing procedures and as defined in the 8.4 in this manual.
Measuring and monitoring equipment:
Requirements for measuring and monitoring equipment are determined by Production and Quality Assurance. This is in accordance with process control and product verification programs defined in product realization planning (refer to Section 8.1 of this manual).
Validation of processes for production & service provision:
Processes where the resulting output cannot be verified by subsequent measurement or monitoring are designated as special processes. The relevant section heads are tasked with the responsibility of handling special processes and to ensure that the process is controlled and validated prior to delivery to the client. Special processes are validated and controlled by applicable methods, equipment and personnel qualification, and work instructions and process procedures. The use of specific methods and procedures are resorted to as applicable. Special process records are established and maintained as appropriate. Depending on the control measures implemented, these records may include process qualification and validation reports, equipment qualification and maintenance records, inspections and tests, operator qualification and training records, and so forth. If there is need for revalidation, that is also considered and handled accordingly.
Welding is considered as a special process and where required validation and revalidation is done for these special processes and works done. Welding procedures is prepared as per relevant standards. Only qualified welders are allowed to do the special welding jobs. Their practical experiences and skills are considered to assign the job to them. Monitoring or inspection of welding activities is done by competent engineer designated by Section Head. Where required third party inspection and certificates for the same will be maintained. The consumables storage, weld repair will be carried out as per the work instructions approved for the specific projects. XXX utilizes some “special processes” where the result of the process cannot be verified by subsequent monitoring or measurement. The special processes in use and the methods of validation of each are defined in Procedure for Validation of process (PR 026)
Ref: Validation of process (PR 026)
8.5.2 Identification and traceability
Purchased products are identified with its names and unique number used as necessary. The identification is the same as, or is cross-referenced with, the designations used in drawings, specifications, bills of materials, Products list, Purchase orders, etc. Purchased products are identified by marking, labelling, or tagging the products or their packaging, or by identification of the area where the products are held or per-codes (as per our new program). During all stages of production, products are usually identified by work orders and other documents that accompany them through the production cycle. Parts and components may also be identified by labels or tags, or the containers in which they are held. Final products are identified by their name, which is labelled by tags on the products. Projects are identified by their project numbers. When required by contracts, laws and regulations, or voluntary standards traceability is implemented to the extent specified. Traceability may also be implemented for internal reasons, to facilitate corrective action. As required, traceability may apply to materials, components, parts, production processes, environmental conditions, inspection and testing, and personnel responsible for processing and verification of products. The scope of traceability is documented in product manufacturing specifications or the production work order. The documented procedure Identification & traceability (PR 027) defines these methods in detail.
Ref: Identification & traceability (PR 027)
8.5.3 Property belonging to customers or external providers
Materials, tools, moulds & etc. provided by customer for the processing of products are received and inspected, in the event such products fail to meet the inspection criteria, or are not suitable for any other reason, the same shall be reported to customer and records shall be maintained. Storage, handling, and preservation of customer’s materials follow the same procedures that apply to purchase products. Customer’s software, documents, and other intellectual property are protected to the same extend as would internal documents of similar content, unless there are contractual requirements for special measure to protect customer’s intellectual property. When specified in a contract, special handling instructions from customers will take precedent over the company’s standard procedures. Customers are contacted in the event of loss, damage, deterioration, or unsuitability of their products by the relevant engineers. Customer’s vehicles and personnel entering to our yard to collect products and services are managed. Traffic flow is controlled by flagmen. All the loading activities are done under surveillance of safety personnel in order to avoid any damages or loss to the customer’s vehicles and personnel. This activity is defined in greater detail in the Procedure Customers or External Providers property (PR 028)
Ref: Customer or External Providers property (PR 028)
8.5.4 Preservation
Preservation of product by XXX describes in the relevant procedures, the conformity of its product at every stage from receipt of raw materials to delivery to its intended destination. It includes the identification, handling, storage and protection of both the products and the constituents of the products in order to maintain the conformity requirements. The section heads are responsible for product handling and preservation, and that products are adequately protected during production and storage. Where required, storage, and holding areas are controlled by the section that brings in new stock or uses the area. Only products that are properly identified and that have passed required inspections are authorized to enter and leave the store area. Products with limited shelf life are identified with expiration dates. These perishable products are also rotated in the storeroom to ensure that the oldest product is used first. The documented procedure Preservation of products (PR 029) defines the methods for preservation of product.
Ref: Preservation of products (PR 029)
8.5.5 Post-delivery activities
XXX shall ensure that all the post-delivery activities associated with the products and services. In determining the extent of post-delivery activities that are required, the organization shall consider
Statutory and regulatory requirements
The potential undesired consequences associated with its products services
The nature, use and intended lifetime of its products and services
Customer requirements and feedbacks.
For road construction, projects completion and warrantee certificates is given upon completion of the works as per contract requirements. Such warrantee is subject to the defect on the workmanship and materials supplied by XXX to be rectified immediately. All other warrantees are subject to the contracts terms and conditions.
8.5.6 Control of changes
XXX shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. All the documented information’s regarding the changes and results of changes shall be retained by XXX, which shall also contain the details of the person(s) authoring the change and any necessary actions arising from the review. In case any change impacts the product or services, XXX shall notify the customer about the changes either through email or by calling telephonically. Corrective action shall be taken as per the procedure for Corrective Action (PR 006). Assessment of Risk and Opportunity shall be done as per Procedure Risk Assessment (PR 002). Processes are monitored and controlled through variety of approaches, activities and techniques. The system is designed to control:
Information, material and human input into the process;
Technology, tools and equipment used;
Process environment and performance; and
Process output.
Organization structure
Key or essential personnel
Critical providers
Design
Management system
Process change management is defined in the Procedure Management of change. Documents are changed in accordance with procedure Control of documented information.
Ref: Risk Assessment (PR 002); Corrective Action (PR 006) Management of change (PR 021); Control of documented information (PR 001).
8.6 Release of products and services
The release of the products and services shall be as per the planned arrangements and by a competent authority as per procedure of Product Release (PR 030). Where there is a release otherwise it shall be approved by the respective departmental authority or as applicable by the customer requirements.
No
Requirement
Releasing authority
1
Incoming Raw Material
QC / Requester
2
During Production Stages
QC / Process Owner
3
Finished products – Production
QC
4
Finished products – Site
QC/Engineer
5
Project Handover
Project Manager
Documented information (Records) related to the stages of the production process and communications related to the acceptance of the product/service by clients will be maintained. Evidence of conformity to product requirements with acceptance criteria will be maintained with the traceability to the person(s) authorizing the release.
All products are released for delivery only after all specified activities have been satisfactorily completed. Regular tests are carried out to ensure the consistency of quality; Lab verifications, plant trails are done in witness of authorities (MOE or consultant) and conformity of the product are obtained. The designs are certified by Ministry of Environment. Documents are changed in accordance with procedure Control of documented information. All products are released after the approval of the client.
Final site inspection is done by the Consultant and the client. If any deviations found during inspection are corrected on the spot or redone as per consultant or client recommendation. A guarantee period of 400 days or else specified in the contract for the materials and workmanship defect and rectification on immediate basis is defined in all road construction projects. Any rectification requested by client within guarantee period has been verified and carried out on immediate basis.
Ref: Release of Product (PR 030)
8.7 Control of non-conforming outputs
XXX have taken special care to ensure that the outputs which do not conform to the planned arrangement or as per the requirements are identified and controlled to prevent unintended use or delivery. The following methods shall be adopted when dealing with non-conforming outputs can be:
correction
segregation, containment, return or suspension of provision of products and services
informing the customer
obtaining the authorization for acceptance under concession
Non-conforming materials are identified and segregated from conforming materials to prevent unintended use or confusion and mixing with conforming materials. A system is established for identifying, controlling, handling and taking proper action on detected non-conformity. These methods are defined through the procedure for control of non-conforming outputs (PR 005).
Ref: Control of non-conforming output procedure (PR 005).
9 PERFORMANCE EVALUATION
9.1 Monitoring, measurement analysis and evaluation
9.1.1 General
The Integration of the whole measuring and improvement system will cover the required improvement processes needed to demonstrate conformity to product requirements, to ensure conformity of the Quality management system and to continually improve the effectiveness of the Quality management system.
Major processes include:
Sales, production and service
Inspection and testing
Purchasing
Control of non-conforming outputs
Internal auditing
Customer satisfaction
Corrective actions
Data analysis
Legal requirements and compliance
Objective achievement
Operational effectiveness
Performance
The effectiveness of the QMS, including the policy and objectives, is monitored by conducting internal audits, and operational reviews, and is measured by customer satisfaction and key performance indicators. The results from the monitoring and measurement shall be analysed and evaluated by the top management.
9.1.2 Customer satisfaction
Customer satisfaction is measured by collecting and analysing direct customer feedback, and by measuring secondary indicators of customer satisfaction. Customer satisfaction data is used by the top management to identify opportunities and priorities for improvement. The procedure of measuring Customer satisfaction has been established as per Procedure for Customer Satisfaction (PR 031). The process owners/department managers is responsible for developing suitable indicators of customer satisfaction, and for defining methods for collecting and analysing the pertinent information in their areas. Information and data pertaining to customer satisfaction are collected from several sources such as but not limited to:
On-going feedback from customers,
Surveys using customer satisfaction survey form at the completion of each project and orders,
Analysis of trends of customer satisfaction/complaints/safety reports issued by client,
Awards and recognitions,
Repeat customer rates, and market share,
Lost business analysis.
Results of customer satisfaction surveys and the perception of the customers is analysed by the management representative and presented during the management review meetings.
Ref: Customer Satisfaction (PR 031)
9.1.3 Analysis and evaluation
XXX collects, complies and analyses information and data required for evaluating the suitability and effectiveness of the management system and for identifying opportunities for continual improvement. Data and information available in records are compiled and analysed periodically to determine trends in the performance and effectiveness of the management system and to identify opportunities for improvement. The Management Representative is responsible for coordinating these activities and for reporting conclusions and trends to the top management. This is usually done within the framework of management reviews of the QMS. Following categories of information and data are recorded, compiled and analysed:
Quality performance and records of communication from employees.
Conformance to product/service requirements (Objectives)
Status of non-conforming products and areas of re-occurrence.
Action against non-conformances (including audits)
Characteristics and trend of processes and products
Supplier performance recorded in supplier re-Evaluation and evaluated for trends by purchasing dept.
Customer satisfaction levels – recorded in customer satisfaction survey form
Customer complaints –evaluated for trends.
Effectiveness of training – recorded in training record.
Effectiveness of Quality management system – recorded in audit observation sheet and evaluated for trends.
Analysis of shall be conducted as per the Procedure for Analysis of Data (PR 032)
Ref: Analysis of Data (PR 032)
9.2 Internal audit
9.2.1 Planning and scheduling
Management representative establishes an internal audit plan ensuring that every activity and area is audited at least once a year. Selected activities are audited more frequently, depending on their importance, risk and opportunities associated with the process, result performance evaluation of process, results of past audits and quality performance history. The audit criteria, scope, frequency and methods are defined in an internal audit plan which also lists the audit criteria, auditor, auditee, date, and time.
9.2.2 Audit team and preparation for audit
Only suitably trained and qualified personnel independent of the audited activities are assigned to conduct internal audits. A list of trained internal auditors is maintained by the Management Representative in list of trained internal auditors form. Also Management Representative can identify third part auditor to conduct internal audit as necessary. The qualified auditors from different sections may audit different section. Auditors prepare for audits by reviewing applicable standards and procedures, analyzing quality records, and establishing questionnaires and checklists.
Conducting the audit
Auditors seek objective evidence indicating whether the audited activities comply with the requirements of the documented QMS system, and whether the QMS system is effective. The evidence is collected by observing activities, interviewing personnel, and examining records. Findings are recorded on an audit observation sheet. Negative findings are reported as non-conformities and documented using non-compliance report form. Also the third party’s audit report also can be used to monitor and follow up for corrective actions. Audits are conducted in a way that minimizes disruption of the audited activities.
Corrective action and follow up
When nonconforming conditions are identified, the process owner for the affected area or process is requested to propose and implement a corrective action. Implementation and effectiveness of the action are verified by a follow-up audit. The non-compliance report form is used for monitoring and recording the implementation of the corrective actions. Non-compliance reports are closed out by the Management Representative after evaluating effectiveness of action taken. Where a non-compliance is raised against the activities of the Management Representative, only the General Manager is authorized to close out these reports.
Reporting
When the auditing cycle is completed, all nonconformity reports established during the cycle are compiled and analysed, and are presented at the management review meeting by the Management Representative. Internal audits aQMS to verify conformance of the planned arrangements to the requirements of the standards and to that of the Quality management system established.
Ref: Internal audit procedure (PR 004).
9.3 Management review
9.3.1 General
XXX reviews established QMS to ensure its suitability, adequacy and effectiveness which includes assessment for opportunities for improvement and the need for changes to the QMS as per the procedure for management review (PR 003).
Management review meeting is conducted at least once a year. The review committee consists of the following members and is chaired by the General Manager.
General manager (GM)
Assistant manager
Management representative (MR)
Document controller (DC)
All section heads/ managers
HSE
Any other special invitee
Method, duration, responsibility, authority, review input/output for the management review is defined through the procedure (PR003) for management review.
9.3.2 Management review inputs
Inputs for the period of review to management review meeting related to the process performance are prepared by the process owners & QUALITY representatives and the system related performances are provided by the management representative.
9.3.3 Management review outputs
The output of the meeting includes the decisions and actions related to the improvement of the effectiveness of the QMS. The minutes, after approval by the General Manager, is circulated to attendees and management representative for further review and discussion and following up the implementing the actions decided in the meeting. The outputs of the management review meeting shall include decisions and actions related to
Opportunities for improvement
Any need for changes to the QMS
Resource needs
The management representative shall maintain the documented information of the results of the review meeting.
Ref: Management review procedure (PR 003).
10 IMPROVEMENT
10.1 General
XXX has deployed continual improvement principle throughout the entire organization. The improvement effort is driven by goals defined in the policy and objectives. Improvement shall include:
Improving products and services to meet requirements as well as to address the future needs and expectations
Correcting, preventing or reducing undesired effects
Improving the performance and effectiveness of the Quality management system
Improvement opportunities are identified by analysing quality performance data and information. Improvement projects are defined and implemented through the system of corrective actions, and management review actions. Causes of identified non-conformities are investigated and, where appropriate, corrective actions are implemented to ensure that non-conformities do not recur. Corrective actions taken are recorded and are followed up to ensure that they have been properly implemented and that they are effective.
10.2 Non conformity and corrective action
Nonconforming products/ services are identified, documented, evaluated, and prevented from being used or delivered to the customer. Repaired or reworked products are re-inspected. Appropriate actions are taken when product nonconformity is identified after delivery. When appropriate, corrective actions are implemented to prevent recurrence of identified nonconformities.
Identification and documentation
XXX identifies and documents all product/ service nonconformities, regardless of how insignificant they seem to be or how easily they can be repaired or reworked. Product nonconformity records are invaluable for tracking performance and trends, and for identifying areas where corrective actions should be implemented.
During purchasing of materials or services or sub-contracting parts of the service, non-conforming products are segregated and reported to the supplier or sub-contractor for corrective actions.
Nonconforming products/ services are documented using a non-compliance report form. It describes the nonconformity, documents the disposition decision, and records close-out of follow-up activities (re-inspection, concessions, corrective actions, etc.). It is a company policy not to deliver nonconforming products/ services to clients and the responsibility for this rests with the Section heads.
Therefore no segregation/ tagging methods are required. Adherence to specifications including delivery times is of prime importance.
Nonconformity review and disposition:
Review of non-conforming products/ services are carried out with the sole intention of re-working and correcting the non-conformity, after which it is delivered to the customer. Under no circumstances, non-conforming products/ services are delivered intentionally to the customers.
Re-verification of repaired or reworked product:
Reworked products are re-inspected and their conformity with the requirements of the customer confirmed prior to delivery. This may also involve interaction with the client and obtaining their acceptance of the product/ service prior to delivery.
All such actions related to control of nonconforming products/ services are recorded in the relevant project files.
If product nonconformity is detected internally after delivery or use has started, customers are informed and instructed what to do with the product. In situations when the nonconformity may create a safety or other hazard, the product may be recalled. Only the General Manager or his appointed deputy is authorized to make recall decisions. Details of the process are available in control of non-conforming outputs (PR 005)
The need for corrective action is determined on the basis of identified actual non-conformities. Corrective action requests are typically triggered by such events as a failed inspection, customer complaint and/or product return, non-conforming delivery from a supplier, or a system audit finding.
The need for corrective action is determined on the basis of identified actual non-conformities. Corrective action requests are typically triggered by such events as a failed inspection, customer complaint, deviation from work instruction/legal requirements/regulations, non-conforming delivery from a supplier, or a system audit finding. XXX has established a procedure for handling corrective actions as below, details of which are available in (PR 006):
Requirement for corrective actions are documented in a noncompliance report form where the nature of the non-compliance is recorded. The process owner identifies the proposed corrective action and sets reasonable time frames for implementation. After the due date, the management representative reviews the action taken and evaluates the effectiveness of the corrective action. The purpose of the corrective action is to:
Review the nonconformities including the customer complaints
Determining the root causes of the non-conformity
Taking action to eliminate the root cause of the problem to ensure that the non-conformity does not recur
Determining and implementing the action needed
Record the result of the actions taken
Reviewing and recording the effectiveness of the action taken
The management representative maintains records of all the corrective actions initiated analyses and reports trends periodically and during management review meetings.
Ref: Control of non-conforming procedure (PR 005), Corrective actions procedure (PR 006).
10.3 Continual improvement
XXX top management ensures the improvement in effective implementation and performance of the Quality management system by systematically reviewing and updating the QUALITY policy, quality objectives, analysing audit results and other data from monitoring and measurement relevant to quality, environment and safety performance, corrective action and the management review. System performance is evaluated by respective section managers and reported in the management reviews of the QMS. Where the performance falls short of a defined objective, the management review identifies specific improvement actions to reach the objective. When an objective is reached, the management review may set a new, higher objective in this area and specify new improvement actions for reaching it.
In addition to management reviews, process owners identify improvement opportunities continually, based on the feedback from their operations and other activities. Employees are also encouraged to come forward with ideas for improving products, processes, systems, productivity, and working environment. These improvement opportunities are evaluated and prioritized by the engineers and section managers and where appropriate they are implemented. Where additional plans and resources are required, these are discussed in the management reviews and approved sought from the management. Changes arising out of the Continual improvement shall be managed as per the Procedure Management of change (PR 021). The section managers shall collate the continual improvement done in there are and present in the continual improvement plan format as per the procedure for continual improvement (PR016)
API Q1 Specification for QualityManagementSystemRequirements forOrganizationsProviding Products for the Petroleum and Natural Gas Industry
The American Petroleum Institute (API) developed API Spec Q1 10th Edition specifically for Organizations Providing Products for the Petroleum and Natural Gas Industry. It’s one of the most prestigious company-based certifications that your organization can obtain to demonstrate its commitment to a sound quality management system. Furthermore, it allows your organization to meet the global demands of an increasingly competitive environment. For starters, ISO 9001:2015 is the basis for most (if not all) of the industry-specific quality management standards. It’s a flexible international standard that outlines the framework and guiding principles for quality management. Achieving ISO certification allows manufacturers to improve the quality of products or services while simultaneously lowering the cost of quality. On the other hand, API Spec Q1 10th Edition structurally deviates from the standard ISO 9001 series, but the results of a compliant quality management system are still the same. API Spec Q1 builds upon the classic structure of the ISO 9001 series by addressing risk and other QMS elements, but takes a different approach to quality management by bringing risk assessment and risk management into the fold. Additionally, there are some other key differences between ISO 9001 and API Q1, including:
Formalizing employee competency and training
Reinforcing risk assessment and risk management throughout the standard
Contingency planning
Controlling the supply chain
Preventative maintenance
Validation of designs
Change management
API Monogram Licensing Program Requirements Part 1 – General Requirements
The information contained herein details the applicable requirements for Organizations seeking approval to use the API Monogram Mark.
To obtain and retain an API Monogram license, an Organization must have a documented and functioning quality management system in place that meets both the requirements of API Spec Q1® (Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry), and at least one of the applicable API Product Specifications.
Issuance of the license(s) is dependent upon a successful evaluation of the Organization’s quality manual, API Spec Q1 Conformity Matrix and satisfactorily passing an on-site audit of the Organization’s facility and processes by API through its designated auditors. Site audits are required to verify demonstrated capability of the Organization to meet program requirements. Associated audit expenses will be paid by the facility.
Review the requirements stated in API Spec Q1 and the applicable API Product Specification(s) for which your Organization is seeking a license. If your Organization feels that its manufacturing processes meet all the stated quality requirements to obtain an API Monogram License for one or more product specifications, please complete and submit the following:
API Certification Programs Application If your Organization is seeking one or more API Monogram licenses and/or registrations, this form must be completed and signed.
API Monogram License Agreement For each API Product Specification for which you are requesting licensing, a separate License Agreement must be completed and signed. NOTE: The applicant is not allowed to use the API Monogram until all steps in the process have been completed (including satisfactorily passing an on-site audit), the applicant has paid the applicable fees, the applicant has agreed to comply with all terms and conditions of the agreement, and signed the License Agreement.
Licensing Information Form: For each API Product Specification for which you are requesting licensing, a separate Licensing Information Form must be completed. Please submit the appropriate forms as applicable to the Product Specification(s).
Do not submit a Licensing Information Form(s) without a completed API Monogram License Agreement(s) (see Part 4 – API Monogram License Agreement), your API Certification Programs Application, your Quality Manual, API Spec Q1 Conformity Matrix and License Fee. For instructions on where to send your submission, see Part 6 – Fee Schedule.
Introductions
API Q1 has been created to deal with quality management systems for organizations in the petroleum and natural gas sector. It lays out the essential requirements for organizations claiming compliance with API Q1. It can be used by organizations providing products for use in this industry. API Q1 defines “product” as the output intended for customers. Earlier versions only applied to organizations making physical products, providing services for physical products, or involved in manufacturing processes. The aim of API Q1’s requirements is to reduce the chance of errors. While API Q1 might include some aspects of other management systems, it doesn’t cover all their specific requirements. It can be used alongside other industry guidelines. Both internal and external parties, including certification bodies, can use API Q1 to check if an organization meets customer, legal, and its own requirements. API Q1 encourages integrating a process approach when developing, implementing, and improving the effectiveness of a quality management system. This ensures continuous control over requirements and facilitates the overlap of processes. To function effectively, an organization must manage various connected activities. Any activity that turns inputs into outputs can be seen as a process. These process activities involve identifying needs, providing resources, realizing products, sequencing activities, monitoring effectiveness, and making necessary changes or corrections. API Spec Q1 10th Edition addresses the following types of organizations in the petroleum and natural gas industry.
manufacturing
engineering/design
physical product realization activity providers such as those performing:
welding
heat treating
coating/plating
machining
inspection
testing
servicing
physical product-related activity providers such as those performing:
distribution
logistics
software development
The verbal forms used to express the provisions in this document are as follows.
Shall: As used in a standard, “shall” denotes a minimum requirement to conform to the standard. Should: As used in a standard, “should” denotes a recommendation or that which is advised but not required to conform to the standard. May: As used in a standard, “may” denotes a course of action permissible within the limits of a standard. Can: As used in a standard, “can” denotes a statement of possibility or capability
Goal of API QI
The aim is to establish the essential criteria for creating a quality management system that encourages dependability and allows for ongoing enhancements. The focus is on preventing errors, reducing differences, and avoiding inefficiencies. This specification does not aim to suggest that all quality management systems should have the same structure or documentation.
Structure of API Q1: 10th Edition
1.Scope
This section review section 1, scope, of the API Q1 10th edition specification. This specification established the minimum quality management system requirements for organizations that provide products for use in the petroleum and natural gas industry..
2.0 Normative references
The text makes reference to API Q1, and some or all of its content serves as requirements for API Q1. For dated references, only the tenth edition mentioned is applicable. For undated references, the most recent edition (including any addenda) is applicable.
ISO1 9000:2015, Quality management systems—Fundamentals and vocabulary
3.0 Terms, Definition and Abbreviations
3.1 Terms and Definition
For the purpose of API Q1: 10th Edition, the terms and definitions given in ISO 9000 and the following shall apply:
3.1.1 acceptance criteria: Specified limits of acceptability applied to process or product characteristics.
3.1.2 acceptance inspection: Demonstration through monitoring or measurement that the product conforms to specified requirements.
3.1.3 calibration: Process of comparison to a standard of known accuracy, comparison of results against TMMDE (testing, measuring, monitoring, and detection equipment) acceptance criteria, and, if applicable, making needed adjustment.
NOTE Calibration of non-adjustable equipment can be referred to as verification.
3.1.4 compliance: Act of satisfying (verb) or the status of having satisfied (noun) legal requirements.
3.1.5 critical: Deemed by the organization, product specification, or customer to be of significant importance and requiring specific action.
3.1.6 delivery: Point in time at which the agreed transfer of ownership takes place.
3.1.7 design acceptance criteria (DAC): Requirements applied to characteristics or combinations of those characteristics, of materials, products, or components to achieve conformity to the specified design requirements and/or required design performance. NOTE 1 DAC can be equal to MAC. NOTE 2 Required design performance is often stated in technical specifications.
3.1.8 design validation: Process of proving a design by testing to demonstrate that the product conforms to design requirements and performs as intended. NOTE Design validation can include one or more of the following (this is not an all-inclusive list): a) prototype tests, b) functional and/or operational tests, c) tests specified by industry standards and/or regulatory requirements, d) field performance tests and reviews.
3.1.9 design verification: Process of examining design outputs to determine conformity with specified requirements. NOTE Design verification activities can include one or more of the following (this is not an all-inclusive list): a) confirming the accuracy of design results through the performance of alternative calculations, b) review of design output documents resulting from design activities, c) comparing new designs to similar proven designs.
3.1.10 key performance indicator (KPI): Quantifiable measure that an organization uses to gauge or compare performance.
3.1.11 legal requirement: Statutory or regulatory requirements.
3.1.12 management [noun]: A person or group of persons with authority and responsibility for the conduct and control of all or part of an organization. NOTE For some organizations, top management (see ISO 9000) and management are the same.
3.1.13 manufacturing acceptance criteria (MAC): Requirements applied to characteristics or combinations of those characteristics, of materials, products, or components to achieve conformity to DAC and other product manufacturing requirements. NOTE 1 MAC can be equal to DAC. NOTE 2 For services, product realization can be substituted for product manufacturing.
3.1.14 outsource [outsourced activity]: Function or process that is performed by an external supplier on behalf of the organization.
3.1.15 preventive maintenance: Systematic servicing of equipment, machines and/or facilities for the purpose of maintaining a satisfactory operating condition.
3.1.16 procedure: Organization’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements. NOTE 1 This definition was previously identified as a “control feature” in earlier editions of this specification. NOTE 2 A procedure can be in many forms, e.g. work instructions, flow diagrams and manuals.
3.1.17 product: Output of an organization intended to be provided to a customer. NOTE As used in this document, the term ‘product’ can include, but is not limited to, hardware, software, production activities, or product related activities such as: servicing, storage, distribution, and logistics.
3.1.18 product realization: Set of interrelated or interacting activities (processes) necessary to provide product.
3.1.19 remote assessment: Assessment conducted by person(s) not physically present at the location being assessed.
3.1.20 risk: A situation or circumstance that has both a probability of occurring and a potentially negative consequence.
3.1.21 servicing: Maintenance, adjustment, and/or repair performed on a product after delivery and/or on-site installation.
3.1.22 supply chain: Suppliers and associated sub-supplier(s) required for product realization.
3.2 Abbreviations
For the purposes of this specification, the following abbreviations shall apply.
DAC: design acceptance criteria ITP: inspection test plan KPI: key performance indicator MAC: manufacturing acceptance criteria MOC: management of change MPS: manufacturing process specification PCP: process control plan QAP: quality activity plan QMS: quality management system QP: quality plan TMMDE: testing, measuring, monitoring, and detection equipment
4 Quality Management System Requirements
4.1 Quality Management System
4.1.1 General
The organization must always plan, set up, record, put into action, and keep up a quality management system in line with this specification’s demands for the product within the organization’s defined scope. Additionally, the organization needs to assess and enhance the effectiveness of this quality management system.
4.1.2 Quality Policy
The organization’s commitment to quality must be clearly outlined, documented, reviewed, and endorsed by top management. The quality policy should:
Align with the organization’s goals and guide its strategic path,
Serve as a foundation for setting quality objectives,
Be effectively communicated, understood, put into practice, and upheld within the organization,
Be accessible to relevant stakeholders as determined by the organization, and
Include a pledge to meet requirements and consistently enhance the efficiency of the quality management system.
4.1.3 Quality Objectives
Quality objectives, including those necessary to fulfill product and customer needs, must be set at appropriate functions and levels within the organization by management, with approval from top management. These objectives should be measurable, communicated, and aligned with the quality policy.
4.1.4 Planning the Quality Management System
4.1.4.1 General
The planning of the quality management system must be conducted. While planning, the organization must specify the scope of the quality management system, including the products covered and any limitations or exclusions. The organization must recognize external and internal factors relevant to the organization’s long-term objectives and goals. Identify relevant stakeholders and their requirements for the quality management system. The organization must establish the sequence and interaction between the processes of the quality management system. The organization must determine and oversee the criteria and methods necessary for the efficient operation and control of quality management system processes. The organization must set quality objectives, detailing actions, resources, responsibilities, timeframes, and methods for monitoring and evaluation. It must address identified risks. It addresses opportunities for improvement. It must identify key personnel involved in the quality management system.
4.1.4.2 Exclusions
If an organization carries out activities covered by API Q1, whether internally or through outsourcing, it cannot claim exclusion of those activities. Excluding certain activities should not impact the organization’s capability or obligation to deliver products that meet customer and legal standards. If any exclusions are made, the reasoning behind them must be documented. When an organization performs activities addressed by this specification, no claims to exclusion of those activities are permitted. When exclusions are permitted, they are limited to the following sections:
API Q1 Clauses
Sections
5.4
Design
5.6.4
Validation of Processes
5.6.7
Externally Owned Property
5.8
Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)
4.1.5 Communication
4.1.5.1 Internal
The organization must set up internal communication processes. These processes should involve communicating, at appropriate levels and functions within the organization the significance of meeting customer, legal, and other relevant requirements; and the outcomes of data analysis.
4.1.5.2 External Communications
The organization must create and put into action a procedure for communicating with external entities, including customers. This process should cover:
Handling inquiries, contracts, or order processing, and any modifications;
Understanding and meeting requirements during contract execution and product creation;
Providing product details, including any non-conformities;
Addressing feedback and customer complaints;
Sharing quality plans and any subsequent adjustments; and
Communicating changes and associated risks.
4.2 Management Responsibility
4.2.1 General
Top management must show leadership and dedication to setting up, implementing, maintaining, and enhancing the quality management system by endorsing the creation of quality objectives at relevant functions and levels within the organization. Top management must allocate necessary resources for the quality management system. These resources can encompass human resources, specialized skills, organizational infrastructure, financial assets, and technology. Top management must involving and backing personnel in implementing and sustaining the quality management system and designating responsibilities and authorities to ensure that processes achieve intended outcomes.
4.2.2 Responsibility and Authority
The duties, powers, and responsibilities of personnel within the organization’s quality management system must be clearly outlined, documented, and communicated across the organization.
4.2.3 Management Representative
Top management must appoint and retain a member of the organization’s management who, regardless of other duties, holds responsibility and authority that involves guaranteeing compliance of the quality management system with the requirements of this specification. Establishing, implementing, and maintaining processes necessary for the quality management system. Providing reports to top management regarding the performance of the quality management system and any areas requiring improvement. Initiating actions to rectify nonconformities. Ensuring the promotion of awareness of customer requirements throughout the organization.
4.3 Organization Capability
4.3.1 Resources and Knowledge
4.3.1.1 Resources
The organization must identify and allocate the necessary resources to implement, maintain, and enhance the effectiveness of the quality management system.
4.3.1.2 Knowledge
The organization must identify the expertise required to sustain the operation of its processes and ensure the consistent conformity of its products. This knowledge should be preserved and accessible as per the organization’s discretion.
Note: Knowledge may be gained through experience, study, training, lessons learned, best practices, or other means.
4.3.2 Human Resources
4.3.2.1 Personnel Competence
Personnel involved in the organization’s quality management system responsibilities must be competent. The organization should uphold a documented procedure concerning personnel competence. This procedure should cover:
Identifying and documenting required competencies.
Identifying necessary education, training, experience, or other actions to attain competence.
Evaluating the effectiveness of measures taken to acquire competencies.
Establishing criteria and methods for assessing, maintaining, and re-assessing competencies.
Designating personnel responsible for assessing competency.
Records of personnel competence must be retained.
4.3.2.2 Training
The organization must establish and uphold a training procedure. The organization must identifying the content and frequency of necessary training. The organization must provide training on the quality management system. It must provide job-specific training, including raising awareness among personnel about the significance of their tasks and their contribution to achieving the organization’s quality objectives. It must offer customer-specified or customer-provided training when necessary. It must assess the effectiveness of the training. It must document the required training records. Records of personnel training must be retained.
4.3.3 Work Environment
The organization must identify, furnish, oversee, and sustain the work environment necessary to ensure product conformity. This work environment encompasses:
Facilities, workspaces, and related utilities;
Process equipment, including both hardware and software;
Ancillary services (e.g., transportation, communication, information systems); and
Work conditions, covering physical, environmental, or other influencing factors.
4.4 Documentation Requirements
4.4.1 General
The documentation of the quality management system should consist of:
An outline of the quality management system’s scope, defining the products covered and providing reasons for any exclusions;
Declarations of the quality policy and quality objectives;
Listing legal and other relevant requirements that the organization must adhere to in order to ensure product conformity;
Explanation of how the quality management system fulfills each requirement outlined in this specification;
Identification of processes requiring validation; and
Procedures, documents, and records necessary for planning, executing, and controlling processes, as well as for meeting specified requirements.
Note: Traditionally, some of this documentation has been incorporated into a quality manual, but it can take various formats and may be presented as either a single document or multiple documents.
4.4.2 Procedures
Every procedure mandated by this specification must outline the organization’s approach to conducting an activity. These procedures must be documented, put into action, and upheld to ensure ongoing appropriateness.
Note: One procedure can encompass the requirements for one or more documented procedures. Likewise, multiple procedures can fulfill any requirement for a documented procedure.
4.4.3 Control of Internal Documents
The organization must maintain a documented procedure for managing internal documents required by the quality management system and this specification, including revisions, translations, and updates. This procedure must cover:
Responsibilities for approval and re-approval;
Review and approval for adequacy before issuance and use;
Periodic reviews for ongoing suitability and necessary revisions;
Identification of changes and current revision status;
Ensuring legibility and proper identification of documents;
Availability of documents at locations where activities are carried out.
Obsolete documents must be removed from all points of distribution or use, or appropriately marked to prevent unintended usage if retained for any purpose. Procedures, work instructions, and forms mandated by the quality management system must be controlled.
4.4.4 Control and Use of External Documents
The organization must uphold a documented procedure for managing documents from external sources necessary for product realization and use, including API or other external specifications. This procedure should cover:
Identifying and documenting the necessary external documents;
Managing access to and distribution of required documents, including relevant versions;
Incorporating requirements from external documents into product realization and any affected processes;
Establishing a process for identifying changes to required documents, such as addenda, errata, and updates;
Assessing the impact of changes;
Incorporating relevant changes.
Note: Normative references specified within API product or other external specifications, essential during product realization, may also be regarded as external documents.
4.5 Control of Records
Records, including those originating from outsourced activities, must be established and managed to demonstrate conformity to requirements and the organization’s quality management system. The organization must maintain a documented procedure outlining the controls and responsibilities for managing records. This procedure should cover:
Identifying records;
Collecting records;
Ensuring legibility of records;
Correcting records when necessary;
Storing records securely;
Safeguarding records from unintended alteration, damage, or loss;
Retrieving records as needed;
Determining retention periods;
Disposing of records when appropriate.
Records must be retained for a minimum of ten years or as required by customer, legal, and other relevant requirements, whichever is longer.
5 Product Realization
5.1 Contract Review 5.1.1 General
The organization must uphold a documented procedure for reviewing requirements related to product provision. This procedure should cover determining requirements, reviewing requirements, and making changes to requirements.
5.1.2 Determination of Requirements
The organization must identify requirements outlined by the customer, legal regulations, and any other applicable criteria, as well as requirements not explicitly mentioned by the customer but deemed necessary by the organization for providing the product. In cases where the customer hasn’t provided documented requirements, the organization must confirm these requirements and keep records of the confirmation process.
5.1.3 Review of Requirements
The organization must assess the requirements regarding product provision. This assessment must occur before the organization commits to delivering the product to the customer. It should confirm that requirements are identified and documented, resolve any discrepancies from previously identified requirements, and ensure the organization can meet the documented requirements. If contract requirements change, the organization must update relevant documents and inform relevant personnel of the changes. Records of the review outcomes, including any resulting actions, must be kept.
5.2 Planning
The organization must identify and strategize the processes and documents necessary for product realization. During planning, the organization should address the following:
Management of required resources and work environment.
Product and customer-specified requirements.
Legal and other applicable requirements.
Design specifications.
Contingency planning.
Specific verification, validation, monitoring, measurement, inspection, and testing activities for the product, along with acceptance criteria.
Management of change (MOC).
Records needed to demonstrate that product realization aligns with requirements.
The outcome of this planning must be documented and regularly updated to reflect changes. These plans should be organized in a structure suitable for the organization’s operational.
5.3 Risk Management 5.3.1 General
The organization must maintain a documented procedure for identifying and managing risks related to product delivery and quality. The procedure should cover:
Techniques for identifying and assessing risks.
The use of risk assessment tools and their application.
Criteria for determining the severity of risks, including potential consequences of product failure.
Actions for mitigating risks.
Assessing the remaining risks.
Contingency planning, including when a contingency plan is necessary based on the assessment of remaining risks.
Risk assessment may involve evaluating severity, probability of occurrence, and detectability. It can also be linked to corrective action.
5.3.2 Risk Assessment 5.3.2.1 Product Delivery
Risk assessment related to product delivery must consider factors such as facility and equipment availability, including maintenance, as well as supplier delivery performance and material availability/supply.
5.3.2.2 Product Quality
Risk assessment concerning product quality must encompass factors such as the delivery of nonconforming products and the availability of competent personnel.
5.3.2.3 Changes Impacting Product Quality
If any of the listed alterations have the potential to adversely affect product quality, a risk assessment concerning product quality must be conducted:
Changes in the organizational structure;
Changes in key personnel;
Alterations in the supply chain of critical products, components, or activities;
Modifications to the management system scope or procedures; and
Adjustments to the organization’s capacity to execute the processes needed for product realization.
Note: Changes may originate internally or externally.
5.3.3 Contingency Planning
If the organization deems it necessary to have a contingency plan due to assessed risks, the plan must, at a minimum, outline actions needed to mitigate the impact of disruptive incidents, assign responsibilities and authorities, and establish controls for internal and external communication. These contingency plans must be documented, communicated to relevant personnel, and revised as necessary.
5.3.4 Records
Records documenting risk assessment and management, including the actions implemented, must be retained.
5.4 Design 5.4.1 General
If the organization is accountable for product design, it must adhere to the requirements outlined in section 5.4. However, these design requirements do not apply if the product is involved in production activities, servicing, storage, distribution, or logistics.
Note: In previous editions, the term “design” was denoted as “design and development.”
5.4.2 Design Planning
The organization must uphold a documented procedure for planning and overseeing the design process. This procedure should cover:
a) Planning, including updates to the plan(s), used for design. b) Various stages of the design process. c) Allocation of resources, responsibilities, authorities, and their interactions. d) Review, verification, and validation activities required for each design stage. e) Requirements for a final review of the design. f) Criteria and approval process for design changes.
When design activities are outsourced or carried out at different locations within the organization, the procedure should outline controls to ensure compliance with design requirements. If design activities are outsourced, the organization remains accountable for design and must ensure that the supplier meets outsourcing requirements.
Note: Design review, verification, and validation serve distinct purposes but can be conducted and recorded separately or in any combination, as appropriate for the product and the organization.
5.4.3 Design Inputs
Inputs must be identified and assessed for adequacy, completeness, clarity, and absence of conflicts. Any identified issues must be resolved. Inputs may encompass functional and technical requirements, along with the following, if applicable:
Customer-specified requirements;
Requirements from external sources, including API product specifications;
Environmental and operational conditions;
Documentation of methodologies, assumptions, and formulas; e) Historical performance and other data from similar previous designs;
Legal requirements; and
Potential consequences of product failure, as required by legal mandates, industry standards, customer specifications, or deemed necessary by the organization.
Records of design inputs must be retained.
5.4.4 Design Outputs
The documentation of outputs must enable verification against the requirements outlined in the design inputs. These outputs should:
Meet the requirements specified in the design inputs.
Provide information for purchasing, production, inspection, testing, and servicing, as applicable.
Identify or reference design acceptance criteria (DAC).
Include identification of, or reference to, products, components, and/or activities considered critical to the design.
Incorporate the results of relevant calculations.
Specify the characteristics of the product essential for its intended purpose and safe and proper function.
Records of design outputs must be retained.
Note: Identification of criticality of products, components, and/or activities may be managed separately from the design process.
5.4.5 Design Review
At appropriate stages, evaluations must be conducted to assess the suitability, adequacy, and effectiveness of the outcomes of design stages in meeting specified requirements, and to identify any issues and recommend required actions. These reviews must involve representatives from relevant functions associated with the design stages under review. Records of the review outcomes and any subsequent actions must be retained.
5.4.6 Design Verification and Final Review
To confirm that the design outputs meet the design input requirements, design verification and a final review must be carried out and documented according to the organization’s procedure. Records of design verification, any required actions, and the final review must be preserved.
5.4.7 Design Validation and Approval
The organization’s procedure must include conducting design validation to ensure that the resulting product can fulfill the specified requirements. Whenever feasible, validation must be concluded before product delivery. After validation, the finalized design must be approved by competent individuals other than those who developed the design. Records of design validation, approval, and any required actions must be retained.
5.4.8 Design Changes
Design changes must be identified and subjected to review, verification, and validation as necessary before being approved for implementation. The review of design changes must assess their impact on the product and its component parts at relevant stages of product realization, including already delivered products. Additionally, the review must evaluate whether customer notification is necessary if the changes adversely affect the specified performance capability of the product. All design changes, including modifications to design documents, must adhere to the organization’s procedure. Records of design changes, reviews, and any required actions must be documented and maintained.
5.5 Purchasing 5.5.1 Purchasing Control 5.5.1.1 Procedure
The organization must maintain a documented procedure for purchasing products, components, and/or activities necessary for product realization. This procedure should cover:
Using identified risks to determine the initial assessment method of the supplier’s capability for critical purchases.
Determining the type and extent of control applied to the supply chain for critical products, components, or activities. Note: Additional requirements for outsourced activities are specified in section 5.5.1.7.
Establishing criteria, scope, frequency, and methods for re-evaluating suppliers.
Identifying approved suppliers and defining the scope of approval.
Identifying customer-specified suppliers and suppliers limited by proprietary and/or legal requirements when section 5.5.1.3 applies.
For critical products, components, or activities, the initial evaluation of suppliers who have not been previously approved must consider the scope of supply and be specific to each supplier. This evaluation must include:
Verifying the implementation of the supplier’s quality management system and its conformity to the organization’s specified quality system requirements for suppliers.
Verifying the type and extent of control applied by the supplier internally and throughout their supply chain to meet the organization’s requirements.
Assessing the supplier’s capability to meet the organization’s specified requirements. This can be done through one or more of the following methods based on identified risks:
Conducting an on-site assessment to verify that relevant product realization processes are performed by process controls and effectively achieve conformity to requirements.
Conducting a remote assessment to verify that relevant product realization processes are performed using process controls and effectively achieve conformity to requirements.
Performing inspection, testing, or verification of relevant characteristics of received products.
For suppliers of critical purchases with high-risk severity, identified by the organization for which an on-site assessment is not conducted, the evaluation of the supplier’s capability must include a remote assessment and inspection, testing, or verification. When conducting a remote assessment, it must include verification of objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology. Additionally, any additions to a supplier’s scope of approval or change from an approved site to a new site of supply must also undergo evaluation as per the requirements outlined in this section.
For critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements that restrict the application of Initial Supplier Evaluation, the initial evaluation process shall involve verifying the implementation of the supplier’s quality management system and its conformity to the quality system requirements specified by the organization and/or the customer’s requirements and identifying how the supplied product, component, or activity conforms to specified requirements. The scope of approval for customer-specified suppliers shall be restricted to the relevant customer contract in cases where an assessment has not been conducted.
For the procurement of noncritical products, components, or activities that influence product realization or the final product, the organization’s criteria for evaluating suppliers must either meet the requirements of Initial Supplier Evaluation—Critical Purchases or fulfill one or more of the following:
Verifying that the supplier’s quality management system aligns with the quality system requirements specified for suppliers by the organization.
Assessing the supplier’s ability to meet the organization’s purchasing requirements.
Evaluating the product or component upon delivery, or activity upon completion.
5.5.1.5 Supplier Reevaluation
For suppliers previously approved for products, components, or activities, the organization must determine the frequency of supplier reevaluation based on identified risk and supplier quality performance. For the reevaluation of suppliers providing critical products, components, or activities, the provisions of section 5.5.1.2 shall be followed. For the reevaluation of suppliers providing critical products, components, or activities specified by the customer or restricted by proprietary and/or legal requirements, the requirements outlined in section 5.5.1.3 shall be adhered to. For the reevaluation of suppliers providing non-critical products, components, or activities that affect product realization or the final product, the guidelines detailed in section 5.5.1.4 shall be followed.
5.5.1.6 Records
Records of evaluation results, comprising objective evidence and any subsequent actions, must be retained. Additionally, records of approved suppliers, customer-specified suppliers, and suppliers bound by proprietary and/or legal requirements must be kept.
5.5.1.7 Outsourcing
When an organization decides to delegate a process or activity from its quality management system to an external supplier, it must ensure that the supplier meets the relevant requirements of the organization’s quality management system. If an organization opts to outsource a process or activity related to product realization, it must retain accountability for ensuring that the product meets specified requirements, which may include relevant API or other external specifications. Documentation of outsourced activities must be retained, including evidence of conformity.
5.5.2 Purchasing Information
The organization must verify the adequacy of specified purchasing information before transmitting it to the supplier. Purchasing information provided to the supplier must be documented and clearly outline the product, component, or activity to be procured. This documentation should include, as appropriate:
a) Acceptance criteria;
b) Requirements for approving the supplier’s procedures, processes, and equipment;
c) Relevant technical data such as specifications, drawings, process requirements, inspection instructions, and traceability requirements;
d) Criteria for qualifying the supplier’s personnel;
e) Requirements related to the quality management system;
f) Conditions for approving product release; and
g) If either the organization or its customer intends to conduct verification at the supplier’s premises, the intended verification arrangements.
Note: Applicable specifications may encompass or derive from customer requirements, API specifications, design output, and/or industry standards.
5.5.3 Verification of Purchased Products, Components or Activities 5.5.3.1 General
The organization must uphold a documented procedure outlining the verification needed to ascertain whether purchased products, components, or activities adhere to specified purchase requirements.
5.5.3.2 Critical Purchases
For critical products, components, or activities, the organization’s verification procedure should cover:
Reviewing the required documentation provided by the supplier;
Ensuring that the correct versions were utilized when specifying specifications, drawings, process requirements, inspection instructions, traceability requirements, and other relevant technical data as outlined in section 5.5.2 item c;
Defining the inspection, testing, and/or verification requirements, including methods, frequency, and the responsible party. The organization should determine these aspects based on identified risks and supplier quality performance.
5.5.3.3 Noncritical Purchases
The organization’s documented procedure must verify noncritical products, components, or activities.
5.5.3.4 Records
Documentation of verification activities and evidence demonstrating conformity to specified requirements must be retained.
5.6 Control of Product Realization 5.6.1 General
The organization must uphold a documented procedure outlining controls related to product realization. This procedure should cover:
Establishing and applying manufacturing acceptance criteria (MAC);
Identifying and documenting critical processes involved in product realization;
Executing the quality plan, if applicable;
Ensuring compliance with design requirements and associated modifications, if applicable;
Utilizing and ensuring the availability of product realization equipment and TMMDE (unless excluded);
Following relevant work instructions;
Employing process control documents;
Maintaining identification and traceability requirements throughout the product realization process;
Executing monitoring and measurement activities.
5.6.2 Quality Plan
When stipulated by contract, the organization must create a quality plan delineating the processes of the quality management system, including product realization, and the resources allocated to a product. This plan should cover the following minimum aspects:
Description of the product or the quality plan’s scope;
Required processes and documentation, encompassing necessary inspections, tests, and record-keeping to ensure compliance with requirements;
Identification of outsourced activities and references to their management;
Identification of each procedure, specification, or document referenced or utilized in each activity;
Specification of the required hold points, witnessing, monitoring, and document review stages.
The quality plan, along with any modifications, must be documented and endorsed by the organization. Additionally, the quality plan and its revisions should be communicated to the customer.
Note: A quality plan may consist of one or more documents and may be known by various terms, such as product quality plan (PQP), inspection and test plan (ITP), manufacturing process specification (MPS), process control plan (PCP), or quality activity plan (QAP).
5.6.3 Process Control Documents
The organization is required to document process controls, which must encompass or make reference to Criteria for verifying compliance with relevant quality plans, API product specifications, customer requirements, and/or other pertinent product standards/codes; Instructions and criteria for processes, tests, inspections, and; When relevant, points designated for the customer’s inspection hold, witnessing, monitoring, and document review.
Note: Process controls may take the form of routings, travelers, checklists, process sheets, or similar controls, and may be electronic or hard copy.
5.6.4 Validation of Processes
The organization is obligated to validate processes in cases where the resulting output cannot be verified through subsequent monitoring or measurement, leading to the detection of deficiencies after product delivery or during its usage. Validation must demonstrate these processes’ capability to achieve planned outcomes. Process validation shall adhere to either of the following:
If a product specification specifies particular processes necessitating validation, only those specified processes shall require validation for the relevant product. (Note: The organization may, at its discretion, opt to validate additional processes beyond those outlined in a product specification.)
If there is no applicable product specification or the specification does not identify processes requiring validation, processes necessitating validation for the product, if applicable, shall include, at a minimum: nondestructive examination (NDE)/nondestructive test (NDT), welding, heat treating, and coating and plating (when deemed critical to product performance by the product specification or the organization).
The organization must maintain a documented procedure for process validation, detailing the review and approval methods. This procedure should cover required equipment; personnel qualification; specific methods, including defined operating parameters; identification of process acceptance criteria; record-keeping requirements; and revalidation criteria. In cases where the organization outsources a process requiring validation, it must retain evidence confirming compliance with the stipulations outlined in section 5.6.4.
5.6.5 Identification and Traceability
The organization is responsible for establishing and preserving identification throughout product realization, encompassing relevant delivery and post-delivery activities. This entails acknowledging traceability requirements outlined by the organization, the customer, and/or pertinent product specifications. The organization must uphold a documented procedure for identification and traceability while the product remains within its control, covering the following:
Methods employed for identification.
Necessary information for traceability, if mandated.
Criteria for maintaining and/or reinstating identification and/or traceability.
Measures to rectify instances of lost identification and/or traceability.
Records documenting traceability must be retained. Please note that “product” may encompass components or raw materials.
5.6.6 Inspection/Test Status
The organization is required to uphold a documented procedure for maintaining the identification of inspection and/or test status throughout product realization, clearly indicating whether the product conforms or exhibits nonconformity.
5.6.7 Externally Owned Property
The organization must uphold a documented procedure for managing externally owned property, including customer property, incorporated into the product while under the organization’s control. This property encompasses intellectual property and non-publicly available data. The procedure should cover identification, verification, safeguarding, preservation, maintenance, and reporting loss, damage, or unsuitability for use to the external owner. Records concerning the control and disposition of externally owned property must be retained.
5.6.8 Preservation of Product
The organization must uphold a documented procedure outlining the approaches employed to maintain the integrity of the product and its component parts during product realization and delivery. This procedure should cover identification and traceability marking, storage procedures (including designated storage areas or stock rooms), periodic condition assessments as specified by the organization, transportation, handling, packaging, and protection. Records of assessment results must be retained.
5.6.9 Inspection, Testing, and Verification 5.6.9.1 General
The organization must maintain a documented procedure for inspecting, testing, and/or verifying the product to ensure that requirements have been met. This procedure should cover:
Methods and application of in-process inspection, testing, and/or verification.
Methods and application of final inspection, testing, and/or verification.
Creation and retention of records.
It’s important to note that in-process and final inspection may be combined into one or more activities, and certain product characteristics may necessitate final inspection/verification during product realization.
5.6.9.2 In-process Inspection, Testing, and Verification
The organization must conduct inspections, tests, and/or verifications of products at predetermined stages as specified by the quality plan, process control documents, and/or documented procedures. Evidence demonstrating conformity with the acceptance criteria must be retained.
5.6.9.3 Final Inspection, Testing, and Verification
The organization must conduct final inspection, testing, and/or verification of the product in accordance with the quality plan, process control documents, and/or documented procedures to ascertain and document conformity of the completed product with the specified requirements. Unless conducted by an automated system, individuals other than those involved in or directly overseeing the product realization process shall carry out final acceptance inspection at scheduled stages of the product realization process.
5.6.9.4 Records
Records documenting all necessary inspection, testing, verification, and final acceptance activities must be preserved.
5.6.10 Preventive Maintenance
The organization must uphold a documented procedure for conducting preventive maintenance on equipment utilized for product realization. This procedure should outline the equipment types subject to maintenance, the frequency of maintenance tasks, and the individuals responsible for carrying them out. Records detailing preventive maintenance activities must be retained.
Note: Preventive maintenance protocols can be devised based on various factors such as risk assessment, system reliability, usage patterns, historical data, industry best practices, applicable regulations, manufacturer recommendations, or other relevant criteria.
5.7 Product Release
The organization must retain a documented procedure concerning the release of products to customers. Product release should not occur until all planned arrangements have been satisfactorily fulfilled. Only products that conform to requirements or have been authorized under concession shall be released by the organization. Records must be kept to facilitate the identification of the individual responsible for authorizing product release.
5.8 Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)
5.8.1 General
The organization must establish the testing, measuring, monitoring, and detection requirements necessary to demonstrate conformity to specified standards. This includes the necessary Test, Measurement, Monitoring, and Detection Equipment (TMMDE). TMMDE, whether owned and maintained by the organization, owned by employees, or obtained from external sources such as third-party vendors, proprietary sources, or customers, must be controlled. Calibration of TMMDE must occur at specified intervals, with documentation of the date of first use when the calibration interval is determined based on this date.
5.8.2 Procedure
The organization must uphold a documented procedure for controlling Test, Measurement, Monitoring, and Detection Equipment (TMMDE). This procedure must encompass specific equipment types and include:
Unique identification;
Calibration status;
Traceability to international or national measurement standards. If such standards are absent, the basis for calibration must be recorded;
Calibration method and acceptance criteria;
Calibration frequency and the commencement of calibration intervals;
Documentation of calibration measurements before and after adjustments, known respectively as ‘as-found’ and ‘as-left’ measurements. If no adjustments are made, ‘as-found’ and ‘as-left’ measurements are the same;
Measures to prevent unintended use of TMMDE identified as out-of-calibration, beyond calibration intervals, or out-of-service;
Assessment of the validity of previous measurements and actions to be taken on the TMMDE and product if TMMDE is found to be out of calibration, including maintaining records and evidence of customer notification if suspect product has been shipped;
Utilization of third-party, proprietary, employee-owned, and customer-owned TMMDE;
Maintenance; and
Suitability for planned monitoring and measurement activities.
5.8.3 Equipment
TMMDE identified in 5.8.1 must adhere to the following:
a) Undergo calibration;
b) Have its calibration status identifiable by the user before and during use;
c) Be safeguarded from adjustments or modifications that could invalidate the measurement result or calibration status;
d) Be protected from damage and deterioration during handling, maintenance, and storage; and
e) Be utilized under environmental conditions suitable for the calibrations, inspections, measurements, and tests being performed.
When utilized in testing, monitoring, measurement, or detection to meet specified requirements, the suitability of computer software to fulfill the intended application must be confirmed before initial use and reconfirmed as necessary.
5.8.4 TMMDE Equipment from Other Sources
When utilizing TMMDE that is third-party, proprietary, or customer-owned, the organization must ensure the equipment is calibrated before use. If constrained by customer, contract, or licensing agreement limitations, the requirements outlined in 5.8.2, Item c), 5.8.2, Item d), 5.8.2, Item e), 5.8.2, Item f), 5.8.2, Item j), and 5.8.2, Item k) shall not be applicable.
5.8.5 Records
The organization is required to uphold a registry documenting the TMMDE outlined in 5.8.1, with each piece of equipment assigned a unique identification. Furthermore, the results of calibration as per 5.8.2 must be documented and retained. In cases where calibration of third-party, proprietary, and customer-owned TMMDE is constrained by customer, contractual, or licensing agreements, the organization must uphold records detailing the imposed limitations.
5.9 Control of Nonconforming Product 5.9.1 Procedure 5.9.1.1 General
The organization must uphold a documented procedure that outlines controls, along with the corresponding responsibilities and authorities, for managing nonconforming products throughout product realization and post-delivery.
5.9.1.2 Nonconforming Product During Product Realization
The procedure for handling a nonconforming product discovered during product realization must encompass guidelines for product identification and control to avoid unintended use or delivery, addressing the identified nonconformity, implementing measures to prevent its initial intended use or delivery, and obtaining authorization for its use, release, or acceptance under concession from the appropriate authority and, if necessary, from the customer.
5.9.1.3 Nonconforming Product After Delivery
The procedure for handling a nonconforming product discovered during product realization must encompass guidelines for product identification and control to avoid unintended use or delivery, addressing the identified nonconformity, implementing measures to prevent its initial intended use or delivery, and obtaining authorization for its use, release, or acceptance under concession from the appropriate authority and, if necessary, from the customer.
5.9.2 Nonconforming Product
The organization shall manage nonconforming products by executing one or more of the following actions:
a) Conducting repair or rework followed by subsequent inspection to ensure compliance with specified requirements;
b) Re-grading for alternative applications;
c) Releasing under concession; and/or
d) Rejecting or scrapping the product.
5.9.3 Release of Nonconforming Product Under Concession
Nonconforming products that do not meet manufacturing acceptance criteria (MAC) may be released under concession if authorized by the organization’s relevant authority, given that:
a) The products still meet the applicable design acceptance criteria (DAC) and customer criteria;
b) It is determined that the violated MAC is unnecessary to meet the applicable DAC and/or customer criteria; or
c) The DAC has been modified, and the affected products comply with the revised DAC and associated MAC requirements. If the DAC was previously agreed upon with the customer, any changes to the DAC must be authorized by the customer.
The organization is not permitted to release products that do not conform to DAC or contract requirements without authorization from the customer.
5.9.4 Customer Notification of Nonconforming Product
The organization is required to inform customers of any delivered product that does not meet the agreed design acceptance criteria (DAC) or contractual requirements. Records of such notifications must be maintained by the organization.
5.9.5 Records
Records documenting nonconformities must be retained, encompassing details of the nonconformity, actions taken thereafter including any concessions secured, the reasoning behind approving product release under concession, and the pertinent authority involved.
5.10 Management of Change (MOC) 5.10.1 General
The organization is required to uphold a documented procedure for Management of Change (MOC) to ensure the integrity of the quality management system amid changes. This MOC procedure shall cover:
a) Description and justification of the change;
b) Allocation and availability of resources, including personnel;
c) Assessment of potential risks associated with the change;
d) Review, approval, and execution of the change;
e) Notifications regarding the change;
f) Verification of the completion of MOC activities and assessment of their impact on the Quality Management System (QMS).
5.10.2 MOC Application
The organization must utilize Management of Change (MOC) for alterations that could adversely affect the product’s quality.
5.10.3 MOC Notification
The organization must inform pertinent internal staff about the change and its associated risks. If mandated by contract, the organization must also notify the customer of the change and its associated risks. Documentation of MOC notifications is required.
5.10.4 Records
Records of MOC activities must be maintained
6 Quality Management System Monitoring, Measurement, Analysis, and Improvement
6.1 General
The organization is responsible for planning and executing the processes for monitoring, measuring, analyzing, and improving the quality management system to ensure compliance with the requirements of this specification and to enhance the system’s effectiveness over time. This includes identifying appropriate methods, including data analysis techniques, and determining their utilization extent.
6.2 Monitoring, Measuring, and Improving 6.2.1 Customer Satisfaction
The organization must have a documented procedure for monitoring customer satisfaction, detailing the frequency and methods for assessing it, along with key performance indicators. Records of customer satisfaction data must be retained.
6.2.2 Internal Audit 6.2.2.1 General
The organization must conduct internal audits to assess the implementation, maintenance, and conformity of the quality management system to both this specification and the organization’s internal quality management system requirements. A documented procedure outlining responsibilities for planning, conducting, and documenting internal audits must be maintained. This procedure should identify audit criteria, scope, frequency, and methods, considering previous audit results, process criticality, and changes to the quality management system. All processes within the quality management system must undergo audits at least once every 12 months, with audits staggered throughout the year if necessary. Critical processes related to product realization must be audited to ensure compliance with requirements, including observation of activities and evaluation of conformity.
6.2.2.2 Performance of Internal Audit
Competent personnel, separate from those involved in or directly overseeing the audited activity, must conduct audits to ensure objectivity and impartiality. Audit records should offer objective evidence of the implementation and maintenance of the quality management system. Note: product specification requirements may be integrated into various quality management system processes and may be audited alongside one or more of these processes.
6.2.2.3 Audit Review and Closure
The organization must define timeframes for responding to identified nonconformities. Management accountable for the audited area must ensure that any required corrections and corrective actions adhere to the specifications outlined in section 6.4.2. Internal audit records must be retained.
6.3 Analysis of Data
The output of data analysis should furnish insights, including trends, regarding:
a) Customer satisfaction.
b) Non conformity to product requirements during product realization.
c) Instances of nonconformities and product failures detected post-delivery or post-use, provided there is accessible product documentation or evidence to facilitate root cause determination.
d) Process performance.
e) Supplier performance.
f) Attainment of quality objectives.
The organization must utilize data to assess areas where continual enhancement of the quality management system’s effectiveness is possible.
6.4 Improvement 6.4.1 General
The organization is required to enhance the effectiveness of the quality management system continuously. This is achieved by assessing, selecting, and implementing improvement opportunities utilizing quality objectives, internal audits, data analysis, corrective actions, and management review.
6.4.2 Corrective Action
The organization must uphold a documented procedure to manage nonconformities, including those arising from customer complaints, and to implement corrective actions both internally and with suppliers. Corrective actions should correspond to the impact of the encountered nonconformity, which can pertain to both quality management system processes and trends in nonconforming products.
The procedure should cover:
Criteria for initiating the corrective action process;
Reviewing the nonconformity;
Determining and implementing corrections;
Identifying the root cause of the nonconformity and assessing the need for corrective actions;
Implementing corrective action to minimize the likelihood of recurrence;
Defining the timeframe and responsible parties for addressing corrections and corrective action;
Verifying the effectiveness of the corrections and corrective action taken;
Updating risks and opportunities identified during planning;
Management of Change (MOC) when corrective actions necessitate new or modified controls within the quality management system; and
Assessing similar potential nonconformities and implementing preventive actions as appropriate.
Records of corrective action process activities should be maintained, including activities conducted to confirm the effectiveness of the corrective actions taken.
6.5 Management Review 6.5.1 General
The organization’s management must conduct a review of the quality management system at least once every 12 months (by the end of the same calendar month as the previous year’s review) to assess its ongoing suitability, adequacy, and effectiveness. This review should encompass evaluations of opportunities for improvement, sufficiency of resources, and the necessity for adjustments to the quality management system, including the quality policy and objectives.
6.5.2 Input Requirements
The minimum inputs required for management review shall encompass:
a) Evaluation of the status and effectiveness of measures taken based on prior management reviews;
b) Findings from internal audits and audits conducted by external parties.
c) Identification of potential changes that may impact the quality management system, encompassing alterations to legal and other relevant requirements (e.g., industry standards), as well as shifts in internal and external factors pertinent to the quality management system.
d) Assessment of customer satisfaction.
e) Consideration of feedback received from customers and other concerned parties.
f) Evaluation of process performance.
g) Review of risk assessment outcomes and the effectiveness of risk mitigation measures. h) Status update on corrective actions.
i) Analysis of supplier performance.
j) Examination of product conformity analysis, including post-delivery or post-use nonconformities;
k) Comparison of actual performance with quality objectives; and
l) Proposals for improvement.
6.5.3 Output Requirements
The outcomes of the management review must comprise:
A concise evaluation of the quality management system’s effectiveness,
Any necessary modifications to processes,
Determinations and ensuing actions,
Essential resource allocations, and
Enhancements aimed at better meeting customer needs.
Senior management is responsible for reviewing and endorsing the results of management reviews. Documentation of management reviews is mandatory, and records of such reviews must be retained.
Annex A Use of API Monogram by Licensees
A.1 Scope
The API Monogram® serves as a registered certification mark, owned by API and sanctioned for licensing by the API Board of Directors. Under the API Monogram Program, API grants product manufacturers the authorization to affix the API Monogram to products meeting product specifications and manufactured under a quality management system in compliance with API Q1 requirements. API maintains a comprehensive, searchable record of all Monogram Licensees on the API Composite List website.
Application of the API Monogram and license number on products signifies a representation and guarantee by the Licensee to API and purchasers that, as of the indicated date, the products were manufactured under a quality management system adhering to API Q1 requirements and fully comply with the relevant standard(s) or product specification(s). API Monogram Program licenses are granted following an on-site audit confirming that an organization has implemented and consistently upheld a quality management system meeting API Q1 requirements, and that resultant products meet the specifications of the applicable API product specification(s) and/or standard(s). While any manufacturer may assert that its products meet API product requirements without featuring the Monogram, only those licensed by API can affix the API Monogram to their products.
In conjunction with the stipulations of the API Monogram license agreement, this annex outlines the prerequisites for organizations seeking voluntary API licensing to furnish API-monogrammed products meeting the criteria of the applicable API product specification(s) and/or standard(s), along with API Monogram Program requirements.
A.2 Normative References
API Q1, Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry
A.3 Terms and Definitions
The following terms and definitions apply.
A.3.1 API monogrammable product: Product that has been manufactured by an API Licensee utilizing a fully implemented API Q1 compliant quality management system and that meets all the API-specified requirements of the applicable API product specification(s) and/or standard(s).
A.3.2 API product specification: Prescribed set of rules, conditions, or requirements attributed to a specified product that address the definition of terms; classification of components; delineation of procedures; specified dimensions; manufacturing criteria; material requirements, performance testing, design of activities; and the measurement of quality and quantity with respect to materials; products, processes, services, and/or practices.
A.3.3 API-specified requirements: Requirements, including performance and Licensee-specified requirements, set forth in API Q1 and the applicable API product specification(s) and/or standard(s).
NOTE Licensee-specified requirements include those activities necessary to satisfy API-specified requirements.
A.3.4 design package: Records and documents required to provide evidence that the applicable product has been designed in accordance with API Q1 and the requirements of the applicable product specification(s) and/or standard(s).
A.3.5 Licensee: Organization that has successfully completed the application and audit process and has been issued a license by API.
A.4 Quality Management System Requirements
Any organization affixing the API Monogram to products must establish, uphold, and consistently operate a quality management system in accordance with API Q1.
A.5 Control of the Application and Removal of the API Monogram
Each Licensee is responsible for regulating the application and removal of the API Monogram according to the following guidelines:
Products that do not meet API-specified requirements should not display the API Monogram.
Each Licensee must establish and uphold an API Monogram marking procedure outlining the monogramming specifications outlined in this annex and any relevant API product specification(s) and/or standard(s). This procedure should:
designate the authority responsible for applying and removing the API Monogram;
specify the method(s) for applying the Monogram;
indicate the location on the product where the API Monogram should be placed;
mandate the inclusion of the Licensee’s license number and the product’s date of manufacture alongside the API Monogram;
stipulate that the date of manufacture must include at least two digits for the month and two digits for the year (e.g., 05-12 for May 2012), unless specified otherwise in the applicable API product specification(s) or standard(s); and
include controls for applying any additional API product specification(s) and/or standard(s) marking requirements, as applicable.
Only an API Licensee is authorized to affix the API Monogram and its corresponding license number to API monogrammable products.
The API Monogram license is site-specific, and therefore the API Monogram should only be applied at the licensed facility’s designated location.
The API Monogram may be applied at any appropriate stage during production, but it must be removed according to the Licensee’s API Monogram marking procedure if the product is later found to be non-conforming with any requirements outlined in the applicable API product specification(s) and/or standard(s) and API Monogram Program.
For specific manufacturing processes or product types, alternative API Monogram marking procedures may be acceptable. Detailed requirements for alternative API Monogram marking can be found in the API Policy, API Monogram Program Alternative Marking of Products License Agreement, accessible on the API Monogram Program website.
A.6 Design Package Requirements
Every Licensee or applicant seeking licensing must uphold an updated design package for all relevant products covered by each Monogram license. The design package should offer tangible proof that the product design aligns with the requirements outlined in the relevant and latest API product specification(s). These design package(s) should be accessible during API audits conducted at the facility. In certain cases, the exclusion of design activities is permissible under the Monogram Program, as elaborated in Advisory #6, which can be found on the API Monogram Program website.
A.7 Manufacturing Capability
The API Monogram Program is structured to recognize facilities that have proven their capacity to produce equipment in accordance with API specifications and/or standards. API reserves the right to decline initial licensing or suspend existing licenses depending on the manufacturing capabilities of a facility. If API deems it necessary to conduct further evaluation, additional audits (at the organization’s cost) may be carried out on any subcontractors to verify their adherence to the requirements outlined in the relevant API product specification(s) and/or standard(s).
A.8 API Monogram Program: Nonconformance Reporting
API requests information regarding products that do not meet API-specified requirements, as well as instances of field failures or malfunctions attributed to specification deficiencies or nonconformities with API-specified requirements. Customers are encouraged to notify API of any issues encountered with API monogrammed products. Nonconformances can be reported using the API Nonconformance Reporting System accessible at http://compositelist.api.org/ncr.asp.
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
Timeallocation
JO / /
JO / /
JO / /
Maintainance/ Other Works
In
Out
HRS
OT
HRS
OT
HRS
OT
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/DeliveryOrderNo.
Date
J.O / W.O.No.
Customer/ Supplier Name
Type of Property
Description
Qty./CopyNo.
Dispositiondetails& date
ReceiptBy
Product/InstrumentIdentificationNo.
DocumentRefNo.(withcurrentRevNo.and Date)
PreparedBy:
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
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 forfurnace
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 forPipe 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 forHydrostatic 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 forTorque 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 forSand 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 forPortable 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
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/QCRelease
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
PREPAREDBY:
REVIEWEDBY:
APPROVEDBY:
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:
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.
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 CONFORMINGPRODUCT REPORT
SOS/ QA / 42
Originator
NCPNumber
JobNo.
NCPDate
Productdetails
AcceptanceStd.
Process/Activity
Processowner
N.C Findings :
Signatureof Orignator:Date
Processowner
Sign& Date
RootCauseof the Non-Conforming product:
Name/ Title Signature & Date:
Dispositionmethod/Reworkrecommendation
Concession – Accept as is Repair/Rework Reject/Scrap Returned to customer
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx
23. Preservation Report
Client:
Date
Part:
JobNo.:
PartSer.:
OEMProcedureNo.
Sr. No.
InspectionItems
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
VerifiedBy:
Name :
Date :
Signature :
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx
24 Pre-Dispatch checklist
Client:
Date
Part:
JobNo.:
PartSer.:
ReportNumber
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
…………………………………………………………………………
CheckedBy:
VerifiedBy:
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
DETAILSOF INDICATION(Above 50%PRL)
LOCATION
RESPONSE LEVEL
TYPE OF INDICATION
DEPTH
DIMENSION (SIZE/SHAPE)
RESULT
TEST RESULTS :
TESTEDBY
EVALUATED BY
ACCEPTEDBY
SIGNATURE
NAME
DATE
DESIGNATION
NDTLevelI / II
NDTLevel II / III
CLIENTREP/AI/TPI
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx
26 Product Recall
CLIENT:
REPORT NO :
JOB NO :
REPORT DATE :
ITEMDESCRIPTION:
CLIENTREFERENCE / PO :
SERIALNUMBER :
PARTNUMBER :
Re-CallNotification
Reason For Re-Call
Disposition/ Replacement
Internal(NCR)
Client
Recommended by: Sign & Date
Approved By: Sign & Date
Statusof 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 #
DATEOFINSPECTION:
SR#
CHECKPOINTS
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
Reviewedby
Name
Name
Date
Date
Sign
Sign
Issue: 01, Rev No.: xx Issue / Rev. Date: xx.xx.xxxx
28. Discrepancy Report
JobNo.
ReportNumber
ClientName
DRDate
Product
Traceability
Product Requirements / Scope of work :
Discrepancy identified:
Disposition recommendation / Clarification Note :
Clarification Note :
NOTE:
Recommended by:
Sign & Date
Approved By:
Sign & Date
Descriptionof 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
1
Visual inspection
Inspection lamp
2
Adhesion test
Pencil eraser
3
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:
Name:
Date:
Date:
Signature:
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
1.
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:
Name:
Date:
Date:
Signature:
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
Machined
Machined
Machined
Machined
PWHT / Stress relieved
Heat treated
Heat treated
Heat treated
Heat treated
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
Machined
Machined
Machined
Machined
PWHT / Stress relieved
Heat treated
Heat treated
Heat treated
Heat treated
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
ReportNumber
ItemDescription
Date
Serial/IDNumber
InstrumentID
JobNumber
Procedureref.
PO Number
Specifications
ITEM S/N :
POINTS
THICKNESS POSITIONS
MIN.THICK
MAX.THICK
REMARKS
A
B
C
D
E
F
G
H
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 PREPARATIONDETAILS
Type of Abrasive & Size
TIME
Abrasive Batch
Ambient (C°)
Surface Cleanliness Std
Dew Point (C°)
Surface Profile
Relative Humidity (%)
BloterTest
Surface Temperature (C°)
Blasting MachineID No.:
Location
Blasting Operator
Coating Applicator
COATINGDETAILS
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)
VisualInsp.
Primer
Intermediate
Top Coat
1
#
ITEM DESCRIPTION
DFT(microns)
VisualInsp.
Primer
Intermediate
Top Coat
1
Remarks:
Visual,Surface Profile, Dust Level, Chloride level of blasted surface inspected and found acceptable.
Records of the results of evaluations including objective evidence and any necessary actions arising from the evaluations shall be maintained. Records of identification of approved suppliers, customer specified suppliers, and suppliers limited by proprietary, and/or legal requirements shall be maintained.
API Q1 (American Petroleum Institute Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry) outlines requirements for organizations in the petroleum and natural gas industry. Purchase control records are documents used to ensure that purchased products or services meet the organization’s requirements. These records typically include:
Purchase Orders: Formal documents specifying the details of what is being purchased, including quantity, specifications, delivery date, and price.
Supplier Evaluation Records: Documentation of how suppliers are evaluated and selected, including criteria such as quality, delivery performance, price, and financial stability.
Supplier Contracts or Agreements: Legal documents outlining the terms and conditions of the relationship between the organization and its suppliers.
Inspection and Test Records: Records of inspections and tests performed on purchased products or services to ensure they meet specified requirements.
Non-Conformance Reports (NCRs): Reports documenting any deviations from specified requirements found during the inspection or testing of purchased products or services.
Supplier Certificates or Certifications: Documentation proving that suppliers meet certain standards or certifications required by the organization.
Records of Material Certifications: Documents certifying the quality and properties of materials used in purchased products.
These records are crucial for demonstrating compliance with API Q1 requirements and ensuring the quality and integrity of purchased products or services in the petroleum and natural gas industry.
Records of the results of evaluations including objective evidence and any necessary actions arising from the evaluations shall be maintained.
In accordance with API Q1 requirements, records of evaluations should include objective evidence and any necessary actions arising from those evaluations. Here’s a breakdown of what these records typically entail:
Evaluation Criteria: Clearly defined criteria used for evaluating suppliers or purchased products/services. These criteria may include quality, delivery performance, price, technical capabilities, and compliance with relevant standards or regulations.
Objective Evidence: Documentation or data that supports the evaluation process and demonstrates the validity of the assessment. This evidence may include inspection reports, test results, audit findings, customer feedback, performance metrics, and any other relevant information.
Evaluation Results: Recorded outcomes of the evaluations, indicating whether suppliers or purchased products/services meet the established criteria and requirements. This could include ratings, scores, pass/fail determinations, or other forms of assessment results.
Necessary Actions: Any actions or decisions resulting from the evaluations, such as approving a supplier, placing corrective actions on non-conforming products/services, updating procurement procedures, or reassessing supplier relationships.
Records of Communication: Documentation of any communication or correspondence related to the evaluations, including emails, meeting minutes, or other forms of communication that may have influenced the evaluation process or outcome.
Follow-up Actions: Documentation of any follow-up actions taken to address identified issues or deficiencies, such as implementing corrective actions, conducting re-evaluations, or making changes to supplier agreements.
Retention of Records: Ensuring that records of evaluations and associated actions are properly maintained and retained for the required period as per organizational procedures and regulatory requirements.
By maintaining comprehensive records of evaluations, organizations can demonstrate accountability, transparency, and compliance with API Q1 requirements, while also facilitating continuous improvement in their procurement processes.
Records of identification of approved suppliers, customer specified suppliers, and suppliers limited by proprietary, and/or legal requirements shall be maintained.
Maintaining records of approved suppliers, customer-specified suppliers, and suppliers limited by proprietary or legal requirements is crucial for compliance and effective supply chain management. Here’s what these records typically include:
Approved Suppliers List (ASL): A documented list of suppliers that have been evaluated, approved, and deemed suitable for providing products or services to the organization. This list may include details such as supplier name, contact information, approved product or service categories, approval dates, and any special conditions or restrictions.
Customer-Specified Suppliers: Records of suppliers designated by specific customers for supplying products or services to their projects or contracts. These records should include information on the customer’s requirements, approved suppliers, and any special agreements or contracts governing the relationship.
Suppliers Limited by Proprietary or Legal Requirements: Documentation of suppliers that are restricted or limited by proprietary information, intellectual property rights, or legal/regulatory obligations. This could include suppliers with exclusive rights to certain technologies or materials, suppliers subject to export control regulations, or suppliers restricted due to confidentiality agreements.
Documentation of Approval Processes: Records of the processes used to evaluate and approve suppliers, including criteria for approval, evaluation methods, review procedures, and decision-making criteria. This documentation ensures transparency and consistency in supplier approval processes.
Records of Supplier Audits or Assessments: Documentation of audits, assessments, or evaluations conducted to verify suppliers’ compliance with quality, regulatory, or contractual requirements. This may include audit reports, assessment findings, corrective action plans, and evidence of follow-up actions taken.
Supplier Contracts or Agreements: Copies of contracts, agreements, or purchase orders with approved suppliers, outlining the terms and conditions of the relationship, including pricing, delivery schedules, quality requirements, warranties, and liabilities.
Retention of Records: Ensuring that records of approved suppliers, customer-specified suppliers, and suppliers limited by proprietary or legal requirements are properly maintained and retained for the required period as per organizational procedures and regulatory requirements.
Example of Purchase Control Documents
By maintaining these records, organizations can ensure that they work with reliable and compliant suppliers, mitigate risks associated with the supply chain, and meet the requirements of API Q1 and other relevant standards or regulations.
1.0 Purchase Order
PurchaseOrder
Purchase Order/Req No:
Ref No:
Material Req No:
Date:
VendorDetails:
FAXNo:
DeliveryTerms:
PaymentTerms:
ItemNo.
Description
Grade/Brand
StockStatus
CostNo.
Unit
QTY
UnitPrice
Total
1
–
2
–
3
–
4
–
5
–
6
–
7
–
8
–
9
–
10
–
General Terms of Supply : Refer general terms and conditions of purchase .Other specific requirements : Applicable / Not Applicable , (If applicable See PO Annex-1)
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx APPROVED VENDOR LIST
5. Master Procurement Register
TotalAverage =
PO .NO
PO Date
MR . NO
MRDate
Supplier
Item
Job
Curr
Amount
Payment Type
PO Expecteddelivery inDays(a)
Actualdeliverydate(b)
Diffb/wPO Date& Act Date( C)
Diff(d = a-c)
Diff in %(e = a/d)
100% asexpecteddelivery
ActualDelta%
AveragePerformace%
6. Supplier Registration form
Please fill in this questionnaire in order to register. Information given in this questionnaire will be handled confidentially. Please attach all other documents requested in the questionnaire.
a.NAME OF COMPANY: ……………………………………………………………….
MAILING ADDRESS: …………………………………………………………………
..………………………………………………………………………………………….
COUNTRY: …………………………………………………………………………………
CONTACT PERSON(S): ……………………………………………………………..
TELEPHONE: ………………………………………………………….…………………
FAX: ………………………….E-mail: …………………………….………………….
WEBSITE: …………………………………………………………………….….
b. TYPE OF ORGANISATION (Please check)
Individual Partnership Non-Profit Organization
Private Limited Liability Company Public Limited Liability Company
……………………………….………………………………………………………….
Year Established:……….…….
Please attach copy of registration certificate
c. TYPE OF BUSINESS (Please check)
Manufacturing Construction Trading Consultancy
Service Provider (e.g. transport, warehousing, quality control, etc.)
……………………………………………………………………………………………
Please describe your company’s major business activity: ………………………….
…………………………………………………………………………………………….
……………………………………………………………………………………………………..
……………………………………………………………………………………………………..
Please indicate the main commodities/services your company offers:…………
……………………………………………………………………………………………
……………………………………………………………………………………………
…………………………………………………………………………………………….
d. SIZE OF BUSINESS (Please provide a copy of your latest audited financial statements)
No. of Employees: ……………..……….. No. of Branches: ……….………….
No. of International Offices: …………………………………………………….…
Location of Factories: ……………… No. of Warehouses: ……………………….
e.AFFILIATED/HOLDING/SUBSIDIARY COMPANIES
Name
Address
Nature of Affiliation
Please attach an organisation chart
f. PERSONS AUTHORISED TO SIGN BIDS, OFFERS AND CONTRACTS
Name
Position
Telephone / Fax
g. BANKING INFORMATION
Name: ………………………………………………………………………………………..
Address:………………………………………………………………………………….……
Account Number: ………………………………. SWIFT Code: ……………………….
IBAN: …………………………………………………….
h. NAMES OF OFFICERS, OWNERS OR PARTNERS
Owner(s):
Chief Executive Officer:
Chief Financial Officer:
i. QUALITY ASSURANCE (Please attach any certificates or documents which denote quality assurance)
Name and Title:…………………………………………………………………
Signature:………………………..……………. Date: …………………………
7.0 Vendor Appraisal Form – Critical Suppliers
Questionnaire for Vendor Evaluation of Supplier/Service Provider/Manufacturers. Please fill in bold letters only. Enclosures may be used wherever the space is inadequate.
I. GENERAL :
Registered Name of the Organization
Category of Industry
Whether sole Proprietorship or Partnership or Limited Company etc.
List of main products/ Services/ manufactured with details of specification, range and sizes and products offered. (Add pages if required)
Enclose your Product Catalogue
Is there any Foreign Collaboration?
Technical Collaboration
Financial Collaboration
Names of few large and prominent customers and the items and values of the supplies made in the last three years.
State details if your products are also exported
II. PERSONNEL EMPLOYED CURRENTLY :
Management
Design
Production
Quality Control
Marketing
Total
III. PRODUCTION FACILITIES :
Details of Plant and Machinery and Equipment available at your works :
Sr. No.
Description of Plant & Machinery
Size / Capacity
No. of Machines
Date of Installation
Make / Brand
See attached brochure
V. QUALITY ASSURANCE:
Is there a Quality Manual
Is there Inwards Goods Inspection? If yes, state details of instruments and equipment’s a available
If in – house facility is not available state the alternative provided
VI. QUALITY CONTROL:
VI. DETAILS OF PRODUCT UNDER AUDIT :
VI.1. Description of product (s) :
VI.2. Names of Consultants and Users who have approved you.
VI.3. Have your products been tested by independent testing agencies? If yes, state details / attach certificates / test results.
VI.4. Have you been certified for ISO 9001 or are you in process of initiating the same: Yes
VII. PRODUCTION INFORMATION OF THE PART / ITEM CONCERNED :
VII.1. Flow chart of the process with inspection points.
VII.2. How is traceability maintained in the production line?
VII.3. Which documents/standards are used for production and product assurance inspection stages?
VII.4. How is the rejected parts identified? What procedure is followed to ensure rejected parts are not used / shipped?
VII.5. Does the manufacturer take periodic samples of finished product for analysis?
VII.6. How is parts stored on completion of production?
VII.7. How is stored parts identified? Is there specific storage conditions?
VII. 8. What final documents are provided with the supply? Like MTCs, User Manual etc
VII. INSPECTION SYSTEMS USED BY THE MANUFACTURER :
VII.1 CONTROL OF SUPPLIERS
VII.1.1. How do you evaluate / qualify / assess / register your suppliers?
VII.1.2. How is Purchase Orders on outside suppliers controlled to ensure incorporation of all authorized technical and quality clauses.
VII.2. CONTROL OF RAW MATERIALS :
VII.2.1. Are Specifications / Drawings used for all raw materials?
VII.2.1. Are Certificates supplied with delivered raw materials?
VII.2.3. How can raw material is traced to certificate supplied?
VII.2.4. Are periodic Chemical, Physical tests performed to check conformance to requirements? How often are these tests performed?
VII.2.5. How do you identify / isolate raw materials which may have exceeded their shelf life.
VIII. Are the organization or its customer intends to perform verification at the supplier premises?
REMARKS AND COMMENTS :(FOR OFFICE USE ONLY) __________________________________________________________________________________ ________________________________________________________________________________ __________________________________________________________________________________
For Trading/ Manufacturer/Local Supplier Co,
Signature & Date :
Name :
Designation :
8. Supplier Audit Checklist
RECORDNO:
ASSESSMENTDATE:
SUPPLIER NO: NAME OF SUB-CONTRACTOR/SUPPLIER: ADDRESS:
RESPONSIBILITY FOR QHSE SYSTEM:NAME: DESIGNATION: C : Comply,NC: Not Comply,NA: Not Applicable
S.NO.
DESCRIPTION
STATUS
C / NC/ NA
1
Availability of documented Quality manual
2
System and practice of tender review / contract review
3
System for controlling of customer supplied product
4
System for product identification and traceability
5
Documented Quality plan
6
Availability of inspection & test records
7
System and practice of in-process inspection & testing
8
Availability of sufficient inspection & test equipments
9
Availability of trained Quality Control personnels
10
Availability of Qualified Welders / Fitters
11
Designated storage area
12
Storage and handling system
13
System for control of nonconformance and corrective action
14
Capability to read and understand the technical specification
15
Knowledge in understanding of International Codes, Stds and HSE requirements
16
Usage of PPE and relevant safety equipment
17
First aid, fire fighting, DDC / other relevant trainings
18
Periodic audit / performance review of QHSE management system
19
Basic HSE and operational control
20
Tool box talk / other safety meetings
Report by assessing officials
Auditor
SupplierRepresentative
M.R
Name, Sign & Date
Name, Sign & Date
Name, Sign & Date
Iss.No./Date: xx / xx.xx.xxxx Rev.No/Rev.Date:xx / xx.xx.xxxx
9. Audit Evaluation Schedule
#
SupplierID
SupplierName
Category
LastEvaluation
EvaluationResults/ Grade
NextDue
ActualDateofEvaluation
Start
End
PreparedBy
Reviewed By
ApprovedBy
Name, Sign & Date
Name, Sign & Date
Name, Sign & Date
Iss.No./Rev. No : xx/xx Date: xx/xx/xxxx
10. Technical Delivery Conditions
SL No
Description
Requirements
1
Material Type
2
Manufacturing Process Requirements
3
Specifications
4
Standards / Internationally Acceptable
5
Delivery Conditions
6
Acceptable Tolerances in Size / Quantity
7
Special Characteristics requirements
8
Value added requirements – Material & Services
9
Product analysis
10
Testing / Inspections
11
Certifications
12
Packing/ Packing Instructions
13
Special Requirements NOTE
11. EVALUATION : SUPPLIER’S CONTROL ON THEIR SUPPLY CHAIN
12 SUPPLIER EVALUATION / RE-EVALUATION ASSESSMENT RECORD
a. Supplier evaluation / re-evaluation criteria
SL No
Assessment/ extent of control
Control implied / Feedback
1
Supplier QMS confirms to Quality System requirement . QMS of the supplier Supplier Audit Verifying the QMS requirements with suppliers
2
Type and extent of controls applied by the supplier in their SC
3
First off inspection in case of manufacturing (QC/TPI)
4
Ability to meet (Proprietary, Legal, Contractual) requirements
5
Third Party Inspection – Auditing by TPI Agency (Stage Inspection)
6
Assessment of product/service upon receipt or completion
b) Risk Assessment
#
CONCERN
% ASSOCIATED RISK
% IMPACT ON PRODUCT
1
Limitation (Proprietary, Legal, or other)
Limitations for the specific product range
30
5
Laboratory cannot meet the manufacturers accuracy
70
80
Laboratory cannot provide repair/rectification service
30
5
2
Product / Service Quality
Non-conformities on the product / service
80
70
Non availability of the master equipment
50
10
Correction in the documentation
20
10
Not meeting the specified requirements
80
80
3
Cost on rejection
Supplied non-conforming product / service
70
70
13. Request for Quote
Date : Fax No. :
Attn :
To:
Subject : Request for Quote
Our Ref No. : MR #
Dear Sir,
Kindly send us the best and lowest prices for the items as per below as early as
possible.
Sl. No.
Description
Unit
Qty.
General Terms and Condition of
Purchase:
(1) The items should be exactly as per our requirement. Any deviation should be informed while quoting. (2) Price-Ex-our stores. (3) Local Supplier to Quote within one working day. (4) Batch/Material Test Certificate is a must where ever applicable.
With regards,
Procurement In Charge
14.Material Receiving Inspection Report
Location of supplier:
W.O / J.O No.:
Date:
MRIR No.:
Supplier Code
Supplier Name & Address
Supplier DO Ref.#
PO Ref.#
MATERIALS DETAILS
Sl. No
Part / ItemNumber
Part / Item Description
Quantity
Details to be Verified / Inspected
Results of Verification / inspection
Remarks
As perPO
As perSupplier DO
Accep.
Rej.
Received & Verified By (Store Keeper)
Inspected By (QA/QC Engineer)
Approved By (Machine Shop Manager)
(Name, Sign & Date)
(Name, Sign & Date)
(Name, Sign & Date)
The accepted items are credited to Stores and rejected items are sent back to supplier
1 Upon receiving on any equipment, this form must be filled in with SRV#. 2 Security Guard must must record in all details and provide a copy of this form to the Account and concerned every Sunday of the week Prepared By:
Upon releasing any job, this form must be filled in with P.O/Invoice#. Security Guard must must record in all details and provide a copy of this form to the Account and concerned every Sunday of the week Prepared By:
The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Management Representative. 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.
Corrective Action Closed & Determined to be Effective?
Yes/ NO
Record Objective Evidence Include revised documents, training dates, closure dates, effective dates and any other relevant information
Name of the Management Representative:
Signature of the Management Representative :
Date:
14) QMS Self Assessment form
1
Is your department working efficiently?
1a
If not why?
1b
What is recommendation?
2
Do you have enough resources?
2a
If not describe.
3
Is the applicable section of the QMS is relevant within your department?
3a
If not describe.
4
Is there any customer complaints due to your/department failure?
4a
If yes, what corrective action taken? Is it effective?
5
What is your recommendation for overall improvement of the QMS?
Date of analysis:
Name of customer:
No of order carried out during last 3 months:
15) Record of Management of Change
Process/Process Area: Initiated or Identified by:
MOC No.
Date:
CHANGEINTHESYSTEM NEEDED
Proposedor identified change
PresentProcess/Function
MOCPROCESS
Change in Organizational Structure Yes No Change in Critical Supplier Yes No Change in Key Personnel or Essential Personnel Yes No Change in Management System Procedure Yes No Others, Please Specify:
Revieweby :
ManagementRepresentative(MR)
Date:
RISKASSOSCIATEDWITHTHECHANGE
#
Risk
Impacton
Significance
Action/Elimination/Mitigation
High(H) Medium (M) Low (L)
1
2
3
4
5
Note: High = Required change in QMS, process, technology, knowledge, personnel or supply chain partners/process, time constrains Medium = Required implementation, resources planning/allocation, or training but possible within the set time frame; Low = none of H or M
RECOMMENDED / NECESSARY ACTIONS FOR THE MITIGATION OF RISK
#
Action
Target
Responsibility
1
2
3
4
5
APPROVEDBY:
Date:
MOC IMPEMENTATION
#
Action
Status
Comments
1
2
3
16. Risk Assessment & Management
CrossFunctionalTeam
RA Performed on:
Preparedby:
RiskAssessement& Management
Approvedby:
Define the process:
Doc No.: SOS / MR / 18
ProcessFunction
PotentialFailureMode
PotentialEffect(s)ofFailures
sev
Class
PotentialCause(s)/Mechanism(s)ofFailures
Occur
CurrentProcessControlsPrevention
CurrentProcessControlsDetection
Detect
RPN
RecommendedAction(s)
Responsibility& TargetCompletionDate
ActionResults
Requirements
ActionTaken
Sev
Occ
Det
RPN
Issue/ Rev. No.:
Date:
SummaryofChanges:
Reasonfor Revision
17. Contingency Planning
Sl.No.
Process/FunctionintheOrganization
IdentifiedCriticalactivityintheOrganization
OutcomeofRiskAssessment–IdentifiedRisk
Impact
ContingencyPlan
Responsibility/Authority
InternalCommunicationControl
ExternalCommunicationControl
Remarks
What
When
Where
Why
Who
How
Howmuch?
18. Corrective and/or Preventive Action Request
REQUEST RAISED FOR
CORRECTIVE ACTION PREVENTIVE ACTION
TO:
PAR/CAR NO:
DATE:
Incident Details:
Identified by: (source/employee)
Potential Risk/Opportunity
Action Planned:
Responsibility & Target (for action):
Action Taken:
Action Details:
Completed by (Signature & Date)
Verified & Accepted by: (MR/Top Management)
Follow-up:
Effectiveness:
Status: Closed / New CAR/PAR
Action Details:
Completed by (Signature & Date)
Verified & Accepted by: (MR/Top Management)
19. Quality Performance Analysis Report
Quality Objectives
S. NO
Department
Objectives
Target
Current Status
Remark
S. NO
Performance Parameter
Current Status
Remark
2
Review of Quality Policy:
3
Effectiveness of action resulting from previous MRM:
4
Result of Audits: a) Internal Audit: b) External Audit:
5
Changes that could affect the quality management system, including changes to legal and other applicable requirements:
6
Customer Complaints:
7
Customer Satisfaction Survey Data:
9
Order Summary (Process Performance):
10
Internal and External issues, Needs and Expectation of Interested parties,
11
Results of Risk Assessments and Contingency planning:
12
Product/service Non conformances, including non conformances identified after delivery or use:
13
Status of Corrective & Preventive actions: (NCR / NCMR)
14
Supplier Performance Summary:
15
Resource needs: a) Quality Improvements: b) Recommendation for Improvement:
The following checklist can be used for both internal audits as well as Gap Analysis tools.
API Specification Q1 Internal Audit checklist
4.0
Quality Management System Requirements
4.1
Quality Management System
4.1.1
General
1
How does the organization plan, establish, document, implement, and maintain a quality management system at all times in accordance with the requirements of this specification for the product provided within the scope defined by the organization?
2
How does the organization measure the effectiveness the quality management system by the requirements of API Specification Q1?
3
How does the organization improve upon the quality management system by the requirements of API Specification Q1?
4.1.2
Quality Policy
1
Has the organization established a Quality policy for its commitment to quality?
2
How does the organization ensure that Quality policy is appropriate to the organization?
3
Does the organization’s top management review the quality policy periodically?
4
How does the organization ensures that Quality policy is appropriate to the organization?
5
How does the organization ensure that Quality policy supports its strategic direction?
6
How does the organization ensures that Quality policy is the basis for the development of quality objectives?
7
How does the organization ensure that Quality policy is communicated, understood, implemented, and maintained within the organization?
8
How does the policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system?
9
How does oes the policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system?
4.1.3
Quality Objectives
1
Are the Quality objectives measurable?
2
How does the management ensure that quality objectives meet product and customer requirements?
3
How does the management ensure that quality objectives are established at relevant functions and levels within the organization?
4
How does the Management Representative ensure the initiation of action(s) to minimize the likelihood of the occurrence of nonconformities?
5
Are the Quality objectives measurable?
6
Is the Quality objectives measurable?
7
How does the management ensure the planning of the quality management system is carried out to meet the requirements of API Specification Q1?
4.1.4
Planning
4.1.4.1
General
1
How is the planning of the quality management system performed?
2
How is the planning of the quality management system performed?
3
How does the organization identify external and internal issues relevant to the organization’s long-term or overall objectives and goals?
4
How does the organization determine relevant interested parties and their requirements for the quality management system?
5
How does the organization determine the sequence and interaction between the processes of the quality management system?
6
How does the organization determine and manage the criteria and methods needed for the effective operation and control of quality management system processes?
7
How does the organization identify quality objectives, including actions, resources, responsibilities, and timeframe, and how results are monitored and evaluated?
8
How does the organization address identified risks?
9
How does the organization address identified opportunities for improvement?
10
How does the organization identify key personnel?
4.1.4.2
Exclusions
1
Has the organization claimed any exclusions to any sections of API Q1 specification Q1 and will the exclusions be limited to the following sections of this specification: — 5.4, Design — 5.6.4, Validation of Processes — 5.6.7, Externally Owned Property — 5.8, Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)
2
Where any exclusions are claimed, are the justifications documented?
3
How does the organization ensure that Excluded activities do not affect the organization’s ability, or responsibility, to provide products that satisfy customer and legal requirements?
4
Has the organization ensured that there are no claims to exclusion of activities addressed by this specification, including outsourced activities, if an organization performs them?
4.1.5
Communication
4.1.5.1
Internal
1
How does the management ensure that appropriate communication processes are established within the organization?
2
How does the organization establish processes to ensure that the results of analysis of data are communicated at relevant levels and functions within the organization?
3
How does the organization establish processes to ensure that the results of analysis of data are communicated at relevant levels and functions within the organization?
4.1.5.2
External
1
Has the organization established and implemented the process for communicating with external organizations, including customers?
2
How does the communication process address the execution of inquiries, contracts, or order handling and amendments?
3
How does the organization determine and understand the requirements throughout contract execution and product realization?
4
How does the communication process address the provision of product information, including nonconformities?
5
How does the communication process address feedback and customer complaints?
6
How does the organization communicate quality plans and subsequent changes to those plans?
7
How does the organization communicate changes and associated risks?
4.2
Management Responsibility
4.2.1
General
1
How does the top management demonstrate leadership and commitment to the establishment, implementation, maintenance, and improvement of the quality management system?
2
How does the top management ensure that quality objectives are established at relevant functions and levels within the organization?
3
How does the top management provide the resources needed for the quality management system?
4
How does the top management engage and support personnel in the implementation and maintenance of quality management systems?
5
How does the top management assign responsibilities and authorities for ensuring the processes achieve intended outputs?
4.2.2
Responsibility and Authority
1
Are the responsibilities, authorities, and accountabilities of personnel within the scope of the Quality Management System defined, documented, and communicated throughout the organization?
4.2.3
Management Representative
1
Has the top management appointed and maintained a member of the organization’s management as a Management Representative?
2
Has the top management ensured that the quality management system conforms to the requirements of this specification?
3
How does the Management Representative ensure that processes needed for the quality management system are established, implemented, and maintained?
4
How does the Management Representative report to top management on the performance of the quality management system and any need for improvement?
5
How does the organization determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system?
6
How does the organization determines and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system?
4.3
Organization Capability
4.3.1
Resources and Knowledge
4.3.1.1
Resources
1
How does the organization determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system?
4.3.1.2
Knowledge
1
How does the organization determine the knowledge needed to provide continued operation of its processes?
2
How does the organization determine the knowledge needed to achieve ongoing conformity of products?
3
How does the organization maintain this knowledge and make it available?
4.3.2
Human Resources
4.3.2.1
Personnel Competence
1
Does the organization ensure that its personnel whose responsibilities fall within the scope of the quality management system are competent?
2
Is there a documented procedure addressing personnel competence that the organization shall maintain?
3
Does the procedure include how required competencies are identified and documented?
4
Does the procedure include how required education, training, experience, or other actions to achieve competence are identified?
5
Does the procedure include an evaluation of the effectiveness of actions taken to acquire competencies?
6
Does the procedure include criteria and methods for assessing, maintaining and, re-assessing competencies?
7
Does the procedure include personnel responsible for assessing competency?
8
Are the records of personnel competence maintained?
4.3.2.2
Training
1
How does the organization develop and maintain a procedure for training?
2
How does the organization identify the content and frequency of training required?
3
How does the organization address the provision of quality management system training?
4
How does the organization address the provision of job training including personnel awareness of the relevance and importance of their activities and how they contribute to the achievement of the organization’s quality objectives ?
5
How does the organization provide customer-specified training and/or customer-provided training, when required?
6
How does the organization evaluate of effectiveness of training?
7
How does the organization identify the required training records?
8
Does the organization maintain appropriate records of personal training?
4.3.3
Work Environment
1
How does the organization determine, provide, manage, and maintain the work environment needed to achieve conformity of the product?
2
Does the work environment include a) buildings, workspace, and associated utilities; b) process equipment (both hardware and software) ; c) supporting services (e.g. transport, communication, information systems); and d) conditions under which work is performed such as physical, environmental, or other factors.
4.4
Documentation Requirements
4.4.1
General
1
Does the quality management system documentation include the scope of the quality management system that identifies the products covered, including justification for any exclusions?
2
Does the quality management system documentation includes statements of quality policy and quality objectives?
3
Does the quality management system documentation include the identification of legal and other applicable requirements to which the organization claims compliance that is needed to achieve product conformity?
4
Does the quality management system documentation include identification of how the quality management system addresses each requirement of API Q1?
5
Does the quality management system documentation include identification of processes that require validation?
6
Does the quality management system documentation include documented procedures established for the quality management system?
7
Does the quality management system documentation include documents and records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements?
4.4.2
Procedures
Are all procedures referenced within API Specification Q1 describing the organization’s method for performing an activity and documented, implemented, and maintained for continued suitability?
4.4.3
Control of Documents
1
Does the organization maintain a documented procedure for the identification, distribution, and control of internal documents required by the quality management system and API Specification Q1, including revisions, translations, and updates?
2
Does the procedure specify responsibilities for approval and re-approval?
3
Does the procedure specify the review and approval for adequacy prior to issue and use?
4
Does the procedure specify the review for continued suitability and revision(s) as necessary?
5
Does the procedure specify the identification of changes and current revision status?
6
Does the procedure specify the legibility and identification of documents?
7
Does the procedure identify the controls needed to ensure that the documents required by the quality management system are available where the activity is being performed?
8
How are obsolete documents removed from all points of issue or use, or otherwise identified to ensure against unintended use if they are retained for any purpose?
9
How are Procedures, work instructions, and forms required by the quality management system controlled?
4.4.4
Use of External Documents in Product Realization
1
Does the organization maintain a documented procedure for the control of documents of external origin required for product realization and used by the organization, including API or other external specifications?
2
Does the procedure address identification and documentation of required documents?
3
Does the procedure address access and distribution of required documents, including relevant versions?
4
Does the procedure address the integration of requirements into product realization and any other affected processes?
5
Does the procedure address the process for identifying when changes to required documents have occurred, including addenda, errata, and updates?
6
Does the procedure address the integration of applicable changes?
7
Does the organization maintain a documented procedure to identify the controls and responsibilities needed for records?
4.5
Control of Records
1
Are records, including those originating from outsourced activities, established and controlled to provide evidence of conformity to requirements and the organization’s quality management system?
2
How does the organization address record identification, collection, legibility, correction, storage, protection from unintended alteration, damage, loss, retrieval, retention time, and disposition?
3
How does the organization address record identification, collection, legibility, correction, storage, protection from unintended alteration, damage, or loss, retrieval, retention time, and disposition?
4
Are the records retained for a minimum of ten years or as required by the customer, legal, and other applicable requirements, whichever is longer?
5.0
Product Realization
5.1
Contract Review
5.1.1
General
1
Does the organization maintain a documented procedure for the review of requirements related to the provision of products?
2
Does the procedure address the determination of requirements, review of requirements; and changes to requirements?
5.1.2
Determination of Requirements
1
How does the organization determine the requirements specified by the customer?
2
How does the organization determine the legal and other applicable requirements?
3
How does the organization determine the requirements not stated by the customer but considered necessary by the organization for the provision of the product?
4
Where the customer provides no documented statement of the requirements, is the customer requirements confirmed by the organization and records maintained?
5.1.3
Review of Requirements
1
How does the organization review the requirements related to the provision of products?
2
Is this review conducted before the organization‘s commitment to deliver the product to the customer?
3
How does the organization ensure that requirements are identified and documented?
4
How does the organization ensure that requirements differing from those previously identified are resolved?
5
How does the organization ensure that the organization can meet the documented requirements?
6
Where contract requirements are changed, how does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?
7
Are the records of the results of the review, including resulting actions, maintained?
5.2
Planning
1
Has the organization identified and planned the processes and documents needed for product realization?
2
How does the organization plan for required resources and work environment management?
4
How does the organization plan for the product and customer-specified requirements?
5
How does the organization plan for the legal and other applicable requirements?
6
How does the organization plan for the contingency?
7
How does the organization plan for the design requirements?
8
How does the organization plan for the required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for acceptance?
9
How does the organization plan for management of change (MOC)?
10
How does the organization plan for the records needed to provide evidence that the product realization conforms to requirements?
11
Is the output of planning documented?
12
Is the output of planning updated as changes occur?
13
Are the plans maintained in a structure suitable for the organization‘s method of operations?
5.3
Risk Management
5.3.1
General
1
Does the organization maintain a documented procedure to identify and control risks associated with product delivery and product quality?
2
Does the procedure address risk identification and assessment techniques?
3
Does the procedure address risk assessment tools and their application?
4
Is the criteria to determine risk severity including potential consequences of product failure established?
5
Does the procedure address risk mitigation actions?
6
Does the procedure address the assessment of remaining risk?
7
Does the organization maintain a documented procedure for identifying, verifying, safeguarding, preserving, maintaining, and controlling customer-supplied property, including intellectual property and data, while under the control of the organization?
5.3.2
Risk Assessment
5.3.2.1
Product delivery
1
Does Risk assessment associated with product delivery include facility/equipment availability including maintenance?
2
Does Risk assessment associated with product delivery include supplier delivery performance and material availability/supply?
5.3.2.2
Product Quality
1
Does the Risk assessment associated with product quality include delivery of nonconforming products?
2
Does the Risk assessment associated with product quality include the availability of competent personnel?
5.3.2.3
Changes Impacting Product Quality
1
If any changes can negatively impact the quality of the product, does the organisation perform a risk assessment associated with product quality?
2
Is a risk assessment associated with product quality performed when there are changes in the organizational structure?
3
Is a risk assessment associated with product quality performed when there are changes in key personnel?
4
Is a risk assessment associated with product quality performed when there are changes in the supply chain of critical products, components, or activities?
5
Is a risk assessment associated with product quality performed when there are changes to the management system scope or procedures?
6
Is a risk assessment associated with product quality performed when there are changes to the organization’s capability to perform the process(es) required for product realization?
5.3.3
Contingency Planning
1
Has the organization determined any contingency plan based on assessed risk?
2
Does the contingency plan include actions required to reduce the effects of disruptive incidents?
3
Does the contingency plan include the identification and assignment of responsibilities and authorities?
4
Does the contingency plan include internal and external communication controls?
5
Is the contingency plan documented, communicated to the relevant personnel, and updated as needed?
5.3.4
Records
Are the Records of risk assessment and management including actions taken maintained?
5.4
Design
5.4.1
General
1
In case the organization is responsible for the design of products, have the requirements of 5.4 applied? (The design requirements of 5.4 is not applied if the product is in production activities, servicing, storage, distribution, or logistics)
5.4.2
Design Planning
1
Does the organization maintain a documented procedure to plan and control the design process?
2
Does the procedure identify the plans, including plan updates, used for design?
3
Does the procedure identify the design stages?
4
Does the procedure identify the resources, responsibilities, authorities, and their interfaces?
5
Does the procedure identify the review, verification, and validation activities necessary to complete each design stage?
6
Does the procedure identify the requirements for a final review of the design?
7
Does the procedure identify the review and approval requirements for design changes?
8
When design activities are outsourced or performed at different locations within the organization, does the procedure identify the controls required to ensure that the designs meet the requirements of 5.4 Design?
9
When design and development are outsourced, how does the organization ensure the supplier meets the requirements of 5.5.1.7 outsourcing?
5.4.3
Design Inputs
1
How does the organization identify and review the Inputs for adequacy, completeness, lack of ambiguity and lack of conflict?
2
How are any issues identified are addressed?
3
Does the Inputs include functional and technical requirements?
4
Do the Inputs include customer-specified requirements?
5
Do the Inputs include requirements provided from external sources, including API product specifications?
6
Do the Inputs include environmental and operational conditions?
7
Do the Inputs include methodology, assumptions, and formulae documentation?
8
Do the Inputs include historical performance and other information derived from previous similar designs?
9
Do the Inputs include legal requirements?
10
Do the Inputs include consequences of potential product failure when required by legal requirements, industry standards, customers, or deemed necessary by the organization?
11
Are the records of design inputs maintained?
5.4.4
Design Outputs
1
How does the organization document its output to allow verification against the design input requirements?
2
Does the output meet the input requirements for design?
3
Does the output provide information for purchasing, production, inspection, testing and servicing as applicable?
4
Does the output identify or refer to design acceptance criteria (DAC)?
5
Does the output include identification of, or reference to, products and/or components deemed critical to the design?
6
Does the output include the results of applicable calculations?
7
Does the output specify the characteristics of the product that are essential for its safe and proper use?
8
Are the Records of design outputs maintained?
5.4.5
Design Review
1
Are Design Reviews performed at suitable stages?
2
Are reviews performed to evaluate the suitability, adequacy, and effectiveness of the results of design and development stages to meet specified requirements?
3
Are reviews performed to identify any problems and propose necessary actions?
4
Do participants in such review(s) include representatives of functions concerned with the design stage(s) being reviewed?
5
Are the records of the results of the review(s) and any necessary actions maintained?
5.4.6
Design Verification and Final Review
1
To ensure that the design outputs have met the design input requirements, how does the organization ensure that design and development verification and a final review are conducted and documented as identified within the organization’s procedure?
2
Are the records of design verification, any necessary actions and the final review maintained?
5.4.7
Design Validation and Approval
1
Are Design and development validation performed in accordance with the organization’s procedure?
2
How does the organization ensure that the Design validation of the resulting product is capable of meeting the specified requirements?
3
When possible does the organization ensure that validation is completed prior to the delivery of the product?
4
How does the organization ensure that the completed design is approved after validation?
5
How does the organization ensure that Competent individual(s) other than the person or persons who developed the design approve the final design?
6
Are records of the design and development validation, approval, and any necessary actions maintained?
5.4.8
Design Changes
1
How are Design changes identified?
2
How does the organization ensure that the changes are reviewed, verified, and validated, as appropriate, and approved before implementation?
3
How does the organization ensure that the review of design changes includes an evaluation of the effect of the changes on the product and their constituent parts in affected stages of product realization, as well as the product already delivered?
4
Does the review of design changes include an evaluation to determine if customer notification is required when design changes negatively affect the specified performance capability of the product?
5
How does the organization ensure that the design and development changes, including changes to design documents, are in accordance with the organization’s procedure?
6
Are the records of design and development changes, reviews of those changes, and any necessary actions maintained?
5.5
Purchasing
5.5.1
Purchasing Control
5.5.1.1
Procedure
1
Does the organization maintain a documented procedure for the purchase of products, components, and/or activities required for product realization?
2
Does the procedure determine the critical products, components, and/or activities?
3
Does the procedure address the initial evaluation and selection of suppliers?
4
Does the procedure address the use of identified risk to determine the initial assessment method of the supplier’s capability for critical purchases?
5
Does the procedure address the type and extent of control applied to the supply chain for critical products, components, or activities?
5
Does the procedure address criteria, scope, frequency, and methods for re-evaluation of suppliers?
6
Does the procedure address the identification of approved suppliers and the scope of approval?
7
Does the procedure address identification of customer-specified suppliers and suppliers limited by proprietary, and/or legal requirements when 5.5.1.3 (Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited) applies?
5.5.1.2
Initial Supplier Evaluation—Critical Purchases
1
For the purchase of critical products, components or activities, does the initial evaluation of suppliers (not previously approved) address the scope of supply, and are site-specific for each supplier?
2
Does the initial Supplier Evaluation for Critical Purchases include the verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization?
3
Does the initial Supplier Evaluation for Critical Purchases include verification of the type and extent of control applied by the supplier, internally and to their supply chain, to meet the organization’s requirements?
4
Does the initial Supplier Evaluation for Critical Purchases include an assessment of the supplier’s capability to meet the organization’s specified requirements by one or more of the following based on identified risk?
5
Does the initial Supplier Evaluation for Critical Purchases include performing an on-site assessment to verify that relevant product realization processes are being performed in accordance with process controls, and are effective in achieving conformity to requirements, performing an on-site evaluation of relevant activities?
6
Does the initial Supplier Evaluation for Critical Purchases include performing a remote assessment to verify that relevant product realization processes are being performed in accordance with process controls and are effective in achieving conformity to requirements?
6
Does the initial Supplier Evaluation for Critical Purchases include performing inspection, testing, or verification of relevant characteristics of a received product?
7
How does the organization ensure that the suppliers of critical purchases with high-risk severity identified by the organization for which an on-site assessment is not performed, the assessment of the supplier’s capability includes performing a remote assessment and performing inspection, testing, or verification?
8
When remote assessment is performed, does it include verification of objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology?
9
Does the evaluation of a supplier be performed in accordance with the requirements of this section for any additions to a supplier’s scope of approval or change from an approved site to a new site of supply?
For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements does the initial evaluation include a) verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization and/or the customer’s requirements; and b) identifying how the supplied product, component or activity conforms to specified requirements.
2
How does the organization ensure that the scope of approval for customer-specified suppliers shall be limited to the relevant customer contract when assessment per 5.5.1.2, Item c) has not been performed?
5.5.1.4
Initial Supplier Evaluation—Noncritical Purchases
1
For the purchase of noncritical products, components, or activities that impact product realization or the final product, do the criteria for evaluation of suppliers by the organization meet the requirements as that of initial Supplier Evaluation for Critical Purchases or satisfy one of the following a) verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization; b) assessment of the supplier to meet the organization’s purchasing requirements; c) assessment of the product upon delivery or activity upon completion
5.5.1.5
Supplier Reevaluation
1
For previously approved suppliers of products, components, or activities, has the organization determined the supplier reevaluation frequency based on identified risk and supplier quality performance?
2
For the re-evaluation of suppliers of critical products, components or activities, have the requirements of 5.5.1.2 been applied?
3
For the re-evaluation of suppliers of critical products, components or activities for customer-specified suppliers and suppliers limited by proprietary, and/or legal requirements, have the requirements of 5.5.1.3 been applied?
4
For the re-evaluation of suppliers of noncritical products, components, or activities that impact product realization or the final product, have the requirements of 5.5.1.4 been applied?
5.5.1.6
Records
1
Are the Records of the results of all evaluations including objective evidence and any necessary actions arising from the evaluations maintained?
2
Are the Records of identification of approved suppliers, customer-specified suppliers, and suppliers limited by proprietary, and/or legal requirements shall be maintained?
5.5.1.7
Outsourcing
1
How does the organization maintain responsibility for product conformance to specified requirements, including applicable API product specifications, associated with product realization?
2
How does the organization maintain responsibility for product conformance to specified requirements, including applicable API product specifications or other external specifications?
3
Are the Records of outsourced activities maintained and include evidence of conformity?
5.5.2
Purchasing Information
1
How does the organization ensure the adequacy of specified purchasing information before their communication with the supplier?
2
Are the Purchasing information provided to the supplier documented and describes the product or activity to be purchased, including acceptance criteria?
3
Does the Purchasing information describe requirements for approval of the supplier’s procedures, processes, and equipment?
4
Does the Purchasing information describe the applicable version of specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data?
5
Does the Purchasing information describe requirements for the qualification of supplier’s personnel?
6
Does the Purchasing information describe requirements for the qualification of the supplier’s personnel?
7
Does the Purchasing information describe the requirements for approval of product release?
8
Does the Purchasing information describe if the organization or its customer intends to perform verification at the supplier’s premises, the intended verification arrangements?
5.5.3
Verification of Purchased Products, Components or Activities
5.5.3.1
General
1
Does the organization maintain a documented procedure defining the verification for determining whether purchased products components or activities conform to specified purchase requirements?
5.5.3.2
Critical Purchases
1
For critical products, components or activities, has the organization established the procedure for verification?
2
Does the procedure address the review of the organization’s required documentation from the supplier?
3
Does the procedure address the verification that the applicable versions are used when specifications, drawings, process requirements, inspection instructions, traceability requirements, and other relevant technical data are specified?
4
Does the procedure address the inspection, testing and/or verification requirements including methods, frequency, and responsible party.?
5
Does the organization determine the methods, frequency, and responsible party based on identified risk and supplier quality performance?
5.5.3.3
Noncritical Purchases
1
In accordance with the organization’s documented procedure, does the organisation verify Non-critical products, components or activities?
5.3.3.4
Records
1
Are the Records of verification activities and evidence of conformity to specified requirements maintained?
5.6
Control of Product Realization
5.6.1
General
1
Does the organization maintain a documented procedure that describes controls associated with the product realization?
2
In the procedure, has the organization determined and implemented the manufacturing acceptance criteria (MAC)?
3
Has the organization identified and documented of processes critical to product realization?
4
Does the procedure address the implementation of the product quality plan, when applicable?
5
Does the procedure address conformance of design requirements and related changes, when applicable?
6
Does the procedure address the availability and use of product realization equipment and TMMDE, unless it has been excluded?
7
Does the procedure address the use of applicable work instructions?
8
Does the procedure address process control documents?
9
Does the procedure address the implementation of monitoring and measurement activities?
10
Does the procedure address implementation of product release including applicable delivery and post-delivery activities?
11
Does the procedure address review and control of product realization changes, required approvals, and records?
5.6.2
Quality Plans
1
When required by contract, has the organization developed a quality plan that specifies the processes of the quality management system (including the product realization processes) and the resources to be applied to a product?
2
Does the Quality plan address the product description or scope of the quality plan?
3
Does the Quality plan address the required processes and documentation, including required inspections, tests, and records, for conformance with requirements?
4
Does the Quality plan address the identification of outsourced activities and reference to control?
5
Does the Quality plan address the identification of each procedure, specification, or other document referenced or used in each activity?
6
Does the Quality plan address the identification of the required hold, witness, monitor, and document review points?
7
Are the quality plans and any revisions to it are documented and approved by the organization?
8
Are the quality plans and any revisions communicated to the customer?
5.6.3
Process Control Documents
1
Has the organization documented process controls?
2
Does the process control include or refer to requirements for verifying conformance with applicable quality plans, API product specifications, customer requirements, and/or other applicable product standards/codes;
3
Does the process control include or refer to instructions and acceptance criteria for processes, tests, and inspections?
4
Where applicable, Does the process control include or refer to the customer’s inspection hold, witness, monitor, and document review points?
5.6.4
Validation of Processes
1
Does the organization validate processes when the resulting output cannot be verified by subsequent monitoring or measurement, and consequently, deficiencies become evident after the product has been delivered or are in use?
2
Does validation demonstrate the ability of these processes to achieve planned results?
3
Do only the processes specified in a product specification require validation for the applicable product?
4
Does the organization validate the following process: — nondestructive examination (NDE)/nondestructive test (NDT); — welding; — heat treating; and — coating and plating (when identified by the product specification or by the organization as critical to product performance).
5
Does the organization have a documented procedure for the validation of processes, including the methods used for review and approval?
6
Does the procedure include the required equipment?
7
Does the procedure include the qualification of personnel?
8
Does the procedure include the use of specific methods, including identified operating parameters?
9
Does the procedure include the identification of process acceptance criteria?
10
Does the procedure include the requirements for records?
11
Does the procedure include the revalidation?
12
Does the organization need to maintain evidence that the requirements of 5.6.4 Validation of process have been satisfied if it outsources a process that requires validation?
5.6.5
Identification and Traceability
1
Has the organization established and maintained identification throughout product realization, including applicable delivery and post-delivery activities?
2
Has the organization identified the traceability requirements as specified by the organization, the customer, and/or the applicable product specifications?
3
Has the organization maintained a documented procedure for identification and traceability while the product is under the control of the organization?
4
Does the documented procedure address the methods of identification?
5
Does the documented procedure address when required, information needed for traceability?
6
Does the documented procedure address the requirements for maintenance and/or reapplication of identification and/ or traceability?
7
Does the documented procedure address the actions required to address loss of identification and/or traceability?
8
Are the Records of traceability maintained?
5.6.6
Inspection/Test Status
1
Does the organization have a documented procedure for identifying inspection and/or test status throughout product realization, indicating product conformity or nonconformity?
5.6.7
Externally Owned Property
1
Does the organization maintain a documented procedure for controlling externally (including customer) owned property that is incorporated into the product while the property is under the organization’s control?
2
Does the Externally owned property include intellectual property and data that are not publicly available?
3
Does the procedure address identification, verification, safeguarding, preservation, maintenance; and reporting loss, damage, or unsuitability for use to the external owner?
4
Are the Records for the control and disposition of externally owned property maintained?
5.6.8
Preservation of Product
1
Does the organization maintain a documented procedure for describing the methods used to preserve the product and constituent parts throughout product realization and delivery?
2
Does the procedure address identification and traceability marks?
3
Does the procedure address storage, including the use of designated storage areas or stock rooms?
4
Does the procedure address the assessment of conditions at intervals specified by the organization?
5
Does the procedure address transportation;?
6
Does the procedure address handling?
7
Does the procedure address packaging?
8
Does the procedure address Protection?
9
Are the records of the results of assessments maintained?
5.6.9
Inspection, Testing, and Verification
5.6.9.1
General
1
Does the organization maintain a documented procedure for inspection, testing and /or verification of the product to confirm that requirements have been met?
2
Does the procedure address in-process inspection, testing, and/ or verification methods and their application?
3
Does the procedure address final inspection, testing, and/or verification methods and their application?
4
Are the records created and retention?
5.6.9.2
In-process Inspection, Testing, and Verification
1
Does the organization inspect, test, and/or verify products at planned stages as required by the quality plan, process control documents and/or documented procedures?
2
Are the evidence of conformity with the acceptance criteria maintained?
5.6.9.3
Final Inspection, Testing, and Verification
1
Does the organization perform final inspection, testing, and/or verification of the product in accordance with the quality plan, process control documents, and/or documented procedures to determine and document conformity of the finished product to the specified requirements?
2
Unless performed by an automated system, do personnel other than those who performed or directly supervised the product realization perform final acceptance inspection at planned stages of the product realization process?
5.6.9.4
Records
1
Are the Records of all required inspection, testing, verification, and final acceptance maintained?
5.6.10
Preventive Maintenance
1
Does the organization maintain a documented procedure for preventive maintenance of equipment used for product realization?
2
Does the procedure address the requirements for the type of equipment to be maintained, frequency of Preventive Maintenance and Responsible personnel?
3
Are the Records of preventive maintenance maintained?
5.7
Product Release
1
Has the organization maintained a documented procedure to address the release of products to the customer?
2
How do the organization ensure that the release shall not proceed until the planned arrangements have been satisfactorily completed?
3
How does the organization ensure that it releases products that conform to requirements or that are authorized under concession?
Are the records maintained to enable identification of the individual releasing the product?
5.8
Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)
5.8.1
General
1
How does the organization determine the testing, measuring, monitoring, and detection requirements and the TMMDE needed to provide evidence of conformity to those requirements?
2
Does the organization ensure that TMMDE owned and maintained by the organization, employee-owned equipment, and TMMDE from other sources (e.g. third-party, proprietary, and customer-owned) used to provide evidence of product conformity and/or monitor process parameters identified by the organization that impact product conformance are controlled.?
3
Are TMMDE calibrated at specified intervals?
4
When the specified interval is based on the date of first use, is the date of first use documented?
5.8.2
Procedure
1
Does the organization maintain a documented procedure for the control of TMMDE?
2
Does the procedure include requirements for the specific equipment type?
3
Does the procedure address unique identification?
4
Does the procedure address calibration status?
5
Does the procedure address traceability to international or national measurement standards?
6
Where no such standards exist, is the basis used for calibration recorded?
7
Does the procedure address the calibration method and acceptance criteria?
8
Does the procedure address the frequency of calibration, and when the calibration interval begins?
9
Does the procedure address documentation of the calibration measurements before adjustment and measurements after any adjustments during calibration?
10
Does the procedure address actions taken to prevent unintended use of TMMDE identified as out-of-calibration, beyond calibration interval, or not in-service?
11
Does the procedure address when the TMMDE is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the TMMDE and product, including maintaining records and evidence of notification to the customer if suspect product has been shipped?
12
Does the procedure address the use of third-party, proprietary, employee-owned, and customer-owned TMMDE?
13
Does the procedure address the maintenance?
14
Does the procedure address suitability for the planned monitoring and measurement activities?
5.8.3
Equipment
1
Are the TMMDE are calibrated?
2
Are the TMMDE calibration status identifiable by the user prior to and during use?
3
Have the TMMDE safeguarded from adjustments or modifications that would invalidate the measurement result or the calibration status?
4
How are the TMMDE protected from damage and deterioration during handling, maintenance, and storage?
5
How does the organization ensure that TMMDE is used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests performed?
6
How does the organization ensure that when used in the testing, monitoring, measurement, or detection of specified requirements, the ability of computer software to satisfy the intended application are confirmed prior to initial use and reconfirmed, as necessary?
5.8.4
TMMDE Equipment from Other Sources
1
When TMMDE is third-party, proprietary, or customer-owned, how does the organization confirm the equipment is in calibration prior to use? (When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item c), 5.8.2, Item d), 5.8.2, Item e), 5.8.2, Item f), 5.8.2, Item j), and 5.8.2, Item k) shall not apply.)
5.8.5
Records
1
Has the organization maintained a registry of the identified TMMDE that includes a unique identification, specific to each piece of equipment?
2
Are the Results of calibration recorded and maintained?
3
When calibration of the third-party, proprietary, and customer TMMDE to the requirements of 5.8 is limited by customer, contract, or licensing agreement, do the organization maintain records of the limitations imposed?
5.9
Control of Nonconforming Product
5.9.1
Procedure
5.9.1.1
General
1
Does the organization maintain a documented procedure addressing the controls and related responsibilities and authorities for nonconforming products during product realization and after delivery?
5.9.1.2
Nonconforming Product During Product Realization
2
For addressing nonconforming products identified during product realization, does the procedure include product identification and controls to prevent unintended use or delivery?
3
How does it address the detected nonconformity?
4
How does it address taking action to preclude its original intended use or delivery?
5
How does it address authorizing its use, release, or acceptance under concession by the relevant authority and, where applicable, by the customer?
5.9.1.3
Nonconforming Product After Delivery
1
How does the procedure address identifying, documenting, and reporting nonconforming products?
2
Does the procedure include the analysis of nonconforming product, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause?
3
How does the procedure address taking action appropriate to the effects, or potential effects, of the nonconformity?
4
Does the procedure include authorizing its use or acceptance under concession by relevant authority and, when required, by the customer?
5.9.2
Nonconforming Product
Does the organization address nonconforming products by performing one or more of the following: a) repair or rework with the subsequent inspection to meet specified requirements; b) re-grade for alternative applications; c) release under concession d) reject or scrap
5.9.3
Release of Nonconforming Product Under Concession
1
For the nonconforming product that does not satisfy manufacturing acceptance criteria (MAC), how does the organization ensure that its release under concession meets one of the following conditions: a) products continue to satisfy the applicable Design Acceptance criteria (DAC) and/or customer criteria; or b) the violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer criteria; or c) the DAC is changed and the products satisfy the revised DAC and associated MAC requirements. When the DAC was previously agreed with the customer, the DAC change shall be authorized by the customer.
2
How does the organization ensure that the product not conforming to DAC or contract requirements is not released without customer authorization?
5.9.4
Customer Notification of Nonconforming Product
1
How does the organization notify customers of a product not conforming to DAC or contract requirements, that has been delivered?
2
Are records of such notification maintained?
5.9.5
Records
1
Are Records of nonconformities maintained?
2
Does the Records of nonconformities include the description of the nonconformity, subsequent actions taken, including concessions obtained, the rationale to support the release of the product under concession, and relevant authority?
5.10
Management of Change (MOC)
5.10.1
General
1
Do the organization maintain a documented procedure for MOC to maintain the integrity of the quality management system when changes occur?
2
Does the MOC procedure address the description of, and the need for, the change?
3
Does the MOC procedure address the availability and allocation of resources (including personnel)?
4
Does the MOC procedure address potential risks that may arise from implementing the change?
5
Does the MOC procedure address the review, approval, and implementation of the change?
6
Does the MOC procedure address notifications?
7
Does the MOC procedure address verification of the completion of MOC activities and impact on the QMS?
5.10.2
MOC Application
1
How does the organization use MOC for changes that may negatively impact the quality of the product?
5.10.3
MOC Notification
1
Does the organization notify relevant internal personnel of the change and associated risk?
2
When required by contract, does the organization notify the customer of the change and associated risk?
3
Are the MOC Notifications documented?
5.10.4
Records
1
Are the Records of MOC activities shall be maintained?
6.0
Quality Management System Monitoring, Measurement, Analysis, and Improvement
6.1
General
1
Have the organization planned and implemented the monitoring, measurement, analysis, and improvement processes needed to ensure conformity of the quality management system to the requirements of API Q1 specification and to continually improve the effectiveness of the quality management system?
2
Does the Quality management system monitoring, measurement, analysis, and improvement include the determination of applicable methods, including techniques for the analysis of data, and the extent of their use?
6.2
Monitoring, Measuring, and Improving
6.2.1
Customer Satisfaction
1
Does the organization maintain a documented procedure to measure customer satisfaction?
2
Does the procedure address the frequency and method of determining Customer satisfaction?
3
Does the procedure address the key performance indicators of customer satisfaction?
4
Are the records of the results of customer satisfaction information maintained?
6.2.2
Internal Audit
6.2.2.1
General
1
Does the organization conduct internal audits to ascertain whether the quality management system is implemented, maintained, and adheres to the specifications outlined in API Q1 as well as the organization’s quality management system requirements?
2
Does the organization maintain a documented procedure to define responsibilities for planning, conducting, and documenting internal audits?
3
Has the organization identified the audit criteria, scope, frequency, and methods of the internal audit?
4
Is the planning of audits conducted with consideration given to the outcomes of previous audits (both internal and external), the criticality of the audited process, and any modifications made to the quality management system?
5
Does the organization ensure that all processes of the quality management system claiming conformity to the requirements of API Q1 specification are audited at least every 12 months?
6
Is the time between audits of each part of the quality management system ensured not to exceed 12 months when the entire quality management system is not audited as one consolidated audit?
7
Do audits for processes performed by the organization, which are identified as critical to product realization, involve observing the activity being conducted and assessing whether it complies with the specified requirements?
6.2.2.2
Performance of Internal Audit
1
Are the Audits performed by competent personnel independent of those who performed or directly supervised the activity being audited to ensure objectivity and impartiality of the audit process?
2
Are records of Internal audits maintained?
3
Do the records provide objective evidence that the quality management system is implemented and maintained?
6.2.2.3
Audit Review and Closure
1
How does the organization identify response times for addressing detected nonconformities?
2
How does the management responsible for the area being audited ensure that necessary corrections and corrective actions are undertaken as per requirements for corrective action?
3
Are the Records of internal audits maintained?
6.3
Analysis of Data
1
Does the organization maintain a documented procedure for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system?
2
Does the analysis include data generated from monitoring and measurement, internal audits, audits by external parties, management reviews, and other relevant sources?
3
Does the data analysis output provide information relating to customer satisfaction, nonconformity to product requirements during product realization, process performance, supplier performance and achiving quality objectives?
4
Does it include the nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause?
5
Does the organization use data to evaluate where continual improvement of the effectiveness of the quality management system can be made?
6.4
Improvement
6.4.1
General
1
Does the organization continually improve the effectiveness of the quality management system by evaluating, selecting, and implementing opportunities for improvement through quality objectives, internal audit, data analysis, corrective action, and management review. ?
6.4.2
Corrective Action
1
Does the organization maintain a documented procedure to handle nonconformities, including those arising from customer complaints, and to initiate corrective actions both internally and with suppliers?
2
Are the Corrective actions appropriate to the effect(s) of the nonconformity encountered?
3
Does the procedure address the criteria for determining when the corrective action process is initiated?
4
Does the procedure address reviewing the nonconformity?
5
Does the procedure address determining and implementing corrections?
6
Does the procedure address identifying the root cause of the nonconformity and evaluating the need for corrective actions?
7
Does the procedure address the implementing corrective action to reduce the likelihood that a nonconformity recurs?
8
Does the procedure address identifying the timeframe and responsible person(s) for addressing corrections and corrective action?
9
Does the procedure address the verification of the effectiveness of the corrections and corrective action taken?
10
Does the procedure address the updating risks and opportunities determined during planning?
11
Does the procedure address the MOC when the corrective actions require new or changed controls within the quality management system?
12
Does the procedure address evaluating similar, potential nonconformities and implementing action to reduce the likelihood of occurrence, as appropriate?
13
Are the Records of corrective action process activities maintained?
14
Do the Records identify the activities performed to verify the effectiveness of the corrective actions taken?
6.5
Management Review
6.5.1
General
1
Is the organization‘s quality management system reviewed at least every 12 months(not later than the end of the same calendar month as the prior year review) by the organization’s management?
2
Does the management review evaluate the quality management system’s continuing suitability, adequacy, and effectiveness?
3
Do the reviews include assessing opportunities for improvement, adequacy of resources and the need for changes to the quality management system, including the quality policy and quality objectives?
6.5.2
Input Requirements
1
Does the input to the management review include the status and effectiveness of actions resulting from previous management reviews?
2
Does the input to management review include the results of audits and audits of the organization by external parties?
3
Does the input to management review include changes that could affect the quality management system, including changes to legal and other applicable requirements(such as industry standards)?
4
Does the input to management review include changes that could affect the quality management system, including changes in external and internal issues that are relevant to the quality management system?
5
Does the input to the management review include an analysis of customer satisfaction?
6
Does the input to the management review include relevant feedback from customers and other interested parties?
7
Does the input to management review include process performance?
8
Does the input to the management review include the results of the risk assessment and the effectiveness of actions taken to address risks?
7
Does the input to management review include the status of corrective actions?
8
Does the input to the management review include the analysis of supplier performance?
9
Does the input to management review include a review of the analysis of product conformity, including nonconformities identified after delivery or use?
10
Does the input to the management review include actual performance compared with quality objectives?
11
Does the input to the management review include recommendations for improvement?
6.5.3
Output Requirements
1
Does the output from the management review include a summary assessment of the effectiveness of the quality management system?
2
Does the assessment include any required changes to the processes and any decisions and actions, required resources, and any improvement to products in meeting customer requirements?
3
Do the Top management reviews and approves the output of management reviews?
4
Has the organization applied the API Monogram to products developed, maintained, and operated at all times in a quality management system conforming to API Q1?
5
Are the records of the management review maintained?
Use of API Monogram by Licensees
A.4
Quality Management System Requirements
1
Has the organization applied the API Monogram to products developed, maintained, and operated at all times in a quality management system conforming to API Q1?
A.5
Control of the Application and Removal of the API Monogram
1
Does the Licensee ensure that Products that do not conform to API-specified requirements shall not bear the API Monogram
2
Has the Licensee developed and maintained an API Monogram marking procedure that documents the marking/monogramming requirements and any applicable API product specification(s) and/or standard(s)?
3
Has the organization applied the API Monogram to products developed, maintained, and operated at all times a quality management system conforming to API Q1.
4
Does the marking procedure define the method(s) used to apply the Monogram?
5
Does the marking procedure identify the location on the product where the API Monogram is to be applied?
6
Does the marking procedure require the application of the Licensee’s license number and date of manufacture of the product in conjunction with the use of the API Monogram?
7
Does the marking procedure require that the date of manufacture, at a minimum, be two digits representing the month and two digits representing the year (e.g. 05-12 for May 2012) unless otherwise stipulated in the applicable API product specification(s) or standard(s)?
8
Does the marking procedure require controls for the application of the additional API product specification(s) and/or standard(s) marking requirements, as applicable?
9
Is the API Monogram removed by the Licensee’s API Monogram marking procedure if the product is subsequently found to be out of conformance with any of the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program?
10
Is the API monogram applied at the site for which the API Monogram license is issued?
11
Is the API Monogram removed in accordance with the Licensee’s API Monogram marking procedure if the product is subsequently found to be out of conformance with any of the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program?
A.6
Design Package Requirements
1
Does the Licensee and/or applicant for licensing maintain a current design package for all of the applicable products that fall under the scope of each Monogram license?
2
Does the design package information provide objective evidence that the product design meets the requirements of the applicable and most current API product specification(s)?
3
Is the design package(s) made available during API audits of the facility?
A.7
Manufacturing Capability
1
Has facilities demonstrated the ability to manufacture equipment that conforms to API specifications and/or standards?
A.8
API Monogram Program: Nonconformance Reporting
1
As a customer do you report to API all problems with API monogrammed products using the API Nonconformance Reporting System available at http://compositelist.api.org/ncr.asp.
The following checklist can be used for both internal audits as well as Gap Analysis tools.
ISO 29001:2020 Checklist
Clause 4:
Context of the organization
4.1
Understanding the organization and its context
1
Has the organization determined the external and internal issues relevant to the Purpose & strategic direction of its QMS and that can affect its ability to achieve the intended results?
2
Does the organization monitor and review information about these external and internal issues?
3
While determining the internal and external issues has the organization considered positive and negative factors or conditions?
4
Was the understanding of the external context facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local?
5
Was the understanding of the internal context facilitated by considering issues arising from values, culture, knowledge and performance of the organization?
6
Does the organization retains documented information that demonstrates the understanding of its context?
4.2
Understanding the needs and expectations of interested parties
1
Has the organization determined the interested parties that are relevant to the QMS?
2
Has the organization determined the requirements of these interested parties relevant to the QMS?
3
Does the organization monitor and review the information about these interested parties and their relevant requirement?
4
Does the organization retains documented information that demonstrates the understanding of the needs and expectations of interested parties?
4.3
Determining the scope of the quality management system
1
Has the organization established the scope of its QMS?
2
Has the organization determined the boundaries and applicability of the QMS?
3
While determining the scope, has the organization determined the external and internal issues, requirements of relevant interested parties, product and services of the organization?
4
While determining Applicability, does the organization determine if it affects its ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction?
5
Does the scope state the types of products and services covered?
6
Does the scope give justification for any requirements that the organization determines and is not applicable to the scope of its QMS?
7
Is the organization’s scope made available and maintained as a Documented Information?
8
When requested, does the organization advises interested parties of any requirements of this document that the organization determines are not applicable to the scope of its quality management system?
4.4
Quality management system and its processes
1
Has the organization established, implemented, maintained and continually improved its QMS?
4.4.1
1
Has the organization determined the processes needed for the QMS?
2
Has the organization determined the application of these process throughout the organization?
3
Has the organization determined the sequence and the interaction of these process?
4
Has the organization determined and applied the criteria and methods needed to ensure the effective operation and control of these processes?
5
Do these methods include the monitoring, measurement and related performance indicator?
6
Has the organization determined the resources needed for the organization?
7
Has the organization ensured the availability of the resources needed for these processes?
8
Has the organization assigned the responsibilities and authorities for these processes?
9
Has the organization addressed the risk and opportunities associated with these processes?
10
Has the organization evaluated these processes and implemented any changes needed to ensure that these processes achieve its intended results?
11
Has the organization made improvement in its processes and its QMS?
4.4.2
1
Has the organization maintained documented information to support the operation of its processes?
2
Do the organization retain documented information as evidence that the processes have been carried out as planned?
4.4.3
1
Has the organization defined the extent of documented information required to meet relevant interested parties’ requirements?
Clause 5
Leadership
5.1
Leadership and commitment
5.1.1
General
1
Does the top management demonstrate leadership and commitment by taking accountability for the effectiveness of its QMS?
2
Has the top management ensured that the quality policy and quality objective are established?
3
Is the quality policy and quality objective compatible with the context and strategic direction of the organization?
4
Has the organization integrated the requirements of QMS with the business processes?
5
Is the organization promoting the use of process approach and risk-based thinking throughout the organization?
6
Is the top management ensuring that the resources needed for the QMS are available?
7
Is the importance of the effectiveness of QMS and meeting QMS requirements communicated?
8
Does the top management ensure that the QMS is achieving its intended results?
9
Does Top Management engage, directs and supports the persons required to contribute to the effectiveness of the QMS requirements?
10
Is Top Management promoting improvements?
11
Is Top Management supporting other relevant management roles to demonstrate their leadership as it applies to their area of responsibilities?
5.1.2
Customer Focus
1
Does the Top Management demonstrate leadership and commitment by ensuring that customer and applicable statutory and regulatory requirements are determined, understood and are consistently meeting the requirements?
2
Are the risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed?
3
Is the focus of enhancing customer satisfaction maintained?
5.2
Policy
5.2.1
Establishing the Quality policy
1
Has the Top Management established, implemented and maintained a quality policy?
2
Is quality policy appropriate to the purpose and context of the organization and does it supports its strategic directions?
3
Does the Quality policy provide the framework for setting quality objective?
4
Does the Quality policy include the commitment to satisfy applicable requirements and to continually improvement of the QMS?
5.2.2
Communicating the quality policy
1
Is Quality policy maintained as documented information?
2
Is Quality policy communicated, understood and applied within the organization?
3
Is Quality policy appropriate and made available to the relevant interested parties?
5.3
Organizational roles, responsibilities and authorities
1
Has the Top management ensured that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?
2
While assigning the responsibilities and authorities, do the top management ensure that the processes are meeting their intended results?
4
While assigning the responsibilities and authorities, do the top management ensure that there is the promotion of customer focus throughout the organization?
5
While assigning the responsibilities and authorities, do the top management ensure that performance of its QMS and opportunities for improvement are reported to them?
6
While assigning the responsibilities and authorities, do the top management ensure that integrity of QMS is maintained when changes to the QMS are planned and maintained?
7
Has the organization defined the relevant roles?
8
Has the organization maintained and retained documented information (record and procedure) covering responsibilities and authorities for these roles?
Clause 6
Planning
6.1
Actions to address risks and opportunities
1
While planning for QMS, does the organization considers the issues referred to in clause 4.1 and requirement referred to in clause 4.2?
6.1.1
1
Has the organization determined the risks and opportunities that have to be addressed so that QMS can achieve its intended results, enhance desirable effects, prevent, or reduce undesired effects and achieve improvement?
6.1.2
1
Has the organization planned actions to address these risks and opportunities?
2
Have these actions implemented and integrated into its QMS processes?
3
Has the organization evaluated the effectiveness of these actions?
4
Is the action proportionate to the potential impact on the conformity of product and services?
6.1.3
1
For managing risks and opportunities has the organization defined techniques, tools and their application for identification and assessment of risks and opportunities, and prevention and mitigation of risks?
2
For managing risks and opportunities has the organization identified relevant interested parties?
3
For managing risks and opportunities has the organization identified sources of risk and opportunity, areas of impacts, events and their causes, and their potential consequences?
4
For managing risks and opportunities has the organization analysed potential risk and opportunity by determining consequences and their likelihood?
5
For managing risks and opportunities has the organization evaluated risk and opportunity and develop controls for them?
6
For managing risks and opportunities has the organization applied appropriate risk treatments and opportunity realization plans?
7
Has the organization maintained and retained documented information (records and procedure) to support and demonstrate the management of risks and opportunities?
6.2
Quality objectives and planning to achieve them
6.2.1
1
Has the organization established quality objectives at relevant functions, levels and process needed for the QMS?
2
Are the quality objectives consistent with the quality policy?
3
Does the organization have quality objectives which are relevant to the conformity of product and services and enhancement of customer satisfaction?
4
Are the quality objective measurable and do they take account of applicable requirements?
5
Are the quality objectives monitored, communicated and updated as required?
6
Does the organization maintain documented information on the quality objectives?
6.2.2
1
For achieving quality objectives do the organization determines what will be done, what resources are required, who will be responsible, when will it be completed and how are the result to be evaluated?
6.3
Planning for change
1
While determining changes for the QMS, are changes carried out in a planned manner?
2
While planning for change, does the organization consider the purpose of the change and their potential consequence; the integrity of the QMS; the availability of resources; and allocation and reallocation of responsibilities and authorities?
3
How does the organization manage risks and opportunities associated with proposed changes?
4
Has the organization maintained and retained documented information (records and procedure) to manage the process of change?
7
Support
7.1
Resources
7.1.1
General
1
Has the organization determined and provided the resources needed for the establishment, implementing, maintaining and continually improvement of the QMS?
2
Has the organization considered the capabilities and constraints of existing internal resources?
3
Has the organization considered what needs to be obtained from external providers?
7.1.2
People
1
Has the organization determined and provided the persons required for effective maintenance of QMS and for operation and control of its processes?
7.1.3
Infrastructure
1
Has the organization determined and maintained the infrastructure needed for the operation of its processes and to achieve conformity of product and services?
7.1.3.1
1
Does the organization maintains and retains documented information of the processes for the determination and usage of its infrastructure to achieve conformity of products and services?
2
Does the documented Information addresses infrastructure to be maintained?
3
Does the documented Information addresses method of maintaining the infrastructure, including frequency and monitoring, that ensure infrastructure integrity to performance requirements?
4
Does the documented Information addresses outcome of maintenance, including applicable testing methods and acceptance criteria?
5
Does the documented Information addresses responsible personnel?
7.1.3.2
1
For service-related infrastructure, does the documented information addresses usage history, repairs or redress, modifications, remanufacturing, inspection, and test activities that allow direct verification for reuse of infrastructure?
2
For service-related infrastructure, does the documented information addresses list of critical spare parts required by the customer and/or technical requirements including those recommended by the original equipment manufacturer?
7.1.3.3
1
Does the organization applies risk-based maintenance which typically includes the concepts of preventive and predictive maintenance and /or reliability centred maintenance and /or mean time between failures and /or system, design and process failure mode and effects analysis and /or failure mode and criticality effects analysis and /or process control plans and/or others that are in context of the organization and its risks.
7.1.4
Environment for the operation of processes
1
Has the organization determined, provided and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services?
7.1.5
Monitoring and measuring resources
7.1.5.1
General
1
Has the organization determined and provided the necessary resources needed when monitoring and measuring are used to verify conformity to product and service requirement?
2
Are resources suitable for the type of monitoring and measurement activities undertaken?
3
Are resources maintained to ensure their continuing fitness?
4
Does the organization retains appropriate documented information (record) as evidence of fitness for the purpose of the monitoring and measurement resources?
5
Does the organization maintains documented information that defines the processes and controls employed to manage monitoring and measurement resources that meet the requirements?
7.1.5.2
Measurement traceability
1
Is there a requirement for measurement traceability?
2
Where measurement traceability is a requirement, is measurement equipment calibrated or verified at a specified interval or prior to use?
3
Is the calibration or done against measurements standards traceable to national or international standards?
4
Where no such standard is existing, are documented information retained for the basis used for calibration or verification?
5
Are the measuring equipment identified in order to determine their status?
6
Are the measuring equipment safeguarded from adjustments, damage or deteriorated that would invalidate the calibration and subsequent measurement results?
7
Does the organization maintains and retains documented information (records and procedure )demonstrating the conformance and measurement traceability of the measuring equipment used to determine product conformity to requirements? Does it includes some of the Common practice like a measuring equipment register?
8
Does documented information includes a unique identification, specific to each piece of equipment?
9
Does the organization determine and take appropriate action if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose?
10
Does the organization shall retain documented information of the action taken and of customer notification, if product(s) or services have been delivered?
7.1.6
Organizational knowledge
1
Does the organization determine the knowledge necessary for the operation of its processes and to achieve conformity of product and services?
2
Does the organization maintain this knowledge and make it available to the extent necessary?
3
While addressing changing needs and trends, does the organization considers its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates?
7.2
Competence
1
Does the organization determine the necessary competence of its employees whose work affects the performance and effectiveness of the QMS?
2
Does the organization ensure that its employees are competent on basis of appropriate education, training or experience?
3
Does the organization take applicable actions to acquire the necessary competence and evaluate the effectiveness of action taken?
4
Does the organization retain the appropriate documented information as evidence of competence?
7.2.1
1
Does the organization validates the competence to the risk level associated with the task?
2
Does the organization maintains documented information that defines the practices employed to manage competence requirements of personnel whose responsibilities influence the achievement of quality objectives?
3
Does it includes developing a competence model that defines a competence catalogue, proficiency levels, criteria for attaining and maintaining proficiency, and resulting competence profiles which can include technical interviews, assessments and online training.
7.3
Awareness
1
Does the organization ensure that the persons doing work under the organization’s control are aware of its quality policy, relevant quality objectives, their contribution to the effectiveness of QMS including the benefits of improved performance and the implications of not meeting QMS requirements?
2
How does the organization ensures that persons doing work under the organization’s control, including external provider’s personnel, are aware of specified regulated and customer quality requirements, risk mitigations and conformity assessment requirements related to their work.?
7.4
Communication
1
Does the organization determine the internal and external communication relevant to the QMS including on what it will communicate, when to communicate, with whom to communicate, how to communicate, and who communicates?
7.5
Documented Information
7.5.1
General
1
Does the organization’s QMS include documents required by ISO 9001:2015 and documents determined by the organization necessary for the effectiveness of the QMS?
7.5.2
Creating and updating
1
While creating and updating documented information, does the organization ensure it is appropriate in terms of identification descriptions?
2
While creating and updating documented information does the organization ensure that it is in proper format and in the correct media?
3
While creating and updating documented information, does the organization ensure that there are appropriate review and approval for suitability and adequacy?
7.5.3
Control of documented information
7.5.3.1
1
Does the organization control its documented information to ensure that it is available and suitable for use, whenever it is needed?
2
Is the documented information adequately protected?
7.5.3.2
1
Is the distribution, access, retrieval and use of documented information adequately controlled?
2
Is the documented properly stored and adequately preserved and it is legible?
3
Is there control of changes (e.g. version control)?
4
Are their adequate control in place for retention and disposition?
5
Is external origin documented information necessary for planning and operation of QMS appropriately identified and controlled?
6
Are records protected for unintended alterations?
7.5.3.3
1
The organization shall maintain documented information (Procedure) that defines the processes and controls used to meet the requirements of control of Documented Information?
2
When external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of a product or service, does the organization maintain and retain documented information for the practices employed for the integration of these requirements into the related operating processes?
Clause 8
Operations
1
Does the organization plan, implement and control the processes needed to meet the requirement for the provision of product and services and to implement the action determined in clause 6?
8.1
Operation planning and control
1
Does the organization determine the requirements for the products and services?
2
Has the organization established criteria for the processes and acceptance of products and services?
3
How does the organization determine the resources needed to achieve conformity to the product and service requirements?
4
How does the organization implement controls of the processes in according with the criteria?
5
How does the organization determine, maintain and retain necessary documented information to have confidence that the processes have been carried out as planned and to demonstrate the conformity of products and services?
6
How does the organization control its planned changes and review the consequences of unintended changes?
7
How does the organization take action to mitigate any adverse effects of its unintended changes?
8
How does the organization ensure that outsourced processes are controlled?
9
When determining the requirements for the products and services, how does the organization take into account the customer’s scope?
10
Do the organization have documented information specifying the processes of the quality management system and the resources to be applied to a specific product, service, project or contract such as a quality plan, service quality plan or inspection and test plan?
11
How do the organization maintain documented information as the basis for operational process control and retain documented information to demonstrate conformance has established the controls?
12
How does the organization apply change management processes in respect to risks to the achievement of specified requirements and to the realization of improvement opportunities when planning the operations?
13
Has the organization established contingency plans as a risk treatment and in case it has does it include roles and responsibility for response, communication, immediate actions?
8.2
Requirements for products and services
8.2.1
Customer communication
1
Does the organization communicate with customers to provide information relating to products and services, handling enquiries, contracts or orders (including any changes)?
2
Does the organization obtain customer feedback relating to products and services including customer complaint?
3
Does the organization communicate with the customers relating to handling or controlling customer property?
4
Has the organization established requirements for contingency action, where required?
8.2.2
Determining the requirements for products and services
1
Has the organization determined the requirements for product and services to be offered the customer?
2
Are the requirements defined and does it includes applicable statutory regulatory requirements and those considered necessary by the organization?
3
Can the organization meet the claims for the product and services it offers?
8.2.3
Review of the requirements for products and services
8.2.3.1
1
Has the organization ensured that it has the ability to meet the requirements for products and services?
2
Has the organization conducted a review before committing to supply product and services?
3
Has the organization reviewed the requirements specified by the customer, including the requirements for delivery and post-delivery activities?
4
Has the organization reviewed the requirements not stated by the customers but necessary for the specified or intended use when know?
5
Has the organization reviewed the statutory & regulatory requirements applicable to the product and services and requirements specified by the organization?
6
Have the organization reviewed and resolved contract or order requirements differing for those previously defined?
7
When the customer does not provide a documented statement of their requirement, does the organization conform to the customer’s requirements before acceptance?
8.2.3.1.1
1
Does the organization maintain documented information (Procedure )that defines the process for the review of requirements related to the provision of products or services?
8.2.3.2
1
Does the organization retain documented information on the results of the review and on any new requirements for the products and services?
8.2.4
Changes to requirements for products and services
1
Does the organization ensure that the relevant documented information is amended and the relevant persons are made aware of the changed requirements when the requirements for the products and services are changed?
8.3
Design and development of products and services
8.3.1
General
1
Has the organization established, implemented and maintain a D&D process that is appropriate to the subsequent provision of product and services?
8.3.2
Design and development planning
1
In determining the stages and controls for D&D, has the organization is taken into consideration the nature, duration and complexity of D&D activities?
2
In determining the stages and controls for D&D, has the organization taken into consideration the required process stages including D&D reviews?
3
In determining the stages and controls for D&D, has the organization taken into consideration the D& D verification and validation activities?
4
In determining the stages and controls for D&D, has the organization taken into consideration the responsibilities and authorities involved in the D&D process?
5
In determining the stages and controls for D&D, has the organization taken into consideration the external and internal resources needed?
6
In determining the stages and controls for D&D, has the organization taken into consideration the need to control interfaces between persons involved in D&D?
7
In determining the stages and controls for D&D, has the organization taken into consideration the need for involvement of customer and user?
8
In determining the stages and controls for D&D, has the organization taken into consideration the requirements of the subsequent provision of product and services?
9
In determining the stages and controls for D&D, has the organization taken into consideration the level of the control expected for the D&D by customers and other relevant interested parties?
10
In determining the stages and controls for D&D, has the organization taken into consideration the documented information needed to demonstrate that design and development requirement has been met?
11
How does the organization ensures that ensure that the required activities for managing risks and opportunities are incorporated in the design development process?
12
Has the organization maintained documented information (Procedure) that defines the processes used to plan and control design and development activities of products and/or services?
8.3.3
Design and Development inputs
1
Has the organization determined the essential requirements for the specific types of products and services to be designed and developed?
2
Does the organization consider the following functional and performance requirements; statutory and regulatory requirements; standards or code of practices that the organization has committed to implement; information derived from previous design and development activities; potential consequences of failure due to the nature of the product and services?
3
Does the organization ensure that the inputs are adequate for D&D purpose, complete and unambiguous?
4
Does the organization resolve the conflicting D&D inputs?
5
Are documented information for D&D inputs retained?
6
Has the organization included environmental and safety conditions as the Performance requirements?
7
Has the organization considered outputs of process of managing risks and opportunities?
8.3.4
Design and development controls
1
Has the organization applied the necessary controls to D & D processes to ensure that the result to be achieved are defined?
2
Has the organization conducted a review to evaluate the ability of the results of D& D to meet the requirements?
3
Has the organization conducted the verification to ensure that D&D meet input requirements?
4
Has the organization conducted the validation to ensure that the resulting product and service meet the requirements of the specified application or intended use?
5
Has the organization taken necessary action on the problems determined during reviews, verification or validation activities?
6
Has the organization retained documented information on the above-mentioned activities?
8.3.5
Design and Development outputs
1
Does the organization ensure that D&D outputs meet the input requirements?
2
Does the organization ensure that D&D outputs are adequate for the subsequent processes for the provision of product and services?
3
Does the organization ensure that D&D outputs include (or has reference) monitoring and measuring requirements and acceptance criteria?
4
Does the organization ensure that D&D outputs specify the characteristics of the products and services that are essential for their intended use?
8.3.6
Design and Development changes
1
Has the organization identified, reviewed and controlled changes made during, or subsequent to the D & D of the product and services to ensure that there is no averse to the impact on conformity to requirement?
2
Has the organization retained the documented information on D&D changes, the result of reviews, authorization of the changes and the action taken to prevent adverse impact?
8.4
Control of externally provided processes, products and services
8.4.1
General
1
Does the organization ensure that the externally provided processes, products and services conform to the requirements?
2
Does the organization determine the controls needed when the product and services from the external providers are incorporated into their own product and services?
3
Does the organization determine the controls needed when the product and services from the external providers are provided directly to the customer by external providers?
4
Does the organization determine the controls needed when the process or part of the process is provided by the external providers?
5
Has the organization determined and applied the criteria for selection, evaluation, monitoring of performance and re-evaluation of external providers?
6
Has the organization retained the documented information of these activities and any action arising out or evaluation/re-evaluation?
8.4.2
Type and extent of control
1
Does the organization ensure that the externally provided processes, product and services do not adversely affect its ability to consistently deliver conforming products and services to the customers?
2
Does the organization ensure that the externally provided process remains within the control of its QMS?
3
Has the organization defined the controls to be applied to an external provider and its resulting outputs?
4
Has the organization taken into consideration the potential impact of the organization’s ability to consistently meet customer and applicable statutory and regulatory requirement?
5
Has the organization taken into consideration the effectiveness of the controls applied by the external providers?
6
Has the organization determined the verification or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?
8.4.2.1
1
How does the organization assess external provider performance at planned intervals, and adjust the type and extent of controls to manage associated risks and opportunities?
2
Has the organization maintained documented Information (procedure ) that defines how the requirements of type and extent of control of externally provided processes, products and services are met?
3
How does the organization addresses the determination of the risks to the achievement of specified requirements and to the realization of improvement opportunities for the products and/or services to conformance to specified requirements?
4
Has the organization retained documented information (records) that demonstrates the effectiveness of verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?
8.4.3
Information for external providers
1
Does the organization ensure the adequacy of requirements prior to their communication to the external provider?
2
Does the organization communicate to the external providers its requirements for the processes, products and services required?
3
Does the organization communicate to the external providers its requirements for the approval of the product and services; methods, processes and equipment; the release of product and services?
4
Does the organization communicate to the external providers its requirements for competence including any qualification of persons?
5
Does the organization communicate to the external providers its requirements for external provider’s interactions with the organizations?
6
Does the organization communicate to the external providers its requirements for control and monitoring of the external providers’ performance to be applied by the organization?
7
Does the organization communicate to the external providers its requirements for verification or validation activities that the organization or its customer intends to perform at the external providers’ premises?
8.5
Production and Service provision
8.5.1
Control of production and service provision
1
Has the organization implemented production and service provision under controlled conditions?
2
Are there any documented information available that defines the characteristics of the product, services or activities to be performed and the results to be achieved?
3
Are any suitable monitoring and measuring resources available? Are they being used?
4
Are monitoring and measuring activities being performed at appropriate stages?
5
Are competent persons (including qualification) being appointed?
6
Is the infrastructure and environment being used suitable for operation of processes?
7
Has the organization implemented any actions to prevent human error?
8
Has the organization implemented any release, delivery and post-delivery activities?
9
Where resulting output cannot be verified by subsequent monitoring or measurement, has the organization conducted validation and periodic revalidation of the process for production and service provision?
8.5.1.1
1
For the validation and periodic revalidation has the organization considered required equipment, competence of personnel, use of specific methods, including identified operating parameters, identification of acceptance criteria and revalidation.
2
How does the organization maintains documented information that defines the controls used to meet the requirements of Control of production and service provision?
3
How does the organization retain documented information (records) to demonstrate the control effectiveness?
8.5.2
Identification and traceability
1
Has the organization used any suitable means to identify output when it is necessary to ensure the conformity of products and services?
2
Has the status of outputs with respect to monitoring and measuring requirements throughout the production and service provision being identified by the organization?
3
Has the organization controlled the unique identification of the outputs when traceability is a requirement?
4
Has the organization retain the documented information necessary to enable traceability, when traceability is a requirement?
8.5.2.1
1
How does the organization maintains documented information that defines the processes used to meet the requirements of Identification and traceability?
8.5.3
Property belonging to customers or external providers
1
When property belonging to customers or external providers is under the organization’s control or being used by the organization, does the organization exercise adequate care?
2
Does the organization identify, verify, protect and safeguard customers’ or external providers’ property?
3
When the property or the customer or external provider is lost, damaged or otherwise, fount to be unsuitable for use, does the organization report this to the customer or external provider? Does the organization retain documented information on what has occurred?
8.5.3.1
1
How does the organization maintains documented information that defines the processes that are used to meet the requirements of Property belonging to customers or external providers?
8.5.4
Preservation
1
Does the organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?
2
Does the organization maintains documented information (Procedure ) for risk-based preservation?
3
Does the documented information defines the methods used to preserve products, including environment controls , and constituent parts throughout operations, delivery to the intended destination, and/or service delivery, in order to maintain conformity to requirements?
Does the documented information defines the storage areas designated to prevent damage or deterioration of product and constituent parts, pending use or delivery?
4
Does the documented information defines the type and frequency of assessment, appropriate to the product being assessed, to detect deterioration?
5
Does the documented information defines the identification and traceability marks, transportation, handling, packaging, and protection requirements, as applicable?
Post-delivery activities
8.5.5
1
Does the organization meet requirements for post-delivery activities associated with the product and services?
2
In determining the extent of post-delivery activities does the organization considers the statutory & regulatory requirements; the potential undesired consequences associated with its product and services; customer requirement & feedback; nature, use and intended lifetime of its product and services?
8.5.6
Control of change
1
Do the organization conduct review and control changes for production or service provision to ensure continuing conformity with requirements? The changes for production or service provision includes a) the organizational structure; b) key or essential personnel; c) critical providers; d) design; e) the management system.
2
How does the organization notify customers where changes impact product and/or services to be delivered to the customer?
3
Does the organization retain documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review?
4
How does the organization reviews changes resulting from assessments of risks and opportunities and corrective actions?
5
When specified how does the the organization notifies the customer of the effect of changes on residual or new risks?
8.6
Release of products and services
1
Has the organization implemented planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?
2
Does the organization ensure that the release of product and service proceed only after the planned arrangement is satisfactorily completed or approved by the relevant authority and as applicable by the customer?
3
Does the organization retain the documented information on the release of products and services and it includes information relating to the evidence of conformity with the acceptance criteria; traceability of the person authorizing the release?
4
How does the organization maintains documented information that defines the processes that are used to meet the requirements of Release of products and services?
8.7
Control of nonconforming outputs
8.7.1
8.7.1
1
Does the organization ensure that the outputs which do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?
2
Is the action appropriate to the nature of the nonconformity and its effect on the conformity of products and services?
3
Do the organization also consider nonconforming product and services detected after delivery of products, during and after the provision of services?
4
When non-conforming products and services are detected does the organization take correction action and/or segregation, containment, return, or suspension of the provision of product & services and/or informing the customer and/or obtaining authorization for acceptance under concession?
5
How are the Conformity to the requirements shall be verified when nonconforming outputs are corrected?
8.7.1.1
1
How does the organization maintains documented information that defines the processes that are used to meet the requirements of Control of nonconforming outputs?
8.7.2
1
Does the organization retain documented information that describes the nonconformity; describes the actions taken; describes any concession obtained; identifies the authority deciding the action in respect of the nonconformity?
Clause 9
Performance evaluation
9.1
Monitoring, measurement, analysis, and evaluation
9.1.1
General
1
Did the organization plan how to monitor, measure, analyze, and evaluate its QMS?
2
Did the organization plan how to monitor QMS performance and effectiveness?
3
Did the organization figure out what needs to be monitored and select methods?
4
Did the organization determine its QMS monitoring requirements?
5
Does the organization select monitoring methods that can produce valid results?
6
Did the organization establish when monitoring should be done and who should do it?
7
Did the organization plan how to measure QMS performance and effectiveness?
8
Did the organization figure out what needs to be measured and did the organization select methods?
9
Did the organization determine its QMS measurement requirements?
10
Does the organization select measurement methods that can produce valid results?
11
Did the organization establish when measuring should be done and who should do it?
12
Did the organization plan how to analyze QMS performance and effectiveness?
13
Did the organization select analytical methods that are capable of producing valid results?
14
Did the organization decide when monitoring and measurement results are analyzed?
15
Did the organization plan how to evaluate QMS performance and effectiveness?
16
Did the organization select evaluation methods that are capable of producing valid results?
17
Did the organization decide when monitoring and measurement results are evaluated?
18
Do the organization monitor, measure, analyze, and evaluate the organization’s QMS?
19
Does the organization monitor the performance and effectiveness of the organization’s QMS?
20
Do the organization record monitoring results and does the organization retain and control these records?
21
Does the organization measure the performance and effectiveness of the organization’s QMS?
22
Do the organization record measurement results and does the organization retain and control these records?
23
Does the organization analyze the performance and effectiveness of its QMS?
24
Do the organization record analytical results and does the organization retain and control these records?
25
Does the organization evaluate the performance and effectiveness of its QMS?
26
Do the organization record evaluation results and does the organization retain and control these records?
9.1.2
Customer satisfaction
1
Does the organization establish methods that the organization can use to monitor customer perceptions?
2
Does the organization figure out how the organization is going to obtain information about how customers feel about how well it is meeting their needs and expectations?
3
Does the organization figure out how the organization is going to review information about how customers feel about how well it is meeting their needs and expectations?
4
Do the organization monitor how well customer needs and expectations are being fulfilled?
5
Do the organization monitor how the organization’s customers feel about how well the organization is meeting their needs and expectations (do the organization monitor the organization’s customers’ perceptions)?
6
How does the organization maintains documented information that defines the process employed to measure customer satisfaction?
9.1.3
Analysis and evaluation
1
Does the organization analyze its monitoring and measurement results?
2
Does the organization analyze and evaluate appropriate data and information?
3
Does the organization use its analytical results to evaluate performance?
4
Does the organization evaluate the performance of its QMS?
5
Does the organization determine if it needs to improve its performance?
6
Does the organization evaluate the performance of its external providers?
7
Does the organization use its analytical results to evaluate effectiveness?
8
Does the organization evaluate the effectiveness of its QMS?
9
Does the organization determine if it needs to improve its effectiveness?
10
Does the organization evaluate the effectiveness of its planning?
11
Does the organization determine if its plans were effectively implemented?
12
Does the organization evaluate the effectiveness of its actions?
13
Does the organization evaluate the effectiveness of actions taken to address risks?
14
Does the organization evaluate the effectiveness of actions taken to address opportunities?
15
Does the organization use its analytical results to evaluate conformity?
16
Does the organization evaluate the conformity of products and services?
17
Does the organization use its analytical results to evaluate satisfaction?
18
Does the organization evaluate the degree of customer satisfaction?
19
How does the organization maintain documented information that defines the process for the identification, collection and analysis of data to demonstrate the suitability and effectiveness of the quality management system?
20
Does the analysis includes include data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources?
9.2
Internal Audit
9.2.1
1
Does the organization conduct internal audits at planned intervals?
2
Did the organization plan a program that can find out if QMS meets the Organization’s own requirement and ISO 9001:2015 requirements?
3
Did the organization plan a program that can find out if QMS is effectively implemented and maintained?
9.2.2
1
Did the organization plan, establish, implement, and maintain an audit program?
2
Did the audit program include the frequency, methods, responsibilities, planning requirements, and reporting?
3
Does the audit program take into consideration the importance of the process concerned, changes affecting the organization, and the results of previous audits?
4
Did the organization define the audit criteria and scope of each audit?
5
Does the organization ensure that the audit is conducted by the auditors to ensure objectivity and impartiality of the audit process?
6
Does the organization ensure that the results of the audits are reported to relevant management?
7
Does the organization take appropriate correction and corrective action without undue delays?
8
Does the retain documented information as evidence of the implementation of the audit program and the audit results?
9.2.3
1
How does the planned intervals of internal audits takes into consideration the risks and opportunities associated with the process of Operational planning and control and the results of performance evaluation?
9.3
Management review
9.3.1
General
1
Does the Top Management review the organization QMS at planned intervals?
2
Does the review ensure QMS’s continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization?
9.3.2
Management review inputs
1
Does the review take into consideration the status of actions from previous management reviews?
2
Are the changes in external and internal issues relevant to QMS considered?
3
Does the review take into consideration information on the performance and effectiveness of the QMS?
4
Does the review take into consideration customer satisfaction and feedback from relevant interested parties?
5
Does the review take into consideration the extent to which the quality objectives have been met?
6
Does the review take into consideration the process performance and conformity of products and services?
7
Does the review take into consideration nonconformities and corrective actions?
8
Does the review take into consideration monitoring and measuring results?
9
Does the review take into consideration audit results?
10
Does the review take into consideration the performance of external providers?
11
Does the review take into consideration the adequacy of resources?
12
Does the review take into consideration the effectiveness of actions taken to address risks and opportunities?
13
Does the review take into consideration the opportunities for improvement?
9.3.3
Management review outputs
1
Do the outputs of the Management review include decisions and actions related to the opportunities for improvement; any need for changes to the QMS; and resources needed?
2
Does the organization retain documented information as evidence of the result of the management review?
Clause 10
Improvement
10.1
General
1
Has the organization determine and select opportunities for improvement?
2
Has the organization implemented any necessary action to meet customer requirements and enhance satisfaction?
3
Has the organization taken action for improving products & services to meet requirements as well as to address future needs and expectations?
4
Has the organization taken action for correcting, preventing, or reducing undesired effects?
5
Has the organization taken action for improving the performance and effectiveness of the QMS?
10.2
Nonconformity and corrective action
1
When any nonconformity (including complaints) occurs, does the organization take action to control and correct it and deal with the consequences?
2
When any nonconformity (including complaints) occurs, does the organization evaluate the need for action to eliminate the causes of the nonconformity?
3
Does the organization reviews and analyzes the nonconformity?
4
Does the organization determine the causes of the nonconformity?
5
Does the organization determine similar nonconformity exist or could potentially occur?
6
Has the organization implemented any action needed?
7
Has the organization reviewed the effectiveness of the corrective action taken?
8
Has the organization updated risk and opportunities determined during planning if necessary?
9
Has the organization made changes to the QMS if necessary?
10
Are the corrective actions appropriate to the effects of the nonconformities encountered?
10.2.2
1
Does the organization retain documented information on the nature of the nonconformities and any subsequent actions taken; and the result of any corrective action?
2
How does the organization maintains documented information that defines the processes that are used to meet the requirements of Nonconformity and corrective action?
10.3
Continual improvement
1
Does the organization continually improve the suitability, adequacy, and effectiveness of the QMS?
2
Does the organization consider the results of analysis and evaluation, and output from management review to determine if there are needs or opportunities to be addressed as part of continual improvement?
10.3.1
1
Does the implementation of improvements shall be subject to management of change processes in accordance with planning of change?
2
How does the organization maintains documented information that defines the processes that are used to meet the requirements of Continual improvement?
3
Does the organization retains documented information to demonstrate its effectiveness?
