API Specification Q1 Tenth Edition 5.5.1.2 Initial Supplier Evaluation—Critical Purchases

QMS for Oil and gas 23 Minutes

For the purchase of critical products, components or activities, the initial evaluation of suppliers (not previously approved) shall address the scope of supply, be site-specific for each supplier and include the following:

  • a) verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization.
  • b) verification of the type and extent of control applied by the supplier, internally and to their supply chain, to meet the organization’s requirements.
  • c) assessment of the supplier’s capability to meet the organization’s specified requirements by one or more of the following based on identified risk:
    • 1) 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,
    • 2) 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,
    • 3) performing inspection, testing, or verification of relevant characteristics of a received product.

For suppliers of critical purchases with high-risk severity [see 5.3.1 Item c)] identified by the organization for which an on-site assessment per 5.5.1.2, Item c) 1) is not performed, the assessment of the supplier’s capability [see 5.5.1.2, Item c)] shall include performing a remote assessment per 5.5.1.2, Item c) 2) and performing inspection, testing, or verification per 5.5.1.2, Item c) 3).
When performed, remote assessment [see 5.5.1.2, Item c) 2)] shall include verification of objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology.
Evaluation of a supplier shall also 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.

In API Q1, the initial supplier evaluation for critical purchases is a crucial step to ensure that selected suppliers meet the organization’s requirements and standards, especially for items essential for product quality, safety, regulatory compliance, or business continuity. Here’s a detailed process for conducting the initial supplier evaluation:

  1. Identification of Critical Purchases: Define critical purchases based on their significance to product quality, safety, regulatory compliance, or business continuity. This may include materials, components, equipment, or services essential for operations.
  2. Establish Supplier Selection Criteria: Determine criteria for evaluating suppliers for critical purchases. Criteria may include:
    • Quality management systems and certifications.
    • Product or service capabilities and specifications.
    • Compliance with relevant standards and regulations (e.g., API standards).
    • Delivery reliability and lead times.
    • Financial stability and business reputation.
    • Past performance and references.
  3. Supplier Identification: Identify potential suppliers that may meet the established selection criteria through market research, supplier databases, industry contacts, and referrals.
  4. Initial Supplier Evaluation: Conduct an initial evaluation of potential suppliers based on the established criteria. This may involve:
    • Reviewing supplier documentation, such as quality certificates, product specifications, and compliance records.
    • Assessing supplier capabilities, facilities, and production processes.
    • Conducting interviews or site visits to evaluate the supplier’s quality management systems and production practices.
    • Checking references and obtaining feedback from other customers or industry contacts.
  5. Risk Assessment: Perform a risk assessment to identify potential risks associated with each potential supplier. This assessment may include risks related to quality, reliability, delivery, compliance, financial stability, and supply chain resilience.
  6. Supplier Evaluation Report: Prepare a comprehensive supplier evaluation report summarizing the findings, recommendations, and risk ratings for each potential supplier. This report will serve as the basis for decision-making and supplier selection.
  7. Supplier Selection and Approval: Review the supplier evaluation report and approve the selection of suppliers for critical purchases based on their suitability, performance, and risk ratings. Approved suppliers are added to the organization’s approved supplier list for critical purchases.
  8. Documentation and Records: Maintain documentation related to the initial supplier evaluation process, including evaluation reports, risk assessments, and supplier approvals. These records should be kept in a centralized repository for audit purposes.

By following this process, organizations can effectively evaluate and select suppliers for critical purchases in accordance with API Q1 requirements, ensuring that selected suppliers meet the organization’s quality, reliability, and performance standards.

For the purchase of critical products, components or activities, the initial evaluation of suppliers (not previously approved) shall address the scope of supply, be site-specific for each supplier

For the purchase of critical products, components, or activities, the initial evaluation of suppliers (particularly those not previously approved) should be thorough and site-specific for each supplier. Here’s a breakdown of how this evaluation process can be structured:

  1. Scope of Supply Assessment:
    • Define the scope of supply required for critical products, components, or activities. This includes specifying the exact requirements, specifications, and quantities needed for each item or service.
    • Ensure that the evaluation addresses whether the potential supplier can meet the entire scope of supply, including any specialized or unique requirements.
  2. Site-Specific Evaluation:
    • Conduct the evaluation at the supplier’s site to assess their capabilities, facilities, and processes firsthand.
    • Evaluate the supplier’s production facilities, equipment, and infrastructure to ensure they have the capacity and capability to meet the required standards and specifications.
    • Assess the supplier’s quality management systems, procedures, and controls to verify their ability to consistently deliver products or services that meet the organization’s quality requirements.
  3. Supplier Qualification Criteria:
    • Establish qualification criteria specific to the critical products, components, or activities being procured. This may include factors such as quality standards, technical expertise, regulatory compliance, and delivery reliability.
    • Ensure that the evaluation criteria are tailored to the unique requirements of each supplier and aligned with the organization’s standards and expectations.
  4. Documentation and Record-Keeping:
    • Document the findings of the site-specific evaluation, including observations, assessments, and any identified areas of concern or improvement.
    • Maintain records of the evaluation process, including site visit reports, inspection findings, and communication with the supplier.
    • Keep all documentation organized and accessible for future reference, audit purposes, and ongoing supplier management.
  5. Risk Assessment and Mitigation:
    • Conduct a risk assessment to identify potential risks associated with each supplier and their ability to meet the scope of supply for critical products, components, or activities.
    • Develop mitigation strategies to address identified risks and ensure that appropriate controls are in place to manage supplier-related risks effectively.
  6. Approval Process:
    • Review the findings of the site-specific evaluation and assess whether the potential supplier meets the organization’s qualification criteria and standards.
    • Obtain approval from relevant stakeholders or authorities before proceeding with the selection and engagement of the supplier for critical purchases.

By conducting a thorough and site-specific evaluation of suppliers for critical purchases, organizations can ensure that selected suppliers have the capability, capacity, and commitment to meet the organization’s requirements and deliver high-quality products or services consistently. This approach helps mitigate risks, enhance supply chain resilience, and support the organization’s overall objectives and performance.

The Initial Supplier Evaluation of Critical Purchases must include the verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization.

Verifying the supplier’s quality management system (QMS) implementation and conformity to the organization’s quality system requirements is crucial during the initial evaluation of critical purchases. Here’s how this verification process can be structured:

  1. Review of Quality Management System Documentation:
    • Request and review documentation related to the supplier’s quality management system, including quality manuals, procedures, work instructions, and records.
    • Assess the comprehensiveness and adequacy of the supplier’s QMS documentation in addressing key quality system requirements.
  2. On-Site Audit or Assessment:
    • Conduct an on-site audit or assessment of the supplier’s facilities to verify the implementation of their quality management system.
    • Observe processes, procedures, and practices to ensure they align with the requirements specified by the organization and relevant standards (e.g., ISO 9001).
  3. Evaluation of Quality System Effectiveness:
    • Evaluate the effectiveness of the supplier’s quality management system in ensuring product quality, process control, and continuous improvement.
    • Assess the supplier’s performance metrics, quality objectives, and measures taken to address non-conformities or process deviations.
  4. Compliance with Quality System Requirements:
    • Verify whether the supplier’s quality management system conforms to the specific quality system requirements specified by the organization.
    • Ensure alignment with the organization’s quality policies, procedures, standards, and contractual obligations.
  5. Documentation and Record-Keeping:
    • Document observations, findings, and any identified non-conformities or areas for improvement during the evaluation process.
    • Maintain records of the verification activities, audit reports, and communication with the supplier for future reference and audit purposes.
  6. Supplier Engagement and Improvement Plans:
    • Communicate findings and observations to the supplier and collaborate on corrective actions or improvement plans, if necessary.
    • Work with the supplier to address any identified gaps or deficiencies in their quality management system implementation.
  7. Continuous Monitoring and Follow-Up:
    • Establish mechanisms for ongoing monitoring and follow-up to ensure the supplier maintains compliance with the organization’s quality system requirements.
    • Conduct periodic reviews or audits to assess the effectiveness of corrective actions and improvements implemented by the supplier.

By verifying the supplier’s quality management system implementation and conformity to the organization’s quality system requirements, organizations can mitigate risks, ensure product quality, and maintain confidence in their supply chain. This proactive approach helps establish a foundation for effective collaboration and continuous improvement with critical suppliers.

The Initial Supplier Evaluation of Critical Purchases must 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.

verifying the type and extent of control applied by the supplier, both internally and throughout their supply chain, is essential during the initial evaluation of critical purchases. Here’s how this verification process can be structured:

  1. Review of Supplier Control Measures:
    • Request and review documentation detailing the supplier’s internal control measures, processes, and procedures related to product quality, safety, and regulatory compliance.
    • Assess the effectiveness and adequacy of these control measures in meeting the organization’s requirements.
  2. On-Site Assessment:
    • Conduct an on-site assessment of the supplier’s facilities to observe firsthand the implementation of control measures and practices.
    • Evaluate the supplier’s production processes, handling procedures, storage practices, and quality assurance protocols.
  3. Supply Chain Assessment:
    • Investigate the supplier’s supply chain management practices to understand how they ensure the quality and integrity of materials, components, or services obtained from external sources.
    • Assess the supplier’s procedures for selecting, evaluating, and monitoring subcontractors, vendors, and other third-party suppliers.
  4. Risk Management and Mitigation:
    • Evaluate the supplier’s risk management processes, including identification, assessment, and mitigation of risks throughout their operations and supply chain.
    • Assess how the supplier addresses potential risks related to product quality, delivery delays, raw material shortages, and regulatory compliance.
  5. Compliance with Organizational Requirements:
    • Verify whether the supplier’s control measures align with the specific requirements and expectations of the organization.
    • Ensure that the supplier’s control measures are consistent with industry standards, regulatory requirements, and contractual obligations.
  6. Documentation and Record-Keeping:
    • Document observations, findings, and any identified gaps or deficiencies in the supplier’s control measures.
    • Maintain records of the verification activities, assessment reports, and communication with the supplier for future reference and audit purposes.
  7. Collaborative Improvement Efforts:
    • Engage with the supplier to address any identified gaps or deficiencies in their control measures.
    • Work collaboratively to develop improvement plans and implement corrective actions to enhance control effectiveness.
  8. Continuous Monitoring and Follow-Up:
    • Establish mechanisms for ongoing monitoring and follow-up to ensure that the supplier maintains effective control measures over time.
    • Conduct periodic reviews or audits to assess the sustainability and continuous improvement of the supplier’s control measures.

By verifying the type and extent of control applied by the supplier, internally and throughout their supply chain, organizations can mitigate risks, ensure compliance with requirements, and maintain the integrity of critical purchases. This proactive approach helps establish confidence in the supplier’s ability to consistently meet the organization’s needs and expectations.

The Initial Supplier Evaluation of Critical Purchases must include assessment of the supplier’s capability to meet the organization’s specified requirements

Assessing the supplier’s capability to meet the organization’s specified requirements is integral to the initial evaluation of critical purchases. Here’s how this assessment can be effectively carried out:

  1. Specification Review:
    • Provide the supplier with detailed specifications, standards, and requirements for the critical purchases.
    • Ensure that the supplier thoroughly understands the organization’s expectations regarding product quality, performance, features, and any other relevant criteria.
  2. Capability Assessment:
    • Evaluate the supplier’s technical capabilities, expertise, and experience in producing or providing the required products, components, or services.
    • Assess the supplier’s manufacturing processes, technologies, and resources to determine their ability to meet the specified requirements.
  3. Capacity Evaluation:
    • Determine whether the supplier has the necessary production capacity and resources to fulfill the organization’s demand for critical purchases.
    • Consider factors such as production volume, lead times, manufacturing facilities, equipment, and workforce capabilities.
  4. Quality Assurance Practices:
    • Review the supplier’s quality management system, procedures, and controls to ensure they align with the organization’s quality requirements.
    • Assess the supplier’s track record in delivering high-quality products or services and their ability to consistently meet quality standards.
  5. Testing and Validation:
    • Request samples or prototypes from the supplier for testing and validation purposes to assess their conformance to specifications and performance requirements.
    • Conduct rigorous testing and evaluation to verify that the supplier’s products or services meet the organization’s expectations.
  6. Compliance Verification:
    • Ensure that the supplier complies with relevant industry standards, regulations, and certification requirements applicable to the critical purchases.
    • Verify the supplier’s adherence to regulatory and compliance obligations, including environmental, health, safety, and legal requirements.
  7. Supplier Performance History:
    • Review the supplier’s performance history, including past projects, client feedback, references, and any relevant performance metrics.
    • Consider factors such as on-time delivery, quality performance, responsiveness to issues, and overall customer satisfaction.
  8. Risk Assessment:
    • Identify and assess any potential risks or challenges associated with the supplier’s capability to meet the organization’s specified requirements.
    • Develop mitigation strategies to address identified risks and ensure continuity of supply.
  9. Documentation and Record-Keeping:
    • Document the results of the capability assessment, including observations, findings, and any identified areas for improvement.
    • Maintain records of communication, agreements, and evaluations conducted during the initial supplier evaluation process.

By thoroughly assessing the supplier’s capability to meet the organization’s specified requirements, organizations can make informed decisions and ensure that critical purchases are sourced from reliable and competent suppliers. This proactive approach helps mitigate risks, enhance product quality, and maintain customer satisfaction.

The organization must perform 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 assessment is crucial for verifying that relevant product realization processes are conducted in accordance with process controls and are effective in achieving conformity to requirements. Here’s how the organization can conduct this assessment:

  1. Planning the On-Site Assessment:
    • Determine the scope of the assessment, including which product realization processes will be evaluated and the specific requirements to be verified.
    • Coordinate with relevant stakeholders, including process owners, quality assurance personnel, and production staff, to schedule the assessment and ensure their availability.
  2. Conducting the On-Site Assessment:
    • Visit the supplier’s facilities or production sites to observe firsthand the execution of relevant product realization processes.
    • Review process documentation, including procedures, work instructions, and control plans, to ensure compliance with specified requirements and process controls.
    • Observe the actual execution of key process activities, including material handling, production operations, inspections, and testing procedures.
    • Interview personnel involved in the product realization processes to gather insights into their understanding of requirements, adherence to procedures, and identification of any challenges or issues encountered.
  3. Verification of Process Controls:
    • Verify the implementation and effectiveness of process controls designed to ensure product quality, safety, and regulatory compliance.
    • Assess the adequacy of process controls in preventing non-conformities, detecting defects, and ensuring traceability throughout the production process.
    • Evaluate the monitoring and measurement activities used to track process performance and product characteristics, including calibration of equipment and measurement devices.
  4. Evaluation of Conformity to Requirements:
    • Assess the extent to which product realization processes are achieving conformity to specified requirements, including customer specifications, industry standards, and regulatory requirements.
    • Verify that products or components produced during the assessment meet quality standards and acceptance criteria defined by the organization.
    • Identify any deviations, non-conformities, or areas of improvement that may affect product quality or process effectiveness.
  5. Documentation and Reporting:
    • Document observations, findings, and any identified areas for improvement during the on-site assessment.
    • Prepare a detailed assessment report summarizing the results of the evaluation, including observations, conclusions, and recommendations for corrective actions or process enhancements.
    • Share the assessment findings with relevant stakeholders and collaborate on action plans to address identified issues and improve process performance.
  6. Follow-Up and Monitoring:
    • Monitor the implementation of corrective actions and process improvements resulting from the assessment.
    • Conduct periodic follow-up assessments to track progress, verify sustained compliance with requirements, and drive continuous improvement in product realization processes.

By performing on-site assessments, organizations can ensure that product realization processes are conducted effectively, adhere to process controls, and achieve conformity to requirements. This proactive approach helps mitigate risks, enhance product quality, and build trust with customers and stakeholders.

The organization must perform 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.

Performing a remote assessment to verify relevant product realization processes is being conducted in accordance with process controls and effectively achieving conformity to requirements requires careful planning and execution. Here’s how the organization can conduct this assessment effectively:

  1. Preparation and Planning:
    • Define the scope and objectives of the remote assessment, including which product realization processes will be evaluated and the specific requirements to be verified.
    • Identify the tools and technologies needed to conduct the assessment remotely, such as video conferencing platforms, document sharing systems, and virtual collaboration tools.
    • Coordinate with relevant stakeholders, including process owners, quality assurance personnel, and production staff, to schedule the assessment and ensure their availability for virtual meetings and discussions.
  2. Documentation Review:
    • Request access to relevant documentation related to the product realization processes, including procedures, work instructions, control plans, and records.
    • Review the documentation remotely to ensure compliance with specified requirements, process controls, and quality standards.
  3. Virtual Observations and Interviews:
    • Conduct virtual meetings and interviews with key personnel involved in the product realization processes to gather insights into their understanding of requirements, adherence to procedures, and identification of any challenges or issues encountered.
    • Use video conferencing tools to observe live demonstrations of process activities, such as material handling, production operations, inspections, and testing procedures.
    • Ask questions and seek clarification on specific aspects of the processes to assess their effectiveness and conformity to requirements.
  4. Verification of Process Controls:
    • Verify the implementation and effectiveness of process controls remotely by discussing with process owners and reviewing documented procedures and controls.
    • Assess the adequacy of process controls in preventing non-conformities, detecting defects, and ensuring traceability throughout the production process.
  5. Evaluation of Conformity to Requirements:
    • Assess the extent to which product realization processes are achieving conformity to specified requirements through virtual discussions, document reviews, and observation of process activities.
    • Verify that products or components produced during the assessment period meet quality standards and acceptance criteria defined by the organization.
  6. Documentation and Reporting:
    • Document observations, findings, and any identified areas for improvement during the remote assessment.
    • Prepare a detailed assessment report summarizing the results of the evaluation, including observations, conclusions, and recommendations for corrective actions or process enhancements.
    • Share the assessment findings with relevant stakeholders and collaborate on action plans to address identified issues and improve process performance.
  7. Follow-Up and Monitoring:
    • Monitor the implementation of corrective actions and process improvements resulting from the remote assessment.
    • Conduct periodic follow-up assessments, either remotely or on-site, to track progress, verify sustained compliance with requirements, and drive continuous improvement in product realization processes.

By leveraging remote assessment methodologies, organizations can effectively verify that product realization processes are conducted in accordance with process controls, achieve conformity to requirements, and drive continuous improvement in quality and performance. This approach enables organizations to adapt to remote work environments while maintaining rigorous quality assurance practices.

The organization must perform inspection, testing, or verification of relevant characteristics of a received product.

Performing inspection, testing, or verification of relevant characteristics of a received product is crucial to ensure that it meets the organization’s requirements and specifications. Here’s how the organization can effectively carry out this process:

  1. Establish Inspection Criteria:
    • Define the characteristics, parameters, and specifications that need to be inspected, tested, or verified for each received product.
    • Determine the acceptance criteria and tolerance limits for each characteristic to ensure compliance with quality standards and customer requirements.
  2. Receiving Inspection Process:
    • Upon receipt of a product, conduct a visual inspection to check for any visible damage, defects, or discrepancies.
    • Verify the completeness of the shipment and compare it against the packing list or purchase order to ensure all items are accounted for.
  3. Sampling Plan:
    • Determine the sampling plan to be used for inspection and testing based on factors such as lot size, risk level, and criticality of the product.
    • Select samples for inspection according to the predetermined sampling plan to ensure representative coverage of the received batch or lot.
  4. Conducting Inspections and Testing:
    • Perform inspections, measurements, and tests on the selected samples to verify compliance with the specified characteristics and requirements.
    • Use appropriate inspection tools, equipment, and testing methods to accurately assess the product’s quality and performance.
  5. Documenting Inspection Results:
    • Record the results of inspections, measurements, and tests conducted for each received product.
    • Document any deviations, non-conformities, or discrepancies identified during the inspection process.
  6. Disposition of Non-Conforming Products:
    • Determine the disposition of non-conforming products based on the severity of the deviation and its impact on product quality and safety.
    • Implement procedures for segregating, quarantining, or returning non-conforming products to the supplier for corrective action or replacement.
  7. Supplier Communication:
    • Communicate any quality issues or concerns identified during the inspection process to the supplier promptly.
    • Provide clear feedback to the supplier regarding the reasons for rejection or non-acceptance of products and collaborate on corrective actions to prevent recurrence.
  8. Continuous Improvement:
    • Monitor trends in inspection results and identify opportunities for process improvement or supplier development.
    • Conduct regular reviews of inspection procedures and criteria to ensure they remain effective and aligned with organizational objectives.
  9. Training and Competence:
    • Ensure that personnel responsible for conducting inspections and tests are adequately trained and competent to perform their assigned tasks.
    • Provide ongoing training and support to enhance the skills and knowledge of inspection personnel.

By performing thorough inspection, testing, or verification of received products, organizations can uphold product quality, prevent defects, and maintain customer satisfaction. This process also enables organizations to identify and address quality issues promptly, leading to continuous improvement in their supply chain management practices.

For 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 shall include performing a remote assessment and performing inspection, testing, or verification.

When an on-site assessment is not feasible for suppliers of critical purchases with high-risk severity identified by the organization, alternative methods must be employed to assess the supplier’s capability effectively. This includes performing a remote assessment and conducting inspection, testing, or verification of received products. Here’s how this process can be structured:

  1. Remote Assessment:
    • Plan and execute a remote assessment of the supplier’s capabilities, processes, and quality management system.
    • Utilize video conferencing, virtual meetings, and digital documentation review to gather information about the supplier’s facilities, procedures, and controls.
    • Assess the supplier’s technical capabilities, production capabilities, quality assurance practices, and compliance with relevant standards and requirements.
    • Evaluate the supplier’s ability to meet the organization’s specified requirements, including product quality, delivery schedules, and responsiveness to issues.
    • Document the findings of the remote assessment and identify any areas for improvement or further investigation.
  2. Inspection, Testing, or Verification:
    • Develop a comprehensive inspection and testing plan for the critical purchases supplied by the remote supplier.
    • Define the relevant characteristics, parameters, and specifications to be inspected, tested, or verified for each received product.
    • Determine the sampling plan and sample size based on risk assessment, lot size, and criticality of the products.
    • Conduct inspections, measurements, and tests on the received products according to the predetermined criteria and acceptance standards.
    • Record the results of inspections, tests, and verifications, including any deviations or non-conformities identified.
    • Communicate with the supplier regarding any quality issues or concerns identified during the inspection process and collaborate on corrective actions.
  3. Documentation and Record-Keeping:
    • Maintain thorough documentation of the remote assessment, inspection activities, and verification results.
    • Record details of the remote assessment findings, including observations, assessments, and conclusions.
    • Document all inspection results, including measurements, test data, and any non-conformities identified during the process.
    • Keep records of communications with the supplier, including feedback, corrective actions, and follow-up activities.
  4. Continuous Monitoring and Improvement:
    • Monitor the supplier’s performance and product quality over time to ensure ongoing compliance with requirements.
    • Conduct periodic reviews and assessments to evaluate the effectiveness of remote assessment methods and inspection processes.
    • Implement corrective actions and process improvements based on lessons learned and feedback from remote assessments and inspection activities.
    • Continuously strive to enhance supplier relationships, mitigate risks, and improve supply chain resilience through effective remote assessment and inspection practices.

By performing remote assessments and conducting thorough inspection, testing, or verification of received products, organizations can effectively assess the capabilities of suppliers providing critical purchases, even when on-site assessments are not feasible. This approach helps ensure that high-risk severity items are sourced from reliable suppliers capable of meeting the organization’s requirements and maintaining product quality and safety standards.

When performed, remote assessment shall include verification of objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology.

when conducting remote assessments, it’s vital to verify objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology (ICT). Here’s how this process can be effectively implemented:

  1. Preparation:
    • Schedule the remote assessment with the supplier, ensuring that all relevant parties are available for the session.
    • Provide clear instructions to the supplier regarding the activities to be observed and the documentation to be reviewed during the assessment.
  2. Technology Setup:
    • Utilize suitable ICT platforms for video conferencing, such as Zoom, Microsoft Teams, or Skype, to facilitate real-time audio/visual communication.
    • Ensure that both parties have access to stable internet connections and necessary equipment, such as webcams, microphones, and screens for sharing documentation.
  3. Verification of Activities:
    • Conduct real-time audio/visual observation of the supplier’s activities, including production processes, quality control procedures, and any other relevant operations.
    • Use video conferencing tools to view live demonstrations, walkthroughs, or simulations of key processes, allowing for direct observation and verification of compliance with requirements.
  4. Review of Documentation:
    • Share relevant documentation electronically using screen-sharing features or file-sharing platforms to enable simultaneous review by both parties.
    • Verify that documented procedures, records, and quality management system documentation align with specified requirements and are being followed effectively.
  5. Communication and Interaction:
    • Maintain clear communication throughout the remote assessment, allowing for questions, clarifications, and discussions between assessors and the supplier’s personnel.
    • Encourage open dialogue and transparency to address any concerns, issues, or discrepancies identified during the assessment process.
  6. Evidence Collection:
    • Capture screenshots, video recordings, or other digital evidence as necessary to document observations, findings, and compliance with requirements.
    • Ensure that all relevant evidence is recorded accurately and securely for future reference and audit purposes.
  7. Assessment Report:
    • Compile the findings of the remote assessment into a comprehensive report, documenting observations, assessments, conclusions, and any recommended actions or follow-up activities.
    • Share the assessment report with the supplier and relevant stakeholders, seeking their input and collaboration on addressing identified areas for improvement or corrective actions.
  8. Follow-Up and Monitoring:
    • Implement follow-up activities, such as corrective actions or process improvements, based on the findings of the remote assessment.
    • Monitor the supplier’s performance and progress in addressing identified issues, ensuring continuous improvement and compliance with requirements.

By incorporating real-time audio/visual observation and documentation review using ICT, organizations can effectively conduct remote assessments, verify compliance with requirements, and ensure the integrity of supplier capabilities and processes. This approach enables organizations to adapt to remote work environments while maintaining rigorous quality assurance practices and supplier oversight.

Evaluation of a supplier shall also 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.

When evaluating a supplier for any additions to their scope of approval or a change from an approved site to a new site of supply, it’s crucial to adhere to the requirements outlined in the relevant section. Here’s how the evaluation process can be conducted in accordance with these requirements:

  1. Scope of Approval Assessment:
    • Review the existing scope of approval for the supplier to understand the products, components, or activities for which they are approved.
    • Identify any additions or expansions to the supplier’s scope of approval, including new products, services, or capabilities being considered.
  2. Change of Site Evaluation:
    • Assess the implications of changing the site of supply from an approved location to a new site.
    • Consider factors such as geographical location, infrastructure, facilities, equipment, and personnel qualifications at the new site.
  3. Risk Assessment:
    • Conduct a risk assessment to evaluate the potential impact of any changes to the supplier’s scope of approval or site of supply.
    • Identify and assess risks associated with product quality, supply chain continuity, regulatory compliance, and other relevant factors.
  4. Supplier Capability Review:
    • Evaluate the supplier’s capability to meet the requirements of the expanded scope of approval or the new site of supply.
    • Consider the supplier’s technical capabilities, production capacity, quality management systems, and track record in delivering similar products or services.
  5. Documentation Review:
    • Review relevant documentation provided by the supplier, including updated quality management system documentation, certifications, and qualifications.
    • Ensure that the supplier has documented processes and procedures in place to support the expanded scope of approval or the transition to a new site of supply.
  6. On-Site or Remote Assessment:
    • Depending on the nature and extent of the changes, conduct an on-site or remote assessment of the supplier’s facilities, processes, and controls.
    • Verify compliance with requirements, assess process effectiveness, and identify any areas for improvement or corrective action.
  7. Approval Process:
    • Obtain approval from relevant stakeholders within the organization for any additions to the supplier’s scope of approval or changes to the site of supply.
    • Document the approval decision, including rationale and justification, for future reference and audit purposes.
  8. Communication and Collaboration:
    • Communicate with the supplier regarding the outcomes of the evaluation process and any requirements or expectations for implementation.
    • Collaborate with the supplier on any necessary corrective actions, process improvements, or additional support needed to ensure successful implementation of the changes.
  9. Follow-Up and Monitoring:
    • Monitor the supplier’s performance and compliance with requirements following the implementation of changes.
    • Conduct periodic reviews and assessments to verify ongoing suitability, adequacy, and effectiveness of the expanded scope of approval or the new site of supply.

By following these steps and adhering to the requirements outlined in the relevant section, organizations can effectively evaluate suppliers for any additions to their scope of approval or changes to their site of supply. This ensures alignment with organizational objectives, maintains product quality and compliance, and supports continuous improvement in supplier management practices.

Example of Procedure: Initial Supplier Evaluation for Critical Purchases

1. Purpose: This procedure outlines the process for evaluating and selecting suppliers for critical purchases to ensure they meet organizational requirements and standards.

2. Scope: This procedure applies to all procurement activities involving critical purchases within the organization.

3. Responsibilities:

  • Purchasing Manager: Responsible for overseeing the supplier evaluation process and ensuring compliance with API Q1 requirements.
  • Procurement Team: Responsible for conducting supplier evaluations, collecting relevant information, and making recommendations for supplier selection.
  • Department Heads: Responsible for identifying critical purchases and providing input on supplier selection criteria and requirements.

4. Procedure:

4.1 Identification of Critical Purchases:

  • Department heads identify purchases that are critical to product quality, safety, regulatory compliance, or business continuity. These may include materials, components, equipment, or services essential for operations.

4.2 Supplier Selection Criteria:

  • The Purchasing Manager, in consultation with relevant stakeholders, establishes supplier selection criteria based on factors such as:
    • Quality management systems and certifications
    • Product or service capabilities and specifications
    • Compliance with regulatory requirements (e.g., API standards)
    • Financial stability and business reputation
    • Delivery reliability and lead times
    • Past performance and references

4.3 Supplier Identification:

  • The Procurement Team identifies potential suppliers that meet the established selection criteria through market research, supplier databases, industry contacts, and referrals.

4.4 Initial Supplier Evaluation:

  • The Procurement Team conducts an initial evaluation of potential suppliers based on the established criteria. This may include:
    • Reviewing supplier documentation, such as quality certificates, product specifications, and compliance records
    • Assessing supplier capabilities, facilities, and production processes
    • Conducting interviews or site visits to assess the supplier’s quality management systems and production practices
    • Checking references and obtaining feedback from other customers or industry contacts

4.5 Risk Assessment:

  • The Procurement Team conducts a risk assessment to identify potential risks associated with each potential supplier. This may include risks related to quality, reliability, delivery, compliance, financial stability, and supply chain resilience.

4.6 Supplier Evaluation Report:

  • Based on the initial evaluation and risk assessment, the Procurement Team prepares a supplier evaluation report summarizing the findings, recommendations, and risk ratings for each potential supplier.

4.7 Supplier Selection and Approval:

  • The Purchasing Manager reviews the supplier evaluation report and approves the selection of suppliers for critical purchases based on their suitability, performance, and risk ratings.
  • Approved suppliers are added to the organization’s approved supplier list for critical purchases.

4.8 Documentation and Records:

  • All documentation related to the initial supplier evaluation, including evaluation reports, risk assessments, and supplier approvals, are maintained in a centralized repository for audit purposes.

5. Revision History:

  • Any revisions to this procedure shall be documented, approved by the Purchasing Manager, and communicated to relevant stakeholders.

Example of a record of the initial supplier evaluation for critical purchases:

Record IDSupplier NameEvaluation DateScope of EvaluationAssessment CriteriaEvaluation OutcomeAction Required
001XYZ Manufacturing2024-05-15Product Component: ABC Widget1. Compliance with technical specificationsCompliance: YesNone
2. Quality management system implementation and effectivenessEffectiveness: Partially effectiveSupplier to provide corrective action plan
3. Production capacity and capabilityCapacity: AdequateNone
4. Previous performance historyPerformance: SatisfactoryNone
5. Compliance with regulatory requirementsCompliance: YesNone
002ABC Components2024-05-20Product Component: XYZ Gear1. Compliance with technical specificationsCompliance: No (Dimensions out of tolerance)Supplier to provide corrective action plan
2. Quality management system implementation and effectivenessEffectiveness: EffectiveNone
3. Production capacity and capabilityCapacity: Insufficient (Long lead times reported)Further evaluation and negotiation with supplier
4. Previous performance historyPerformance: Limited experience with critical productsAdditional monitoring and support during onboarding
5. Compliance with regulatory requirementsCompliance: YesNone

Published by Pretesh Biswas

Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your system development, training or auditing needs. He has helped dozens of organizations in implementing effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has experience in training at hundreds of organizations in several industry sectors. His training is unique in that which can be customized as to your management system and activities and deliver them at your facility. This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic equipment, assemblies & components, batteries, computer hardware and software, printing, placement and Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students. Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education & professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001. He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt .

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