For previously approved suppliers of products, components, or activities the organization shall determine the supplier reevaluation frequency based on identified risk and supplier quality performance.
For the re-evaluation of suppliers of critical products, components or activities, the requirements of 5.5.1.2 shall apply.
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, the requirements of 5.5.1.3 shall apply.
For the re-evaluation of suppliers of noncritical products, components, or activities that impact product realization or the final product, the requirements of 5.5.1.4 shall apply.
In API Q1, supplier reevaluation is a crucial aspect of maintaining a robust supply chain and ensuring continuous improvement. The process involves periodically reassessing suppliers to verify their ongoing compliance with organizational requirements, quality standards, and performance expectations. Here’s an overview of the supplier reevaluation process:
- Frequency of Reevaluation: The organization establishes a schedule for the periodic reevaluation of suppliers based on factors such as risk, criticality of supplies, and regulatory requirements. This frequency should ensure that suppliers are reassessed at regular intervals to maintain quality and performance standards.
- Criteria for Reevaluation: The criteria for supplier reevaluation include factors such as quality performance, delivery reliability, responsiveness to issues, adherence to specifications, changes in regulatory requirements, and feedback from internal stakeholders or customers.
- Data Collection and Analysis: Relevant data pertaining to supplier performance and compliance are collected and analyzed. This may include quality metrics, on-time delivery rates, corrective action requests, audit findings, customer feedback, and any changes in regulatory or legal requirements.
- Risk Assessment: Suppliers are assessed for any potential risks they pose to product quality, delivery timelines, or overall business operations. This assessment helps prioritize suppliers for reevaluation based on their impact on organizational objectives and outcomes.
- Reevaluation Process: The organization conducts a thorough reevaluation of suppliers, which may involve a combination of methods such as on-site audits, performance reviews, surveys, and interviews. The scope of reevaluation may vary based on the criticality of supplies and the results of risk assessment.
- Verification of Compliance: During reevaluation, the organization verifies whether suppliers continue to meet the established quality system requirements, customer specifications, regulatory standards, and any contractual obligations. This includes assessing the effectiveness of corrective actions implemented in response to previous issues.
- Performance Feedback: Feedback on supplier performance is provided to the supplier, highlighting areas of improvement and commendation. This feedback fosters transparency and collaboration between the organization and its suppliers, driving continuous improvement initiatives.
- Documentation and Records: All reevaluation activities, findings, and outcomes are documented systematically. Records should include reevaluation reports, audit findings, corrective action requests, communication with suppliers, and any other relevant documentation.
- Decision Making: Based on the results of the reevaluation, decisions are made regarding the continued approval, suspension, or termination of supplier contracts. These decisions should be aligned with organizational objectives, risk management strategies, and quality improvement initiatives.
- Continuous Improvement: The supplier reevaluation process is subject to continuous improvement, with feedback mechanisms in place to capture lessons learned and identify opportunities for enhancing the effectiveness and efficiency of the process over time.
By implementing a robust supplier reevaluation process, organizations can mitigate risks, maintain quality standards, and foster long-term partnerships with their suppliers, ultimately contributing to the overall success and sustainability of the business.
Organizations should conduct supplier reevaluation for several reasons:
- Quality Assurance: Supplier reevaluation ensures that suppliers continue to meet the organization’s quality standards and specifications. It helps verify that suppliers are delivering products and services of consistent quality, reducing the risk of non-conformities and defects in the organization’s processes and products.
- Compliance: Regular reevaluation helps ensure that suppliers adhere to regulatory requirements and industry standards. It allows organizations to verify that suppliers maintain compliance with relevant laws, regulations, and certifications, minimizing legal and regulatory risks associated with non-compliant suppliers.
- Performance Monitoring: Supplier reevaluation enables organizations to monitor supplier performance over time. By assessing factors such as delivery reliability, responsiveness, and customer service, organizations can identify strengths and weaknesses in supplier performance and take appropriate actions to address any issues.
- Risk Management: Reevaluating suppliers helps organizations identify and mitigate risks associated with their supply chain. It allows organizations to assess the financial stability, reliability, and resilience of suppliers, reducing the risk of disruptions to the supply chain and ensuring continuity of operations.
- Continuous Improvement: Supplier reevaluation is integral to a culture of continuous improvement. By providing feedback to suppliers and collaborating on areas for enhancement, organizations can drive ongoing improvements in supplier performance, product quality, and overall supply chain efficiency.
For previously approved suppliers of products, components, or activities the organization shall determine the supplier reevaluation frequency based on identified risk and supplier quality performance.
Determining the supplier reevaluation frequency based on identified risk and supplier quality performance is crucial for maintaining an effective supply chain in API Q1. Here’s how the process might look:
- Risk Assessment: The organization conducts a comprehensive risk assessment of its suppliers, considering factors such as criticality of supplies, historical performance, financial stability, regulatory compliance, and geographic location. This assessment helps prioritize suppliers based on their potential impact on product quality, delivery schedules, and overall business operations.
- Supplier Quality Performance Evaluation: The organization evaluates the quality performance of its suppliers on a regular basis, using metrics such as on-time delivery rates, product quality metrics, frequency of non-conformities, customer complaints, and audit findings. This evaluation provides insights into the effectiveness of each supplier’s quality management system and their ability to meet the organization’s requirements.
- Determining Reevaluation Frequency: Based on the risk assessment and supplier quality performance evaluation, the organization determines the reevaluation frequency for each approved supplier. Suppliers with higher levels of risk or lower quality performance may require more frequent reevaluation to mitigate potential risks and ensure ongoing compliance with quality standards.
- Establishing Reevaluation Criteria: The organization establishes clear criteria for supplier reevaluation, outlining the specific parameters and metrics that will be used to assess each supplier’s performance and risk level. These criteria may include factors such as delivery performance, product quality, responsiveness to issues, financial stability, and regulatory compliance.
- Documenting Reevaluation Frequency: The determined reevaluation frequencies for each approved supplier are documented in the organization’s supplier management system or quality management system. This documentation ensures transparency and accountability in the supplier reevaluation process, providing a clear record of when each supplier is due for reevaluation.
- Continuous Monitoring and Adjustment: The organization continuously monitors supplier performance and risk factors, making adjustments to the reevaluation frequency as needed based on changing circumstances. Suppliers may be reevaluated more frequently if issues arise or if their risk profile changes significantly over time.
By determining the supplier reevaluation frequency based on identified risk and supplier quality performance, organizations can proactively manage risks in their supply chain and ensure the ongoing reliability and quality of their products and services.
For the re-evaluation of suppliers of critical products, components or activities, the requirements of Initial Supplier Evaluation of Critical Purchases shall apply.
For the re-evaluation of suppliers of critical products, components, or activities, the requirements outlined in the Initial Supplier Evaluation of Critical Purchases shall apply. This means that the organization must follow a comprehensive process similar to the initial evaluation when re-evaluating critical suppliers. Here’s how the requirements of the Initial Supplier Evaluation of Critical Purchases apply to the re-evaluation process:
- Verification of Quality Management System (QMS) Implementation: The organization verifies that the supplier’s QMS implementation continues to conform to the quality system requirements specified for critical purchases.
- Assessment of Supplier Capability: The organization reassesses the supplier’s capability to meet the organization’s specified requirements for critical purchases, ensuring they can maintain the necessary quality standards and delivery performance.
- Verification of Control Measures: The organization verifies the type and extent of control measures applied by the supplier to ensure the quality and reliability of critical products, components, or activities.
- On-site or Remote Assessment: Depending on the risk and criticality of the supplies, the organization may conduct on-site assessments or remote assessments to verify supplier capabilities and QMS effectiveness.
- Evaluation of Product/Component/Activity Conformity: The organization evaluates how the supplied critical products, components, or activities conform to specified requirements, ensuring they meet the organization’s quality standards and expectations.
- Compliance with Customer Requirements: The organization ensures that critical suppliers comply with any specific customer requirements or proprietary specifications relevant to the supplies.
- Documentation and Recordkeeping: All activities related to the re-evaluation of critical suppliers, including assessments, findings, and corrective actions, are documented and maintained as records for future reference.
By applying the requirements of the Initial Supplier Evaluation of Critical Purchases to the re-evaluation process, organizations can ensure that critical suppliers continue to meet the organization’s quality and performance standards, mitigating risks associated with critical supplies and maintaining product integrity.
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, the requirements of Initial Supplier Evaluation of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements shall apply.
For the re-evaluation of suppliers of critical products, components, or activities that are customer-specified or limited by proprietary and/or legal requirements, the organization must adhere to the requirements outlined in the Initial Supplier Evaluation for critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements. This means that the re-evaluation process must follow the same rigorous standards and procedures as the initial evaluation for such critical suppliers. Here’s how the requirements of the Initial Supplier Evaluation for critical products, components, or activities apply to the re-evaluation process for these suppliers:
- Verification of Quality Management System (QMS) Implementation: The organization verifies that the supplier’s QMS implementation continues to conform to the quality system requirements specified for critical purchases, considering any additional customer-specified requirements or proprietary/legal obligations.
- Assessment of Supplier Capability: The organization reassesses the supplier’s capability to meet the specific requirements specified by the customer or proprietary/legal requirements relevant to the critical products, components, or activities.
- Verification of Control Measures: The organization verifies the type and extent of control measures applied by the supplier to ensure compliance with customer-specified requirements or proprietary/legal obligations, in addition to general quality system requirements.
- On-site or Remote Assessment: Depending on the risk and criticality of the supplies and any customer or proprietary/legal requirements, the organization may conduct on-site assessments or remote assessments to verify supplier capabilities and QMS effectiveness.
- Evaluation of Product/Component/Activity Conformity: The organization evaluates how the supplied critical products, components, or activities conform to the specific requirements specified by the customer or proprietary/legal obligations, ensuring compliance with all relevant standards and specifications.
- Compliance with Customer Requirements: The organization ensures that critical suppliers comply with any specific customer requirements or proprietary/legal specifications relevant to the supplies, in addition to general quality system requirements.
- Documentation and Recordkeeping: All activities related to the re-evaluation of critical suppliers, including assessments, findings, and corrective actions, are documented and maintained as records for future reference, with particular attention to any customer-specified or proprietary/legal requirements.
By applying the requirements of the Initial Supplier Evaluation for critical products, components, or activities to the re-evaluation process for customer-specified suppliers and suppliers limited by proprietary and/or legal requirements, organizations can ensure continued compliance with all relevant standards and specifications, maintaining product quality and meeting customer expectations.
For the re-evaluation of suppliers of noncritical products, components, or activities that impact product realization or the final product, the requirements of Initial Supplier Evaluation of non Critical Purchases shall apply.
For the re-evaluation of suppliers of noncritical products, components, or activities that impact product realization or the final product, the organization must adhere to the requirements outlined in the Initial Supplier Evaluation of non-critical purchases. This means that the re-evaluation process should follow similar standards and procedures as the initial evaluation for such noncritical suppliers. Here’s how the requirements of the Initial Supplier Evaluation of non-critical purchases apply to the re-evaluation process for these suppliers:
- Verification of Quality Management System (QMS) Implementation: The organization verifies that the supplier’s QMS implementation continues to conform to the quality system requirements specified for noncritical purchases.
- Assessment of Supplier Capability: The organization reassesses the supplier’s capability to meet the organization’s purchasing requirements for noncritical products, components, or activities.
- Verification of Control Measures: The organization verifies the type and extent of control measures applied by the supplier to ensure the quality and reliability of noncritical products, components, or activities.
- Evaluation of Product/Component/Activity Conformity: The organization evaluates how the supplied noncritical products, components, or activities conform to specified requirements, ensuring they meet the organization’s quality standards and expectations.
- Documentation and Recordkeeping: All activities related to the re-evaluation of noncritical suppliers, including assessments, findings, and corrective actions, are documented and maintained as records for future reference.
By applying the requirements of the Initial Supplier Evaluation of non-critical purchases to the re-evaluation process for noncritical suppliers, organizations can ensure continued adherence to quality standards and mitigate risks associated with these suppliers’ products, components, or activities impacting product realization or the final product.
Examples of Supplier Reevaluation Procedure
- Purpose:
- The purpose of this procedure is to outline the process for reevaluating suppliers of critical and noncritical products, components, or activities to ensure continued compliance with quality standards and requirements.
- Scope:
- This procedure applies to all suppliers of critical and noncritical products, components, or activities identified by the organization.
- Responsibilities:
- Quality Manager: Responsible for overseeing the supplier reevaluation process.
- Procurement Team: Responsible for coordinating supplier reevaluation activities.
- Quality Assurance Team: Responsible for conducting assessments and evaluations of supplier performance.
- Procedure:a. Identification of Suppliers for Reevaluation:
- The procurement team identifies suppliers for reevaluation based on risk assessment, quality performance, and other relevant factors.
- The organization determines the reevaluation frequency for each supplier based on identified risks, quality performance, and criticality of supplies.
- Suppliers selected for reevaluation are notified in advance of the reevaluation process and provided with any necessary documentation or instructions.
- For Critical Suppliers: i. Conduct initial assessment based on Initial Supplier Evaluation requirements. ii. Verify quality management system implementation and conformity to requirements. iii. Assess supplier capability and control measures. iv. Evaluate product/component/activity conformity. v. Document findings and recommendations.
- For Noncritical Suppliers: i. Conduct assessment based on Initial Supplier Evaluation requirements for noncritical purchases. ii. Verify quality management system implementation and conformity to requirements. iii. Assess supplier capability and control measures. iv. Evaluate product/component/activity conformity. v. Document findings and recommendations.
- All activities related to supplier reevaluation, including assessments, findings, and corrective actions, are documented and maintained as records in the organization’s supplier management system.
- Based on the results of the reevaluation, the organization takes appropriate follow-up actions, including corrective actions, supplier development initiatives, or changes to supplier status or approvals.
- Review and Approval:
- This procedure is subject to periodic review and approval by the quality manager to ensure its effectiveness and alignment with organizational goals and requirements.
Example of supplier reevaluation :
| Supplier Name | Supplier ID | Reevaluation Date | Reevaluation Frequency | Evaluation Criteria | Assessment Results | Actions Taken | Next Reevaluation Date |
|---|---|---|---|---|---|---|---|
| ABC Manufacturing | SUP001 | 2024-04-15 | Annual | Quality Management System | Conforms to requirements | N/A | 2025-04-15 |
| XYZ Components | SUP002 | 2024-03-22 | Bi-annual | Capability and Control | Requires improvement | Supplier development initiated | 2024-09-22 |
| DEF Electronics | SUP003 | 2024-05-10 | Quarterly | Product Conformity | Nonconformities identified | Corrective actions initiated | 2024-08-10 |
| GHI Technologies | SUP004 | 2024-02-05 | Bi-annual | Quality Management System | Conforms to requirements | N/A | 2024-08-05 |
| JKL Solutions | SUP005 | 2024-06-30 | Annual | Capability and Control | Meets requirements | N/A | 2025-06-30 |
| MNO Manufacturing | SUP006 | 2024-04-18 | Quarterly | Product Conformity | No nonconformities found | N/A | 2024-07-18 |
| PQR Components | SUP007 | 2024-03-05 | Annual | Quality Management System | Requires improvement | Corrective actions initiated | 2025-03-05 |
| STU Electronics | SUP008 | 2024-05-28 | Quarterly | Capability and Control | Conforms to requirements | N/A | 2024-08-28 |
| VWX Technologies | SUP009 | 2024-02-15 | Bi-annual | Product Conformity | Nonconformities identified | Corrective actions initiated | 2024-08-15 |
| YZA Solutions | SUP010 | 2024-06-10 | Quarterly | Quality Management System | Conforms to requirements | N/A | 2024-09-10 |
| BCD Manufacturing | SUP011 | 2024-04-20 | Annual | Capability and Control | Requires improvement | Supplier development initiated | 2025-04-20 |
| EFG Components | SUP012 | 2024-03-15 | Bi-annual | Product Conformity | Meets requirements | N/A | 2024-09-15 |
| HIJ Electronics | SUP013 | 2024-05-05 | Quarterly | Quality Management System | Conforms to requirements | N/A | 2024-08-05 |
| KLM Technologies | SUP014 | 2024-02-20 | Annual | Capability and Control | Meets requirements | N/A | 2025-02-20 |
| NOP Solutions | SUP015 | 2024-06-15 | Quarterly | Product Conformity | Nonconformities identified | Corrective actions initiated | 2024-09-15 |

