For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements that limit application of 5.5.1.2, the initial evaluation shall include the following:
a) verification of the supplier’s quality management system implementation and conformity to 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.
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.
For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements that limit the application of API Q1 5.5.1.2 Initial Supplier Evaluation—Critical Purchases, the initial evaluation must include verification of the supplier’s quality management system implementation and conformity to quality system requirements specified for suppliers by the organization and/or the customer’s requirements
When the supplier for critical products, components, or activities is specified by the customer or involves proprietary and/or legal requirements that restrict the scope of the initial supplier evaluation process, the organization must adopt a tailored approach to ensure compliance and meet customer expectations. Here’s a structured method for conducting such evaluations:
- Understand Requirements:
- Thoroughly review the customer’s specifications and any proprietary or legal requirements associated with the critical purchases.
- Clarify with the customer and legal department any specific criteria or constraints that must be considered during the evaluation process.
- Identify Evaluation Criteria:
- Determine the key evaluation criteria based on the customer’s specifications, proprietary requirements, and legal constraints.
- Include criteria such as adherence to technical specifications, quality management system conformity, compliance with proprietary standards, and legal regulations.
- Supplier Communication:
- Engage in open communication with the customer-specified supplier to understand their capabilities, processes, and compliance measures.
- Request relevant documentation, such as quality management system certifications, compliance statements, and product specifications, from the supplier.
- Documentation Review:
- Review the supplier’s documentation to assess the implementation of their quality management system and conformity to specified requirements.
- Verify alignment with both organizational quality system requirements and any additional requirements mandated by the customer or proprietary/legal standards.
- On-Site or Remote Assessment:
- Conduct an on-site or remote assessment of the supplier’s facilities, processes, and controls, if feasible and necessary.
- Verify the effectiveness of quality management system implementation and the supplier’s ability to meet customer specifications and proprietary/legal requirements.
- Product Inspection/Testing:
- Perform inspection and testing of samples or prototypes of the critical products/components to ensure they conform to specified requirements.
- Use objective measurement tools and testing methods to verify compliance with technical specifications and quality standards.
- Compliance Verification:
- Validate the supplier’s compliance with proprietary standards and legal regulations by reviewing relevant certifications, audit reports, and compliance documentation.
- Ensure that the supplier’s processes and products align with the organization’s and customer’s expectations.
- Risk Assessment:
- Conduct a risk assessment to identify any potential risks associated with the supplier’s capabilities, processes, or products.
- Mitigate identified risks through appropriate measures, such as additional inspections, supplier audits, or contingency plans.
- Documentation and Record-Keeping:
- Maintain comprehensive records of the initial supplier evaluation process, including evaluation criteria, assessment findings, compliance verification, and any necessary actions taken.
- Ensure that documentation is accurate, up-to-date, and accessible for future reference and audit purposes.
- Continuous Monitoring and Improvement:
- Continuously monitor the performance of the customer-specified supplier and their adherence to specified requirements.
- Implement feedback mechanisms and performance metrics to track supplier performance and address any deviations or non-conformities promptly.
By following this systematic approach, organizations can effectively conduct initial supplier evaluations for critical purchases specified by customers or subject to proprietary/legal requirements. This ensures alignment with customer expectations, compliance with relevant standards, and the delivery of high-quality products/components that meet organizational and regulatory requirements.
The organization must also identify how the supplied product, component or activity conforms to specified requirements.
After completing the initial evaluation of suppliers for critical purchases, it’s essential for the organization to identify how the supplied product, component, or activity conforms to specified requirements. Here’s how this can be achieved:
- Verification Process:
- Establish a verification process to ensure that the supplied product, component, or activity meets the specified requirements.
- Define criteria and methods for verifying conformity, including inspection, testing, and review of documentation.
- Inspection and Testing:
- Conduct thorough inspections and testing of the supplied product, component, or activity to assess its conformity to specified requirements.
- Use appropriate measurement tools, equipment, and techniques to verify critical dimensions, performance characteristics, and other relevant parameters.
- Documentation Review:
- Review documentation provided by the supplier, including certificates of conformity, test reports, and compliance statements.
- Ensure that the documentation accurately reflects the characteristics and performance of the supplied product, component, or activity.
- Comparative Analysis:
- Compare the supplied product, component, or activity against the technical specifications, drawings, and other requirements provided by the customer or organization.
- Identify any deviations or non-conformities and assess their impact on product quality and performance.
- Customer Feedback:
- Seek feedback from the customer regarding the supplied product, component, or activity to verify its conformity to their specified requirements.
- Address any concerns or discrepancies raised by the customer through effective communication and corrective action.
- Supplier Communication:
- Communicate with the supplier to clarify any discrepancies or non-conformities identified during the verification process.
- Collaborate with the supplier to resolve issues and ensure future compliance with specified requirements.
- Record-Keeping and Documentation:
- Maintain detailed records of the verification process, including inspection results, test reports, customer feedback, and corrective actions taken.
- Ensure that documentation is accurate, traceable, and accessible for future reference and audit purposes.
- Continuous Improvement:
- Use the findings from the verification process to identify opportunities for improvement in supplier performance, product quality, and conformity to specified requirements.
- Implement corrective and preventive actions to address root causes of non-conformities and enhance overall product quality and customer satisfaction.
By identifying how the supplied product, component, or activity conforms to specified requirements, the organization can ensure that critical purchases meet customer expectations, regulatory compliance, and quality standards. This verification process contributes to the organization’s commitment to delivering high-quality products/components and maintaining customer trust and satisfaction.
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.
When assessment per API Q1 5.5.1.2, Item c) has not been performed, the scope of approval for customer-specified suppliers must be limited to the relevant customer contract. This means that the approval granted to such suppliers is contingent upon their ability to meet the specific requirements outlined in the contract with the customer. Without the assessment mandated by API Q1 5.5.1.2, Item c), the organization relies solely on the terms and conditions agreed upon in the customer contract to ensure that the supplier is capable of providing products, components, or activities that meet the specified standards and expectations. This limitation underscores the importance of thorough assessment and evaluation processes to establish supplier approval based on objective criteria and performance metrics, ensuring consistency, reliability, and compliance throughout the supply chain.
Example of a procedure for Initial Supplier Evaluation for Critical Purchases where the supplier is specified by the customer or involves proprietary and/or legal requirements:
- Purpose:
- The purpose of this procedure is to establish a systematic process for evaluating suppliers of critical purchases where the supplier is specified by the customer or involves proprietary and/or legal requirements to ensure they meet the organization’s requirements and standards.
- Scope:
- This procedure applies to all critical purchases made by the organization, where the supplier is specified by the customer or involves proprietary and/or legal requirements that limit the scope of the evaluation process.
- Responsibilities:
- The [Purchasing Department/Procurement Team/Supplier Quality Team] is responsible for implementing this procedure and ensuring compliance with its requirements.
- [Designated Personnel] are responsible for conducting supplier evaluations and documenting the results.
- Procedure:a. Identification of Critical Purchases:
- The Purchasing Department identifies critical purchases where the supplier is specified by the customer or involves proprietary and/or legal requirements.
- The organization defines evaluation criteria for assessing suppliers of critical purchases, considering factors such as customer requirements, proprietary specifications, legal compliance, quality standards, and supplier capabilities.
- Upon identifying critical purchases, the organization evaluates potential suppliers based on the established criteria.
- Evaluation methods may include reviewing supplier documentation, conducting site visits, obtaining certifications, and assessing past performance.
- The organization verifies that the supplier’s quality management system conforms to the quality system requirements specified by the organization, customer requirements, and applicable legal standards.
- The organization assesses the supplier’s capability to meet the organization’s specified requirements, customer requirements, proprietary specifications, and legal standards.
- The organization ensures that the supplier complies with customer-specified requirements and legal standards applicable to the critical purchases.
- All evaluations, assessments, and related documentation are recorded and maintained for future reference.
- Records include supplier evaluation forms, assessment reports, correspondence, certifications, and any other relevant documentation.
- Based on the evaluation results, approved suppliers for critical purchases are identified and added to the organization’s approved supplier list.
- Review and Revision:
- This procedure shall be periodically reviewed and revised as necessary to ensure its effectiveness and alignment with organizational requirements.
Example of a record for the initial evaluation of a supplier for critical purchases where the supplier is specified by the customer or involves proprietary and/or legal requirements:
| Record ID | Supplier Name | Evaluation Date | Scope of Evaluation | Assessment Criteria | Evaluation Outcome | Action Required |
|---|---|---|---|---|---|---|
| 001 | Customer Specified Inc. | 2024-05-15 | Product Component: ABC Widget | 1. Verification of quality management system implementation | Conformity: Partial (Some elements not fully implemented) | Supplier to provide corrective action plan |
| 2. Conformity to organization’s quality system requirements | Conformity: Yes | None | ||||
| 3. Conformity to customer’s specified requirements | Conformity: Yes (Fully complies with customer specifications) | None | ||||
| 4. Identification of how the supplied product conforms to requirements | Conformity: Partial (Documentation incomplete) | Supplier to provide additional documentation | ||||
| 5. Compliance with proprietary and legal requirements | Compliance: Yes | None |
