QCI-1014 Supplier Selection and Quality Assessment - New.docx

**PURPOSE AND SCOPE** 2. **STANDARDS AND REFERENCES (CURRENT VERSIONS)** - ISO 9001, "Quality Management Systems" - AS9100, "Quality Management Systems - Requirements for Aviation, Space and Defense Organizations" - ISO/IEC 80079, "Explosive Atmospheres Part 34: Applic...

**PURPOSE AND SCOPE** 2. **STANDARDS AND REFERENCES (CURRENT VERSIONS)** - ISO 9001, "Quality Management Systems" - AS9100, "Quality Management Systems - Requirements for Aviation, Space and Defense Organizations" - ISO/IEC 80079, "Explosive Atmospheres Part 34: Application of Quality Systems for Ex Product Manufacture" - ISO/IEC 17025, "General Requirements for the Competence of Testing and Calibration Laboratories" - ISO/IEC 17021, "Conformity Assessment --- Requirements for Bodies Providing Audit and Certification of Management Systems" - 10 CFR Part 50\_Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants - BPVC\_XIII, "ASME Boiler and Pressure Vessel Code Section XIII- Mandatory Appendix III: Quality Control System" - 2014/68/EU, "Pressure Equipment Directive (PED -- Module D: Conformity to the Type Based on Quality Assurance of the Production Process" - ISO 3834-3, "Standard Quality Requirements for Fusion Welding of Metallic Materials" - CDC Quality Assurance Manual - CDC Approved Suppliers List 3. **SUPPLIER APPROVAL CRITERIA** **\ ** 1. 1. **ILAC-MRA Accredidation**: Required for laboratories performing commercial grade dedication, calibration, dimensional measurement, mechanical and chemical testing, and non-destructive examinations (NDE). International Laboratory Accreditation Cooperation (ILAC) -- Mutual Recognition Agreement (MRA) accredidation includes ISO/IEC 17025 with adherence to specific industry-related standards and will be marked on the supplier's certificate. 2. **ILAC-MRA Accredidation w/ QMS Audit**: Required for laboratories performing NDE services on CDC part numbers or customer orders that state "Nuclear Safety Related". The QMS audit shall occur at the supplier's certified location and be completed within the twelve months prior to the release of the purchase order. 3. - Procedure Qualification Record (PQR) for all weld processes and standards. - Welder Performance Qualification (WPQ) for each welder performing work and for all weld processes and standards. All weld qualification testing shall be performed by a laboratory who has third party accreditation with a scope of approval that encompasses materials testing and metallographic evaluation of welds for the processes performed. - Weld Procedure Specification (WPS) for all weld processes and standards. - Evidence of welder qualification prolongation review. 4. 2. 5. 6. 4. 3. **Customer Specific Suppliers: Suppliers designated on a customer purchase order shall be provided "Approved Supplier" status for use in conjunction with that specific customer. The need for additional qualification shall be determined based upon the product or service being supplied and any code or regulatory requirements applicable to the product or service. Product or services furnished by a customer-approved supplier shall be subject to all receiving inspection and quality policies.** 4. **Commercial Product Suppliers: Distributors or retailers who supply commercial or brand name product to be incorporated into a CDC product are not required to maintain a documented quality system and meet pre-qualification requirements. Commercial product shall be inspected at receipt for conformance to purchase order and delivery requirements.** **\ ** 5. **ITAR/EAR Restricted Suppliers: Suppliers of products or services associated with an ITAR/EAR restricted product must be domestic and registered with the DDTC.** A Supplier's qualification (DDTC Registration with expiration date) and contact information for authorized individuals within the organization to receive ITAR restricted information **shall be stored electronically in the current ERP system within the supplier's profile and noted on the Approved Supplier's List.** 5. **MONITORING SUPPLIER PERFORMANCE** 6. - On-Time Delivery: 90% - Product Acceptance: 95% - Purchasing Activity: 12 Months - Quality Management System (QMS): Approved 7. **Low Performing Suppliers: Suppliers that fall below the stated metrics shall be evaluated to determine the risk to Continental Disc Corporation and the appropriate action required to mitigate this risk. Mitigation efforts may include the issuance of corrective action, requalification, or revocation of "Approved Supplier" status. The evaluation will take into consideration the following:** - **Root cause of MRB and NCR cases** - **Responsiveness to reported issues** - **Improvement activities** - **Quantity of Purchase Orders received** 8. 9. **Dormant Suppliers: Suppliers who have not been issued a purchase order from Continental Disc Corporation within a 12-month period shall be identified as dormant on the Approved Supplier's List. Dormant suppliers shall be evaluated by Quality Assurance prior to the issuance of a new purchase order to ensure continued compliance to the supplier requirements detailed in this document. Suppliers designated with dormant status for a 24-month period will have their approval status revoked.** 10. 6. **REVISION CONTROL** **Rev** **Description** **Date** **Approved** --------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ---------- ---------------- X Full document rewrite to incorporate all CDC required supplier selection and evaluation criteria into one document. Previous revisions and history can be viewed on QCI-1014 in the current ERP system. 6/3/2024 Valerie Stuart