Podcast
Questions and Answers
What happens when a supplier's QMS certificate has expired?
What happens when a supplier's QMS certificate has expired?
How can a supplier with revoked 'Approved Supplier' status regain their status?
How can a supplier with revoked 'Approved Supplier' status regain their status?
Why does Quality Assurance monitor supplier certifications?
Why does Quality Assurance monitor supplier certifications?
What is required for laboratories performing commercial grade dedication, calibration, dimensional measurement, mechanical and chemical testing, and non-destructive examinations (NDE)?
What is required for laboratories performing commercial grade dedication, calibration, dimensional measurement, mechanical and chemical testing, and non-destructive examinations (NDE)?
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What is the purpose of maintaining records on qualifications of personnel performing special processes?
What is the purpose of maintaining records on qualifications of personnel performing special processes?
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Where must a QMS audit for a supplier take place?
Where must a QMS audit for a supplier take place?
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What is required for all weld processes and standards?
What is required for all weld processes and standards?
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What is the requirement for suppliers of products or services associated with an ITAR/EAR restricted product?
What is the requirement for suppliers of products or services associated with an ITAR/EAR restricted product?
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What is the minimum on-time delivery percentage for suppliers?
What is the minimum on-time delivery percentage for suppliers?
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What is the purpose of evaluating low-performing suppliers?
What is the purpose of evaluating low-performing suppliers?
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What is the requirement for commercial product suppliers?
What is the requirement for commercial product suppliers?
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What is the timing requirement for a QMS audit for a supplier of product or service identified as "Nuclear Safety Related"?
What is the timing requirement for a QMS audit for a supplier of product or service identified as "Nuclear Safety Related"?
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What happens to suppliers who have not received a purchase order within a 12-month period?
What happens to suppliers who have not received a purchase order within a 12-month period?
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What happens to suppliers who have been dormant for a 24-month period?
What happens to suppliers who have been dormant for a 24-month period?
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What is the minimum product acceptance percentage for suppliers?
What is the minimum product acceptance percentage for suppliers?
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What is the requirement for suppliers performing NDE services on CDC part numbers or customer orders that state 'Nuclear Safety Related'?
What is the requirement for suppliers performing NDE services on CDC part numbers or customer orders that state 'Nuclear Safety Related'?
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Where should a supplier's qualification and contact information for authorized individuals be stored?
Where should a supplier's qualification and contact information for authorized individuals be stored?
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What happens to suppliers who fall below the stated metrics?
What happens to suppliers who fall below the stated metrics?
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What is the primary purpose of monitoring supplier performance?
What is the primary purpose of monitoring supplier performance?
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What is a consequence of a supplier falling below the stated metrics?
What is a consequence of a supplier falling below the stated metrics?
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Study Notes
Revocation of Approved Supplier Status
- Suppliers may have their "Approved Supplier" status revoked if they fail to meet Continental Disc Corporation's needs, violate a secrecy agreement, or fail to comply with the document's requirements.
Certification Monitoring
- Supplier certifications are monitored for expiration to ensure continued compliance with their approved Quality Management System (QMS).
Revocation Procedure
- A supplier with an expired QMS certificate is given 45 days to provide a valid certificate before their "Approved Supplier" status is revoked.
- After revocation, Quality Assurance notifies affected departments, updates the supplier profile in the current ERP system, and distributes an updated Approved Supplier List.
Reinstatement of Approved Supplier Status
- Suppliers seeking reinstatement must go through a new approval process and submit evidence of compliance with CDC's requirements.
- Quality Assurance may impose additional requirements for reinstatement of "Approved Supplier" status.
Certification and Accreditation
- Certified QMS requires assessment and certification by a signatory accreditation organization conforming to ISO/IEC 17021
- Certification must be up-to-date and within the scope of requested services listed on the purchase order
- CDC issues certification to the supplier location, verified in CDC's supplier ERP file
QMS Evaluation
- QMS Questionnaire (QCF-1014-1) is required for compliance
- QMS Audit is necessary, with a focus on special processes
Special Processes
- Suppliers providing special services must hold specific certifications
- Suppliers performing NDE services must submit qualification and training records for all inspectors
- Purchase orders must be reviewed and approved by Quality Assurance prior to release
ILAC-MRA Accreditation
- Required for laboratories performing commercial grade dedication, calibration, dimensional measurement, mechanical and chemical testing, and non-destructive examinations (NDE)
- Includes ISO/IEC 17025 accreditation with adherence to specific industry-related standards
- Marked on the supplier's certificate
QMS Audit and Examination
- QMS audit shall occur at the supplier's certified location and be completed within 12 months prior to the release of the purchase order
- NDE personnel must be qualified in accordance with applicable codes, standards, and specifications
- Examinations must be performed in accordance with written procedures and applicable codes
Non-Destructive Examination (NDE) Processes
- NDE personnel must be qualified and examinations performed in accordance with written procedures
- NDE equipment must be calibrated and maintained in accordance with applicable codes and standards
- Records of qualifications and equipment calibration must be maintained
Standards and References
- 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 and Approved Suppliers List
Supplier Approval Criteria
- ILAC-MRA Accreditation: Required for laboratories performing commercial grade dedication, calibration, dimensional measurement, mechanical and chemical testing, and non-destructive examinations (NDE)
- ILAC-MRA Accreditation with QMS Audit: Required for laboratories performing NDE services on CDC part numbers or customer orders that state "Nuclear Safety Related"
- 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
- Weld Procedure Specification (WPS) for all weld processes and standards
- Evidence of welder qualification prolongation review
Customer Specific Suppliers
- Suppliers designated on a customer purchase order shall be provided "Approved Supplier" status for use in conjunction with that specific customer
- Product or services furnished by a customer-approved supplier shall be subject to all receiving inspection and quality policies
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
ITAR/EAR Restricted Suppliers
- Suppliers of products or services associated with an ITAR/EAR restricted product must be domestic and registered with the DDTC
- 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
Monitoring Supplier Performance
- On-Time Delivery: 90%
- Product Acceptance: 95%
- Purchasing Activity: 12 Months
- Quality Management System (QMS): Approved
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
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
Standards and References
- 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: 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
Supplier Approval Criteria
- Laboratories require ILAC-MRA accreditation for commercial grade dedication, calibration, dimensional measurement, mechanical and chemical testing, and non-destructive examinations (NDE)
- ILAC-MRA accreditation with QMS audit is required for laboratories performing NDE services on CDC part numbers or customer orders that state "Nuclear Safety Related"
- Procedure Qualification Record (PQR) is required for all weld processes and standards
- Welder Performance Qualification (WPQ) is required for each welder performing work and for all weld processes and standards
- Weld Procedure Specification (WPS) is required for all weld processes and standards
- Evidence of welder qualification prolongation review is required
Customer Specific Suppliers
- Suppliers designated on a customer purchase order are provided "Approved Supplier" status for use in conjunction with that specific customer
- Additional qualification may be required based on the product or service being supplied and any code or regulatory requirements applicable to the product or service
Commercial Product Suppliers
- Distributors or retailers who supply commercial or brand name products 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
ITAR/EAR Restricted Suppliers
- Suppliers of products or services associated with an ITAR/EAR restricted product must be domestic and registered with the DDTC
- 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
Monitoring Supplier Performance
- On-Time Delivery: 90%
- Product Acceptance: 95%
- Purchasing Activity: 12 Months
- Quality Management System (QMS): Approved
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
- Evaluation will take into consideration the root cause of MRB and NCR cases, responsiveness to reported issues, improvement activities, and quantity of Purchase Orders received
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
- Suppliers designated with dormant status for a 24-month period will have their approval status revoked
Standards and References
- 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: 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
Supplier Approval Criteria
- Laboratories require ILAC-MRA accreditation for commercial grade dedication, calibration, dimensional measurement, mechanical and chemical testing, and non-destructive examinations (NDE)
- ILAC-MRA accreditation with QMS audit is required for laboratories performing NDE services on CDC part numbers or customer orders that state "Nuclear Safety Related"
- Procedure Qualification Record (PQR) is required for all weld processes and standards
- Welder Performance Qualification (WPQ) is required for each welder performing work and for all weld processes and standards
- Weld Procedure Specification (WPS) is required for all weld processes and standards
- Evidence of welder qualification prolongation review is required
Customer Specific Suppliers
- Suppliers designated on a customer purchase order are provided "Approved Supplier" status for use in conjunction with that specific customer
- Additional qualification may be required based on the product or service being supplied and any code or regulatory requirements applicable to the product or service
Commercial Product Suppliers
- Distributors or retailers who supply commercial or brand name products 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
ITAR/EAR Restricted Suppliers
- Suppliers of products or services associated with an ITAR/EAR restricted product must be domestic and registered with the DDTC
- 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
Monitoring Supplier Performance
- On-Time Delivery: 90%
- Product Acceptance: 95%
- Purchasing Activity: 12 Months
- Quality Management System (QMS): Approved
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
- Evaluation will take into consideration the root cause of MRB and NCR cases, responsiveness to reported issues, improvement activities, and quantity of Purchase Orders received
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
- Suppliers designated with dormant status for a 24-month period will have their approval status revoked
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Description
This quiz covers the procedures and policies for supplier approval and ongoing performance monitoring.
