ML21160A241
| ML21160A241 | |
| Person / Time | |
|---|---|
| Issue date: | 06/09/2021 |
| From: | Deanna Zhang NRC/NRR/DRO/IQVB |
| To: | |
| Diaz-Castillo Y | |
| References | |
| Download: ML21160A241 (7) | |
Text
Design Control: Importance of Adherence to Procurement Specifications Deanna Zhang June 24, 2021 NRR/DRO/IQVB
- Criterion III to Appendix B of Title 10 of the Code of Federal Regulations (10 CFR) Part 50 requires, in part, that:
- Measures are established to ensure that applicable regulatory requirements and the design basis for safety-related structures, systems, and components (SSC)s are correctly translated into specifications, drawings, procedures, and instructions.
- Design control measures are provided for verifying or checking the adequacy of design, such as by the performance of design reviews, by the use of alternate or simplified calculational methods, or by the performance of a suitable testing program.
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- Criterion IV to Appendix B of 10 CFR Part 50 requires that:
- Measures are established to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its contractors or subcontractors.
- Procurement documents require contractors or subcontractors to provide a quality assurance program consistent with the pertinent provisions of this appendix.
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- Licensees must impose regulatory requirements, such as Appendix B to 10 CFR Part 50 and 10 CFR Part 21, in procurement specifications to vendors for safety-related SSCs.
- Licensees may impose other requirements in procurement specifications. Examples include compliance to:
- Codes and standards and other technical requirements
- Plant design and licensing basis requirements
- The vendors issuance of Certificates of Compliance (CoCs) to these requirements within the procurement specification may be included as a requirement in the purchase order.
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- During recent vendor inspections, the NRC inspection team observed the following:
- Requirements from standards imposed by the licensee in purchase orders (POs) were not verified to have been met.
- CoCs did not clearly state what requirements within applicable standards were met.
- Compliance to standards imposed by licensees PO did not get translated to sub-suppliers.
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- Vendors that supply safety-related SSCs and services should as a minimum verify the following:
- Requirements from licensees PO are correctly translated into design requirements, including those that apply to testing and qualification.
- Activities and documentation provide clear objective evidence that these requirements have been met.
- If portions or all the licensees PO need to be supplied by a sub-supplier or contractor, the applicable requirements from the licensees PO need to be correctly translated to procurement documents to the sub-supplier or contractor.
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Contact Information:
Deanna.Zhang@nrc.gov 7