ML22168A165
| ML22168A165 | |
| Person / Time | |
|---|---|
| Issue date: | 06/23/2022 |
| From: | Yamir Diaz-Castillo NRC/NRR/DRO/IQVB |
| To: | |
| Diaz-Castillo, Y 301-415-2228 | |
| Shared Package | |
| ML22168A146 | List: |
| References | |
| Download: ML22168A165 (21) | |
Text
ASME vs. Appendix B:
Ensuring Compliance with the Regulatory Requirements 30th Annual NUPIC Vendor Conference Yamir Diaz-Castillo NRR/DRO/IQVB June 23, 2022 1
Agenda
- Background
- Appendix B vs. ASME Section III
- Quality Assurance Manuals
- Procurement Requirements
- Qualification of Sub-Suppliers
- Commercial-Grade Dedication vs. Utilization of Unqualified Source Material
- Knowledge Check
- Questions
- Section III of the ASME B&PV Code is incorporated by reference in 10 CFR 50.55a, Codes and Standards.
- Current rulemaking will incorporate the 2019 Edition of the ASME B&PV Code and the 2008 through 2015 Editions of NQA-1.
- New rule expected to be issue in the Summer of 2022
- IN 86-21, Recognition of American Society Of Mechanical Engineers Accreditation Program For N Stamp Holders, and its 2 supplements:
- Documents the NRCs recognition of ASMEs Accreditation Program as evidence the holder of the certificate has a documented QA program that meets Appendix B to 10 CFR Part 50
- However, there are 2 stipulations!!
- Stipulation #1
- Recognition of ASMEs accreditation program only applies to the programmatic aspects of the QA programs. Licensees, applicants, and suppliers are still responsible for ensuring that their sub-suppliers are effectively implementing the approved QA program.
- Stipulation #2
- Recognition of ASMEs accreditation program only applies to Code items; it does not apply to non-Code items that may be supplied by ASME certificate holders.
- IN 86-21 also clarified that implementation audits are not necessary for procuring items that are:
- Relatively simple and standard in design, manufacturing and testing
- Adaptable to standard or automated inspections or tests of the end product to verify quality characteristics after delivery
Quality Assurance Manuals
- Criterion II, Quality Assurance Program, of Appendix B to 10 CFR Part 50, requires, amongst other things:
- the establishment of a Quality Assurance Program.
- Program shall be documented by written policies, procedures, or instructions.
Quality Assurance Manuals
- NCA-3211.6, Filing of the Quality Assurance Manual, requires the Certificate Holder to file copies of the Quality Assurance Manual with the Authorized Inspection Agency.
- NCA-4134.2, Quality Assurance Program, requires the use of NQA-1, Requirement 2, and the system used to meet these requirements to be described in the Quality Assurance Manual.
Quality Assurance Manuals
- NCA-4253.1, Quality System Manual, requires the Quality System Program be described and summarized in a Quality Manual that shall be the basis for demonstration of compliance with the rules of this section.
Quality Assurance Manuals
- Are suppliers required by regulation to implement two Quality Assurance Manuals to meet regulatory and Code requirements?
- No, there is no regulatory requirement to establish two different Quality Assurance Manuals.
- What happens if theres a conflict between Appendix B and ASME Code requirements?
Quality Assurance Manuals
- Example: Use of the ILAC Accreditation Process
- ASME not up to date with all the latest conditions for use
- 2021 Edition of ASME still includes the 2005 edition of ISO 17025
- A suppliers Quality Assurance Manual SHALL include the necessary requirements to meet Appendix B to 10 CFR Part 50
Procurement Requirements
- When buying a basic component (i.e., safety-related) from an ASME accredited supplier, Appendix B to 10 CFR Part 50 and 10 CFR Part 21 SHALL be imposed in the procurement documents.
- Important because:
- Ensures adequate Quality Assurance is applied throughout the manufacturing process
- Ensures Appendix B to 10 CFR Part 50 and 10 CFR Part 21 is passed down to the sub-suppliers
Qualification of Sub-Suppliers
- NCA-3842.2 allows for ASME accredited suppliers to qualify Material Organizations (MOs)
- Qualified MOs QA program shall meet the requirements of NCA-4200
- Majority of qualified MOs QA programs are based on ISO 9001, others on ISO 17025, and most are located outside the US
Qualification of Sub-Suppliers
- When inspecting how a MO was qualified, ensure that:
- There is sufficient objective evidence to support the conclusion that the sub-supplier met the controls and applicable requirements of NCA-4200; and
- The verification of the MOs 10 CFR Part 21 program is adequate.
Commercial-Grade Dedication vs.
Utilization of Unqualified Source Material
- Utilization of Unqualified Source Material (also known as material upgrade)
- Acceptance process for material not produced by an ASME accredited supplier
- ASME rules for material upgrade can be used for the commercial-grade dedication process when the material will be used for non-Code safety-related applications. For Code related applications, the material upgrade process is enough.
Knowledge Check
- True or False: When buying a basic component from a supplier holding an N-Type certificate, Appendix B and 10 CFR Part 21 do not need to be imposed in the purchase order (PO).
- False, Appendix B & Part 21 ALWAYS need to be imposed in POs when buying a basic component.
- True of False: All ASME Code material is considered safety-related.
- True, ASME Code material is pressure retaining, therefore, it is always safety-related.
Knowledge Check
- Can ASME Code material procured from an un-audited ASME accredited supplier be classified as a basic component?
- If the vendor did not perform an implementation audit and performs material testing upon receipt, theres a small window of time where the material is not considered a basic component until testing is completed. Alternatively, if the vendor had performed the implementation audit, then the material would already be considered a basic component.
Knowledge Check
- True or False: ASMEs material upgrade process and commercial-grade dedication are the same.
- False, both processes implement different requirements.
- If Im buying a relatively simple and standard item and Im not planning to audit the supplier, am I required to do anything else besides issuing the PO?
- Yes, use of this exception should be documented and evaluated.
Knowledge Check
- Can ASMEs material upgrade process be applied for performing commercial-grade dedication?
- Yes, provided this method of selection, identification, and verification of critical characteristics is documented in the suppliers commercial-grade dedication process.
Questions Contact Information:
Phone: 301-415-2228 Email: yamir.diaz-castillo@nrc.gov