ML24157A075

Yamirs 2024 Workshop Presentation

ML24157A075
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Issue date:	06/13/2024
From:	Yamir Diaz-Castillo NRC/NRR/DRO/IQVB
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1 9th NRC Workshop on Vendor Oversight - June 13, 2024 - Baltimore, MD NRCs Recognition of the American Society of Mechanical Engineers Conformity Assessment Process Yamir Diaz-Castillo, Reactor Operations Engineer Quality Assurance & Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation

Agenda

• NRCs Participation on Consensus Codes & Standards

• What is ASME Conformity Assessment?

• Lets Go Back in Timeto the 1980s!

• Information Notice 86-21 and its Supplements

• Summary & Closing Thoughts

NRCs Participation on Consensus Codes & Standards

• The NRC has been an active participant in the development and use of consensus codes and standards since its creation in 1974.

• Consensus codes and standards promote the safe operation of nuclear power plants and improve the effectiveness and efficiency of the regulatory oversight.

• Federal law requires agencies to use technical standards developed by voluntary consensus standards bodies and participate in their development vs. developing their own.

NRCs Participation on Consensus Codes & Standards

• The NRC staff participates on consensus codes and standards development committees along with other stakeholders.

• Codes and standards are developed based on a consensus process with input from all stakeholders.

• The NRC staff reviews codes and standards for possible endorsement in regulatory documents.

ASME Conformity Assessment

• What is ASMEs Conformity Assessment?

- The recognition of a companys or individuals capability to fulfill the requirements of an ASME standard to advance public safety and facilitate international commerce.

• How does conformity assessment relate to Appendix B to 10 CFR Part 50?

- Licensees issue purchase orders for safety-related components or services that invoke the Quality Assurance (QA) requirements of Appendix B to 10 CFR Part 50.

- Licensees will then perform an audit of its suppliers to ensure compliance with the QA requirements of Appendix B to 10 CFR Part 50.

• How did the NRC recognize ASMEs Conformity Assessment process?

Lets Go Back in Timeto the 1980s!

• March 1981 - The NRC, ASME, and the National Board of Boiler and Pressure Vessel Inspectors (NB) signed an Exchange of Correspondence.

• This document outlined an agreement, with conditions, to work toward establishing:

- A single set of quality requirements; and

- Recognition by the NRC of ASMEs accreditation program.

Lets Go Back in Timeto the 1980s!

• The NRC had incorporated portions of the ASME Code into 10 CFR 50.55a, Codes and Standards, except for complete recognition of ASMEs accreditation program and stamping.

• Several U.S. states had passed laws requiring overall construction of components and systems be performed in accordance with Section III of the ASME Code (Divisions 1 and 2).

Lets Go Back in Timeto the 1980s!

• The overlapping of similar functions resulted in separate audits, surveys, and inspections to the same suppliers of nuclear equipment.

• This caused a duplication of efforts in the evaluation and inspection of the suppliers QA programs.

• An effort began to develop a program to establish compatible QA requirements in the interest of efficiency and greater effectiveness in assuring the ultimate safety of nuclear power plants.

Lets Go Back in Timeto the 1980s!

• The goal of the program was to establish conditions that would allow for the NRCs recognition and utilization of the ASME/NB system of nuclear accreditation and 3rd party inspection.

• Some of the conditions included:

- Allow the NRC staff to audit ASME & NB activities;

- Maintain procedures for conducting and documenting the nuclear accreditation program; and

- Use of the NQA-1 QA standard, supplemented by NRC positions in Regulatory Guides, as the basis for issuing Certificates of Authorization.

Lets Go Back in Timeto the 1980s!

• December 1985 - The NRC, ASME, and NB agreed that based on the requirements contained in the 1986 Edition of the ASME Code, all the conditions in the Exchange of Correspondence had been met.

• The NRCs recognition would allow licensees and applicants to satisfy NRCs programmatic QA requirements related to the evaluation and inspection of a suppliers QA program.

• The NRCs recognition was documented in Information Notice (IN) 86-21, Recognition of American Society of Mechanical Engineers Accreditation Program for N Stamp Holders.

Information Notice 86-21

• March 1986 - IN 86-21 documents the NRCs recognition of ASMEs accreditation program as evidence the ASME Certificate Holder has a documented QA program that meets the requirements of Appendix B to 10 CFR Part 50.

• Recognition of ASMEs accreditation program only applies to the programmatic aspects of the ASME Certificate Holders QA programs.

• Licensees, applicants, and suppliers are still responsible for ensuring that their sub-suppliers are effectively implementing the approved QA program - Criterion VII of Appendix B to 10 CFR Part 50.

Information Notice 86-21, Supplement 1

• December 1986 - IN 86-21, Supplement 1, provided clarification for ASME Quality System Certificate (QSC) Holders.

• QSC Holders were excluded from recognition in IN 86-21 as they were not part of the Exchange of Correspondence between the NRC, ASME, and the NB.

• Licensees misinterpretation of this exclusion resulted in licensees removing QSC Holders from their Approved Suppliers List (ASL).

• If a licensees NRC-approved QA program allowed material organizations to be placed in the ASL based on a QSC, then this method for evaluating and selecting vendors is not affected by the issuance of IN 86-21.

Information Notice 86-21, Supplement 2

• April 1991 - IN 86-21, Supplement 2, provides additional clarification on a licensee, applicant, and suppliers responsibilities for verifying effective implementation of a sub-suppliers QA program.

• Regulatory Guide (RG) 1.144, Auditing of Quality Assurance Programs for Nuclear Power Plants, Revision 1, and RG 1.28, Quality Assurance Program Requirements (Design and Construction), states that implementation audits are not necessary for procuring items that are:

- Relatively simple and standard in design, manufacturing, and testing; and

- Adaptable to standard or automated inspections or tests of the end-product to verify quality characteristics after delivery.

Information Notice 86-21, Supplement 2

• IN 86-21, Supplement 2, clarifies that recognition on 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 88-95, Inadequate Procurement Requirements Imposed by Licensees on Vendors, provides additional information regarding the procurement of non-pressure boundary parts used on ASME components.

Flash Forward 40 Years

Summary & Closing Thoughts

• The NRC recognizes that ASME Certificate Holders have a documented QA program that meets the requirements of Appendix B to 10 CFR Part 50.

• This recognition is only for the programmatic aspects of ASMEs accreditation program, it does not recognize that it is evidence a supplier is effectively implementing the approved QA program.

• Proper nuclear oversight is essential to ensure the adequate implementation of technical and regulatory requirements for the protection of public health and safety.

Contact Information Yamir Diaz-Castillo 301-415-2228 yamir.diaz-castillo@nrc.gov