ML23290A121
| ML23290A121 | |
| Person / Time | |
|---|---|
| Issue date: | 10/25/2023 |
| From: | Andrea Keim NRC/NRR/DRO/IQVB |
| To: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| References | |
| Download: ML23290A121 (5) | |
Text
October 25, 2023 MEMORANDUM TO: Kerri Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation Signed by Keim, Andrea on 10/25/23 FROM: Andrea Keim, Reactor Operations Engineer Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
SUBJECT:
SUMMARY
OF SEPTEMBER 27, 2023, NUCLEAR ENERGY INSTITUTE PRESUBMITTAL OF NEI 22-01 PUBLIC MEETING On September 27, 2023, the U.S. Nuclear Regulatory Commission (NRC) staff held an observation meeting with representatives from the Nuclear Energy Institute (NEI) to discuss NEIs proposal of utilizing the International Organization for Standardization (ISO)-9001, Quality Management Systems - Requirements, program with additional controls to satisfy the regulatory requirements of Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants to Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities (hereafter referred to as Appendix B) for advanced reactors and operating reactors.
The meeting notice is available in the NRCs Agencywide Documents Access and Management System (ADAMS) at Accession No. ML23263B082, and the presentation slides are available under ADAMS Accession No. ML23261C379. The enclosure to this summary provides the attendees for the meeting as captured by Microsoft Teams.
Mr. Mark Richter from NEI, provided background information and the industry motivation for the proposed methodology of utilizing suppliers with an ISO-9001 quality management system program (hereafter referred as ISO-9001 suppliers) in anticipation of advanced reactor deployment. Mr. Richter also stated that the planned proposal to use ISO-9001 suppliers for the operating fleet, based on the decreasing number of suppliers with Appendix B quality assurance programs that are available to procure basic components needed to support the operating fleet.
Mark Richter introduced additional speakers to discuss different parts of the presentation. The additional speakers included Mike Dunkelburger (MPR Associates), Mark Coren (Duke Energy),
Mark Tannenbaum (Electric Power Research Institute), and Ed Renaud (Westinghouse).
CONTACT: Andrea Keim, NRR/DRO/IQVB 301-415-1671
K. Kavanagh 2 The presenters discussed the development of the methodology incorporated in NEI 22-04, Utilization of ISO 9001 and Other Non-nuclear Suppliers for Safety Related Application. A gap analysis was performed for ISO-9001:2015 to Appendix B of 10 CFR Part 50. NEI 22-04 provides guidance for determining the gaps and differences, supplemental requirements and actions needed to satisfy Appendix B of 10 CFR Part 50. In addition, the presenters discussed options for 10 CFR Part 21, Reporting of Defects and Noncompliance, that are addressed in the proposed document.
The presentation included a discussion addressing how gaps were identified and recommendations to address a selection of gap examples. Mr. Coren and Mr. Renaud continued the NEI presentation and provided their experience on the two pilot assessments for two suppliers with ISO-9001 programs using the methodology in NEI 22-04.
At the completion of the NEI presentation, the NRC staff had an open dialogue with the NEI representatives. Ms. Kerri Kavanagh, Chief, Quality Assurance and Vendor Inspection Branch (IQVB) commented and emphasized the importance of the prevention of counterfeit, fraudulent, and suspect items from entering the supply chain when evaluating the gaps of the proposed ISO-9001 methodology and developing enhancements to meet Appendix B.
The NRC staff provided information and allotted time for stakeholder comments and questions.
Stakeholders provided feedback on several topics and asked clarifying questions.
At the conclusion of the meeting, Ms. Kavanagh provided closing remarks for the meeting. NEI is planning to submit NEI 22-04 in November 2023 Please direct any inquires to Andrea Keim at 301-415-1671 or via email at Andrea.Keim@nrc.gov .
Enclosure:
Attendance List
K. Kavanagh 3
SUBJECT:
SUMMARY
OF SEPTEMBER 27, 2023, NUCLEAR ENERGY INSTITUTE PRESUBMITTAL OF NEI 22-01 PUBLIC MEETING DATED: October 25, 2023 DISTRIBUTION:
PMcKenna RFelts LFields YLaw NRR_DRO_IQVB Distribution ADAMS Accession Number: ML23290A121 NRC-001 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NRR/DRO/IQVB/
NAME AKeim GGalletti KKavanagh DATE 10/25/2023 10/23/2023 10/25/2023 OFFICIAL RECORD COPY
Pre-submittal Public Meeting List of Attendees September 27, 2023 Name Organization March Richter* Nuclear Energy Institute (NEI)
Mark Coren Duke Energy Mike Dunkelberger* MPR Associates Marc Tannenbaum* Electric Power Research Institute (EPRI)
Ed Renaud Westinghouse Greg Galletti U.S. Nuclear Regulatory Commission (NRC)
Kerri Kavanagh* NRC Andrea Keim* NRC Raju Patel NRC Katie Wagner NRC Lesslie Fields NRC Deanna Zhang NRC Bruce Montgomery NEI Michael Torbit GE Vernova Rachel Czuba Mark Mlachak Taylor Blake GE Vernova Trace Orf Eddie Neville Jonathan Thomas Zachary Betsill Les Taggart Olimpio Brandy Torres Milton Concepcion Constellation Nuclear Adrienne Hudson Henry Pollock RJ Roux Rodney McCullum Tracy Honeycutt Rob Burg Andrea Segiet Paul Ragan GE Vernova Mark Svajger GE Vernova Stephen Kimura Ewa Muzikova Steven Shelton GE Vernova Allison Read EPRI Steven Pope Jack Bastermaji Aaron Thomlinson Monica Gaul GE Vernova Enclosure
Brandon Chisholm Ararat Torosyan Camille Zozula Elliot Korb David Ethington GE Vernova Stanely Griffin GE Vernova Diane Mlynarczyk Timothy Franchuk Sineaid Wilding B Janal Jana Bergman Curtiss-Wright Mary Miller
- On-Site at NRC Headquarters Attendance list based on Microsoft Teams Participant list. This list does not include all individuals that connected via phone.