ML21348A313
| ML21348A313 | |
| Person / Time | |
|---|---|
| Issue date: | 12/15/2021 |
| From: | Yiu Law NRC/NRR/DRO/IQVB |
| To: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| Law Y | |
| References | |
| Download: ML21348A313 (1) | |
Text
December 15, 2021 MEMORANDUM TO: Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation Signed by Law, Yiu Kui FROM: Yiu Law, Reactor Operations Engineer nature: on 12/15/21 Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
SUBJECT:
SUMMARY
OF THE OBSERVATION PUBLIC MEETING TO DISCUSS NEIS PLANNED PROPOSAL OF QUALITY ASSURANCE STANDARD ISO-9001 AND ITS POTENTIAL USE TO SATISFY THE REGULATORY REQUIREMENTS OF QUALITY ASSURANCE On November 30, 2021, the U.S. Nuclear Regulatory Commission (NRC) held an observation public meeting with representatives from the Nuclear Energy Institute (NEI) to discuss NEIs planned proposal of utilizing the International Organization for Standardization (ISO)-9001 quality assurance standard 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 as Appendix B) for advanced reactors and operating reactors. The meeting notice can be found in the Agencywide Documents Access and Management System (ADAMS) under Accession Number ML21327A458. The presentation slides can also be found under ADAMS Accession Number ML21327A263.
The meeting was opened by Ms. Kerri Kavanagh, Chief, Quality Assurance and Vendor Inspection Branch (IQVB), Division of Reactor Oversight (DRO), Office of Nuclear Reactor Regulation (NRR). Ms. Kavanagh provided opening remarks and stated that the meeting was held at the request of NEI. It was noted that the NRC staff has not endorsed ISO-9001 to meet the requirements of Appendix B.
Mr. Mark Richter from NEI, provided background information and industry motivation in NEIs planned proposal to use suppliers that have an approved ISO-9001 QA program (hereafter referred as ISO-9001 suppliers) in anticipation to support the development of advanced reactors and the rulemaking effort of 10 CFR Part 53, Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors. Mr. Richter also stated that the planned proposal to use ISO-9001 suppliers may provide near-term benefits for the operating fleet with the decreasing number of suppliers with Appendix B QA programs that are available to procure components needed to support the operating fleet.
CONTACT: Yiu Law, NRR/DRO/IQVB (301) 415-0523
K. Kavanagh Mr. Mark Coren from Duke Energy continued the NEI presentation and provided his perspectives on recent audits of several manufacturing suppliers with both ISO-9001 and Appendix B QA programs. In his presentation, Mr. Coren also presented a table identifying the high level gaps between the requirements from ISO-9001 and the requirements from Appendix B.
Mr. Marc Tannenbaum from the Electric Power Research Institute (EPRI) closed the NEI presentation and provided his perspectives on the reasons and benefits of using ISO-9001 suppliers in procuring components for the nuclear industry. Mr. Tannenbaum stated that to address the gaps between the requirements from ISO-9001 and the requirements from Appendix B, a proposed solution would be for the ISO-9001 suppliers to accept contractual requirements to address these gaps in the procurement process, and to provide the licensees with rights of access to their facilities for the purpose of assessment and oversight. A targeted assessment plan would be developed to assess the areas of disparity between the requirements from ISO-9001 and requirements from Appendix B. An inspection and test plan would also be developed from the ISO-9001 suppliers during the procurement process.
At the end of the NEI presentation, the NRC staff had an open dialogue with the NEI representatives. Ms. Kavanagh commented and emphasized the importance of understanding the scope of safety-related components as it relates to advanced reactors, which is not yet well-defined. It is likely that the number of safety-related components will decrease in advanced reactors and therefore, meeting the requirements of Appendix B may not be an impediment for supplying safety-related components for advanced reactors. In addition, the resources spent to bridge the gaps between the requirements from ISO-9001 and the requirements from Appendix B may not be fully realized as a cost saving for the industry. Mr. Paul Prescott from the NRC also commented that a similar effort to what NEIs currently proposing has been attempted before, and since the scope of safety-related components for advanced reactors is not yet well-defined, it may be beneficial for NEI to introduce a different approach to secure suppliers for advanced reactors, as opposed to trying to bridge the gaps between ISO-9001 and Appendix B for both advanced reactors and operating reactors.
After discussion with the NRC staff, Mr. Richter, Mr. Coren, Mr. Tannenbaum and Mr. Edward Renaud from Westinghouse, collectively provided the following additional information:
- One major difference between NEIs planned proposal to adopt ISO-9001 and the current regulation on commercial grade dedication in securing safety-related components is that commercial grade dedication is predicated on not knowing the initial acceptance requirements of a safety-related item, thus having to determine the safety functions and failure modes of such item. Another difference is that the ISO-9001 approach is a more holistic approach, as opposed to commercial grade dedication being an assessment for every different item being procured.
- To address gaps between the requirements of ISO-9001 and the requirements of Appendix B, such as special processes like welding, the licensee procuring the safety-related item or service and the ISO-9001 supplier supplying the item or service would have to address these gaps through procurement specifications and contractual agreements.
- 10 CFR Part 21 requirements would be contractually passed down from the licensee procuring an item to the ISO-9001 supplier supplying the item through the procurement specifications.
K. Kavanagh - To provide oversight of an ISO-9001 supplier, the licensee would extend their Appendix B QA program requirements to the ISO-9001 supplier.
After discussion between the NRC staff and the NEI representatives, the NRC staff provided the public an opportunity to provide comments or ask questions. A comment was made by a member of the public on the history of QA and safety of nuclear power plants in relation to NUREG-1055, Improving Quality and the Assurance of Quality in the Design and Construction of Nuclear Power Plants: A Report to Congress, which is publicly available on the NRC website.
At the conclusion of the meeting, Ms. Kavanagh provided closing remarks for the meeting. NEI is planning to submit a white paper providing a more detailed proposal of using ISO-9001 to satisfy Appendix B requirements in 2022 for NRC review.
Enclosure:
List of Attendees
ML21348A313 *via email NRC-001 OFFICE NRR/DRO/IQVB NRR/DRO/IQVB NAME YLaw* KKavanagh*
DATE 12/8/2021 12/15/2021 List of Attendees Name Organization Mark Richter Nuclear Energy Institute (NEI)
Marcus Nichol NEI Mark Coren Duke Energy Marc Tannenbaum Electric Power Research Institute (EPRI)
Marc Albert EPRI Allison Read EPRI Jessica Lemieux EPRI Rick Way EPRI Minneva Taltoan Next Era Energy Aixa Belen X Energy Theo Odendaal X Energy Charlotte Geiger X Energy Travis Chapman X Energy Ingrid Nordby X Energy Jon Facemire X Energy Steve Vanugh X Energy Zenas McLucas X Energy Earl Mayhorn Ameren Roy Linthicum Exelon Phil Couture Entergy Ron Gaston Entergy Edward Renaud Westinghouse Rob Burg Engineering Planning and Management Inc.
Robert Thompson Energy Harbor Nuclear William Coll Energy Harbor Nuclear William Avery Energy Harbor Nuclear Vince Gilbert Model Performance, LLC Robert Seipel Shine Technologies Mike Dunkelberger MPR Associates Shanrokhi Farshid FRA-CORP Ewa Muzikova Ultra Safe Nuclear Corporation Jana Bergman Curtiss-Wright Michael Keegan State of Michigan Enclosure
Kerri Kavanagh U.S. Nuclear Regulatory Commission (NRC)
Yiu Law NRC Yamir Diaz-Castillo NRC Paul Prescott NRC Greg Galletti NRC Deanna Zhang NRC Andrea Keim NRC Dong Park NRC Laura Smith NRC Frankie Vega NRC Timothy Drzewiecki NRC Ian Jung NRC Steven Lynch NRC Philip McKenna NRC Eric Oesterle NRC Joseph Sebrosky NRC John Segela NRC Adam Stein Ernest Bates Zachary Betsill Bob Thompson Michael Anthony Brown Fred Madden Fred Mizell Jamie Schlarb Jason Christensen Jerry Ice Paul Martyak Rick Way Ross Mike Ruffolo Sam M.
Wayne Massie Zackary Rad 2