ML20324A216
| ML20324A216 | |
| Person / Time | |
|---|---|
| Issue date: | 11/19/2020 |
| From: | Yamir Diaz-Castillo NRC/NRR/DRO/IQVB |
| To: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| Diaz-Castillo Y | |
| References | |
| Download: ML20324A216 (6) | |
Text
November 19, 2020 MEMORANDUM TO: Kerri A. Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation FROM: Yamir Diaz-Castillo, Reactor Operations Engineer /RA/
Quality Assurance and Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
SUBJECT:
SUMMARY
OF THE PUBLIC MEETING TO DISCUSS LICENSEES PLANS FOR SUPPLIER OVERSIGHT BEYOND FREQUENCY EXTENSION LIMITS ALLOWED DURING THE CURRENT EXIGENT CONDITION On November 2, 2020, the U.S. Nuclear Regulatory Commission (NRC) held a Category 2 public meeting with industry representatives to discuss the licensees approach for performing supplier oversight when the 25% audit or survey frequency extension limit for the current exigent conditions allowance caused by Coronavirus Disease 2019 (COVID-19) is exceeded.
The meeting notice can be found in the Agencywide Documents Access and Management System (ADAMS) under Accession Number (No.) ML20293A173. The presentation slides can also be found under ADAMS Accession Nos. ML20303A041 and ML20303A043.
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 restated the purpose of the meeting and described that the nuclear industry, in conjunction with the Electric Power Research Institute (EPRI), is working on guidance for performing remote audits or surveys that is expected to be completed by the end of 2020. The timing of when the industry guidance will be submitted to the NRC for review and approval has not yet been established.
Mr. Justin Wearne, Project Manager with the Nuclear Energy Institute (NEI), Ms. Amy Aughtman, Chair of the Nuclear Quality Management Leaderships Vendor Audit Relief Subcommittee (VARS), and Mr. Cal Taylor, Exelon Corporations Corporate Corrective Action Program (CAP) Owner, represented the industry in its presentation of approaches to address procurement from suppliers that have exceeded the 3-year auditor survey cycle because licensees have been unable to safely conduct an audit or survey due to the current COVID-19 pandemic. Some of the interim procurement approaches included: (1) procuring from an alternate source, (2) performing commercial-grade dedication, (3) implementing a hybrid method for performing the audit on-site and remotely, and (4) using a provisional procurement authorization in conjunction with the CAP.
CONTACT: Yamir Diaz-Castillo, NRR/DRO (301) 415-2228
K. Kavanagh Mr. Wearne started his remarks by announcing that NEI and the VARS will be hosting a meeting in the upcoming weeks to discuss how licensees can implement these approaches. Mr. Wearne also clarified that the topics to be discussed during the meeting would be limited to how to remedy overdue supplier audits and surveys as a result of public health emergencies; no major changes to Quality Assurance (QA) program descriptions would be discussed.
Ms. Aughtman explained that most utilities have an allowance for a 25% grace period to complete an audit or survey beyond the 36-month period. Ms. Aughtman also stated that travel restrictions caused by COVID-19, both domestic and international, are precluding licensees from conducting on-site audits and surveys of vendors as required by Criterion VII, Control of Purchase Equipment, Materials, and Services, of Appendix B, Quality Assurance Program 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.
Mr. Wearne described the four multiple paths being taken by the industry to mitigate these challenges. Path A consists of interim guidance recently developed by the Nuclear Procurement Issues Committee which allows the audit Team Leader some flexibility to determine the minimum on-site team size required to conduct the audit or survey while other members support the audit or survey remotely. Path B consists of an effort led by EPRI to develop more comprehensive guidance to support a hybrid audit and survey approach and conducting audits and surveys fully remotely, should extensive travel and vendor restrictions not support any on-site presence. Path C consists of using a decision tree to explore procurement alternatives to accomplish each licensees needs should a supplier be approaching or go beyond the 25% grace period. Path D consists of a methodology to use the CAP to document an evaluation for provisional authorization of the vendor, item, or service as the method of last resort. Mr. Wearne stated the focus of the presentation would be on paths C and D, developed by the VARS to address these challenges. These two paths are considered bridging strategies until the EPRI guidance, as described by Ms. Kavanagh during her opening remarks, can be submitted to the NRC staff for review and approval.
Mr. Wearne proceeded to describe the decision tree containing several steps that provide licensees with decision points and options for procuring the item or service. Once all the options from the decision tree have been explored and determined not to be a viable solution, then the last option would be to utilize the CAP to document a vendors expiration date and complete the provisional procurement authorization. Ms. Aughtman described the basis, which was derived from Callaway Plants NRC Safety Evaluation (ADAMS Accession No. ML20216A681), for provisional procurement authorization and the compensatory measures for the continued use of suppliers that have exceeded the maximum allowed audit or survey time due to extenuating circumstances. Mr. Taylor walked through an example evaluation of a provisional procurement authorization form within the CAP with two parts: Part A, which focused on a suppliers QA program, and Part B, which focused on the technical and quality characteristics of a specific item.
Ms. Aughtman resumed the presentation by describing the basis developed by the VARS to evaluate whether the proposed use of the decision tree or the CAP does not represent a reduction in commitment requiring prior NRC approval in accordance with 10 CFR 50.54(a)(4).
The conclusion reached by the industry is that prior NRC approval is not needed since the industry does not expect to make any changes to an NRC-approved QA program description and therefore, 10 CFR 50.54(a) does not apply. Mr. Wearne concluded the industrys
K. Kavanagh presentation by thanking the NRC staff, reiterating the industrys position that its proposed approach is for implementation only during the public health emergency, and requesting NRC feedback.
Ms. Kavanagh started the NRC feedback by stating the NRC staff has considered the industrys proposal and did not have any issues with the proposed approach and the use of the CAP as a last resort. Licensees use of the CAP for conditions adverse to quality is within a licensees licensing basis and/or regulatory framework. The NRC staff understands that this approach is intended to be temporary while the NRC awaits a formal submittal a formal submittal from a licensee for review and approval for performing remote supplier audits and surveys. Upon NRC review and approval of such guidance, the proposed interim approach would no longer be implemented, with consideration for a timely transition period. Mr. Paul Prescott and Mr. Greg Galletti, Senior Reactor Operations Engineers, NRR/DRO/IQVB, echoed Ms. Kavanaghs feedback and stated that the use of the CAP with the applicable compensatory measures in place, is an appropriate measure that does not require prior NRC approval under 10 CFR 50.54(a)(4). Since each licensee has a unique QA program description, it is the licensees responsibility to evaluate the proposal in accordance with their stations procedures to determine prior NRC review and approval is not needed.
The NRC staff provided the public an opportunity to provide comments or ask questions.
Several questions and comments made by members of the public and the industry were addressed by the NRC staff, including requests for the NRC staff to clarify why licensees are not required to submit changes to their QA program descriptions under 10 CFR 50.54(a)(4) in order to use the proposed approaches.
At the conclusion of the meeting, Ms. Kavanagh invited the members of the public and the industry to provide feedback or any suggestions and/or questions regarding the meeting. There were no action items identified during the meeting.
Enclosure:
List of Attendees
ML20324A216 *via email NRC-001 OFFICE NRR/DRO/IQVB* NRR/DRO/IQVB NAME YDiaz-Castillo* KKavanagh*
DATE 11/19/2020 11/19/2020 List of Attendees Name Organization Justin Wearne Nuclear Energy Institute Nuclear Quality Management Leaderships Amy Aughtman Vendor Audit Relief Subcommittee Chair Nuclear Procurement Issues Corporation Earl Mayhorn Steering Committee/Ameren Cal Taylor Exelon Corporation Kevin P. Buckley Exelon Corporation Rob D. Radulovich Exelon Corporation Marc Tannenbaum Electric Power Research Institute (EPRI)
Allison Read EPRI Milton Concepción Dominion Energy Ted Shashaty Dominion Energy Randolph J. Hugenroth Omaha Public Power District Timothy Czuba Entergy Joe P. Pennington Entergy Mark Harvey Framatome Gary E. Szabatura Framatome Ryan Joschak Framatome Mark Coren Duke Energy Tom N. Welch Duke Energy John Conly Certrec Corporation William R. Avery Energy Harbor Nuclear Mark Mlachak Energy Harbor Nuclear Robert Thompson Energy Harbor Nuclear Leonard Weaver Energy Harbor Nuclear William Coll Energy Harbor Nuclear David M. Ambrose Talen Energy Camille T. Zozula Westinghouse Electric Company (WEC)
Douglas Burget WEC Scott R. Day WEC Tracy K. Clasey DTE Energy Scott T. Fairburn BWXT Technologies Enclosure
Name Organization Rob Burg Engineering Planning and Management Brendan Kusisto Indiana Michigan Power James W. McIntyre Sargent & Lundy Rachel K. Czuba Sonic Systems International. Inc.
John DeBonis Curtiss-Wright Stephanie Terwilliger NuScale John S. Larson Nebraska Public Power District Barney Poole Luminant Richard Swanson Luminant Dan Roberts Engine Systems, Inc.
David Soward Xcel Energy Cynthia E. Larson American Electric Power Raj Jolly Bechtel National, Inc.
Andres Torralba Ergytech, Inc.
Michael Buel Evergy Richard Buechler Southern Nuclear Operating Company Brian J. Hendel Energy Northwest Matty Ongchangco Cameron Dr. Bernard Johnson Cameron Kerri Kavanagh U.S. Nuclear Regulatory Commission (NRC)
Yamir Diaz-Castillo NRC Paul Prescott NRC Greg Galletti NRC Deanna Zhang NRC Andrea Keim NRC Jonathan Ortega-Luciano NRC Dong Park NRC Nicholas Savwoir NRC