ML24261B889
| ML24261B889 | |
| Person / Time | |
|---|---|
| Issue date: | 01/25/2024 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| Download: ML24261B889 (14) | |
Text
NRC Update Nuclear Oversight Conference January 24-25, 2024 Clearwater, FL Kerri Kavanagh Quality Assurance & Vendor Inspection Branch Office of Nuclear Reactor Regulation
Topics 2
Summary of Inspections Results Recent NRC vendor inspection locations Mistras Services Ansys Draft RIS: Required Assessment of Government Labs and Services Regulations for QA Program Change RG 1.8, Qualification and Training of Personnel for Nuclear Power Plants RG 1.28, Quality Assurance Program Criteria (Design and Construction) 9th Vendor Workshop
FY2023 Vendor Inspections 3
FY2023 Violations & Nonconformances Completed 18 Vendor Inspections & 3 observations in fiscal year 2023.
Issued four violations &
12 nonconformances.
Recent & Upcoming NRC Inspections 4
Recent:
Namco ILAC Observation (Brazil)
Thermo Fisher Henry Pratt Company Rosemount (NUPIC Observation)
Hanna Cylinders Upcoming:
KHNP - SGI Consolidated Power Westinghouse Columbia Fuel Cycle Facility NuScale SDAA QA implementation inspection FY24 has QA Implementation and Protection of SGI Inspections planned, in addition to routine Vendor QA Inspections.
Mistras Services 5
Vendor Inspection performed March 6-10, 2023.
Evaluated nondestructive examination services provided for safety-related equipment.
Inspection Report (ML23151A458)
Resulting enforcement actions included:
Two Violations (SL IV) for Part 21 Notifications One Nonconformance against Criteria I Department of Justice (DOJ) Prosecution of Mistras Personnel On October 18, 2023, DOJ issued a press release announcing that two men pled guilty for their roles in creating false calibration certificates in a matter within the jurisdiction of the NRC.
Both helped create and transmit final testing reports to the owners of the plants which, among other things, contained calibration certificates for the equipment used.
Both created numerous false calibration certificates for AE testing equipment, and 15 of these false certificates were sent a total of 29 times to nuclear plant owners as part of final testing reports required by the NRC. The falsified calibration certificates were discovered in 2021 during an NUPIC audit.
Both are scheduled to be sentenced on Jan. 25, 2024. Each faces a maximum penalty of five years in prison.
Mistras Services 6
Office of Investigation Report 1-2022-003 (ML23340A106)
Resulting enforcement action - 1 apparent violation to:
10 CFR 50.5(a)(2) Deliberate misconduct Criterion XVII Quality Assurance Records Criterion XII Control of Measuring and Test Equipment Mistras has requested Alternative Dispute Resolution (ADR)
ANSYS Vendor Inspection 7
Vendor Inspection performed June 26-30, 2023.
Evaluated software development and support services provided for safety-related services.
Inspection Report documents (ML23237B258):
Inadequate Part 21 procedures and actions related to notification to the Commission and Purchasers.
Company failed to establish a quality assurance program that met the applicable provisions of Appendix B to 10 CFR Part 50. Specifically, procedures failed to document the policies, procedures, and instructions of a quality assurance program which complies with Appendix B.
Resulting enforcement actions included:
Two Violations (SL IV) for Part 21 Notifications Two Nonconformances against Criteria II & XVI NRC received a response from ANSYS on October 10, 2023 (ML23285A168), in which ANSYS stated that they are a provider of commercial grade software products and does not accept any responsibility for Part 21 reporting.
NUPIC led a team of nuclear industry organizations in a meeting with ANSYS on November 17, 2023.
NRC is awaiting a revised response from ANSYS.
Draft RIS - Required Assessment of DOE Labs 8
Developed a Regulatory Issue Summary (RIS) to clarify the agencys regulatory position on the required assessment of U.S. Department of Energy Laboratories by licensees, applicants, and suppliers.
60 days public comment period closed on December 5, 2023.
No comments received.
Currently working to issue document by Spring 2024.
Regulations for QA Program Change 9
Quality Assurance Programs
§ 50.54 (a)(3)
Allows change to quality assurance (QA) program provided that the change does not reduce the existing commitments
§ 50.54 (a)(4)
A change to the QA program that reduces a commitment must receive NRC approval before its implementation
10 CFR 50.54(a)(3) 10 What constitutes no reduction in commitments under §50.54(a)(3)?
(i) The use of a QA standard approved by the NRC which is more recent than the QA standard in the licensee's current QA program at the time of the change; (ii) The use of a QA alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility; (iii) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles; (iv) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text; (v) The elimination of QA program information that duplicates language in regulatory guides and QA standards to which the licensee is committed; and (vi) Organizational revisions that ensure that persons and organizations performing QA functions continue to have the requisite authority and organizational freedom
- RG 1.8, Qualification and Training of Personnel for Nuclear Power Plants 11 Many licensees have moved administrative requirements from the technical specifications to the NRC approved Quality Assurance Program Description (QAPD), in pursuant of Administrative Letter 95-06, Relocation of Technical Specification Administrative Controls Related to Quality Assurance.
For those licensees that have personnel qualifications in QAPD, it is typically a commitment to Regulatory Guide 1.8, Qualification and Training of Personnel for Nuclear Power Plants.
RG 1.8 endorses a revision of ANSI/ANS-3.1, Selection, Qualification, and Training of Personnel for Nuclear Power Plants.
RG 1.8 Rev. 2 endorses ANSI/ANS-3.1-1981, while RG 1.8 Rev. 4 endorses ANSI/ANS-3.1-2014.
ANSI/ANS-3.1 is not a quality standard. It is a guidance document for the selection, qualification, and training of personnel for nuclear power plants.
Therefore, 10 CFR Part 50.54(a)(3)(i) does not apply.
Information on personnel qualifications is a requirement of 10 CFR 50.34(b)(6)(i) which is not tied to Appendix B.
Regulatory Guide (RG) 1.28 12 RG 1.28 Revision 6 was published on September 7, 2023 (ML23177A002)
Endorses Part I & II requirements in NQA-1-2017, NQA 2019, and NQA-1-2022 subject regulatory positions.
Majority of regulatory positions from Revision 5 still applicable in Revision 6.
New regulatory positions:
Direct users to use Revision 1 of NEI 14-05A Subpart 2.2 - "Etching should not be used on nickel alloys, weld areas, or sensitized areas of stainless steel."
Subpart 5.5 - "When the referenced or invoked code or standard becomes superseded or canceled, licensees or applicants need to submit their proposed alternative for NRC review and approval, as appropriate, for continued use of the code or standard or a proposed alternative."
9th Vendor Workshop on Vendor Oversight 13 The workshops provide an open forum for exchanging information regarding oversight of the supply of components, and materials to both new and operating nuclear power plants.
Scheduled for Thursday June 13, 2024, in Baltimore, MD.
Currently coordinating presentation topics and presenters with NUPIC/industry. If you have any feedback or suggestions, please contact Michael Fitzgerald.
Michael.Fitzgerald@nrc.gov (301) 415-0420
14 Kerri Kavanagh Branch Chief (301) 415-3743 Kerri.Kavanagh@nrc.gov