ML24261B897
| ML24261B897 | |
| Person / Time | |
|---|---|
| Issue date: | 03/08/2024 |
| From: | Kerri Kavanagh NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| Download: ML24261B897 (14) | |
Text
NRC Regulatory Update 3rd CNRA Working Group on Supply Chain Meeting March 7 - 8, 2024 Kerri Kavanagh, Branch Chief Quality Assurance and Vendor Inspection Branch Office of Nuclear Reactor Regulation
Map of Power Reactor Sites 2
IQVB Current Initiatives/Focus 3
NRC Vendor Inspections VIP Plan - 2023 Annual Self Assessment Mistras Services ANSYS Regulatory Guide 1.28 9th NRC Workshop on Vendor Oversight
NRC Vendor Inspections 4
Since the October 2023 meeting completed 8 vendor inspections/observations Thermo Fisher, Oakwood Village, OH (October 2024)
Henry Pratt Company, Kimball, TN (October 2024)
Rosemount, (June 2023) (NUPIC Observation)
Hanna Cylinders, Pleasant Prairie, WI (January 2024)*
KHNP, Vienna, VA (January 2024)*
Consolidated Power Supply, Birmingham, AL (January 2024)*
Westinghouse Columbia Fuel Facility, Columbia, SC (February 2024)*
NuScale Standard Design Approval Application QA Implementation inspection, Corvallis, OR and Rockville, MD (February 2024)*
One NUPIC observation and four vendor inspections currently announced through the beginning of May 2024. Two additional inspections being planned for late April/May.
- Report not issued yet
VIP Plan - 2023 Annual Self-Assessment 5
IQVBs Vendor Inspection Program (VIP) plan establishes an overall approach, including goals, priorities, performance metrics, and resources management strategies.
Annual Self-Assessment 2023 Self-Assessment was published in November 2023 (ML23290A222)
VIP Plan and Annual Self-Assessments are available on the NRCs website.
VIP Plan - 2023 Annual Self-Assessment 6
FY2023 Violations & Nonconformances Completed 22 Oversight Activities in FY23:
18 Vendor Inspections 3 Observations 1 Audit Issued four violations &
12 nonconformances.
Mistras Services 7
NRC inspection performed on 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 were banned from working in the nuclear industry for 5 and 2 years respectively.
Mistras Services 8
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
ANSYS Vendor Inspection 9
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
ANSYS Vendor Inspection 10 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.
ANSYS provided a clarification to its October 2023 response to the NRC on Feb 23, 2024, stating that ANSYS does provide software that can be used as a basic component with the purchase of optional quality assurance services agreement.
Regulatory Guide (RG) 1.28 11 RG 1.28 Revision 6 was published on September 7, 2023 (ML23177A002)
Endorses Part I & II requirements in NQA-1-2017, NQA-1-2019, 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 12 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 -
in person only.
Agenda being finalized - registration should open in a few weeks.
Previous workshop materials available at https://www.nrc.gov/reactors/new-reactors/how-we-regulate/oversight/quality-assurance/vendor-oversight.html
For More Information 13 The Quality Assurance Website offers a variety of information including:
Vendor Inspection Program (VIP) Plan http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/vendor-insp-prog-plan.html Vendor Quality Assurance (QA) Inspection Reports http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/vendor-insp/insp-reports.html Quality Assurance (QA) Implementation Inspections for New Reactor Licensing http://www.nrc.gov/reactors/new-reactors/oversight/quality-assurance/qual-assure-license.html
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