ML23261C373
| ML23261C373 | |
| Person / Time | |
|---|---|
| Issue date: | 09/13/2023 |
| From: | Fitzgerald M, Greg Galletti NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| Download: ML23261C373 (16) | |
Text
NRC Update NUPIC General Membership Meeting September 19-20, 2023 Detroit, MI Greg Galletti & Michael Fitzgerald Quality Assurance & Vendor Inspection Branch Office of Nuclear Reactor Regulation
Recent & Upcoming NRC Inspections 2
Recent: Upcoming:
ANSYS Namco Fluor ILAC Observation (Brazil)
Velan Thermo Fisher (FY24)
Westinghouse Henry Pratt Company (FY24)
Completing 21 Inspections in FY23 Planning Vendor Inspections for FY24
NRC Vendor Inspections & Findings 3
Part 21 Violations:
Section 21.21(a)(1) - Mistras Services Evaluation of Deviations and Failures to Comply Section 21.21(a)(2) - Mistras Services Submission of Evaluation within 60 days from Discovery Section 21.21(a)(1) - ANSYS Evaluation of Deviations and Failures to Comply Section 21.21(b) - ANSYS Failed to inform the purchasers or affected licensees, based on not having capability to perform defect evaluations.
NRC Vendor Inspections & Findings 4
Appendix B Nonconformances:
Criterion I, Organization - Mistras Services Failed to implement a QA organization with adequate control and independence to perform QA responsibilities.
Criterion II, Quality Assurance Program - ANSYS Failed to establish a quality assurance program that met the applicable provisions of Appendix B to 10 CFR Part 50.
Criterion VII, Control of Purchased Material, Equipment, and Services - Prysmian Group (General Cable)
Source Selection and Evaluation Criterion XVI, Corrective Action - ANSYS Failed to implement effective corrective actions for conditions adverse to quality, including evaluation of impact.
Mistras Services Vendor Inspection 5
Vendor Inspection performed March 6-10, 2023.
Evaluated nondestructive examination services provided for safety-related equipment.
Inspection Report documents (ML23151A458):
Inadequate Part 21 procedures and actions related to notification to the Commission and Purchasers.
Company failed to ensure that its QA organization had adequate authority and span of control to assure QA functions are adequately performed by individuals with organizational freedom.
Resulting enforcement actions included:
Two Violations (SL IV) for Part 21 Notifications One Nonconformance against Criteria I
ANSYS Vendor Inspection 6
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
Spent Fuel Cask Basket Design Change 7
Division of Fuel Management, within Office of Nuclear Material Safety and Safeguards (NMSS) identified three apparent violations of Holtec related to a design change to four spent fuel cask designs.
10 CFR 72.48(c)(2)(viii) - Holtec failed to obtain CoC amendments pursuant to 10 CFR 72.244 prior to implementing proposed design changes to multi-purpose canister (MPC) continuous basket shims (CBS) for four spent fuel cask designs.
10 CFR 72.48(d)(1) - Holtec failed to maintain records of changes that included written evaluations that provided an adequate bases for the determination that changing to the MPC CBS basket variants did not require CoC amendments pursuant to 10 CFR 72.48(c)(2).
10 CFR 72.146(c) - Holtec failed to subject design changes for the MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants to design control measures commensurate with those applied to the original design.
Holtec International Inspection Report 07201014/2022-201 (ML23145A175) dated September 12, 2023
Updating Training Requirements 8
Dominion Energy submitted changes to DOM-QA-1 under provisions of 10 CFR 50.54(a) on June 20, 2023.
One change included change in commitment from various revisions of Reg. Guide (RG) 1.8 Qualification and Training of Personnel for Nuclear Power Plants to Revision 4.
After discussion with Dominion Energy, the NRC staff determined that a review was necessary of change in commitment for RG 1.8 Rev. 4.
During discussion with Dominion Energy, the NRC staff became aware that other utilities had made a change in commitment to RG 1.8 Rev. 4, but were previously unable to identify related 50.54(a) review performed.
RG 1.28 Revision 6 was published on Sept. 7, 2023.
Endorses Part I & II requirements included in NQA-1-2017, NQA-1-2019, and NQA-1-2022 subject to exceptions:
Audit Participation Requirement Laboratory Calibration and Testing Services - Controls &
Conditions Lifetime and Nonpermanent Records Managing Quality Assurance Records in Electronic Media Internal and External Audits QA Requirements for Packaging, Shipping, Receiving, Storage and Handling of Items for Nuclear Facilities QA Requirements for Installation, Inspection, Testing of Structural Concrete, Structural Steel, Soils, and Foundations for Nuclear Facilities
Draft RIS - Required Assessment of DOE Labs Public Comment Period 10 The NRC staff 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.
When licensees, applicants, and vendors procure items or services from a DOE national laboratory that will be used in a safety-related application, they are responsible for verifying the effective implementation of the laboratorys programmatic quality controls and other technical and regulatory requirements imposed through contractual documents, consistent with Appendix B to 10 CFR Part 50, Subpart H to 10 CFR Part 71, or Subpart G to 10 CFR Part 72, as applicable.
The draft RIS is expected to be posted for public comment in late September and will be open for public comment for 60 days.
Commercial-Grade Dedication Inspections at Licensees 11 Will continue through 2026 with each site having an inspection.
Ten inspections have been performed against IP 71111.21N.03.
No more than minor findings identified to date.
Common themes observed:
Control of material once it leaves the warehouse Shelf life of parts in the warehouse Adherence to established procedures Part 21 Reporting and Evaluation
Commercial-Grade Dedication Inspections at Licensees 12 10 CFR Part 21 compliance Reporting an event under 10 CFR Part 50.72, 50.73 or 73.71 can be used to meet Part 21 reporting requirements.
However, the report must include information on defect in 50.72, 50.73 or 73.71 report (to meet Part 21 reporting requirements).
Must still evaluate for defects under Part 21 requirements.
See Grand Gulf Nuclear Station inspection report 05000416/2023001 (ML23110A800)
Commercial-Grade Dedication Inspections at Licensees 13 Lessons Learned:
First time inspecting these areas, so it could be the first time many staff are interacting with the NRC.
Early, clear communication between the NRC inspection team and licensee staff is essential.
Key Takeaways:
Ensure clear communications between licensee staff and NRC inspectors If unsure of what the inspectors are asking for, ask the inspectors CGD inspections are being implemented properly.
Licensees are conducting CGD adequately, with mostly minor issues identified so far.
Understand Part 21 evaluation and reporting requirements.
Maintain Commercial Grade Surveys
EPA Proposed Rulemaking 14 DecaBDE Developed Interagency Comment in response to Interagency Review of Proposed Rulemaking.
PFAS & PFOS Performed Interagency Review of Proposed Rulemaking for Interagency Comment.
Asbestos Responded to request from EPA staff on Chrysotile Gaskets.
Connected EPA staff to representatives from NEI.
Joint IQVB/IOB NUPIC Observation 15 Inspection and Oversight Branch (IOB) is IQVBs sister branch within Nuclear Material Safety and Safeguards (NMSS)
Division of Fuel Management.
IOB performs Quality Assurance reviews and Inspections of Dry Fuel Storage and Transportation Services Vendors IOB has expressed interest in performing a joint NUPIC Observation with IQVB for Vendors with Part 71 and 72 programs.
Michael Fitzgerald Greg Galletti Reactor Operations Engineer Senior Reactor Operations Engineer (301) 415-0420 (301) 415-1813 Michael.Fitzgerald@nrc.gov Greg.Galletti@nrc.gov 16