ML26035A268
| ML26035A268 | |
| Person / Time | |
|---|---|
| Issue date: | 02/04/2026 |
| From: | Yamir Diaz-Castillo NRC/NRR/DRO/IQVB |
| To: | |
| References | |
| Download: ML26035A268 (18) | |
Text
1 Nuclear Oversight Conference - February 18 & 19, 2026 - Clearwater, FL NRCs Regulatory Update Yamir Diaz-Castillo Reactor Operations Engineer Quality Assurance & Vendor Inspection Branch Division of Reactor Oversight Office of Nuclear Reactor Regulation
Topics
- FY2025 Vendor Inspections
- Planned Rulemaking Activities of Interest
- The Vendor Times - 2025 Edition
- Quality Assurance Program Descriptions
- Recent & Upcoming Inspections
- NRC Inspection Findings
- Information Notices
FY2025 Vendor Inspections
Planned Rulemaking Activities of Interest
- Part 53, Risk Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors
- Submit the draft final rule package to the Commission by May 1, 2026
- Issue the Final Rule by April 2027
- Executive Order 14300, Ordering the Reform of the Nuclear Regulatory Commission
- Revision to 10 CFR Part 21 (update to definitions, reporting criteria, etc.)
- Proposed rule publication date in April 2026
- 30-day public comment period with no public meeting
The Vendor Times - 2025 Edition In this issue:
FY 2025 Inspection Findings Information Notice on COVID-19 Alternatives 2025 Quality Assurance Program Reviews 2025 Vendor Inspection Plan Assessment Regulatory Information Conference 2025 NEI 22-04 & NEI 25-05 Retirement of Kerri Kavanagh
Quality Assurance Program Descriptions Approved:
- NuScale Standard Design Application
- TerraPower
- General Atomics
- Appalachian Power
- Dow Long Mott
- Dominion New Nuclear Under Review:
- Blue Energy
- Hadron
- Energy Northwest
- Aalo Atomics
Recent & Upcoming Inspections Recent:
- Element Materials Technology
- Sargent & Lundy, LLC
- Operation Technology, Inc.
- Flow America, LLC
- Westinghouse Electric Company (Limerick D&IC)
Upcoming:
- USO SFR Owner (Kemmerer Unit 1)
- Marmon Industrial Energy
& Infrastructure (RSSC Wire
& Cable)
NRC Inspection Findings
- GE Vernova Hitachi Nuclear Energy - Wilmington, NC
- Criterion XI, Test Control
- (1) Failed to examine for leakage the two plug welds on each of the four cylinder tube and flange assemblies after performing the hydrostatic pressure test, and (2) failed to verify the conductivity of the demineralized water after the hydrostatic pressure test was completed.
NRC Inspection Findings
- GE Vernova Hitachi Nuclear Energy (cont.)
- Criterion XV, Nonconforming Materials, Parts, or Components
- The NRC inspection team identified 186 NCRs that were still open without a documented disposition, the oldest being from August 10, 2023. For one of the oldest NCRs, GVH could not locate the item, and for the other two oldest NCRs, GVH could not properly identify them due to the illegibility of the serial number markings used for traceability.
NRC Inspection Findings
- Element Materials Technology - Huntsville, AL
- Criterion XVI, Corrective Action
- Failed to consistently performed a weekly review of open Corrective/Preventive Action Reports (CPARs) and failed to direct the Department Manager to ensure CPARs were closed in a timely manner, as required by their procedure.
- Failed to establish a timeliness metric for closing of Significant Conditions Adverse to Quality (SCAQ) and as a result, eight CPARs from 2024 and 2025 were still open.
NRC Inspection Findings
- Element Materials Technology (cont.)
- Criterion XVI, Corrective Action
- Failed to verify the implementation of CPARs to ensure proper implementation and effectiveness to prevent repetition. Two CPARS were opened in November 2024 and in January 2025 to address issues identified with training and qualification records (e.g., missing records, overdue qualifications, etc.). The NRC inspection team identified the qualification records of two test technicians were expired or not available.
NRC Inspection Findings
- Operation Technology - Irvine, CA
- Criterion XVI, Corrective Action
- Failed to establish a documented corrective action program. Specifically, the Quality Assurance Manual and implementing procedures did not adequately provide criteria to: (1) address all programmatic and product related conditions adverse to quality; (2) classify SCAQs, determine the cause, and implement corrective actions to preclude repetition; and (3) report SCAQs to appropriate levels of management.
Information Notices
- Information Notice (IN) 25-04, Use of Approved Quality Assurance Alternatives During Exigent Conditions.
- The purpose of the IN is to inform the nuclear industry of the potential for inappropriate implementation of the QA alternatives approved for use during exigent conditions:
- (1) Use of the QA alternatives to qualify new suppliers, and (2) licensees, applicants, and/or vendors incorrectly determining when an exigent condition exists.
- The IN provides information on who can declare an exigent condition that will allow for the QA alternatives to be implemented.
Information Notices
- IN 25-06, Lessons Learned from U.S Nuclear Regulatory Commission Inspections of Commercial Grade Dedication at Nuclear Power Plants.
- The purpose of the IN is to alert the nuclear industry to recent information related to lessons learned from the commercial-grade dedication inspections at nuclear power plants.
- The NRC inspections identified that some licensees:
- Failed to appropriately identify and/or evaluate critical characteristics (CCs).
- Failed to (1) provide objective evidence to demonstrate conformance, and (2) include appropriate acceptance criteria.
- Failed to ensure the instructions in procedures appropriately verified the CCs.
Revision 0 of NEI 22-04
- On May 22, 2025, the Nuclear Energy Institute (NEI) submitted for NRCs review and endorsement Revision 0 of NEI 22-04, Utilization of ISO 9001 and Other Non-nuclear Suppliers for Safety-Related Applications (ADAMS Accession No. ML25162A176).
- Following submission of NEI 22-04, the NRC received 4 letters from stakeholders providing feedback: (1) NUPIC (ML2517A185), (2) ASME NQA-1 (25246C400), (3) Radiant (ML25323A024), and (4) a member of the public (ML25323A082).
- On September 18, 2025, the NRC held a public meeting with NEI to discuss NEI 22-04 (ML25330A003).
Revision 0 of NEI 22-04
- On November 14, the NRC provided its initial comments to NEI on NEI 22-04 (ML25260A045):
1.
This process will require end users to possess a strong understanding of both Appendix B to 10 CFR Part 50 and ISO 9001 to effectively identify and address the gaps between the two frameworks.
2.
Explore the concerns received in the NUPIC & ASME NQA-1 letters and how these concerns could be addressed and resolved.
3.
ISO 9001 certification offers a more robust and repeatable process, less prone to errors, would be preferable to a gap assessment alone.
4.
ISO 19443 may be better suited to support the increasing demand for nuclear-grade components.
Revision 0 of NEI 25-05
- On July 11, 2025, NEI submitted for NRCs review and endorsement Revision 0 of NEI 25-05, Fabrication of ASME Code Items Prior to the Identification of an Owner/Licensee (ML25192A126).
- The purpose of NEI 22-05 is to propose a process for a licensee or applicant to accept for use safety-related ASME Code items that were fabricated by an ASME Certificate Holder prior to the identification of an Owner.
- The NRC staff continues to review NEI 25-05.
18 Yamir Diaz-Castillo Reactor Operations Engineer 301-415-2228 Yamir.Diaz-Castillo@nrc.gov QUESTIONS?