ML25021A016

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Enclosure 1 - Holtec Risk Significance Topical Report Audit Report Summary
ML25021A016
Person / Time
Site: 99902049
Issue date: 02/20/2025
From: Sayoc E
NRC/NRR/DNRL/NLIB
To:
Shared Package
ML25021A014 List:
References
Download: ML25021A016 (2)


Text

Enclosure 1 UNITED STATES NUCLEAR REGULATORY COMMISSION AUDIT

SUMMARY

FOR THE REGULATORY AUDIT OF SMR, LLC (HOLTEC) LICENSING TOPICAL REPORT, HOLTEC PSA RISK SIGNIFICANCE DETERMINATION METHODOLOGY LICENSING TOPICAL REPORT Docket No. 99902049 AUDIT

SUMMARY

REPORT VENDOR:

SMR, LLC (Holtec)

CONTACTS: Andrew Brenner and Clark Shurtleff DURATION:

August 15, 2024 - November 7, 2024 LOCATION:

U.S. Nuclear Regulatory Commission (NRC) Headquarters (via SMR (Holtecs) Electronic Reading Room (eRR))

One White Flint North 11545 Rockville Pike Rockville, Maryland 20852-2738 AUDIT TEAM: Michael Swim, (Technical Reviewer) Office of Nuclear Reactor Regulation (NRR)

Steven Alferink, (Technical Reviewer) (NRR)

Stephanie Garza, (Technical Reviewer) (NRR)

Emmanuel Sayoc, (Project Manager) (NRR)

Victoria Huckabay, (Project Manager) (NRR)

India Banks, (Project Manager) (NRR)

Tim Parkes (Observer) United Kingdom Office of Nuclear Regulation (UK ONR)

Joshua Gordon, (Observer) (UK ONR)

Robert Le Grove, (Observer) (UK ONR)

Becky Mogridge, (Observer) (UK ONR)

Mike Webley, (Observer) (Environment Agency of England)Andrew Brenner (SMR (Holtec))

Clark Shurtleff (SMR (Holtec))

Monica Haneman (SMR (Holtec))

2 AUDIT

SUMMARY

REPORT REGULATORY AUDIT BASIS This regulatory audit is based on SMR, LLC (Holtec) Licensing Topical Report (LTR) titled Holtec PSA Risk Significance Determination Methodology Licensing Topical Report.1 REGULATORY AUDIT SCOPE AND ACTIVITIES The audit team discussed LTR Information Needs requested by the NRC staff with SMR (Holtecs) and reviewed proposed revisions to the LTR provided in the online portal. The audit team met with SMR (Holtec) approximately bi-weekly to share observations and identify any additional information needed to gain further understanding of the technical bases of the methodology being reviewed in the LTR. Near the end of the audit, SMR (Holtec) provided a draft update to the LTR that incorporated its response to several Information Needs.

DEVIATIONS FROM AUDIT PLAN The audit was announced via the publicly available audit plan which was issued on August 8, 2024.2 The audit plan included Information Needs 1 through 5 originally. During the audit, Information Needs 6 through 9 were added, as outlined in Enclosure 2.

LIST OF DOCUMENTS AUDITED The audit team reviewed the LTR revisions SMR (Holtec) developed to respond to the items provided in Enclosure 2, List of Information Needs/Observations.

AUDIT CLOSURE This audit exit briefing was held on October 8, 2024. During this meeting, the NRC staff summarized the audit results and discussed the overall effectiveness. There were nine audit items, of which one was resolved during the audit, and eight were resolved with the submittal of Revision 1 of the LTR.3 There were no Requests for Additional Information.

1 SMR, LLC, SMR, LLC, Holtec PSA Risk Significance Determination Methodology Licensing Topical Report, June 11, 2024, (ML24163A399, part of package ML24163A397).

2 U.S. NRC, Audit Plan for the Regulatory Audit of SMR, LLC Submittal of Holtec PSA Risk Significance Determination Methodology Licensing Topical Report (Project No. 99902049), August 6, 2024 (ML24211A226).

3 SMR, LLC, SMR, LLC, Submittal of Holtec PSA Risk Significance Determination Methodology Licensing Topical Report, Revision 1, October 28, 2024 (ML24292A045).