ML23244A650
| ML23244A650 | |
| Person / Time | |
|---|---|
| Site: | 99902079 |
| Issue date: | 09/20/2023 |
| From: | Vechioli-Feliciano L NRC/NRR/DANU/UAL2 |
| To: | Westinghouse |
| Vechioli-Feliciano L | |
| References | |
| EPID L-2022-TOP-0059, EPID L-2022-TOP-0060 | |
| Download: ML23244A650 (1) | |
Text
WESTINGHOUSE ELECTRIC COMPANY, LLC AUDIT PLAN FOR TOPICAL REPORTS ON THE ADVANCED LOGIC SYSTEM VERSION 2 DIGITAL PLATFORM AND DEVELOPMENT PROCESS EPIDS: L-2022-TOP-0059 AND L-2022-TOP-0060 Applicant:
Westinghouse Electric Company, LLC Applicant Address:
1000 Westinghouse Dr. Cranberry Twp, PA 16066 Plant Name:
eVinciTM Project No.:
99902079
Background:
By letter EVR_LTR_220213 dated December 21, 2022, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22355A230), Westinghouse Electric Company, LLC (WEC), (the applicant) requested a review of topical reports for the Advanced Logic System Version 2 (ALS-v2) platform.
The U.S. Nuclear Regulatory Commission (NRC) staff reviewed the topical reports and determined that a regulatory audit would assist in the timely completion of the review. The NRC staff will conduct a regulatory audit to support its review in accordance with this audit plan. A regulatory audit is a planned activity that includes the examination and evaluation of primarily non-docketed information.
Purpose:
The purpose of the audit is for the NRC staff to increase its understanding of the topical reports and identify information that will require docketing to support the NRC staffs regulatory findings.
The NRC staff plans to conduct the audit virtually at the NRC Headquarters in Rockville, Maryland via an applicant-established electronic portal. However, should the NRC staff determine that an in-person audit would be a more efficient method to conduct the audit and gather needed information, the NRC staff may use that approach in addition to the virtual audit.
Regulatory Audit Basis:
A regulatory audit is a planned license or regulation-related activity that includes the examination and evaluation of primarily non-docketed information. The audit is conducted with the intent to gain understanding, to verify information, and to identify information that will require docketing to support the basis of a licensing or regulatory decision. Performing a regulatory audit is expected to assist the NRC staff in efficiently conducting its review and gaining insights to the applicants processes and procedures. Information that the NRC staff relies upon to make the safety determination must be submitted on the docket.
The NRC staff will perform the audit in accordance with NRR Office Instruction LIC-111, Regulatory Audits, Revision 1, dated October 2019 (ML19226A274).
Regulatory Audit Scope and Methodology:
The objective of this audit is to verify, via an independent evaluation, that the ALS v2 platform that will be used in the eVinciTM micro-reactor and its development process conform to applicable regulations, standards, guidelines, plans, and procedures by assessing the implementation of the systems developmental life cycle processes. A review of activities associated with the establishment of a secure development environment may also be conducted.
The NRC staff will also review the applicants supporting documents to determine if additional information will require docketing to develop and support conclusions for the NRC staffs safety evaluation of the topical reports.
Information and Other Material Necessary for the Regulatory Audit:
One of the primary information resources that the NRC staff will use to determine what potential information gaps may exist is the Open Items list to identify the information to be audited. The Open Items list has been shared with the applicant via e-mail correspondence and the NRCs Box portal in support of periodic public meetings to discuss the Open Items list. The NRC staff will attach redacted versions of the Open Items to the public meeting summaries.
When the NRC staff determines that additional documentation will need to be made available on the portal after reviewing the requested information, it will generate new Open Items to request such information.
Team Assignments and Logistics:
The audit team will consist of the following NRC staff from NRR.
NAME DIVISION BRANCH Ms. Lucieann Vechioli Feliciano Division of Advanced Reactors and Non-power Production and Utilization Facilities (DANU)
Advanced Reactor Licensing Branch 2 (UAL2)
Mr. Calvin Cheung Division of Engineering and External Hazards (DEX)
Instrumentation and Controls Branch (EICB)
Mr. William Roggenbrodt DEX EICB Mr. Richard Stattel DEX EICB The NRC staff will use the periodic public meetings for the Open Items to discuss the purpose of the audit requests and information needs. The NRC staff will confirm with the applicant, the sensitivity of any information discussed or presented on the online portal.
The audit will occur via an internet-based portal at the NRC Headquarters Office in Rockville, Maryland, from August 28, 2023, through May 1, 2024. However, should the need arise, the audit may also be conducted in-person either in Rockville, Maryland or a suitable site chosen by the applicant. The NRC staff requests the applicant to have the information readily available and accessible for the NRC staffs review via an internet-based portal. During predetermined periods where the NRC staff needs to confer with technical experts representing the applicant, the NRC staff requests the applicant to have its staff available at mutually agreeable business daytimes (e.g., Monday - Thursday, 9:00 a.m. to 4:00 p.m., EST) by telephone if the NRC staff has any questions during the audit related to any information on the portal.
When the NRC staff determines that any information on the portal is relevant to the safety determination, the NRC staff will request the applicant to place that information on the docket via the use of the Open Item List or via the request for additional information (RAI) process.
Additionally, the NRC staff will use the Open Items List and the RAI or confirmation of information processes in lieu of using an exit meeting for that purpose. The NRCs licensing project manager will inform the applicant via routine communications when the NRC staff no longer needs access to the portal.
Deliverables:
The NRC staff will develop any RAIs or confirmations of information, as needed, which will be provided to the licensee via separate docketed correspondence. At the completion of the audit, the audit team will issue an audit summary.
If you have questions regarding this audit, please contact me via email at Lucieann.VechioliFeliciano@nrc.gov.
Sincerely, Lucieann Vechioli, Project Manager Advanced Reactors Licensing Branch 2 Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Project No.: 99902079 cc: Westinghouse eVinci via GovDelivery Signed by Vechioli, Lucieann on 09/20/23
ML23244A650 NRR-106 OFFICE NRR/DANU/UAL2:PM NRR/DANU/UAL2:LA NRR/DEX/EICB: BC NAME LVechioli CSmith RStattel DATE 9/5/2023 9/19/2023 9/19/2023 OFFICE NRR/DANU/UAL2:BC NRR/DANU/UAL2:PM NAME MWentzel LVechioli DATE 9/20/2023 9/20/2023