ML23249A230
| ML23249A230 | |
| Person / Time | |
|---|---|
| Site: | 99902039 |
| Issue date: | 09/13/2023 |
| From: | Smith N Licensing Processes Branch |
| To: | Sneddon J Mitsubishi Electric Corp, Mitsubishi Electric Power Products |
| References | |
| MELTAC, EPID L-2023-TOP-0036 | |
| Download: ML23249A230 (1) | |
Text
September 13, 2023 Jay Sneddon - Department Manager Mitsubishi Electric Power Products, Inc.
Nuclear Systems Department 547 Keystone Drive Suite 200 Warrendale, PA 15086
SUBJECT:
MITSUBISHI ELECTRIC COMPANY REGULATORY AUDIT IN SUPPORT OF REVIEW OF THE REVISION TO THE MELTAC PLATFORM TOPICAL REPORT (EPID L-2023-TOP-0036)
Dear Sir or Madam:
By letter dated June 16, 2023 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23167C168), Mitsubishi Electric Corporation (MELCO, the vendor) requested review of a topical report on the revised Mitsubishi Electric Total Advanced Controller (MELTAC) Platform. The MELTAC platform is a computer based programmable-logic controller consisting of a pre-defined set of hardware and software components which was developed for nuclear applications.
The U.S. Nuclear Regulatory Commission (NRC) staff reviewed the vendors application and determined that a regulatory audit would assist in the timely completion of the NRC staffs review. The NRC staff will conduct a regulatory audit to support its review on the basic design information of the revised MELTAC Platform in accordance with the enclosed audit plan. A regulatory audit is a planned activity that includes the examination and evaluation of primarily non-docketed information.
The NRC staff will conduct the audit to increase its understanding of the application and identify information that will require docketing to support the NRC staffs regulatory findings. The NRC staff plans to conduct the audit virtually at NRC Headquarters in Rockville, Maryland via a vendor-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 staff may use that approach in addition to the virtual audit.
If you have any questions, please contact me at (301) 415-2509 or by email at Nicholas.Smith@nrc.gov.
Sincerely,
/RA/
Nick Smith, Project Manager Licensing Projects Branch Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No. 99902039
Enclosure:
Audit Plan
Enclosure REGULATORY AUDIT PLAN BY THE OFFICE OF NUCLEAR REACTOR REGULATION IN SUPPORT OF THE REVIEW OF THE REVISION TO THE MELTEC PLATFORM TOPICAL REPORT MITSUBISHI ELECTRIC COMPANY DOCKET NO. 99902039
1.0 BACKGROUND
By letter dated June 16, 2023 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23167C168), Mitsubishi Electric Corporation (MELCO, the vendor) requested review of a topical report on the revised Mitsubishi Electric Total Advanced Controller (MELTAC) Platform.
By email dated August 16, 2023 (ADAMS Accession No. ML23179A168), the U.S. Nuclear Regulatory Commissions (NRCs) staff accepted the MELTAC Platform for review.
The NRC staff has identified the need to conduct a regulatory audit to better understand the vendors platform by reviewing supporting documentation for the MELTAC Platform.
2.0 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 vendors 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 this audit plan and Office of Nuclear Reactor Regulation (NRR) Office Instruction LIC-111, Regulatory Audits, Revision 1, dated October 2019 (ADAMS Accession No. ML19226A274).
3.0 REGULATORY AUDIT SCOPE AND METHODOLOGY The objective of this audit is to verify, via an independent evaluation, the basic design information of the updated MELTAC Platform, as described in Revision 3 of the associated topical report, conforms to applicable regulations, standards, guidelines, plans, and procedures.
The NRC staff will review the vendors supporting documents, as discussed in Section 4.0 of this audit plan, to determine if additional information will require docketing to develop and support conclusions for the NRC staffs safety evaluation of the requested application.
4.0 INFORMATION AND OTHER MATERIAL NECESSARY FOR THE REGULATORY AUDIT The NRC staff requests that the vendor have the following information readily available and accessible for the NRC staffs review via online portal:
MELTAC-Nplus S Environmental Test Report, JEXU-1041-1044 MELTAC-Nplus S Seismic Test Report, JEXU-1041-1045 MELTAC-Nplus S EMC/ESD Test Report, JEXU-1041-1046 MELTAC-Nplus S Isolation Test Report, JEXU-1041-1047 Additional information may be requested to be added to the portal by the NRC staff based on the staffs continued review of the application and documents and based on audit discussions with the vendor. If the topical report relies on newer revisions of documents currently in the NRC records, copies of those may be requested on the audit portal until they are provided to the NRC through the document control desk.
Based on the audit, the NRC staff will determine whether additional information needs to be submitted on the docket for the staff to complete the review of the requested changes via request for additional information (RAI).
5.0 TEAM ASSIGNMENTS The audit team will consist of the following NRC staff:
NAME DIVISION BRANCH Ms. Lois James Division of Operating Reactor Licensing (DORL)
Licensing Projects Branch (LLPB)
Mr. Nick Smith DORL LLPB Mr. Jack Zhao Division of Engineering and External Hazards (DEX)
Instrumentation and Controls Branch (EICB)
Mr. Richard Stattel DEX EICB Mr. Calvin Cheung DEX EICB 6.0 LOGISTICS The audit will be conducted from September 25, 2023, to March 30, 2024, through an online portal (also known as electronic portal, ePortal, or electronic reading room) established by MELCO.
The audit team will conduct a TEAMS-based entrance meeting with the vendor on September 25, 2023, for the purposes of introducing the team, discussing the scope of the audit, and describing the information to be made available on the portal. Through the audit period, especially during the week of September 25, 2023, the NRC staff will hold breakout sessions with representatives of MELCO to answer audit team questions. An exit meeting/call will be held at the conclusion of the audit.
The NRC staff does not foresee the need for an onsite visit or in-person discussions between the NRC and vendor staff to discuss information to be provided on the portal at this time.
However, if the need for a such a meeting is identified in the future, the audit plan will be revised, and the schedule for the audit will be adjusted accordingly. The NRC project manager will coordinate any changes to the audit schedule and location with the vendor.
7.0 SPECIAL REQUESTS The audit team would like access to the documents listed in Section 4.0 above through an online portal that allows the audit team to access documents via the internet. The following conditions associated with the online portal must be maintained throughout the duration that the audit team has access to the online portal:
The online portal will be password-protected, or use two-factor authentication and separate passwords or two-factor access credentials will be assigned to the NRC staff members who are participating in the audit.
The online portal will be sufficiently secure to prevent the NRC staff from printing, saving, downloading, or collecting any information on the online portal.
Conditions of use of the online portal will be displayed on the login screen and will require acknowledgement by each user.
Access credential information should be provided directly to the NRC staff. The NRC project manager will provide to MELCO the names and contact information of the NRC staff who will be participating in the audit. All other communications should be coordinated through the NRC project manager.
8.0 DELIVERABLES An audit summary report will be prepared within 90 days of the completion of the audit. If the NRC staff identifies information during the audit that is needed to support its regulatory decision, the NRC staff will issue RAI to the vendor.
- via email NRR-106 OFFICE NRR/DORL/LLPB/PM NRR/DORL/LLPB/PM NRR/DORL/LLPB/LA NRR/DEX/EICB/BC NAME NSmith LJames DHarrison RStattel (A)
DATE 9/07/2023 9/07/2023 9/11/2023 9/11/2023 OFFICE NRR/DORL/LLPB/BC NRR/DORL/LLPB/PM NAME GGeorge NSmith DATE 9/11/2023 9/13/2023