ML25344A029
| ML25344A029 | |
| Person / Time | |
|---|---|
| Site: | 99902041 |
| Issue date: | 12/16/2025 |
| From: | Ngola Otto Licensing Processes Branch |
| To: | Framatome |
| References | |
| EPID L-2024-TOP-0029, ANP-10357P | |
| Download: ML25344A029 (0) | |
Text
OFFICIAL USE ONLY - PROPRIETARY INFORMATION OFFICIAL USE ONLY - PROPRIETARY INFORMATION JANUARY 5-9, 2026, REGULATORY AUDIT PLAN FOR FRAMATOME, INC.
ANP-10357P, REVISION 0, TXS COMPACT PLATFORM TOPICAL REPORT REGARDING PLATFORM DESIGN AND DEVELOPMENT QUALITY ASSURANCE DOCKET NO. 99902041 EPID L-2024-TOP-0029
1.0 BACKGROUND
By letter dated August 2, 2024 (Agencywide Documents Access and Management System (ADAMS) Package Accession No. ML24218A279) and supplemented by letters dated June 30, July 22, and August 14, 2025 (ML25188A148, ML25203A339, and ML25226A233) respectively Framatome, Inc. (hereafter as Framatome) submitted Topical Report (TR) ANP-10357P, Revision 0, TXS COMPACT Platform Topical Report, for U.S. Nuclear Regulatory Commission (NRC) staff review. As stated in the submittal letter, the TR presents the generic application of the TXS COMPACT system which has been developed as a new platform based on field programmable gate array technology that could be integrated with different modules from the TXS portfolio to implement safety related instrumentation and control (I&C) systems in nuclear power plants (NPPs). Framatome submitted this TR to obtain NRC approval for use in NPP safety related I&C applications in the United States.
During the March 31 - April 4, 2025, audit (ML25154A653), the NRC staff observed issues related to quality assurance (QA) program implementation for the design and development of TXS COMPACT platform, in which the NRC staff issued Request for Additional Information (RAI) 10688 for Framatome to address the observed issues and gaps in the information documented in the TXS COMPACT platform TR. In addition, Framatome SAS1, the design and developer of the TXS COMPACT platform, created a corrective action report (CAR) to address one issue observed by the NRC staff during the regulatory audit. On July 30, 2025, Framatome submitted its response to the RAI 10688 (ML25212A176), and subsequently, the NRC staff held a public meeting on September 18, 2025 (ML25246C344), to discuss these RAI responses.
Framatome plans to revise some of the RAI responses, which will include edits to the TR. This regulatory audit will be used to confirm whether the (1) details and draft markups to the TR adequately support the RAI responses, and (2) the corrective actions implemented to address the NRC staffs observations during the March 31 - April 4, 2025, regulatory audit were adequately implemented.
1 Framatome SAS ((Société par Actions Simplifiée) is the organization in France and owned by Électricité de France (EDF).
OFFICIAL USE ONLY - PROPRIETARY INFORMATION OFFICIAL USE ONLY - PROPRIETARY INFORMATION 2.0 REGULATORY AUDIT BASES An audit is a planned regulatory activity that includes the examination and evaluation of primarily non-docketed information and other associated aspects. The regulatory audit is conducted with the intent to gain understanding, to verify information, and to identify information that will be required to be docketed to support the basis of a regulatory decision. Performing a regulatory audit is expected to assist the NRC staff in efficiently conducting its review and gaining insights into the applicants processes, specification, procedures, testing results, and other associated activities. Information that the NRC staff relies upon to make the safety determination must be submitted on the docket. This regulatory audit will be conducted in accordance with the NRC Nuclear Reactor Regulation (NRR) Office Instruction LIC-111, Regulatory Audits, Revision 2, dated December 30, 2024 (ML24309A281). This regulatory audit will support the NRC staffs review of the TR.
Applicable criteria within Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, relevant to the NRC staffs review of the QA portions of the TR include:
Criterion III, Design Control, which requires, in part, that quality standards be specified and that design control measures shall provide for verifying or checking the adequacy of design.
Criterion IV, Procurement Document Control, which requires, in part, that procurement documents to be include applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services.
Criterion V, Instructions, Procedures, and Drawings, requires, in part, that activities affecting quality shall be prescribed by documented procedures of a type appropriate to the circumstances Criterion VII, Control of Purchased Material, Equipment, and Services," addresses control of purchased material, equipment, and services.
Criterion XVI, Corrective Actions, which requires, in part, that conditions adverse to quality are promptly identified and corrected.
3.0 SCOPE AND PURPOSE The scope of this regulatory audit mainly includes the QA program applicable to the design and development of the TXS COMPACT platform. This includes the results of commercial grade surveys performed of ((
)), any corrective actions identified because of the surveys, any evaluations/tests performed to address issues/gaps identified during the surveys, and draft markups for the TXS COMPACT platform TR.
For this audit, the NRC staff also plan to use the following regulatory guidance for the QA design and development activities:
Regulatory Guide (RG) 1.28, Revision 5, Quality Assurance Program Criteria (Design and Construction), which endorses American Society of Mechanical Engineers (ASME)
Nuclear Quality Assurance (NQA)-1, Quality Assurance Requirements for Nuclear Facility Applications. This revision of RG 1.28 endorses, with certain clarifications and regulatory positions, three versions of the ASME NQA-1 standard: NQA-1-2015 and is
OFFICIAL USE ONLY - PROPRIETARY INFORMATION OFFICIAL USE ONLY - PROPRIETARY INFORMATION subject to the provisions and modifications identified in the RG. This RG provides an adequate basis for complying with the pertinent QA requirements of Appendix B to 10 CFR Part 50.
RG 1.164, Dedication of Commercial-Grade Items for Use in Nuclear Power Plants, Revision 1. This RG provides guidance for the dedication of commercial-grade items and services used in nuclear power plants. This RG endorses, in part, Electric Power Research Institute (EPRI) 3002002982, Revision 1, to EPRI NP-5652 and TR-102260, Plant Engineering: Guideline for the Acceptance of Commercial-Grade Items in Nuclear Safety Related Applications.
4.0 INFORMATION AND OTHER MATERIAL NECESSARY FOR THE REGULATORY AUDIT If available, please make documents related to the following areas accessible to the NRC audit team members to review:
- 1. Completion of CAR created to address NRC audit observations
- 2. Commercial grade survey reports for the ((
)).
- 3. CARs associated with commercial grade survey report findings.
- 4. Any additional evaluations/tests performed to address commercial grade survey report findings.
- 5. Draft markups to the TXS COMPACT platform TR.
5.0 AUDIT TEAM The members of the audit team are:
Ngola Otto, Project Manager (remote)
Deanna Zhang, Senior Reactor Operations Engineer (remote) 6.0 LOGISTICS The audit will start on January 5 and end on January 9, 2026, and will be conducted remotely.
The audit will commence at 9:00 a.m. each day from January 5, 2026 (Monday) to January 9, 2026 (Friday) and conclude by noon on January 9, 2026. During the audit entrance briefing, the NRC staff will provide an overview of the audit plan, agenda, and objectives. During the exit briefing, the NRC staff will provide a summary of the audit, and its observations to be made during the audit.
The audit team will not remove any non-docketed documents or other materials from the location of the audit. If the audit team identifies information that requires docketing to support the basis for a regulatory decision concerning the review of the Framatome TXS COMPACT platform TR, the NRC staff will use the RAI process.
Any changes in the audit logistics will be properly coordinated and communicated with the applicant.
OFFICIAL USE ONLY - PROPRIETARY INFORMATION OFFICIAL USE ONLY - PROPRIETARY INFORMATION 7.0 SPECIAL REQUEST If any of the supporting information is not available in English, please provide the audit team with a translated version for the purpose of the audit.
8.0 DELIVERABLES An audit summary report, which may be made public, will be prepared within 90 days after the completion of the audit.