ML19080A290
| ML19080A290 | |
| Person / Time | |
|---|---|
| Site: | 99902036 |
| Issue date: | 04/03/2019 |
| From: | Joseph Holonich NRC/NRR/DLP/PLPB |
| To: | Powers J Toshiba America Nuclear Energy Corp |
| Holonich J, NRR/DLP/PLPB, 415-1002 | |
| References | |
| CAC ME9861, EPID L-2012-TOP-0003 | |
| Download: ML19080A290 (5) | |
Text
April 3, 2019 Mr. James Powers Vice President, Nuclear Island & Business Development Toshiba America Energy Systems Corporation 3545 Whitehall Park Drive Suite 500 Charlotte, NC 28273
SUBJECT:
REGULATORY AUDIT PLAN FOR TOSHIBA LICENSING TOPICAL REPORT FOR TOSHIBA NONREWRITABLE-FIELD PROGRAMMABLE GATE ARRAY-BASED INSTRUMENTATION AND CONTROL SYSTEM FOR SAFETY-RELATED APPLICATION, UTLA 0020P, REVISION 2 (CAC NO. ME9861; EPID: L-2012-TOP-0003)
Dear Mr. Powers:
By letter dated February 23, 2015, Toshiba Corporation (Toshiba) submitted Revision 2 to Licensing Topical Report for Toshiba NRW [non-re-writable]-FPGA [field programmable gate array-Based Instrumentation And Control System For Safety-Related Application (Agencywide Documents Access and Management System Accession No. ML15062A183). The licensing topical report (TR) is supported by documentation that includes plans, requirements, design specifications, programming and hardware testing, independent verification and validation, and equipment qualification testing.
The U.S. Nuclear Regulatory Commission (NRC) staff is currently reviewing the licensing TR for use in safety system equipment at nuclear power plants. On November 9, 2017, Toshiba representatives and the NRC staff discussed the quality of Toshiba documents (ADAMS Accession No. ML17334A013). Toshiba performed an extensive review of its documents and submitted a report to the NRC (ADAMS Accession No. ML18176A034) summarizing its findings.
Toshiba determined that several documents required modifications and by letter dated November 9, 2018, submitted the revised documents to the NRC (ADAMS Accession No. ML18320A026). In addition, Toshiba placed in the Toshiba portal several supplemental documents and reports which were prepared to describe its findings in detail. As part of its review, the NRC staff will perform a regulatory audit of the documents placed in Toshibas portal in April 2019.
The audit will examine the assessment performed by Toshiba and the impact of the revisions to Toshibas documents to address the quality issues of documents supporting the safety basis of the proposed platform. This audit will provide information necessary to complete the NRC staffs evaluation of the Toshiba TR. Enclosed is a copy of the plan the NRC staff will follow on the audit.
J Powers If you any questions or require any additional information, please feel free to contact me at 301-415-7297 or Joseph.Holonich@nrc.gov.
Sincerely,
/RA/
Joseph J. Holonich, Project Manager Licensing Processes Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation
Enclosure:
Audit Plan Docket No. 99902036
19080A290 *concurred via e-mail NRR-106 OFFICE DPR/PLPB/PM* DPR/PLPB/LA DE/EICB/BC DPR/PLPB/BC DPR/PLPB/PM NAME JHolonich DHarrison MWaters DMorey JHolonich DATE 03/28/2019 03/28/2019 03/20/2019 04/01/2019 04/03/2019 U.S. NUCLEAR REGULATORY COMMISSION STAFF AUDIT PLAN FOR TOSHIBA NONREWRITABLE FIELD-PROGRAMMABLE GATE ARRAY BASED POWER RANGE MONITORING SYSTEM AND OSCILLATION POWER RANGE MONITORING UNIT April 2019
Background
The U.S. Nuclear Regulatory Commission (NRC) staff is currently engaged in a review of the Toshiba Non-Rewritable-Field-Programmable Gate Array (FPGA)-Based Power Range Monitoring (PRM) and Oscillation Power Range Monitoring (OPRM) system licensing topical report (TR). The PRM system is a digital platform that Toshiba believes is appropriate for use in replacing existing PRM systems in boiling water reactors (BWRs) in U.S. nuclear plants. The OPRM unit is a digital unit that can be used in conjunction with PRM systems for advanced BWRs to be constructed in the U.S.
Toshiba is seeking generic acceptance of the basic features and attributes of these two systems. This regulatory audit is intended to assist the NRC staff in confirming information submitted as part of the licensing TR.
Regulatory Audit Bases The NRC staff is currently evaluating Toshibas design and development processes for the PRM system and for the OPRM unit. Over the course of its review, the NRC staff identified a number of areas where the quality of documents has not been at the level expected and consistent with the Toshiba quality assurance program. These areas came from a number of different interactions with Toshiba and the details were discussed on the November 9, 2017, public telephone call (Agencywide Documents Access and Management System (ADAMS) Accession No. ML17334A013).
Toshiba performed an extended review of its documents and submitted a report to the NRC (ADAMS Accession No. ML18176A034) summarizing its findings. Toshiba determined that several documents required modifications and by letter dated November 9, 2018, submitted the revised documents to the NRC (ADAMS Accession No. ML18320A026). In addition, Toshiba placed in the Toshiba portal several supplemental documents and reports which were prepared to describe its findings in detail. As part of its review, the NRC staff will perform a regulatory audit of the documents placed in Toshibas portal in April 2019.
The purpose of the audit is to evaluate the assessment performed by Toshiba and the impact of the revisions to Toshibas documents to address the quality of its documents that support the safety basis of the proposed system. These documents are identified in Toshibas letters submitted on November 9, December 6, and December 27, 2018 (ADAMS Accession Nos.
ML18320A026, ML18346A087, and ML19002A131).
Enclosure
Regulatory Audit Scope As part of the audit, the NRC staff will review the documents placed in Toshibas portal. The staff will be evaluating whether the results of these actions substantiate the processes described in the licensing TR.
As needed, the NRC staff may have to hold telephone discussions with Toshiba representatives as part of the audit.
Deliverables The NRC regulatory audit report should be issued by May 31, 2019.