ML20155D298

Notice of Nonconformance from Insp on 880125-28. Nonconformances Noted:Failure to Clearly Establish Duties & Authorities of Engineering Personnel to Ensure safety- Related Design & Engineering Activities Performed

ML20155D298
Person / Time
Issue date:	06/03/1988
From:	Office of Nuclear Reactor Regulation
To:
Shared Package
ML20155D292	List: ML20155D288 ML20155D294 ML20155D298 ML20155D301
References
REF-QA-99900871 EA-88-129, NUDOCS 8806150090
Download: ML20155D298 (3)

Text

O APPENDIX B Elgar Corporation EA 88-129 Docket No. 99900871/88-01 NOTICE OF NONCONFORMANCE During an inspection conducted January 25-28, 1988, the implementation of the quality assurance (QA) program at the Elgar Corporation (Elgar) facilities in San Diego, California was reviewed. The results of the inspection revealed that certain of its activities were not conducted in accordance with NRC requirements. These items are set forth below and have been classified as nonconformances with the requirements of Appendix B to 10 CFR Part 50. -

1. Criterion I, "Organization," of Appendix B to 10 CFR Part 50 requires, in part, that the authority and duties of persons and organizations perfoming activities affecting the safety-related functions of structures, systems, and components be clearly established and delineated in writing. These activities include both the perfoming functions of attaining quality and the quality assurance functions.

Contrary to the above criteria, Elgar has failed to clearly establish the duties and authorities of its engineering personnel to ensure its safety-related design and engineering activities are satisfactorily accomplished. Examples of this failure were revealed during the inspection of Elgar internal documents concerning engineering and design activities listed below.

-Part 5.0, "Design," of Section 04 of Elgar's OAM

-Section 17. "QA Seconds," of Elgar's QAM

-Procedure EEP-1, "Engineering Release and Change"

-Procedure EEP-3, "Engineering Change Requests"

-Procedure EEP-20, "Engineering Design Review"

-Procedure 56007-01, "Flow Diagram" [ design changes]

-Procedure 60002-01, "Change Notices" [ design e,hange notices)

-Procedure 60003-01, "Change Control Board"

2. Criterion III, "Design Control," of Appendix B to 10 CFR Part 50 requires, in part, that measures be established for the control of design interfaces and for coordination among participating design organizations. The design control measures shall provide for verifying or checking the adequacy of design, such as by the performance of design reviews. The verifying or checking process shall be performed by individuals other than those who performed the original design. Design control measures shall be applied to items such as compatibility of materials, maintenance, repair, and delineation of acceptance criteria for inspection and tests. Design changes, including field changes, shall be subject to design control measures commensurate with those applied to the origini.1 design, 8806150090 880603 PDR QA999 EMVELOAR 99900871 ncn

Notice of Ponconformance Part 5.0, "Design Control" Section of Elgar's QA manual (QAM) in part implement 10 CFR Part 50, Appendix B, Criterion III and requires, in part, that Elgar engineering review technical requirements, descriptions, and-documentation, and approve or take exception to each of the itams they review. Additionally, Elgar engineering is required to maintain drawing and design control by following the prescribed steps in the "Document Control" section of its QAM.

Pert 7.0, "Document Control" section of Elgar's QAM requires, in part, that Elgar engineering: (a) assure that drawir.gs, specifications and procedures conform to applicable standards and codes, (b) assure that obsolete drawing masters be marked accordingly, removed from active files, and filed in the obsolete file, (c) maintain a current status log for drawings, and (d) provide assurance that drawings and change controls are maintained in accordance with the procedure.

Contrary to tne above, tne inspection revealed that:

a. Elgar has failed to assure that its design control measures provide for an independent verification of the technical adequacy of its design changes for at least its 7.5 and 25KVA inverters. The inspection of Elgar engineering design changes (ECN) revealed that the following 12 (out of a total of 55) ECNs were prepared, reviewed, and approved by the same person:

-ECN 1104, -ECH 1397, -ECN 1473 -ECN 1493, -ECN 1499, -ECN 1687,

-ECH 1796, -ECN 1836, -ECN 2212 -ECN 3800, -ECN 5988, -ECN 6216;

b. Elgar has failed to assure that the cumulative affect of multiple design changes on an individual drawing does not negatively affect the functioning of the safety-related system or component in regard to the original design. A review of the 55 aforementioned ECNs revealed that no design function reviews are performed by Elgar to assess the possible affects of the collective design changes; and

c. Elgar could not provide previous revisions of drawings to the NRC inspector for any of the nine inverter component drawings that were being reviewed to determine if, cumulative changes had been addressed.

These drawings include: '

-643-209-42, -643-101-42, -643-102-41, -642-107-40, -643-103-42,

-642-211-43, -549-000-2, -543-118-1, -549-000-9.

3. Criterion XVIII, "Audits," of Appendix B to 10 CFR Part 50, requires, in part, that a comprehensive system of planned and periodic audits be carried out to verify compliance with all aspects of the QA program and

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Notice of Nonconformance to determine the effectiveness of the program. The audits will be performed by trained personnel not having direct responsibilities in the areas being audited. Audit results shall be documented and reviewed by management having responsibility in the area audited.

Co.itre y to the above, it was noted that the last two internal QA department audits dated July 1987 and September 1987, respectively, used QA personnel to perform the audits. The QA Manager was the audit team leader on one of the two audits.

Please provide to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, PC 20555 in writing within 30 days of the date of this Notice, the reason for the nonconformances, the corrective steps which have been taken and the results achi ./ed, the corrective steps which will be taken to avoid further nonconformanct s, and the date when your corrective action will be completed. Where good cause is shown, consideration will be given to extending the response time.

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