ML20058A816
ML20058A816 | |
Person / Time | |
---|---|
Site: | 05200004 |
Issue date: | 11/18/1993 |
From: | Office of Nuclear Reactor Regulation |
To: | |
Shared Package | |
ML20058A814 | List: |
References | |
REF-QA-99900403 NUDOCS 9312010251 | |
Download: ML20058A816 (3) | |
Text
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NOTICE OF NONCONFORMANCE GE Nuclear Energy Docket Nos52-004 San Jose, California 99900403 Based on the results of a Nuclear Regulatory Commission (NRC) inspection conducted on August 9-13, 1993, it appears that certain of your activities were not conducted in accordance with NRC requirements.
A.
Criterion III of Appendix B to 10 CFR Part 50, " Design Control,"
requires that the design control measures shall provide for verifying _or checking the adequacy of design.
Engineering Operating Procedure (EOP) 40-3.00, " Engineering Computer Programs" (ECPs), states in Section 4.4.1, that "GE-NE components that apply approved ECPs to design and development activities are responsible for documenting both verification of inputs and confirmation that the utilization is within the application range of the ECP."
Contrary to the above, (1) the TRACG input decks used to model the GIST facility were not independently verified to be correct, and (2) the GE-NE Code Qualification Document (CQD), Licensing Topical Report NEDE-32177P, "TRACG Qualification," dated February 1993, which provides a description of the qualification of TRACG against various activities including the GDCS integrated systems test, was submitted to the NRC for review and approval for referencing in licensing actions for the SBWR without receiving independent design verification or design review as required for a level I code used to support design basis analyses.
(93-01-01)
B.
Criterion XVII of Appendix B to 10 CFR Part 50, " Quality Assurance Records," states, in part, "that sufficient records shall be maintained to furnish evidence of activities affecting quality and that the records shall include operating logs and the results of reviews, inspections, tests, and that records shall be identifiable and retrievable."
Engineering Operating Procedure (E0P) 42-10.00, " Design Record Files" (DRF), requires, in part, that the DRF contain or reference (as applicable) design and evaluation records, test reports, controlled documents, and documentation and pertinent references that support the design.
E0P 35-3.00, " Engineering Tests," further defines evaluation records as including instrument calibration records.
~I-9312010251 93111e PDR ADOCK 05200004 A
'n The GIST Program Test Plan and Procedure (TP&P) 521.1322, Revision 2, dated November 29, 1988, specifies documents to be included in the DRF, including "all test records."
Contrary to the above, certain documentation required to be contained or referenced in the DRF was not included therein.
Specific documents that should have been contained or referenced in the DRF were: the Final Test Report (NED0-31680) for the GIST Program; instrument calibration records, which were located in a desk drawer in another building; and final design drawings for the facility. Some drawings were found in a cabinet at the facility itself.
This set of drawings did not include final numbered, approved, as-built design drawings, which are required by the QA Plan to be retained for the lifetime of the item.
Also, data tapes for the GIST tests, which are part of the test records specified for inclusion in the DRF by TP&P 521.1322, were not referenced therein.
(93-01-02)
C.
Criterion III of Appendix B to 10 CFR Part 50, " Design Control,"
requires that design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design and be approved by the organization that performed the original design unless the applicant designates another responsible organization.
GE-NE QA Program topical report, NE00-11209-04A, under Section 3.11,
" Design Change Control," states, in part, "The control procedure requires that every change must be documented, design verified, approved by the responsible engineer, and reviewed by the appropriate interfacing components."
Contrary to the above, there was no documentation or independent verification of changes made to the TRACG code as a result of the GIST program.
The changes include changes to the interfacial shear and heat transfer when a two-phase level is present, changes to the model for condensation on cold walls when air is present, and the implementation of a horizontally stratified flow map.
(93-01-03)
D.
Criterion XII of Appendix B to 10 CFR Part 50, " Control of Measuring and Test Equipment," states that, " measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits."
Section 2.2 of E0P 35-3.20, " Calibration Control," Revision 2, dated September 2, 1988, states that maintenance and test equipment calibrations were to be performed using controls which assured traceability to certified equipment having known valid relationships to nationally recognized standards.
In addition, E0P 35-3.20 states that calibration services should be classified as safety-related services unless justified and documented otherwise.
~
e GIST Program TP&P 521.1322, Section 4.1.2, requires test equipment be l
calibrated against auditable standards traceable to the National Bureau
{
of Standards.
Contrary to the above, GE-NE purchased flow meters used in the GIST tests from a commercial grade supplier, not on GE-NE's approved supplier list, and accepted and used the instruments as calibrated by the i
supplier without further verification of the quality or traceability of those calibrations.
(93-01-04)
E.
Criterion XI of Appendix B to 10 CFR Part 50, " Test Control," states, in part, " Test results shall be documented and evaluated to assure that test requirements have been satisfied."
i E0P 35-3.00, " Engineering Tests," requires, in part, that all test anomalies be reviewed and dispositioned.
Documented evidence of the i
review and disposition must be traceable and consistent with E0P 42-10.00, " Design Record Files."
E0P 42-10.00, " Design Record Files," requires that supporting information must conform to requirements of E0Ps or other authorizations governing the work activity.
GIST Program TP&P 521.1322, Section 4.2.4, requires that nonconformance reports (NCRs) are to be prepared for tests that do not meet acceptance criteria, and that copies of the completed, approved NCRs are to be included in the DRF.
Contrary to the above, GE-NE failed to document in the DRF the review and disposition of anomalies in three tests, 001, D01, and D03.
These tests were considered to be " invalid" as a result of incorrect valve alignment (C01) or incorrect power input to the test section (D01 and D03).
For one of the tests (C01), a note was found on the folder in the DRF in which hard-copy data plots were stored,-indicating that a problem existed for the test; however, the problem indicated on the folder (incorrect power input) was not consistent with the actual reason given in NED0-31680 for the test's invalidation (incorrect valve alignment).
(93-01-05)
Please provide a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN:
Document Control Desk, Washington, D.C.
20555
'J with a copy to the Chief, Vendor Inspection Branch, Division of Reactor Inspection and Licensee Performance, Office of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of i
Nonconformance.
This reply should be clearly marked as a " Reply to a Notice of Nonconformance" and should include for each nonconformance: (1) a description of the steps that have or will be taken to correct these items; (2) a description of the steps that have been or will be taken to prevent l
recurrence; (3) the dates your corrective actions and preventive measures were or will be completed.
Dated at Rockville, Maryland this 18th day of November
, 1993 l
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