ML20056A526
| ML20056A526 | |
| Person / Time | |
|---|---|
| Issue date: | 08/03/1990 |
| From: | Office of Nuclear Reactor Regulation |
| To: | |
| Shared Package | |
| ML20056A524 | List: |
| References | |
| REF-QA-99900403 NUDOCS 9008080105 | |
| Download: ML20056A526 (3) | |
Text
__
.3
.gs APPENDIX A GE Nuclear Energy Docket No. 99900403/90-01 NOTICE OF NONCONFORMANCE Based.on the results of an NRC inspection conducted on April 23 through 26, 1990, it appears that vrtain activities were not conducted ir, accordance with NRC requirements and GEhE Topical Report NE00-11209-04A.
1.
Criterion XVI of Appendix B to 10 CFR Part 50, " Corrective Action,"
states, in part: " Measures shall be established to assure that cor.'
adverse to quality, such as... nonconformances are promptly ident and corrected.
In the case of significant conditions adverse to qi t,
the measures shall assure that the cause of'the condition is detennined and corrective action taken to preclude repetition."
GENE Quality Assurance Program Description, Topical Report NEDO
..:09-04A, Revision 8, dated March 31, 1989, Section 16. " Corrective Action," states, in part: " Procedures and practices are established and documented which provide assurance that conditions adverse to quality or nonconformance...
are promptly identified, documented and corrected or otherwise handled in accordance with established procedures. Corrc.ctive action followup and closeout procedures. provide for assuring that corrective action commit-ments are implemented in a systematic and timely manner." With respect to significant conditions adverse to quality, this section further states, in part:
"Each cognizant GENE QA organization is responsible for... Verifying to assure that corrective action is taken which will preclude repetition-of the problem or satisfactorily control the cause of the problem."
Contrary to the above, GENE failed to establish adequate measures to assure that conditions adverse to quality are promptly corrected and that corrective' action is taken to preclude repetition in that GENE failed to adequately correct the deficiencies in their commercial-grade dedication iprogram for molded case circuit breakers that were identified during the 89-01'02. -This included p(revious NRC inspection under Nonconformance1) inadequate and/or inaccu instructions which were revised to include applicable critical charac-teristes and define methods of surveillance, testing and inspection to l
L adequately. verify critical characteristics, (2) failure to verify by audit of the manufacturer those particular critical characteristics depen-dent on audit for verification, and (3) failure to assure that testing
[
performed by the manufacturer to verify critical characteristics did i
actually verify those characteristics prior to acceptance of test reports as the basis of dedication for molded case circuit breakers for use in safety-related applications and sold to various nuclear power plants, i
l 9008000105 900803,_
l PDR DA999 EMVGENe l
99900403 PDC I
- c..
c.;
j' a
'o
, 2.-
Criterion VII' of Appendix B to 10 CFR Part 50, " Control of Purchased Material. Equipment, and Services," states, in part: " Measures shall be
~
t established to assure that purchased material,' equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measu es shall include objec-tive evidence of quality furnished by the contractor or subcontrt, cor,
+
sour 9.spection at the cor. tractor or subcontractor source, and exam 16 3 tion of products upon delivery.
GENE Quality Assurance Program Description. Topical Report NE00-11209-04A, Revision 8, dated March 31, 1989, in Section 7. " Control of Purchased Material, Equipment And Services" states in part, " Procedures and practices are established and documented to provide assurance that purchased items and services, whether purchased directly or through subcontractors, conform to the procurement document requirements. These measures include provisions, as appropriate, for the following:
source evaluation and selection; appropriate objective evidence of quality
. furnished by the supplier; Land examination or review of items or services i
upon delivery or completion. Spare and renewal parts that perform safety-related functions are procured to a level of quality standarcs 6nd controls-that are at least as stringent as those employed for the-purchase of the original equipment.
Contrary to the above, GENE failed to assure that material and equipment, purchased by contractors and subcontractors such as, Automatic Valve Corporation, Ralph A.~ Hiller Company, and The Sheffer Corporation, met the opplicable procurement documents.
GENE failed to ensure that their contractors and subcontractors conveyed the quality and regulatory requirements, specified in the GENE purchase orders, to their vendors and L
subvendors' and failed to verify the validity of certificates of conformance for the material and equipment purchased by contractors and subcontractors prior to acceptance.- The material purchased was used in.
the assembly of environmentally qualified, safety-related pneumatic / hydraulic actuators, for the main steam isolation valves installed at various nuclear power plants.
3.
Criterion XVIII of Appendix B to-10 CFR Part 50, " Audits," states, in i
part:
"A comprehensive system of planned and periodic audits shall be 1
carried out to verify compliance with all aspects of the quality assurance program and to' determine the-effectiveness of the program.... Audit results shall be documented..... Followup action, including reaudit of deficient areas, shall be taken where indicated."
GENE Quality Assurance Program Description, Topical Report NE00-11209-04A, Revision 8, dated March 31, 1989, in Section 18. " Audits," states, in L
part:
... audits of GENE suppliers of safety-related engineered l
equipment are conducted by QA Representatives at least every 3 yms, or more frequently."
L L
l l
l
4-T',
Contrary--to the above, GENE does not require, nor has GENE conducted triennial audits of suppliers holding N, NA, NPT and NY stamps and the u
associated Certificates of Authorization and Qualit) System certificates issued to Material Manufacturers snd Material Suppliers by the American-Society of Mechanical Engineers (ASME).
In addition, GENE did not-maintain adequate documentation of surveillances or surveys of these suppliers, and the audits of Automatic Valve Corporation and Ralph A. Hiller Company were inadequate or lacking objective evidence.
4.
Criterion V of Appendix B to 10 CFR Part 50, " Instructions, Procedures, and Drawings," states, in part:
" Activities affecting quality shall be prescribed by documented instructions, procedures...and shall be accom-plished in accordance with these instruct ions, procedures....
Instruc-tions, p.rocedures...shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."
GE Nuclear Energy Business Operations (NIB 0) Procedure 70-42, " Reporting of. Defects and Noncompliances under 10 CFR Part 21," states, in part: "If thePotentialReportableCondition(PRC)isdeterminedtobenon-rep (L&CS) or-table but Germane-To-Safety, the Licensing and Consultir.g Services L
L manager will provide a copy of the letter-report for the process of_ noti.
L fication to all affected parties."
Contrary to the above, GENE failed to notify any other BWR owners except Clinton Station of a potential operability problem with the configura-tions of the three position type CR2940 key lock switches identified by Drawing No. 145C3040 Part 116 and Part 022, for a condition which should
'have been' determined to be Germane-to-Safety by the Safety & Licensing Operation (S&LO) group (currentlyL&CS)perthePotentielReportable L
Condition'(PRC).84-03 evaluation, dated January 9,1986. PRC 89-24 L
determined a similar switch failure with Part 022 at the River Bend Station'to be a Germane-to-Safety Condition, but in this case, GENE I
notified all BWR owners in December 1989 of the problem with the CR240 Part 022 key lock switch. The inspectors determined that GENE had sufficient information in the PRC 84-03 evaluation dated January 9,1986 to make a Germane-to-Safety determination and notification to customers.
l 1
L I
--