ML19289E782
| ML19289E782 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19289E764 | List: |
| References | |
| REF-QA-99900403 NUDOCS 7905290104 | |
| Download: ML19289E782 (5) | |
Text
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General Electric Company Docket No. 99900403/79-01 NOTICE OF DEVIATION Based on the results of a NRC inspection conducted on February 5-9, 1979, it appeared that certain of your activities w3re not conducted in full compliance with NRC requirements as indicated below:
A.
10 CFR 50, Appendix B, Criterion XVIII (Audits), states in part,
" Audits shall be performed in accordance with written procedures...."
GE implementing procedure QCSI No. 7.2.17 states in part, "The lead auditor shall plan the audit then meet with the audit team.... This meeting must be mentioned in the audit Summary Report.... The lead auditor shall prepare the report... and ensure that the report contains the following minimum contents....
Identification of the check list or procedures used.
Persons contacted at the pre-audit, audit, and post-audit activities."
Contrary to the above:
1.
The audit sunmary reports of the Ingersoll Rand Aydit (November 8-9, 1978), Dikkers Audit (June ~20-22, 1978), and CB&I Nuclear Audit (June 13-15, 1978) made no mention of an audit team meeting.
2.
The audit summary report of the CB&I Nuclear Audit (June 13-15,1978) did not identify the check list or procedures used.
3.
The audit summary reports of the Bingham Willamette Audit (October 24-26,1978) and Ingersoll Rand Audit (November 8-9, 1978) did not contain the names of those persons contacted during the audit.
B.
10 CFR 50, Appendix B, Criterion V (Instructions, Procedures, and Drawings), states in part, " Activities affecting quality shall be prescribed by decumented instructions, procedures or drawings...
and shall be accomplished in accordance with these instructions, procedures or drawings."
Contrary to the above, procedures or instructions do not exist describing the method by which changes to the evaluation model are reported in amendments submitted to the NRC as required by para-graph 1.b of Section II of 10 CFR 50, Appendix K.
C.
Section 4 of Topical Report NED0-11209-04A states in part, " Measures are established and documented for the preparation, review, approval, and control of procurement documents to provide assurance that regulatory requirements, design bases, and other requirements which eg 905 29 010 4 2048 123
. are necessary to assure the requisite level of quality are included or referenced in the documents for procurement of items and services...."
Section IV, Revision 9, dated February 10, 1978, of the Nuclear Quality Assurance Manual:
1.
Paragraph 4.1.1(d) states in part, " Revisions made to ASME Code and Safety Related Material Request must be signed with a full name and dated. Other types may be initialed and dated."
2.
Paragraph 4.2(d) states, "For Safety-Related items, Purchasing places the order with a qualified supplier (See Exhibit 71) or the supplier qualification procedure is implemented (See Section 7.0!."
Exhibit 71 is the Qualified Suppliers List.
Contrary to the above requirements:
1.
Material Request No. 399284, dated November 2, 1978, for safety-related hardware, exhibited seven (7) revisions which had not been signed with a full name.
2.
Purchase Order No. 282-KE999, dated November 2, 1978, for safety-related hardware had been issued to a company not included in the Qualified Suppliers List, nor had the supplier qualification procedure been implemented.
D.
Section 4 of Topical Report NED0-11209-04A states in part, " Measures are established and documented... to provide assurance that regulatory requirements, design bases, and other requirements...
necessary to assure the requisite level of quality dre included or referenced in the documents for procurement of items and services....
Additional quality compliance requirements such as supplier QA Program and documentation requirements... are... issued by QA organizations for inclusion in the procurement document packages."
Section IV, Revision 9, dated February 10, 1978, of the Nuclear Quality Assurance Manual, paragraph 4.2(c), states in part, "The Purchase Order incorporates the requirements of-the procurement initiation document including the Quality Assurance requirements and any additional Quality Plans."
Purchase Order No. 282-KE475, Revision 00, dated April 24, 1978, invokes Quality Plan No. 30.123, Revision 0, while Purchase Order No.
282-KE999, Revision 00, dated November 2,1978, invokes Quality Plan No.30-123, Revision 1.
Paragraph 5.4 of Quality Plan No. 30.123 (both versions), states in part, "Upon the detection of a Seller nonconformity or deficiency by the Buyer, either at the Seller's or 2048 324
the Buyer's facility, a Corrective Action Request (Exhibit 4) may be issued by the Buyer.... The Seller shall reply within the time specified by the Buyer and correct the condition within the committed time.
Paragraph 2.0 of Manufacturing Procedure No. 5.01, dated June 21, 1978,
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states in part, " Corrective Action Requests are issued as necessary to... suppliers," while paragraph 4.4.1 states, " CAR's which remain open for over 30 days are reported to management monthly to enhance followup action. EXCEPTION:
CAR's which are subject to specific product follow-up (i.e., referenced in product records packages and which must be closed prior to product acceptance) need not be reported."
Contrary to the above requirements:
1.
Monthly reporting to management of Corrective Action Requests (CAR's) open over 30 days had not enhanced follow-up action inasmuch as CAR's SJ34213 and SJ34214 had been identified, in the Outstanding CAR Report of November 1978, as 152 days overdue due to no response. Also, the seller had not responded to them within the time specified (no later than July 1,1978) by the buyer (GE-San Jose).
2.
The seller had not responded to CAR SJ34217 within the time specified (no later than September 17,1978) by the buyer (GE-SanJose).
Also, it had not been identified in the Outstanding CAR Report as of January 12, 1979, despite its being open for over 30 days.
E.
Section 15 of Topical Report NEDO-11209-04A states in part, " Procedures and practices are established and documented to provide for positive control of items which do not conform to specified requirements....
"A disposition decision to 'use as is' or to ' repair' a nonconforming item is made... by e Material Review Board... the engineering represent:tive must determine that... the 'as is' or ' repaired' condition will not infringe upon the capability of the item to satisfactorily perform... and must document the rationale for acceptance."
1.
Section XV, Revision 7, dated August 31, 1977, of the Nuclear Quality Assurance Manual, paragraph 15.6, states in part, " Decisions to repair or use as is require approval of both the Quality Assurance and Design Engineering MRB representatives." Paragraph 15.7(f) states, "' Repair' and 'use-as-is' dispositions are accomplished by a statement on the IR/DDR by the responsible Design Engineering Representative indicating the justification for the disposition."
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. Contrary to the above requirements:
a.
Inspection Report (IR) No. R672T, dated November 10, 1978, contained a " repair" disposition provided by the MRB (Material Review Board); however, it contained no state-ment of justification for the disposition.
This document had been closed out and was located in the PGCC Records
- Center, b.
IR No. R689T, dated November 17, 1978, states in part, " Repair broken barriers per MSP 16.014 Revision 1.
Repair has no affect on form, fit, or function." There were no signatures in the "MRB Disposition Approval" spaces indicating no review or approval by the MRB as required.
MSP 16.014 is entitled-Repair of Broken Terminal Board Barriers.
The IR had been closed out and was located in the PGCC Records Center.
2.
Paragraph 4.3 of Manufacturing Procedures (MP) No. 5.03, dated July 24, 1978, requires assigning disposition codes (e.g. " repair" or "use as is.") to each nonconformance.
Paragraph 4.6.2 states in part, "All dispositions must be completed and the inspection signature or stamp applied in the appropriate columns according to instruction No. 24.
Individual Deviation Letters must be closed out in the required spaces (space No. 24) on the form by acceptance stamp or signature for those accepted and by signature and listing of subsequent IR number for those not accepted.
The IR must be signed or stamped and dated...." This requirement also existed in the October 7,1977, version of MP No. 5.03.
Contrary to the above requirements:
a.
IR No. R785T, dated January 4,1979, displayed eighteen (18) nonconformances that had not been assigned disposition codes; of these, fifteen (15) of the nonconformances had been corrected and accepted by Quality Assurance as evidenced by QA stamp and date in space 24 of the IR.
b.
IR No. R142W, dated April 13, 1978, indicated
" Accepted-1 Rejected-0"; however, no stamp or signature or date appeared in the appropriate space (24) of the Individual Deviation Letters to show product acceptance even though the electrical cable had been corrected, retested, reinspected and released.
This document was located in the Open IR file which also indicates a Nonconforming Tag was attached to the product, it was not.
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. c.
IR No. R318W, dated January 15, 1979, contained no indication of inspection activity in space 24 of the IR even though the electrical cable had been corrected, retested, reinspected, and stamped.
This document was located in the Open IR File which also indicates a Norconforming Tag was attached to the product, it was not.
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