ML20023C009
| ML20023C009 | |
| Person / Time | |
|---|---|
| Issue date: | 04/20/1983 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20023C006 | List: |
| References | |
| REF-QA-99900387 NUDOCS 8305090482 | |
| Download: ML20023C009 (3) | |
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l APPENDIX A GA Technologies, Inc.
Electronic Systems Division Docket No. 99900387/83-01 NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on February 7-10, 1983, it appears that certain of your activities were not conducted in accordance with NRC requirements as indicated below:
A.
The GA Technologies, Inc. (GA) corrective action response letter of March 23, 1982, states with respect to Item C in the Notice of Nonconformance of NRC Inspection Report No. 99900387/81-02, "... a series of discussions have been conducted with the objective of these discussions... to insure adherence to the stipulated test methods and entries."
Contrary to the above, the referenced discussions did not assure adherence to stipulated test methods and entries as evidenced by the omission of stamps at steps 5.1 and 13.7 on Test Procedure 0365-9305 after completion of the test for area monitor 0365-4501-001, Serial No. 13.
B.
The GA corrective action response letter of March 23, 1982, indicates with respect to Item D in the Notice of Nonconformance of NRC Inspection Report No. 99900387/81-02 that the document issuing function would be reassigned to Product Quality to prevent recurrence of the problem that travelers did not reflect the appropriate document numbers.
Contrary to the above, reassignment of the document issuing function to Product Quality did not prevent recurrence of the problem as evidenced by the NRC inspector identification of one traveler in a sample of three containing inappropriate document numbers; i.e., a traveler for liquid monitor 0352-2601-001, Serial No. 4, showed an incorrect revision status in regard to Drawing No. 0352-2601, Parts List 0352-2601-01, and Test Procedure No. 0357-0201.
C.
The GA corrective action response letter of March 23, 1982, states with respect to Item E in the Notice of Nonconformance of NRC Inspection Report No. 99900387/81-02, "... a series of retraining sessions were conducted for test personnel... to provide clear direction concerning clean up-test sheet initiation, disposition and close out."
Contrary to the above, the series of retraining sessions did not provide clear direction concerning clean-up-sheets as evidenced by the NRC inspector identification of the absence of an applicable Clean-Up-Sheet No. 10102 on the traveler for area monitor 0365-4401-001, Serial No. 1.
8305090482 830420 PDR GA999 EMVGAT 99900387 PDR
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. 4 O.
The GA corrective action response letter of March 23, 1982, states with respect to Item H in the Notice of Nonconformance of NRC Inspection Report No. 99900387/81-02, "A plan has been developed which will provide reporting of... discrepancies.
In addition, failure log (test department discrepancies) information will be entered into the monthly evaluation report."
Contrary to the above, there was no documented plan addressing the trend 4
analysis or monthly evaluation of discrepancies.
It was also noted that the most recent monthly evaluation showed no test department discrepancies for the months of November and December 1982 although such discrepancies had occurred.
E.
Criterion V of Appendix B to 10 CFR Part 50 states:
" Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings.
Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."
Paragraph 5.2.2. in Section 15, " Nonconforming Material," of the Quality Manual states, in part, " Corrections which require repair or do not i
return the item to full compliance with applicable drawings, procedures, and specifications require QE concurrence."
Contrary to the above, the NRC inspector noted that QE concurrence had not been obtained on CUS No. 9499 for the repair of an offline gamma monitor 0365-2901-001.
F.
Criterion V of Appendix B to 10 CFR Part 50 states, in part, " Activities affecting quality... shall be accomplished in accordance with...
instructions, procedures, or drawings...."
Paragraph 3.3. in Section ll, " Test Control," of the Quality Manual states in regard to test operators, " Sign and date all data and traveler entries as indicated."
Contrary to the above, the testing for a subassembly RD-8 was completed and the subassembly installed in a top assembly 0365-4401-001 without the subassembly final testing operation (No. 2100) being signed on its traveler.
G.
Criterion V of Appendix B to 10 CFR Part 50 states, in part, " Activities affecting quality... shall be accomplished in accordance with...
instructions, procedures, or drawings...."
i
. Paragraph 5. in Section 12, " Control of Measuring and Test Equipment," of the Quality Manual states, in part, "If readings are found for equipment under calibration beyond manufacturer's specified limits and/or needed accuracy....
The Product Quality Manager shall initiate a documented investigation to determine the quality status of items measured with the unacceptable instrument."
Contrary to the above, no evidence was made available to the NRC inspector to indicate that a documented investigation had been made in regard to determining the quality status of voltmeters (and, if applicable, products inspected by these voltmeters) which had been calibrated with an unacceptable primary standard; i.e., GA was notified in April 1982 by a calibration subvendor (Report No. 72654) that a digital voltmeter used as a primary standard had been found to be outside the required tolerance.
H.
Criterion V of Appendix B to 10 CFR Part 50 states, in part, " Activities affecting quality... shall be accomplished in accordance with...
instructions, procedures, or drawings...."
Paragraphs 2. and 3. in Section 18, " Quality Assurance Audits," of the Quality Manual state, in part, "The results of audits shall be documented....
Follow-up action, including reaudit of areas found to be deficient, shall be taken....
The Product Manager shall insure that as a minimum one audit for each section of the Quality Manual is performed within a calendar year."
Contrary to the above:
1.
Audit results were not formally documented (i.e., an audit report was not issued) for an audit performed of Section 15 of the Quality Manual from June 11 to July 10, 1982.
The findings of the audit had not been documented on " Audit Finding Forms" and the NRC inspector was unable to ascertain from existing informal notes the exact number of findings.
2.
Followup actions were not taken in regard to the findings made during an audit performed in 1982 of Section 1 of the Quality Manual.
The designated scheduling of followup resulting from a 1982 audit of Section 3 of the Quality Manual was also not accomplished.
3.
During 1982, only 6 of the 18 Quality Manual sections were audited.
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