ML20041G130
| ML20041G130 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/1982 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20041G128 | List: |
| References | |
| REF-QA-99900387 NUDOCS 8203190302 | |
| Download: ML20041G130 (5) | |
Text
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General Atomic Company Docket:
99900387/81-02 APPENDIX A NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on December 14-18, 1981, it appears that certain of your activities were not conducted in accordance with NRC requirements as indicated below:
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."
Nonconformances with these requirements are as follows:
A.
Quality Manual Section 5, Instructions, Procedures, and Drawings, Revision F, Paragraph 5, states in part:
" Operations are sequentially performed unless bracketed by the planner during traveler preparation to indicate that sequence can be interchanged."
Contrary to the above, unbracketed operations were not always performed in sequence.
For example, the Process Air Monitor (351-1801-01) serial number 3 traveler had Operation 25, a burn-in test, dated October 11, 1981, and Operation 20 dated November 3, 1981.
B.
Quality Manual Section 2, Assurance Program, Revision F, Paragraph 3, states:
"The Quality Department Manager shall ensure that the Integrated Manufacturing and Quality Plan (IMQP) describes all procedures, activities, hold-and-witness points, and applicable standards documents that will apply so as to assure compliance with contract requirements."
Contrary to the above, the standard IMQP and the project IMQP did not describe the test procedures and standards contained in the applicable contract requirements listed in Service Request 171207.
8203190302 820226 bDR GA999 EMVGAT 99900387 PDR 1
General Atomic Company 2
C.
Quality Manual Section 11, Test Control, Revision 5, paragraph 5, states in part:
"The assigned Quality Inspector... verifies that an approved test procedure is available and stamps it with the ' Test Performance Copy' stamp and signs and dates the stamp impression... when testing is finished, the Quality Inspector reviews the data for:
1.
Complete and properly recorded data entries.
2.
All required signatures and dates.
3.
Contrary to the above, the assigned Quality Inspector did not perform the required verification of all testing activities, as evidenced by the following:
1.
Operation 7, a test operation, was signed and dated on the traveler for Particulate, Iodine and Gas Detector (373-1101-03) serial number 1, without an impression of the " Test Performance Copy" stamp having been signed and dated on the approved test procedure.
2.
Quaiification Test Procedure 0360-2082 exhibited the following:
a.
The required data used for baseline acceptance as specified by paragraph 6.5 had not been entered.
b.
The Test Data Sheet for the fourth run had not been initialed at paragraphs 6.3.6.4.3; 6.3.6.4.4; 6.4.3.3 and 6.4.3.4.
c.
The Test Article Record form did not have the date of test, operator signature, inspector signature, and serial numbers of items tested.
3.
Test Report 0359-9004 dated September 30, 1981, which had been incorporated into report E-255-1047 dated October 1981, exhibited:
a.
Incorrect information in Table 1 at steps 6.3.1 and 6.4.2 was found in that measured volts were not recorded as required, b.
M!ssing data were noted in Tables 2 and 3, the deviation and discrepancy records.
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4 General Atomic Company 3
D.
Manufacturing Operations Manual Section 14, Traveler Control, Revision A, paragraph 4.1 states in part:
" Completed travelers serve as objective evidence that all manufacturing, inspection, and test operations were performed on the finished unit... The operation code for any operation requiring a specific instruction document is entered in the upper portion of the card after OPER, and the appropriate document number is entered adjacent to the code under DOC NO."
Contrary to the above, travelers did not reflect the appropriate document numbers, as evidenced by the following examples:
1.
A Control Room Cabinet (373-0501-02) serial number 1 travelers had drawing 373-0522-00, Revision A, erroneously entered.
2.
Particulate, Iodine and Gas Detector (373-1101-01) serial number 1 had test procedure 0373-9003, Revision 1, erroneously listed.
E.
Quality Manual Section 11, Test Control, Revision E, paragraph 5.3, states in part:
... Discrepancies are handled as described in Section 15...." Paragraph 5.2.5 in Section 15 requires that Inspection Clean-up sheet serial numbers be entered on the Traveler at the appropriate operation.
Contrary to the above,' CUSS generated by the Test Department are not entered on travelers.
For example:
1.
Liquid Monitor (373-2501-01) serial number 1 Traveler did not have CUS T10000 305 entered on the Traveler.
2.
Process Air Monitor (351-1801-01) serial number 3 Traveler did not have CUSS 7804 and 7901 entered on the Traveler.
3.
Area Monitor (373-3801-01) serial number 2 Traveler did not have CUS 7172 entered on the Traveler.
F.
Quality Manual Section 15, Nonconforming Materials, Revision F, paragraph 5.2.5, states in part, when a discrepancy has been identified the:
" Traveler operation remains 'open' until the discrepancy is corrected or otherwise resolved. "
I Section 10, Inspection Program, Revision F, paragraph 5.3, requires the Traveler to be closed in order to release the material.
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General Atomic Company 4
Contrary to the above, material is being released for subsequent assembly operations with discrepancies unresolved or uncorrected.
For example a CUS 4655 was issued on a microprocessor (357-0123-02).
This microprocessor was assembled into a Process Area Monitor Assembly (351-1801-01) serial number 3 although the CUS was unresolved or uncorrected.
G.
Quality Manual Section 15, Nonconforming Ma!.erials, Revision F, paragraph 5.2.8 states in part:
"The Manufacturing Department Manager assigns a person to perform the designated corrective action.
The assigned person signs and dates the BY Signature /Date column as evidence of completion of the action." (On the CUS.)
Contrary to the above, a Process Area Monitor (351-1801-01) serial number 3 had CUS 7804 issued, a flow transducer replaced, and the system in Transfer Calibration Test, yet, the CUS had not been signed and dated as completed.
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H.
Quality Manual Section 16, Corrective Action, Revision G, paragraph 2, states in part:
" Procedures shall be implemented which provide for i
regular review of quality-related data...."
r Contrary to the above, not all discrepancies are subject to review, as evidenced by the following examples:
1.
Discrepancies coded as engineering errors are not entered into the monthly evaluation.
2.
Discrepancies identified by the Test Department CUSS in the test reports on the Test Procedures and Failure Log were not entered into the monthly evaluation.
I.
Quality Manual Section 9, Control of Special Processes, Revision E, paragraph 2, states in part, " Personnel performing special processes shall be qualified and the fact of their qualification shall be a matter of record."
Contrary to the above, personnel performing special processes were not J'
qualified and qualifications were not matter of record.
For example:
1.
Operator #35 was soldering on Liquid Monitor (351-2501-01) serial number 10-81-01, but was not qualified to solder.
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General Atomic Company 5
l 2.
- Operator #1 was soldering on Particulate and Iodine Monitor (332-1801-01) serial number 2, but was not qualified to that category of soldering according to the qualification log.
3.
Operator #44's Qualification Card listed two categories, clean and repair / rework; however, the qualification log identified two different categories, chassis and PCB.
4.
Operator #7's Qualification Card listed cleaning; however, the qualification log did not include cleaning.
5.
Operator #45's Qualification Card listed two categories, chassis and repair / rework; however, the qualification log did not identify any qualifications for this operator.
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