ML19309C272
| ML19309C272 | |
| Person / Time | |
|---|---|
| Issue date: | 01/24/1980 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19309C253 | List: |
| References | |
| REF-QA-99900387 99900387-79-1, NUDOCS 8004080382 | |
| Download: ML19309C272 (4) | |
Text
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O General Atomic Company Electronic Systems Division Docket No. 99900387/79-01 NOTICE OF DEVIATION Based on the results of an NRC inspection conducted on December 10-14, 1979, 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 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 l.
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." Deviations from these requirements are as follows:
A.
Paragraph 5. of Section iv, Issue D, dated June 1, 1979, of the Quality Manual, states in part, "When an individual becomes qualified to per-form insp::stion, examination. or testing, the facts pertinent to the qualification are entered in a Personnel Qualification record, made out and signed by the individual's supervisor or the department manager."
Paragraph 6. of Section iv, Issue D, dated June 1, 1979, of the Quality Manual, states in part, "A file of Personnel Qualification records is kept both by the individual's supervisor and by the Quality Assurance Department."
Contrary to the above, a file of Personnel Qualification records had not been kept by supervisors in the Manufacturing, and Microprocessor Engineering Departments; even though such records had been completed for qualified personnel.
Copies of Personnel Qualification Records were distributed to all affected supervisors prior to close of the inspection.
The NRC inspector verified that one supervisor had received appropriate copies.
To prevent recurrence, the QA Analyst will verify that supervisors retain a copy of submitted Personnel Qualification Records; also, the internal audit for 1980 will verify the Records are being maintained by the supervisors.
Based on the foregoing, written response to this deviation is not required.
B.
Contrary to Criterion V of Appendix B to 10 CFR 50, QA implementing
[
instructions / procedures made no provisions for identifying Test l
Procedures (by number) on Travellers.
Example:
Travellers for subassembly and assembly level tests of the Liquid Monitor Skid 8004080 N b
2 Assembly (without pump), and the Particulate Iodine Gas Monitor Assembly required a Burn-in Test; however, the Test Procedure to be used had not been specified.
C.
Paragraph 3.2.1 of the Workmanship Inspection Standard No. E-286-127, Revision 6, dated April 1978, states in part, " Hand crimping tools shall be evaluated periodically to ensure conformance to the requirements of Table 3-4."
Paragraph 3.4 of the Workmanship Inspection Standard No. E-286-127, Revision 6, dated April 1978, states in part, " Crimp connectors shall be able to meet the pull tests between the wire and terminal listed in Table 3-4."
Table 3-4 is entitled - Crimp Connection Pull Tests, and identifies various wire sizes and minimum tension (in pounds).
Contrary to the above:
1.
Hand crimping tools were in use but they had not been evaluated periodically to ensure conformance to the requirements of Table 3-4.
2.
Crimp connectors had not been subjected to pull tests between the wire and terminal to determine whether or not they met the pull tests listed in Table 3-4.
D.
Paragraph 5. of Section 5, Issue D, dated June 1,1979, of the Quality Manual, states in part, " Travelers sequence manufacturing, inspection,-
test operations, and hold and witness points in accordance with division procedures and customer requirements.
Changes to operations and se-quencing of operations require same approval as the original."
i Contrary to the above, the addition of Operation No. 17 to Traveler for Level 3/4 Test for Gas Monitor No. 0351-1501-03, had not been approved the same as the original traveler.
Copies of this traveler were lo-cated in the Completed Records File, on hardware in the Manufacturing Area, and in the Master QA Files.
E.
Paragraph 5.1.2 of Section 6, Issue D, dated June 1, 1979, of the t
Quality Manual, states in part, "The design documentation require-ments for each new project are identified at its initiation by the Project Manager via the Drawing Approval Authorization (DAA) form.
The Project Manager determines which approvals are re-quired prior to release of drawings and identifies the individuals who are authorized to sign for the various functions. The Project Manager also determines who must approve changes and lists them (by name or title) in the ' Required Change Approvals' section of the form.
3 Paragraph 5.1.6 of Section 6, Issue D, dated June 1, 1979, of the Quality Manual, states in part, "The Project Manager indicates on the DAA form which signatures are required for the approval of changes."
Paragraph 5.4 of Section 6, Issue D, dated June 1,1979, of the Quality Manual, states in part, " Test procedures are issued and controlled either as drawings as described in paragraph 5.1 or as standards in the ESD Standards manuals."
Contrary to the above:
1.
The revisions to Drawing No. 3534520 exhibited the following:
(a) Revision A, dated September 26, 1978, had not been approved by the Project Manager as required '>f paragraph 5.1.6, and indicated in the change approval section of the Drawing Approval Authorization (DAA) fonn No. 0113, dated May 22, 1978.
(b) Revision B, dated January 24, 1979, had not been approved by either the Engineer or Project Manager as required by para-graph 5.1.6, and in the change approval section of DAA form No. 0113, dated May 22, 1978.
(c)
Revision D, dated November 5, 1979, had not been approved by the Project Manager as re-quired by paragraph 5.1.6, and indicated in the change approval section of DAA form No. 0113A, dated June 27, 1979.
2.
Revision A, dated November 9, 1979, to Test Procedure No. 3539011 (controlled as a drawing), had not been approved by the Engineer identified in the change approval section of DAA form No. 0113A, dated June 27, 1979, as required by paragraph 5.1.6; nor had it been approved by the Project Manager.
3.
Revisica B, dated September 4, 1979 to Test Procedure No. 3572031 (controlled as a drawing), had not been approved by either of the several Engineers identified in the change approval section of DAA form No. 0119, dated June 19, 1978, as required by paragraph 5.1.6; nor had it been approved by the Project Manager.
4.
Revisions - B, dated September 11, 1979; C, dated October 8, 1979; to Test Procedure No. 3573101 (controlled as a drawing), had not been approved by the Project Manager as required by paragraph 5.1.6, and indicated in the change approval section of DAA form No. 0119, dated June 19, 1978.
5.
Further, a DAA form had not been initiated to indicate change approval authority as required by paragraph 5.1.2 of Section 6 of the Quality Manual, for Project No. 281.
4 F.
Electronic Systems Standard Introduction, Issue G,. dated November 2, 1979, entitled - General Atomic Systems Division Standards Program, states in part,
" Designation Type of Standard Classification Approval Agent A Series Reference Specifi-Acceptance Test Cog. Dept. Mgr.
cations Procedures S Series Reference Specifi-Process Cog. Dept. Mgr.
cations "Each department affected by the standard shall be given an opportunity to review the new issue or change.
"The Quality Assurance (QA) Manager shall review all Guide Standards and Reference Specifications for quality content.
Those affecting quality activities shall be approved by the QA Manager as well as by the Approval Agents shown above." Note: The approval requirements were the same in Issue F, dated August 23, 1979, of the cited document.
Contrary to the above:
1.
B, dated October 16, 1979, to Reference Specification No. ESD-2000 (Process) had not been approved by the Cognizant Department Manager.
2.
Issue B, dated October 6, 1979, to Reference Specification No.
ATP-408 (Acceptance Test Procedure) had not been approved by the Cognizant Department Manager or the QA Manager, even though the Reference Specification affected quality activities.
Note:
The requirement was identical in Issue F, dated August 23, 1979, of the Electronic Systems Standard Introduction.
.