ML19270F488
| ML19270F488 | |
| Person / Time | |
|---|---|
| Issue date: | 12/18/1978 |
| From: | Potapovs U NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | Finley W GENERAL ATOMICS (FORMERLY GA TECHNOLOGIES, INC./GENER |
| Shared Package | |
| ML19270F481 | List: |
| References | |
| REF-QA-99900402 NUDOCS 7902140185 | |
| Download: ML19270F488 (2) | |
Text
pnMc UNITED STATES f'
oq'o NUCLE AR REGULATORY COMMIS510N
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o REGION IV 5
611 RYAN PLAZA DRIVE,SUlTE 1000 7
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ARLINGTON, TEXAS 76011 18 DEC 1978 Docket No. 99900402/78-01 General Atomic Company ATTN:
Mr. W. W. Finley, Jr.
President Post Office Box 81608 San Diego, Califcrnia 92138 Gentlemen:
This refers to the QA Program Inspection conducted by J. M. Johnson of this office on November 13-17, 1978, of your facility at San Diego, California, and to the discussions of our findings with Mr. T. R. Colandrea and members of your staff at the conclusion of the inspection.
Areas examined during the QA Program inspection and our findings are discussed in the enclosed report.
Within these areas, the inspection consisted of an examination of procedures and representative records, interviews with personnel, and observations by the inspector.
During this inspection it was found that the implementation of your QA Program failed to meet certain NRC requirements.
The specific findings and references to the pertinent requirements are identified in the enclosures to this letter.
Please. provide us within thirty (30) days a written statement containing, (1) a description of steps that have been or will be taken to correct these items, (2) a description of steps that have been or will be taken to prevent recurrence, and (3) the dates your corrective actions and preventive measures viere or will be completed.
In accordance with Section 2.790 of the Commission's " Rules of Practice,"
Part 2, Title 10, Code of Federal Regulations, a copy of this letter with enclosure and your reply together with the enclosed inspection report will be placed in the Commission s Public Document Room.
If this report contains any information that you believe to be proprietary, it is necessary that you make a written application within thirty (30) days to this office to withhold such information from public disclosure.
Any such application must include a full statement of the reasons on the basis of which it is claimed that the information is proprietary, and should be prepared so that proprietary information identified in the application is contained in a separate part of the dccument.
If we do not hear from you in this regard w! thin the specified peritd, the report will be placed in the Public Document Room.
7902140/ f5
Attachment:
Detailed Responses (Cont.)
Action to Prevent Recurrence - The following actions have been or will be accom-plished to prevent recurrence of the problem identified as Deviation "B":
(a)
Lead responsibility for the audit activity has been reassigned.
The individual formerly responsible for the activity was transferred into a technical assignment and a more senior individual was placed in the lead position for auditing.
(b) QA Division management counselled the Manager, Quality Operations Branch, whose responsibilities include the audit function, on the need for greater attention to detail.
(c) Audit procedure QP-18 is currently being revised to address specific AtlSI N45.2.12 requirements that are not presently covered.
(d) The new revision of audit procedures QDI 18-1 will provide detailed instruction on the use of the CAP, form for audit findings, includ-ing use of the " Evaluation" block on the form.
(e) Two full time auditors were added to the staff of the Quality Cperations Branch.
Completion Dates - The actions to correct reported deficiencies were completed, or are scheduled for completion, as follows:
B.1.
Policy of written audit notification instituted by verbal instruction: 12/1/78.
B.2.
Institution of auditor instruction on obtaining documented evidence of entrance / exit interviews: 12/1/78.
B.3.
Completion of all scheduled 1978 audits and follow-ups: 1/31/79.
B.4.
Instructions on attention to check list administrative details:
Started 12/4/78; continuing.
B.S.
Adoption of requirement for completing " Evaluation" block on audit CAR's: 12/4/78.
B.6.
Auditor certification files reviewed, brought into full compliance:
11/30/78.
Actions to prevent recurrence were completed or are scheduled for comple. tion by the dates indicated below:
(a)
Reassignment of lead responsibility: 12/4/78.
(b) Management counselling of Manager, Quality Operations Branch:
i1/17/78 and continuing.
Attachment:
Detailed Responses (Cont.)
(c)
Issuance of revised procedure QP-18: 3/30/79.
(d)
Issuance of revised procedure QDI 18-1: 3/30/79.
(e) Assignment of two additional full-time auditors to Quality Operations Branch staff: 1/2/79.
1 Attachnent: Detailed Responses 2
Deviation "A":
"10CFR50, Appendix B, Criterion XVI requires ' measures to assure that conditions adverse to quality are... corrected.'
" Contrary to the above, General Atomic appears to lack a system or measures to assure completion of committed cor-rective and preventive actions as evidenced by the failore to meet certain of their commitments in all five (5) devia-tions identified in the 77-01 Inspection Report..."
Response to "A" Action to Correct Reported Deficiencies - Those corrective action cc:=it-ments for Inspection 77-01 findings that were implemented late to the com-mitted schedule, or were not fully implemented, or for which action was judged to have differed from the commitment, have been completed a., follows:
A.l.
As indicated in flRC Report 78-01, Record Control Branch pro-cedures were issued March 31, 1978.
p A.2.
The promised dual storage of design specifications had inad-vertently been accomplished to a special purpose design document index that listed a limited selection of the documents actually in the system. The mistake appears to have occurred because the flRC Inspection 77-01 audit of design records was accomplished to that list.
Upon discovery of the error, during HRC Inspection 78-01, dual storage was undertaken for the remainder of the documents in the total affected population, and was completed and ready for follow-up audit by December 18, 1978.
A.3.
As indicated in ilRC Inspection Report 78-01, a total QA program audit of QA Record; was accomplished in November,1978.
I t-should also be noted that QA Records audits were performed on i
all GA projects between t;ovember,1977 and !4 arch,1978, and I
that each such audit included the interfacc between the audited project and the QA Division.
As further indicated in f:RC Inspection Report 78-01, QA train-ing was audited in February,1978.
Training activities were again audited in December,1978 A.4.
At the time that i;RC Inspection 77-ll exposed the fact that the controlled acceptance of verbal commitments to corrective action was not covered in the GA QA Manual, the decision was made to corrert that omission, specifying the requ'^ed elements of con-trol. The required change was processed and was issued July 5, 1977. At the same time, an administrative check list was
Attachment:
Detailed Responses (Cont.)
inaugurated to assure that dated signatures were present wher-ever explanatory notes or written corrective action commitments appeared on the audit check lists.
In the preparation of the formal response to flRC Inspection Report 77-01, the procedure change formalizing the verbal commitment alternative'was inad-vertently omitted.
The past year's experience has shown the verbal commitment option to have potential weaknesses and therefore this option has been deleted from our system.
With regard to the fact that four auditors missed the required refresher tra ning, all four received individual instruction i
which specifically addressed the material of the refresher sessions. However, this training was not reported to the training records n;nction and therefore was not captured in our records.
Audits performed by those individuals during the past year have been reviewed and show no deficiencies in the administrative details covered by the refresher training.
A.S.
QA indoctrination make-up sessions were held 12/2')/78, 1/11/79, 1/12/79, and 1/16/79. All personnel on the indoctrination
" delinquency" list have been trained, except Fusion project personnel.
QA indoctrination in that project (for the few individuals who have not yet attended scheduled sessions) has been undertaken by the Senior Project Engineer - Quality
- Assurance (SPE-QA) for rusion. That indoctrination is being cond7.ted for one or two people at a time as openings in the testing schedule permit.
Action to Prevent Recurrence - Action has been initiated to revise or incor-porate applicable procedures in the QA Manual to accomplish the following:
(a) A "QA problem" tracking system is being instituted.
The system is designed to list all QA program problers (e.g.,
audit findings, CAR's, etc.), corrective action commitments and responsible managers. The system provides for frequent, periodic reporting of the status of all listed problems, flagging approaching due dates, and escalating past-due items to successively higher management levels until appro-priate action is accomplished. We are presently debugging this system and expect to have it operating effectively by June 30, 1979.
(b) A formal requirement will be included in the revised pro-cedures for notifiying the appropriate authcrity of cormiit-ment. schedules that are in danger of slipping.
The required notification will include an explanation of the circumstances that are producing the delay and a request for approval of the revised schedule date(s).
Attachment:
Detailed Responses (Cont.)
Response to "B" The following actions were taken to address the specific deficiencies cited in the NRC Inspection 78-01 report.
B.l.
Verbal. instruction was issued to the individual responsible for audit activities that all audits are to be preceded by written notification to the audited activities.
Each audit instruction sheet' now includes that requirement.
B.2.
Each audit team leader is now instructed, at the time an audit is. assigned, that documentary evidence of audit entrance and exit interviews must be obtained.
The preferred method of documenting them is also described at that time.
B.3.
All scheduled 1978 audits and follow-ups were assigned at the time of the NRC inspection. Only one of those audits is still in work at this time.
B.4.
The individual responsible for audit activities was counselled to emphasize to each auditor the importance of meticulous atten-
~
tion to the administrative details of audit check lists, as such check lists constitute the official, raw record of the audi t.
B.S.
The CAR form is used for audit findings (under specific, limited circumstances) merely because of the convenience of the format.
Although audit CAR's are kept outside the formal CAR system, and acccpta.nce of the responses to audit CAR's is evident by their inclusion in tne audit report, our audit procedures failed to address the applicability or non-appli-cability of the " Evaluation" block.
Instructions have been issued that, until and unless a change to QP-16 or QP-13 exempts audit CAR's from the requirement of appropriate signatures in the " Evaluation" block. that block shall be signed when the response is accepted, precisely as would be the case for a normal CAR.
B.6.
The auditor certification file has been reviewed for accuracy.
of the entries on each' certification and for compliance of qualifying data with requirements of QDI 18-2, " Auditor Qualifi-ca tion. " The two certifications cited had been processed in error, due to a misinterpretation of req'lirements on the part of the responsible individual.
Those certifications were can-celled, and typographic errors found on three other certifica-tions were corrected.
Attachment:
Detailcd Responses (Cont.)
'c) A comprehensive working level instruction for QA training, QDI 2-5, has been prepared and reviewed.
Comments are being resolved at this time.
Completion Dates - The actions described above to correct reported discrepan-cies of " Deviation A" were completed, or are scheduled for completion, by the dates indicated below:
A.l.
-RCB procedures issued: 3/31/78.
A.2.
-Dual storage, engineering records: 12/18/78
-Follow-up audit: February, 1979 A.3.
-QA Records audits, all projects: November,1977 to March,1978.
-Across-all-programs QA Records Audit: November, 1978.
-QA training activities audits: February, 1978 and December, 1978.
A.4.
-Accertance of verb.~. corrective action commitments for audit finngs stopped by verbal supervisory instruction:.2/1/78.
-11anagement direction memo issued: 1/16/79.
-QP-18 and QDI 18-1 revisions sche.iuled for issuance: 3/30/79.
A.5.
-Delinquent QA indoctrination (except Fusion) completed: 1/16/79.
-Fusion QA indoctrination completion scheduled: 2/28/79.
-QDI 2-5, "QA Training Program," scheduled for issuance: 3/15/79 Pie revisions of corrective action and audit procedures to accomplish the
" Actions to Prevent Recurrence" are scheduled for issuance by 3/30/79.
Deviation "B":
"10CFR50, Appendix B, Criterion XVIII requires ' A compre-hensive system of planned and periodic audits... performed in accordance with written procedures....'
" General Atomic Topical GA-A13010A states in.17.18
' Audits--The requirements of AfiSI N45.2.12 are' implemented by the GA Quality Assurance Division.'
" Contrary to the bbove, the GA audit system and practices are not being effectively implemented to assure that audit planning and performance, in confo'rmance to the require-ments of ANSI N45.2.12 and GA audit procedures, are attained..."