ML20199L098
| ML20199L098 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 11/25/1997 |
| From: | Dicharry R SOURCE PRODUCTION & EQUIPMENT CO., INC. |
| To: | Shankman S NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20199L102 | List: |
| References | |
| CAL-97-7-06, CAL-97-7-6, NUDOCS 9712010294 | |
| Download: ML20199L098 (4) | |
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November 25,1997 U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Document Control Desk cc:
Dr. Susan F. Shankman, Chief Transportation, Safety and Inspection Branch Spent Fuel Project Office, NMSS
Subject:
REPLY TO CONFIRMATORY ACTION LETTER NO. 97-7-006 UPDATE
Reference:
Confirmatory Action Letter No. 97-7-006, dated June 24,1997 SPEC letter to NRC dated July 14,1997 NRC Letter to SPEC dated July 23,1997 SPEC letter to NRC dated September 2,1997 SPEC letter to NRC dated September 19,1997 NRC Confirmatory Action Letter No. 97-7 006 Update dated October 27,1997 Docket 71-0102
Dear Dr. Shankman:
BACKGROUND in SPEC's letter to the NRC dated July 14,1997 a plan was submitted which segmented corrective actions (CA's) into three (3) phases to address the various concerns and findings resulting from the NRC inspection, the SPEC intemal audit, ar.d the independent expert audit.
(As a note, while the independent expert audit had not yet been conducted as of July 14,1997, this audit was planned and provisions were included in the CA plan to address any findings from this audit] Phase I actions were completed by us and accepted by Carl J. Paperiello in his correspondence to us dated July 23,1997. We were allowed to resume fabrication limited to no more than five new Type B packages each week while we addressed Phase II and Phase Ill CA's.
An Independent Audit was conducted on August 19 and 25,1997. Tluse results were forwarded to the NRC in correspondence from us dated September 2,1997. The SPEC Phase 111 CA Plan was revised to incorporate the results from the audit. The revised plan was forwarded to the NRC in correspondence from us dated September 19,1997.
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PDR Nource Production & Equipment Co., Inc.
113 Teal Street St. Rose, LA 70087-9691 Phone 504!%4-9471 Telex 460156 FAX 504/467 7685
Dr. Shankman Page 2 11/25/97
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STATUS OF SPEC's CORRECTIVE ACTION PLAN Attachment A contains the detailed hiatrix of Assignments and Corrective Actions - Phase 11, Revision (8), dated October 10,1997. There are exceptions to four (4) corrective actions contained in the matrix - CAISB, CA16B, CA25B and CA32B - as explained in the memo appended to the Phase 11 hiatrix. All Phase 11 corrective Actions have been implemented and were closed out by us on or before October 10,1998.
Work was underway on implementing the Phase 111 corrective actions when the NRC CAL Update dated October 27,1997 was received. Attachment B contains the detailed hiatrix of Assignments and Corrective Actions - Phase 111, Revision (2), dated Noven.ber 25,1997. All corrective action except as noted have been implemerited. The remaining open corrective actions all relate to the review and revision to SPEC's Quality System, which is presently in progress.
We have completed an assessment of our Quality System. A review of the QA Program document by us and by the expert independent consultant who perfonned the independent audit (Qh1S - Quality hianagement Support, Inc.) has determined that revisions to the QA Program document are not necessary. The QA Program document meets the requirements of 10 CFR Part 71 Subpart H. Therefore, we do not plan to revise this document and will not be submitting a revised QA Psogram for your review and approval as we stated we anticipated we would need to do in our facsimile correspondence to hir. Tom hiatula dated September 19,1997.
A review of the implementing procedures (identified as QAhi's" in our QA hianual) by us and by QhtS has determined that revisions to these procedures are necessary. Therefore, we have started a review and are in the process of making revisions to these implementing procedures.
We have retained the services of QhiS to assist us in this effort.
NRC Confirmatory Action Letter No. 97-7-006 Update dated October 27,1997 states that "...the procedures that implement the SPEC QA program must be reviewed and revised in their entirety...(and that)...the revised implementing procedures...must be fully implemented before resumption of full fabrication can be authorized." This work is currently in progress. The plan to effect its completion is detailed b: low.
In summary, all corrective actions arising from the internal audit, the NRC inspection of June 16-
- 19. W97 and July 9-10,1997 and the independent expert audit, identified in various documents as Phase I, Phase 11, and Phase 111 corrective actions, have been implemented and are closed, except those that relate to the review and revision to the implementing procedures of SPEC's Quality System - as noted below.
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.t OPEN CORRECTIVE ACTION Corrective actions which remain open relate to the review and revision to the implementing QA -
manual procedures. The plan to complete this review and revision incorporates the expert assistance of QMS to assure that the revised SPEC QA Program implementing procedures have; 3
been fully implemented and root causes responsible for "...the lapses in the current quality system at r
SPEC..." have been corrected. The plan has a February 13,1998 date for the NRC to be notified that we have completed all corrective actions. At that time we will be seeking authorization to resume full production of new Type B packages.
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President
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,c Attachment A Date:
October 10,1997
Subject:
Matrix of Assignments and Corrective Actions - Phase 11
Reference:
SPEC Quality Assurance Program, NRC Certificate of Compliance No. 0102 Corrective Action Implementation Plan SPEC has completed the corrective actions listal in the subject Matrix of Assignments and Corrective Actions -
Phase II, with exceptions as follows:
1)
Corrective action ISB, item 6 states:
6 month re-evaluation of vendors and component lists to ensure that each vendor of a Type B package component has been evaluated as applicable.
Upon resiew of the US Nuclear Regulatory Commission Regulatory Guide 7.10 ar.J the requirements of our QA Program, we believe that yearly evaluation of these venders is sufficient and appropriate to assure acceptable quality of vendor-supplied items..
2)
Corrective action 16B states:
Revise QA manual 4.0 to require distribution of drawings to fabrication workers with shop orders...
Considering the drawing distribution system currently in place, consisting of QA controlled drawing books located at multiple information stations in both SPEC buildings, we modified that portion of corrective action 16B requiring distribution ofdrawings. Instead ofincluding copies of drawings with each shop order, we designed the shop order procedure and form to require both a QA inspector and the production worker to log the drawing and resision number of the drawing (s) and/or traveler (s) used in the execution of the shop order.
3)
Corrective action 258 states:
...Mr. Ross Chapel of NRC will be cont 9cted to discuss further remedial action.
Mr. Chappell was contacted by Mr. Dicharry to discuss a similar observation by the NRC during the inspection. Mr. Chappell clarified tint it is necessary for the packages to meet the drawings referenced in the Certificate of Compliance. We have confimut that the outlet nipple boss purchased for the C-1 meets the approved design. The fmding is related to the use of an unapproved drawing to purchase the part. TLt finding has been addressed in corrective action 18B No further corrective action is raluired.
4)
Corrective action 32B states:
The QA manager will review the preUminary drawings used to fabricate the early (spec-150) prototypes and create a report documenting any differences from the equivalent approved drawing 5 Since prototype testing for the SPEC 150, SPEC-2T, and C-1 was validated through re-testing all three designs, we believe that reviewing and reporting of ditTerences between preliminary and approved drawings is unnecessary, and that the etTort required would be better spent on the implementation of Phase ill corrective actions.
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