ML20151U920
| ML20151U920 | |
| Person / Time | |
|---|---|
| Issue date: | 08/12/1988 |
| From: | Brach E Office of Nuclear Reactor Regulation |
| To: | Becker V AMERSHAM CORP. |
| Shared Package | |
| ML20151U923 | List: |
| References | |
| REF-QA-99901105 NUDOCS 8808190299 | |
| Download: ML20151U920 (3) | |
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UNITED STATES v
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WASHING TON, D. C. 20555 l
August 12, 1988 j
l Docket No. 99901105/88-01 Victor J. Becker Operations Manager Amersham Corporation 40 North Avenue l
Burlington, Massachusetts 01803
Dear Mr. Becker:
This letter addresses the inspection of your facility at Burlirgton, Massachusetts conducted by Mr. James T. Conway of this office on June 27-2P, 1988, and the discussions of his findings with you and other members of your staff at the conclusion of the inspection.
1 i
The inspection was conducted to perform a programmatic evaluation of the imple-mentation of Amersham's QA program as it relates to the fabrication of gama j
ray projectors. Areas examined during the NRC inspection and our findings are discussed in the enclosed report. This inspection consisted of an examination of procedures and representative records, interviews with personnel, and observa-tions by the inspector.
During this inspection, it was found that the implementation of your QA program failed to meet certain NRC requirements.
Significant items included failures to:
(1) impose QA and Part 21 requirements upon vendors, (2) have procedures /instruc-tions for quality-affecting activities, (3) perform external and internal audits. (4) control special processes such as welding and heat treating, and (5) control measuring and test equipment.
The enclosed Notice of Violation is sent to you pursuant to the provisions of Section 206 of the Energy Reorganization Act of 1974.
You are required to submit to this office within 30 days from the date of this letter 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 were or will be completed. We will consider extending the response tiirs if you can show good cause for us to do so.
8808190299 880812 PDR O A999 ENVACP
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99901105 PNU
Victor J. Becker You are also requested to submit a similar written statement for each item which appears in the enclosed Notice of Nonconfonnance.
The responses requested by this letter are not subject to the clearance proce-dures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
In accordance with 10 CFR 2.790 of the Conrnission's regulations, a copy of this letter and the enclosed inspection report will be placed in the NRC's Public Document Room.
Should you have any questions concerning this inspection, we will be pleaseo to discuss them with you.
Sincerely, 1
CRIGINAL SIGED BY.
E. William Brach, Chief Vendor Inspection Branch Division of Reactor Inspection and Safeguards Office of Nuclear Reactor RegLlation
Enclosures:
1.
Appendix A-Notice of Violation 2.
Appendix B-Notice of Nonconformance 3.
Appendix C-Inspection Report No. 99901105/88-01 DISTRIBUTION:
RIDS Code IE:09 VIB Reading DRIS Redding BGrimes EBrach EBaker JConway LParker (2)
ABarnett, NMSS CMacDonold, HMSS LGordon, HMSS see previous concurrence page. 7 p ], #
VIB:DRIS ASC/VIB:DRis C/VIB:DR JConway: tt
- EBaker
- EBrach
- os' io'88 os /11/88 08/12/88
Victor J. Becker You are also requestcd to submit a similar written statement for each item which appears in the enclosed Notice of Nonconfomance.
The responses requested by this letter are not subject to the clearance proce-dures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
In accordance with 10 CFR 2.790 of the Comission's regulations, a copy of this letter and the enclosed inspection.
report will be placed in the NRC's Public Document Room.
Should you have any questions concerning this inspection, we will be pleased to discuss them with you.
Sincerely.
ORIGINM. SIGNED BY:
E. William Brach, Chief Vendor Inspection Branch Division of Reactor Inspection and Safeguards Office of Nuclear Reactor Regulation
Enclosures:
1.
Appendix A-Notice of Violation 2.
Appendix B-flotice of Nonconformance 3.
Appendix C-Inspection Report No. 99901105/88-01 DISTRIBUTION:
RIDS Code IE:09 VIB Reading TDRIS Reading BGrimes-1 EBrach EBaker l
JConway LParker(2)
ABarnett, NMSS CMacDonald, HMSS i
LGordon, NMSS l
See previous concurrence page{/g C/V!B:0RV
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VIB:DRIS ASC/VIB:DRIS JConway: tt
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EBrach *
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