ML20039B429
| ML20039B429 | |
| Person / Time | |
|---|---|
| Site: | 07100466 |
| Issue date: | 11/30/1981 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | MINNESOTA MINING & MANUFACTURING CO. (3M CO.) |
| References | |
| NUDOCS 8112230027 | |
| Download: ML20039B429 (3) | |
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Gentlemen:
This refers to your application dated September 28, 1981 requesting approval of your.QA program as meeting the applicable QA requirements identified in 10 CFR 571.51(a).
Review of your QA program revealed the need for the additional infonnation identified in the enclosure to this letter in order to satisfy the applicable QA requirements. Please revise your QA program description toaddresstheinformationincludedintheenclosure,andsubmitseven(7) copies of your response within 30 days of the date of this letter.
Your QA program description need not include detailed individual procedures or instructions (e.g., acceptance tests, survey tests, etc.) provided in your submittal. Such procedures / instructions constitute implementation of your described QA program and should be readily available as verification in case of an NRC audit or inspection.
If you have any questions regarding this request, please contact Mr. Len Gordon of sqy staff at (301)427-4122.
Sincerely, Cric te n W -! W c w. m L.'s c m a Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and j
Material Safety, NMSS
Enclosure:
As stated 8112230027 811130 PDR ADOCK 07100466 l
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om j NRC FORM 318 (10-80) NRCM O2M OFFICIAL RECORD COPY
Static Control Systems; Department of 3M I
(71-0466) l Encl to ltr dtd:NOV 3 01981 l
1.
Provide a statement describing how disputes involving activities important to safety, arising from a difference of opinion between the Plant Manager, Static Control Systems Department and Plant Manager, Medical Products Division are resolved.
2.
Provide a statement that modification of shipping packages are not covered under the QA program.
However.
if in the future modification of shipping packages is planned, for example to DOT specification containers 55 and 6M owned by 3M, then the QA program would be revised to address Design Control (Criterion 3 of Appendix E) and submitted to NRC for approval.
3.
Provide a statement that procurement documents identify the applicable 10 CFR Part 71, Appendix E requirements which must be complied with and described in suppliers' QA programs.
4.
Provide a statement that a master list, or equivalet t, is established to identify current revision number of instructions / procedures, specs., drawings, and procurement documents.
5.
Provide a statement that procedures are established to identify and control materials, parts, and components.
6.
If applicable, provide a statement that special processes such as welding, heat treating, etc, are procedurally controlled.
7.
Provide a statement that identification of the inspection, test, and operating status of packages'and components is known by affected organizations. Also identify means (e.g., tags or stamps) for identifying operating status of parts or components.
8.
Identify QA records to be controlled by the QA program.
These records include, as applicable, ~ operating logs; results of reviews, inspections, tests, audits, qualification of personnel, proceduies, and equipment; procurement, documents, calibration documents, nonconformance reports; and corrective action reports.
9.
Provide a statement that records are identifiable and retrievable.
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- 10. Provide a statement that design related records (e.g., drawings, calculations, etc.) are maintained.for the life of shipping packages and all-other records are maintained for a minimum of 2 years.-
11.
Provide a statement that audits are perfomed in accordance with preestablished written procedures or checklists and conducted by ersonnel not having direct responsibilities in the areas being audited.
- 12. Provide a statement that audits of activities important to safety are perfomed at least annually.
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- 13. Provide a statement that deficient areas are reaudited on a timely i
basis' to verify implementation of corrective actions.
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