ML19296B963
| ML19296B963 | |
| Person / Time | |
|---|---|
| Site: | 07100348 |
| Issue date: | 02/11/1980 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Cook G MICHIGAN, UNIV. OF, ANN ARBOR, MI |
| References | |
| NUDOCS 8002220469 | |
| Download: ML19296B963 (5) | |
Text
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'o,j UNITED STATES NUCLEAR REGULATORY COMMISSION e
WASHINGTON, D. C. 20555 i
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FEB 11 1980 FCTC: RHO 71-0348 University of Michigan ATTN: Mr. Gary M. Cook Phoenix Memorial Laboratory Ann Arbor, til 48109 Gentlemen:
i We have evaluated your Quality Assurance Program submitted with your September 21, 1979 letter to satisfy the requirements of 10 CFR 571.51.
Our review indicates that additional information is required to satisfy the applicable requirements of Appendix E to 10 CFR Part 71. Although supporting written procedures, such as Administrative Procedure No.16, are required to implement your QA program, they shoul' not be submitted as part of your QA program description. Please revise your QA program description to address the enclosed request for additional infomation and submit seven copies of the revised program within 60 days following receipt of this letter.
If you have any questions regarding this request, please feel free to con. tact Mr. Jim Conway at (301) 492-7741.
Sincerely,
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f)# Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Request for Additional Information O
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UNIVERSITY OF MI"CHIGAN - FORDNUCLEAR REACTOR (71-0348)
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Request for Additional Information 1.
In Section 1.2, reference the fact that the QA program will also apply to those quality-affecting activities related to shipping packages for radioactive material.
2.
Identify the 'avel of management responsible for establishing the laboratory's QA policies, goals, and objectives.
Identify the position that retains overall authority and responsibility for the 3.
QA program.
4.
Describe the qualification requirements for the position of Reactor Manager.
5.
Provide a statement that verification of conformance to established requirements is accomplished by individuals or groups who do not have direct responsibility for performing the work being verified.
6.
Describe the management level (i.e., above or outside the QA organization) who regularly assesses the scope, status, implementation, and effectiveness of the QA program to assure that the program is adequate and complies with 10 CFR Part 71, Appendix E criteria.
7.
Provide a statement that provisions are established to control the distribution of the QA manuals and revisions thereto.
8.
Describe how disputesinvolving quality, arising from a difference of opinien between QA/QC personnel and other department (engineering, procurement, manu-facturing, etc.) personnel are resolved.
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9.
Provide a statement that an indoctrination and training program is established such that:
Personnel responsible for performing quality-affecting activities are a.
instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures, b.
Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
The scope, the objective, und the method of implementing the indoctrination c.
and training program are documented.
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d.
Proficiency of personnel performing quality-affecting activities is main-tained by retraining, reexamining, and/or recertifying.
- 10. Provide a statement that procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, review, approval,
and control of procurement documents.
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11.
Provide a statement that a review and concurrence of the adequacy of quality requirements stated in procurement documents is performed by qualified personnel.
This review should determine that quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements.
12.
Provide a statement that the review and approval of procurement documents are documented prior to release and available for verification.
13.
Provide a statement that procurement documents identify the applicable 10 CFR Part 71, Appendix E requirements which must be complied with and described in the supplier's QA program. This QA program or portions thereof shall be reviewed and concurred with by qualified personnel in QA prior to initiation of activities affected by the program, 14.
Provide a statement that procurement documents contain or reference the design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
15.
Provide a statement that procurement documents identify the documentation (e.g.,
drawings, specifications, procedures, inspection and fabricatior plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submittid
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to the purchaser for review and approval.
16.
Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to the laboratory prior to use or installation of the hardware.
17.
Provide a statement that procurement documents contain the procuring agency's right of access to supplier's facilities and records for source inspection and audit.
18.
Provide a statement that provisions are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures, and drawings.
19.
Provide a statement that the QA, organization reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and specifi-cations; and changes thereto or acceptable alternatives are described.
20.
Provide a statement that the review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
21.
Provide a statement that changes to documents are reviewed and approved by the same organizations that performed the original review and approval or by other qualified responsible organizations delegated by the applicant.
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- 22. Provide a statement that approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the change.
- 23. Provide a statement that documents are available at the location where the activity will be perfomed prior to coninencing the work.
- 24. Provide a statement that a master list or equivalent is utablished to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents. This list is updated and distributed to predetermined, responsible personnel to preclude use of superseded documents.
- 25. Provide a statement that special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
- 26. Provide a statement that an inspection program whichcertifies confomance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written controlled procedures.
27.
Provide a statement that inspection personnel are independent from the individuals perfoming the activity being inspected.
- 28. Provide a statement that measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to ha out of calibration.
29., Provide a statement that special handling, preservation, storage, cleaning.,
packaging, and shipping requirements are established and accomplished by qualified individuals in accordance with predetermined work and inspection instructions.
- 30. Provide a statement that all necessary shipping papers will be prepared, as required.
- 31. Provide a statement that all conditions of the NRC package approval and the U.S.
Department of Transportation shipping requirements are satisfied prior to shipment.
- 32. Provide a statement that departure, arrival time, and destination of a package will be established and monitored to a degree consistent with the safe trans-portation of the package.
- 33. Provide a statement that identtfication of the'. inspection, test, and operating status of structures, systems, and components is known throughout manufacturing and installation.
- 34. Provide a statement that the application and removal of inspection and welding stamps and status indicators such as tags, markings, labels, and stamps are procedurally' controlled.
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4 35.
Identify those records which are maintained to provide documentary evidence of the quality of items and the activities affecting quality.
36.
Provide a statement that records are identifiable and retrievable.
- 37. Provide a statement that audits are performed in accordance with preestablished written procedures or check lists and conducted by trained personnel not having direct responsibilities in the areas being audited.
38.
Provide a statement that audit results are documented and then reviewed with management having responsibility in the area audited.
39.
Provide a statement that responsible management takes the necessary action to correct the deficiencies revealed by the audit.
40.
Provide a statement that deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of deficiencies.
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