ML19318A467

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Forwards Request for Addl Info Re Research Reactor Facility QA Program,Submitted w/780627 Ltr.Includes Questions Re QA Responsibilities of Each Organizational Element in App I & Requirements for Position of Reactor Manager
ML19318A467
Person / Time
Site: 07100108
Issue date: 06/04/1980
From: Macdonald C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Mckibben J
MISSOURI, UNIV. OF, COLUMBIA, MO
References
NUDOCS 8006230174
Download: ML19318A467 (4)


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JUN 0 41980 FCTC: RHO 71-0108 Univeristy of Missouri ATTH: Mr. James C. McKibben Research Park

. Columbia, MO 65201 Gentlemen:

We have evaluated your Research Reactor Facility Quality Assurance Program sub-mitted with your June 27, 1978 letter to satisfy the requirements of 10 CFR 171.51.

Our review indicates that additional information is required to satisfy the applicable requirements of Appendix E to 10 CFR Part 71. Please addres.c the enclosed request for additional information 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 contact Mr. Jim Conway at (301) 492-7741.

Sincerely,

[b u

Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, NMSS

Enclosure:

Request for Additional Information 8006230l h g

P UNIVERSITY OF MISSOURI (71-0108)

Request for Additional Information 1.

Describe the QA responsibilities of each organizational element identified..in Appendix I.

2.

Describe the qualification requirements for the position of Reactor Manager.

3.

Provide a statecant that designated QA individuals have the responsibility and authority, delineated in writing, to stop unsatisfactory work and control further processing, delivery, or installation of nonconforming material.

4.

Identify the management level who regularly assesses the scope, status, implemen-tation, and effectiveness of the QA program to assure that the program is adequate and complies with 10 CFR Part 71 Appendix E criteria.

5.

Provide a statement that provisions are established to control the distribution of the QA manual and revisions thereto.

6.

Provide a statement that training and experience for all QA functions will be required and accomplished in accordance with established procedures.

7. _ Describe how disputes involving quality, arising from a difference of opinion between designated QA/QC personnel and other department personnel,are resolved.

8.

Provide a statement that quality-related activities are performed with specified equipment and under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test.

9.

Provide a statement that for modifications quality standards are specified in the design documents, and deviations and changes from these quality standards are controlled.

10. Provide a statement that designs are reviewed to assure that (1) design character-istics can be controlled, inspected, and tested and (2) inspection and test cri-teria are identified.
11. Provide a statement that the review and approval of procurement documents are documented prior to release and available for verification.
12. 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 cencurred with by qualified personnel in QA prior to initiation of activities affected by the program.
13. Provide a statement that procurement documents identify the documentation (e.g.,

drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemicci and physical test results of material) to be prepared, maintained, and submitted to the Univer-sity of Missouri for review and approval.

. 14. Provide a statement that procurement documents identify those records to be re-tained, controlled, and maintained by the supplier, and those delivered to the University of Missourt prior to use or installation of the hardware.

15. Provide a statement that procurement documents contain the University of Missouri's right of access to supplier's facilities and records for source inspection and audit.
16. Provide a statement that approved cfianges are included in instructions, procedures, drawings, and other documents prior to i.nplementation of the change.
17. Provide a statement that documents are available at the location where the activity will be performed prior to comencing the work.
18. Provide a statement that a master 1tst or equivalent is established to-identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents. This list is updated and distributed to predetemined, responsible personnel to preclude use of superseded documents.
19. Clarify that an inspection program which veriffes confomance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written controlled procedures.
20. Provide a statement that inspection personnel are independent from the individuals perfoming the activity being inspected.

2L Provide a statement that measuring and test equipment is identified and traceable to the calibration test data.

22. Previde a statement that measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability charac-teristics, and other conditions affecting the measurement.
23. Provide a statement that measures are taken and documented to detemine the validity of previous inspections perfomed when measuring and test equipment is found to be out of calibration.
24. Provide a statement that reference and transfer standards are traceable to nationally recognized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
25. Provide a statement that handling, pres (rvattor., storage, cleaning, packaging, and shipping requirements are established and accomplished by qualified individuals in accordance with predetermined work and inspection instructions.
25. Provide a statement that shipments will not be made unless all tests, certifications, acceptances, and final inspections have been completed.
27. Provide a statement taat decarture, arrival time, and c ination of a package will be established anc monitorea to a degree consistent wi-e safe transportation of the package.

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J-28.

Provide a statement that bypassing of required inspections, tests, and other j

critical operations is procedurally controlled under the cognizance of the Reactor Manager.

39. Provide a statement that the identification, documentation, segregation, review, disposition, and notification to affected organizations of nonconforming materials, parts, components, or services are procedurally controlled.

30.

Identify those records which are maintained to provida documentary evidence of the quality of items and the activities affecting quality. QA records should be iden-tifiable and retrievable and include operating logs; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and correc-tive action reports.

31. 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.
32. Provide a statement that audit results are documented and then reviewed with manage-ment having responsibility in the area audited.
33. Provide a statement that responsible management takes the necessary action to cor-rect the deficiencies revealed by the audit.
34. Provide a statenent that deficient areas are reaudited on a timely basis to verify implementation of co rective actions which minimize recurrence of deficiencies.

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