ML20137S468

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Forwards Request for Addl Info Re Nutech QA Program,Per 850910-11 Meetings
ML20137S468
Person / Time
Issue date: 09/25/1985
From: Rouse L
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Massey J
NUTECH ENGINEERS, INC.
References
REF-PROJ-M-39 NUDOCS 8509300387
Download: ML20137S468 (5)


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ATTM: Dr. John V. Passey t'UH0"S Project Manacer 145 Partinvale Lane San Jose, California 95119 Gentlemen:

I have enclosed our recuest for additional infomation enncerninq your cuality assurance oroars. This request was discussed informally et the NUTECF, Inc. A'RC meeting of Sentenber 10-11, 1985 between Frandon Tho as of your staff and John Spraul of HPC's Quality Assurance f1 ranch.

Sincerely, Origir.*,t s1 M by Joke F. Roberts

, Leland C. Rouse, Chief 1 Advanced Fuel and Spent Fuel Licensinr1 Pranch Divisten of fuel Cycle and Paterial ';efety

Enclosure:

Recuest for Additional Infonration DISTRIBUTION:

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- O Enclosure f

REQUEST FOR ADDITIONAL INFORMATION Nutech - Submittal of August 27, 1985

1. Describe the qualification requirements for the Corporate Quality Assurance Manager, the Quality Assurance Administrators, and the Field Quality Assurance Supervisor. The requirements should demonstrate management and technical competence commensurate with the responsibilities noted in the QA Manual sections 1.2.2, 1.5, and 1.6 respectively.

2.

QA Manual sections 1.2.2 and 1.6 indicate'that the Corporate QA Manager and field.QA Supervisors can " control or stop further processing...." QA Manual section 1.5 indicates that the QA Administrators can " control further processing. . . ." without the "or stop" authority. Clarify that the QA Administrators have stop work authority or justify why they do not. Describe how the stop work authority is carried out.

3. QA Manual section 2.1.4 indicates that Nutech uses Project Plans to assure adequate QA coverage.

Provide a commitment that the extent of QA controls is determined by the QA staff in combination with the line staff and is dependent upon the specific activity, item complexity, and its importance to safety or justify not doing so.

4.

Describe provisions for the resolution of disputes involving quality, arising from a dif ference of opinion between QA/QC personnel and other department (engineering, procurement, etc. ) personnel.

5.

QA Manual section 2.4 addresses indoctrination and training. Provide a commitment that indoctrination, training, and qualification programs are established such that:

a.

Personnel responsible for performing activities affecting quality are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.

b. Personnel performing activities affecting quality are trained and qualified performed.

in the principles and techniques of the activity being

c. Proficiency of personnel performing quality-affecting activities is l

maintained by retraining, reexamining, and/or recertifying: I

d. Specific documentation of completed training and qualification should be described in general terms.
e. Qualified personnel are certified in accordance with applicable codes and standards.
6. 5 Provide a commitment that designs are reviewed to ensure that:

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a. Design characteristics can be controlled, inspected, and tested. ' I
b. Inspection and test criteria are identified. L
7. Provide a commitment that a review and concurrence of the adequacy of -

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quality requirements stated in procurement documents is performed by qualified personnel and that this review determines that quality require-ments 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.

8. Provide a commitment that a QA individual (i.e. , the Corporate QA Manager, a QA Administrator, or a Field QA Supervisor) reviews and concurs with j

project plans; inspection plans; test,. calibration, and special process l procedures; drawings and specifications; and changes thereto.

! 9. Provide a commitment that surveillance of Nutech suppliers during fabrication, 1

inspection, testing, and shipment of materials, equipment, and components is planned and performed in accordance with written procedures to assure  !

conformance to the purchase order requirements and that these procedures i provide for:

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a. Instructions that specify the characteristics or processes to be l witnessed, inspected or verified, and accepted; the method of  ;

surveillance and the extent of documentation required; and those '

responsible for implementing these instructions.

b. Audits and surveillance which assure that the supplier complies with the quality requirements. Surveillance is performed on those items  ;

where verification of procurement requirements cannot be determined  !

upon receipt. '

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10. Provide a commitment that Nutech suppliers furnish the following records as.

a minimum: ,

a. Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and i

. specifications) met by the items. I

b. Documentation that identifies any procurement requirements which have f' not been met together with a description of those nonconformances dispositioned " accept as is" or " repair."

Describe the review and acceptance of these documents which should, as a minimum, be undertaken by a responsible QA individual.

11.  !

Provide a commitment that certificates of conformance from Nutech suppliers are periodically evaluated by audits, independent inspections, or tests to  ;

assure that they are valid.

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12. Provide a commitment that hardware identification requirements are determined during generation of design drawings and specifications such that the location and method of identification do not affect the fit, function, or quality of the item being identified.
13. Provide a commitment that, unless limited by the state-of-the-art, cali-brating standards have an error requirement of no more than 1/4 of the ~

tolerance of the equipment being calibrated.

14. Provide a commitment 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.
15. Provide a commitment that bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizance of QA.
16. Provide a commitment that nonconforming items dispositioned use-as-is are reported to the client.
17. Provide a commitment that nonconformance reports are periodically analyzed to show quality trends and to help identify root causes of nonconformances and that significant results are reported to responsible management for review and assessment.
18. Provide a commitment that QA records include results of reviews, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and equipment; drawings; specifications; procurement documents; calibration procedures and reports; design review reports; nonconformance repurts; corrective action reports; and inspection and test records which contain the following when applicable:
a. A description of the type of observation.
b. The date and results of the inspection or test.
c. Information related to conditions adverse to quality.
d. Inspector or data recorder identication.
e. Evidence as to the acceptability of the results.
f. Action taken to resolve any discrepancies noted.
19. Provide a commitment that requirements and responsibilities for record creation, transmittal, retention (such as duration, location, fire protection, and assigned responsibilities), and maintenance subsequent to completion of work are consistent with applicable codes, standards, and procurement documents.
20. Provide a commitment that audit deficiency data are analyzed and trended and that resultant reports, which indicate quality trends and the effective-ness of the QA program, are given to management for review, assessment, corrective action, and follow-up.
21. Section 11.2 of the topical report identifies'the NUHOMS system components important to safety. It indicates that the design of the horizontal storage.

module is important to safety but that the procurement, fabrication, etc.

will be considered important to safety only if defined as such by a utility.

It appears that the procurement, inspection, testing, fabrication, and construction of the horizontal storage module are also important to safety.

Clarify that Nutech will tr~ eat its involvement in these activities as important to safety and, thus, under the control of its QA program or justify not doing so.

22. The last sentence of section 11.2 of the topical report states: " Suitable transfer casks licensed under 10 CFR 71 shall be employed to transport the DSC," i.e., the dry shielded cannister. It appears that transfer casks licensed under 10 CFR 71 will require modification before being used to transport the DSC. Therefore, delete this last sentence of section 11.2 or jus'tify not doing so.

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