ML19210C740

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Forwards Request for Addl Info Re QA Program.Response Should Be Submitted within 60 Days
ML19210C740
Person / Time
Site: 07100230
Issue date: 11/01/1979
From: Macdonald C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Olsen A
BABCOCK & WILCOX CO.
References
NUDOCS 7911200031
Download: ML19210C740 (6)


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UNITED STATES y

g NUCLEAR REGULATORY COMMISSION E

WASHINGTON, D. C. 20555

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NOV 011979 FCTC: RHO 71-0230 Babcock & Wilcox Company Research & Development Division ATTN: Mr. A. F. Olsen P.O. Box 1260 Lynchburg, VA 24505 Gentlemen:

We have evaluated your quality assurance program for the Lynchburg Research Center submitted with your December 21, 1978, letter to satisfy the require-ments of 10 CFR 571.51.

Our review indicates that additional infomation is required to satisfy the applicable requirements of Appendix E to 10 CFR Part 71. Please 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 fre,e to contact Mr. Jim Conway at (301) 492-7741.

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

Enclosure:

Request for Additional Information 1371 280 031 q

7911200 V

BABC0CK & WILC0X COMPANY (71-0230)

Request for Additional Infomation 1.

Provide an organizational chart which identifies the organizational elements which function under the control of the QA program.

2.

Describe the QA responsibilities of each organizational element identified in item 1 above.

3.

Identify the level of management that is responsible for establishing the corporate or company QA policies, goals, and objectives.

4.

Provide evidence that the authority and independence of the Quality Assurance Administrator are such that he can direct and control the organization's QA/QC program.

5.

Describe the qualificatic_n requirements for the position of Quality Assurance Administrator..

6.

Provide a statement that verification of confomance to established requirements is accomplished by individuals or groups who do not have direct responsibility for perfoming the work being verified.

7.

Provide a statcaent that designated QA individuals have the responsibility and authority, delineated in writing, to stop unsatisfactory. work and con-trol further processing, delivery, or installation of nonconfoming material.

8.

Provide a statement that trained, qualified personnel within B&W are assigned to detemine that functions delegated to his suppliers are being properly accomplished.

9.

Give a brief summary of B&W's corporate QA policies, goals, and objectives.

10. Provide a statement that all responsible organizations and individuals are aware that quality policies, QA manuals, and procedures are mandatory requirements.
11. List the QA procedures plus a matrix of these procedures cross referenced to each criterion of Appendix E to 10 CFR Part 71.

12.

Identify the safety-related structures, systems, and components controlled by the QA program.

13. Provide a statement that B&W reviewers and documents agreement with the QA program provisions of his suppliers to the extent that he can be assured that Appendix E will be implemented.

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. 14. Provide a statement that an inucctrination and training program is established such that:

a.

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

b.

Personnel perfoming quality-affecting activities are trained and qualified in the principles and techniques of the activity being perfomed.

c.

The scope, the objective, and the method of implementing the indoctrina-tion and training program are documented.

d.

Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.

15. Provide a statement that quality-related activities are perfomed with specified equipment and under suitable environmental conditions.
16. Provide a statement that quality standards are specified in the design documents, and deviations and changes from these quality standards are controlled.

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17. Provide a statement that suitable design controls are applied to such activities as seismic, stress, thermal, hydraulic, radiation, and acci-dent analyses; compatibility of materials; and accessibility for inservice inspection, maintenance, and repair.
18. Provide a statement that designs are reviewed to assure that (1) design characteristics can be controlled, inspected, and tested and (2) inspec-tion and test criteria are identified.
19. Provide a statement that proper selection and accomplishment of design verification or checking processes such as by design reviews, alternate calculations, or qualification teacing are perfomed. When a test program is used to verify the adequacy of a design, a qualification test of a pro-totype unit under adverse design conditions shall be used.
20. Provide a statement that errors and deficiencies in the design, including the design process, that could adversely affect safety-related structures, systems, and components are documented; and corrective action is taken to preclude repetition.
21. Provide a statement that materials, parts, and equipment which are standard, comercial (off the shelf) or which have been previously approved for a different application are reviewed for suitability prior to selection.

22.

Identify the positions or groups responsible for design reviews and other design verification activities.

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. 23. Provide a statement that measures are established for the selection of suitable materials, parts, equipment, and processes for safety-related structures, systems, and components which include the use of valid industry standards and specifications.

24. Provide a statement that the review and approval of procurement documents are documented prior to release and available for verification.
25. Provide a statement that procurement documents for spare cr replacement parts of safety-related structures, systems, and components are subject to controls at least equivalent to those used for the original equipment.
26. Provide a statement that the QA organization reviews and concurs with inspection plans; drawings and specifications; and changes thereto or describe acceptable alternatives.
27. Provide a statement that surveillance of suppliers during fiorication, inspection, testing, and shipmer.t of materials, equipment, and coniponents is planned and performed in accordance with written precedures to assure confomance to the purchase order requirements. Theta procedures provide for:

a.

Instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveil-lance 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 perfomed on those items where verification of procurement requirements cannut be detemined upon receipt.

28. Provide a statement that the supplier furnishes the following records as a minimum to B&W:

a.

Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications) met by the items.

b.

Documentation that identifies any procurement requirements which have not been met together with a description of those nonconfomances dis-positioned " accept as is" or " repair."

The review and acceptance of these documents shall be described in the purchaser's QA program and as a minimum shall be undertaken by a responsible QA individual.

29. Provide a statement that supplier's certificates of confomance are periodi-cally evaluated by audits, independent inspections, or tests to assure they are valid.

1371 N

. 30. Provide a statement that receiving inspection of the supplier-furnished material, equipment, and services is perfomed to assure:

a.

The material, component, or equipment is procerly identified and corresponds with the identification on receiving documentation.

b.

Material, components, equipments, and acceptance records are inspected and judged acceptable in accordance with predetemined inspection instructions, prior to installation or use.

c.

Inspection records or certificates of confomance attesting to the acceptance of material, components, and equipment are available prior to installation or use.

d.

Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for installation or further work.

31. Provide a statement that the effectiveness of the control of quality by suppliers is assessed by B&W at intervals consistent with the importarfee, complexity, and quantity of the item.
32. Provide a statement that identification requirements are detemined during generation of specifications and design drawings.
33. Provide a statement that the location and the method of identification do not affect the fit, function, or quality of the item being identified.
34. Provide a statement that inspection procedures or instructions are used with necessary drawings and specifications when perfoming inspection operations.
35. Provide a statement that inspectors are qualified in accordance with appli-cable codes, standards, and company training programs; and their qualifica-tions and certifications are kept current.
36. Provide a statement that modifications, repairs, and replacements are inspected in accordance with the original design and inspection require-ments or acceptable alternatives.
37. Provide a statement that provisions are established that identify mandatory inspection hold points for witness by an inspector.
38. Provide a statement that provisions are established for indirect control by monitoring processing methods, equipment, and personnel if direct inspec-tion is not possible.
39. Provide a statement that written test procedures incorporate or reference:

a.

The requirements and acceptance limits contained in applicable design and procurement documents.

b.

Instructions for perfoming the test.

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. c.

Mandatory inspection hold points for witness by owner, contractor, or inspector.

d.

Acceptance and rejection criteria.

e.

Methods of documenting or recording test data and results.

40. Provide a statement that measuring and test eoutpment is identified and traceable to the calibratton test data.
41. Provide a statement that measuring and test equipment is labeled or tagged to indicate date of the next calibration.
42. Provide a statement that calibrating standards have an uncertainty (error) requirement of no more than 1/4th of the tolerance of the equipment being calibrated. A greater uncertainty may be acceptable when limited by the

" state-of-the-art."

43.

Provide a statement that bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizance of the QA organization.

44.

Provide a statement that documentation identifies the nonconfaming item; describes the nonconfomance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the dispc-sition.

45. Provide a statement that acceptability of rework or repair of materials, parts, components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.

Inspection, testing, rework, and repair procedures are documented.

46. Provide a statement that nonconfomance reports dispositioned " accept as is" or " repair" are made part of the inspection records and forwarded with the hardware to Brid for review and assessment.
47. Provide a statement that QA records include results of reviews, inspections, tests, audits, and material analyses; monitoring of work perfomance; quali-fication of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration proce-dures and reports; nonconformance reports; and corrective action reports.
48. Provide a statement that record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration by environmental conditions such as temperature or humidity.
49. Provide a statement that audits include an objective evaluation of quality-related practices, procedures, and instructions and the effec,tiveness of implementation.
50. Provide a statement that audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.

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