ML20024G936

Responds to 901126 Request for NRC Position on Questions Re Audits & Procurement Documents

ML20024G936
Person / Time
Issue date:	04/26/1991
From:	Potapovs U Office of Nuclear Reactor Regulation
To:	Mcgraw D JAMES C. WHITE CO., INC.
References
REF-QA-99901221 NUDOCS 9105020176
Download: ML20024G936 (4)

Text

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APR 2 01991 Docket No. 99901221 Nr. Deaver D. McCraw Quality Assurance Manager James C. White Company, Inc.

P. O. Box 5495 Greenville, South Carolina 29606

SUBJECT:

RESPONSE TO 10 CFR PART 21 INQUIRY By letter dated November 26, 1990, to Mr. Uldis Potapovs you reouested the NRC to state its position on several questions relating to audits and procurement documents. Our response to your cuestions is included as an enclosure to this letter.

Should you have any further questions, please contact Mr. Gregory Cwalina (301) 492-3221 of my staff.

Sincerely,

/

Uldis Pot povs, Acting Chief Vendor Inspection Branch Division of Reactor Inspection and Safeguards Office of Nuclear Reector Regulation

Enclosure:

Response to Questions DISTRIBUTION:

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ENCLOSURE RESPONSE TO JAMES C. WHITE COMPANY QUESTIONS QUESTION 1:

Is it necessary for a company which supplies safety-related items to the nuclear power industry to audit its suppliers of calibration services (other than the National Institute of Standards and Technology) for measuring and test equipment used in the production, inspection, testing, certification, etc., of the safety-related items?

NRC Response: Criterion XVIII, " Audits," of Appendix B to Part 50 of Title 10 of the Code of Federal Regulations (10 CFR Part 50) requires that a comprehensive system of planned and periodic audits be carried out to verify compliance with all aspects of the quality dssurance program and to determine the effectiveness of the program.

Criterion Vil, " Control of Purchased Material, Equipment, and Services," of Appendix B to 10 CFR Part 50 requires that the effectiveness of the control of quality by contractors and subcontractors be assessed at intervals consistent with the importance, complexity, and quantity of the product or services.

If the calibration services for the measuring and test equipment used in the production, inspection, testing, certification, etc., of the safety-related items is an activity that affects or ensures that the item will perform its safety-related function, it is the responsibility of the purchaser to verify that the quality of the calibration service meets the requirements specified in the procurement document (s).

These verification activities are generally accomplished by en audit of the supplier of the calibration service. Additionally, for Code items, the requirements of NCA-3800 and NCA-4100 of the ASME Section Ill Code apply as well as Basic Requirements 7 and 18 and Supplements 75-1 and 185-1 of NQA-1 for controlling and auditing of calibration services.

QUESTION 2:

In lieu of an audit, is it acceptable to review and evaluate the above calibration-service supplier's qualifications and procedures?

NRC Response:

Criterion X of 10 CFR Part 50, Appendix B requires that "A program for the inspection of activities affecting quality shall be established and executed...to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity."

_ _ - _ _ - - - - - - - - - - - - " - ^ - - ^ ' - - " ^ ^ ~ " ^ ~ ~ ^ ~ ~ ~ ~ ~ ~ " ~ ~

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8 Criterion XII of 10 CFR Part 50, Appendix B requires that,

" Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, ano adjusted at specified periods to maintain accuracy within specified limits."

It is not sufficient to only perform an evaluation of the calibration service supplier's qualifications and procedures to ensure that the supplier is effectively implementing the quality assurance (QA) program that controls the calibration services performed. A review of the procedures will not assure that the calibration service is being accomplished according to the QA program and procedure requirements nor does it assure the proper control and calibration of the devices used in the service.

Therefore, the purchaser should verify that the supplier is effectively implementing the QA program and procedures controlling the calibration services provided.

QUESTION 3:

If the NRC pcsition on Question 1 above requires the material manufacturer to audit the calibration service supplier, please state the NRC position on ASME-8&PY Code Interpretation III-90-132. A copy of this interpretation is attached for your convenience.

l NRC Response: ASME Code Interpretation !!I-80-132 was issued in May 1980.

As noted in the foreward of ASME Interpretations No. 7, the l

interpretations apply to the latest _ Edition and Addenda of the Code at the time of the inquiry.

Later editions of the ASME l

Code Section 111 have provided more prescriptive text concerning the responsibilities of Material Manufacturers and Suppliers (i.e., NCA-3866.3 and NCA-3868 of the 1989 Edition of the ASME Code Section III) in the areas of assuring that purchased services comply to the _ requirements of the Code. Also, see NRC Response to Question 2.

Since the issuance of Code Interpretation 111-80-132, the NRC has provided positions'on the need to verify the effective-implementation of QA programs in numerous Information Notices (IN), Regulatory Guides, and correspondence with licensees.

For example, IN 86-21-and its supplement, which recognizes the ASME Accreditation System as a basis for demonstrating the existence of an acceptable QA program, states that licensees, CP holders and their subcontractors are still responsible for verifying effective implementation of that program. A copy of IN 86-21, Supplement 2, is enclosed for your information.

QUESTION 4:

Is it necessary to invoke 10 CFR 21 on procurement documents for service such as those outlined in Question 1 above?

NRC Response: The NRC position on the applicability of 10 CFR Part 21 to calibration services has consistently been that it is applicable where the service is related to a basic component,

6 as defined in 10 CFR Part.21.3, and a deviation from specified requirements of a procutement document, or failure to comply, 1

l

-could create a substantial safety hazard, as defined in 10 CFR i

Part 21.3( k).1 In such a situation,10 CFR Part-21 must be--

t included in the purchase order for the procured product or service. -However, if an evaluation shows that-incorrect application.of the calibration service would not affect the safety-related function of the basic component in preventing or mitigating the consequences of postulated accidents or would not create a substantial safety hazard, then Part 21'would not have to be invoked in contracting for such service.