ML20043B913
| ML20043B913 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1990 |
| From: | Brach E Office of Nuclear Reactor Regulation |
| To: | Mckee T VALIDYNE ENGINEERING SALES CORP. |
| References | |
| REF-QA-99901088 GL-89-02, GL-89-2, NUDOCS 9006010024 | |
| Download: ML20043B913 (2) | |
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May 21, 1990 Docket No. 99901088 Mr. Thomas McKee President Validyne Engineering Corporation 8626 Wilbur Avenue Northridge, California 91324
Dear Mr. McKee:
Your letter of April 18, 1990 to the NRC requested guidance on NRC's expectations of a licensee's or vendor's comercial-grade procurement and dedication program.
The information provided below identifies the NRC regulations applicable to the comercial-grade dedication activities and describes recent NRC guidance on this topic.
NRC regulations for quality assurance for products to be used in safety-related applications are esmlished in 10 CFR Part 50, Appendix B.
These requirements are structured ta assure suitability of products, including comercial-grade items, for use in safety-related systems. The process used to satisfy these requirements when upgrading comercial-grade items for use in safety-related a;plications is comanly called dedication. The process of dedication and of ensuring compliance with 10 CFR Part 50, Appendix B, must include those activities necessary to assure product suitability for safety-related application.
In March 1989, NRC issued Generic Letter 89-02, " Actions to improve the Detection of Counterfeit and Fraudulently Marketed Products,"
which provides NRC guidance on procurement and dedication programs. This Generic Letter discusses the importance of engineering involvement in all aspects of the procurement / dedication process and provides NRC's conditional endorsement of acceptable methods for dedicating comercial-grade items for safety-related application. A copy of the Generic Letter is enclosed for your information. For your information, in April 1990, NRC requested NUMARC comment on an additional draft Generic Letter on comercial-grade procurement and dedica-tion programs which, when finalized, will provide additional implementing guidance on dedication processes, critical characteristics, and corrective action programs.
In addition you raised a question on identification of critical characteristics.
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The Generi letter addresses this issue; basically, the responsibility for identi-fying cri.
characteristics rests with the nuclear utility (licensee) who is ultimately
.s Further, you :ponsible for the safe operation and use of the procured part.
tated that you do not impose 10 CFR Part 21 on your suppliers and that you verify your supplier's certifications durin For commercial-grade items, as defined in 10 CFR 21.3(a)g receipt inspection.(4),10 CFR Part 21 is no required to be imposed in the procurement documents; however, for basic com-Donents or parts thereof 10 CFR Part 21 is required to be imposed in such l$
- ocurement documents.
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May 21. 1990 If you have any questions on the enclosure or the above discussion on commercial. grade procurement and dedication activities, please contact we at 301 492 0961.
Sincerely.
ORIGINAL SIGNED BY:
l E. WILLIAM BRACH E. William Brach, Chief Vendor Inspection Branch Division of Reactor Inspection and Safeguards Office of Nuclear Reactor Regulation
Enclosure:
Generic Letter 89 02, dated March 21, 1989 DISTF.lBUT: ON senwe'ly^aes}
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March 21,1989 10:
ALL HOLDERS OF OPERATING LICENSES AND CONSTRUCTION PERMITS FOR NUCLEAR POWER REACTORS
SUBJECT:
ACTIONS TO IMPROVE THE DETECTION OF COUNTERFEIT AND FRAUDULENTLY MARKETED PRODUCTS (GENERIC LETTER 89 02)
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Recent instances of counterfeit and fraudulently marketed-vendor products have heightened the NRC's concerns for licensees' capability to assure the quality of procured products and to reduce the likelihood of the use of counterfeit or fraudulent products in nuclear-)ower plants.
During recent NRC inspections of licensees and vendors, the NRC 1as observed a wide variety of practices ~and programs for procurement, receipt inspection, testing and dedication of equip-ment and material for safety-related applications. - The purpose of this generic letter is to share with all licensees some of the elements cf programs that appear to be effective in providing the capability to-detect counterfeit or.
fraudulently marketed products and in assuring the' quality of vendor products.
The staff is aware of and encourages the industry working group" efforts to develop guidance in these areas.
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Three characteristics of effective procurement and dedication programs have been identified during these NRC inspections. Thesecharacteristicsare(1)the.
involvement of engineering staff in the procurement and product acceptance pro--
cess (3) thorough,engineeringbased,programsforreview, testing,anddedica-(
and tion of commercial-grade products for suitability for use in safety-related applications. NRC has found that programs that embodied the-above three ele-ments were generally effective in providing enhanced capability to detect counterfeit or fraudulently marketed products and in assuring the quality of procured products, both in safety-related and other plant systems.
Licensees may want to consider the applicability of these characteristics to their programs to reduce the likelihood cf the introduction of counterfeit or fraudulent products into their plants and to assure the quality of procured vendor products.
It should be noted that the NRC staff conditionally endorses the guidelines contained in EPRI NP-5652, " Guideline for the Utilization of Commercial-Grade Items in Nuclear Safety-Related Applications (NCIG-07)," that was issued by EPRI in June 1988 for evaluating commercial-grade products for suitability for use in safety-related applications.
Background:
Numerous instances have been identified by the NRC during the past 2 years in which the. nuclear industry received, accepted, and installed items of hardware
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Multiple Addressees.
that were not of the quality pPrported by the manufacturer or supplier due to apparent misrepresentation. Significant deficiencies have also berm identified in the programs for dedicating commercial-grade products for use it safety-related applications.
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The use in nuclear facilities of products which are counterfeit or fraudulently marketed increases the likelihood that some plant equipment may not perform
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as expected.
(See the enclosed list of NRC Information Notices and Bulletins regarding this matter.)
7 Discussion:
4 Procurement quality assurance (QA) controls for products to be used in safety-q related applications are established in Appendix B to 10 CFR Part 50, and in 1j Regulatory Guides 1.28, 1.33, and 1.123.
It is recognized that Appendix B pro-vides criteria for QA programs-and does not specifically address fraudulent activities; however, an effectively implemented licensee QA program would increase the likelihood of detecting fraudulently marketed vendor products.
Although a properly implemented QA program may more readily detect substandard -
products than will the commercial-grade component upgrade process, a licensee's q;
commercial-grade dedication process, as described in paragraph C., will greatly enhance the effectiveness of current upgrade practices. The actions described in paragraphs A. and B. have also prcved useful in cetecting substandard, a
counterfeit or fraudulently marketed products ~ intended for use in sjstems needed for the safe operation of the facility.
2, A.
Engineering Involvement in the Procurement Process Appropriate engineering involvement is warranted during the procurement and product acceptance processes, including testing, for products used in nuclear power plants.
Inadequate engineering involvement has been a common weakness in licensees' procurement programs, particularly when com-mercial-grade procurements were involved.
Involvement of a licensee's engineering staff in an effective procurement process would normally include (1) development of specifications to be used for the procurement ofproductstobeusedintheplant,(2)determinationofthecritical-characteristics of the selected products that are to be verified during product acceptance, (3) determination of specific testing requirements a>plicable to the selected products, and (4) evaluation of test results.
g Tae extent of necessary engineering involvement is dependent on the nature and use of the products involved.
D.
Product Acceptance Programs c
Experience indicates that reliance on part number verification and certi-fication documentation is insufficient to ensure the quality of procured products. Licensees with effective product acceptance rograms havr included receipt / source inspection and appropriate testing criteria, effective vendor audits, special tests and inspections and post-installa-tion tests in their programs. These licensees have applied the inspection
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BULLETINS AND INFORMATION NOTICES CONCERNING NONCONFORMING
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MATERIALS AND. EQUIPMENT AND INSTANCES OF INADEQUATE-
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DEDICATION OF EQUIPMENT FOR SAFETY-RELATED APPLICATIONS g7 y.
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Tit 1e-Date
' 87-02*'-
Fastener Testing to Determine Conformance
.11/06/87 with Applicable Material Specifications 87-02, Supplement 1*
04/22/88 87-02 Supplement 2*
06/10/88-88-05*
Nonconforming Materials Supplied by Piping-05/06/88 Supplies. Inc., at Folsum, New Jersey, and 4
West-Jersey Manufacturing Company at Williamstown, New Jersey 88-05, Supplement 1*
06/15/88?
88,05,. Supplement 2*
08M3/887
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88-10*
Nonconforming Molded-Case. Circuit: Breakers 11/22/88 Information Notice No. 87-66 Inappropriate Application of Comercial-Grade 12/31/87 Components 88-19*
Questionable' Certification of Class.IE 04/26/88 Components 88-35 Inadequate Licensee Performed Vendor' Audits!
'06/03/88 88-46*
Licensee Report of Defective Refurbished 07/08/88 Circuit Breakers 08-46, Supplement 1*
07/21/88 88-46, Supplement'2*
12/30/88 88-48*
Licensee Report of Defective Refurbished Yalves 07/12/88 88-48, Supplement 1*
08/24/88 88-97 Potentially Substandard Valve Replacement Parts 12/16/88'
- These items reflect instances in which suppliers and manufacturers of safety-related mater'.a1 may have intentionally eluded QA requirements to misrepresent-the quality of their products.
In the instances marked by.an asterisk, the pro-blec. was brought to NRC's attention by either a licensee or a' nuclear supplier.
Enclocure 2 LIST OF RECENTLY ISSUED GENERIC LETTERS
'1 Generic Date of Letter No.
Subject Issuance Issued To 89-01 IMPLEMENTATION OF 1/31/89 ALL LICENSEES RGL0iN6 %"~'*
PROGRAMMATIC CONTROLS OPERATING LICENSES FOR RADIOLOGICAL EFFLUENT AND CONSTRUCTION TECHNICAL SPECIFICATIONS PERMITS FOR NUCLEAR IN THE ADMINISTRATIVE POWER REACTOR FACILITIES.
CONTROLS SECTION OF THE TECHNICAL SPECIFICATIONS AND THE RELOCATION OF PROCEDURAL DETAILS OF RETS TO THE OFFSITE DOSE CALCULATION MANUAL OR TO THE PROCESS CONTROL PROGRAM.
88-20 INDIVIDUAL PLANT 11/23/88 ALL LICENSEES HOLDING EXAMINATION FOR SEVERE OPERATING LICENSES ACCIDENT VULNERABILITIES -
AND CONSTRUCTION 10CFR50.54(f)
PERMITS FOR NUCLEAR POWER REACTOR FACILITIES 88-19 USE OF DEADLY FORCE BY 10/28/88 ALL FUEL CYCLE FACILITY LICENSEE GUARDS TO PREVENT LICENSEES WHO POSSESS, THEFT OF SPECIAL NUC'. EAR USE. IMPORT EXPORT, MATERIAL OR TRANSPORT FORMULA
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QUANTITIES OF STRATEGIC SPECIAL NUCLEAR MATERIAL 88-18 PLANT RECORD STORAGE ON 10/20/88 ALL LICENSEES OF OPTICAL DISKS OPERATING REACTORS AND HOLDERS OF CONSTRUCTION PERMITS 88-17 LOSS OF DECAY HEAT REMOVAL 10/17/88 ALL HOLDERS OF 10CFR50.54(f)
OPERATING LICENSES OR CONSTRUCTION PERMITS FOR PRES $URIZED WATER REACTORS 88-16 REMOVAL OF CYCLE-SPECIFIC 10/04/88 ALL POWER REACTOR PARAMETER LIMITS FROM LICENSEES AND TECHNICAL SPECIFICATIONS APPLICANTS 8! 15 ELECTRIC POWER SYSTEMS -
09/12/88 ALL POWER REACTOR INADEQUATE CONTROL OVER LICENSEES AND DESIGN PROCESSES APPLICANTS
l Multiple Addressees l i
1 and testing criteria to products procured for use in safety-related systems ar.6 for all comercial-grade products being evaluated for suitability for use a safety-related systems. The inspection and testing criteria also I
have required identification and verification of the products' critical characteristics.
In selecting the critical characteristics to be verified, consideration may be given to the safety significance, complexity, and application of the various products.
For suppliers with acceptable QA pro-grams, as confirmed by licensee audits, sampling plans are often utilized to perform the required inspections and tests.
In addition to these receipt / source inspections and tests, effective licensee programs.normally verify the traceability to the original manufacturerG of procured materials, equipment, and coir.ponents in those cases where original manufacturer's certificationa are element of the safety-related pro-curement or commercial-grade dedication program.
Effective audits have included consideration of audit approach, depth of audit, and audit team composition and have included appropriate engineering / technical represen-tatives.
Comprehensive multi-licensee audit teams have also been found to be effectiva.
C.
Dedicat on Programs i
It is each licensee's responsibility to. provide reasonable assurance that nonconforming products are not introduced into their plants. Dedication programs that ensure the adequacy of critical parameters of products used in safety-related applications can also contribute to the identification of counterfeit or f raudulently marketed vendor products.
The NRC staff believes that licensees who use methods similar to those described in EPRI NP-5652 " Guideline for the Utilization of Comercial-Grade Items in Nuclear Safety-Related Applications (NC1G-07)," to verify the critical characteristics of comercial-grade items intended for safety-I related applications have the Msis for effective dedication programs, j
Properly implemented, tne EPRI guidelines, as modified below, establish metiods which satisfy existing requirements of Appendix B to 10 CFR Part 50 as they apply to the dedication process of commercial-grade items.
1.
Acceptance Method 2, "Comercial-Grade Survey of-Supplier,"
should r 't be employed as the basis for accepting items from suppliers with undocumented commercial quality control pro-grams or with programs that do' not effectively implement their own necessary controls.
Likewise Nethod 2 should not be employed as the basis for acctpting items from distributors unless the survey includes the part manufacturer (s) and the I
survey confirms adequate controls by both the dish ibutor and the part manufacturer (s).
2.
Acceptance Method 4 " Acceptable W plier / Item Performance Record," should not be employed alone unless:
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The established historical record is ' based onHndustry-a.
wide performance data that is directly applicable to' the item's critical characteristics and the intended safety-
-5 related application; and Dl e
b.
The manufacturer's measures for the control of design,'
process, and material changes have been adequately imple-mented as verified by audit (multi-licensee team audits are acceptable).
The NRC staff believes that if licensees' procurement programs effectively implement the elements discussed in paragraphs, A., B., and C., they will reduce the likelihood of the introduction of counterfeit or fraudulent pro-ducts into their plants.
Although no response to this letter is required, if you have any questions regarding this matter, please <,ontact the technical contact listed below.
Sincerely,
)
OJ h even
. V3rta Acting Associate rector for Projects Office of Nuclear Reactor Regulatica
Enclosures:
- 1. Li t of Bulletins and Information Notices
- 2. List of Recently Issued Generic Letters CONTACT:
E. William Brach, NRR (301) 492-0961
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