ML14134A340

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Draft Regulatory Guide (DG) 1070 - Sampling Plans Used for Dedicating Simple Metallic Commercial Grade Items for Use in Nuclear Power Plants.
ML14134A340
Person / Time
Issue date: 09/30/1997
From: Mayfield M, Vora J
Office of Nuclear Regulatory Research
To:
References
DG-1070 NUDOCS 9710030269
Download: ML14134A340 (40)
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Text

U.S. NUCLEAR REGULATORY COMMISSION September 1997 OFFICE OF NUCLEAR REGULATORY RESEARCH Division I Draft 0G-1070 DRAFT REGULATORY GUIDE

Contact:

M.E. Mayfield (3011415.6690 U

J.P. Vora 1301)415-5833 L

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1 A. INTRODUCTION 2

3 The U.S. NucWea Regulatory Commission INRC) has promulgated regulations to provide 4 quality assuance requirements for nuclear power plants and fuel reprocessing plants for the 5 design, construclion. and operation of structures, systems, and components that prevent or 0 mitigatt the consequences of postulated accidents that could cause undue risk to the health 7 and safety of the public. Those specific regulations are set forth in Appendix B.. OurAily a Ausurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Pan 50, 9 "Domesic Ucensing of Production and Utilization Facilities," in the U.S. Code of Federal 10 Regulations. Dedication Is an acceptance process undertaken to provide reasonable assurance II that a commercial grade item (CGI) to be used as a basic component of a nuclear power plant 12 will perform its intended safety function and is deemed equivalent to an item designed and 13 manufactured under a quality assurance program In accordance with Appendix B. Terms that 14 are used in this regulatory guide ate defined and interpreted in Appendix A to this guide.

15 This regulatory guide describes a method acceptable to the NRC staff for complying with 16 the NRC's regulations with regard to quality assurance requirements when using a sampling 17 plan for dedicating simple metallic CGIs for unrestricted use in nuclear power plants.

18 AMl relevant criteria of Appendix B to 10 CFR Part 50 must be satisfied for the dedication 19 of commercial grade items.

20 21 Criterion ill. "Design Control," of Appendix B requires. in part. that measures be 22 established for the selection and review for suitability of application of materials and 23 parts that are essential to the safety-related functions of structures, systems, and 24 components.

25 Criterion IV. "Procurement Document Control," requires. in part, that regulatory 28 requirements, design bases, and other requirements are included or referenced in 2? procurement documents.

28 Criterion V. instructions, Procedures. and Drawings,' requires, in part, that measures be 29 established to assure that activities affecting quality be accomplished in accordance with 30 written Instructions, procedures, and drawings.

31 Criterion VII, "Control of Purchased Material. Equipment. and Services." requires, in part.

32 that measures be established to assure that purchased material conform to procurement 33 documents.

3

1.. . Criterion XVII, "Guality Assurance Records,- requires, in part. that such records.

2 procedures, documented bases, and so forth, be maintained to furnish evidence of 3 activities affecting quality.

4 5 Regulatory guides are issued to describe and make available to the public such 6 Information as methods acceptable to the NRC staff for implementing specific parts of the 7 NAC's regulations. techniques used by the staff for evaluating specific problems or postulated 8 accidents, and guidance to applicants. Regulatory guides are not substitutes for regulations.

  • an compliance with regulatory guides is not required. Regulatory guides are issued In draft 10 form for public comment to Involve the public in the early stages of developing the regulatory 11 positions. Draft regulatory guides have not received complete staff review and do not represent 12 official NRC staff positions. However. if a licensee or its supplier elects to use or reference this 13 guide, the licensee or supplier must comply with certain provisions in the Regulatory Position of 14 this guide.

15 The information collections contained in this draft regulatory guide awe covered by the 16 requirements of 10 CFR Part 50. which were approved by the Office of Management and 17 Budget, approval number 3150.0011. The NRC may not conduct or sponsor, and a person is 18 not required to respond to, a collection of information unless it displays a currently valid OMB 19 control number.

20 21 8. DISCUSSION 22 23 This regulatory guide provides guidance on the use of sampling plans during commercial 24 grade dedication of simple metallic items for unrestricted use in nuclear power plants INPPs) 25 using Electric Power Research Institute (EPRI Method 1, -Special Tests and Inspections* lRef.

26 1). The use of sampling plans for dedicating these items is currently of particular concern 27 because items dedicated for unrestricted use could be used in applications with high safety 28 significance. Draft Regulatory Guide DG-1064. -An Approach for Plant-Specific. Risk-informed 29 Declsionmaking: Graded Quality Assurance" lRef. 21 proposes guidance on determining 30 whether an item Is of high or low safety significance. This Draft Regulatory Guide CG.1070 31 also contains specific instructions and cautions in the application of sampling plans for 32 commercial grade dedication. The guidance is limited to simple metallic CGIs with critical 33 characteristics that can be verified after their manufacture.

4

I This regulatory guide incorporates experience gained from inspections and a review of 2 irndusry programs and practices, knowledge of the theoretical and practical aspects of 3 Statistics. and practices of the melting mills, where metals are mixed, purified, and formed.

4 This experience was balanced against the need for a sampling methodology that will provide a 5 reasonable asuance that an item will perform its intended safety function and is equivalent to 6 an item designed and manufactured under a quality assurance program consistent with 7 Appendix 8 to 10 CFR Part 5O.

B Three important concepts are Incorporated in Qhis regulatory guide. The first concept is 9 traceability, or the ability to document the development, processing, or history of an item, 10 especially through markings or paperwork. The second concept is limiting the defect rate, the 11 frequency with which nonconformances. Imperfections, or flaws occur in a set of items. The 12 third concept Involves the variability of concentration of basic chemical elements that must be 13 used to verify the identity of metallic items. This regulatory guide provides guidance on these 14 topics to reasonably assure the consistent high quality of dedicated simple metallic CGls.

18 An underlying premise of this regulatory guide is that individual inspection lots should be 16 sampled in a way that will give a high confidence of a low defect rate. To satisfy this premise.

17 this regulatory guide provides sampling plans that result in at least 95 percent confidence that 18 lots with more than 5 percent defective items will be rejected. This level of sampling is called a 19 95105 plan, and this standard confidence level was chosen to control the consumer's risk,' that 20 is. the risk that an unacceptable lot is accepted. Other sampling plans, such as the EPRI NP.

21 7218 guideline (Ref. 31 are based on MIL-STC-105E IRAf.41 and call for sample sizes smaller 22 than those called for by this regulatory guide. In some cases, not all critical characteristics can 23 be verified at the dedicating entity. Consequently. plans based on a 95/05 plan involve higher 24 consumers' risk {the probability of accepting a lot with more than 5 percent defective items),

25 especially for lot sizes below 100. However, experience has shown that the assumptions in 26 MIL-STD-IOSE frequently are not appropriate for commerci,,l grade items. Unlike MIL-STD-27 105oe, this regulatory guide does not assume a continuous manufacturing process: therefore.

28 larger sample sizes are required to provide assurance of lot quality.

29 This criterion, 95 percent confidence that no more than 5 percent of the acceptable 30 items could have defects, was chosen as the appropriate level of assurance necessary to 31 maintain the current levels of component performance. The criterion establishes a standard

  • Note the distinCtbon between consumer's risk and pfvdef'S 14h; the I*o hold cotrary goals.

5

I statistical confidence interval and provides reasonable assurance that the lot of items meets its 2 acceptance criteria. Alternative sampling plans are available, for example, a double sampling 3 plan, but this regulatory guide does not address those alternative plans.

4 5 C. REGULATORY POSITION 6

7 This regulatory guide Is being developed to provide guidance, acceptance criteria, and 8 sampling tables that are acceptable to the NRC stalr for performing sampling for commercial 9 grade dedication of simple metallic items. Licensees' and suppliers' use of this guidance will 10 result In a more uniform application of sampling, improve overall confidence in the Industry's SI sampling process for the dedication of CGIs. provide additional supplier performance history to 12 the dedicating entity, and provide a reasonable assurance that the Item will perform its intended 13 safety function.

14 Dedication programs for simple metallic CG[s that are written according to this 15 regulatory guide must be based on a two-part process involving inspection and nondestructive 16 examination 4I&NOEI and destructive tests.

17 In some Instances, not all the CGIs' critical characteristics can be verified after receipt at 18 the dedicating entity. For these items, other methods of verification, such as a commercial 18 grade survey (EPRI Method 21. or source verification (EPRI Method 31, may be necessary.

20 Guidance on using these methods is not provided in this regulatory guide, but can be found in 21 other NRC guidance and other referenced documents.

22 Written Instructions nr procedures for commercial grade dedication programs that permit 23 the use of sampling should either include the generic documented technical basis for the 24 acceptance criteria and selected sampling plans or should include a requirement that such 25 documentation be provided for a given circumstance. Further. such instructions or procedures 26 should contain provisions for ensuring that the sampling plan selected provides adequate 27 controls to ensure conformance to purchaser-specific procurement document requirements.

28 applicable material specification requirements, and other requirements to which the Item must 29 conform.

30 6

L

1 1. ASSESSMENT OF SAFETY SIGNIFICANCE AND FUNCTION 2

3 This regulatory guide applies to simple metallic CGIs when their end use is not known or 4 when sampling has been determined to be necessary. No assessment of an itemns safety s significance or function Is necessary when using this guidance for dedication of en item for 5 unrestricted utility.

7 8 2. IDENTIFICATION OF CRITICAL CHARACTERISTICS, VERIFICATION METHODS, AND 9 ACCEPTANCE CRITERIA 10 11 12 For CGIs such as simple metallic products to be dedicated for unrestricted use in NPPs.

13 Inspections, tests, and analyses that are II) identified in the product description, 121 listed on 14 the certified material test report (CMTRI. and 43) required by the purchaser should be verified.

15 Inspections, tests, and analyses are. for example. heat number, heat code or lot, chemical IS constituents, physical attributes, microsiructure. mechanical properties le.g.. tensile strength.

17 hardness), and markings. The inspections, tests, and analyses, in general, provide critical 18 characteristics and need to be verified. The chemical constituents that should be verified during 19 the partial chemical test are: for carbon and alloy steels, chromium, copper, manganese, 20 molybdenum, nickel, silicon, phosphorus, and sulfur; for stainless steels, chromium.

21 molybdenum, and nickel; and for other metals and alloys, principal iloying elements and 22 commonly recognized impurities. For the full chemical analysis, all elements identified in this 23 guide In the Table of Product Analysis Tolerance's and in the material specifications should be 24 verified. Additionally, any element not identified in the table that is identified in the 25 manufacturer's certification should be verified. Requirements imposed by the purchaser should 26 also be considered for use when identifying critical characteristics. Further guidance or the 27 selection of critical characteristics can be found in Generic Letter 89-02 (Ref. 51. Generic Letter 28 91-05 (Ref. 61. Information Notice 95-12 (Ref. 7). Supplement 1 to Information Notice 92-68 29 (Ref. 81. Information Notice 96-40 MRef. 91. Supplement 1 to Information Notice 96-40 (Rea.10).

30 and NRC Inspection Procedure 38703 (Ref. 111.

31 Verification methods should be chosen on the basis of their accuracy. precision. and 32 ability to verify the critical characteristics in question. Accordingly, the accuracy and precision 33 of these methods, as well as their appropriateness for the material in question, should be 34 evaluated before they are designated for use. For example, an alloy separator Is capable of 7

1 distinguishing between differing families of steels. However. it cannot identify the material's 2 chemical constituents, and therefore, would not be capable of reliably identifying 3 nonconforming or defective items. Similarly, a spark test. where one observes the color and 4 shape of spaks generated when a metallic item is subject to grinding, iS capable of Identifying 6 the presence of elements in a material, but it is not a quantitative process and, therefore. would S not be suitable for verifying the concentration of elements In the material, In contrast. a mass 7 spectrometer can accurately identify the presence of and quantity the chemical composition of a a metallic item.

9 The acceptance criteria for chemical elements are the same for both the partial (part of 10 the I&NDEI and full chemical tests (part of the destructive tests) and are given below in the II Table of Product Analysis Tolerances and associated Figures 1 through 3. The table and figures 12 must be used to build acceptance criteria for both the partial chemical (part of the I&NOEI and 13 the full chemical tewts (part of the destructive tests). The tolerance given in the figures and 14 tables bracket the values listed on the CMTR and are a subset of the material specification is range and Its tolerance. Therefo-e. if the tolerances given in the material specification are more 16 liUniting. the tolerances given in the material specification should be used. Additionally, If the 17 table or figures are not applicable to the element or material in question, the tolerances IS contained In the material specificatinn should be used. For nonchemical properties (e.g., yield, 19 tensile, impact strength, fracture toughness), the results may be listed on the CMTR. The 20 measured value should be within

  • 15 percent of each value listed on the CMTR and should 21 meet the limits and tolerances given by the purchase order or material specification, whichever 22 value is more restrictive. For hardness, tolerance limits do not apply; the measured hardness 23 should meet the hardness value in the material specification or the customer's specification.

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1 3. LOT FORMATION 2

3 The forming of inspection lots should incorporate the following practices. items from 4 different production runs, different models. or different manufacturers should not be included in 5 the inspection lot. Proper lot formation must have evidence of traceability such as (1) original 6 manufactum malkings on each Item. (21 originsl manufacturer certifications. 13) original 7 CMTRs. or (4) original packing slips from the receiving inspection. Combining dissimilar lots to 8 form a larger lot for sampling purposes is not permitted; the destructive testing requirements 9 we applicable only to homogeneous inspection lots. Lots with different pedigrees should be to dedicated independently. Finally, any suspected nonconforming items should be removed from I1 the nsM ilon lot before sampling. The Inspection lot should be kept as "clean" as possible; 12 that is, Inspection lots should be segregated so that the risk of cross-contamination is 13 minimized.

14 15 4. SELECTION OF SAMPLING PLANS FOR INSPECTION AND NONDESTRUCTIVE 16 EXAMINATION 17 16 19 Two I&NDE sampling plans that are acceptable to the stall are described In this section 20 for CGI dedication. The first plan. SPI. allows lot sampling for the I&NDE portion of the 21 dedication but mandates that the accepted lot be sent to the purchaser without being 22 subdivided. The size of the samples is based on lot size, and the table in Appendix B shows the 23 sample size needed to meet the 95105 criterion. The second plan, SP2. specifies 100 percent 24 sampling for the I&NOE portion of the dedication. However, it allows large lots to be dedicated 25 and distributed in a piecewise manner. In both plans, the I&NDE verifies all the critical 28 characteristics, such as dimensions, hardness, partial chemistry. manufacturer's markings, heat 27 number or code. without rendering the items unusable.

I* The I&NDE sampling plans SPI and SP2 are designed for situations In which high confidence in the inherent quality of the inspection lot is needed. For example, SPI Is used if 30 the dedicating entity wants to dedicate one lot of CGIs and send that lot to a licensee to satisfy 31 a purchase order. The Inspection lot size and acceptance number is determined and the sample 32 size read from Table Al In Appendix B. The sample should be randomly drawn using either of 33 the methods given in Regulatory Position 5 or a similar method. The critical characteristics of 34 the sample are then verified using I&NDE. l1 the number of defective items in the sample is less 35 than or equal to the acceptance number. c, the lot is provisionally accepted pending the results II

I of the destructive tests. If the number of defective items in the sampie is larger than c. the 2 dedicating entity may switch to SP2. Otherwise, the inspection lot Is rejected. The flowchart 3 in Figure 4 summarizes the general process.

4 Figure 4 - Summary of the Overall CGI Dedication Sampling Methodology 6 Note that SPI does not allow inspection lots to be sampled, accepted, and then divided and 6 shipped to different purchasers. The dedicated lot must be sent in its entirety to the purchaser.

7 This ensures that the quality of individual shipped lots meets or exceeds the 95105 criterion.

SP2 may be used to dedicate a full inventory of a specific item and subdivide for 9 shipment to vrious purchasers, or SP2 may be used it the inspection lot was rejected by SPI.

10 As in SPI. the inspection lot must be from the same heat or production run and must have 11 traceability to the original manufacturer, original manufacturer's certifications, and CMTRs.

12 However, this plan requires 100 percent sampling for the I&NDE portion of the dedication. The 13 acceptance number for this plan is based on an acceptable defect rate of 5 percent. To 14 calculate the acceptance number. c, for SP2. multiply the inspection lot size by 0.05, rounding 15 up to the nearest whole number. If. during the 100 percent I&NDE, the number of defective 12

I Items is greater than c, the entire lot is rejected. If the number of defective items is less than c, 2 the lot Is provisionally accepted pending the results of the destructive tests. In either case, the 3 detective Items must be discarded or segregated from future inspection lots.

4 In summery. SPI allows sampling of larger inspection lots, as long as the entire 5 dedicated lot is shipped to satisfy a purchase order. SP2 requires 100 percent I&NDE of the 6 items In the Inspection lot. However, only one set of destructive tests is required regardless of 7 lot size. When the SP2 sampling Is completed satisfactorily. the dedicated lot can be subdivided 8 and shipped as separate lots without further Inspection or testing.

9 1o 5. SAMPLE SELECTION

!1 12 The samples selected for the I&NOE should be chosen in a random manner without any 13 bias for or against any portion of the lot. For example, either of the following two methods 14 could be used to select samples for the I&NDE The items can be spread out one layer deep on 15 a large table. The items should be picked at rat Jom from the table, without bias toward any 16 side or corner. In another method, a set of random numbers from a random number generator S 17 or a table of random numbers is used. The number of random numbers chosen should be equal 1i to the sample size and their values should be no larger than the inspection lot size. The items 19 in the inspection lot are then numbered consecutively, setting aside the items whose numbers 20 match the generated random numbers. The second method is preferable but is not required.

21 The dedicating entity should establish criteria, standard practices, and procedures for the 22 storage and treatment of samples that have been selected and for the segregation of the 23 remaining items. Areas where these items are stored should be clearly marked for ready 24 identification.

25 28 6. INSPECTiON AND NONDESTRUCTIVE EXAMINATION 27 28 Once the sample items have been selecteo, each of the critical characteristics identified 29 is verfied on every Item in the sample. An item that fails to meet the acceptance criteria for 30 one oa more critical characteristics counts as one reject against the previously chosen 31 acceptance number. Regardless of whether an inspection lot was accepted or rejected.

S 32 defective items must be removed and discarded, destroyed, or controlled so they are not used 33 for safety-related applications. Rejected items must not be included in future inspection lots.

13

1 7. DESMT CTIVE TESTING 2

3 Destn"ctive tests are performed only if the inspection lot was accepted by I&NDE.

4 Therefore, the Items to be destructively tested are assumed to represent the inspection lot for 5 the propertles tosed (full chemical properties. material properties, and other properties that 6 cannot be inspected or measured nondestructively). These tests may require that more than 7 one Item be subjected to destructive tests If the item Is too small to be used as a test specimen 8 for al the required tests. Examples of destructive tests are full chemical tests, tensile tests, 9 Impact tests, ductility tests (percent elongation, reduction In area), and microstructural 10 examinations.

11 With regard to verification of the concentration of chemical elements, the destructive 12 tests should verify, at aeminimum, all the elements listed on the Table of Product Analysis 13 Tolerances In this guide. Any additional elements required by the material specification or 14 purchase order must also be verified to meet the tolerances provided in the material 15 specflication or purchase order, whichever is smaller.

16 Regardless of whether SPI. SP2, or another sampling plan is used, the results of the 17 destructive tests must be acceptable for an Inspection lot to be dedicated. For full chemical 18 analyses, the test results for all required elements are compared with the values documented In 19 the manufacturer's or supplier*s certifications. If any result varies by more than the value 20 allowed by the acceptance criteria or does not meet the requirements of the purchase order and 21 material specification, the lot is unacceptable and must be rejected.

22 For nonchemical properties, if any result varies by more than the acceptance criteria but 23 meets the limits and tolerances given by the purchase order or material specification and the 24 items are accepted. a documented engineering evaluation providing the rationale must be 25 provided to the purchaser Ithe customer). This technical evaluation must be provided as part of 26 the certification package for the dedicated material. If the destructive test results do not meet 27 the acceptance criteria, the purchase order, or the material specification, the lot must be 218 rejected.

29 14

I a. DOCUMENTATION OF RESULTS 2

3 Putsuant to Appendix B to 10 CFR Part 60. the CG! dedication process must be 4 documented. Appendix B contains criteria for the necessary elements of a quality assurance 5 program. The following is a list of information that typically is provided for documentation.

6 7

  • Reference number 8
  • Purchase order number (customer's and dedicating entity's) 9
  • Manufacturte's certification number and date lwhen applicablel to 1 Description of lot (e.g., serial numbers, unique characteristics) 11 Critical characteristics sampled (with tolerances usedl 12
  • Sample size selected 13
  • Verification methods 14 a Acceptance criteria Is
  • Results of I&NDE 16 0 Results of OTs 17
  • Comparison of I&NDE and destructive test results with acceptancu criteria 18
  • Lot disposition (accepted. rejected. 100 percent examinedl 19 , Sampling plans used (give reference or description) 20
  • Measurement and test equipment 21
  • Technical evaluations 22 23 D. IMPLEMENTATION 24 25 The purpose of this section is to provide information to applicants and licensees 26 regarding the staff's plans for using this regulatory guide.

27 This draft guide has been released to encourage public participation in its development.

26 Except In those cases in which an applicant or licensee proposes en acceptable alternative 29 method for complying with specified portions of the NRC's regulations, the methods to be 30 described In the active guide reflecting public comments will be used in the evaluation of 31 sampling plans and processes used for the dedication of simple metallic commercial grade 32 Items.

33 15

2 3 1. Electric Powee Research Institute. 'Guideline for the Util~zation of Commercial Grade 4 Items in Nuclear Safety-Related Applicalions." NP-5652. Palo Alto. California, June 6 1988. Ptoprietary information. Not publicly avallable.

7 2. U.S. Nuclear Regulatory Commission. 'An Approach for Plant-Specific. Risk-informed 8 Decisionmaking: Graded Quality Assurance.' Draft Regulatory Guide DG-1064. June 9 1997.'

10 11 3. Electric Power Research Institute, NP-7218. 'Guideline for the Utilization of Sampling 12 Plans for Commercial-Grado Item Acceplance.'Palo Alto. California. June 1992.

13 Proprietarylntonmauion. Nor publicly available.

14 15 4. U.S. Department of Defense. MIL-STD-105E. 'Sampling Procedures and Tables for 16 Inspection by Attributes.' 1989.

17 18 5. U.S. Nuclear Regulatory Commission. Generic Letter 89-02. 'Actions to Improve the 19 Detection of Counterfeit and Fraudulently Marketed Products,' March 1989.2 20 21 8. U.S. Nuclear Regulatory Commission, Generic Letter 91-05, Licensee Commercial-Grade 22 Procurement and Dedication Programs.' April 19911.2 23 24 7. U.S. Nuclear Regulatory Commission. Information Notice 95-12. OPotentially 25 Nonconforming Fasteners Supplied by A&G Engineering II, Inc..' 1995.,

26 27 8. U.S. Nuclear Regulatory Commission, Information Notice 92-68. Supplement 1.

28 ,Potentially Substandard Slip-on. Welding Neck. and Blind Flanges,0 September 1996.,

29 30 9. U.S. Nuclear Regulatory Commission. Information Notice 96-40. *Deficiencies In Material 31 Dedication and Procurement Practices and In Audits of Vendors.' July 1996.2 32 33 10. U.S. Nuclear Regulatory Commission. Information Notice 96-40. Supplement 1, 34 "Deficiencies in Material Dedication and Procurement Practates and in Audits of 35 Vendors." October 1996.2 36 37 11. U.S. Nuclear Regulatory Commission. 'Commercial Grade Oedicatlion." Inspection 38 Procedure 38703. April 1996.'

'Aequests to s&eincopes of draft or active efeito'y guides (whch may be ieproducedi or for ptacem, we an Autom6tic diStrobation list for single copies of Iultse draft gudes in specdac drvtions shotid be made in writng to the U.S. Nucdat Rei*u.tory Commisson. Washington. DC 20555-0001. Attention: PW*miOn.

Graptcs and Distribtion Branch. o by tax to (3011415.5272, Copies ate avidab&e for pection or copvag for a fee from the NRC Pubkc Documat Room at 2120 L Street NW.. Washington. DC. the POR's maihn addren is Mai Stoo LL*4. Washngton. DC 20555; telephone 1202)634.3273; lax 1202)834.3343.

'Copies &a evata for inspection oa copydng for a fee trom the NRC Pubbc 0Docunent Room at 2120 LStret.

NW.. WaShington. DC. the PORs me., ng address is Mad Stop LL.6. Wamhngton. DC 20555: teephon.e 12021834-3273; fox (2021634-3343.

16

APPENDIX A 2 GLOSSARY 3

4 5 This glossary discusses terms used in this regulatory guide and provides some formal 6 and some working definitions and Interpretations.

7 8Basic Component- When applied to a nuclear power plant licensed pursuant to 10 CFR 9 Pat 50, a structure, system. component, or part thereof that affects a safety function 10 necesay to ensure one of the following:

II The Integrity of the reactor coolant pressure boundary 12

  • The capability to shut down the reactor and maintain it in a safe shutdown 13 condition.

14

  • The capability to prevent or mitigate the consequences of accidents that could 15 result In potential of fsite exposures comparable to those referred to in 10 CFR 16 100.11.

17 18 Commerca Grade Item -- When applied to nuclear power pants licensed pursuant to 10 CFR 19 Part 50. a structure. system. component, or part thereof that affects its safety function and 20 that was not designed and manufactured as a basic component. Commercial grade items do 21 not Include items for which the design and manufacturing process many in.process inspections 22 and verifications to ensure that defects or failure: to comply are identified and corrected 1I.e.,

23 one or more of the item's choice critical characteristics cannot be verfied).

24 25 Certificate of Compliance - A written statement, signed by a qualified party, attesting that the 26 associated items or material is in accordance witl the specified requirements and accompanied 27 by additional Information to substantiate the statement.

28 29 Certfifed Material Test Report - A document attesting that the associated material is in 30 accordance with the specified requirements, Including chemical analyses, tests, and 31 exaninations of the heat of steel, preferably from a test sample obtained during the pouring of 32 the steal. When required chemical analyses (heat analyses), heat treatment, tests, 33 exeminations, or repairs are subcontracted, the subcontractor's certification for the operations 4-4 performed Is furnished as an attachment to the original certified material test report.

35 36 Crtcal Chawcterutics - When applied to nuclear power planis licensed pursuant to 10 CFR 37 Part 50, those Important design, material, and performance characteristics of a commercial 38 grade Item that, once verified, will provide reasonable assurance that the item will perform its 39 Intended safety function.

40 41 Dedication - When applied to nuclear power plants licensed pursuant to 10 CFR Part 50. an 42 acceptance process undertaken to provide reasonable assurance that a commercial grade Item 43 to be used as a basic component will perform its intended safety function. In this respect, the 44 Item is deemed equivalent to an item designed and manufactured under a quality assurance 45 program that conforms to Appendix 8 of 10 CFA Part 50. This assurance is achieved by 46 inspectIons, tests, or analyses performed by the purchaser or thirdi-porty dedicating entity after 47 delivery, supplemented as necessary by one or more of the following: commercial grade 48 surveys, product inspections or a witness at hold points at the manufacturer's facility, and 49 analysis of historical records for acceptable performance. In all cases, the dedication process

I must be eLnducted in accordance with the applicable provisions of Appendix 8 to 10 CFR Part 2 50. The procass Is considered complete when the item Is designated for use as a basic

.3 component.

4 5 Dedicat*ng Entity - When applied to nuclear power plants licensed pursuant to 10 CFR Pan 50.

a the organization that Implements the dedication process. Dedication may be performed by the 7 manufacturer of an Item, a third-pary dedicating entity, or the licensee lany of these may also

  • be called a dedicatorl. Pursuant to 10 CFR 21.21(c), the dedicating entity is responsible for 9 Identifying and evaluating deviations, reporting defects in and failures to comply for the 10 dedicated Item, and maintaining auditable records of the dedication process.

11 12 Destructlve Test - Any process of verification of a commercial grade item's critical 13 characteristics whereby the item is substantially altered or changed in a way that would fender 14 It unusable for Its Intended purpose.

15 1A Inspection Lot - A batch or lot of items specifically formed for the purpose of being dedicated 17 for use as a basic component in a nuclear power plant.

t8 19 MalMlarl Manufacturer - An organization that performs or directly controls one or more of the 20 operations required by the material specifications that affect the material's mechanical 21 properties and issues the certified material test report for the material.

22 23 Nondestructive Examination -- Any process of verification of a commercial grade item's critical

  • 24 characteristics whereby the item Is nor substantially altered or changed in a way that would 25 render it unusable for its Intended purpose.

20 27 Product Analysis - A chemical analysis of the semifinished or finished product, usually for the 28 purpose of derermintng conformance to the specification requirements. The range of the 29 specified composition applicable to the product analysis is normally greater than that applicable 30 to host analysis in order to take into account deviations associated with analytical 31 reproducibility and the heterogeneity of steel. (American Society of Mechanical Engineers.

32 ANSI/ASME SA-751. "Specification for Test Methods. Practices, and Terminology for Chemical 33 Analysis of Steel Pboducts," Now York. 1992.)

34 35 Product Analysis Tolerances - A permissible variation over the maximum limit or under the 35 minimum limit of a specified element and applicable only to product analyses, not cast or heat 37 analyses. (ANSI/ASME SA-751) 38 39 Safety-Related - When applied to equipment in nuclear power plants licensed pursuant to 10 10 CFR Part 50, relied on to remain functional during and following design basis events to 41 ensure IIl the Integrity of the reactor coolant pressure boundary. 121 the capability to shut 42 down the reactor and maintais) it in a safe shutdown condition, and (3) the capability to 43 prevent or mitigate the consequences of accidents that could result in potential offsite 44 exposures comparable to those referred to in 10 CFR Part 100. Design basis evenms are 45 defined as conditions of normal operation, including anticipated operational occurrences, 46 design basis accidents, external events, and natural phenomenoa for which the plant must be 47 designed to ensure functions (1) through 13) of this paragraph.

48 A-2

I Unmrstwctsd UOe - Use that is either safty-related or non-safety-reiated, or not restricted to a 2 SpecIfic rIsk-significance level of category in a nuclear power plant.

A-3

1 Appendix 8 2 Sampling Tables with instructions 3

The sampling table in this appendix is to be used to determine the correct sample size 6

for the Inspection and nondestructive examination portion of sampling plan SPI. The table 6 should be used as follows.

7

1. Determine the Inspection lot size. m. This probably will be the purchase order quantity.

9 plus one destructive test item, plus the number of allowable defective items from the 10 sample plan.

S 11 2. Choose the appropriate sample plan. There may be son'" iteration with Step 1 to 12 determine the final Inspection lot size.

13 3. Choose the maximum number of defective items. c. allowable in the semple.'

14 4. Follow the selected column for c down to the corresponding inspection lot size m, and 15 record the sample size n.

16 5. Draw a random sample of size n from the m items In the lot and inspect each.

17 6. Accept the lot if the number of nonconforming items In the sample does not exceed c.

Reject the lot if the number of nonconforming Items exceeds c.

19 20 NOTE that for lot sizes greater than 1000, which is the largest lot size in Table 1, the sample 21 sizes should correspond to a lot size of 999. The example on the following page illustrates the 22 use of Table I for SPI In this appendix.

DThe mnmmimui number ol defeClive smingr the sample. C. has assocuted wth f a SaRVIO $ile 0a rask of meecion imthe ikwpMer;On lot is of acetable quahty. The srrWe the value of c. the smane the samp4e sue WiA the retrthe risk of rejection. Increasong the value of c, however. wif cost the ded~caung emity mote tine to exwhin a Ws mple. sometikmes eppawo0i the inspect ion lot Wem. The tradeofl bt~#eeti the risk of rejction and comt of essminaion is left to the dedicating etvy. it the inspection lOt sue nsosthan 20. the only aCc ai. value of Cis c - 0. Otherwve. here isatways mote than one acceptable value of C,that s.

no Mten Se-a , P la;ie sample site.

B-I

Mlus4athny OhW Use of Table I for SPI

&4""M tatadedicaftinfettywantstoglanwoder for100 sfmle nmetalic Rtems. SPI Is chosen for this application. Furthe, suppose the ddicating entity chooses to allow at moat I defective Item in the ,osale, (I.o., C31) wnd since the item Isr*atvoely lrge, I

."destructive test Item Is required. From Step 1, the Inspection lot SlIzesthusma100+I +1-02. From Tabl l, rowl02and column cwz 1.find the sample size of 67. Thus, a random sample of 67 Items from the inspection lot must be examined. If no morn than

" of the 67 Items Is nonconforming, the lot Is accepted as being no

..-mor than 5 perceM defective with at least 95 percent confidence.

The destructive tests awe performed if the lot isacceptable after the Inspection and nondestructive examination. If the destructive tests e'reacceptable, the dedicating entity sends the 100 items to the purch ser In aacordance with the purchase order.

SNothat tf the sample of67 has 2 defective or nocnforming Items (mom Ohwn the acceptable number). the dedicating entity may choose to implement SP2 and inspec the remaining 35 iem Ma Woere not sampled (100 percent Inspection). After discarding all defedhie Items, the dedicating entity Is 100 percent confident that all of the remaining items In the inspection lot are acceptable for the chftaceristics examined. However, if 6 or more defective items are fotund, the entire lot must be rejected because it contained more

-than 5 percent defective items.

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4 T"le 1. 8amle Size Roeed To SadtWSe 9Ciftedmn Lot Sine 0 1 2 4 7 10 Lot Sime 0 1 2 4 7 10 57 go 119 172 244 311 901 57 go 119 171 243 311 57 90 119 172 244 312 902 57 90 119 171 244 311 87 57 90 119 172 244 312 903 57 90 119 172 244 312 an 57 go 119 172 245 312 904 57 90 119 172 244 312 Nio so 91 120 172 245 313 gas 57 90 119 172 245 313 870 so 91 120 173 245 313 905 57 90 119 172 245 313 871 so 91 120 173 245 314 907 57 go 120 172 245 313 872 58 91 120 173 246 314 w~e so 91 120 173 245 314 873 58 91 120 173 246 314 909 so 91 120 173 246 314 874 so 91 120 173 246 315 910 so 91 120 173 246 314 875 so 91 120 174 247 31S 911 s8 91 120 173 246 315 se 91 121 174 247 31S 912 58 91 120 173 245 315 677 58 91 121 174 247 316 913 so 91 120 174 247 315 878 58 121 174 247 316 914 so 91 120 174 247 318

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4 T"blg 1. Sample Sin Reqired To Satisy the 95/5 Otteoan LotSin 0 1 2 4 7 10 LotStz 0 1 2 4 7 10 93J7 92 121 174 248 317 973 so 91 121 174 248 317 g38 58 121 58 92 175 248 317 974 58 9l 121 174 248 317 939 57 92 121 175 249 318 975 s8 91 121 174 248 317 g4o go 57 00 119 171 244 312 976 58 92 121 175 248 316 941 57 119 172 244 312 977 58 92 121 175 249 31S o42 90 go 119 172 244 313 57 978 58 92 121 175 249 318 943 M 119 172r 245 313 5o 92 121 175 944 57 90 119 172 245 970 249 319 57 313 57 90 119 172 245 313 945 90 91 119 172 245 314 g81 57 90 119 172 245 313 946 57 91 120 173 962 57 245 314 57 go 119 172 245 314 947 go g9 120 173 246 so 314 963 57 90 119 172 245 314 046 O1 120 173 246 315 964 57 90 120 173 246 314 949 se 120 173 248 58 31S 965 57 91 120 173 ,4 314 gO's 91 120 173 246 315 .9" 58 91 120 173 246 315 0o 951 58 S91 120 173 247 316 56 91 120 173 246 315 952 s6 91 120 174 247 31W se 9l 120 173 247 315 953 so 01 120 174 247 316 969 s8 91 120 173 247 316 954 so 91 121 174 248 317 9900 58 91 120 174 247 316 955 58 91 121 174 248 317 991 58 91 120 174 247 316 958 57 91 121 174 248 317 992 58 91 121 174 248 317 957 so 92 121 175 248 318 993 so 9t 121 174 248 317 958 s8 92 121 175 249 318 994 so 91 121 174 248 317 959 so 92 90 121 175 249 318 58 91 121 174 248 318 WO 57 119 172 244 312 58 92 121 175 249 318 901 57 119 172 244 313 58 92 121 175 249 310 982 57 go 119 172 245 313 SO 92 121 175 249 319 953 57 go 119 172 245 313 58 92 121 175 249 319 064 57 90 58 110 172 245 314 1000 57 go 119 172 245 313 57 90 120 173 245 314 s8 50 Ol 120 173 314 go?

967 so Ol 248 58 so 91 01 120 173 246 315 58 120 173 248 315 TON 989 56 Ol 120 173 247 315 070 5s 91 120 173 247 318 071 91 120 174 247 316 972 120 of 174 247 318 0 0

C p

1 REGULATORY ANALYSIS 2

3 1. STATEMENT OF PROBLEM 4

5 The U.S. Nuclear Regulatory Commission has promulgated regulations to provide quality a assurance requirements for ruclear power plants. Those requiremenls are contained in 7 Appendix B to 10 CFR Part 50. which provides criteria for quality assurance programs fNr a structwes. systerns, and components that prevent or mitigate the consequences of postulated 9 accidents that could cause undue safety risk to the health and safety of the public.

10 In the past, nuclear utilities have relied on suppliers with qtoallfied Appendix B quality II assuance programs to provide replacement parts necessary (or general maintenance and repair 12 or replacement. For economic reasons, those suppliers have relinquished their Appendix B 13 quality assurance programs. This change has caused a shortage of qualified Appendix 8 14 suppliers for nuclear utilities and has forced an increasing reliance on suppliers of commercial 15 grafe items.

16 So that the safety of the public is assured, commercial grade items intended for safety-17 related applications undergo a dedication process to verify their ability to perform their safety 18 function. Currently, nuclear utilities and their suppliers dedicate these items to verify a CGl's 19 critical characteristics. However. as utilities Increase their purchases of CGIs Intended for 20 unrestricted use in nuclear power plants, they are relying on various sampling programs to 21 establish the acceptability of purchased lots.

22 To satisfy the requirements of Appendix B to 10 CFR Part 50. there is a need for 23 methods acceptable to the NRC staff for performing sampling to dedicate simple metallic 24 commercial grade items. Dedication is the process undertaken to provide a reasonable 25 assurance that a CGI to be used as a basic component will perform its intended safety 26 function. When this is dedicated, an item Is deemed equivalent to an item designed and 27 manufactured under an Appendix B quality assurance program.

28 There is wide variation in sampling programs applied by vendors in the dedication of 29 commercial grade items. The use of this standardized guidance increases the ability of the 30 NRC and utilities to-assess dedicat.-d CGI quality and ensures that actual dedicated CGI quality 31 levels will provide a reasonable assurance that the item will perlorm its intended safety 32 function.

33 34 2. OBJECTIVE 35 36 The objective of this guide Is to provide guidelines. acceptance criteria, and sampling 37 tables that are acceptable to the NRC staff for performing sampling for commercial grade 38 dedication of simple metallic items. The use of this guidance by licensees and their suppliers 39 will result in a more uniform applicaticn of sampling. This will improve the overall confidence 40 in the industry's sampling process for CGI dedication, provide additional supplier performance 41 history to the dedicating entity, and provide a reasonable assurance that the item will perform 42 its intended safety function in compliance with Appendix 8 to 10 CFR Part 50.

43 44 3. ALTEMNATIVES 46 46 The alternatives to issuing a regulatory guide on the use of sampling for dedicating 47 simple, metallic commercial grade items are as follows:

48 RA-!

1 3.1 Do Not Issue Regulator Guidance 2 The detailed guidance, acceptance criteria, and seapling methods considered 3 acceptable to the staff could be provided to the licensees and vendors through individual 4 reviews and discussions. Individual discussions with licensees are extrdinely time-consuming 6 foa both the NRC staff and the licensee, -we highly subject to individual interpretation, and do 6 not result in an established standard.

7 Individual discussions with vendors, e.g.. suppliers of components and services to a nuclear power plants, are equally time-consuming. Generally. discussions occur between the 9 vendor and NRC staff shortly before, during, and after NRC inspections. Without an to established standard, vendors will be hesitant to change their dedication programs as a result II of those discussions. This-alternative is basically the same as the current practice and is 12 equivalent to taking no action.

13 14 3.2 Issue Generic Letter 15 Guidance similar to that proposed in this regulatory guide could be included in a generic 16 letter. However. this is not considered an acceptable alternative since a generic letter does not 17 provide a wide consensus from the public or industry.

18 19 3.3 issue a RegWatory Guide Endorsing a NUREG-Series Report 20 Guidelines for dedicating simple metallic commercial grade items in nuclear power plants 21 could be published in a NUREG-series report and referenced by a regulatory guide. However.

22 these NUREG reports generally do not receive ACRS or public review and are not appropriate 23 for providing regulatory guidance.

24 25 4. COSTS AND BENEFITS 26 27 The costs and benefits of the decision to issue this guidance as a regulatory guide are 28 as follows, 29 30 4.1 Benefits 31 This regulatory guide delineates two methods acceptable to the NRC staff for sampling 32 for commercial grade item dedication. These methods may be used to meet the requirements 33 of Appendix a to 10 CFR Part 50. By using either of these methods, the licensees, acting as 34 either the dedicators or purchasers of dedicated CGls. may have confidence in the quality and 35 consistency of the dedication and know that vendors will be using identical references.

38 acceptance criteria, and confidence intervals while performing the dedications.

37 38 4.2 NRC Costs 39 The NRC costs are limited to the time and expenses needed to properly train inspectors 40 and revise Inspection procedures if deemed necessary by the staff. The costs associated with 41 performing inspections of commercial grade dedication programs would be substantially 42 reduced, since the need to discuss and explain NRC policy for sampling would be eliminated.

43 44 4.3 Licensee Costs 45 The specific, per-item cost of dedicated commercial grade items should Increase as a 46 result of the costs of testing by this guidance being passed down from licensees to vendors 47 performing the dedications. Licensees may also have to spend some time familiarizing 48 themselves with the new acceptance criteria and samole sizes. However, the market will 49 adjust to the changes by eliminating suppliers that can not comply with the new requirements RA-2

I (which may serve to boost prices) and standardizing, among all vendors, the criteria that must 2 be met (which may serve to reduce prices by increasing competition).

3 iUcensees may also realize a decrease in degradation or failure rate of replacement pans.

4 and a corresponding increase in availability of components or systems. This benefit may be 5 difficult to estimate, given that many repairs and replacements are included in estimates of 6 preventive maintenance activities.

7 a 4.4 Vendo Cos" 9 Vendors that currently do not meet the intent of Appendix 8 to 10 CFR Part 50 must 10 decide whether to remain in the nuclear supply business. For other vendors, added costs may 1 be limited to upgrading equipment and procedures and training personnel in the new 12 methodology. Ultimately, all costs associated with the changes will be passed on to the 13 customer.

14 16 5. DECISION RATIONALE 15 17 This guidance should be issued as a regulatory guide because I I I a wider consensus of 18 the NRC. ACAS. industry, and the public would be possible. (2) a standard methodology would 19 be established, and (31 Inefficient use of the NRC staff, vendor, and licensee resources would 20 be eliminated.

21 The other alternatives. Identified above, for providing guidance on the use of s~mpting 22 for the dedication of simple metallic commercial grade items do not provide the level of review 23 and wide consensus required. In addition, while these alternatives may result in the same 24 costs to licensees or vendors, they result In inefficient use of NRC staff resources. The 25 alternatives wre therefore judged to be unacceptable.

26 27 r-e Pscym n RA-3

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