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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
ML003739230
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Issue date: 09/30/1997
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DG-1070
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U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REGULATORY RESEARCH DRAFT REGULATORY GUIDE

Contact:

M.E. Mayfield J.P. Vora Division 1 Draft DG-1070 (301)415-6690 (301)415-5833 DRAFT REGULATORY SAMPLING PLANS SIMPLE METALLIC FOR USE I GUIDEOiD*,L 1070 6ý 5i~i l,,",l!i!

DEDICATING RIAL GRADE ITEMS POWER PLANTS This regulatory guide is being issued in draft form to involve the public in the early stages of the development of a regulatory position in this area.

It has not received complete staff review and does not represent an official NRC staff position.

Public comments are being solicited on the draft guide (including any implementation schedule) and its associated regulatory analysis or value/impact statement. Comments should be accompanied by appropriate supporting data. Written comments may be submitted to the Rules and Directives Branch, DAS, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Copies of comments received may be examined at the NRC Public Document Room, 2120 L Street NW., Washington, DC. Comments will be most helpful if received by December 1, 1997.

Requests for single copies of active or draft guides (which may be reproduced) or for placement on an automatic distribution list for single copies of future draft guides in specific divisions should be made in writing to the U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Printing, Graphics and Distribution Branch; or by fax to (301)415-5272.

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September 1997

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A.

INTRODUCTION The U.S. Nuclear Regulatory Commission (NRC) has promulgated regulations to provide quality assurance requirements for nuclear power plants and fuel reprocessing plants for the design, construction, and operation of structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. Those specific regulations are set forth in Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities," in the U.S. Code of Federal Regulations. Dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item (CGI) to be used as a basic component of a nuclear power plant will perform its intended safety function and is deemed equivalent to an item designed and manufactured under a quality assurance program in accordance with Appendix B. Terms that are used in this regulatory guide are defined and interpreted in Appendix A to this guide.

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

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

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

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

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

Criterion VII, "Control of Purchased Material, Equipment, and Services," requires, in part, that measures be established to assure that purchased material conform to procurement documents.

1 Criterion XVII, "Quality 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.

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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

NRC'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, 9

and 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 are 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.

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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 (NPPs) 25 using Electric Power Research Institute (EPRI) Method 1, "Special Tests and Inspections" (Ref.

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 Decisionmaking: Graded Quality Assurance" (Ref. 2) proposes guidance on determining 30 whether an item is of high or low safety significance. This Draft Regulatory Guide DG-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.

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1 This regulatory guide incorporates experience gained from inspections and a review of 2

industry 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 assurance 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 B to 10 CFR Part 50.

8 Three important concepts are incorporated in this 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 CGIs.

15 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 95/05 plan, and this standard confidence level was chosen to control the consumer's risk,1 that 20 is, the risk that an unacceptable lot is accepted. Other sampling plans, such as the EPRI NP 21 7218 guideline (Ref. 3) are based on MIL-STD-105E (Ref.4) 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-105E frequently are not appropriate for commercial grade items. Unlike MIL-STD 27 105e, 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 1Note the distinction between consumer's risk and provider's risk; the two hold contrary goals.

1 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.

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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 staff 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 11 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 CGIs that are written according to this 15 regulatory guide must be based on a two-part process involving inspection and nondestructive 16 examination (I&NDE) 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 19 grade survey (EPRI Method 2), or source verification (EPRI Method 3), 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 or 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.

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1.

ASSESSMENT OF SAFETY SIGNIFICANCE AND FUNCTION This regulatory guide applies to simple metallic CGIs when their end use is not known or when sampling has been determined to be necessary. No assessment of an item's safety significance or function is necessary when using this guidance for dedication of an item for unrestricted utility.

2.

IDENTIFICATION OF CRITICAL CHARACTERISTICS, VERIFICATION METHODS, AND ACCEPTANCE CRITERIA For CGIs such as simple metallic products to be dedicated for unrestricted use in NPPs, inspections, tests, and analyses that are (1) identified in the product description, (2) listed on the certified material test report (CMTR), and (3) required by the purchaser should be verified.

Inspections, tests, and analyses are, for example, heat number, heat code or lot, chemical constituents, physical attributes, microstructure, mechanical properties (e.g., tensile strength, hardness), and markings. The inspections, tests, and analyses, in general, provide critical characteristics and need to be verified. The chemical constituents that should be verified during the partial chemical test are: for carbon and alloy steels, chromium, copper, manganese, molybdenum, nickel, silicon, phosphorus, and sulfur; for stainless steels, chromium, molybdenum, and nickel; and for other metals and alloys, principal alloying elements and commonly recognized impurities. For the full chemical analysis, all elements identified in this guide in the Table of Product Analysis Tolerances and in the material specifications should be verified. Additionally, any element not identified in the table that is identified in the manufacturer's certification should be verified. Requirements imposed by the purchaser should also be considered for use when identifying critical characteristics. Further guidance on the selection of critical characteristics can be found in Generic Letter 89-02 (Ref. 5), Generic Letter 91-05 (Ref. 6), Information Notice 95-12 (Ref. 7), Supplement 1 to Information Notice 92-68 (Ref. 8), Information Notice 96-40 (Ref. 9), Supplement 1 to Information Notice 96-40 (Ref.10),

and NRC Inspection Procedure 38703 (Ref. 11).

Verification methods should be chosen on the basis of their accuracy, precision, and ability to verify the critical characteristics in question. Accordingly, the accuracy and precision of these methods, as well as their appropriateness for the material in question, should be evaluated before they are designated for use. For example, an alloy separator is capable of 8

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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 sparks generated when a metallic item is subject to grinding, is capable of identifying 5

the presence of elements in a material, but it is not a quantitative process and, therefore, would 6

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 quantify the chemical composition of 8

a metallic item.

9 The acceptance criteria for chemical elements are the same for both the partial (part of 10 the I&NDE) and full chemical tests (part of the destructive tests) and are given below in the 11 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&NDE) and 13 the full chemical tests (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 15 range and its tolerance. Therefore, if the tolerances given in the material specification are more 16 limiting, 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 18 contained in the material specification 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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TABLE OF PRODUCT ANALYSIS TOLERANCES Tr) RF= i i~qFfl F~riR (zi Ar~FPPTAN(r'.P Cr.ITPPIA TYPE OF ELEMENT 1

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10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 RESIDUAL ELEMENTS ELEMENT NAME CARBON

% TOLERANCE FROM CMTR VALUE SEE FIGURE 1 MANGANESE SEE FIGURE 2 SILICON SEE FIGURE 3 ALUMINUM NITROGEN

+/-15%

CHROME

+/-10%

COLUMBIUM

+/-10%

NICKEL

+/-10%

COPPER

+/-8%

MOLYBDENUM

+/-8%

VANADIUM

+/-5%

TITANIUM

+/-5%

PHOSPHORUS

+15%

SULFUR OTHERS

+12%

+/-20%

FERRITIC ELEMENTS TYPICALLY SILICON

+/-12.5%

AND ADDED TO MAKE CHROME

+/-10%

MARTENSITIC STAINLESS STEEL MOLYBDENUM

+/-5%

STAINLESS NICKEL

+/-5%

STEEL(

MANGANESE

+/-3%

CARBON

+/-12.5%

AUSTENITIC ELEMENTS TYPICALLY SILICON

+/--12.5%

STAINLESS ADDED TO MAKE CHROME

+/-1.25%

STEEL(Z STAINLESS STEEL MOLYBDENUM

+/-5%

NICKEL

+/-1.5%

MANGANESE

+/-2%

NITROGEN

+/-10%

ALL

PRIMARY, To BE SPECIFIED To BE SPECIFIED OTHER METALS SECONDARY, AND BY THE CUSTOMER BY THE CUSTOMER ANfl Ai I oYs RF1sirI l Fi FMFNT
  • Tolerances for carbon, phosphorus, and sulfur do not apply for rimmed or capped rimmed steel unless misapplication is suspected.
    • Aluminum may be used to verify if the steel is killed.

(

Residual elements not identified in the certified material test report (CMTR) should not be used for verification activities.

() For stainless steel with special alloy additions, those additional elements must be verified to be within *5% of the values shown on the CMTR.

"-For CMTR values of 0.010 wt% and below, use+/-0.002 wt% tolerance.

9 CARBON AND Low ALLOY STEEL*

ELEMENTS TYPICALLY ADDEDTO MAKE CARBON AND LOW ALLOY STEEL

Figure I - Product Analysis Tolerance for Carbon in Carbon and Low Alloy Steels 0.0 7

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. i i "0.06 -

0.05 0.0 3*

0.02 0.050.10 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.00 CMTR Wt% Carbon Carbon Low Alloy its Figure 2 - Product Analysis Tolerance for Manganese in Carbon and Low Alloy Steels 0.10 0.09 0.08 0.07

.L 0.06 0.05 0.04 0.03 0.02 C

pOp

~-00 00 D.30 2.00

't CMTR Wt% Manganese Figure 3 - Product Analysis Tolerance for Silicon in Carbon and Low Alloy Steels 0.050-0.045-A-0.040-g: 0.035 -

. 0.030 0.025 0.020 0.015 0.03 0.05 0.15 CMTR Wt% Silicon Killed Steel Semi-killed 0.60 its 10 1

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3.

LOT FORMATION The forming of inspection lots should incorporate the following practices. Items from different production runs, different models, or different manufacturers should not be included in the inspection lot. Proper lot formation must have evidence of traceability such as (1) original manufacturer markings on each item, (2) original manufacturer certifications, (3) original CMTRs, or (4) original packing slips from the receiving inspection. Combining dissimilar lots to form a larger lot for sampling purposes is not permitted; the destructive testing requirements are applicable only to homogeneous inspection lots. Lots with different pedigrees should be dedicated independently. Finally, any suspected nonconforming items should be removed from the inspection lot before sampling. The inspection lot should be kept as "clean" as possible; that is, inspection lots should be segregated so that the risk of cross-contamination is minimized.

4.

SELECTION OF SAMPLING PLANS FOR INSPECTION AND NONDESTRUCTIVE EXAMINATION Two I&NDE sampling plans that are acceptable to the staff are described in this section for CGI dedication. The first plan, SP1, allows lot sampling for the I&NDE portion of the dedication but mandates that the accepted lot be sent to the purchaser without being subdivided. The size of the samples is based on lot size, and the table in Appendix B shows the sample size needed to meet the 95/05 criterion. The second plan, SP2, specifies 100 percent sampling for the I&NDE portion of the dedication. However, it allows large lots to be dedicated and distributed in a piecewise manner. In both plans, the I&NDE verifies all the critical characteristics, such as dimensions, hardness, partial chemistry, manufacturer's markings, heat number or code, without rendering the items unusable.

The I&NDE sampling plans SP1 and SP2 are designed for situations in which high confidence in the inherent quality of the inspection lot is needed. For example, SP1 is used if the dedicating entity wants to dedicate one lot of CGIs and send that lot to a licensee to satisfy a purchase order. The inspection lot size and acceptance number is determined and the sample size read from Table Al in Appendix B. The sample should be randomly drawn using either of the methods given in Regulatory Position 5 or a similar method. The critical characteristics of the sample are then verified using I&NDE. If the number of defective items in the sample is less than or equal to the acceptance number, c, the lot is provisionally accepted pending the results 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35

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

Figure 4 - Summary of the Overall CGI Dedication Sampling Methodology Note that SP1 does not allow inspection lots to be sampled, accepted, and then divided and shipped to different purchasers. The dedicated lot must be sent in its entirety to the purchaser.

This ensures that the quality of individual shipped lots meets or exceeds the 95/05 criterion.

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

As in SP1, the inspection lot must be from the same heat or production run and must have traceability to the original manufacturer, original manufacturer's certifications, and CMTRs.

However, this plan requires 100 percent sampling for the I&NDE portion of the dedication. The acceptance number for this plan is based on an acceptable defect rate of 5 percent. To calculate the acceptance number, c, for SP2, multiply the inspection lot size by 0.05, rounding up to the nearest whole number. If, during the 100 percent I&NDE, the number of defective 12 1

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1 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

defective items must be discarded or segregated from future inspection lots.

4 In summary, SP1 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.

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5.

SAMPLE SELECTION 11 The samples selected for the I&NDE should be chosen in a random manner without any bias for or against any portion of the lot. For example, either of the following two methods could be used to select samples for the I&NDE. The items can be spread out one layer deep on a large table. The items should be picked at random from the table, without bias toward any side or corner. In another method, a set of random numbers from a random number generator or a table of random numbers is used. The number of random numbers chosen should be equal to the sample size and their values should be no larger than the inspection lot size. The items in the inspection lot are then numbered consecutively, setting aside the items whose numbers match the generated random numbers. The second method is preferable but is not required.

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

6.

INSPECTION AND NONDESTRUCTIVE EXAMINATION Once the sample items have been selected, each of the critical characteristics identified is verified on every item in the sample. An item that fails to meet the acceptance criteria for one or more critical characteristics counts as one reject against the previously chosen acceptance number. Regardless of whether an inspection lot was accepted or rejected, defective items must be removed and discarded, destroyed, or controlled so they are not used for safety-related applications. Rejected items must not be included in future inspection lots.

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DESTRUCTIVE TESTING 2

3 Destructive 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 properties tested (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 all 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 a minimum, 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 specification or purchase order, whichever is smaller.

16 Regardless of whether SP1, 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 (the 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 28 rejected.

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8.

DOCUMENTATION OF RESULTS 1

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10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Pursuant to Appendix B to 10 CFR Part 50, the CGI dedication process must be documented. Appendix B contains criteria for the necessary elements of a quality assurance program. The following is a list of information that typically is provided for documentation.

Reference number Purchase order number (customer's and dedicating entity's)

Manufacturer's certification number and date (when applicable)

Description of lot (e.g., serial numbers, unique characteristics)

Critical characteristics sampled (with tolerances used)

Sample size selected Verification methods Acceptance criteria Results of I&NDE Results of DTs Comparison of I&NDE and destructive test results with acceptance criteria Lot disposition (accepted, rejected, 100 percent examined)

Sampling plans used (give reference or description)

Measurement and test equipment Technical evaluations D.

IMPLEMENTATION The purpose of this section is to provide information to applicants and licensees regarding the staff's plans for using this regulatory guide.

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

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

1 REFERENCES 2

3

1.

Electric Power Research Institute, "Guideline for the Utilization of Commercial Grade 4

Items in Nuclear Safety-Related Applications," NP-5652, Palo Alto, California, June 5

1 988. Proprietary information. Not publicly available.

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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

1997.1 10 11

3.

Electric Power Research Institute, NP-721 8, "Guideline for the Utilization of Sampling 12 Plans for Commercial-Grade Item Acceptance,"Palo Alto, California, June 1992.

13 Proprietary information. Not publicly available.

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4.

U.S. Department of Defense, MIL-STD-105E, "Sampling Procedures and Tables for 16 Inspection by Attributes," 1989.

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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

6.

U.S. Nuclear Regulatory Commission, Generic Letter 91-05, "Licensee Commercial-Grade 22 Procurement and Dedication Programs," April 1991.2 23 24

7.

U.S. Nuclear Regulatory Commission, Information Notice 95-1 2, "Potentially 25 Nonconforming Fasteners Supplied by A&G Engineering II, Inc.," 1995.2 26 27

8.

U.S. Nuclear Regulatory Commission, Information Notice 92-68, Supplement 1, 28 "Potentially Substandard Slip-on, Welding Neck, and Blind Flanges," September 1996.2 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 Practices and in Audits of 35 Vendors," October 1996.2 36 37

11.

U.S. Nuclear Regulatory Commission, "Commercial Grade Dedication," Inspection 38 Procedure 38703, April 1996.2

'Requests for single copies of draft or active regulatory guides (which may be reproduced) or for placement on an automatic distribution list for single copies of future draft guides in specific divisions should be made in writing to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Printing, Graphics and Distribution Branch, or by fax to (301)415-5272. Copies are available for inspection or copying for a fee from the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555; telephone (202)634-3273; fax (202)634-3343.

2Copies are available for inspection or copying for a fee from the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555; telephone (202)634-3273; fax (202)634-3343.

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APPENDIX A GLOSSARY 1

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10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 This glossary discusses terms used in this regulatory guide and provides some formal and some working definitions and interpretations.

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

The integrity of the reactor coolant pressure boundary The capability to shut down the reactor and maintain it in a safe shutdown condition, The capability to prevent or mitigate the consequences of accidents that could result in potential offsite exposures comparable to those referred to in 10 CFR 100.11.

Commercial Grade Item -- When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, a structure, system, component, or part thereof that affects its safety function and that was not designed and manufactured as a basic component. Commercial grade items do not include items for which the design and manufacturing process many in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e.,

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

Certificate of Compliance -- A written statement, signed by a qualified party, attesting that the associated items or material is in accordance with the specified requirements and accompanied by additional information to substantiate the statement.

Certified Material Test Report -- A document attesting that the associated material is in accordance with the specified requirements, including chemical analyses, tests, and examinations of the heat of steel, preferably from a test sample obtained during the pouring of the steel. When required chemical analyses (heat analyses), heat treatment, tests, examinations, or repairs are subcontracted, the subcontractor's certification for the operations performed is furnished as an attachment to the original certified material test report.

Critical Characteristics -- When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, those important design, material, and performance characteristics of a commercial grade item that, once verified, will provide reasonable assurance that the item will perform its intended safety function.

Dedication -- When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended safety function.

In this respect, the item is deemed equivalent to an item designed and manufactured under a quality assurance program that conforms to Appendix B of 10 CFR Part 50. This assurance is achieved by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys, product inspections or a witness at hold points at the manufacturer's facility, and analysis of historical records for acceptable performance.

In all cases, the dedication process

1 must be conducted in accordance with the applicable provisions of Appendix B to 10 CFR Part 2

50. The process is considered complete when the item is designated for use as a basic 3

component.

4 5

Dedicating Entity -- When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, 6

the organization that implements the dedication process. Dedication may be performed by the 7

manufacturer of an item, a third-party dedicating entity, or the licensee (any of these may also 8

be called a dedicator). 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 Destructive 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 render 14 it unusable for its intended purpose.

15 16 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.

18 19 Material 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 not substantially altered or changed in a way that would 25 render it unusable for its intended purpose.

26 27 Product Analysis -- A chemical analysis of the semifinished or finished product, usually for the 28 purpose of derermining 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 heat 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 Products," New York, 1992.)

34 35 Product Analysis Tolerances -- A permissible variation over the maximum limit or under the 36 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 40 10 CFR Part 50, relied on to remain functional during and following design basis events to 41 ensure (1) the integrity of the reactor coolant pressure boundary, (2) the capability to shut 42 down the reactor and maintain 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 events 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 (3) of this paragraph.

48 A-2

1 Unrestricted Use -- Use that is either safety-related or non-safety-related, or not restricted to a 2

specific risk-significance level or category in a nuclear power plant.

A-3

1 2

3 4

5 6

B-1 7

Appendix B Sampling Tables with Instructions The sampling table in this appendix is to be used to determine the correct sample size for the inspection and nondestructive examination portion of sampling plan SPi. The table should be used as follows.

1.

Determine the inspection lot size, m. This probably will be the purchase order quantity, plus one destructive test item, plus the number of allowable defective items from the sample plan.

2.

Choose the appropriate sample plan. There may be some iteration with Step 1 to determine the final inspection lot size.

3.

Choose the maximum number of defective items, c, allowable in the sample.1

4.

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

5.

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

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.

NOTE that for lot sizes greater than 1000, which is the largest lot size in Table 1, the sample sizes should correspond to a lot size of 999. The example on the following page illustrates the use of Table 1 for SP1 in this appendix.

1 The maximum number of defective items in the sample, c, has associated with it a sample size and a risk of rejection if the inspection lot is of acceptable quality. The smaller the value of c, the smaller the sample size but the greater the risk of rejection. Increasing the value of c, however, will cost the dedicating entity more time to examine a larger sample, sometimes approaching the inspection lot size. The tradeoff between the risk of rejection and cost of examination is left to the dedicating entity. If the inspection lot size is less than 20, the only acceptable value of c is c = 0. Otherwise, there is always more than one acceptable value of c, that is, more than one acceptable sample size.

8 9

10 11 12 13 14 15 16 17 18 19 20 21 22

1 2

3 Example Illustrating the Use of Table 1 for SP1 B-2 Suppose that a dedicating entity wants to fill an order for 100 simple metallic items, SIPi is chosen for this application. Further, suppose the dedicating entity chooses to allow at most 1 defective item in the sample, (i.e., c = 1) and since the item is relatively large, 1 destructive test item is required. From Step 1, the inspection lot size is thus m = 100 + 1 + 1 = 102. From Table 1, row 102 and column c = 1, find the sample size of 67. Thus, a random sample of 67 items from the inspection lot must be examined. If no more than 1 of the 67' items is nonconforming, the lot is accepted as being no more than 5 percent defective with at least 95 percent confidence.

The destructive tests are performed if the lot is acceptable after the inspection and nondestructive examination. If:the destructive tests are acceptable, the dedicating entity sends the 100 items to the purchaser in accordance with the purchase order.

Note that if the sample of 67 has 2 defective or nonconforming items (more than the acceptable number), the dedicating entity may choose to implement SP2 and inspect the remaining 35 items that were not sampled (100 percent inspection). After discarding all defective items, the dedicating entity is 100 percent confident that all of the remaining items in the inspection lot are acceptable for the characteristics examined. However, if 6 or more defective items are found, the entire lot must be rejected because it contained more than 5 percent defective items.

S~~~~~~~...

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Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 1

1 37 36 37 2

2 38 37 38 3

3 39 38 39 4

4 40 31 39 40 5

5 41 32 40 41 6

6 42 33 41 42 7

7 43 33 42 43 8

8 44 34 43 44 9

9 45 35 44 45 10 10 46 36 45 46 11 11 47 37 46 47 12 12 48 37 47 48 13 13 49 38 48 49 14 14 50 39 49 50 15 15 51 40 50 51 16 16 52 40 51 52 17 17 53 41 52 53 18 18 54 42 53 54 19 19 55 43 54 55 20 19 20 56 44 55 56 21 20 21 57 44 56 57 22 21 22 58 45 57 58 23 22 23

.59 46 58 59 24 23 24 60 38 52 59 25 24 25 61 38 53 60 26 25 26 62 39 54 61 27 26 27 63 40 55 62 28 27 28 64 40 55 63 29 28 29 65 41 56 64 30 29 30 66 42 57 65 31 30 31 67 42 58 66 32 31 32 68 43 59 67 33 32 33 69 43 60 68 34 33 34 70 44 61 69 35 34 35 71 45 62 70 36 35 36 72 45 62 71

°

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 73 46 63 72 109 49 71 88 108 74 47 64 73 110 49 72 89 109 75 47 65 74 111 50 73 90 110 76 48

-66 75 112 50 73 91 111 i

77 48 67 76 113 51 74 91 112 78 49 68 77 114 51 75 92 113 79 50 68 78 115 51 75 93 114 80 42 60 72 80

° 116 52 76 94 115 81 42 61 73 81 117 52 77 95 116 82 43 61 74 82 118 53 77 96 117 83 43 62 75 83 119 53 78 96 118 84 44 63 76 84

° 120 47 69 87 113 85 45 64 77 85 121 47 70 88 114 86 45 64 78 86 122 47 71 89 114 w

87 46 65 79 87 123 48 71 89 115 88 46 66 80 88 124 48 72 90 116 89 47 67 80 89

° 125 49 72 91 117 90 47 67 81 90 o

126 49 73 91 118 91 48 68 82 91 127 49 73 92 119 92 48 69 83 92 128 50 74 93 120

° 93 49 70 84 93 129 50 75 94 121 94 49 70 85 94 130 51 75 94 122 95 50 71 86 95 131 51 76 95 123 96 50 72 87 96

° 132 51 76 96 124 97 51 73 88 97 133 52 77 97 125 98 51 73 89 98

° 134 52 77 97 126

° 99 52 74 89 99

° 135 53 78 98 127 100 45 65 81 99 136 53 79 99 128 101 45 66 82 100

° 137 53 79 99 129 102 46 67 83 101 138 54 80 100 129 103 46 67 83 102 139 54 80 101 130 104 46 68 84 103 140 48 72 92 122 140 105 47 69 85 104 141 49 73 92 123 141 106 47 69 86 105 142 49 73 93 124 142 107 48 70 87 106

° 143 49 74 94 124 143 108 48 71 87 107 144 50 74 94 125 144

(

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 50 50 51 51 51 52 52 52 53 53 53 54 54 54 55 49 50 50 50 51 51 51 52 52 52 52 53 53 53 54 54 54 55 55 55 50 75 75 76 76 77 78 78 79 79 80 80 81 81 82 82 75 75 76 76 77 77 77 78 78 79 79 80 80 81 81 82 82 83 83 84 77 95 126 145 96 127 146 96 128 147 97 129 148 98 130 149 98 131 150 99 131 151 100 132 152 100 133 153 101 134 154 102 135 155 102 136 156 103 137 157 104 138 158 104 138 159 95 129 159 96 130 160 97 130 161 97 131 162 98 132 163 98 133 164 99 134 165 100 134 166 100 135 167 101 136 168 101 137 169 102 138 170 103 138 171 103 139 172 104 140 173 104 141 174 105 142 175 106 143 176 106 143 177 107 144 178 98 134 173 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 51 77 51 77 51 78 51 78 52 79 52 79 52 80 53 80 53 80 53 81 53 81 54 82 54 82 54 83 55 83 55 83 55 84 55 84 56 85 51 78 51 78 52 79 52 79 52 80 52 80 53 80 53 81 53 81 53 82 54 82 54 82 54 83 54 83 55 84 55 84 55 84 99 135 99 136 100 136 100 137 101 138 102 139 102 139 103 140 103 141 104 142 104 142 105 143 105 144 106 145 106 145 107 146 108 147 108 148 109 148 101 139 101 139 102 140 102 141 103 141 103 142 104 143 104 1,44 105 144 105 145 106 146 106 146 107 147 107 148 108 148 108 149 109 150 174 175 176 177 178 179 179 180 181 182 183 184 185 186 187 188 189 190 191 182 200 183 201 184 202 185 203 186 204 187 205 188 206 189 207 190 208 191 209 192 210 192 211 193 212 194 213 195 214 196 215 197 216

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 217 218 219 220 221 222 223 224 225 226 227 228 229 230

,p 231

0) 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 55 56 56 52 52 52 52 53 53 53 53 54 54 54 54 55 55 55 55 56 56 56 56 52 53 53 53 53 53 54 54 54 54 55 55 55 85 85 86 79 80 80 80 81 81 82 82 82 83 83 83 84 84 84 85 85 86 86 86 80 81 81 81 82 82 82 83 83 83 84 84 84 109 150 198 110 151 199 110 152 200 103 142 190 103 143 191 103 144 192 104 144 193 104 145 193 105 146 194 105 146 195 106 147 196 106 147 197 107 148 198 107 149 199 108 149 199 108 150 200 109 151 201 109 151 202 110 152 203 110 153 204 111 153 205 111 154 206 111 155 206 104 145 196 105 146 197 105 147 198 106 147 198 106 148 199 106 148 200 107 149 201 107 150 202 108 150 203 108 151 203 109 151 204 109 152 205 109 153 206 217 218 219 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 233 234 235 236 237 238 239 240 241 242 243 244 244 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 55 85 55 85 56 85 56 86 56 86 56 87 56 87 53 81 53 82 53 82 53 82 54 83 54 83 54 83 54 84 54 84 55 84 55 84 55 85 55 85 55 85 56 86 56 86 56 86 56 87 56 87 57 87 53 82 53 82 54 83 54 83 54 83 54 84 54 84 55 84 55 85 110 153 110 154 111 154 111 155 112 156 112 156 113 157 106 148 106 148 106 149 107 150 107 150 108 151 108 151 109 152 109 153 109 153 110 154 110 154 111 155 111 155 111 156 112 157 112 157 113 158 113 158 113 159 107 150 107 151 108 151 108 152 108 152 109 153 109 153 110 154 110 154 207 245 207 246 208 247 209 248 210 249 211 250 212 251 201 243 202 244 203 245 203 246 204 246 205 247 206 248 207 249 207 250 208 251 209 252 210 253 210 254 211 255 212 256 213 257 214 258 214 259 215 260 216 260 205 251 206 251 207 252 208 253 208 254 209 255 210 256 211 257 211 258

(

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 C

304 "305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 55 55 55 55 56 56 56 56 56 57 57 54 54 54 54 54 54 55 55 55 55 55 56 56 56 56 56 56 57 57 57 54 54 54 54 55 85 85 85 86 86 86 87 87 87 87 88 83 83 83 84 84 84 85 85 85 85 86 86 86 86 87 87 87 88 88 88 83 84 84 84 85 110 155 212 111 156 213 111 156 213 112 157 214 112 157 215 112 158 216 113 158 216 113 159 217 113 159 218 114 160 219 114 160 219 108 152 209 108 153 210 109 153 210 109 154 211 109 154 212 110 155 213 110 155 213 111 156 214 111 156 215 111 157 215 112 157 216 112 158 217 112 158 217 113 159 218 113 159 219 113 160 220 114 160 220 114 161 221 115 161 222 115 162 222 109 154 212 109 154 213 110 155 214 110 155 214 110 156 215 259 259 260 261 262 263 264 265 266 267 268 257 258 259 260 260 261 262 263 264 265 266 266 267 268 269 270 271 272 272 273 262 263 264 265 266 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 55 85 55 85 55 85 55 86 55 86 56 86 56 86 56 87 56 87 56 87 56 87 57 88 57 88 57 88 57 88 54 84 54 84 54 85 55 85 55 85 55 85 55 86 55 86 55 86 56 86 56 87 56 87 56 87 56 87 56 88 57 88 57 88 57 88 57 89 57 89 54 85 111 156 111 157 111 157 112 158 112 158 112 159 113 159 113 160 113 160 114 161 114 161 114 162 115 162 115 163 115 163 110 155 110 156 110 156 111 157 111 157 111 158 112 158 112 159 112 159 113 160 113 160 113 160 114 161 114 161 114 162 115 162 115 163 115 163 116 164 116 164 111 157 216 267 216 267 217 268 218 269 218 270 219 271 220 271 220 272 221 273 222 274 222 275 223 276 224 276 224 277 225 278 215 267 216 268 216 269 217 269 218 270 218 271 219 272 220 273 220 273 221 274 221 275 222 276 223 277 223 277 224 278 225 279 225 280 226 281 227 281 227 282 218 271

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 361 362 363 364 365 366 367 368 369 370 371 372 373 374 w

375 co 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 55 55 55 55 55 55 55 56 56 56 56 56 56 57 57 57 57 57 57 55 55 55 55 55 55 55 56 56 56 56 56 56 57 57 57 57 85 85 85 85 86 86 86 86 87 87 87 87 88 88 88 88 89 89 89 85 85 85 86 86 86 86 87 87 87 87 87 88 88 88 88 89 111 157 218 111 158 219 111 158 219 112 159 220 112 159 221 112 159 221 113 160 222 113 160 222 113 161 223 114 161 224 114 162 224 114 162 225 115 162 226 115 163 226 115 163 227 116 164 227 116 164 228 116 165 229 116 165 229 111 158 220 112 158 220 112 159 221 112 159 222 112 160 222 113 160 223 113 160 223 113 161 224 114 161 225 114 162 225 114 162 226 114 163 226 115 163 227 115 163 227 115 164 228 116 164 229 116 165 229 272 273 273 274 275 276 277 277 278 279 280 280 281 282 283 283 284 285 286 275 276 276 277 278 278 279 280 281 281 282 283 284 284 285 286 286 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 57 89 57 89 57 89 55 85 55 86 55 86 55 86 55 86 56 86 56 87 56 87 56 87 56 87 56 88 56 88 56 88 57 88 57 88 57 89 57 89 57 89 57 89 57 89 55 86 55 86 55 86 55 86 56 87 56 87 56 87 56 87 56 87 56 88 56 88 56 88 57 88 116 165 117 166 117 166 112 159 112 159 112 160 113 160 113 161 113 161 114 161 114 162 114 162 114 163 115 163 115 163 115 164 116 164 116 165 116 165 116 165 117 166 117 166 117 167 112 160 113 160 113 161 113 161 113 162 114 162 114 162 114 163 115 163 115 164 115 164 115 164 116 165 230 287 230 288 231 289 222 278 222 279 223 279 224 280 224 281 225 282 225 282 226 283 226 284 227 284 227 285 228 286 229 286 229 287 230 288 230 289 231 289 231 290 232 291 232 291 224 281 224 282 225 282 225 283 226 284 226 284 227 285 227 286 228 286 229 287 229 288 230 288 230 289

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449

(.0 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 57 57 57 57 57 57 58 55 55 55 56 56 56 56 56 56 56 56 57 57 57 57 57 57 57 57 58 55 55 56 56 56 56 56 56 56 88 89 89 89 89 89 90 86 86 86 87 87 87 87 87 88 88 88 88 88 89 89 89 89 89 90 90 86 87 87 87 87 87 88 88 88 116 165 231 116 165 231 116 166 232 117 166 232 117 167 233 117 167 233 118 167 234 113 161 225 113 161 226 113 162 226 114 162 227 114 162 227 114 163 228 114 163 228 115 164 229 115 164 229 115 164 230 116 165 231 116 165 231 116 165 232 116 166 232 117 166 233 117 167 233 117 167 234 117 167 234 118 168 235 118 168 235 113 162 227 114 162 227 114 163 228 114 163 228 114 163 229 115 164 229 115 164 230 115 164 230 115 165 231 290 290 291 292 292 293 294 284 284 285 285 286 287 287 288 289 289 290 291 291 292 293 293 294 295 295 296 286 287 287 288 288 289 290 290 291 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 56 88 57 88 57 88 57 89 57 89 57 89 57 89 57 89 57 90 58 90 58 90 55 87 56 87 56 87 56 87 56 87 56 88 56 88 56 88 56 88 57 88 57 88 57 89 57 89 57 89 57 89 57 89 57 90 57 90 58 90 58 90 56 87 56 87 56 87 56 87 56 88 116 165 116 165 116 166 116 166 117 166 117 167 117 167 117 168 118 168 118 168 118 169 114 163 114 163 114 163 115 164 115 164 115 164 115 165 116 165 116 165 116 166 116 166 116 166 117 167 117 167 117 167 117 168 118 168 118 168 118 169 118 169 114 163 114 164 115 164 115 164 115 165 231 292 232 292 232 293 233 293 233 294 234 295 234 295 235 296 235 297 236 297 236 298 228 288 229 289 229 289 230 290 230 290 231 291 231 292 232 292 232 293 233 294 233 294 234 295 234 295 234 296 235 297 235 297 236 298 236 298 237 299 237 300 230 290 230 291 230 291 231 292 231 292

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 o

521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 56 56 56 56 57 57 57 57 57 57 57 57 58 58 58 56 56 56 56 56 56 56 56 57 57 57 57 57 57 57 57 57 58 58 58 56 88 88 88 88 89 89 89 89 89 89 90 90 90 90 90 87 87 88 88 88 88 88 88 89 89 89 89 89 89 90 90 90 90 90 90 87 115 165 232 116 165 232 116 166 233 116 166 233 116 166 234 117 167 234 117 167 235 117 167 235 117 168 236 117 168 236 118 168 236 118 169 237 118 169 237 118 169 238 119 170 238 115 164 231 115 164 231 115 165 232 115 165 232 115 165 232 116 166 233 116 166 233 116 166 234 116 167 234 117 167 235 117 167 235 117 167 236 117 168 236 117 168 237 118 168 237 118 169 237 118 169 238 118 169 238 119 170 239 119 170 239 115 165 232 293 294 294 295 295 296 296 297 298 298 299 299 300 301 301 292 292 293 294 294 295 295 296 296 297 298 298 299 299 300 300 301 301 302 303 294 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567 568 569 570 571 572 573 574 575 576 56 88 115 165 56 88 115 165 56 88 116 166 56 88 116 166 56 88 116 166 56 88 116 166 57 89 116 167 57 89 117 167 57 89 117 167 57 89 117 168 57 89 117 168 57 89 118 168 57 90 118 169 57 90 118 169 57 90 118 169 58 90 118 170 58 90 119 170 58 90 119 170 58 91 119 170 56 88 115 165 56 88 115 165 56 88 116 166 56 88 116 166 56 88 116 166 56 88 116 167 57 89 117 167 57 89 117 167 57 89 117 168 57 89 117 168 57 89 117 168 57 89 118 168 57 90 118 169 57 90 118 169 57 90 118 169 57 90 118 170 58 90 119 170 232 294 233 295 233 295 234 296 234 296 234 297 235 297 235 298 236 298 236 299 237 300 237 300 237 301 238 301 238 302 239 302 239 303 240 303 240 304 233 295 233 296 234 296 234 297 234 297 235 298 235 298 236 299 236 299 237 300 237 300 237 301 238 301 238 302 239 303 239 303 240 304

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 9

592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 58 58 58 56 56 56 56 56 57 57 57 57 57 57 57 57 57 57 58 58 58 58 58 56 56 56 56 57 57 57 57 57 57 57 57 57 90 90 91 88 88 88 88 88 89 89 89 89 89 89 89 90 90 90 90 90 90 91 91 88 88 88 88 89 89 89 89 89 89 89 90 90 119 170 240 119 171 240 119 171 241 116 166 234 116 166 234 116 166 235 116 167 235 116 167 235 117 167 236 117 167 236 117 168 237 117 168 237 117 168 237 118 169 238 118 169 238 118 169 239 118 169 239 118 170 239 119 170 240 119 170 240 119 171 241 119 171 241 119 171 241 116 166 235 116 166 235 116 167 235 116 167 236 117 167 236 117 168 237 117 168 237 117 168 237 117 168 238 118 169 238 118 169 239 118 169 239 118 170 239 304 305 305 297 297 298 298 299 299 300 300 301 301 302 302 303 303 304 304 305 305 306 306 298 298 299 299 300 300 301 301 302 302 303 303 304 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 57 90 118 170 57 90 119 170 58 90 119 170 58 90 119 171 58 91 119 171 58 91 119 171 58 91 120 172 56 88 116 167 56 88 116 167 56 88 116 167 56 89 117 167 57 89 117 168 57 89 117 168 57 89 117 168 57 89 117 169 57 89 118 169 57 89 118 169 57 90 118 169 57 90 118 170 57 90 118 170 57 90 119 170 58 90 119 170 58 90 119 171 58 90 119 171 58 91 119 171 58 91 120 172 58 91 120 172 56 88 116 167 56 88 117 167 56 89 117 168 57 89 117 168 57 89 117 168 57 89 117 168 57 89 117 169 57 89 118 169 57 89 118 169 240 304 240 305 241 305 241 306 241 306 242 307 242 307 235 299 236 300 236 300 237 301 237 301 237 302 238 302 238 303 239 303 239 304 239 304 240 304 240 305 240 305 241 306 241 306 242 307 242 307 242 308 243 308 236 300 237 301 237 301 237 302 238 302 238 303 238 303 239 304 239 304

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 IP 664 "665 666 667 668 669 670 671 672 673 674 675 676 677 678 679 680 681 682 683 684 57 57 57 57 57 58 58 58 58 58 58 56 56 57 57 57 57 57 57 57 57 57 57 57 58 58 58 58 58 58 58 56 57 57 57 57 90 90 90 90 90 90 90 91 91 91 91 88 89 89 89 89 89 89 89 90 90 90 90 90 90 90 91 91 91 91 91 89 89 89 89 89 118 169 240 118 170 240 118 170 240 119 170 241 119 171 241 119 171 241 119 171 242 119 171 242 119 172 243 120 172 243 120 172 243 117 168 237 117 168 237 117 168 238 117 168 238 117 169 238 117 169 239 118 169 239 118 169 239 118 170 240 118 170 240 118 170 241 119 170 241 119 171 241 119 171 242 119 171 242 119 171 242 119 172 243 120 172 243 120 172 243 120 172 244 117 168 238 117 168 238 117 168 238 117 169 239 117 169 239 305 305 306 306 306 306 307 308 308 309 309 301 302 302 303 303 304 304 305 305 306 306 306 307 307 308 308 309 309 310 310 302 303 303 304 304 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 57 89 57 89 57 90 57 90 57 90 57 90 57 90 57 90 58 90 58 90 58 91 58 91 58 91 58 91 58 91 57 89 57 89 57 89 57 89 57 89 57 89 57 90 57 90 57 90 57 90 57 90 57 90 57 90 58 90 58 91 58 91 58 91 58 91 58 91 58 91 57 89 118 169 118 169 118 170 118 170 118 170 119 170 119 171 119 171 119 171 119 171 119 172 120 172 120 172 120 172 120 173 117 168 117 168 117 169 118 169 118 169 118 169 118 170 118 170 118 170 119 170 119 171 119 171 119 171 119 171 119 172 120 172 120 172 120 172 120 173 120 173 117 169 239 305 240 305 240 306 240 306 241 306 241 307 242 307 242 308 242 308 243 309 243 309 243 310 244 310 244 311 244 311 238 303 239 304 239 304 239 305 240 305 240 306 240 306 241 306 241 307 241 307 242 308 242 308 242 309 243 309 243 310 243 310 244 310 244 311 244 311 245 312 239 304

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 721 722 723 724 725 726 727 728 729 730 731 732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 117 169 239 118 169 240 118 169 240 118 170 240 118 170 241 118 170 241 118 170 241 119 170 242 119 171 242 119 171 242 119 171 243 119 171 243 119 172 243 120 172 244 120 172 244 120 172 244 120 173 245 120 173 245 120 173 245 117 169 239 118 169 240 118 169 240 118 170 240 118 170 241 118 170 241 118 170 241 119 171 242 119 171 242 119 171 242 119 171 243 119 171 243 119 172 243 119 172 244 120 172 244 120 172 244 120 173 245 305 305 306 306 306 307 307 308 308 309 309 309 310 310 311 311 312 312 312 305 306 306 306 307 307 308 308 309 309 309 310 310 311 311 311 312 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787 788 789 790 791 792 CO 3

58 91 120 173 58 91 120 173 58 91 120 173 57 89 118 169 57 89 118 169 57 89 118 170 57 89 118 170 57 90 118 170 57 90 118 170 57 90 119 171 57 90 119 171 57 90 119 171 57 90 119 171 57 90 119 171 58 90 119 172 58 91 119 172 58 91 120 172 58 91 120 172 58 91 120 173 58 91 120 173 58 91 120 173 58 91 120 173 58 91 121 174 57 89 118 170 57 89 118 170 57 89 118 170 57 90 118 170 57 90 118 170 57 90 118 171 57 90 119 171 57 90 119 171 57 90 119 171 57 90 119 172 57 90 119 172 58 90 119 172 58 91 120 172 245 312 245 313 246 313 240 306 240 306 241 307 241 307 241 308 242 308 242 308 242 309 243 309 243 310 243 310 244 311 244 311 244 311 244 312 245 312 245 313 245 313 246 313 246 314 241 307 241 307 241 308 241 308 242 308 242 309 242 309 243 310 243 310 243 310 244 311 244 311 244 312

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 58 58 58 58 58 58 58 57 57 57 57 57 57 57 57 57 57 58 58 58 58 58 58 58 58 58 58 57 57 57 57 57 57 57 57 57 91 91 91 91 91 91 91 89 89 90 90 90 90 90 90 90 90 90 91 91 91 91 91 91 91 91 91 89 90 90 90 90 90 90 90 90 120 172 245 120 173 245 120 173 245 120 173 245 120 173 246 120 173 246 121 174 246 118 170 241 118 170 241 118 170 242 118 170 242 118 171 242 119 171 243 119 171 243 119 171 243 119 172 243 119 172 244 119 172 244 120 172 244 120 172 245 120 173 245 120 173 245 120 173 246 120 173 246 120 173 246 121 174 246 121 174 247 118 170 241 118 170 242 118 170 242 118 171 242 119 171 243 119 171 243 119 171 243 119 172 244 119 172 244 312 312 313 313 314 314 314 308 308 308 309 309 310 310 310 311 311 311 312 312 313 313 313 314 314 315 315 308 309 309 309 310 310 311 311 311 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 844 845 846 847 848 849 850 851 852 853 854 855 856 857 858 859 860 861 862 863 864 w

57 90 58 91 58 91 58 91 58 91 58 91 58 91 58 91 58 91 58 91 58 92 57 90 57 90 57 90 57 90 57 90 57 90 57 90 57 90 57 90 58 90 58 91 58 91 58 91 58 91 58 91 58 91 58 91 58 91 58 91 58 92 57 90 57 90 57 90 57 90 57 90 119 172 120 172 120 172 120 173 120 173 120 173 120 173 120 173 121 174 121 174 121 174 118 170 118 171 118 171 119 171 119 171 119 171 119 172 119 172 119 172 119 172 120 172 120 173 120 173 120 173 120 173 120 173 120 174 121 174 121 174 121 174 118 171 118 171 119 171 119 171 119 171 244 312 244 312 245 312 245 313 245 313 246 314 246 314 246 314 247 315 247 315 247 315 242 309 242 309 243 310 243 310 243 310 243 311 244 311 244 312 244 312 245 312 245 313 245 313 245 313 246 314 246 314 246 314 247 315 247 315 247 316 247 316 242 310 243 310 243 310 243 311 243 311

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 865 866 867 868 869 870 871 872 873 874 875 876 877 878 879 880 881 882 883 884 885 886 887 888 889 890 891 892 893 894 895 896 897 898 899 900 57 57 57 57 58 58 58 58 58 58 58 58 58 58 58 57 57 57 57 57 57 57 57 58 58 58 58 58 58 58 58 58 58 58 58 57 90 90 90 90 91 91 91 91 91 91 91 91 91 92 92 90 90 90 90 90 90 90 90 91 91 91 91 91 91 91 91 91 91 92 92 90 119 172 244 119 172 244 119 172 244 119 172 245 120 172 245 120 173 245 120 173 245 120 173 246 120 173 246 120 173 246 120 174 247 121 174 247 121 174 247 121 174 247 121 174 248 118 171 243 119 171 243 119 171 243 119 171 244 119 172 244 119 172 244 119 172 244 119 172 245 120 172 245 120 173 245 120 173 246 120 173 246 120 173 246 120 173 246 120 174 247 121 174 247 121 174 247 121 174 247 121 174 248 121 175 248 119 171 243 C1 311 312 312 312 313 313 314 314 314 315 315 315 316 316 316 310 311 311 311 312 312 312 313 313 313 314 314 314 315 315 316 316 316 317 317 311 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 920 921 922 923 924 925 926 927 928 929 930 931 932 933 934 935 936 57 90 119 171 57 90 119 171 57 90 119 172 57 90 119 172 57 90 119 172 57 90 119 172 57 90 120 172 58 91 120 173 58 91 120 173 58 91 120 173 58 91 120 173 58 91 120 173 58 91 120 174 58 91 120 174 58 91 121 174 58 91 121 174 58 91 121 174 58 92 121 174 58 92 121 175 57 90 119 171 57 90 119 171 57 90 119 172 57 90 119 172 57 90 119 172 57 90 119 172 57 90 119 172 58 91 120 173 58 91 120 173 58 91 120 173 58 91 120 173 58 91 120 173 58 91 120 174 58 91 120 174 58 91 121 174 58 91 121 174 58 91 121 174 243 311 244 311 244 312 244 312 245 313 245 313 245 313 245 314 246 314 246 314 246 315 246 315 247 315 247 316 247 316 248 316 248 317 248 317 248 317 244 311 244 312 244 312 244 312 245 313 245 313 245 313 245 314 246 314 246 314 246 315 246 315 247 315 247 316 247 316 248 316 248 317

(

Table 1. Sample Size Required To Satisfy the 95/5 Criterion Inspection Maximum Number of Defectives in Sample (c)

Inspection Maximum Number of Defectives in Sample (c)

Lot Size 0

1 2

4 7

10 Lot Size 0

1 2

4 7

10 937 938 939 940 941 942 943 944 945 946 947 948 949 950 951 952 953 954 955 956 957 958 959 960 961 962 963 964 965 966 967 968 969 970 971 972 58 58 58 57 57 57 57 57 57 57 58 58 58 58 58 58 58 58 58 58 58 58 58 57 57 57 57 57 57 58 58 58 58 58 58 58 973 974 975 976 977 978 979 980 981 982 983 984 985 986 987 988 989 990 991 992 993 994 995 996 997 998 999 1000 58 91 121 174 248 317 58 91 121 174 248 317 58 91 121 174 248 317 58 92 121 175 248 318 58 92 121 175 249 318 58 92 121 175 249 318 58 92 121 175 249 319 57 90 119 172 245 313 57 90 119 172 245 313 57 90 119 172 245 314 57 90 119 172 245 314 57 90 120 173 246 314 57 91 120 173 246 314 58 91 120 173 246 315 58 91 120 173 246 315 58 91 120 173 247 315 58 91 120 173 247 316 58 91 120 174 247 316 58 91 120 174 247 316 58 91 121 174 248 317 58 91 121 174 248 317 58 91 121 174 248 317 58 91 121 174 248 318 58 92 121 175 249 318 58 92 121 175 249 318 58 92 121 175 249 319 58 92 121 175 249 319 57 90 119 172 245 313

..w 0) 92 92 92 90 90 90 90 90 90 91 91 91 91 91 91 91 91 91 91 91 92 92 92 90 90 90 90 90 90 91 91 91 91 91 91 91 121 174 248 121 175 248 121 175 249 119 171 244 119 172 244 119 172 244 119 172 245 119 172 245 119 172 245 120 173 245 120 173 246 120 173 246 120 173 246 120 173 246 120 173 247 120 174 247 120 174 247 121 174 248 121 174 248 121 174 248 121 175 248 121 175 249 121 175 249 119 172 244 119 172 244 119 172 245 119 172 245 119 172 245 120 173 245 120 173 246 120 173 246 120 173 246 120 173 247 120 173 247 120 174 247 120 174 247 317 317 318 312 312 313 313 313 314 314 314 315 315 315 316 316 316 317 317 317 318 318 318 312 313 313 313 314 314 314 315 315 315 316 316 316

REGULATORY ANALYSIS

1.

STATEMENT OF PROBLEM 1

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10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 RA-1 The U.S. Nuclear Regulatory Commission has promulgated regulations to provide quality assurance requirements for nuclear power plants. Those requirements are contained in Appendix B to 10 CFR Part 50, which provides criteria for quality assurance programs for structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue safety risk to the health and safety of the public.

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

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

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

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

2.

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

3.

ALTERNATIVES The alternatives to issuing a regulatory guide on the use of sampling for dedicating simple, metallic commercial grade items are as follows:

1 3.1 Do Not Issue Regulatory Guidance 2

The detailed guidance, acceptance criteria, and sampling 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 extremely time-consuming 5

for both the NRC staff and the licensee, are 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 8

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 10 established standard, vendors will be hesitant to change their dedication programs as a result 11 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 Regulatory 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 B to 10 CFR Part 50. By using either of these methods, the licensees, acting as 34 either the dedicators or purchasers of dedicated CGIs, may have confidence in the quality and 35 consistency of the dedication and know that vendors will be using identical references, 36 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 sample sizes. However, the market will 49 adjust to the changes by eliminating suppliers that can not comply with the new requirements RA-2

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9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 RA-3 (which may serve to boost prices) and standardizing, among all vendors, the criteria that must be met (which may serve to reduce prices by increasing competition).

Licensees may also realize a decrease in degradation or failure rate of replacement parts, and a corresponding increase in availability of components or systems. This benefit may be difficult to estimate, given that many repairs and replacements are included in estimates of preventive maintenance activities.

4.4 Vendor Costs Vendors that currently do not meet the intent of Appendix B to 10 CFR Part 50 must decide whether to remain in the nuclear supply business. For other vendors, added costs may be limited to upgrading equipment and procedures and training personnel in the new methodology. Ultimately, all costs associated with the changes will be passed on to the customer.

5.

DECISION RATIONALE This guidance should be issued as a regulatory guide because (1) a wider consensus of the NRC, ACRS, industry, and the public would be possible, (2) a standard methodology would be established, and (3) inefficient use of the NRC staff, vendor, and licensee resources would be eliminated.

The other alternatives, identified above, for providing guidance on the use of sampling for the dedication of simple metallic commercial grade items do not provide the level of review and wide consensus required. In addition, while these alternatives may result in the same costs to licensees or vendors, they result in inefficient use of NRC staff resources. The alternatives are therefore judged to be unacceptable.

F Printed Jon recycled Federal Recycling Program

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 20555-0001 FIRST CLASS MAIL POSTAGE AND FEES PAID USNRC PERMIT NO. G-67 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300

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