ML20136C334
| ML20136C334 | |
| Person / Time | |
|---|---|
| Issue date: | 02/28/1997 |
| From: | NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | |
| Shared Package | |
| ML20136C331 | List: |
| References | |
| NUDOCS 9703120043 | |
| Download: ML20136C334 (68) | |
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SAMPLING PLANS FOR DEDICATING SIMPLE, METALLIC-COMMERCIAL GRADE ITEMS AT NUCLEAR POWER i
PLANTS 4
i Technical Report j
U.S. Nuclear Regulatory Commission Office of Nuclear Regulatory Research i
February 1997 9
'l 9703120043 970227 PDR ORO NREA PDR
I ABSTRACT I
The Nuclear Regulatory Commission's (NRC's) Office of Nuclear Regulatory Research developed this report as a result of a request from NRC's Office of Nuclear Reactor Regulation. The original request was for a review and endorsement, if justified, of the I
sampling methodology described in EPRI NP-7218, " Guidelines for the Utilization of Sampling Plans for Commercial-Grade item Acceptance (NClG-19)." The review of that report identified several deficiencies so that it could not be endorsed. Consequently, this I
report was developed to serve as a referenes to the NRC staff on the use of sampling plans for dedicating simple, metallic commercial grade items at nuclear power plants.
l This report was developed through the efforts of an interoffice team led by Electrical, B
Materials, and Mechanical Engineering Branch of the Division of Engineering Technology (EMMEB/DET), RES. The team members were staff from the EMMEB/DET/RES, Probabilistic Risk Assessment Branch of the Division of Systems Technology, RES, the I
Quality Assurance and Maintenance Branch of the Division of Reactor Controls and Human Factors, NRR, and the Materials and Chemical Engineering Branch of the Division of Engineering, NRR. The team reviewed the history, practices, and guidelines for commercial I
grade dedication in the nuclear industry to understand the particular needs for a new sampling reference. Additionally, they analyzed various material standards such as those in the American Society of Mechanical Engineers Boiler and Pressure Vessel Code, Section 11, and the American Society for Testing and Materials, and reviewed standard industrial steel-making practices. This report builds on that analysis and review, and provides technical criteria for assuring the integrity of a sampling process for simple, metallic I
commercial grade items.
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l TABLE OF CONTENTS 1
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.P_ age 1
I NT RO D U CTI O N.............................................. 1 I
2 SCOPE....................................................2 3
BACKGROUND.............................................. 3 1
4 SdMPLING FOR ACCEPTANCE OF COMMERCIAL GRADE ITEMS........... 5 4.1 Assessment of Safety Significance and Function.................. 5 1
4.2 Identification of Critical Characteristics, Verification Methods, and Acceptance Crite ria...................................... 6 4.3 Lot Formation........................................ 10 4.4 Selection of Sampling Plans for Inspection and Nondestructive Ex a mi n a ti o n.......................................... 10 4.5 Sample Sele ction....................................... 12 4.6 Implementation of Sampling Plan............................ 13 4.7 Destructive Testing
.....................................13 4.8 Documentation of Results................................. 14 5
S U M M A RY................................................ 1 4 6
B I B LI O G R A PH Y............................................. 1 6 G l o s s a ry....................................................... 1 9 Appendix A: Sampling Table with Instructions for Acceptance Sa mpling of CGls............................................ 2 3 Appendix B: Example of CGI Dedication with Sampling Methodology............. 40 Appendix C: Discussion of Sampling Methodology.......................... 43 Appendix D: Operating Characteristic Curves for Selected Sample Sizes.......... 48 I
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INTRODUCTION I
This report contains technical criteria for using sampling plans to dedicate commercial grade items (CGis) for unrestricted use in nuclear power plants (NPPs). It makes use of the Electric Power Research Institute (EPRI) Method I, Special Tests and Inspections (EPRI I
NP-5652,1988), and is limited to simple, metallic CGis with critical characteristics that can be verified after their manufacture. This report also contains specific instructions and cautions in the application of sampling plans for comnwial grade dedication.
The criteria provided in this report are based on experience gained from inspections and a review of industry programs and practices, statistical analysis, and on the practices of the I
melting mills, where metals are mixed, purified, and formed. This experience was balanced against the need for an exacting sampling methodology that will provide a reasonable assurance that an item will perform its intended safety function.
Three important concepts form the basis for this report. The first concept is traceability, the ability to follow the development, process, or history of an item, especially through markings or paperwork. The second concept considers defect rate, the frequency with I
which nonconformances, imperfections, flaws occur in a set of items. The third concept involves the variability of concentration of basic chemical elements that must be used to g
verify the identity of metallic items. These concepts are discussed frequently throughout l
the report. The report applies them to reasonably ensure the consistent high quality of dedicated CGis.
l The underlying premise is that individualinspection lots should be sampled in a way that will give a high confidence of a low defect rate. The sampling plan in this report provides 95 percent confidence that 5 percent or less of a lot of items are nonconforming. This is called a 95/05 plan. This standard confidence level was chosen to control the consumer's risk, that is, the risk that an unacceptable lot is accepted. Other sampling plans, such as the EPRI NP-7218 guideline (EPRI NP-7218,1992) provide sampling plans for use in accepting and dedicating CGls. The sample sizes in these plans, which are based on MIL STD 105E (U.S. Department of Defense,1989), are smaller than those in the plans provided in this report. The EPRI plans are based on MIL-STD 105E, which assumes the I
items in question are manufactured at the same time, using the same processes, with the same quality control and personnel. Consequently, the EPRI plans involve higher consumer's risk (the probability of accepting a lot with more than 5 percent nonconforming I
items) especially for lot sizes below 100. However, this report does not assume a continuous manufacturing process and, therefore, requires larger sample sizes to provide assurance of lot quality.
Through the years, NPP experience has shown that, in general, most plant equipment can be counted on to operate reliably and safely. This observation is also true concerning the parts used to repair or replace that equipment. Since unavailability has been reduced and reliability has increased over time, and common-mode failures of structures, systems, or
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components caused by the failure of simple metallic items are rare, we conclude that the past procedure of procuring replacement parts from Appendix B qualified suppliers has been 1
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successful. However, the number of qualified Appendix B suppliers is shrinking. In light of
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the current supplier situation, this information is needed to provide a consistent level of assurance that should maintain this current high level of performance. This is becoming Increasingly relevant due to the decreasing number of suppliers qualified in accordance with
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Appendix B to Part 50 of Title 10 of the Code of Federal Regulations (10 CFR Part 50)(U.S.
Code of FederalReguletions,1996b).
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The criterion of 95 percent confidence that no more than 5 percent of the acceptable items are nonconforming was subjectively chosen as an appropriate level of assurance necessary to maintain the current level of performance. Alternative sampling plans are available, for
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example, a double sampling plan. References are given to helpful texts on this subject if the user desires more information on this topic. However, this report does not discuss the alternatives in detail. For alternative sampling plans, the intent of this report is met as long
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as the applicable restrictions are followed.nd the 95/05 criterion is satisfied.
This report contains the following four appendices: Appendix A, " Sampling Table with
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Instructions for Acceptance Sampling of CGis," Appendix B, " Example of CGI Dedication with NRC Sampling Methodology," Appendix C, " Discussion of NRC Sampling Methodology, and Appendix D, " Operating Characteristic Curves." Appendix A is an
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essentir.1 part of this report. Appendix B through Appendix D are not essential, however, they may enhance the user's understanding of the process.
2 SCOPE This report provides technical criteria for the use of sampling plans for dedicating simple,
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metallic CGls at NPPs. The scope of the criteria is limited to piece parts, such as pipe, pipe fittings, structural shapes, and fasteners intendad for unrestricted use at NPPs. The sampling plan is based on a statistical approach that should limit the maximum defect rate
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of individuallots shipped to NPPs. This approach can be used to assess CGI nonconformance, in defect,' rates and, therefore, CGI quality for individual lots. The statistical appros:h minimizes the required number of inspections, nondestructive examinations, and destructive tests necessary to maintain a high level of quality.
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- The term " defect", as generally used in this report, means a nonconforming, unacceptable, or substandard part or condition. This should not be confused with the term as used in 10 CFR Part 21 (U.S.
Code of Federal Regulations,1996a), in Part 21, the term means (1) e deviation in a basic component
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delivered to a purchaser for use in a facility or en activity subject to the regulations in Part 21 if, on the basis of an evaluation, the deviation could create a substantial safety hazard; (2) the installation, use, or operation of a basic component containing a defect; (3) a deviation in a portion of a facility subject to Part 50 provided, on the basis of an evaluation, the deviation could create a substantial safety hazard and the portion of the facility
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containing the deviation has been offered to the purchaser for acceptance; or (4) a condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit as defined in a licensee's technical specifications.
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3 BACKGROUND Part 21 of 10 CFR (U.S. Code of FederalRegulations,1SS6a) contains rules for reporting nonccmpliances or defects in, or failures to comply with specifications for, basic components of NPPs and other nuclear facilities. The requirement to report known defects in products supplied to NPPs and other nuclear facilities includes basic components. Any knowledge of noncompliance, defects, or failures to comply with specifications for, dedicated CGis supplied to NPPs and other nuclear facilities that could create a substantial safety hazard must be reported to the Commission.
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The restrictive definition of CGI, first promulgated in Part 21 in 1977, led industry representatives to request e rulemaking to broaden the definition of a CGI, to revise the definition of " dedication" to add flexibility, and to suggest that the reporting of defects and
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failures to comply should be the responsibility of the party performing the dedication. Part 21 was revised in 1995 after lengthy consideration of comments from petitioners and the public. The definition of " basic component" was revised to mean an item that affects a
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safety function. A " commercial grade item" was redefined as a structure, system, or component, or part thereof, that affects a safety function and that was not designed or manufactured as a basic component. The rulemaking also added the definitions of terms
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such as " critical characteristics," " dedication," and " dedicating entity." This report is intended to be consistent with the revised Part 21 definitions unless stated otherwise.
Commercial grade dedication by sampling is currently being used two ways. The first use is for small items, such as mill shapes, flanges, bolts, pipe, and fittings, which fall under the "small parts" exemption of ASME Code Section lil, NX-2610 (American Society of l
Mechanical Engineers,1992). These CGis are purchased, dedicated, and then furnished as l
ASME Section ill Code material under the provisions of NX-2610. The second use is for CGis bought and dedicated by suppliers or manufacturers for unrestricted, non-ASME Code use in NPPs. These criteria apply both to items designated as NX-2610 small parts and to those CGis purchased and dedicated for unrestricted use.
I A CGI is dedicated for use as a basic component in a NPP when the critical characteristics of the item are identified, their acceptability is verified, and the item is designated as suitable for use as a basic component. The dedication process provides reasonable assurance to the NRC, industry, and public that the dedicated CGI can perform its function I
as if it had been designed, manufactured, and purchased under a Part 50, Appendix B (U.S.
Code of FederalRegulations,1996b) quality assurance program.
Four basic commercial grade dedication methods are described by EPRI (EPRI NP-5652, I
1988) and are summarized below. The U.S. Nuclear Regulatory Commission (NRC) has reviewed and approved the use of these methods subject to the limitations and exceptions described in Generic Letter 85-02 (U.S. NRC,1989) and Generic Letter 91-05 (U.S. NRC, 1991). The CGI dedication criteria discussed herein build on that earlier work.
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EPRI Method 1: Special Tests and Inspections Under this method the purchaser or its agent performs tests and inspections to verify that the critical characteristics identified for the CGI meet established acceptance criteria. The.
f verification provides reasonable assurance that the item will perform its intended function, if sampling plans are used, they must be controlled and have an adequately documented technical basis. Proper consideration should be given to the traceability and homogeneity of the production lot, the complexity of the item, the adequacy of supplier controls, and the performance history of the supplier and the item.
f EPRI Method 2: Commercial Grade Survey Under this method the purchaser or its agent conducts surveys at the supplier's facilities to verify that the supplier's or manufacturer's quality activities control the critical characteristics of the CGI production line. As noted in Generic Letter 89-02, " Method 2 should not be employed solely as the basis for accepting items from distributors unless the survey includes the part manufacturer (s) and the survey confirms adequate controls by both the distributor and the part manufacturer (s)."
EPRI Method 3: Source Verification Under this method the purchaser or its agent witnesses quality activities at the supplier's facilities, focusing on the specific items to be supplied, to verify that the supplier or manufacturer adequately controls the critical characteristics of the item.
EPRI Method 4: Acceptable Supplier / Item Performance Recnrd Under this method historical performance data, such as the msults o' commercial grade surveys or source verifications conducted by the purchaser or its agent, are collected and l
analyzed to allow the purchaser or its agent to accept a CGI for unrestricted use. As noted in Generic Letter 89-02, this method alone is not acceptable to the NRC staff and must be-combined with one or more of the other three methods.
This report provides criteria on the sampling plans that may be used as part of a
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commercial grade dedication process Dased on Method 1, above. The following eight steps I
outline the entire CGI dedication process using sampling.
Step 1:
Assessment of safety significance and function
- Step 2:
-Identification of critical characteristics, verification methods, and acceptance criteria Step 3:
Lot formation Step 4:
Selection of sampling plans for inspection and nondestructive examination Step 5:
Sample selection
- Suppliers of CGis may not have sufficient information or engineering capabilities to determine the end use or safety significance of the item or items to be dedicated. Under these conditions, the supplier must dedicate the items for unrestricted use.
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Step 6:
Implementation of sampling plans
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Step 7:
Destructive testing Step 8:
Documentation and record keeping 4
SAMPLING FOR ACCEPTANCE OF COMMERCIAL GRADE ITEMS
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This section contains specific information on implementing EPRI Method 1 for CGI dedication in commercial NPPs where sampling is used. CGI dedication programs for simple, metallic items written according to the criteria provided in this report should be
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based on a two-part process involving inspection and nondestructive examination (l&NDE),
and destructive tests (DTs), based on steps 1 through 6, and step 7, respectively.
Sampling plans are one part of l&NDE discussed in this report. The rest of l&NDE is concerned with examining traceability and conformance to specifications a'nd the original manufacturer's certifications. The information on the traceability and conformance of the items being sampled allows a judgment to be made as to the acceptability of their use for sampling.
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if the lot is acceptable after l&NDE, the DTs verify the material critical characteristics and provides reasonable assurance that the lot conforms to the specific material specifications and characteristics listed in the manufacturer's certification. The two parts of the
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dedication, the l&NDE and the DTs, are linked by the verification of material chemistry and properties. If, by sampling, the l&NDE verifies item traceability, the manufacturer's certifications, compliance with applicable material specifications and any additional purchase order requirements, then there is confidence that the results from the DTs
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represent the entire inspection lot. The DTs do not require sampling, but do require that a minimum number of acceptable items be destructively tested. More than one item may be chose.n for the DTs if desired, and in some cases more than one item may be required if a
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single item is not adequately sized for all of t'he required tests.
Note that in some cases, nothing less than 100 percent verification of an item's critical
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characteristics will provide adequate assurance that the item will perform its intended function. In other cases, evaluations may reveal that not all of the critical characteristics of sor6e CGis can be properly verified by sampling alone. For these items, other methods
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of verification, such as a commercial grade survey (EPRI Method 2), or source verification (EPRI Method 3), may be necessary. Guidance on the use of these methods is not provided in this report, but can be found in NRC guidance and other documents referenced in the bibliography.
4.1 Assessment of Safety Significance and Function Because manufacturers, suppliers, and dedicators of simple, metallic items typically do not know the intended end use for their products in a nuclear environment, they should
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dedicate these products as if they are for unrestricted use in an NPP by confirming that all of the technical requirements (e.g., material specification requirements applicable to the 5
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item, manufacturer's certifications, and other technical requirements specified by the customer) have been met.
This report has been structured for the case where the end use is not known or where sampling has been determined to be necessary. Therefore, no guidance on assessment of an item's safety significance or function is necessary for an item to be dedicated for unrestricted use. Users with knowledge of the end use and safety significance of a CGI, bear the responsibility to adequately implement CGI dedication activities in a graded manner.
4.2 Identification of Critical Characteristics, Verification Methods, and Acceptance Criteria
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The' specific characteristics that affect an item's ability to accompiish its intended safety function are its critical characteristics (CCs). The identification and verification of these characteristics should, with a high confidence (95 percent or better), ensure that the item
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meets all applicable design, construction, material, and pe_rformance specifications. For CGis to be dedicated for unrestricted use in NPPs, every CC identified in the product description, or in the certified material test report (CMTR), or by the purr.haser should be
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verified. Examples of CCs are heat number, heat code or lot, chemical constituents, hardness, physical attributes, microstructure, mechanical properties, t.nd markings.
Properties from the manufacturer's certifications and material specifications, as well as any
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identifying CCs. Gu; dance on the identification of CCs can be found in Generic Letter additional requirements imposed by the purchaser, should be considered for use when 89-02 (U.S. NRC,1989), Generic Letter 91-05 (U.S. NRC,1991), Information Notice 95-12
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(U.S. NRC,1995b), Information Notice 95-12 Supplement 1 (U.S. NRC,1995c),
Information Notice 96-40 (U.S. NRC,1996a), EPRI NP-5652 (EPRI,1988), and NRC Inspection Procedure 38703 (U.S. NRC,1996b).
Verification methods should be chosen on th' basis of their accuracy, precision, and ability e
to verify the CCs in question. Accordingly, the accuracy and precision of these methods,
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as well as their appropriateness for the material in question, should be evaluated before i
they are designated for use. For example, an alloy separator may.be capable of distinguishing t atween differing families of steels. However, it cannot identify the
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material's chemical constituents and, therefore, would not be capable of reliably identifying L
nonconforming items. Similarly, a spark test, where one observes the color and shape of sparks generated when a metallic item is subject to grinding, is capable of identifying the presence of elements in a material, but is not a quantitative process and, therefore, would
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not be suitable for verifying the concentration of elements in the material. In contrast, a mass spectrometer can accurately identify the presence, and quantify the concentration of, even trace elements in a metallic item.
For the purposes of this report, the partial chemicc! test is used during the l&NDE sampling phase for verifying the concentration of a limited number of elements in a material or item.
f The acceptance criteria for those elements are the same as those for the full chemical test (part of the DTs) and are given in the Table of Product Analysis Tolerances, which follaws, 6
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and associated I;g':tes 1 through 3. The elements necessary to be verified during the r
1 partial chemical t est are as follows: for carbon and alloy steels, chromium, copper, manganese, mof ybdenum, nickel, silicon, and either phosphorus or sulfur; for stainless steels, chrom'am, molybdenum, and nickel; and for other metals and alloys, all metallic f
elements (e.g., aluminum, chromium, cobalt, columbium, copper, iron, lead, manganese, magnesium, molybdenum, nickel, titanium, and zine). Note: If the partial chomistry tests or any nondestructive test (e.g., the hardness test) renders a CGI unacceptabie for use, then j
those types of CGis should not be sampled.
The full chemical test, used as part of the DTs, is the chemical analysis and quantification f
of the concentration of the complete set of elements identified as CCs. The complete set of elements should include, at a minimum, all of the elements identified in the manufacturer's certification to the tolerances provided in the Table of Product Analysis f
Tolerances. For additional a::surance, any additional element identified in the Table of Product Analysis Tolerances may be used. The full chemical test, when properly used as the final phase of this sampling plan, verifies the item is the same as is certified, with the
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properties necessary to satisfy the purchase order.
As previously discussed, the Table of Product Analysis Tolerances and associated Figures 1
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through 3 must be used to build acceptance criteria for both the partial chemical (part of the l&NDE) and the full chemical (part of the DTs) tests. These tolerances will bracket the values listed on the CMTR and must be used in lieu of any tolerances given in the material
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specification. If the table or figures are not applicable to the element or materialin question, the tolerances given in the material specification should be used. For nonchemical properties (e.g., yield, tensile, impact strength, or fracture toughness), for
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which the results may be listed on the CMTR, the measured value should be within
- 15 percent of the value listed on the CMTR and also meet the limits and tolerances given by the P.O or material specification. For hardness limits, the measured hardness should
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meet the specified hardness of the material specification if these properties do not fall within these limits, but meet the limits and tolerances given by the PO or material specification, a documented engineering evaluation shall be provided. This technical l
evaluation shall be provided to the customer as part of the certification package for the dedicated material.
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In general, the Table of Product Analysis Tolerances and associated figures will provide the t
necessary tolerances for verifying chemical properties. However, if the material specification is more limiting than the table, the tolerances in the material specification for those elements should be used.
The Table of Product Analysis Tolerances is found on the following page.
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TABLE OF PRODUCT ANALYSIS TOLERANCES TO BE USED FO;t CGI ACCEPTANCE CRITERIAt TYPE OF ELEMENT ELEMENT NAME TOLERANCE (Wr. % UNLESS SPECIFIED)
CARSON-SEE FIGURE 1 MANGANE8E SEE FIGURE 2 StuCon SEE FIGURE 3 ALUMINUM EEMENTS N Y NITROGEN 115%
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' ADDED TO MAKE l
CAReON AND LOW CHROME 110 %
ALLOY STEEL COLUMeluM 110%
CARSON f
ANo NICKEL 210 %
COPPER tS%
y STEEL
- MOLYsDENUM 28 %
VANADtVM 25 %
TITANIUM 25%
+15%
+12%
RESIDUAL ELEMENTS OTHERS CAR N
,a FERRmC ELEMENTS TYPICALLY SauCON t12.5%
AND ADDED TO MAKE MARTENSmC STMNLESS STEEL CHROME t10%
- STAINLESS STEELe MOLYSOENUM 25%
- 5%
MANGANESE i3%
CARooN 212.5 %
AUSTENmC ELEMENTS TYPICALLY SauCON i12.5%
STMNLESS ADDED TO MAKE STEEL @
STAINLESS STEEL CHROME t1.25%
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MOLYBOENUM tS%
NICKEL 11.5 %
MANGANESE 22 %
NITROGEN 110 Au.
- PRIMARY, ALL ELEMENTS To TOLERANCES GIVEN p
OTHER METALS SECONDARY,ANo GIVEN IN MATERIAL IN MATERIAL SPECIFICATION
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AND ALLOYS RESIDUAL ELEMENTS SPEC $1 CATION
- t These tolerances are intended for use in lieu of any product enelysis tolerances that may be given in the applicable meterial specification (s). See Appendia C for further discuseson of the beeis for values given in this table.
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- Tolorences for carbon, phosphorus, and sulfur do not apply for nmmed or capped steel unless misapplication is suspected.
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- Alurnmum may be used to venty if the steelis killed.
@ Resedual elements not identifed in the certified metonal test report should not be used for venfication activities.
@ For s.s. with specisi enoy edditions, thos edditionei siements must be ventied to be wittwn a s% ebsoiute concentration.
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Figure 1 - Product Analysis Tolerance for Carbon in Carbon and Low Alloy Steels j
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-r-0.05 J.L "* i' *,,,..
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g 0.04 e-j O.03.....,?,,,...
0.02 i
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O.050.10 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.00 Wt.% Element Cerbon Low Alloy as f
Figure 2 - Produ;t Analysis Tolerance for Manganese in Carbon and Low Alloy Steels 0.10 0.09 0.Os
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wt o,oy s
.06 0
4 a
g O.05 0.04 o
O.Os O.02 0.30 2.00 Wt.% Element Figure 3 - Product Analysis Tolerance for Silicon in Carbon and Low Alloy Steels 0.050
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O.045 0.040
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&O.035y
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O.020 I
I O.015 O.03 0.05 0.15 0.60 Wt.% Element Killed Steel S e mi-kille d RB 9
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The tolerances shown in the Table of Product Analysis Tolerances and Figures 1 through
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3 are based on a review of the allowable chemical tolerances for product analyses given in the ASME/ ASTM material specifications (ASME,1992b) and on experience with standard steel mill practice. It is recognized that the chemical variability under a given
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material specification is typically larger that the variability that should be expected in a specific product, lot, or heat. Therefore, the tolerances were chosen to reflect this experience.
in general, acceptance criteria may come from various sources, for example, the catalogue description of the item, design specifications, material soe:ifications,
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manufacturer certifications, the purchase order, or this report. The acceptance criteria should be documented and list the acceptable range of values for each CC when appropriate. For acceptance criteria for both the partial and full chemical analyses,
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tolerances not greater than those provided in the Table of Product Analysis Tolerances and Figures 1 through 3 should be applied to the heat analysis values listed on the CMTR.
The CMTR may also give results from tests other than chemical tests. For these cases,
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the tolerances or range of acceptable values from the material specification must be applied. Tolerances other than those described here may be used if justification is provided.
4.3 Lot Formation
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Inspection lots should be homogeneous to provide a rationale for the very limited destructive testing requirements. To form a homogeneous inspection lot, it should be verified that the items constituting the lot are similar enough to group them. For many
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cases this may be reasonable. However, for some cases, the variability of the manufacturing process may yield a CGI whose properties may not be sufficiently similar from part to part to give confidence that a sampling process can be applied. Examples of
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. such cases are items from different heats or heat treatment lots. For other cases, the l
CGis may have become mixed during storage or shipment.
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Homogeneous inspection lots can be formed by following certain practices. For example, i
items from different production runs, different models, or different manufacturers should not be included in the inspection lot. To do this, procurement planning may be required, r
Proper lot formation requires evidence of traceability such as (1) original manufacturer i
markings or) each item, (2) original manufacturer certifications, (3) original CMTRs, or (4) original packing slips from the receiving inspection. Pooling lots with different pedigrees y
to form a larger lot for sampling purposes is not recommended; the destructive testing
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requirements in this report apply 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
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should be kept as " clean" as possible; that is, inspection lots should be se'gregated so that the risk of cross-contamination is minimized.
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4.4 Selection of Sampling Plans for inspection and Nondestructive Examination Two l&NDE sampling plans are described in this section for performing the first part of the CGI dedication. The first plan, SP1, allows lot sampling for the l&NDE portion of the dedication, and requires that the accepted lot be sent to the purchaser without being I
subdivided. The second plan, SP2, specifies 100 percent sampling for the l&NDri portion of the dedication. However, it allows larger lots to be dedicated and distributed in a piecewise manner. In either of the plans, the l&NDE verifies all the CCs, such as I
dimensions, hardness, partial chemistry, manufacturer's markings, heat r. umber or code, without rendering the item unusable.
I The l&NDE sampling plans SP1 and SP2 are designed for situations in which high confidence in the inherent quality of the inspection lot is desired. For example, SP1 is used if the dedicating entity wants to dedicate one lot of CGis and send that lot to a l
licensee to satisfy a purchase order. The inspection lot size and acceptance number must be determined and the sample size read from Table 1 in Appendix A. The sample should be randomly drawn using either one of the plans given in Section 4.5 or a similar method.
I The CCs of the sample are then verified using l&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 of the DTs. If the number of defective items in the sample is larger than c, the dedicating entity has the option of switching to SP2. Otherwise, the I
inspection lot should be rejected. The flowchart in Figure 4 on the following page summarizes the process.
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Figure 4. Summary of the Overall CGI Dedication Sampling Methodology Crioose sempie R&NDE semple
""b Domeen eue &
Select random W verWy CCs Y
D to use 8P1 acceptance semple (met parisal nwnbar (c) chemsetry) 1, I
I&NDE 100% of M
Use $P2 q
defective tems =
M 4
chemselry) l DM rete vue Use att
>6 sample plan?
I N)
Go to e nems N)
"M 1,
y=h
- i h
9 Perform DT on one (or more)
Perform DT on OK aem(s)(met OK
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m=
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l l
p y'
DT reewp DT tosuas WI a0ree w/CMTR &
agree w/CMTR S apecs.?
spece.?
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For most of the individual sampling sizes (plans) in Table 1 in Appendix A, a risk of rejection of an acceptable lot exists. This risk increases as the acceptance number, c, decreases. The higher risk of rejection and smaller sample sizes associated with a smaller c must be balanced against the lower risk of rejection and larger sample sizes associated with larger c's. The operating characteristic curves in Appendix D may be used to I
determine the probability of acceptance given the lot size, acceptance number, and defect rate (inspection lot fraction defective).
1 Note that SP1 does not allow inspection lots to be sampled, accepted, and then divided and shipped to di//erent purchasers. The dedicated lot should be sent in its entirety to the purchaser. This is desirable so that the quality of individual shipped lots meets the 1
95/05 criterion. However, this plan does allow the dedicating entity to dedicate /ess than its full inventory of that specific item, thereby requiring fewer items to be sampled. This plan requires more destructive testing to dedicate many smaller lots than one larger lot 3
dedicated by SP2 because these criteria were written to control the nonconformance rates in shipped lots.
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SP2 may be used to dedicate a full inventory of a specific item and subdivide for shipment r
i to various purchasers, or if the inspection lot was rejected by SP1. As in SP1, the inspection lot should be from the same heat or production run and must have traceability to the original manufacturer, original manufacturer certifications, and CMTRs. However, this h
plan requires 100 percent sampling for the l&NDE portion of the dedication. The acceptance number for this plan is based on hn acceptable defect rate of 5 percent. To calculate the acceptance r umber, c, for SP2, multiply the inspection lot size by 0.05,
(
rounding up to the nearet : whole number. If, during the 100 percent l&NDE, the number of defective items is greater than c, the entire lot should be rejected. if the number of defective items is less than c, the lot is provisionally accepted pending the results of the
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DTs. In either case, the defective items should be discarded or segregated from future inspection lots.
f in summary, SP2 requires 100 percent l&NDE of the items in the inspection lot. However, only one set of DTs is required regardless of lot size. The dedicated lot can then be shipped as separate lots without further inspection or testing.
Plans other than SP1 may be used which would permit retesting of rejected lots. For example, a double sampling plan may be used in the dedication. However, to meet the
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intent of this report, any alternative plan must ment the 95/05 confidence level for controlling consumer's risk. Listed among the references in Section 6 is a book by A. J. Duncan that contains a theoretical discussion of double sampling plans based on the.
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hypergeometric distribution.
4.5 Sample Selection A cample consists of one or more units of a product drawn at random from an inspection lot, where the units of the sample being selected is random. The following two methods are frequently used. Method 1: 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. Method 2: a set of random numbers from a random number generator or a table of random numbers can be 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, setting aside the items whose numbers
[
match the generated random numbers. The second method is preferable but is not i
required.
The dedicating entity should establish criteria, standard practices, and procedures for the f
storage and treatment of samples, once selected, and the segregation of the remaining items. Areas where these items are stored should be clearly marked for ready identification.
4.6 Implementation of Sampling Plan f
After the lot is formed, the samples are ready to be inspected and nondestructively examined. By means of the previously identified CCs, verification methods, and 13 r
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acceptance criteria, the sample is then examined. Each of the characteristics identified is verified on every item in the sample. An item that fails to meet the acceptance criteria for one or more CCs counts as one reject against the previously chosen acceptance number. Regardless of whether an inspection lot was accepted or rejected, defective items should be removed and discarded, destroyed, or otherwise dealt with. Rejected items must not be included in future inspection lots.
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4.7 Destructive Testing Destructive tests (DTs) are performed only if the inspection lot was accepted by l&NDE.
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Therefore, the items tested by the DTs are assumed to represent the inspection lot for the properties tested (e.g., full chemical properties, material properties, and other properties that cannot be inspected or measured nondestructively). The DTs are simply a set of tests performed on the sample. The sampling plans discussed in this report demand only one item be destructively tested, however, more than one item may be necessary if the items are too small to be used as a test specimen for all of the required tests. Examples of DTs are full chemical tests, tensile tests, impact tests, ductility tests (percent elongation, reduction in area), and microstructural examinations.
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The comparison of results from the partial chemistry test (from the l&NDE) and the full chemistry test (from the DTs) forms part of the basis for the treatment of the DTs in this report. This comparison is important because it provides confidence that the material
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being tested is the same as that ordered and certified on the CMTR, and that the results of the DTs will represent the inspection fot.
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Regardless of whether SP1, SP2, or an alternative sampling plan is used, the results of the DTs should be acceptable for an inspection lot to be fully dedicated, in destructive testing, the test results are compared with the previously defined acceptance criteria. If
(
any result varies by more than the value allowed by the acceptance criteria, as described in Section 2, or does not meet the requirements of the material specification and/or purchase order, the lot ir, unacceptable and should be rejected.
4.8 Documentation of Results The CGI dedication process must be documented. The requirement to do so is contained
[
in Appendix B to Part 50 of 10 CFR (U.S. Code of FederalRepu/ations,1SS6b). Appendix B contains criteria for the necessary elements of a quality assurance program. The 7
following Appendix B criteria apply directly to the topic of documentation in the context L
of CGI dedication. Criterion ill, " Design Control," of Appendix B requires, in part, that measures be established for the selection and review of suitability of the application of materials that are essential to the safety-related functions of structures, systems, and
[
components. In other words, instructions or procedures must be written for its use and must include the basis for the sampling plan (s) selected for a given circumstance. Also, Criterion V, " Instructions, orocedures, and Drawings," requires, in part, that activities
(
affecting quality be accomplished in accordance with written instructions, procedures, and drawings. Therefore, written procedures or instructions must be developed.
14
1 I
Additionally, the basis for the sampling plan selected must be documented. Criterion Vil,
" Control of Purchased Material, Equipment, and Services," requires, in part, that I
measures be established to assure that purchased material conforms to procurement documents. If the procurement documents invoke purchaser-specific requirements, material specification (s), and Appendix B requirements to which the item must conform, I
then there must be a documented basis to substantiate that the sampling plan selected was adequate to ensure conformance to the procurement document requirements. And finally, Criterion XVil, " Quality Assurance Records," requires, in part, that such records, I
procedures, documented bases, and so forth, be maintained to furnish evidence of activities affecting quality.
The following is a partial list of information that may be required for documentation:
I reference number purchase order number (customer's and dedicating entity's) a manufacturer's certification number and date (when applicable)
I description of lot (e.g., serial numbers, unique characteristics) e CCs sampled (with tolerances used) sample size selected I
verification methods a
acceptance criteria e
results of I&NDE e
results of DTs comparison of l&NDE and DTs results with acceptance criteria
=
lot disposition (accepted, rejected,100 percent examined)
I sampling plans used (give reference or description) e measurement and test equipment technical evaluations 1
5
SUMMARY
Sampling plans, and the associated inspection, nondestructive examination, and destructive tests, provide a cost effective means for assuring the quality of commercial grade items. Approaches to developing sampling plans that have been proposed, i.e., the EPRI NP-7218 guideline is based on MIL-STD-105E, are based on continuous manufacturing processes, which is not necessarily valid for commercial grade dedication in the nuclear industry. Consequently, technical criteria appropriate to this application were developed.
This report including the tables and figures presents technical criteria that can be used in developing sampling plans when CGis are being dedicated using EPRI's Method 1. Two approaches to developing sampling plans are discussed. An alternative approach, such as a double sampling plan, may be used if the user can demonstrate that it provides 95 percent confidence that no more than 5 percent of the inspection lot is defective.
Whatever method of sampling is used, any inference as to lot quality based on the results of an inspection or test (s) applies only to the inspection lot and not to any larger population from which it may have been drawn.
15
6 BIBLIOGRAPHY American Society for Quality Control, ANSI /ASQC Standard Q3-1988, " Sampling Procedures and Tables for inspection of isolated Lots by Attributes," Milwaukee, Wisconsin.
American Society for Quality Control, ANSl/ASQC 21.41993, " Sampling Procedures and Tables for Inspection by Attributes," Milwaukee, Wisconsin.
American Society of Mechanical Engineers, ANSl/ASME B18.18.1 M 1987,
" Inspection and Quality Assurance for General Purpose Fasteners," New York.
American Society of Mechanical Engineers, ANSI /ASME SA-751, " Specification for Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products," New York,1992.
American Society of Mechanical Engineers, Boiler and Pressure Vessel Code, Section ll, " Materiel Specifications," 1992b edition, New York.
American Society of Mechanical dngineers, Boiler and Pressure Vessel Code, Section lil, " Rules for Construction of Nuclear Power Plant Components," 1992 I
edition, New York.
American Society of Mechanical Engineers, Code Case N-483-2, " Alternative Rutas I
to the Provisions of NCA-3800 Requirements for Purchase of Material Section Ill, Division 1," New York,1995. (As of the date of issuance of this report, NRC had not endorsed this ASME code case.)
Cochran, W. G., Sampling Techniques (3rd Edition), John Wiley and Sons, Inc.,
New York,1977.
I Duncan, A. J., Quality Controlandindustria/ Statistics (5th Edition), Richard D.
Irwin, Inc., Homewood, Illinois,1986.
Electric Power Research Institute, NP-5652, " Guideline for the Utilization of Commercial Grade items in Nuclear Safety-Related Applications,"Palo Alto, California, June 1988. Proprietary information. Not publicly available.
Electric Power Research Institute, NP-7218, " Guideline for the Utilization of l
Sampling Plans for Commercial-Grade item Acceptance,"Palo Alto, California, June 1
1992. Proprietary information. Not publicly available.
Fastener Quality Act, Pub. L. No. 101592,104 Stat. 2943,1990.
Odeh, R. E., Attribute Sampling Plans, Tables of Tests and Confidence Limits for Proportions, Marcel Dekker, Inc., New York,1983.
16 r
Sherr, T. S., Attribute Sampling Inspection Procedures Based on the
-Hypergeometric Distribution, WASH-1210, UC-15, U.S. Atomic Energy Commission,1972.
l U.S. Code of FederalRepu/stions, Part 21, " Reporting of Defects and Noncompliance," Title 10, " Energy," 1996a.
U.S. Code of FederalRegulations, Part 50, Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," Title 10, " Energy," 1996b.
U.S. Department of Defense, MIL-STD-105E, " Sampling Procedures and Tables for inspection by Attributes," 1989.
U.S. Department of Defense, MIL-STD-414, " Sampling Procedures and Tables for inspection by Variables for Percent Defective," 1957.
U.S. Nuclear Regulatory Commission, " Development of Graded Quality Assurance Programs," Draft Evaluation Guide,1995a.
U.S. Nuclear Regulatory Commission, Generic Letter 89-02, " Actions to improve the Detection of Counterfeit and Fraudulently Marketed Products," March 1989.
U.S. Nuclear Regulatory Commission, Generic Letter 91-05, " Licensee Commercial-Grade Procurement and Dedication Programs," April 1991.
U.S. Nuclear Regulatory Commission, Information Notice 92-68, "Potentially Substandard Slip-on, Welding Neck, and Blind Flanges," September 1992.
U.S. Nuclear Regulatory Commission, Information Notice 92 68, Supplement 1, "Potentially Substandard Slip-on, Welding Neck, and Blind Flanges," September 1996.
U.S. Nuclear Regulatory Commission, Information Notice 95-12, "Potentially Nonconforming Fasteners Supplied by A&G Engineering 11, Inc.," 1995b.
U.S. Nuclear Regulatory Commission, Information Notice 95-12, Supplement 1, i
"Potentially Nonconforming Fasteners Supplied by A&G Engineering II, Inc.,"
1995c.
1 U.S. Nuclear Regulatory Commission, Information Notice 96-40, " Deficiencies in Material Dedication and Procurement Practices and in Audits of Vendors," July 1996a.
U.S. Nuclear Regulatory Commission, Information Notice 96-40, Supplement 1,
" Deficiencies in Material Dedication and Procurement Practices and in Audits of
^
Vendors," October 1996.
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17 W
U.S. Nuclear Regulatory Commission, inspection Procedure 38703, " Commercial Grade Dedication," April 1996b.
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Glossary 9
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This glossary of terms pertains to the terms discussed in this report 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 a
condition the capability to prevent or mitigate the consequences of accidents that could a
result in potential offsite exposures comparable to those referred to in 10 CFR 100.11 Commercial Grade item-When applied to nuclear power plants licent.ed pursuant to
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10 CFR Part 50, a structure, system, component, or part thereof that affects its safety
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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 requires 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 critical characteristics cannot be verified).
Certificate of Compliance-A written statement, signed by a qualified party, attesting that the associated itt;ms or material is in accordance with the specified requirements and accompanied by additional information to substantiate the statement.
Certified Niatorial 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 l
pouring of the steel. When required chemic,al analyses (heat analyses), heat treatment, I
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.
1 Critical Characteristics-When applied to nuclear power plants licensed pursuant to j
10 CFR Part 50, those important design, material, and performance characteristics of a I
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 f
this respect, the item is deemed equivalent to an item designed and manufactured under a 10 CFR Part 50, Appendix B, quality assurance program. 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 witness at hold points at the manufacturer's 20
l l
l facility, and analysis of historical records for acceptable performance, in all cases, the dedication process must be conducted in accordance with the app'icable provisions of 10 CFR Part 50, Appendix B. The process is considered complete svhen the item is designated for use as a basic component.
I Dedicating Entity-When applied to nuclear power plants licensed pursuant to 10 CFR Part 50, the organization that implements the dedication process. Dedication may be performed by the manufacturer of an item, a third-party dedicating entity, or the licensee itself (any of which may also be called a dedicator). Pursuant to 10 CFR 21.21(c), the dedicating entity is responsible for identifying and evaluating deviations, reporting defects in and failures to comply for the dedicated item, and maintaining auditable records of the dedication process.
Destructive Test-Any process of verification of a commercial grade item's critical I
characteristics whereby the item is substantially altered or changed in a way that would render it unusable for its intended purpose.
Inspection Lot A lot of items specifically formed for the purpose of being dedicated for I
use as a basic component in a nuclear power plant.
Material Manufacturer-An organization that performs or directly controls one or more of I
the operations required by the material specification that affect the material's mechanical properties and issues the certified material test report for the material.
Nondestructive Examination-Any process of verification of a commercial grade item's critical characteristics whereby the item is n_ot substantially altered or changed in a way that would render it unusable for its intended purpose.
Product Analysis-A chemical analysis of the semifinished or finished product, usually for the purpose of determining conformance to the specification requirements. The range of the specified composition applicable to the product analysis is normally greater than that applicable to heat analysis in order to take into account deviations associated with analytical reproducibility and the heterogeneity of steel. (American Society of Mechanical Engineers, ANSI /ASME SA-751, " Specification for Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products," New York,1992.)
l Product Analysis Tolerances-A permissible variation over the maximum limit or under the minimum limit of a specified element and applicable only to product analyses, not cast or heat analyses. (ANS!/ASME SA-751)
Safety-Related When applied to equipment in nuclear power plants licensed pursuant to 10 CFR Part 50, relied on to remain functional during and following design-basis events to ensure (1) the integrity of the reactor coolant pressure boundary, (2) the capability to shut down the reactor and maintain it in a safe shutdown conditica, and (3) 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 Part 100. Design-basis events are
[
21
N defined as conditions of normal operation, including anticipated operational occurrences, f
design-basis accidents, external events, and natural phenomenon for which the plant must be designed to ensure functions (1) through (3) of this paragraph.
Unrestricted Use-Use that is either safety-related or non-safety-related, or not restricted to a specific risk significance level or category in a nuclear power plant.
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Appendix A: Sampling. Table with Instruct!ons for Acceptance Sampling of CGis
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Instructions for the use of Table 1 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 SP1.
1 l
The table should be used as follows:
s (1)
Determine the inspection lot size, m. This most probably will be the purchase order quantity, plus one destructive test item, plus the number of allowable I
defective items from the sampling plan.
(2)
Choose the appropriate sampling plan. There may be some iteration with Step 1 to determine the final inspection lot size.
I Choose the maximum number of defective items, c, allowable in the sample'.
(3)
(4)
Follow the sc!ected column for c down to the corresponding inspection lot size m, and record the sample :ize n.
(5)
I 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 nonconform!.ng items in the sample does not exceed c. Reject the lot if the number of nonconforming items exceeds c.
Note, for lot sizes greater than 1000, which is the largest lot size in Table 1, u:e the sample sizes corresponding to a lot size of 999. The example on the following page illustrates the use of Table 1 for SP1 in this appendix.
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- The maximum number of defective items in the sample, c, has associated with it a sample size og a risk of rejection if the inspection lot is of acceptable quality. The smaller the value of c, the smaller the sample J
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 inspectim lot size is less than 2o, the only acceptable value of c is c - O. Otherwise, there is always more than one acceptable value of c, that is, more than one acceptable sample size.
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Example lilustrating the Use of Table 1 for SP1
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r Suppose that s ' dedicating entity wants'to fill an order for.100 simple [
imetallic items. SP1 is chosen for this application.: Further, suppose.
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the dedicating entity chooses to allow at most.1l defective item in the :
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. sample,'(i.e., c = 1) and,Lainee the item is relatively large,1 Ldestructive test item is required.: From Step 1, the inspection lot sizel
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eis thus m = 100' 1 + 1 = 102.. From Table 1, row 102 and column c
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o = 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
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ltems is nonconforming, then the lot is accepted as being no more1 than 5 percent defective with at least 95 percent confidence.
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' The destructive tests (DTs) are performed.if the lot it' acceptable after l
the inspection and nondestructive examination.~.lf the DTs are -
acceptable, the dedicating entity sends the' 100. items to the'
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purchaser in accordance with the purchase order.
Note that if the sample of 67 has 2 defective or nonconforming items I (more than the acceptable number), the dedicating entity may choose f
1 o implement SP2 and inspect the remaining 35 items that were not; t
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. sampled (100~ percent inspection).' After discarding'all defective' _
. Items, the dedicating entity is 100 percent confident that all of the f
remaining items in the inspection lot are acceptable for theD characteristics examined. However, if 6 or more defective items are found, the entire lot must be rejected because it contained more than -
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5 percent defective items.
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i r, 1 r, r umme - ~ - 1 Table 1. Sesmyte SIso Itoquesed to Seusly tige SBS Cdteston - l Inspec00n m lesseer as possessee in the temple tel Inspeedon -leisutseretDegesguestnsieSmugestut tat Stas e 1 2 4 -7 to Lotseen 0 1 -2 4 7 19 217 -- 55 e5 10e, 12 : m198 u,/r 217 37. ;253: a 1 f.55"yW TC119;g )segg 35Fs% 348 m 218 I-SS 85 11047181 Fi199N's titM{.Q 21 sty sese c;+ Se:dessimittu.usseM(M@9et fj. 24" . iMAfW855%jte24184i '21e
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- 145 1:',190k@'32ES I % D MS JSEf V N C W " ~
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- 238 SS 85 119 <
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- 213 -
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- 214 280
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i I q-Table 1. Sample 80ss Resguised to SsIIsfy 91e 9875 Cetterton y griepaggest beentueusa Benentier et Defoedvee In see temple tel klepecWen Ifumberof DalesevesIm9eeSangesl4 Let Stae e 1 2 4 7 10 Let8tse e 1 2 -4 7-18 see 56 e5 110 155.:. 2 g212 55. :, 85 : m1113189;$m2154g35F,p Esp n m MB<- f SN M I'MI @2750 J IWZWii s 200 SS-85 111, ' 198 F' '213 i2134 +'."200Mf ?G8EfEWIN l D SSM fi11hsTMS%22$8%.M% 5 291 2. 55 85 111 d' 198 ;.l R180.tM$lfddMSL 292 55 88 112 15F 214 301 su 55 as 112 ISB 218 -238 233 98 86 112 157 215 amt ses SS Os 112 ISB1 218 * " 279 See Ss 88 112 ISS 216 L 283 330 Se 88 112 198 ' '2t9 N1 205 SS ~ 57? 113 9195'ft218- ;i205,Q T F:939jf W f '88 M !;'88 E #113?T U $ E N W $ 9FI @A. +254 ' ass .SB 87! 113 :: 195.n 217 4 D att TIG - 85' ~ b ST P 1131:M 190 $ 3 D N CSF2 257: 98 ' 8F - 113 i('198 d !214 ysgBidie 3050 #SS ? *, W JEf,.1137S!518BNWidft.173% 200 57 87 114 100 219 2s7 334 SS SF 114 161 222 54-200 57 88 114 100 219 1 20B 355 SS. SF 114 161 202 .275 ; 300 54 El 108 152 209 257 338 SF 88 114 1st. 223 R$ 301 54 83 108 W MY FSBFE : ? 5F-H i et /W115 MT181fWEB4'X'iW5Ti 153 [ :210 @O SSBISe 5 O C SIS U M 8Fi -.at *.:115P /1933%29 See se-as 109 185. Cate l 303 54 84 109 154 ~ 1211 Mf 30 QD l mL; /J : z SFJ 4.,'N :. C118 : h.183Mk.M5MSFS M w 304 54 84 109 154 212 300 Set 54 84 110 198 215 ,28F O 305 54 84 110 155 213! 281 M1 54 84 110 158 1 218 ' See 308 55 85 110 155 213 as2 Set 54 5 110 ' 198 - 218 L - 200 30F 55 85- >111-158 4 214pf;383W CSES: ~M ;5f,;'LW (:.EttiM2$f.$ Fg.4MS]~ 111. ' F15F'd f 215.b;T304 GM!MS? :%.: :W ? . W f diiMisr r ee 111 .ISS'? 215 ) i 4 J kF6 ~ SOS 95 85 9 see 55 ' 85 - - 205tdl;*1SGB!i! d W 9 $ 85ihil~11 M i198 M et4% W9PCN 1 '318 55 88 112 157 218 g 388 308 56. 88 -112 iSB
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r e-c 4. Table 1. Seaple SIse flequired to Segefy Wie SEf5 Cellerlost ~ U-hiopec1km aanmenism leseber of Desseewee kt the Sasuple Qel inspeCWoft IIE'8'EE'E II'EEU8F 88 088'80'88 h 8'8 OE'UI'III - LotStas 0 1 2 4 7 to Let Slas e 1 2 4 7 10 4 381 55 85 til 157 s..;218 6 52 c,. .WFc. ;, : 5Fu,- W qc.4 116 2 ale 5 m E3B 95BFt+ s3 ?c.T ens; W.5F1:ul80JMlit?1 Mist ##IMOh754fiasdi,117i* WiesMMat 158 -M2191 W3 P4 ftetO n. 5FT 382 85 85 111.' ass s5 a5 ill ins W21ei:- ^ 384 55 85 112 159 220 2F4 Age W 85
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'278 4 305 55 88 112 150 221 275 401' M 88 : 112 150 222 - 279 - 308 55 to 112 150 221 WS det 55 88 112 100
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- 441..f.. SS
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- 295 444 58 87 114 182 227
' 2BS ~ 438 58 SF 114 tes 2EE ,200' i-445 58 SF 114 ' ~ 183ZES i ENF%[%402 Y $7258 W. !SF M14 $$$bb att DSOSO M St79 Er~l#:*tWISF W il14IOEISS M SESTE MS# 114 :'.1883 M38 " 138F)! 448 ? 58 87 . 447 58 87 115 764SM2ES I. ses.MCf,408it tWBBB2d8F) Mf,115hft194MmeMSB0i; 448 58 88 115 144 .229 MB 464 38 87-115 1M 230 290 449 58 88 115 164 230 att 485 58 85 115 184 231 291 450 56 88 116 165 B1 290 408 SS OS 115 105 231 292 185;dat LM 291M']lWr.M;SB.L rrM Fjg:g05 3 3118 Q 1M ff 2g 3833 451 ' SF es its : -116 105 m$ SWMj20t2fl8y40BJi/3.iSPtjd[SS;Nhd4E!j;198w@SEM 2 -Estdh 31 + **.e 40th vW 19ievg 482 - 57 88 - 116 +.,1998d 8B e$5dB$M340 483 57 8B 454 57 89 117 1es 233 233
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- 335
'298 . 188 f;' 338 7 308 lh f' 300Dj #57W (W 'y 117MfM.%BBM298 183 .:338 M ; ISB d M,W1'} & ' SF+:
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[ f ( Appendix B: Example of CGI Dodication with Sampling Methodology ( ( { { { { { { 40
L [ A licensee issues a purchase order (PO) to a vendor for the supply of 59 small, simple, ( metallic items and invokes 10 CFR Part 50, Appendix B, and 10 CFR Part 21 and the vendor's nuclear quality assurance manual. The PO identifies item configuration, size, and applicable material specifications, and requires in addition that the item have certain ( impact values and that each item be examined by radiography according to a specified code. Because the PO does not indicate the end use of the items and does not note the use of graded QA program requirements, the vendor processes this PO as a PO for items ( of unrestricted use at a nuclear power plant. Here, the vendor is the dedicating entity. The vendor receiving this PO decides to purchase these items as commercial grade itema ( and then dedicate them as basic components. When placing the PO for the items, the vendor is informed by its subsupplier that the vendor must purchase a minimum of 100 of these items. The vendor agrees and places a PO with the subsupplier for the items. The ( vendor does not invoke 10 CFR Part 50, Appendix B, or 10 CFR Part 21, but does require that the 100 items have the manufacturer's marking on them and that the manufacturer's certified material test report (CMTR) including the impact test results be furnished with [ the 100 items. When the items arrive, the vendor reviews the manufacturer's CMTR and verifies that it { meets the requirements of the applicable material specifications and that it includes the material impact test results. Since the CMTR is complete, the vendor then documents the critical characteristics to be verified, the verification methods, and the acceptance criteria. { The vendor then chooses sampling plan SP1, realizing that it does not need to dedicate all I of the stock and can sell the rest as commercial grade items. Because of the good quality history of the supplier, the vendor determines the size of the sample by choosing an [ acceptance number of zero; the inspection and nondestructive examination (l&NDE) will accept no defective or nonconforming items. The vendor determines that the inspection lot size is 62 items (59 items to be supplied to the customer, plus 3 items to be subjected [ to full chemical, tensile, yield, elongation, and impact tests, plus 0 items allowed to be rejected). In some instances, the size of the item and the number of tests to be performed may require that only one item be destructively tested. Here, because of their small size, three items will be necessary. [- The vendor then reviews Table 1 in Appendix A and determines that for an inspection lot of 62, a total of 39 items would have to be sampled and subjected to the required l&NDE. The vendor then reviews the applicable material specification and determines that the following inspections, examinations, and tests are required; h (1) product marking (inspection, 39 items) (2) dimensions (inspection, 39 items) (3) hardness (nondestructive examination, 39 items) ( (4) partial chemical test (nondestructive examination, 39 items) (5) tensile (destructive testing,1 item) (6) yield (destructive testing,1 item) (.- (7) full chemistry (destructive testing, 3 items) (8) impact testing (destructive testing,1 item) [ 41 suf
in addition, the vendor dete mines that its customer's PO requires (9) radiographic examiriation (nondestructive evaluation required by customer PO, 59 items) The required inspections and nondestructive examinations are performed. Because the vendor elected to sample only 39 items, the lot will be rejected should any fail the nondestructive examination. Had the vendor elected to sample 54 of the 62 items, there I could have been one reject (c = 1) in the I&NDE portion of the dedication and the lot of I, 62 items could have still been accepted for destructive testing. In case the lot is rejected as discussed above, the vendor always has the opportunity to do 100 percent sampling as allowed by SP2. For this example, the results of the l&NDE were acceptable (met the acceptance criteria), and the vendor proceeded with the destructive testing. In this case the PO specified radiographic examination for all 59 items to be shipped. The I vendor selects all 62 accepted items and performs the radiography. The results of the radiography are acceptable to the dedicating entity. The vendor could have performed the radiography before the l&NDE or DTs and removed any items found to be nonconforming and then proceeded with the sampling. When additional tests, such as radiography, are required, it may be more cost effective for the dedicating entity to subject the whole lot received to radiography. The inspection I lot could then be drawn from the acceptable remaining items. The vendor then performs the identified DTs using the three remaining items (the items 1 were too smallindividually to be acceptable test specimens). If the results of the tests meet the requirements of the customer's PO, are within the tolerances allowed for the values on the manufacturer's CMTR (Table of Product Analysis Tolerances), meet the I applicable DTs acceptance criteria, meet the applicable material specification requirements, and reasonably agree with the results of the partial chemical tests, then the whole inspection lot is accepted. 1 Once all PO requirements have been met, the dedicating entity documents the process as ~ suggestec in Section 4.8 in the main body of this report and sends the documentation (including the CMTR, mill certification, and radiographic results) and the 59 dedicated items to the licensee. I I I I 42 l W i
[ { f Appendix C: Discussion of Sampling Methodology { l { 43
I The purpose of the statistical sampling plans presented in this report is to limit the number of items that must be inspected while providing reasonable confidence that the items I inspected represent the entire lot. Lot quality is measured by the percentage of defective items in a lot, which is denoted by p. An item is considered defective if one or more of l'.s critical characteristics are not satisfactory. Assume that a lot has acceptable quality if p s I p, for some maximum acceptable percent defective, p. However, unless every item in a lot is inspected (100 percent sampling), the exact value of p cannot be determined. Furthermore, if a lot is accepted on the basis of a sampling plan, no assertion is made I about the. actual percent defective in the lot. The quantity p simply refers to the hypothetical fraction defective in the lot. The sampling plan, SP1, presented in Appendix A controls lot quality by controlling the I probability that unacceptable lots will be accepted. This probability is called the consumer's risk. For example, if p, = 5 percent, the sampling plan in Appendix A is designed to accept a lot with percent defective p exceeding 5 percent no more than 5 I percent of the time. Equivalently, the sampling plan in Appendix A provides at least 95 percent confidence that lots with unacceptable quality (i.e., p > 5 percent) will be rejected. It should be emphasized that the required lot quality pertains only to the lot in question and does not extend to any larger population of which the lot may be a part. Furthermoro, the purpose of the sampling plans is not to estimate the percent defective p, but rather to I accept or reject the lot. Although the inspection results may be used to estimate p, a decision rule, based on the estimate of p, must still be specified for accepting or rejecting the lot. The sampling plans presented in this report omit this intermediate step and directly specify the decision rule. l Sampling plans for each inspection lot size between 1 and 1000 are presented in Appendix A for p, = 5 percent and for 95 percent confidence levels. Each sampling plan is characterized by a sample size, n, and an acceptance number, c, such that a lot is accepted if the number of defective items in the sample does not exceed c. It is essential that the sample be drawn at random from the items forming the lot. For each lot size, sampling plans are presented for c = 0,1,2,4,7, and 10. Every sampling plan given in Appendix A associated with a given lot size provides the desired lot quality with the required I confidence level. However, the sampling plans differ in that there are different sample sizes and different probabilities of accepting a good lot (i.e., a lot such that p s p ). In general, the larger the value of c, the larger the sample size and the larger the acceptance probability for good lots. For a given lot size and a given sampling plan (characterized by m and c), the probability of I acceptance (denoted by p.) as a function of p is called the operating characteristic (OC) curve of the sampling plan. For a given lot size, the choice of sampling plan will depend on the desired tradeoff between the required sample size and the OC curve. If the dedicating I entity believes that the lot quality is much better than required (i.e., p is much smaller than p.), it may choose a sampling plan with a small sample size. If, on the other hand, the l [ dedicating entity is concerned that the lot quality may not be much better than required 44 F
(i.e., p may be close to po), it may choose a sampling plan with a larger sample size in order to increase the probability of acceptance for p < p. Operating Characteristic (OC) Curves For any sampling plan, an OC curve gives the probability of accepting an inspection lot as a function of p, the fraction defective in the lot. Because the number of defective items in the lot is necessarily an integer, the OC curves are actually discrete curves that do not I exist for values of p corresponding to noninteger values of the lot size times p. Such OC curves are commonly referred to as " Type A OC curves." The true values of such OC curves are the points at the bottom of each successive " step" in the curve. The OC curves are plotted as step functions because it is convenient and conventional to do so. The OC curves have been computed for lot sizes of 30,40,50,60,80,100,150,200, I 400,700, and 1000, and for acceptance number c, values of 0 and 1, and also values of 2 and 4 when appropriate. Such OC curves can be used to identify a unique sampling plan having a desired acceptance probability for any value (or values) of p of interest. The OC curves are given in Appendix D. EPRI Sampling Plans EPRI NP-7218' describes sampling plans for use in accepting and dedicating commercial grade items. These plans, which are based on MIL-STD-105E** use smaller sample sizes than those in the plans discussed in this report. Consequently, the EPRI plans involve I higher consumer's risk (the probability of accepting a lot with more than 5 percent defective items) than do SP1 and SP2, especially for lot sizes below 100. The reason is that the EPRI plans emphasize controlling the producer's risk (the probability of rejecting a I good lot) whereas SP1 and SP2 emphasize controlling the consumer's (i.e., nuclear power plant's) risk of accepting a defective lot. With MIL STD-105E, and thus EPRI NP-7218, it is assumed that all sampled items are manufactured at the same time, using the same I process, with the same quality controls and the same personnel. However, this guideline coes not assume that there is a continuous manufacturing process. Therefore, larger tample sizes are necessary to provide a reasonable assurance of item quality, i EPRI NP-7218 discusses three types of plans: reduced, normal, and tightened. All of these plans have acceptance numbers, c, equal to zero. A comparison of the required sample sizes for only SP1, the EPRI Normal Sampling Plan (N), and the EPRI Tightened Sampling Plan (T) is given in Figure C.1 for selected tot sizes between 25 and 1000. The corresponding OC curves for lot sizes of 50 and 500 are compared in Figures C.2 and C.3. I
- Electric Power Research Institute, NP 7218, " Guideline for the Utilization of Sampling Plans for Commercial-Grade item Acceptance," Palo Alto, Califomia, June 1992.
- U.S. Department of Defense, MIL STD 105E, " Sampling Procedures and Tables for inspection by I
Attributes," 1989. 45 m u-=-
[ r Figure C.1 - Comparison of Sample Figure C.2 - Comparison of OC Curves. L Sizes-SP1 vs. EPRI Plans (c = 0) SP1 vs. EPRI Plans (n = 50) 80 0.8 ] ) 0.7 -g 50 0.8 \\ a s 40 0.5 g E 'x O.4 v0 5 r1 l N " " * + g a o 0.02 0.04 0.06 0.08 0.1 0.12 % Deme 25 50 100 500 1000 [ Inspeccon Lot Stre SP1 - * - EPRLT C SP1 E EPRbT E EPRLN EPRLN [ For n = 50, the OC curves for the EPRI plans Figure C.3 - Comparison of OC Curves-are much higher than the OC curve for SP1, SP1 vs. EPRI Plans (n = 500) ( reflecting the much larger sample size required 0.5 by SP1. Although the probability of acceptance for a good lot (percent defective < 5 percent) is 0.4 much higher for the EPRI plans, so is the probability of acceptance for a bad lot. Thus, 02 g,, " s . while the producer's risk is lower for the EPRI plans, the consumer's risk is higher. For g n = 500, only the OC curve for EPRl-N is ' 0.1 significantly higher than the OC curve for SP1. d' ' " { The OC curve for EPRl-T is only slightly higher 4,y y y y y, than the OC curve for SP1, reflecting the s oes.c.,e comparable sample sizes for the two plans. SP1 -~ EPRI-T EPRLN Product Analysis Tolerances for CGI Acceptance Criteria The tolerances listed in the Table of Product Analysis Tolerances in Section 4.2 of the main body of this report are intended to be used in lieu of any product analysis tolerances given in the applicable material specification (s). They are necessary to assist the dedicating [ entity in the verification of values listed in the certified material test report (CMTR). It is acknowledged that the values for concentration for any element may vary in a product and may be dependent on element behavior in the molt, the production process, the [ manufacturer's standard practices, and the material specification allowable va;ues. This was accounted for in the table by taking into account standard steel industry processes and metallurgical practices. { 46 w
The American Society of Mechanical Engineers (ASME), American Society for Testing and Materials (ASTM), and similar codes give in their material specifications product analysis tolerances for the chemical concentrations found in metals. These tolerances generally are designed to be applied to the heat analysis for verification of chemical composition. However, after a survey of various material specifications and discussions with professionals in the field of metal manufacture regarding their suitability, it was decided I that they would not be appropriate for verifying the validity of CMTRs. This decision was based on mill standard practices and their ability to control the chemical elements of I materials. Since standard mill production tolerances are considerably more stringent than the material specification tolerances allowed, and since those material specification tolerances would not provide reasonable assurance that indeed the CMTR represented the I material, the table was needed to balance these two variables. The aspects of variability for en element, such as analysis tolerance, manufacturer's tolerances, and variability within a heat, were accounted for. The uncertainty inherent in the results of a chemical analysis was judged to be at least an order of magnitude lower than the tolerances specified in the I table and so its additive effect in the tolerances may not be readily apparent. Figures 1 through 3 in Section 4.2 of the main body of this report are based on the I expected range of the chemical composition of carbon and alloy plate and bar steels. The tolerances required for the verification of CMTRs for sheet and deep-draw stock may differ. They are based on the composition of a flat bath of steel and the usual compositions of I plate and bar. The composition of plate and bar will be greater than 0.10 carbon. A flat bath is 0.03 carbon. The composition of a flat bath of steel will usually be above 0.10 manganese and 0.01 silicon. The usual additions to steel during refining and the addition of alloying elements are expected to fall within the ranges shown in Figures 1 through 3. l I I I L [ [ 47
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