ML20045D651

Summary of 930322 Meeting W/Numarc to Discuss Revised Draft NRC Insp Procedure for Commercial Grade Item Dedication

ML20045D651
Person / Time
Issue date:	04/05/1993
From:	Norrholm L Office of Nuclear Reactor Regulation
To:	Rossi C Office of Nuclear Reactor Regulation
References
NUDOCS 9306290262
Download: ML20045D651 (24)

Text

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APR 0 51993 MEMORANDUM FOR:

Char E. Rossi, Dir_ector O

y

'3 Division of Reactor Ins'p:ct-ion and Licensee Performance Office of Nuclear Reactor Regulation FROM:

Leif J. Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance 4

Office of Nuclear Reactor Regulation

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SUBJECT:

MINUTES OF PUBLIC MEETING WITH NUMARC ON COMERCIAL GRADE DEDICATION On March 22, 1993, the Director and Deputy Director of the Division of Reactor Inspection and Licensee Performance and other NRC staff members met with NUMARC to discuss the revised draft NRC inspection procedure for comercial grade item dedication and issues identified during the five pilot inspections.

The objective of the meeting was to obtain input from NUMARC on the revised inspection procedure and dedication guidance contained in that procedure.

The inspection procedure and its dedication guidance were discussed in detail and the NRC staff agreed to consider NUMARC's coments.

NUMARC indicated

'that although they had no significant disagreements with the issues discussed, they would probably provide additional comments during the public coment period.

The use of dedication examples during the comercial grade procurement and dedication workshop scheduled for April 1993 was also discussed.

4 Leif J. Nor holm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation

Enclosure:

1.

Draft Revised Inspection Procedure 2.

Meeting Attendees DISTRIBUTION:

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APR 0 51993 4

MEMORANDUM FOR:

Charles E. Rossi, Director Division of Reactor' Inspection and Licensee Performance l

Office of Nuclear Reactor Regulation FROM:

Leif J. Norrholm, Chief Vendor Inspection Branch i

Division of Reactor Inspection and Licensee Performance i

Office of Nuclear Reactor Regulation

SUBJECT:

MINUTES OF PUBLIC MEETING WITH NUMARC ON COMMERCIAL GRADE DEDICATION On March 22, 1993, the Director and Deputy Director of the Division of Reactor Inspection and Licensee Performance and other NRC. staff members met with 3

NUMARC to discuss the revised draft NRC inspection procedure for commercial grade item dedication and issues identified during the five pilot inspections.

The objective of the meeting was to obtain input from NUMARC on the revised inspection procedure and dedication guidance contained in that procedure.

The inspection procedure and its dedication guidance were discussed in detail and the NRC staff agreed to consider NUMARC's coments.

NUMARC indicated that although they had no significant disagreements with the. issues discussed, they would probably provide additional coments during the public coment period.

The use of dedication examples during the comercial gr procurement and dedication workshop scheduled for April 1993 was a o is ussed.

Leif J. > rrh 1m, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation

Enclosure:

1.

Draft Revised Inspection Procedure 2.

Meeting Attendees

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NRC INSPECTION MANUAL Rv!B INSPECTION PROCEDURE 38703 COMMERCIAL GRADE PROCUREMENT INSPECTION PROGRAM APPLICABILITY:

2515 SALP FUNCTIONAL AREA: ENGINEERING 38703-01 INSPECTION OBJECTIVE This procedure is provided in two sections and is intended to cover: (A) reactive

-inspections (38703A) in response to the failure or malfunction of dedicated commercial grade items (CGIs), and (B) inspections of the implementation of a licensee's process (387038) for dedicating CGIs to determine if it meets the requirements of Appendix B of 10 CFR Part 50, and ensures that CGIs will perform their intended safety functions.

38703A-01 REACTIVE INSPECTION OBJECTIVES Determine whether the failure of a system, structure, component, (SSC) or part te perform its intended safety function was the result of a deficient CGI l

dedication process. A failure resulting from inadequate dedication, in general, may occur when the important design, material, and performance characteristics that are necessary to ensure that the dedicated CGI will perform its intended safety function, are not addressed during dedication.

l 38703A-02 REACTIVE INSPECTION REQUIREMENTS 02.01 Schedulino the Inspection and Contactina Licensee.,

This inspection procedure should be considered for implementation when there is reason to believe that the failure of a SSC, or part to perform its intended safety function was i

the result of an inadequate CGI dedication.

This inspection procedure may be implemented independently or it may be used as a supplement to inspections such as an Augmented Inspection Team investigating failures, or other major team inspections such as those for maintenance, modification, or system specific inspections where review of failed SSCs or parts is appropriate.

02.02 Pre-Inspection Activities. Review the circumstances associated with the failure including any identified root cause analysis by the licensee. It may be appropriate to contact the licensee and obtain additional information prior to determining if an inspection is required. If it is determined that the item did not perform its intended safety function because of a hardware failure, determine if the failed item was purchased as a CGI and dedicated for its safety-related application.

If the failed item was dedicated, then this inspection procedure Issue Date: XX/XX/XX

-I-38703

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is applicable.

l 02.03 On-Site Conduct of the Insoection. Contact licensee personnel responsible l

for defining procurement requirements, and if not previously perfomed, determine if the failed item was procured as a CGI and dedicated for safety-related i

applications. If the failed item was dedicated, obtain the complete procurement and dedication records.

Typical records included in a dedication package are described in Section'03.02(b) of 38703B.

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02.04 Determine if the Failure was the Result of an Inadeauate Dedication.

Review and discuss with licensee personnel the failure analysis for the faile'd CGI.

Once the failure mode and cause ' of. failure have been postulated or detemined, review the dedication process to.see if the critical characteristics identified encompassed the characteristics associated with the failure.

Section-l 1 of Appendix A to Inspection Procedure 38703 provides methods for determining if the important critical characteristics related to the failed - item were y

identified.

If the critical characteristics associated with the failure are detemined to be adequately addressed in the dedication package, detemine if the methods used for verifying / accepting those critical characteristics are acceptable. The following should be considered when reviewing the methods used to accept the critical characteristics related to the failure.

a.

Where receipt inspection along with testing of the item (Method 1) was the method for accepting the critical characteristics, Sections 02.04 and 03.04(a) of 387038 should be used for determining the acceptability of' receipt inspection and testing activities.

. Proper calibration of measuring and test equipment, the use of approved vendors to' perform tests, and use of qualified personnel should also be considered.

b.

Where a commercial grade survey (Method 2) was the method used to accept a critical characteristic, Sections 02.04 and 03.04(b) of 38703B should be used for determining the acceptability of the commercial grade survey.

c.

Where a source verification (Method 3) was the method used for accepting a critical characteristic, Sections 02.04 and 03.04(c) of 38703B should be used for determining the acceptability of the source verification.

d.

Where supplier history (Method 4) was the method used for accepting a critical characteristic, Sections 02.04 and 03.04(d) of 38703B should be used to determine the acceptability of the use of the supplier's history.

e.

Any documentation that is furnished with the item and is relied on by the-licensee to accept critical characteristics, should be validated by a commercial grade survey, source verification,. or methods discussed in Section 6 of Appendix A to Inspection Procedure 38703.

i 02.05 Generic Considerations.

If it is determined that the. dedicated item failed as the result of certain critical characteristics not being identified and/or properly accepted, the inspector should perform the following assessments:

I a.

Determine if other CGIs from the same accepted lot or batch as the failed dedicated CGI have been similarly dedicated and installed in ' other safety-related applications.

If yes, determine if the licensee has evaluated.the operability of the systems or components where these CGIs are installed.

38703 Issue Date: XX/XX/XX

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.b.

In an effort determine if a full prCgram spection (387038) is necessary, the inspector should select and review at least three other dedicated CGIs having similar applications and critical characteristics as the CGI(s) that resulted in the identified failures. Section 02.02 of 38703B should be used in selecting these dedication packages.

c.

If, after performing (b) above, it is determined that other CGIs were i

inadequately dedicated, regional management should determine whether it i

is appropriate to perform a more comprehensive inspection of the licensee's dedication process in accordance with 38703B of this procedure, or if the inspector should review those portions of the 1

dedication program most pertinent to the deficiencies already identified.

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38703A-03 REACTIVE INSPECTION GUIDANCE Guidance for the inspection requirements is contained in the guidance section for 38703B.

38703A-04 REACTIVE INSPECTION RESOURCE ESTIMATE 04.01 Insoector Resources. The typical react've inspection will be conducted by one inspector either independently or in conjunction with other NRC inspection 0

efforts.

04.02 Estimated Insoection Hours. The following are estimates of the inspection effort needed to complete this inspection.

Pre-inspection in-office review

-4 inspection hours On site inspection

- 24 inspection hours 38703A-05 REFERENCES Refer to 38703B-05 for the appropriate references.

38703B-01 PROGRAM INSPECTION OBJECTIVES Verify that the licensee's process for dedicating CGIs, as implemented, meets the requirements of 10 CFR 50, Appendix B, and ensures that CGIs will perform their intended safety function.

2 387038-02 PROGRAM INSPECTION REQUIREMENTS 02.01 Schedulina the Inspection and Contactina Licensee. Coordinate with the appropriate NRC and licensee personnel to schedule the inspection.

When practical, inform the licensee of the objectives of the inspection 4-6 weeks before the inspection is to begin.

Reauest that the licensee prepare a list, prior to the inspection, consisting of items that the licensee purchased as commercial grade and subsequently dedicated for use in safety-related applications within the past two years.

If time permits, prior to the beginning of the on-site inspection, the inspector should request and review the licensee's program and procedures to become familiar with the licensee's procurement and dedication process.

Issue Date: XX/XX/XX 38703

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In addition, explore with the licensee 7 hu 70ssibility of cbtaining a list'of l

recent component failures. Request this list only if the licensee states this i

type of information would be easily retrievable. The list of component failures can be used by the inspector during the selection of dedication packages described in section 02.02.

02.02 Selection and Content of Dedication Packaaes. From the list of dedicated items provided by the licensee, the inspector should select approximately twenty dedication packages for review. Additional inspection guidance for the selection of packages for review is contained in Section 03.02(a) of 387038.

After the selections have been made, the inspector should request that the licensee compile a complete package of all the procurement and dedication records for each item. Inspection guidance on the contents of these dedication packages is provided in Section 03.02(b) of 38703B.

02.03 Review of Proaram and Procedures.

Review the licensee's program and procedures for the procurement and dedication of CGIs so the inspector understands the basic operation of the licensee's program.

Specifically, the inspectors should become familiar with the licensee's procedures that control:

procurement activities; material control; the dedication of commercial grade items, including receipt inspection and acceptance testing; audits and surveys of commercial grade suppliers; classification of components; training of personnel; trending of supplier performance; and equipment failures.

The inspectors should attempt to identify any apparent weak areas to concentrate on i

during the evaluation of the program implementation.

If plant equipment performs reliably and there are no identified failures of dedicated components, then there should be no need for the inspector to further i

examine the licensee's program and procedures beyond the initial review for familiarization. However, if after evaluation of the program implementation, it i

is determined that a full review of program and procedures is warranted, then Section 03.03 of 38703B provides guidance for this review.

02.04 Review of Dedication Packaaes. Review the dedication packages selected j

in Section 02.02 and perform a detailed review as described below and as per Section 03.04 of 38703B, depending on the dedication method (s) used.

The inspectors should perform the following steps to assist in the review.

• Determine the safety-related function of the item for its intended use in the plant by reviewing the technical evaluation portion of the package including, as applicable:

- classification of the item;

- consideration of credible failure modes; and,

- item equivalency / substitution evaluations.

. Determine if the important design, material and performance characteristics relevant to the safety function have been identified. Determine whether the licensee verified the characteristics necessary to provide reasonable assurance that the item will perform its intended safety function.

If appropriate, take into account post installation testing and periodic surveillance testing and inspection.

• Determine whether the item is a like-for-like replacement, or a new item replacement of an obsolete item.

38703 Issue Date: XX/XX/XX

nU o Determine if the item is or cay be used in a d1Tferent safety-related application than previously evaluated for, where different design, material, and performance characteristics may be applicable.

This is especially applicable for generic dedications of bulk items and stock material.

Determine if the dedication assures those design, material, and performance characteristics relevant to the most critical safety application.

• Determine why the item is being replaced. Have there been repeated failures?

Is the degraded performance a result of adve se environment?

Did it fail because it was a refurbished or fraudulent item? Additional information on these activities is provided in ANSI N45.2 - 1977, " Quality Assurance Program Requirements for Nuclear. Power Plants," Section 17, " Corrective Action."

• Determine how the identity of the item is controlled from the time it is receipt inspected up to when it is installed. Additional information in this area is provided in ANSI N45.2 - 1977, Section 9,

" Control of Parts and Components."

• Determine whether information learned during the dedication process is fed back to the appropriate persons to evaluate existing stock items, or installed items, and for future use in surveys and source verifications.

This information could include positive and adverse findings obtained during surveys and source verifications. Additional information on these activities is provided in ANSI N45.2.13 - 1976, " Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants,"

Section 9, " Corrective Action."

02.05 Review of Trainino Effectiveness. If the inspectors review of comercial grade dedication activities indicates there are weaknesses in the way these activities are being performed, the inspector should investigate further to determine if the licensee has established an effective training program. Section 03.05 of 38703 provides additional guidance. Additional information in this area is provided in ANSI N45.2 -1977, Section 2, " Quality Assurance Program."

38703B-03 PROGRAM INSPECTION GUIDANCE General Guidance. The procurement of safety-related spare and replacement parts for operating plants in the nuclear industry has changed considerably over the past several years. Because of a decrease in the number of qualified nuclear-grade vendors, the NRC staff is aware that there has been a change in the industry's procurement practices.

Ten years ago, licensees procured major assemblies from approved vendors who maintained QA programs pursuant to Appendix B of 10 CFR Part 50 (Appendix B). Currently, due to the reduction in the number of qualified nuclear-grade vendors, licensees are increasing the numbers of comercial grade replacement parts that they procure and dedicate for use in safety-related applications. This is a substantial change from the environment in which Appendix B was promulgated.

Licensees are required to maintain procurement and dedication programs that adhere to the requirements of Appendix B, and thus assure the quality of items purchased and installed in safety-related applications.

Since comercial grade dedications have increased in number, the NRC has developed this inspection procedure (IP) to provide guidance to assist the inspector in completing the inspection requirements.

This IP applies to the review of comercial grade procurement and dedication activities with regard to the technical and acceptance requirements of Appendix B.

It is not intended to provide a detailed, step-by-step, checklist for the inspection.

Issue Date: XX/XX/XX 38703

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The guidance discussed below is intended to assist the inspector to assess the effectiveness of the implementation of the licensee's commercial grade procurement practices. The evaluated areas should help the inspector discern any developing trends or emerging problems in the implementation of the program.

The Vendor Inspection Branch, NRR, is available to assist with specific questions that arise during the performance of this procedure.

03.01 No inspection guidance 03.02 Selection and Content of Dedication Packaoes.

a.

Selection of Dedication Packaoes:

The selection process should be performance-oriented; weighted toward the review of dedication packages for equipment, components or parts that have experienced failures.

To accomplish this, the inspector should select approximately twenty packages for review using the two step approach described below:

Steo 1: Review the licensee's records available at the plant site to identify recent failures (approximately the last two years) of equipment, components or parts. Review these failures to determine if any were CGIs dedicated for use in safety-related applications.

If available, select approximately 75% of the total sample from CGI failures.

Steo 2: From the list of dedication packages supplied by the licensee, select the remainder of pacxages for review.

The total sample size including packages from step 1 and step 2 should be approximately twenty packages.

However the inspector can select a larger or smaller sample depending on the complexity of the packages and the time available. The inspector should select these packages based on the following considerations:

The inspector should select packages for items whose failure would have the most impact on the ability of the plant to safely operate, safely shutdown from an adverse condition, or maintain a safe shutdown condition.

The plant specific probabilistic risk assessment (PRA), individual plant examination (IPE), and risk based inspection guides (RIGS) provide information on the risk significance of safety-related plant equipment.

The inspector should take a performance oriente"d approach to the selection process by including in the sample packages those items that have been problems in the past.

The inspector should review available sources of information to identify any known failures of CGIs that were used in safety-related applications. These sources of information could include:

Component failure lists or lists of items requiring frequent maintenance or replacement as provided by the licensee.

Hisrepresented or fraudulent items reported in NRC Information Notices.

Licensee trending of equipment and supplier performance.

Previous history of component failures or malfunctions as 38703 Issue Date: XX/XX/XX

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OV reported in licensee event reports, plant nonconformance reports, or NRC morning reports.

The inspector should include both simple and complex packages in the sample as well as packages that include a variety of dedication methods (i.e., Methods 1,2,3, and 4) described in guidance Section 03.05a through 03.05d.

In addition to selecting packages based on the above considerations (safety significance, complexity, and failures) the inspector should attempt to select samples from each of the following areas:

electrical, instrumentation and control, mechanical equipment, and materials.

b.

Contents of Dedication Packaaes:

The dedication packages compiled by the licensee may contain the following items, as applicable, depending on the item chosen and the dedication methods used.

Purchase requisitions and purchase orders.

Other pertinent vendor / licensee correspondence.

Design specifications - original and updated to verify certain important parameters, such as original design pressure of a system or degraded pick-up voltage of a solenoid or relay.

Catalog specifications.

Procurement basis evaluation - Like-for-like, equivalency, plant i

design change packages, drawing and specification updates.

10 CFR Part 50.59 safety evaluation, if required.

Material receiving reports, packing lists / invoices and other shipping documents.

Receipt inspection reports and any related test reports.

Other documents to trace the item from the time it was dedicated to

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the time it was installed, tested and accepted.

Certificates of Conformance/ Compliance / Quality.

Vendor test and inspection reports.

Third party or subvendor test and inspection reports.

Shelf life information.

Vendor dedication / partial dedication information.

Design / material / process change history information.

Completed commercial grade dedication document including:

identification of safety functions / application requirements Issue Date: XX/XX/XX 38703

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identification of crit'iiarcharacteristics identification of verification methods and' acceptance criteria.

for the critical characteristics 1

evaluation of credible failure modes Any deviation from design, material and performance characteristics _

relevant to the safety function (Nonconformance~ dispositions).

Documents showing objective evidence:

Special test and inspection procedures and results 1

Commercial grade survey reports - item, design, material -and 1

performance characteristic specific (relevant to. safety function)

Source inspection reports Completed post installation test procedure and results.

Completed stock or material issue forms and installation work orders or reports.

Historical performance information.

03.03 Review of Proaram and Procedures. Conduct a familiarization tour of'the engineering, receipt ' inspection, component testing, and warehouse areas.

Contact, as necessary, systems engineers, procurement engineers', receipt inspectors, quality assurance. engineers and inspectors, and warehouse personnel in order to gain an understanding'of:

• How processing of CGI procurement documents is controlled under the QA program and receive QA review and approval.

Additional information on these activities is provided in -' ANSI N45.2.13

.1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13</br></br>.1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.,- Section 3,

" Procurement j

Document Preparation, Review, and Change Control."

• How technical personnel participate in the preparation,-review, and approval process of purchase requisitions and purchase orders.

• How consistency and ' coordination is maintained -between _ corporate level, engineering / support

level, and site level programs and implementing procedures.

03.04 Review of Dedication Packnoes. The goal of the review of the procurement and dedication packages-is to ensure that the _CGIs being dedicated by the licensee for safety-related applications will perform their intended safety functions. The inspectors should not place an over emphasis..on the review of documentation. Inspection resu'.ts should be directed towards the' identification i

of inadequate dedications of 'JGIs that' could potentially render SSCs or. parts inoperable. The inspectors 1hould use the " Operable / Operability:: Ensuring the Functional Capability of a System or Component," section of NRC' Inspection Manual Part 9900, " Technical Guidance," for the review ~ of-licensee' operability determinations for inadequately dedicated CGIs that could affect the SSCs _or parts operability.

Appendix _ A to this procedure contains a' discussion of significant dedication 38703. Issue'Date:. XX/XX/XX 4

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issues that can be ussd during the review of dedication packages. The following

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specific guidance is included for the review of CGIs dedicated using any of the four methods listed below, a.

Method 1 - Special Tests and Insoections Additional information on these activities is provided in ANSI N45.2.13 -

1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process., Section 10. " Acceptance of Item or Service." Use the following approach to review packages that were dedicated using Method 1:

Attempt to witness receipt inspections and tests of the design, material, and performance characteristics relevant to the most critical safety application.

Review receiving records and associated tests and inspe'ctions.

Review post-installation test records.

Verify that the tests and inspections specified for acceptance, adequately verify performance and suitability for all intended applications.

Verify that sampling plans are controlled and have adequate technical basis, considering lot traceability and homogeneity, complexity of the item, and adequacy of supplier controls.

Verify that CGI receiving inspection activities are adequately controlled under the QA program regardless of whether they are being done in conjunction with other plant QA receipt inspection activities.

Verify that receipt inspection activities establish and maintain traceability of CG!s by capturing and appropriately relating traceability documents through identification and monitoring of CGIs.

b.

Method 2 - Commercial Grade Survey Use the following guidance to review packages that were dedicated using Method 2:

Determine if the guidance of Genersc Letter (GL) 89-02 is included in the appropriate procedures.

Specifically, that (1) the documented commercial quality prog, a= was effectively implemented, and (2) the surveys were conductea at the location necessary to verify that adequate controls were exercised on distributors as well as manufacturers.

Determine if the persons who perform vendor audits and surveys are knowledgeable in the following:

The use of performance-based audits.

Screening third-party audits and surveys.

Processing and evaluating adverse findings resulting from the review of third party audits and surveys to ascertain if those findings impact CGIs already installed or stored in the Issue Date: XX/XX/XX 38703 1

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warehouse awaiting future.. installation.

Additional information on these activities is provided in ANSI N45.2.12 - 1977, " Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants," and ANSI N45.2.23 - 1978,

" Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants."

Verify that the supplier's commercial quality controls are imposed in the procurement documents.

Determine if design, material, and performance characteristics relevant to the safety function that are to be verified by the survey team are accurately and completely incorporated in the survey plans.

Determine if the validity of supplier documentation relied upon in the dedication of the item, is verified during the survey.

Determine if surveys of commercial grade suppliers are performance-based as opposed to broad-based programmatic audits. Specifically, verify that selected

design, material, and performance characteristics relevant to the safety function for the CGIs being surveyed are controlled by the supplier's quality activities.

Determine if survey teams include technical and quality personnel that are knowledgeable in the operation of the item (s) and the associated critical characteristics to be verified, including any special processes such as welding and heat treatment that are specific to the critical characteristics.

Determine if surveys are conducted at appropriate times relative to the procurement.

Are surveys required to be updated on a regular basis to support dedication?

Determine if the control of subvendors is adequately addressed by the surveys so that the supplier has an adequate basis to accept test results and certifications from the subvendor.

Determine if pertinent information about a supplier or his products is used to plan, conduct, and report results of surveys and source verifications.

Such information could have been available from source verifications, receiving inspections, the dedication process and supplier / product performance history or outside sources such as (NRC Information Notices and Bulletins, NPRDS reports, or NUPlc joint audit or commercial grade survey reports).

c.

Method 3 - Source Verification Additional information on these activities is provided in ANSI N45.2.13 -

1976Property "ANSI code" (as page type) with input value "ANSI N45.2.13 -</br></br>1976" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process., Section 10.3.2, " Acceptance by Source Verification." Use the following approach to review packages that were dedicated using Method 3:

Determine if source verifications involve witnessing the supplier performing quality activities on the actual items being procured, and adequately verify the design, material, and performance characteristics relevant to the safety function.

38703 Issue Date: XX/XX/XX

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a Determine if personnel who participated in the source verification surveys had technical backgrounds.

Determine if appropriate hold points are imposed in the purchase orders. This would include a hold point to verify design, material, and performance characteristics relevant to the safety function, 4

that can not be verified after the item has been completely manufactured.

4 Determine if the results of the source verifications were adequately i

documented.

d.

Method 4 - Acceptable Sucolier/ Item Performance Record l

Use the following guidance to review packages that were dedicated using 1

Method 4:

i Determine if the guidance of GL 89-02 has been. incorporated.

e Specifically, (1) the established historical record is based on industry-wide performance data that is directly applicable to the item's critical characteristics and the intended safety-related application, and (2) the manufseturer's measures for the control of

design, process, and mat

• t1 changes have been' adequately implemented as verified by audit (multi-licensee team audits are acceptable).

Determine if information pertinent to the CGI's quality of performance, obtained from outside sources (e.g. 0ER, NRC, VETIP, INP0 etc.) and from commercial grade Surveys,. source verifications, receipt inspections, previous dedication or qualification and operational history, is factored into the dedication process.

Determine if the item or manufacturer is included in the licensees performance trending program.

i 03.05 Review of Trainina Effectiveness. Select and review the training records for individuals involved in the following areas:

• Determining the safety classification of an item.

• Specifying design, material and performance characteristics relevant to the safety function and establishing the acceptance criteria for these characteristics.

• Specifying or performing commercial grade surveys, source verifications, and j

tests and inspections, including enhanced post-receipt verification testing or inspection.

• The preparation and review of purchase orders.

Through observation, interviews and a review of records of work performed by the -

individuals:

• Determine if the individuals selected have adequate knowledge to perform _ the specific tasks assigned to them. Attend a training course, if wa11able, or review the lesson plans for selected training courses.

• Determine whether training inadequacies contributed to any of the deficiencies Issue Date: XX/XX/XX 38703-

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which cay be identified during the inspection.

• Determine if the personnel are familiar with the program requirements and procedures and if they have been properly trained in the dedication process.

387038-04 PROGRAM INSPECTION RESOURCE ESTIMATE 04.01 Inspection Resources.

The typical procurement and commercial grade dedication program inspection will consist of two or three inspectors for one a

week.

The inspectors should be knowledgeable of procurement requirements and j

include at least one mechanical engineer and one electrical / instrumentation and j

control engineer.

04.02 Estimated Inspection Hours. The following are estimates of the inspection effort needed to complete this inspection.

In-office review of program and procedures - 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> / inspector = 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> On-site inspection

- 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> / inspector = 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> Total for inspection = 192 hours0.00222 days <br />0.0533 hours <br />3.174603e-4 weeks <br />7.3056e-5 months <br /> 38703B-05 REFERENCES

• Generic Letter 89-02, " Actions to Improve the Detection of' Counterfeit and Fraudulently Narketed Products."

(microfiche'48960-001)-

• Generic Letter 91-05,." Licensee Commercial Grade Procurement and Dedication Programs." (microfiche 57468-264)

• American National Standards Institute (ANSI) N45.2 -.1977, " Quality Assurance Program Requirements for Nuclear Power Plants," as endorsed by NRC Regulatory Guide (RG) 1.28 Revision 2.

• ANSI N45.2.12 - 1977, " Requirements ' for Auditing. of Quality Assurance Programs for Nuclear Power Plants."

• ANSI N45.2.13

1976,

" Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants,"

• ANSI N45.2.23 - 1978, " Qualification of Quality Assurance Program Audit i

Personnel for Nuclear Power Plants."

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• SECY-90-304, "NUMARC Initiatives on_ Procurement" (microfiche 55277-049)

• SECY-91-291, " Status of NRC's Procurement Assessments and Resumption of Programmatic Inspection Activity" (microfiche 59490-079)

• NUMARC 90-13 " Nuclear Procurement Program Improvement"

• EPRI NP-5~52, " Guidelines for the Utilization Of Commercial-grade Items In Nuclear Safety Related Applications-(NCIG-07)"

• EPRI NP-6406, " Guidelines for the Technical Evaluatic,n of Replacement Items in Nuclear Power Plants (NCIG-ll)"

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• EPRI NP-6629, ' Guidelines for the Procurement and Receipt of Itcms for Nuclear Power Plants (NCIG-15)"

• EPRI NP-6630, " Guidelines For Performance-Based Supplier Audits (NCIG-16)

• EPRI NP-6895,

" Guidelines for the Safety Classification of Systems, 4

Components, and Parts Used in Nuclear Power Plant Applications (NCIG-17)"

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• EPRI NP-7218, " Guideline for the Utilization of Sampling Plans for Commercial Grade Item Acceptance (NCIG-19)"

END Appendix A.

Dedication Issues B.

Definitions i

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APPENDIX A 1

DEDICATION ISSUES I

7 1.

Basis for the selection and verification of critical characteristics.

j a.

Consideration of Item's Safety Function i

critical characteristics should be based on the item's' safety function.

i The licensee is responsible for. identifying the ~ important 1 design,-

material, and performance characteristics which have direct impact on the item's ability to accomplish its intended safety function, establishing acceptance criteria for these characteristics, and providing reasonable i

assurance of conformance to these criteria. When an existing _ equipment specification is available that contains adequate technical requirements for the item being purchased, that specification can be used to establish the critical characteristics for this item. Criterion II of Appendix B l

provides for the application of quality control over activities affecting the quality of structures, systems, and components 'to an extent consistent with their importance to safety. This approach can be used in the selection of critical characteristics and acceptance criteria-for ~

commercial grade items.

b.

Consideration of Failure Modes.

An evaltation of credible failure modes of an item in _ its ' operating l

environment and the effects of these failure modes on the item's safety function may be used in the safety classification of ant item and as a basis for the selection of critical characteristics.

c.

Reasonable Assurance The dedication process is not a substitute for' Appendix B.

Rather, it represents a method of achieving compliance with Appendix B with the purchaser ~ assuming many of the responsibilities for assuring quality and-functionality of an item which had previously been the responsibility of the vendor.

In this context, ' reasonable assurance consists of the purchaser controlling the activities affecting the it'em's quality to~an extent consistent with the item's importance to safety or assuring that these activities are adequately ' controlled by the supplier.

For more complex items, dialogue with the original equipment manufacturer may be necessary to identify the design and functional parameters of specific piece parts. Upon the completion of the dedication process,.the quality assurance and/or other measures applied to those ' aspects of ' the item which directly affect its safety function should result in the same level

.i performance reliability as for a like item manufactured or purchased under an Appendix B program.

d.

Engineering Judgement-Engineering judgement can be used in selecting those important design, material,_ and performance characteristics which are identified as the' item's critical characteristics. The bases for engineering judgement for this application 'should be documented.

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2.

Samol ina, a.

Established Heat Traceability (materials)

When heat traceability of material has been established and each piece of the material is marked with the material heat number, all analyses and tests required to verify the identified critical characteristics may be performed on one piece of this material.

b.

Established Lot / Batch Control When Lot / Batch (defined as units of product of a single type, grade, class, size and composition, manufactured under essentially the same conditions, and at essentially the same time) control is established through a commercial grade survey, the party performing dedication can use sampling prescribed by standard statistical methods which are based on homogeneous product lots. Such sample plans should be documented and provide for the verification of the critical characteristics with confidence level consistent with the item's importance to safety.

c.

Items With No Lot / Batch Control t

When Lot / Batch traceability can not be established, sampling plans need to be considered on individual, item-specific basis and assure that they are capable of providing a high level of assurance of the item's suitability for service. There may be situations where each item needs to be tested.

3.

Traceability.

a.

Material / Items Purchased from Distributors Traceability can be defined as the ability to verify. the history, location, or application of an item by means of recorded identification.

Where the item's acceptance is based entirely or partially on a certification by the manufacturer, the traceability must extend to the manufacturer.

In situations where intermediaries (distributors) are included in the supply chain and have physical possession of the item during the procurement process, their capability of maintaining i

traceability should be assured by audit or surveys. Distributor audits or surveys do not need to be performed on item-specific basis but should demonstrate that the distributor has adequate traceability controls in place for the type of items being supplied.

4.

Commercial Grade Surveys.

a.

Verification of Vendor's Control of Specific characteristics A commercial grade survey should be specific to the scope of the commercial grade item or items being purchased. The vendor's controls of j

specific critical characteristics to be verified during the survey should be identified in the survey plan.

The verification should be accomplished by reviewing the vendor's program / procedures controlling these characteristics and observing the actual implementation of these controls in the manufacture of items identical or similar to the items being purchased.

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b.

Identification of Applicable Program / Procedures The vendor must have a documented program and/or procedures to control the critical characteristics of the item or items being procured which are to be verified during the survey.

When many items are being purchased, a survey of a representative group of similar items may be sufficient to demonstrate that adequate controls exists. If the vendor's controls are determined to be satisfactory, purchase orders for these items should invoke these controls as contract requirements by referencing the applicable program / procedure and revision.

Upon completion of the work, the vendor should certify compliance with the purchase requirements.

c.

Documentation of Survey results Commercial grade survey documentation should include the identification of item or items for which the vendor is being surveyed, identification of the critical characteristics of these items which the vendor is expected to control, identification of the controls to be applied (program / procedure and revision) and a description of the verification activities performed and results obtained.

Deficiencies identified during the survey which may affect control of the identified critical characteristics should be addressed by requiring the vendor to institute additional controls or by utilizing other verification and acceptance methods.

5.

Like-For-like Replacements, a.

Like-for-Like Verification If it can not be demonstrated that the replacement item is identical with the item that it replaces, or if differences between the items are identified, an evaluation is necessary to determine if any changes in design, material, or manufacturing process could impact the item's critical characteristics and its ability to perform the intended safety

)

function.

6.

Acceptance Of Certified Material Test Reports (CMTRs)

And Certificates Of Comoliance (C0Cs).

a.

Validity Verified Through Vendor / Supplier Audit or Testing The validity of vendor CNTRs and CoCs should be verified.

This can be accomplished through a commercial grade survey or, for simple items, periodic testing of the product upon receipt. Such verifications should be conducted at intervals commensurate with the vendor's past performance.

If the item's supply chain includes a distributor who has physical possession of the items during the procurement process, the verification survey should include warehousing and/or traceability controls at the distributor's facility. The purchaser may develop other means to accomplish this verification consistent with its QA program comitments.

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APPENDIX B DEFINITIONS The following terms are listed to provide the inspectors with working definitions j

of important terms used during the pr.ocurement and dedication of commercial grade i

items (CGIs). These terms are defined only in the context of the CGI dedication process and are solely to aid the inspector in the inspection process.

Acceptance - The employment of methods to produce objective evidence that the CGI will perform its intended safety function.

Commercial Grade Item - An item satisfying all three of the following criteria:

i I.

Not subject to design or specification requirements that are unique to nuclear facilities; nd 2.

Used in applications other than nuclear facilities; nd 3.

Is to be ordered from the manufacturer / supplier on the basis of-specifications set forth in the manufacturer's published product description (i.e. catalog).

i Commercial Grade Survey - Activities conducted by the purchaser or its agent to verify that a supplier of CGIs controls, through quality activities, the critical characteristics of specifically designated CGIs, as a method to accept those items for safety-related use.

Critical characteristics - Are those important design, material, and performance characteristics which have direct impact on the CGI's. ability to accomplish its intended safety function.

Dedication - Is the process which assures the suitability of commercial grade parts, materials and services intended for safety-related applications by identifying, and obtaining assurance with respect to, the important design, material, and performance characteristics which are relevant to the intended safety function.

Eauivalency Evaluation - A technical evaluation performed to confirm that an alternate replacement

item, not identical to the original

item, will satisfactorily perform its intended safety function once in service, i

Like-for-like Replacement - The replacement of an item with an item that is identical.

Reasonable Assurance -

In the context of dedication of a CGI, reasonable assurance consists of the purchaser controlling the activities affecting the item's quality to an extent consistent with the item's importance to safety and providing adequate justification that the SSC or part will perform its designed safety function.

Source Verification - Activities witnessed at the suppliers'-facilities by the' purchaser or its agent for specific items to verify that a supplier of CGIs controls the critical characteristics of that item, as a method to accept the Issue Date: XX/XX/XX A-4 38703-

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item for safety-related use.

Special Tests and Inspections - Activities conducted during or after receipt of a CGI to verify certain critical characteristics ~ as a method to accept the item for safety-related use.

Technical Evaluation - An evaluation performed to assure that the correct' requirements for an item are specified in the procurement document.

Traceability - Is the ability to verify the history, location, or application of an item by means of recorded identification.

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ENCLOSURE 2 O

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l MEETING WITH NUMARC ON DEDICATION ISSUES 03/22/93 tLAtiE AFFLIATION Alex Marion NUMARC Biff Bradle;r NUMARC t

Charles E. Rossi NRC/DRIL Roy Zimmerman NRC/DRIL Leif J. Norrholm NRC/VIB Uldis Potapovs NRC/VIB Charles D. Petrone NRC/DRIL Larry L. Campbell NRC/VIB 7

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