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NEI Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services- 14-05A - Rev.1-with RAI 2 and 3 Updates 09-2020 + Attachments
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Issue date:	09/11/2020
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	NEI 14-05A, Rev. 1
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NEI 14-05A, Revision 1 GUIDELINES FOR THE USE OF ACCREDITATION IN LIEU OF COMMERCIAL GRADE SURVEYS FOR PROCUREMENT OF LABORATORY CALIBRATION AND TEST SERVICES September 2020 Nuclear Energy Institute, 1201 F Street N. W., Suite 1100, Washington D.C. (202.739.8000)

ACKNOWLEDGEMENTS This guidance was developed by the Nuclear Energy Institute (NEI) International Laboratory Accreditation Cooperation (ILAC) Task Force with the valuable assistance of the NEI Quality Assurance Task Force and the Nuclear Procurement Issues Committee (NUPIC) ILAC Committee under the leadership of Earl Mayhorn, AMEREN. The Electric Power Research Institute (EPRI) Joint Utility Task Group (JUTG) on commercial grade dedication (CGD) helped assure fidelity with CGD guidance was maintained, where appropriate. Members of ILAC also assisted in the review this document to assure the ILAC process is accurately described. We also recognize the direct participation of the licensees and suppliers who contributed to the development of the guidance. The dedicated and timely effort of the many participants, including management support of the effort, is greatly appreciated.

NOTICE Neither NEI, nor any of its employees, members, supporting organizations, contractors, or consultants make any warranty, expressed or implied, or assume any legal responsibility for the accuracy or completeness of, or assume any liability for damages resulting from any use of, any information apparatus, methods, or process disclosed in this report or that such may not infringe privately owned rights.

NEI 14-05A Revision 1 September 2020 FOREWORD The purpose of this guidance is to describe an acceptable approach for using laboratory accreditation by Accreditation Bodies (ABs) that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) (referred to as the ILAC process) in lieu of commercial grade surveys as part of commercial grade dedication. The scope includes commercially procured calibration and test services performed by domestic and international laboratories accredited by ILAC signatories. The approach also includes continued oversight of the ILAC process by the nuclear industry to verify that the ILAC process continues to be an equivalent alternative to a commercial grade survey. In developing this approach, NEIs ILAC Task Force observed peer evaluations of international Accreditation Bodies, assessments of calibration and testing laboratories, training for peer evaluators, and ILAC accreditation meetings. Based upon these observations, it was concluded that the ILAC process is essentially equivalent to the U.S. Nuclear Regulatory Commission (NRC) accepted practices for performing commercial grade surveys.

NRCs endorsement of this guidance expands NRCs recognition of the ILAC process first documented in a Safety Evaluation Report (SER) on an Arizona Public Service (APS) request.

NRCs earlier recognition was limited to laboratory calibration services accredited by specific U.S. Accreditation Bodies. With endorsement by the NRC, licensees and suppliers may use this guidance to credit accreditation by ILAC signatories, both domestic and international, in the commercial grade dedication of laboratory calibration and test services.

Summary of Revision 1 changes The NRC endorsed the process described in NEI 14-05A Rev 0 as reflected in the Final Safety Evaluation Report 1 dated February 9, 2015.

Prior to a licensee implementing the methodology outlined in NEI 14-05A, Revision 0, the NRC required a licensee to submit a revision to its Operating Quality Assurance Program (OQAP) for NRC acceptance in accordance with 10 CFR 50.54(a)(4) since implementation of NEI 14-05A represented a reduction in commitment. Ameren (AUE) revised the Ameren Callaway Unit 1 OQAP adopting NEI 14-05A and submitted it to the NRC for approval in October 2015. The NRC issued a Final Safety Evaluation Report on April 1, 2016 approving Ameren's implementation of the ILAC process in accordance with NEI 14-05A, revision 0. Other licensees subsequently revised their Quality Assurance Programs to implement the ILAC process based on the NRC's Safety Evaluation Report (SER) issued to AUE.

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NEI 14-05A Revision 1 September 2020 On November 30, 2017, the International Standards Organization (ISO) released ISO/IEC 17025:2017. Since the above-mentioned SERs only recognized ISO/IEC 17025:2005, the NEI ILAC Taskforce performed a gap analysis between ISO/IEC 17025:2005 and ISO/IEC 17025:2017 and concluded the newer version (2017) of the standard is equivalent to the older version (2005) which was previously recognized by the NRC. ISO/IEC 17025:2017 included some updates and enhancements but did not represent a reduction in commitment to quality.

Based on this conclusion, the nuclear industry requested the NRC's recognition of ISO/IEC 17025:2017 during the ISO-designated three-year transition period (that began on November 30, 2017) in a letter dated October 1, 2018. On April 16, 2019, the NRC issued a letter provisionally recognizing ISO/IEC 17025:2017 during the transition period with the expectation that the industry would submit a revision to NEI 14-05A requesting NRC recognition of ISO/IEC 17025:2017 beyond the transition period which was originally scheduled to end on November 30, 2020. However, due to travel restriction resulting from the COVID-19 Pandemic, ILAC extended the transition period to June 1, 2021. In addition to revising NEI 14-05A to recognize ISO/IEC 17025:2017 as the basis of the ILAC process, the revision was expected to address other minor editorial changes, clarifications, and adjustments based on operating experience subsequent to the NRC endorsement in February 2015. The changes represented in NEI 14-05A, Revision 1 are summarized as follows:

References to ISO/IEC 17025:2005 have been replaced with references to ISO/IEC 17025:2017, with the understanding that ISO/IEC 17025:2005 will remain valid through June 1, 2021.

Clarifications on limits of use have been added to indicate the ILAC process is not intended to be utilized for the commercial grade dedication of Nondestructive Examination (NDE) services.

Subcontracting of accredited services is prohibited. The laboratory that is contracted to perform the required accredited calibration or testing must perform the service and cannot subcontract the services to another accredited laboratory.

The ILAC process is intended for use by licensees and suppliers of basic components as a part of the commercial grade dedication process and must be used in conjunction with other NRC-endorsed commercial grade dedication guidance such as EPRI TR3002002982. This includes clarifying that a commercial grade dedication technical evaluation is required as a part of the ILAC process to document the critical characteristics and acceptance method for calibration and testing services.

The NRC's endorsement of the use of accreditation to ISO/IEC 17025:2017 by Accreditation Bodies (ABs) that are signatories to the ILAC MRA in lieu of performing a commercial grade survey for the acceptance of calibration and testing services was iv

NEI 14-05A Revision 1 September 2020 largely based on ABs performing on-site accreditation assessments at laboratories. Due to travel restrictions caused by the COVID-19 pandemic, ABs are performing remote accreditation assessments. A limitation has been placed on the use of remote accreditation assessments to maintain accreditation. Accredited testing or calibration services performed on behalf of licensees and suppliers of basic components cannot be accepted from laboratories who have not undergone an on-site accreditation assessment within the past 48 months of the date of services. In effect, this means that such laboratories cannot maintain accreditation based on consecutive remote accreditation assessments.

Sample technical evaluations for both calibration and testing services have been included as attachments to NEI 14-05A, Rev. 1.

These changes represent clarifications and conservative adjustments and the ILAC process that was endorsed by the NRC in NEI 14-05A, Revision 0 remains fundamentally unchanged.

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NEI 14-05A Revision 1 September 2020 TABLE OF CONTENTS 1 INTRODUCTION ............................................................................................................ 1 1.1 PURPOSE .........................................................................................................................1 1.2 REGULATORY BASIS .......................................................................................................1 1.3 ACCEPTANCE OF ACCREDITATION BY ILAC SIGNATORIES IN LIEU OF COMMERCIAL GRADE SURVEYS.............................................................................................................2 1.4 ACRONYMS .....................................................................................................................5 2 INTERNATIONAL LABORATORY ACCREDITATION COOPERATION (ILAC)................. 6

2.1 DESCRIPTION

OF THE INTERNATIONAL LABORATORY ACCREDITATION COOPERATION ................................................................................................................6

2.2 DESCRIPTION

OF THE REGIONAL ORGANIZATIONS ......................................................9

2.3 DESCRIPTION

OF ACCREDITATION BODIES ...................................................................9

2.4 DESCRIPTION

OF CONFORMITY ASSESSMENT BODIES..................................................9 3 USE OF LABORATORY SERVICES ACCREDITED BY ILAC MRA SIGNATORIES AS PART OF COMMERCIAL GRADE DEDICATION ACTIVITIES ...................................... 10 3.1 OVERVIEW OF COMMERCIAL GRADE DEDICATION OF CALIBRATION AND TESTING LABORATORY SERVICES ..............................................................................................10

3.2 TECHNICAL EVALUATION

............................................................................................11 3.3 ACCEPTANCE METHOD ................................................................................................12 3.4 LIMITATIONS OF USE....................................................................................................12 4 PURCHASERS QUALITY ASSURANCE PROGRAM .................................................. 13 4.1 ORGANIZATION.............................................................................................................14 4.2 PROCUREMENT DOCUMENT CONTROL .......................................................................14 4.3 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES .........................15 4.4 CONTROL OF MEASURING AND TEST EQUIPMENT ......................................................15 4.5 CORRECTIVE ACTION...................................................................................................16 5 U.S. NUCLEAR INDUSTRY OVERSIGHT OF THE ILAC PROCESS ............................. 16 5.1 ORGANIZATION.............................................................................................................16 5.2 VERIFICATION THAT THE ILAC PROCESS CONTINUES TO BE CONSISTENT WITH NRC ACCEPTED PRACTICES ........................................................................................17 5.3 VERIFICATION THAT IMPLEMENTATION OF THE ILAC PROCESS CONTINUES TO BE CONSISTENT WITH NRC ACCEPTED PRACTICES ........................................................18 5.4 OPTIONAL ACTIVITIES .................................................................................................18 6 NUCLEAR INDUSTRY REVIEW OF THE ILAC PROCESS ........................................... 18 vi

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6.1 TECHNICAL EVALUATION

OF ILAC REQUIREMENTS AND PROCEDURES ..................21 6.2 OBSERVATION OF TRAINING ........................................................................................24 6.3 OBSERVATION OF A MUTUAL RECOGNITION ARRANGEMENT MEETING ..................25 6.4 OBSERVATION OF PEER EVALUATIONS AND LABORATORY ASSESSMENTS ...............27 APPENDIX A - QUALITY ASSURANCE PROGRAM TEMPLATE .......................................... 1 ATTACHMENT 1 - EXAMPLE CALIBRATION SERVICES TECHNICAL EVALUATION ATTACHMENT 2 - EXAMPLE TESTING SERVICES TECHNICAL EVALUATION vii

NEI 14-05A Revision 1 September 2020 Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services 1 INTRODUCTION 1.1 PURPOSE The purpose of this guidance is to provide an acceptable approach for procuring commercial grade calibration and testing services by laboratories accredited by International Laboratory Accreditation Cooperation (ILAC) signatories. Access to internationally (including both domestic and international) accredited calibration and testing services benefits licensees and their suppliers through reduced cost, expanded access to services, improved quality of services, and improved regulatory confidence.

This approach takes advantage of the internationally recognized standards and accreditation process when qualifying suppliers to perform calibration and test services for the nuclear industry. Purchasers (licensees and suppliers of basic components) that procure commercial grade calibration or testing laboratory services are able to rely on laboratory accreditation by Accreditation Bodies (ABs) that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) (referred to as the ILAC process) in lieu of commercial grade surveys to provide the necessary evidence of compliance to qualify calibration or test suppliers under a Commercial Grade Dedication process. The net result will be a substantial reduction in duplication of effort for qualifying these suppliers across the industry, while ensuring that the applicable requirements for commercial grade dedication continue to be met.

1.2 REGULATORY BASIS Items and services used in safety related applications at US commercial nuclear power plants are designated as basic components and are required to be provided in accordance with 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants. 10 CFR Part 50, Appendix B, includes requirements for calibration and testing associated with basic components.

It is not always possible or practical to procure items and services directly from suppliers that implement quality assurance programs that meet 10 CFR Part 50, Appendix B.

Therefore, the NRC established requirements in 10 CFR Part 21, Reporting of Defects and Noncompliance, that permit the use of commercial grade items and services in nuclear safety related applications through a commercial grade dedication process.

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NEI 14-05A Revision 1 September 2020 Although the suppliers of commercial grade items and services are not required to comply with 10 CFR Part 50, Appendix B requirements, the commercial grade dedication activities must be performed under a Quality Assurance Program that meets the requirements of 10 CFR Part 50, Appendix B.

The process for accepting items and services for use as basic components from commercial suppliers is known as Commercial Grade Dedication (CGD or Dedication).

An acceptable approach for dedicating commercial grade items includes the need to verify the critical characteristics for commercial grade items and services and a Commercial Grade Survey is one of four acceptable methods to perform this verification. This approach is described in EPRI TR03002002982, "Plant Engineering:

Guideline for the Acceptance of Commercial-Grade Items in Nuclear Safety-Related Applications," Revision 1 to EPRI NP-5652 and TR-102260 or other equivalent EPRI guidance 2.

The Nuclear Procurement Issues Corporation (NUPIC) is an association of U.S. nuclear power plant operators and a number of international nuclear power plant operators with the mission to improve supplier quality assurance and oversight processes through cooperative efforts. NUPIC has established processes and checklists to perform commercial grade surveys that meet the applicable requirements of 10 CFR Part 21 and 10 CFR Part 50, Appendix B, and associated guidance.

This guidance document describes a method for using the ILAC process in the procurement of commercial grade laboratory calibration and test services and dedication of these laboratory services in compliance with 10 CFR Part 21 and 10 CFR Part 50, Appendix B. This guidance is applicable to dedicating entities subject to the quality assurance requirements of 10 CFR Part 50, Appendix B 10 CFR Part 52, 10 CFR Part 71 and 10 CFR Part 72 licensees and suppliers. Only such licensees and suppliers should use the methodology described herein in lieu of performing a commercial grade survey during the dedication of commercial calibration and testing services.

1.3 ACCEPTANCE OF ACCREDITATION BY ILAC SIGNATORIES IN LIEU OF COMMERCIAL GRADE SURVEYS Calibration and testing services provided by internationally accredited laboratories under the ILAC process are commercial grade services. The guidance within describes an approach to rely on the accreditation by an ILAC signatory in lieu of commercial grade surveys in the commercial grade dedication process. The approach used to develop this 2

EPRI guidance on commercial grade dedication titled Guideline for the Acceptance of Commercial Grade Items in Nuclear Safety-Related Applications, Revision 1, 3002002982, has been used which supersedes EPRI-NP5652 and EPRI TR-102260. The approach in EPRI TR 3002002982 has been endorsed in NRC Regulatory Guide 1.164. The user of this guidance document on the use of the ILAC process in lieu of a commercial grade survey should use the NRC endorsed guidance available at the time the dedication activities are performed.

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NEI 14-05A Revision 1 September 2020 guidance was to compare the ILAC process with NRC accepted practices for commercial grade surveys to evaluate their equivalence and determine whether any additional actions are necessary to address differences between them. Section 2 describes the ILAC processes and Section 6 provides the U.S. nuclear industrys evaluation of ILAC process and comparison with NRC accepted practices. Section 5 describes the approach for the U.S. nuclear industry to provide continued oversight of the ILAC process in order to confirm that the ILAC process can continue to be used in lieu of commercial grade surveys for the purpose of commercial grade dedication, as described in this guidance.

Based upon the conclusion that the ILAC process is essentially equivalent to NUPIC practices, it has been determined that the accreditation by ILAC signatories can be used, with the inclusion of a few requirements in the procurement documents, in lieu of a commercial grade survey to comply with the applicable requirements of 10 CFR Part 50, Appendix B and10 CFR Part 21, and associated guidance. It should be noted that commercial grade surveys are required to be performed at the supplier/laboratory site.

Due to travel restrictions resulting from the COVID-19 Pandemic, ABs are employing remote accreditation assessments. As a result, this document imposes a limitation on the use of remote assessment accreditation. Laboratories performing work for licensees and suppliers of basic components based on the laboratory's accreditation to ISO/IEC 17025:2017 cannot maintain their accreditation based on consecutive remote accreditation assessments. This limitation helps maintain the equivalence of the accreditation process to the nuclear industry's commercial grade survey process.

Section 3 describes how purchasers of international calibration and testing laboratory services should use the accreditation by ILAC signatories as part of their commercial grade Dedication activities. It is noted that this guidance should be used in conjunction with guidance on commercial grade dedication. Therefore, the ILAC process is intended for use in lieu of commercial grade surveys by licensees and suppliers of basic components and licensees and suppliers implementing 10 CFR Part 71 and 10 CFR Part 72 programs. In addition, Section 4 describes information that purchasers should ensure is included in their Quality Assurance Programs.

The following are the actions and steps that are necessary in order for a purchaser to accept accreditation of international calibration and test laboratory services by ILAC MRA signatories in lieu of performing a commercial grade survey as part of commercial grade dedication. Additional detail on performing these steps is discussed in subsequent sections of this guidance.

1) The method to use accreditation by an ILAC MRA signatory in lieu of a commercial grade survey (alternative method) is documented in the purchasers QA program.

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2) The method the purchaser needs to follow, and document in their QA program, consists of:

1. A documented review of the suppliers accreditation is performed and includes a verification of the following:

a. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories.

b. For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

c. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

d. The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected AB within the past 48 months. The laboratory's accreditation cannot be based on two consecutive remote accreditation assessments.

2. The purchase documents require that:

a. The service must be provided in accordance with their accredited ISO/IEC-17025:2017 program and scope of accreditation.

b. As-found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance. (for calibration services only)

c. The equipment/standards used to perform the calibration must be identified in the certificate of calibration. (for calibration services only)

d. Subcontracting of these accredited services is prohibited.

e. The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

f. Performance of the services listed on this order is contingent on the laboratory's accreditation having been achieved through an on-site accreditation assessment by the Accreditation Body within the past 48 months.

g. Any additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

3. It is validated, at receipt inspection, that the laboratorys documentation certifies that:

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a. The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2017 program, and has been performed within their scope of accreditation, and

b. The purchase orders requirements are met.

ISO/IEC 17025:2017 was released on November 30, 2017. During the transition period, both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 are valid. Originally, ILAC assigned a three-year transition period ending on November 30, 2020.

However, in June 2020, ILAC extended the end of the transition period from November 30, 2020 to June 1, 2021 due to travel restrictions caused by the global coronavirus disease 2019 (COVID-19) outbreak. This additional time will allow all laboratories the time needed to complete the transition. After June 1, 2021, ISO/IEC 17025:2005 will become invalid and only accreditation to ISO/IEC 17025:2017 can be achieved and recognized under the ILAC MRA process. Therefore, this document recognizes accreditation to ISO/IEC 17025:2005 through June 1, 2021.

1.4 ACRONYMS A2LA - American Association for Laboratory Accreditation AB - Accreditation Body APLAC - Asia Pacific Laboratory Accreditation Cooperation CAB - Conformity Assessment Body CFR - Code of Federal Regulations CGD - Commercial Grade Dedication EA - European Cooperation for Accreditation EPRI - Electric Power Research Institute GL - Generic Letter IAAC - Inter American Accreditation Cooperation IAF - International Accreditation Forum IEC - International Electrotechnical Commission ILAC - International Laboratory Accreditation Cooperation ISO - International Organization for Standardization JAB - Japan Accreditation Board 5

NEI 14-05A Revision 1 September 2020 JIG - Joint Inspection Group M&TE - Measuring and Test Equipment MRA - Mutual Recognition Arrangement NDT - Non-Destructive Testing NDE - Non-Destructive Examination NEI - Nuclear Energy Institute NIST - National Institute of Standards and Technology NRC - Nuclear Regulatory Commission NUPIC - Nuclear Procurement Issues Corporation QA - Quality Assurance QC - Quality Control 2 INTERNATIONAL LABORATORY ACCREDITATION COOPERATION (ILAC)

2.1 DESCRIPTION

OF THE INTERNATIONAL LABORATORY ACCREDITATION COOPERATION ILAC was formalized as a cooperative agreement in 1996 by a memorandum of understanding signed by 44 national bodies. In 2000, 36 laboratory accreditation bodies, (ILAC full members) signed a Mutual Recognition Arrangement (MRA or Arrangement) to promote the acceptance of accredited technical test and calibration data worldwide.

The signatories had been evaluated by their peers (against the acceptance criteria of the then relevant ISO/IEC requirements) and demonstrated that they met ILAC criteria for competence. The current requirements for laboratories are in ISO/IEC 17025:2017, "General requirements for the competence of testing and calibration laboratories.

Periodic reevaluations of ILAC signatories are conducted to maintain ILAC recognition.

ILAC MRA documentation, including requirements for evaluation of accrediting bodies, is publicly available on the ILAC website.

The key to the Arrangement is the developing global network of accredited laboratories and inspection bodies that are assessed and recognized as being competent by ILAC Arrangement signatory accreditation bodies (ABs). The signatories have, in turn, been evaluated by their peers (against the requirements of ISO/IEC-17011:2017) and shown to meet ILACs criteria for competence.

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NEI 14-05A Revision 1 September 2020 ILAC has several membership levels as described below:

Full Members - Full members are also known as ILAC MRA signatories. Each accreditation body that is a signatory to the MRA must maintain conformance with ISO/IEC-17011:2017 and other ILAC guidance and requirements, and ensure that all its accredited labs comply with the relevant international standard (i.e., ISO/IEC-17025:2017 for calibration and testing laboratories). The signatories have also been peer-reviewed and shown to meet ILACs criteria for competence. This guidance is only applicable for services provided by laboratories accredited by ILAC signatories (Full Members).

Associates - Accreditation bodies that are not signatories to the ILAC MRA, but which can provide evidence that they are operational and committed to comply with the requirements in relevant standards (e.g., ISO/IEC and ILAC) and obligations of the ILAC MRA, and are recognized in their economy as offering an accreditation service.

Affiliates - Accreditation bodies that are currently operating, being developed or intend to be developed, and declare their intention to operate their accreditation programs in compliance with the requirements in relevant standards (e.g., ISO/IEC and ILAC).

Stakeholders - Representative international, national and regional organizations having an interest in the work of ILAC, including associations of laboratories, regulatory authorities and trade organizations. NEI is a stakeholder member on behalf of the U.S.

nuclear industry.

ILAC accomplishes its mission through the use of committees. The current listing of committees and their responsibilities are found on the ILAC website and are summarized as follows:

General Assembly - is the primary body of ILAC and ensures that specific tasks are pursued in accordance with the objectives of ILAC. All members of ILAC are eligible to nominate one representative (delegate) to the General Assembly. The ILAC Chair is responsible for chairing meetings of the General Assembly.

Executive Committee - Responsible for the day-to-day management of ILAC and its activities. The members of this committee consist of the Chair and Vice Chair of ILAC, the Chairs of those committees having strategic responsibilities for ILACs development, a representative of participating Regional Cooperation bodies, a representative of unaffiliated economies and other participants as determined by the General Assembly.

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Arrangement Council - is the decision-making body for determining signatory and recognition status under the ILAC Arrangement. The members of the Arrangement Council are delegates nominated by the Full and Associate members.

Arrangement Committee - Responsible for harmonized implementation and continual improvement of the ILAC Arrangement. Deals with the approach of accreditation bodies to the assessment and accreditation of laboratories, the establishment of agreements between accreditation bodies and related policy areas.

Accreditation Committee - Responsible for harmonization and improvement of accreditation practice at the international level. It is involved in the investigation of technical issues related to accreditation, and the development of technical documentation related to ILAC's work.

Laboratory Committee - Provides a means of interaction and exchange of ideas between ILAC and the laboratory community.

Marketing and Communications Committee - Responsible for internal and external marketing and communication issues. It is involved with the promotion of ILAC's objectives, and the publication of ILAC documents, newsletters and other information.

Arrangement Management Committee - Responsible for the day-to-day management activities of the ILAC Arrangement on behalf of the Arrangement Council and provides advice on its further development and operation.

Joint Development Support Committee - Responsible for representing the interests of developing countries and operates in conjunction with the International Accreditation Forum (IAF). This committee provides a forum for developing countries to present their needs and to work with ILAC and IAF on practical ways of addressing these needs.

Inspection Committee - Responsible for the harmonization and improvement of accreditation practices for inspection activities at the international level. This Committee replaces the ILAC/IAF Joint Inspection Group (JIG). Members of ILAC and IAF with an interest in inspection activities participate in this Committee.

Financial Audit Committee - Responsible for oversight of ILACs financial accounting and reporting systems. Reviews and audits the finances of ILAC and 8

NEI 14-05A Revision 1 September 2020 provides advice on financial matters to the ILAC Executive Committee and General Assembly.

Joint Meetings of the ILAC Executive and the IAF Executive - Responsible for the stewardship of joint activities between ILAC and the International Accreditation Forum (IAF).

2.2 DESCRIPTION

OF THE REGIONAL ORGANIZATIONS In addition to the global ILAC organization, the accreditation bodies also belong to Regional Cooperation Bodies. Currently, the five regional cooperation bodies, whose Arrangements have been recognized by ILAC, are the Asian Pacific Accreditation Cooperation (APAC), African Accreditation Cooperation (AFRAC), Arab Accreditation Cooperation (ARAC), European Accreditation (EA), and Inter-American Accreditation Cooperation (IAAC).

There is close cooperation between ILAC and the regional cooperation bodies, and this cooperation is formalized in the ILAC MRA Policy Statement. Regional cooperation bodies evaluate and re-evaluate their member accreditation bodies. ILAC in turn recognizes the evaluation and re-evaluation of its member accreditation bodies carried out by the regional cooperation bodies. In addition, ILAC performs peer-evaluations of the regional cooperation bodies to establish and recognize their competence in management of the Arrangement.

2.3 DESCRIPTION

OF ACCREDITATION BODIES Accreditation Bodies (ABs) are organizations that assess and accredit Conformity Assessment Bodies (CABs). ABs assess and assure the competence of the CABs to perform conformity assessment services, including testing and calibration. ABs that are signatories to the ILAC MRA undergo peer evaluation to affirm their competence.

2.4 DESCRIPTION

OF CONFORMITY ASSESSMENT BODIES Conformity assessment bodies are organizations, including laboratories, that provide conformity assessment services for calibration and testing documented under specific, individual Scopes of Accreditation. CABs assess products, services and suppliers to assure conformity to specification and/or requirements under their Scopes of Accreditation. In this guidance document, the term laboratory is used to mean CAB.

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NEI 14-05A Revision 1 September 2020 3 USE OF LABORATORY SERVICES ACCREDITED BY ILAC MRA SIGNATORIES AS PART OF COMMERCIAL GRADE DEDICATION ACTIVITIES The ILAC process is essentially equivalent to NRC accepted practices for commercial grade surveys that comply with the applicable requirements of 10 CFR Part 50, Appendix B and10 CFR Part 21, and associated guidance. Therefore, accreditation by ILAC signatories can be used in lieu of a commercial grade survey as part of the commercial grade dedication process. This section describes how purchasers of internationally accredited calibration and testing laboratory services should use the ILAC process as part of their commercial grade dedication activities. It is noted that this guidance should be used in conjunction with EPRI guidance on commercial grade dedication (e.g., EPRI TR 3002002982).

3.1 OVERVIEW OF COMMERCIAL GRADE DEDICATION OF CALIBRATION AND TESTING LABORATORY SERVICES The process of commercial grade dedication is widely utilized by purchasers to accept commercial grade calibration and testing services from commercial laboratories based on dedication of these services in accordance with the requirements of 10 CFR Part 50, Appendix B and10 CFR Part 21, and associated guidance.

The commercial grade dedication process described in EPRI guidance includes the following activities:

1) Perform a technical evaluation to identify and document the safety function of the service;

2) Identify and document the credible failure modes for the service;

3) Identify and document the critical characteristics,

4) Identify and document the acceptance method(s), and

5) Implement the acceptance method(s).

The following are the four acceptable methods of verifying the adequacy of the critical characteristics for a commercial grade item and/or service (Activities 4 and 5):

Method 1 - Special Test/Inspection Method 2 - Commercial Grade Survey3 Method 3 - Source Verification Method 4 - Acceptance Item/Supplier Performance Record History 3

It is noted that Method 2 - Commercial Grade Survey - is widely accepted as the most practical acceptance method for calibration and testing laboratories that have well documented programs for controlling the critical characteristics identified by Purchasers.

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NEI 14-05A Revision 1 September 2020 Use of laboratory accreditation by ILAC signatories will be in lieu of commercial grade surveys as an acceptable alternative for Method 2. For purchasers that use internationally accredited calibration and testing laboratories, activities #1 through #3 of the commercial grade dedication process remain mostly the same. However, activities #4 and #5 for acceptance, would credit the accreditation by an ILAC signatory in lieu of a commercial grade survey (Method 2) as the means to verify the laboratorys control over the critical characteristics. Dedication of the contracted service is not complete until documentation has been reviewed to assure compliance will all purchase order requirements. The guidance in subsequent subsections describes how these activities are performed. Please note that the ILAC process is only intended to be used as a part of the dedication process and in lieu of commercial grade surveys by licensees and suppliers of basic components.

3.2 TECHNICAL EVALUATION

As part of the commercial grade dedication process, the purchaser will perform and document a technical evaluation for the calibration and testing services being procured.

This technical evaluation includes identification of the safety function to be performed, the credible failure modes, the critical characteristics, and requirements for the purchase of calibration and/or testing services that need to be included in the purchase documents.

The purchaser may perform a single technical evaluation for calibration services and a single technical evaluation for testing services and apply them to future procurements provided the technical evaluation covers the scope of services being procured.

Section 6.1 identifies the critical controls/characteristics for calibration and testing services and provides an evaluation of the ability for the ILAC process to control the critical characteristics. The evaluation concludes that the critical controls/characteristics are included in the ISO/IEC-17025:2017 standard requirements and are verified to be properly controlled by a laboratory as part of the ISO/IEC-17025:2017 accreditation process. When procuring calibration and testing services, the purchaser needs to verify that the laboratorys scope of accreditation covers the scope of services being procured.

For calibration services, the published scope of accreditation for the calibration laboratory must cover the needed measurement parameters, ranges, and uncertainties. For testing services, the published scope of accreditation for the test laboratory must cover the needed testing services including test methodology and tolerances/uncertainty.

There are two situations in which commercially procured laboratory services may be used as part of the commercial grade dedication process. The first situation is when the laboratory service is procured as a stand-alone service that is being dedicated. This is typical for calibration services, but may also occur for some testing services. The guidance described herein is for the dedication of the laboratory service itself for which a commercial grade dedication technical evaluation is needed to address the dedication of the laboratory services.

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NEI 14-05A Revision 1 September 2020 The second situation is when the laboratory service is procured as part of a larger dedication package (e.g., where a commercial test is used as one part of the dedication of a commercial item). For example, the Charpy V-notch test when the materials fracture toughness or impact resistance is a critical characteristic for dedicating the material.

Under this scenario, the dedicating entity needs a technical evaluation addressing the safety function and critical characteristics of the commercial grade item itself in addition the technical evaluation for the laboratory services. Therefore, two technical evaluations are required: one for the dedication of the laboratory service and one for the dedication of the commercial grade item.

For both situations discussed above, the purchaser, as part of the evaluation of the laboratory, will verify that the laboratory is accredited to ISO/IEC-17025:2017, General requirements for the competence of testing and calibration laboratories, by an Accreditation Body that is a signatory to the ILAC Mutual Recognition Arrangement, and the services being procured are included in the scope of the laboratory's accreditation.

3.3 ACCEPTANCE METHOD Purchasers should document in their dedication plan the use of commercial calibration and test laboratories accredited to ISO/IEC 17025:2017 by ILAC signatories in lieu of performing a commercial grade survey. To assure the critical characteristics are met, the purchaser should document that the acceptance method needs to include verification that the laboratory is accredited to ISO/IEC-17025:2017, General requirements for the competence of testing and calibration laboratories, by an Accreditation Body that is a signatory to the ILAC Mutual Recognition Arrangement, and that the procured services are within the laboratorys scope of accreditation.

A documented review of calibration and testing records will be completed in order to implement the acceptance method. The purchaser needs to verify, at receipt inspection, that the laboratory has certified that it provided the service in accordance with their accredited ISO/IEC-17025:2017 program and scope of accreditation, and have complied with any other requirements specified in the Purchasers procurement documents.

3.4 LIMITATIONS OF USE The guidance provided in this document was developed for use as a part of the commercial grade dedication process for laboratory calibration and testing services by licensees and suppliers of basic components. It is recognized that commercial suppliers that do not implement a 10 CFR 50, Appendix B program routinely utilize sub-tier suppliers of calibration and testing services based these sub-tier suppliers accreditation to ISO/IEC 17025:2017. During dedication of items or services from commercial suppliers, licensees and 10 CFR 50, Appendix B suppliers are reminded that the 12

NEI 14-05A Revision 1 September 2020 guidance of EPRI 3002002982, "Guideline for the Acceptance of Commercial-Grade Items in Nuclear Safety-Related Applications" applies. Therefore, when Method 2, "Commercial Grade Surveys" are utilized as an acceptance method, the survey report must document the commercial supplier's control over the identified critical characteristics and the associated quality controls that affect the critical characteristics such as calibration of Measuring and Test Equipment (M&TE). The survey report must document the acceptability of the commercial suppliers control over calibration and not merely state the commercial supplier uses accredited calibration or testing service providers based on accreditation to ISO/IEC 17025:2017. Survey reports should address the selection and approval of supplier and the overall procurement controls as applicable for such suppliers.

EPRI 3002002982 discusses commercial grade dedication of services. The document recognizes that Nondestructive Examination (NDE) services or Nondestructive Testing (NDT) services can potentially be dedicated. For the purpose of this document, the terms NDE and NDT are considered equivalent and can be used interchangeably.

However, the ILAC process is not intended for the dedication of NDE services based on the laboratory's accreditation to ISO/IEC 17025:2017. There are specific personnel qualification and certification requirements for personnel performing NDE activities for the nuclear industry that may not be addressed during the accreditation process.

Therefore, to avoid misuse of the accreditation process, NEI 14-05A cannot be used to dedicate NDE services (including ASME Code and non-Code safety related applications) in lieu of a commercial grade survey. It should be noted that use of the ILAC process to dedicate NDE services required by ASME Code is also prohibited by ASME Code.

With regard to the procurement of both calibration and testing services, the procurement document must prohibit the accredited calibration or testing laboratory from subcontracting the service being procured. The disallowance of subcontracting the service being procured will help reduce the chance of misuse of the ILAC process and not receiving an accredited service. The procurement document for accredited services must be submitted directly to the entity performing the calibration or testing.

4 PURCHASERS QUALITY ASSURANCE PROGRAM Purchasers that rely on the accreditation by ILAC signatories in lieu of commercial grade surveys are required by 10 CFR Part 50, Appendix B to document this alternative method in their QA program. The following sections discuss criteria that need to be addressed in the QA Program in order to credit the ILAC process. The purchaser will qualify the service provider as described in Section 3 of this guidance, and will impose any additional technical or quality program requirements, as necessary, to meet regulatory 13

NEI 14-05A Revision 1 September 2020 requirements and purchaser QA program commitments. A template for describing the use of the ILAC process in lieu of a commercial grade survey in a purchasers QA Program is provided in Appendix A. Although a purchaser is not required to use the template in Appendix A, all of the actions and steps described in Appendix A need to be included in the purchasers QA Program.

In addition, a commercial grade dedication technical evaluation is required since the implementation of the ILAC process is a part of the commercial grade dedication process.

The technical evaluation must identify safety function and the critical characteristics of the calibration or testing services along with the acceptance method(s). This document includes a sample technical evaluation/dedication plan for dedicating calibration services and one for dedicating laboratory testing services. Although a purchaser is not required to use the attached example technical evaluations, these technical evaluations represent acceptable technical evaluations for dedicating calibration and testing services.

4.1 ORGANIZATION The purchaser retains overall responsibility for assuring that purchased calibration and/or testing services meet applicable technical and regulatory requirements and that reasonable assurance of quality is provided.

4.2 PROCUREMENT DOCUMENT CONTROL When purchasing commercial grade calibration or testing services from laboratories accredited by an ILAC signatory, the procurement documents will impose additional technical and quality requirements, as necessary, to satisfy the purchasers QA Program and technical requirements. These include as a minimum:

1) The service must be provided in accordance with their accredited ISO/IEC-17025:2017 program and scope of accreditation.

2) As-found calibration data must be reported in the certificate of calibration when calibrated items are found to be out of tolerance. (for calibration services only)

3) The equipment/standards used to perform the calibration must be identified in the certificate of calibration. (for calibration services only)

4) Subcontracting of these accredited services is prohibited.

5) The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

6) Performance of the services listed on this order is contingent on the laboratory's accreditation having been achieved through an on-site accreditation assessment by the Accreditation Body within the past 48 months.

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NEI 14-05A Revision 1 September 2020

7) Any additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

4.3 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES In lieu of a commercial grade survey, purchasers can take credit for accredited ISO/IEC-17025:2017 programs for commercial grade calibration and testing services suppliers by ILAC Accreditation Bodies provided purchasers validate at receipt inspection, the service providers documentation meets and supports their scopes of accreditation for the contracted calibration / test service, as-found calibration data is provided when calibrated items are found to be out-of-tolerance, and that purchase order technical and quality requirements are met.

For commercial grade calibration and testing service providers with programs accredited by ILAC signatories, the reliance on this accreditation process and adherence to ISO/IEC-17025:2017 requirements provide for the integrity of the technical data produced as well as the necessary evidence of compliance for the qualification of calibration or test suppliers under a commercial grade dedication process. Purchasers using the accredited laboratories will be responsible for reviewing objective evidence for conformance to the procurement documents, such as review of documentation to validate the service providers accreditation and review of the actual certificates provided by the laboratory. The purchasers do not need to directly perform technical verification of data produced nor do they need to perform commercial grade surveys of the accredited laboratory activities.

Purchasers will review the objective evidence for conformance to the procurement documents as part of the dedication process to verify that the technical and quality requirements identified in the purchase documents are met.

4.4 CONTROL OF MEASURING AND TEST EQUIPMENT ISO/IEC-17025:2017 does not require that the accredited supplier provide as-found calibration data when the item being calibrated is found to be out-of-tolerance. Since this data is needed to support the purchaser in performing the required evaluations for potentially impacted services, an additional requirement will be imposed via the procurement documents for the accredited laboratory to provide as-found calibration data when the item being calibrated is found to be out-of-tolerance. This will also support the evaluations necessary to meet the purchasers obligations for reporting any defects and non-compliance as required by 10 CFR Part 21.

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NEI 14-05A Revision 1 September 2020 4.5 CORRECTIVE ACTION ISO/IEC-17025:2017 does not require the laboratory to notify the AB of any significant condition adverse to quality, and ISO/IEC-17011:2017 does not require the AB to notify the Region or ILAC of any significant conditions adverse to quality. Although ILAC procedures require laboratories to notify the AB of a condition that potentially impacts their scope of accreditation within a given period of time (typically 30 days), the notification is not required to be immediate.

Since this data is needed to support the purchaser in performing the required evaluations for potentially impacted services, an additional requirement will be imposed via the procurement documents for the accredited laboratory to provide notification of any significant conditions adverse to quality. Based upon the conclusion that the laboratory scope of accreditation encompasses the critical characteristics and because the ILAC process does not use the term significant condition adverse to quality, an equivalent requirement would be for the laboratory to notify the purchaser of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

5 U.S. NUCLEAR INDUSTRY OVERSIGHT OF THE ILAC PROCESS The objective of the continued oversight of the ILAC process by the U.S. nuclear industry is to confirm that the ILAC process can continue to be used in lieu of commercial grade surveys as part of the purchasers commercial grade dedication activities. This oversight will monitor ILAC activities to verify that requirements and procedures used in the ILAC process (e.g., ISO/IEC-17011:2017 and ISO/IEC-17025:2017) continue to be consistent with the NRC accepted practices, and that the ILAC process continues to be implemented in conformance with ILAC standards and procedures. Early identification of potentially adverse changes will also afford the nuclear industry the opportunity to discuss any impact with the NRC and to modify this guidance as necessary.

5.1 ORGANIZATION NEI has formed an industry team, consisting of licensees (including NUPIC members) and suppliers, to monitor ILAC activities as they relate to industrys use of the ILAC process as part of commercial grade dedication. NEI is a stakeholder member of ILAC as a liaison for the nuclear industry and provides to its licensee and supplier members access to ILAC information and activities in an effective and efficient manner. Membership in ILAC permits attendance at meetings, receipt of notification of potential changes to ILAC requirements and guidelines (including related international standards), and is 16

NEI 14-05A Revision 1 September 2020 important for access to observing peer evaluations and laboratory assessments. The NEI team has a close association and coordinates with the NUPIC membership for monitoring of the ILAC process.

NUPIC has formed a group to support the industrys efforts to monitor the ILAC process.

NUPIC plays a central role in the continued oversight activities, and a NUPIC member leads or participates in many of the oversight activities described below.

5.2 VERIFICATION THAT THE ILAC PROCESS CONTINUES TO BE CONSISTENT WITH NRC ACCEPTED PRACTICES The assessments and conclusions of the rigor of the ILAC process documented herein are based in large part on the evaluation of the ILAC requirements and procedures. The comparison of ILAC requirements and procedures, in particular standard ISO/IEC-17025:2017, to NRC requirements, NRC endorsed guidance, and NUPIC checklists, which conform to these requirements and guidance, is the primary basis for the approach documented within to use the ILAC process in lieu of a commercial grade survey.

As part of the continued oversight, the nuclear industry (NEI, NUPIC members, and other industry representatives) will monitor the ILAC requirements and procedures to verify that they continue to be consistent with NRC accepted practices. Because ISO/IEC-17025:2017 is the main standard that assures consistency with NRC accepted practices and because it is not often revised, it is expected that changes that would make the ILAC process no longer be consistent with NRC accepted practices would be few and infrequent, if at all. A summary of the monitoring of ILAC requirements and procedures will be documented on an annual basis.

As a Stakeholder Member, NEI has the ability to participate in the process to maintain ILAC requirements and procedures. If changes are proposed, NEI will be notified by ILAC of the potential change. The NEI team, including members from NUPIC, will evaluate whether the potential changes could materially affect the manner in which the ILAC process is used by the nuclear industry. If changes would result in the ILAC process no longer being consistent with NRC accepted practices, then the nuclear industry has the ability to provide feedback in writing and at ILAC Arrangement Committee meetings that oversee ILAC policies. The nuclear industry would also make the NRC aware of any potential adverse changes and industrys actions to mitigate them.

If changes to ILAC requirements and procedures are implemented that result in the ILAC process no longer being consistent with NRC accepted practices, then the nuclear industry and NRC would have substantial advanced notification, and would have time to implement changes to this guidance or otherwise issue communications to users of the guidance.

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NEI 14-05A Revision 1 September 2020 5.3 VERIFICATION THAT IMPLEMENTATION OF THE ILAC PROCESS CONTINUES TO BE CONSISTENT WITH NRC ACCEPTED PRACTICES The assessments and conclusions of the rigor of the implementation of the ILAC process documented herein are based in part on the direct observations of the performance of peer evaluations of ABs. These peer evaluations are performed to verify the ABs adherence to ISO/IEC-17011:2017, and their ability to accredit laboratories to ISO/IEC-17025:2017.

The U.S. nuclear industrys observation of these peer evaluations and associated laboratory assessments provide additional confidence in the ILAC processes.

As part of the continued oversight, the nuclear industry (NEI, NUPIC, and other industry representatives) will observe Peer Evaluations of an AB and the associated assessments of calibration and testing laboratories to verify that the ILAC process continues to be implemented consistent with ILAC requirements and procedures. U.S. nuclear industry observations of peer evaluations will be performed on a frequency of once every three years. This frequency is consistent with the guidance in EPRI NP-5652 to establish the frequency for commercial grade surveys. These observations will be led by a knowledgeable NUPIC member with support from other NEI team members. The NRC may request to participate on these observations.

5.4 OPTIONAL ACTIVITIES Several additional monitoring activities are available to the nuclear industry as ILAC stakeholder members, but are not necessary to achieve the objectives of the industrys continued oversight. These activities may provide additional benefits to the efficiency of the industrys monitoring efforts and will be considered as optional activities.

Through NEIs stakeholder membership in ILAC, the nuclear industry is permitted to attend general ILAC meetings. These meetings may provide additional information on the ILAC process and interaction with other ILAC members, but are otherwise not essential to the industrys continued oversight. Similarly, the ability to attend peer evaluator training offered by one of the Regions may provide additional insight into the ILAC process, but is not essential to the industrys continued oversight.

6 NUCLEAR INDUSTRY REVIEW OF THE ILAC PROCESS The ILAC process was assessed by the nuclear industry to determine its rigor and whether it could satisfy requirements for commercial grade dedication of calibration and laboratory services. This assessment was based upon an evaluation of the ILAC procedures, training, MRA meetings, and observations of peer evaluations and laboratory assessments. The ILAC process was compared to NRC requirements, NRC endorsed 18

NEI 14-05A Revision 1 September 2020 guidance and NUPIC practices, which conform these requirements and guidance for performing commercial grade surveys to determine if the ILAC process is equivalent.

It was concluded that the ILAC process is equivalent to NUPIC practices when the following four items are addressed by the inclusion of requirements in the procurement documents:

1. ISO/IEC-17025:2017 does not require the laboratory to include as-found calibration data in the Certificate of Calibration when calibrated items are found to be out of tolerance.

2. ISO/IEC-17025:2017 does not require the laboratory to identify in the certificate of calibration, the standards used to perform the calibration.

3. ISO/IEC-17025:2017 does not require the laboratory to notify the AB of any significant condition adverse to quality, and ISO/IEC-17011:2017 does not require the AB to notify the Region or ILAC of any significant conditions adverse to quality. Based upon the conclusion that the laboratory scope of accreditation encompasses the critical characteristics and because the ILAC process does not use the term significant condition adverse to quality, an equivalent requirement would be for the laboratory to notify the purchaser of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

4. The NRC's original endorsement of the use of accreditation to ISO/IEC 17025 by Accreditation Bodies (ABs) that are signatories to the ILAC MRA in lieu of performing a commercial grade survey for the acceptance of calibration and testing services was largely based on ABs performing on-site accreditation assessments at laboratories. Due to travel restrictions caused by the COVID-19 pandemic, ABs are performing remote accreditation assessments. While use of remote accreditation assessments were determined by the industry to be acceptable during extenuating circumstances, the industry found it necessary to impose a limitation on the use of remote assessment for laboratories performing calibrations and testing for licensees and suppliers of basic components. Such laboratories cannot maintain accreditation based on consecutive remote accreditation assessments. This will maintain the spirit and intent of ISO/IEC 17011 which requires onsite assessments every 24 months. ISO/IEC 17011 does allow the use of remote assessments if the AB determines a remote assessment can be justified. Currently, NUPIC Commercial Grade surveys are required to be performed on-site at the supplier's facility. Extenuating circumstances include: 1) declaration of a national emergency; 2) severe localized or national weather conditions or damage to licensee or supplier infrastructure; or 3) localized outbreak of a severe health concern to the public and licensee.

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NEI 14-05A Revision 1 September 2020 Two additional differences with NUPIC practices were identified, but determined to be acceptable and thus do not need to be addressed through the inclusion of requirements in the procurement documents.

1. ISO/IEC-17025:2017 Section 7.1 requires the laboratory to establish and maintain the capability and resources to meet purchasers procurement requirements.

However, it was noted during an observation of a peer evaluation, that the AB assessment of the laboratory only verified that the laboratory could meet procurement document requirements related to the scope of accreditation, and did not evaluate the capability to meet requirements not related to the scope of accreditation. This is acceptable because the scope of accreditation encompasses the critical characteristics, and thus there is reasonable assurance that the requirements of 10 CFR Part 21 and 10 CFR Part 50, Appendix B will be met for the dedicated service. Furthermore, this difference cannot be addressed through a requirement in the procurement documents, because the purchaser does not have the capability to independently verify it. However, this difference was discussed with ILAC representatives, who indicated that they would consider if training could be enhanced to clarify that assessments should include verification of the ability to comply with all special contract requirements, and are not limited to only those specifically related to the scope of accreditation.

2. ISO/IEC-17025:2017 includes quality controls that address suspect counterfeit and fraudulent items. In particular, Sections 6.6 and 7.1 establish requirements for subcontracting tests and calibrations, including verification that the subcontractor is accredited and notification to the purchaser when subcontracting these services.

Section 4.6 establishes requirements for purchasing services and supplies, including inspections to verify that they meet the requirements and the evaluation of suppliers. However, ISO/IEC-17025:2017 does not include a specific requirement for laboratory controls to identify suspect counterfeit and fraudulent items. NUPIC checklists include a question that would identify controls the supplier has in place to prevent ingress of suspect counterfeit or fraudulent items.

The risk of counterfeit and fraudulent items is low in an environment that procures and uses traceable standards to perform calibration. However, counterfeit or fraudulent items could enter the supply chain in certain cases, such as when the laboratory subcontracts calibration services and the subcontractor misrepresents their accreditation. The topic of counterfeit and fraudulent items was discussed with ILAC representatives, who indicated that the topic would be discussed further by ILAC membership to determine if any enhancements to the ILAC process are warranted. EPRI updated guidance on counterfeit and fraudulent items, Plant Support Engineering: Counterfeit, Fraudulent and Substandard Items, EPRI-1019163 Revision 1 in 2014. Use of the EPRI 20

NEI 14-05A Revision 1 September 2020 guidance on counterfeit and fraudulent items is voluntary; however, it does provide practical measures to further enhance protections against counterfeit and fraudulent items and includes a standard procurement clause that could be used in the procurement of calibration and testing services.

It should be noted that the original industry review of the ILAC process was performed to ISO/IEC 17025:2005 and ISO/IEC 17011:2004. However, the conclusions drawn from the review remain unchanged and apply to ISO/IEC 17025:2017 and ISO/IEC 17011:2017 since the later versions of these standards were found to be equivalent to the earlier versions.

6.1 TECHNICAL EVALUATION

OF ILAC REQUIREMENTS AND PROCEDURES A technical evaluation of the ILAC requirements and procedures was performed in order to assess whether the ILAC process is an acceptable alternative to commercial grade surveys for dedication. ISO/IEC-17025: 2017, General requirements for the competence of testing and calibration laboratories, and ISO-17011: 2017, Conformity assessment -

General requirements for accreditation bodies accrediting conformity assessment bodies, were reviewed and compared with NUPIC checklists for supplier surveys. Based upon this evaluation, it is concluded that 1) the ILAC process meets the criteria for a commercial grade survey, and 2) the ISO/IEC-17025: 2017 standard is equivalent to the critical characteristics identified in the NUPIC Commercial Grade Item Survey Checklist and Commercial Grade Calibration Services Checklist.

Acceptable Alternative Method For a commercial grade survey, EPRI guidance and NRC Commercial Grade Dedication Inspection Procedure 43004 indicate that the commercial grade surveys should be used when:

1. The purchaser desires to verify one or more of the critical characteristics based on the merits of a laboratory's commercial quality controls.

2. The laboratory has a documented and effectively implemented program and/or procedures to control the critical characteristics of the services being procured.

3. The survey should be conducted by an individual(s) that is also trained in auditing and knowledgeable in the operation of the item(s) and the associated critical characteristics to be verified.

4. The verification is accomplished by reviewing the vendor's program/procedures controlling these characteristics and observing the actual implementation of these 21

NEI 14-05A Revision 1 September 2020 controls in the manufacture of items identical or similar to the items being purchased.

All of the above criteria are met for laboratories accredited to ISO/IEC-17025:2017 by AB's that are signatories to the ILAC MRA. Therefore, the ILAC process is an acceptable alternative to performing commercial grade surveys.

Critical Characteristics The technical evaluation includes identification of critical characteristics as part of the dedication process. Below are lists of the typical critical characteristics for calibration services and laboratory testing services.

Critical Characteristics for Calibration Services The critical controls/characteristics for calibration services are identified in the NUPIC Commercial Grade Calibration Survey Checklist and consist of the following attributes.

These characteristics apply to all calibration services regardless of the type of Measuring

& Test Equipment (M&TE):

Traceability of calibration and calibration standards to nationally recognized standards (e.g., NIST), equivalent international standards or other acceptable measurement standards (intrinsic)

Calibrations performed in accordance with written procedures/instructions

Documented training/qualification of personnel

Environmental conditions, e.g., temperature, humidity, vibration, etc.

Adequacy, accuracy, stability, tolerances (uncertainty) and range of measurement standards

Intervals of calibration for standards

Software control, e.g., adequate review/approval, verification, validation, error notification, etc.

Calibration status

Out of tolerance & corrective action

Subcontractor calibration controls

Calibration certification documentation 22

NEI 14-05A Revision 1 September 2020 Entities performing commercial grade dedication of calibration services must document a commercial grade dedication technical evaluation which includes the safety function, critical characteristics and acceptance method(s) for the service. The failure modes and effect analysis are not necessarily required since the critical characteristics are known. of this document includes an acceptable technical evaluation for the dedication of commercial calibration services.

Critical Characteristics for Laboratory Testing Services:

While NUPIC does not have a standard survey checklist for laboratory testing services, licensees have widely determined the following critical characteristics to apply to all testing services regardless of the type of testing being performed:

Identification/traceability of the item during testing and processing is maintained.

Testing for the required characteristics/parameters is performed in accordance with written industry recognized standards or other validated and approved test methods.

Actual testing is performed in accordance with written and approved procedures.

Testing is performed by trained and qualified personnel.

M&TE including chemical standards are calibrated as applicable and are traceable to national or international standards, or intrinsic properties/natural law.

Traceability of the test results to the item being tested is maintained.

Certification includes test results, identification of the item, test method used, results, and signature of responsible laboratory authority.

Entities performing commercial grade dedication of laboratory testing services must document a commercial grade dedication technical evaluation which includes the safety function, critical characteristics and acceptance method(s) for the service. The failure modes and effect analysis are not necessarily required since the critical characteristics are known. Please note that Attachment 2 of this document includes an acceptable technical evaluation for the dedication of commercial laboratory testing services.

Review of the ISO/IEC-17025:2017 standard and observations of the accreditation process by NEI/NUPIC has determined that each of the above critical characteristics are 23

NEI 14-05A Revision 1 September 2020 included in the ISO/IEC-17025:2017 standard and are verified to be properly controlled by a laboratory as a part of the ISO/IEC-17025:2017 accreditation process.

Suppliers Quality Program In order for laboratories to be accredited to ISO/IEC-17025:2017, they must have an adequately documented quality program. The laboratory also needs to comply with any additional quality requirements specified in the procurement documents. The quality program of an accredited supplier is adequate for the purchasers commercial grade dedication activities, which must be invoked in a procurement document.

6.2 OBSERVATION OF TRAINING An observation of the ILAC/APLAC Evaluator Training Course was performed in order to gain a comprehensive understanding of the capabilities and experience of assessment personnel, and to evaluate the rigor of the training. Based upon these observations, it was concluded that ILAC/Regional training for peer evaluators is essentially equivalent to NUPIC auditor training.

The training course consists of ten modules presented over a three-day period and it was conducted by senior representatives of Accreditation Bodies. The class that was observed consisted of 17 individuals from 12 different countries. Students are recommended by AB leadership and must pass a screening process (at the regional level), which may include demonstrating written and oral capability in the English language.

The training session included the establishment of scenarios for each of the teams with questions and deliverables assigned for each activity. Specific activities assessed through this process included team selection, agenda development, and activity scheduling. Each team was provided a unique scenario that was challenging and realistic. Each training instructor, as well as several students, shared their experience in performing these evaluations. It became apparent to the students that the resources allocated to the assessment are a key decision and deployment strategies are not identical. Each group performed well and used several different acceptable strategies. For example, one group used a vertical slice approach, having each individual look at each element in their area; while other groups used an approach which parceled out individual sections.

A detailed walk through of the Standard Checklist was performed. Each question was discussed and expectations as to what was required were provided for each question. The training instructors shared personal experience in each area addressed. Active participation was noted with very good questions being asked at appropriate times.

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NEI 14-05A Revision 1 September 2020 It was reinforced that recognition decisions are made by competent persons based on the results of the peer evaluations; therefore, it was emphasized that enough accurate information must be provided to allow for appropriate decisions.

Training includes a section that mirrors many of the requirements of 10 CFR Part 50, Appendix B. The presentation to the training class was very effective and represented the material in the handouts.

Training emphasized the importance of maintaining independence. Each team was provided with a unique scenario with different challenges and issues. Teams worked for one hour to evaluate the organizational structures and legal entities. The teams were provided immediate feedback on their presentations. Similar to previous courses, the learning was achieved through the student engagement with appropriate references with training instructors providing key insights which contributed to the learning experience.

Organizational learning was accomplished through review of the individual scenarios with the entire class. The effectiveness of this training, as evidenced by interviews with students and facilitators, was determined to be very good.

Additional training sessions focused on the writing of findings and other issues. The class was tasked with documenting appropriate findings from a set of information provided.

The instructors placed a significant amount of focus on improving the strength and consistency in the students ability to write findings and document issues. This included developing appropriate problem statements based upon objective evidence. It was judged that the capabilities of the students exiting the class to write findings were on par with the capabilities of auditors at the completion of NUPIC training.

This training is favorably compared to NUPIC Lead Auditor training in as much as most Lead Auditor classes have an element of role playing with various scenarios played out and discussions are held critiquing the team. In addition, the observed training contained elements of NUPICs annual auditor training which is held each February where the auditors are brought up to date on changing regulations and changes to the checklist.

6.3 OBSERVATION OF A MUTUAL RECOGNITION ARRANGEMENT MEETING An observation of an APLAC MRA meeting was performed in order to evaluate the rigor of the recognition decision making process. The purpose of the MRA council is to review and ensure standards for accreditation are established and met. The MRA meeting was observed to be a rigorous process and was well controlled and implemented. Based upon these observations, it was concluded that the ILAC/Regional decision-making process is essentially equivalent to NUPIC practices.

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NEI 14-05A Revision 1 September 2020 The APLAC MRA meeting lasted three days, during which decisions on initial accreditations and renewals were made. It was observed that the group was very effective and demonstrated excellent technical skills and management capabilities. The technical capabilities were evident; however, as with most technical groups, the challenge is in regard to auditing and understanding the standard and not rationalizing the standard.

The MRA has achieved a good balance and works effectively through these challenges.

It was noted that many challenges that the MRA is addressing have been addressed by NUPIC; examples include team formation and the use of technical specialists during evaluation (audit) and surveillances, team feedback, scorecards, and sharing of operating experience. Differences between regions poses a challenge, while at the same time creating a dynamic that encourages continuous improvement.

During the meeting, a decision on the initial assessment of a national accreditation body was made. The MRA council considered the report from the peer evaluation team for the initial assessment, which it reviewed prior to the meeting and was also presented by the team leader at the meeting. The team recommended approval of the accreditation body on the basis of their review of the responses to the issues identified in the peer evaluation.

The evaluation included several locations, key meetings and other activities, and was conducted after the accreditation body addressed all of the findings from the earlier performed pre-peer evaluation. The questioning and process of the MRA council deliberation was rigorous. Finally, the accreditation body was requested to leave, and the MRA council voted to make their decision. The accreditation body was approved and accepted as an APLAC/ILAC MRA signatory.

The MRA council also reviewed an accreditation body for a four-year re-evaluation that was requesting to expand their approved scope of services. In this case, the peer evaluation concluded that the accreditation body met all ILAC requirements, but also identified two non-conformities and three deficiencies. The accreditation body addressed all non-conformities and deficiencies to the satisfaction of the peer evaluation team, and the team recommended approval. The questioning and process of the MRA council deliberation followed the rigor previously described. It was noted that the IAAC process is different from APLAC as they send reports out prior to the meeting and questions are sent to the team lead as a lead up to the meeting. In addition, all issues are reviewed and discussed during the decision-making meeting. This does not appear to be a significant difference.

Several other peer evaluations were reviewed by the MRA council with the same level of rigor as previously described.

The MRA council also reviewed the list of candidates for lead peer evaluator and approved four new team leaders. The Evaluator Performance Working Group reviews 26

NEI 14-05A Revision 1 September 2020 candidates and makes recommendations to the full MRA. This is not an automatic process and there are many controls in place to assure the high quality of evaluators.

6.4 OBSERVATION OF PEER EVALUATIONS AND LABORATORY ASSESSMENTS Observations of peer evaluation of ABs and assessments of laboratories were performed in order to verify that the ILAC process is implemented according to relevant requirements and procedures and to verify the implementation is an acceptable alternative to a commercial grade survey for dedication. Based upon these observations, it is concluded that the implementation of the ILAC process is essentially equivalent to NUPIC practices for supplier surveys.

Observation of Peer Evaluation of the Japan Accreditation Body A NUPIC/NEI team, led by a NUPIC member, observed the Asia Pacific Laboratory Accreditation Cooperation (APLAC) peer evaluation of the Japan Accreditation Board (JAB) the week of November 11, 2013. The team observed the APLAC entrance meeting, the evaluation of JAB, the evaluation of JAB assessment of calibration and testing laboratories, and the exit meeting.

Observation of Peer Evaluation of the American Association for Laboratory Accreditation A NUPIC/NEI team, led by a NUPIC member, observed the joint APLAC/IAAC peer evaluation of the American Association for Laboratory Accreditation (A2LA) the week of March 3, 2014. The team observed the APLAC/IAAC entrance meeting, the evaluation of A2LA, the evaluation of A2LA assessment of a testing laboratory, and the exit meeting.

Conclusions The activities observed were found to be essentially equivalent to NUPIC practices for acceptance Method 2 - Commercial Grade Survey - for dedication of commercial grade calibration and laboratory services. The following are details from the observation that support this conclusion:

The observation team verified that the overall operations of the peer evaluation under the ILAC process is robust, comprehensive, and in compliance with ISO/IEC-17011:2004.

The peer evaluators under the ILAC process were found to be true peers in that they currently lead or direct other Accreditation Bodies.

27

NEI 14-05A Revision 1 September 2020

The peer evaluation process was found to be performance-based and included real time observations of testing and calibration services. All evaluations observed were of high standard.

Lead assessor and technical assessors/experts were found to be very knowledgeable and possessed extensive experience in the areas assessed and they were very familiar with the assessment process. The competence of the assessors and evaluators is a key strength of the ILAC process.

The overall operation of ABs is in accordance with the requirements of ISO/IEC-17011:2004.

Scope of accreditation specified by ABs and the laboratories was verified to accurately reflect the capabilities of the laboratory.

AB staff members are skilled and technically qualified for the functions they perform. They have well established accreditation processes which are applied consistently to the accreditation of their testing and calibration laboratories.

Laboratories accredited by ABs have been assessed against and found to comply with the requirements of ISO/IEC 17025:2005/2017.

The accreditation assessments were found to be technically equivalent to or better than a NUPIC style commercial grade survey. Both the management system and technical operation of the laboratories were effectively assessed.

The Accreditation Assessment process was found to be performance-based and included real time observations of testing and calibration services. All assessments observed were of a high standard.

It should be noted that the original industry observations of the ILAC peer evaluations were performed to ISO/IEC 17025:2005 and ISO/IEC 17011:2004. However, the conclusions drawn from these observations also apply to ISO/IEC 17025:2017 and ISO/IEC 17011:2017 since the later versions of these standards were found to be equivalent to the earlier versions.

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NEI 14-05A Revision 1 September 2020 APPENDIX A - QUALITY ASSURANCE PROGRAM TEMPLATE A.1.a Dedication of Commercial Grade Items Commercial grade items (items not originally designed or manufactured as a basic component) are subject to a commercial grade dedication process as defined and authorized by Engineering in accordance with procedures that meet the requirements of the NRC, before such items are approved for safety-related applications. Commercial grade dedication also applies to a commercial grade service that is associated with basic component hardware, design certification, design approval, or information in support of an early site permit application under 10 CFR Part 52, whether these services are performed by the component supplier or others (e.g., safety-related design, analysis, inspection, testing, or fabrication that is associated with a basic component).

Procedures are established to describe the responsibilities for Engineering to perform a technical evaluation, select applicable critical characteristics, and determine an appropriate dedication method for acceptance. Procedures are also established to enhance the detection of counterfeit and fraudulent items and to minimize the likelihood of the introduction of such items in safety-related applications.

[Purchaser] may utilize commercial grade items or services in its supply of basic components in a manner consistent with the guidance in [Generic Letter (GL) 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products.

GL 89-02 documents the NRCs conditional endorsement of EPRI NP-5652, Guideline for the Utilization of Commercial grade Items in Nuclear Safety Related Applications (NCIG-07).] In addition, Regulatory Guide 1.164 documents the NRC's endorsement of EPRI TR 3002002982, "Plant Engineering: Guideline for the Acceptance of Commercial-Grade Items in Nuclear Safety-Related Applications," Revision 1 to EPRI NP-5652 and TR-.102260.

[Purchaser] utilizes a commercial grade dedication process consistent with Generic Letter 89-02 and 10 CFR 21 for the supply of basic components. When a commercial grade item is modified, inspected, and/or tested to demonstrate compliance to requirements more restrictive than the manufacturers original specifications such item is uniquely identified as different from the commercial grade (off-the-shelf) item and traceable to documents that record the difference.

When purchasing commercial grade calibration or testing services from a laboratory holding accreditation by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA),

commercial grade surveys need not be performed provided each of the following conditions are met:

A-1

NEI 14-05A Revision 1 September 2020

1. A documented review of the suppliers accreditation is performed and includes a verification of the following:

a. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2017, "General Requirements for the Competence of Testing and Calibration Laboratories.

b. For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

c. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

d. The laboratory has achieved accreditation based on an on-site accreditation assessment by the selected AB within the past 48 months. The laboratory's accreditation cannot be based on two consecutive remote accreditation assessments.

2. The purchase documents require that:

a. The service must be provided in accordance with their accredited ISO/IEC-17025:2017 program and scope of accreditation.

b. As-found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance. (for calibration services only)

c. The equipment/standards used to perform the calibration must be identified in the certificate of calibration. (for calibration services only)

d. Subcontracting of these accredited services is prohibited.

e. The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

f. Performance of the services listed on this order is contingent on the laboratory's accreditation having been achieved through an on-site accreditation assessment by the Accreditation Body within the past 48 months.

g. Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

3. It is validated, at receipt inspection, that the laboratorys documentation certifies that:

a. The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2017 program, and has been performed within their scope of accreditation, and

b. The purchase orders requirements are met.

A-2

NEI 14-05A Revision 1 September 2020 As discussed in Section 3.4 of this document, NEI 14-05A cannot be used to dedicate NDE services (including ASME Code and non-Code safety related applications) in lieu of a commercial grade survey.

A commercial grade dedication technical evaluation is required to document the critical characteristics and acceptance methods when dedicating calibration services based on the ILAC Process. The same is true for the dedication testing services. Attachment 1 and of this document include acceptable examples of a technical evaluation for calibration services and testing services, respectively.

A-3

- CGI Item Dedication Technical Evaluation Page: 1 of 17 SECTION A ITEM/SERVICE DESCRIPTION - CALIBRATION SERVICES This Technical Evaluation addresses M&TE calibration services from commercial calibration service providers including ISO/IEC 17025:2005/2017 accredited laboratories and non-accredited service providers. It provides the Commercial Grade Item (CGI) dedication requirements for commercial calibration services. The critical characteristics are same whether one verifies the critical characteristics via a commercial grade survey or takes credit for the laboratory being accredited to ISO/IEC 17025:2005/2017as detailed in NEI 14-05A. NEI 14-05A has been endorsed by the US NRC and allows the dedicating entity to take credit for verification of the critical characteristics by virtue of the laboratory being accredited to ISO/IEC 17025:2005/2017 by an Accreditation Body (AB) which is signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) in lieu of performing a commercial grade survey to verify the laboratorys control over the critical characteristics. This evaluation also covers the calibration of new M&TE, recalibration of M&TE on assigned intervals, calibration of M&TE that has been repaired, reworked or updated, and on-site calibration services by calibration suppliers service representatives.

SECTION B END USE / PARENT / HOST EQUIPMENT INFORMATION Note: If the specific end-use(s) / plant applications are not known, complete Section C of this form in lieu of Section B prior to proceeding.

Not Applicable (Section C Completed Below)

EQUIPMENT ID (TAG) NUMBERS OR DESCRIPTION OF ITEM/SERVICE USAGE:

PARENT COMPONENT / HOST DESCRIPTION:

FUNCTIONAL SAFETY CLASS OF COMPONENT / BASIS / SOURCE:

HOST:

Safety-Related Non-Safety Related (If non-safety, item/service is not a candidate for dedication)

IDENTIFICATION OF PARENT COMPONENT / HOST EQUIPMENT FUNCTION(S)

FUNCTIONAL BASIC SAFETY FUNCTION(S) DESCRIBE (AS REQUIRED)

MODE Active Passive PARENT COMPONENT / HOST EQUIPMENT IS (CHECK ALL THAT APPLY):

EQ ASME SECTION III CLASS 1E CONTAINMENT PRESSURE BOUNDARY SEISMIC CLASS 1 SERVICE LEVEL 1 COATING OTHER: (see below)

- CGI Item Dedication Technical Evaluation Page: 2 of 17 SECTION C BOUNDED SCOPE OF USE Only complete Section C when specific end-use of the item/service being dedicated is unknown.

Not Applicable (Section B Completed Above)

Is the item/service being dedicated a commodity or standard item/service designed and Yes constructed in accordance with an industry standard? No IF YES LIST THE STANDARD(S) BELOW ISO/IEC 17025:2005/2017, "General Requirements for the Competence of Testing and Calibration Laboratories.

LIST FUNCTIONS AND / OR APPLICATIONS CONSIDERED WHEN COMPLETING THIS EVALUATION Calibration results and data provided may be used in accordance with the [Enter Company Name] 10 CFR 50 Appendix B QA program to evaluate the ability of safety-related equipment to perform its safety-related design functions.

The basic safety function of calibration services is to verify Measuring & Test Equipment (M&TE) is working properly and providing accurate and reliable data and to make adjustments to M&TE as need to ensure the M&TE is working properly and providing accurate and reliable data.

This TE addresses commercial calibration services for M&TE / standards including those provided by commercial calibration service providers accredited to ISO/IEC 17025:2005/2017 and non-accredited service providers.

EQUIPMENT QUALIFICATION CONSIDERATIONS / LIMITATIONS (CHECK ALL THAT APPLY):

CONSIDERATION QUALIFICATION BASIS / LIMITATIONS OF USE: Not applicable. M&TE addressed in this evaluation are not permanently installed in the plant. The actual M&TE is considered non-safety but the calibration of the M&TE is considered safety related.

ENVIRONMENTAL QUALIFICATION SEISMIC QUALIFICATION OTHER: (see below)

SECTION D SERVICE INFORMATION ITEM/SERVICE DESCRIPTION:

This technical evaluation covers the commercial grade dedication for the commercial calibration of essentially all Measuring & Test Equipment (M&TE) and standards including electrical, mechanical, dimensional, thermodynamic, etc. A separate technical evaluation is therefore not needed for each calibration service for each instrument since the critical characteristics of the calibration service are identical.

FUNCTIONAL SAFETY CLASS OF BASIS / SOURCE:

ITEM/SERVICE:

Safety-Related The basic safety function of calibration services Non-Safety Related (If non-safety, item/service is to verify Measuring & Test Equipment (M&TE) is not a candidate for dedication) is working properly and providing accurate and reliable data and to make adjustments to M&TE as need to ensure the M&TE is working properly and providing accurate and reliable data.

- CGI Item Dedication Technical Evaluation Page: 3 of 17 IDENTIFICATION OF ITEM/SERVICE FUNCTION(S)

FUNCTIONAL BASIC SAFETY FUNCTION(S) DESCRIBE (AS REQUIRED)

MODE Active The basic safety function of Calibration services performed by commercial Passive calibration services is to verify suppliers on behalf of [Enter Company Name]

Measuring & Test Equipment must be controlled in accordance with the (M&TE) is working properly and [Enter Company Name] 10 CFR 50, providing accurate and reliable Appendix B-compliant QA program. The data and to make adjustments to associated M&TE can then be used by [Enter M&TE as needed to ensure the Company Name] to perform inspections and M&TE is working properly and test in accordance with [Enter Company providing accurate and reliable Name] 10 CFR 50 Appendix B QA program to data. evaluate the ability of safety-related items to perform their safety-related design functions.

ITEM/SERVICE IS (CHECK ALL THAT APPLY):

EQ ASME SECTION III CLASS 1E CONTAINMENT PRESSURE BOUNDARY SEISMIC CLASS 1 SERVICE LEVEL 1 COATING OTHER: (see below)

SECTION E ELIGIBLITY FOR DEDICATION Is the item/service eligible for dedication in accordance with 10 CFR Yes No Part 21?

If the answer is no, this item/service cannot be dedicated.

SECTION F FAILURE MODES / MECHANISMS AND EFFECTS ANALYSIS CREDIBLE FAILURE EFFECTS ON SYSTEM/COMPONENT FUNCTION MODE/MECHANISM Failure Modes/Mechanisms and Effects Failure Modes/Mechanisms and Effects Analysis is Analysis is normally performed to help normally performed to help determine the critical determine the critical characteristics. In characteristics. In the case of calibration services, the the case of calibration services, the critical characteristics are known as specified in NEI 14-critical characteristics are known as 05A. Therefore, a FMEA is not required.

specified in NEI 14-05A. Therefore, a FMEA is not required.

BASIS FOR SELECTION OF CREDIBLE FAILURE MODE(S)/MECHANISM(S)

Failure Modes/Mechanisms and Effects Analysis is normally performed to help determine the critical characteristics. In the case of calibration services, the critical characteristics are known as specified in NEI 14-05A. Therefore, a FMEA is not required.

SECTION G OPERATING EXPERIENCE / HISTORICAL PERFORMANCE INFORMATION SOURCES REVIEWED AND RESULTS External - An INPO OE search was conducted using the terms calibration lab, vendor calibration, calibration dedication, calibration cgi, and calibration service.

The only OE found that is considered pertinent to this evaluation was Information Notice 90-36.

- CGI Item Dedication Technical Evaluation Page: 4 of 17 SOURCES REVIEWED AND RESULTS IN 90-36 documents an apparent falsification of State of Connecticut weight certificates by a calibration service facility. Dedicating entities should be aware that the calibration of measuring devices can only be considered accurate if when the standards used to perform the calibration are in current calibration.

Internal - Include any Internal Operating Experience

- CGI Item Dedication Technical Evaluation Page: 5 of 17 SECTION H IDENTIFICATION ATTRIBUTES IDENTIFICATION ATTRIBUTES DESCRIPTION OF INSPECTION ACCEPTANCE CRITERIA Calibration service provider Visual Calibration service provider is as specified in the purchasing document for the calibration service performed.

Device Identification Visual The device to be calibrated has the same manufacturer and other identification (part/model number, serial number, etc.,) specified in the purchasing document for the calibration service.

SECTION I CRITICAL CHARACTERISTICS ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE ACCEPTANCE PLAN CRITERIA METHOD ACTIVITY (INCLUDING TOLERANCES) 1 Traceability of calibration and calibration standards Commercial Perform Not Calibration standards to nationally recognized standards (e.g., NIST), Grade Survey Commercial Grade Applicable and reference equivalent international standards or other Survey to verify the materials are traceable acceptable measurement standards (intrinsic). service provider to national, Or adequately international, or controls this CC. intrinsic standards.

ILAC Verify the service Not Calibration standards Accreditation in provider is Applicable and reference lieu of accredited to materials are traceable Commercial ISO/IEC to national, Grade Survey 17025:2005/2017 international, or by an Accreditation intrinsic standards Body which is a where available.

signatory to the ILAC MRA.

- CGI Item Dedication Technical Evaluation Page: 6 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE ACCEPTANCE PLAN CRITERIA METHOD ACTIVITY (INCLUDING TOLERANCES) 2 Calibrations are performed in accordance with Commercial Perform Not Adequate documented written procedures/instructions. Grade Survey Commercial Grade Applicable instructions exist for Survey to verify the performance of service provider accurate calibration.

Or adequately controls this CC.

ILAC Verify the service Not Adequate documented Accreditation in provider is Applicable instructions exist for lieu of accredited to performance of Commercial ISO/IEC accurate calibration.

Grade Survey 17025:2005/2017 by an Accreditation Body which is a signatory to the ILAC MRA.

- CGI Item Dedication Technical Evaluation Page: 7 of 17 SECTION I CRITICAL CHARACTERISTICS ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 3 Documented training/qualification of personnel. Commercial Perform Not Personnel have the Grade Survey Commercial Grade Applicable adequate skills, Survey to verify the training, and service provider experience to ensure Or adequately accurate and controls this CC. repeatable calibration.

ILAC Verify the service Not Personnel have the Accreditation in provider is Applicable adequate skills, lieu of accredited to training, and Commercial ISO/IEC experience to ensure Grade Survey 17025:2005/2017 accurate and by an Accreditation repeatable calibration.

Body which is a signatory to the ILAC MRA.

- CGI Item Dedication Technical Evaluation Page: 8 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 4 Environmental Conditions, e.g., temperature, Commercial Perform Not The calibration humidity, vibration, etc. Grade Survey Commercial Grade Applicable environment is Survey to verify the controlled to the extent service provider necessary to ensure adequately continued Or controls this CC. measurement with required accuracy on standards and measuring equipment.

ILAC Verify the service Not The calibration Accreditation in provider is Applicable environment is lieu of accredited to controlled to the extent Commercial ISO/IEC necessary to ensure Grade Survey 17025:2005/2017 continued by an Accreditation measurement with Body which is a required accuracy on signatory to the standards and ILAC MRA. measuring equipment.

- CGI Item Dedication Technical Evaluation Page: 9 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 5 Adequacy, accuracy, stability, tolerances Commercial Perform Not The service provider's (uncertainty) and range of measurement standards Grade Survey Commercial Grade Applicable M&TE and standards Survey to verify the have the needed service provider accuracy, stability, adequately tolerances Or controls this CC. (uncertainty) and range for the items being calibrated.

ILAC Verify the service Not The service provider's Accreditation in provider is Applicable M&TE and standards lieu of accredited to have the needed Commercial ISO/IEC accuracy, stability, Grade Survey 17025:2005/2017 tolerances by an Accreditation (uncertainty) and range Body which is a for the items being signatory to the calibrated.

ILAC MRA

- CGI Item Dedication Technical Evaluation Page: 10 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 6 Intervals of calibration for standards Commercial Perform Not The service provider's Grade Survey Commercial Grade Applicable calibration standards Survey to verify the are calibrated at service provider defined intervals Or adequately controls this CC.

ILAC Verify the service Not The service provider's Accreditation in provider is Applicable calibration standards lieu of accredited to are calibrated at Commercial ISO/IEC defined intervals Grade Survey 17025:2005/2017 by an Accreditation Body which is a signatory to the ILAC MRA.

- CGI Item Dedication Technical Evaluation Page: 11 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 7 Software control, e.g., adequate review/approval, Commercial Perform Not The service provider verification, validation, error notification, etc. Grade Survey Commercial Grade Applicable has a process for Survey to verify the performing Or service provider validation/verification adequately testing to ensure the controls this CC. software performs as intended and controlling the version level of the applicable software.

ILAC Verify the service Not The service provider Accreditation in provider is Applicable has a process for lieu of accredited to performing Commercial ISO/IEC validation/verification Grade Survey 17025:2005/2017 testing to ensure the by an Accreditation software performs as Body which is a intended and signatory to the controlling the version ILAC MRA. level of the applicable software.

- CGI Item Dedication Technical Evaluation Page: 12 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 8 Calibration status Commercial Perform Not The service provider's Grade Survey Commercial Grade Applicable M&TE and standards Survey to verify the are uniquely identified Or service provider and labeled to indicate adequately calibration status.

controls this CC. Items that are not calibrated to their full range, or have other limitations, are identified to that condition.

ILAC Verify the service Not The service provider's Accreditation in provider is Applicable M&TE and standards lieu of accredited to are uniquely identified Commercial ISO/IEC and labeled to indicate Grade Survey 17025:2005/2017 calibration status.

by an Accreditation Items that are not Body which is a calibrated to their full signatory to the range, or have other ILAC MRA. limitations, are identified to that condition.

- CGI Item Dedication Technical Evaluation Page: 13 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 9 Out of tolerance notification & corrective action Commercial Perform Not Service provider has Grade Survey Commercial Grade Applicable an adequate Survey to verify the notification process service provider when the suppliers adequately M&TE/standards are Or controls this CC. found to be out of tolerance to an extent that customers calibration results may be impacted.

ILAC Verify the service Not Service provider has Accreditation in provider is Applicable an adequate lieu of accredited to notification process Commercial ISO/IEC when the suppliers Grade Survey 17025:2005/2017 M&TE/standards are by an Accreditation found to be out of Body which is a tolerance to an extent signatory to the that customers ILAC MRA. calibration results may be impacted.

- CGI Item Dedication Technical Evaluation Page: 14 of 17 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE METHOD ACCEPTANCE PLAN CRITERIA ACTIVITY (INCLUDING TOLERANCES) 10 Subcontractor calibration controls Commercial Perform Not Sub-suppliers Grade Survey Commercial Grade Applicable providing calibration Survey to verify the services for the service service provider provider's M&TE and adequately standards are capable Or controls this CC. of performing the required services with adequate quality.

ILAC Verification the Not Sub-suppliers Accreditation in service provider is Applicable providing calibration lieu of accredited to services for the service Commercial ISO/IEC provider's M&TE and Grade Survey 17025:2005/2017 standards are capable by an Accreditation of performing the Body which is a required services with signatory to the adequate quality.

ILAC MRA.

11 Calibration certification documentation Commercial Perform Not The service provider Grade Survey Commercial Grade Applicable submits the required Survey to verify the certification service provider documentation Or adequately including certificates of controls this CC. calibration.

Verify the service ILAC provider is Accreditation in accredited to Not The service provider lieu of ISO/IEC Applicable submits the required Commercial 17025:2005/2017 certification Grade Survey by an AB which is documentation a signatory to the including certificates of ILAC MRA calibration.

- CGI Item Dedication Technical Evaluation Page: 15 of 17 DESCRIPTION OF SAMPLING PLAN (if see below is selected in the sampling plan column above)

Not applicable OTHER RELEVANT INFORMATION Commercial Grade Surveys If a commercial grade survey is utilized to verify the laboratory controls the critical characteristics identified above, a survey report and checklist must be used to document the laboratory's control over the critical characteristics in accordance with applicable procedures.

ILAC Process Through their endorsement of NEI 14-05A, the NRC determined that the ILAC process is an acceptable method for verification that a laboratory controls the above critical characteristics in lieu of a survey. Therefore, the above critical characteristics can be verified by performing a commercial grade survey, source verification, or by taking credit for the ILAC process. The ILAC process requires verification that a laboratory is accredited to ISO/IEC 17025:2005/2017 by an Accreditation Body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) along with the following:

1. A documented review of the supplier's accreditation is performed and includes a verification of the following:

a. The calibration laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005/:20052017, "General Requirements for the Competence of Testing and Calibration Laboratories."

b. The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

2. The purchase documents require that:

a. The service must be provided in accordance with their accredited ISO/IEC-17025:2005/2017:2005 program and scope of accreditation.

b. As-found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance.

c. The equipment/standards used to perform the calibration must be identified in the certificate of calibration.

d. Subcontracting of this accredited services is prohibited.

Attachment 1 - CGI Item Dedication Technical Evaluation Page: 16 of 17 OTHER RELEVANT INFORMATION

e. The customer must be notified of any condition that adversely impacts the laboratory's ability to maintain the scope of accreditation.

f. Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

3. It is validated, at receipt inspection, that the laboratory's documentation certifies that:

a. The contracted calibration service has been performed in accordance with their ISO/IEC-17025:2005/2017:2005 program, and has been performed within their scope of accreditation.

b. The purchase order's requirements are met.

Successful completion of the receiving activities, along with a supplier certificate of calibration and certification attesting that the calibration service provided has been performed in accordance with the laboratory's ISO/IEC-17025:2005/2017 program and within the laboratory's scope of accreditation, provides reasonable assurance that the calibration service provided will not adversely impact the safety function of associated plant equipment that is calibrated or tested using the subject M&TE item.

BASIS FOR SELECTION OF SAMPLING PLANS (IF SAMPLING PLANS ARE USED)

Not Applicable SECTION J REFERENCES DOCUMENT / SOURCE REVISION / DATE COMMENTS

[Enter Company's Name] Quality Program Manual or This document provides the requirements for accepting Procedure commercial services without conducting a commercial grade survey.

NEI 14-05A Guidelines for the use of Accreditation in Lieu Rev. 1 This document provides guidance to an acceptable of Commercial Grade Surveys for Procurement of approach for procuring commercial grade calibration by Laboratory Calibration and Test Services laboratories accredited by International Laboratory Accreditation Cooperation (ILAC) signatories.

Plant Engineering: Guideline for the Acceptance of EPRI 3002002982, This document provides guidance for the dedication of Commercial-Grade Items in Nuclear Safety-Related Revision 1 to EPRI commercial grade dedicated services.

- CGI Item Dedication Technical Evaluation Page: 17 of 17 DOCUMENT / SOURCE REVISION / DATE COMMENTS Applications NP-5652 and TR-102260/9-2014 SECTION K REVIEW AND APPROVAL Prepared By: Date Reviewed By: Date

Attachment 2 - CGI Dedication Technical Evaluation Page : 1 of 7 SECTION A ITEM/SERVICE DESCRIPTION - TESTING SERVICES This Technical Evaluation addresses laboratory testing services from commercial testing service providers including ISO/IEC 17025:2005/2017 accredited laboratories and non-accredited service providers. It provides the Commercial Grade Item (CGI) dedication requirements for commercial testing services. The critical characteristics are the same whether one verifies the critical characteristics via a commercial grade survey or takes credit for the laboratory being accredited to ISO/IEC 17025:2005/2017 as detailed in NEI 14-05A. NEI 14-05A has been endorsed by the US NRC and allows the dedicating entity to take credit for verification of the critical characteristics by virtue of the laboratory being accredited to ISO/IEC 17025:2005/2017 by an Accreditation Body (AB) which is signatory the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). This process can be used in lieu of performing a commercial grade survey to verify the laboratorys control over the critical characteristics. This evaluation also covers laboratory testing services from various disciplines including chemical, mechanical, metallurgical, etc.

SECTION B END USE / PARENT / HOST EQUIPMENT INFORMATION Note: If the specific end-use(s) / plant applications are not known, complete Section C of this form in lieu of Section B prior to proceeding.

Not Applicable (Section C Completed Below)

EQUIPMENT ID (TAG) NUMBERS OR DESCRIPTION OF ITEM/SERVICE USAGE:

PARENT COMPONENT/HOST DESCRIPTION:

FUNCTIONAL SAFETY CLASS OF COMPONENT / HOST: BASIS / SOURCE:

Safety-Related Non-Safety Related (If non-safety, item/service is not a candidate for dedication)

IDENTIFICATION OF PARENT COMPONENT/HOST EQUIPMENT FUNCTION(S)

FUNCTIONAL BASIC SAFETY FUNCTION(S) DESCRIBE (AS REQUIRED)

MODE Active Passive PARENT COMPONENT/HOST EQUIPMENT IS (CHECK ALL THAT APPLY):

EQ ASME SECTION III CLASS 1E CONTAINMENT PRESSURE BOUNDARY SEISMIC CLASS 1 SERVICE LEVEL 1 COATING OTHER: (see below)

SECTION C BOUNDED SCOPE OF USE Only complete Section C when specific end-use of the item/service being dedicated is unknown.

Not Applicable (Section B Completed Above)

Is the item/service being dedicated a commodity or standard item/service designed and constructed in Yes accordance with an industry standard? No IF YES, LIST THE STANDARD(S) BELOW ISO/IEC 17025:2005/2017, "General Requirements for the Competence of Testing and Calibration Laboratories.

LIST FUNCTIONS AND/OR APPLICATIONS CONSIDERED WHEN COMPLETING THIS EVALUATION Test results and data provided may be used in accordance with the [Enter Company Name] 10CFR50 Appendix B QA program to verify the acceptability of an item or specific critical characteristics of an item for use as a basic component and its ability to perform its safety-related design functions.

The basic safety function of testing is to verify the acceptability of a single critical characteristic or multiple critical characteristics which supports the safety function of a items which will be dedicated as a basic component. For instance, a commercial testing service can be used to verify the material of construction of a fasteners which is being dedicated for use as a basic component.

This TE addresses commercial testing services including those supplied by providers under an ISO/IEC 17025:2005/2017 accreditation and those supplied by a provider that is not accredited.

EQUIPMENT QUALIFICATION CONSIDERATIONS / LIMITATIONS (CHECK ALL THAT APPLY):

CONSIDERATION QUALIFICATION BASIS / LIMITATIONS OF USE: Not applicable. While testing services can be used to verify one or more critical characteristics associated with environmental or seismic qualification, the testing service itself is not being environmentally or seismically qualified.

Attachment 2 - CGI Dedication Technical Evaluation Page : 2 of 7 ENVIRONMENTAL QUALIFICATION SEISMIC QUALIFICATION OTHER: (see below)

SECTION D SERVICE INFORMATION ITEM/SERVICE DESCRIPTION:

This technical evaluation covers the commercial grade dedication for the commercial testing services including mechanical, electrical, chemical, metallurgical, etc. A separate technical evaluation is therefore not needed for each type of testing service since the critical characteristics all testing services are the same.

FUNCTIONAL SAFETY CLASS OF ITEM/SERVICE: BASIS / SOURCE:

Safety-Related The basic safety function of testing is to verify the acceptability of a Non-Safety Related (If non-safety, item/service is not a candidate single critical characteristic or multiple critical characteristics which for dedication) supports the safety function of a items which will be dedicated as a basic component. For instance, a commercial testing service can be used to verify the material of construction for a fasteners which is being dedicated for use as a basic component.

IDENTIFICATION OF ITEM/SERVICE FUNCTION(S)

FUNCTIONAL BASIC SAFETY FUNCTION(S) DESCRIBE (AS REQUIRED)

MODE Active The safety function of testing is to verify the Testing services performed by commercial suppliers on Passive acceptability of a single critical characteristic behalf of [Enter Company Name] must be controlled in or multiple critical characteristics which accordance with the [Enter Company Name] 10CFR50, supports the safety function of a item which Appendix B-compliant QA program. Test results may be will be dedicated for use as a basic component. used in accordance with the [Enter Company Name]

For instance, a commercial testing service can 10CFR50 Appendix B QA program to verify the be used to verify the material of construction of acceptability of a critical characteristic of an item being a fastener which is being dedicated for use as a dedicated for use as a basic component.

basic component.

ITEM/SERVICE IS (CHECK ALL THAT APPLY):

EQ ASME SECTION III CLASS 1E CONTAINMENT PRESSURE BOUNDARY SEISMIC CLASS 1 SERVICE LEVEL 1 COATING OTHER: (see below)

SECTION E ELIGIBLITY FOR DEDICATION Is the item/service eligible for dedication in accordance with 10CFR, Part 21? Yes No If the answer is no, this item/service cannot be dedicated.

SECTION F FAILURE MODES / MECHANISMS AND EFFECTS ANALYSIS CREDIBLE FAILURE MODE/MECHANISM EFFECTS ON SYSTEM/COMPONENT FUNCTION Failure Modes/Mechanisms and Effects Analysis is normally Failure Modes/Mechanisms and Effects Analysis is normally performed to help determine performed to help determine the critical characteristics. In the the critical characteristics. In the case of testing services, the critical characteristics are case of testing services, the critical characteristics are known as known as specified in NEI 14-05A. Therefore, a FMEA is not required.

specified in NEI 14-05A. Therefore, a FMEA is not required.

BASIS FOR SELECTION OF CREDIBLE FAILURE MODE(S)/MECHANISM(S)

Failure Modes/Mechanisms and Effects Analysis is normally performed to help determine the critical characteristics. In the case of testing services, the critical characteristics are known as specified in NEI 14-05A. Therefore, a FMEA is not required.

SECTION G OPERATING EXPERIENCE / HISTORICAL PERFORMANCE INFORMATION SOURCES REVIEWED AND RESULTS External - An INPO OE search was conducted using the terms testing lab, vendor testing, dedication testing, testing cgi, and testing service. There was no information identified.

Internal - Include any Internal Operating Experience

Attachment 2 - CGI Dedication Technical Evaluation Page : 3 of 7 SECTION H IDENTIFICATION ATTRIBUTES IDENTIFICATION ATTRIBUTES DESCRIPTION OF INSPECTION ACCEPTANCE CRITERIA Testing service provider Visual The testing service provider is as specified in the purchasing document for the testing service performed.

Test Specimen Visual The item to be tested has the same identification number as the one specified in the purchasing document for the testing service.

SECTION I CRITICAL CHARACTERISTICS ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE CRITERIA METHOD ACCEPTANCE PLAN (INCLUDING ACTIVITY TOLERANCES) 1 Commercial Perform Commercial Not Applicable The testing lab has a process Identification/traceability of the item during testing/and processing is Grade Survey Grade Survey to verify for maintaining the maintained. the service provider identification and traceability adequately controls this of the test specimen.

CC.

Or ILAC Verify the service Not Applicable The testing lab has a process Accreditation in provider is accredited to for maintaining the lieu of Survey ISO/IEC identification and traceability Commercial 17025:2005/2017 by an of the test specimen.

Grade Source Accreditation Body which Verification is a signatory to the ILAC MRA Commercial Perform Commercial 2 Testing for the required characteristics/parameters is performed in Adequate documented Grade Survey Grade Survey to verify Not Applicable accordance with written industry recognized standards or other validated instructions exist for the service provider and approved test methods. performance of testing based adequately controls this CC. on internally or externally validated methodology Or Verify the service ILAC provider is accredited to Not Applicable Adequate documented Accreditation in ISO/IEC instructions exist for lieu of Survey 17025:2005/2017 by an performance of testing based Commercial Accreditation Body which on internally or externally Grade Source is a signatory to the ILAC validated methodology Verification MRA

Attachment 2 - CGI Dedication Technical Evaluation Page : 4 of 7 SECTION I CRITICAL CHARACTERISTICS ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE CRITERIA METHOD ACCEPTANCE PLAN (INCLUDING ACTIVITY TOLERANCES) 3 Actual testing is performed in accordance with written and approved Commercial Perform Commercial Not Applicable Testing is performed in procedures. Grade Survey Grade Survey to verify accordance with approved the service provider procedures and instructions adequately controls this CC.

Or ILAC Verification the service Not Applicable Testing is performed in Accreditation in provider is accredited to accordance with approved lieu of Survey ISO/IEC procedures and instructions Commercial 17025:2005/2017 by an Grade Source Accreditation Body which Verification is a signatory to the ILAC MRA 4 Testing is performed by trained and qualified personnel. Commercial Perform Commercial Not Applicable Laboratory has a documented Grade Survey Grade Survey to verify process for the training and the service provider qualification of personnel and adequately controls this performing the testing have CC. been approved to perform the testing in accordance with the Or quality program.

ILAC Verification the service Not Applicable Laboratory has a documented Accreditation in provider is accredited to process for the training and lieu of Survey ISO/IEC qualification of personnel and Commercial 17025:2005/2017 by an performing the testing have Grade Source Accreditation Body which been approved to perform the Verification is a signatory to the ILAC testing in accordance with the MRA quality program.

Attachment 2 - CGI Dedication Technical Evaluation Page : 5 of 7 ID CRITICAL CHARACTERISTICS ACCEPTANCE DESCRIPTION OF SAMPLING ACCEPTANCE CRITERIA METHOD ACCEPTANCE PLAN (INCLUDING ACTIVITY TOLERANCES) 5 M&TE including chemical standards are calibrated as applicable and are Commercial Perform Commercial Not Applicable The service provider's M&TE traceable to national, international, or intrinsic properties/natural law. Grade Survey Grade Survey to verify and standards have the needed the service provider accuracy, stability, tolerances adequately controls this (uncertainty) and range for the Or CC. items being calibrated.

ILAC Verification the service Not Applicable The service provider's M&TE Accreditation in provider is accredited to and standards have the needed lieu of Survey ISO/IEC accuracy, stability, tolerances Commercial 17025:2005/2017 by an (uncertainty) and range for the Grade Source Accreditation Body which items being calibrated.

Verification is a signatory to the ILAC MRA 6 Traceability of the test results to the item being tested is maintained. Commercial Perform Commercial Not Applicable Grade Survey Grade Survey to verify the service provider adequately controls this Or CC.

ILAC Verification the service Not Applicable Accreditation in provider is accredited to lieu of Survey ISO/IEC Commercial 17025:2005/2017 by an Grade Source Accreditation Body which Verification is a signatory to the ILAC MRA 7 Certification includes test results, identification of the item, test method Commercial Perform Commercial Not Applicable used, results, and signature of responsible laboratory authority Grade Survey Grade Survey to verify the service provider adequately controls this Or CC.

ILAC Verify the service Accreditation in provider is accredited to Not Applicable lieu of Survey ISO/IEC Commercial 17025:2005/2017 by an Grade Source Accreditation Body which Verification is a signatory to the ILAC MRA

Attachment 2 - CGI Dedication Technical Evaluation Page : 6 of 7 DESCRIPTION OF SAMPLING PLAN (if see below is selected in the sampling plan column above)

Not applicable OTHER RELEVANT INFORMATION Commercial Grade Surveys If the a commercial grade survey is utilized to verify the laboratory controls the critical characteristics identified above, a survey report and checklist must be used to document the laboratory's control over the critical characteristics in accordance with applicable procedures.

Commercial Grade Source Verifications If a commercial grade source verification is utilized to verify the laboratory controls the critical characteristics identified above, the source verification must be performed for each item calibrated by the laboratory. Sampling is not permitted. In addition, a report and checklist must be used to document the laboratory's control over the critical characteristics in accordance with applicable procedures.

ILAC Process Through their endorsement of NEI 14-05A, the NRC determined that the ILAC process is an acceptable method for verification that a laboratory controls the above critical characteristics in lieu of a survey. Therefore, the above critical characteristics can be verified by performing a commercial grade survey, source verification, or by taking credit for the ILAC process. The ILAC process requires verification that a laboratory is accredited to ISO/IEC 17025:2005/2017 by and Accreditation Body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) along with the following: .

1. A documented review of the supplier's accreditation is performed and includes a verification of the following:

a. The testing laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005/:20052017, "General Requirements for the Competence of Testing and Calibration Laboratories"

b. The published scope of accreditation for the testing laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

2. The purchase documents require that:

a. The service must be provided in accordance with their accredited ISO/IEC-17025:2005/2017:2005 program and scope of accreditation.

b. The customer must be notified of any condition that adversely impacts the laboratory's ability to maintain the scope of accreditation.

c. Subcontracting of this accredited services is prohibited.

d. Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

3. It is validated, at receipt inspection, that the laboratory's documentation certifies that:

a. The contracted testing service has been performed in accordance with their ISO/IEC-17025:2005/2017:2005 program, and has been performed within their scope of accreditation, and

b. The purchase order's requirements are met.

Attachment 2 - CGI Dedication Technical Evaluation Page : 7 of 7 OTHER RELEVANT INFORMATION Successful completion of the receiving activities, along with a supplier test report and certification attesting that the testing service provided has been performed in accordance with the laboratory's ISO/IEC-17025:2005/2017 program and within the laboratory's scope of accreditation, provides reasonable assurance that the testing service provided will not adversely impact the safety function of item associated with the testing.

BASIS FOR SELECTION OF SAMPLING PLANS (IF SAMPLING PLANS ARE USED)

Not Applicable SECTION J REFERENCES DOCUMENT / SOURCE REVISION / DATE COMMENTS

[Enter Company's Name] Quality Program Manual or Procedure This document provides the requirements for accepting commercial services without conducting a commercial grade survey.

NEI 14-05A Guidelines for the use of Accreditation in Lieu of Commercial Rev. 1 This document provides guidance to an acceptable approach for procuring Grade Surveys for Procurement of Laboratory Calibration and Test Services commercial grade testing services by laboratories accredited by International Laboratory Accreditation Cooperation (ILAC) signatories.

Plant Engineering: Guideline for the Acceptance of Commercial-Grade Items in EPRI 3002002982, Revision This document provides guidance for the dedication of commercial grade Nuclear Safety-Related Applications dedicated services.

1 to EPRI NP-5652 and TR-102260/9-2014 SECTION K REVIEW AND APPROVAL Prepared By: Date Reviewed By: Date

v t e Letter Sequence Request
EPID:L-2020-TOP-0011, 2-20-20_Public_Meeting_NEI_Wireless_Presentation (Open)
Initiation Request, Request, Request, Request, Request Acceptance... Administration Questions Answers 11 September 2020 Results Approval... Other:
MONTHYEAR2020-02-20 [Table View]

ML20259B731

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3.2 TECHNICAL EVALUATION

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3.2 TECHNICAL EVALUATION

6.1 TECHNICAL EVALUATION

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