ML20321A316

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Review of NRCs Draft Safety Evaluation for 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
ML20321A316
Person / Time
Site: Nuclear Energy Institute
Issue date: 11/16/2020
From: Richter M
Nuclear Energy Institute
To: Leslie Fields
Document Control Desk, Office of Nuclear Reactor Regulation
References
EPID L-2020-TOP-0011
Download: ML20321A316 (12)


Text

MARK A. RICHTER, PH.D.

Senior Project Manager, Used Fuel and Decommissioning 1201 F Street, NW, Suite 1100 Washington, DC 20004 P: 202.739.8106 mar@nei.org nei.org November 16, 2020 Ms. Leslie Fields Senior Project Manager U.S. Nuclear Regulatory Commission Office of Nuclear Reactor Regulation Washington, DC 20555-0001

Subject:

Review of NRC's Draft Safety Evaluation for 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" Project Number: 689

Dear Ms. Fields:

The Nuclear Energy Institute (NEI)1 is pleased to review the draft Safety Evaluation for 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," prior to issuance. Based on our review, we have one comment relative to inclusion of a more accurate statement regarding the purpose of Revision 1 to NEI 14-05A. The reason for the changes was not to update Revision 1 of NEI 14-05A to ensure conformance to the 2017 edition of ISO/IEC 17025 as stated on page 2 (lines 40-44) of the draft SE. The purpose of the revision was to recognize ISO/IEC 17025:2017 as the basis for NEI 14-05A and provide clarifications needed based on operating experience subsequent to the NRCs initial recognition of the ILAC accreditation process. An edited version of the Draft Safety Evaluation and the Comment Resolution Table, identifying the page and line numbers for the proposed change to the SER, are attached.

1 The Nuclear Energy Institute (NEI) is the organization responsible for establishing unified industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations and entities involved in the nuclear energy industry.

Ms. Leslie Fields November 16, 2020 Page 2 NEI appreciates the opportunity to provide comments on the draft Safety Evaluation and NRCs consideration of the proposed change. If you have any questions or require additional information, please contact me.

Sincerely, Mark A. Richter Attachments (2) c:

Ms. Kerri Kavanagh, Chief, NRC/NRR/MVIB Mr. Yamir Diaz-Castillo, NRC /NRR/MVIB Mr. Dong Park, NRC/NRR/MVIB Mr. Dennis Morey, NRC Mr. Earl Mayhorn, NUPIC/Ameren NRC Document Control Desk

Enclosure 1

2 3

4 5

DRAFT SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION 6

7 FOR THE NUCLEAR ENERGY INSTITUTE TECHNICAL REPORT 14-05A, 8

9 "GUIDELINES FOR THE USE OF ACCREDITATION IN LIEU OF COMMERCIAL 10 11 GRADE SURVEYS FOR PROCUREMENT OF LABORATORY 12 13 CALIBRATION AND TEST SERVICES," REVISION 1 14 15 EPID L-2020-TOP-0011 16 17 18

1.0 INTRODUCTION

19 20 By letter dated February 20, 2020 (Reference (Ref.) 1), the Nuclear Energy Institute (NEI) 21 submitted Revision 1 to Technical Report (TR) NEI 14-05A, Guidelines for the Use of 22 Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration 23 and Test Services, for U.S. Nuclear Regulatory Commission (NRC) staff review and 24 endorsement. Revision 1 of NEI 14-05A provides an updated approach for licensees and 25 suppliers of basic components for using laboratory accreditation by Accreditation Bodies (ABs) 26 that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual 27 Recognition Arrangement (MRA) (hereby after referred to as the ILAC accreditation process) in 28 lieu of performing commercial-grade surveys for procurement of calibration and testing services.

29 This method of qualifying the calibration and testing supplier and accepting its calibration and 30 testing services would be applied only to dedication of commercial-grade calibration and testing 31 services as defined by Title 10 of the Code of Federal Regulations (10 CFR) Part 21, Reporting 32 of Defects and Noncompliance.

33 34

2.0 BACKGROUND

35 36 In a letter dated August 28, 2014 (Ref. 2), NEI submitted Revision 1 to NEI 14-05, "Guidelines 37 for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of 38 Laboratory Calibration and Test Services," for NRC staff review and endorsement. In its safety 39 evaluation (SE) dated February 9, 2015 (Ref. 3), the NRC staff determined that Revision 1 of 40 NEI 14-05 provided an acceptable approach for licensees and suppliers subject to the quality 41 assurance (QA) requirements of Appendix B, Quality Assurance Criteria for Nuclear Power 42 Plants and Fuel Reprocessing Plants, to 10 CFR Part 50, Domestic Licensing of Production 43 and Utilization Facilities, for using laboratory accreditation by ABs that are signatories to the 44 ILAC MRA in lieu of performing commercial-grade surveys as part of the commercial-grade 1

dedication process for procurement of calibration and testing services performed by domestic 2

and international laboratories accredited by signatories to the ILAC MRA.

3 4

By letter dated April 1, 2016 (Ref. 4), the NRC staff approved a request to change the 5

Operating Quality Assurance Manual for Callaway Plant, Unit 1, pursuant to 10 CFR 50.54(a) 6 to incorporate the QA alternative of using the ILAC accreditation process in lieu of performing a 7

commercial-grade survey. With this approval, other licensees could use the ILAC accreditation 8

process in lieu of performing commercial-grade surveys for procurement of calibration and 9

testing services performed by domestic and international laboratories accredited by signatories 10 to the ILAC MRA provided the bases of the NRC approval are applicable to the licensee's 11 facility pursuant to the requirements of 10 CFR 50.54(a)(3)(ii).

12 13 In a letter dated October 1, 2018 (Ref. 5), NEI requested the NRC to recognize the 2017 edition 14 of the International Standard Organization /International Electrotechnical Commission standard 15 No. 17025 (2017 edition ISO/IEC 17025), General Requirements for the Competence of 16 Testing and Calibration Laboratories, for use during the three-year transition period that began 17 on November 30, 2017, and is set to expire on November 30, 2020. This time period was 18 established by ISO to allow accredited laboratories to transition from the 2005 to the 2017 19 edition of ISO/IEC 17025. Subsequently, in a letter responding to NEI's request dated April 16, 20 2019 (Ref. 6), the NRC concluded that the 2017 edition of ISO/IEC 17025 maintains the same 21 technical and quality requirements as the 2005 edition of ISO/IEC 17025. Therefore, licensees 22 and suppliers of basic components may procure calibration and/or testing services from 23 domestic and international laboratories accredited to the 2017 edition of ISO/IEC 17025 in lieu 24 of performing a commercial-grade survey as part of the commercial-grade dedication process 25 during the transition period established by ISO, with the expectation the industry would seek 26 recognition of the 2017 edition of ISO/IEC 17025 beyond the transition period through a revision 27 of NEI 14-05A.

28 29 By electronic mail (e-mail) dated May 1, 2020 (Ref. 7), the NRC transmitted a request for 30 additional information (RAI) to complete its review of Revision 1 of NEI 14-05A. In a letter dated 31 May 13, 2020 (Ref. 8), NEI submitted its response to the RAI and an update to Revision 1 of 32 NEI 14-05A (Ref. 9), which incorporated NEIs response to the NRC staffs RAI. By e-mail 33 dated July 6, 2020 (Ref. 10), the NRC transmitted a second round of RAIs to address issues 34 related to the recent Coronavirus Disease 2019 (COVID-19) pandemic. In a letter dated 35 September 11, 2020 (Ref. 11), NEI submitted its response to the RAIs and an update to 36 Revision 1 of NEI 14-05A (Ref. 12), which incorporated NEIs responses to the NRC staffs 37 RAIs.

38 39 Revision 1 of NEI 14-05A was updated to recognize ISO/IEC 17025:2017 as the basis for the 40 ILAC process and to address other minor editorial changes, clarifications, and adjustments 41 based on operating experience identified subsequent to the NRC's initial endorsement in 42 February 2015.

43 Revision 1 of NEI 14-05A was updated to ensure conformance to the 2017 edition of 44 ISO/IEC 17025. The proposed changes to Revision 1 of NEI 14-05A addresses some updates 45 and enhancements made in the 2017 edition ISO/IEC 17025 as well some adjustments and 46 clarifications needed based on operating experience learned after the NRCs initial recognition 47 of the ILAC accreditation process.

48 1

3.0 TECHNICAL EVALUATION

2 3

3.1.

Limitations of Use 4

5 Section 3.4, Limitations of Use, in Revision 1 of NEI 14-05A clarifies that the guidance for the 6

use of the ILAC accreditation process was developed as part of the commercial-grade 7

dedication process for laboratory calibration and testing services by licensees and suppliers of 8

basic components. The NRC staff recognizes that the use of the 2017 edition ISO/IEC 17025 9

for procurement of calibration and testing services is not limited to licensees and suppliers of 10 basic components. However, the NRCs approval for using the ILAC accreditation process in 11 lieu of performing commercial-grade surveys, and the acceptance of inspection and tests results 12 to determine conformance with the applicable requirements, can only be implemented by a 13 supplier who has a QA program that meets the applicable requirements of Appendix B to 14 10 CFR Part 50. When commercial-grade surveys are utilized as an acceptance method, the 15 commercial-grade survey report must document the commercial supplier's control over the 16 identified critical characteristics and the associated quality controls that affect the critical 17 characteristics such as calibration of measuring and test equipment. Subsequent use of the 18 ILAC accreditation process by commercial sub-suppliers is inadequate and should be 19 adequately controlled irrespective of the fact that the commercial sub-suppliers are 20 implementing the same QA program based on ISO 17025. The commercial-grade survey report 21 must document the acceptability of the commercial sub-suppliers control over calibration and 22 not merely state the commercial sub-supplier uses accredited calibration or testing service 23 providers based on the accreditation to the 2017 edition of ISO/IEC 17025. Commercial-grade 24 survey reports should address the selection and approval of supplier and the overall 25 procurement controls as applicable for such suppliers.

26 27 Section 3.4 also describes the use of the ILAC accreditation process for nondestructive 28 examination (NDE) or nondestructive testing (NDT) since these services can potentially be 29 dedicated. For the purposes of this SE, the terms NDE and NDT are considered equivalent and 30 can be used interchangeably. The Electric Power Research Institute (EPRI) TR 31 No. 3002002982, Plant Engineering: Guideline for the Acceptance of Commercial-Grade Items 32 in Nuclear Safety-Related Applications, dated September 2014 (Ref. 13), states that the 33 procurement of NDE services performed on safety-related equipment may be dedicated.

34 Although EPRI 3002002982 is endorsed by Regulatory Guide (RG) 1.164, Dedication of 35 Commercial-Grade Items for Use in Nuclear Power Plants, Revision 0, dated June 2017 36 (Ref. 14), the NRCs recognition of the ILAC accreditation process did not intend to include the 37 commercial-grade dedication of NDE services based on a laboratory's accreditation to the 2017 38 edition of ISO/IEC 17025. There are specific personnel qualification and certification 39 requirements for personnel performing safety-related NDE activities for the nuclear industry that 40 are not addressed by the ILAC accreditation process. Therefore, the ILAC accreditation 41 process cannot be used as part of the commercial-grade dedication process of NDE services in 42 lieu of performing a commercial-grade survey. This is applicable to both American Society of 43 Mechanical Engineers (ASME) Boiler and Pressure Vessel (B&PV) Code and non-ASME B&PV 44 Code safety-related applications. It should be noted that use of the ILAC accreditation process 45 for NDE services required by the ASME B&PV Code is also prohibited by the ASME B&PV 46 Code.

47 48 3.2 Performing and Documenting a Technical Evaluation for the Calibration and/or Testing 1

Services 2

3 As part of the commercial-grade dedication process, licensees and suppliers of basic 4

components should perform and document a technical evaluation to ensure that the correct 5

technical requirements are specified in the procurement documents. The NRCs recognition of 6

the ILAC accreditation process allows licensees and suppliers of basic components to use this 7

accreditation in lieu of performing a commercial-grade survey as part of the commercial-grade 8

dedication process for calibration and testing services. As such, the NRC staff expects 9

licensees and suppliers of basic components to follow the commercial-grade dedication 10 process, which includes performing and documenting a technical evaluation for the calibration 11 and/or testing services being procured.

12 13 and Attachment 2 to Revision 1 of NEI 14-05A include acceptable examples of a 14 technical evaluation for calibration services and testing services, respectively. These technical 15 evaluations address measuring and calibration services from commercial calibration service 16 providers and laboratory testing services from commercial testing service providers including 17 ISO/IEC 17025:2005 and ISO/IEC 17025:2017 accredited laboratories and non-accredited 18 service providers.

19 20 3.3 New Conditions: Subcontracting of Services and Remote Accreditation Assessments 21 22 3.3.1 Subcontracting of Services 23 24 The use of subcontracting services is allowed by the 2017 edition of ISO/IEC 17025. At the 25 time the NRC staff recognized the ILAC accreditation process, none of the conditions imposed 26 prohibited the use of subcontractors to perform any calibration and/or testing work. However, in 27 order to ensure that the calibration and/or testing work is performed by an ILAC accredited 28 laboratory and reduce the chance of misuse of the ILAC accreditation process and not receive 29 an accredited service, the procurement documents must prohibit the accredited calibration or 30 testing laboratory from subcontracting the service being procured. The procurement document 31 for accredited services must be submitted directly to the entity performing the calibration or 32 testing. It should be noted when using the ILAC accreditation process under the ASME B&PV 33 Code, subcontracting of services is also prohibited.

34 35 3.4.

Remote Accreditation Assessments 36 37 The NRCs recognition of the ILAC accreditation process allows licensees and suppliers of 38 basic components to take credit for the ILAC accreditation process in lieu of performing an 39 on-site commercial-grade survey as part of the commercial-grade dedication process of 40 calibration and testing services. In its initial recognition of the ILAC accreditation process, the 41 NRC staff determined that as part of the on-site renewal assessments performed by the ABs, 42 the critical characteristics for calibration and testing services would be verified as part of the 43 on-site renewal assessment. Due to the travel restrictions caused by the COVID-19 pandemic, 44 ABs are performing remote accreditation assessments. While use of remote accreditation 45 assessments were determined by the nuclear industry to be acceptable during extenuating 46 circumstances, it is necessary to impose a limitation on the use of remote assessment for 47 laboratories performing calibrations and testing for licensees and suppliers of basic 48 components. Accredited calibration or testing services performed on behalf of licensees and 1

suppliers of basic components cannot be accepted from laboratories who have not undergone 2

an on-site accreditation assessment within the past 48 months of the date of services. Such 3

laboratories cannot be used by licensees and suppliers of basic components if their 4

accreditation is based on consecutive remote accreditation assessments. Due to the travel 5

restrictions caused by the COVID-19 pandemic, the NRC approved an overall 25 percent 6

extension (9 months) prior to the end of the 90-day grace period for triennial audits or surveys 7

during periods where performance of such activities is not feasible as a result of extenuating 8

circumstances. With the added assurance that remote renewal accreditations are 24 months, 9

the NRC staff concludes that there is reasonable assurance that the on-site accreditation 10 assessments within 48 months meet the requirement with respect to performing 11 commercial-grade surveys as part of the commercial-grade dedication process.

12 13 3.5 Implementation of the ILAC Accreditation Process in Lieu of a Commercial-Grade Survey 14 15 The following are the actions and steps that are necessary for a licensee and/or a supplier of 16 basic components to accept accreditation of domestic and international calibration and test 17 laboratory services by ILAC MRA signatories in lieu of performing a commercial-grade survey 18 as part of the commercial-grade dedication process:

19 20

1)

The method to use accreditation by an ILAC MRA signatory in lieu of a 21 commercial-grade survey (alternative method) is documented in the licensee 22 and/or supplier of basic components QA program.

23 24

2)

The method the licensee and/or supplier of basic components needs to follow, 25 and document in their QA program, consists of:

26 27

1. A documented review of the laboratorys accreditation is performed and 28 includes a verification of the following:

29 30

a. The calibration or test laboratory holds accreditation by an accrediting 31 body recognized by the ILAC MRA. The accreditation encompasses 32 ISO/IEC-17025:2017, General Requirements for the Competence of 33 Testing and Calibration Laboratories.

34 35

b. For procurement of calibration services, the published scope of 36 accreditation for the calibration laboratory covers the needed 37 measurement parameters, ranges, and uncertainties.

38 39

c. For procurement of testing services, the published scope of accreditation 40 for the test laboratory covers the needed testing services including test 41 methodology and tolerances/uncertainty.

42 43

d. The laboratory has achieved accreditation based on an on-site 44 accreditation assessment by the selected AB within the past 48 months.

45 The laboratory's accreditation cannot be based on two consecutive 46 remote accreditation assessments.

47 48

2. The purchase documents require that:

1 2

a. The service must be provided in accordance with their accredited 3

ISO/IEC-17025:2017 program and scope of accreditation.

4 5

b. As-found calibration data must be reported in the certificate of calibration 6

when calibrated items are found to be out-of-tolerance (for calibration 7

services only).

8 9

c. The equipment/standards used to perform the calibration must be 10 identified in the certificate of calibration (for calibration services only).

11 12

d. Subcontracting of these accredited services is prohibited.

13 14

e. The customer must be notified of any condition that adversely impacts the 15 laboratorys ability to maintain the scope of accreditation.

16 17

f.

Performance of the services listed on this order is contingent on the 18 laboratory's accreditation having been achieved through an on-site 19 accreditation assessment by the AB within the past 48 months.

20 21

g. Any additional technical and quality requirements, as necessary, based 22 upon a review of the procured scope of services, which may include, but 23 are not necessarily limited to, tolerances, accuracies, ranges, and 24 industry standards.

25 26

3. It is validated, at receipt inspection, that the laboratorys documentation 27 certifies that:

28 29

a. The contracted calibration or test service has been performed in 30 accordance with their ISO/IEC-17025:2017 program, and has been 31 performed within their scope of accreditation, and 32 33
b. The purchase orders requirements are met.

34 35 4.0 APPLICABILITY 36 37 Due to the travel restrictions resulting from the COVID-19 pandemic, ILAC extended the 38 transition period originally scheduled to end on November 30, 2020, to June 1, 2021. During 39 the transition period between the issuance of this SE endorsing Revision 1 of NEI 14-05A 40 through June 1, 2021, the NRC staff determined that the 2005 and 2017 editions of 41 ISO/IEC 17025, as well as Revision 0 and Revision 1 of NEI 14-05A, are acceptable for use.

42 Starting on June 2, 2021, after the transition period has ended, Revision 0 of NEI 14-05A will 43 become superseded by Revision 1 of NEI 14-05A and licensees and suppliers of basic 44 components using the ILAC accreditation process in lieu of performing a commercial-grade 45 survey for calibration and testing services will have to start implementing Revision 1 of 46 NEI 14-05A. However, if a licensee or a supplier of basic components incorporates Revision 1 47 of NEI 14-05A into its QA program before the transition period ends on June 1, 2021, the new 1

conditions as described in Revision 1 of NEI 14-05A will go into effect.

2 3

For licensees, the use of the 2017 edition of ISO/IEC 17025 as part of the ILAC accreditation 4

process in lieu of performing a commercial-grade survey represents a QA alternative to the 5

previously accepted QA program. As such, licensees may adopt the QA alternative of using the 6

2017 edition of ISO/IEC 17025 provided that the bases of the NRCs approval are applicable to 7

the licensees facility pursuant to the requirements of 10 CFR 50.54(a)(3)(ii).

8 9

After June 1, 2021, the 2005 edition of ISO/IEC 17025 will become invalid and only 10 accreditation to the 2017 edition of ISO/IEC 17025 can be achieved and recognized under the 11 ILAC MRA process. Therefore, this SE recognizes accreditation to the 2005 edition of 12 ISO/IEC 17025 through June 1, 2021.

13 14

5.0 CONCLUSION

15 16 On the basis of its review, the NRC staff concludes that Revision 1 of NEI 14-05A continues to 17 provide an acceptable approach for licensees and suppliers subject to the QA requirements of 18 Appendix B to 10 CFR Part 50 for using laboratory accreditation by ABs that are signatories to 19 the ILAC MRA in lieu of performing commercial-grade surveys as part of the commercial-grade 20 dedication process for procurement of calibration and testing services performed by domestic 21 and international laboratories accredited by signatories to the ILAC MRA.

22 23

6.0 REFERENCES

24 25

1. Letter from Mr. Mark A. Richter, Senior Project Manager, Used Fuel and Decommissioning 26 Programs, NEI, to Ms. Kerri A. Kavanagh, Chief, Quality Assurance and Vendor Inspection 27 Branch, Submittal of NEI 14-05A, Revision 1, Guidelines for the Use of Accreditation in 28 Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test 29 Services, dated February 20, 2020 (Agencywide Documents Access and Management 30 System (ADAMS) Accession No. ML20054C066).

31 32

2. Letter from Mr. Marcus R. Nichol, Senior Project Manager, Quality Issues and Licensing 33 Actions, NEI, to Mr. Joseph Colaccino, Chief, New Reactor Rulemaking and Guidance 34 Branch, Division of Advanced Reactors and Rulemaking, Office of New Reactors, Submittal 35 of NEI 14-05, Revision 1, Guidelines for the Use of Accreditation in Lieu of Commercial 36 Grade Surveys for Procurement of Laboratory Calibration and Test Services, dated 37 August 28, 2014 (ADAMS Accession No. ML14245A391).

38 39

3. Letter from Mr. Joseph Colaccino, Chief, New Reactor Rulemaking and Guidance Branch 40 Division of Advanced Reactors and Rulemaking, Office of New Reactors, to Mr. Marcus R.

41 Nichol, Senior Project Manager Quality Issues and Licensing Actions, Nuclear Energy 42 Institute, Final Safety Evaluation for Technical Report NEI 14-05, Guidelines for the Use of 43 Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory 44 Calibration and Test Services, Revision 1, dated February 9, 2015 (ADAMS Accession 45 No. ML14322A535).

46 47

4. Letter from Mr. L. John Klos, Project Manager, Plant Licensing Branch IV-1 1

Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation to Mr. Fadi 2

Diya, Senior Vice President and Chief Nuclear Officer, Union Electric Company, Callaway 3

Plant, Unit 1 - Operating Quality Assurance Manual Revision 31, Change Notice 15-002, 4

dated April 1, 2016 (ADAMS Accession No. ML16089A167).

5 6

5. Letter from Mr. Mark A. Richter, Senior Project Manager, Used Fuel and Decommissioning 7

Programs, NEI, to Ms. Kerri A. Kavanagh, Chief, Quality Assurance Vendor Inspection 8

Branches 1 & 2, Endorsement of ISO/IEC 17025: 2017, General Requirements for the 9

Competence of Testing and Calibration Laboratories, dated October 1, 2018 (ADAMS 10 Accession No. ML18275A121).

11 12

6. Letter from Ms. Jennivine Rankin, Chief, Licensing Branch 2, Division of Licensing, Siting, 13 and Environmental Reviews, Office of New Reactors to Mr. Mark A. Richter, Senior Project 14 Manager, Used Fuel and Decommissioning Programs, Nuclear Energy Institute, Provisional 15 Recognition of the International Standard Organization/International Electrotechnical 16 Commission Standard No. 17025, General Requirements for the Competence of Testing 17 and Calibration Laboratories, 2017 Edition, dated April 16, 2019 (ADAMS Accession 18 No. ML19056A451).

19 20

7. E-mail transmittal from Leslie Fields, Senior Project Manager, Licensing Processes Branch, 21 Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation to Mr. Mark 22 A. Richter, Senior Project Manager, Used Fuel and Decommissioning Programs, NEI, 23 Request for Additional Information for NEI 14-05A Revision 1, dated May 1, 2020 (ADAMS 24 Accession No. ML20121A319).

25 26

8. Letter from Mr. Mark A. Richter, Senior Project Manager, Used Fuel and Decommissioning 27 Programs, NEI, to Leslie Fields, Senior Project Manager, Licensing Processes Branch, 28 Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation, Submittal of 29 Response to Request for Additional Information (RAI) for NEI 14-05A, Revision 1, 30 Guidelines for the Use of Accreditation in Lieu of Commercial-Grade Surveys for 31 Procurement of Laboratory Calibration and Test Services, dated May 13, 2020 (ADAMS 32 Accession No. ML20135H214).

33 34

9. Revision 1 of NEI 14-05A, Revision 1 of NEI 14-05A, Guidelines for the Use of 35 Accreditation in Lieu of Commercial-Grade Surveys for Procurement of Laboratory 36 Calibration and Test Services, dated May 2020 (ADAMS Accession No. ML20135H229).

37 38

10. E-mail transmittal dated from Leslie Fields, Senior Project Manager, Licensing Processes 39 Branch, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation to 40 Mr. Mark A. Richter, Senior Project Manager, Used Fuel and Decommissioning Programs, 41 NEI, Request for Additional Information (RAI) for NEI 14-05A, Revision 1, dated July 6, 42 2020 (ADAMS Accession No. ML20184A288).

43 44

11. Letter from Mr. Mark A. Richter, Senior Project Manager, Used Fuel and Decommissioning 45 Programs, NEI, to Leslie Fields, Senior Project Manager, Licensing Processes Branch, 46 Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation, Submittal of 47 Response to Request for Additional Information (RAI) for NEI 14-05A, Revision 1, 48 Guidelines for the Use of Accreditation in Lieu of Commercial-Grade Surveys for 1

Procurement of Laboratory Calibration and Test Services, dated September 11, 2020 2

(ADAMS Accession No. ML20259C391).

3 4

12. Revision 1 of NEI 14-05A, Guidelines for the Use of Accreditation in Lieu of Commercial-5 Grade Surveys for Procurement of Laboratory Calibration and Test Services, dated 6

September 2020 (ADAMS Accession No. ML20259B731).

7 8

13. EPRI TR 3002002982, Plant Engineering: Guideline of Commercial-Grade Items in 9

Nuclear Safety-Related Applications, Revision 1, September 2014 (ADAMS Accession 10 No. ML181999A161).

11 12

14. RG 1.164, Dedication of Commercial-Grade Items for Use in Nuclear Power Plants, 13 Revision 0, dated June 2017 (ADAMS Accession No. ML17041A206).

14 15 Principal Contributors: Yamir Diaz-Castillo, NRR/DRO 16 Dong Park, NRR/DRO 17 18 Date: November 19 20

Topical Report NEI 14-05A, "GUIDELINES FOR THE USE OF ACCREDITATION IN LIEU OF COMMERCIAL GRADE SURVEYS FOR PROCUREMENT OF LABORATORY CALIBRATION AND TEST SERVICES", Revision 1 COMMENT RESOLUTION TABLE Comment Number Text Location in the DSE Comment Type (Clarification, Editorial,

Accuracy, Proprietary)

NEI Suggested Revision NRC Response Page Line 1

2 40-44 Accuracy Please replace the current wording in Lines 40-44 with the following:

"Revision 1 of NEI 14-05A was updated to recognize ISO/IEC 17025:2017 as the basis for the ILAC process and to address other minor editorial changes, clarifications, and adjustments based on operating experience identified subsequent to the NRC's initial endorsement in February 2015."