Safety Evaluation Reports Concerning the Revised Basis for QA Programs for Operating Reactors (including Calibration Services) and New Reactor Licensing Activities
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Regulatory Guide 1.28, Revision 5
Regulatory Guide 1.28, Revision 5, extends the NRC's endorsement of NQA-1, "Quality Assurance Requirements for Nuclear Facility Applications," to the NQA-1b-2011 Addenda to ASME NQA-1-2008, NQA-1-2012, and NQA-1-2015 versions, with certain clarifications. The NRC has determined that the NQA-1b-2011 Addenda to ASME NQA-1-2008, NQA-1-2012, and NQA-1-2015 provide the most current guidance for the implementation of a QA program during design and construction phases of nuclear power plants and fuel reprocessing plants and meets the requirements of Appendix B to 10 CFR Part 50. Additionally, Regulatory Guide 1.28, Revision 5, provides updated guidance for managing quality assurance records in electronic media and incorporates the NRC's approval of NEI-14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," as an acceptable approach for using laboratory accreditations in lieu of performing a commercial grade survey.
Adoption of ASME NQA-1-1994
For several licensees, the U.S. Nuclear Regulatory Commission (NRC) approved changing the licensing basis from ANSI N45.2, ''Quality Assurance Program Requirements for Nuclear Power Plants," to NQA-1-1994, "Quality Assurance Requirements for Nuclear Facility Applications." Part II of NQA-1-1994 sets forth programmatic requirements for establishing and executing quality assurance programs for the siting, design, construction, operation, and decommissioning of nuclear facilities. To augment those requirements, Part II of NQA-1-1994 sets forth non-programmatic quality assurance requirements for planning and executing identified tasks during the fabrication, construction, modification, repair, maintenance, and testing of structures, systems, and components for nuclear facilities. The guidance provided by Parts I and II of NQA-1-1994 is similar to that provided by the ANSI N45.2 daughter standards developed in the 1970s and early 1980s. The licensees in question proposed to adopt NQA-1-1994 in lieu of certain current commitments to ANSI N45.2 daughter standards.
The bases for staff approval of the proposed change are documented in the following safety evaluation reports:
Laboratory Accreditation and Testing Services
By a letter dated February 20, 2020, the Nuclear Energy Institute (NEI) submitted Revision 1 to NEI 14-05A, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," to the U.S. Nuclear Regulatory Commission (NRC) for NRC staff review and approval. NEI 14-05 provides an approach for licensees and suppliers of basic components to use laboratory accreditation by Accreditation Bodies (ABs) that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) (hereafter referred to as the ILAC accreditation process) in lieu of performing commercial-grade surveys for procurement of calibration and testing services performed by domestic and international laboratories accredited by signatories to the ILAC MRA. NEI 14-05A was updated to recognize the 2017 edition of the International Standard Organization (ISO)/International Electrotechnical Commission (IEC) 17025, “General Requirements for the Competence of Testing and Calibration Laboratories,” as the basis for the ILAC accreditation process and to address other minor adjustments based on operating experience identified subsequent to the NRC’s initial approval in a safety evaluation dated February 9, 2015. In addition, Revision 1 to NEI 14-05A includes 2 new conditions related to subcontracting of services and remote accreditation assessments due to the travel restrictions caused by the COVID-19 pandemic.
When purchasing commercial-grade calibration and testing services from domestic and international calibration and testing laboratories accredited by an ILAC MRA signatory, licensees and suppliers of basic components may use the ILAC accreditation process in lieu of performing a commercial-grade survey as part of the commercial-grade dedication process provided the conditions from the NEI 14-05A, Revision 1, safety evaluation are met.
For licensees, the use of the 2017 edition of ISO/IEC 17025 as part of the ILAC accreditation process in lieu of performing a commercial-grade survey represents a QA alternative to the previously accepted QA program. As such, licensees may adopt the QA alternative of using the 2017 edition of ISO/IEC 17025 provided that the bases of the NRC’s approval are applicable to the licensee’s facility pursuant to the requirements of 10 CFR 50.54(a)(3)(ii).
After June 1, 2021, the 2005 edition of ISO/IEC 17025 will become invalid and only accreditation to the 2017 edition of ISO/IEC 17025 can be achieved and recognized under the ILAC MRA process. Therefore, the NRC’s safety evaluation above recognizes accreditation to the 2005 edition of ISO/IEC 17025 through June 1, 2021.
Use of National Metrology Institutes
By letter dated June 4, 2014, the Nuclear Energy Institute (NEI) requested clarification on the U.S Nuclear Regulatory Commission's (NRC) position on the quality assurance (QA) program requirements for international National Metrology Institutes (NMIs) as suppliers of primary reference standards and calibration services. By letter dated August 24, 1983, the NRC had clarified that for the U.S. NMI, which is the National Institutes of Standards and Technology (NIST) (formerly known as the National Bureau of Standards), it is not necessary for the purchaser to assure that NIST has a QA program that meets the applicable requirements of 10 CFR Part 50, Appendix B. However, this letter was silent on the applicability of the NRC position to NMIs in other countries.
In a letter dated April 30, 2015, the NRC clarified its position with regards to the use of domestic and international NMIs as suppliers of primary reference standards and calibration services. The NRC's position is as follows:
Licensees and suppliers of basic components may procure primary reference standards and calibration services from NMI's that are signatories to the CIPM MRA without the need to perform an audit or a commercial-grade survey as the NMIs are organizations with proven abilities and disciplines. However, licensees and suppliers of basic components are still responsible for: (1) ensuring that the appropriate technical requirements are included in the procurement documents, and (2) performing receipt inspections to ensure that the procurement document requirements are met. Furthermore, it is not necessary for licensees and suppliers of basic components to invoke the requirements of Appendix B to 10 CFR Part 50 or 10 CFR Part 21, "Reporting of Defects and Noncompliance," in the procurement documents for primary reference standards and calibration services.
QA Program Reviews
The NRC reviewed and approved QA-related topical reports for potential applicants using the guidance in Standard Review Plan (SRP) 17.5. The bases for staff approval are documented in the following safety evaluation reports:
- X-Energy, Topical Report XEQAPD-NP, "QUALITY ASSURANCE PROGRAM DESCRIPTION," REVISION 3
- Westinghouse Electric Company (WEC), Final Safety Evaluation LTR-NRC-19-15, "NOTIFICATION OF CHANGES TO WESTINGHOUSE QMS"
- GE Hitachi Nuclear Energy Americas LLC (GEH), Final Safety Evaluation amendment to Topical Report (TR) NEDO-11209, "GE Hitachi Nuclear Energy Quality Assurance Program Description," Revision 13
- Sargent & Lundy, LLC (S&L), Final Safety Evaluation Topical Report (TR) SL-TR-1, "Nuclear Quality Assurance Program," Revision 24
- Westinghouse Electric Company, Final Safety Evaluation Topical Report "Quality Management System," Revision 7
- Holtec International, Final Safety Evaluation Topical Report HI-2135649-NP, Revision 3, "Topical Report on Quality Assurance Program for Holtec International's Small Modular Reactor Design Certification"
- Chicago Bridge and Iron (CB&I), U.S. Nuclear Regulatory Commission Approval Letter for Topical Report CMS-720-03-PL-00020, Revision 0, "Quality Assurance Program Description"
- Nuclear Energy Institute, Final Safety Evaluation for Technical Report NEI 11-04, "Quality Assurance Program Description," Revision 0
- NuScale Power, LLC, Final Safety Evaluation Regarding the Review of NuScale Topical Report NP-TR-1010-859-NP, Revision 1, "Quality Assurance Program Description for Design Certification of the NuScale Power Reactor"
- Westinghouse Electric Company Quality Management System, Revision 6
- General Electric Hitachi (GEH) Nuclear Energy Americas Topical Report NEDO-11209, Revision 9, "GE Hitachi Nuclear Energy Quality Assurance Program Description"
- Babcock & Wilcox Nuclear Energy (B&W NE) INC., Topical Report 08-00000320-000, Revision 2, "Quality Assurance Program for the Design Certification of the B&W NE mPower Reactor"
- Shaw Nuclear Services, INC., Quality Assurance Topical Report (QATR), SWSQAP1-74A, Revision B
- Nuclear Energy Institute, NEI 06-14, Revision 9, "Quality Assurance Program Description"
- Nuclear Energy Institute, NEI 06-14, Revision 7, "Quality Assurance Program Description"
- Mitsubishi Heavy Industries Topical Report PQD-HD-19005, Revision 1, "Quality Assurance Program (QAP) Description for Design Certification of the US-APWR"
- Bechtel Nuclear Topical Report (TR), BQ-TOP-1, 2007 Edition, Revision 1, "Quality Assurance Program For Nuclear Power Plants"
- Areva NP, Inc., "QA Program Description for Design Certification of the U.S. EPR"
- Nuclear Energy Institute, NEI 06-14, Revision 4, "QA Program Description Template for ESP and COL Licensing Activities"
- UniStar Nuclear, "QA Program Description for Early Site Permit (ESP), Combined License (COL), Construction, Pre-Operation, and/or Operation Activities" (corrected pages associated with the UniStar submittal)
Page Last Reviewed/Updated Wednesday, March 24, 2021