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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 4

Regulatory Guide 1.28, Revision 4, establishes the acceptance of Part I and Part II requirements included in NQA-1-2008 and the NQA-1a-2009 Addenda, "Quality Assurance Requirements for Nuclear Facility Applications," for the implementation of a QA program during design and construction phases of nuclear power plants and fuel reprocessing plants. The NRC has determined that NQA-1-2008 and the NQA-1a-2009 Addenda provide an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50, subject to the additions and modifications of NQA-1-2008 and the NQA-1a-2009 Addenda identified in RG 1.28, Revision 4

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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:

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Laboratory Calibration and Testing Services

By a letter dated August 28, 2014, the Nuclear Energy Institute (NEI) submitted Revision 1 of NEI 14-05, "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 endorsement. 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.

NRC's endorsement of NEI 14-05, Revision 1, expands the NRC's acceptance of the ILAC accreditation process first documented in a safety evaluation on an Arizona Public Service request. NRC's earlier acceptance was limited to laboratory calibration services accredited by specific U.S. ABs. Although the NRC has endorsed NEI 14-05, Revision 1, licensees and suppliers of basic components use of the ILAC accreditation process in lieu of performing a commercial-grade survey represents a reduction in commitment to the previously accepted QA program. As such, once the NRC approves the QA program change for a licensee in accordance with 10 CFR 50.54(a)(4), other licensees may adopt the QA alternative of using the ILAC accreditation process in lieu of performing a commercial-grade survey provided that the bases of the NRC approval are applicable to the licensee's facility pursuant to the requirements of 10 CFR 50.54(a)(3)(ii). Currently, no licensee has submitted a license amendment.

Once the NRC approves the QA program change for a licensee, other licensees may use 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. Suppliers of basic components may begin to use the ILAC accreditation process and do not have to wait for the NRC to approve the QA program change for a licensee. 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 14-05, Revision 1, safety evaluation are met.

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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.

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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:

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Page Last Reviewed/Updated Thursday, May 21, 2015