Regulatory Guide 1.28: Difference between revisions

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{{Adams
{{Adams
| number = ML003739981
| number = ML17207A293
| issue date = 08/31/1985
| issue date = 10/31/2017
| title = Quality Assurance Program Requirements (Design and Construction) (Task Rs 002-5)
| title = Quality Assurance Program Criteria (Design and Construction)
| author name =  
| author name = Ferguson A
| author affiliation = NRC/RES
| author affiliation = NRC/NRO/DCIP/QVIB3
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person =  
| contact person = Burton S C
| document report number = RG-1.028, Rev 3, RS 00-5
| case reference number = DG-1326
| document report number = RG-1.028, Rev 5
| package number = ML17207A277
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 15
| page count = 14
}}
}}
{{#Wiki_filter:Revision 3* August 1985 U.S. NUCLEAR REGULATORY  
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION
COMMISSION
REGULATORY GUIDE RG 1.28, REVISION 5 Issue Date: Octobe r2017Technical Lead: A. Ferguson Written suggestions regarding this guide or development of new guides may be submitted through the NRC's public Web site in the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/, under Document Collections, in Regulatory Guides, at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html ,  Electronic copies of this RG, previous versions of this guide, and other recently issued guides are also available through the NRC's public Web site in the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/, under Document Collections, in Regulatory Guides. This RG is also available through the NRC's Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under ADAMS Accession Number (No.) ML17207A293. The regulatory analysis may be found in ADAMS under Accession No. ML16180A263. The associated draft guide DG-1326 may be found in ADAMS under Accession No. ML16180A264, and the staff responses to the public comments on DG-1326 may be found under ADAMS Accession No. ML17207A289.
REGULATORY  
 
GUIDE d~ r OFFICE OF NUCLEAR REGULATORY
QUALITY ASSURANCE PROGRAM
RESEARCH REGULATORY
CRITERIA (DESIGN AND CONSTRUCTION)
GUIDE 1.28 QUALITY ASSURANCE  
PROGRAM REQUIREMENTS (DESIGN AND CONSTRUCTION) (Task RS 002-5)


==A. INTRODUCTION==
==A. INTRODUCTION==
Nuclear power plants and fuel reprocessing plants include structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. Appendix B to 10 CFR Part 50 establishes quality assurance requirements for the design, construc tion, and operation of those structures, systems, and components.
Purpose  This regulatory guide (RG) describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for complying with the provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part 50, "Domestic Licensing of Production and Utilization Facilities" (Ref. 1), and 10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants"
(Ref. 2), which refer to 10 CFR Part 50, Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," for establishing and implementing a quality assurance (QA) program for the design and construction of nuclear power plants and fuel reprocessing plants.


The pertinent requirements of Appendix B apply to all activities affecting the safety-related func tions of those structures, systems, and components.
Applicability This RG applies to all applicants for a construction permit and operating license subject to 10 CFR Part 50, Appendix B, and all applicants for a combined operating license, early site permit, design approval, design certificate, and manufacturing license subject to 10 CFR Part 50, Appendix B, through 10 CFR Part 52.


These activities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying.
Applicable Rules


This regulatory guide describes a method acceptable to the NRC staff for complying with the provisions of Appendix B with regard to establishing and implement S, ing the requisite quality assurance program for the design and construction of nuclear power plants. Guid ance for the establishment and execution of quality assurance programs during operation and decommission ing of nuclear power plants have been or will be addressed in separate regulatory guides. Similarly, quality assurance provisions concerning fuel cycle facilities have been or will be addressed in separate regulatory guides.  Any information collection activities mentioned in this regulatory guide that may be subject to the Paperwork Reduction Act of 1980 (44 U S.C. 3501 et seq.) have been reviewed by the Office of Management and Budget and were included in OMB Approval No. 3150-0011.
* 10 CFR Part 50 establishes QA program requirements for the design and construction of nuclear power plants.


The Advisory Committee on Reactor Safeguards has been consulted concerning this guide and has concurred in the regulatory position.
o Appendix A, General Design Criterion 1 (GDC 1), "Quality Standards and Records," to 10 CFR Part 50 requires that a QA program be established and implemented.


*The substantial number of changes in this revision has made it impractical to indicate the changes with lines in the margins.
o 10 CFR 50.34(a)(7) requires a description of the QA program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility, and a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 Appendix B will be satisfied.


==B. DISCUSSION==
RG 1.28, Page 2  
Regulatory Guide 1.28 (Safety Guide 28) was issued in June 1972 and endorsed the general requirements and guidelines for establishing and executing a quality assurance program during the design and construction phases of nuclear power plants provided in ANSI N45.2 1971,1 "Quality Assurance Program Requirements for Nuclear Power Plants." This standard had been devel oped by Subcommittee N45-2.7 (formerly N45-3.7) of the American National Standards Committee N45, Reac tor Plants and Their Maintenance, and provided general requirements for establishing and executing a quality assurance program during the design, construction, and operation of nuclear power plants. ANSI N45.2-1971 was later revised to update its requirements and to expand its applicability to other nuclear facilities that were subject to Appendix B to 10 CFR Part 50. That revised standard was subsequently approved and designated ANSI/ASME
N45.2-1977,' "Quality Assur ance Program Requirements for Nuclear Facilities," by the American National Standards Institute (ANSI) on April 7, 1977. Revision 1 to Regulatory Guide 1.28 was issued for public comment in March 1978. With supple mental provisions, it proposed endorsement of the quality assurance program requirements in ANSI/ASME
N45.2-1977 for the design and construction phases of nuclear power plants. In February 1979, the NRC issued Revision 2 to Regulatory Guide 1.28, which, with supplemental provisions, also endorsed the quality assurance program requirements of ANSI/ASME
N45.2 1977 for the design and construction phases of nuclear power plants.  The American Society of Mechanical Engineers (ASME) Committee on Nuclear Quality Assurance has prepared a new standard that includes requirements and guidance for establishing and executing quality assurance lCopies may be obtained from the American Society of Mechani cal Engineers, 345 East 47th Street, New York, New York 1001


===7. USNRC REGULATORY ===
* 10 CFR Part 52 references 10 CFR Part 50, Appendix B, for QA programs associated with Part 52 licensees.
GUIDES Regulatory Guides are issued to describe and make available to the public methods acceptable to the NRC staff of implementing specific parts of the Commission's regulations, to delineate tech niques used by the staff In evaluating specific problems or postu lated accidents, or to provide guidance to applicants.


Regulatory Guides are not substitutes for regulations, and compliance with them is not required.
o 10 CFR 52.17(a)(1)(xi) requires an early site permit applicant to include a description of the QA program applied to site-related activities for the future design, fabrication, construction, and testing of the SSCs of a facility or facilities that may be constructed on the site that satisfies applicable portions of Appendix B to 10 CFR Part 50, as well as a discussion of how the applicable requirements of Appendix B to Part 50 will be satisfied.


Methods and solutions different from those set S-out in the guides will be acceptable if they provide a basis for the findings requisite to the issuance or continuance of a permit or license by the Commission.
o 10 CFR 52.47(a)(19) requires a standard design certification applicant to include a description of the QA applied to the SSCs of the facility that satisfies applicable portions of Appendix B to 10 CFR Part 50, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 were satisfied.


This guide was Issued after consideration of comments received from the public. Comments and suggestions for improvements in these guides are encouraged at all times, and guides will be revised, as appropriate, to accommodate comments and to reflect new Informa tion or experience.
o 10 CFR 52.79(a)(25) requires a combined license applicant to include description of the QA program, applied to the design, and to be applied to the fabrication, construction, and testing, of the SSCs of the facility, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 have been and will be satisfied, and how the quality assurance program will be implemented.


Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:
o 10 CFR 52.137(a)(19) requires a standard design approval applicant to include a description of the QA program applied to the design of the SSCs of the facility, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 were satisfied.
Docketing and Service Branch.  The guides are issued In the following ten broad divisions:
1. Power Reactors 6. Products 2. Research and Test Reactors


===7. Transportation ===
o 10 CFR 52.157(f)(17) requires a manufacturing license applicant to include a description of the QA program applied to the design, and to be applied to the manufacture of, the SSCs of the reactor, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 have been and will be satisfied.
3. Fuels and Materials Facilities
8. Occupational Health 4. Environmental and Siting 9. Antitrust and Financial Review 5. Materials and Plant Protection
10. General Copies of issued guides may be purchased at the current Government Printing Office price. A subscription service for future guides in spe cific divisions is available through the Government Printing Office.  Information on the subscription service and current GPO prices may be obtained by writing the Superintendent of Documents, U.S.  Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082.


programs for the design, construction, operation, and decommissioning of nuclear facilities.
Related Guidance


This standard is based on the contents of ANSI N46.2-1978, ANSI/ ASME N45.2-1977, and the following standards in the ANSI N45.2 series: 1 N45.2.6 "Qualification of Inspection, Examina tion, and Testing Personnel for Nuclear Power Plants" N45.2.9 "Requirements for Collection, Storage and Maintenance of Quality Assurance Records for Nuclear Power Plants" N45.2.10 "Quality Assurance Terms and Defini tions" N45.2.11 "Quality Assurance Requirements for the Design of Nuclear Power Plants" N45.2.12 "Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants" N45.2.13 "Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants" N45.2.23 "Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants" The standard that evolved was approved and desig nated ANSI/ASME
* NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants" (Ref. 3), Section 17.5, "Quality Assurance Program Description- Design Certification, Early Site Permit and New License Applicants," provides guidance to the NRC staff in reviewing QA program descriptions submitted by applicants for a design certification, combined license, early site permit, construction permit, and operating license.
NQA-l-1979,1 "Quality Assurance Program Requirements for Nuclear Power Plants," by ANSI on July 24, 1979. Three addenda to ANSI/ASME
NQA-l-1979 were developed by the American Society of Mechanical Engineers.


These addenda, contained in ANSI/ASME
* RG 1.33, "Quality Assurance Program Requirements (Operation)" (Ref. 4), addresses additional guidance for the establishment and execution of QA programs for nuclear power plants during the operations phase.
NQA-la-1981, NQA-lb-1981, and NQA-Ic 1982, were issued by ANSI on April 30, 1981, January 31, 1982, and December 31, 1982, respectively, follow ing approval by the Main Committee of the ASME Committee on Nuclear Quality Assurance.


On July 1, 1983, ANSI/ASME
Purpose of Regulatory Guides The NRC issues RGs to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. Regulatory guides are not substitutes for regulations and compliance with them is not required. Methods and solutions that differ from those set forth in RGs will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.
NQA-1-1983 was issued. It incorpor ated ANSI/ASME
NQA-l-1979 and the NQA-la-1981, NQA-lb-1981, and NQA-Ic-1982 Addenda into the 1983 edition without changing any of the previous requirements, supplements, or appendices described in ANSI/ASME
NQA-1-1979 and addenda. On December 31, 1983, after approval by the Main Committee of the ASME Committee on Nuclear Quality Assurance, the ANSI/ASME
NQA-la-1983 Addenda were issued. They clarified previous sections of ANSI/ASME
NQA-1-1983.


The standard notes that addenda will be published up to the publication date of the next edition of the standard.
RG 1.28, Page 3 Paperwork Reduction Act This RG provides guidance for implementing the mandatory information collections in 10 CFR Parts 50 and 52 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. seq.). These information collections were approved by the Office of Management and Budget (OMB), under control numbers 3150-0011 and 3150-0151. Send comments regarding this information collection to the Information Services Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information and Regulatory Affairs,NEOB-10202, (3150-0011, 3150-0151) Office of Management and Budget, Washington, DC 20503.


The NRC staff will evaluate addenda and subsequent editions of NQA-1 after their issuance to determine whether a revision to this guide would be appropriate.
Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.


ANSI/ASME
RG 1.28, Page 4
NQA-1-1983 has been organized into three main sections:
(1) Basic Requirements, (2) Supple-ments, and (3) Appendices.


The Basic Requirements section sets forth basic requirements for establishing and executing quality assurance programs.
==B. DISCUSSION==
 
Reason for Revision This revision of the guide (Revision 5) updates the guidance to endorse, with clarification or exceptions, multiple revisions of the American Society of Mechanical Engineers (ASME) standard NQA-1, "Quality Assurance Requirements for Nuclear Facility Applications."
The Supplements section amplifies the individual requirements of the Basic Requirements section. The Appendices section provides nonmandatory guidance for meeting the Basic Requirements and Supplements sections.
Background This revision of RG 1.28 endorses, with certain clarifications and regulatory positions, various versions of the ASME NQA-1 standard; the standards included are the NQA-1b-2011 Addenda to ASME NQA-1-2008 (Ref. 5), NQA-1-2012 (Ref. 6), and NQA-1-2015 (Ref. 7). The previous version of RG 1.28 (Revision 4) (Ref. 8), approved the use of NQA-1-2008 (Ref. 9), and the NQA-1a-2009 Addenda (Ref. 10), with certain clarifications and regulatory positions. The staff 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 QA. The NRC issued RG 1.28, Revision 4, in June 2010. The guide extended the scope of the NRC's approval of NQA-1 to include Part II, which contains amplifying QA requirements for certain specific work activities that occur at various stages of a facility's life. The work activities include, but are not limited to, management, planning, site investigation, design, computer software development commercial-grade dedication, procurement, fabrication, installation, inspection, and testing. Part II of NQA-1 versions NQA-1-2012 and NQA-1-2015 include Subpart 2.22, "Quality Assurance Requirements for Management Assessment and Quality Improvement for Compliance with 10 CFR 830 and Department of Energy (DOE) Order 414.1 for DOE Nuclear Facilities." Subpart 2.22 of NQA-1-2015 contains guidance for complying with 10 CFR 830 and DOE Order 414.1 for DOE Nuclear Facilities.
 
The intent of ANSI/ASME  
NQA-l-1983 was to consolidate the quality assurance programmatic standards to reduce redundancy without changing the overall intent of the standard.
 
This Revision 3 to Regulatory Guide 1.28 was developed to endorse ANSI/ASME  
NQA-l-1983.
 
In its development, the NRC staff intended it to be equivalent to the methods described in Regula tory Guides 1.28 (Rev. 2), 1.58 (Rev. 1), 1.64 (Rev. 2), 1.74, 1.88 (Rev. 2), 1.123 (Rev. 1), 1.144 (Rev. 1), and 1.146. To accomplish this equivalency, parts of the "nonmandatory guidance" in ANSI/ASME  
NQA-1-1983 that were previously requirements in the ANSI/ASME
N45.2 series were included as regulatory positions in Proposed Revision 3 to Regulatory Guide 1.28, which was issued in March 1981 for public comment. Also, several of the previous regulatory positions endorsing the ANSI/ASME
N45.2-series standards were included as regulatory positions in Proposed Revision 3 to Regula tory Guide 1.28.  Based on public comments and further NRC staff review, the regulatory positions have been reassessed to determine their value and impact on nuclear power plant safety. In this reassessment, the advantage of minimizing the number of exceptions taken to a national standard was considered.
 
Consequently, a number of regulatory positions that were intended as clarifications to provi sions of the standard were reconsidered and deleted from the regulatory position.
 
The guide now retains positions in only those areas in which the staff believes additional guidance is necessary.
 
Retaining these positions also attempts to avoid building in more differences among facilities than already exist. The safety advantage of these positions will be to encourage greater stan dardization of quality assurance practices.


Although the standard contains general provisions covering the subjects addressed in the regulatory positions, it does not pro vide detailed guidance for implementing its general requirements.
Facilities subject 10 CFR 830 and Department of Energy (DOE) Order 414.1are not within the regulatory jurisdiction of the NRC. Thus, the NRC's approval for use of NQA-1-2015, as set forth in this regulatory guide, excludes Subpart 2.22 and this Subpart is not appl icable to NRC-regulated facilities.


Without these positions, detailed case-by case reviews will be necessary in the licensing review process, and the likelihood of unnecessary differences between facilities is increased.
In addition, Revision 4 of RG 1.28 introduced the use of electronic media as a way to satisfy the requirements for the maintenance of QA records. The guide discussed Generic Letter No. 88-18, "Plant Record Storage on Optical Disk," dated October 20, 1988 (Ref. 11), which was issued to inform licensees of the NRC approval of the use of optical disk document imaging systems for the storage and retrieval of quality assurance records and documented the appropriate quality controls for the use of optical disks. Revision 4 also discussed Regulatory Issue Summary (RIS) 2000-18, "Guidance on Managing Quality Assurance Records in Electronic Media," dated October 23, 2000 (Ref. 12). Attachment 1 to RIS 2000-18 lists guidance documents on establishing an electronic recordkeeping system to maintain the integrity, authenticity, and acceptability of QA records during their required retention period in accordance with the requirements of Appendix B to 10 CFR Part 50 and other regulations for the storage of QA records in electronic media. The guidance documents listed in RIS 2000-18 also describe methods that the licensee or applicant can use to authenticate electronic records; to prevent their alteration or falsification; to protect them from, or to recover them following a disaster; and to manage their software configuration. The staff determined that more current guidance is available, as discussed in Section C of this RG.


Although ANSI/ASME
Harmonization with International Standards The NRC staff reviewed guidance from the International Atomic Energy Agency (IAEA) and did not identify any standards that provided useful guidance to NRC staff, applicants, or licensees.
NQA-1-1983 provides require ments and guidance for the establishment and execution of quality assurance programs during the design, con struction, operation, and decommissioning of nuclear facilities, this Revision 3 to Regulatory Guide 1.28, with supplemental provisions, addresses only those portions of ANSI/ASME
NQA-l-1983 applicable to the design and construction phases of nuclear power plants. Updated guidance for complying with the Commission's regula tions with regard to quality assurance program require ments for the operations phase of nuclear power plants 1.28-2 will be provided in Regulatory Guide 1.33, Revision 3, "Quality Assurance Program Requirements (Operation)," which is presently undergoing NRC staff review and is .expected to endorse, with supplemental provisions, ANSI/ ANS-3.2-1982, 2  "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants." Regulatory Guide 1.8, "Personnel Selection and Training," provides guidance on personnel selection and training, including the qualifications of certain operators, technicians, and maintenance personnel who may perform inspections and tests during preoperational, startup, and operational testing. The requirements of Supplement
2S-1 and recommendations of Appendix 2A-1 in NQA-l also provide guidance on personnel qualifications.


Personnel performing inspection and testing that are' qualified to the guidance contained in Regulatory Guide 1.83 need not be qualified in accordance with the requirements of NQA-1. It is not the intent that such personnel be qualified in accordance with both Regu latory Guide 1.8 and NQA-1.  In the development of Regulatory Position 2, "Quality Assurance Records," Section 3 of Appendix 17A-1 was used in the preparation of Table 1 in accordance with the requirements for records classification defined in paragraph
RG 1.28, Page 5 Documents Discussed in Staff Regulatory Guidance This regulatory guide endorses, in part, the use of one or more codes or standards developed by external organizations, and other third party guidance documents. These codes, standards and third party guidance documents may contain references to other codes, standards or third party guidance documents ("secondary references"). If a secondary reference has itself been incorporated by reference into NRC regulations as a requirement, then licensees and applicants must comply with that standard as set forth in the regulation. If the secondary reference has been endorsed in a regulatory guide as an acceptable approach for meeting an NRC requirement, then the standard constitutes a method acceptable to the NRC staff for meeting that regulatory requirement as described in the specific regulatory guide. If the secondary reference has neither been incorporated by reference into NRC regulations nor endorsed in a regulatory guide, then the secondary reference is neither a legally-binding requirement nor a "generic" NRC approved acceptable approach for meeting an NRC requirement. However, licensees and applicants may consider and use the information in the secondary reference, if appropriately justified, consistent with current regulatory practice, and consistent with applicable NRC requirements.
2.7 of Supplement
17S-I. Although Table 1 provides a list of nonpermanent and lifetime records and their respective retention times, the emphasis should be placed on the quality of the product rather than the records generated.


If an applicant or licensee indicates to the NRC that it will conform to 'the recommendations of this regulatory guide and it does not qualify its willingness to conform, it has agreed to comply with the require ments of ANSI/ASME
RG 1.28, Page 6
NQA-l-1983 and the ANSI/ASME
NQA-la-1983 Addenda, as supplemented or modified by the regulatory positions in this guide. An applicant or licensee that has committed itself to the recommendations of this regulatory guide is respon sible for ensuring that the requirements of ANSI/ASME
NQA-l-1983 and the ANSI/ASME
NQA-la-1983 Addenda, as supplemented or modified by the regulatory positions of this guide, are met by its suppliers to the extent necessary.


C. REGULATORY  
==C. REGULATORY POSITION==
POSITION The basic and supplementary requirements that are included in ANSI/ASME
The Part I and Part II requirements included in the NQA-1b-2011 Addenda to ASME  
NQA-l-1983 and the ANSI/ ASME NQA-la-1983 Addenda for the establishment and 2 Copies may be obtained from the American Nuclear Society, 555 North Kensington Avenue, La Grange Park, Illinois 60525.  ' 3In response to Section 306 of Public Law 97-425, the lessons learned from the Three Mile Island accident, public comments, and additional staff review, a third Proposed Revision 2 to Regu latory Guide 1.8 entitled "Qualification and Training of Personnel for Nuclear Power Plants" was issued for public comment in January 1985 with the identification number Task OL 403-5.execution of quality assurance programs during the design and construction phases of nuclear power plants are acceptable to the NRC staff and provide an adequate basis for complying with the pertinent quality assurance requirements of Appendix B to 10 CFR Part 50, subject to the additions and modifications to ANSI/ASME
NQA-1-2008, NQA-1-2012, and NQA-1-2015, "Quality Assurance Requirements for Nuclear Facility Applications," for the implementation of a QA program during the design and construction phases of nuclear power plants and fuel reprocessing plants are endorsed by the NRC staff, and provide an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50, subject to the exceptions and clarifications of NQA-1b-2011, NQA-1-2012, and NQA-1-2015 identified below.
NQA-l-1983 and the ANSI/ASME
NQA-la-1983 Addenda identified below.


===1. QUALIFICATION ===
1. QA Program (NQA-1 Requirement 2)  
OF INSPECTION
AND TEST PERSONNEL
Appendix 2A-1, "Nonmandatory Guidance on the Qualifications of Inspection and Test Personnel," pro vides guidance on the qualifications of inspection and test personnel The provisions of Appendix 2A-1 (or acceptable alternatives)  
should be met as part of Supple ment 2S-1, "Supplementary Requirements for the Quali fication of Inspection and Test PersonneL"


===2. QUALITY ASSURANCE ===
====a. Audit Participation ====
RECORDS Section 2.8, "Retention of Records," of Supplement
(1) Prospective lead auditors, with comparable industry experience, may satisfy the lead auditor qualification requirement of participating in a minimum of five QA audits within a period of 3 years prior to the date of qualification by alternatively demonstrating the ability to properly implement the audit process, effectively organize and report results, and participate in at least one nuclear audit within the year preceding the date of qualification, subject to review and acceptance by the responsible QA
17S-1, "Supplementary Requirements for Quality Assur ance Records," states that the retention period for nonpermanent records is required to be established in writing. Programmatic nonpermanent records 4 should be retained for at least 3 years and product nonperma nent records 5 should be retained for at least 10 years or -the life of the item if less than 10 years. For programmatic nonpermanent records, the retention period should. be considered to begin upon completion of the activity.
organization.


For product nonpermanent records generated before commercial operation begins, the retention period should be considered to begin upon completion of delivery.
2. Control of Purchased Items and Services (NQA-1 Requirement 7)
a. Laboratory Calibration and Testing Services
(1) The NRC finds that Nuclear Energy Institute (NEI) 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1 (Ref. 13), provides an acceptable approach for licensees and suppliers subject to the QA requirements of Appendix B to 10 CFR Part 50 for using laboratory accreditation by Accreditation Bodies that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) in lieu of performing commercial-grade surveys as part of the commercial-grade dedication process for procurement of calibration and testing services performed by domestic and international laboratories accredited by signatories to the ILAC MRA.


In addition, product and programmatic nonpermanent records should be retained at least until the date of issuance of the full-power operating license of the unit. Table 1 provides a list of nonpermanent and lifetime records and their respective retention times, Although Table 1 is intended to be a comprehensive list, it is the responsibility of the owner to assure itself, in accordance with Criterion
3. QA Records (NQA-1 Requirement 17)
17 of Appendix B to 10 CFR Part 50, that sufficient records are maintained to furnish evidence of activities affecting quality. It should be recognized that the nomenclature of these records may vary. For records not listed in Table 1, the type most nearly describing the record in question should be followed with respect to its reten tion period.  4 Programmatic nonpermanent records are those documents that were used to prescribe activities affecting quality but that are not considered permanent records. Such records include docu ments prescribing the planning, execution, and auditing of activities affecting quality. Records such as audit checklists, audit results, and actual examinations used to qualify inspection and test personnel are included in this category.
a. Lifetime and Nonpermanent Records
(1) Paragraph 400, "Classification," of Requirement 17, "Quality Assurance Records," provides guidance on the retention of "lifetime" and "nonpermanent" records. Paragraph 401, "Lifetime Records," discusses the scope and responsibilities related to these records. The owner or an authorized agent must maintain lifetime records for the life of the particular item while it is installed in the plant or stored for future use.


5 ,Product nonpermanent records document that specific struc tures, systems, and components of a nuclear power plant have been designed and constructed in accordance with applicable require ments but are such that it is not necessary to retain them as lifetime records. These records include design verification data, receiving records, calibration records, maintenance records, inspection records, radiographs not associated with inservice inspection, and test records that are not otherwise designated as lifetime records.1.28-3
RG 1.28, Page 7
3. AUDITS Section 2, "Scheduling," of Supplement
(2) Paragraph 402, "Nonpermanent Records," identifies nonpermanent records as those records that "-show evidence that an activity was performed in accordance with the applicable requirements-" The owner or an authorized agent does not need to retain these records for the life of the item, because they do not meet the criteria for lifetime records. However, Paragraph 700, "Retention," specifies that document retention periods be documented and records maintained for their retention period.
18S-1, "Supplementary Requirements for Audits," requires audits to be scheduled in a manner that provides coverage and coordination with ongoing quality assur ance program activities.


The following guidelines are considered acceptable for scheduling audits: 3.1 Internal Audits Applicable elements of an organization's quality assurance program should be audited at least once each year or at least once during the life of the activity, whichever is shorter. In determining the scope of the audit, an evaluation of the activity being audited may be useful. The evaluation may include results of previous quality assurance program audits and the results of audits from other sources, including the nature and frequency of identified deficiencies and any significant changes in personnel, organization, or quality assurance program.
NQA-1 Part III, Nonmandatory Subpart 3.1-17.1, "Guidance on Quality Assurance Records," Paragraph 200, "List of Typical Lifetime Records," lists typical lifetime records containing information that meets Requirement 17 of Part I. The list of typical lifetime records in Nonmandatory Subpart 3.1-17.1 should be considered for guidance purposes only. Note that the nomenclature of these records may vary. For records not listed in Subpart 3.1-17.1, the type of record that most nearly describes the record in question should be followed with respect to its retention classification. The applicant or licensee should be cognizant that the list is not considered to be all-inclusive. The applicant or licensee itself is responsible for ensuring, in accordance with Criterion XVII, "Quality Assurance Records," of Appendix B to 10 CFR Part 50, that it maintains sufficient records to furnish evidence of activities affecting quality.


3.2 External Audits After the award of a contract, the applicant or licensee may determine, based on the evaluation con ducted in accordance with Section 5.1 of Appendix 4A-1, that external audits are not necessary for procur ing items that are (1) relatively simple and standard in design, manufacturing, and testing and (2) adaptable to standard or automated inspections or tests of the end product to verify quality characteristics after delivery.
b. Managing Quality Assurance Records in Electronic Media
(1) For the management of electronic records, appropriate controls on quality assurance include the following:
(a) No deletion or modification of records unless authorized pursuant to the record retention rule (b) Redundancy (system backup, dual storage, etc.) is provided (c) Legibility is required of each record (d) Records media are properly maintained (e)  Inspections to ensure no degradation of records (f) Records are acceptably converted into any new system before the old system is taken out of service The Nuclear Information and Records Management Association (NIRMA) technical guides (TGs), as listed below, provide guidance to establish the appropriate quality controls that incorporates the implementation of enterprise content management systems, web-based technologies, and higher capacity LAN/WAN networks. The NRC approves for use the 2011 versions of the NIRMA TGs.


For other procurement actions not covered by the above exceptions, audits should be conducted as described below. 1. The applicant or licensee should either audit its supplier's quality assurance program on a triennial basis or arrange for such audit. In either case, the audit should be implemented in accordance with Supplement
(a) NIRMA TG 11, "Authentication of Records and Media" (Ref. 14);
18S-1 of ANSI/ASME
(b) NIRMA TG 15, "Management of Electronic Records" (Ref. 15);
NQA-l-1983.
(c) NIRMA TG 16, "Software Configuration Management and Quality Assurance" (Ref. 16); and (d) NIRMA TG 21, "Electronic Records Protection and Restoration" (Ref. 17). 
RG 1.28, Page 8
  4. Audits (NQA-1 Requirements 7 & 18)


The triennial period begins when an audit is performed.
====a. Internal Audits ====
(1) Applicable elements of an organization's QA program should be audited at least once each year or at least once during the life of the activity, whichever is shorter. In determining the scope of the audit, an evaluation of the activity being audited may be useful. The evaluation may include results of previous QA program audits and the results of audits from other sources, including the nature and frequency of identified deficiencies and any significant changes in personnel, the organization, or the QA program.


An audit may be performed when the supplier has completed sufficient work to demonstrate that its organization is implement ing a quality assurance program that has the required scope for purchases placed during the triennial period. If a subsequent contract or a contract modification signif icantly enlarges the scope of or changes the methods or controls for activities performed by the same supplier, an audit of the modified requirements should be con ducted, thus starting a new triennial period. If the supplier is implementing the same quality assurance program for other customers that is proposed for use on the auditing party's contract, the pre-award survey may serve as the first triennial audit if conducted in accor dance with the requirements of ANSI/ASME
====b. External Audits ====
NQA-l 1983. Therefore, when such pre-award surveys are employed as the first triennial audits, they should satisfy the same audit elements and criteria as those used on other triennial audits.2. The applicant or licensee should perform or arrange for annual evaluations of suppliers.
(1) After the award of a contract, the applicant or licensee may determine, based on the evaluation conducted in accordance with Regulatory Position 4.b.(4) below, that external audits are not necessary for procuring items (a) that are relatively simple and standard in design, manufacturing, and testing and (b) that are adaptable to standard or automated inspections or tests of the end product to verify quality characteristics after delivery. For other procurement actions not covered by the above exceptions, audits should be conducted as described below.


This evalua tion should be documented and should take into account, where applicable, (1) review of supplier.
(2) The applicant or licensee should either audit its supplier's QA program on a triennial basis or arrange for such an audit. The triennial period begins when an audit is performed. The licensee or applicant may perform an audit when the supplier has completed sufficient work to demonstrate that its organization is implementing a QA program that has the required scope for purchases placed during the triennial period. If a subsequent contract or a contract modification significantly enlarges the scope or changes the methods or controls for activities performed by the same supplier, the licensee or applicant should conduct an audit of the modified requirements, thus starting a new triennial period. If the supplier is implementing the same QA program for other customers as that proposed for use on the auditing party's contract, the preaward survey (initially established as a requirement in ASME NQA-1-2008) may serve as the first triennial audit. Therefore, when a preaward survey is used as the first triennial audit, it should satisfy the same audit elements and criteria as those used on other triennial audits.


furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions; (2) results of previous source verifications, audits, and receiving inspections;
(3) If more than one purchaser buys from a single supplier, a purchaser may either perform or arrange for an audit of the supplier on behalf of itself and other purchasers to reduce the number of external audits of the supplier. The scope of this audit should satisfy the needs of all the purchasers, and all the purchasers for whom the audit was conducted should receive the audit report. Nevertheless, each of the purchasers relying on the results of an audit performed on behalf of several purchasers remains individually responsible for the adequacy of the audit.
(3) operating experience of identical or similar products furnished by the same supplier;
and (4) results of audits from other sources, e.g., customer, ASME, or NRC audits.  3. If more than one purchaser buys from a single supplier, a purchaser may either perform or arrange for an audit of the supplier on behalf of itself and other purchasers to reduce the number of external audits of the supplier.


The scope of this audit should satisfy the needs of all of the purchasers, and the audit report should be distributed to all the purchasers for whom the audit was conducted.
(4) The applicant or licensee should perform or arrange for annual evaluations of suppliers. It should document these evaluations and take the following considerations into account, where applicable:
(a) the review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions;
(b) results of previous source verifications, audits, and receiving inspections; and RG 1.28, Page 9 (c) operating experience of identical or similar products furnished by the same supplier and results of audits from other sources (e.g., Nuclear Procurement Issues Committee audit reports or NRC inspection reports).
Note: the NRC recognizes the ASME Accreditation Program and associ ated certificates of authorization as evidence that the holder of the certificate of authorization has a documented QA program that meets the requirements of Appendix B to 10 CFR Part 50. However, recognition of the ASME Accreditation Program applies only to the programmatic aspects of the QA programs. Applicants and licensees or their subcontractors should ensure that the suppliers are effectively implementing their approved QA programs. For additional information, see Information Notice (IN) 86-21, "Recognition of American Society of Mechanical Engineers Accreditation Program for N
Stamp Holders," dated March 31, 1986 (Ref. 18).  


Nevertheless, each of the purchasers relying on the results of an audit performed on behalf of several purchasers remains individually responsible for the adequacy of the audit.
RG 1.28, Page 10


==D. IMPLEMENTATION==
==D. IMPLEMENTATION==
The methods described in this revision (through endorsement of ANSI/ASME
The purpose of this section is to provide information on how nuclear licensees and applicants
NQA-1-1983 and the ANSI/ASME
1 may use this guide and information regarding the NRC's plans for using this RG. In addition, it describes how the NRC staff complies with 10 CFR 50.109, "Backfitting," and any applicable finality provisions in 10 CFR Part 52.
NQA-la-1983 Addenda) for complying with the provisions -of Appendix B to 10 CFR Part 50 with regard to the establishment and implementation of the requisite quality assurance program are considered to be generally equivalent, from a programmatic standpoint, to the methods described in Revision 2 to Regulatory Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, 1.88, 1.123, 1.144, and 1.146 (through endorsement of ANSI/ASME
N45.2 and seven programmatic ANSI/ ASME N45.2-series standards). 
Applicants and licensees that have committed to ANSI/ASME
N45.2 and the appropriate ANSI N45.2 series standards as addressed in the applicable regula tory guides may continue to follow ANSI/ASME
N45.2 and the appropriate ANSI/ASME
N45.2-series standards instead of ANSI/ASME
NQA-l-1983.
 
Applicants and licensees may commit to follow either the ANSI/ASME
N45.2-series standards or the ANSI/ASME
NQA-l-1983 standard but not a combination of the two.  Because ANSI/ASME
NQA-1-1983 consolidates ANSI/ ASME N45.2 and the seven programmatic ANSI/ASME
N45.2-series standards, these standards have been replaced with ANSI/ASME
NQA-l-1983.
 
Consequently, except in those cases in which an applicant or licensee proposes an acceptable alternative method for complying with specified portions of the Commission's regulations, the method described in this revision will be used in the evaluation of all new (1) construction permit applications, (2) standard design approvals that can be referenced in construction permit applications, and (3) licenses to manufacture.
 
1.28-4
,4-.-ý TABL91-Retention Times for Lifetime and Nonpermanent Records Nonpermanent*
Record Type Lifetime 3 yr 10 yr 1. Design Records Applicable codes and standards used in design X Design drawings X Design calculations and record of checks X Approved design change requests X Design deviations and nonconformances X Design reports X Design verification data X Design specifications and amendments X Safety analysis report X Certified stress reports for code items X System descriptions X System process and instrumentation diagrams X Technical analysis, evaluations, and reports X Master change record X Reliability analysis, evaluation, and reports X Equipment qualification documentation X Design review reports X Design procedures and manuals X Design control procedures X Reports of engineering surveillance of field activitiy X 2. Procurement Records Procurement specification X Purchase order (unpriced)
including amendments X Procurement procedures X Purchaser's pre-award quality assurance survey X Receiving records X Supplier's quality assurance program manual X Source surveillance data plans, audit and surveillance reports X 3. Manufacturing Records Applicable code data reports X As-built drawings and records: X Certificate of compliance X Eddy-current examination final results X Electrical control verification test results X Ferrite test results X Heat treatment records i. X Liquid penetrant examination final results X Location of weld filler material X Magnetic particle examination final results X Major defect repair records X Material properties records X Nonconformance reports X Performance test procedure and results records X Pipe and fitting location report X Pressure test results (hydrostatic or pneumatic)
X Radiograph review records X Ultrasonic examination final results X 1.28-5 TABLE I (Continued)
Record Type Nonpermanento Lipfetime
3 yr 10 yr 3. Manufacturing Records (Continued)
Welding procedures X Radiographs not required by ASME Section X1 X Certificate of inspection and test personnel qualification X Cleaning procedures X Eddy-current examination procedure X Ferrite test procedure X Forming and bending procedure qualifications X Heat treatment procedures X Hot bending procedure X Inspection and test instrumentation and tooling calibration records (after last calibration)
X Liquid penetrant examination procedure X Magnetic particle examination procedure X Packaging, receiving, storage procedures X Product equipment calibration procedure X QA manuals, procedures, and instructions X Radiographic procedures X Ultrasonic examination procedures X Welding materials control procedures X Welding procedure qualifications and data reports X Work processing and sequencing documents X Product equipment calibration records (after last calibration)
X 4. Installation Construction Records 4.1 Receiving and Storage Nonconformance reports X Inspection reports for stored items X Receipt inspection reports on items X Receiving, storage, and inspection procedures X Storage inventory and issuance records X Vendor quality assurance releases X 4.2 Civil Checkoff sheets for tendon installation X Concrete cylinder test reports and charts X Concrete design mix reports X Concrete placement records X Inspection reports for channel pressure tests X Material property reports on containment liner and accessories X Material property reports on metal containment shell and accessories X Material property reports on reinforcing steel X Material property reports on reinforcing steel splice sleeve material X Material property reports on steel embedments in concrete X Material property reports on structural steel and bolting X Material property reports on tendon fabrication material X Pile drive log X Pile loading test reports X Procedure for containment vessel pressure proof test and leak-rate tests and results X 1.28-6 TABLE i (Continued)
Nonpermanent*
Record Type Lifetime 3 yr 10 yr 4.2 Civil (Continued)
Reports for periodic tendon inspection X Reports of high-strength bolt torque testing X Soil compaction test reports X Aggregate test reports X Batch plant operation reports X Cement grab sample reports X Material property reports on steel piling X Mix water chemical analysis X Releases to place concrete X Slump test results X User's tensile test reports on reinforcing steel X User's tensile test reports on reinforcing steel splices X 4.3 Welding Ferrite test results X Heat treatment records X Liquid penetrant test final results X Material property records X Magnetic particle test final results X Major weld repair procedure and results X Radiograph review records and final results X Ultrasonic test final results X Weld location diagrams X Weld procedures X Welding filler metal material reports X Ferrite test procedures X Heat treatment procedures X Liquid penetrant test procedures X Magnetic particle test procedures X Radiographic test procedures X Ultrasonic test procedures X Welding materials control procedures X Welding personnel qualifications X Weld fitup reports X Weld procedure qualifications and results X 4.4 Mechanical Cleaning procedures and results X Installed lifting and handling equipment procedures, inspection, and test data X Lubrication procedures X Material properties records X Pipe and fitting location reports X Pipe hanger and restraint data X Safety valve response test procedures X Code data reports X Pressure test results (hydrostatic or pneumatic)
X Chemical composition user's test (grab samples) for thermal insulation X Chemical tests of water used for mixing insulation cement X Data sheets or logs on equipment installation, inspection, and alignment X 1.28-7 TABLE 1 (Continued)
Record Type Nonpermanent*
Lifetime 3 yr 10 yr 4.4 Mechanical (Continued)
Documentation of system checkoffs (logs or data sheets) X Material property test reports for thermal insulation X Safety valve response test results X Cleaning procedures X Construction lifting and handling equipment test procedures X Erection procedures for mechanical components X Hydrotest procedures X 4.5 Electrical and Instrumentation and Control Cable pulling tension data X Cable separation data X Cable terminating procedures X Certified cable test reports X Relay test procedures and test results X Voltage breakdown test results on liquid insulation X Cable pulling procedures X Cable separation checklists X Instrument calibration results (after last calibration)
X Documentation of testing performed after installation and prior to conditional acceptance of systems X Field workmanship checklist or equivalent logs X Reports of preinstallation tests X 4.6 General As-built drawings and records X Final inspection reports and releases X Nonconformance reports X Specifications and drawings X Index system to record file X Quality assurance and quality control manuals X Fire protection reports X Security plan procedures and activities X Emergency plan, procedures, and activities X Evaluation of results of reportable safety concerns as required by regulations X Calibration reports for measuring and test equipment and instruments (after last calibration)
X Calibration procedures for measuring and test equipment and instruments X Certificate of inspection and test personnel qualification X Field audit reports X Field quality assurance manuals X Quality assurance system audit reports and related correspondence X Special tool calibration records (after last calibration)
X 5. Preoperational and Startup Test Records Final system adjustment data X Initial plant loading data X Plant load ramp change data X Plant load step change data X 1.28-8 TABLE 1 (Continued)
Nonpermanent*
Record Type Lifetime 3 yr 10 yr .s. Preoperational and Startup Test Records (Continued)
Preoperational test procedures and results X Reactor protection system tests and results X Startup test procedures and results X Inservice inspection reports X Records of reactor tests and experiments X Records and logs of maintenance activities, inspections, repair, and replacement of principal items of structures, systems, and components X Automatic emergency power source transfer procedures and results X Initial heatup, hot functional, and cooldown procedures and results X Initial reactor criticality test procedures and results X Instrument AC system and inverter test procedures and reports X Main and auxiliary power transformer test procedures and results X Offsite power source energizing procedures and test reports X Onsite emergency power source energizing procedure and test reports X Primary and secondary auxiliary power test procedures and results X Startup logs X Station battery and DC power distribution test procedures and reports X Water chemistry report X Records of reviews performed for changes made to procedures or equipment or reviews of tests and experiments X Startup problems and resolutions X Flushing results X Power transmission substation test procedures and results X Surveillance activities, inspections, and calibrations required by the technical specifications records X System lubricating oil flushing procedures X Flushing procedures X Pressure test procedures X Periodic checks, inspections, and calibrations performed to verify that surveillance requirements are being met X Table 1 is to be used in conjunction with Regulatory Position C.2, which states that nonpermanent records should be retained at least until the date of issuance of the full-power operating license of the unit.128-9 REGULATORY
ANALYSIS
 
===1. STATEMENT ===
OF THE PROBLEM Appendix B to 10 CFR Part 50, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reproces sing Plants," sets forth the quality assurance require ments for the design, construction, and operation of those structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public.  Current guidance on controls the NRC staff con siders acceptable for complying with Appendix B to 10 CFR Part 50 concerning programmatic quality assurance requirements during design and construction is provided in a number of regulatory guides that endorse the standard ANSI/ASME
N45.2-1977, "Quality Assurance Program Requirements for Nuclear Facilities," and seven N45.2-series standards that cover specific quality assurance topics. A new standard, ANSI/ASME
NQA-l-1979, approved by the American National Standards Institute on July 24, 1979, con consolidates ANSI/ASME
N45.2-1977 and these seven N45.2-series standards.
 
The intent of ANSI/ASME
NQA-1-1979 was to consolidate the programmatic standards to avoid redundancy without changing their intent. ANSI/ASME
NQA-l-1979 is a second genera tion standard in which industry experience is reflected in changing certain controls and also eliminating certain activities considered to be ineffective in enhancing quality or the overall effectiveness of the program.
 
ANSI/ASME
NQA-1-1979 was developed through I a consensus agreed to by the American National Stan dards Institute.
 
On July 1, 1983, NQA-1-1979 and the NQA-la-1981, NQA-lb-1981, and NQA-Ic-1982 Addenda were incorporated into NQA-l-1983 without changing any of the requirements, supplements, or appendices deicribed in ANSI/ASME
NQA-1-1979.
 
As encouraged by the Office of Management and Budget (OMB) Circular No. A-I19, "Federal Participa tion in the Development and Use of Voluntary Stan dards," which was published as a final rule in the Federal Register November 1, 1982 (47 FR 49496), several NRC representatives participated in the develop ment of ANSI/ASME
NQA-l-1983.
 
Since ANSI/ASME
NQA-1-1983 represents a consolidation of the seven programmatic N45.2-series standards, these standards along with ANSI/ASME
N45.2-1977 will not be revised to incorporate any new positions and will eventually be replaced with ANSI/ASME
NQA-l-1983 and the ANSI/ASME
NQA-la-1983 Addenda. This standard is now published in its final form and the NRC must decide what action to take concerning endorsement of the standard.
 
The consequences of the NRC staff taking no action in the development or endorsement of the standard would result in the NRC staff having to either ignore the NQA-1 effort and continue to rely on Revision 2 of Regulatory Guide 1.28 (which in essence means living with ANSI/ASME
N45.2-1977 and the seven daughter standards)
or develop its own guidance or standard to achieve a consolidated docu ment and minimize redundancy.
 
===2. OBJECTIVES ===
Proposed Revision 3 to Regulatory Guide 1.28 endorsing ANSI/ASME
NQA-1-1983 focuses on the following three objectives:
I. Endorse the consolidation of ANSI/ASME;
N45.2 and the seven ANSI/ASME
N45.2-series standards into one document,'
thus eliminating certain redundancies and certain activities.
 
2. Consolidate the eight applicable NRC regulatory guides endorsing the above ANSI/ASME
standards into one document.
 
3' Reflect current NRC guidance, from a program matic standpoint, concerning quality assurance during design and construction of nuclear power plants and fuel reprocessing facilities.
 
In developing Revision 3 to Regulatory Guide 1.28 (through endorsement of ANSI/ASME
NQA-1-1983), it was the intent that Revision 3 would be equivalent to the methods described by Revision 2 to Regulatory Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, 1.88, 1.123, 1.144, and 1.146 (through endorsement of ANSI/ASME
N45.2 and the programmatic N45.2-series standards).
In order to achieve this equivalence, parts of the "nonmandatory guidance" of ANSI/ASME
NQA-1-1983 that were previously requirements in the ANSI/ASME
N45.2-series standards will be treated the same as requirements of ANSI/ASME
NQA-l-1983, ie., a commitment to follow Regulatory Guide 1.28, Revision 3, without exceptions will be a commitment to follow the requirements of ANSI/ASME
NQA-1 1983 and the endorsed "nonmandatory guidance" of the standard.
 
In addition, some of the regulatory positions related to the ANSI/ASME
N45.2-series standards were retained in order to achieve equivalence and provide consistency in the quality assurance program review process. The guide does indicate that it describes a method acceptable to the NRC staff for complying with the provisions of Appendix B to 10CFR Part 50 with regard to the establishment and implementation of a quality assurance program during design and construction of nuclear power plants. This does represent a change from the guide issued for public comment since the present Regulatory Guide 1.28 (Revision
2) references only Appendix B to 10 CFR Part 50, and the references to Appendix A to 10 CFR Part 50 have been deleted from the proposed Revision 3 to Regulatory Guide 1.28. The NRC staff 1.28-10
is currently examining on a generic basis the subject ol how to implement the quality assurance provisions ol Appendix A to 10 CFR Part 50 for structures, sys. tems, and components important to safety. The subjecl of application of a quality assurance program for itemi important to safety but not safety related is beinj addressed separately by the NRC staff in connection S-with the January 5, 1984, generic letter to all holders of operating licenses, applicants for operating licenses, and holders of construction permits for power reactors concerning the use of the terms "Important to Safety" and "Safety Related."
 
===3. ALTERNATIVES ===
The following alternatives were considered with respect to revising Regulatory Guide 1.28: 3.1 Alternative
1 Remain with the NRC regulatory guides presently endorsing ANSI/ASME
N45.2 and the seven program matic daughter standards.
 
Any new or revised quality assurance regulatory positions considered sufficiently important to ensure protection of the public health and safety could be incorporated through appropriate revisions to the applicable quality assurance regulatory guides.  3.2 Alternative
2 Develop a consolidated version of quality assurance guidance for design and construction in the form of a regulatory guide or NUREG-series document.  3.3 Alternative
3 Review 1.28 to equivalent previously
1.28.NQA-1-1983 and revise Regulatory Guide ensure quality assurance program controls (from a programmatic standpoint)
to those endorsed by Revision 2 to Regulatory Guide 4. CONSEQUENCES, COSTS, AND BENEFITS OF EACH ALTERNATIVE
4.1 Alternative
1 Benefits:
Alternative
1 eliminates the need to devote NRC resources to the review and evaluation of ANSI/ ASME NQA-1-1983 in order to formulate NRC positions commensurate with current quality assurance require ments. Licensees, permit holders, vendors, subvendors, and NRC Headquarters and Regional inspection personnel are presently familiar with the quality assurance regula tory guides that endorse the N45.2-series quality assur ance standards.
 
Also, industry presently has the N45.2-series standards and NRC regulatory guides that endorse these standards in their possession.
 
Industry and NRC would not be required to spend considerable time, effort, or resources to interpret and implement the r regulatory positions endorsing the Basic Requirements, r Supplements, and selected "nonmandatory guidance" of ANSI/ASME
NQA-1-1983.
 
Also, industry already has these guides and standards at their sites and shops, and their quality assurance manuals and implementing Sprocedures have either incorporated or referenced them I in their documents.
 
Consequently, little or no effort I would be required of the industry to update should NRC include new positions to existing regulatory guides.  Consequences:
ASME has initiated action for ANSI to withdraw the N45.2-series standards that have been consolidated into NQA-I; thus the N45.2-series stan dards will be replaced with NQA-l. Also, as stated in OMB Circular No. A-I 19, policy and administrative guidance is provided to Federal agencies on using voluntary standards for procurement and regulatory purposes and participating with private sector organiza tions to develop such standards as NQA-1. Finally, the 1982 Winter Addenda of the ASME Boiler and Pres sure Vessel Code has endorsed ANSI/ASME
NQA-I 1979 in Sections III and XI and it is expected they will ultimately endorse ANSI/ASME
NQA-1-1983.
 
Costs: The format and subject matter of existing standards and regulatory guides are readily under standable and usable by the 79 licensees, 63 permit holders, and their approximately
700 vendors. Because the majority of the industry has committed to the existing N45.2-series standards and regulatory guides, it would not result in any increased burden or costs to the industry to continue using these documents.
 
4.2 Alternative
2 Benefits:
From a regulatory viewpoint, this effort would represent precise methods for guidance on how the Commission's quality assurance provisions relating to the design and construction of nuclear power plants must be implemented.
 
Consequences:
This alternative is contrary to the policy expressed in OMB Circular No. A-119 and has the possibility of bureaucratic delays.  Costs: The development of an initial draft of a consolidated quality assurance standard such as ANSI/ ASME NQA-l-1983 would take the NRC staff about two months. The resolution of both internal NRC staff and public comments would take about one year for a total cost of approximately
$120,000 (2000 hours x $60/hour). 
4.3 Alternative
3 Benefits:
Since current guidance for quality assur ance programs is contained in a series of different standards and corresponding regulatory guides, the proposed action will be of value to the NRC staff owing to the consolidation of a large number of requirements and recommendations concerning quality 1.28-11 assurance into a single document consisting of sections on basic requirements, supplemental requirements, and nonmandatory guidance.
 
The previous eight quality assurance standards and quality assurance regulatory guides that endorsed these standards consisted of approximately
85 pages and the consolidated documents and proposed regulatory guide would consist of approximately
5 pages for "a net reduction of about 80 pages. The previous eight regula tory guides endorsing the standards consolidated into ANSI/ASME
NQA-l-1983 consisted of 46 regulatory positions.
 
The proposed regulatory guide consists of 3 positions for a net reduction of 43 regulatory positions.
 
The proposed action also provides an opportunity to incorporate experience from the use of N45.2 and its daughter standards.
 
Additionally, consolidation of design- and construction-phase quality assurance guid ance should provide a more effective evaluation of compatibility between ANSI quality assurance require ments and the quality assurance requirements in the ASME Boiler and Pressure Vessel Code.  ANSI/ASME
NQA-l-1983 represents a consensus document on requirements for quality assurance programmatic action. In a letter dated March 10, 1980, from Jack E. Vessely, Chairman, ASME Main Committee on Nuclear Quality Assurance to W. J. Dircks, Executive Director for Operations of the NRC, early endorsement by the NRC of ANSI/ASME
NQA-1-1979 was requested since, according to the letter, many companies are anxious to use the standard.
 
However, some members of the industry have indicated reservations regarding the usefulness of this document.


The proposed action establishes an NRC position on an existing national standard and therefore reduces uncertainty as to what the staff considers acceptable in the area of quality assurance requirements for the design and construction of nuclear power plants.  The cumulative benefit of the consolidation effort will be to eliminate redundant controls and to incorporate current NRC quality assurance guidance and practices for design and construction of nuclear power plants. The controls described in the regulatory position of Revision 3 to Regulatory Guide 1.28 and the endorse ment of ANSI/ASME
Use by Nuclear Licensees and Applicants Nuclear licensees and applicants may voluntarily
NQA-l-1983 are considered to be generally equivalent, from.a programmatic standpoint, to the controls described in Revision 2 to Regulatory Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, 1.88, 1.123, 1.144, and 1.146, which endorse N45.2 and its daughter standards.
2 use the guidance in this document to demonstrate compliance with the underlying NRC regulations. Methods or solutions that differ from those described in this RG may be deemed acceptable if they provide sufficient basis and information for the NRC staff to verify that the proposed alternative demonstrates compliance with the appropriate NRC regulations. Current licensees may continue to use guidance the NRC found acceptable for complying with the identified regulations as long as their current licensing basis remains unchanged
.  Licensees may use the information in this RG for actions that do not require NRC review and approval, such as changes to a facility design under 10 CFR 50.59, "Changes, Tests and Experiments." Licensees may use the information in this RG or applicable parts to resolve regulatory or inspection issues.  Use by NRC Staff The NRC staff does not intend or approve any imposition or backfitting of the guidance in this RG. The NRC staff does not expect any existing licensee to use or commit to using the guidance in this RG, unless the licensee makes a change to its licensing basis. The NRC staff does not expect or plan to request licensees to voluntarily adopt this RG to resolve a generic regulatory issue. The NRC staff does not expect or plan to initiate NRC regulatory action that would require the use of this RG. Examples of such unplanned NRC regulatory actions include issuance of an order requiring the use of the regulatory guide, requests for information under 10 CFR 50.54(f) as to whether a licensee intends to commit to use of this regulatory guide, generic communication, or issuance of a rule requiring the use of this regulatory guide without further backfit consideration.


As a result, applicants or licensees may commit either to this regulatory guide or to Revision 2 of Regulatory Guide 1.28 and the current issues of the regulatory guides that endorse the seven daugher standards.
During regulatory discussions on plant-specific operational issues, the staff may discuss with licensees various actions consistent with staff positions in this RG, as one acceptable means of meeting the underlying NRC regulatory requirement. Such discussions would not ordinarily be considered backfitting even if prior versions of this RG are part of the licensing basis of the facility. However, unless this RG is part of the licensing basis for a facility, the staff may not represent to the licensee that the licensee's failure to comply with the positions in this RG constitutes a violation.


However, since ANSI/ASME
If an existing licensee voluntarily seeks a license amendment or change and (1) the NRC staff's consideration of the request involves a regulatory issue directly relevant to this new or revised regulatory                                                           
NQA-l-1983 consolidates ANSI/ASME
1  In this section, "licensees" refers to licensees of nuclear power plants under 10 CFR Parts 50 and 52; and the term
N45.2 and the seven programmatic ANSI/ ASME N45.2-series standards, these standards will be replaced with ANSI/ASME
"applicants" refers to applicants for licenses and permits for (or relating to) nuclear power plants under
NQA-l-1983.
10 CFR Parts 50 and 52, and applicants for standard design approvals and standard design certifications under
10 CFR Part 52. 2 In this section, "voluntary" and "voluntarily" mean that the nuclear licensee or applicant is seeking the action of its own accord, without the force of a legally binding requirement or an NRC representation of further licensing or enforcement action.


Consequently, except in those cases in which an applicant proposes an acceptable alternative method for complying with specified portions of the Commission's regulations, the method described in Revision 3 to Regulatory Guide 1.28 will be used in the evaluation of all new (1) construction permit appli- '-ý cations, (2) standard design approvals that can be refer enced in construction permit applications, and (3) licenses to manufacture.
RG 1.28, Page 11 guide and (2) the specific subject matter of this regulatory guide is an essential consideration in the staff's determination of the acceptability of the licensee's request, then the staff may request that the licensee either follow the guidance in this regulatory guide or provide an equivalent alternative process that demonstrates compliance with the underlying NRC regulatory requirements. This is not considered backfitting as defined in 10 CFR 50.109(a)(1) or a violation of any of the issue finality provisions in 10 CFR Part 52.


Consequences:
If a licensee believes that the NRC is either using this regulatory guide or requesting or requiring the licensee to implement the methods or processes in this regulatory guide in a manner inconsistent with the discussion in this Implementation section, then the licensee may file a backfit appeal with the NRC in accordance with the guidance in NUREG-1409, "Backfitting Guidelines" (Ref. 19), and NRC Management Directive (MD) 8.4, "Management of Facility-specific Backfitting and Information Collection" (Ref. 20).  
Should members of the industry (utilities, architect/engineers, nuclear steam supply system suppliers, or vendors) wish to commit to this regula tory guide, indoctrination and training programs would have to be developed to ensure that the regulatory position of Revision 3 to Regulatory Guide 1.28 and the controls of NQA-l-1983 and how these controls are to be implemented are understood.


Particular atten tion would have to be focused on clarifying the poten tial confusion in interpreting the degree to which the Basic Requirements and Supplements Sections, which are addressed as mandatory, and the nonmandatory guidance in ANSI/ASME
RG 1.28, Page 12 REFERENCES
NQA-l-1983 are to be implemented.
3 1. U.S. Code of Federal Regulations, 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities."
2. U.S. Code of Federal Regulations, 10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants"
3. U.S. Nuclear Regulatory Commission (NRC), NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition," Section 17.5, "Quality Assurance Program Description- Design Certification, Early Site Permit and New License Applicants," Washington, DC, August 2015. (ADAMS Accession No. ML15037A441)
4. NRC, "Quality Assurance Program Requirements (Operation)," Regulatory Guide 1.33, Washington, DC.


Also, present principal contractors and utilities that wish to commit to this guide will have to (1) conduct a detailed comparison of existing quality assurance controls and determine what changes are necessary to comply with the new regulatory guide and NQA-1, which, as a minimum, will involve changes from the regulatory guides that endorse N45.2 and its seven daughter standards to Revision 3 to Regulatory Guide 1.28 and ANSI/ASME  
5. American Society of Mechanical Engineers (ASME), "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1b-2011 Addenda to ASME NQA-1-2008, New York, NY.
NQA-l-1983;
(2) make the neces sary changes to their quality assurance manuals and detailed implementing procedures;
(3) indoctrinate and train the work force on the correct interpretation of the changes and how they are to be implemented;
(4) review their quality assurance programs with the NRC staff to ensure that they are meeting the spirit and intent of the regulatory guide and NQA-1; (5) where necessary, inform contractors, subcontractors, vendors, and subvendors of the changes, including any appropriate indoctrination and training;
and (6) determine the impact on these suppliers relative to additional purchase costs. This may necessitate the utility having to maintain two sets of quality assur ance manuals and two sets of implementing procedures (one set meeting the existing regulatory guides and stan dards and the other set meeting ANSI/ASME
NQA-1 1983). This problem will be compounded because record keeping, audits, and NRC inspections will have to keep in mind which system is being used. Architect/engineers or nuclear steam supply system suppliers working with present contracts to existing regulatory guides and stan dards and ANSI/ASME
NQA-l-1983 would have record keeping and implementation problems similar to the above.  Costs: For new applicants, committing to Revision 3 to Regulatory Guide 1.28 may result in lower costs 1.28-12 than committing to the regulatory guides presently endorsing N45.2 and the seven programmatic daughter standards.


The reason is that some of the quality assurance requirements once considered important have now been made nonmandatory guidance in ANSI/ ASME NQA-l-1983.
6. ASME "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1-2012, New York, NY.


Also, the fact that certain require ments have been reduced or more clearly defined will also result in lower costs to a new applicant, e.g., the amount of radiographs to be retained for lifetime has been reduced. Only radiographs required for inservice inspections are to be maintained for lifetime pursuant to ASME Boiler and Pressure Vessel Code require ments. We regard this practice to be as stringent as or more stringent than the practice for other nondestruc tive examination records. Also, the records facility, which previously had to have a four-hour fire rating, now may have a two-hour fire rating provided certain provisions are met.  Applicants who are presently committed to imple ment the existing NRC quality assurance regulatory guides and ANSI/ASME  
7. ASME, "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1-2015, New York, NY.
standards and who elect to change and use Revision 3 to Regulatory Guide 1.28 and ANSI/ASME
NQA-1-1983 will benefit somewhat from the examples in the above paragraph, but will encounter additional costs to offset such benefits.


The additional costs will be revising the Safety Analysis Report (SAR) (or quality assurance topical report), quality assurance manuals, and implementing proce dures and retraining personnel to accommodate this change. In addition, considerable time, effort, and resources will be expended in maintaining an account ability of outstanding purchase orders, items, and activities already under way as opposed to new activ ities with respect to the appropriate application of the previous commitment and the new commitment to Revision 3 to Regulatory Guide 1.28. The average SAR revision to accommodate ANSI/ASME
8. NRC, "Quality Assurance Program Criteria (Des ign and Construction)," Regulatory Guide 1.28, Revision 4, Washington, DC.
NQA-l 1983 and the revised Regulatory Guide 1.28 would affect about 20 SAR pages and take about 16 staff hours for NRC review and acceptance or approxi mately $960 per plant (16 hours x $60/hour).
It would take about 2 staff months for the average utility to review and revise the quality assurance program and implementing procedures to incorporate the revision for a cost of approximately
$25,600 140 days x 8 hours at $80/hour).
Retraining the plant and corporate staff would cost about $32,000 (400 people x $80/hour). 
Therefore, the total cost for the average plant to change to Regulatory Guide 1.28 and ANSI/ ASME NQA-l-1983 would be about $58,560 ($960 NRC fees, $25,600 procedures review and revision, and $32,000 for retraining plant and corporate staff). The total cost to industry, should they all adopt ANSI/ASME
NQA-1-1983 and Revision 3 to Regulatory Guide 1.28, could be in the range of $30,779,520
(79 licensees, 63 permit holders, and 25 nuclear steam supply system suppliers and architect/engineers
= 167 x $58,560 = $9,779,520
and 700 subcontractors x $30,000 = $21,000,000).
4.4 Conclusions In consideration of the above three alternatives, the NRC staff believes Alternative
3 will be the most viable alternative from which to base future quality assurance guidance upon meeting the Commission's regulations relative to quality assurance.


This conclu sion is primarily based upon offering the industry the choices of (1) committing to the N45.2-series stand ards and appropriate regulatory guides that endorse these standards or (2) committing to comply with Revision 3 to Regulatory Guide 1.28 endorsing ANSI/ ASME NQA-1-1983.
9. ASME, "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1-2008, New York, NY.


In either case, they have the flexibility to develop alternatives meeting the Com mission's quality assurance regulations, regulatory guides, and standards.
4  10. ASME, "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1a-2009 Addenda to ASME NQA-1-2008, New York, NY.


5. IMPACTS ON OTHER REQUIREMENTS
11. NRC, "Plant Record Storage on Optical Disks," GL 88-18, Washington, DC, October 20, 1988.
As discussed earlier in this Regulatory Analysis, the primary rationale for the proposed revision to Regulatory Guide 1.28 was to consolidate the programmatic stan dards without changing their intent, to eliminate certain redundancies and certain activities, and to reflect certain NRC quality assurance controls considered important by the staff to provide consistency in the quality assurance program review process. These new positions do not represent significant changes in regulatory practices.


The staff has evaluated the guidance included in ANSI/ASME
12. NRC, "Guidance on Managing Quality Assurance Records in Electronic Media," RIS 2000-18, Washington, DC, October 23, 2000.
NQA-I-1983 and, coupled with the guidance included in the regulatory position in Revision 3 to Regulatory Guide 1.28, finds this is equivalent to the guidance, from a programmatic standpoint, contained in the N45.2 series of documents and the regulatory guides that endorsed them. The staff also endorses this consolida tion effort as an acceptable method of meeting the requirements of paragraph
50.34(a)(7)
and Appendix B to 10 CFR Part 50. Consequently, any impact on existing NRC requirements should be minimal.


===6. CONSTRAINTS ===
3  Publicly available NRC-published documents are available electronically through the NRC Library on the NRC's public Web site at: http://www.nrc.gov/reading-rm/doc-collections/. The documents can also be viewed online or printed for a fee in the NRC's Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone 301-415-4737 or 800-397-4209; fax 301-415-3548; and e-mail pdr.resource@nrc.gov.
Legal and institutional constraints, including issues related to enforceability, were discussed in Section 3, "Alternatives."


===7. DECISION RATIONALE ===
4  Copies of American Society of Mechanical Engineers (ASME) standards may be purchased from ASME, Three Park Avenue, New York, NY 10016-5990; telephone 800-843-2763. Purchase information is available through the ASME
7.1 NRC Since current guidance for quality assurance programs is contained in a series of different standards and corresponding regulatory guides, the proposed action will be of value to the staff owing to the consolidation of a large number of requirements and recommendations concerning quality assurance into a single document.
Web-based store at http://www.asme.org/Codes/Publications/.  
RG 1.28, Page 13
13. Nuclear Energy Institute (NEI) 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1, Washington DC, August 2014 (ADAMS Accession No. ML14245A392)
14. Nuclear Information and Records Management Association (NIRMA), "Authentication of Records and Media," TG 11-2011, New York, NY.


Additionally, consolidation of design- and construction phase quality assurance guidance should provide a more effective evaluation of compatibility between ANSI quality assurance requirements and the quality assurance 1.28-13 requirements in the ASME Boiler and Pressure Vessel Code. By taking advantage of previous staff effort in conjunction with approval of ANSI/ASME
5  15. NIRMA, "Management of Electronic Records," TG 15-2011, Windham, NH.
NQA-l-1983, the proposed action establishes an NRC position on the recently approved standard with minimum impact on the staff.  .7.2 Industry ANSI/ASME
NQA-1-1983 represents a consensus docu ment on requirements for quality assurance programmatic action agreed to by the American National Standards Institute.


The proposed action establishes an NRC position on an existing national standard and therefore reduces uncertainty as to what the staff considers acceptable in the area of quality assurance requirements for the design and construction of nuclear power plants.  7.3 Public The consolidation of quality assurance criteria could result in more effective reviews of nuclear power plant quality assurance programs.
16. NIRMA, "Software Configuration Management and Quality Assurance," TG 16-2011, Windham, NH.  17. NIRMA, "Electronic Records Protection and Restoration," TG 21-2011, Windham, NH.


The consolidation document could also result in improved quality assurance programs at nuclear power plants and hence increased safety for the public since the standard has eliminated certain activities considered to be ineffective in enhancing the overall quality or effectiveness of the quality assurance program. The financial impact on the public will be a slight increase in the cost of generating power as a result of any procedure modifications necessary to comply with this regulatory guide.
18. NRC, "Recognition of American Society of Mechanical Engineers Accreditation Program for N Stamp Holders," IN 86-21, Washington, DC, March 31, 1986.


===8. IMPLEMENTATION ===
19. NRC NUREG-1409, "Backfitting Guidelines," Washington, DC, July 1990.
8.1 Schedule for Implementing the Proposed Guidance The methods described in Revision 3 to Regulatory Guide 1.28 (through endorsement of ANSI/ASME
NQA-l-1983 and the ANSI/ASME
NQA-la-1983 Addenda) for complying with the provisions of Appen dix B to 10 CFR Part 50 with regard to the estab lishment and implementation of the requisite quality assurance program are considered to be generally equivalent, from a programmatic standpoint, to the methods described by Revision 2 to Regulatory Guide 1.28 and Regulatory Guides 1.58, 1.64, 1.74, 1.88, 1.123, 1.144, and 1.146 (through endorsement of ANSI/ASME
N45.2 and seven programmatic ANSI/ ASME N45.2-series standards). 
Applicants and licensees who have committed to ANSI/ASME
N45.2 and the appropriate ANSI N45.2 series standards as addressed in the applicable regu latory guides may continue to follow ANSI/ASME
N45.2 and the appropriate ANSI/ASME
N45.2-series standards in lieu of ANSI/ASME
NQA-l-1983.


Applicants or licensees may commit to follow the ANSI/ASME
20. NRC, "Management of Facility-Specific Backfitting and Information Collection," MD 8.4, October 9, 2013. (ADAMS Accession No. ML12059A460)
N45.2-series standards or the ANSI/ASME
NQA-1-1983 standard, but not a combination of the two.  Since ANSI/ASME
NQA-1-1983 consolidates ANSI/ ASME N45.2 and the seven programmatic ANSI/ASME
N45.2-series standards, these standards will be replaced with ANSI/ASME
NQA-1-1983.


Consequently, except in those cases in which an applicant proposes an acceptable alternative method for complying with specified portions of the Commission's regulations, the method described in Revision 3 to Regulatory Guide 1.28 will be used in the evaluation of all new (I) construction permit applications, (2) standard design approvals that can be referenced in construction permit applications, and (3) licenses to manufacture.
5  Copies of Nuclear Information & Records Management (NIRMA) technical guides may be purchased from NIRMA, 245 Sunnyridge Avenue #34 Fairfield, CT 06824; telephone
203 388 8795. Purchase information is available through the NIRMA Web based store at https://www.nirma.org/shop.


8.2 Relationship to Other Existing or Proposed Requirements The proposed Revision 3 to Regulatory Guide 1.28 does not represent an increase in regulatory require ments since it allows present applicants and licensees to continue the use of the N45.2-series standards if they had previously committed to those standards.
RG 1.28, Page 14 BIBLIOGRAPHY
1. Final Safety Evaluation for Technical Report NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1, ADAMS Accession No. ML14322A535.


1.28-14 UNITED STATES NUCLEAR REGULATORY
2. Safety Evaluation of the Quality Assurance Topical Report, Amendment 40 for Catawba Nuclear Station, Unit Nos. 1 and 2, McGuire Nuclear Station Unit Nos. 1 and 2, Oconee Nuclear Station, Unit Nos 1, 2 and 3; Docket Nos 50-269, 50-270, and 50-287; Renewed License Numbers DPR-38, DPR-47, and DPR-55, ADAMS Accession No. ML15099A561.}}
COMMISSION
WASHINGTON, D.C. 20555 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300 FIRST CLASS MAIL POSTAGE & FEES PAID .USNRC PERMIT No. G-67}}


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Revision as of 22:30, 15 September 2018

Quality Assurance Program Criteria (Design and Construction)
ML17207A293
Person / Time
Issue date: 10/31/2017
From: Ashley Ferguson
NRC/NRO/DCIP/QVIB3
To:
Burton S C
Shared Package
ML17207A277 List:
References
DG-1326 RG-1.028, Rev 5
Download: ML17207A293 (14)
v • d • e


U.S. NUCLEAR REGULATORY COMMISSION

REGULATORY GUIDE RG 1.28, REVISION 5 Issue Date: Octobe r2017Technical Lead: A. Ferguson Written suggestions regarding this guide or development of new guides may be submitted through the NRC's public Web site in the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/, under Document Collections, in Regulatory Guides, at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html , Electronic copies of this RG, previous versions of this guide, and other recently issued guides are also available through the NRC's public Web site in the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/, under Document Collections, in Regulatory Guides. This RG is also available through the NRC's Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under ADAMS Accession Number (No.) ML17207A293. The regulatory analysis may be found in ADAMS under Accession No. ML16180A263. The associated draft guide DG-1326 may be found in ADAMS under Accession No. ML16180A264, and the staff responses to the public comments on DG-1326 may be found under ADAMS Accession No. ML17207A289.

QUALITY ASSURANCE PROGRAM

CRITERIA (DESIGN AND CONSTRUCTION)

A. INTRODUCTION

Purpose This regulatory guide (RG) describes methods that the staff of the U.S. Nuclear Regulatory Commission (NRC) considers acceptable for complying with the provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part 50, "Domestic Licensing of Production and Utilization Facilities" (Ref. 1), and 10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants"

(Ref. 2), which refer to 10 CFR Part 50, Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," for establishing and implementing a quality assurance (QA) program for the design and construction of nuclear power plants and fuel reprocessing plants.

Applicability This RG applies to all applicants for a construction permit and operating license subject to 10 CFR Part 50, Appendix B, and all applicants for a combined operating license, early site permit, design approval, design certificate, and manufacturing license subject to 10 CFR Part 50, Appendix B, through 10 CFR Part 52.

Applicable Rules

  • 10 CFR Part 50 establishes QA program requirements for the design and construction of nuclear power plants.

o Appendix A, General Design Criterion 1 (GDC 1), "Quality Standards and Records," to 10 CFR Part 50 requires that a QA program be established and implemented.

o 10 CFR 50.34(a)(7) requires a description of the QA program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility, and a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 Appendix B will be satisfied.

RG 1.28, Page 2

o 10 CFR 52.17(a)(1)(xi) requires an early site permit applicant to include a description of the QA program applied to site-related activities for the future design, fabrication, construction, and testing of the SSCs of a facility or facilities that may be constructed on the site that satisfies applicable portions of Appendix B to 10 CFR Part 50, as well as a discussion of how the applicable requirements of Appendix B to Part 50 will be satisfied.

o 10 CFR 52.47(a)(19) requires a standard design certification applicant to include a description of the QA applied to the SSCs of the facility that satisfies applicable portions of Appendix B to 10 CFR Part 50, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 were satisfied.

o 10 CFR 52.79(a)(25) requires a combined license applicant to include description of the QA program, applied to the design, and to be applied to the fabrication, construction, and testing, of the SSCs of the facility, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 have been and will be satisfied, and how the quality assurance program will be implemented.

o 10 CFR 52.137(a)(19) requires a standard design approval applicant to include a description of the QA program applied to the design of the SSCs of the facility, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 were satisfied.

o 10 CFR 52.157(f)(17) requires a manufacturing license applicant to include a description of the QA program applied to the design, and to be applied to the manufacture of, the SSCs of the reactor, as well as a discussion of how the applicable requirements of Appendix B to 10 CFR Part 50 have been and will be satisfied.

Related Guidance

  • NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants" (Ref. 3), Section 17.5, "Quality Assurance Program Description- Design Certification, Early Site Permit and New License Applicants," provides guidance to the NRC staff in reviewing QA program descriptions submitted by applicants for a design certification, combined license, early site permit, construction permit, and operating license.
  • RG 1.33, "Quality Assurance Program Requirements (Operation)" (Ref. 4), addresses additional guidance for the establishment and execution of QA programs for nuclear power plants during the operations phase.

Purpose of Regulatory Guides The NRC issues RGs to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. Regulatory guides are not substitutes for regulations and compliance with them is not required. Methods and solutions that differ from those set forth in RGs will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.

RG 1.28, Page 3 Paperwork Reduction Act This RG provides guidance for implementing the mandatory information collections in 10 CFR Parts 50 and 52 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. seq.). These information collections were approved by the Office of Management and Budget (OMB), under control numbers 3150-0011 and 3150-0151. Send comments regarding this information collection to the Information Services Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information and Regulatory Affairs,NEOB-10202, (3150-0011, 3150-0151) Office of Management and Budget, Washington, DC 20503.

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.

RG 1.28, Page 4

B. DISCUSSION

Reason for Revision This revision of the guide (Revision 5) updates the guidance to endorse, with clarification or exceptions, multiple revisions of the American Society of Mechanical Engineers (ASME) standard NQA-1, "Quality Assurance Requirements for Nuclear Facility Applications."

Background This revision of RG 1.28 endorses, with certain clarifications and regulatory positions, various versions of the ASME NQA-1 standard; the standards included are the NQA-1b-2011 Addenda to ASME NQA-1-2008 (Ref. 5), NQA-1-2012 (Ref. 6), and NQA-1-2015 (Ref. 7). The previous version of RG 1.28 (Revision 4) (Ref. 8), approved the use of NQA-1-2008 (Ref. 9), and the NQA-1a-2009 Addenda (Ref. 10), with certain clarifications and regulatory positions. The staff 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 QA. The NRC issued RG 1.28, Revision 4, in June 2010. The guide extended the scope of the NRC's approval of NQA-1 to include Part II, which contains amplifying QA requirements for certain specific work activities that occur at various stages of a facility's life. The work activities include, but are not limited to, management, planning, site investigation, design, computer software development commercial-grade dedication, procurement, fabrication, installation, inspection, and testing. Part II of NQA-1 versions NQA-1-2012 and NQA-1-2015 include Subpart 2.22, "Quality Assurance Requirements for Management Assessment and Quality Improvement for Compliance with 10 CFR 830 and Department of Energy (DOE) Order 414.1 for DOE Nuclear Facilities." Subpart 2.22 of NQA-1-2015 contains guidance for complying with 10 CFR 830 and DOE Order 414.1 for DOE Nuclear Facilities.

Facilities subject 10 CFR 830 and Department of Energy (DOE) Order 414.1are not within the regulatory jurisdiction of the NRC. Thus, the NRC's approval for use of NQA-1-2015, as set forth in this regulatory guide, excludes Subpart 2.22 and this Subpart is not appl icable to NRC-regulated facilities.

In addition, Revision 4 of RG 1.28 introduced the use of electronic media as a way to satisfy the requirements for the maintenance of QA records. The guide discussed Generic Letter No. 88-18, "Plant Record Storage on Optical Disk," dated October 20, 1988 (Ref. 11), which was issued to inform licensees of the NRC approval of the use of optical disk document imaging systems for the storage and retrieval of quality assurance records and documented the appropriate quality controls for the use of optical disks. Revision 4 also discussed Regulatory Issue Summary (RIS) 2000-18, "Guidance on Managing Quality Assurance Records in Electronic Media," dated October 23, 2000 (Ref. 12). Attachment 1 to RIS 2000-18 lists guidance documents on establishing an electronic recordkeeping system to maintain the integrity, authenticity, and acceptability of QA records during their required retention period in accordance with the requirements of Appendix B to 10 CFR Part 50 and other regulations for the storage of QA records in electronic media. The guidance documents listed in RIS 2000-18 also describe methods that the licensee or applicant can use to authenticate electronic records; to prevent their alteration or falsification; to protect them from, or to recover them following a disaster; and to manage their software configuration. The staff determined that more current guidance is available, as discussed in Section C of this RG.

Harmonization with International Standards The NRC staff reviewed guidance from the International Atomic Energy Agency (IAEA) and did not identify any standards that provided useful guidance to NRC staff, applicants, or licensees.

RG 1.28, Page 5 Documents Discussed in Staff Regulatory Guidance This regulatory guide endorses, in part, the use of one or more codes or standards developed by external organizations, and other third party guidance documents. These codes, standards and third party guidance documents may contain references to other codes, standards or third party guidance documents ("secondary references"). If a secondary reference has itself been incorporated by reference into NRC regulations as a requirement, then licensees and applicants must comply with that standard as set forth in the regulation. If the secondary reference has been endorsed in a regulatory guide as an acceptable approach for meeting an NRC requirement, then the standard constitutes a method acceptable to the NRC staff for meeting that regulatory requirement as described in the specific regulatory guide. If the secondary reference has neither been incorporated by reference into NRC regulations nor endorsed in a regulatory guide, then the secondary reference is neither a legally-binding requirement nor a "generic" NRC approved acceptable approach for meeting an NRC requirement. However, licensees and applicants may consider and use the information in the secondary reference, if appropriately justified, consistent with current regulatory practice, and consistent with applicable NRC requirements.

RG 1.28, Page 6

C. REGULATORY POSITION

The Part I and Part II requirements included in the NQA-1b-2011 Addenda to ASME

NQA-1-2008, NQA-1-2012, and NQA-1-2015, "Quality Assurance Requirements for Nuclear Facility Applications," for the implementation of a QA program during the design and construction phases of nuclear power plants and fuel reprocessing plants are endorsed by the NRC staff, and provide an adequate basis for complying with the requirements of Appendix B to 10 CFR Part 50, subject to the exceptions and clarifications of NQA-1b-2011, NQA-1-2012, and NQA-1-2015 identified below.

1. QA Program (NQA-1 Requirement 2)

a. Audit Participation

(1) Prospective lead auditors, with comparable industry experience, may satisfy the lead auditor qualification requirement of participating in a minimum of five QA audits within a period of 3 years prior to the date of qualification by alternatively demonstrating the ability to properly implement the audit process, effectively organize and report results, and participate in at least one nuclear audit within the year preceding the date of qualification, subject to review and acceptance by the responsible QA

organization.

2. Control of Purchased Items and Services (NQA-1 Requirement 7)

a. Laboratory Calibration and Testing Services

(1) The NRC finds that Nuclear Energy Institute (NEI) 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1 (Ref. 13), provides an acceptable approach for licensees and suppliers subject to the QA requirements of Appendix B to 10 CFR Part 50 for using laboratory accreditation by Accreditation Bodies that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) in lieu of performing commercial-grade surveys as part of the commercial-grade dedication process for procurement of calibration and testing services performed by domestic and international laboratories accredited by signatories to the ILAC MRA.

3. QA Records (NQA-1 Requirement 17)

a. Lifetime and Nonpermanent Records

(1) Paragraph 400, "Classification," of Requirement 17, "Quality Assurance Records," provides guidance on the retention of "lifetime" and "nonpermanent" records. Paragraph 401, "Lifetime Records," discusses the scope and responsibilities related to these records. The owner or an authorized agent must maintain lifetime records for the life of the particular item while it is installed in the plant or stored for future use.

RG 1.28, Page 7

(2) Paragraph 402, "Nonpermanent Records," identifies nonpermanent records as those records that "-show evidence that an activity was performed in accordance with the applicable requirements-" The owner or an authorized agent does not need to retain these records for the life of the item, because they do not meet the criteria for lifetime records. However, Paragraph 700, "Retention," specifies that document retention periods be documented and records maintained for their retention period.

NQA-1 Part III, Nonmandatory Subpart 3.1-17.1, "Guidance on Quality Assurance Records," Paragraph 200, "List of Typical Lifetime Records," lists typical lifetime records containing information that meets Requirement 17 of Part I. The list of typical lifetime records in Nonmandatory Subpart 3.1-17.1 should be considered for guidance purposes only. Note that the nomenclature of these records may vary. For records not listed in Subpart 3.1-17.1, the type of record that most nearly describes the record in question should be followed with respect to its retention classification. The applicant or licensee should be cognizant that the list is not considered to be all-inclusive. The applicant or licensee itself is responsible for ensuring, in accordance with Criterion XVII, "Quality Assurance Records," of Appendix B to 10 CFR Part 50, that it maintains sufficient records to furnish evidence of activities affecting quality.

b. Managing Quality Assurance Records in Electronic Media

(1) For the management of electronic records, appropriate controls on quality assurance include the following:

(a) No deletion or modification of records unless authorized pursuant to the record retention rule (b) Redundancy (system backup, dual storage, etc.) is provided (c) Legibility is required of each record (d) Records media are properly maintained (e) Inspections to ensure no degradation of records (f) Records are acceptably converted into any new system before the old system is taken out of service The Nuclear Information and Records Management Association (NIRMA) technical guides (TGs), as listed below, provide guidance to establish the appropriate quality controls that incorporates the implementation of enterprise content management systems, web-based technologies, and higher capacity LAN/WAN networks. The NRC approves for use the 2011 versions of the NIRMA TGs.

(a) NIRMA TG 11, "Authentication of Records and Media" (Ref. 14);

(b) NIRMA TG 15, "Management of Electronic Records" (Ref. 15);

(c) NIRMA TG 16, "Software Configuration Management and Quality Assurance" (Ref. 16); and (d) NIRMA TG 21, "Electronic Records Protection and Restoration" (Ref. 17).

RG 1.28, Page 8

4. Audits (NQA-1 Requirements 7 & 18)

a. Internal Audits

(1) Applicable elements of an organization's QA program should be audited at least once each year or at least once during the life of the activity, whichever is shorter. In determining the scope of the audit, an evaluation of the activity being audited may be useful. The evaluation may include results of previous QA program audits and the results of audits from other sources, including the nature and frequency of identified deficiencies and any significant changes in personnel, the organization, or the QA program.

b. External Audits

(1) After the award of a contract, the applicant or licensee may determine, based on the evaluation conducted in accordance with Regulatory Position 4.b.(4) below, that external audits are not necessary for procuring items (a) that are relatively simple and standard in design, manufacturing, and testing and (b) that are adaptable to standard or automated inspections or tests of the end product to verify quality characteristics after delivery. For other procurement actions not covered by the above exceptions, audits should be conducted as described below.

(2) The applicant or licensee should either audit its supplier's QA program on a triennial basis or arrange for such an audit. The triennial period begins when an audit is performed. The licensee or applicant may perform an audit when the supplier has completed sufficient work to demonstrate that its organization is implementing a QA program that has the required scope for purchases placed during the triennial period. If a subsequent contract or a contract modification significantly enlarges the scope or changes the methods or controls for activities performed by the same supplier, the licensee or applicant should conduct an audit of the modified requirements, thus starting a new triennial period. If the supplier is implementing the same QA program for other customers as that proposed for use on the auditing party's contract, the preaward survey (initially established as a requirement in ASME NQA-1-2008) may serve as the first triennial audit. Therefore, when a preaward survey is used as the first triennial audit, it should satisfy the same audit elements and criteria as those used on other triennial audits.

(3) If more than one purchaser buys from a single supplier, a purchaser may either perform or arrange for an audit of the supplier on behalf of itself and other purchasers to reduce the number of external audits of the supplier. The scope of this audit should satisfy the needs of all the purchasers, and all the purchasers for whom the audit was conducted should receive the audit report. Nevertheless, each of the purchasers relying on the results of an audit performed on behalf of several purchasers remains individually responsible for the adequacy of the audit.

(4) The applicant or licensee should perform or arrange for annual evaluations of suppliers. It should document these evaluations and take the following considerations into account, where applicable:

(a) the review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions;

(b) results of previous source verifications, audits, and receiving inspections; and RG 1.28, Page 9 (c) operating experience of identical or similar products furnished by the same supplier and results of audits from other sources (e.g., Nuclear Procurement Issues Committee audit reports or NRC inspection reports).

Note: the NRC recognizes the ASME Accreditation Program and associ ated certificates of authorization as evidence that the holder of the certificate of authorization has a documented QA program that meets the requirements of Appendix B to 10 CFR Part 50. However, recognition of the ASME Accreditation Program applies only to the programmatic aspects of the QA programs. Applicants and licensees or their subcontractors should ensure that the suppliers are effectively implementing their approved QA programs. For additional information, see Information Notice (IN) 86-21, "Recognition of American Society of Mechanical Engineers Accreditation Program for N

Stamp Holders," dated March 31, 1986 (Ref. 18).

RG 1.28, Page 10

D. IMPLEMENTATION

The purpose of this section is to provide information on how nuclear licensees and applicants

1 may use this guide and information regarding the NRC's plans for using this RG. In addition, it describes how the NRC staff complies with 10 CFR 50.109, "Backfitting," and any applicable finality provisions in 10 CFR Part 52.

Use by Nuclear Licensees and Applicants Nuclear licensees and applicants may voluntarily

2 use the guidance in this document to demonstrate compliance with the underlying NRC regulations. Methods or solutions that differ from those described in this RG may be deemed acceptable if they provide sufficient basis and information for the NRC staff to verify that the proposed alternative demonstrates compliance with the appropriate NRC regulations. Current licensees may continue to use guidance the NRC found acceptable for complying with the identified regulations as long as their current licensing basis remains unchanged

. Licensees may use the information in this RG for actions that do not require NRC review and approval, such as changes to a facility design under 10 CFR 50.59, "Changes, Tests and Experiments." Licensees may use the information in this RG or applicable parts to resolve regulatory or inspection issues. Use by NRC Staff The NRC staff does not intend or approve any imposition or backfitting of the guidance in this RG. The NRC staff does not expect any existing licensee to use or commit to using the guidance in this RG, unless the licensee makes a change to its licensing basis. The NRC staff does not expect or plan to request licensees to voluntarily adopt this RG to resolve a generic regulatory issue. The NRC staff does not expect or plan to initiate NRC regulatory action that would require the use of this RG. Examples of such unplanned NRC regulatory actions include issuance of an order requiring the use of the regulatory guide, requests for information under 10 CFR 50.54(f) as to whether a licensee intends to commit to use of this regulatory guide, generic communication, or issuance of a rule requiring the use of this regulatory guide without further backfit consideration.

During regulatory discussions on plant-specific operational issues, the staff may discuss with licensees various actions consistent with staff positions in this RG, as one acceptable means of meeting the underlying NRC regulatory requirement. Such discussions would not ordinarily be considered backfitting even if prior versions of this RG are part of the licensing basis of the facility. However, unless this RG is part of the licensing basis for a facility, the staff may not represent to the licensee that the licensee's failure to comply with the positions in this RG constitutes a violation.

If an existing licensee voluntarily seeks a license amendment or change and (1) the NRC staff's consideration of the request involves a regulatory issue directly relevant to this new or revised regulatory

1 In this section, "licensees" refers to licensees of nuclear power plants under 10 CFR Parts 50 and 52; and the term

"applicants" refers to applicants for licenses and permits for (or relating to) nuclear power plants under

10 CFR Parts 50 and 52, and applicants for standard design approvals and standard design certifications under

10 CFR Part 52. 2 In this section, "voluntary" and "voluntarily" mean that the nuclear licensee or applicant is seeking the action of its own accord, without the force of a legally binding requirement or an NRC representation of further licensing or enforcement action.

RG 1.28, Page 11 guide and (2) the specific subject matter of this regulatory guide is an essential consideration in the staff's determination of the acceptability of the licensee's request, then the staff may request that the licensee either follow the guidance in this regulatory guide or provide an equivalent alternative process that demonstrates compliance with the underlying NRC regulatory requirements. This is not considered backfitting as defined in 10 CFR 50.109(a)(1) or a violation of any of the issue finality provisions in 10 CFR Part 52.

If a licensee believes that the NRC is either using this regulatory guide or requesting or requiring the licensee to implement the methods or processes in this regulatory guide in a manner inconsistent with the discussion in this Implementation section, then the licensee may file a backfit appeal with the NRC in accordance with the guidance in NUREG-1409, "Backfitting Guidelines" (Ref. 19), and NRC Management Directive (MD) 8.4, "Management of Facility-specific Backfitting and Information Collection" (Ref. 20).

RG 1.28, Page 12 REFERENCES

3 1. U.S. Code of Federal Regulations, 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities."

2. U.S. Code of Federal Regulations, 10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants"

3. U.S. Nuclear Regulatory Commission (NRC), NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition," Section 17.5, "Quality Assurance Program Description- Design Certification, Early Site Permit and New License Applicants," Washington, DC, August 2015. (ADAMS Accession No. ML15037A441)

4. NRC, "Quality Assurance Program Requirements (Operation)," Regulatory Guide 1.33, Washington, DC.

5. American Society of Mechanical Engineers (ASME), "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1b-2011 Addenda to ASME NQA-1-2008, New York, NY.

6. ASME "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1-2012, New York, NY.

7. ASME, "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1-2015, New York, NY.

8. NRC, "Quality Assurance Program Criteria (Des ign and Construction)," Regulatory Guide 1.28, Revision 4, Washington, DC.

9. ASME, "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1-2008, New York, NY.

4 10. ASME, "Quality Assurance Requirements for Nuclear Facility Applications," ASME NQA-1a-2009 Addenda to ASME NQA-1-2008, New York, NY.

11. NRC, "Plant Record Storage on Optical Disks," GL 88-18, Washington, DC, October 20, 1988.

12. NRC, "Guidance on Managing Quality Assurance Records in Electronic Media," RIS 2000-18, Washington, DC, October 23, 2000.

3 Publicly available NRC-published documents are available electronically through the NRC Library on the NRC's public Web site at: http://www.nrc.gov/reading-rm/doc-collections/. The documents can also be viewed online or printed for a fee in the NRC's Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone 301-415-4737 or 800-397-4209; fax 301-415-3548; and e-mail pdr.resource@nrc.gov.

4 Copies of American Society of Mechanical Engineers (ASME) standards may be purchased from ASME, Three Park Avenue, New York, NY 10016-5990; telephone 800-843-2763. Purchase information is available through the ASME

Web-based store at http://www.asme.org/Codes/Publications/.

RG 1.28, Page 13

13. Nuclear Energy Institute (NEI) 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1, Washington DC, August 2014 (ADAMS Accession No. ML14245A392)

14. Nuclear Information and Records Management Association (NIRMA), "Authentication of Records and Media," TG 11-2011, New York, NY.

5 15. NIRMA, "Management of Electronic Records," TG 15-2011, Windham, NH.

16. NIRMA, "Software Configuration Management and Quality Assurance," TG 16-2011, Windham, NH. 17. NIRMA, "Electronic Records Protection and Restoration," TG 21-2011, Windham, NH.

18. NRC, "Recognition of American Society of Mechanical Engineers Accreditation Program for N Stamp Holders," IN 86-21, Washington, DC, March 31, 1986.

19. NRC NUREG-1409, "Backfitting Guidelines," Washington, DC, July 1990.

20. NRC, "Management of Facility-Specific Backfitting and Information Collection," MD 8.4, October 9, 2013. (ADAMS Accession No. ML12059A460)

5 Copies of Nuclear Information & Records Management (NIRMA) technical guides may be purchased from NIRMA, 245 Sunnyridge Avenue #34 Fairfield, CT 06824; telephone

203 388 8795. Purchase information is available through the NIRMA Web based store at https://www.nirma.org/shop.

RG 1.28, Page 14 BIBLIOGRAPHY

1. Final Safety Evaluation for Technical Report NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1, ADAMS Accession No. ML14322A535.

2. Safety Evaluation of the Quality Assurance Topical Report, Amendment 40 for Catawba Nuclear Station, Unit Nos. 1 and 2, McGuire Nuclear Station Unit Nos. 1 and 2, Oconee Nuclear Station, Unit Nos 1, 2 and 3; Docket Nos 50-269, 50-270, and 50-287; Renewed License Numbers DPR-38, DPR-47, and DPR-55, ADAMS Accession No. ML15099A561.


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