Regulatory Guide 1.28: Difference between revisions

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{{Adams
{{Adams
| number = ML13038A083
| number = ML17207A293
| issue date = 02/28/1979
| issue date = 10/31/2017
| title = Quality Assurance Program Requirements (Design and Construction)
| title = Quality Assurance Program Criteria (Design and Construction)
| author name =  
| author name = Ferguson A
| author affiliation = NRC/OSD
| 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
| document report number = RG-1.028, Rev. 2
| 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 = 3
| page count = 14
}}
}}
{{#Wiki_filter:Revision 2 PR REG"              U.S. NUCLEAR REGULATORY COMMISSION                                                                               February 1979 REGULATORY GUIDE
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION
                                    OFFICE OF STANDARDS DEVELOPMENT
                          REGULATORY GUIDE RG 1.28, REVISION 5 Issue Date: October 2017 Technical Lead: A. Ferguson QUALITY ASSURANCE PROGRAM
                                                                      REGULATORY GUIDE 1.28 QUALITY ASSURANCE PROGRAM REQUIREMENTS
                      CRITERIA (DESIGN AND CONSTRUCTION)
                                                            (DESIGN AND CONSTRUCTION)
*:°    .-Q  .;. ,


==A. INTRODUCTION==
==A. INTRODUCTION==
Standards, of the American National Standards Committee N45 and the full N45 committee and Appendix B, "Quality Assurance Criteria for                                  by Subcommittee N46-2, the full N46 committee, Nuclear Power Plants and Fuel Reprocessing                                        and the N18 committee. It was subsequently Plants," to .10 CFR Part 50, "Domestic Licens-                                    approved and designated N45.2-1977, "Quality ing of. Production and Utilization Facilities,"                                  Assurance Program Requirements for Nuclear establishes overall quality assurance require-                                    Facilities," by the American National Standards ments for the design, construction, and opera-                                    Institute on April 7, 1977.1 tion of safety-related structures, systems, and components. This guide describes a method                                            The NRC staff has evaluated the guidelines acceptable to the NRC staff for complying with                                    contained in N45.2-1977 and has identified the Commission's regulations with regard to                                      those that are important to safety. The indica- overall quality assurance program requirements                                    tion of conformance to this regulatory guide in during design and construction of nuclear                                         an application without qualification means that power plants.                                                                    the requirements of ANSI N45.2-1977 as sup- plemented or modified by the regulatory posi-
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)
*f The Advisory Committee on Reactor Safe-                                            tion of this guide will be followed.
  program for the design and construction of nuclear power plants and fuel reprocessing plants.


.1guards has been consulted concerning this guide and has                  concurred in              the regulatory                            C.    REGULATORY                POSITION
Applicability This RG applies to all applicants for a construction permit and operating license subject to
      position.
  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.


The overall quality assurance program re-  
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.
 
Written suggestions regarding this guide or development of new guides may be submitted through the NRCs 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 NRCs 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 NRCs 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.
 
*  10 CFR Part 52 references 10 CFR Part 50, Appendix B, for QA programs associated with Part 52 licensees.
 
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 agencys 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 2
 
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 3


==B. DISCUSSION==
==B. DISCUSSION==
quirements for the design and construction phases that are included in ANSI N45.2-1977 Subcommittee N45-2.7 (formerly N45-3.7) of                                   provide an adequate basis for complying with the American National Standards Committee                                        the quality assurance program requirements of N45, Reactor Plants and Their Maintenance,                                       Appendix B to 10 CFR Part 50, as supple- developed a standard designated ANSI N45.2-                                       mented or modified by the following:
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.
      1971 that included general requirements for es- tablishing and executing a quality assurance program during the design and construction                                            1. Section 2, "Quality Assurance Program,"
 
      phases of nuclear power plants. This standard                                    of N45.2-1977 requires, in part, that "A docu- was        endorsed            by        Regulatory          Guide 1.28         mented Quality Assurance Program which (Safety Guide 28). To update the requirements                                    complies with the applicable sections and ele- of the standard and to make it applicable to                                      ments of this standard shall be established at other nuclear facilities subject to Appendix B                                    the earliest practical time consistent with the to 10 CFR Part 50, the standard was revised                                      schedule for accomplishing the -activities for by the N45-2.7 work group in cooperation with                                     the nuclear facility." The following information the N46-2 subcommittee.                                                          should be used to clarify the requirement of Section 2 of ANSI N45.2-1977.
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 NRCs 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 facilitys 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 Facilitie
 
====s. Facilities subject====
10 CFR 830 and Department of Energy (DOE) Order 414.1are not within the regulatory jurisdiction of the NRC. Thus, the NRCs approval for use of NQA-1-2015, as set forth in this regulatory guide, excludes Subpart 2.22 and this Subpart is not applicable 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 4
 
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 5
 
==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)


The revised standard was approved by Sub- committee N45-2, Nuclear Quality Assurance
====a. Audit Participation====
                                                                                          'Copies may be obtained from the American Society of Me- chanical Engineers, United Engineering Center, 345 East 47th Lines indicate substantive changes from previous issue.                      Street, New York, N.Y. 10017.
                (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.


USNRC REGULATORY GUIDES                                        Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20655, Attention: Docketing and Regulatory Guides are issued to describe and make available to the public        Service Branch.
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.


methods acceptable to the NRC staff of implementing specific parts of the Commission's regulations, to delineate techniques used by the staff in evalu-    The guides are issued in the following ten broad divisions:
3.       QA Records (NQA-1 Requirement 17)
    sting specific problems or postulated accidents, or to provide guidance to applicants. Regulatory Guides are not substitutes for regulations, and corn-     1. Power Reactors                            6. Products pliance with them is not required. Methods and solutions different from those    2. Research and Test Reactors                7. Transportation set out in the guides will be acceptable if they provide a basis for the findings 3. Fuels and Materials Facilities            8. Occupational Health requisite to the issuance or continuance of a permit or license by the            4. Environmental and Siting                  9. Antitrust and Financial Review Commission.                                                                      5. Materials and Plant Protection          10. General Requests for single copies of issued guides 1which may be reproduced) or for Comments and suggestions for improvements in these guides are encouraged at      placement on an automatic distribution list for single copies of future guides all times, and guides will be revised, as appropriate, to accommodate comments    in specific divisions should be made in writing to the U.S. Nuclear Regulatory and to reflect new information or experience. This guide was revised as a result  Commission. Washington, D.C. 20555, Attention: Director, Division of of substantive comments received from the pub!ic and additional staff review.    Technical Information and Document Control.
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.


-1 -
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.
  For those safety-related activities that are        patible with their requirements. However, this initiated by the applicant prior to submitting          standard does not apply to the activities its application for a construction permit, the         covered by Section III and Section XI of the requirements set forth in ANSI N45.2-1977 and          Code."      It is important to consider the rela- amplified    in the applicable N45.2      series      tionship of the quality assurance requirements standards    should be in effect prior to              included in Section III of the Code with those accomplishing the activities. Examples of such          included in ANSI N45.2. Code-covered activ- activities that are or may be initiated prior to        ities are primarily intended to ensure the submitting the application are:                        integrity of the pressure boundary of an item.


Section III of the Code does not address activi- a. Activities performed in establishing the        ties necessary to ensure functional operability information to be included in the Preliminary          of some Code-covered items such as pumps or Safety Analysis Report.                                valves. Therefore, to ensure the satisfactory performance of activities affecting the func- b. Activities pertaining to preparing de-          tional operability of these items, the quality sign and procurement documents that affect              assurance program for design and construction safety-related structures, systems, and com-            should be extended to these other activities, ponents.                                                and the requirements in N45.2 should be used, as appropriate.
RG 1.28, Page 6


2. The guidelines (indicated by the verb
(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.
"should") of ANSI N45.2-1977 contained in the                        
 
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 7
 
4. Audits (NQA-1 Requirements 7 & 18)
 
====a. Internal Audits====
  (1)      Applicable elements of an organizations 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 suppliers 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 partys 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 8
 
(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 associated 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 9


==D. IMPLEMENTATION==
==D. IMPLEMENTATION==
following sections have sufficient safety impor- tance to be treated the same as the require-              Except in those cases in which the applicant ments (indicated by the verb "shall") of the           proposes an acceptable alternative method for standard:                                              complying with the specified portions of the Commission's regulations, the method described a. Section 14, "Handling, Storage, and Ship-       herein will be used in the evaluation of applica- ping," second paragraph - The guidelines on            tions docketed after October 1979 for:
The purpose of this section is to provide information on how nuclear licensees and applicants1 may use this guide and information regarding the NRCs 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
procedures for critical, sensitive, or perish- able -articles and on use and control of special          (1) standard reference system preliminary or handling tools.                                        Type-2 final design approvals (PDA orFDA-2),
  10 CFR Part 52.
    b. Section 19, "Audits," third paragraph -            (2) licenses to manufacture, and The guideline in the first sentence of the para- graph that indicates the three general areas of            (3) construction permits (CP), except those evaluation to include in an audit.                     portions that:
 
                                                                (a) reference an approved standard ref-
Use by Nuclear Licensees and Applicants Nuclear licensees and applicants may voluntarily2 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
   3. In Section 19, "Audits," the second and           erence system preliminary or final design (PDA
  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.
fifth paragraphs include general guidelines for         or FDA) or applications for such approval, audit scheduling. Audit scheduling, including the guidelines of these paragraphs, is ad-                     (b) reference an approved standard du- dressed separately an'd in more detail in Regu-        plicate plant preliminary or final design (PDDA
 
latory Guide 1.144, "Auditing of Quality As-           or FDDA),
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.
surance Programs for Nuclear Power Plants."
 
                                                                (c) reference parts of a base plant de-
Licensees may use the information in this RG or applicable parts to resolve regulatory or inspection issues.
   4. The Foreword and Section 1.2, "Applica-           sign qualified and approved for replication, bility," of ANSI N45.2-1977 state: "The ASME
 
Boiler and Pressure Vessel Code, as well as                    (d) reference a plant design approved or other American National Standards, have been            being reviewed for approval for manufacture considered in the development of this stand-           under a Manufacturing License or applications ard, and this standard is intended to be corn-         for such approval.
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 licensees 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 staffs 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 10
 
guide and (2) the specific subject matter of this regulatory guide is an essential consideration in the staffs determination of the acceptability of the licensees 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 11
 
REFERENCES3
  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 (Design 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 NRCs 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 NRCs 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 12
 
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 13
 
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.


1.28-2
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.


UNITED STATES
RG 1.28, Page 14}}
NUCLEAR REGULATORY COMMISSION
    WASHINGTON, D. C,- 20555                                POSTAGE AND FEESPAID
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                              OFFICE OF THE COMMISSIONERS
                              DR JOSEPH  HENDRIE
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Latest revision as of 16:39, 18 March 2020

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
Shared Package
ML17207A277 List:
References
DG-1326 RG-1.028, Rev 5
Download: ML17207A293 (14)
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U.S. NUCLEAR REGULATORY COMMISSION

REGULATORY GUIDE RG 1.28, REVISION 5 Issue Date: October 2017 Technical Lead: A. Ferguson 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.

Written suggestions regarding this guide or development of new guides may be submitted through the NRCs 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 NRCs 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 NRCs 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.

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 agencys 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 2

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 3

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 NRCs 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 facilitys 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 Facilitie

s. Facilities subject

10 CFR 830 and Department of Energy (DOE) Order 414.1are not within the regulatory jurisdiction of the NRC. Thus, the NRCs approval for use of NQA-1-2015, as set forth in this regulatory guide, excludes Subpart 2.22 and this Subpart is not applicable 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 4

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 5

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 6

(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 7

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

a. Internal Audits

(1) Applicable elements of an organizations 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 suppliers 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 partys 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 8

(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 associated 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 9

D. IMPLEMENTATION

The purpose of this section is to provide information on how nuclear licensees and applicants1 may use this guide and information regarding the NRCs 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 voluntarily2 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 licensees 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 staffs 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 10

guide and (2) the specific subject matter of this regulatory guide is an essential consideration in the staffs determination of the acceptability of the licensees 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).

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REFERENCES3

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 (Design 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 NRCs 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 NRCs 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/.

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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.

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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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