Regulatory Guide 1.28: Difference between revisions

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{{Adams
{{Adams
| number = ML17207A293
| number = ML13350A384
| issue date = 10/31/2017
| issue date = 03/31/1978
| title = Quality Assurance Program Criteria (Design and Construction)
| title = Quality Assurance Program Requirements (Design and Construction)
| author name = Ferguson A
| author name =  
| author affiliation = NRC/NRO/DCIP/QVIB3
| author affiliation = NRC/OSD
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = Burton S
| contact person =  
| case reference number = DG-1326
| document report number = RG-1.028, Rev 1
| document report number = RG-1.028, Rev 5
| package number = ML17207A277
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 14
| page count = 2
}}
}}
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION  
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION
REGULATORY GUIDE RG 1.28, REVISION 5
Revision i March 1978 REGULATORY GUIDE
 
OFFICE OF STANDARDS DEVELOPMENT
Issue Date: October 2017 Technical Lead: A. Ferguson
REGULATORY GUIDE 1.28 QUALITY ASSURANCE PROGRAM REQUIREMENTS
 
(DESIGN AND CONSTRUCTION)
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.
 
QUALITY ASSURANCE PROGRAM  
CRITERIA (DESIGN AND CONSTRUCTION)  


==A. INTRODUCTION==
==A. INTRODUCTION==
Purpose
National Standards Institute olt A
'1 7, 1977.'
Some uncertainty has arise ith regard !o the Appendix B. "Quality Assurance Criteria for Nu- NRC staff's position when e
R tory guide cn- clear Power Plants and Fuel Reprocessing Plants,"
dorses, as an acceptabIe rd od,
"i'guidelines- to 10 CFR Part 50. "Licensing of Production and as well as the "requir It.


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)
nclu ed in a stand- Utilization Facilities," establishes overall quality ard. The NRC staf d the guidelines assurance requirements for the design, construction, contained in N45
program for the design and construction of nuclear power plants and fuel reprocessing plants.
97
'th r spect ,o importance and operation of safety-related structures, systems, to safety. Thi.,  
to guide is interded (o and components. This guide describes a method ac- clarify the ,  
C
f'sosition on the "reqtsie.


Applicability
ceptable to the NRC staff for complying with the ments.. a u
,nes included in ANSI
Commission's regulations with regard to overall N45.2.


This RG applies to all applicants for a construction permit and operating license subject to
7.
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
 
*
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.


*
conformance to the recommen- quality assurance program requirements during de- datio rc ulatory guide is indicated in an sign and construction of nuclear power plants.
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
cat out further qualification, this indi- c
at e applicant will comply with the "re- B.DSUSINts" of ANSI N45.2-1977, as supplemented Subcommittee N45-2.7 (formerly N45-3.7) of the di ied by the regulatory position of this guide.


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.
American National Standards Committee Reactor Plants and Their Maintenance, dev ope
 
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 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 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==
==C. REGULATORY POSITION==
The Part I and Part II requirements included in the NQA-1b-2011 Addenda to ASME
ANSI N45.2-1971 that included general r
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.
're- The overall quality assurance program require- ments for establishing and executing a y a ments for the design and construction phas.s that are ante program during the design an const tion included in ANSI N45.2-1977 provide an adequate phases of nuclear power plants. This nd was basis for complying with the quality assurance pro.
 
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 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)  
endorsed by Regulatory Guide 1.28 (  
The applicant or licensee should perform or arrange for annual evaluations of suppliers.
Guide gram requirements of Appendix B to 10 CFR Part
28). To update the requirements of the standard and
50, as supplemented or modified by the following:
to make it applicable toft nuclear facilities sub- ject to 10 CFR Part AI dix B, the standard Section 2 of N45.2-1977 requires. in part. that was revised by the N4 A
iGroup in coopera-
"A documented Quality Assurance Program which tion with the N
4,Groupc ioittee.


It should document these evaluations and take the following considerations into account, where applicable:
complies with the applicable sections and elements The revised rna wapproved by Subcom- of this standard shall be established at the earliest mittee N45*
ear ality Assurance Standards, practical time consistent with the schedule for ac- of the A
Ci I~p l
Standards Committee N45 complishing the activities for the nuclear facility."
and the 1
45 committee and by Subcommittee The following information should be used to clarify N46-2, the fIN46 committee, and the N18 commit- the requirement of Section 2 of ANSI N45.2-1977.


(a) the review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions;
tee. It was s sequently approved and designated Copies may be obtained from the American Society (if N45.2-1977, "Quality Assurance Program Re- Mechanical Engineers, United Engineering Center. 345 East quirements fur Nuclear Facilities," by the American
47th Street. New York, N.Y. 10017.


(b) results of previous source verifications, audits, and receiving inspections; and
USNi C REGULATORY GUIDES
Comments should be iint to the Semetary of the coniuon. US NutrWhe' squ RMgtalory GU.deware iNRCd toRdescbe
"
GUa&"AabiDtoIthe Publicmethods wre, Commission. Washflgton, D C
2055S. Attiteon Docha,.
,*n #'d S.*. r, socettable it the NRC staff of #empteetirigl V
ietc Pan& of the Comm'suon't Branch.


RG 1.28, Page 9
irgulations. tO delineteitt tCthn-Cl' r used by the itaff in *valuating tSp*cifc problemt The h
uidiesa I *suud i* the foltott ,ng It, b*toi dwsvont or Pomlulatsc iccde*t.


(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).
oat tn to rovidte uid¢nce to mpp*icatts. Reutatony Guid"
 
are Mot subaulate for regultitons, and complianet wieth thorn ts not required.
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 10
 
==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 11
 
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 12
 
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.


1. Power Reaido.,
6 Produ~cts lethodo and sul'or diff erent from thos, let o
ut i'n the gsacde wtlt l be e et
2. Researca Teo Rectors
7.
7.


ASME, Quality Assurance Requirements for Nuclear Facility Applications, ASME NQA-1-2015, New York, NY.
Rtonapotrifro
 
't Ae it they hOitds a belt, for the finditp rmielete to the isance or ocontInuance
8.


NRC, Quality Assurance Program Criteria (Design and Construction), Regulatory Guide 1.28, Revision 4, Washington, DC.
===3. Fuels and f ===
*sttr.alt Facities


9.
====a. Occuiaoluo nat t ====
th o fa parmth or license by the Comttlion
*r.


ASME, Quality Assurance Requirements for Nuclear Facility Applications, ASME NQA-1-2008, New York, NY.4 
4. E
s i'ieontni
,tat v
ietdSiting
9. Antitust Rle..no
,
S. M*runt*' end Plant Protection.


10.
10.


ASME, Quality Assurance Requirements for Nuclear Facility Applications, ASME NQA-1a-2009 Addenda to ASME NQA-1-2008, New York, NY.
An Ue t
Comments end wemiorn for impeoment. in those guds ae encourage at
.11 timtet. end guidem will be revised. &I appropriate. to semmmottdarte coni"Wents and Rettueti for single copisi t o ttsted queJes teet,dt m~ay be ,eiyduca1t or to, Ptace to teflBect ltow information o, e.perttence.


11.
I4o~vw. coerton'v as on tttrt guhde~it mnwt on an automattc dirttr*utoon tilt to, Single cove"
ot tutwje 2.4% ' UC.n SKih d within about two montht SOtWr .s rusuhtie. Will be OsltiCutetl useful in dftvtons houtld be made in writng to the US. Nuclo& Rglatory C",nmn
,n.


NRC, Plant Record Storage on Optical Disks, GL 88-18, Washington, DC, October 20, 1988.
ef= uitg the need lot an aaly sewiton.


12.
Waahngtort. O.C.


NRC, Guidance on Managing Quality Assurance Records in Electronic Media, RIS 2000-18, Washington, DC, October 23, 2000.
M 55. Allet ton Onector. ODnsuon ot Ootument Contro
//


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
Il
PDR, Washington, DC 20555; telephone 301-415-4737 or 800-397-4209; fax 301-415-3548; and e-mail pdr.resource@nrc.gov.
-- .-  
.
For those safety-related activities that are initiated by the applicant prior to submitting its application for a construction permit, the requirements set forth in ANSI N45.2-1977 and amplified in the applicable N45.2 series standards should be in effect prior to accomplishing the activities. The following are examples of such activities that are or may be ini- tiated prior to submitting the application:
a. Activities performed in the establishment of the information required to he included in the Prelimi- nary Safety Analysis Report.


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
h. Activities pertaining to the preparation of de- sign and procurement documents affecting safety- related structures, systems. and components,
Web-based store at http://www.asme.org/Codes/Publications/.  
2. The guidelines (indicated by the verb "should")
of ANSI N45.2-1977 contained in the following sec- tions have sufficient safety importance to be treated the same as the requirements (indicated by the verb
"shall") of the standard:
a. Section 14. second paragraph-The guidelines on procedures for critical, sensitive, periihable. oi'
high-value articles and on use and control of special handling tools.


RG 1.28, Page 13
b. Section 19. second paragraph-The guideline on when to perform audits.


13.
c. Section 19. third paragraph-The guideline in the first sentence of the paragraph that indicates the three general areas of evaluation to include in an audit.


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)
d. Section 19. fifth paragraph-The guideline on developing an audit plan, e. Section 19. sixth paragraph-The guideline on scheduling of audits and the guideline that specifies the conditions that require conducting audits.


14.
3. The Foreword and Section 1.2. "Applicability."
of ANSI N45.2-1977 state: "The ASME Boiler and Pressure Vessel Code, as well as other American National Standards, have been considered in the de- velopment of this standard, and this standard is in- tended to be compatible with their requirements.


Nuclear Information and Records Management Association (NIRMA), Authentication of Records and Media, TG 11-2011, New York, NY.5 
However. this standard does not apply to Ihe at'.
tivities covered hy Section III mid t'clioti XIl otf li Code."
It is important to consider the relationship of the quality assurance requirements included in Section III of the Code with those included in ANSI
N45.2. Code-covered activities are primarily in- tended to ensure the integrity of the pressure bound- ary of an item. Section III of the Code does not ad- dress activities necessary io ensure fuactional operability of sonic Code-covered items such as pumps or values. Therefore. to ensure functional operability of these items, the quality assurance program for design and construction should hb ex- tended to these other activities, and the guidance in N45.2 should be used, as appropriate.


15.
==D. IMPLEMENTATION==
 
The purpose of this section is to provide informa- tion to applicants and licensees regarding the NRC
NIRMA, Management of Electronic Records, TG 15-2011, Windham, NH.
staff's plans for using this regulatory guide. Except in those cases in which the applicant proposes an alternative method for complying with specified por- tions of the Commission's regulations. the method described herein will be used in the evaluation of submittals for construction permit applications dock- eted after November 30. 1978. If an applicant whose application for a construction permit is docketed on or before November 30, 1978. wishes to use this reg- ulatory guide in developing submittals for applica- tions, the pertinent portions of the application will be evaluated on the basis of this guide.
 
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.}}
1.28-2}}


{{RG-Nav}}
{{RG-Nav}}

Revision as of 00:16, 11 January 2025

Quality Assurance Program Requirements (Design and Construction)
ML13350A384
Person / Time
Issue date: 03/31/1978
From:
NRC/OSD
To:
References
RG-1.028, Rev 1
Download: ML13350A384 (2)
v • d • e


U.S. NUCLEAR REGULATORY COMMISSION

Revision i March 1978 REGULATORY GUIDE

OFFICE OF STANDARDS DEVELOPMENT

REGULATORY GUIDE 1.28 QUALITY ASSURANCE PROGRAM REQUIREMENTS

(DESIGN AND CONSTRUCTION)

A. INTRODUCTION

National Standards Institute olt A

'1 7, 1977.'

Some uncertainty has arise ith regard !o the Appendix B. "Quality Assurance Criteria for Nu- NRC staff's position when e

R tory guide cn- clear Power Plants and Fuel Reprocessing Plants,"

dorses, as an acceptabIe rd od,

"i'guidelines- to 10 CFR Part 50. "Licensing of Production and as well as the "requir It.

nclu ed in a stand- Utilization Facilities," establishes overall quality ard. The NRC staf d the guidelines assurance requirements for the design, construction, contained in N45

97

'th r spect ,o importance and operation of safety-related structures, systems, to safety. Thi.,

to guide is interded (o and components. This guide describes a method ac- clarify the ,

C

f'sosition on the "reqtsie.

ceptable to the NRC staff for complying with the ments.. a u

,nes included in ANSI

Commission's regulations with regard to overall N45.2.

7.

conformance to the recommen- quality assurance program requirements during de- datio rc ulatory guide is indicated in an sign and construction of nuclear power plants.

cat out further qualification, this indi- c

at e applicant will comply with the "re- B.DSUSINts" of ANSI N45.2-1977, as supplemented Subcommittee N45-2.7 (formerly N45-3.7) of the di ied by the regulatory position of this guide.

American National Standards Committee Reactor Plants and Their Maintenance, dev ope

C. REGULATORY POSITION

ANSI N45.2-1971 that included general r

're- The overall quality assurance program require- ments for establishing and executing a y a ments for the design and construction phas.s that are ante program during the design an const tion included in ANSI N45.2-1977 provide an adequate phases of nuclear power plants. This nd was basis for complying with the quality assurance pro.

endorsed by Regulatory Guide 1.28 (

Guide gram requirements of Appendix B to 10 CFR Part 28). To update the requirements of the standard and

50, as supplemented or modified by the following:

to make it applicable toft nuclear facilities sub- ject to 10 CFR Part AI dix B, the standard Section 2 of N45.2-1977 requires. in part. that was revised by the N4 A

iGroup in coopera-

"A documented Quality Assurance Program which tion with the N

4,Groupc ioittee.

complies with the applicable sections and elements The revised rna wapproved by Subcom- of this standard shall be established at the earliest mittee N45*

ear ality Assurance Standards, practical time consistent with the schedule for ac- of the A

Ci I~p l

Standards Committee N45 complishing the activities for the nuclear facility."

and the 1

45 committee and by Subcommittee The following information should be used to clarify N46-2, the fIN46 committee, and the N18 commit- the requirement of Section 2 of ANSI N45.2-1977.

tee. It was s sequently approved and designated Copies may be obtained from the American Society (if N45.2-1977, "Quality Assurance Program Re- Mechanical Engineers, United Engineering Center. 345 East quirements fur Nuclear Facilities," by the American

47th Street. New York, N.Y. 10017.

USNi C REGULATORY GUIDES

Comments should be iint to the Semetary of the coniuon. US NutrWhe' squ RMgtalory GU.deware iNRCd toRdescbe

"

GUa&"AabiDtoIthe Publicmethods wre, Commission. Washflgton, D C

2055S. Attiteon Docha,.

,*n #'d S.*. r, socettable it the NRC staff of #empteetirigl V

ietc Pan& of the Comm'suon't Branch.

irgulations. tO delineteitt tCthn-Cl' r used by the itaff in *valuating tSp*cifc problemt The h

uidiesa I *suud i* the foltott ,ng It, b*toi dwsvont or Pomlulatsc iccde*t.

oat tn to rovidte uid¢nce to mpp*icatts. Reutatony Guid"

are Mot subaulate for regultitons, and complianet wieth thorn ts not required.

1. Power Reaido.,

6 Produ~cts lethodo and sul'or diff erent from thos, let o

ut i'n the gsacde wtlt l be e et

2. Researca Teo Rectors

7.

Rtonapotrifro

't Ae it they hOitds a belt, for the finditp rmielete to the isance or ocontInuance

3. Fuels and f

  • sttr.alt Facities

a. Occuiaoluo nat t

th o fa parmth or license by the Comttlion

  • r.

4. E

s i'ieontni

,tat v

ietdSiting

9. Antitust Rle..no

,

S. M*runt*' end Plant Protection.

10.

An Ue t

Comments end wemiorn for impeoment. in those guds ae encourage at

.11 timtet. end guidem will be revised. &I appropriate. to semmmottdarte coni"Wents and Rettueti for single copisi t o ttsted queJes teet,dt m~ay be ,eiyduca1t or to, Ptace to teflBect ltow information o, e.perttence.

I4o~vw. coerton'v as on tttrt guhde~it mnwt on an automattc dirttr*utoon tilt to, Single cove"

ot tutwje 2.4% ' UC.n SKih d within about two montht SOtWr .s rusuhtie. Will be OsltiCutetl useful in dftvtons houtld be made in writng to the US. Nuclo& Rglatory C",nmn

,n.

ef= uitg the need lot an aaly sewiton.

Waahngtort. O.C.

M 55. Allet ton Onector. ODnsuon ot Ootument Contro

//

Il

-- .-

.

For those safety-related activities that are initiated by the applicant prior to submitting its application for a construction permit, the requirements set forth in ANSI N45.2-1977 and amplified in the applicable N45.2 series standards should be in effect prior to accomplishing the activities. The following are examples of such activities that are or may be ini- tiated prior to submitting the application:

a. Activities performed in the establishment of the information required to he included in the Prelimi- nary Safety Analysis Report.

h. Activities pertaining to the preparation of de- sign and procurement documents affecting safety- related structures, systems. and components,

2. The guidelines (indicated by the verb "should")

of ANSI N45.2-1977 contained in the following sec- tions have sufficient safety importance to be treated the same as the requirements (indicated by the verb

"shall") of the standard:

a. Section 14. second paragraph-The guidelines on procedures for critical, sensitive, periihable. oi'

high-value articles and on use and control of special handling tools.

b. Section 19. second paragraph-The guideline on when to perform audits.

c. Section 19. third paragraph-The guideline in the first sentence of the paragraph that indicates the three general areas of evaluation to include in an audit.

d. Section 19. fifth paragraph-The guideline on developing an audit plan, e. Section 19. sixth paragraph-The guideline on scheduling of audits and the guideline that specifies the conditions that require conducting audits.

3. The Foreword and Section 1.2. "Applicability."

of ANSI N45.2-1977 state: "The ASME Boiler and Pressure Vessel Code, as well as other American National Standards, have been considered in the de- velopment of this standard, and this standard is in- tended to be compatible with their requirements.

However. this standard does not apply to Ihe at'.

tivities covered hy Section III mid t'clioti XIl otf li Code."

It is important to consider the relationship of the quality assurance requirements included in Section III of the Code with those included in ANSI

N45.2Property "ANSI code" (as page type) with input value "ANSI</br></br>N45.2" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.. Code-covered activities are primarily in- tended to ensure the integrity of the pressure bound- ary of an item.Section III of the Code does not ad- dress activities necessary io ensure fuactional operability of sonic Code-covered items such as pumps or values. Therefore. to ensure functional operability of these items, the quality assurance program for design and construction should hb ex- tended to these other activities, and the guidance in N45.2 should be used, as appropriate.

D. IMPLEMENTATION

The purpose of this section is to provide informa- tion to applicants and licensees regarding the NRC

staff's plans for using this regulatory guide. Except in those cases in which the applicant proposes an alternative method for complying with specified por- tions of the Commission's regulations. the method described herein will be used in the evaluation of submittals for construction permit applications dock- eted after November 30. 1978. If an applicant whose application for a construction permit is docketed on or before November 30, 1978. wishes to use this reg- ulatory guide in developing submittals for applica- tions, the pertinent portions of the application will be evaluated on the basis of this guide.

1.28-2


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