Regulatory Guide 1.168: Difference between revisions

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{{Adams
{{Adams
| number = ML040410189
| number = ML003740098
| issue date = 02/29/2004
| issue date = 09/30/1997
| title = Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants
| title = (Draft Was DG-1054) Verification,Validation,Reviews & Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants
| author name =  
| author name =  
| author affiliation = NRC/RES
| author affiliation = NRC/RES
Line 10: Line 10:
| license number =  
| license number =  
| contact person =  
| contact person =  
| case reference number = DG-1123
| case reference number = DG-1054
| document report number = RG-1.168, Rev 1
| document report number = RG-1.168
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 12
| page count = 8
}}
}}
{{#Wiki_filter:Regulatory guides are issued to describe and make available to the public such information as methods acceptable to the NRC staff for implementing specificparts of the NRC's  regulations, techniques used by the staff in evaluating specific problems or postulated accidents, and data needed by the NRC staff in itsreview of applications for permits and licenses.  Regulatory guides are not substitutes for regulations, and compliance with them is not required.  Methods andsolutions different from those set out in the guides will be acceptable if they provide a basis for the findings requisite to the issuance or continuance of a permitor license by the Commission.This guide was issued after consideration of comments received from the public.  Comments and suggestions for improvements in these guides are encouragedat all times, and guides will be revised, as appropriate, to accommodate comments and to reflect new information or experience.  Written comments may besubmitted to the Rules and Directives Branch, ADM, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.  Regulatory guides are issued in ten broad divisions:  1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmentaland Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health; 9, Antitrust and Financial Review; and 10, General. Single copies of regulatory guides (which may be reproduced) may be obtained free of charge by writing the Distribution Services Section, U.S. NuclearRegulatory Commission, Washington, DC 20555-0001, or by fax to (301)415-2289, or by email to DISTRIBUTION@NRC.GOV.  Electronic copies of this guideand other recently issued guides are available at NRC's home page at <WWW.NRC.GOV> through the Electronic Reading Room, Accession NumberML040410189.U.S. NUCLEAR REGULATORY COMMISSION               Revision 1February 2004REGULATORY GUIDEOFFICE OF NUCLEAR REGULATORY RESEARCHREGULATORY GUIDE 1.168(Draft was issued as DG-1123)VERIFICATION, VALIDATION, REVIEWS, AND AUDITS FORDIGITAL COMPUTER SOFTWARE USED IN SAFETY SYSTEMSOF NUCLEAR POWER PLANTS
{{#Wiki_filter:September 1997 U.S. NUCLEAR REGULATORY COMMISSION
REGULATORY GU
OFFICE OF NUCLEAR REGULATORY RESEARCH
REGULATORY GUIDE 1.168 (Draft was DG-1 054)  
VERIFICATION, VALIDATION, REVIEWS, AND AUDITS FOR
DIGITAL COMPUTER SOFTWARE USED IN SAFETY SYSTEMS
OF NUCLEAR POWER PLANTS


==A. INTRODUCTION==
==A. INTRODUCTION==
In 10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities," paragraph50.55a(a)(1) requires, in part, that structures, systems, and components be designed, tested, and inspected to quality standards commensurate with the importance of the safety function to be performed. In Appendix A, "General Design Criteria for Nuclear Power Plants," to 10 CFR Part 50,
In 10 CFR Part 50, "Domestic Licensing of Pro duction and Utilization Facilities," paragraph 55a(a)(1)  
Criterion 1, "Quality Standards and Records," requires, in part, that a quality assurance program be established and implemented in order to provide adequate assurance that structures, systems, and components important to safety will satisfactorily perform their safety functions. Appendix B,
requires, in part, that systems and components be de signed, tested, and inspected to quality standards com mensurate with the safety function to be performed. 1 Criterion 1, "Quality Standards and Records," of Ap pendix A, "General Design Criteria for Nuclear Power Plants," to 10 CFR Part 50 requires, in part, 1 that a qual ity assurance program be established and implemented in order to provide adequate assurance that systems and components important to safety will satisfactorily per form their safety functions. Appendix B, "Quality As surance Criteria for Nuclear Power Plants and Fuel Re processing Plants," to 10 CFR Part 50 describes criteria that must be met by a quality assurance program for systems and components that prevent or mitigate the consequences of postulated accidents. In particular, be sides the systems and components that directly prevent or mitigate the consequences of postulated accidents, the criteria of Appendix B also apply to all activities af fecting the safety-related functions of such systems and components, such as designing, purchasing, installing, t ln this regulatory guide, many of the requirements have been paraphrased;
"Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part
see 10 CFR Part 50 for the full text IDE
50 describes criteria that must be met by a quality assurance program for structures, systems, and components that prevent or mitigate the consequences of postulated accidents. In particular, besides the structures, systems, and components that directly prevent or mitigate the consequences of postulated accidents, the criteria of Appendix B also apply to all activities affecting the safety-related functions of such structures, systems, and components, such as designing, purchasing, installing, testing, operating, maintaining, or modifying. A specific requirement is contained in 10 CFR 50.55a(h)(2) that protection systems in nuclearpower plants with construction permits issued after January 1, 1971, but before May 13, 1999, must meet the requirements stated in either IEEE Std 279, "Criteria for Protection Systems for Nuclear
testing, operating, maintaining, or modifying. A spe cific requirement is contained in 10 CFR 50.55a(h),
1 IEEE publications may be obtained from the IEEE Service Center, 445 Hoes Lane, Piscataway, NJ 08854.2 Revision 1 of Regulatory Guide 1.153, "Criteria for Safety Systems," endorses IEEE Std 603-1991, "Criteria for Safety Systemsfor Nuclear Power Generating Stations," as a method acceptable to the NRC staff for satisfying the NRC's regulations withrespect to the design, reliability, qualification, and testability of the power, instrumentation, and control portions of the safetysystems of nuclear power plants.1.168-2Power Generating Stations,"1 or in IEEE Std 603-1991, "Criteria for Safety Systems for Nuclear Power Generating Stations," and the correction sheet dated January 30, 1995.1,2 The NRC staffconsiders IEEE Std 279-1971 to meet the requirements in 10 CFR 50.55a(h)(2).  Protection systems in nuclear power plants with construction permits issued before January 1, 1971, are to be consistent with their licensing basis or may meet the requirements of IEEE Std 603-1991 and the correction sheet dated January 30, 1995.  Protection systems in applications filed on or after May
which requires that reactor protection systems satisfy the criteria of IEEE Std 279-1971, "Criteria for Protec tion Systems for Nuclear Power Generating Stations." 2 Paragraph 4.3 of IEEE Std 279-19713 states that quali ty of components is to be achieved through the specifi cation of requirements known to promote high quality, such as requirements for design, inspection, and test.
13, 1999, are to meet the requirements for safety systems in IEEE Std 603-1991 and the correction sheet dated January 30, 1995.Clause 4.3 of IEEE Std 279-1971 states that the quality of components is to be achievedthrough the specification of requirements known to promote high quality, such as requirements for design, inspection, and test.  Clause 5.3 of IEEE Std 603-1991 states that components and modules (of safety systems) must be of a quality that is consistent with minimum maintenance requirements and low failure rates.  Safety system equipment must be designed, manufactured, inspected, installed, tested, operated, and maintained in accordance with a prescribed quality assurance program. Note that guidance on the application of these criteria for safety system equipmentemploying digital computers and programs or firmware is found in IEEE Std 7-4.3.2-1993,
"Standard Criteria for Digital Computers in Safety Systems of Nuclear Power GeneratingStations,"1 which is endorsed by Revision 1 of Regulatory Guide 1.152, "Criteria for DigitalComputers in Safety Systems of Nuclear Power Plants."In Appendix B to 10 CFR Part 50, many of the criteria contain requirements closely relatedto the activities of verification and testing.  Criterion I, "Organization," in describing theestablishment and execution of a quality assurance program, specifies that applicants must (a)
ensure that an appropriate quality assurance program is established and effectively executed and (b) verify, such as by checking, auditing, and inspection, that activities affecting safety-related functions have been correctly performed.  Criterion II, "Quality Assurance Program," states, inpart, that activities affecting quality must be accomplished under suitably controlled conditions.


Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that all prerequisites for the given activity have been satisfied. It also states, in part, that the program must take into account the need for verification of quality by inspection and test. Criterion III, "Design Control," requires, in part, that design controlmeasures provide for verifying or checking the adequacy of design. Criterion XI, "Test Control,"requires, in part, that a test program be established to ensure that all testing required to demonstrate that structures, systems, and components will perform satisfactorily in service is identified and performed in accordance with written test procedures that incorporate the requirements and acceptance limits contained in applicable design documents. Finally, Criterion XVIII, "Audits," requires, in part, that a comprehensive system of planned and periodic audits be  
In Appendix B,1 "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,"
3 The term "safety systems" is synonymous with "safety-related systems."  The General Design Criteria cover structures, systems,and components "important to safety."  The scope of this regulatory guide is, however, limited to "safety systems."1.168-3carried out to verify compliance with all aspects of the quality assurance program and to determinethe effectiveness of the program.This regulatory guide endorses IEEE Std 1012-1998, "IEEE Standard for SoftwareVerification and Validation,"1 and IEEE Std 1028-1997, "IEEE Standard for Software Reviewsand Audits."1 IEEE Std 1012-1998, with the exceptions stated in the Regulatory Position,describes a method acceptable to the NRC staff for complying with parts of the NRC's regulationsfor promoting high functional reliability and design quality in software used in safety systems.3  Inparticular, the method is consistent with the previously cited General Design Criteria and the criteria for quality assurance programs in Appendix B, as applied to software verification and validation (V&V). The criteria of Appendices A and B apply to systems and related quality assurance processes. If those systems include software, the requirements extend to the software elements. IEEE Std 1028-1997 provides guidance acceptable to the NRC staff for carrying out software reviews, inspections, walkthroughs, and audits subject to certain provisions.In general, information provided by regulatory guides is reflected in the Standard ReviewPlan, NUREG-0800. The Office of Nuclear Reactor Regulation uses the Standard Review Plan to review applications to construct and operate nuclear power plants. This regulatory guide provides guidance that is consistent with the revised Chapter 7 of NUREG-0800; Section 7.0,
to 10 CFR Part 50, many of the criteria contain require ments closely related to the activities of verification and testing. Criterion I, "Organization," of Appendix B, in describing the establishment and execution of a quality assurance program, specifies that applicants must (a) assure that an appropriate quality assurance program is established and effectively executed and (b)
"Instrumentation and Controls," which was revised in June 1997.The information collections contained in this regulatory guide are covered by therequirements of 10 CFR Part 50, which were approved by the Office of Management and Budget (OMB), approval number 3150-0011. The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.
2Revision 1 of Regulation Guide 1.153, "Criteria for Safety Systems," en dorses IEEE Std 603-199 1, "Criteria for Safety Systems for NuclearPow er Generating Stations," as a method acceptable to the NRC staff for satis fying the NRC's regulations with respect to the design, reliability, qualifi cation, and testability of the power, instrumentation, and control portions of the safety systems of nuclear power plants.
 
31EEE publications may be obtained from the IEEE Service Center, 445 Hoes Lane, Piscataway, NJ 08854.
 
USNRC REGULATORY GUIDES
The glides ae Issued In the following ten broad divisions:
Regulatory Guides wre issued to describe and make available to toe public ruch Inrforma Non as mehods aoceptable to the NRC slff for Implementing specific parts of tie Com-
 
===1. Power Reactors ===
8. Products mssionfs regultJons, tediques used byt,*etf ieveltuing specific problemsor pos-
2. Research and Test Reactors
7. Transportation tulated accidents, and data needed by fe NRC=
taff n review of applications or per-
. Fuels and Materials Facilities
&. Occupational Health mile and licenses. Regulatory gOides are not eubstitutes for regulationa
"d compliance
& Environentsl end Siting
9. Antitrust and Financial Review with them Is not required. Methods end solutions different rom those et out In theguides
&. Materials and Plant Protection
10. General wil be acceptable Nt dey provide a basis for the fincligs requisite to the Issuance or con Ilrajnce of a permit or license by fti Commisasion.
 
Single copies of regulatory guides may be obtained free of charge by writing gie Printing.
 
This gOide was Issued ater consideration of comments received ftni the public, Corn- G*raphics and Distribution rench, Offoce of Admlnistraftio U.S. Nuclear Regulatory Corn ments ard suggestions for Improvements Inthese guides ae encouaaged idal tines, and mission, Washington, DC 20555-0001; or by fax at (301)415-5272.
 
will be revised, as appropriate, to accommodate comments and to reflect new In
=
on or o~erlnce.
 
Issued guides may also be purchased from tie National Techdical Information Service on Writtn comments may be submitted to the Rules Review and Directives Branch. DFIPS,
a standing order basis. Details on ths service may be obtained by writing NTIS, 5285 Port ADM, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
 
Royal Road, Springfield, VA 22161.
 
/
 
verify, such as by checking, auditing, and inspection, that activities affecting safety-related functions have been correctly performed. Criterion II, "Quality Assur ance Program," of Appendix B states, in part, that activ ities affecting quality must be accomplished under suit ably controlled conditions. Controlled conditions include the use of appropriate equipment, suitable envi ronmental conditions for accomplishing the activity, and assurance that all prerequisites for the given activi ty have been satisfied. It also states, in part, that the pro gram must take into account the need for verification of quality by inspection and test. Criterion III, "Design Control," of Appendix B requires, in part, that design control measures provide for verifying or checking the adequacy of design. Criterion XI, "Test Control,"  
requires, in part, that a test program be established to ensure that all testing required to demonstrate that structures, systems, and components will perform sat isfactorily in service is identified and performed in accordance with written test procedures that incorpo rate the requirements and acceptance limits contained in applicable design documents. Finally, Criterion XVIII, "Audits," requires, in part, that a comprehensive system of planned and periodic audits be carried out to verify compliance with all aspects of the quality assur ance program and to determine the effectiveness of the program.
 
This regulatory guide endorses IEEE Std  
1012-1986,3 "IEEE Standard for Software Verification
*/
and Validation Plans," and IEEE Std 1028-1988,3
"IEEE Standard for Software Reviews and Audits."  
IEEE Std 1012-1986, with the exceptions stated in the Regulatory Position, describes a method acceptable to the NRC staff for complying with parts of the NRC's regulations for promoting high functional reliability and design quality in software used in safety systems. 4 In particular, the method is consistent with the pre viously cited General Design Criteria and the criteria for quality assurance programs in Appendix B, as applied to software verification and validation. The cri teria of Appendices A and B apply to systems and related quality assurance processes, and if those sys tems include software, the requirements extend to the software elements. IEEE Std 1028-1988 provides an approach that is acceptable to the NRC staff for carry
4The term "safety systems" is synonymous with "safety-related systems."
The General Design Criteria cover systems, structures, and components
"important to safety." The scope of this regulatory guide is, however, limited to "safety systems," which are a subset of"systems important to safety."
ing out software reviews, inspections, walkthroughs, and audits subject to certain provisions.
 
In general, information provided by regulatory guides is reflected in the Standard Review Plan (NUREG-0800). The Office of Nuclear Reactor Regu lation uses the Standard Review Plan to review applica tions to construct and operate nuclear power plants.
 
This regulatory guide will apply to the revised Chapter  
7 of the Standard Review Plan.
 
The information collections contained in this regu latory guide are covered by the requirements of 10 CFR  
Part 50, which were approved by the Office of Manage ment and Budget, approval number 3150-0011. The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information un less it displays a currently valid OMB control number.


==B. DISCUSSION==
==B. DISCUSSION==
The use of industry consensus standards is part of an overall approach to meeting therequirements of 10 CFR Part 50 when developing safety systems for nuclear power plants.
The use of industry consensus standards is part of an overall approach to meeting the requirements of  
10 CFR Part 50 when developing safety systems for nuclear power plants. Compliance with standards does not guarantee that regulatory requirements will be met.


Conformance to such standards does not guarantee that regulatory requirements will be met.
However, compliance does ensure that practices accepted within various technical communities will be incorporated into the development and quality assur ance processes used to design safety systems. These practices are based on experience, and they represent industry consensus on approaches used for develop ment of such systems.


However, conformance does ensure that practices accepted within various technical communities will be incorporated into the development and quality assurance processes used to design safety systems.  These practices are based on experience, and they represent industry consensus on approaches used for development of such systems.Software incorporated into instrumentation and control systems covered by Appendix Bwill be referred to in this regulatory guide as safety system software.  For safety system software, software V&V, reviews, and audits are important parts of the effort to achieve compliance with NRC requirements.  Software engineering practices rely, in part, on software V&V and on
Software incorporated into instrumentation and control systems covered by Appendix B will be referred to in this regulatory guide as safety system software.
1.168-4technical reviews and audits to meet general quality and reliability requirements in Criteria 1 and21 of Appendix A to 10 CFR Part 50, as well as Criteria II, III, XI, and XVIII of Appendix B.  Inaddition, management reviews and audits of software processes are part of a verification process consistent with Criterion I of Appendix B.General design verification processes, but not details of software V&V planning and theconduct of reviews and audits, are described by IEEE Std 7-4.3.2-1993, which is endorsed by Revision 1 of Regulatory Guide 1.152, and ASME/NQA-1-1994, "Quality AssuranceRequirements for Nuclear Facility Applications."  Two consensus standards on softwareengineering, IEEE Std 1012-1998 and IEEE Std 1028-1997 (reaffirmed in 2002), describe the software industry's approaches to software verification, validation, review, and audit activities thatare generally accepted in the software engineering community.  Meeting these standards helps to meet regulatory requirements by ensuring that disciplined software V&V, review, and audit practices accepted within the software community will be incorporated into software processes applied to safety system software.  IEEE Std 1012-1998 describes the process of software V&V,
including elements of a software V&V plan, and describes a minimum set of V&V activities for software at different integrity levels.  IEEE Std 1028-1997 is a process standard that provides guidance on how to conduct audits, inspections, and walkthroughs, and technical and management reviews.Technical reviews, some audits, and software inspections and walkthroughs are focused onthe V&V of products of the software development process.  Management reviews and other audits are focused on ensuring that planned activities are being accomplished effectively.  Reviews and audits are closely associated with V&V activities since technical reviews and audits are frequently conducted by the V&V organization and because the V&V organization normally participates in management reviews.  Because of this close connection of the V&V activity with reviews and audits, IEEE Std 1012-1998 and IEEE Std 1028-1997 are addressed together in this regulatory guide.Additional information on conducting software reviews can be found in the annexes toIEEE Std 1028-1997.  Annex A lists different review titles and shows which of the five review types in the standard are appropriate to use with each review title.  For example, a Software Requirements Review may be carried out using the IEEE Std 1028-1997 Technical Review.


Annex B to IEEE Std 1028-1997 compares the five review types according to various characteristics of the review types and provides guidance in choosing a review type.This regulatory guide is based on current standards and describes methods acceptable forany safety system software. This regulatory guide discusses required V&V activities. The applicant or licensee determines how the required activities will be implemented.
For safety system software, software verification and validation (V&V), reviews, and audits are important parts of the effort to achieve compliance with the NRC's requirements. Software engineering practices rely, in part, on software V&V and on technical reviews and audits to meet general quality and reliability requirements consistent with Criteria 1 and 21 of Ap pendix A to 10 CFR Part 50, as well as Criteria II, III,
XI, and XVIII of Appendix B. In addition, manage ment reviews and audits of software processes are part of a verification process consistent with Criterion I of Appendix B.
 
General design verification requirements, but not details of software V&V planning and the conduct of reviews and audits, are described by IEEE Std
7-4.3.2-1993, "Standard Criteria for Digital Comput ers in Safety Systems of Nuclear Power Generating Sta tions," 3 which is endorsed by Revision 1 of Regulatory
1.168-2 K
 
Guide 1.152, "Criteria for Digital Computers in Safety Systems of Nuclear Power Plants," and ASME/
NQA-1-1994, "Quality Assurance Requirements for
)j Nuclear Facility Applications." Two consensus stan dards on software engineering, IEEE Std 1012-1986 (reaffirmed in 1992) and IEEE Std 1028-1988 (re affirmed in 1993), describe the software industry's ap proaches to software verification, validation, review, and audit activities that are generally accepted in the software engineering community. Compliance with these standards helps to meet regulatory requirements by ensuring that disciplined software V&V, review, and audit practices accepted within the software communi ty will be incorporated into software processes applied to safety system software. IEEE Std 1012-1986 de scribes the elements of a software V&V plan and, for software deemed "critical software" by IEEE Std
1012-1986, describes a minimum set of V&V activi ties to be included in the plan. IEEE Std 1028-1988 is a process standard that provides guidance on how to con duct audits, inspections and walkthroughs, and techni cal and management reviews.
 
Technical reviews, some audits, and software in spections and walkthroughs are focused on the verifica tion and validation of products of the software develop ment process. Management reviews and other audits are focused on ensuring that planned activities are be ing accomplished effectively. Reviews and audits are closely associated with V&V activities since technical reviews and audits are frequently conducted by the V&V organization and because the V&V organization normally participates in management reviews. Because of this close connection of the V&V activity with reviews and audits, IEEE Std 1028-1988 and IEEE Std
1012-1986 are addressed together in this regulatory guide.
 
IEEE Std 603-1991 and IEEE Std 7-4.3.2-1993, which are endorsed by Revision 1 of Regulatory Guide
1.153 and Revision 1 of Regulatory Guide 1.152, respectively, do not provide for classification, although the foreword to IEEE Std 7-4.3.2-1993 recommends the addition of grading to future versions of IEEE Std
603. This regulatory guide is based on current standards and describes methods acceptable for any safety system software. Within the framework of the acceptable methods described by this regulatory guide, certain V&V activities are required. For smaller, less complex systems or components, these activities should require
>
less effort. Additionally, the applicant or licensee deter mines how the required activities will be implemented, commensurate with the item's importance to safety.
 
The benefits of this approach are that the concepts ad dressed in the standard are applied within the context of safety system development while the applicant or licensee has flexibility in implementation.


==C. REGULATORY POSITION==
==C. REGULATORY POSITION==
IEEE Std 1012-1998, "IEEE Standard for Software Verification and Validation," providesmethods that are acceptable to the NRC staff for meeting the requirements of 10 CFR Part 50 as
The requirements specified in IEEE Std 1012
1.168-5they apply to the verification and validation of safety system software, subject to the exceptionslisted in these Regulatory Positions.The methods in IEEE Std 1028-1997, "IEEE Standard for Software Reviews and Audits,"provide an approach acceptable to the NRC staff for carrying out software reviews, inspections, walkthroughs, and audits, subject to the exceptions listed below in Regulatory Position 8. These methods are often used in association with software quality assurance activities.The annexes to IEEE Std 1012-1998 and IEEE Std 1028-1997 contain information thatmay be useful, but the information in these annexes should not be viewed as the only possible solution or method.  Since a consensus has not been reached in the nuclear industry regarding the use of these methods, these annexes are not endorsed by the NRC staff, except as noted below.In this Regulatory Position, the cited criteria are in Appendix B to 10 CFR Part 50 unlessotherwise noted.1.CRITICAL SOFTWAREIEEE Std 1012-1998 defines a four-level method of quantifying software criticality, inwhich level 4 is the highest and level 1 the lowest (Clause 4.1). IEEE Std 1012-1998 requires the applicant or licensee either use the method in the standard or define another method and provide a mapping between the applicant's or licensee's method and the method defined in the standard. Software used in nuclear power plant safety systems should be assigned integrity level 4 or equivalent, as demonstrated by a mapping between the applicant or licensee approach and integrity level 4 as defined in IEEE Std 1012-1998.2.SOFTWARE RELIABILITYIn its discussion of component and integration test plans in Table 1, IEEE Std 1012-1998identifies measurement of software reliability as a criterion for determining whether software elements "correctly implement software requirements" (Activity 5.4.3, "Design V&V Activity,"Task (5), "Component V&V Test Plan Generation and Verification," and Task (6), "IntegrationV&V Test Plan Generation and Verification").Consistent with the staff's position on reliability measures for digital safety systemscontained in other regulatory guides, the NRC staff's acceptance of quantitative reliability goals for computer-based safety systems is predicated on deterministic criteria for the computer system in its entirety (i.e., hardware, system software, firmware, application, and interconnections).3.INDEPENDENCE OF SOFTWARE VERIFICATION AND VALIDATIONCriterion I, "Organization," requires that persons and organizations performing qualityassurance functions report to a management level such that sufficient authority and organizational freedom exist, including sufficient independence from cost and schedule limitation
1986 provide an approach that is acceptable to the NRC  
staff for meeting the requirements of 10 CFR Part 50  
and the guidance given in Revision 1 of Regulatory Guide 1.152, "Criteria for Digital Computers in Safety Systems of Nuclear Power Plants," as they apply to the verification and validation of safety system software, subject to the exceptions listed below in Regulatory Positions 1 through 8 and 11.
 
IEEE Std 1028-1988 provides an approach accept able to the NRC staff for carrying out software reviews, inspections, walkthroughs, and audits, subject to the exceptions listed below in Regulatory Positions 9 through 11. These are often performed in association with V&V or software quality assurance activities.
 
Except as noted below, the appendices to these stan dards are not covered by this regulatory guide. In this Regulatory Position, the cited criteria are in Appendix B to 10 CFR Part 50 unless otherwise noted.
 
To meet the requirements of 10 CFR 50.55a(h) and Appendix A of 10 CFR Part 50 as ensured by comply ing with the criteria of Appendix B applied to the verifi cation, validation, reviews, and audits of safety system software, the following exceptions are necessary and will be considered by the NRC staff in the review of submittals from applicants and licensees.
 
1.
 
CRITICAL SOFTWARE
IEEE Std 1012-1986 refers to critical and noncriti cal software. It defines the contents of a Software V&V
Plan (SVVP) for all software and, for critical software, identifies a minimum set of software V&V tasks and their inputs and outputs that must be included in the SVVP. Critical software is defined in IEEE Std
1012-1986 to be software whose failure could have an impact on safety or could cause large financial or social loss. For the purposes of this regulatory guide, critical software means software used in nuclear power plant safety systems per footnote 4 of this guide, a narrower set of critical software than that defined in IEEE Std  
1012-1986.
 
2.
 
SOFTWARE RELUABILITY
In its discussion of component and integration test plans in Table 1, IEEE Std 1012-1986 identifies measurement of software reliability as a criterion for
1.168-3
 
determining whether software elements correctly im plement software requirements. The following is noted in Revision I of Regulatory Guide 1.152.
 
Section
5.15,
"Reliability,"
of IEEE Std
7-4.3.2-1993 states, "When qualitative or quanti tative reliability goals are required, the proof of meeting the goals shall include software used with the hardware." The staff does not endorse the con cept of quantitative reliability goals as a sole means of meeting the Commission's regulations for reliability of the digital computers used in safety systems.
 
3. INDEPENDENCE OF SOFTWARE V&V
IEEE Std 1012-1986 does not require indepen dence in the performance of software V&V, but the NRC does require independence. Criterion III, "Design Control," imposes an independence requirement for the verification and checking of the adequacy of the design, requiring that those who perform the verification and checking be different from those who accomplish the design. Approaches to performing independent soft ware V&V are described in Revision 1 of Regulatory Guide 1.152. Regardless of the approach selected for a given V&V task, the responsibility for the adequacy of V&V lies with the organization responsible for the in dependent V&V. The person accountable for V&V
must also be independent of the person accountable for the design. This independence must be sufficient to en sure that the V&V process is not compromised by schedule and resource demands placed on the design process. The independent verifiers must be sufficiently competent in software engineering to ensure that soft ware V&V is adequately implemented. Criterion II,  
"Quality Assurance Program," states that the program must provide for indoctrination and training of person nel performing activities affecting quality as necessary to ensure that suitable proficiency is achieved and maintained. It is beneficial if the independent verifiers are also knowledgeable regarding nuclear applications.
 
===4. DESIGN CHANGES ===
IEEE Std 1012-1986, in paragraph 3.7.2, requires a description in the SVVP of the criteria for determin ing the extent to which a V&V task must be reper formed following a change to an input of the task. The criteria described in the SVVP must be consistent with Criterion III, "Design Control," which requires that de sign changes be subject to design control measures commensurate with those applied to the original de sign. In addition, IEEE Std 1012-1986 includes cost and schedule as possible criteria for determining the ex- tent of re-performance of V&V tasks. Such cost and schedule criteria, if used, must be commensurate in im portance with the cost and schedule criteria that applied to verification of the original design. Any use of these criteria must be consistent with the requirement of 10
CFR 50.57(a)(3) that there be reasonable assurance that the activities authorized by the operating license can be conducted without endangering the health and safety of the public.
 
5.
 
CONFORMANCE OF MATERIALS
Criterion III, "Design Control," states that measures are to be established for the selection and re view for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems, and components. Criterion VII, "Control of Purchased Material, Equipment, and Services," states that measures are to be established to ensure that purchased material, whether purchased directly or through con tractors and subcontractors, conform to the procure ment documents. In its discussion of V&V during the operation and maintenance phase of the software life cycle, IEEE Std 1012-1986 (in paragraph 3.5.8) pro vides requirements and guidance for retrospective V&V of software that was not verified under the stan dard. The use of this guidance for the acceptance of pre existing (e.g., commercial off-the-shelf) critical soft ware not verified during development to the provisions of this regulatory guide or its equivalent is not en dorsed. Revision 1 of Regulatory Guide 1.152 provides information on the acceptance of pre-existing software.
 
Additional detailed information on acceptance pro cesses is available in EPRI TR-106439, "Guideline on Evaluation and Acceptance of Commercial Grade Dig ital Equipment for Nuclear Safety Applications" (Octo ber 1996). 5
 
===6. QUALITY ASSURANCE ===
Criterion I identifies the quality assurance func tions of (a) assuring that an appropriate quality assur ance program is established and effectively executed and (b) verifying, such as by checking, auditing, and in specting, that activities affecting the safety-related functions have been correctly performed. Criterion XVII requires that sufficient records be maintained to furnish evidence of activities affecting quality. Criteri on III requires that design changes be subject to design
511ectric Power Research Institute documents may be obtained from the EPRI Distribution Center, 207 Coggins Drive, P.O. Box 23205, Pleasant Hill, CA 94523. EPRI TR-106439 is also available for inspection or copying for a fee in the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555-0001; telephone
(202)634-3273;
fax
(202)634-3343.
 
1.168-4 K
 
control measures commensurate with those applied to the original design. In addition to the requirements of IEEE Std 1012-1986 (in paragraph 3.7.4) regarding control procedures, any V&V materials necessary for the verification of the effectiveness of the V&V pro grams or necessary to furnish evidence of activities af fecting quality must be maintained as quality assurance records. Those materials necessary for the reverifica tion of changes must be maintained under configura tion management. 6
7.


====s. Quality ====
TOOLS FOR SOFITWARE DEVELOPMENT
1.168-6assurance functions include "verifying, such as by checking, auditing, and inspection, thatactivities affecting the safety-related functions have been correctly performed."  Criterion III,"Design Control," imposes an independence requirement for the verification and checking of theadequacy of the design, requiring that those who perform the verification and checking be persons other than those who performed the design.  A method of performing independent software V&V
Tools used in the development of safety system software should be handled according to IEEE Std
is described in Revision 1 of Regulatory Guide 1.152. Another acceptable method is described in IEEE Std 1012-1998 in Clause 7.4.1 and Annex C.Regardless of the approach selected for a given V&V task, ultimate responsibility for theadequacy of V&V and the quality of subsequent safety system software lies with the applicant or licensee.  This is particularly important when an external organization has performed the V&V
7-4.3.2-1993, "Standard Criteria for Digital Comput ers in Safety Systems of Nuclear Power Generating Sta tions," as endorsed by Revision 1 of Regulatory Guide  
tasks (e.g., a licensee acquires a commercial-grade product approved by the NRC staff for implementation in a safety-related system).  In these cases, the applicant or licensee is not relieved of the responsibility of assuring that the V&V and subsequent software quality satisfy the NRC'srequirements for reliability.  As such, the extent of independence between the organization responsible for design and the organization responsible for verification and checking of the design must be verified by the applicant or licensee to meet the NRC's requirements contained inAppendix B.  This independence is to be sufficient to ensure that the V&V process is not compromised by schedule and resource demands placed on the design process.  Criterion II,
1.152. IEEE Std 7-4.3.2-1993 states that "V&V tasks of witnessing, reviewing, and testing are not required for software tools, provided the software that is pro duced using the tools is subject to V&V activities that will detect flaws introduced by the tools." If this cannot be demonstrated, the provisions of this Regulatory Guide 1.168 are applicable.
"Quality Assurance Program," states that the program must provide for indoctrination and trainingof personnel performing activities affecting quality as necessary to ensure that suitable proficiency is achieved and maintained.  The independent verifiers must be sufficiently proficient in software engineering to ensure that software V&V is adequately implemented.  Accordingly, it is beneficial if the independent verifiers are also knowledgeable regarding nuclear applications. IEEE Std 1012-1998 provides guidance for establishing financial, managerial, andtechnical independence for software V&V.  Criterion 1 of Appendix B requires that persons and organizations performing quality assurance functions report to a management level such that they have authority and organizational freedom, including independence from cost and schedule considerations, sufficient to identify quality problems; initiate, recommend, or provide solutions;
and verify implementation of solutions.  The IEEE Std 1012-1998 guidance for financial independence provides appropriate freedom with respect to the V&V organization's budget, andthe standard's guidance for managerial independence provides appropriate freedom with respect toV&V schedules, as well as overall project cost and schedule considerations.Similarly, the IEEE Std 1012-1998 guidance for technical independence satisfies therequirements in Criterion III of Appendix B that design verification or checking be performed by individuals or groups other than those who performed the original design.  Note that Clause C.4.1 of IEEE Std 1012-1998 states that the V&V responsibility "is vested in an organization that isseparate from the development organization." The NRC staff position is that this does not meanthat a separate company should perform independent V&V.  However, the requirements specified in Criterion I and III of Appendix B described above must be met. 4.CONFORMANCE OF MATERIALS
4 Available from EPRI Distribution Center, 207 Coggins Drive, P.O. Box 23205, Pleasant Hill, CA 94523; phone 510-934-4212.1.168-7Criterion III, "Design Control," states that measures are to be established for the selectionand review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems, and components to which Appendix B applies. Criterion VII, "Control of Purchased Material, Equipment, and Services,"states that measures are to be established to ensure that purchased material, whether purchased directly or through contractors and subcontractors, conforms to the procurement document


====s. IEEE====
8.
Std 1012-1998 provides guidance for retrospective V&V of software that was not verified under the standard.  Specifically, Clauses 1.2, 1.4, and 4.1, Task 1 of Activity 5.6.1 in Table 1, and Annex D, "V&V of Reusable Software," discuss V&V of pre-existing (e.g., commercial off-the-shelf) software during the operation and maintenance phase of the software lifecycle.  The use of this guidance for the acceptance of pre-existing safety system software not verified during development to the provisions of this regulatory guide or its equivalent is not endorse


====d. Revision====
V&V TASKS
1 of Regulatory Guide 1.152 provides information on the acceptance of pre-existing software.
Table 2 of IEEE Std 1012-1986 lists optional V&V
)/
tasks. These are further described in the appendix (which is for information only) to IEEE Std
1012-1986. These tasks are intended to provide a tai loring capability by allowing tasks to be added to the minimum set for critical software. Exception is taken to the 'optional' status of some tasks on this list; they are considered by the NRC staff to be acceptable methods for meeting the requirements of Appendices A and B to
10 CFR Part 50 as applied to software, regardless of whether they are performed by the V&V organization.


Additional detailed information on acceptance processes is available in EPRI TR-106439,
The following tasks are considered by the NRC staff to be part of the minimum set of V&V activities for criti cal software unless they are (1) incorporated into other V&V tasks in the SVVP or (2) performed outside the software V&V organization as part or all of the duties of some other organization.
"Guideline on Evaluation and Acceptance of Commercial Grade Digital Equipment for NuclearSafety Applications" (October 1996).45.QUALITY ASSURANCECriterion I identifies the quality assurance functions of (a) ensuring that an appropriatequality assurance program is established and effectively executed and (b) verifying, such as by checking, auditing, and inspecting, that activities affecting the safety-related functions have been correctly performed.  Criterion XVII requires that sufficient records be maintained to furnish evidence of activities affecting quality.  Criterion III requires that design changes be subject todesign control measures commensurate with those applied to the original design.  In addition to the provisions of IEEE Std 1012-1998 (in Clause 7.7.4) regarding control procedures, any V&V
materials necessary for the verification of the effectiveness of the V&V programs or necessary to furnish evidence of activities affecting quality should be maintained as quality assurance records.


The records necessary for the verification of changes must be maintained in accordance with Criterion XVII.6.TOOLS FOR SOFTWARE DEVELOPMENTTools used in the development of safety system software should be handled according toIEEE Std 7-4.3.2-1993,1 as endorsed by Revision 1 of Regulatory Guide 1.152.  IEEE Std 7-4.3.2-1993 states that "V&V tasks of witnessing, reviewing, and testing are not required for softwaretools, provided the software that is produced using the tools is subject to V&V activities that will detect flaws introduced by the tools."  If this cannot be demonstrated, the provisions of thisregulatory guide are applicable.7.VERIFICATION AND VALIDATION TASKS
8.1 Configuration Management Configuration management (CM), and software configuration management in particular, are not option al functions, but are identification and control functions considered to be mandatory under Criterion VIII,  
1.168-8Table 3 of IEEE Std 1012-1998 lists "optional" V&V tasks.  These are further described inAnnex G (which is for information only) to IEEE Std 1012-1998. These tasks are intended to provide a tailoring capability by allowing tasks to be added to the minimum set for critical software.  Exception is taken to the "optional" status of some tasks on this list; they are consideredby the NRC staff to be necessary components of acceptable methods for meeting the requirements of Appendices A and B to 10 CFR Part 50 as applied to software, regardless of whether they are performed by the V&V organization. The following tasks are considered by the NRC staff to be part of the minimum set of V&V activities for critical software unless they are (1) incorporated into other V&V tasks in the software verification and validation plan (SVVP) or (2) performed outside the software V&V organization as part or all of the duties of some other organization.7.1Audits Criterion I of Appendix B defines quality assurance functions as including verifying, suchas by checking, auditing, and inspection, that activities affecting safety-related functions have been correctly performed.  Criterion III requires design control measures for verifying or checking the adequacy of design. Safety system software V&V organizations may employ audits, including functional audits, in-process audits, and physical audits of software. Although these audits are commonly considered to be the responsibility of the software quality assurance organization and the configuration management organization, they may be performed and relied upon by the V&V
6See the guidance in Regulatory Guide
organization. If so, the audits should be described in the SVVP. An acceptable method of conducting these audits is described in IEEE Std 1028-1997.7.2Regression Analysis and TestingCriterion III, "Design Control," requires that design changes be subject to design controlmeasures commensurate with those applied to the original design. Regression analysis and testing following the implementation of software modifications is an element of the V&V of software changes. It is considered by the NRC staff to be part of the minimum set of software V&V
1.169, "Configuration Management Plans for Digital Computer Software Used in Safety Sys tems of Nuclear Power Plants."
activities for safety system software.7.3Security AssessmentA security breach of a digital system containing safety system software has the potential toprevent that software from fulfilling its safety function.  Appendix A imposes functional and reliability requirements with respect to safety systems.  According to 10 CFR 73.46, vital equipment (which includes safety system software) must be protected by physical barriers and access control. The NRC staff considers security assessment of safety system software to be part of the minimum set of software V&V activities for such software.7.4Test EvaluationTest evaluation includes confirming the technical adequacy of test materials such as plans,designs, and results. These materials are evaluated for consistency with Criterion II, "Quality  
"Identification and Control of Materials, Parts, and Components," as applied to software. The same per sonnel who perform the V&V functions may perform the software configuration management functions.
1.168-9Assurance Program," in its requirement for controlled conditions, and with Criterion XI, "TestControl," in its requirement for the evaluation of test results.7.5Evaluation of User Documentation User documentation is important to the safe operation and proper maintenance of safetysystem software. The requirements of Criterion III, "Design Control," for correctly translating thedesign basis of safety system software into specifications, procedures, drawings, and instructions, apply to software documentation, including user documentation.8.OTHER CODES AND STANDARDSVarious sections of IEEE Std 1012-1998 and IEEE Std 1028-1997 reference other industrycodes and standards. These references to other standards should be treated individually. If a referenced standard has been incorporated separately into the NRC's regulations, licensees andapplicants must comply with that standard as set forth in the regulation. If the referenced standard has been endorsed in a regulatory guide, the standard constitutes a method acceptable to the NRC
 
staff for meeting a regulatory requirement as described in the regulatory guide. If a referenced standard has been neither incorporated into the NRC's regulations nor endorsed in a regulatoryguide, licensees and applicants may consider and use the information in the referenced standard, if appropriately justified, consistent with current regulatory practice.
8.2 Audits Criteria III, "Design Control," and XVIII, "Au dits," require the performance of audits. These audits include functional audits, in-process audits, and physi cal audits for software. These audits are commonly considered to be the responsibility of the software qual ity assurance organization and the configuration man agement organization, but they may be handled by the V&V organization. If so, the audits should be described in the SVVP. An acceptable method of conducting these audits is described in IEEE Std 1028-1988.
 
8.3 Regression Analysis and Testing Criterion III, "Design Control," requires that design changes be subject to design control measures commensurate with those applied to the original design. Regression analysis and testing following the implementation of software modifications is a neces sary element of the V&V of software changes. It is con sidered by the staff to be part of the minimum set of software V&V activities for critical software.
 
8.4 Installation and Checkout Testing Criterion XI, "Test Control," requires that the test program include, as appropriate, proof tests prior to installation, pre-operational tests, and operational tests.
 
The user of IEEE Std 1012-1986 must identify in the SVVP which tests will be performed to meet Criterion XI.
 
8.5 Test Evaluation
.Test evaluation, an optional task described in the Appendix to IEEE Std 1012-1986, calls for confirma tion of the technical adequacy of test materials such as plans, designs, and results. The evaluation of these ma terials is necessary for consistency with Criterion II,  
"Quality Assurance Program," in its requirement for controlled conditions and with Criterion XI, "Test Con trol," in its requirement for the evaluation of test results.
 
8.6 Evaluation of User Documentation Table 2 of IEEE Std 1012-1986 includes User Documentation Evaluation as an optional V&V task.
 
The requirements of Criterion III, "Design Control,"  
for verifying and checking the design apply to software documentation, including user documentation.
 
1.168-5
 
===9. CLARIFICATIONS ===
Criterion III, "Design Control," requires measures, such as the performance of design reviews, to be pro vided for verifying or checking the adequacy of the design, and Criterion II, "Quality Assurance Program,"
requires activities affecting quality to be accomplished under suitably controlled conditions. Criterion V,
"Instructions, Procedures, and Drawings," requires activities affecting quality to be directed by written instructions, procedures, and drawings that include ac ceptance criteria for determining that these activities are successfully accomplished. IEEE Std 1028-1988 contains a mix of verbs (such as "will," variants of "to be," or verbs used in the present tense (as described be low)), and it may not be clear whether the usage is in tended to be a requirement of the standard or a state ment of fact. In this regulatory guide, the following are considered to be conditions for audits and reviews.
 
9.1 The responsibilities and prerequisites of sections
3.1 and 3.2 and the minimum process description template of section 3.3 of IEEE Std 1028-1988.
 
9.2 Anything with the terms "must," "required,"
"shall," "minimum requirements," "is responsible for," "will ensure," "is to (or 'is not allowed to'),"
"minimum input,"
"necessary input,"
"is conducted when," "reports that identify (or
'contain')," "output is," or variations of any of these terms.
 
9.3 The responsibilities, minimum inputs, entry and exit criteria, procedures, and auditability of items described in sections 4 through 8 of IEEE Std 1028, unless the IEEE Std 1028-1988 phraseology indicates a recommended or optional item.
 
10. TABLE 1 IN IEEE STD 1028-1988 In Table 1 in IEEE Std 1028-1988, the word 'in clude' in the column heading means representative but not exhaustive. Table 1 relates quality assurance processes to quality assurance objectives, adds 'test'
for completeness, and matches key processes to quality assurance objectives. In so doing, it does not provide an exhaustive list of all process and objective relation ships. In particular, the relationship of testing to verifi cation is not indicated, but this relationship is added by this regulatory guide.
 
11. OTHER CODES AND STANDARDS
Various sections of IEEE Std 1012-1986 and IEEE  
Std 1028-1988 reference other industry codes and stan dards. These references to other standards should be treated individually. If a referenced standard has been incorporated separately into the NRC's regulations, licensees and applicants must comply with that stan dard as set forth in the regulation. If the referenced stan dard has been endorsed in a regulatory guide, the stan dard constitutes a method acceptable to the NRC staff of meeting a regulatory requirement as described in the regulatory guide. If a referenced standard has been nei ther incorporated into the NRC's regulations nor en dorsed in a regulatory guide, licensees and applicants may consider and use the information in the referenced standard, if appropriately justified, consistent with cur rent regulatory practice  


==D. IMPLEMENTATION==
==D. IMPLEMENTATION==
The purpose of this section is to provide information to applicants and licensees regardingthe NRC staff's plans for using this regulatory guide. No backfitting is intended or approved inconnection with the issuance of this guide. Except when an applicant or licensee proposes or has previously established an acceptablealternative method for complying with the specified portions of the NRC's regulations, themethods described in this guide will be used in the evaluation of (1) submittals in connection with applications for construction permits, design certifications, operating licenses, and combined licenses involving safety system software, and (2) submittals from operating reactor licensees who voluntarily propose safety system software modifications that have a clear nexus to this guidance.
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. No back fitting is intended or approved in connection with the issuance of this guide.
 
Except in those cases in which an applicant or licensee proposes an acceptable alternative method for complying with the specified portions of the NRC's regulations, the methods described in this guide will be used in the evaluation of submittals in connection with applications for construction permits and operating licenses. This guide will also be used to evaluate sub mittals from operating reactor licensees who propose system modifications that are voluntarily initiated by the licensee if there is a clear nexus between the pro posed modifications and this guidance.
 
1.168-6 K
 
BIBLIOGRAPHY
2 Hecht, H., A.T. Tai, K.S. Tso, "Class 1E Digital Sys tems Studies," NUREG/CR-6113, USNRC, October
1993.1 Hecht, H., et al., "Verification and Validation Guide lines for High Integrity Systems," NUREG/CR-6293, USNRC, March 1995.1 Institute of Electrical and Electronics Engineers, "Stan dard Criteria for Digital Computers in Safety Systems of Nuclear Power Generating Stations," IEEE Std
7-4.3.2-1993.
 
Lawrence, J.D., "Software Reliability and Safety in Nuclear Reactor Protection Systems,"
NUREG/
CR-6101 (UCRL-ID-117524, Lawrence Livermore National Laboratory), USNRC, November 1993.1 ICopies may be purchased at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328 (telephone
(202)512-2249); or from the National Technical Information Service by writing NTIS at 5285 Port Royal Road, Springfield, VA 22161. Copies are available for inspection or copying for a fee from the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop L.-6, Washington, DC 20555-0001;
telephone (202)634-3273; fax (202)634-3343.


1 Copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328(telephone (202)512-1800); or from the National Technical Information Service by writing NTIS at 5285 Port Royal Road, Springfield, VA 22161; <http://www.ntis.gov/ordernow>; telephone (703)487-4650.  Copies are available for inspection orcopying for a fee from the NRC Public Document Room at 11555 Rockville Pike, Rockville, MD; the PDR's mailing address isUSNRC PDR, Washington, DC 20555; telephone (301)415-4737 or (800)397-4209; fax (301)415-3548; email is PDR@NRC.GOV.1.168-10BIBLIOGRAPHYHecht, H.A., T. Tai, K.S. Tso, "Class 1E Digital Systems Studies," NUREG/CR-6113, USNRC,October 1993.1Hecht, H., et al., "Review Guidelines for Software Languages for use in Nuclear Power PlantSafety Systems," NUREG/CR-6463, Revision 1, USNRC, October 1997.1Hecht, H., et al., "Verification and Validation Guidelines for High Integrity Systems,"NUREG/CR-6293, Volumes 1 and 2, USNRC, March 1995.1Lawrence, J.D., "Software Reliability and Safety in Nuclear Reactor Protection Systems,"NUREG/CR-6101 (UCRL-ID-117524, Lawrence Livermore National Laboratory), USNRC,
Lawrence, J.D., and G.G. Preckshot, "Design Factors for Safety-Critical Software,"  
November 1993.1Lawrence, J.D., and G.G. Preckshot, "Design Factors for Safety-Critical Software," NUREG/CR-6294, USNRC, December 1994.1Seth, S., et al., "High Integrity Software for Nuclear Power Plants: Candidate Guidelines,Technical Basis and Research Needs," NUREG/CR-6263, Volumes 1 and 2, USNRC, June 1995.1  
NUREG/CR-6294, USNRC, December 1994.1 Seth, S., et al., "High Integrity Software for Nuclear Power Plants: Candidate Guidelines, Technical Basis and Research Needs," NUREG/CR-6263, USNRC,  
1.168-11REGULATORY ANALYSISA separate regulatory analysis was not prepared for this regulatory guide.  The regulatoryanalysis prepared for Draft Regulatory Guide DG-1123, "Verification, Validation, Reviews, andAudits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants" (January2003), provides the regulatory basis for this regulatory guide as well. DG-1123 was issued for public comment as the draft of this present regulatory guide.  A copy of the regulatory analysis (attached to DG-1123) is available for inspection and copying for a fee at the U.S. Nuclear Regulatory Commission Public Document Room, 11555 Rockville Pike, Rockville, MD; the PDR's mailing address is USNRC PDR, Washington, DC 20555; telephone (301)415-4737 or 1-(800)397-4209; fax (301)415-3548; e-mail <PDR@NRC.GOV>.  DG-1123 is also available in the NRC's ADAMS system at WWW.NRC.GOV under Accession Number ML030270328.
June 1995.1 USNRC, "Criteria for Digital Computers in Safety Systems of Nuclear Power Plants," Regulatory Guide
1.152, Revision 1, January 1996.2 USNRC, "Standard Review Plan," NUREG-0800,
February 1984.1
2Single copies of regulatory guides may be obtained free of charge by writing the Office of Administration, Printing, Graphics and Distribu tion Branch, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; orby fax at (301)415-5272. Copies are available for in spection or copying for a fee from the NRC Public Document Room at
2120 L Street NW, Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555-0001; telephone (202)634-3273;  
fax (202)634-3343.


}}
REGULATORY ANALYSIS
A separate regulatory analysis was not prepared for this regulatory guide. The regulatory analysis prepared for Draft Regulatory Guide DG-1054, "Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants," provides the regulatory basis for this guide. A
copy of the regulatory analysis is available for inspection and copying for a fee at the NRC Public Document Room, 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555-0001; phone
(202)634-3273; fax (202)634-3343.
 
paper Federal Recycling Program
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Latest revision as of 02:07, 17 January 2025

(Draft Was DG-1054) Verification,Validation,Reviews & Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants
ML003740098
Person / Time
Issue date: 09/30/1997
From:
Office of Nuclear Regulatory Research
To:
References
DG-1054 RG-1.168
Download: ML003740098 (8)


September 1997 U.S. NUCLEAR REGULATORY COMMISSION

REGULATORY GU

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 1.168 (Draft was DG-1 054)

VERIFICATION, VALIDATION, REVIEWS, AND AUDITS FOR

DIGITAL COMPUTER SOFTWARE USED IN SAFETY SYSTEMS

OF NUCLEAR POWER PLANTS

A. INTRODUCTION

In 10 CFR Part 50, "Domestic Licensing of Pro duction and Utilization Facilities," paragraph 55a(a)(1)

requires, in part, that systems and components be de signed, tested, and inspected to quality standards com mensurate with the safety function to be performed. 1 Criterion 1, "Quality Standards and Records," of Ap pendix A, "General Design Criteria for Nuclear Power Plants," to 10 CFR Part 50 requires, in part, 1 that a qual ity assurance program be established and implemented in order to provide adequate assurance that systems and components important to safety will satisfactorily per form their safety functions. Appendix B, "Quality As surance Criteria for Nuclear Power Plants and Fuel Re processing Plants," to 10 CFR Part 50 describes criteria that must be met by a quality assurance program for systems and components that prevent or mitigate the consequences of postulated accidents. In particular, be sides the systems and components that directly prevent or mitigate the consequences of postulated accidents, the criteria of Appendix B also apply to all activities af fecting the safety-related functions of such systems and components, such as designing, purchasing, installing, t ln this regulatory guide, many of the requirements have been paraphrased;

see 10 CFR Part 50 for the full text IDE

testing, operating, maintaining, or modifying. A spe cific requirement is contained in 10 CFR 50.55a(h),

which requires that reactor protection systems satisfy the criteria of IEEE Std 279-1971, "Criteria for Protec tion Systems for Nuclear Power Generating Stations." 2 Paragraph 4.3 of IEEE Std 279-19713 states that quali ty of components is to be achieved through the specifi cation of requirements known to promote high quality, such as requirements for design, inspection, and test.

In Appendix B,1 "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,"

to 10 CFR Part 50, many of the criteria contain require ments closely related to the activities of verification and testing. Criterion I, "Organization," of Appendix B, in describing the establishment and execution of a quality assurance program, specifies that applicants must (a) assure that an appropriate quality assurance program is established and effectively executed and (b)

2Revision 1 of Regulation Guide 1.153, "Criteria for Safety Systems," en dorses IEEE Std 603-199 1, "Criteria for Safety Systems for NuclearPow er Generating Stations," as a method acceptable to the NRC staff for satis fying the NRC's regulations with respect to the design, reliability, qualifi cation, and testability of the power, instrumentation, and control portions of the safety systems of nuclear power plants.

31EEE publications may be obtained from the IEEE Service Center, 445 Hoes Lane, Piscataway, NJ 08854.

USNRC REGULATORY GUIDES

The glides ae Issued In the following ten broad divisions:

Regulatory Guides wre issued to describe and make available to toe public ruch Inrforma Non as mehods aoceptable to the NRC slff for Implementing specific parts of tie Com-

1. Power Reactors

8. Products mssionfs regultJons, tediques used byt,*etf ieveltuing specific problemsor pos-

2. Research and Test Reactors

7. Transportation tulated accidents, and data needed by fe NRC=

taff n review of applications or per-

. Fuels and Materials Facilities

&. Occupational Health mile and licenses. Regulatory gOides are not eubstitutes for regulationa

"d compliance

& Environentsl end Siting

9. Antitrust and Financial Review with them Is not required. Methods end solutions different rom those et out In theguides

&. Materials and Plant Protection

10. General wil be acceptable Nt dey provide a basis for the fincligs requisite to the Issuance or con Ilrajnce of a permit or license by fti Commisasion.

Single copies of regulatory guides may be obtained free of charge by writing gie Printing.

This gOide was Issued ater consideration of comments received ftni the public, Corn- G*raphics and Distribution rench, Offoce of Admlnistraftio U.S. Nuclear Regulatory Corn ments ard suggestions for Improvements Inthese guides ae encouaaged idal tines, and mission, Washington, DC 20555-0001; or by fax at (301)415-5272.

will be revised, as appropriate, to accommodate comments and to reflect new In

=

on or o~erlnce.

Issued guides may also be purchased from tie National Techdical Information Service on Writtn comments may be submitted to the Rules Review and Directives Branch. DFIPS,

a standing order basis. Details on ths service may be obtained by writing NTIS, 5285 Port ADM, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

Royal Road, Springfield, VA 22161.

/

verify, such as by checking, auditing, and inspection, that activities affecting safety-related functions have been correctly performed. Criterion II, "Quality Assur ance Program," of Appendix B states, in part, that activ ities affecting quality must be accomplished under suit ably controlled conditions. Controlled conditions include the use of appropriate equipment, suitable envi ronmental conditions for accomplishing the activity, and assurance that all prerequisites for the given activi ty have been satisfied. It also states, in part, that the pro gram must take into account the need for verification of quality by inspection and test. Criterion III, "Design Control," of Appendix B requires, in part, that design control measures provide for verifying or checking the adequacy of design. Criterion XI, "Test Control,"

requires, in part, that a test program be established to ensure that all testing required to demonstrate that structures, systems, and components will perform sat isfactorily in service is identified and performed in accordance with written test procedures that incorpo rate the requirements and acceptance limits contained in applicable design documents. Finally, Criterion XVIII, "Audits," requires, in part, that a comprehensive system of planned and periodic audits be carried out to verify compliance with all aspects of the quality assur ance program and to determine the effectiveness of the program.

This regulatory guide endorses IEEE Std 1012-1986,3 "IEEE Standard for Software Verification

  • /

and Validation Plans," and IEEE Std 1028-1988,3

"IEEE Standard for Software Reviews and Audits."

IEEE Std 1012-1986, with the exceptions stated in the Regulatory Position, describes a method acceptable to the NRC staff for complying with parts of the NRC's regulations for promoting high functional reliability and design quality in software used in safety systems. 4 In particular, the method is consistent with the pre viously cited General Design Criteria and the criteria for quality assurance programs in Appendix B, as applied to software verification and validation. The cri teria of Appendices A and B apply to systems and related quality assurance processes, and if those sys tems include software, the requirements extend to the software elements. IEEE Std 1028-1988 provides an approach that is acceptable to the NRC staff for carry

4The term "safety systems" is synonymous with "safety-related systems."

The General Design Criteria cover systems, structures, and components

"important to safety." The scope of this regulatory guide is, however, limited to "safety systems," which are a subset of"systems important to safety."

ing out software reviews, inspections, walkthroughs, and audits subject to certain provisions.

In general, information provided by regulatory guides is reflected in the Standard Review Plan (NUREG-0800). The Office of Nuclear Reactor Regu lation uses the Standard Review Plan to review applica tions to construct and operate nuclear power plants.

This regulatory guide will apply to the revised Chapter

7 of the Standard Review Plan.

The information collections contained in this regu latory guide are covered by the requirements of 10 CFR

Part 50, which were approved by the Office of Manage ment and Budget, approval number 3150-0011. The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information un less it displays a currently valid OMB control number.

B. DISCUSSION

The use of industry consensus standards is part of an overall approach to meeting the requirements of

10 CFR Part 50 when developing safety systems for nuclear power plants. Compliance with standards does not guarantee that regulatory requirements will be met.

However, compliance does ensure that practices accepted within various technical communities will be incorporated into the development and quality assur ance processes used to design safety systems. These practices are based on experience, and they represent industry consensus on approaches used for develop ment of such systems.

Software incorporated into instrumentation and control systems covered by Appendix B will be referred to in this regulatory guide as safety system software.

For safety system software, software verification and validation (V&V), reviews, and audits are important parts of the effort to achieve compliance with the NRC's requirements. Software engineering practices rely, in part, on software V&V and on technical reviews and audits to meet general quality and reliability requirements consistent with Criteria 1 and 21 of Ap pendix A to 10 CFR Part 50, as well as Criteria II, III,

XI, and XVIII of Appendix B. In addition, manage ment reviews and audits of software processes are part of a verification process consistent with Criterion I of Appendix B.

General design verification requirements, but not details of software V&V planning and the conduct of reviews and audits, are described by IEEE Std

7-4.3.2-1993, "Standard Criteria for Digital Comput ers in Safety Systems of Nuclear Power Generating Sta tions," 3 which is endorsed by Revision 1 of Regulatory

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Guide 1.152, "Criteria for Digital Computers in Safety Systems of Nuclear Power Plants," and ASME/

NQA-1-1994, "Quality Assurance Requirements for

)j Nuclear Facility Applications." Two consensus stan dards on software engineering, IEEE Std 1012-1986 (reaffirmed in 1992) and IEEE Std 1028-1988 (re affirmed in 1993), describe the software industry's ap proaches to software verification, validation, review, and audit activities that are generally accepted in the software engineering community. Compliance with these standards helps to meet regulatory requirements by ensuring that disciplined software V&V, review, and audit practices accepted within the software communi ty will be incorporated into software processes applied to safety system software. IEEE Std 1012-1986 de scribes the elements of a software V&V plan and, for software deemed "critical software" by IEEE Std 1012-1986, describes a minimum set of V&V activi ties to be included in the plan. IEEE Std 1028-1988 is a process standard that provides guidance on how to con duct audits, inspections and walkthroughs, and techni cal and management reviews.

Technical reviews, some audits, and software in spections and walkthroughs are focused on the verifica tion and validation of products of the software develop ment process. Management reviews and other audits are focused on ensuring that planned activities are be ing accomplished effectively. Reviews and audits are closely associated with V&V activities since technical reviews and audits are frequently conducted by the V&V organization and because the V&V organization normally participates in management reviews. Because of this close connection of the V&V activity with reviews and audits, IEEE Std 1028-1988 and IEEE Std 1012-1986 are addressed together in this regulatory guide.

IEEE Std 603-1991 and IEEE Std 7-4.3.2-1993, which are endorsed by Revision 1 of Regulatory Guide

1.153 and Revision 1 of Regulatory Guide 1.152, respectively, do not provide for classification, although the foreword to IEEE Std 7-4.3.2-1993 recommends the addition of grading to future versions of IEEE Std 603. This regulatory guide is based on current standards and describes methods acceptable for any safety system software. Within the framework of the acceptable methods described by this regulatory guide, certain V&V activities are required. For smaller, less complex systems or components, these activities should require

>

less effort. Additionally, the applicant or licensee deter mines how the required activities will be implemented, commensurate with the item's importance to safety.

The benefits of this approach are that the concepts ad dressed in the standard are applied within the context of safety system development while the applicant or licensee has flexibility in implementation.

C. REGULATORY POSITION

The requirements specified in IEEE Std 1012

1986Property "IEEE" (as page type) with input value "IEEE 1012</br></br>1986" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process. provide an approach that is acceptable to the NRC

staff for meeting the requirements of 10 CFR Part 50

and the guidance given in Revision 1 of Regulatory Guide 1.152, "Criteria for Digital Computers in Safety Systems of Nuclear Power Plants," as they apply to the verification and validation of safety system software, subject to the exceptions listed below in Regulatory Positions 1 through 8 and 11.

IEEE Std 1028-1988 provides an approach accept able to the NRC staff for carrying out software reviews, inspections, walkthroughs, and audits, subject to the exceptions listed below in Regulatory Positions 9 through 11. These are often performed in association with V&V or software quality assurance activities.

Except as noted below, the appendices to these stan dards are not covered by this regulatory guide. In this Regulatory Position, the cited criteria are in Appendix B to 10 CFR Part 50 unless otherwise noted.

To meet the requirements of 10 CFR 50.55a(h) and Appendix A of 10 CFR Part 50 as ensured by comply ing with the criteria of Appendix B applied to the verifi cation, validation, reviews, and audits of safety system software, the following exceptions are necessary and will be considered by the NRC staff in the review of submittals from applicants and licensees.

1.

CRITICAL SOFTWARE

IEEE Std 1012-1986 refers to critical and noncriti cal software. It defines the contents of a Software V&V

Plan (SVVP) for all software and, for critical software, identifies a minimum set of software V&V tasks and their inputs and outputs that must be included in the SVVP. Critical software is defined in IEEE Std 1012-1986 to be software whose failure could have an impact on safety or could cause large financial or social loss. For the purposes of this regulatory guide, critical software means software used in nuclear power plant safety systems per footnote 4 of this guide, a narrower set of critical software than that defined in IEEE Std 1012-1986.

2.

SOFTWARE RELUABILITY

In its discussion of component and integration test plans in Table 1, IEEE Std 1012-1986 identifies measurement of software reliability as a criterion for

1.168-3

determining whether software elements correctly im plement software requirements. The following is noted in Revision I of Regulatory Guide 1.152.

Section

5.15,

"Reliability,"

of IEEE Std

7-4.3.2-1993 states, "When qualitative or quanti tative reliability goals are required, the proof of meeting the goals shall include software used with the hardware." The staff does not endorse the con cept of quantitative reliability goals as a sole means of meeting the Commission's regulations for reliability of the digital computers used in safety systems.

3. INDEPENDENCE OF SOFTWARE V&V

IEEE Std 1012-1986 does not require indepen dence in the performance of software V&V, but the NRC does require independence. Criterion III, "Design Control," imposes an independence requirement for the verification and checking of the adequacy of the design, requiring that those who perform the verification and checking be different from those who accomplish the design. Approaches to performing independent soft ware V&V are described in Revision 1 of Regulatory Guide 1.152. Regardless of the approach selected for a given V&V task, the responsibility for the adequacy of V&V lies with the organization responsible for the in dependent V&V. The person accountable for V&V

must also be independent of the person accountable for the design. This independence must be sufficient to en sure that the V&V process is not compromised by schedule and resource demands placed on the design process. The independent verifiers must be sufficiently competent in software engineering to ensure that soft ware V&V is adequately implemented. Criterion II,

"Quality Assurance Program," states that the program must provide for indoctrination and training of person nel performing activities affecting quality as necessary to ensure that suitable proficiency is achieved and maintained. It is beneficial if the independent verifiers are also knowledgeable regarding nuclear applications.

4. DESIGN CHANGES

IEEE Std 1012-1986, in paragraph 3.7.2, requires a description in the SVVP of the criteria for determin ing the extent to which a V&V task must be reper formed following a change to an input of the task. The criteria described in the SVVP must be consistent with Criterion III, "Design Control," which requires that de sign changes be subject to design control measures commensurate with those applied to the original de sign. In addition, IEEE Std 1012-1986 includes cost and schedule as possible criteria for determining the ex- tent of re-performance of V&V tasks. Such cost and schedule criteria, if used, must be commensurate in im portance with the cost and schedule criteria that applied to verification of the original design. Any use of these criteria must be consistent with the requirement of 10

CFR 50.57(a)(3) that there be reasonable assurance that the activities authorized by the operating license can be conducted without endangering the health and safety of the public.

5.

CONFORMANCE OF MATERIALS

Criterion III, "Design Control," states that measures are to be established for the selection and re view for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems, and components. Criterion VII, "Control of Purchased Material, Equipment, and Services," states that measures are to be established to ensure that purchased material, whether purchased directly or through con tractors and subcontractors, conform to the procure ment documents. In its discussion of V&V during the operation and maintenance phase of the software life cycle, IEEE Std 1012-1986 (in paragraph 3.5.8) pro vides requirements and guidance for retrospective V&V of software that was not verified under the stan dard. The use of this guidance for the acceptance of pre existing (e.g., commercial off-the-shelf) critical soft ware not verified during development to the provisions of this regulatory guide or its equivalent is not en dorsed. Revision 1 of Regulatory Guide 1.152 provides information on the acceptance of pre-existing software.

Additional detailed information on acceptance pro cesses is available in EPRI TR-106439, "Guideline on Evaluation and Acceptance of Commercial Grade Dig ital Equipment for Nuclear Safety Applications" (Octo ber 1996). 5

6. QUALITY ASSURANCE

Criterion I identifies the quality assurance func tions of (a) assuring that an appropriate quality assur ance program is established and effectively executed and (b) verifying, such as by checking, auditing, and in specting, that activities affecting the safety-related functions have been correctly performed. Criterion XVII requires that sufficient records be maintained to furnish evidence of activities affecting quality. Criteri on III requires that design changes be subject to design

511ectric Power Research Institute documents may be obtained from the EPRI Distribution Center, 207 Coggins Drive, P.O. Box 23205, Pleasant Hill, CA 94523. EPRI TR-106439 is also available for inspection or copying for a fee in the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555-0001; telephone

(202)634-3273;

fax

(202)634-3343.

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control measures commensurate with those applied to the original design. In addition to the requirements of IEEE Std 1012-1986 (in paragraph 3.7.4) regarding control procedures, any V&V materials necessary for the verification of the effectiveness of the V&V pro grams or necessary to furnish evidence of activities af fecting quality must be maintained as quality assurance records. Those materials necessary for the reverifica tion of changes must be maintained under configura tion management. 6

7.

TOOLS FOR SOFITWARE DEVELOPMENT

Tools used in the development of safety system software should be handled according to IEEE Std

7-4.3.2-1993, "Standard Criteria for Digital Comput ers in Safety Systems of Nuclear Power Generating Sta tions," as endorsed by Revision 1 of Regulatory Guide

1.152. IEEE Std 7-4.3.2-1993 states that "V&V tasks of witnessing, reviewing, and testing are not required for software tools, provided the software that is pro duced using the tools is subject to V&V activities that will detect flaws introduced by the tools." If this cannot be demonstrated, the provisions of this Regulatory Guide 1.168 are applicable.

8.

V&V TASKS

Table 2 of IEEE Std 1012-1986 lists optional V&V

)/

tasks. These are further described in the appendix (which is for information only) to IEEE Std 1012-1986. These tasks are intended to provide a tai loring capability by allowing tasks to be added to the minimum set for critical software. Exception is taken to the 'optional' status of some tasks on this list; they are considered by the NRC staff to be acceptable methods for meeting the requirements of Appendices A and B to

10 CFR Part 50 as applied to software, regardless of whether they are performed by the V&V organization.

The following tasks are considered by the NRC staff to be part of the minimum set of V&V activities for criti cal software unless they are (1) incorporated into other V&V tasks in the SVVP or (2) performed outside the software V&V organization as part or all of the duties of some other organization.

8.1 Configuration Management Configuration management (CM), and software configuration management in particular, are not option al functions, but are identification and control functions considered to be mandatory under Criterion VIII,

6See the guidance in Regulatory Guide

1.169, "Configuration Management Plans for Digital Computer Software Used in Safety Sys tems of Nuclear Power Plants."

"Identification and Control of Materials, Parts, and Components," as applied to software. The same per sonnel who perform the V&V functions may perform the software configuration management functions.

8.2 Audits Criteria III, "Design Control," and XVIII, "Au dits," require the performance of audits. These audits include functional audits, in-process audits, and physi cal audits for software. These audits are commonly considered to be the responsibility of the software qual ity assurance organization and the configuration man agement organization, but they may be handled by the V&V organization. If so, the audits should be described in the SVVP. An acceptable method of conducting these audits is described in IEEE Std 1028-1988.

8.3 Regression Analysis and Testing Criterion III, "Design Control," requires that design changes be subject to design control measures commensurate with those applied to the original design. Regression analysis and testing following the implementation of software modifications is a neces sary element of the V&V of software changes. It is con sidered by the staff to be part of the minimum set of software V&V activities for critical software.

8.4 Installation and Checkout Testing Criterion XI, "Test Control," requires that the test program include, as appropriate, proof tests prior to installation, pre-operational tests, and operational tests.

The user of IEEE Std 1012-1986 must identify in the SVVP which tests will be performed to meet Criterion XI.

8.5 Test Evaluation

.Test evaluation, an optional task described in the Appendix to IEEE Std 1012-1986, calls for confirma tion of the technical adequacy of test materials such as plans, designs, and results. The evaluation of these ma terials is necessary for consistency with Criterion II,

"Quality Assurance Program," in its requirement for controlled conditions and with Criterion XI, "Test Con trol," in its requirement for the evaluation of test results.

8.6 Evaluation of User Documentation Table 2 of IEEE Std 1012-1986 includes User Documentation Evaluation as an optional V&V task.

The requirements of Criterion III, "Design Control,"

for verifying and checking the design apply to software documentation, including user documentation.

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9. CLARIFICATIONS

Criterion III, "Design Control," requires measures, such as the performance of design reviews, to be pro vided for verifying or checking the adequacy of the design, and Criterion II, "Quality Assurance Program,"

requires activities affecting quality to be accomplished under suitably controlled conditions. Criterion V,

"Instructions, Procedures, and Drawings," requires activities affecting quality to be directed by written instructions, procedures, and drawings that include ac ceptance criteria for determining that these activities are successfully accomplished. IEEE Std 1028-1988 contains a mix of verbs (such as "will," variants of "to be," or verbs used in the present tense (as described be low)), and it may not be clear whether the usage is in tended to be a requirement of the standard or a state ment of fact. In this regulatory guide, the following are considered to be conditions for audits and reviews.

9.1 The responsibilities and prerequisites of sections

3.1 and 3.2 and the minimum process description template of section 3.3 of IEEE Std 1028-1988.

9.2 Anything with the terms "must," "required,"

"shall," "minimum requirements," "is responsible for," "will ensure," "is to (or 'is not allowed to'),"

"minimum input,"

"necessary input,"

"is conducted when," "reports that identify (or

'contain')," "output is," or variations of any of these terms.

9.3 The responsibilities, minimum inputs, entry and exit criteria, procedures, and auditability of items described in sections 4 through 8 of IEEE Std 1028, unless the IEEE Std 1028-1988 phraseology indicates a recommended or optional item.

10. TABLE 1 IN IEEE STD 1028-1988 In Table 1 in IEEE Std 1028-1988, the word 'in clude' in the column heading means representative but not exhaustive. Table 1 relates quality assurance processes to quality assurance objectives, adds 'test'

for completeness, and matches key processes to quality assurance objectives. In so doing, it does not provide an exhaustive list of all process and objective relation ships. In particular, the relationship of testing to verifi cation is not indicated, but this relationship is added by this regulatory guide.

11. OTHER CODES AND STANDARDS

Various sections of IEEE Std 1012-1986 and IEEE Std 1028-1988 reference other industry codes and stan dards. These references to other standards should be treated individually. If a referenced standard has been incorporated separately into the NRC's regulations, licensees and applicants must comply with that stan dard as set forth in the regulation. If the referenced stan dard has been endorsed in a regulatory guide, the stan dard constitutes a method acceptable to the NRC staff of meeting a regulatory requirement as described in the regulatory guide. If a referenced standard has been nei ther incorporated into the NRC's regulations nor en dorsed in a regulatory guide, licensees and applicants may consider and use the information in the referenced standard, if appropriately justified, consistent with cur rent regulatory practice

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. No back fitting is intended or approved in connection with the issuance of this guide.

Except in those cases in which an applicant or licensee proposes an acceptable alternative method for complying with the specified portions of the NRC's regulations, the methods described in this guide will be used in the evaluation of submittals in connection with applications for construction permits and operating licenses. This guide will also be used to evaluate sub mittals from operating reactor licensees who propose system modifications that are voluntarily initiated by the licensee if there is a clear nexus between the pro posed modifications and this guidance.

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BIBLIOGRAPHY

2 Hecht, H., A.T. Tai, K.S. Tso, "Class 1E Digital Sys tems Studies," NUREG/CR-6113, USNRC, October

1993.1 Hecht, H., et al., "Verification and Validation Guide lines for High Integrity Systems," NUREG/CR-6293, USNRC, March 1995.1 Institute of Electrical and Electronics Engineers, "Stan dard Criteria for Digital Computers in Safety Systems of Nuclear Power Generating Stations," IEEE Std

7-4.3.2-1993.

Lawrence, J.D., "Software Reliability and Safety in Nuclear Reactor Protection Systems,"

NUREG/

CR-6101 (UCRL-ID-117524, Lawrence Livermore National Laboratory), USNRC, November 1993.1 ICopies may be purchased at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328 (telephone

(202)512-2249); or from the National Technical Information Service by writing NTIS at 5285 Port Royal Road, Springfield, VA 22161. Copies are available for inspection or copying for a fee from the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop L.-6, Washington, DC 20555-0001;

telephone (202)634-3273; fax (202)634-3343.

Lawrence, J.D., and G.G. Preckshot, "Design Factors for Safety-Critical Software,"

NUREG/CR-6294, USNRC, December 1994.1 Seth, S., et al., "High Integrity Software for Nuclear Power Plants: Candidate Guidelines, Technical Basis and Research Needs," NUREG/CR-6263, USNRC,

June 1995.1 USNRC, "Criteria for Digital Computers in Safety Systems of Nuclear Power Plants," Regulatory Guide

1.152, Revision 1, January 1996.2 USNRC, "Standard Review Plan," NUREG-0800,

February 1984.1

2Single copies of regulatory guides may be obtained free of charge by writing the Office of Administration, Printing, Graphics and Distribu tion Branch, U.S. Nuclear Regulatory Commission, Washington, DC

20555-0001; orby fax at (301)415-5272. Copies are available for in spection or copying for a fee from the NRC Public Document Room at

2120 L Street NW, Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555-0001; telephone (202)634-3273;

fax (202)634-3343.

REGULATORY ANALYSIS

A separate regulatory analysis was not prepared for this regulatory guide. The regulatory analysis prepared for Draft Regulatory Guide DG-1054, "Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety Systems of Nuclear Power Plants," provides the regulatory basis for this guide. A

copy of the regulatory analysis is available for inspection and copying for a fee at the NRC Public Document Room, 2120 L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555-0001; phone

(202)634-3273; fax (202)634-3343.

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