2

.. 4 -WM Record File7 i4 _

WYATT ROGERS LETTERDistribution: - 1--5are, U:&n-NuA,JC &9_f,,a~ffM^~(Return to WM; 623-SS)

.WM Projec tDocket No.

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JUL 3 OLi -l DISTRIBUTION:b7Ls5 ni, :Js i s/f JGreeves

4,d h Sma', WMPC: r/f------- _riginator

WMPC: S'LREBrowningMJBellPJustusMKnappJLinehanJOBunting

Mr. Wyatt M. Rogers, Jr.Nuclear Waste Project ManagerCouncil of Energy Resource Tribes1580 Logan Street - Suite 400Denver, Colorado 80203

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Dear Mr. Rogers:

The Division of Waste Management has the lead responsibilty 'for coordinatingall NRC actions mandated by -the Nuclear Waste Policy Act (NWPA) of 1982 inthe high-level waste (HLW) area. In our continuing effort to work closelywith the states and Indian tribes in fulfilling this responsibility, we haveassigned Ms. Alma Hale to assist Ms. Cathy Russell as the point of contact forinteractions regarding the siting of a HLW repository in Washington State.Unfortunately, Ms. Russell has been ill, and the date for her return isuncertain at this time. Therefore, please feel free to contact me or Ms. Haleif you have any questions or need information in the HLW area. Her addressand telephone number are listed below.

Alma Hale, Project ManagerState/Tribal ParticipationU.S. Nuclear Regulatory CommissionMailstop 623-SSWashington, D.C. 20555301/427-4133

Also, per your recent request of Ms. Mattson, I am enclosing a draft copy ofNRC's review plans for the Quality Assurance (QA) Programs related to sitecharacterization. The final QA plan has not been completed at this time.

Sincerely,

Jo ph unting, ChiefPolicy and Program Control BranchDivision of Waste Management

Enclosure:as stated

R.N.: Per discussion between MDelligati and JKennedy(RP), 7/22/86,7this draftplan has been previously released.

OFC :WMPC \1g 4PC lWiIP::14~IAI e61O2O1~7860730

NAME :AHale ' :DMattson . JO 9 n pDR WASTE 87RDAE ---- ---860724

DATE :86/07/24 : 1> i[to~ /

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. , ., ;- i

II

1

ENCLOSURE 1

- . V-

. 2 D,-DRAFT

U. S: NUCLEAR REGULATORY COMMISSION

NRC REVIEW PLAN:

QUALITY ASSURANCE PROGRAMS

FOR SITE CHARACTERIZATION

OF HIGH LEVEL NUCLEAR WASTE REPOSITORIES

Compiled byRepository Projects BranchDivision of Waste Management

Office of Nuclear Material Safety and Safeguards

Quality Assurance BranchDivision of Quality Assurance, Safegyards, and Inspection Programs

Office of Insipection ahd Enforcement

June 1984

-DPAr

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ABSTRACT

Licensing .of-4-geologic repository for high-level waste involves assessingwhether the geologic setting and the engineered system will perform in a mannerwhich will meet the performance objectives and requirements of 10 CFR Part 60.Important questions in conducting these licensing assessments will relate tothe quality and the assurance of quality of data and analyses used in supportof the license application for proposed sites. In addition to questioning the -relevance and completeness of data supplied in the license application, thelicensing process will address the question of whether data and analyses are ofadequate and known quality so that there will be reasonable assurance thatoperation and long-term disposal of high level waste in the geologic repositorywill not provide an unreasonable risk to the health and safety of the public.A quality assurance program is therefore necessary to provide confidence in thework performed in development of the repository. -

The purpose of this Review Plan is to define the criteria and methods by whichthe DOE quality assurance program for site characterization activities will bereviewed by the NRC staff during the prelicensing phase. At the same time, thestaff positions in this plan provide guidance to DOE for establishing anacceptable program. In particular, it defines how the 18 criteria of Appendix-B, 10 CFR Part 50, which were developed for nuclear reactors, can be applied tothe site characterization phase of repositories.- It also describes the staffreview and consultation process with DOE during the site characterizationphase.

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w-. _

TABLE OF CONTENTS

PAGE NO.

1.0 INTRODUCTION AND BACKGROUND 4

2.0 REGULATORY FRAMEWORK 5..

2.1 PROCEDURAL PROVISIONS, 10 CFR Part 602.2 TECHNICAL PROVISIONS, 10 CFR Part 602.3 APPLICABLE REGULATORY AND STANDARDS GUIDANCE

DOCUMENTS

3.0 DISCUSSION _ _

3.1---QUALITY ASSURANCE PROGRAM DESCRIPTION3.2 APPLICATION OF QUALITY ASSURANCE TO SITE CHARACTERIZATION

ACTIVITIES

4.0 NRC REVIEW PLAN

FIGURES

57

8

8

8

9

10

APPENDIX A

5

1.0 INTRODUCTION AND BACKGROUND

DOE and its contractors are currently involved in performing laboratoryand field investigations (site characterization activities) involvingvarious technical areas such as geology, hydrology, seismology,geophysics, geochemistry, and rock mechanics - all of which are generally _considered part of geotechnical studies and/or investigations. In -

addition, waste package testing and conceptual design activities are beingperformed, including development of performance requirements forrepository system components. Information being gathered and data beingcollected and analyzed will be used by DOE to support license applicationsto the NRC for the construction and operation of geologic repositories tobe used for permanent disposal of high-level nuclear wastes. As part ofthe regulatory requirements-in 10 CFR Part 60,-OOE must implement aquality assurance (QA) program to provide confidence in the work performeddurtng development of the repository, including information developed insupport of licensing proceedings. -10 CFR Part 60 also requires DOE andNRC to conduct prelicensing consultation prior to submittal of a licenseapplication to aid in identification and resolution of issues prior tolicensing. This Review Plan presents positions on quality assurance whichare acceptable to NRC staff and, if properly carried out by DOE, would besuitable for use in. itcensing. To.give.context to these positions, thisdocument also describes generally some of the prelicensing interactionsbetween DOE and NRC through which licensing information needs areestablished. As these prelicensing consultations progress, and as less6nslearned from the application of quality assurance in other programs isassimilated, revisions to this Review Plan may be necessary andappropriate.

It is important to recognize the roles of the DOE and NRC. DOE hasoverall responsibility for achieving and assuring the quality ofhigh-level waste repositories. Other organizations are responsible to theextent that DOE delegates responsibility. However, ultimateresponsibility, even though delegated, is retained by DOE. The role ofthe NRC in licensing is to exercise sufficient, but limited, oversight toprovide reasonable assurance that a license applicant meets all of theapplicable requirements. During prelicensing, there is a simtlar limitedfunction for the NRC. This NRC role does not abrogate DOE'sresponsibility for assuring that all aspects of a project must be inaccordance with NRC requirements. DOE has the burden of proof inlicensing proceedings and is responsible for developing informationrequired to make findings in these proceedings. More specifically, DOE isresponsible for assuring that information is both complete and ofdemonstrably adequate quality. The ability to demonstrate quality depends

6

upon DOE-having an adequate quality assurance program during theprelicensing site investigation and design development phase.

2.0 REGULATORY FRAMEWORK

The NRC has established quality assurance requirements for nuclear wasterepositories in both the procedural and technical portions of 10 CFR Patt ,60, as listed below. This summary of quality assurance requirements isnot exhaustive. Other sections of 10 CFR Part 60 address qualityassurance and information to be submitted throughout the life of therepository.

2.1 PROCEDURAL PROVISIONS (10 CFR Part 60, Subparts A-D)

The procedural rule identifies when DOE will submit information on_quality assurance to the NRC, and what NRC monitoring of QAactivities will be permitted during site characterization. It alsodefines the scope of site characterization and the quality assuranceprogram. These requirements* are as follows:

§60.2 Definitions - -

"Site characterization" means the program of exploration andresearch, both in the laboratory and in the field, undertaken toestablish the geologic conditions and the ranges of those parametersof a particular site relevant to the procedures under this part.

A-/_ Site characterization includes borings, surface excavations,excavation of exploratory shafts, limited subsurface lateralexcavations and borings, and in situ testing at depth needed todetermine the suitability of the site for a geologic repository, butdoes not include preliminary borings and geophysical testing neededto decide whether site characterization should be undertaken.

"Important to safety," with reference to structures, systems, andcomponents means those engineered structures, systems, and componentsessential to the prevention or mitigation of an accident that couldresult in a radiation dose to the whole body, or any organ, of 0.5rem or greater at or beyond the nearest boundary of the unrestrictedarea of any time until the completion of permanent closure.

"Isolation," means inhibiting the transport of radioactive materialso that amounts and concentrations of this material entering the' "accessible environment will be kept within prescribed limits.

*10 CFR Part 60 is currently being revised to conform to the Nuclear WastePolicy Act of 1982; this Review Plan will be modified as necessary to reflectthese rule changes when completed.

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§60711 Site Characterization .Report*

a. As early as possible after commencement of planning for aparticular geologic repository operations area, and prior tosite characterization, the DOE shall submit to the Director aSite Characterization Report*. The report shall include (1) adescription of the site to be characterized; (2) the criteria -

used to conduct site characterization and for which DOEanticipates arrive at the candidate area; (3) the method bywhich the site was selected for site characterization; (4)identification and location of alternative media and sites atwhich DOE intends to submitting subsequent Site CharacterizationReports; (5) a description of the decision process by which thesite was selected for characterization, including the means usedto obtain public, Indian tribal and State views duringselection; (6) a description of the site characterizationprogram including (i) the extent of planned excavation and plansfor in situ testing, (ii) a conceptual design of a repositoryappropriate to the named site in sufficient detail to allowassessment of the site characterization program with respect toinvestigation activities which address the ability of the siteto host a repository and isolate radioactive waste, or which mayaffect such ability, and (ili) provisions to control anyadverse, safety-related effects from site characterization,including appropriate quality programs; (7) a description ofthe quality assurance program to be applied to data collection;(emphasis added) and (8) any issues related to the site

K._> selection, alternative candidate areas or sites, or design ofthe geologic repository operations area which the DOE wishes theCommission to review. Also included shall be a description ofthe research and development activities being conducted by DOEwhich deal with the waste form and packaging which may beconsidered appropriate for the site to be characterized,including research planned or underway to evaluate theperformance of such waste forms and packaging.

§60.11(g): During site characterization...NRC staff shall bepermitted to visit and inspect the site and observe excavations,borings, and in situ tests as they are done.

*Referred to as "Site Characterization Plan" in the Nuclear Waste Policy Actof 1982

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§60;21 Content of Application [i.e., construction authorizationapplication]

(a) An application shall consist of general information and a SafetyAnalysis Report...

§60.21(c) The Safety Analysis Report shall include:

(1)(ii)(E) An analysis of the performance of the major designstructures, systems, and components, both surface and subsurface, toidentify those that are important to safety.

(4) A description of the quality assurance program to be applied tothe structures, systems, and components important to safety and tothe engineered and natural barriers important to waste isolation.

§60.31 Construction authorization

Upon review and consideration of an application and environmentalreport submitted under this part, the Commission may authorizeconstruction if it determines:

(3) The DOE's quality assurance program complies with therequirements of Subpart G.

2.2 TECHNICAL PROVISIONS (10 CFR Part 60, Subparts E-I)

The technical rule identifies the scope, applicability, andimplementation of a QA program for nuclear waste repositories inSubpart G of 10 CFR Part 60. These requirements are as follows:

SUBPART G - QUALITY ASSURANCE

§ 60.150 Scope.

As used in this part, "quality assurance" comprises all those plannedand systematic actions necessary to provide adequate confidence thatthe geologic repository and its subsystems or components will perform

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sat4sfactorily in service. Quality assurance includes qualitycontrol, which comprises those quality assurance actions related to-the physical characteristics of a material, structure, component, orsystem which provide a means to control the quality of the material,structure, component, or system to predetermined requirements.

§ 60.151 Applicability. - -

The quality assurance program applies to all systems, structures andcomponents important to safety, to design and characterization ofbarriers important to waste isolation and to activities relatedthereto. These activities include: site characterization, facilityand equipment construction, facility operation, performanceconfirmation, permanent closure, and decontamination and dismantlingof surface facilities.'

§ 60.152 Implementation.

DOE shall implement a quality assurance program based on the criteriaof Appendix 8 of 10 CFR Part 50, as applicable, and appropriatelysupplemented by additional criteria as required by §60.151. --

2.3 APPLICABLE REGWLtATORY AND STANDARDS GUIDANCE DOCUMENTS

In addition to the regulations discussed above, NRC Regulatory Guide4.17, "Standard Format and Content of Site Characterization Reportsfor High-Level Waste Geologic Repositories," states that DOE should"Describe the quality assurance (QA) programs that have been appliedduring site exploration activities and that will be applied to datacollection during the planned site characterization program. The QAmethods should be presented in sufficient detail to allow NRC to makean independent evaluation of the precision, accuracy,reproducibility, analytic sensitivity, and limitation of dataacquisition and analysis methods that were used during siteexploration and will be used during site characterization."

3.0 DISCUSSION

3.1 QA PROGRAM DESCRIPTION

DOE is required in 10 CFR 60.11 to submit in the Site CharacterizationPlan (SCP) a description of the quality assurance program to be applied todata collection. An adequate QA program description, properlyimplemented, is required to provide confidence in the data gathered duringsite characterization. Each QA program description should identify how the

10

10 CFR Port 50 Appendix B criteria will be implemented and how compliancewith the-criteria will be assured. Because design activities will beperformed during the site characterization phase, it is important that theoverall quality assurance program description, including that for designand design activities, be provided well before licensing, preferably inthe Site Characterization Plan. The term design refers to specifications,drawings, design criteria, and component performance-requirements for thenatural and engineered components of the repository system. It includesdesigns at each stage of design development (i.-e., from conceptual designto final design). Design information and design activities refer to datacollection and analysis activities that are used in supporting designdevelopment and verification. They include general plans and detailedprocedures for data collection and analysis activities that are'used insupporting design development, and. related informat1on such as testresults and analysis. Data analysis includes the initial step of datareduction as well as broad level systems analyses, such as performanceassessments, which integrate many other data and analysis 6f individualparameters. The above is consistent with the definition and usage ofthese terms in 10 CFR Part 60 and the Atomic Energy Act of 1954.

Appendix A of this Review Plan lists each of the 18 criteria of Appendix -and identifies staff positions and information needs-to be addressed inthe Site CharacterizationfPlan. A'copy of Appendix B, 10 CFR Part 50 is.presented in Figure 1. In addition to the DOE QA program, the QA programsof the prime contractor (for 'example, Rockwell Hanford Operations for theBasalt Waste Isolation Project) and other organizations participating inthe project should be described and the interaction of the QA groupsincluding management meetings, audits, inspections, and performancemonitoring by DOE should be discussed. DOE should. also identify the itemsand activities important to safety or waste isolation to be controlled bythe QA program and the basis for their selection. A list of QA andtechnical procedures which implement the program description in the SiteCharacterization Plan should be identified and referenced in the SCP.

3.2 APPLICATION OF QUALITY ASSURANCE TO SITE CHARACTERIZATION ACTIVITIES

A complex, technical program such as site-characterization, which includesdata gathering and analysis and design development, needs to be based on asystematic approach to planning and controlling the program. The plansoutlining the conduct of a data gathering program are of varying levels ofdetail ranging from identification of general performance objectives andcriteria to detailing specific technical procedures (Figure 2). Qualityassurance needs to be applied at all levels. As shown in this figure,site characterization planning must start by considering the performance

objectives established in NRC regulations. After considering sitespecific conditions, specific issues are identified based on these

-criteria-and preliminary evaluations of repository component performancerequirements are established. The program can then be divided intoprogram areas related to the technical disciplines of investigations.These program areas-then identify information needed to resolve issues inthe site characterization program. From these information needs, test.-plans are developed which identify how testing will-be accomplished. As' -

part of the test plans, detailed test procedures and instructions areprepared. Figure 3 illustrates the chronology of events in planning andperforming such a testing program and shows how the 18 criteria ofAppendix B can be applied. It also shows the involvement of QA throughoutthe entire process, including how procedures may require review.by peerreview groups. Peer review groups should be utilized for untried orstate-of-the-art testing and analysis procedures, or where detailedtechnical criteria or requirements do not exist or are under development.Outside consultants aretretained when required to obtain needed expertise.

As described above, a QA program for site characterization involvesdocumentation of procedures. It is important to make a distinctionbetween (1) administrative QA procedures and (2) detailed technical or -

implementing procedures (Figure 4). Quality assurance procedures provideinstructions for itpelementatogn and application of the 18 criteria of 10CFR Part 50 Appendix 6. These are generated by the quality assuranceorganization (with assistance from the technical organizations) and applyto all technical program areas (e.g.,-procedures for test plandevelopment). The detailed technical (implementing) procedures aredeveloped by qualified personnel in accordance with the requirementsspecified in the administrative quality assurance procedures. Thesecontain instructions for actual performance of testing and investigations(e.g., hydrologic pump tests, setting a packer, etc.).

4.0 NRC REVIEW PLAN

The Repository Projects Branch (WaRP) of NRC has the lead responsibilityfor reviews of DOE QA programs for site characterization ninvestigationsfor nuclear tiaste repositories. Quality assurance specialists from theOffice.vop Inspectionand Enforcement, the Policy and Program ControlBranch (ItMPC) ard other branches will provide assistance to WMRP in thesereviews.-'These reviews will involve several activities and will utilizethe staff positions presented in Appendix A, which are based on the 18criteria of Appendix B, 10 CFR Part 50. The first involves the review ofthe QA program description submitted at the latest in the-Site

12

Charactefization Plan'(SCP) for each site, as required by 10 CFR 60.11,-and other.QA program.documents and procedures. In addition to the reviewsof quality assurance program documents, NRC staff will conduct on-sitereviews and meetings with DOE staff and contractors to identify andresolve at an early time potential quality assurance issues which arise inimplementation of these programs.

Some of the reviews of the formal quality assurance aspects of DOE progamswill occur in connection with the reviews and prelicensing consultationsbeing conducted to establish the technical information needs of licensing.In addition to consultations on potential technical issues and generalplans and strategies for resolving these issues, these consultations andreviews deal with specific data collection and analysis procedures. Thequality and completeness of-data being collected are virtually determinedby such plans and procedures. Becausb all of the procedures that arebeing-used cannot practically be supplied with SCP's or SCP. updates, dueto their volume,' site visits by staff will be necessary. For conductingthese visits (as provided for by §60.11(g) of 10 CFR Part 60), the NRCtechnical staff evaluating data and data collection and analysisprocedures may be accompanied by NRC staff QA specialists who areevaluating issues which relate to implementation of the quality assuranceprogram. These visits and reviews are intended to raise issues forconsultation and eirty resolution.

The positions in this Review Plan represent solutions and approaches thatare acceptable to the staff, but which may not be the only possiblesolutions and approaches. Various alternatives to the detailed guidancein this Plan may be found acceptable provided the DOE documents andjustifies these deviations. A commitment to conform to the guidance inthis Plan is considered to be a commitment to implement all staffpositions unless exceptions or alternatives are specifically identified.

As discussed in the Introduction and Background section it is importantfor DOE to recognize the limited role of the NRC in identifyingquality-related problems. Deviations from requirements or standardsidentified by the NRC staff must therefore be carefully examined by DOE todetermine-.a) the root cause of the deficiency and b) if similardeficiencies exi-st in other areas of the program not reviewed by the NRCstaff. The corrective action taken by DOE should be sufficient to assurethat similar future deficiencies can be avoided or mitigated.

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12.2 QA and other organizations' responsibilities are described forestablishing, implementing, and assuring effectiveness of thecalibration program.

12.3 Procedures are established and described for calibration (techniqueand frequency), maintenance, and control of the measuring and testequipment (instruments, tools, gages, fixtures, reference andtransfer standards, and nondestructive test equipment) used formeasurement, inspection, and monitoring. The review and documentedconcurrence of these functions is identified.

12.4 Measuring and test equipment is labeled, tagged or otherwisedocumented to indicate due date of the next calibration an4 toprovide traceability to calibration test data.

12.5 Measuring and test equipment is calibrated at specified intervals--based on required accuracy, precision, purpose, degree of usage,stability, characteristics, and other conditions which could affectmeasurement.

12.6 Calibration standards are traceable to nationally recognizedstandards. Where national standards do not exist, provisions areestablished to document acceptability of the calibration standardused. .

12.7 When measuring and test equipment is found to be out of calibration,evaluations are made and documented to determine the validity andacceptability of measurements performed since the last calibration.Inspections or tests are repeated on items determined to be suspect.

13. Activities related to Sample Handling, Storage, and Shipping areacceptable to the NRC staff if:

13.1 Sampling, handling, preservation, storage, packaging,and shipping requirements are established and accomplished bysuitably trained individuals in accordance with predetermined workand Inspection instructions.

13.2 Procedures are established and described to control samplehandling, itorage, packaging, and shipping in accordance with designand-procurement requirements to preclude damage, loss, ordeterioration by environmental conditions such as temperature orhumidity.

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14. Activities related to.Inspection, Test and Operating Status are acceptableto the NRC staff if:

14.1 Procedures are established to indicate by the use of markings thestatus of inspections and tests on individual items.

15. Activities related to Nonconformances are acceptable to the NRC staff if:

15.1 Procedures are established for identifying, documenting, tracking,segregating, reviewing, dispositioning, and notifying affectedorganizations of nonconforming items and activities. The proceduresidentify individuals authorized to dispose of and close outnonconformances.

15.2 QA responsibilittes related to nonconformance-control are described.

15.3-Documentatjon identifies and describes the nonconformance,dispositions the nonconformance, and includes signature approval ofthe disposition.

15.4 Nonconformance reports are periodically analyzed by the QAorganization to show quality trends and to help identify root causesof non-conformances; and the significant results are reported toupper management for review and assessment.

16. Activities related to Corrective Action are acceptable to the NRC staffif:

16.1 Procedures are established indicating an effective corrective actionprogram has been established. The QA organization reviews anddocuments concurrence with the procedures.

16.2 Corrective action is documented and initiated following anonconformance to preclude recurrence. The QA organization isinvolved in documented concurrence of the adequacy of correctiveaction to assure that QA requirements are satisfied.

16.3 Follow-up action is taken by the QA organization to verify properimplementation of corrective action and to close out the correctiveaction in a timely manner.

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16.4 Significant conditions adverse to quality, the cause of theconditions, and the corrective action taken to preclude repetitionare-documented .and reported to immediate management and upper levelsof management for review and assessment.

17. Activities related to Quality Assurance Records are acceptable to the NRCstaff if:

17.1 The scope of the records program is described. QA records includegeotechnical samples and data; results of reviews; inspections;tests, audits, and material analyses; monitoring of workperformance; qualification of personnel, procedures, and equipment;and other documentation such as drawings, specifications, procurementdocuments, calibration procedures and reports; design review reports;peer review reports; nonconformance reports; and-corrective actionreports.

17.2 QA and other organizations are identified and their responsibilitiesare described for the definition and implementation of activitiesrelated to QA records.

17.3 Inspection and test records contain the following where applicable:

a. A description of the type of observation..b. The date and results of the inspection or test.c. Information related to conditions adverse to quality.d. Inspector or data recorder identification.e. . Evidence as to the-acceptability of the results.f. Action taken to resolve any discrepancies noted.

17.4 Suitable facilities for the storage of records are described andutilized.

18. Activities related to Audits are acceptable to the NRC staff if:

18.1 Internal and external audits to assure that procedures andactivittes comply with the overall QA program are performed by DOEand fts contractors. DOE should perform audits of the primecontractor and representative subcontractors, consultants, vendors,

.and laboratories to assess the effectiveness of the primecontractor's audit program.

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18.2 An audit plan is prepared identifying audits to be performed, theirfrequencies, and schedules. Audits are regularly scheduled basedupon the status and safety importance of the activities beingperformed and are initiated early enough to assure effective QA.

18.3 Audits include an objective evaluation of the quality-relatedpractices, procedures, instructions, activities, and items and the _review of documents and records to ensure that the QA program iseffective and properly implemented.

18.4 Audit data are analyzed by the QA organization and the results arereported to responsible management for review, assessment, andappropriate action.

18.5 Audits are performed in accordance with pre-established written_-procedures or checklists and conducted by trained personnel having nodirect responsibilities in the areas being audited.

18.6 A tracking system for audit findings is established to help assurethat all findings are appropriately addressed and to trend auditfindings.

18.7 The audited organization describes in a formal report the correctiveaction to be taken to address findings. This report is submitted tothe auditing organization and/or responsible management.

18.8 In the resolution of findings, the root cause of each finding is alsoidentified and corrective action for it described.

rurv i, #pp. a llt1ie 0-Enegy Chmoer I_-Nvdear Regluatory Commisi

APPrENDIX B-QUALITY ASsURANtCz CRI-TERIA FOR NUCLsR POWER PLArSAND! PURL RERtocessiNG PLANTS

Iifrodctffot. Every applicant for a con-siruction permit Is required by the provi-sions of 3 50.34 to Include In Its preliminarysafety analysis report a description of thequalilty assurance program to be applied tot he design. fabrication, construction. andrsting of the structures, systems, and com-ponents of the facility. Every applicant for'an operating license Is required to Include.in its final safety analysis report. Informa-tlion pertaining to the managerial and ad-ministrative controls to be used to assuresafe operation. Nuclear power plants andluel reprocessing plants include structures.systems, and components that prevent ormitigate the consequences of postulated ac-eidents that could cause undue risk to thehealth and safety of the public. This appen-dix establishes quality assurance require-ments for the design, construction, and op.eratlon of those structures. systems, andcomponents. The pertinent requirements ofthis appendix apply to all activities affect-ing the safety-related functions of thosestnhctures.systems. and components; theseactivities Include designing. purchasing. fa-brieating. handling, shipping. storing, clean-Ing. erecting. Installing. Inspecting. testing.operating. maintaining. repairing. refueling.and modifying:

As used In this appendix. "quality assur-sone' comprises all those planned and sys-tematic actions necessary to provide ade-quate confidence that a structure, system.or component will perform satisfactorily In.service. Quality assurance Includes qualitycontrol, which comprises those quality as-suranee actions related to the physical char-acteristics of a material, structure, compo-nvnt, or system which provide a means toconlrol the quality of the material, struc-lure. component, or system to predeter-mined requirements.

1. ORGAnZATIOnThe applicantI shall be responsible for

the establishment and execution of the

While the term 'applicant Is used Intlhese criteria, the requirements are ofcourse. applicable after such a person hasreceived a license to construct and operate al'tlear powerplant or a fuel reprocessingPlant. These criteria will also be used for

quality assurance progrant"' 'te appllea"may delegate to others. su_ contraetoagents, or consultants. the work of edalishing and executing the quality assuranceprogram. or any part thereof. but shallretain responsibility therefor. The authorl-ty and duties of persons and organisationsperforming activities affecting the safety-re-lated functions of structures, systems, andcomponents shall be clearly established anddelineated In writing. These activities In-clude both the performing functions of at-tamning quality objectives and the quality as-surance functions. The quality assurance

ituetions are those of (a) assuring that Anappropriate quality assurance program is es-tablished and effectively executed and (blverifying, such as by checking, auditing andInspection, that activities affecting thesafety-related functions have been correctlyperformed. The persons and organizationsperforming quality assurance functionsshall have sufficient authority aAd organi-zational freedom to identify quallty prob-lems; to Initiate, recommend. or provide so-lutions: and to verity Implementation of so-lutions. Such persons and organizations per-forming quality assurance functions shallreport to a management level such that thisrequired authority and organizational free-dom. Including sufficient Independencefrom cost and schedule when opposed tosafety considerations, are provided. Becauseof the many variables Involved. such as thenumber of personnei, the type of activitybeing performed, and the location or loca-tions where activities are performed, the or-ganizational unructure for executing thequality assurance program may take various,forms provided that the persons and organi-zations assigned the quality assurance func-tions have this required authority and orga-nizational freedom, Irrespective of the orga.nizational structure, the individual(s) a-signed the responsibility Tor assuring effec-tive execution of any portion of the qualityassurance program at any location whereactivities subject to this appendix are beingperformed shall have direct access to suchlevels of management as may be necessaryto perform this function,

1. QuALITY ABSURAnC i'OGRAM

The applicant shall establish at the earli-est practicable time. consistent with theschedule for accomplishing the activities. aquality assurance program which complieswith the requirements of this appendix,This program shall be documented by writ-ten policies, procedures. or Instructions and

guidance In evaluating the adequacy ofquality assurance programs In use by hold-ers of construction permits and operating 1i-censes.

FIGURE I[page 1)

shall be carried out throughtC lant life Inaccordance with.those pollek- procedures.or Instructions. The applicant shall identifythe structures, systems. and components tobe covered by the quality assurance pro-gram and the major organizations partici-pating I the program. together with thedesignated functlons of these organizations.The quality assurance program shall pro-vide control over activities affecting thequality of the identifled structures, systemsand components to an extent consistentwith their Importance to safety. Activitiesaffecting quality shall be accomplishedunder suitably controlled conditions. Con-trolled conditions include the use of appropriate equipment; suitable environmentalconditions for accomplishing the activity,such as adequate cleanness: and assurancethat all prerequisites for the given activityhave been satisfied, The program shall takeInto account the need for special controls.processes. test equipment, tools, and skillsto attain the required quality, and the needfor verification of quality by Inspection andtest, The program shall provide for Indoctri-nation and training of personnel performingactivities affecting quality as necessary toassure that sultable proficiency Is achievedand maintained. The applicant shall regu-larly review the status and adequacy of thequality assurance program. Management ofother organizations participating in thequality assurance program shall regularlyreview the status and adequacy of that partof the quality assurance program whichthey are executing.

111. Destoy COMMOL

Measures shall be established to assurethat applicable regulatpry requirements andthe design basis, as defined In S 50.2 and asspecified In the license applicaton, forthose structures, systems. and componentsto which this appendix applies are correctlytranslated into specifkations. drawings, pro-cedures, and Instructrons. These measuresshall Include provisions to assure that ap-propriate quality standards are specifiedand Included In design documents and thatdeviations fromn such standards are con-t-olled. Measures shall also be establishedfor the selection and review for suitabilityof application of materials, part equip-ment, and processes that are essential to thesafety-related functions of the structures.systems and components;

Measures shall be established for theidentification and control of design Inter-faces and for coordination among partici-pating design organizations, These measures,shill Include the establishment of proce-dures among participating design organiations for the review, approval, release, dis-trIbution, and revision of documents Invofv-Ing deslgn Interfaces.

ilon Pra 50, App.

The design control ni sshall providefor verifying or check. e adequacy Otdesign, such as by the performance of4design reviews, by the use of alternate orsimplified calculational methods. or 'by the'performance of a suitable testing program.-The verifying or checking process shall beperformed by Individuals or groups otherthan those who performed the orignaldesign. but 'who may be from the same orga-nization. Where a test program Is used toverify the adequacy of a specific design fea-ture In lieu opf other virifying or checkingprocesses, It shalllinciqde suitable qualifiea-tions testing 'of a prototype unit under themost adverse design conditions. Design con-trol measures shall be applied to items suchas the following reactor physics, stress,thermal. hydraulic. and accident analyses;compatibility of materials; accessibility forInservice Inspection, Maintenance, andrepair, and delineation of acceptance crna for Inspectlons and tests.Design changes. including field changes,

shall be subject to design control measurescommensurate with those applied to theoriginal design apd be approved by the orga-nization that performed the original designunless the applicant designates another re-sponsible organization.

IV. Pnocunruwr Docuffarr COMMOL

Measures shall be established to assurethat applicable regulatory requirements.design bases, and other requirements whichare necessary to assure adequate quality aresuitably Included or refcrenced In the docu-ments for procurement of material, equip-ment, and services, whether purchased bythe applicant or by Its contractors or sub-contractors. To the extent necessary, pro-curement documents shall require contrac-tors or subcontractors to provide a qualityassurance program consistent with the per-tinent provisions of this appendix.

V. ItsTRUCnIons. PRocuRICs. At"DRAwitios

Activities affecting quality shall be pre-scribed by documented instructions. proce-dures, or drawings. of a type appropriate tothe circumstances and shall be accom-plished In accordance with these Instruc-tions, procedures, or drawings, Instructions,procedures, or drawings shall Include appro-priate quantitative or qualitative acceptancecriteria for determining that Important a-etivitles have been satisfactorily accom-plished.

VI. DdcuUwwm CONTROL

Measures shall be established to controlt the issuance of documents. such as instruc-tions, procedures. and drawings, Includingchanges thereto, which prescribe all activi-

Part 50, Arm. B

ties affec11 llty. These measures shallassure tha. uments. Including changes.are reviewed for adequacy and approved forrelease by authorked personnel and are dis.tributed to and used at the location wherethe prescribed activity Is performed.Changes to documents shall be reviewedand approved by the same organizatlonsthat performed the original review and ap-proval unless the applicant designates an-other responsible organization.

VII. CO"tROL OF PURCHASED MATX iAL,,EquirwrNT. AND SfavIczs

Measures shall be established to assurethat purchased material, equipment, andservices, whether purchased directly orthrough contractors and subcontractots,conform to the procurement documents.These measures shall Include provisions, asappropriate, for source evaluation and selec-tion, objective evidence of quaity furnishedby the contractor or subcontractor, Inspec-tlon at the contractor or subcontractorsource, and exmunination of products upondelivery. Documentary evidence that mate-rial and equipment conform to the procure-ment requirements shall be available at thenuclear powerplant or fuel reprocessingplant site prior to Installation or use of suchmaterial and equipment. This documentaryevidence shall be retained at the nuclearpowerplant or fuel reprocessing plant siteand shall be sufficient to Identify the speelf-Ic requirements, such as codes, standards, orspecificatlons, met by the purchased materi-al and equipment. The effectiveness of thecontrol of quality by contractors and sub-contractors shall be assessed by the appli-cant or designee at Intervals consistent withthe importance, complexity, and quantity ofthe product or services.

VIII. IDEQIFICATION AND CONOL orMAWPIALS. PARTS, AND COMeONa-TS

Measures shall be established for theIdentification and control oft materials,parts, and components, Including partiallyfabricated assemblies. These measures shallassure that ilentificalion of the Item Ismaintaine~d by heat number, part number.serial number, or other appropriate means.either on the Item or on records traceable tothe Item, as required throughout fabrica-Uion. erection, installation, and use of theItem. These Identification and control mesas-tires shall be designed to prevent the use ofIncorrect or defective material, parts, andcomponents.

IX. CONTROL OP SPECIAL PoCeassrs

Measures shall be established to assurethat special processes Including welding,heat treating, and nondestructive testing,are controlled and accomplished by quali-lied personnel using qualified procedures In

accordance with IpIia -des. standspecifications, criteria, and other specialquirements.

X. IsiauoronA program for Inspection of activities at-

fecting quality shall be established and ex-ecuted by or for the organization perform-Ing the activity to verify conformance withthe documented Instructions, procedures,and drawings for accomplishing the activity,Such Inspection shall be performed by Indl-viduals other than those who performed theactivity being Inspected. Examinations,nieasurements, or tests of material or prod-ucts processed shall be performed for eachwork operation where necessary to assurequality. If Inspection of processed materialor products Is Impossible or disadvanrt-geous, Indirect control by monitoring proc-essing methods, equipment, and personnelshall be provided. Both Inspection and proe-ess monitoring shall be provided when con-trol is Inadequate without both. If manda-*tory Inspection hold points, which requirewitnessing or Inspecting by the applicantsdesignated representative and beyond whichwork shall not proceed without the consentof Its designated representative are re-quired, the specific hold points shall be Indi-cated In appropriate documents.

Xl. TUSv Commot.

A test program shall be established lbassure that all testing required to demon-strate that structures. systems, and compo-nents will perform satIsfactorily In service IsIdentifled and performed In accordance withwritten test procedures which Incorporatethe requirements and acceptance limits con-tained In applicable design documents Thetest program shall Include, as appropriate,proof tests prior to Ihstallation. preopera-tional tests, and operational tests during nu-clear power plant or fuel reprocessing plantoperation, of structures, systems, and com-ponents. Test procedures shall Include pro-visions for assuring that all prerequisites forthe given test have been met, that adequatetest. instrumentation Is available and used,and that the test Is performed under suit-able environmental conditions. Test resultsshall be documented and evaluated toassure that test requirements have been sat-1sf led.

XlI. ConTroL Of MEASURING AnD TestEQUIPMENT

Measures shall be established to assurethat tools, gages, Instruments. and othermeasuring and testing devices used In activi-ties affecting quality are properly con-trolled, calibrated, and adjusted at specifiedperiods to maintain accuracy within neces-sary limits. FIGURE 1 ,parje

Chaptr S-Nvdear ReguatrAM Commission

XMIT. HAND G STORAGE AC NIPPINO

Measures shall be established to controlthe handling, storage, shipping. cleaningand preservation of material and equipmentIn accordance with work and InspectionInstructions to prevent damage or deteriora-tion. When necessary for particular prod-ucts, special proyectlve environments, suchas Inert ga at nosphere, specific moisturecontent levels, and temperature levels, shallbe specified and provided.

XIV. INsemon. TESr, AND OPERATINOSTATUS

Measures shall be established to Indicate,by the use of markings such as stamps tagslabels. routing cards, or other suitablemeans, the status of Inspections and testsperformed upon Individual Items of the nu-clear power plant or fuel reprocessing plant.These measures shall provide for the identi-fication of Items which have satisfactorilypassed required Inspections and tests, wherenecessary to preclude Inadvertent bypassingof such Inspections and tests. Measuresshall also be established for Indicating theoperating status of structures, systems, andcomponents of the nuclear power plant -orfuel reprocessing plantk such as by taggingvalves and switches. iV prevent Inadvertentoperation.

XV. NOWCOWPORWruG MATERIALS. PARTs, ORCouwpowms

Measures shall be established to controlmaterials parts, or components which donot conform to requirements In order toprevent their Inadvertent use -or Installa-tion These measures shall Include as ap-propriate, procedures for Identification. doc-umentation, segregation, dsposlton, andnotification to affected organizations, Non-conforming Items shnhl be reviewed and ac-cepted. rejected, repaired or reworked In Dc-cordance with documented procedures.

Part 50, A",. E

; RecORe :XVII. QiALAT? Ast

Sufficient records shall ne maintained tofurnish evidence of activities affecting qu4(Ity. The records shall Include at leist thecfollowing: Operating logs and the results ofreviews, Inspections, tests, audits, monitor-Ing of work performance, and materlal;analyses, The records shall also Jncludeclosely-related data such as qualifications ofpersonnel. procedures, and equipment In-spection and test records shall, as a Mini-mum. Identify the Inspectow or data record-er, the type pf oflervt"on. tMe results. theacceptability, and the action taken In con-nection with any deficiencies noted. Recordsshall be Identifiable and retrietable. Con-sistent with applicable regulatory require-ments, the applicant shall establish require-ments concerning recorq retention, such asduration, location, and assigned responsibill-ty. ;

XVIII. AuDITsA comprehensive system of planned and

periodic audits shall be carried out to verifycompliance with all aspects of the qualityassurance program and to determine the ef-fectiveness of the program. The audits shallbe performed in accordance with the writ-ten procedures or check lists by appropri-ately trained personnel not having direct re-sponsibilities In the areas being audited.Audit results shall be documented and re-viewed by management having responsibili-ty In the area audited, Pollowup action, In-cluding reaudit of deficient areas, shall betaken where Indicated.

fSS PR 10499, June 27, 1970. as amended at36 Ft 18201. Sept. 17. 1971: 40 PR J210D,Jan. 20, 19751

CXVI.,ColutzcvE AcTIoN

Measures shall be established to assurethat conditions adverse to quality, such asfatilures, malfunctions, deficlencies, devi-ations, defective material and equipment.and nonconformances are promptly Identi-fied and corrected. In the case of significantconditions adverse to quality, the measuresshall assure that the cause of the conditionis determined and corrective action taken topreclude repetition. The Identification ofthe Significant condition adverse to quality.the cause of the condition, and the correc-tlive action taken shall be documented andreported to appropriate levels of manage-ment,

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10 CFR 60.

10 CFR 50, APPENDIX B

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QUALITY ASSURANCEPROGRAM PLAN

l!

I I

QUALITY ASSURANCEPROCEDURES

- - _ ._--- I --I_ _ _DETAILED TECHNICAL

- PROCEOURES

I.,

C0 JALITY ASSURANCE PROGRAM STRUCTURE

*I * .;

APPENDIX A

., 1

CRITERIA FOR QA PROGRAM(HIGH.LEVEL WASTE REPOSITORY PROGRAM)

This Appendix is broken down into sections which correspond to each of the 18criteria of Appendix B to 10 CFR 50. The structure of each section isorganized in a way that elaborates on or identifies specific information needsfor individual requirements as they appear within the 18 Appendix 8 criteria _Some individual requirements in Appendix 8 are not discussed in this Appendix, -but should be addressed in the DOE QA program description.

The positions in this Review Plan represent solutions and approaches that areacceptable to the staff, but which may not be the only possible solutions andapproaches. Various alternatives to the detailed guidance in this Plan may befound acceptable provided these deviations are documented and justified. Acommitment to conform to the guidance in this Plan is considered to be acommitment to implement all staff positions unless exceptions or alternativesare specifically identified.'

1. The Organization elements responsible for the QA program are acceptable tothe NRC staff if:

1.1 The responsibility for the overall program is retained and exercisedby the DOE at.a level which is commensurate withi the level of the DOEofficial who will submit the license application. While the lineorganization is responsible for performing quality affectingactivities properly, the QA organization shall verify the properperformance of work through implementation of appropriate QAcontrols.

1.2 DOE describes major delegation of work involved in establishing andImplementing the QA program or any part thereof to otherorganizations.

1.3 DOE describes how responsibility is exercised for the overall QAprogram. The extent of management responsibility and authority fromDOE headquarters and from the field office should be addressed.

1.4 DOE evaluates the performance of work delegated to otherorganizati6ns. This shall include audits of the prime contractor'sQA program and audits of representative subcontractors, consultants,

* "Contractor" as used in this Appendix refers to all contractors,subcontractors, vendors, consultants, or agents performing workcovered by the quality assurance program.

2

vendors, and laboratories furnishing equipment or services to theprime contractor or DOE. The frequency and method of evaluationshould be specified.

1.5 Qualified individual(s) or organization element(s) are identifiedwithin DOE's organization as responsible for the quality of thedelegated work prior to initiation of activities. -

1.6 Clear management controls and effective lines of communication existfor QA activities between DOE and its contractors, to assuredirection of the QA program.

1.7 Organization charts-clearly identify all the "onsite' and "offsite"organizational elements which function under the cognizance of the QAprogram and the lines of responsibility.

1.8 The QA organization is involved in the aspects of the high levelwaste repository program that affect safety and waste isolation. Theextent of QA controls is determined by the QA staff in combinationwith the line staff and is dependent upon the specific activity, itscomplexity, and its importance to safety or waste isolation as 7-

defined in 10 CFR Part 60.2. -

1.9 DOE and its prime contractor describe the QA responsibilities of eachof the organizational elements noted on the organization charts.

1.10 DOE and its prime contractor identify a management position withineach respective organization that retains overall authority andresponsibility for the QA program. This position, occupied by anindividual with appropriate management and QA knowledge andexperience has the following .caracteristics:

a. Is at the same or higher organization level as the highest linemanager directly responsible for performing activities affectingquality (such as design, engineering, site investigations,-procurement, manufacturing, etc.) and is sufficientlyindependent from cost and schedule.

b. -Has effective communication channels with other seniormanagement positions.

c. Has responsibility for approval of QA Manual(s), changesthereto, and interpretations thereof.

d. Has no other duties or responsibilities unrelated to QA thatwould prevent full attention to QA matters.

3

1.11 Verification of conformance to established requirements isaccomplished by individuals or groups within the QA organization.Certain exceptions for: design, item 3..7; inspections, item 10.2;and test data evaluation, item 11.3 are outlined in these sections.

1.12 Persons and organizations performing QA functions have direct accessto management levels which will assure the ability to: .

a. Identify quality problems.

b. Initiate, recommend, or provide solutions through designatedchannels.

c. Verify implementation of solutions.

d. Stop unsatisfactory work.

The persons and organizations with the above authority are identifiedand a description of how those actions are carried out is provided.

1.13 Provisions are established for the resolution of disputes involving-quality arising from a difference of opinion between QA personnel andother department personnel.

.1.14 Policies regarding the implementation of the QA program aredocumented and made mandatory.

1.15 The persons responsible for directing and managing the overallQA program are identified and have appropriate organizationalposition, responsibilities, and authority to exercise proper controlover the QA program.. This individuals are free from non-QA dutiesand can thus give full attention to assuring that the QA program isbeing effectively implemented.

2. Activities related to Quality Assurance Program are acceptable to the NRCstaff if -

2.1 The.QA program includes all items and activities important to safetyand waste isolation as defined in 10 CFR Part 60.2. The items andactivities covered by the QA program are identified and the rationaleprovided for determining how items or activities are important tosafety or waste isolation, as defined in 10 CFR 60.2. These termsare defined as numerical performance objectives and standards. The

4 i

rationale should include systems analyses that are used to determinewhat specific items and activities are covered.

2.2. The QA program includes a commitment that all development, control,and/or use of computer programs will be conducted in accordance withthe QA program. Guidance for the content of documentation ofcomputer codes is provided by NUREG-0856, "Final Technical Position -

on Documentation of Computer Codes for High-Level Waste Management. -

2.3 Provisions are established to assure that technical and qualityassurance procedures required to implement the QA program areconsistent with QA program requirements and are properly documented,controlled, and mandated through a policy statement or equivalentdocument signed by a responsible official.

2.4 The QA organization reviews and documents concurrence with the--quality-related* procedures relative to QA requirements.

2.5 The QA organization and the necessary technical organizationsparticipate early in the QA program definition stage to determine andidentify the extent QA controls are to be applied to specific items--and activities. This effort involves applying a defined gradedapproach in accordance with impo-rtance to safety or waste isolationas defined in 10 CFR Part 60.2 and affects such disciplines asdesign, data analysis (such as performance assessment), procurement,document control, inspections, tests- special processes, records,audits, and others described in 10 CFR Part 50, Appendix B.

2.6 Existing or proposed QA procedures and detailed technical proceduresare identified and documented reflecting that each criterion of 10CFR Part 50, Appendix B, appropriate to specific items andactivities, will be met.

2.7 A description Is provided of how management (above or outside the QAorganization) regularly assesses the scope, status, adequacy, andcompliance of the QA program tol10 CFR Part 50, Appendix B. Thesemeas~ures should include:

*The term "quality-related" refers to the quality of items "important tosafety" or "important to waste isolation."

- 5

a. --Frequent contact with program status through reports, meetings,and/or audits.-

b. Performance of an annual assessment which is preplanned anddocumented with corrective action identified and tracked.

2.8 Indoctrination, training, and qualification programs are established _such that:

a. Personnel responsible for performing quality-related activitiesare instructed as to the purpose, scope, and implementation ofthe quality-related manuals, instructions, and procedures.

b. Personnel verifying activities affecting quality are qualifiedin the principles-, techniques, and requirements of the activitybeing performed.

c. For formal training and qualification programs, documentationincludes the objective, content of the program, attendees, anddate of attendance.

d. Appropriate management monitors the performance of individualsinvolved in activities affecting quality aind determines the needfor retraining and/or replacement. A system of annual appraisaland evaluation can satisfy this criterion.

e. Qualified personnel are certified in accordance with applicablecodes and standards.

3. Activities related to Design Control are acceptable to the NRC staff if:

3.1 The definitions of design, design information, and design activitiesused in the design control program are as defined in this section.The term design refers to specifications, drawings, design criteria,and component performance requirements for the natural and engineeredcomponents of the repository system. It includes designs at eachstage of design development (i.e., from conceptual design to finaldesibn). Design information and design activities refer to datacolfection-and analyses activities that are used in supporting designdevelopment and verification. This includes general plans anddetailed procedures for data collection and analyses and relatedinformation such as test results and analysis. Data anlaysisincludes the initial step of data reduction as well as broad level

6

systems analyses (such as performance assessments) which integratemany-other data and analyses of individual parameters. The above isconsistent with the definition and usage of these terms in 10 CFRPart 60 and the Atomic Energy Act of 1954.

3.2 The design control program is implemented at the time of submissionof the Site Characterization Plan and includes design and designactivities as described in 3.1. It provides for the correcttranslation of applicable regulatory requirements and design basesinto design, procurement, and procedural documents. Performancerequirements are specified for repository system components tosupport: (a) identification of which items are important to wasteisolation; (b) establishment of a graded QA approach; and (c)establishment of data gathering and analysis needs.

3.3 Organizational responsibilities are described for preparing,_reviewing, approving, verifying and validating design and designinformation documents.

3.4 Errors and deficiencies in approved design and design informationdocuments are documented, and action is taken to assure that allerrors and deficiencies are corrected.

3.5 Interface controls amnong organizations or groups involved in designdevelopment and other design activities are described.

3.6 Procedures require that design drawings, specifications, criteria,and analyses be reviewed by the QA organization to assure that thedocuments are prepared, reviewed, and approved in accordance withdocumented procedures and quality assurance requirements.

3.7 Procedures are established and described for verification of designsand design activities, the verifier of which is qualified and notdirectly responsible for the design (i.e., not the performer or hisimmediate supervisor). In exceptional cases, the designer'simmediate supervisor can, however, perform the verification,provided:

*(a) The supervisor is the only technically qualifiedindividual.

(b) The need is individually documented and approved in advancewith concurrence of the quality assurance manager.

.

A . _

*7

It ti preferable.to have qualified personnel not associated with theresponsible design organization conduct verification activities.

3.8 For design or design activities which involve use of untried orstate-of-the-art testing and analysis procedures and methods or wheredetailed technical criteria and requirements do not exist or arebeing developed, a peer review should be conducted. The proceduresdefining the selection process for a peer group, and the process bywhich the peer group conducts its review should be described. A peerreview Js a critical review performed by personnel who areindependent of, but have expertise equivalent to, those who performedthe work. Outside consultants are retained for needed expertise,where required. 0

3.9 The responsibilities of the verifier, theireis arid features to beverified, the pertinent considerations to be verified, and the extent'of documentation are identified in the procedures.

3.10 Design changes, including field changes, are .subject to the samedesign controls that were applicable to the original design. Such aconfiguration control system should be in place at the earliest --practicable time. These changes should be analyzed to assure thatchange is required. Associated changes to procedures and trainingshould be considered, and changes should be communicated to allaffected groups or individuals.

4. Activities related to Procurement Document Control are acceptable to theNRC staff if:

4.1 Procedures are established for the review of procurement documents byQA personnel to determine that applicable regulatory requirements,design bases, and other requirements are referenced or stated inprocurement documents; there are adequate acceptance and rejectioncriteria, where appropriate; and procurement documents have beenprepared, reviewed, and approved in accordance with QA programrequirements. Procurement documents should require contractors,subcontractors and consultants to provide an acceptable qualityassurance program.

4.2 Organizational responsibilities are described for: (1) procurementplanning; (2) the preparation, review, approval, and control ofprocurement documents; (3) supplier selection; (4) bid evaluations;and (5) review and concurrence of supplier QA programs prior to

* 6

8

init.tation of activities affected by the program. The involvement ofthe QA organization is described.:

5. Activities related to Instructions, Procedures, and Drawings areacceptable to the NRC staff if:

5.1 Organizational responsibilities are described for assuring thatquality-related activities are: '(1) specified in instructions, -

procedures, and drawings; and (2) accomplished through implementationof these documents. These documents should be verified and approvedas described in Section 3.

5.2 Procedures are established to assure that instructions, procedures,and drawings include acceptance criteria for determining thatquality-related activities have been satisfactorily accomplished.

6. Activities related to Do'cument Control are acceptable to the NRC staff if:

6.1 The scope of the document control program is described, and the typesof controlled documents are identified.

6.2 Procedures for the review, approval, issuance, and revision ofdocuments are.establ'ished. These.procedures assure technicaladequacy and inclusion of appropriate quality requirements. The QAorganization reviews and concurs with these documents with respect toquality-related aspects.

6.3 Procedures are established to assure that correct and applicabledocuments are available at the location where the activity will beperformed prior to commencing the work.

6.4' Procedures are established and described to assure that obsolete orsuperseded documents are removed and replaced by applicable revisionsat work areas in a timely manner.

6.5 A master list or equivalent document control system is established toidentify the current revision of instructions, procedures,specjffications, drawings, and procurement documents.

6.6 When documents which require verification are'released prior toverification, they are so identified and controlled.

7. Activities related to Control of Purchased Materials, Equipment, andServices are acceptable to the NRC staff if:

7.1 Organizational responsibilities are described for the control ofpurchased material, equipment, and services.

7.2 Procedures governing procurement of items or services, includingappropriate QA organization participation, provide for: (a)evaluation and selection of suppliers; (b) verification of supplier'sactivities; and (c) receiving inspections.

7.3 The organization providing materials, equipment, or servicesfurnishes the following records to the purchaser:

a. Documentation that identifies the purchased service and thespecific procurement requirements (e.g., codes, standards, andspecifications) met.

b. Documentation identifying any procurement requirements that havenot been met.

c. A description of those nonconformances from the procurementrequirements dispositioned "accept as is" or "repair."

The procedure for review and acceptance of these documents should bedescribed in the purchaser's QA program.

7.4 Suppliers' certificates of conformance are periodically evaluated byaudits, independent inspections, or tests to assure they are validand the results documented.

7.5 In developing quality assurance requirements for data collection testequipment and other equipment, consideration should be given towhether proper performance of a-test can be determined during orafter testing (i.e., whether failure or malfunction of test equipmentcan be detected). Where no specific QA controls are found to benecessary, special quality/performance verification requirementsshall be established and described in procedures governing the use, ofthe equipment.

8. Activities related to sample Identification and Control are acceptable tothe NRC staff if:

8.1 Controls are established and described to identify and controlsamples. The description should include organizationalresponsibilities.

10

8.2 Procedures are established which assure that identification ismaintained either on the samples or their containers, or on recordstra'ceable'thereto.'

8.3 Identification of samples can be traced to the appropriatedocumentation such as drawings, specifications, purchase orders,drilling logs, test records, inspection documents, and nonconformance -

reports.

8.4 Correct identification of samples is verified and documented prior torelease for use or analysis.

9. Activities related to Control of Special Processes are acceptable to theNRC staff if:

9.1 .The criteria for determining those processes that are controlled asspecial processes are described. As complete a listing as possibleof special processes, which are generally those processes wheredirect inspection is impossible or disadvantageous, is provided.

9.2 Organizational responsibilities including those for the QA --

organization are described for qualification of-special processes,equipment, and personnel;'

9.3 Procedures, equipment, and personnel associated with specialprocesses are qualified and are in conformance with applicable codes,standards, QA procedures., and specifications. The QA organization isinvolved in the qualification activities to help assure they aresatisfactorily performed.

9.4 Procedures are established for recording evidence of acceptableaccomplishment of special processes using qualified procedures,equipment, and personnel.

9.5 Qualifications records of procedures, equipment, and personnelassociated with special processes are established and maintained.

10. Activities related to Inspection are acceptable to the NRC staff if:

10.1 'The scope of the inspection program is described that indicates aneffective inspection program has been.established. Programprocedures provide-criteria for determining when inspections arerequired or define how and when inspections are performed. The QAorganization participates in these functions.

* sK .

wA ad* * 11

10.2 Organizational responsibilities for inspection are described.Individuals performing inspections are part of the QA organization.For-fnspections requiring special expertise, other individuals may beused provided the independence of the inspection 'function ismaintained.

10.3 A qualification program for inspectors is established anddocumented, and the qualifications and certifications of inspectors -

are kept current.

10.4 Inspection procedures, instructions, or checklists provide for thefollowing:

a. Identification of characteristics and activities to beinspected. ' '

b. A description of the method of inspection. -

c. Identification of the individuals or groups responsible forperforming the inspection operation.

d. Acceptance and rejection criteria. _

e. Identification of required procedures, drawings, andspecifications and revisions.

f. Recording inspector or data''recorder and the results of theinspection operation.

g. Specifying necessary measuring and test equipment includingaccuracy requirements.

10.5 Procedures include identification of mandatory inspection holdpoints beyond which work may not proceed until inspected by adesignated inspector.

10.6 Inspection results are documented and evaluated, and theiracceptability is determined by a responsible individual.

11. Activities related to Test Control are acceptable to the NRC staff if:

11.1 The description of the scope of the test control program indicatesan effective test program has been established. Program proceduresprovide criteria for: (a) determining when a test is required or how

11.2 Test plans and procedures are reviewed in accordance with theverification requirements in Section 3.7, 3.8, and 3.9.

11.3 The potential sources of uncertainty and error in test plans and-procedures, and parameters which must be controlled and-measured to-assure that tests are well-controlled, are identified.

11.4 Test procedures or instructions provide for the following:

a. The requirements and acceptance limits contained in applicabledocuments, including precision and accuracy.

b. Instructions for performing the test.

C. Test prerequisites such as calibrated instrumentation, adequatetest equipment and instrumentation, completeness of item to betested, suitable and controlled environmental conditions, andprovisions for data collection and storage. a 3

d. Mandatory inspection holda points casorequired).

e. Acceptan ce and rejection criteria, including required levels ofprecision and accuracy.

_f. Methods of data analysis.

g. Methods of documenting or recording test.data and results.

h. Provisions for assuring test prerequisites have been met.

11.3 Test results.are documented, evaluated, and their acceptabilitydetermined by a responsible individual or group as described inSectponv3.

12. Activities related to Control of Measuring and Test Equipment areacceptable to the NRC staff if:

12.1 The scope of the program for the control of measuring and testequipment is described and the types of equipment to be controlledare established.