)e- pff /a/s8 - nrc

ENCLOSURE 3

HQ0. 880205.002t

BASALT WASTE ISOLATION PROJECT

BASALT QUALITY ASSURANCEREQUIREMENTS DOCUMENT

(BQARD)

REVISION 3

DECEMBER 1987 I

DOCUMENT MONITOR:C. K asch. Quality Systems Division AMC /DateU.S. Department of Energy - Richland, WA

IREVIEWED: )e- Pff / /A/s8

R. P. Saget, gfualty Systems Director, AMC DiteU.S. Depar nt of Energy - Richland WA

J. HAnttonen, Assistant Manager for DateOff I e of Commercial Nuclear WasteU.S. Department of Energy - Richland, WA

IAPPROVED:

8904040o279 880204F'1uR WASTEW 1 PDC

Page of Revision

BASALT QUALITY ASSURANCE REQUIREMENTS DOCUMENT

('BQARD')

- FOREWORD -

... Some of these projects have experienced problems in plantquality--parts of the plants were .jlt ncorrectly. Some of theseprojects experienced problems in the assurance of quality--theutility was unable to demonstrate whether its plant was builtcorrectly...'

(Extracted from Chapter 1, NUREG 1055, 'Improving Quality and the Assuranceof Quality in the Design and Construction of Nuclear Power Plants' a.k.a,'The NRC Ford Amendment Study.')

'As used n this appendix. 'quality assurance' comprises allthose planned and systematic actions necessary to provide adequateconfidence that a structure, system, or component will performsatisfactorily in service. Quality assurance includes qualitycontrol, which comprises those quality assurance actions related tothe physical characteristics of a material, structure, component,or system to-predetermined requirements."

(Extracted from Title 10, Chapter 1, Code of Federal Regulations, Part 50,Appendix B, Introduction.)

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BASALT QUALITY ASSURANCE REQUIREMENTS DOCUMENT (BQARD')For Site Characterization Activities

and/orDesign and Constrtiction of a High Level Waste Repository

INTRODUCTION

1. PURPOSE. For items or activities "important to safety or wasteisolation" (i.e., "Q-list items or activities, and certain otheritems/activities assigned a Level I designation through use of theGraded Quality Assurance (QA) Methodology), the BQARD:

a. Identifies and consolidates federally mandated QA programmatic |;requirements into a single document;

b. Provides guidance and consistency in interpretation of QAprogrammatic requirements;

c. Provides Basalt Waste Isolation Project (BWIP) pecific Arequirements and

d. Provides baseline control for BWIP participant Site Characterizationand/or Design/Construction QA Programs.

2. BQARD ORGANIZATION. Each criteria within this document is comprised oftwo parts. The first part of the right column, entitled "W!P ProjectImplementation," provides a discussion of the intent of the criteriarequirements in implementing the elements that comprise a viable system.This part of each criterion is guidance and does not contain any DOE,NQA-1, or NRC requirements. It is recognized there may be other equallyacceptable methods of meeting the requirements.

The second part of each criterion begins with the 10 CFR 50 Appendix 8criterion listed in the left column with the discrete QA requirementsthat shall apply during site characterization and construction. Undereach Appendix B requirement is additional guidance provided by theNuclear Regulatory Commission (NRC) Review Plan on how the NRC willreview to the Appendix "B" requirement when applied to sitecharacterization activities.

The column on the right side contains BWIP interpretations and imple-menting requirements. It frequently references NQA-1-1986 Supplementswhich are applicable to and not in conflict with the NRC Review Planguidance on the left side.

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Discrete QA requirements that apply to site characterization andlicensable construction are Included in the BQARD. It is anticipatedthat participants performing construction work "Important to Safety orWaste Isolation" will have or be required to comply with codes thatrequire) NRC acceptable QA Programs (for example, NCA 4000 of the B&PVcodes, section III). To amplify further, f a participant already has "Nstamp" authority, the construction BQARD should cause minor, if any,changes to that QA Program.

3. BQARO SOURCE DOCUMENTS. The QA requirements included within the BQARDare from several documents:

a. 10 CFR 60

b. 10 CFR 50, Appendix B

c. NRC Review Plan: QA Programs for Site Characterization of High LevelNuclear Waste Repositories, dated June 1984

d. QA Management Policies and Requirements, OCRWM, October 1985(OOE/RW/0032)

e. QA Plan for High-Level Radioactive Waste Repositories, OGR/B-3,Rev. 1, August 1986 and Supplements

f. DOE Order 5700.6B, Quality Assurance" and DOE-RL Order 5700.1A,"Quality Assurance"

g. DOE Order 4700.1, "Project Management System"

h. ANSI/ASME NQA-1 1986

1. Federal Acquisition Regulation (FAR) Part 46, "Quality Assurance"

J. DOE Order 5000.3, Unusual Occurrence Reporting System.

4. UTILIZATION OF NQA-1 WTHIN THE BQARD. QA Programs that meet therequirements of 10 CFR 50, Appendix B will meet all of the 18 BasicRequirements of NQA-1. Therefore, the QARD (for Level I sitecharacterization activities) utilizes 10 CFR 50 Appendix B the 18 NQA-1Basic Requirements, the NQA-1 supplements, and the NRC Review Plan, todefine QA Program requirements. Further, certain NQA-1 appendicesidentified as nonmandatory in the source document are included verbatim(except for title) as requirements in the BQARO, in order to precludemisunderstandings.

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5. ADDITIONAL GUIDANCE Participants should note that the NRC is providingadditional guidance in several areas directly affecting site Icharacterization QA activities. The additional NRC guidance is in theareas of:

a. Qualification of previously acquired data Ii

b. Peer reviews

c. The Q-list

There are also a number of supplements to the Office of GeologicRepository (OGR) QA Plan that have been incorporated by reference withinthe appropriate criterion where other requirements did not provide thisinformation.

6. REVISION STATUS OF BQARD. Revisions to the BQARD will be made by ndi-vidual page revision. Each page will have a page number and revisionnumber. The Table of Contents will identify individual pages by title orcriterion number, indicating page number, revision number, and issuedate.

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CONTENTS

PageNumber

RevisionNumber Issue Date

Abstract

DOE-RL ApprovalForewordIntroduction

Contents

Criterion 1.0 Organization

123111231231234567891011121312345678910111213141516171819

3 Mar 19873 Mar 19873 Mar 19873 Mar 19870 Feb 19863 Dec 19873 Dec 19873 Dec 19873 Mar 19873 Mar 19873 Mar 19870 Feb 19862 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19871 Nov 19860 Feb 19862 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19870 Feb 19860 Feb 19861 Mar 19871 Mar 19871 Mar 19871 Mar 19872 Mar 19873 Mar 19871 Mar 1987

I

Criterion 2.0 Quality Assurance

Page of 3Revision 3 I

Pagelumber

Criterion 3.0

Criterion 4.0

Criterion 5.0

Criterion 6.0

Criterion 7.0

Criterion 8.0

Criterion 9.0

Criterion 10.0

Design Control

Procurement Document Control

Instructions, Procedures,and Drawings

Document Control

Control of Purchase Material,Equipment, and Services

Identification and Controlof Materials, Parts, andComponents

Control of Special Processes

Inspection

123456789

101112

1234123123412345671234123123456789-

RevisionNumber Issue Date

0 Feb 19863 Dec 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19873 Dec 19873 Dec 19872 Mar 19873 Dec 19872 Mar 19871 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19873 Mar 19872 Mar 19872 Mar 19871 Mar 19872 Mar 19873 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19873 Mar 19873 Mar 19873 Dec 19873 Dec 19872 Mar 19872 Mar 19872 Mar 19872 Mar 1987

I)'

IxIs

I x

ix

Page of 3Revision 31

Issue DatePage

NumberRevisionNumber

Criterion 11.0 Test Control

Criterion 12.0

Criterion 13.0

Criterion 14.0

Criterion 15.0

Criterion 16.0

Criterion 17.0

Control of Measuring andTest Equipment

Handling, Shipping, andStorage

Inspection, Test, andOperating Status

Nonconforming Materials,Parts, or Components

Corrective Action

Quality Assurance Records

I Feb 19862 Mar 19873 Dec 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19873 Mar 19872 Mar 19872 Mar 19872 Mar 19873 Dec 19872 Mar 19872 Mar 19872 Mar 19873 Dec 19873 Mar 19872 Mar 19872 Mar 19873 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19873 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19872 Mar 19873 Mar 19873 Mar 1987

"x

iIIx

Criterion 18.0 Audits

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BQARDCRITERION 1: ORGANIZATIONREVISION 0 (sheet 1 of 13)

Requirement BWIP Project Implementation

Site Characterization

The ntent of this criterion during site characterizationis to establish requirements for critical areas of eachparticipant contractor's organization in order to ensurethat project activities are accomplished within a definedand controlled organizational structure. The criterionrequires a defined organizational structure thatdelineates (a) overall responsibilities, (b) delegation ofwork, (c) evaluation of performance, (d) managementcontrols and effective lines of communication,(e) interfaces, (f) management positions and responsi-bilities for each organizational element, (g) qualityassurance personnel independence, (h) policies, ()verification of performance, and () access to management.

Potentially Licenseable Construction

It is expected that potentially licenseable constructionwill be performed coincident with BIP site characteri-zation activities. Those participants who will performboth construction and site characterization work shallestablish a project organization meeting Site Characteri-zation Criterion 1. Construction only participantsperforming level I construction work shall, to the extentpractical, establish a project organization that conformsto the requirements of Site Characterization Criterion 1.Deviations, and the alternate method of providingequivalent control, will be documented.

NOTE: Contractorw as used in this BQARD refers to allcontractors, subcontractors, vendors, consultants, agentsor agencies, and institutions performing work covered bythe quality assurance program.

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CRITERION 1:BQARD

ORGANIZATION - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 2 of 131 I

Requirement I BWIP Project Implementation

KtqulKMtNT 1: 10 CFR 50 APPENDIX B

The applicant shall be responsible for the establishmentand execution of the quality assurance program.

NRC REVIEW PLAN SECTION 1.1

The responsibility for the overall program is retainedand exercised by the DOE at a level which is commensuratewith the level of the DOE official who will submit thelicense application. While the line organization isresponsible for performing quality affecting activitiesproperly, the QA organization shall verify the properperformance of work through implementation of appropriateQA controls.

This requirement shall be implemented as stated.

For site characterization, additional guidance has beenprovided in Section 1.1 of the NRC Review Plan.

This requirement shall be implemented as stated. Inaddition, Supplement S-i, Section 2.1 of QA-1-1986 shallbe Implemented.

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CRITERION 1:BQARD

ORGANIZATION - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 3 of 13)

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Requirement BWIP ProJect ImplementationI r

REQUIREMENT 2: 10 CFR 50 APPENDIX B

The applicant may delegate to others, such ascontractors, agents, or consultants, the work ofestablishing and executing the quality assuranceprogram, or any part thereof, but shall retainresponsibility therefor.


DOE describes major delegation of work involved inestablishing and implementing the QA program or any partthereof to other organizations.


DOE describes how responsibility is exercised for theoverall QA program. The extent of managementresponsibility and authority from DOE headquarters andfrom the field office should be addressed.


DOE evaluates the performance of work delegated to otherorganizations. This shall include audits of the primecontractor's QA program and audits of representativesubcontractors, consultants, vendors, and laboratoriesfurnishing equipment or services to the prime contractoror DOE. The frequency and method of evaluation shouldbe specified.

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This requirement shall be implemented as stated. I

For siteprovidedPlan.

characterization, additional guidance has beenIn Section 1.2 through 1.6 of the RC Review

This requirement shall be implemented as stated. Inaddition, Supplement S-I, Section 2.2 of NQA-1-1986 shallbe implemented.

This requirement shall be mplemented as stated. Inaddition, Supplement S-1, Section 3 of QA-1-1986 shallbe implemented.

This requirement shall be implemented as stated. Inaddition, Supplement 15-1, Section 2 of NQA-1-1986 shallbe implemented.

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CRITERION 1:BQARD

ORGANIZATION - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 4 of 13) I



Qualified individual(s) or organizationidentified within DOE's organization asthe quality of the delegated work prioractivities.

element(s) areresponsible forto initiation of

This requirement s not specifically addressed in NQA-1-1986. Therefc e, this requirement shall be implemented asstated.

This requirement shall be implemented as stated. Inaddition, Supplement S-1, Section 3 of NQA-1-1986 shallbe implemented.

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Clear management controls and effective lines ofcommunication exist for QA activities between DOE andits contractors, to assure direction of the QA program.

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BQARDCRITERION 1: ORGANIZATION - FOR SITE CHARACTERIZATION

REVISION 2 (sheet of 13) IRequirement BWIP Project Implementation

IREQUIREMENT 3: 10 CFR 50 APPENDIX B

The authority and duties of persons and organizationsperforming activities affecting the safety-relatedfunctions of structures, systems, and components shall beclearly established and delineated in writing.


Organization charts clearly identify all the "onsite and"offsite' organizational elements which function underthe cognizance of the QA program and the lines ofresponsibility.


DOE and its prime contractor describe the QAresponsibilities of each of the organizational elementsnoted on the organization charts.


DOE and its prime contractor identify a managementposition within each respective organization that retainsoverall authority and responsibility for the QA program.This position, occupied by an individual with appropriatemanagement and QA knowledge and experience has thefollowing characteristics:

a. Is at the same or higher organizational level as thehighest line manager directly responsible forperforming activities affecting quality (such asdesign, engineering, site investigations, procurement,manufacturing, etc.) and is sufficiently independentfrom cost and schedule.


For site characterization, additional guidance has beenprovided in Sections 1.7, 1.9, 1.10, and 1.15 of the NRCReview Plan.

This requirement is not specifically addressed in NQA-1-1986. Therefore, this requirement shall be implemented asstated.

This requirement shall be implemented as stated. Inaddition, Supplement S-i, Section 3 of NQA-1-1986 shallbe implemented.


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CRITERION 1:BQARD

ORGANIZATION - FOR SITE CRACTERrZATIONREVISION 2 (sheet 6 of 13) I

Requirement IBIP Project Implementation

b. Has effective communication channels with othersenior management positions.

c. Has responsibility for approval of QA manual(s).changes thereto, and interpretations thereof.

d. Has no other duties or responsibilities unrelated toQA that would prevent full attention to QA matters.


The persons responsible for directing and managing theoverall QA program are dentified and have appropriateorganizational position, responsibilities, and authorityto exercise proper control over the QA program. Theseindividuals are free from non-QA duties and can thus givefull attention to assuring that the QA program is beingeffectively implemented.


____________________________________________________________________________________________________ .1~~~~~~~~~~~~

CRITERION 1:BQARD


Requirement BWIP Proiect IlementationI ___ WP roet mneenato


These activities nclude both the performing functions ofattaining quality objectives and the quality assurancefunctions.


The QA organization is involved in the aspects of thehigh-level waste repository program that affect safetyand waste isolation. The extent of QA controls isdetermined by the QA staff in combination with the linestaff and is dependent upon the specific activity, itscomplexity, and its importance to safety or wasteisolation as defined in 10 CFR Part 60.2.


For site characterization, additional guidance has beenprovided In Section 1.8 of the NRC Review Plan.

This requirement shall be implemented as stated. Inaddition, Supplement S-1, Section 2 of NQA-1-1986 shallbe implemented. The requirements and methodology forformulating a Q-List and application of Graded QA aredelineated in OGR/B-3, Supplements 3 and .

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CRITERION 1:BARD

ORGANIZATION - FOR SITE CHARACTERIZATIONREVISIO 2 (sheet of 131


REQUIREMENT 5: 10 CFR 50 APPENDIX 8

The quality assurance functions are those of (a) assuringthat an appropriate quality assurance program isestablished and effectively executed and (b) verifying,such as by checking, auditing, and inspection, thatactivities affecting the safety-related functions havebeen correctly performed.


Verification of conformance to established requirementsis accomplished by individuals or groups within the QAorganization. Certain exceptions for: design, item 3.7;inspections, item 10.2; and test data evaluation, tem11.5 are outlined in these sections.

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This requirement is not specifically addressed in NQA-1-1986. Therefore, this requirement shall be mplemented asstated.

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CRITERION 1:BQARD

ORGANIZATION - FOR SITE CARACTERIZATIONREVISION 2 (sheet 9 of 13) I

Requirement BWIP Project ImplementationL


The persons and organizations performing qualityassurance functions shall have sufficient authority andorganizational freedom to identify quality problems; toinitiate, recommend, or provide solutions; and to verifyimplementation of solutions.


Persons and organizations performing QA functions havediect access to management levels which will assure theability to:

a. Identify quality problems.

b. Initiate, recommend, or provide solutions throughdesignated channels.

c. Verify implementation of solutions.

d. Stop unsatisfactory work.

The persons and organizations with the above authorityare identified and a description of how those actions arecarried out s provided.



For site characterization, additional guidance has beenprovided in Section 1.12, 1.13, and 1.14 of the NRC ReviewPlan.

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.1This requirement shall be implemented as stated.addition, this requirement is also addressed inNQA-1-1986, Basic Requirement 1.

In

Provisions are established for the resolution of disputesinvolving quality arising from a difference of opinion2tween QA personnel and other department personnel.


CRITERION 1:BQAD


Requirement BWIP ProJect ImplementationI e .e a


Policies regarding the implementation of the QA programare documented and made mandatory.

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This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall beimplemented as stated.

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BQADCRITERION 1: ORGAHIZATIOH - FOR SITE CHARACTERIZATION

REVISION 2 (sheet 11 of 13) IRequirement I BWIP Project Implementation


Such persons and organizations performing qualityassurance functions shall report to a management levelsuch that this required authority and organizationalfreedom, ncluding sufficient independence from cost andschedule when opposed to safety considerations, areprovided.


For site characterization, additional guidance has beenprovided n Section 1.15 of the NRC Review Plan (seesheet 6 of this criterion). In addition, this requirementshall be implemented in accordance with NQA-1-1986, BasicRequirement 1.

CRITERION 1:BQARD



I RI.QUIREMENT 8: 10 CFR 50 APPENDIX B

Because of the many variables involved, such as thenumber of personnel, the type of activity beingperformed, and the location or locations where activitiesare performed, the organizational structure for executingthe quality assurance program may take various formsprovided that the person and organizations assigned thequality assurance functions have this required authorityand organizational freedom.

This requirement shall be implemented as stated. Inaddition, Supplement 1S-1, Section 3 of NQA-1-1986 shallbe implemented.

1.

QARDCRITERION : ORGANIZATION - FOR SITE CHARACTERIZATION

REVISIO 2 (sheet 13 of 13) I



Irrespective of the organizational structure, theindividual(s) assigned the responsibility for assuringeffective execution of any portion of the qualityassurance program at any location where activitiessubject to this Appendix are being performed shall havedirect access to such levels of management as may benecessary to perform this function.

This requirement shall be implemented as stated. Inaddition, Supplement S-i, Section 3 of NQA-1-1986 shallbe implemented.

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BPROCRITERION 2: QUALITY ASSURANCE PROGRAM

REVISION 1 (sheet 1 of 19)



The intent of this criterion during site characterizationis to require DOE-RL (BWIP Division) to establish acomprehensive quality assurance program that controlsboth the design and construction of all Items andactivities important to safety or waste isolation, inorder to ensure the adequacy of the completed repositoryfacility. Consequently, each BWIP participant shallestablish a complementary quality assurance program,consistent with its assigned scope of work. All qualityassurance programs established shall meet the program-matic requirements identified within this criterion,along with the additional requirements included withinthe remaining seventeen (17) criteria of 10 CFR 50,Appendix B. Note that the NRC Review Plan, as ncorpo-rated herein, provides an acceptable means of meetingmany of the Appendix 8 programatic requirements.

In addition, NQA-1-1986 also provides an acceptable meansof meeting Appendix B programmatic requirements, providedNQA-1 is applicable to the site characterization activitybeing considered and is not in conflict with NRC ReviewPlan guidance.

The NRC makes a distinction between (1) administrative QAprocedures and (2) detailed technical or implementingprocedures. Quality assurance administrative proceduresprovide instructions for mplementation and applicationof the 18 criteria of 10 CFR Part 50 Appendix B. Theseapply to all technical program areas (e.g., proceduresfor test plan development). The detailed technical

BQARDCRITERION 2: QUALITY ASSURANCE PROGRAM



(implementing) procedures are developed by technicallyqualified personnel in accordance with the requirementsspecified in the administrative quality assuranceprocedures. These contain instructions for actualperformance of testing and investigations (e.g.,hydrologic pump tests, setting a packer).

In order to meet the stated requirements, the QA andtechnical organizations shall define the QA controls tobe applied to speciric tems and activities using adefined, graded approach in accordance with importance tosafety or waste isolation as defined in 10 CFR Part 60.2.Implementing procedures shall be prepared, controlled,and mandated through a policy statement signed bymanagement. Management shall be required to assess theadequacy of the QA program through frequent contact withthe program and a documented annual performanceassessment.


It is expected that potentially licenseable constructionwill be performed coincident with BWIP site characteriza-tion activities. Those participants who will performboth construction and site characterization work shallestablish a project QA program meeting Site Characteriza-tion Criterion 2. Construction only participantsperforming level I construction work shall, to the extentpractical, establish a project QA Program that conformsto the requirements of Site Characterization Criterion 2.Deviations and the alternate method of providingequivalent control, will be documented.

CRITERION 2:BQARD

QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 3 of 19) I



The applicant shall establish at the earliestpracticable time, consistent with the schedule foraccomplishing the activities, a quality assuranceprogram which complies with the requirements of thisappendix.


The QA organization and the necessary technicalorganizations participate early in the QA programdefinition stage to determine and identify the extentQA controls are to be applied to specific items andactivities. This effort involves applying a definedgraded approach in accordance with importance to safetyor waste isolation as defined in 10 CFR Part 60.2 andaffects such disciplines as design, data analysis (suchas performance assessment), procurement, documentcontrol, inspections, tests, special processes,records, audits, and others described in 10 CFR Part50, Appendix B.


Existing r proposed QA procedures and detailedtechnical procedures are identified and documentedreflecting that each criterion of 10 CFR Part 50,Appendix B, appropriate to specific items andactivities, will be met.


For site characterization, additional guidance has beenprovided in Section 2.5 and 2.6 of the NRC Review Plan.

This requirement is not specifically addressed in NQA-1-1986. Therefore, this requirement shall be implementedas stated.

The methodology for formulating a Q-List and theapplication of a Graded QA Program and the requirementsimposed by Headquarters-OGR are as delineated n theQuality Assurance Plan for High-Level Radioactive WasteRepositories OGR/B-3), Supplements 3 and 8.


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CRITERION 2:BQARD

QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATIONREVISION 2 (sheer 4 of 19)


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This program shall be documented by written policies,procedures, or instructions and shall be carried outthroughout plant life in accordance with those policies,procedures, or instructions.


Provisions are established to assure that technical andquality assurance procedures required to implement theQA program are consistent with QA program requirementsand are properly documented, controlled, and mandatedthrough a policy statement or equivalent document signedby a responsible official.


The QA organization reviews and documents concurrencewith the quality-related procedures relative to QArequirements.

The term quality-related* refers to the quality ofitems' important to safety' or important to wasteisolation.'

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For site characterization, additional guidance has beenprovided in Section 2.3 and 2.4 of the NRC Review Plan.

This requirement is notNQA-1-1986. Therefore,implemented as stated.

specifically addressed inthis requirement shall be


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CRITERION 2:BQARD


Requirement BWIP Project mplementationI~ ~~~WPPoetIpeetto


The applicant shall identify the structures, s3 .ems,and components to be covered by the quality assuranceprogram and the major organizations participating in theprogram, together with the designated functions of theseorganizations.


The QA program includes all items and activitiesimportant to safety and waste isolation as defined in 10CFR Part 60.2. The tems and activities covered by theQA program are Identified and the rationale provided fordetermining how items or activities are important tosafety or waste solation, as defined in 10 CFR Part60.2. These terms are defined as numerical performanceobjectives and standards. The rationale should includesystems analyses that are used to determine whatspecific items and activities are covered.

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The methodology for formulating a Q-List is imposed byHeadquarters-OGR as delineated in the QA Plan for High-Level Radioactive Waste Repositories (OGR/B-3).Supplement 3.

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CRITERION 2:BQARD



KUqU!KLMLNF 4: 10 CFR 50 APPENDIX B

The quality assurance program shall provide control overactivities affecting the quality of the identifiedstructures, systems, and components, to an extentconsistent with their importance to safety.


The QA program includes a commnitment that alldevelopment, control, and/or use of computer programswill be conducted in accordance with the QA program.Guidance for the content of documentation of computercodes is provided by NUREG-0856, Final TechnicalPosition on Documentation of Computer Codes for High-Level Waste anagement.*

The requirements and methodology for formulating a Q-Listand application of Graded QA are contained in theHeadquarters-OGR QA Plan for High-Level Radioactive WasteRepositories (OGR/B-3), Supplements 3 and 8.


This requirement is notNQA-1-1986. Therefore,implemented as stated.Criterion 3 controls.)

specifically addressed inthis requirement shall be(This is incorporated in

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CRITERION 2:BQARD

QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 7 of 19)


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IRUQUIREMENT 5: 10 CFR 50 APPENDIX B

Activities affectin, quality shall be accomplished undersuitably controlled conditions.

This requirement shall be implemented in accordance withNQA-1-1986s Basic Requirement 2.

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CRITERION 2:BQARD

QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATIONREVISION 2 (sheet of 19) I

Requirement BWIP Project ImplementationREQUIREMENT 6: 10 CFR 50 APPENDIX B

Controlled conditions nclude the use of appropriateequipment; suitable environmental conditions foraccomplishing the activity, such as adequate cleanness;and assurance that all prerequisites for the givenactivity have been satisfied.

This requirement shall be implemented in accordance withHQA-1-1986, Basic Requirement 2. I

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CRITERION 2:BQARD

QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATIOHREVISION 2 (sheet 9 of 19)

Requirement BWIP Project ImplementationI


The program shall take nto account the need forspecial controls, processes, test equipment, tools, andskills to attain the required quality, and the need forverification of quality by inspection and test.

This requirement shall be implemented in accordance withNQA-1-1986, Basic Requirement 2.

CRITERION 2:BQARD


Requirement 8WIP Project Implementation


The program shall provide for indoctrination andtraining of personnel performing activities affectingquality as necessary to assure that suitableproficiency is achieved and maintained.


Indoctrination, training, and qualification in programsare established such that:

a. Personnel responsible for performing quality-relatedactivities are Instructed as to the purpose, scope,and implementation of the quality-related manuals,instructions and procedures.

b. Personnel verifying activities affecting quality arequalified in the principles, techniques, andrequirements of the activity being performed.

c. For formal training and qualification programs,documentation includes the objective, content of theprogram, attendees, and date of attendance.

d. Appropriate management monitors the performance ofindividuals involved in activities affecting qualityand determines the need for retraining and/orreplacement. A system of annual appraisal andevaluation can satisfy this criterion.

e. Qualified personnel are certified in accordance withapplicable codes and standards.

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1. NQA-1-1986 addresses personnel erforming quality-related activities in Basic Requirement 2 andSupplement 2S-4. This requirement shall be met byimplementing the requirements of 2.Ba, c, d, and whenapplicable, e, in cases such as welder certification,etc., as stated. Additional requirements arespecified in OGR/B-3, Supplement 1, Section 5.0.

2. For personnel verifving quality-related activities,Requirements a, b, c, d, and e shall be implemented.NQA-1-1986 provides supplemental guidance as follows:

Design Reviewers - Supplement 3S-1, Section 4Inspectors - Supplements 2S-1 and/or 2S-2Auditors - Supplement 2S-3Indoctrination and Training - Supplement 2S-4.

Note that the Review Plan Criterion 3.8 providesqualification standards for peer reviewers.

In addition, the prospective lead auditor shall haveverifiable evidence that a minimum of 10 credits underthe following score system have been accumulated(DOE-RL).

1. Education 4 Credits Maximum)

Associate degree from an accredited institution:score one (1) credit, or if the degree is in

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BARDCRITERION 2: QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATION



engineering, physical sciences, mathematics, orquality assurance, score two (2) credits; or abachelor's degree from an accredited institution:score two (2) credits, or if the degree s inengineering, physical sciences, mathematics, orquality assurance, score three (3) credits; Inaddition, score one (1) credit for a master's degreein engineering, physical sciences, businessmanagement, or quality assurance from an accreditedinstitution.

2. Experience ( Credits Maximum)

Technical experience in engineering, manufacturing,construction, operation, or maintenance: score one1) credit for each full year, with a maximum of five5) credits for this aspect of experience.

If two (2) years of this experience have been n thenuclear field, score one () additional credit; or

If two (2) years of this experience have been inquality assurance, score two (2) additional credits;or

If two (2) years of this experience have been inauditing, score three (3) additional credits; or

If two (2) years of this experience have been in'uclear quality assurance, score three (3) additionalcredits; or

If two (2) years of this experience have been innuclear quality assurance auditing, score four (4)additional credits.

BWARDCRITERION 2: QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATION



3. Other Credentials of Professional Competence(2 Credits aximuMl

For certification of competency in engineering,science, or quality assurance specialities issued andapproved by a State Agency or National Professionalor Technical Society: score two (2) credits.

4. Rights of Management (2 Credits Maximum}

The lead auditor's employer may grant up to two (2)credits for other performance factors applicable toauditing that 'ay not be explicitly called out inthis appendix. Examples of these factors areleadership, sound judgment, maturity, analyticalability, tenacity, past performance, and qualityassurance training courses.

The sample form shown in NQA-1 may be utilized as arecord of lead auditor qualification.

In addition, the following requirements on thequalifications of inspection and test (verification)personnel are made mandatory (DOE-RL):

NOTE: NQA-1 uses Test and Inspection personnel n thecontext of verifiers of previously completed work. Forsite characterization, test personnel actually performthe site characterization tests (refer to Criterion XI),not verify them, and thus are not required to meet thesespecific qualifications. However, personnel assigned tothe testing organization and designated by the testingsupervisor to be an in-process inspectoru shall havethe qualifications identified herein (as well as otherrequired qualifications, see Review Plan 2.8(b) that areconsistent with the n-process inspection tasks assigned.

BQARDCRITERION 2: QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATIOP'

REVISION I (sheet 13 of 19)


In-process inspectors' shall have no direct responsi-bility in performing the work being nspected/verified.The inspection function may be part of the line organi-zation provided the QA organization performs periodicsurveillance to verify sufficient independence from theIndividuals who performed the activity.

1. FUNCTIONAL QUALIFICATIONS

Three levels of qualification shall be utilizeddepending on the complexity of the functionsinvolved. The recommendations for each level arenot limiting with regard to organizational positionor professional status but, rather, are limitingwith regard to functional activities.

1.1 Level I Personnel Capabilities

A Level I person shall be capable of performing anddocumenting the results of inspections or tests thatare required to be performed n accordance withdocumented procedures, acceptance standards, and/orindustry practices as defined in user's writtenprocedures.

1.2 Level II Personnel Capabilities

A Level II person shall have all of the capabilitiesof a Level I person for the inspection or testcategory or class in question. Additionally, aLevel II person shall have demonstrated capabilitiesin planning inspections and tests; in setting uptests, including preparation and setup of relatedequipment, as appropriate; in supervising ormaintaining surveillance over the inspections andtests; in supervising and certifying lower level

BQADCRITERION 2: QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATION

REVISION 1 (sheet 14 of 19) I


personnel; and in evaluating the validity andacceptability of nspection and test results.

1.3 Level III Personnel Capabilities

A Level III person shall have all of the capabili-ties of a Level II person for the inspection or testcategory or class in question. In addition, theindividual shall also be capable of evaluating theadequacy of specific programs used to train andcertify inspection and test personnel whose qualifi-cations are covered in this requirement. Inaddition a Level III person shall review and approveinspection and test procedures, evaluating theadequacy of such procedures to accomplish test andInspection objectives.

2. EDUCATION AND EXPERIENCE QUALIFICATIONS

These education and experience recommendations shallbe considered with recognition that other factorscommensurate with the scope, complexity, or specialnature of the activity may provide reasonableassurance that a person can competently perform aparticular task. Other factors that may demonstratecapability in a given job are previous performanceor satisfactory completion of capability testing.These factors and the basis for their equivalencyshall be documented.

2.1 Level I

2.1.1 Two years of related experience in equivalentinspection or testing activities; or

I.

BQARDCRITERION 2: QUALITY ASSURANCE PROGRAM - FOR SITE CHARACTERIZATIO1.


Requirement BWIP Project lI4'ementation

2.1.2 High school graduation and six months ofrelated experience in equivalent inspection ortesting activities; or

2.1.3 Completion of college level work leading toan associate degree In a related discipline plusthree months of related experience in equivalentinspection or testing activities.

2.2 Level II

2.2.1 One year of satisfactory performance as aLevel I in the corresponding inspection or testcategory or class; or

2.2.2 High school graduation plus three years ofrelated experience in equivalent inspection ortesting activities; or

2.2.3 Completion of college level work leading toan associate degree in a related discipline plus oneyear of related experience In equivalent Inspectionor testing activities; or

2.2.4 Graduation from a four-year college plus sixmonths of related experience in equivalentinspection or testing activities.

2.3 Level III

2.3.1 Six years of satisfactory performance as aLevel II in the corresponding inspection or testcategory or class; or

2.3.2 High school graduation plus ten years ofrelated experience in equivalent inspection ortesting activities; or high school graduation plus

BQARDCRITERION 2: QUALITY ASSURANCE PROGRA - FOR SITE CHARACTERIZATION



eight years of experience in equivalent in;pection ortesting activities with at least two years s LevelII and with at least two years associated wi'hnuclear facilities--or, if not, at least sufficienttraining to be acquainted with the relevant r.alityassurance aspects of a nuclear facility; .

2.3.3 Completion of college level work leading to an

associate degree and seven years of related experi-ence in equivalent inspection or testing activities,with at least two years of this experience associatedwith nuclear facilities or, if not, at least suffi-cient training to be acquainted with the relevantquality assurance aspects of a nuclear facility; or

2.3.4 Graduation from a four-year college plus fiveyears of related experience in equivalent inspectionor testing activities, with at least two years ofthis experience associated with nuclear facilities--or, if not, at least sufficient training to beacquainted with the relevant quality assuranceaspects of a nuclear facility.

CRITERION 2:BQARD


Requirement I BWIP. Project Implementation

REQUIREMENT 9: 10 CR 50 APPENDIX B

The applicant shall regularly review the status andadequacy of the quality assurance program.

This requirement shall be met by implementing all therequirements of NRC Review Plan Section 1.4 as addressedin Criterion 1, Requirement 2 of the BQARD andRequirement 10 of this criterion of the BQARD.

In addition, management assessments of the QA programshall be implemented as specified in OGR/B-3, QA Plan,Section 4.4.

I.

,

CRITERION 2:BQARD



I


Management of other organizations participating in thequality assurance program shall regularly review thestatus and adequacy of that part of the qualityassurance program which they are executing.

NRC REVIEV PLAN SECTION 2.7

A description Is provided of how management (above oroutside the QA organization) regularly assesses thescope, status, adequacy, and compliance of the QAprogram to 10 CFR Part 50, Appendix B. These measuresshould include:

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

b. Performance of an annual assessment which ispreplanned and documented with corrective actionidentified and tracked.


For site characterization, additional guidance has been,provided in Section 2.7 of the NRC Review Plan.

Additional requirements for the overview of QA activitiesare specified in OGR/B-3, Supplement 2.

This requirement is addressed in NQA-1-1986, BasicRequirement 2. Therefore, this requirement shall beImplemented as stated.

Also refer to Criterion 15, Requirement 2 andCriterion 16, Requirement 1.

In addition, participants shall submit audit schedules,schedule revisions, and audit reports to the-integratingcontractor (HQ-OGR).

Management assessments shall be conducted at leastannually for determining (a) the effectiveness of thesystem of management controls that are established toachieve and ensure quality and (b) the adequacy ofresources and personnel provided to the QA program.Management shall verify that the QA program s beingeffectively implemented and that personnel are trained tothe QA requirements of the program. Copies of the reportof management assessments generated by participantcontractors shall be provided to DOE-RL.

1

CRITERION 2:BQD



Management assessments shall be performed by HQ-OGR, theproject offices and their major contractors. Eachorganization shall develop its internal procedures forthe planning, organizing, performing, and documentingthe management assessment conducted, including theanalysis and reporting of the results and the trackingof recommendations (OGR/B-3 QA Plan, Section 4.4).

BQARDCRITERION 3: DESIGN CONTROLREVISION 0 (sheet 1 of 12)



The intent of this criterion during site characterization isto establish the requirements for controls over therepository design activities in order to ensure that (a)design products to be used during site characterization datacollection/testing/analysis (e.g., detailed procedures ordata analysis computer programs) are correct and consistentwith repository conceptual design, and (b) resultantrepository design products are correct and consistent withthe analyzed data obtained through site characterizationactivities. Refer to Review Plan Section 3.1 of thisCriterion (sheet 2) for additional information.


The Intent of this criterion during construction is toestablish the requirements for controls over the repositorydefinitive design processes, in order to ensure thatapplicable regulatory requirements and design bases (in partderived from site characterization activities) are correctlytranslated into construction specifications, drawings,procedures, and instructions (definitive design products),and that any subsequent change to a verified definitivedesign product is consistent with the original correcttranslation.

It is expected that definitive design for potentiallylicenseable construction will be performed coincident withBWIP site characterization design work. Those participantswho will perform both construction and site characterizationdesign work shall establish Design Controls meeting sitecharacterization Criterion 3. Those participants performingonly definitive design for Level I construction work shallestablish those design controls required by the specific codeor standard to be met, and, to the extent practical, shallconform to the requirements of Site CharacterizationCriterion 3. Deviations, and the alternate method ofproviding equivalent control, will be documented.

I-

CRITERION 3:BQARD

DESIGN CONTROL - FOR SITE tHARACTERIZATIONREVISION 3 (sheet 2 of 12) x



Measures shall be established to assure that applicableregulatory requirements and the design basis, asdefined in Sub-section 50.2 and as specified in thelicense application, for those structures, systems, andcomponents to which this appendix applies are correctlytranslated into specifications, drawings, procedures,and instructions.


The definitions of design, design information, anddesign activities used n the design control programare as defined in this section. The term design refersto specifications, drawings, design criteria, andcomponent performance requirements for the natural andengineered components of the repository system. Itincludes designs at each stage of design development(i.e., from conceptual design to final design). Designinformation and design activities refer to datacollection and analyses activities that are used insupporting design development and verification. Thisincludes general plans and detailed procedures for datacollection and analyses and related information such astest results and analysis. Data analysis includes theinitial step of data reduction as well as broad-levelsystems analyses (such as performance assessments)which integrate many other data and analyses ofindividual parameters. The above is consistent withthe definition and usage of these terms in 10 CFRPart 60 and the Atomic Energy Act of 1954.


For site characterization, additional guidance has beenprovided n Sections 3.1 and 3.2 of the NRC Review Plan.

This requirement is not specifically addressed InNQA-1-1986. Therefore, this requirement shall beimplemented as stated.

Requirementsfor geologicrequirements

for the control of the reliability of datarepository projects, shall comply with theof the WIP QA Plan Section 3.3.

CRITERION 3:BQARD

DESIGN CONTROL - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 3 of 12)

I


KiK REVIEW PLAN SECTION 3.2

The design control program is implemented at the time ofsubmission of the Site Characterization Plan andIncludes design and design activities as described in3.1 (of the NRC Review Plan). It provides for thecorrect translation of applicable regulatory require-ments and design bases into design, procurement, andprocedural documents. Performance requirements arespecified for repository system components to support:(a) identification of which items are important to wasteisolation; (b) establishment of a graded A approach;and (c) establishment of data gathering and analysisneeds.

This requirement shall be implemented as stated. Inaddition, Supplement 3S-1, Sections 2, 3, and 7 ofRQA-1-1986 shall be implemented.

In addition, performance assessment and allocation, andchanges thereto, based on data analysis results, shall becontrolled in accordance with the applicable requirementsof the System Engineering Management Plan. (DOE-RL)

CRITERION 3:BQARD

DESIGN CONTROL - FOR SITE CARACTERIZATIONREVISION 2 (sheet 4 of 12) I

Requirement BWIP Project Implementation--- - -I - -


These measures shall include provisions to assure thatappropriate quality standards are specified and includedin design documents and that deviations from suchstandards are controlled.


Procedures require that design drawings, specifications,criteria, and analysis be reviewed by the QAorganization to assure that the documents are prepared,reviewed, and approved in accordance with documentedprocedures and quality assurance requirements.

This requirement shall be met by implementing NQA-1-1986,Supplement 3S-1, Section 2.

For site characterizatio, additional guidance has beenprovided n Section 3.6 of the NRC Review Plan.


I

I

1.

CRITERION 3:BQW


Requirement BWIP ProJect ImplementationI - I - - -~~~~~~~~~~~~~~


Measures shall also be established for the selection andreview for suitability of application of materials,parts, equipment, and processes that are essential tothe safety-related functions of the structures, systems,and components.

This requirement shall be met by implementing NQA-1-1966, Supplement 3S-1.

In addition, requirements for the methodology forformulating a Q-List are as specified in OGR/B-3,Supplement 3.

I

t

CRITERIOH 3:BQARO

DESIGN CONTROL - FOR SITE CHARACTERIZATIONREVISION 2 (sheet-6 of 12) I



Measures shall be established for the dentification andcontrol of design interfaces and for coordination amongparticipating design organizations.

#RC REVIEW PLAN SECTION 3.5

Interface controls among organizations or groupsinvolved in design development and other designactivities are described.


For site characterization, the NRC has providedadditional guidance in Section 3.5 of the NRC ReviewPlan.

This requirement shall be Implemented as stated. Inaddition, Supplement 3S-1, Section 6 of NQA-1-1986 shallbe implemented.

CRITERION 3:BQARD


Requirement BWIP ProJect ImplementationI~ ~~~WPPoetIpeetto

REQUIREMENT 5: 10 CFR 50 APPENDIX

These measures shall include the establishment ofprocedures among participating design organizations forthe review, approval, release, distribution, andrevision of documents involving design interfaces.


Organizational responsibilities are described forpreparing, reviewing, approving, verifying, andvalidating design and design information documents.

-I

I

II

This requirement shall be met by mplementingSupplement 3S-1, Section 6 of NA-1-1986.

For site characterization, the RC has providedadditional guidance in Section 3.3 of the RC ReviewPlan.

This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall beimplemented as stated. In addition, design/engineering*holds shall be included (DOE-RL).

Note the use of the word Nvalidating. It pertains tothe design of computer codes, as discussed in NUREG 0856in the definitions of validating and verifying* whenused in the context of computer codes, to provideassurance that a model s a correct representation of theprocess or system for which it is intended.

I

CRITERION 3:BQARD


Requirement BWIP Project Implementtion

REQUIREMENT 6: 10 CR 50 APPENDIX B

The design control measures shall provide for verifyingor checking the adequacy of design, such as by theperformance of design reviews, by the use of alternateor simplified calculational methods, or by theperformance of a suitable testing program.


Errors and deficiencies in approved design and designinformation documents are documented, and action istaken t assure that all errors and deficiencies arecorrected.

This requirement shall be met by implementing therequirements of NQA-1-1986, Supplement 3S-1, Section 4.

For site characterization, the RC has provided addi-tional guidance in Sections 3.4 and 3.8 of the NRC ReviewPlan.

This requirement shall be met by implementing therequirements of NQA-1-1986, Supplement 3S-1, Section 5.

This method of design verification is not specificallyaddressed in NQA-1-1986. Therefore, this requirementshall be implemented. Requirements for the control ofpeer reviews conducted for geologic repository projectshall be as specified in the BWIP QA Plan Section 3.5.

I

i

INRC REVIEW PLAN SECTION 3.8

For design or design activities which involve use ofuntried or state-of-the-art testing and analysisprocedures and methods or where detailed technicalcriteria and requirements do not exist or are beingdeveloped, a peer review should be conducted. Theprocedures defining the selection process for a peergroup, and the process by which the peer group conductsits review should be described. A peer review is acritical review performed by personnel who areindependent of, but have expertise equivalent to, thosewho performed the work. Outside consultants areretained for needed expertise, where required.

CRITERION 3:BQD


Requirement BWIP Prolect ImplementationI Pro nion


The verifying or checking process shall be performed byindividuals or groups other than those who performed theoriginal design, but who may be from the sameorganization.


Procedures are established and described for verifica-tion of designs and design activities, the verifier ofwhich is qualified and not directly responsible for thedesign, (i.e., not the performer or his immediatesupervisor). In exceptional cases, the designer'sImmediate supervisor can, however, perform the verifica-tion, provided:

(a) The supervisor is the only technically qualifiedindividual.

(b) The need s individually documented and approvedin advance with concurrence of the QualityAssurance manager.

It is preferable to have qualified personnel notassociated with the responsible design organizationconduct verification activities.


The responsibilities of the verifier, the areas andfeatures to be verified, the pertinent considerations tobe verified, and the extent of documentation areidentified in the procedures.

-4


For site characterization, the NRC has providedadditional guidance for this requirement in Sections 3.7and 3.9 of the NRC Review Plan.


This requirement shall be met by implementing therequirements of NQA-1-1986, Supplement 3S-1, Sections 4and 7.

I1)~

J.

CRITERION 3:BQARD

DESIGN CONTROL - FOR SITE CHARACTERIZATIONREVISIOH 2 (sheet 10 of 12)

R..1rr.mnt BWIP Project Implementation..- I- . I - -1


Where a test program is used to verify the adequacy ofa specific design feature in lieu of other verifying orchecking processes, t shall nclude suitablequalification testing of a prototype unit under themost adverse design conditions.

This requirement shall be met by implementing therequirements of Supplement 3S-1, Subsection 4.2.3 ofNQA-1-1986.

Refer to Criteric'a 11 for additlonal information.

____________________________________________________________________________________________________ i~~~

CRITERION 3:BQARD


Requirement BWIP Project Ilementation________I - - - -----


Design control measures shall be applied to items suchas the following: reactor physics, stress, thermal,hydraulic, and accident analyses; compatibility ofmaterials; accessibility for in- service inspection,maintenance, and repair; and delineation of acceptancecriteria for inspections and tests.

This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall beimplemented to the level of detail apparent in therequirement. Additional non mandatory guidance Isprovided in NQA-1-1986, Appendix 3A-1.

In addition, the word reactor is deleted and the words'high level waste disposal added in its stead (DOE-RL).

In addition, the delineation of appropriate acceptancelimits for verification and tests (site characterizationtesting) shall be directly relatable to the design inputthat must be confirmed via performance of the test (DOE-RL).

I

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I

CRITERION 3:BQARD

DESIGN CONTROL - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 12 of 12) I

Requirement BWIP Project ImplementationI ___


Design changes, including field changes, shall besubject to design control measures commensurate withthose applied to the original design and be approved bythe organization that performed the original designunless the applicant designates another responsibleorganization.


Design changes, including field changes, are subject tothe same design controls that were applicable to theoriginal design. Such a configuration control systemshould be in place at the earliest practicable time.These changes should be analyzed to assure that changeis required. Associated changes to procedures andtraining should be considered, and changes should becommunicated to all affected groups or individuals.


For site characterization, the NRC has providedadditional guidance for this requirement n Section 3.10of the NRC Review Plan.

This requirement shall be implemented as stated. Inaddition, Supplement 3S-1, Section 5 of NA-1-1986 shallbe implemented.

NOTE: "Configuration Management and Change Control shallcomply with DOE Order 4700.1, Part C,OConfiguration Management and Change Control."

I

BERDCRITERION 4: PROCUREMENT DOCUMENT CONTROL




The intent of this criterion during site characterizationis to establish the requirements for the control ofProcurement Documents including content, in order toensure that only correct and complete Procurement Docu-ments are utilized by BWIP. This Criterion andCriterion 7 shall establish the requirements for thecontrol of procurement activities, from procurementplanning through supplier QA program approval, in orderto assure that qualified suppliers furnish BWIPmaterials, equipment, and services. (Refer to BQARDinterpretation of NRC Review Plan Section 4.2 foradditional information.)

Note the NQA-1 definitions of 'Procurement Documents,.OFinal Design (Documents),' and 'Design Output (Docu-ments)." As used herein, Procurement Documents means alldocuments included within the bid package' (or equiva-lent) transmitted to suppliers, and other directlyrelated documents (e.g., RFP's, contract modifications).Procurement Documents include Final Designs documentswhich, during site characterization are often approved'Statements of Work." Final Design Documents shallinclude those technical QA requirements applicable to theprocurement, and the organization preparing the FinalDesign Documents shall recommend to the purchaser thoseprogrammatic QA requirements applicable to theprocurement. It is preferable that the supplierdocumentation to be submitted for both the QA technicaland QA programmatic requirements be identified in aconsolidated Deliverable List" (or submittal list")that is an integral part of the Final Design Documents.In any case, agreement between the design organizationand the purchaser with respect to both QA technical and

QARDCRITERION 4: PROCUREMENT DOCUMENT - FOR SITE CHARACTERIZATION



recommended programmatic requirements shall be reachedprior to design review of the Design Output Documents.The purchaser shall assure that any QA requirements notincluded in the Final Design Documents are includedwithin the Procurement Documents.

Note tat Criterion 6, Document Control," NRC ReviewPlan 65, identifies Procurement Documents for inclusionwithin-a document control system.

Note that Procurement Document changes (i.e., contractmodifications) that result from-unsatisfactory supplierperformance may be considered significant conditionsadverse to quality' and shall be documented as requiredby Criterion 16. NRC Review Plan Section 16.4.

Potentially Lcenseable Construction

The intent of this criterion during construction isidentical to its intent during site characterization.

_ .~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

CRITERION 4:BQARD

PROCUREMENT DOCUMENT - FOR STE CHARACTERIZATIONREVISION 2 (sheet 3 of 4) I



Measures shall be established to assure thatapplicable regulatory requirements, design bases, andother requirements which are necessary to assureadequate quality are suitably included or referencedin the documents for procurement of material,equipment, and services, whether purchased by theapplicant or by its contractors or subcontractors.


Organizational responsibilities are described for:(1) procurement planning; (2) the preparation,review, approval, and control of procurementdocuments: (3) supplier selection; (4) bidevaluations; and (5) review and concurrence ofsupplier QA programs prior to initiation of activitiesaffected by the program. The involvement of the QAorganization is described.

This requirement shall be met by implementing NQA-1-1986,Basic Requirement 4 and Supplement 4S-1.



In addition, Sections 2, 3, and 4 of Supplement 4S-4 andSupplement 7S-1, Sections 1, 3, 4, and 5 of NQA-1-1986,shall be implemented for activity (2).

I

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CRITERION 4:BARD

PROCUREMENT DOCUMENT - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 4 of 4) I

Requirement ISIP Project Implementation


To the extent necessary, procurement documents shallrequire contractors or subcontractors to provide aquality assurance program consistent with the pertinentprovisions of this appendix.


Procedures are established for the review of procurementdocuments by QA personnel to determine the applicableregulatory requirements, design bases, and otherrequirements are referenced or stated in procurementdocuments; there are adequate acceptance and rejectioncriteria, where appropriate; and procurement documentshave been prepared, reviewed, and approved n accordancewith QA program requirements. Procurement documentsshould require contractors, subcontractors, and consul-tants to provide an acceptable Quality Assuranceprogram.



This equirement shall be Implemented as stated. Inaddition, Supplement 4S-1, Sections 2 and 3 of NQA-1-1986shall be implemented.

Note that Federal Acquisition Regulations (FAR's) mayrequire acceptance inspections if the procurementincludes turnover of tangible, capital equipment to thepurchaser.

It is anticipated that BWIP site characterizationactivities will require a limited number of acceptanceinspections. These will be planned and conducted on acase-by-case basis in response to project procurementregulations and procedures.

L

BARDCRITERION 5: INSTRUCTIOHS, PROCEDURES. AND DRAWINGS


Requirement WBIP Project Implementation-~~ ~~~~~~~~~~~~~~~~~~ I


The intent of this criterion during site characterizationis to establish the requirements for the control ofproject quality-related activities through the use ofwritten procedures, instructions, and drawings (that havebeen subjected to a documented review/verification andapproval process), in order to ensure that activities areperformed correctly, and if required, can be reproducedat a later date.

NOTE: QA-1 Supplement S-i makes a distinction betweenOProcedure and Qualified Procedures which is "anapproved procedure that has een demonstrated to meet thespecified requirements for its intended purpose.'Qualified procedures are normally required in advance ofperformance of a special process (Criterion 9). Thosetechnical procedures required by Criterion 5 may beconverted to Qualified Procedures,' if desired, upondetermination by the design organization (Criteria 3)that the procedure produced valid results. Also refer toCriterion 2 for additional procedural information.


The intent of this criterion during construction isidentical to ts intent during site characterization.

I

BQWCRITERION 5: INSTRUCTIONS, PROCEDURES, AND DRAWINGS - FOR SITE CHARACTERIZATION


Requ1rement BWIP Project ImplementationBWIP Project ImplementationL ____________________________________________________________________________________________________

REQUIREMENT : 10 CFR 50 APPENDIX B

Activities affecting quality shall be prescribed bydocumented nstructions, procedures, or drawings, of atype appropriate to the circumstances and shall beaccomplished in accordance with these instructions,procedures, or drawings.


Organizational responsibilities are described forassuring that quality-related activities are: (1)specified in Instruction, procedures, and drawings; and(2) accomplished through implementation of thesedocuments. These documents should be verified andapproved as described in Section 3 (of the NRC ReviewPlan).

This requirement is addressed in NQA-1-1986, BasicRequirement 5.



CRITERION 5:B4ARD

INSTRUCTIONS, PROCEDURES, AND DRAWINGS - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 3 of 3)

Requirement BWIP Prolect ImplementationI Pro ---le-e-tatio-


Instructions, procedures, or drawings shall ncludeappropriate quantitative or qualitative acceptancecriteria for determining that important activities havebeen satisfactorily accomplished.


Procedures are established to assure that nstructions,procedures, and drawings include acceptance criteria fordetermining that quality-related activities have beensatisfactorily accomplished.

I~~~~~----__ -


For site characterization, additional guidance has beenprovided in Section 5.2 of the RC Review Plan.

This requirement shall be met by implementing NQA-1-1986,Basic Requirement 5.

BQARDCRITERION 6: DOCUMENT CONTROL

REVISION 2 (sheet 1 of 4) |



The intent of this criterion during site characterizationis to establish the requirements for the control ofproject quality-affecting documents, in order to ensurethat correct and applicable documents are available atthe location where the activity will be performed priorto commencing the work.

NOTE: QA-1 Supplement S-1 provides an acceptabledefinition of Document and QA Record," as well as thedistinction between the two. Further, QA-1 permits a*Deviation* from the specified requirements of acontrolled document provided an approved waiver isobtained on a case-by-case basis. Project participantsshall establish a deviation/waiver procedure that ensuresadequate control over case-by-case changes to controlleddocuments, if deviations/waivers are to be used.



I

CRITERION 6:BA

DOCUMENT CONTROL - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 2 of 4)

. _

Requirement BWIP ProJect ImplementationI~ ~~~WPPoetIpeetto


Measures shall be established to control the issuanceof documents, such as instructions, procedures, anddrawings, including changes thereto, which prescribeall activities affecting quality.


The scope of the document control program isdescribed, and the types of controlled documents areidentified.


Procedures for the review, approval, Issuance, andrevision of documents are established. Theseprocedures assure technical adequacy and inclusion ofappropriate quality requirements. The QA organizationreviews and concurs with these documents-with respectto quality-related aspects.


A master list or equivalent document control system Isestablished to identify the current revision ofinstructions, procedures, specifications, drawings,and procurement documents.


When documents which require verification are releasedprior to verification, they are so identified andcontrolled.

This requirement shall be implemented as stated inNQA-1-1986, Basic Requirement 6 and Supplement 6S-i.

Additional guidance has been provided in Sections 6.1,6.2, 6.5, and 6.6 of the NRC Review Plan.

This requirement shall be met by implementing allrequirements in QA-1-1986, Supplement 6S-1, Sections 1and 2, provided the requirement to describe the scope ofthe document control program is addressed.

This requirement shall be implemented as stated.addition, NQA-1-1986, Supplement 6S-1 shall beimplemented.

In

This requirement is not specifically addressed in NQA-1-1986. Therefore, this requirement shall be implementedas stated.

This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall beimplemented as stated, and in addition, any project dataresulting from application of the unverified documentshall be clearly identified (DOE-RL).

CRITERION 6:BQARD


Requirement BWIP Project Implementation_ . _ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~I


These measures shall assure that documents, Includingchanges, are reviewed for adequacy and approved forrelease by authorized personnel and are distributed toand used at the location where the prescribed activity Isperformed.

NRC REVPY4 PLAN SECTION 6.3

Procedures are established to assure that correct andapplicable documents are available at the location wherethe activity will be performed prior to commencing thework.


Procedures are established and described to assure thatobsolete or superseded documents are removed and replacedby applicable revisions at work areas in a timely manner.

,

.

This requirement shall be implemented as stated inNQA-1-1986, Supplement 6S-1, Section 1.

Additional guidance has been provided in6.4 of the NRC Review Plan.

Sections 6.3 and



I

CRITERION 6:BARD


-

Requirement BWIP ProJect Implementation________________________________ I


Changes to documents shall be reviewed and approved bythe same organizations that performed the original reviewand approval unless the applicant designates anotherresponsible organization.

,

This requirement shall be met by implementingSupplement 6S-1, Section 3 of NQA-1-1986.

In addition, change controls shall comply with DOEOrder 4700.1, Part C, 'Configuratlon Management andChange Control.'

BQARDCRITERION 7: CONTROL OF PURCHASED MATERIAL. EQUIPtENT, AND SERVICES


Requirement BWIP Project Iaplementation


The intent of this criterion during site characterizationIs to establish the minimu requirements for control ofpurchased material, equipment and services, to ensurethey conform to the procurement documents. Documentaryevidence that tems (not limited to materials andequipment) conform to procurement requirements shall beprovided by the supplier and reviewed and accepted by thepurchaser prior to installation or use of the Items.

Procedures shall be written to provide for: (a) sourceevaluation and selection, (b) inspection of items at thesource or upon delivery, and (c) periodic assessment ofthe suppliers quality program. Documentary evidence thatitems conform to procurement requirements shall beprovided by the supplier and retained at the nuclearfacility.

Note that this criterion provides greater definition of*QA Records' as t applies to external suppliers. Referalso to QA-1 Supplement S-1 for definition of the termsused herein.



CRITERION 7: CONTROL OF PRCASED MATERIAL, EQUIPENT, A SERVICES - FOR SITE RTERIZATIONREVISION 2 sheet 2 of 71

-- - - - -- -F

Requirement SWIP Project IplementationfEm a. . *-. - --- - I

KtqI KLMLf4 I: IO CFR 50 APPENDIX B

Measures shall be established to ssure that purchasedmaterial, equipment, and services, whether purchaseddirectly or through contractors and subcontractors,conform to the procurement documents.


Organization responsibilities are described for thecontrol of purchased material, equipment, andservices.

IThis requirement shall be imp'ented as stated.

For site characterization, additional gu1dance. has beenprovided in Section 7.1 of the HRC Review' Plan.

This requirement shall be met by lmplementirgSupplement S-1, Section 2 of NQA-1-1986.

In addition, receiving inspection requirements uay beminimized for items packaged for preservation at thesupplier's activity, provided inspection s performed atthe supplier's activity and Criterion 13, 'Handling,Storage, and Shipping,' is appropriately implemented forthe procurement (DOE-RL).

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CRITERION 7: CONTROL OF PURCHASED MATERIAL, UIPMENTr, AND SERVICES - FOR SITE RCTE IREISO 2 sret 3 of 71

Requirement BWIP Project Implementationr. A - - - -.

I

IKLVU1IKtE Z: 10 CFR 50 APPENDIX B

These measures shall include provisions, as appropriate,for source evaluation and selection, objective evidenceof quality furnished by the contractor or subcontractorsInspection at the contractor or subcontractor source,and examination of products upon delivery.


Procedures governing procurement of items or services,including appropriate tJA organization participation,provide for: (a) evaluation and selection of suppliers;(b) verification of supplier's activities; and (c)receiving inspections.



This requirement shall be Implemented as stated. Inaddition Supplement 7S-1 Section(s) 3, 4, 5, 8, and 10 ofNQA-1-1986 shall be Implemented.

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DMARCRITERION 7: CONTROL OF PURCHASED MATERIAL, EQUIPEKT, AND SERVICES - FOR SITE CHARACTERIZATION

REVISION 3 sheet 4 of 71- - - I-1

Requirement BWIP Project ImplementationF~~e~es -- ea-, - I _ _ _

KLIJUIKLK I : 10 CFR 50 APPENDIX

Documentary evidence that material and equipment conformto the procurement requirements shall be available atthe nuclear powerplant or fuel reprocessing plant siteprior to Installation or use of such material andequipment.


The organization providing materials, equipment, orservices furnishes the following records to thepurchaser:

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

b. Documentation identifying any procurementrequirements that have not been met.

c. A description of those nonconformances from theprocurement requirements dspositioned accept as is'or repair.6

The procedure for review and acceptance of thesedocuments should be described in the purchaser's QAprogram.


For site characterization, additional guidance has beenprovided in Section 7.3 of the NC Review Plan.

The words repository site' shall be substituted whereappropriate.

This requirement shall be met by implementingSupplement 7S-1, Section 8 of QA-1-1986.

This requirement shall be met by implementingSupplement 7S-I, Sections 8 and 9 of NQA-1-1986.

This requirement shall be met by ImplementingSupplement 7S-1, Section 9, Subsection (b) of NQA-1-1986.

This requirement shall be met by mplementingSupplement 7S-1, Sections 5, 6, 7, and 9 of NQA-1-1986. I

CRITERION 7:BQW

CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES - FOR SITE CARACTERIZATIONREVISION 2 (sheet 5 of 7)


RQUIREKENT 4: 10 CFR 50 APPENDIX B

I

This documentary evidence shall be retained at thenuclear powerplant or fuel reprocessing plant site andshall be sufficient to identify the specificrequirements, such as codes, standards, orspecifications, met by the purchased material andequipment.

This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall be imple-mented as stated, with the words repository site*substituted where appropriate.

Refer to Criteria 17 for additional records retentionrequirements.

BQARDCRITERION 7: CONTROL or PURCHASED MATERIAL, EQUIPMENT, AND SERVICES - FOR SITE CHARACTERIZATION

REVISION 2 (sheet 6 of 7). . .

Requirement BWIP Project ImplementationGod. . . 0

I.KtqUIRLMENT 5: 10 CFR 50 APPENDIX

The effectiveness of the control of quality bycontractors and subcontractors shall be assessed by theapplicant or designee at intervals consistent with theimportance, complexity, and quantity of the product orservices.


Suppliers' certificates of conformance are periodicallyevaluated by audits, independent inspections, or teststo assure they are valid and the results documented.


In developing quality assurance requirements for datacollection test equipment and other equipment,consideration should be given to whether properperformance of a test can be determined during or aftertesting (i.e., whether failure or malfunction of testequipment can be detected). When no specific QAcontrols are found to be necessary, specialquality/performance verification requirements shall beestablished and described in procedures governing theuse of the equipment.


For site characterization, additional guidance has beenprovided in Sections 7.4 and 7.5 of the NRC Review Plan.

This requirement shall be implemented as stated. inaddition, Supplement 7S-1, Section 8.2.1 of NQA-1-1986shall be implemented.

This requirement shall be met during the selection anduse of equipment for data collection activities underCriterion 11, for use with Criterion 3.

While preparation, review, and approval of data -

acquisition planning and procedure generation arecontrolled under the design control provisions of the QAprogram, actual performance of the experiments,measurement, collection, etc., for acquiring data iscontrolled under applicable provisions of Section 11.0,Test Control.

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CRITERION 7: CONTROL OF PURCHASED* BRD

MATERIAL, EQUIPMENT, AND SERVICES - FOR SITE CHARMCTERIZATIONREVISION 1 (sheet 7 of 7)' I

'V

Require.mnt BWIP Prolect Iplementatlon_ ~~~~~~~~~~~~~~~~~~~~~I

II

i

For nstrumentation and/or equipment used n datacollection, project participants are expected toconsider whether failure or malfunction of theinstrumentation during test will be detectable, eitherduring data collection or by examination of the data.Where ability to detect such failure or malfunction is

questionable, (a) technical and quality procurementrequirements shall be selected specifically to minimize

the likelihood of undetectable anomalies, and (b) test

planning and procedures shall include any specialprovisions for equipment/instrumentation configuration,Installation, and use that can further reduce risk of

undetectable failure or malfunction.

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CRITERION 8: IDENTIFICATION AND CONTROL OF MATERIALS. PARTS, AND COMPONENTSREVISION 2 chppt 1 f l

Requirement I OWIP Project Implementation


The intent of this criterion during site characterizationis to establish the requirements for identification andcontrol of samples in order to ensure that the identity ofa discrete sample is known with certainty at all timesduring its useful life on the BIP. This criterion mayalso have applicability to other critical site charac-terization items. Note Test Procedure Requirements.


The intent of this criterion during construction is toestablish the requirements for identification and control(including traceability) of materials, parts, andcomponents used in Level I repository construction, norder to ensure that only correct materials, parts, andcomponents are utilized.

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QRDCRITERION 8: IDENTIFICATION AND CONTROL OF MATERIAlS. PARTS, AND COMPONENTS - FOR SITE CHARATERIZATION

REVISION 3 (sheet 2 of 4) IRequirement BWIP Prolect Ilementatn

PREQUIREMENT 1: 10 CFR 50 APPENDIX

Measures shall be established for the identification andcontrol of materials, parts, and components, includingpartially fabricated assemblies.

This requirement shall be implemented as stated.addition, Supplement 8S-1 of NQA-1-1986 shall beimplemented.

In

JHRC REVIEW PLAN SECTION 8.1

Controls are established and described to identify andcontrol samples. The description should ncludeorganization responsibilities.


Identification of samples can be traced to theappropriate documentation such as drawings,specifications, purchase orders, drilling logs, testrecords, inspection documents, and nonconformancereports.

For site characterization, additional guidance has beenprovided in section 8.1 and 8.3 of the NRC Review Plan.

This requirement is addressed in QA-1-1986,Supplement 8S-1, under the term items.4

In addition, the method used to determine identificationmarkings for each sample shall preclude the assignment ofa discreet identifier to more than one discrete sample(DOE-RL).

This requirement shall be met by implementing NQA-1-1986,Supplement 8S-1.

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BARDCRITERION : IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS - FOR SITE CHARACTERIZATION

REVISION 2 (sheet 3 of 4) IRequirement BSIP Project Implementation


These measures shall assure that Identification of theitem is maintained by heat number, part number, serialnumber, or other appropriate means, either on the item oron records traceable to the item, as required throughoutfabrication, erection, installation, and use of the item.


Procedures are established which assure thatIdentification is maintained either on the samples ortheir containers, or on records traceable thereto.

IThis requirement shall be implemented as stated.


This requirement shall be met by implementing NQA-1-1986,Supplement BS-1.

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____________________________________________________________________________________________________ I~~~~~~~~~~~~

BQARCRITERION 8: IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS - FOR SITE CARACTERIZATION



IKtQUIREMENT 3: 10 CFR 50 APPENDIX B

These identification and control measures shall bedesigned to prevent the use of incorrect or defectivematerial, parts, and components.


Correct identification of samples s verified anddocumented prior to release for use or analysis.



This requirement s not specifically addressed inNQA-1-1986. Therefore, this requirement shall beimplemented as stated.

In addition, for a sample discretely dentified only byIts container, verification and documentation shall beextended to include sample return to the discretecontainer, f permitted by lab practice. Any transfer ofmaterial shall contain the sample identification number(DOE-RL).

CRITERION 9: CONTROL OF SPECIAL PROCESSESREVISION 2 heet I of 1 I

Requirement J BWIP Project ImplementationI


The intent of the criterion during site characterizationis to establish the lnlium requirements for the controlof special processes, n order to ensure that sitecharacterization processes where direct inspection isimpossible or disadvantageous produce results that aredemonstrably valid through the use of other acceptedassurance techniques.


The intent of this criterion during construction sidentical to its intent during site characterization.

.

CRITERION 9:BMRD

CONTROL OF SPECIAL PROCESSES - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 2 of 31


RUQUIREMENT 1: 10 CFR 50 APPENDIX B

Measures shall be established to assure that specialprocesses, including welding, heat treating, andnondestructive testing, are controlled and accomplishedby qualified personnel using qualified procedures inaccordance with applicable codes, standards,specifications, criteria, and other special requirements.


The criteria for determining those processes that arecontrolled as special processes are described. Ascomplete a listing as possible of special processes,which are generally those processes where directInspection is impossible or disadvantageous, is provided.


Organizational responsibilities including those for theQA organization are described for qualification ofspecial processes, equipment, and personnel.


Procedures, equipment, and personnel associated withspecial processes are qualified and are in conformancewith applicable codes, standards, QA procedures, andspecifications. The QA organization is involved in thequalification activities to help assure they aresatisfactorily performed.


For site characterization, the NRC has providedadditional guidance for this requirement in Sections 9.1through 9.5 of the NRC Review Plan.

This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall beImplemented as stated.

This requirement is not specifically addressed nNQA-1-1986. Therefore, this requirement shall beimplemented as stated.

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IThis requirement shall be implemented as stated.addition, Supplement 9S-1 of NQA-1-1986 shall beimplemented.

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CRITERION 9:BRD

CONTROL OF SPECIAL PROCESSES - FOR SITE CHARACTERIZATIONREVISIO 2 het 3 f I



Procedures are established for recording evidence ofacceptable accomplishment of special processes usingqualified procedures, equipment, and personnel.


Qualifications records of procedures, equipment, andpersonnel associated with special processes areestablished and maintained.

This requirement shall be met by implementation ofNQA-1-1986, Supplement 9S-1, Section 3.

This requirement shall be implemented as stated. Inaddition, Supplement 9S-1, Section 3.3 of NQA-1-1986shall be mplemented.

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BMRDCRITERION 10: INSPECTIONREVISION 2 (sheet 1 of 9)



Inspection as used herein means the ndependent verifica-tion of a physical characteristic being determined duringa site characterization activity. The wording utilized byparticipants to implement this activity is not critical,provided implementation meets the functional intent ofthis criterion.

The intent of this criterion during site characterizationis to establish the requirements for an inspection programthat directly complements the Site Characterization TestProgram, and to establish controls on inspections beingperformed within the program, in order to ensure that anyresultant physical data is demonstrably valid. Inaddition to independent verification of the physical databeing obtained, Inspection shall also verify conformanceto the instructions, procedures, and drawings beingutilized.

For site characterization data gathering activities (e.g.,laboratory testing and analysis) a combination ofinspection and special process methods may be bettersuited to provide reliability of the data gathered. Sincethe quality of the end result cannot be directly measuredor inspected (there is no acceptance criteria for testingresults), the control of testing may be similar to thecontrols of special processes (i.e., procedures approvedprior to use through technical and/or peer reviews; -testing personnel qualified through experience, educationand training; equipment qualifiedO through calibration;and monitoring of performance of the test). Datasubjected to an independent technical and/or peer reviewwill constitute a final verification of the data'svalidity.

____________________________________________________________________________________________________ I~~~

BQARDCRITERION 10: INSPECTIOHREVISION 3 (sheet 2 of 9)


Final inspections shall be performed by qualifiedpersonnel not reporting directly to the nediatesupervisors who are responsible for performing the workbeing inspected. Final inspections should be performedjust prior to tear down* or cover up" of a sitecharacterization activity; they are normally indicated by"hold points* on the nspection plan.

All project personnel, particularly project inspectionpersonnel, shall be advised that the phrase acceptanceinspection has a specific contractural meaning and mustbe used with discretion. In addition, inspectionplanners and those producing inspection procedures shallensure they are aware of and responsive to Federal Acqui-sition Regulations pertaining to inspections.


The intent of this criterion during construction is* similar to its intent during site characterization, with

the possible exception of nspection report distribution,and greater utilization of the guidance in DOEOrder 4700.1. IX

CRITERION 10:BQARD

INSPECTION - FOR SITE CHARACTERIZATIONREVISION 3 (sheet 3 of 9) I



A program for inspection of activities affecting qualityshall be established and executed by or for theorganization performing the activity to verifyconformance with the documented nstructions, procedures,and drawings for accomplishing the activity.

KRC REVIEW PLAN SECTION 10.1

The scope of the inspection program is described thatIndicates an effective inspection program has been -established. Program procedures provide criteria fordetermining when inspections are required or define howand when inspections are performed. The QA organizationparticipates in these functions.


In addition. the program shall be operative and provideinput to the design documents and procurement documentsused during site characterization (DOE-RL).

In addition, the procedures shall require that adequateinterfacing occurs between the performing organization andthe inspecting organization to permit cost effective useof personnel on a daily basis from both organizations(DOE-RL).


This requirement shall be implemented as stated. Inaddition,--Supplement OS-1, Sections 4, 5.1, 6, and 7 o£NQA-1-1986 shall be implemented.

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B6AROCRITERION 10: INSPECTION - FOR SITE CHARACTERIZATION

REVISION 3 (sheet 4 of 9)I

Requirement GWIP Project Implementation


Such inspection shall be performed bythan those who performed the activity

Iindividuals otherbeing inspected.


Organizational responsibilities for nspection aredescribed. Individuals performing inspections are partof the QA organization. For inspections requiringspecial expertise, other individuals may be used providedthe independence of the inspection function ismaintained.


A qualification program for inspectors is established anddocumented, and the qualifications and certifications ofinspectors are kept current.


For site characterization, additional guidance has beenprovided in Sections 10.2, 10.3, and 10.6 of the NRCReview Plan.


In addition, when one contractor is to inspect the work ofanother, written instructions shall be furnished to theinspecting contractor defining his responsibilities andstating that he is not authorized to modify the terms andconditions of the contract, nor to direct additional work,nor to waive any requirements of the contract, nor tosettle any claim or dispute. Copies of these instructionsshall be furnished to the contractor whose work is to beinspected, with a request that he acknowledge receipt on acopy to be returned to the contracting officer. In thismanner, both contractors are on express notice of theauthority, and limitations on the authority, of theinspecting contractor.

This requirement shall be implemented as stated. Inaddition, Supplement OS-1, Section 2.2 of NQA-1-1986shall be implemented.

Is

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CRITERION 10:BQARCDA T IZTO

INSPECTION - FOR SITE CHARACTERIZATIONREVISION 3 (sheet 5 of 9) I

Reauirwment BWIP Project Iplementation-I ----- I _________________________


Inspection results are documented and evaluated, andtheir acceptability is determined by a responsibleindividual.

Certification of Inspection personnel shall be met byimplementation of NQA-1-1986, Supplement 2S-1 andAppendix 2A-1.

This requirement shall be met by ImplementingSupplement IOS-1, Sections 6 and 8 of NQA-1-1986.

In addition, each Inspection shall be documented. and allinspection results pertaining to an activity shall befurnished to the reviewer of the resultant data(Criterion 3) (DOE-RL).

VI

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________________________________________________________________________ .

BQARDCRITERION 10: INSPECTION - FOR SITE CARACTERIZATION


Re" '1 rement

REQUIREMENT 3: 10 CF 50 APPENDIX B

Examinations, measurements, or tests of material orproducts processed shall be performed for each workoperation where necessary to assure quality.


Inspection procedures, instructions, or checklistsprovide for the following:

a. Identification of characteristics and activities to beinspected.

b. A description of the method of inspection.

c. Identification of the individuals or groupsresponsible for performing 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 resultsof the inspection operation.

g. Specifying necessary measuring and test equipmentincluding accuracy requirements.

BWIP Project Implementation



This requirement shall be implemented as stated. Inaddition, Supplement OS-I, Section 8 of NQA-1-1986 shallbe implemented.

CRITERION 10:BQW

IKSPECTION - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 7 of 9) I

_ _ _



If inspection of processed material or products isimpossible or disadvantageous, indirect control bymonitoring processing methods, equipment, and personnelshall be provided.

This requirement shallHQA-1-1986, Supplement

be met by Implementation oflOS-I, Section S. I

Inspection of certain defined special processes shall bemet by Implementation of Criterion 9.

BQmDCRITERION 10: INSPECTION - FOR SITE CHARACTERIZATION

REVISION 2 (sheet 8 of 9)_eqirmen {BWI Pojct mpemetaio

Requirement E ---- BIP Project Iplementation

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REQUIREMENT 5: 10 CFR 50 APPENDIX B I

Both inspection and process monitoring shall be providedwhen control s inadequate without both.

'his requirement shall be met by implementation of

Suspplement lOS-i, Section 5 of NQA-1-1986.

BQCRITERION 10: INSPECTION - FOR SITE CHARACTERIZATION

REVISION 2 (sheet 9 of 9)I

Requirement BWIP Project Implementation. . ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~I


If mandatory inspection hold points, which requirewitnessing or inspecting by the applicant's designatedrepresentative and beyond which work shall not proceedwithout the consent of its designated representative arerequired, the specific hold points shall be indicated inappropriate documents.


Procedures include identification of mandatory inspectionhold points beyond which work may not proceed untilinspected by a designated nspector.

This requirement shall be met by implementi gSupplement lOS-l Section 3 of NQA-1-1986.

For site characterization, the NRC has provided additionalguidance for this requirement as shown in Section 10.5 ofthe NRC Review Plan.

This requirement shall be met by implementingSupplement lOS-i, Section 3 of NQA-1-1986. I

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BQARDCRITERION 11: TEST CONTROL

RFVTSTnN I thept 1 f l



The intent of this criterion during site characterizationIs to establish the minimum requirements that shall be metby the implemented Site Characterization Test Program.These controls are necessary in order to ensure thatinformation resulting from the test program is bothcomplete and of demonstrably adequate quality. Note thattest program as used by the RC during site character-ization refers to testing performed in advance of, orconcurrent with, and in support of, the design of therepository system components (both engineered andnatural). Therefore, this criterion requires significantinterfacing with the repository design organization toensure that an adequate bsis exists to support repositorydesign development and verification. The criterionextends the design organization interfacing down to alevel of detail that includes review of specific testprocedures, as well as evaluation and acceptance of testresults.

It s not intended that this criterion apply to testingperformed incidental to the development of a test processthat will later be used for site che-acterization testing.unless the purpose of the testing is to verify theadequacy of the test process design. Also excluded arepreliminary borings and geophysical testing needed todecide whether site characterization should be undertaken,unless it s intended that the test results have anadditional use within the site characterization phase.

IxI

BQRDCRITERION 11: TEST CONTROL




The intent of this criterion during construction issimilar to ts intent during site characterization, exceptthat interfacing with the design organization is notrequired unless testing s for design prototypequalification.

CRITERION 11:BQARD

TEST CONTROL - FOR SITE CHARACTERIZATIONRFVIIN 3 Ishrte nf Ri

Requrem _ Projec Iplemn t aRequirement IBWIP Project Implementation

nrr ~.. ._ .._ __ __KL4UIKLMLHN 1: 10 CFR 50 APPENDIX B

A test program shall be established to assure that alltesting required to demonstrate that structures, systems,and components will perform satisfactorily in service isidentified and performed n accordance with written testprocedures which incorporate the requirements andacceptance limits contained in applicable designdocuments.


The description of the scope of the test control programindicates an effective test program has been established.Program procedures provide criteria for: (a) determiningwhen a test is required or how and when testingactivities are performed; and (b) the test program isconducted by trained or appropriately qualifiedpersonnel. The QA organization, as a minimum, auditsthese functions.

This requirement shall be met by implementing therequirements of NQA-1-1986, Supplement 1S-1 as furtherdefined in Section A below.

Additional guidance has been provided in Sections 11.1,11.2, and 11.3 of the NRC Review Plan.

A. The first sentence of this requirement is not specif-ically addressed in NQA-1-1986. Therefore, thisrequirement shall be met by implementing the guidanceprovided in figure 3 of the NRC Review Pai, as sum-marized below.

1. A Test Control Program Plan shall be developedwhich defines program requirements based on:

a. Site issuesb. Information needsc. Program objectives.

This plan shall include:

a. Purposeb. Scopec. Description of workd. Specific requirementse. Interfacesf. Equipment and facilitiesg. Milestones.

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BQARDCRITERION 11: TEST CONTROL - FOR SITE CARACTERIZATION

REVISION 2 chpot 4 f l


Individual test plans shall be developed which definehow needed information will be gathered. These plansshall include, as appropriate, the following:

a. Test objectivesb. Scope of testsc. Justificationd. Test descriptionse. Expected resultsf. Listing of required technical implementing

proceduresg. Responsibilities/personnelh. ScheduleI. Format of reportsJ. Referencesk. List of applicable QA administrative procedures1. List of required QA technical procedures.

B. The second sentence of this requirement s not specif-ically addressed in QA-1-1986, Supplement llS-1.Therefore, Requirement (a)u of this sentence shall beimplemented as stated, and Requirement (b)" of thissentence shall be implemented in Criterion 2.

C. The requirement of sentence three is that the qualityassurance organization shall, as a-minimum, auditthese functions in accordance with the requirements ofCriterion 18, Audits.'

CRITERION 11:BQARD

TEST CONTROL - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 5 of 8) I

Requirement BWIP Project-Implementation_ I


Test plans and procedures are reviewed in accordance withthe verification requirements in Sections 3.7, 3.8, and3.9 (of the NRC Review Plan).


The potential sources of uncertainty and error n testplans and procedures, and parameters which must becontrolled and measured to assure that tests are wellcontrolled, are identified.

,

.

This requirement is not specifically addressed In QA-1-1986. Therefore, this requirement shall be implementedas stated. See Criterion 3 for the detailed interpreta-tion of NRC Review Plan, Sections 3.7, 3.8, and 3.9.

This requirement s not specifically addressed in QA-1-1986. Therefore, this requirement shall be implemented asstated

Note that NRC Review Plan, Section 11.3 providesidentification of some of the nspectable characteristicsthat are to be verified in accordance with Criterion 10,NRC Review Plan, Section 10.4.

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CRITERION 11:BQARD

TEST CONTROL - FOR SITE CHARACTERIZATIONRFVIIOU 7 heet 6 of ) I



The test program shall nclude, as appropriate, proofte-ts prior to installation, preoperational tests, andoperational tests during nuclear power plant or fuelreprocessing plant operations, of structures, systems,and components.

This requirement shall be met by implementing all therequirements of NQA-1-1986, Supplement lS-l Section 2,with the following modification made:

A. The words prototype qualification tests, productiontests, proof tests prior to nstallation, constructiontests, preoperations tests, and operational tests'shall be deleted and the words 'site characterizationactivities' substituted in their stead. Involved areperformance of laboratory and field Investigations(site characterization activities) involving varioustechnical areas (e.g., geology, hydrology, seismology,geophysics, geochemistry, and rock mechanics), all ofwhich are generally considered part of geotechnicalstudies and/or investigations. In addition, wastepackage testing and conceptual design activities areperformed, including development of performancerequirements for repository system components(DOE-RL).

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CRITERION 11:BQARD

TEST CONTROL - FOR SITE CHARACTERIZATIONRFVTItAn 7 chant 7 f t I


KtQUIKtMLNT 3: 10 CFR 50 APPENDIX B

Test procedures shall include provisions for assuringtrat prerequisites for the given test have been met, thatadequate test Instrumentation is available and used, andthat the test is performed under suitable environmentalconditions.


Test procedures or instructions provide for thefollowing:

A. The requirements and acceptance limits are containedin applicable documents, including precision andaccuracy.

B. Instructions for performing the test.

C. Test prerequisites such as calibratedinstrumentation, adequate test equipment andinstrumentation, completeness of Item to be tested,suitable and controlled environmental conditions, andprovisions for data collection and storage.

D. Mandatory inspection hold points (as required).

E. Acceptance and rejection criteria, including requiredlevels of precision and accuracy.

F. Methods of data analysis.

G. Methods of documenting or recording test data andresults.

H. Provisions for assuring test prerequisites have been


For site characterization, the NRC has provided addi-tional guidance for this requirement in the NRC ReviewPlan Section 11.4.

This requirement is not specifically addressed in NQA-1-1986, in the detail given in the NRC Review Plan.Therefore, this requirement shall be implemented asstated.

In addition, the test procedures shall be complete to theextent that another qualified individual may at a laterdate reproduce the test results, if deemed necessary.Test results that are outside the dentified acceptancelimits, or other nonconformances with respect to a testprocedure, shall be dispositioned utilizing Criterion 15,NNonconformances (DOE-RL).

met.

CRITERION 11BOARD

TEST CONTROL - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 8 of 8)

Requirement 8WIP ProJect ImplementationI

P


Test results shall be documented and evaluated to assure

that test requirements have been satisfied.


Test results are documented, evaluated, and theiracceptability determined by a responsible individual orgroup as described in Section 3.0 (of the NRC ReviewPlan).


For site characterization, the NRC has provided addi-tional guidance for this requirement In Section 11.5 ofthe RC Review Plan.

This requirement shall be met by implementing NQA-1-1986,Supplement IIS-1, paragraph 4, provided: the words asdescribed in Criterion 3 are added after the"responsible party."

The requirement for test records shall be met by imple-menting the requirements of the NRC Review PlanSection 17.3, and the requirements of NQA-1-1986,Supplement IIS-I, paragraph 5.

In addition, document requirements for experiment andresearch for geologic repository projects are specified InOGR/B-3, Supplement 5, Section 5.0.

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BQARDCRITERION 12: CONTROL OF MEASURING AND TEST EQUIPMENT




The intent of this criterion during site characterizationis to establish the controls necessary over measuring andtest equipment, in order to ensure that tools, ges,instruments, and other measuring and testing devices usedin activities affecting quality are demonstrably accurate.Measures shall be established to define the scope of theprogram, describe the types of equipment to be controlled,the organizations responsible for implementing theprogram, and the records to be maintained to show evidencethat the program s functioning.


The intent of this criterion during construction sIdentical to its ntent during site characterization.

CRITERION 12:BQARD

CONTROL OF MEASURING AND TEST EQUIPMENT - FOR SITE CHARACTERIZATIONREVISION 3 (sheet 2 of 4)

Requirement BWIP ProJect Implementation-t- --- -- - -- -


Measures shall be established to assure that tools,gages, instruments, and other measuring and testingdevices used in activities affecting quality are properlycontrolled, calibrated, and adjusted at specified periodsto maintain accuracy within necessary limits.


The scope of the program for the control of measuring andtest equipment is described and the types of equipment tobe controlled are established.


QA and other organizations' responsibilities aredescribed for establishing, implementing, and assuringeffectiveness of the calibration program.

l


For site characterization, additional guidance has beenprovided in Sections 12.1 through 12.7 of the NRC ReviewPlan.



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CRITERION 12:BQARD

CONTROL OF EASURING AND TEST EQUIPMEWt - FOR SITE CHARACTERIZATIONREVISION 2 Iheet 3 f 41 I



Procedures are established and described for calibration(technique and frequency), maintenance, and control ofthe measuring and test equipment (instruments, tools,gages, fixtures, reference and transfer standards, andnondestructive test equipment) used for measurement,inspection, and monitoring. The review and documentedconcurrence of these functions is identified.


Measuring and test equipment is labeled, tagged orotherwise documented to indicate due date of the nextcalibration and to provide traceability to calibrationtest data.


Measuring and test equipment is calibrated at specifiedIntervals based on required accuracy, precision, purpose,degree of usage, stability, characteristics, and otherconditions which could affect measurement.


This requirement shall be mplemented as stated. Inaddition, Supplement 12S-I. Section 5 of NQA-1-1986 shallbe implemented.

This requirement shall be implemented as stated. Inaddition, Supplement 12S-1, Sections 2, 3, and 4 ofNQA-1-1986 shall be implemented.

CRITERION 12:BARD

CONTROL OF MEASURING AND TEST EQUIPMENT - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 4 of 4) I

Requirement BWIP ProJect ImplementationI


Calibration standards are traceable to nationallyrecognized standards. Where national standards do notexist, provisions are established to documentacceptability of the calibration standard used.


When measuring and test equipment is found to be out ofcalibration, evaluations are made and documented todetermine the validity and acceptability of measurementsperformed since the last calibration. Inspections ortests are repeated on items determined to be suspect.

This requirement shall be implemented as stated. Inaddition, Supplement 12S-1, Section 3.1 of NQA-1-1986shall be implemented.

In sentence 2 of the supplement section the words thebasis for calibration shall be documented' shall bedeleted and the words provisions are established todocument acceptability of the calibration standard used'shall be added in their place, which only serves as aclarification.

This requirement shall be mplemented as stated. Inaddition, Supplement 12S-1, Section 3.2 of QA-1-1986shall be implemented.

In addition, refer to Criterion 15 for documentationrequirements (DOE-RL).

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BOARDCRITERION 13: HANDLING, SHIPPING AND STORAGE

REVISION 2 (sheet of 3 …

Requirement f BSIP Project Implementation


The intent of this criterion during site characterizationis to establish the minimum requirements for the controlof samples during handling, shhping and storage to ensurethat samples are appropriately cnd adequately handled,preserved, stored, packaged, and shipped. Significantinterfacing is required with the site testing organiza-tions to establish correct methods for the preservationand shipping of sensitive items (e.g., environmental andgeological samples taken during site characterization).This criterion may also have applicability to othercritical site characterization items. Note Test ProcedureRequirements.


The ntent of this criterlon during construction sidentical to ts intent during site characteriztion: thatis, to establish requirements for controlling thehandling, storage, shipping, cleaning, and preservation ofmaterials and equipment used in level I repositoryconstruction, in order to prevent damage or deterioration.

CRITERION 13:BQARD

HANDLING, SHIPPING AND STORAGE - FOR SITE CHARACTERIZATIONOFVlr.Tnm i Ichot nf l

Requirement WBIP Project Implementation

KLQUIREMENT 1: 10 CFR 50 APPENDIX B

Measures shall be established to control the handling,storage, shipping, cleaning and preservation of materialand equipment in accordance with work and inspectioninstructions to prevent damage or deterioration.


Sampling, handling, preservation, storage, packaging, andshipping requirements are established and accomplished bysuitably trained individuals in accordance withpredetermined work and inspection instructions.



This requirement shall be met by implementation ofSupplement 13S-1, Sections 2, 3, and 4 of NQA-1-1986.

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BQARDCRITERION 13: HANDLING, SHIPPING AND STORAE - OR SITE CHARACTERIZATION

REVI5I 2 hppt I nF 1RFTsn * *_-r.,p _ nE 1w_ _v

- e-r--- - - - I

Requirementj BWIP Project ImplementationI

IRUQUIREMENT 2: 10 CFR 50 APPENDIX B

When necessary-for particular products, specialprotective environments, such as inert gas atmosphere,specific moisture content levels, and temperature levels,shall be specified and provided.

HRC REVIEW PLAN SECTION 13.2

Procedures are established and described to controlsample handling, storage, packaging, and shipping inaccordance with design and procurement requirements topreclude damage, loss, or deterioration by environmentalconditions such as temperature or humidity.



This requirement shall be implemented as stated. Inaddition, Supplement 13S-1, Sections 3.1 and 3.2 ofNQA-1-1986 shall be implemented.

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BQARDCRITERION 14: INSPECTION. TEST AND OPERATING STATUS

REVISION 2 (sheet I of 4)

Requirement 8WIP Project Implementation


The intent of this criterion during site characterizationis to establish the minimum requirements for controllingthe status of site characterization inspection, test, andtesting equipment to ensure the status of inspection andtest activities for a specific sample or material areknown with certainty, and the operating/operational statusof test equipment is also known.


The intent of this criterion durinn construction issimilar to Its Intent during site characterization. I

BQARDCRITERION 14: INSPECTION, TEST AND OPERATING STATUS - FOR SITE CHARACTERIZATION




Measures shall be established to indicate, by the use ofmarkings such as stamps, tags, labels, routing cards, orother suitable means, the status of inspections and testsperformed upon Individual items of the nuclear powerplantor fuel reprocessing plant.


Procedures are established to indicate by the use ofmarkings the status of inspections and tests onindividual items.


For site characterization, the RC has provided additionalguidance for this requirement in Section 14.1 of the NRCReview Plan.

This requirement shall be met by mplementing NQA-1-1986,Basic Requirement 14.

In addition, procedures shall be established to ensurethat inspection, test, and operating status is clearlyindicated by means of markings, tagging, boundary markers,etc., as appropriate to the nature of the equipment ornatural region affected and of the inspection, test oroperation involved.

In addition, procedures shall be established to controlthe issuance and use of unique marking devices (e.g.,stamps, tags, labels) to ensure traceability to theIndividual or to the specific activity utilizing themarking device (DOE-RL).

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CRITERION 14:BQARD

INSPECTION, TEST AND OPERATING STATUS - FOR SITE CHARACTERIZATIONMummln 3 tchppt i f i..---. _... -IthP.t - f .,

Requirement BWIP Project Implementation-- ~~-

KtQUIREMENT 2: 10 CFR 50 APPENDIX B

These measures shall provide for the identification ofitems which have satisfactorily passed requiredinspections and tests, where necessary to precludeInadvertent bypassing of such inspections and tests.

This requirement shall be implemented as specified nNQA-1-1986, Basic Requirement 14.

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BQARDCRITERION 14: INSPECTION, TEST AND OPERATING STATUS - FOR SITE CHARACTERIZATION

REVISION 3 (sheet 4 of 4) --

Requirement I BWIP Project ImplementationREQUIREMENT 3: 10 CFR 50 APPENDIX 8

1IMeasures shall also be established for ndicating theoperating status of structures, systems, and componentsof the nuclear power plant or fuel reprocessing plant,such as by tagging valves and switches, to preventinadvertent operation.

This requirement shall be implemented as stated inNQA-1-1986, Basic Requirement 14.

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BQARDCRITERION 15: NONCONFORMINNG MATERIALS, PARTS. OR COMPONENTS

REVISION 2 (sheet of 4)


The intent of this criterion during site characterizationIs to establish the minimum requirements for controllingproject nonconformances, to ensure that all nonconform-

ances affecting site characterization activities areidentifled, documented, segregated, reviewed, tracked,dispositioned, affected organization notified, corrected,

and trended, and the implementation of the corrective

action is verified.

Refer to NQA-1-1986 Supplement S-1 for Nonconformancedefinition. Note that procedural deficiencies are

included.

*Reject* shall not be used to disposition test data unless

the root cause clearly establishes a basis for rejectionof the data. Accept' or use-as-isl dispositionsgenerally implies a design change will need to be made.


The intent of this criterion during construction isidentical to ts intent during site characterization.

BQARDCRITERION 15: NONCORFORINNG MATERIALS, PARTS, OR COMNENTS - FOR SITE CHARACTERIZATION

DrUICTnU 'I at9 A%Dw~U1CnflU I.I rr4 W eU1j



Heasures shall be established to control materials,parts, or components which do not conform to requirementsin order to prevent their inadvertent use orinstallation.


Procedures are established for dentifying, documenting,tracking, segregating, reviewing, dispositioning, andnotifying affected organizations of nonconforming itemsand activities. The procedures identify ndividualsauthorized to dispose of and close out nonconformances.



This requirement shall be met by mplementing NQA-1-1986,Supplement 15S-1.

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BQARDCRITERION 15: NONCONFORNIKNG MATERIALS. PARTS, OR COMPONENTS - FOR SITE CHARACTERIZATION

OFVTCTnu 2 e.I.nt A%

- Requirement 8WIP ProJect Implementation

KtYUIKL&MNT 2: 10 CFR 50 APPENDIX

These measures shall include, as appropriate, proceduresfor identification, documentation, segregation,disposition, and notification to affected organizations.


QA responsibilities related to nonconformance control aredescribed.

This requirement shall be implemented as stated. Inaddition, Supplement 15S-1, Sections 2, 3, and 4 ofNQA-1-1986 shall be implemented.

For site characterization, additional guidance has beenprovided in Sections 15.1, 15.2, 15.3, and 15.4 of the RCReview Plan.

This requirement s not specifically addre:sed inHQA-1-1986. Therefore, this requirement stall beimplemented as stated.

This requirement shall be implemented as specified inNQA-1-1986, Basic Requirement 15.

This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall beimplemented consistent with Criterion 16.

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INRC REVIEW PLAN SECTION 15.3

Documentation identifies and describes the nonconfor-mance, dispositions the nonconformance, and includessignature approval of the disposition.


Nonconformance reports are periodically analyzed by theQA organization to show quality trends and to helpidentify root causes of nonconformances, and thesignificant results are reported to upper management forreview and assessment.

BSQARDCRITERION 1S: NONCONFORIN~NG MATERIALS, PARTS, OR COMPONENTS - FOR SITE CHARACTERIZATION

Druyetnlu v % A -t as IDW JflU CW IL £ YIC UTI )

LRequirement BWIP Project Implementation

KttJULKLMU4I 3: 10 CFR 50 APPENDIX B

Nonconforming tems shall be reviewed and accepted,rejected, repaired or reworked in accordance withdocumented procedures.

This requirement shall be implemented as stated. Inaddition, Supplement 15S-1, Sections 4.4 and 4.5 ofNQA-1-1986 shall be implemented. I

sQARDCRITERION 16: CORRECTIVE ACTION

REVISION 2 (sheet I of 4)



The intent of this criterion during site characterizationis to establish the minimum requirements for controllingproject corrective actions, to ensure that conditionsadverse to quality are identified and corrected in atimely manner. Each project participant shall dent'fythe need for corrective action, ensure that correctiveaction is initiated (which may involve actions to precluderecurrence), and verify that corrective action isImplemented in a timely manner. Participants shall definea method to classify significant conditions adverse toquality and shall provide for documenting and reportingthese conditions, ncluding actions taken to precluderepetition, as well as evaluation of the mpact oncompleted work, and report these actions to highermanagement for review and assessment.


The intent of this criterion during construction sIdentical to its intent during site characterization.

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CRITERION 16:BQARD

CORRECTIVE ACTION - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 2 of 4) I

Requirement BWIP ProJect Implementation


Measures shall be established to assure that conditionsadverse to quality, such as failures, malfunctions,deficiencies, deviations, defective material andequipment, and nonconformances are promptly identifiedand correctd.


Procedures are established indicating an effectivecorrective action program has been established. The QAorganization reviews and documents concurrence with theprocedures.


Corrective action is documented and nitiated following anonconformance to preclude recurrence. The QAorganization is involved in documented concurrence of theadequacy of corrective action to assure that QArequirements are satisfied.


Follow-up action is taken by the QA organization toverify proper implementation of corrective action and toclose out the corrective action n a timely manner.

1IThis requirement shall be implemented as stated.

For site characterization, additional guidance has beenprovided in Sections 16.1, 16.2, and 16.3 of the NRCReview Plan.



This requirement is not specifically addressedNQA-1-1986. Therefore, this requirement shallimplemented as stated.

Inbe



CRITERION 16:BQARD

CORRECTIVE ACTION - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 3 of 4) I

Requirement BWIP Project ImplementationBWIP Project Implementation

______________________________________ I


In the case of significant conditions adverse to quality,the measures shall assure that the cause of the conditionis determined and corrective action taken to precluderepetition.

This requirement shall be met by implementing NQA-1-1986,Basic Requirement 16.

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CRITERION 16:BQARI

(ORRECTIVE ACTIOh - FOR SITE CHARACTERIZATIONDFUTCUM I tehAA A f Al IraWP Paro ct lemet ats ion

Eequirement LBWIP Project ImplementationREQUIREMENT 3: 10 CFR 50 APPENDIX B

The identification of the significant condition adverseto quality, the cause of the condition, and thecorrective action taken shall be documented and reportedto appropriate levels of management.


Significant conditions adverse to quality, the cause ofthe conditions, and the corrective action taken topreclude repetition are documented and reported toiumediate management and upper levels of management forreview and assessment.


For site characterization, the NRC has provided additionalguidance for this requirement in Section 16.4 of the NRCReview Plan.

This requirement s also addressed in QA-1-1986, BasicRequirement 16.

In addition, trend analysis of NCR's and audit findingsshall be used to help identify sgnificant conditionsadverse to quality, and the cause of the conditions(DOE-RL).

In addition, significant conditions adverse to qualityshall require an Unusual Occurrence Report (Q-OCRWM).

Unusual Occurrence Reporting. Contractors are required toreport any significant event that results in any deviationfrom the planned or expected behavior of an activity oroperation of course of events that has or could havesignificant programmatic (reliability, cost, or schedule),safety, health, or environmental impacts. Significantevents are to be reported in accordance with DOEOrder 5000.3 (HQ-OGR).

In addition, significant conditions adverse to quality.shall be reported to both the integrating contractor andDOE-RL QSD as soon as possible but not later tanfive calendar days from the date of occurrence (DOE-RL).

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BQARDCRITERION 17: QUALITY ASSURANCE RECORDS




The intent of this criterion during site characterizationis to establish the requirements for control of projectrecords, to nsure that documents and samples thatfurnish evidence of activities affecting quality remainvalid and retrievable.

In general, a QA record is preceded by a controlleddocument. Upon completion of the controlled document, itis incorporated into the QA Records System. Subsequentchanges to the controlled document also become QArecords, identifiable to but distinct from the initial QArecords. It is essential that QA records be correct andcomplete, and allow accurate determination of the finalsor as-builtu conditions.

In addition, records submitted to the Commission must beof demonstrable validity. Therefore, access to the QArecord copy of BWIP documents and samples will be limitedand controlled. Corrections to a QA record may beaccomplished under limited and controlled conditions,provided the original, incorrect area of the QA recordremains legible. Samples, if removed from the controlledstorage fa~lity, shall be handled in such a manner as topreclude adulteration (DOE-RL).



____________________________________________________________________________________________________ A.

CRITERION 17:BQAR

QUALITY ASSURANCE RECORDS - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 2 of 7)

Requirement BWIP Project ImplementationI~ ~~~BI rietI~eetto


Sufficient records shall be maintained to furnishevidence of activities affecting quality.


QA and other organizations are identified and theirresponsibilities are described for the definition andimplementation of activities related to QA records.

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CRITERION 17:BOQARD

QUALITY ASSURANCE RECORDS - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 3 of 7) I

RequirementI BWP Project Implementation


The records shall include at least the following:Operating logs and the results of reviews, inspections,tests, audits, monitoring of work performance, andmaterials analyses.


The scope of the records program Is described. QArecords include geotechnical samples and data; resultsof reviews; inspections; test, audits, and materialanalyses; monitoring of work performance; qualificationof personnel, procedures, and equipment; and otherdocumentation such as drawings, specifications,procurement documents, calibration procedures andreports; design review reports; peer review reports;nonconformance reports; and corrective action reports.




In addition, each participant shall establish adefinitive list of documents that are to become qualityassurance records (DOE-RL).

In addition, each participant's records program shall beconsistent with the project Records Management Plan(HQ-OGR).

Records of personnel qualification evaluations,indoctrination, training, and proficiency evaluationsshall be retained as lifetime QA records. (OGR/B-3,Supplement 1, Section 5.7)

Additional requirements for the control of QA records arespecified in OGR/B-3, Supplement 4.

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CRITERION 17:BQARD

QUALITY ASSURANCE RECORDS - FOR SITE CHARACTERIZATIONREVISION 2 (sheet 4 of 7)

Requirement BWIP Project Implementation JKLQUIREMENT 3: 10 CR 50 APPENDIX B

The records shall also nclude closely related data suchas qualifications of personnel, procedures, andequipment.

This requirement s not specifically addressed inNQA-1-1986. Therefore, this requirement shall beImplemented as stated, and as required by OGR/B-3,Supplement 5.

BQARDCRITERION 17: QUALITY ASSURANCE RECORDS - FOR SITE CHARACTERIZATION

REVISION 2 (sheet 5 of 7) IRequirement BWIP Project Implementation

I rREQUIREMENT 4: 10 CFR 50 APPENDIX

Inspection and test records shall, as a minimum,identify the Inspector or data recorder, the type ofobservation, the results, the acceptability, and theaction taken in connection with any deficiencies noted.


Inspection and test records contain the following whereapplicable:

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.



This requirement s not specifically addressed InNQA-1-1986. Therefore, this requirement shall beimplemented as stated.

In addition, the inspection record shall be identifiablewith the test activity inspected, and the personevaluating test or inspection results shall be identified(DOE-RL).

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Requirement BWIP Project Implementation4


Records shall be Identifiable &cod retrievable. This requirement shall be met by ImplementingSupplement 17S-1. Sections 2 and of NQA-1-1986,provided participants record storage facility isconsistent with Requirement 17.4.




REQUIREMENT 6:

Consistent withapplicant shallretention, suchresponsibility.

I10 CFR 50 APPENDIX B

applicable regulatory requirements, theestablish requirements concerning recordas duration, location, and assigned

This requirement shall be met by ImplementingSupplement 17S-1, Sections 2, 3, 4, and 6 of QA-1-19B6.

For site characterization, additional guidance has beenprovided n Section 17.4 of the NRC Review Plan.

This requirement shall be met by ImplementingSupplement 17S-1, Section 4 of QA-1-1986.


Suitable facilities for the storage of records aredescribed and utilized.

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BQARDCRITERION 18: AUDITS


Requirement T BWIP Project Implementation

The intent of this criterion during site characteriza-tion is to establish requirements for a comprehensivesystem of planned and periodic audits, as well as estab-lish controls over the audit process, in order to ensurethat the management feedback nformation contained nBWIP audit reports is timely, impartial, and correct.

Project participants are advised that audit planning mustInclude consideration of surveillance results, inspectionresults, previous audit results, NCR's, and projectdeliverables, as well as the need to provide coverageover a defined period of time.

After confirmation of QA program implementation, auditsperformed within BWIP shall place emphasis upon verifica-tion of the achievement of quality in project endproducts.


The intent of this criterion during construction sidentical to its intent during site characterization.

BQARDCRITERION 18: AUDITS - FOR SITE CHARACTERIZATION




A comprehensive system of planned and periodic auditsshall be carried out to verify compliance with allaspects of the quality assurance program and todetermine the effectiveness of the program.


Internal and external audits to assure that proceduresand activities comply with the overall QA program areperformed by DOE and Its contractors. DOE shouldperform audits of the prime contractor andrepresentative subcontractors, consultants, vendors, andlaboratories to assess the effectiveness of the primecontractor's audit program.


An audit plan is prepared identifying audits to beperformed, their frequencies, and schedules. Audits areregularly scheduled based upon the status and safetyimportance of the activities being performed and areinitiated early enough to assure effective A.


For site characterization, additional guidance has beenprovided in Sections 18.1, 18.2, 18.3, 18.6, 18.7, and18.8 of the NRC Review Plan.

This requirement is not specifically addressed inNQA-1-1986. Therefore, this requirement shall beImplemented as stated.

This requirement shall be met by implementingSupplement lBS-I, Section 2, and each audit of the audit-plan shall receive the detailed planning required bySection 3.1 of NQA-1-1986.

In addition, frequency of regularly scheduled internaland external audits shall be based on evaluation of allapplicable and active elements of the quality assuranceprograms. These evaluations shall include an assessmentof the effectiveness of the applicable and activeelements of the program based on such information as thefollowing (DOE-RL):

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(a)(b)(c)

Previous audits and corrective actionsNonconformance reportsIndependent nformation (e.g., from other sourcessuch as generic experience of the nuclear industry,ASME, peer organizations, regulating bodies).

____________________________________________________________________________________________________ A.



Requirement BWIP Project ImplementationIRegularly scheduled audits shall be supplemented byadditional audits for one of the reasons given below:

(a) To determine the capability of a Supplier's qualityassurance program prior to awarding a contract orpurchase order

(b) When after award of a contract sufficient time haselapsed for implementing the quality assuranceprogram and it is appropriate to determine that theorganization s adequately performing the functionsas defined in the quality assurance programdescription, codes, standards, and other contractdocuments

(c) When significant changes are made in functionalareas of the quality assurance program (e.g.,significant reorganization or procedure revisions)

(d) When it is suspected that the quality of an tem isin jeopardy due to deficiencies in the qualityassurance program

(d) When a systematic, ndependent assessment ofprogram effectiveness is considered desirable

(f) When it is necessary to verify implementation ofrequired corrective action.

This requirement shall be met by ImplementingSupplement 18S-1, Section 4 of QA-1-1986.

In addition, all audits shall include an evaluation ofthe extent to which top management is aware of and actson critical project information related to quality(DOE-RL).

In addition, participants shall submit audit schedules,audit schedule revisions, and audit reports to theintegrating contractor (HQ-OGR).


Audits include an objective evaluation of the quality-related practices, procedures, instructions, activities,and items and the review of documents and records toensure that the QA program is effective and properlyimplemented.



Requirement J BWIP Project Implementation


A tracking system for audit findings is established tohelp assure that all findings are appropriatelyaddressed and to trend audit findings.


The audited organization describes in a formal reportthe corrective action to be taken to address findings.This report is submitted to the auditing organizationand/or responsible management.


In the resolution of findings, the root cause of eachfinding is also identified and corrective action for itdescribed.


In addition, each audit report shall Include an"Executive Summary* of the audit findings (HQ-OCRWM).

This requirement shall be met by mplementingSupplement 18S-I, Section 6 of NQA-1-1986.


In addition, the impact of the findings on completed workshall be evaluated (DOE-RL).

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REVISION 2 (sheet 5 of 71



The audits shall be performed in accordance with thewritten procedures or checklists by appropriatelytrained personnel not having direct responsibilitiesthe areas being audited.

.1

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Audits are performed in accordance with pre-establishedwritten procedures or checklists and conducted bytrained personnel having no direct responsibilities inthe areas being audited.


For site characterization, the NRC has providedadditional guidance for this requirement in Section 18.5of the NRC Review Plan.

This requirement shall be implemented as stated. Inaddition, Supplement ISS-I, Sections 3.1, 3.2, and 3.3 ofNQA-1-1986 shall be implemented.

In addition, auditor orientation shall be specific to theaudit to be performed, so that the auditors are preparedfor their specific roles during the audit, and arefamiliar with the audited organization, key individuals,and policies and procedures, as well as how to selectsystems for reviews (DOE-RL).

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BOARDCRITERION 18: AUDITS - FOR SITE CHARACTERIZATION


Requirement BWIP Project ImplementationI- --


Audit results shall be documented and reviewed bymanagement having responsibility in the area audited.


Audit data are analyzed by the QA organization and theresults are reported to responsible management forreview, assessment, and appropriate action.

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IThis requirement shall be implemented as stated.

For site characterization, the NRC has providedadditional guidance for this requirement in Section 18.4of the NRC Review Plan.

This requirement shall be mplemented as stated. Theauditee's and auditor's organizations shall respond tothis requirement and to Requirement 18.6. In addition,Supplement 18S-1, Section of NQA-1-1986 shall beimplemented.

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PEVISION 3 (sheet I of 7)


1,'


rollow-up action, including reaudit of deficient areas,shall be taken where ndicated.

This requirement shall be met by mplementingSupplement 18S-1, Sections 6 and 7 of QA-1-1986 and therequirements of Criterion 18, sheet 3 of this document.

ixAudit records shall comply with Supplement 18S-1,Section 8 of NQA-1-1986.

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