ML20134G209

Rev 0 to Guidance for Review of Twrs Privatization Contractor Initial Quality Assurance Program

ML20134G209
Person / Time
Site:	07003091
Issue date:	10/29/1996
From:	ENERGY, DEPT. OF
To:
Shared Package
ML20134G080	List: ML20134G076 ML20134G191 ML20134G209
References
RL-REG-96-01, RL-REG-96-1, NUDOCS 9611130089
Download: ML20134G209 (22)

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PREFACE The Department of Energy's (DOE) Richland Operations Office as the Policy) and implemented through the document entitled (RL) issued the 7WRS Prrvatar. anon Request for Proposal (PIP)

Afemorandum of Agreement for the Execurwn of Radiological, u

for Hanford Tank Waste Remediation System (TWRS) Privatiza-Nuclear, and Process Safety Regulation of the 7WRS Privanzation tion in February 1996. Offerors were requested to submit pro-Contractors (referred to as the MOA). The Policy is signed by posals for the mitral processing of the tank waste at Hanford.

the Under Secre:ary of Energy; the Manager, RL; the Assistant Some of this radioacuve waste has been stored in large under.

Secretary for Enytronment, Safety and Health (ASEH); and the gmund storage tanks at the Hanford Site since 1944. Currendy, Assistant Secretary for Environmental Management (ASEM).

approximately 56 nulhon gallons of waste containmg approxi-The MOA is signed by the Manager, RL; the ASEH; and the mately 240,000 metne tons of processed chemicals and 250 ASEM. The nature and charactenstics of this regulation are also mega-curies of radionuchdes are being stored in 177 tanks.

specified in these documents. The MOA details certain interac.

These caustic wastes are in the form of hquids, slurnes, saltcakes, tions among RL, the ASEH, and the ASEM as well as their re-and sludges.The wastes stored in the tanks are defined as high-spective roles and responsibilities for implementation of this level radioactive waste (10 GR Part 50, Appendis P) and haz-regulation.

ardous waste (Resource Conservation and Recoverv Act).

The authority of the RU to regulate the TWRS Privatization Con-Under the privatization concept. DOE will purcnase waste treat.

tractors is derived solely from the terms of the TWRS Privatiza-ment services from a contractor-owned, contractor-operated fa.

tion Contracts. Its authority to regulate the Contractors on behalf cihty under a fixed-pdce contract. DOE wtD provide the waste of DOE is derived from the Policy. The nature and scope of this feedstock to be processed but maintain ownership of the waste, snecial regulation (in the sense that it is based on terms of a con-The contractor must a) provide private financing; b) design the tract rather than formal regulations) is delineated in the MOA, the equipment and facihty; c) apply for and receive required permits TWRS Privanzanon Contracts, and the four documents (listed and hcenses; d) construct the facihty and bring it on-hne; e) oper-below), which are incorporated into the Contracts. This seccial are the facility to treat the waste according to DOE specificanons; regulation by the RU in no way replaces any legally established and f) deactivate the facihty-external regulatory authority to regulate in accordance with their duly promulgated regulations nor relieves the Contractors from The TWRS Privatization Program is divided into two phases, any obligations to comply with such regulations or to be subject to Phase I and Phase II. Phase I is a proof-of-concept / commercial the enforcement practices contained therein.

demonstration. scale effort the objecoves of which are to a) dem-onstrate the tedhnical and bt'siness viability of using privatized The Policy, the MOA, the 1WRS Privatization Contacts, and the contractors to treat Hanford tank waste; b) define and mamtato four documents incorporated in the Contracts define the essential adequate levels of radiological, nuclear, process, and occupa-clements of the regulatory program, which will be executed by tic,nal safety; c) maintain environmental protection and comph-the RU and to which the TWRS Pnvatization Contractors rnust ance; and d) substantially reduce life-cycle costs and time re-conform. The four documents incorporated in the Contracts (and quired to treat the tank waste. The Phase I effort conststs of two also incorporated in the MOA) are parts: Part A and Part B.

Concept of the DOE Regulatory Processfor Radiologi-Part A consists of a twenty-month development period to establish cal Nuclear, and Process Safety for TWRS Privarua-appropriate and necessary technical, operational, regulatory.

non Contractors, DOE /RL-96 0005, business, and financial elements. This wiu include identification by the TWRS Pnvannnon Contractors and approval by DOE of DOE Regulatory Process for Radiological Nuclear, oppropriate safety standards, formulation by the Contractors and and Process Safety for TWRS Privannnon Contrac-approval by DOE of integrated safety management plans, and tors DOF/RL 96-000.f.

preparation by the Contractors and evaluanon by DOE of initial safety assessments. Of the twenty-month penod, sixteen months Top-Level Radiological Nuclear, and Process Safety will be used by the Contractors to develop the Part-A products Standards and Principles for TWRS Privatization Con-and four months will be used by DOE to evaluate the products.

tractors, DOF/RL-96-0006, and Part B consists of a demonstration period to provide tank waste Process for Establishing a Set of Radiological. Nu-treatment services by one or more of the TWRS Privatization clear, and Process Safety Standards and Requirernents Contractors who successfully complete Part A. Demonstration for TWRS Privatization, DOFJRL-96-0004.

will address a range of wastes tepresentauve of those in the Han-ford tanks. Part B will be 10 to 14 years in duration. Within Part in the execution of the regulatory program, the RU will consider B, westes will be processed during a 5-to 9-year period and will not only the relevant approaches and practices of DOE but also result in treatment of 6 to 13 percent of the Hanford tank waste.

those of the Nuclear Regulatory Comnussion (NRC). The Policy states that Phase 11 will be a full-scale production phase in which the re-maming tank waste will be processed on a schedule that will ac-

"It is DOE's policy that TWRS privatized contractor comphsh removal from all single-shelled tanks by the year 2018.

activities be regulated in a manner that assures ade-The objectives of Phase 11 are to a) implement the lessons learned quate radiological, nuclear, and process safety by ap-from Phase I; and b) process all tank waste into forms suitable for phcation of regulatory concepts and principles consis-final disposal.

tent with those of the Nuclear Regulatory Cornmis-sion."

A key element of the TWRS Privatization Contracts is DOE regulation of radiological, nuclear, and process safety through the To this end, the RU will interact with the NRC (under the provi-establishment of a specifically chartered, dedicated Regidatory sions of a memorandum of understandmg with the NRC) during Unit (RU) at RL. This regulanon by the RU is authorized by the development of regulatory guidance and dunng execution of the document entitled Policy for Radiological Nuclear, and ProceJJ regulatory program to ensure implementation of this policy.

Sqfety Regulanon of TWRS Privarnanon Contractors (referied to Alldocuments issued by the Office of Radiological Nuclear, and Process Safety Regulation for TWRS Privatization Contractors are available to the pubhc through the DOE /RL Pubuc Reading Room at the Washington State University.

Tri-Cities Campus,100 Sprout Road, Room 130 West, Richland, Washington.

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Initial Quality Assurance Program Review Guidance Table of Contents

1. I N T R O D U CT I O N......................................................................................... 1

2. PURPOSE.................................................................................................1

3. STRUCTURE.............................................................................................1

4. QU A LITY ASS U RANCE ~1EQUIR EM ENTS........................................................ 1

5. PA RT-A Q A R EL ATED A CTIVITIES................................................................ 2

6. KEY 10 CFR PART 830.120 Q A CRITERI A FOR PA RT. A..................................... 2

7. Q A ATT RI B UTES A N D R E VI EW..................................................................... 3 7.1 Introduction......

...........3 7.2 General Quality Assurance Program Requirements......

..4 7.3 Quality Assurance Criteria That Apply To Work Management...

..5 7.4 Quality Assurance Criteria"Ihat Apply To Work Performance.............

.................8 7.5 Quality Assurance Criteria That Apply To Work Assessment.........

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8. OTH E R C ON S I D E R ATION S......................................................................... 1 3

9. SOURCES...............................................................................................13 g,

10. A B B R E V I A T I O N S.................................................................................... 1 4

11. GLOSSARY............................................................................................14 APPENDIX A. ADDENDUM TO CRITERION 6, DESIGN........................................

16 RIJREG-96-01 Rev 0,10-25-96 i

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Initial Quality Assurance Program Review Guidance 4

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11 Rev 0,10-25-96 R1/ REG-96-01

Initial Quality Assurance Program Review Guidance porates the effects of the requirements in the docu-1, 1NTRODUCTION ment Top-Level Radiological, Nuclear, and Process Safety Standards and Principlesfor TWRS Privatiza-Under its Contract, each TWRS Privatization Con-tion Contractors, DOE /RI 96-0006; Revision 0; and tractoris required to submit an initial Quality Assur-addresses the requirements in the Contract for Con-ance Program (QAP) that supports performance of tractor submittal of an initial QAP. An effort has Part-A activities 45 days after Contract award. He been made to focus on known Pr-A activities. The Contract further stipulates that the QAP be based on Reviewer should note that the in.al QAP is an in-existing Contractor systems wherever possible. He terim measure to establish a basis for Contractor Department of Energy (DOE) Regulatory Unit (RU),

work until the standards are established. The QAP, Office of Radiological, Nuclear, and Process Safety based on the results of the standards identification Regulation for TWRS Privatization Contractors at process should be submitted for approval as part of the Richland Operations Office (RL), will pmvide the ISMP. Finally, this Guide also addresses Re-comments within 15 days of the Contractor's sub-viewer actions to support the potential future transi-mission. His Guide provides the basis which the tion to Nuclear Regulatory Commission (NRC) regu-RU will use to review the Contractor's initial QAP lation. (See Section 8.0.)

and develop comments.

De Reviewer should be aware that new rules ard 3.

STRUCTURE regulations establish requirements that go beyond a prescriptive approach to product quality, to a tailored Section 4 identifies the requirements and pmvides ad-approach to the quality of all Contractor activities ditional considerations important to the review of the consistent with their importance. Particularly, the QAP. Section 5 lists Part-A activities that should be DOE /RL Regulatory Unit views the Contractor's included by the Contractor in the initial QAP and QAP as a primary tool of Contractor management to provides the guiding principle for judging the Con-guarantee that quality achievement is integrated into tractor's selection of other Part-A activities that the Contractor's total activities through integrated should also be included in the QAP. Section 6 pro-planning, implementation, assessment, and corrective vides the Quality Assurance Criteria considered to be actions. It also means that the quality assurance ap-most important to Part-A activities. Section 7 pro-proaches should be tailored to the activity, for exam-vides specific guidance for the review of the initial plc, the quality assurance for design (application of QAP and identifies attributes the RU considers impor-defined techniques) and for analyses (intellectual in-tant and which constitutes its expectations for the quiry activities) may differ in approach and applica-Contractor's QAP. Section 8 notes the possible tran-tion. Since the DOE /RL Regulatory interest in qual-sition of the regulatory program to the NRC in the ity assurance is dominated by interest in the Contrac-future and provides additionalinstructions to the Re-tor management's achievement of meaningful quality viewer related to that transition. This Guide reserves for all activities that influence safety, the Reviewer the use ofitalicized text to set apart text quoted from should expect the QAP to be an essential integrated authoritative sources.

feature of the Contractor's Integrated Safety Manage-ment Plan (ISMP).

4.

QUALITY ASSURANCE REQUIRE-MENTS 2,

PURPOSE In the four documents describing DOE's regulatory ne DOE has issued,... CFR Part 830.120, Quality approach, DOE /RL-96-0002 through 0006, there are Assurance Requirements (the Rule), and a related im-tinee tenets that are basic to the TWRS Privatization plementation guide which apply to the TWRS Priva-Contractors for radiological, nuclear, and process tization Contractors. When the Rule was issued, safety. The Contractor is responsible for:

DOE practices and requirements focused mainly on management and operating contractors. While these Achieving adequate safety;

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practices are still generally applicable, some differing Complying to applicable laws, and legal re-perspectives also exist that reflect the present rela-quirements, and tionship between the TWRS Privatization Contrac-Conforming to top-level safety standards and

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tors and the DOE. Rese differing perspectives are principles stipulated by the DOE.

expressed here.

The QA principles stipulated by DOE, which are con-This Guide accommodates the new relationship be-tained in the document Top-level Radiological, Nu-tween the DOE and its Privatized Contractors; incor-clear, andProcess Safety Standards and Principlesfor RI / REG-96-01 Rev 0,10-25-96 Page 1 of 18

Initial Quality Assurance Program Review Guidance TWRS Privatization Contractors, DOFJRL-96-0006; ment of Part-A deliverables for radiological, nuclear, Revision 0, are as follows:

and process safety (Table S4-1)', and the design ac-tivities to be emphasized in the initial QAP. In addi-4.1.4.1 Safety / Quality Culture tion to design, the deliverables of key interest to the RUinclude:

A safety /qualityprogmm should be established

' that governs the Contmetor's actions and interac-Safety Requirements Document tions ofallpersonnel and organizanons engaged Integrated Safety Management Plan in activities telated to thefacility and emphasizes Hazards Analysis Report excellence in allactivities. The Contractor Employee Concerns Management System should have safety and quality responsibilities Badiation Exposure Standard for Workers Under specspcally identsped in its operations.

Accident Conditions Quality Assurance Program 4.1.6.1 Quality Assurance Application Initial Safety Assessment Quality assurance and quality contml should be As mentioned earher, the Contractor's selection of applied thmughout all phases and to all activities other Part-A activities to be included in the initial associated with thefacility as part ofa compre-QAP should be considered and reviewed. The guiding hensive system to ensure with high confidence principle governing the Contractor's selection of that all items delivered and services and tasks per-other Part-A activities is to choose those activities formedanect requiredstandards. -

which will have a lasting influence on the safety to be achieved in Part B. The Reviewer should expect This same source aiso stipulates other principles re-the Contractor to declare which of the Part-A results lated to activities subject to quality control including they will use in Part B should their participation con-Configuration Management, Section 4.1.5; Design, tinue, and should expect those activities to be empha-Section 4.2.1; and Proven Engineering Prac-sized in its QAP.

tices/ Margins, Section 4.2.2.

The Reviewer guidance provided herein is based on 6.

KEY 10 CFR PART 830.120 QA the principles found in the document containing the CRITERIA FOR PART-A top-level safety standards and principle stipulated by DOE, the QA Rule, that is,10 CFR Part 830.120, De Rule has three general requirements and ten spe-and the companion guidance document to the Rule, cific Criteria. Section 5 addresses Part-A activities implementation Guide for use with 10 CFR Purt that should be c=A=ci~' in the initial QAP, As 830.120 Quality Assurance, G-830.120-Rev. O, April noted in the next section, the Reviewer should expect 15,1994.

the initial QAP to include a discussion of how the general requirements and each QA Criterion will be satisfied. Because the profile of activities in Part A is 5.

PART-A QA RELATED ACTIVITIES limited to design and design-related activities and not to construction, operations, or deactivation, and be-Under the phased structure of the TWRS Privatization

_ cause the Contractor is requend to apply the Criteria-Program, work related to the design spans Part A and using a smded approach, the Reviewer should expect Part B of Phase I(see Preface on inside of the cover),

the Contractor to provide a greater level of detail for

' The Contractor is responsible for identifying all Part-certain Criterion than for others.

A activities which will be subject to QA. "Ihis selec-tion will be subject to review.-

The Reviewer should balance the review with the in-dividualimportance of the Criterion. Procurement, Part-A activities are limited by the Contract to design for example,is not a large part of Part-A activities.

and design-related activities. While the safety signifi.

However, if Part-A activities involve procurement cance of Part-A activities to the Part-A period of work implementation standards and practices for Part B, is limited, the influence of Part-A activities on Part-B procurement of design or design development studies, activities is of interest in the initial QAP review.

this Criterion should be considered. 'Ihe following Some of the Part-A activities that must be empha-table lists the Rule's Criteria, a judgment as to their sized in the initial QAP are safety deliverables of the Contract.

Part A deliverables for Radiological, Nuclear, and Based on the Contract, the Reviewer should expect Process Safety contained in Table S4-1, Section C, the Contractor's activities that support the develop-

p. 22, of 7WRS Privarization Requestfor Proposals, DE-RP06-96RL13308, February 1996.

Page 2 of 18 Rev 0,10-25-96 R11 REG-96-01

Initial Quality Asserance Program Review Guidance expected use in Part A, and the reasoning for that as providing special relief to the Contractor from any judgment. Table 1 is to be used by the Reviewer in obligations under the Rule.

preparing for the review. It should not be construed Table I.

Relative Measure of Criteria Applicability to Part A Work CONSIDERATION OF TIIE RULE'S 10 CRITERIA IN TIIE REVIEW OF CONTRACTOR'S PART-A QA PROGRAM CRITERION TITLE EXPECTED JUSTIFICATION USE IN PART A

1 Program Greater To achieve Part-A deliverables the organiza.

l tion must be well defined and functional.

2 Qualification & Training of Greater Qualified personnel strongly impact the Personnel quality of the design.

3 Quality Improvement lesser Design controls probably suffice.

4 Documents & Records Greater Consideration should be given to D&R storing media, retention & retrieval.

5 Work Processes Greater Engages management and worker in quality design processes.

6 Design Greater This is the main emphasis of Part A.

7 Procurement lesser Limited to procurement of design and de-sign development studies in Part A.

8 Inspection and Acceptance lesser May have some implications in defining Testing item or process prototypes.

9 Management Assessments Greater Management needs organizational control.

10 Independent Assessments Lesser In Part A, assessments are part of design control.

DOE. A common sense approach to the requirements 7.

QA ATTRIBUTES AND REVIEW as they apply to Part-A activities is expected. Re-quirements having major influence on the quality of 7.1 Introduction Part-A, safety-significant results should receive more detailed and extensive treatment. Those requirements ne intent of tids Guide is to encourage the Reviewer justifiably meriting reduced attention, may receive tojudge the adequacy of the Contractor's measures to less.

accomplish quality, rather than its compliance with established prescriptions. Ultimately, the Contractor The guidance below is organized to follow the struc-should bejudged on the effectiveness of its measures ture of the Rule. Here are general requirements to achieve excellence. This will require the Contrac-(called General Quality Assurance Program Require-tor to adopt a coherent and rational approach that ad-ments) for the QAP, as well as specific Criteria that dresses the QA needs and is effective for achieving should be satisfied by the QAP. The General Quality quality in Part-A activities. The Reviewer should be Assurance Program Requirements noted below ad-receptive to any competent and rational approach do.

dress: I) demonstrating how the ten Criteria are satis-veloped within the framework of the Rule and the fled,2) using the graded approach, and 3) using the top-level safety standards and principles stipulated by appropriate standards. Rese general requirements in-Rl/ REG-96-01 Rev 0,10-25-96 Page 3 of 18

Initial Quality Assurance Program Rzview Guidance

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fluence the Contractor's use of the ten Criteria. The Reuew Under the Rule there is flexibility for the Revieweris tojudge the adequacy of the Contractor's Contractor to devise its own approach for achieving approach to these general requirements.

quality. The Contractor may choose those measures upon which it intends to rely. However, with the un-In the Rule, and in this Guide, the ten Criteria an:

certainty introduced by this flexibility, a Contractor's grouped into three sections: Management, Perform-stated commitment in the QAP to comply with the ance, and Assessment. Each of the ten Criteria has a ten Criteria does not provide sufficient information to e

number of specific requirements. Reviewers should judge the adequacy of its approach. The Reviewer judge the adequacy of the Contractor's response to sat-should expect a discussion of what activities will be isfying each Criterion.

placed under the QAP and how QA measures will be used to achieve quality. This discussion will include For each requirement listed below, this section quotes methods and systems to be used and specifically iden-related requirements contained in the top-level safety tify how the Criteria are to be satisfied. The use of standards and principles stipulated by DOE, and pro-existing systems is acceptable, provided they meet vides reviewer guidance on what the Reviewer ought adequate standards for the functions they are intended I

to expect in the QAP and important considerations for to perform. For either existing or proposed systems, t

judging the adequacy of the Contractor's approach.

the Reviewer should expect a description of the func.

Contractor use of related sections in the companion tions to be performed and the standards to which they 4

document to the Rule, implementation Guidefor 10 conform.

CFR Part 830.120, G-830.120-REV. O, April 15, 1994,is acc.eptable, insofar as, all of the QA requue-Reqmrement 2 The criteria of pamgrqph (c) of this i

ments ior TWRS Privatization Contractors are ad-section shall be applied using a graded approach.

2 dressed. Contractor use of NQA 1 style information is also acceptable provided the information is organ.

Review All Contractor activities are subject to QA j

ized and presented in a manner which demonstrates but not all processes, items, activities, or services that the requirements of the Rule are effectively satis-have the same effect on quality or safety. A graded i

fied.

approach is to be used in the application of the Crite-ria. According to the Rule:

During the review process, the Reviewer sliculd: 1) become familiar with the Implementation Guide for

" Graded Approach means a process by which the the Rule,2) read the review statements in this section level of analysis, documentation, and actions for each requirement 3) become iamiliar with the necessary to comply with a requirement in this Contractor's QAP and implementation plan, if pro-Partare commensurate with:

vided,4) evaluate the Contractor's QAP against the (1) The relative importance to safety, safeguards, 1'

review statements in this Guide and relative to the andsecurity; scope of work for Part A, and 5) judge if the QAP, if (2) The magnitude ofany ha:ard involved; implemented, would satisfy the requirements of the (3) The hfe cycle stage ofafacility; Rule and the related top-level safety standards and (4) The programmaric mission of afacility; 4

principles stipulated by DOE. The Reviewer, there-(5) 1he particular characteristics ofafacility; and fore, needs to have a working knowledge of quality

. (6) Any other relevantfactor."

requirements, methods for implementing quality pro-grams, and of the TWRS Privatization Program.

The Reviewer should expect a presentation of the ra-tionale and method used by the Contractor to dis-7.2 General Quality Assurance Program criminate between levels of analysis, documentation, j

Requirements and actions, as well as a description of the method's application and its results. The rationale should take There are three general requirements of 10 CFR Part into consideration the above six factors as they apply 4

830.120, Quality Assurance Requirements, part (b) to the Contractor. The objective of the graded ap-Quality Assurance Program:

proachis to establish the level of effort necessary to achieve quality; therefore, the Reviewer should judge.

Rouuu.,..a.t 1 A QAP shallinclude a discussion of the adequacy of the process applied to activities in the j -

how the criteria of pwwa (c) of this section will context of their importance to safety and quality and be satisfied.

their continued influence in Part B.

Reuuu...ua 3 The contractor shall use qppropriate standards, whenever applicable, to develop tad im-piement its QAP.

8 ASME NQA-1-1994 Edition, Quality Assurance Re.

.quirementsfor Nuclear Facility Applications.

Page 4 of 18 Rev 0,10-25-96 RUREG-96-01

Initial Quahty Assurance Program Review Guidance Review For the Privatization Contractors, ing the QAPare adequate. The Reviewer should con-firm that the Contractor's policies and requirements

'7he DOE regulatory approach requires that the establishing the management system include provi-Contractor take an active and sigmpcant role in sions for management's development of measures to identifying and recommending the standards and ensure that all personnel, including management, im-requirements it will use to achieve adequate safety plement the management system.

he Reviewer for its specific activities" 3 should identify a commitment to develop an imple-mentation plan and evaluate the methods of manage-The Reviewer shnuld expect a presentation of the ment implementation and maintenance. Maintenance standards used by the Contractor to develop the initial considerations may include: 1) periodic program re-QAP and ajustification for their use. Because the re.

views, 2) demonstration of adequacy, 3) provisions suits of the standards and requirements identification for changes, and 4) method of approval. He Re-process will not be available for the initial QAP, the viewer should identify the Contractor's policies and Reviewer should consider the acceptability of the requirements for assessing the adequacy of work, standards in the context of commercial and DOE pme-tice such as ASQC E4', ASME NQA-l', and ASQC Reouirement 5 The OAP shall descdbe the organi:a-Q 900l*. As a minimum, the Reviewer should can-tional structure, functional responsibihties, levels of firm the Contractors use of the Rule and QA-related authority, andinterfacesfor those managing, perform.

top-level safety standards and principles stipulated by ing, and assessi rg the work.

DOE in the QAP.

Egy.itw The Reviewer should evaluate the adequacy 7.3 Quality Assurance Criteria That Ap.

of the Contractor's organizational structure and the ply To Work Management provisions enabling those personnel responsible for developing and implementing the QAP to have ade-quate lines of communication and sufficient influence Criterion 1: Program to be effective. The Reviewer should see a presenta-tion of the function of the various parts of the organi-Introduction The general requirements just discussed zation, their responsibilities, and how each supports in Section 7.2 are concerned with measures to achieve the mission,i.e., organizational unit responsibilities, safety, the necessary level of effort, and the use of ac-the level of authority for each tier of the organization, ceptable standards. His Criterion addresses the man-the interfaces among personnel managing, perform-agement systems for implementing the QAP.

ing, and assessing the work, and authorities, respon-sibilities, and interfaces among multiple contractors Reauirement 4 A wdtten GAP shall be developed or subcontractors. The communication among differ-implemented, and maintained, ent organizations and between the organization and parties outside the organization should be described.

Review he Reviewer should expect a presentation The Reviewer should identify and evaluate a method of the Contractor's management system. The man-for resolving inconsistencies among organizations and agement system should include the Contractor's between organizations and parties.

methods for managing, performing, and assessing the adequacy of work, including work assigned to panners Reouirement 6 The QAP shall describe the manage-or parties outside the organization.

ment processes, including planning, scheduling, ad resource considerationr.

The Reviewer should evaluate the Contractor's man-agement system's capability to achieve quality, with Review ne Reviewer should identify and evaluate emphasis on the contractor's requirements for man-the adequacy of the Contractor's policies and require-agement qualification and participation. He Re-metits that establish the management processes. De viewer should be satisfied that the method and re-Reviewer should identify and evaluate the Contrac-sources for developing, implementing, and maintain-tor's cost schedule control system (CSCS) and the Management Information System (MIS). He Re-viewer should assess how the CSCS will be used, in-8 DOE /RL-96-0005; Revision 0, February 1996, p.1.

cluding the ability to track program progress and han-ANSI /ASQC Standard E4, Quality Systems Require-die resourceloading. The Reviewer should determine ments for Environmental Programs,1994.

if the MIS is in place, and assess how it will be used 8

ASME NQA-1-1994 Edition, Quality Assurance Re-and its adequacy to accommodate interfaces with all quirementsfor Nuclear Facility Applications.

organizations and parties.

ANSllASQC-Q9001, Quality Systems -Modelfor Quality Assurance in Design / Development, Produc-tion, Installation, and Servicing,1993.

Ri> REG-96-01 Rev 0,10-25-96 Page 5 of 18

Initial Quality Assurance Program Review Guidance Criterion 2: Personnel Training and Quahpcation to enable them to perform their duties safely and effciently.

Introduction his Criterion addresses the ability of personnel to perform their work. It applies to all 4.3.4.3 Conditions BeyondDesign Basis Contractor activities, including design, and should be used consistent with the results of the graded ap-Operating stafshould be trained and retmined in proach. In evaluating the Contractor's approach, the the procedures tofollow ifconditions exceed the Revicwer should consider the constraints imposed by design basis of thefacility.

the dynamic nature of Part-A activities and the limited period of work on the Contractor's selection of meth-Review The Reviewer should identify and evaluate ods to satisfy this Criterion.

the Contractor's policies and requirements to establish continuing training. He constraints imposed by the Reauirement 7 Personnel shall be tmmed and quali-dynamic nature of Part-A activities and the limited pe-fed to ensure they are capable of performing their as-riod of work should be considered while gauging the signed work.

importance and judging the adequacy of the Contrac-tor's approach. De Reviewer should consider the ap-Related ton-level safety standards and nrineintes stinu-proach of using refresher courses to ensure personnel lated by DOE are trained in current procedures and on organizational processes, particularly if a condition adverse to quality' 4.3.4.1 PersonnelTraining may involve processes being perfonned incorrectly.

The evaluation may consider 1) a periodic assessment Personnel engaged in activities bearing onfacil-oi training needs,2) an assessment oi process prob-ity safety should be trained and quahfied to per-lems that may be solved by training, 3) instructor form their duties, qualification and experience,4) appropriate instruction materials and facilities, and 5) assessment of person-Review he Reviewer should identify and evaluate nel proficiency.

the Contractor's policies, requirements, and methods to ensure that personnel are trained and qualified to perform their work. Consider the following ques.

Criterion 3: Quality Improvement tions. Are the personnel required to have an adequate understanding of the work they are to perform? Does Introduction his Criterion addresses the processes to the Contractor certify the qualifications of its person-continually improve quality. It applies to all Con-net and is the process adequate? Has the Contractor tractor activities, including design, and should be used identified the skills required to perform the work of consistent with the results of the graded approach. In Part A, such as knowledge of systems engineering the evaluation, the Reviewer should consider the con-methods, special computer codes, etc.?

straints imposed by the dynamic nature of Part-A a>

tivities and the limited period of work on the Contrac-he Reviewer should identify and evaluate the Con-tor's selection of methods to satisfy this Criterion.

tractor's provisions for training. He evaluation may consider 1) formal and informal training, such as on-Requirement 9 Processes to detect andprevent quality the-job training,2) training formats including semi-problems shall be established and implemented.

nars and classroom instruction, 3) establishing mini-mum requirements for each job task, 4) instructor Review qualification and experience,5) appropriate training materials and facilities, and 6) assessing personnel

" Quality Improvement is a dualfoldprocess of proficiency.

addressing and remedying sporadicproblems, sud-den adverse changes in the status quo ofa work Reouirement 8 Personnel shall be provided continu-process, and solving chronic problems, long-ing training to ensure that job propciency is main-standing adverse conditions in a workprocess, tained.

i.e. continual scrap ofseveralpercent, to improve a workprocess by changing the status quo to a Related ton-level saferv standards and nrincinles stinu-new improved level. "'

lated by DOE 4.3.4.2 Training Programs Programs should be establishedfor continual Derived from Quality Planning and Analysis, by J.

training ofoperations and maintenance personnel M. Juran and Frank M. Gryna,3r., McGraw-Hill, 1980, p. 99.

Page 6 of 18 Rev 0,10-25-96 Rl/ REG-96-01

Initial Quality Assurance Program Revi:w Guidance The Reviewer should identify and evaluate the Con-vides data or results'. It controls policies, administra-tractor's policies, requirements, and methods to detect tive and technicalinformation regarding processes, re-and prevent quality problems, take prompt, effective, qmrements, and design. The Reviewer should identify and complete corrective actions, and improve per-and evaluate the Contractor's policies and require-formance. He Reviewer should consider Contractor's ments for document control and the implementation management measures to document and communicate of a documents control process. He Reviewer should the policies to all levels of the organization and consider measures that ensure all elements of the or-among organizations, to implement related practices, ganization establish document control procedures.

including those to improve worker awareness of the ne Reviewer should identify and evaluate the Con-importance of quality, to encourage participation of tractor's requirements and standards for document all workers in quality improvement, and to vest preparation, review, approval, use, access, and revi-authority in workers to identify quality problems and sion. The Reviewer should consider approaches for initiate corrective actions. The Reviewer should con-controlling distribution, identifying recipients, and es-sider the use of methods like the Shewhart Cycle tablishing required actions when documents are re-(also known as the Plan, Do, Check, Act or PDCA vised or canceled consistent with the results of the cycle) by the Contractor to formalize the process of graded approach. He Reviewer should consider improving planning activities, procedures, processes, measures that ensure qualified reviewers based on sub-and designs.

ject matter expertise. The Reviewer should also evaluate the Contractor's QAP document control pro-Requirement 10 Items, services, and processes that visions against the requirements for configuration do not meet established requirements shall be identi-management in the top-level safety standards atul fled, controlled, and corrected according to the impor-principles stipulated by DOE. (See Criterion 5, tance of the problem and the work afected Correc-Work Processes, and Criterion 6, Design.)

tion shall include identifying the causes of problems and working to prevent recurrence. Item chamcteris.

Reauirement 12 Records shall be speciped, prepared tics, process implementation, and other quality-related reviewed, approved, andmaintained information shall be reviewed and the data analyzed to identtfy items andprocesses needing improvement.

Review A record is recorded information that is re-tained for its expected future value? The Reviewer RcYlew The Reviewer should identify and evaluate should identify and evaluate the Contractor's policies the Contractor's policies for implementing procedures and requirements for the specification, preparation, re-thatidentify, control, and correct quality deficiencies.

view, approval, and maintenance of records. He Re-De Reviewer should consider the Contractor's use of viewer should consider how records are determined, methods for controlling items, services, or processes the process of preparation, the method of review, the that do not meet requirements or specifications such process of approval, and the system for maintenance as a classification system using the structure: accept, in light of a graded approach. The Reviewer should reject, repair, rework, use-as-is, or re-evaluate; and the evaluate the Contractor's record control system con-methods for identification and correction including the sidering the requirements for retention, protection, tools of tracking, trending, and root cause analysis to preservation, changes, and traceability. He or she ensure that the underlying causes of quality problems should assess the adequacy of requirements to preserve are averted.

the integrity of the storage system and the media.

He Reviewer should use the records control system requirements of NARA (National Archives and Rec-Criterion 41 Documents and Records ords Administration) to assess control of the TWRS Privatized Program Government records.

Introduction his Criterion addresses the control of documents and record functions related to processes, requirements, and design. It provides requirements af-fecting matters such as configuration control, related to work performance, such as design.

From 10 CFR Part 830.3, Definitions: Document Reauuuent 11 Documents shall be prepared, re-means recorded information that describes, speci-viewed, approved, issued, used, and revised to pre-fies, reports, cernfies, requires, or provides data or scribe processes, specify requirements, or establish results. A document is not considered a record until design.

it meets the definition of a record.

From 10 CFR Part 830.3, Definitions: Record Review A document is recorded information that de-means a completed document or other media that scribes, specifies, reports, certifies, requires, or pro-provides objective evidence of an item, service, or process.

Rl/ REG-96-01 Rev 0,10-25-96 Page 7 of 18

initial Quality Assurance Program Review Guidance 7.4 Quality Assurance Criteria That Ap-The Reviewer should identify Contractor's policies ply To Work Perforsmance and requirements for identifying and controlling items. He Reviewer should expect the Contractor to use a system to inventory items and a method to track Criterion 5 Work Processes and controlitems and accompanying documentation, depending on importance. De Reviewer should con-Introducuan This Criterion addresses measures to firm Contractor's management's commitment to a achieve process goals. It applies to all Contractor ao-system that is readily usaole by workers. He Re-tivities such as planning, scheduling, accounting, viewer should identify Contractor's policies and re-

~'

project management, design, analysis, fabrication, quirements ensuring that personnel take responsibility procurement, construction, installation, testing, op-for proper use of the items. De Reviewer should see eration, modification, maintenance, and deactivation that the following are addressed: one of a kind items,

[

consistent with the results of the gmded approach.

items specific to a particular craft, and common items he Reviewer should consider the scope of Part-A ac-that may be misused.

J tivities in the evaluation of the Contractor's ap-proach. In particular, Requirements 14,15, and 16 De

=: 15 Items shallbe maintained to prevent should require less detailed information from ne their damage, loss, or descrioration.

1 Contractor.

Review The Reviewer should identify and evaluate Re -==: 13 Work shall be performed to estab-the Contractor's policies and requirements for a proc-lished technical samdardt md administrative controls ess or prmare that ensures item maintenance or using approved instructions, procedures, or other m-special care accordmg to their importance (graded ap-propriate means.

proach). The Reviewer should consider measures in the maintenance management program to promote Review The Reviewer should identify and evaluate worker safety and environmental protection, and to the Contractor's policies and requirements for such monitor iteni condition. He Reviewer should con-i management controls as providing criteria for accept-sider the following attributes: maintenance requue-able work performance, planning and designing work ments, an item control process, maintenance sched-processes; ensuring qualified personnel to accomplish ules, personnel or organization identified for mainte-the work; ensuring personnel take responsibility for nance, assignment of authority and resources to meet j

the quality of their own work and that they follow requirements, handling and storage requirements to i

prescribed standards, procedures, or instructions.

prevent damage, a method of measuring deterioration, Documents expressing management controls should and establishing metrics for determining deterioration.

1) clearly identify authorities, responsibilities, and in-A provision should be included for identifying items terfaces,2)be readily acmaible to and usable by the with unique requirements such as in-storage mainte-j workers, and 3) address work process elements such as nance, limited shelf life, or ones that pose a particular methods to prevent use of incorrect or defective items.

harad to the environment, facilities, or personnel.

%e Reviewer should also evaluate the Contractor's work process measures intended for use in Part B.

Requirement 16 Equipment usedforprocess monitor-he Reviewer should evaluate the attention given to ing or daar collection shall be nA-kd md main-each impoitant element of each work process: people, rained equipment, environmental conditions, supply, man-agement, support, resources, and requirements, based Review The Reviewer should identify and evaluate on the results of the graded approach.

the Contractor's policies and requirements for identi-fying, controlling, and maintaining equipment used P--y a=: 14 Items shall be identified and con-for monitoring processes or collecting process or trolled to ensure theirproper use, other data. De Reviewer should identify and evaluate the Contractor's requirements for a formal, docu-Review " Item is an all-inclusive term used in place mented, calibration program. De Reviewer should of any of the followingt appurrenance, assembly, consider requirements for 1) calibration standards component, equipment, material, module, part, struc-traceable to the National Institute of Standards and ture, subassembly, subsystem, system, unit, or sup-Technology NIST), or some other nationally recog-port system".'"

nized standard, or a method that gives the basis for the calibration; and 2) procedures and training for those workers who perform calibrations. De training pro-From 10 CFR Part 830.3, Definitions: ltem is an all-inclusive term used in place of any of thefollow-ment, material, module, part, structure, subassem-ing: appurtenance, assembly, component, equip.

bly, subsystem system, unit, or support system.

/

i Page 8 of 18 Rev 0,10-25-96 RIJREG-96-01 l

a Initial Quality Assurance Program Revi;w Guidance gram should include training for personnel that main-unique to analysis. He Reviewer should also verify tain such equipment.

measures to preclude the use of unverified design data and ensure that appropriate verification or qualifica-tion testing is completed before design data are used Criterion 6: Design in subsequent activities, consistent with the results of the graded approach. He Reviewer should identify Introduction This Criterion addresses the definition, and evaluate the Contractor's requirements for identi-control, and verification of design and is more specific fying and using suitable standards appropdate to the than those measures stipulated for Criterion 5, Work design product.

Processes. It app?ies to the design and supporting ac-tivities such as analysis. His Criterion recognizes Reouirement 18 Design work, including changes, the need for additional measures, including the control shall incorporate applicable requirements and design of design inputs, outputs, verification, configuration bases.

and design changes, documentation, records, and tech-nical interfaces consistent with the results of the Related ton-level safety standards and orincioles stinu-graded approach. His Criterion ensures that adequate lated by DOE measures exist for systems, structures, and compo-nents important to safety. The Reviewer should rec-4.1.5 Configuration Management ognize the potentialimportance of this Criterion to Part-A activities.

4.1.5.1 Formal Confguration Management Principles stipulated by DOE that are related to the Formal confguration management should be ap-activities subject to this Criterion include plied to allfacility activities during the pro.

" Configuration Management," Section 4.1.5, gram 's hfetime to ensure that programmatic ob.

" Design," Section 4.2.1, and " Proven Engineering jectives, including safety, arefully achieved.

Practices / Margins," Section 4.2.2 of the Top-Level Work should be performed and controlled accord-Radiological, Nuclear, and Process Safety Standards ing to pre-approvedplans andprocedures that and Principles for TWRS Privatization Contractors, clearlydelineate responsibilities. Documented DOE /RL-96-0006; Revision 0. Sections 4.1 and 4.2 recordsshouldbe retained are included in Appendix A for the Reviewer's con-venience.

4.1.5.2 ContractorDesign Knowledge Reuuuuwt 17 Items and processes shal: be de-The Contractor operating organizations should signed using sound engineering /scientipc panciples become and remainfamiliar with thefeatures and andappropriatestandtids limitations ofcomponents included in the design of thefacility. They shouldobtain appropriate Related top-level safety standards and principles stipu-inpuffrom the design organization on pre-lated by DOE.

operational testing, operating procedures, and the planning and conduct oftraining.

4.2.2.1 Proven Engineering Practices 4.1.5.3 Design Documentation Safety technologies incorporated into thefacility design should have been proven by experience or A system should be used to control and maintain testing and should be rejected in approved codes accurate as-built drawings during the hfe of the andstandards. Sigmpcantnewdesignfeatures facility.

should be introduced only after thorough research and model orprototype resting at the component, Review The Reviewer should identify and evaluate system, orfacility level, as appropriate.

the Contractor's policies and requirements for a for-mal process, including systems engineering, to prop-Review The Reviewer should identify and evaluate erly establish and accurately incorporate requirements the Contractor's policies and requirements for using and design bases into the design and design changes.

sound engineering / scientific principles.

Tne Re-He Reviewer should verify that design changes, in-viewer should consider the use of accepted design cluding those made during fabrication or construction, practices; valid analytical methods, tools, and data; subsequent modifications, and any nonconforming proven technology or measures to demonstrate ado.

items will be subject to design standards and controls quacy of new technology; and formal design processes consistent with those applied to the original design.

that ensure quality. De Reviewer should confirm the he Reviewer should identify requirements for con-Contractor's measures that address the QA methods figuration management and control to ensure that d>

RIJREG-96-01 Rev 0,10-25 96 Page 9 of 18 l

i

Initial Quality Assurance Program Review Guidance sign documents and records are appropriately gener-ture, or component will be fit for its intended use.

ated, controlled, and retained. The following is an ac-he Reviewer should identify and evaluate the Con-cepted consensus standard definition for Configuration tractor's policy and reqmrements to verify or validate Management (CM)",

design products consistent with the results of the graded approach. Measures may include technical re-

"An integrated managementprogram that estab-views, peer reviews, ahemate calculations, qualifica-lishes consistency among design requirements, tion testing or limited use of reviews of comparable physical confguration, andfacility documenta-systems. Interim reviews may be made at predeter-tion, and maintains this consistency throughout mined stages of development. De extent and number the hfe of thefacility as changes occur. The CM of reviews should be based on the importance arxi program consists of CMfunctions associated complexity of the design product. He Reviewer with thefollowing program elements: program should confirm that technically quali5ed personnel, management, design requirements, document con-separate from those performing the design, will verify trol, change control, and assessments. The CM the design. The Reviewer may consider measures to program also includes design reconstitution and promote quality improvement as part of the design material condition andaging management as ad-verification.

junctprograms."

Reauirement 21 Venpcation and validation work he Reviewer should identify and evaluate the Con-shall be completed before approval and implementa-tractor's requirements for a process to identify struc-tion of the design.

tures, systems, and components (SSCs) important to safety based on the results of the graded approach and Review he Reviewer should identify and evaluate should be able to establish the life expectancy of the the Contractor's policies and requirements to verify SSC" he Reviewer should also identify require-and validate the design before its use by other organi-ments for design documents to be usable by all end zations. If verification cannot be completed before users.

use by other organizations, unverified portions of the design should be identified and controlled. In all cases Reauirement 19 Design interfaces shall be idennfed the design should be verified before it is approved and andcontrolled, implemented.

Review he Reviewer should identify and evaluate the Contractor's policies and requirements for deter-Criterion 7t Procurement mining design interfaces among interacting disci-plines or multiple contractors, both technical and ad-Introduction his Criterion addresses the Contractor's ministrative. These interacting disciplines and or-establishing of measures to ensure that items and ganizations should have well-defined roles with re-services provided by suppliers meet end-user require-spect to responsibilities, design reviews, design-basis ments consistent with the results of the graded ap-exchange among disciplines and organizations, deliv-proach. The Reviewer should acknowledge the lim-etables among disciplines and organizations, and as-ited procurement during Part-A activities in the sociated approvals. He Reviewer should identify and evaluation of the Contractor's approach to this Crite-evaluate the Contractor's requirements for an interface rion. Should procurement become a significant con-control system that avoids, or identifies and corrects sideration, the Reviewer is referred to the Implementa-conflicts, tion Guide for 10 CFR Part 830.120 for a fuller de.

scription of the measures to be conside;ed in the Reauirement 20 The adequacy of design products evaluation.

shallleenpedor validated by individuals or groups other than &se who performed the work.

Reauirement 22 Procured items and services shall meet established requirements and perform as speci-Review Design verification is a formal documented fed.

process to establish that the resulting system, struc-Review The Reviewer should identify and evaluate the Contractor's policies and requirements for the DOE-STD-1073-93-Pt.1 *Guidefor Operational planning and control of the procurement process con-Configuration Management Programs," Glossary, sistent with the results of the graded approach. He page x.

Reviewer should focus on measures to ensure the pro-Top-level Radiological Nuclear, and Process Stan-curement process meets end-user requirements.

dards and Principlesfor 7WRS Privatization Con-Measures should provide for the clear, complete, and tractors, DOE /RL-96-0006; Revision 0. Sections; accurate communication of end-user requirements to 4.2.2.2, 4.2.2.3, 4.2.7.1, and 4.2.7.2.

Page 10 of 18 Rev 0,10-25-96 RilREG-96-01

Initiil Quality Assurance Program Review Guidance the supplier; meeting suppliers', designen', and erd-Requirement 25. Inspection and testing of specifed users' requirements during production of the item or items, services, andprocesses shall be conducted us-services; and delivering the product on time and main-ing establshed acceptance andperformance criteria.

taining it until use.

Related too-level safety standards and orincioles stiou-End-user requirements should include supplier docu-lated by DOE mentation, handling, packaging, shipping, or storage requirements. The Reviewer should identify and 4.3.5.1 Operational Testing, Inspection, and evaluate the Contractor's policies and requirements for Maintenance documenting and controlling nonconforming items or services until compliance with the technical sequire-Structures, systems, and components important ments is demonstrated; and for acceptable deviations to safety should be the subject of appropriate, from requirements to be documented, controlled, tw regularpreventive maintenance, inspection, and viewed, and approved.

testing andservicing when needed, to ensure that they remain capable ofmeeting theirdesign re.

Requirement 23 Prospective suppliers shallbe evalu-quirements throughout the lufe of thefacility.

ated and selected on the basis ofspecuped criteria.

Such activities should be carried out in accor-dance with written procedures supported by qual-Review De Reviewer should identify Contractor's ity assurance measures, policies and requirements to ensure suppliers are qualified to provide required items or services. %e Review The Reviewer should identify and evaluate Reviewer may consider use of metrics such as per-the Contractor's policies and requirements to establish formance history and results of supplier evaluation inspection and testing of SSCs consistent with Part-based on facility visits or documented evidence.

A activities and the results of the gaded approach.

The Reviewer should consider measures to ensure that Reauirement 24 Processes to ensure that approved inspection and testing acceptance and performance cri-suppliers continue to provide acceptable items ad teria are developed based on requirements, and inspec-services shallbe establishedandimplemented tion and testing activities are adequately planned, con-trolled, and documented. He Reviewer should con-Review The Reviewer should identify and evaluate sider provisions to control disposition of SSCs that the Contractor's policies and requirements to establish do not conform, including tracking, repair, replace-aprocess to continually evaluate a supplier's contin-ment, re-testing, and revaluation to specified criteria ued capability to provide acceptable items and serv-and disposal. he Reviewer should identify measures ices. He extent and number of reviews should be to ensure that equipmer used for inspections is ap-a based on the results of the graded approach. EhwM propriate, and that personnel performing inspections reviews may be stimulated by receipt of non-and tests are trained and qualified in the test procedures conforming items from the supplier. The Reviewer and the equipment to be used and are certified in the may consider performance criteria such as: work ac-appropriate discipline as necessary, e.g.,

Non-tivities, facility inspection, process evaluation, prog-Destructive Examination qualifications.

ress reports, change information, and nonconformance reviews.

Reuuuent 26 Equipment usedfor inspections ad tests shall be calibrated and maintained Criterion 8: Inspection and Acceptanec Testing Review he Reviewer should identify Contractor's policies and requirements, to establish a formal, Introduction his Criterion addresses Contractor in-documented, calibration program consistent with Part-spection and testing provisions to verify that sys-A activities and the results of the graded approach.

tems, structures, and components (SSCs) are accept-Calibradon standards should be traceable to a recog-able to specified requirements, consistent with the re-nized authority, such as the National Institute of sults of the graded approach. The Reviewer should Standards and Technology that gives the basis for the consider the limited use of SSCs during Part-A activi-calibration. The Reviewer should evaluate the Con-ties in the evaluation of the Contractor's approach.

tractor's provisions for the calibration of equipment Should use of SSCs become a significant considera-and instruments used to establish the acceptance of tion, the Reviewer is referred to the implementation items, processes, procedures or services; corrective ac-Guide for 10 CFR Pan 830.120 for a fuller desenp-tions where out-of-calibration conditions occur; and tion of measures to be considered in the evaluation.

the use of qualified personnel performing calibrations.

R1/ REG-96-01 Rev 0,10-25-96 Page 11 of 18

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i i

Initial Quahty Assurance Program Review Guidance 7.5 Quality Assurance Criteria That Ap.

the attention given by the Contractor to methods of ply To Work Assessment improving processes and eliminating the barriers to achieving strategic goals and objectives.

Criterion 9: Management Assessment Cnterion 10: Independent Assessment Intro' duction This Criterion addresses Contractor management awareness of its organizational perform.

Introduction This Criterion addresses management ance telated to achieving its goals and objectives and awareness of performance of work processes related to to the provisions management uses to encourage a the requirements and expectations of customers and continuous quality improvement process and to en-towa-d achievitg the organization's goals and objec-sure conective actions are promptly, effectively and tives. The Reviewer should evaluate the Contractors completely addressed-This Criterion applies to all measures to asses its establishment of the QAP and Contractor activities and should be used consistent implementation. The provisions for input to a con-with the results of the gradext approach. The Re-tinuos quality improvement process should also be viewer should consider the constraints imposed by the considered. The Reviewer should consider the con-dynamic nature of Part-A activities and the limited pe-straints imposed by the dynamic nature of Part-A ac-riod of work on the Contractor's selection of methods tivities and the limited period of work on the Contrac-to satisfy this Criterion, tor's selection of methods to satisfy this Criterion.

Reauirement 27 Management shall assess their man.

Reauirement 29 Independent assessments shall be agementprocesses.

planned and conducted to measure item and senice quality, to measure the adequacy of work performance, Review his Reviewer should identify and evaluate and to promote improvement.

the Contractor's policies and requirements for assess-ing management processes. The Reviewer should Related ton-level safety standards and orincioles stiou-consider measures to establish organizational goals lated by DOE and objectives, and the conduct of periodic assess-ments that evaluate the eifectiveness oi the entire in-4.3.1.5 Internal Surveillance and Audits tegrated management system to focus on achieving organizational goals. These measures should be con-Internal safety review procedures should be used sistent with the period of work for Part-A activities.

by the Contractor to provide a continuing sur-De Reviewer should consider management identifica-reillance and audit offacility operational safety tion oi 1) processes for assessment such as strategic and to support thefacility manager in overall planning, organizational interfaces, cost control, use safety responsibilities, of performance indicators, staff training and qualifica-tions, and supervisory oversight and support; 2) con-and ditions such as employee knowledge, motivation, and morale; worker trust and communication; worker 4.4.1 Safety Review Organization dedication to creativity and improvement; and ad>

quacy of human resources; and 3) work observations The Contractor should establish aframeworkfor such as upward evaluations, worker interviews, re-its safety review organi:ations that are responsi-view of documentation, and conduct of drills or exer-blefor assuring the safety of thefacility. The cises.

separation between the responsibilities of the safety review organizations and those of the other Requirement 28 Problems that hinder the organiza-organizations should remain clear so that the tion from achieving its objectives shall be identified safety review organizations retain their independ-andconected ence as safety authorities.

Review he Reviewer should identify Contractor's Review The Reviewer should identify and evaluate policies and requirements for identification and correc-the Contractor's policies and requirements for man-tion of problems that hinder the organization from agement to develop and implement an independent as-achieving its objectives, including corrective actions.

sessment program. The program should assess or-he Reviewer should consider measures to use the in-ganizations, programs, and projects with the objective formation acquired during assessments combined with of evaluating the performance of work processes, and other internal and external infonnation to identify promoting improvement with regard to requirements problems and to develop input to a continuos im-and expectations of DOE. He Reviewer should con-provement process. The Reviewer should evaluate sider the establishment of specified criteria grounded Page 12 of 18 Rev 0,10-25-96 Rl/ REG-96-01

[

Initial Quality Assurance Program Rzview Guidance in a performance-based approach. The Reviewer sure the assessor's credentialt qualifying them to per-should consider the planning of assessments, and se-form the particular assessment, lection of activities for assessment, such as design, that are most directly related to final objectives, and its emphasis on safety and product quality. De Re-8.

OTHER CONSIDERATIONS viewer should consider the selection of types of inde-pendent assessments such as inspections, peer and As an additional consideration,it should be noted that technical reviews, audits, surveillances, or combina-the DOE intends to transition regulation of the tions thereof; and the frequency of iadaaaadaat as-TWRS Privatization Contractors to the NRC in the sessments in light of activities being assessed and future. It will be extremely useful to document the their importance. ~ ne Reviewer should evaluate the level of consistency that exists between the Contrac-effectiveness of the Contractor's approach to measure tor's initial QAP as reviewed against 10 CFR Part item and service quality, to measure adequacy of work 830.120 and NRC requirements. Within the bounds performance, and to promote improvement.

of 10 CFR Part 830.120, the Reviewer should evalu-ate the Contractor's initial QAP for consistency with Requirement 30 The group performing independent NRC QA practices related to 10 CFR 70. Inconsis-assessments shall have supicient authority andfree-tencies with NRC requirements should be noted for domfrom the line to carry out its responsibilities.

use by the RU to assist the future transition. This part of the review will not reflect on the acceptability Review he Reviewer should evaluate the independ-of the Contractor's initial QAP, but is only for the ence and authority afforded the Contractor's group per-benefit of the RU.

forming the assessment. De Reviewer should con-siderthe advisory function of the group, the level to which the group reports in the overall organization, 9.

SOURCES and its independence and access to appropriate author-ity. De Reviewer should also confirm that the group 1.

7WRS Privatization Requestfor Proposals DE-would have no direct responsibilities or danaadaarian RP06-%RL13308, February 1996.

in the areas they are assessing. De Reviewer should 2.

10 CFR Part 820 - Procedural Rules for DOE also confirm that the group,s role m, eludes assisting those who are bemg assessed to improve quality.

Nuclear Activities, September 1993, 3.

G 414.1-1, implementation Guidefor the use P= "=== 31 Persons conducting independent as-with the independent and Management Assess-sessments shall be technically quahfed and knowl-ment Requirements of10 CFR Part 830.120 and edgeablein the areas assessed.

the Order $700.6C Quality Assurance, REV. O, August 1996.

Palatad too-level safety ce=adanis and nrincioles stinu-4.

DOE P 450.4, Safety Management System Pol-lated by DOE scy, August 28,1996.

4.4.2 QuahpedPersonnel 5.

ANSIIASQC Standard E4, Quality Systems Re-quirementsfor Environmental Programs,1994.

Internal sqfety oversight should be conducted by quahfed personnel to ensure that the safety stan.

6.

10 CFR Part 830.3, Definitions, April 5,1996.

dards are consistently met.

7.

10 CFR Part 830.120, Quality Assurance Re-quirements, April 5,1996.

Review The Reviewer should identify Contractor's policies and requirements for ensuring personnel con.

8.

10 CFR Part 70, Domestic Licensing of Special ducting independent assessments are technically quali-Nuclear Material, as amended through September

- fied and knowledgeable. The Reviewer should con.

1996.

sider measures to establish appropriate qualifications 9.

Concept of the DOE Regulatory Processfor Ra.

- for the assessments and to select appropriate person-diological, Nuclear, and Process Safetyfor nel for conduct of the assessment. For assessments 7WRS Privatization Contractors, DOE /RI performed by personnel who are internal to the or-0005' ganization, the Reviewer should identify a policy that requires the use of certified personnel, as established

10. DOERegulatory ProcessforRadiological Nu-by Criterion 2 for assessing work. For assessments clear, and Process Safetyfor 7WRS Privatizatio a performed by personnel who are external to the or-Contractors, DOE /RI-96-0003.

genization, the Reviewer should identify a policy that requires a certification program be established to en-RIlREG.96-01 Rev 0,10-25 96 Page 13 of 18

=

e Initial Quality Assurance Program Review Guidance I1. Top-LxvelRadiological, Nuclear, andProcess 11.

GLOSSARY Safety Standards and Principlesfor TWRS Priva-ti ation Contractors, DOE /RL-96-0006 Administrative Controls. Provisions relating to or-

12. Processfor Establishing a Set ofRadiological, ganizati n and mana8ement, procedures, record keep-mg, ssess ent, and reporting necessary to ensure Nuclear, and Process Safety Standards andre-

• • I' *P*'i*" *I

• I**ElI'Y' quirementsfor TWRS Privatization, DOEIRL-950004.

Common-Cause Failures. Dependent failures that are Y * ""

• "'"***'Y"'

• ' *I D

13. Implementation Guidefor 10 CFR 830.120, G-830.120-REV. O, April 15,1994.

C mPonents that make system or multiple component failures more probable than multiple independent fail-

14. ANSIIASQC-Q9001, Quality Systems -Model ures.

for Quality Assurance in Design / Development, Common-Mode Failures. Dependent failures caused Production, Installation, and Servicing,1993.

by susceptibilities inherent in certain systems or

15. ASME NQA-1, Ouality Assurance Requirements components that make their failures more probable forNuclear Facilities Applications,1994 Edi-than multiple independent failures due to those com-t:an.

ponents having the same design or design conditions 8*

16. DOE 5700.6C, Quality Assurance, August 21 1991.

Contractor (sl The private company (ies) selected to contract with DOE for construction and operation of

17. IAEA Code on the Safety of Nuclear Power the technologies and fccilities necessary to retrieve, Plants: Quality Assurance, Safety Series No. 50-process tank waste, and deliver treated waste products C-QA (Rev.1),1988.

to DOE for storage or disposal.

I 8. DOE Order 5000.3B, Occurrence Reporting and Controlled Area. He physical area enclosing the fa-Processing of Operations Information, Febmary cility by a common perimeter (security fence). Ac-22,1993.

cess to this area can be controlled by the Contractor.

19. Quality Planning and Analysis, J. M. Juran and The controlled area may include identified restricted Frank M. Gryna, Jr., McGraw-Hill,1980.

areas.

20. Statistical Methodfrom the Viewpoint of Qual-Eksign " The process and the result of developing ity Control, Walter A. Shewhart, Graduate the concept, detailed plans, supporting calculations School, Department of Agriculture, Washington, and specifications for a nuclear facility and its parts.

D. C.,1939, and Dover in 1986.

Desien Basis. He information that identifies the specific functions to be performed by structures, sys-

10. ABBREVIATIONS tems, or components of the facility and the specific values or ranges of values chosen for controlling pa-CFR Code of FederalRegulation rameters as reference bounds for design.

CM Configuration Management Director of the Rerulatory Unit. An individual who has been delegated the authority to execute the radio.

DOE Department of Energy logical, nuclear, ami process safety regulation of NRC Nuclear Regulatory Commission TWRS Privatization Contractors.

D cu ent. Document means recorded information QA Quality Assurance that describes, specifies, reports, certifies, requires, or QAP Quality Assurance Program provides data or results. A document is not consid-RL Richland Operationc Office cred a record until it meets the definition of record.

RFP

'IWRS Privatization Request for Proposal Facihty. Those buildings and equipment directed to a common purpose and those activities and supporting RU Office of Radiological, Nuclear, and Process elements occurring at a single location.

Safety Regulation (Regulatory Unit)

SSC Structures, Systems, and Component.

TWRS Hanford Tank Waste Remediation System Derived from the definition of design used in IAEA Code on the Safety of Nuclear Power Plants: Quality Assurance,50-C-QA (Rev.1)

Page 14 of 18 Rev 0,10-25-96 RI/ REG-96-01 l

t.

a t

Initial Quality Assurance Program R;vi;w Guidance Graded Anoroach. A process by which the level of rials in such form or quantity that a nuclear hazard analysis, documentation, and actions necessary to potentially exists.

comply with a requirement in this part are commen-surate with-Normal Operation. Steady-state operation and those

1) The relative importance to safety, safeguards, and security.

departures from steady-state operation that are ex-

2) The inagnitude of any hazard involved; Pected frequently orregularly in the course of facility 3)The life cycle stage of a facility; peration, system testing, and maintenance. It in-

4) The programmatic mission of a facility; cludes conditions such as startup, shutdown, standby,

5) ne particular characteristics of a facility; and andenpated operational occurrences, operation with

6) Any other relevant factor.

Specific equipment out of service as permitted by the approved operational constramts, and routine inspec-Intecrated Safety Manacement Plan (ISMP) Evalua-tion, testing, and maintenance of components and tion Reoort. The document, approved and issued by systems during any of these conditions ifit is consis-the Director of the Regulatory Unit, that addresses the tent with the approved operational constraints.

adequacy of the Contractor's Integrated Safety Man-agement Program as reflected in its Integrated Safety Nuclear Facility. Reactor and nonreactor nuclear fa-Management Plan.

cilities.

Intecrated Safety Manacement Program A set of in-Process (Related to Safety) Any activity involving a tegrated activities that is directed toward the manage-highly hazardous cherrucal meluding use, storage, ment or control of radiological, nuclear, and process manufacturing, handling, or the on-site movement of hazards such that adequate protection is provided to such chemicals, or a combination of these activities.

workers, the public, and the environment.

Process. (Related to Quality Assurance) A series of lism. Item is an all-inclusive term used in place of actions that achieves an end or result.

any of the following: appurtenance, assembly, com-Process Safety. The operation of facilities that han-ponent, equipment, material, module, part, structure, die, use, process, or store hazardous materials in a subassembly, subsystem, system, unit, or support manner free of episodic or catastrophic incidents.

systems.

However, the handling, use, processing, and storage Nonreactor Nuclear Facilitv. Those activities or op.

f matedals with inherent hazardous properties can crations that involve radioactive and/or fissionable never be done m, the total absence of risk. Process materials in such form and quantity that a nuclear safety is an ideal condition towards which one strives.

haz ard potentially exists to the employees or the gen-Pubhc Individuals who are not occupationally en-eral public. Incidental use and generating of radioac-gaged at the Hanford Site.

tive materials in a facility operation (e.g., check and calibration sources, use of radioactive sources in re.

Ouahty. 'Ihe condition actu.eved when an item, serv-search and experimental and analytical laboratory ac-ice, or precess meets or exceeds the user's require-tivities, electron microscopes, and X-ray machines) ments and expectations.

would not ordinarily require the facility to be included Ouality Assurance. All those actions that provide in this definition. Transportation of radioactive mate-confidence that quality is achieved.

rials, accelerators and reactors and their operations are not included. The application of any rule to a nonre.

Ouality Assurance Procram or OAP. The overall actor nuclear facility shall be applied using a graded Program established to assign responsibilities ard approach. Included are activities or operations that:

authorities, define policies and requirements, and pro-vide for the performance and assessment of work.

1) Produce, process, or store radioactive licuid or solid waste, fissionable materials, or tritium; Record A completed document or other media that provides objective evidence of an item, service, or

2) Conduct separations operations; process.

3) Conduct irradiated materials inspection, fuel fabri-Reculatory Unit. The organization reporting to the cation, decontamination, or recovery operations; Director of the Regulatory Unit dedicated to support-

4) Conduct fuel enrichment operations; ing the Director in executing regulatory authority.

5) Perform environmental remediation or waste man.

Reliability Tarcets. Quantified probabilistic expecta-agement activities involving radioactive materials; tions that a component, equipment, or system will or Perform its intended function satisfactorily under given circumstances, such as environmental condi-

6) Design, manufxture, or assemble items for use tions,limitauons as to operation time, and frequency with radioactive materials and/or fissionable mate-and thoroughness of maintenance for a specified pe-R11 REG-96-01 Rev 0,10 25-96 Page 15 of 18 l

e -

Initia! Qurlity Assurance Program Review Guidance riod of time. Identified important to safety items are Acceptable risk analyses should be applied during the expected to perform their function satisfactorily design to delineate provisions for the prevention and

/

through all design basis accident conditions.

mitigation, including emergency Wsduess and re-k Reauirements. Standards that are mwd by an Sponse, of otherwise risk-dominant events.

authority through statute, regulation, or contract.

4.2.1.3 Safety Analysis Safe State. A situation in which the facility process has been rendered safe and no pressurized material A safety analysis should be carried out as required to flow occurs in the process lines. Any active, energy evaluate the safety performance of the design and iden-generating, process reactions are in controlled or pas-tify requirements for operations.

sive equipment. He structures, systems, and com-ponents necessary to reach and maintain this condi-4.2.2 Proven Encineerine Practices /Marcins tion are functioning in a stable manner, with all proc-ess parameters within normal safe state ranges.

4.2.2.1 Proven Engineering Practices Service ne performance of work, such as design, construction, fabrication, inspection, nondestructive Safety technologies incorporated into the facility de-sign should have been proven by experience or testing examination / testing., environmental qualification, equipment qualification, repair, installation, or the and should be reflected in approved codes and stan-like.

dards. Significant new design features should be in-traduced only after thorough research and model or Standards The expressed expectation for the perform-Prototype testing at the component, system, or facil-ance of work.

ity level, as appropriate.

Worker Worker means an individual within the con-4.2.2.2 Common-Mode / Common-Cause Failure trolled area of the facility performing work for or in conjunction with the Contractor or utilizing Contrac-Design provisions should be included to limit the tor facilities.

loss of safety functions due to damage to several structures, systems, or components important to safety ses,ilting from a common-cause or common-APPENDIX A.

ADDENDUM TO CRITE-mode failure.

RION 6, DESIGN The following is an addendum to Criterion 6, Design.

This appendix is a duplication of Section 4.2.

Structures, systems, and components important to

" Design, Construction, and Pre-Operational Testing" safety should be designed and qualified to function as of the DOE document titled, Top. Level Radiological, intended in the environments associated with the Nuclear, and Process Safety Standards and Principles for TWRS Privati:ation Contractors, DOE /RI 96-events for which they are intended to respond. The ef-fects of aging on normal and abnormal functioning 0006; Revision 0. Because conformance to DOFJRL-should be considered in design and qualification.

96-0006is required, this Section will be used by the Reviewers to evaluate the Contractor's Quality As-4.2.2.4 Codes and Standards surance Program plan of the TWRS Privatization Program.

Codes and standards for vessels and piping should be supplemented by additional measures (such as ero-4.2 Desien. Constmetion. and Pre-Onerational sion/ corrosion programs and piping in-service inspec-Testme tions) to mitigate conditions arising that could lead to an unacceptable release of radioactivity du.ing the op-4.2.1 Design crationallife of the facility.

4.2.1.1 Safety Design 4.2.2.5 Criticality The facility should be designed for a set of events The facility should be designed and operated in a such as: normal operation, including anticipated oP-manner that prevents nuclear criticality.

erational occurrences, maintenance, and testing; exter-nal events; and postulated accidents.

4.2.3 Radiation Protection 4.2.1.2 Risk Assessment 4.2.3.1 Radiation Protection Practices Page 16 of 18 Rev 0,10-25-96 Rl/ REG-96-01

(

Initial Quality Assurance Program Revi w Guidance An acceptable system of radiation protection practices 4.2.6.2 Instrumentation and Control Design should be followed in the design, construction, and pre-operational testing phases of the facility for the Sufficient. instrumentation and control capability protection of workers and the public.

should be provided so that under normal operating and postulated accident conditions the operators can diag-4.2.3.2 Radiation Protection Features nose facility conditions, place and maintain the facil-ity in a safe state, and mitigate accidents. If neces-At the design stage, radiation protection features rary, measures should be provided to protect the op-should be incorporated to protect workers from radia-erator ic the performance of these functions.

tion exposure and to keep emissions of radioactive ef-fluents ALARA and within prescribed limits.

4.2.6.3 Safety Status 4.2.3.3 Deactivation, Decontamination, and De-Parameters to be monitored in the control room commissioning Design should be selected and their displays should be ar-ranged to ensure that operators have clear and unam-The design of the facility should incorporate provi-biguous indications of the status of facility conditions sions to facilitate deactivation and the final decom-important to safety, especially for the purpose of missioning. The objective of these provisions should identifying and diagnosing the actuation and operation be to reduce raimion exposures to Hanford Site per-of a system or components important to safety.

sonnel and the public both during and following deac-tivation and decommission'..g activities and to mini-4.2.7 Reliability. Availmhility. Maiatminshility.

mize the quantity of radioactive waste =-- O ds-and Inspectabihty (RAMD ing deactivation, decontamination and /=

!ssion-ing.

4.2.7.1 Reliability 4.2.3.4 Deactivation Plan Reliability targets should be assigned to structures, systems, and components or functions important to There should be an approved plan for deactivation of safety. The targets should be consistent with the the facility before it is constructed.

roles of the structures, systems, and components or functions in different accident conditions. Provision 4.2.4 ' Emergency Preparedness should be made for appropriate testing and inspection of structures, systems, and components for which re-4.2.4.1 Support Facilities liability targets have been set.

The facility design should provide additional capabil-4.2.7.2' Availability, Maintainability, and Inspec-ity to place and maintain the facility in a safe state tability following an accident if the normal control areas are expected to become uninhabitable.

Structures, systems and components important to safety should be designated, designed and constructed 4.2.5 Inherent / Passive Safety Characteristics for appropriate inspection, testing, and maintenance throughout their operating lives to verify their con-4.2.5.1 Safety Margin Enhancement tinued ac-ptability for service with an adequate safety margm.

Design features that enhance the margins of safety through simplified, inherent, passive, or other highly 4.2.8 Pre-Oneratinami Taeeing reliable means to accomplish safety functions should be employed to the maximum extent practical.

4.2.8.1 Testing Program

4.2.6 Human Factors A pre-operational testing program should be estab-lished and followed to swa,es.ie that the entire fa-

. 4.2.6.1 Human Error cility, especially items important to safety, have been constructed and function accordmg to the design in-The possibility of human error in facility operations tent, and to ensure that weaknesses are detected and should be taken into account in the design by facili-corrected tating correct decisions by operators and inhibiting wrong decisions and by providing means for detecting 4.2.8.2 Operational Systems and Functional Testi'ig and correcting or compensating for error.

Procedures Validation R1/ REG.96-01 Rev 0,10-25-%

Page 17 of 18

Initia! Quality Assurance Program Review Guidance 1

Procedures for normal facility and systems operation and for functional tests to be performed during the op-erating phase should be vaMaraA as part of the pre-operational testing program.

4.2.8.3 Safety Systems Data During pre-operational testing, detailed diagnostic data r

. should be collected on systems and components im-portant to safety and the initial operating i-ee of the systems and components should be recorded.

4.2.8.4 Design Operating Characteristics During the pre-operational testing program, the as-built operating characteristics of process systems, and systems and components important to safety should be detemuned and documented. Operating points should be adjusted to conform to values in the design basis. Training procedures and limiting conditions for operation should be moddied to accurately reflect the operating charactenstics of the systems and com-ponents as built.

Page 18 of 18

- Rev 0,10 25-96 RIJREG-96-01

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