ca9600034 can3-n286.2-86 design quality assurance for

CA9600034

CAN3-N286.2-86Design QualityAssurance forNuclear Power Plants

vs'lTHOUT CHANGE

A National Standard of Canada

The Canadian Standards Association (CSA), underwhose auspices this National Standard has been pro-duced, was chartered in 1919 and accredited by theStandards Council of Canada to the National Standardssystem in 1973. It is a not-for-profit, nonstatutory,voluntary membership association engaged in stan-dards development and certification activities.CSA standards reflect a national consensus of produc-

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GeneralInstruction No. 1CAN3-N286.2-86July 1986

CSA Standard CAN3-N286.2-86, Design Quality Assurance for Nuclear Power Plants,consists of 34 pages, each dated July 1986.

This Standard, like all CSA Standards, is subject to periodical review, andamendments in the form of replacement pages may be issued from time to time; suchpages will be mailed automatically to those purchasers who complete and return theattached card.* Some Standards require frequent revision between editions, whereasothers require none at all. It is planned to issue new editions of the Standard,regardless of the amount of revision, at intervals not greater than 5 years. Except inunusual circumstances, replacement pages will not be issued during the last year ofthat edition.'This card will appear with General Instruction No. 1 only.

Although any replacement pages that have been issued will be sold with theStandard, it is for the purchaser to insert them where they apply. The responsibility forensuring that his or her copy is complete rests with the holder of the Standard, whoshould, for the sake of reference, retain those pages which have been replaced.Note: A General Instruction sheet will accompany replacement pages each time they are issuedand will list the latest date of each page of the Standard.

Cut along dotted line.

Name

Organization

Address

City

Prov./State

country CSA Standardpostai/ziP code CAN3-N286-2-86

Canadian Standards AssociationConsolidated Mailing List178 Rexdale BoulevardRexdale (Toronto), OntarioCanadaM9W1R3

National Standard of Canada CAN3-N286.2-86

Design Quality Assurance for Nuclear Power Plants

Prepared byCanadian Standards Association

Approved byStandards Council of Canada

ISSN 0317-5669Published in July 1986 by Canadian Standards Association, 178 Rexdale Boulevard,Rexdale (Toronto), Ontario, Canada M9W1R3.Copyright © Canadian Standards Association—1986All rights reserved. No part of this publication may be reproduced in any form, in anelectronic retrieval system or otherwise, without the prior permission of the publisher.

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Contents

Contents

Technical Committee on Overall Quality Assurance for Nuclear Power Plants 5

Working Group on Design Quality Assurance for Nuclear Power Plants 7

Preface 8

The N286 Series of Standards 9

1. Scope 13

2. Definitions 13

3. Management Functions 143.1 Responsibilities 143.2 Policy 753.3 Organization 753.4 Authority 163.5 Personnel Qualifications and Training 163.6 Design Quality Assurance Program and Manual 163.7 Program Review 773.8 Design Interfaces 77

4. Performance Functions 184.1 General 184.2 Work Planning 184.3 Work Order Review 184.4 Work Assignment 184.5 Design Input 794.6 Conceptual Studies 794.7 Design Process 794.8 Design Output 204.9 Design Documentation 204.10 Change Control 214.11 Feedback of Information 22

5. Design Verification 225.1 General Requirements 225.2 Responsibility for Design Verification 225.3 Design Verification Plans 235.4 Design Verification Methods 235.5 Design Corrections 24

6. Audits 246.1 General Requirements 246.2 Scope and Timing 246.3 External Audits 25

7. Corrective Action 25

8. Records 258.1 Design Product Records 25

[Design Quality Assurance for Nuclear Power PlantsJury 1986

Contents

8.2 Design Assurance Records 26

8.3 Record Maintenance 26

Figure 27

AppendicesA—Design Input List 28B—Design Procedures List 29C—Design Review List 30D—Qualification Testing Program 32

CAN3-N286.2-86July 1986

Technical Committee

Technical Committee on OverallQuality Assurance for NuclearPower Plants

R.B.V. Simmons

D.R. Anderson

J.S. Christians

A.W. Cockerill

I.N. Daly

R. Denom

J.J. Fowles

G.P. Gauthier

K.B. Hall

N. Hanssmann

J. Holliday

R. Jeppesen

T.H. Joore

G.G. Legg

J.S. Lovaglio

R.N. MacDonald

J.V. Mullan

Consultant, ChairmanToronto, Ontario

CANATOM Inc.,Toronto, Ontario

Ontario Hydro,Toronto

Deltatech Systems,Peterborough, Ontario

Ontario Hydro, AssociateToronto

Lavalin Inc., AssociateMontreal, Quebec

Department of Labour and Manpower,Fredericton, New Brunswick

Lavalin Inc./NBS,Montreal, Quebec

Unionville, OntarioConsumer Representative





Atomic Energy of Canada Limited,CANDU Operations,Mississauga, Ontario

AMCA International Limited,Kanata, Ontario

CECO Consultants Limited,Toronto, Ontario

Atomic Energy Control Board,Ottawa, Ontario

Design Quality Assurance for Nuclear Power PlantsJury 1986

Technical Committee

D.P. Nguyen

D.S. Nguyen

M.J. Nichols

J.R. Patrick

G.R. Quarrington

F.A. Sainz

P.L. Ward

L.G. Bortolin

Ministere de I'Habitation et de laProtection du consommateur,Montreal, Quebec

Versatile Vickers Inc.,Montreal, Quebec


The Foundation Company of CanadaLimited,Toronto, Ontario


The New Brunswick Electric PowerCommission,Fredericton

Canadian General Electric CompanyLimited,Guelph, Ontario

Canadian Standards Association,Rexdale, Ontario

Associate

StandardsAdministrator,Nonvoting

CAN3-N286.2-86July 1986

Working Group

Working Group on Design QualityAssurance for Nuclear PowerPlants

G.G. I.egg

H.W. Alting Mees

R.W. Barnes

R. Beauchamp

M. Morin

J.S.C. Tong

In addition, the followingmembers of the Working

H. Douglas

J. Mees


Canadian General Electric CompanyLimited,Peterborough, Ontario


Hydro Quebec,Montreal

CANATOM Limited,Montreal, Quebec

Atomic Energy Control Board,Pickering, Ontario

made valuable contributions to the developmGroup:

CANATOM Ltd.,Montreal


Chairman

Vice-Chairman

Design Quality Assurance for Nuclear Power PlantsJuly 1986

Preface

Preface

This new edition of CSA Standard N286.2, Design Quality Assurance for Nuclear PowerPlants, supersedes the preliminary edition published in May, 1979.

This Standard is one in the N286 series on quality assurance for nuclear powerplants. The purpose of this Standard is to provide a set of rules for assuring that designsof safety related equipment, systems, and structures will be of the required quality. It mayalso be applied, at the discretion of the Owner of the Plant or client, in whole or in part, toother equipment, systems, and structures. Users of this Standard are reminded that thedesign of nuclear facilities in Canada is subject to the provisions of the Atomic EnergyControl Act and Regulations. Thus, requirements additional to those specified in thisStandard may be imposed by the Atomic Energy Control Board.

This Standard was prepared by the Working Group on Design Quality Assurance forNuclear Power Plants and approved by the Technical Committee on Overall QualityAssurance for Nuclear Power Plants and the Steering Committee on Nuclear Standards andwas formally approved by these Committees. It has been approved as a National Standardof Canada by the Standards Council of Canada.July 1986

Note: Although the intended primary application of this Standard is stated in its Scope, it isimportant to note that it remains the responsibility of the user of the Standard to judge its suitabilityfor his or her particular purpose.

CSA Standards are subject to periodic review and suggestions for their improvement will bereferred to the appropriate committee. All enquiries regarding this Standard, including requests forinterpretation, should be addressed to Canadian Standards Association, Standards Division,178 Rexdale Boulevard, Rexdale (Toronto), Ontario M9W 1R3. Requests for interpretation should(a) define the problem, making reference to a specific Clause, and, where appropriate, include anillustrative sketch;(b) provide an explanation of circumstances surrounding the actual field condition; and(c) be phrased, where possible, to permit a specific "yes" or "no" answer.

Interpretations are published in "CSA Information Update". For subscription details and a freesample copy, write to CSA Marketing or telephone (416) 747-2292.

CAN3-N286.2-868 July 1986

The N286 Series of Standards


The preparation of the N286 series of Quality Assurance Standards was initiated by theCanadian Nuclear Association, in response to a recognition by the utilities, jurisdictions,and industries concerned with the design, construction, commissioning, operation, anddecommissioning of nuclear power plants in Canada, of a need for standards pertaining tothe assurance of quality throughout the life cycle of a nuclear plant.

The N286 Standards are administrative in nature and complement the CSA "N" series ofnuclear technical standards. Proper implementation of the requirements of the N286Standards requires compliance with these other nuclear technical standards, and shouldprovide assurance that both the safety and technical objectives for a nuclear power plantare met. The CSA N286 series comprises two tiers.

The first-tier Standard, CAN3-N286.0, contains the requirements for the overall qualityassurance program and applies to the complete life cycle of a nuclear power plant projectfrom conceptual design to decommissioning. It is addressed to the owner, andencompasses all the generic quality assurance principles that apply to major participants aswell.

The N286.0 Standard(a) defines the requirements of an overall quality assurance program applicable to theowner;(b) identifies and controls the interfaces between the different second-tier documents andbetween CAN3-N286.0 and other standards;(c) establishes the scope and applicability of second-tier standards;(d) establishes the authority for approval of quality programs developed to meet second-tier standards;(e) specifies the responsibilities of participating organizations.

The standards in the second-tier series develop in detail the requirements of the qualityassurance program as they apply to the specific needs of each of the constituent phases ofa power plant's life cycle.

Each second-tier Standard embodies the generic quality assurance principles set forth inthe first-tier Standard, CAN3-N286.0, as well as including specific program requirements,limits of responsibility, authority, and application of criteria.

The scopes of the second-tier standards are as follows:

N286.1, ProcurementThis Standard covers all procurement activities, including the evaluation and selection ofsuppliers and bids and the surveillance of suppliers' performance carried on during anyphase of the life cycle of a nuclear power plant. It applies to the procurement activities ofboth the owner and contractors or consultants acting on behalf of the owner or the primecontracting parties. Procurement is an activity that applies to any of the constituentphases, rather than a distinct phase in the cycle. When undertaken by the owner or a mainparticipant, it may precede or overlap the phases covered by the other second-tierstandards. In order to avoid possible gaps in the second-tier standards, procurement hasbeen taken as the subject of the first of the second-tier series of standards.

Design Quality Assurance for Nuclear Power PlantsJuly I986


N266.2, DesignThis Standard applies to all engineering design activities carried out by the owner and hisdesign consultants that lead to the production of engineering documents. Suchdocuments may include drawings, data sheets, and specifications; they may also includefabrication, testing, erection, construction, installation, or commissioning instructions foruse during any phase of the project. The Standard contains mandatory and optionalrequirements for conceptual, preliminary, and final design, and associated analytical anddevelopment work. These requirements cover management, document control, changecontrol, performance, verification, and audit procedures.

N286.3, Construction and InstallationThis Standard covers all activities carried out for and by the owner from the receipt ofcomponents or materials on the site to their incorporation in systems or structures asrequired by drawings or other formal engineering information. It also covers the provisionof required support activities and equipment and applies at all stages on the site as far asthe testing of components or systems before they are submitted for commissioning.

N286.4, CommissioningThis Standard applies to all activities carried out after completion of installation and relatedtesting to ensure that equipment and systems will perform effectively and within the intentof their design when they are declared in service. It covers the pertinent documentationand test equipment required for commissioning activities.

N286.5, OperationThis Standard covers all activities concerned with the operation and maintenance of theplant and applies throughout the life of the plant, component, or system from the declaredin-service date to final shutdown.

N286.6, DecommissioningThis Standard covers all activities from final shutdown to approved stabilized sitecondition.

In addition, the four standards in the CSA Z299 series:CAN3-Z299.1 Quality Assurance Program—Category 1CAN3-Z299.2 Quality Assurance Program—Category 2CAN3-Z299.3 Quality Assurance Program—Category 3CAN3-Z299.4 Quality Assurance Program—Category 4have been adopted for use by the owner or participants within their N286 qualityassurance programs.

These Standards apply to items whose design, production, fabrication, and assemblytake place on the premises of the supplier or his agent. They also cover handling,storage, and shipping, as required, as well as site construction where this is the contractualresponsibility of the supplier.

The Z299 Standards cover the manufacture of all components, equipmont, andfabricated items required for installation or incorporation in the nuclear power plant at anyphase. In addition to manufacturing, these Standards also cover a number of otheractivities, such as procurement, design, and fabrication, and may be used to supplementthe second-tier N286 Standards when appropriate.

The plant owner may directly undertake activities covered by the second-tierstandards. In this event, the owner must meet directly the requirements of the relevantsecond-tier Standard, in addition to those stated in the first-tier Standard, CAN3-N286.0.

The owner's overall program may be, in large measure, an integration of the individualconstituent phase programs. His responsibility for the effectiveness of the overallprogram, however, will require him to exercise effective control over the whole project andto assure coordination of the work between the constituent phases.

CAN3-N286.2-861 0 July 1986


It is important to highligl.' the fundamental concept of quality assurance functions asthey relate to the quality of items or services. Quality itself is achieved in the performanceactivities and the main emphasis must therefore be placed on adequate performance. Thisrequires that these activities be appropriately planned, controlled, and implemented,together with the necessary verification, audit, and review activities which ascertain theexistence of the required quality. It is the integrated combination of these activities whichprovides assurance of quality. In addition, the importance of complete and thoroughdocumentation to the achievement of a successful quality assurance program must also bestressed.

This philosophy of quality assurance has served as the basis for the preparation of theN286 Standards.

In all instances the Standards in this series are intended to apply within the framework ofDertinent regulatory and jurisdictional requirements established by the various federal andprovincial governments and governmental agencies. Thus, requirements for inspection,tests, documentation, etc, arising therefrom are not affected by the provisions of the N286Standards.

Design Quality Assurance for Nuclear Power PlantsJuly 1986 1 1

CAN3-N286.2-861 2 July 1986

Scope—Definitions

CAN3-N286.2-86Design Quality Assurance forNuclear Power Plants

1. Scope1.1This Standard contains the requirements for the quality assurance program applicable tothe design phase of a nuclear plant, and is applicable to the design of safety-relatedequipment, systems, and structures, as identified by the owner.

1.2This Standard is applicable to all aspects of design work, including conceptual studies,preliminary design, detailed design, and the production of design technical documentationfor licensing, procuring, fabricating, constructing, installing, testing, commissioning, andoperating activities.Note: The design quality assurance process model given in Figure 1 is provided to assist the readerin gaining an understanding of the design quality assurance process and of the interrelationship ofthe various activities.

1.3This Standard embodies the relevant quality assurance requirements of CSA StandardN286.0, and is the governing standard for design quality assurance activities.Note: Interpretations of this Standard by the Technical Committee will be in accordance with theintent expressed in CSA Standard CAN3-N286.0.

1.4This Standard applies to the selection but not to the design of components whose design isdefined by an industrial standard such that no additional design information is required fortheir production.

1.5This Standard recognizes that the extent of the application of the quality assurancerequirements to the particular system, structure, component, or activity can vary accordingto the degree of potential impact on the safety of the plant.

1.6This Standard does not apply to the design of structures and components when theappropriate design quality assurance program to be specified is CSA Standard Z299.1 orequivalent.Note: In certain instances the application of this Standard may be extended, limited or replaced byan equivalent standard. These instances are covered by Clauses 3.1.4 to 3.1.6.

2. Definitions2.1The following definitions apply in this Standard:

Audit means those activities which are carried out to confirm that applicable elements ofthe quality assurance program have been established in accordance with the requirementsof the quality assurance program, and are being effectively implemented in accordancewith specified requirements.

Design Quality Assurance for Nuclear Power PlantsJury I986 1 3

Definitions—Management Functions

Client means the organization under whose authority an order for goods or services isissued.

Corrective action means measures taken to determine the cause of deficiencies or non-conformances and to prevent their recurrence.

Design means technical activities that commence with the identification of conceptualinput and lead to and include the production of output documentation.

Design organization means any organization whose design activities are required tocomply with this Standard.

Design output means the documentation defining a structure, system, or component andits characteristics necessary for its fabrication, installation, and operation; anddocumentation required for licensing purposes.

Design quality assurance program means the management system defined by the manualand procedures covering the design quality assurance actions for the execution of acontract or project.

Designer means the person responsible for the design of a structure, system, orcomponent, or specified part thereof.

Documentation means any written or pictorial information describing, defining, specifying,reporting, or certifying activities, requirements, procedures, or results.

Owner means the party who has or will have title to the nuclear power plant.

Participant means an organization required by the owner to meet one or more of thestandards in the N286 series.

Procedure means a document that states the purpose and scope of an activity andspecifies how to perform it.

Quality assurance means a planned and systematic pattern of all actions necessary toprovide adequate confidence that items or services meet contract and jurisdictionalrequirements and will perform satisfactorily in service.

Regulatory authority means the Atomic Energy Control Board or its designatedrepresentatives.

Verification means the act of reviewing, inspecting, testing, checking, or otherwisedetermining and documenting whether items, processes, services, or documents conformto specu'ied requirements.

3. Management Functions3.1 Responsibilities

3.1.1The owner shall be responsible for identifying the participants required to meet therequirements of the Standard.

3.1.2The owner may delegate to participants part or all of the activities of planning,establishing, and implementing the overall design quality assurance program, but shallretain responsibility for its effectiveness.

3.1.3Each design organization shall establish and implement a design quality assuranceprogram for its design work that is effective and in accordance with this Standard.

CAN3-N286.2-861 4 July 1986

Management Functions

3.1.4When the documents for a previously finished and verified design are to be used, thedesign quality assurance program shall comply, as a minimum, with the applicablerequirements for Responsibilities, Work Order Review, Design Documentation, ChangeControl, Design Verification, and Design Product Records.

3.1.5When a design organization selects a specific component from a manufacturer's normalline of product, with or without design change of a minor nature, the design organizationmay, as applicable, specify to use its own design quality assurance program in lieu of themanufacturer's quality assurance program to provide assurance of design quality.

3.1.6When a new design or a modification, other than minor, to an existing design is undertakenby the manufacturer, the manufacturer shall implement a design quality assuranceprogram complying with CSA Standard CAN3-Z299.1 or equivalent, unless the clientspecifies CSA Standard CAN3-N286.2 to the manufacturer or specifies that the new designor modification is to be subject to his own design quality assurance program.

3.1.7The design organization shall be responsible to its client for establishing and implementingthe design quality assurance programs for the items and services it is supplying.

3.1.8The design organization shall ensure that the applicable portions of its design qualityassurance program are in effect before any activity covered by this Standard is undertaken.

3.1.9The design organization shall provide access to the client and the owner for the purpose ofauditing the design quality assurance program of the design organization.

3.2 Policy

3.2.1Senior management of each design organization shall issue a written policy which commitsits organization to implement and maintain the design quality assurance program andwhich establishes the authority of the program.

3.2.2

This policy statement shall be binding on all levels and functions of management.

3.3 Organization

3.3.1An organizational plan shall be documented showing(a) organizational structure;(b) functional responsibilities;(c) levels of authority;(d) internal interfaces.Where multiple organizational arrangements exist, the responsibility of each organizationshall be clearly established.

3.3.2The individual responsible for the implementation and effectiveness of the design qualityassurance program shall be identified.Note: This usually is the individual with corporate responsibility for design.



3.3.3Appropriate independence shall be established between persons executing performance,verification, and audit activities.

3.3.4The individual delegated the responsibility for monitoring and assessing the effectivenessof the quality assurance program shall report to a management level such that the requiredauthority and organizational freedom are provided, including sufficient independence fromcost and schedule considerations.

3.4 AuthorityAuthority shall be delegated to those individuals responsible for verification, audit, andprogram review to allow for an assessment of the effectiveness of the quality assuranceprogram.

They shall have the authority to(a) identify problems related to quality procedures or arising from deviations from theprogram;(b) initiate or recommend solutions to such problems;(c) confirm the implementation and effectiveness of the solutions.

3.5 Personnel Qualifications and Training

3.5.1The management of the design organization shall be responsible for establishing thequalifications required for personnel involved in the execution of the design qualityassurance program (eg, the design, verification, and audit functions) and for ensuring thatonly qualified personnel perform these activities.

3.5.2Personnel assigned authority and responsibility for design, verification, or audit activitiesshall have the appropriate training, qualifications, and competence to perform effectivelytheir assigned tasks.

3.5.3Training programs shall be established as necessary to ensure that proficiency ofpersonnel is achieved and maintained.

3.5.4Records shall be maintained of the relevant qualifications of the personnel executing thedesign quality assurance program.

3.6 Design Quality Assurance Program and Manual

3.6.1The design quality assurance program shall provide for the establishment andmaintenance of prescribed activities appropriate for the adequate execution and control ofthe required design, design support, and documentation.

3.6.2Each design organization shall describe and document its program in a quality assurancemanual in sufficient detail to demonstrate that the requirements of this Standard aremet. Relevant other manuals, procedures, directives, etc, formally issued by the designorganization are to be incorporated by reference in the quality assurance manual whereappropriate.

CAN3-N286.2-861 6 Ju|y 1986


3.6.3The manual shall contain the following as a minimum, either directiy or by reference:(a) a policy statement;(b) a statement on applicability;(c) a description of the organizational structure;(d) procedures for implementing the program; and(e) identification of the interrelationship and hierarchy of documents used in theprogram.

3.6.4The manual may take the form of a generic quality assurance manual governing the designactivities on an ongoing basis, supplemented where necessary by additional specificquality assurance manuals prepared for a particular project. Such supplementarymanuals where required shall receive the same approval and have the same authority asthe generic quality assurance manual and shall be considered as extensions to it.

3.6.5The design quality assurance program and revisions thereto shall be approved by thesenior management of the design organization.

3.6.6Revisions to the program shall be incorporated in the quality assurance manual and thereferenced documents.

3.6.7The manual(s) and referenced procedures shall be controlled, reviewed, and updated asnecessary with appropriate records being maintained.

3.6.8Each design organization shall submit its quality assurance manual for design andrevisions thereto to the client for acceptance.

3.7 Program Review

3.7.1Reviews of the design quality assurance program shall be conducted by or on behalf of themanagement of the design organization at intervals not exceeding one year to assess itsadequacy and effectiveness.

3.7.2Reviews shall include assessment of reports and recommendations arising fromperformance, verification, audit, corrective action, and feedback activities.

3.7.3The results of reviews shall be documented; corrective actions required and their executionshall also be documented.

3.7.4In addition, reviews of the program shall be conducted whenever the effectiveness of theprogram is in doubt.

3.8 Design Interfaces

3.8.1Design interfaces shall be identified between(a) departments within the design organization;


Management Functions—Performance Functions

(b) the design organization and(i) its client;(ii) other design organizations;(iii) other organizations.

3.8.2Controls pertaining to design interfacing shall be established and shall include theassignment of responsibilities and the issuance of documents to and from interfacingorganizations.

3.8.3Interfaces with organizations involved with other phases of a project shall be established asappropriate.

4. Performance Functions4.1 GeneralDesign activities associated with the performance functions shall be identified, plannedand controlled to:(a) ensure a systematic approach;(b) ensure that the design meets the technical and quality requirements and therequirements of the design input;(c) ensure design documentation is readily traceable for safety related systems,structures, and components; and(d) permit verification and audit to be carried out.

4.2 Work Planning

4.2.1Design activities shall be planned so as to define the systematic progression of activitiesand the measures to be employed to ensure the quality of the design and the outputdocumentation. Such plans shall be documented.

4.2.2Planning shall include a review of technical requirements, work order requirements,feedback information, and previous experience.

4.3 Work Order Review

4.3.1Methods shall be established to ensure that when a work order is received by the designorganization it is examined in detail for technical content and scope so that therequirements are clearly understood.

4.3.2Incomplete, ambiguous, or conflicting information shall be resolved and agreed to with theorganization(s) responsible for generating requirements.

4.3.3

The results of the examination shall be documented.

4.4 Work Assignment

4.4.1The design organization shall establish methods for arranging, as appropriate, the designactivities into discrete work assignments.

CAN3-N286.2-861 8 July 1986

Performance Functions

4.4.2The scope of each assignment and the individual(s) responsible shall be identified.

4.4.3The scope of the work assignment shall be defined so as to permit the design activity to beperformed correctly.

4.4.4Revisions to work assignments shall be documented to show(a) changes in scope of assignments; and(b) the reassignment of all or defined portions of the work to others.

4.5 Design Input

4.5.1Design inputs, such as functional requirements, results of conceptual studies,environmental conditions, regulatory requirements, applicable codes and standards, andrevisions to them, shall be identified, controlled, and documented.

4.5.2Design inputs shall be detailed to the degree necessary to provide a reference base formaking decisions and performing design verification, and evaluating design changes.

4.5.3The selection of specific design inputs and revisions thereto shall be subject to review andapproval. Revisions, including the reasons for the changes, shall be identified, controlled,and documented.Note: A non-mandatory list of typical design inputs is given in Appendix A.

4.6 Conceptual StudiesWhere a conceptual study is required, the results of the study shall be documented.Conceptual studies mean those design activities which are performed for evaluating thepracticality of a design approach or for selecting a design approach over alternatives, thefindings of which are used subsequently in the preparation of design requirements or asevidence in confirming adequacy of design.

4.7 Design Process

4.7.1Procedures shall be established and implemented for the activities undertaken in thedesign process to ensure that the design meets the requirements of the design input.

4.7.2Calculations, records, stress reports, and other formal documents produced as part of thedesign process and analytical work shall be prepared, approved, and filed in accordancewith procedures.

4.7.3The design shall be adequately documented to enable it to be related back to the designinput.

4.7.4The use, validation, and revision of computer programs employed in the design processshall be controlled in accordance with procedures.

Design Quality Assurance for Nuclear Power PlantsJury 1986 1 9


4.7.5When analytical work is performed, the inputs, assumptions, methods, computermodelling, coordination of test and development work, and the results shall bedocumented.

4.7.6Design information, including changes, shall be communicated from one organization toanother, and within an organization, by controlled documents that are uniquely identifiedand issued by authorized persons.

4 r.7Procedures shall be established to ensure that those deviations found during procurement,fabrication, construction, installation, commissioning, or operation which arecommunicated in writing to the design organization are recorded, reviewed, and theirevaluation communicated to the relevant organizations.Note: A non-mandatory list of typical design activities which may require consideration in thedesign process is given in Appendix B.

4.8 Design Output

4.8.1Procedures shall be established to manage the production and issuance of design outputdocuments for a project.

4.8.2These procedures shall cover the requirements for verification (Clause 5) and approval(Clause 4.9) of design output documents.

4.8.3Measures shall be established to ensure that the applicable jurisdictional requirements,codes, standards, classifications, and other criteria are identified in the design outputdocuments.

4.8.4Identifications assigned to systems, structures, and components to facilitate traceability insubsequent phases shall be included in the design output documents.

4.8.5Where required, the design output documents shall specify the quality assurancestandards to be applied to the system, structure, or component in subsequent phases. Insuch cases, the methodology for the selection of quality assurance programs shall bedocumented.

4.9 Design Documentation

4.9.1Procedures shall be established to control the preparation, approval, issuance, distribution,and revision of all formal design documents, including(a) those used as part of the design process and analytical work;(b) design input, design output, and substantiating documents; and(c) submissions in the licensing process.

4.9.2The procedures shall specify requirements for each type of document for(a) format and presentation;

CAN3-N286.2-8620 July 1986


(b) identification;(c) indication of status;(d) verification and approval;(e) revisions;(f) issuance and distribution; and(g) storage and retrieval of originals or masters.

4.9.3New or revised documents shall be issued to all areas in which they are required.

4.9.4Measures shall be established to ensure that obsolete documents are identified as such andpromptly removed from areas where their inadvertent use could affect quality.

4.9.5The procedures shall make provision for the control of documents prepared by others (eg,manufacturer's drawings, as-built drawings, and manufacturing specifications) that arepertinent to the design process.

4.9.6Complete and up to date listings of all design documents and their status shall bemaintained.

4.9.7Where copies of documents are submitted to regulatory authorities, clients, or participantsfor comment or formal approval, the returned documents shall be catalogued and filed inaccordance with established procedure(s).

4.9.8Where computer programs are used in major design or analytical work, the programdescription, the user's manual, the program listing, validation reports, changes to theprogram and the results are to be documented.

4.10 Change Control

4.10.1Procedures shall be established to identify and control changes to designs and designdocuments after they have been approved, including correcting identified deficiences.

4.10.2These changes shall be subject to review and approval similar to that applied to the originaldesign and included in the design output.

4.10.3The change and the reason(s) for it shall be documented. Where a significant designchange is required because the design is incorrect, the design and verification activitiesshall be reviewed and modified as necessary.

4.10.4Where concessions that permit deviation from the design are granted to fabricators,installers, construction forces, and commissioning or operational groups, approvalmethods, records, and filing systems are to be introduced which show the nature anddisposition of each such concession.


Performance Functions—Design Verification

4.10.5Where changes are required and the original design organization is no longer available toperform the work, a new organization competent in the specific design area of interestshall be appointed and shall be given access to all pertinent information necessary toobtain an adequate understanding of the requirements and the intent of the originaldesign.

4.11 Feedback of Information

4.11.1Measures shall be established for obtaining, where possible, information from previousdesigns and the procurement, fabrication, construction, installation, commissioning, andoperational phases; and for identifying and processing the information received.

4.11.2These measures shall provide for assessing the need for and relevance of feedbackinformation and for incorporating ensuing improvements in the design or quality assuranceprogram, or both.

5. Design Verification5.1 General Requirements

5.1.1The design organization shall establish and implement procedures to plan and carry outverification of each design and revisions to it.

5.1.2The nature and extent of verification shall depend on the following criteria: theimportance of the structures, systems and components; the complexity of the design; thedegree of standardization; the state of the art; and the similarity to previously provendesigns.

5.1.3When previously finished and verified designs are to be used, verification for the newapplication need only confirm that(a) the application of the design is correct; and(b) the analyses are still valid.

5.1.4Verification of design activities or design decisions shall be carried out by suitablyqualified persons (including the designer's supervisor) who did not execute those activitiesor make those design decisions.

5.1.5

Personnel performing verification shall be given the necessary authority and access.

5.2 Responsibility for Design Verification

5.2.1Line supervision shall be responsible for ensuring that the design is adequately verified,including confirmation that planned verification activities have been completed, beforeapproving design documents.

CAN3-N286.2-8622 July 1986

Design Verification

5.2.2The designer's supervisor shall be responsible in all cases to ensure that design work iscorrect, that it meets requirements, and that the required verification has been properlycompleted.

5.2.3Where verifiers are not readily available within the design organization, verification shall beperformed by competent personnel from(a) a qualified third party;(b) the client; or(c) the client's delegate.

5.3 Design Verification PlansPlans for verification shall identify the following:(a) the design activities to be verified;(b) the nature and extent of the verification;(c) the verifier, eg, review committee, qualified independent party, etc;(d) the verification method(s), the method of reporting and follow-up; and(e) the relative location of the verification activities in the design cycle.

5.4 Design Verification Methods

5.4.1Design verification methods include, but are not limited to: design review, alternativeanalysis, or qualification testing. When alternative analysis or qualification testingmethods are used, the ensuing documents shall be reviewed for adequacy, validity, andrelevancy in order to complete the verification process.

5.4.2The purpose of design reviews is to confirm that the design meets the design requirementsand that design documents are correct and satisfactory. These reviews may be done asgroup reviews or single person reviews.Note: A non-mandatory list for design review considerations is given in Appendix C.

5.4.3The purpose of alternative analyses is to check the validity of design calculations. Suchanalyses may employ simplified calculations and assumptions to yield approximateresults. Differences in results shall be reviewed and the acceptability of the originalcalculations shah be justified. The alternative analyses, assumptions and results shall bedocumented.

5.4.4The purpose of qualification testing a prototype or initial production unit is to verify thedesign or specific design features. In the case of the latter, the other features of thedesign shall be verified by other means. Reports of such qualification testing shall bereviewed for validity and for relevancy to design requirements. Organizations performingqualification testing shall have a qualification testing program that corresponds to theguidelines given in Appendix D.

5.4.5Computer software that itself is part of the design output shall be verified to a documentedplan that sets out(a) the test method to be used;(b) the equipment used for software verification;

Design Quality Assurance for Nuclear Power PlantsJuly 1986 23

Design Verification—Audits

(c) the input to be processed; and(d) the output acceptance criteria.

The development of such software shall be in accordance with a software qualityassurance program.

5.5 Design Corrections

5.5.1Deficiencies found in the design and the design documents during the verification processshall be identified and corrected.

5.5.2The cause of significant deficiencies shall be established and corrective measuresimplemented.

6. Audits6.1 General Requirements

6.1.1A system of planned and documented audits shall be carried out to confirm that activitiesaffecting quality comply with all aspects of the design quality assurance program, and thatthe program has been implemented effectively.

6.1.2Audits shall be carried out in accordance with written procedures and check lists byappropriately trained and qualified personnel who(a) are not directly responsible for the performance of the activities being audited; and(b) have not carried out the verification of the activities being audited.

6.1.3Auditors shall notify management of deficiencies revealed by the audit, and subsequentlyshall confirm the acceptability of the corrective action taken.

6.1.4Where independent auditors are not readily available within the design organization,auditing shall be performed by competent personnel from(a) a qualified third party;(b) the client; or(c) the client's delegate.

6.2 Scope and Timing

6.2.1Audits shall assess conformity to procedures and instructions, and the effectiveness oftheir implementation. The auditing process shall provide for an assessment of(a) the design procedures and instructions;(b) the design and verification processes; and(c) the design documents and records.

6.2.2Audits shall be carried out at regular intervals and with sufficient frequency to confirmconformance to the program. Scheduled audits shall be supplemented by additionalaudits when the effectiveness of the program is in doubt. Audit scope and timing shalltake into consideration the maturity of the quality assurance program and the executionstatus and duration of the design phase.

CAN3-N286.2-8624 July 1986

Audits—Corrective Action—Records

6.3 External AuditsWhen any portion of the design is delegated to an organization that is required to complywith CSA Standard CAN3-N286.2, audits shall be conducted by the delegating party onthat organization's quality assurance program.

7. Corrective Action7.1Measures shall be established for correcting conditions identified during program review(Clause 3.7), design verification (Clause 5.5.2), and audits (Clause 6) that are adverse toquality.

7.2These measures shall address(c) determining the cause of significant conditions adverse to quality;i ) defining the corrective action;< ) implementing corrective action;• ) confirming implementation and effectiveness of corrective action; and••) documenting the above activities.

T.3: arsons responsible for initiating, implementing, and confirming corrective actions shall be•. lentified.

8. Records6.1 Design Product Records

8.1.1Design product records shall include design documents that(a) specify design requirements and sources of design inputs;(D) contain technical information for fabrication, construction, installation,ommissioning, or operation;i substantiate the technical adequacy of the design; and•) are required for licensing purposes.

1.2?sign product records shall be established and maintained as required by the applicabledes, standards, and regulatory requirements.

1.3ie design organization shall supply to the owner, or to his client for submission to thevner, those design product records which are identified as permanent records.Permanent records are those which meet one or more of the following criteria:

(.i) those which would be of value in demonstrating capability for safe operation;(o) those which would be required to maintain, rework, repair, replace, or modify an item;• z) those which would be of value in determining the cause of an accident, malfunction,.;r unscheduled occurrence;•J) those required to provide baseline data for periodic inspection; andi) those which would be of value in decommissioning an item.


Records

8.2 Design Assurance Records

8.2.1Design assurance records shall be maintained in accordance with procedures that(a) rr anage and control design activities; and(b) provide evidence of the management and control of design activities.

8.2.2These design assurance records shall be retained until the assigned work is complete andits completion is accepted by the client. The client may specify that certain designassurance documents be supplied for his use.

8.3 Record MaintenanceMeasures shall be established to maintain, store and routinely inspect the condition of allessential records so as to ensure their preservation and protection from loss, deterioration,or destruction.

CAN3-N286.2-8626 July 1986

figure I

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55

Scope (1)Applicability

Responsibilities (3.1)Policy (3.2)

rQA Department-

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cCO

c

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Personnel (3.5)qualifications

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1 *Program (3.6)Manual (3.6)

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Informationfeedback (4.11)

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4-4-

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\

tProgramreview (3.7)

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Design (4.1-4.4)pre-requisites

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Notes:(1) Only major quality assurance relationships are shown.(2) Numbers in parenthesis reference clause in the Standard.(3) For clarity, records from all functions are not shown.

Figure 1Design Quality Assurance Process Model


Appendix A

Appendix ADesign Input List

Hots: This Appendix is not a mandatory part of this Standard.

A1.This list is intended as a guide only. Since the factors to be considered in establishing anddetermining the adequacy of the design input will vary with the assignment, this list may bedeficient in some respects or it may include irrelevant factors in others.(a) Basic requirements (independent of conceptual design):

(i) function of the plant, structure, system, and components;(ii) location and interfacing requirements;(iii) performance requirements, eg, capacity, rating, output;(iv) operational requirements under various conditions, eg, startup, normal operation,

emergency operation, shutdown, accident, standby;(v) environmental conditions, eg, loadings, dead, live; impact, wind, snow; thermal,

dynamic, vibration, seismic, and physical conditions; temperature, humidity, chemicals,radiation, erosion;

(vi) safety requirements, eg, personnel safety, physical damage, fire hazards, radiationhazards;

(vii) failure considerations, eg, safety: limiting consequences of failure; andoperation: limiting effect on plant functioning and adjacent equipment; standbyequipment; effects of adjacent failures;

(viii) standards, including mandatory and contractual codes, standards, and regulatoryrequirements; procedures and guidelines imposed by the design organization; applicableissue or addenda, or both;(b) derived requirements (dependent on conceptual design):

(i) design requirements for specific disciplines, eg:(1) Structural: loadings, pressures, stress, supports, bracing;(2) Mechanical: vibration, speed, lubrication, mechanisms;(3) Electrical: voltage, power, regulation, insulation;(4) Hydraulic and pneumatic: flow, pressure, fluids, velocities, suction head;(5) Chemical: fluid chemistry, corrosion;(6) Control and instrumentation: controls, alarms, ranges, stability, readability;(7) Metallurgical and material: protective coatings, welding, galling, wear, erosion,

creep;(ii) fabricating requirements, eg, size and weight, fabricating processes, quantity,

interchangeability, spares;(iii) installation requirements, eg, shipping, storage, installation, proof tests, run-in;(iv) in-service requirements, eg, reliability, redundancy, accessibility, serviceability,

inspection, adjustments, repairability;(v) engineering input data—validity of reference data, test reports, analyses, in-service

reports;(c) documentation—confirmation, updating or revision, or both, of approved inputs.

CAN3-N286.2-8628 July 1986

Appendix B

Appendix BDesign Procedures List

Note: This Appendix is not a mandatory part of this Standard.

B1.This list is intended as a guide only. Since the scope of design activities can varysignificantly, this list may be deficient in some respects or it may include irrelevant items inothers.

B2.Typical design activities covered by procedures are(a) responsibilities of the organizations participating in the design and interfacingarrangements;(b) assignment of work and responsibility within the design organization;(c) application of codes, standards, procedures, practices, and guides, whethermandatory, contractual, or adopted, that are to be used in the design process;(d) preparation: approval, issuance, and revision of the following design documents:

(i) submissions for licencing purposes;(ii) drawings;(iii) design descriptions or manuals;(iv) design analyses, calculations;(v) technical specifications;

(e) distribution of documents, both internally and externally;(f) maintenance, filing, and retention of documents;(g) submissions to the regulatory authorities for acceptance or approval;(h) procurement documents;(i) fabricating instructions;(j) installation instructions;(k) commissioning instructions;(I) operational instructions.

[Design Quality Assurance for Nuclear Power PlantsJuly 1986 29

Appendix C

Appendix CDesign Review List

Note: This Appendix is not a mandatory part of this Standard.

C1.This list is intended as a guide only. Since the scope of a design review can varysignificantly, this list may be deficient in some respects or it may include irrelevant items inothers.

C2.Aspects typically covered by design review procedures are(a) preliminaries:

(i) status of design at time of review: conceptual, preliminary, final;(ii) list of all available design documents;(iii) have the design inputs been reviewed?(iv) have the design process procedures been reviewed?

(b) compliance:(i) have the applicable codes, standards, and regulatory requirements, including issue

and addenda, been identified? Have their requirements been met? Where options areavailable and exercised, are reasons stated?

(ii) have the necessary regulatory approvals been obtained? Are there any queriesand comments outstanding?

(iii) have the contract requirements been complied with and met?(c) documents:

(i) have the following documents been approved and are their contents satisfactory?(1) drawings—flowsheets, their arrangement, detail, etc;(2) lists—material, equipment, instrument, valve, etc;(3) design description or manuals;(4) specifications—including inspection and testing;(5) installation instructions;(6) commissioning instructions;(7) operational instructions;(ii) have the reference data used in the design been reviewed, approved, and

documented? For example, test reports, computer programs, analyses, studies;(iii) does the information in the above documents agree with that in the documents

submitted to obtain the project licence?(iv) have the appropriate quality assurance requirements been specified?(v) have procedures for changes to documents been followed?

(d) design:(i) have the design inputs been incorporated in the design?(ii) have the assumptions necessary to perform the design activity been documented

and are they reasonable?(iii) were the design methods used appropriate?(iv) have the design interface requirements been met?(v) are the specified parts, equipment, and processes suitable for the required

application?(vi) are the specified materials compatible with the design conditions?(vii) has applicable fabricating, installing, and operating experience been considered?

CAN3-N286.2-8630 July 1986

Appendix C

(viii) have the consequences of failure been considered and adequately resolved?(ix) have reliability, maintenance, and accessibility requirements been met?(x) have the health and safety requirements for both the public and the operating staff

been met?(xi) does the design meet the input requirements in a practical, reasonable, and

adequate manner?


Appendix D

Appendix DQualification Testing Program

Note: This Appendix is not a mandatory part of this Standard but it is written in mandatorylanguage to accommodate its adoption.

D1. ScopeD1.1This document defines the quality assurance requirements for activities associated withqualification testing.

D1.2Qualification testing is defined as that testing which is performed to demonstrate that aproduct type meets specified requirements.

D1.3It does not include the testing performed to develop or improve the characteristics of aproduct nor that testing performed during or after production to ensure that the product isof the required quality.

D2. Management FunctionsD2.1 Responsibilities(a) the organization performing qualification testing shall comply with the requirementsof this Appendix; and(b) if the testing organization does not have persons assigned specifically to monitorcompliance with the program then such duties shall be performed by the organizationrequiring the testing to be performed, or its delegate.

D2.2 PolicySenior management of the testing organization shall issue a written policy that commits alllevels of its organization to implementing and maintaining the qualification testing programand establishes the authority of the program.

D2.3 QA Manual

D2.3.1The testing organization shall prepare, approve, issue and maintain a manual describing itsqualification testing program.

D2.3.2The manual shall define directly or by reference(a) the organization structure and the authority and responsibilities of the individuals whoare involved with qualification testing activities;(b) testing procedures and practices;(c) documentation procedures; and(d) auditing procedures and practices.

CAN3-N286.2-8632 July 1986

Appendix D

D2.4 Program ReviewReviews of the qualification testing program shall be conducted periodically bymanagement to assess its conformance with this document or whenever the effectivenessof the program is in doubt.

D2.5 PersonnelPersonnel assigned authority and responsibility for testing activities shall have the training,qualifications and competence necessary to perform effectively their assigned tasks.

D3. Performance FunctionsD3.1 Test Objective and Requirements ReviewWhen an order is received by the testing organization it shall be reviewed in detail so thatthe test objective and test requirements are clearly understood.

D3.2 Test ProgramA document shall be produced that gives directly or by reference(a) a list of tests to be performed;(b) the objectives of the tests;(c) the test conditions;(d) the acceptance criteria;(e) the reports required;(f) other essential information.

D3.3 Test InstructionsWritten test instructions shall be issued to augment the information given in the testprogram. These instructions shall define(a) test facilities to be used;(b) test pieces;(c) test preparation;(d) testing;(e) data to be recorded;(f) test reports; and(g) witnessing of testing activities.

D3.4 Test Procedures

D3.4.1Test procedures shall be issued for those testing activities which are of a repetitive nature.

D3.4.2

All testing activities shall be controlled by test procedure or test instructions.

D3.5 Test Facilities

D3.5.1All measuring and testing equipment shall be controlled and maintained.

D3.5.2Information on each article of measuring or testing equipment shall be readily available thatshall(a) define the equipment (eg, type, model number, serial number);(b) define its use;(c) define its capabilities;(d) contain operation and maintenance instructions; and(e) give calibration status.


Appendix D

D3.5.3At prescribed intervals or prior to use, all measuring and testing equipment shall becalibrated and adjusted against certified equipment having a known valid relationship torecognized standards.

D3.6 Test PiecesProcedures shall be implemented to ensure(a) identification and traceability of each test piece;(b) that each test piece is inspected and accepted prior to testing; and(c) that alterations and repairs to test pieces are controlled and documented.

D3.7 Test PreparationPrior to each test, checks shall be performed on the preparation for the test to ensurecompliance with requirements, procedures and instructions.

D3.8 Test ProcessTesting shall be performed and witnessed in accordance with the test program and testinstructions.

D3.9 Test DataData to be recorded prior to, during, and following each test shall be defined in the testprocedures or test instructions.

D3.10 Test ReportsReports of the tests performed shall be prepared and approved. Reports shall containpertinent information on the test pieces, the tests performed, the data collected, andconclusions drawn from the results obtained.

D4. DocumentationD4.1All documents relating to testing activities shall be controlled in accordance with writtenprocedures.

D4.2Such procedures shall cover the preparation, approval, issuance, and revision ofdocuments.

D4.3Revisions to documents shall receive the same authorization as that required for theoriginal document.

D5. AuditsD5.1Audits shall be held to confirm that testing is being performed in accordance with therequirements of the qualification testing program.

D5.2These audits shall be conducted annually by the testing organization or by the organizationrequiring the testing.

CAN3-N286.2-8634 July I986

Proposal for Change

To help our volunteer members to assess proposals to change requirements we recommend that eachproposal for change be submitted in writing and identify the(a) Standard number;(b) Clause number;(c) proposed wording of the Clause (requirement, test, or pass/fail criterion) using mandatory languageand underlining those words changed from the existing Clause (if applicable); and(d) rationale for the change, including all supporting data necessary to be considered.

The proposal should be submitted to the Standards Administrator at least one month prior to the nextmeeting of the Committee. It is CSA Committee practice that only those proposals sent out to membersprior to a meeting can be the subject of discussion and action. This is to allow the members time toconsider the proposal and to do any research they may feel necessary.

Date: - -YY MM DD

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Affiliation:

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Phone: Fax:,

Re: Request for an Amendment, Deletion, or Addition to Clause(s).

Proposed change:

(Use reverse and additional pages as required.)

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