quality assurance standards: comparison between iaea 50-c

ll t.

XAO100029

IAEA-TECDOC-1182

Quality assurance standards:comparison between IAEA 50-C/SG-Q

and ISO 9001:1994

INTERNATIONAL ATOMIC ENERGY AGENCY

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November 2000

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QUALITY ASSURANCE STANDARDS:COMPARISON BETWEEN IAEA 50-C/SG-Q AND ISO 9001:1994

IAEA, VIENNA, 2000IAEA-TECDOC-1182

ISSN 1011^289

© IAEA, 2000Printed by the IAEA in Austria

November 2000

FOREWORD

The International Atomic Energy Agency (IAEA) and the International Organization forStandardization (ISO) agreement regarding the scope and coverage of documents publishedby both organizations points out that the standards of safety developed by the IAEA arerecommendations for use by its Member States in the framework of national regulations forthe safe utilization of nuclear energy. Such standards should be considered as nuclear safetyregulatory documents. The standards developed by the ISO are complementary technicaldocuments emphasizing industrial application and contractual aspects. Regarding the qualityassurance topic, the IAEA standards 50-C/SG-Q are mostly used directly or indirectly toestablish the nuclear safety requirements at the utility-regulatory interface. The industrial ISO9001 standards have progressively been used to implement the quality assurance requirementsat the interface utility-supplier.

The relationship between both standards is growing in significance owing to the impact uponthe owners/operators of nuclear facilities and their contractors/suppliers. The relationshipbetween the IAEA and ISO standards is considered critical, in particular regarding supplierswith a small range of nuclear supplies. These organizations are not always willing to preparespecial quality assurance programmes based on nuclear safety standards. On the other hand,these organizations may be qualified on the basis of the ISO quality assurance standards. Inany case, for delivering nuclear items and services the quality assurance programme mustcomply with the requirements established in the nuclear safety regulatory standards. Thisimplies that the utility-supplier will have to demonstrate that the acceptable degree of qualityassurance in relation to nuclear safety is accomplished. This may be achieved by imposingadditional requirements on the supplier over and above those contained within the ISO.

In order to provide a description of the differences between the IAEA and ISO standardswhen applied in nuclear installations, and to support the practical way of fulfilling nuclearsafety, the IAEA established a project for producing a guidance report. Valuable contributionsfrom the European Atomic Forum (FORATOM) were committed and contractualarrangements made, with the target of finalizing the report in the shortest feasible timeframecommensurable with available resources.

The issue as to which ISO 9001 standard should be used for the comparison, i.e. the currentversion 1994 or future version 2000, was discussed quite extensively by the members of theinitial consultants meeting held in Vienna in January 1999. The consultants recommendedproceeding with the use of ISO 9001 version 1994 on the grounds that some time would stillbe needed before the next version 2000 is adopted and effectively implemented. In themeantime guidance based upon the ISO 9001 version 1994 was considered to be applicableand the efforts expended in the preparation of the guidance report worthwhile. The report willsubsequently be updated to include the new ISO 9001 version 2000 standard.

In thanking the contributors to this report, the IAEA wishes to acknowledge the efforts andassistance provided by FORATOM and by the participants at the preparatory and reviewmeetings, who are listed at the end of the report. Special acknowledgement is due to K.-P.Kleinert (Germany), E. Glauser (Switzerland), M. Hille (Germany) and N. Redman (UnitedKingdom) for their contributions. The IAEA officer responsible for this work was N. Pieroniof the Division of Nuclear Power.

EDITORIAL NOTE

The use of particular designations of countries or territories does not imply any judgement by thepublisher, the IAEA, as to the legal status of such countries or territories, of their authorities andinstitutions or of the delimitation of their boundaries.

The mention of names of specific companies or products (whether or not indicated as registered) doesnot imply any intention to infringe proprietary rights, nor should it be construed as an endorsement orrecommendation on the part of the IAEA.

CONTENTS

1. INTRODUCTION 1

1.1. Background 11.2. Objective 11.3. Scope 1

2. STANDARDS USED IN THE COMPARISON 1

2.1. IAEA Code and Safety Guides on Quality Assurance 50-C/SG-Q 12.2. Quality System Standard ISO 9001:1994 3

3. MAJOR DIFFERENCES AND LINKAGES 4

3.1. IAEA Code 50-C-Q basic requirements and IAEA Safety Guides50-SG-Q1 to Q14 4

3.2. IAEA Code 50-C-Q basic requirements and clauses of ISO 9001:1994 43.2.1.Underlying approaches 43.2.2. Identification of the customer 43.2.3. Additional requirements 5

3.3. Linkages between the IAEA Safety Guides 50-SG-Q1 to Q14 andclauses of ISO 9001:1994 7

4. GUIDANCE WHEN USING ISO 9001:1994 8

4.1. Additional requirements of the IAEA Code 50-C-Q 84.2. Additional guidance of the IAEA Safety Guides 11

APPENDIX: CORRELATION MATRICES 21

Matrix 1: IAEA Code 50-C-Q basic requirements coverage in the IAEASafety Guides 50-SG-Q1 to Q14 21

Matrix 2: Correlation between the clauses of ISO 9001:1994 and the IAEA Code50-C-Q basic requirements 22

Matrix 3: Correlation between the clauses of ISO 9001:1994 and the IAEA SafetyGuides 50-SG-Q1 to Q14 23

REFERENCES 24

CONTRIBUTORS TO DRAFTING AND REVIEW 25

IAEA PUBLICATIONS ON QUALITY ASSURANCE/QUALITY MANAGEMENT 27

1. INTRODUCTION

1.1. Background

The International Atomic Energy Agency (IAEA) Code and Safety Guides contained in theSafety Series No. 50-C/SG-Q [1] define basic quality assurance requirements, which must beconsidered to ensure safety, and provides recommendations on how to fulfil these basicrequirements. The IAEA 50-C/SG-Q standard reflects the performance based approach toquality assurance covering all aspects of plant safety, economics and efficiency. The IAEArequirements and recommendations are generally used at the nuclear utility-regulatorinterface.

The International Organization for Standardization (ISO) International Standard ISO9001:1994 [2] specifies quality system requirements for use where any supplier's capability todesign and supply a conforming product needs to be demonstrated. The requirementsspecified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through to servicing. The ISO 9001:1994 standard issometimes used at the nuclear utility-supplier interface.

1.2. Objective

The objective of this report is to compare the requirements of IAEA 50-C/SG-Q (1996) [1]with ISO 9001:1994 [2] in order to identify the main differences and additional requirementscontained within [1]. The report also provides information and guidance, which may beconsidered when ISO 9001:1994 is utilized by the nuclear industry.

1.3. Scope ' —""""

The comparison is made with the following publications:

IAEA Safety Series No. 50-C/SG-Q (1996), Quality Assurance for Safety in Nuclear PowerPlants and other Nuclear Installations, Code and Safety Guides Q1-Q14 [1].

ISO 9001:1994, Quality Systems — Model for Quality Assurance in Design, Development,Production, Installation and Servicing [2].

ISO 9002:1994, Quality Systems — Model for Quality Assurance in Production, Installationand Servicing [3].

ISO 9003:1994, Quality Systems — Model for Quality Assurance in Final Inspection andTest [4].

Throughout this report, the comparison discussed is the comparison against ISO 9001:1994only, as it contains all the requirements contained in ISO 9002:1994 and ISO 9003:1994.

Suppliers, utilities, regulatory bodies, as well as research and development organizationscould use this report when considering using ISO 9001:1994 to procure items and services foruse in the nuclear industry.

2. STANDARDS USED IN THE COMPARISON

2.1. IAEA Code and Safety Guides on Quality Assurance 50-C/SG-Q

The IAEA Safety Series includes one Code 50-C-Q on quality assurance and 14 related SafetyGuides 50-SG-Q1 to Q14 [1].

The quality assurance Code 50-C-Q establishes the basic requirements that must be met toensure adequate safety of nuclear power plants and other nuclear installations.

The Code consists of 10 basic requirements (BR) to be adopted by the responsibleorganization as the foundation for establishing and implementing a comprehensive qualityassurance programme related to the safety of nuclear power plants. The basic requirementsare presented in three functional categories:

I. Management

BR 1: Quality Assurance ProgrammeBR 2: Training and Qualification

BR 3: Non-Conformance Control and Corrective Actions

BR 4: Document Control and Records

II. Performance

BR5:WorkBR 6: Design

BR 7: ProcurementBR 8: Inspection and Testing for Acceptance

III. Assessment

BR 9: Management Self-Assessment

BR 10: Independent Assessment

The Code includes an annex, which provides guidance to aid the understanding andimplementation of the basic requirements. The content of this annex is included in thiscomparison.

The Safety Guides describe acceptable methods of implementing particular parts of the Code.

The Safety Guides 50-SG-Q1 to Q14 are one of two types:

• Basic requirement related Safety Guides

These Safety Guides provide recommendations and guidance on how to fulfil the basicrequirements of the Code that are relevant in all of the life-cycle stages of nuclear powerplants and other nuclear installations.

The BR related guides are:

Safety Guide Ql: Establishing and Implementing a Quality Assurance ProgrammeSafety Guide Q2: Non-conformance Control and Corrective ActionsSafety Guide Q3: Document Control and RecordsSafety Guide Q4: Inspection and Testing for AcceptanceSafety Guide Q5: Assessment of the Implementation of the Quality Assurance ProgrammeSafety Guide Q6: Quality Assurance in Procurement of Items and ServicesSafety Guide Q7: Quality Assurance in Manufacturing

• Stage related Safety Guides

These Safety Guides provide specific recommendations and guidance on how to implementthe Code during the different life-cycle stages of nuclear power plants and other nuclearinstallations.

The Stage related guides are:

Safety Guide Q8: Quality Assurance in Research and DevelopmentSafety Guide Q9: Quality Assurance in SitingSafety Guide Q10: Quality Assurance in Design (this specific guide may also be used as a

BR related Guide when the design activities are carried out in any stage).Safety Guide Ql 1: Quality Assurance in ConstructionSafety Guide Q12: Quality Assurance in CommissioningSafety Guide Q13: Quality Assurance in OperationSafety Guide Q14: Quality Assurance in Decommissioning

2.2. Quality System Standard ISO 9001:1994

The ISO 9001:1994 standard defines the requirements for a quality management system inclauses 4.1 to 4.20. The clauses are sequentially numbered to reflect the sequence of eventsand activities supporting production, from developing the quality policy to the after sales

service.

The clauses

4.14.24.34.44.54.64.74.84.94.104.114.124.134.144.154.164.174.184.194.20

of ISO 9001:1994 are:

Management ResponsibilityQuality SystemContract ReviewDesign ControlDocument and Data ControlPurchasingControl of Customer-Supplied ProductProduct Identification and TraceabilityProcess ControlInspection and TestingControl of Inspection, Measuring and Test EquipmentInspection and Test StatusControl of Nonconforming ProductCorrective and Preventive ActionHandling, Storage, Packaging, Preservation and DeliveryControl of Quality RecordsInternal Quality AuditsTrainingServicingStatistical Techniques

These 20 clauses have a relationship with and are comparable to the 10 basic requirements ofthe IAEA Code 50-C-Q. The ISO 9001:1994 standard, however, does not give any guidanceor recommendations on how the defined requirements can be implemented.

3. MAJOR DIFFERENCES AND LINKAGES

3.1. IAEA Code 50-C-Q basic requirements and IAEA Safety Guides 50-SG-Q1 to Q14

While the IAEA Code 50-C-Q specifies the ten basic requirements for quality assurance innuclear power plants and other nuclear installations, the Safety Guides providerecommendations relative to the fulfilment of these basic requirements for different topics andlife-cycle stages. An overview showing how each Safety Guide addresses the basicrequirements is given in the Appendix: Matrix 1.

3.2. IAEA Code 50-C-Q basic requirements and clauses of ISO 9001:1994

The linkages between the ten basic requirements of the IAEA Code 50-C-Q and the 20clauses of ISO 9001:1994 are provided in the Appendix: Matrix 2. In general the basicrequirements of the IAEA Code 50-C-Q are addressed by one or more clauses of ISO9001:1994. However the IAEA Safety Guides provide more detailed and comprehensiveguidance and recommendations on how to implement the basic requirements of the IAEACode.

Each basic requirement of the IAEA Code 50-C-Q addresses one or more of the clauses ofISO 9001:1994. However there are some significant differences in the approaches,identification of the customer and additional requirements.

3.2.1. Underlying approaches

The IAEA Code 50-C-Q provides the basic requirements to be adopted for establishing andimplementing quality assurance programmes related to the safety of nuclear power plants andother nuclear installations. These basic requirements apply to the overall quality assuranceprogramme of the responsible organization, i.e. the organization having overall responsibilityfor the nuclear power plant, as well as to any other separate quality assurance programmes ineach stage of the life of a nuclear power plant.

The objective of the IAEA Code is to establish basic requirements for quality assurance inorder to enhance nuclear safety by continuously improving the methods employed to achievequality. The Code recognizes that all work is a process that can be planned, performed,assessed and improved.

The quality assurance model set out in ISO 9001:1994 provides the framework for the qualityassurance programme of a supplier, which enables the supplier to demonstrate the capabilityto produce a quality product and provides a vehicle for assessment by external parties. Therequirements specified are aimed primarily at achieving customer satisfaction by preventingnon-conformity at all stages from design to servicing. They are generic and independent ofany specific industry sector.

The comparison suggests that the IAEA Code 50-C-Q is a top-down approach focused onmeeting the overall safety requirements for the plant, personnel and the society in generalwhilst ISO 9001:1994 is a bottom-up approach focusing on satisfying the specificrequirements of the immediate customer.

3.2.2. Identification of the customer

The nuclear utility in meeting national regulatory requirements satisfies the safetyrequirements of its customer: society at large. The regulator, representing the customer in this

case, utilizes the IAEA Code 50-C-Q to define the requirements for the quality assuranceprogramme of its supplier; the nuclear utility. The nuclear utility also fulfils the role of thecustomer utilizing, where appropriate, ISO 9001:1994 plus any additional requirements todefine the quality assurance programme of its suppliers of items and services. The suppliersatisfies the nuclear utility (the customer) by supplying a quality product. (See Figure 1)

Regulator(Customer)

Supplier(Items or Services)

IAEA Code 50-C-Q ISO 9001:1994+ additional requirements

Nuclear utility(Supplier / Customer)

Requirement path

. Satisfaction path

Fig. 1: Application of IAEA Code 50-C-Q and ISO 9001:1994.

3.2.3. Additional requirements

3.2.3.1. Management self-assessment

The IAEA Code 50-C-Q defines specific requirements for "Management self-assessment", anactivity not required by ISO 9001:1994.

"Management at all levels shall regularly assess the processes for which it isresponsible. Management shall determine its effectiveness in establishing, promotingand achieving nuclear safety objectives. Management process weaknesses and barriersthat hinder the achievement of the nuclear safety objectives shall be identified andcorrected." (Section 401)

This statement in the Code is further clarified in the Annex:

"The thrust of management self-assessment is to identify, correct and preventmanagement problems that hinder the achievement of the organization's objectives. ThisCode establishes the requirement for a routine and continuing assessment of themanagement system by the organization's managers.

This self-assessment methodology is in addition to the traditional audit/appraisal thatdetermines the adequacy and extent of the QA programme development, documentationand implementation in accordance with specified requirements. This basic requirementimproves on the standard stipulation in many QA programmes, which requires thatmanagement regularly assess the adequacy of the portion of the programme for which itis responsible and ensure its effective implementation. This standard requirement istypically achieved, on an annual basis, by an independent consultant or group ofconsultants on behalf of management, and it addresses compliance issues rather thanbroad categories of management issues. Management self-assessment goes beyondsuch matters as conformance to regulations, item standards or established procedures.

An effective management self-assessment evaluates issues such as:

— mission of the organization— whether employees understand the mission— what is expected of the organization— whether the expectations are being met— opportunities for improving quality and enhancement safety— how to make better use of human resources.

The results of the management self-assessment are documented. Decisions and relatedactions resulting from the recommendations are promptly followed up to evaluate theireffectiveness.

The assessment process involves all levels of management, but senior managementretains the overall responsibility for management self-assessments. It is essential thatsenior management directly participate in this process. "

3.2.3.2. Grading

The IAEA QA Code 50-C-Q recommends a graded approach for the application of qualityassurance during the various stages of a nuclear power plant life cycle.

All items, services and processes have various controls built in to ensure they performcorrectly. The grading process is a means of determining what types and extent of controlsare applied to specific items, services and processes.

Applying controls costs money, therefore they should be applied and focused where necessaryand not applied or applied to a lesser degree for less important activities. Errors in moresignificant activities can potentially cost huge amounts of money, could shut down a plant orproduction line and could cause a threat to the staff and the environment. Additional controlsthat may reduce or eliminate such errors are therefore a good investment.

"Nuclear safety shall be the fundamental consideration in the identification of the items,services and processes to which the quality assurance programme applies. A gradedapproach based on the relative importance to nuclear safety of each item, service or

process shall be used. The graded approach shall reflect a planned and recognizeddifference in the applications of specific quality assurance requirements.

In general, the highest grade should require the most stringent application of thequality assurance requirements; the lowest grade the least stringent.

The following are examples of topic areas where grading should be applied:

— Type and content of training— Amount of detail and degree of review and approval of instructions— Need for and detail of inspection plans,— Degree of in-process reviews and controls,— Requirements for material traceability— Type of assessment,— Records to be generated and retained. (Section 210).

When items, processes or services are modified, the assigned grade of quality assurancerequirements could become more stringent or less stringent depending on whether achange in nuclear safety significance has occurred." (Section 211)

Safety Guide 50-SG-Q1 explains what the "graded approach" in relation to nuclear safetymeans:

"Whilst the quality assurance principles remain the same, the extent to which thequality assurance requirements are to be applied shall be consistent with theimportance to nuclear safety of the item, service or process. A graded approach whichcan satisfy the necessary requirements and ensure the required quality and safety shallbe used. " (Section 209)

ISO 9001:1994 does not specify or define a graded approach for applying the controlsspecified in the quality system.

3.2.3.3. Independence of inspection and testing personnel

The IAEA Code 50-C-Q requires that inspection and testing of specified items, services andprocesses shall be conducted using established acceptance and performance criteria. The levelof inspection and testing and the degree of independence of personnel shall be established.

ISO 9001:1994 does not specifically cover the independence of inspection and testingpersonnel.

3.3. Linkages between the IAEA Safety Guides 50-SG-Q1 to Q14 and clauses of ISO9001:1994

The linkages between the content of the IAEA Safety Guides and the ISO clauses arepresented in the Appendix: Matrix 3.

Matrix 3 supports the following observations:

• The IAEA Safety Guides do not directly consider the customer-related requirements ofISO 9001 defined in Clauses 4.3 Contract Review, 4.7 Control of Customer-SuppliedProduct and 4.19 Servicing.

• Similar requirements defined under the clauses 'management responsibility' and 'qualitysystem' in ISO 9001 can be found in all of the Safety Guides.

• Stage related Safety Guides in general address the majority of subjects in the ISO clauses.

4. GUIDANCE WHEN USING ISO 9001:1994

A detailed comparison of the IAEA Code 50-C-Q and BR related Safety Guides with ISO9001:1994 to identify all additional requirements and guidance was carried out. In thiscomparison the annexes of the IAEA publications 50-C/SG-Q have not been considered asthey contain examples illustrative of how the guidance could be implemented. The stagerelated Safety Guides, with exception of the Safety Guide "Quality Assurance in Design" (50-SG-Q10), were not included in this comparison as they provide specific recommendations forthe content of the quality systems at each of the life-cycle stages. The Safety Guide 50-SG-Q10 was included as it provides guidance that may be relevant to the design activity of allstages.

The detailed results of the comparison are included in Sections 4.1 and 4.2. These sectionsidentify additional requirements or guidance found in the IAEA publications 50-C/SG-Q thatare not found in ISO 9001:1994. Where the additional requirement or guidance is not self-explanatory some additional notes on application to suppliers are provided.

The application of additional requirements or guidance from the IAEA Code and SafetyGuides 50-C/SG-Q should be considered by the nuclear utility from two points of view:

— Should the nuclear power plant/utility address this difference within its own qualityassurance programme?

— Should the nuclear power plant/utility require its suppliers to address the difference asan additional requirement in the procurement documents?

The consideration should also take into account the regulatory requirements of each MemberState.

4.1. Additional requirements of the IAEA Code 50-C-Q

The following table identifies additional or more detailed requirements in the IAEA Code 50-C-Q that are not contained within ISO 9001:1994.

Section

101 to 108

104

201 to 205

204

Additional Requirement

Introduction

The responsible organization has to demonstratethe effective fulfilment of the quality assurancerequirements to the satisfaction of the regulatorybody...

BR 1: Quality Assurance Programme

Nuclear safety shall be the fundamentalconsideration in the identification of the items,services and processes to which the qualityassurance programme applies. A gradedapproach based on the relative importance tonuclear safety of each item, service or processshall be used. The graded approach shall reflecta planned and recognized difference in theapplications of specific quality assurancerequirements.

Notes to aid application

The utility should demonstrate that its qualityprogramme takes account of and incorporatesany requirements from the regulatory body.

The utility should require its suppliers to applyany of these specific requirements wherenecessary.

The graded approach for activities and items,including procurement, should be describedwithin the utility quality programme. Theapplication of grading to supplier activitiesshould be clarified. The utility should considerwhether its supplier should adoptcomplimentary grading and provide guidance.

Section

206

206

206 to 208

304 to 305

305

Annex

306 to 308

308

309 to 310

309

401


BR 2: Training and Qualification

Personnel shall be trained and qualified so thatthey are competent to perform their assignedwork and understand the safety consequences oftheir activities.

BR 3: Non-Conformance Control andCorrective Actions

BR 6: Design

The adequacy of design, including design toolsand design inputs and outputs shall be verifiedor validated by individuals or groups other thanthose who originally performed the work.Verification, validation and approval shall becompleted before implementation of the design.

.. .Design inputs include all requirements for thedesign, such as the technical bases for thedesign (design basis), performancerequirements, reliability requirements, andsafety and security requirements. ...

... Computer programs used in design arevalidated through testing or simulation prior touse if not proven through previous use.

BR 7: Procurement

Requirements for reporting deviations fromprocurement requirements shall be specified inthe procurement documents.

BR 8: Inspection and Testing for Acceptance

Inspection and testing of specified items,services and processes shall be conducted usingestablished acceptance and performance criteria.The level of inspection and testing and thedegree of independence of personnel shall beestablished.

BR 9: Management Self-Assessment


The utility should identify personnel involvedwith safety matters and provide the relatedtraining and qualification programme. Theutility should notify its suppliers when theirpersonnel are involved with safety matters andensure they are trained appropriately.

Non-conformance (as per IAEA Code 50-C-Q)covers non-conforming product, system andprocess non-conformity as per the ISO standard.

The utility quality programme addressing designshould specify that persons in charge of safetyrelated design verification and validation shouldbe different from those performing the work.The utility should notify the relevantrequirements to suppliers when they performsafety related design activities. Any designverification and approval should be performedbefore implementation of design. Generallydesign validation is performed throughcommissioning under defined operatingconditions and specific dispositions should beapplied for accidental conditions.

Suppliers in IAEA terms are equivalent tosubcontractors.

The option contained within ISO 9001:1994 forreporting deviations (non-conforming product)should be identified as being necessary.

It is recommended that utilities request suppliersto include this requirement in their qualityprogramme, when appropriate.

Management Self-Assessment is more complexand detailed than the ISO Management-Review.Management Self-Assessment focuses on theachievement of the nuclear safety objectives.Although ISO 9001:1994 covers themanagement review and internal audit processesit does not cover management self-assessment.(It is therefore recommended that suppliersproviding items and services to ISO Standardalso include management self-assessment intheir quality assurance programme.)

Section

401

402 to 405


Management at all levels shall regularly assessthe processes for which it is responsible.Management shall determine its effectiveness inestablishing, promoting and achieving nuclearsafety objectives. Management processweaknesses and barriers that hinder theachievement of the nuclear safety objectivesshall be identified and corrected.

BR 10: Independent Assessment


The management review should include theassessment of nuclear safety related processes.Nuclear safety objectives should be part of thequality objectives, with associated performanceindicators. Weaknesses and barriers should behandled through corrective and preventiveaction. Management assessment should becarried out at all levels.

Independent Assessment includes qualitysystems internal audits, peer evaluation,technical review, design review, inspection.Utilities should consider expanding the type ofassessments that their suppliers perform.

10

4.2. Additional guidance of the IAEA Safety Guides

The following tables identify guidance and recommendations that are not contained withinISO 9001:1994.

Safety Guide Ql: Establishing and Implementing a Quality Assurance (QA) Programme

Section

101 to 108

107

201 to 211

203

209

211

301 to 319

307

308

Additional guidance/recommendations

Introduction

This Safety Guide applies to the establishmentand implementation of a QA programme by theresponsible organization as well as to theestablishment and implementation of otherseparate programmes at all stages of a nuclearpower plant project. It covers items, servicesand processes important to nuclear safety.

Establishing the QA Programme

The responsible organization shall develop QAprogrammes for all nuclear power plant stages(siting, design, construction, commissioning,operation and decommissioning) at a timeconsistent with the schedule for accomplishingstage-related activities.

Whilst the QA principles remain the same, theextent to which the QA requirements are to beapplied shall be consistent with the importanceto nuclear safety of the item, service or process.A graded approach, which can satisfy thenecessary requirements and ensure the requiredquality and safety, shall be used.

When items, processes or services aremodified, the assigned grade of QArequirements could become more stringent orless stringent depending on whether a changein nuclear safety significance has occurred.

Documentation of the QA Programme

The QA programmes should take account ofthe details contained in the correspondingSafety Guides and should also recognize thatthe planning and development of the later stageQA programmes commences during the earlystages of a project, for example design reviewrequires consideration of inspectability,constructability, operability, maintainabilityand ALARA requirements before finalizationof the design. To do this effectively, the adviceof constructors and operators should be soughtearly in the design stage.

The requirements and needs of the QAprogramme for a particular stage should beconsidered during earlier stages so that they arefully established prior to the commencement ofthe stage. For example, establishing the QAprogramme for operations includes: providingfully documented detailed working documents;having a trained and qualified workforce; andensuring that workshops, facilities, tools andsuitable working environments are in place.


The utility quality system is considered asbeing the quality programme as per the IAEAcode.

The utility quality programme should bedeveloped according to the actual stages of theplant.

The suppliers' quality systems should meet theQA requirements notified by the utility,including provisions for grading its own QArequirements to its own sub-suppliers wherenecessary. The suppliers' graded approachshould be acceptable to the utility.

The utility should ensure that any requirementsfor subsequent stages are identified andcommunicated to suppliers. Also see clause313 of Safety Guide Q3.

ALARA stands for As Low As ReasonablyAchievable.

11

Section

312

401 to 413


The following should be included in the QAprogramme description:

1. Management's quality policy statement;2. The mission and objective of the

organization;3. The organizational structure and outline of

the management procedures;4. The level of the authority and the

responsibilities and accountabilities ofpersons and organizational units;

5. The lines of internal and externalcommunications and interfacearrangements;

6. The responsibilities of each organizationinvolved in the work;

7. Requirements for training, facilities andworking environment;

8. Requirements for the development ofdetailed working documents for theperformance and assessment of work;

9. The arrangements for establishing a gradedapproach to nuclear safety;

10. The arrangements for measuringeffectiveness and management self-assessment of the QA programme.

Implementing the QA Programme


This list is basically equivalent to therequirements of ISO 9001:1994, but it may beuseful to consider if any of the guidance ishelpful to suppliers.

Plans mentioned in the Safety Guide should behandled through quality planning

12

Safety Guide Q2: Non-conformance Control and Corrective Actions

Section

301 to 313

303

305

308

309

311

313

401 to 406

406


Non-conformance Control

Non-conformances may be discovered duringregulatory inspections.

On being advised of a non- conformance, theline management should promptly inform theregulatory body and other nuclear powerplants if necessary.

Non-conformances should be reviewed assoon as practicable by appropriate personnelwho should be selected by taking thefollowing into account:1. The QA grade or classification of the

affected item, service or process;2. The need for the safety implications of the

non-conformance to be independentlyreviewed;

3. The need to involve the regulatory body.The review should determine:

1. The cause of the identified non-conformance, which could includefailures, malfunctions, incorrectmaterials, tools, equipment,procedures, information, training, orhuman error. Root cause analysistechniques should be utilized.

2. Any safety implications of the non-conformance.

During the review additional informationabout the nature of the non-conformance andrestrictions to be imposed on furtherprocessing or operation should be madeavailable to involved organizations, includingthe regulatory body and other nuclear powerplants if required.

Relevant information on the status of non-conformances should be reported tomanagement and the regulatory body, whererequired.

Corrective Actions

Implementation of preventive actions mayproceed in stages. In such cases each stageshould be clearly defined and specify themeans of verification that assures that theactions have been effective. Prior toimplementation, all proposed actions shouldhave been agreed, documented and authorizedby appropriate personnel and the regulatorybody if required.


Utilities should determine how they addresssuch non-conformances and inform theirsuppliers that the regulator may wish toconduct inspections.

There may also be a need for suppliers toidentify non-conformances that should bebrought to the attention of the regulator via theutility representative.

13

Safety Guide Q3: Document Control and Records

Section

301 to 332

305

313

401 to 427

425


Document Control

During preparation, activities described by thedocuments should be assessed using thegrading system, so that the appropriatecontrols are chosen and included.

Where acceptance by, or approval of, aregulatory body is required, this should beobtained before the document is issued foruse.

Establishment of a Record System

The responsible organization should identifywho is responsible for transferring ordisposing of records.


QA documents should contain provisions forassuring that document prepared includeall/any controls necessary for the activities tobe properly implemented.

This may apply to suppliers.

Utilities should ensure suppliers are aware ofany specific documents requiring forregulatory approval

This is a utility responsibility. The utility mustcommunicate record requirements to suppliersand ensure suitable records are generated andstored in suitable conditions. Ensuring theyare transferred to the utility at some point intime.

14

Safety Guide Q4: Inspection and Testing for Acceptance

Section

201 to 208

204

301 to 323

319

401 to 410

501 to 514

501

508

509

510

511

512

513

514


General Considerations

Personnel shall be trained and qualified so that they arecompetent to perform their assigned work and so theyunderstand the safety consequences of their activities.

Inspection and Testing

Testing should demonstrate that the safety function of an itemor service has been maintained.

Acceptance of Items and Services from Suppliers

Plant Inspections and Testing

Systematic inspection and testing following installation ofmajor plant systems is an essential element during thecommissioning stage.

In-service inspection and testing should be an integral part ofpreventive maintenance aimed at the early detection of thepotential failure of items. It also provides data on which tobase judgements related to the continued operation and lifeextension of the plant.

In-service inspection and testing should be concentrated onitems that may affect safety to ensure that operation has notresulted in an unacceptable degradation or deviation from thedesign intent.

In-service inspection and testing during operation willcomprise both routine checks and periodic examinationswhich may require the plant to be shut down. Both activitiesshould be defined.

Routine in-service inspection and testing activities shouldconfirm the availability and reliability of systems and shouldindicate the current plant status.

For evaluation purposes, the results of in-service inspectionsand tests during plant shutdown should be recorded usingappropriate media such as photographs, videos,instrumentation printouts and computer records.

Results of in-service inspections and tests should be promptlyreviewed and evaluated. Non-conformances should beinvestigated to determine their root cause. The resulting datashould be analysed for trends using statistical methods.

Plant management should be periodically appraised of all in-service inspection and testing performed on the operatingplant. Plant management should also be provided withsummary reviews of the results. Issues requiring attention,such as problems that could jeopardize the safe operation ofthe plant, should be highlighted.


seeBR2

—

Suppliers may need to beinvolved in this activity.

15

Safety Guide Q5: Assessment of the Implementation of the QA Programme

Section

201

202

208

211

501 to 509

501

502

503

504


Assessments are carried out to determine thatrequirements are met and that processes areadequate and effective, and to encouragemanagers to implement improvements,including safety improvements.

The assessment activity falls into two broadcategories:

1. Management self-assessment, which is anon-going process conducted bymanagement in order to evaluate theeffectiveness of performance in all areasof their responsibility.

2. Independent assessment, which is usuallyconducted by an independentorganizational unit in order to determinethe effectiveness of managementprocesses, the adequacy of workperformance and the quality of items andservices.

Performance indicators should be developedto measure whether performance issatisfactory or not, with particular emphasison safety.

Managers should make arrangements toensure that all personnel performingassessment activities, including themselves,have appropriate qualification, training andexperience.

Management Self-Assessment

The purpose of management self-assessmentshould be to evaluate known performanceissues, identify contributing managementaspects and make improvements.

Management self-assessment should beregarded as an on-going process thatdetermines how well leadership is beingprovided to meet requirements andexpectations.

Management at all levels (for example senior,line and supervisory managers) perform theseself-assessments with an emphasis on theallocation of human and financial resources toachieve organizational goals and objectives.

At the senior management level it isappropriate to perform a self-assessment todetermine if the overall performanceeffectively focuses on meeting strategic goals,including safety goals. Reports from linemanagement, summaries of both categories ofassessment and regulatory feedback are usefulsources of information on the overallperformance of the organization. It also assiststhe manager in targeting improvement actions.


seeBR9

see BR9

seeBR2

Careful consideration should be given toimposing this requirement on suppliers,grading should help in the determination.

16

Section

601 to 620

601

602

606

608

613

617


Independent Assessment

Independent assessment, such as internalaudits, external audits, surveillance, peerevaluation and technical review, should befocused on safety aspects and areas whereproblems have been found. Assessmentobjectives should be reviewed periodically toreflect current management concerns andperformance activities. Appropriatecombinations of various types of assessmentshould be used to provide the best balancedevaluation of performance.

A system for internal audits should beestablished by the assessment unit and agreedwith the management of the organization.

External audits of suppliers should bemanaged by the assessment unit on behalf ofmanagement, who agree the schedule of auditsto be performed. The frequency of auditsshould be determined by factors such as theimportance of items and the performance ofthe supplier.

Surveillance of work performance isconsidered to be the best technique forassessing and reporting on a specific area, oran on-going activity. It is flexible and lessformal than audits and can be performed in arelatively short period of time with limitedpreparation.

Peer evaluation is a critical examination ofspecific nuclear safety related subjects bysenior staff from one or more other nuclearpower plants to seek improvements and topromote good practices. The evaluation teamshould consist of experts in all areas ofevaluation in order to promote the sharing ofexperience and to develop relationshipsbetween the peers and the people at thenuclear power plants.

Senior management may arrange for a reviewof the technical content of activities andprocesses, with a view to improving theeffectiveness of these activities or processes.


Consideration might be given to recognizingthat suppliers rnay adopt one or more methodsof assessment.

17

Safety Guide Q6: Quality Assurance in Procurement of Items and Services

Section

201 to 206

201

202

204

205

501 to 503

501

502

601 to 607

603

S01 to 802

801


Arrangement for Procurement

The responsible organization shall ensure thatprocured items and services meet establishedrequirements and perform as specified and thatselected suppliers continue to provideacceptable items and services during thefulfilment of their procurement obligations.The responsible organization may delegateprocurement activities to other organizations,but shall retain the responsibility for theoverall effectiveness of these activities.

Procurement activities shall conform to theregulatory requirements of the Member Stateand, as applicable, to the provisions ofrecognized codes, standards and specificationsused in the design, manufacture, installationand operation of items and services.

Nuclear safety shall be the fundamentalconsideration in the identification of the items,services and processes to which the QAprogramme applies. A graded approach basedon the relative importance to nuclear safety ofeach item, service or process shall be used.The graded approach shall reflect a plannedand recognized difference in the applicationsof specific QA requirements.

This graded approach should be appliedthroughout the supply chain.

Evaluation of Quotations and award ofContract

Submitted quotations (bids or tenders) fromprospective suppliers should be evaluated in alogical manner to ensure that they conform tothe requirements of the procurementdocuments.

The evaluation of quotations carried out by theresponsible organization should be a teameffort involving the organizational unitsresponsible for the technical and procurementactivities. The size of the team undertaking theevaluation should be determined by the sizeand complexity of the item or service to bepurchased.

Evaluation of suppliers performance

The extent and necessity of pre- and post-award communication depends on theuniqueness of the product, its complexity, theprocurement frequency with the same supplierand past performance in the supply of similaritems or services.

Commercial Grade items

Certain items with a proven record may beavailable from commercial stock. Procurement


—

18

Section

802

901

901


documents should provide sufficientinformation from catalogues and suppliers'specifications to enable the correct item to besupplied. All relevant technical data and trialinformation should be requested. These itemsmay require confirmatory analysis or testing todemonstrate the adequacy of the item toperform its intended function.

When a commercial grade item is proposedfor any safety function, a thorough technicalevaluation of the complexity of the item andits safety significance should be carried out.The critical characteristics required for thefunction should be included as acceptancecriteria in the procurement documents.

Procurement of Spares

The plant management may arrange to obtainspares of plant items at the time ofprocurement of the original items. The sparesshould meet the same QA requirements as theoriginals, with additional requirements toassure protection during long term storage.


Methods to be used for such technicalevaluation should be delineated in the utilityquality system and in the supplier qualitysystem when applicable.

Safety Guide Q7: Quality Assurance in Manufacturing

Section

201 to 205

202

301 to 311

303


General

The responsibility for the effectiveness of theoverall QA programme of the nuclear powerplant remains with the responsibleorganization without prejudice to themanufacturer's obligations and the legalrequirements imposed on the manufacturer.

The Manufacturing Process

The manufacturer shall be made aware of therequirements of the responsible organizationand regulatory body (see the Code 50-C-G(Rev.l)) for sampling points, hold points andwitness points.


see BR1

19

Safety Guide Q10: Quality Assurance in Design

Section

201 to 223

207

208

223


Management

The responsible organization shall identify theprincipal designer who has responsibility forspecifying the design requirements and forapproving the design output on its behalf.

The responsibilities of the principal designershould include:

- Defining the base requirement/specification— Involvement in design reviews— Involvement in design verification— Approval of detail design— Review and approval of design changes

during all stages— Control of interfacesSuitable working environment shall beprovided and maintained so that work can becarried out safely and satisfactorily withoutimposing unnecessary physical andpsychological stress on personnel.


20

APPENDIX: CORRELATION MATRICES

MATRIX 1: IAEA CODE 50-C-Q BASIC REQUIREMENTS COVERAGE IN THEIAEA SAFETY GUIDES 50-SG-Q1 TO Q14

Horizontal AxisBasic Requirements BR1 to BR10 ofthe IAEA Code in Safety Series No. 50-C/SG-Q

Vertical AxisSafety Guides Q1 to Q14 of the IAEASafety Series No. 50-C/SG-Q

ides

O

1en

c R

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ed E

Top

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ides

Saf

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Rel

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Q3

Q4

Q5

Q6

Q7

Q8

Q9

Q10

Q11

Q12

Q13

Q14

Establishing andImplementing a QualityAssurance Programme

Non-Conformance Controland Corrective Actions

Document Control andRecords

Inspection and Testing forAcceptance

Assessment of theImplementation of theQuality AssuranceProgramme

Quality Assurance inProcurement of Items andServices

Quality Assurance inManufacturing

Quality Assurance inResearch andDevelopment

Quality Assurance inSiting

Quality Assurance inDesign

Quality Assurance inConstruction

Quality Assurance inCommissioning

Quality Assurance inOperation

Quality Assurance inDecommissioning

Management

BR1

Qua

lity

Ass

uran

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amm

e

•; - ' • . *i * H

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BR9

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pend

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: ..?!"1 ir ..r :•

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21

MATRIX 2: CORRELATION BETWEEN THE CLAUSES OF ISO 9001:1994 ANDTHE IAEA CODE 50-C-Q BASIC REQUIREMENTS

Horizontal Axis

Clauses in ISO 9001:1994

Vertical AxisBasic Requirements BR1 to BR10 ofthe IAEA Code in Safety SeriesNo. 50-C/SG-Q

c

CD

nsns

8cns

Per

forr

smen

t

CD

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BR2

BR3

BR4

BR5

BR6

BR7

BR8

BR9

BR10

Quality AssuranceProgramme

Training andQualification

Non-ConformanceControl and CorrectiveActions

Document Control andRecords

Work

Design

Procurement

Inspection and Testingfor Acceptance

Management Self-Assessment

IndependentAssessment

1

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22

MATRIX 3: CORRELATION BETWEEN THE CLAUSES OF ISO 9001:1994 ANDTHE IAEA SAFETY GUIDES 50-SG-Q1 TO Q14

Horizontal AxisClauses of ISO 9001:1994

Vertical AxisSafety Guides Q1 to Q14 of the IAEASafety Series No. 50-C/SG-Q

CD

ICO

C/5

Q3

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Q5

Q11

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Q1 Establishing andImplementing a Quality |Assurance Programme t

Q2 Non-ConformanceControl and CorrectiveActionsDocument Control andRecordsInspection and Testingfor AcceptanceAssessment of theImplementation of theQuality AssuranceProgramme

Q6 Quality Assurance inProcurement of Itemsand Services

Q7 Quality Assurance inManufacturing

Q8 Quality Assurance inResearch andDevelopment

Q9 Quality Assurance inSiting

Q10 Quality Assurance inDesignQuality Assurance inConstruction

Q12 Quality Assurance inCommissioning

Q13 Quality Assurance inOperation

Q14 Quality Assurance inDecommissioning

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23

REFERENCES

[1] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance for Safety inNuclear Power Plants and other Nuclear Installations, Code and Safety Guides Q1-Q14,Safety Series No. 50-C/SG-Q (1996).

[2] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Systems —Model for Quality Assurance in Design, Development, Production, Installation andServicing, ISO Standard 9001:1994, ISO, Geneva (1994).

[3] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Systems —Model for Quality Assurance in Production, Installation and Servicing, ISO Standard9002:1994, ISO, Geneva (1994).

[4] INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Quality Systems —Model for Quality Assurance in Final Inspection and Test, ISO Standard 9003:1994, ISO,Geneva (1994).

24

Berthon, P.

Cerzosimo, R.

Dua, S.

Glauser, E.C.

Hille, M.

Karbassioun. A.

Kleinert, K.-P.

Lyne, D.

Mazzini, M.

Perrin, R.

Pieroni, N.

Redman, N.

Rim, Youngj o

Rondinelli, V.

Steinberg, N.

Szabo, T.

Van der Geld, F.

Vassileva, E.

Vincze, P.

CONTRIBUTORS TO DRAFTING AND REVIEW

European Atomic Forum FORATOM

Webcraft Inc., USA

Atomic Energy Canada Limited, Canada

Swiss Federal Nuclear Safety Inspectorate

Siemens AG, Germany

International Atomic Energy Agency

Siemens AG, Germany

United Kingdom

Comisión Nacional de Energía Atómica, Argentina

Framatome, France

International Atomic Energy Agency

Amethyst Management Ltd, United Kingdom

KEPCO, Republic of Korea

Eletronuclear, Brazil

Atomaudit Ltd, Ukraine

International Organization for Standardization

Stork Nucon BV, Netherlands

Kozloduy NPP, Bulgaria

Paks Nuclear Power Plant, Hungary

Consultants MeetingVienna, Austria: 19-21 January 1999

Advisory Group MeetingVienna, Austria: 1-13 January 2000

25

IAEA PUBLICATIONS ON QUALITY ASSURANCE/QUALITY MANAGEMENT

2000 Quality Assurance for Software Important to Safety (Technical Reports Series No. 397)

2000 Managing Suspect and Counterfeit Items in the Nuclear Industry (IAEA-TECDOC-1169)

1999 Management of Delayed Nuclear Power Plant Projects (IAEA-TECDOC-1110)

1999 A Framework for a Quality Assurance Programme for PSA (IAEA-TECDOC-1101)

1999 Quality Assurance within Regulatory Bodies (IAEA-TECDOC-1090)

1996 Management of Procurement Activities in a Nuclear Installation (IAEA-TECDOC-919)

1995 Quality Assurance for Radioactive Waste Packages (Technical Reports Series No. 376)

1994 Management for Excellence in Nuclear Power Plant Performance — A Manual (TechnicalReports Series No. 369)

1994 Quality Assurance for the Safe Transport of Radioactive Material (Safety Series No. 50-P-6)

1992 Quality Assurance Integrated Training Packages — A Manual (Technical Reports Series No.340)

1991 Grading of Quality Assurance Requirements (Technical Reports Series No. 328)

1991 Assessing the Effectiveness of Quality Management for Nuclear Power Plant Operation(IAEA-TECDOC-609)

1990 Quality Management for Nuclear Power Operation — A Manual (Technical Reports SeriesNo. 315)

1990 Implementation of Quality Assurance Corrective Actions — A Manual (Technical ReportsSeries No. 317)

1989 Regulatory Inspection of the Implementation of Quality Assurance Programmes — AManual (Technical Reports Series No. 296)

1989 Manual on Quality Assurance for Installation and Commissioning of Instrumentation,Control and Electrical Equipment in Nuclear Power Plants (Technical Reports Series No.301)

1988 Manual on Quality Assurance for Computer Software Related to the Safety of Nuclear PowerPlants (Technical Reports Series No. 282)

1987 Quality Assurance for the Survey, Evaluation and Confirmation of Nuclear Power Plant Sites(IAEA-TECDOC-416)

1987 Towards Improvement in Quality Assurance (INSAG Technical Note No. 1)

1986 Manual on Training, Qualification and Certification of Quality Assurance Personnel(Technical Reports Series No. 262)

1984 Manual on Quality Assurance Programme Auditing (Technical Reports Series No. 237)

1983 Guidebook on Quality Control of Water Reactor Fuel (Technical Reports Series No. 221)

1982 Quality Assurance for Nuclear Power Plants (Proceedings Series)

1976 Quality Assurance and Control in the Manufacture of Metal-Clad UO2 Reactor Fuels(Technical Reports Series No. 173)

27

quality assurance standards: comparison between iaea 50-c

Documents