Manual On Quality Assurance Programme Auditing
Responsible lierCommonSupplierTECHNICAL REPORTS SERIES No.237Manualon Quality AssuranceProgramme AuditingJI N T E R N A T I O N A L A T O M I C ENERGY A G E N C Y , V I E N N A , 1 9 8 4
MANUAL ON QUALITY ASSURANCE PROGRAMME AUDITING
T h e f o l l o w i n g S t a t e s are M e m b e r s of t h e I n t e r n a t i o n a l A t o m i c E n e r g y A g e n c y :AFGHANISTANHAITIH O L Y SEEHUNGARYICELANDINDIAINDONESIAIRAN, ISLAMIC REPUBLIC O BELGIUMBOLIVIABRAZILBULGARIABURMABYELORUSSIAN SOVIETSOCIALIST REPUBLICCAMEROONCANADACHILECHINACOLOMBIACOSTA RICACUBACYPRUSCZECHOSLOVAKIADEMOCRATIC KAMPUCHEADEMOCRATIC PEOPLE'SREPUBLIC OF KOREADENMARKDOMINICAN REPUBLICECUADOREGYPTEL SALVADORETHIOPIAFINLANDFRANCEGABONGERMAN DEMOCRATIC REPUBLICGERMANY, FEDERAL REPUBLIC OFGHANAGREECEGUATEMALAIRAQIRELANDISRAELITALYIVORY COASTJAMAICAJAPANJORDANKENYAKOREA, REPUBLIC OFKUWAITLEBANONLIBERIALIBYAN ARAB THERLANDSNEW Z E A L A N PERUPHILIPPINESPOLANDPORTUGALQATARROMANIASAUDI ARABIASENEGALSIERRA LEONESINGAPORESOUTH AFRICASPAINSRI LANKASUDANSWEDENSWITZERLANDSYRIAN ARAB REPUBLICTHAILANDTUNISIATURKEYUGANDAUKRAINIAN SOVIET SOCIALISTREPUBLICUNION OF SOVIET SOCIALISTREPUBLICSUNITED ARAB EMIRATESUNITED KINGDOM OF GREATBRITAIN AND N O R T H E R NIRELANDUNITED REPUBLIC OFTANZANIAUNITED STATES O F AMERICAURUGUAYVENEZUELAV I E T NAMYUGOSLAVIAZAIREZAMBIAT h e A g e n c y ' s S t a t u t e was a p p r o v e d o n 2 3 O c t o b e r 1956 b y t h e C o n f e r e n c e o n t h e S t a t u t e of t h eI A E A h e l d at U n i t e d N a t i o n s H e a d q u a r t e r s , N e w Y o r k ; it e n t e r e d i n t o f o r c e o n 2 9 J u l y 1 9 5 7 . T h eH e a d q u a r t e r s of t h e A g e n c y are s i t u a t e d in V i e n n a . Its p r i n c i p a l o b j e c t i v e is " t o a c c e l e r a t e a n d enlarge t h econtribution of atomic energy to peace, health and prosperity t h r o u g h o u t the world". IAEA, 1984Permission t o r e p r o d u c e or t r a n s l a t e t h e i n f o r m a t i o n c o n t a i n e d in this p u b l i c a t i o n m a y b e o b t a i n e dby writing t o t h e I n t e r n a t i o n a l A t o m i c Energy A g e n c y , W a g r a m e r s t r a s s e 5, P . O . B o x 100, A - 1 4 0 0 Vienna,"Austria.P r i n t e d b y the I A E A in AustriaJuly 1984
TECHNICAL REPORTS SERIES No. 237MANUALON QUALITY ASSURANCEPROGRAMME AUDITINGINTERNATIONAL ATOMIC ENERGY AGENCYVIENNA, 1984
MANUAL ON QUALITY ASSURANCE PROGRAMME AUDITINGIAEA, VIENNA, 1984STI/DOC/10/237ISBN 92—0—155184—3
FOREWORDThe Agency's plans for establishing safety standards for nuclear powerplants, referred to as the NUSS Programme, include the development of threetypes of documents:(1)(2)(3)Codes of Practice for thermal neutron nuclear power plants that establishthe objectives and minimum requirements which must be fulfilled toprovide adequate safety for these plantsSafety Guides that provide additional requirements and recommend procedures that should be followed to implement the Codes of PracticeUser's Manuals, directed primarily to nuclear power plant operators, thatnormally present possible methods and techniques for solving specificproblemsWork on Codes and Guides was initiated in 1975 in five main fields: government organization, siting, design, operation and quality assurance.In the field of quality assurance the Code of Practice and eleven Safety Guideshad been developed by 1983 and published in English, French, Spanish andRussian. These documents are now used in a number of Member States as qualityassurance requirements for nuclear power plants. To facilitate this use theTechnical Review Committee on Quality Assurance has stressed on a number ofoccasions the need for and importance of proceeding with the development ofUser's Manuals. These documents should provide Member States implementingthe Code and the Safety Guides with practical examples of procedures, practicesand documents illustrating quality assurance methods and techniques used inthose organizations in Member States having broad experience in qualityassurance. The same opinion was expressed in the discussions during the International Symposium on Quality Assurance for Nuclear Power Plants held inParis in May 1981. A number of topics have been identified for which User'sManuals could provide additional information and facilitate correct implementation of the Code and Guides in nuclear power plant project activities.To implement these recommendations, work has been initiated in theSecretariat to develop those User's Manuals which are most needed in MemberStates embarking on nuclear power programmes and starting quality assuranceactivities. Keeping in mind the difference between User's Manuals and Codesand Safety Guides, work on development of these documents is undertaken outside the NUSS Programme and the established procedures for development,review and approval of the documents used in this Programme. For User's
Manuals it was decided to follow the standard practices used in the developmentof the Agency's publications such as Guidebooks and Technical Reports. Thisprocedure will reduce the time and cost of preparation of User's Manuals, whichare at the lower level in the hierarchy of NUSS Programme documents and do notcontain requirements for whose formulation a broad consensus of QA expertswould be needed.However, it will be ensured that the Manuals are fully consistent with theCode and Safety Guides through information exchange between the Secretariatand members of the Technical Review Committee on Quality Assurance and theSenior Advisory Group of the NUSS Programme. Also, members of these twoCommittees in the capacity of consultants to the Agency and members ofAdvisory Groups will be engaged in the development, review and approval of theManuals before the documents are recommended to the Director General forpublication.The present Manual on Quality Assurance Programme Auditing containssupporting material and illustrative examples for implementing requirementsfor quality assurance programme audits as stated in the Code of Practice onQuality Assurance for Safety in Nuclear Power Plants, IAEA Safety SeriesNo. 50-C-QA, Section 13, and additional requirements and recommendationspresented in the Safety Guide on Quality Assurance Auditing for Nuclear PowerPlants, IAEA Safety Series No. 50-SG-QA10. This Manual is directed primarilytowards quality assurance programme auditors and managers and it presentsmethods and techniques considered appropriate for the preparation and performance of audits and the evaluation of results.
CONTENTS1.2.3.4.INTRODUCTION11.1. Manual objective and use1.2. Purpose of audits1.3. Responsibility for auditing112AUDIT MANAGEMENT42.1. Policies and organization42.2. Procedures5PRE-AUDIT ACTIVITIES63.1. Overall planning and scheduling63.2. Schedule review3.3. Individual audit plan3.3.1. Preparation3.3.2. Definition of purpose and scope3.3.3. Schedule for individual audit3.3.4. Identification of performance standards3.3.5. Preparation of check-lists and procedures3.3.6. Audit plan documentation3.4. Audit team organization and preparation3.4.1. Personnel requirements3.4.2. Audit team preparation3.5. Audit notification and initial contact with auditee3.6. Pre-audit conference77788910111213131415AUDIT PERFORMANCE174.1. Audit techniques4.1.1. Sampling4.1.2. Reviewing documents4.1.3. Interviewing4.1.4. Witnessing implementation4.1.5. Tracing4.1.6. Corroboration4.2. Recording audit findings4.3. Audit team co-ordination171718181919202021
5.6.POST-AUDIT ACTIVITIES215.1.5.2.5.3.5.4.22232425Post-audit conferenceReportingResponseFollow-upRECORDSANNEX: EXAMPLES OF AUDIT DOCUMENTSExample 1.Extract from a quality assurance programme 6.17.18.19.20.21.22.23.Conduct of quality assurance department auditsScheduling of quality assurance department audit activitiesInternal audit scheduleAudit project reminder check-listAudit planIndividual audit scheduleAudit agendaSupplier QA system evaluation check-listQuality assurance audit check-listSupplier evaluation check-listCheck-list for auditing specific activityCheck-list for auditing specific activity(Document distribution)Audit procedureLead auditor qualification recordQualification of audit personnelCheck-list based on tracing techniqueCheck-list for corroborationFinding recording formAudit finding formAudit report formAudit report: transmittal letter and audit reportAudit report: transmittal letter, audit report finding, andresponse letterDRAFTING AND REVIEWING 1132133134135137143149
1.INTRODUCTION1.1 Manual objective and useThe IAEA Code of Practice on Quality Assurance for Safety in Nuclear PowerPlants, hereafter referred to as the Code, establishes requirements for implementing asystem of planned and documented internal and external audits to verify compliancewith all aspects of a quality assurance (QA) programme and to determine itseffectiveness. These requirements are further elaborated in the Safety Guide onQuality Assurance Auditing for Nuclear Power Plants (IAEA Safety SeriesNO.50-SG-QA10), which contains requirements and recommendations on themanagement, preparation and performance of QA programme audits.The objective of this Manual is to provide guidance and illustrative examplesof the methodology and techniques of internal and external audits that are consistent with the requirements and recommendations of the Code and the SafetyGuide. The methodology and techniques are based on the practices of MemberStates having considerable experience in auditing QA programmes. This Manualis directed primarily towards QA programme auditors and managers and presentsmethods and techniques considered appropriate for the preparation and performance of audits and the evaluation of results. Its scope includes the techniquesand methods used to carry out QA programme audits variously described as'System', 'Product' and 'Process' audits. The techniques and methods describedhere may be used as one approach to the evaluation of suppliers' QA capabilitiesas defined in 50-SG-QA10.Although the Manual is primarily directed towards purchasers and suppliers,it is also relevant to regulatory organizations, such as government offices responsiblefor quality assurance, which carry out external audits independent of purchasersand suppliers. In such cases similar methods, procedures and techniques may beused.1.2. Purpose of auditsAccording to the Code an audit is "A documented activity performed todetermine by investigation, examination and evaluation of objective evidence theadequacy of, and adherence to, established procedures, instructions, specifications,codes, standards, administrative or operational programmes and other applicabledocuments and the effectiveness of implementation".This broad definition, when applied to a QA programme audit, implies thatan audit (1) represents a documented activity, (2) uses methods of evaluation,examination and investigation of objective evidences, and (3) has the objective ofverifying the adequacy and compliance of a QA programme with specified requirements and determining its effectiveness.1
According to the Code an overall QA programme must be established as anintegral part of a nuclear power project. The responsible organization (as definedin the Code) is responsible for establishing and implementing this programme.This organization may delegate to others the work of establishing and implementingall or part of the QA programme but must retain the responsibility for ensuring itseffectiveness in complying with regulatory requirements. Similarly, any organizationhaving delegated technical responsibility for a work scope in a nuclear power project,including pertinent actions required by the overall quality assurance programme,may further delegate to a lower-tier organization a part of that work scope and theappropriate quality assurance actions. An organization verifies the effectiveness ofits own QA programme and the effectiveness of that portion which is delegated toother organizations by performing internal or external QA programme audits,respectively. Regardless of whether an audit is performed internally or externallythe objectives can be summarized as follows:(1)(2)(3)(4)(5)(6)To determine that an adequate QA programme exists and that QA procedureshave been developed and documented;To determine, by examination of objective evidence, that the QA programmeis being implemented in compliance with specific requirements;To evaluate the effectiveness of the programme;To identify deficiencies and non-conformances;To recommend corrective action;To provide management of the audited organization with an assessment of thestatus and adequacy of the QA programme.1.3. Responsibility for auditingThe responsible organization is ultimately accountable for every aspect of anuclear power plant because it is the applicant for a construction permit andlincensee for reactor operation. This responsibility stems from regulatory requirements for safety and includes establishing and implementing the overall QAprogramme and the auditing function, which is a major element of the QAprogramme. This system encompasses the whole hierarchical chain of nuclearpower project participants and includes all purchasers and suppliers of items andservices, as indicated in Fig. 1.In this system an internal audit encompasses those portions of an organization'sQA programme retained under its direct control. An external audit covers thoseportions which are not retained under its direct control and not within itsorganizational structure.The responsibility of each participant in this chain may be a consequence ofdirect regulatory requirements and/or of contractual requirements. Contractrequirements are normally specified by referencè to the applicable Codes orStandards.2
Responsible erSupplierSupplierFIC.l.Purchasers in the hierarchical chain are normally responsible for audits of suppliers.However, when considered necessary to verify the effectiveness of the QA programme forwhich he is responsible, the purchaser may also perform an audit of the lower tier supplier orparticipate in external audits performed by his supplier.Where audits are being carried out to evaluate suppliers, the extent and natureof the auditing organization's activities may vary depending on such considerationsas:(1)Previous third-party audit for the purpose of evaluation of an organization'sgeneric QA programmes. There are many national and international schemesfor accrediting these programmes of suppliers of items and services, e.g. ASME 1 ,AFCEN 2 , etc. In scheduling audits and developing specific audit plans dueaccount should be taken of current supplier accreditation.1American Society of Mechanical Engineers.2Association française pour les règles de conception et de construction des matérielsdes chaudières électro-nucléaires.3
(2)(3)2.The likely requirements of other purchasers involved in the nuclear project.There are economic advantages to be gained by collaboration betweenpurchasers in the evaluation of potential suppliers, e.g. purchasers A and B,both involved in a nuclear project, identify common suppliers and performcollaborative audits. Responsibilities of all parties involved in collaborativeaudits must be established and agreements reached with respect to selectionof team leaders and team members.The availability of information from formal collaborative agreements suchas CASE. 3AUDIT MANAGEMENT2.1. Policies and organizationThe requirements for QA programme audits are implemented through anorganization's policies and procedures established at levels consistent with theorganization's scope of work and responsibilities. The highest level policy relevantto the audit programme might consist of a commitment to an effective QAprogramme consistent with a regulatory requirement or an industrial standard orboth. Such a policy may be included in a management policy guide or other toplevel organizational document and should at least be referenced in the nexthierarchical level of policy statement.The next hierarchical level of policy may be documented in a QA programmedescription or manual and may be a policy statement with a commitment toestablish a system of internal and external audits consistent with regulatory requirements, applicable codes and standards, and the organization's delegated programmeresponsibility. When QA requirements are based on the Code, the policy statementin the programme description may have a form such as given in Example 1 of theAnnex. Thus, the policy constitutes a commitment by the organization's seniormanagement to establish an independent system of audits which will be used bythe management as a tool to reveal and correct possible deficiencies in the QAprogramme.The responsibility for carrying out the audit policy may be delegated to aspecific audit group or it may be the responsibility of an ad hoc team of qualifiedindividuals from various organizational units. Regardless of how each audit teamis made up, there should be a group with responsibility for the audit which reportsto the person or organization responsible for ensuring the effectiveness of the QAprogramme. This implies that the basic principles for the organization of the QAfunctions as outlined in the Code should be observed when establishing audit teamauthority, responsibility and operating procedures. As a group having responsibility34Co-ordinating Agency for Supplier Evaluation.
for quality verification functions, the audit team must be independent of the groupit audits and shall report at the same level, or higher, than the organization, functionor group it audits. This organizational independence applies also to each individualauditor, who must be sufficiently independent from the activities and functionsbeing audited including cost and schedule and be able to report facts as he observesthem. For this reason, he must not report to a supervisor who is directly responsiblefor activities that he must examine.This organizational independence of the audit group and of each individualaudit m e m b e r shall be clearly defined and documented. This is normally donethrough development of an organization chart and the associated descriptions ofresponsibilities which are part of the audit management procedure.2.2. ProceduresThe QA auditing policy requires the development of written procedures todescribe methodology. There may be two types of procedures related to QAaudits: the first is a general type of programmatic procedures applicable to allunits; the second includes implementing procedures prepared for the individualaudit.Programmatic procedures provide directives for preparing and performingaudits in a planned and systematic manner for b o t h external and internal audits.Such procedures are primarily concerned with management actions and providerequirements for the responsibility of groups and persons and proceed withspecifications of the sequence of events to be followed in preparing, performing,documenting results, and reporting audits. These procedures also specify schedulingand planning activities to be followed.The Annex provides examples of programmatic procedures of an organizationhaving overall responsibility for plant construction. In this specific case there aretwo programmatic procedures which are a part of the Department of QualityAssurance Procedure Manual:Proc. No. QP 18.1, Conduct of Quality Assurance Departmen
Example 1. Extract from a quality assurance programme description 28 Example 2. Conduct of quality assurance department audits 29 Example 3. Scheduling of quality assurance department audit activities 37 Example 4. Internal audit schedule 44 Example 5. Audit project reminder check-list 45
critical issues the University has established a Quality Assurance Directorate, which is mandated to develop a Quality Assurance Framework and a Quality Assurance Policy. The Quality Assurance Framework would clearly spell out the Principles, Guidelines and Procedures for implementing institutional quality assurance processes.
2 Contents Page The Song Tree Introduction 3-7 Programme 1 Fly, golden eagle 8 Programme 2 Magic hummingbird 9 Programme 3 It’s hard to believe 10 Programme 4 Another ear of corn 11 Programme 5 The door to a secret world 12 Programme 6 Song of the kivas 13 Programme 7 Mighty Muy’ingwa 14 Programme 8 Heavenly rain 15 Programme 9 Rehearsal 16 Programme 10 Performance 17
This quality assurance manual specifies the methods to prepare and submit Quality Assurance Process Design Diagram for products and parts to be supplied to NSK by suppliers. 2. Purpose Each supplier should prepare quality assurance process design diagram clearly showing the quality assurance methods used in each products and parts production .
Quality Assurance and Improvement Framework Guidance 2 Contents Section 1: Quality Assurance and Improvement Framework 1.1 Overview 1.1.1 Quality Assurance (QA) 1.1.2 Quality Improvement (QI) 1.1.3 Access 1.2 Funding Section 2: Quality Assurance 2.1 General information on indicators 2.1.1 Disease registers 2.1.2 Verification
Software Quality Assurance Plan (SQAP) for the SRR-CWDA-2010-00080 H-Area Tank Farm (HTF) Performance Revision 0 Assessment (PA) Probabilistic Model August 2010 Page 5 of 15 1.0 SCOPE This Software Quality Assurance Plan (SQAP) was developed in accordance with the 1Q Quality Assurance Manual, Quality Assurance Procedure (QAP) 20-1, Rev. 11.
2 Contents Page Music Workshop Introduction 3 Programme 1 Loki the Joker 7 Programme 2 Odin, Mighty World-Creator 8 Programme 3 Goblins a Go-Go! 9 Programme 4 Sing us a Saga 10 Programme 5 Thor on a journey 11 Programme 6 Apples of Iduna 12 Programme 7 Birds of the North 13 Programme 8 Rehearsal and Performance (1) 14 Programme 9 Rehearsal and Performance (2) 15 .
Sep 02, 2020 · Zetec Quality Assurance Manual Revision M Page 1 of 30 QUALITY ASSURANCE MANUAL ZQA-001 Revision M Successful implementation of the requirements defined in this Quality Assurance Manual requires the concerted effort of all Zetec employees since everyone contributes to the quality of our products and services.
there are questions to answer and diagrams to label. Marieb (2007) is the core anatomy and physiology text used, which corresponds to local undergraduate pre-registration and learning beyond registration curriculum’s at the University of Southampton. A recommended reading list is provided.
