QS90001327157.pptx

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1、INTERNAL AUDITING FORQS-9000WelcomeRestroomsBreaksRegistration sheetsPhonesEvaluationsFor assistance after this course.Introductionsn nNameNamen nCompanyCompanyn nTitle/PositionTitle/Positionn nCurrent responsibilitiesCurrent responsibilitiesn nExperience in quality systemsExperience in quality syst

2、emsn nExperience in auditingExperience in auditingn nWhat do you expect to learn from this What do you expect to learn from this course?course?Agendan nAuditing fundamentalsAuditing fundamentalsn nThe audit systemThe audit systemn nHuman factors role in auditingHuman factors role in auditingn nAudit

3、 preparationAudit preparationn nAudit performanceAudit performancen nOpening meetingOpening meetingn nClosing meetingClosing meetingn nAudit reportAudit reportn nFollow-up actionFollow-up actionn nCase studyCase studyn nExamExamExam(3-1/2 hours)n n1-1/2 hours1-1/2 hoursPart 1(open book)Part 1(open b

4、ook)1.1.Seven case studiesSeven case studies2.2.Answer as the team leaderAnswer as the team leader3.3.If there is a nonconformance,cite the closest If there is a nonconformance,cite the closest element/subelement of QS-9000element/subelement of QS-9000n n15 minute break15 minute breakn n2 hours2 hou

5、rsPart 2(closed book)Part 2(closed book)1.1.General questions about auditingGeneral questions about auditing2.2.Multiple choice/fill in the blank/true-falseMultiple choice/fill in the blank/true-false3.3.Part 3(closed book)Part 3(closed book)4.4.QS-9000 requirementsQS-9000 requirements5.5.Multiple c

6、hoice/fill in the blank/true-falseMultiple choice/fill in the blank/true-falseMODULE 1IntroductionIntroductionn nThis module will discuss:This module will discuss:n nDefinition of qualityDefinition of qualityn nCost of nonqualityCost of nonqualityn nCost of qualityCost of qualityn nPrevention costsP

7、revention costsn nAppraisal costsAppraisal costsn nQuality systemQuality systemDefinition of QualityQuality =?Definitions of Qualityn nDictionaryDictionaryA characteristic or attribute of something;property;A characteristic or attribute of something;property;a feature.Excellence;superiority.Degree o

8、r grade a feature.Excellence;superiority.Degree or grade of excellenceof excellence.n nDemingDemingQuality has meaning only in terms of the customer,Quality has meaning only in terms of the customer,his needs,what he is going to use it for.his needs,what he is going to use it for.Continuous improvem

9、ent.Continuous improvement.Definitions of Qualityn nJuranJuranFitness for use/fitness for purpose as seen by the Fitness for use/fitness for purpose as seen by the user.For long-lived items:availability,reliability user.For long-lived items:availability,reliability and maintainability (the“abilities

10、”).and maintainability (the“abilities”).n nRegulated IndustriesRegulated IndustriesMeeting specifications or requirements.Meeting specifications or requirements.Definitions of Qualityn nCrosby Crosby Conformance to requirements.Conformance to requirements.n nIshikawaIshikawaProducts and services whi

11、ch are economical,most Products and services which are economical,most useful,and always satisfactory to the consumer.useful,and always satisfactory to the consumer.n nISO 8402ISO 8402The totality of characteristics of an entity that bear The totality of characteristics of an entity that bear on its

12、 ability to satisfy stated and implied needs.on its ability to satisfy stated and implied needs.Costs of Nonqualityn nWaste due to scrap or rejected itemsWaste due to scrap or rejected itemsn nReperformance of workReperformance of workn nInefficient use of resources Inefficient use of resources n nS

13、ervice and warranty costsService and warranty costsn nCustomer loss of confidence Customer loss of confidence n nLoss of market shareLoss of market sharen nLiability costsLiability costsCost of Qualityn nPrevention and appraisal costsPrevention and appraisal costsn nCosts to prevent nonconformancesC

14、osts to prevent nonconformancesn nCosts to evaluate qualityCosts to evaluate qualityn nNonquality costsNonquality costsn nInternal failure costsInternal failure costsn nExternal failure costsExternal failure costsVariables Affecting Qualityn nAccuracy in identifying customer Accuracy in identifying

15、customer requirements and expectationsrequirements and expectationsn nAdequacy of raw materialsAdequacy of raw materialsn nAdequacy of product designAdequacy of product designn nCompetency of personnelCompetency of personneln nVariances in process equipmentVariances in process equipmentn nAdequacy o

16、f measures taken to prevent Adequacy of measures taken to prevent damage to the product after productiondamage to the product after productionVariables Affecting Qualityn nControl of production conditions,such as Control of production conditions,such as cleanliness,humidity,and temperaturecleanlines

17、s,humidity,and temperaturen nControl of changes in design or in customer Control of changes in design or in customer requirementsrequirementsn nControl of production process support Control of production process support systems,such as electric power,compressed systems,such as electric power,compres

18、sed air,and waterair,and watern nAdequacy and accuracy of test and Adequacy and accuracy of test and inspection equipmentinspection equipmentn nCorrectly identifying inspection and test Correctly identifying inspection and test criteriacriteriaQuality System Definition:“The organizational structure,

19、responsibilities,procedures,processes,and resources needed to implement quality management.”ISO 8402 Types of Quality Systemsn nInternal Quality SystemInternal Quality Systemn nImplements policies and objectivesImplements policies and objectivesn nIncludes quality control functionsIncludes quality c

20、ontrol functionsn nIncludes quality assurance activitiesIncludes quality assurance activitiesn nExternal Quality SystemExternal Quality Systemn nProvides assurance specifically for Provides assurance specifically for the customerthe customerMODULE 2QS-9000OverviewQS-9000 Overviewn nThis module will

21、discuss:This module will discuss:n nQuality system documentationQuality system documentationn nThe twenty elements that are ISO basedThe twenty elements that are ISO basedn nThe automotive sector-specific requirementsThe automotive sector-specific requirementsn nThe customer-specific requirementsThe

22、 customer-specific requirementsQS-9000 Overviewn nQuality System Requirements QS-9000 Quality System Requirements QS-9000 n nDeveloped by Chrysler,Ford,General MotorsDeveloped by Chrysler,Ford,General Motorsn nHarmonizes Chryslers Supplier Quality Harmonizes Chryslers Supplier Quality Assurance Manu

23、al,Fords Q-101 Quality System Assurance Manual,Fords Q-101 Quality System Standard,and GMs NAO Targets for ExcellenceStandard,and GMs NAO Targets for Excellencen nFounded on ISO 9001:1994,Section 4Founded on ISO 9001:1994,Section 4QS-9000 Overviewn nQS-9000 applies to all direct internal and QS-9000

24、 applies to all direct internal and external suppliers to OEMs of:external suppliers to OEMs of:n nProduction materialsProduction materialsn nProduction or service partsProduction or service partsn nHeat treating,painting,plating,or Heat treating,painting,plating,or other finishing servicesother fin

25、ishing servicesQS-9000 Overviewn nQuality system documentationQuality system documentationn nSuppliers must establish,document,and Suppliers must establish,document,and implement effective quality systems based on QS-implement effective quality systems based on QS-90009000n nAll requirements of QS-9

26、000 must be incorporated All requirements of QS-9000 must be incorporated into the suppliers quality system(see quality into the suppliers quality system(see quality system documentation progression)system documentation progression)Quality System Documentation ProgressionQS-9000 Overviewn nQuality s

27、ystem documentation(cont.)Quality system documentation(cont.)n nLevel 1:Quality ManualLevel 1:Quality ManualDefines managements quality policy and Defines managements quality policy and commitment to qualitycommitment to qualityn nLevel 2:ProceduresLevel 2:ProceduresSpecifies who does what,and when

28、it is to be Specifies who does what,and when it is to be donedonen nLevel 3:InstructionsLevel 3:InstructionsSpecifies how the work should be performed by Specifies how the work should be performed by one individual or functionone individual or functionn nLevel 4:Records and Other DocumentationLevel

29、4:Records and Other DocumentationProvides the objective evidence of implementation Provides the objective evidence of implementation and resultsand resultsComparison of Quality System RequirementsTOPICChryslerFordGMSuppliers quality policyXSuppliers business planXTrainingXXXProcess monitoring instru

30、ctionsXXXEvaluating subcontractor supply baseXXApproved materialsXXXControl of purchased production materialsXXXQuality PlanningXXX -Resources for quality planningX -Planning for new product launchesXXX -Process flow chartXXX -Feasibility studiesX -Design failure mode&effects analysisXX -Process fai

31、lure mode&effects analysisXX -Control plans(part specific)XXX -Gage planningX -Preliminary capabilityXXX -Packaging planningXXX -Prototype quality initiativesXXX -Special characteristics symbologyXXXOngoing capability requirementsXXMeasurement Systems AnalysisXXXIn-process&final inspectionXXXMeasuri

32、ng&testing equipmentXXXAnnual layoutXXAnnual material&functional testXFunctional(ES)test performanceXXXIndication of product statusXXXVerification of new set-upsXReworked productsXXXReturned product analysisXXProblem reporting&resolutionXXXScheduled preventive maintenanceXXXLot traceabilityXXXContin

33、uous improvementXXXQuality proceduresXXXRecords retentionXXXDrawing&change controlXXXEngineering Approved Product AuthorizationsXXXProcess ChangesXXXInternal System AuditsXXXQuality System AssessmentsXXXInitial sample approval processXXXColor/grain/texture approvalXXXSupplier performance indicatorsX

34、XContract reviewXSPC requirementsXXXQS-9000-Quality System Requirementsn nCONTAINS 23 ELEMENTS THAT CAN BE CONTAINS 23 ELEMENTS THAT CAN BE GROUPED IN FOUR CATEGORIES:GROUPED IN FOUR CATEGORIES:n nQuality management and leadershipQuality management and leadershipn nQuality system structure and contr

35、olQuality system structure and controln nProduct and process managementProduct and process managementn nAutomotive sector specific requirementsAutomotive sector specific requirementsn nPlus customer specific requirementsPlus customer specific requirementsFormat Examplen nElement Number Title of Elem

36、entElement Number Title of Elementn nRequirements:Requirements:ISO based requirementsISO based requirementsn nAdditional:Additional:Automotive interpretationsAutomotive interpretationsQuality Management&Leadershipn nProvides requirements for the effective Provides requirements for the effective mana

37、gement of the quality system:management of the quality system:n nOutlines managements responsibility,Outlines managements responsibility,involvement,and support of the quality systeminvolvement,and support of the quality systemn nProvides organizational structure Provides organizational structure re

38、quirements for the support of requirements for the support of quality functionsquality functionsn nEmphasizes training of personnel Emphasizes training of personnel affecting qualityaffecting qualityQuality Management&Leadershipn nElement 4.1 Management ResponsibilityElement 4.1 Management Responsib

39、ilityn nRequirements:Requirements:l lDefine/communicate quality policy understood at all Define/communicate quality policy understood at all levelslevelsl lDefine objectives and commitment to qualityDefine objectives and commitment to qualityl lDefine responsibilities and authority for personnel Def

40、ine responsibilities and authority for personnel affecting qualityaffecting qualityl lProvide organizational independence where neededProvide organizational independence where neededl lProvide adequate resources/trained personnel Provide adequate resources/trained personnel(including internal audits

41、)(including internal audits)l lAppoint management representative Appoint management representative l lReview all elements of quality system periodicallyReview all elements of quality system periodicallyQuality Management&Leadershipn nElement 4.1 Management Responsibility Element 4.1 Management Respo

42、nsibility(cont.)(cont.)n nAdditional:Additional:l lManage appropriate activities during concept Manage appropriate activities during concept development,prototype,and productiondevelopment,prototype,and productionl lUse multidisciplinary decision makingUse multidisciplinary decision makingl lCommuni

43、cate information/data in a customer-Communicate information/data in a customer-prescribed formatprescribed formatl lDocument a formal,comprehensive business planDocument a formal,comprehensive business plan Methods to determine customer expectationsMethods to determine customer expectations Based on

44、 an objective valid process to collect informationBased on an objective valid process to collect information Methods to track,update,and review planMethods to track,update,and review planl lDocument trends in quality and operational performance Document trends in quality and operational performance

45、l lFollow a process for determining,analyzing,and Follow a process for determining,analyzing,and documenting trends in customer satisfaction and documenting trends in customer satisfaction and dissatisfactiondissatisfactionQuality Management&Leadershipn nElement 4.18 TrainingElement 4.18 Trainingn n

46、Requirements:Requirements:l lIdentify needs and provide training for all personnel Identify needs and provide training for all personnel affecting qualityaffecting qualityl lQualify personnel on the basis of education,Qualify personnel on the basis of education,training and/or experience training an

47、d/or experience l lMaintain records Maintain records n nAdditional:Additional:l lView as a strategic issueView as a strategic issuel lPeriodically evaluate effectivenessPeriodically evaluate effectivenessQuality System Structure&Controln nProvides the framework for and control of Provides the framew

48、ork for and control of the quality system:the quality system:n nRequires a documented quality system be Requires a documented quality system be established and maintained established and maintained n nProvides controls for documents Provides controls for documents and dataand datan nRequires investi

49、gation and Requires investigation and corrective action of corrective action of nonconformancesnonconformancesn nProvides controls for quality recordsProvides controls for quality recordsn nRequires audits of the quality systemRequires audits of the quality systemQuality System Structure&Controln nE

50、lement 4.2 Quality SystemElement 4.2 Quality Systemn nRequirements:Requirements:l lEstablish a documented quality system and effectively Establish a documented quality system and effectively implementimplementl lPrepare quality plansPrepare quality plansl lIdentify and acquire required controls,equi