Qs9000审核员培训教材推荐英语版ppt185

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1、无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台INTERNAL AUDITING FORQS-9000无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台WelcomeRestroomsBreaksRegistration sheetsPhonesEvaluationsFor assistance after this course.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Introductionsn nNameNamen nCompanyCompanyn nTitle/PositionTitle/Positi

2、onn nCurrent responsibilitiesCurrent responsibilitiesn nExperience in quality systemsExperience in quality systemsn nExperience in auditingExperience in auditingn nWhat do you expect to learn from this course?What do you expect to learn from this course?无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Agendan n

3、Auditing fundamentalsAuditing fundamentalsn nThe audit systemThe audit systemn nHuman factors role in auditingHuman factors role in auditingn nAudit preparationAudit preparationn nAudit performanceAudit performancen nOpening meetingOpening meetingn nClosing meetingClosing meetingn nAudit reportAudit

4、 reportn nFollow-up actionFollow-up actionn nCase studyCase studyn nExamExam无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Exam (3-1/2 hours)n n1-1/2 hours1-1/2 hoursPart 1 (open book)Part 1 (open book)n nSeven case studiesSeven case studiesn nAnswer as the team leaderAnswer as the team leadern nIf there is a

5、 nonconformance, cite the closest If there is a nonconformance, cite the closest element/element/subelementsubelement of QS-9000 of QS-9000n n15 minute break15 minute breakn n2 hours2 hoursPart 2 (closed book)Part 2 (closed book)n nGeneral questions about auditingGeneral questions about auditingn nM

6、ultiple choice/fill in the blank/true-falseMultiple choice/fill in the blank/true-falsePart 3 (closed book)Part 3 (closed book)n nQS-9000 requirementsQS-9000 requirementsn nMultiple choice/fill in the blank/true-falseMultiple choice/fill in the blank/true-false无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MO

7、DULE 1Introduction无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Introductionn 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 costsPrevention costsn nAppraisal costsAppraisal

8、costsn nQuality systemQuality system无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Definition of QualityQuality = ?无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Definitions of Qualityn nDictionaryDictionaryA characteristic or attribute of something; property; a A characteristic or attribute of something; property; a f

9、eature. Excellence; superiority. Degree or grade of feature. Excellence; superiority. Degree or grade of excellenceexcellence. .n nDemingDemingQuality has meaning only in terms of the customer, his Quality has meaning only in terms of the customer, his needs, what he is going to use it for. Continuo

10、us needs, what he is going to use it for. Continuous improvement.improvement.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Definitions of Qualityn nJuranJuranFitness for use/fitness for purpose as seen by the user. Fitness for use/fitness for purpose as seen by the user. For long-lived items: availability, r

11、eliability and For long-lived items: availability, reliability and maintainability (the “abilities”).maintainability (the “abilities”).n nRegulated IndustriesRegulated IndustriesMeeting specifications or requirements.Meeting specifications or requirements. 无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Defini

12、tions of Qualityn nCrosby Crosby Conformance to requirements.Conformance to requirements.n nIshikawaIshikawaProducts and services which are economical, most Products and services which are economical, most useful, and always satisfactory to the consumer.useful, and always satisfactory to the consume

13、r.n nISO 8402ISO 8402The totality of characteristics of an entity that bear on The totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.its ability to satisfy stated and implied needs.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Costs of Nonqualityn nWaste du

14、e 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 nService and warranty costsService and warranty costsn nCustomer loss of confidence Customer loss of confidence n nLoss of marke

15、t shareLoss of market sharen nLiability costsLiability costs无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Cost of Qualityn nPrevention and appraisal costsPrevention and appraisal costsn nCosts to prevent nonconformancesCosts to prevent nonconformancesn nCosts to evaluate qualityCosts to evaluate qualityn nNo

16、nquality costsNonquality costsn nInternal failure costsInternal failure costsn nExternal failure costsExternal failure costs无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Variables Affecting Qualityn nAccuracy in identifying customer requirements Accuracy in identifying customer requirements and expectationsa

17、nd 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 of measures taken to prevent Adequacy of measures tak

18、en to prevent damage to the product after productiondamage to the product after production无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Variables Affecting Qualityn nControl of production conditions, such as Control of production conditions, such as cleanliness, humidity, and temperaturecleanliness, humidity

19、, and temperaturen nControl of changes in design or in customer Control of changes in design or in customer requirementsrequirementsn nControl of production process support systems, Control of production process support systems, such as electric power, compressed air, and such as electric power, com

20、pressed air, and waterwatern nAdequacy and accuracy of test and inspection Adequacy and accuracy of test and inspection equipmentequipmentn nCorrectly identifying inspection and test Correctly identifying inspection and test criteriacriteria无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality SystemDefiniti

21、on: “The organizational structure,responsibilities, procedures,processes, and resources needed to implement quality management.”ISO 8402 无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Types of Quality Systemsn nInternal Quality SystemInternal Quality Systemn nImplements policies and objectivesImplements polic

22、ies and objectivesn nIncludes quality control functionsIncludes quality control functionsn nIncludes quality assurance activitiesIncludes quality assurance activitiesn nExternal Quality SystemExternal Quality Systemn nProvides assurance specifically for Provides assurance specifically for the custom

23、erthe customer无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MODULE 2QS-9000Overview无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台QS-9000 Overviewn nThis module will discuss:This module will discuss:n nQuality system documentationQuality system documentationn nThe twenty elements that are ISO basedThe twenty elements

24、that are ISO basedn nThe automotive sector-specific requirementsThe automotive sector-specific requirementsn nThe customer-specific requirementsThe customer-specific requirements无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台QS-9000 Overviewn nQuality System Requirements QS-9000 Quality System Requirements QS

25、-9000 n nDeveloped by Chrysler, Ford, General MotorsDeveloped by Chrysler, Ford, General Motorsn nHarmonizes Chryslers Supplier Quality Assurance Harmonizes Chryslers Supplier Quality Assurance Manual, Fords Q-101 Quality System Standard, and Manual, Fords Q-101 Quality System Standard, and GMs NAO

26、Targets for ExcellenceGMs NAO Targets for Excellencen nFounded on ISO 9001:1994, Section 4Founded on ISO 9001:1994, Section 4无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台QS-9000 Overviewn nQS-9000 applies to all direct internal and QS-9000 applies to all direct internal and external suppliers to OEMs of:ext

27、ernal 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 finishing services无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台QS-9000 Ove

28、rviewn nQuality system documentationQuality system documentationn nSuppliers must establish, document, and implement Suppliers must establish, document, and implement effective quality systems based on QS-9000effective quality systems based on QS-9000n nAll requirements of QS-9000 must be incorporat

29、ed into All requirements of QS-9000 must be incorporated into the suppliers quality system (see quality system the suppliers quality system (see quality system documentation progression)documentation progression)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Documentation Progression无忧资源： 中国最大最

30、全的资源下载网教育新天地：中国最大的学习培训咨询平台QS-9000 Overviewn nQuality system documentation (cont.)Quality system documentation (cont.)n nLevel 1: Quality ManualLevel 1: Quality ManualDefines managements quality policy and commitment Defines managements quality policy and commitment to qualityto qualityn nLevel 2: Pr

31、oceduresLevel 2: ProceduresSpecifies who does what, and when it is to be doneSpecifies who does what, and when it is to be donen nLevel 3: InstructionsLevel 3: InstructionsSpecifies how the work should be performed by one Specifies how the work should be performed by one individual or functionindivi

32、dual or functionn nLevel 4: Records and Other DocumentationLevel 4: Records and Other DocumentationProvides the objective evidence of implementation and Provides the objective evidence of implementation and resultsresults无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Comparison of Quality System RequirementsT

33、OPICChryslerFordGMSuppliers quality policyXSuppliers business planXTrainingXXXProcess monitoring instructionsXXXEvaluating subcontractor supply baseXXApproved materialsXXXControl of purchased production materialsXXXQuality PlanningXXX - Resources for quality planningX - Planning for new product laun

34、chesXXX - Process flow chartXXX - Feasibility studiesX - Design failure mode & effects analysisXX - Process failure mode & effects analysisXX - Control plans (part specific)XXX - Gage planningX - Preliminary capabilityXXX - Packaging planningXXX - Prototype quality initiativesXXX - Special character

35、istics symbologyXXXOngoing capability requirementsXXMeasurement Systems AnalysisXXXIn-process & final inspectionXXXMeasuring & testing equipmentXXXAnnual layoutXXAnnual material & functional testXFunctional (ES) test performanceXXXIndication of product statusXXXVerification of new set-upsXReworked p

36、roductsXXXReturned product analysisXXProblem reporting & resolutionXXXScheduled preventive maintenanceXXXLot traceabilityXXXContinuous improvementXXXQuality proceduresXXXRecords retentionXXXDrawing & change controlXXXEngineering Approved Product AuthorizationsXXXProcess ChangesXXXInternal System Aud

37、itsXXXQuality System AssessmentsXXXInitial sample approval processXXXColor/grain/texture approvalXXXSupplier performance indicatorsXXContract reviewXSPC requirementsXXX无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台QS-9000 - Quality System Requirementsn nCONTAINS 23 ELEMENTS THAT CAN BE CONTAINS 23 ELEMENTS T

38、HAT CAN BE GROUPED IN FOUR CATEGORIES:GROUPED IN FOUR CATEGORIES:n nQuality management and leadershipQuality management and leadershipn nQuality system structure and controlQuality system structure and controln nProduct and process managementProduct and process managementn nAutomotive sector specifi

39、c requirementsAutomotive sector specific requirementsn nPlus customer specific requirementsPlus customer specific requirements无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Format Examplen nElement Number Title of ElementElement Number Title of Elementn nRequirements:Requirements:ISO based requirementsISO bas

40、ed requirementsn nAdditional:Additional:Automotive interpretationsAutomotive interpretations无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality Management & Leadershipn nProvides requirements for the effective Provides requirements for the effective management of the quality system:management of the qualit

41、y system:n nOutlines managements responsibility, involvement, Outlines managements responsibility, involvement, and support of the quality systemand support of the quality systemn nProvides organizational structure Provides organizational structure requirements for the support of requirements for th

42、e support of quality functionsquality functionsn nEmphasizes training of personnel Emphasizes training of personnel affecting qualityaffecting quality无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality Management & Leadershipn nElement 4.1 Management ResponsibilityElement 4.1 Management Responsibilityn nRe

43、quirements:Requirements:l lDefine/communicate quality policy understood at all levelsDefine/communicate quality policy understood at all levelsl lDefine objectives and commitment to qualityDefine objectives and commitment to qualityl lDefine responsibilities and authority for personnel affecting Def

44、ine responsibilities and authority for personnel affecting qualityqualityl lProvide organizational independence where neededProvide organizational independence where neededl lProvide adequate resources/trained personnel (including Provide adequate resources/trained personnel (including internal audi

45、ts)internal audits)l lAppoint management representative Appoint management representative l lReview all elements of quality system periodicallyReview all elements of quality system periodically无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality Management & Leadershipn nElement 4.1 Management Responsibilit

46、y (cont.)Element 4.1 Management Responsibility (cont.)n nAdditional:Additional:l lManage appropriate activities during concept development, Manage appropriate activities during concept development, prototype, and productionprototype, and productionl lUse multidisciplinary decision makingUse multidis

47、ciplinary decision makingl lCommunicate information/data in a customer- prescribed Communicate information/data in a customer- prescribed formatformatl lDocument a formal, comprehensive business planDocument a formal, comprehensive business plan Methods to determine customer expectationsMethods to d

48、etermine customer expectations Based on 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 tre

49、nds in quality and operational performance l lFollow a process for determining, analyzing, and documenting Follow a process for determining, analyzing, and documenting trends in customer satisfaction and dissatisfactiontrends in customer satisfaction and dissatisfaction无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学

50、习培训咨询平台Quality Management & Leadershipn nElement 4.18 TrainingElement 4.18 Trainingn nRequirements:Requirements:l lIdentify needs and provide training for all personnel affecting Identify needs and provide training for all personnel affecting qualityqualityl lQualify personnel on the basis of educat

51、ion, Qualify personnel on the basis of education, training and/or experience training and/or experience l lMaintain records Maintain records n nAdditional:Additional:l lView as a strategic issueView as a strategic issuel lPeriodically evaluate effectivenessPeriodically evaluate effectiveness无忧资源： 中国

52、最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln nProvides the framework for and control of the Provides the framework for and control of the quality system:quality system:n nRequires a documented quality system be established Requires a documented quality system be established and m

53、aintained and maintained n nProvides controls for documents Provides controls for documents and dataand datan nRequires investigation and Requires investigation and corrective action of corrective action of nonconformancesnonconformancesn nProvides controls for quality recordsProvides controls for q

54、uality recordsn nRequires audits of the quality systemRequires audits of the quality system无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln nElement 4.2 Quality SystemElement 4.2 Quality Systemn nRequirements:Requirements:l lEstablish a documented quality system and effective

55、ly Establish a documented quality system and effectively implementimplementl lPrepare quality plansPrepare quality plansl lIdentify and acquire required controls, equipment, resources Identify and acquire required controls, equipment, resources and skills and skills l lEnsure compatibility of design

56、 and production processesEnsure compatibility of design and production processesl lUpdate quality control and inspection and test techniquesUpdate quality control and inspection and test techniquesl lUpdate measurement systems capabilityUpdate measurement systems capabilityl lIdentify suitable verif

57、ication activities at appropriate stagesIdentify suitable verification activities at appropriate stagesl lClarify standards of acceptabilityClarify standards of acceptabilityl lIdentify and prepare quality recordsIdentify and prepare quality records无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System

58、 Structure & Controln nElement 4.2 Quality System (cont.)Element 4.2 Quality System (cont.)n nAdditional:Additional:l lUse the Use the Advanced Product Quality Planning and Control Plan Advanced Product Quality Planning and Control Plan reference manual reference manual l lIdentify special character

59、istics Identify special characteristics l lConfirm manufacturing feasibility before contractConfirm manufacturing feasibility before contractl lDevelop process FMEAs as a prevention toolDevelop process FMEAs as a prevention tooll lCross-functional teams develop control plansCross-functional teams de

60、velop control plans prototypeprototype prelaunch prelaunch productionproduction无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln Phases of Product Quality Planning (APQP)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln nElement 4.5 Document and Data Con

61、trolElement 4.5 Document and Data Controln nRequirements:Requirements:l lEnsure that:Ensure that: Documents and data are reviewed and approved for useDocuments and data are reviewed and approved for use Changes to the documents are reviewed, approved, and Changes to the documents are reviewed, appro

62、ved, and controlledcontrolledl lControl external documents (e.g., customer drawings) Control external documents (e.g., customer drawings) n nAdditional:Additional:l lHave current releases of referenced documents availableHave current releases of referenced documents availablel lIdentify special char

63、acteristics on documentsIdentify special characteristics on documentsl lTimely review, distribution, and implementation of customer Timely review, distribution, and implementation of customer specifications and standards specifications and standards l lKeep records of the implementation date Keep re

64、cords of the implementation date 无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln nElement 4.14 Corrective and Preventive ActionElement 4.14 Corrective and Preventive Actionn nRequirements:Requirements:l lInvestigate nonconformances and take corrective actionsInvestigate nonc

65、onformances and take corrective actionsl lInitiate preventive measures Initiate preventive measures l lTake measures to prevent nonconformances Take measures to prevent nonconformances from occurringfrom occurringl lEnsure corrective and preventive actions are effectiveEnsure corrective and preventi

66、ve actions are effectiven nAdditional:Additional:l lUse disciplined problem-solving methods Use disciplined problem-solving methods l lRespond in customer prescribed manner for external Respond in customer prescribed manner for external nonconformancesnonconformancesl lAnalyze parts returned by the

67、customer and take action to Analyze parts returned by the customer and take action to prevent recurrenceprevent recurrence无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln nElement 4.16 Control of Quality RecordsElement 4.16 Control of Quality Recordsn nRequirements:Requiremen

68、ts:l lControl records through:Control records through: Identification Identification Collection, indexing, and access Collection, indexing, and access Filing and storageFiling and storage Maintenance and dispositionMaintenance and dispositionl lStore and retain records in a Store and retain records

69、in a way which makes them:way which makes them: Readily retrievableReadily retrievable Prevents deterioration,Prevents deterioration, damage, or lossdamage, or loss无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln nElement 4.16 Control of Quality Records (cont.)Element 4.16 Co

70、ntrol of Quality Records (cont.)n nAdditional:Additional:l lFollow customer or government retention periodsFollow customer or government retention periodsl lIf none are specified, use the following as minimums:If none are specified, use the following as minimums: while active plus one calendar year:

71、while active plus one calendar year: PPAP approvals, tooling records, P.O.s, and amendmentsPPAP approvals, tooling records, P.O.s, and amendments one calendar year after year in which created:one calendar year after year in which created: quality performance records, e.g., control charts, test resul

72、tsquality performance records, e.g., control charts, test results three years:three years: internal quality system audits and management reviewsinternal quality system audits and management reviewsl lRetain documents from superseded parts required for new part Retain documents from superseded parts

73、required for new part qualification in new part filequalification in new part file无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Quality System Structure & Controln nElement 4.17 Internal Quality AuditsElement 4.17 Internal Quality Auditsn nRequirements:Requirements:l lPlan and implement internal quality audi

74、ts:Plan and implement internal quality audits: Verify that activities comply with the quality planVerify that activities comply with the quality plan Determine the effectiveness of the quality systemDetermine the effectiveness of the quality system Base the schedule on status/importance of the activ

75、ityBase the schedule on status/importance of the activity Done by independent personnelDone by independent personnell lRecord and report results to the audited departmentRecord and report results to the audited departmentl lTake timely corrective action Take timely corrective action l lVerify the ef

76、fectiveness of the corrective action with follow-up Verify the effectiveness of the corrective action with follow-up auditsauditsn n Additional: Additional:l lInclude suitable work environment as part of the internal audit Include suitable work environment as part of the internal audit processproces

77、s无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nDescribes the controls necessary for the Describes the controls necessary for the management of processes, activities, and management of processes, activities, and materials necessary to provide assurance in the materials necessary

78、 to provide assurance in the product:product:n nRequires:Requires:l l a review of contracts before acceptance a review of contracts before acceptancel l product identification and traceability product identification and traceabilityl l test status identification test status identificationl l measure

79、s to control handling and delivery of product measures to control handling and delivery of productl l identification of statistical techniques needed identification of statistical techniques needed无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nProvides controls for:Provides cont

80、rols for:n nDesign activitiesDesign activitiesn nPurchased and customer supplied productPurchased and customer supplied productn nProduction processesProduction processesn nInspection and testing processesInspection and testing processesand related equipmentand related equipmentn nNonconforming prod

81、uctNonconforming productn nServicing activities (if in contract)Servicing activities (if in contract)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.3 Contract ReviewElement 4.3 Contract Reviewn nRequirements:Requirements:l lReview contracts to ensure that:Review contra

82、cts to ensure that: Customer requirements are adequately defined and documentedCustomer requirements are adequately defined and documented Verbal orders are agreed upon before acceptanceVerbal orders are agreed upon before acceptance Differences are resolvedDifferences are resolved Supplier has the

83、capability to meet the requirementsSupplier has the capability to meet the requirementsl lIdentify contract amendments processIdentify contract amendments processl lMaintain contract review records Maintain contract review records n nAdditional:Additional:l lMeet all customer requirements (including

84、 customer specific)Meet all customer requirements (including customer specific)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.4 Design Control (applies to design Element 4.4 Design Control (applies to design responsible suppliers only)responsible suppliers only)n nRequ

85、irements:Requirements:l lIdentify activities, resources, responsibilities, and technical Identify activities, resources, responsibilities, and technical interfaces (use qualified personnel with adequate resources)interfaces (use qualified personnel with adequate resources)l lIdentify design input re

86、quirementsIdentify design input requirements Include statutory/regulatory requirementsInclude statutory/regulatory requirements Resolve unclear requirementsResolve unclear requirements Consider results of Consider results of contract reviewscontract reviews无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Produc

87、t & Process Managementn nElement 4.4 Design Control (cont.)Element 4.4 Design Control (cont.)n nRequirements (cont.):Requirements (cont.):l lDocument design output (verifiable and reviewed before Document design output (verifiable and reviewed before release)release)l lPlan and conduct design review

88、s with appropriate Plan and conduct design reviews with appropriate functions/specialistsfunctions/specialistsl lPerform design verification (ensure design output meets input Perform design verification (ensure design output meets input requirements)requirements)l lPerform design validation (ensure

89、product conforms to user Perform design validation (ensure product conforms to user needs)needs)l lReview, approve, and control design changesReview, approve, and control design changes无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.4 Design Control (cont.)Element 4.4 D

90、esign Control (cont.)n nAdditional:Additional:l lHave ability to use CAD/CAE (unless waived) Have ability to use CAD/CAE (unless waived) l lDesign output results from a process that includes:Design output results from a process that includes: Efforts to simplify, optimize, innovate, and reduce waste

91、Efforts to simplify, optimize, innovate, and reduce waste Use of geometric dimensioning and tolerancing as applicableUse of geometric dimensioning and tolerancing as applicable Analysis of cost/performance/risk trade-offsAnalysis of cost/performance/risk trade-offs Use of feedback from testing, prod

92、uction, and the fieldUse of feedback from testing, production, and the field Use of design FMEAsUse of design FMEAs无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.4 Design Control (cont.)Element 4.4 Design Control (cont.)n nAdditional (cont.):Additional (cont.):l lHave

93、a comprehensive prototype program, using the same Have a comprehensive prototype program, using the same production subcontractors, tools, and processes, wherever production subcontractors, tools, and processes, wherever possiblepossiblel lInclude product life, reliability, and durability in perform

94、ance Include product life, reliability, and durability in performance testing; track to monitor timely completion and conformance to testing; track to monitor timely completion and conformance to requirementsrequirementsl lHave written customer approval or waiver on design changesHave written custom

95、er approval or waiver on design changesl lHave customer review proprietary design changesHave customer review proprietary design changes无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.6 PurchasingElement 4.6 Purchasingn nRequirements:Requirements:l lEvaluate, select, an

96、d control subcontractorsEvaluate, select, and control subcontractorsl lMaintain records of acceptable subcontractors Maintain records of acceptable subcontractors l lEnsure purchasing documents clearly describe the product Ensure purchasing documents clearly describe the product orderedorderedl lRev

97、iew and approve purchasing documentsReview and approve purchasing documentsl lVerify product at subcontractor or by customerVerify product at subcontractor or by customer无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.6 Purchasing (cont.)Element 4.6 Purchasing (cont.)n

98、nAdditional:Additional:l lUse customer approved subcontractorsUse customer approved subcontractorsl lSatisfy governmental and safety requirements for production Satisfy governmental and safety requirements for production materialsmaterialsl lDevelop subcontractors using QS-9000Develop subcontractors

99、 using QS-9000l lRequire 100% on-time delivery performance from Require 100% on-time delivery performance from subcontractors (supplier provides appropriate subcontractors (supplier provides appropriate planning information and purchase commitments)planning information and purchase commitments)l lIm

100、plement a system to monitor delivery performance of Implement a system to monitor delivery performance of subcontractorssubcontractors无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.7 Control of Customer Supplied ProductElement 4.7 Control of Customer Supplied Productn

101、nRequirements:Requirements:l lEstablish methods to verify, store, and maintain customer supplied Establish methods to verify, store, and maintain customer supplied productsproductsl lRecord and report lost, damaged, or unsuitable product to the Record and report lost, damaged, or unsuitable product

102、to the customercustomern nAdditional:Additional:l lIncludes customer owned toolingIncludes customer owned tooling and and returnable packagingreturnable packaging无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.8 Product Identification and TraceabilityElement 4.8 Product

103、 Identification and Traceabilityn nRequirements:Requirements:l lWhere appropriate, identify product by suitable Where appropriate, identify product by suitable means from receipt and during all stages of means from receipt and during all stages of production and deliveryproduction and deliveryl lWhe

104、re traceability is a specified Where traceability is a specified requirement, provide for unique requirement, provide for unique identification of product and identification of product and record identificationrecord identification无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nE

105、lement 4.9 Process ControlElement 4.9 Process Controln nRequirements:Requirements:l lDocument procedures defining manner of productionDocument procedures defining manner of productionl lUse suitable equipment and in a suitable working environmentUse suitable equipment and in a suitable working envir

106、onmentl lComply with standards, control plans, proceduresComply with standards, control plans, proceduresl lMonitor and control key process parameters Monitor and control key process parameters and product characteristicsand product characteristicsl lApprove processes and equipmentApprove processes

107、and equipmentl lStipulate criteria for workmanshipStipulate criteria for workmanshipl lProvide suitable maintenance Provide suitable maintenance of of equipmentequipmentl lQualify special processesQualify special processes无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.

108、9 Process Control (cont.)Element 4.9 Process Control (cont.)n nAdditional:Additional:l lHave a process to ensure compliance with government safety Have a process to ensure compliance with government safety and environmental regulationsand environmental regulationsl lComply with customer requirements

109、 for special characteristicsComply with customer requirements for special characteristicsl lProvide an effective total preventive maintenance system Provide an effective total preventive maintenance system l lDocument process monitoring and operator instructionsDocument process monitoring and operat

110、or instructionsl lPerform preliminary process capability studies and meet Perform preliminary process capability studies and meet customer targets customer targets l lMeet ongoing process performance requirements defined by Meet ongoing process performance requirements defined by customer customer 无

111、忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.9 Process Control (cont.)Element 4.9 Process Control (cont.)n nAdditional (cont.):Additional (cont.):l lVerify job setups Verify job setups l lNotify the customer and record effective dates for process Notify the customer a

112、nd record effective dates for process changeschangesl lFor appearance items, provide:For appearance items, provide: Appropriate lighting for evaluationAppropriate lighting for evaluation Masters for color, grain and texture, as appropriateMasters for color, grain and texture, as appropriate Qualifie

113、d personnel to make appearance evaluationsQualified personnel to make appearance evaluations无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.10 Inspection and TestingElement 4.10 Inspection and Testingn nRequirements:Requirements:l lVerify incoming product before use acc

114、ording to planVerify incoming product before use according to planl lIn determining the approach, consider:In determining the approach, consider: Amount of control at subcontractorAmount of control at subcontractor Recorded evidence of conformance providedRecorded evidence of conformance providedl l

115、If product is released prior to verification:If product is released prior to verification: Positively identify and recordPositively identify and record Recall or replace if found nonconformingRecall or replace if found nonconformingl lInspect and test in-process product according to planInspect and

116、test in-process product according to planl lHold product until verification is completedHold product until verification is completed无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.10 Inspection and Testing (cont.)Element 4.10 Inspection and Testing (cont.)n nRequirement

117、s (cont.): Requirements (cont.): l lInspect and test final product according to planInspect and test final product according to planl lComplete all specified activities and meet requirementsComplete all specified activities and meet requirementsl lDispatch no product unless all planned activities ar

118、e completedDispatch no product unless all planned activities are completedl lEstablish records which show the inspection Establish records which show the inspection status and inspection authoritystatus and inspection authority无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nEleme

119、nt 4.10 Inspection and Testing (cont.)Element 4.10 Inspection and Testing (cont.)n nAdditional:Additional:l lUse zero defects for attribute data sampling plansUse zero defects for attribute data sampling plansl lDocument acceptance criteria for other situations Document acceptance criteria for other

120、 situations l lUse accredited laboratories when required by the customerUse accredited laboratories when required by the customerl lUse one or more of the following in the incoming quality Use one or more of the following in the incoming quality system:system: Receipt of statistical dataReceipt of s

121、tatistical data Receiving inspection and/or testingReceiving inspection and/or testing Second or third-party assessmentsSecond or third-party assessments Use an accredited laboratory for part evaluationUse an accredited laboratory for part evaluation Use subcontractor warrants or certifications (inc

122、lude test results Use subcontractor warrants or certifications (include test results and use one of the other methods)and use one of the other methods)l lPerform layout inspection and functional verification at Perform layout inspection and functional verification at customer prescribed frequencycus

123、tomer prescribed frequency无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.11 Control of Inspection, Measuring, Element 4.11 Control of Inspection, Measuring, and Test Equipmentand Test Equipmentn nRequirements:Requirements:l lDetermine measurements and accuracy required

124、Determine measurements and accuracy requiredl lSelect capable equipmentSelect capable equipmentl lCalibrate equipmentCalibrate equipmentl lIdentify equipment with a calibration status indicatorIdentify equipment with a calibration status indicatorl lMaintain calibration recordsMaintain calibration r

125、ecordsl lEvaluate previous results when out-of-calibration is foundEvaluate previous results when out-of-calibration is foundl lEnsure suitable handling and environmental conditionsEnsure suitable handling and environmental conditionsl lSafeguard equipment from unauthorized adjustmentsSafeguard equi

126、pment from unauthorized adjustments无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.11 Control of Inspection, Measuring, Element 4.11 Control of Inspection, Measuring, and Test Equipment (cont.)and Test Equipment (cont.)n nAdditional:Additional:l lInclude in calibration

127、records:Include in calibration records: Revisions following engineering changesRevisions following engineering changes Gage conditions and actual readings as received for calibrationGage conditions and actual readings as received for calibration Notification to customer if suspect material shippedNo

128、tification to customer if suspect material shippedl lAnalyze variation of measurement and test equipment with Analyze variation of measurement and test equipment with statistical studiesstatistical studies无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.12 Inspection and

129、 Test StatusElement 4.12 Inspection and Test Statusn nRequirements:Requirements:l lIdentify the inspection and test status of product by suitable Identify the inspection and test status of product by suitable means and maintain throughout the production process to means and maintain throughout the p

130、roduction process to ensure that only verified product is usedensure that only verified product is usedn nAdditional:Additional:l lLocation of product in normal production flow is Location of product in normal production flow is insufficient indication of status unlessinsufficient indication of stat

131、us unlessinherently obviousinherently obviousl lAdditional verification/identificationAdditional verification/identification customer requirements must be met customer requirements must be met PASS无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.13 Control of Nonconformi

132、ng Element 4.13 Control of Nonconforming ProductProductn nRequirements:Requirements:l lIdentify, document, evaluate, segregate (when practical), Identify, document, evaluate, segregate (when practical), dispose of nonconforming product, and notify functions dispose of nonconforming product, and noti

133、fy functions concernedconcernedl lDefine responsibility/authority for disposition Define responsibility/authority for disposition l lReview nonconforming productReview nonconforming product Rework to meet specified requirementsRework to meet specified requirements Accept with or without repair by co

134、ncessionAccept with or without repair by concession Regrade for alternative applicationsRegrade for alternative applications Reject or scrapReject or scrapl lObtain customer concession for use or repair where required Obtain customer concession for use or repair where required by contractby contract

135、l lRecord the nonconformity accepted and repairs Record the nonconformity accepted and repairs l lReinspect repaired/reworked product according to planReinspect repaired/reworked product according to plan无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.13 Control of Nonc

136、onforming Element 4.13 Control of Nonconforming ProductProductn nAdditional:Additional:l lControl suspect productControl suspect productl lUse rework instructions Use rework instructions l lQuantify and analyze nonconforming productsQuantify and analyze nonconforming productsl lEstablish a prioritiz

137、ed reduction plan Establish a prioritized reduction plan l lTrack progress toward plan Track progress toward plan l lDo not permit visible rework on exterior of service parts Do not permit visible rework on exterior of service parts without prior approvalwithout prior approvall lGet prior written cu

138、stomer authorization when product or Get prior written customer authorization when product or process is different than PPAP approvedprocess is different than PPAP approved无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.15 Handling, Storage, Packaging, Element 4.15 Hand

139、ling, Storage, Packaging, Preservation, and DeliveryPreservation, and Deliveryn nRequirements:Requirements:l lProvide handling methods that prevent damage or deteriorationProvide handling methods that prevent damage or deteriorationl lProvide secure storage areas and periodically assess condition Pr

140、ovide secure storage areas and periodically assess condition of productof productl lControl packing, packaging, and marking processesControl packing, packaging, and marking processesl lApply appropriate methods for preservation/segregation of Apply appropriate methods for preservation/segregation of

141、 productproductl lProtect product after final inspection and testProtect product after final inspection and test无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.15 Handling, Storage, Packaging, Element 4.15 Handling, Storage, Packaging, Preservation, and DeliveryPreserva

142、tion, and Deliveryn nAdditional:Additional:l lEstablish an inventory management system:Establish an inventory management system: Continuously optimize inventory turns over timeContinuously optimize inventory turns over time Assure stock rotationAssure stock rotation Minimize inventory levelsMinimize

143、 inventory levelsl lMeet customer labeling and Meet customer labeling and packaging requirementspackaging requirementsl lEstablish systems to support Establish systems to support 100% on-time shipments:100% on-time shipments: If not met, implementIf not met, implementcorrective actioncorrective acti

144、on无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.15 Handling, Storage, Packaging, Element 4.15 Handling, Storage, Packaging, Preservation, and Delivery (cont.)Preservation, and Delivery (cont.)n nAdditional (cont.):Additional (cont.):l lUse a systematic approach to mee

145、t lead time requirements and Use a systematic approach to meet lead time requirements and track performancetrack performancel lShip in conformance with customer requirements Ship in conformance with customer requirements (transportation modes and routings)(transportation modes and routings)l lUse or

146、der-driven production schedulingUse order-driven production schedulingl lUse a computerized system and aUse a computerized system and abackup for advance shipping backup for advance shipping notificationsnotifications无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.19 Se

147、rvicingElement 4.19 Servicingn nRequirements:Requirements:l lWhen specified in the contract, establish methods for When specified in the contract, establish methods for performing and verifying servicing performing and verifying servicing n nAdditional:Additional:l lCommunicate the information on se

148、rvice concerns to Communicate the information on service concerns to manufacturing, engineering, and design activitiesmanufacturing, engineering, and design activities无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Product & Process Managementn nElement 4.20 Statistical TechniquesElement 4.20 Statistical Techn

149、iquesn nRequirements:Requirements:l lIdentify the need for statistical techniques for establishing, Identify the need for statistical techniques for establishing, controlling, and verifying process capability and product controlling, and verifying process capability and product characteristicscharac

150、teristicsl lImplement and control the application of these techniquesImplement and control the application of these techniquesn nAdditional:Additional:l lSelect appropriate statistical tools during advanced quality Select appropriate statistical tools during advanced quality planningplanningl lInclu

151、de statistical tools in the control planInclude statistical tools in the control plan无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Automotive Sector Specific Requirementsn nProduction Part ApprovalProduction Part Approvaln nComply with all requirements set forth in the Comply with all requirements set forth

152、in the Production Part Approval Process Production Part Approval Process (PPAP) manual(PPAP) manual无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台When Submission is RequiredIF THERE IS ANY QUESTION CONCERNING IF THERE IS ANY QUESTION CONCERNING THE NEED FOR PRODUCTION PART THE NEED FOR PRODUCTION PART APPROVA

153、L, CONTACT THE CUSTOMER APPROVAL, CONTACT THE CUSTOMER PART APPROVAL ACTIVITYPART APPROVAL ACTIVITY. .Production part approval is always required Production part approval is always required prior to the first production shipment of prior to the first production shipment of product in the following s

154、ituations:product in the following situations:无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台1. 1. A new part or product (i.e., a specific part, material, or A new part or product (i.e., a specific part, material, or color not previously supplied to the specific customer)color not previously supplied to the s

155、pecific customer) 2. 2. Correction of a discrepancy on a previously-submitted Correction of a discrepancy on a previously-submitted partpart3. 3. Product modified by an engineering change to design Product modified by an engineering change to design records, specifications, or materialsrecords, spec

156、ifications, or materials When Submission is Required (cont.)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台When Submission is Required (cont.)Additionally, suppliers must notify the customer and Additionally, suppliers must notify the customer and submit for part approval prior to the first production submit

157、for part approval prior to the first production shipment in the following situations unless the shipment in the following situations unless the responsible part approval activity has specifically responsible part approval activity has specifically waived this requirement for the subject part. waived

158、 this requirement for the subject part. If the If the customer waives a formal submission, all items in customer waives a formal submission, all items in the PPAP be reviewed and updated as necessary the PPAP be reviewed and updated as necessary to reflect the current process. The PPAP contain to re

159、flect the current process. The PPAP contain the name of the responsible part approval activity the name of the responsible part approval activity person granting the waiver and the date.person granting the waiver and the date.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台When Submission is Required (cont.)4.

160、 4.Use of another optional construction or Use of another optional construction or material than was used in the previously-material than was used in the previously-approved partapproved part5. 5.Production from new or modified tools Production from new or modified tools (except perishable tools), d

161、ies, molds, patterns, (except perishable tools), dies, molds, patterns, etc., including additional or replacement toolingetc., including additional or replacement tooling6. 6.Production following refurbishment or Production following refurbishment or rearrangement of existing tooling or equipmentrea

162、rrangement of existing tooling or equipment无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台When Submission is Required (cont.) 7. 7.Production following any change in process Production following any change in process or method of manufactureor method of manufacture8. 8.Production from tooling and equipment Pr

163、oduction from tooling and equipment transferred to a different plant location transferred to a different plant location or from an additional plant locationor from an additional plant location9. 9.Change of source for subcontracted parts, Change of source for subcontracted parts, materials or servic

164、es (e.g.: heat treating, plating)materials or services (e.g.: heat treating, plating)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台When Submission is Required (cont.)10.10. Product re-released after the tooling has Product re-released after the tooling has been inactive for volume production for been inactiv

165、e for volume production for twelve months or moretwelve months or more11.11. Following a customer request to suspend Following a customer request to suspend shipment due to a supplier quality concernshipment due to a supplier quality concern无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Requirements for Part

166、ApprovalThe purpose of these requirements is to identify The purpose of these requirements is to identify changes that might affect the direct customer or changes that might affect the direct customer or ultimate purchaser of the vehicle or component. ultimate purchaser of the vehicle or component.

167、Primary suppliers are responsible for Primary suppliers are responsible for subcontracted material and services.subcontracted material and services.IF THERE IS ANY QUESTION CONCERNING IF THERE IS ANY QUESTION CONCERNING THE NEED FOR PRODUCTION PART THE NEED FOR PRODUCTION PART APPROVAL, CONTACT THE

168、CUSTOMER APPROVAL, CONTACT THE CUSTOMER PART APPROVAL ACTIVITY.PART APPROVAL ACTIVITY.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Requirements for Part Approval (cont.)The following documents and items must be The following documents and items must be completed by the supplier for each part when completed

169、by the supplier for each part when any of the situations in Section II, When any of the situations in Section II, When Submission is Required, occur. Direction on Submission is Required, occur. Direction on which of these items must be provided to the which of these items must be provided to the cus

170、tomer is defined in Section IV, Submission customer is defined in Section IV, Submission Levels.Levels.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Requirements for Part Approval (cont.)1. 1.Production Part Submission Warrant.Production Part Submission Warrant.2. 2.Appearance Approval Report (AAR) for Appea

171、rance Approval Report (AAR) for parts with color, grain, or surface parts with color, grain, or surface requirements.requirements.3. 3.Two sample parts or as agreed to in the Two sample parts or as agreed to in the Process Control Plan. Master sample to Process Control Plan. Master sample to be reta

172、ined by the supplier.be retained by the supplier.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Requirements for Part Approval (cont.)4. 4.All customer and supplier design All customer and supplier design records.records.5. 5.Any authorized engineering change Any authorized engineering change documents not ye

173、t incorporated in the design documents not yet incorporated in the design record but incorporated in the part.record but incorporated in the part.6. 6.Dimensional results referenced to the Dimensional results referenced to the part drawing requirements or on a marked part drawing requirements or on

174、a marked drawing.drawing.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Requirements for Part Approval (cont.)7. 7.Checking aids used in inspecting or testing.Checking aids used in inspecting or testing.8. 8.Material, performance, and durability Material, performance, and durability test results as specified

175、on the design record.test results as specified on the design record.9. 9.Process flow charts.Process flow charts. 1010a. a.Process FMEA Process FMEA 1010b. b.Design FMEA (if supplier has design Design FMEA (if supplier has design responsibility).responsibility).无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台R

176、equirements for Part Approval (cont.)11.11. Control Plans. Control Plans. 12.12. Process capability results.Process capability results.13.13. Measurement system analysis Measurement system analysis (Gage R & R accuracy, linearity, and stability (Gage R & R accuracy, linearity, and stability studies)

177、studies)14.14. Engineering approval when so required Engineering approval when so required on the customers part drawing or on the customers part drawing or specification.specification.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Automotive-Sector-Specific Requirementsn nContinuous improvementContinuous imp

178、rovementn nContinuously improve quality, service, and price/costContinuously improve quality, service, and price/costn nContinue developing innovative improvementsContinue developing innovative improvementsn nDevelop specific action plans for improving processes Develop specific action plans for imp

179、roving processes most important to the customer once stability and most important to the customer once stability and capability demonstratedcapability demonstratedn nPerfect process methods for characteristics evaluated Perfect process methods for characteristics evaluated using attributes datausing

180、 attributes datan nIdentify and implement opportunities for quality and Identify and implement opportunities for quality and productivity improvementsproductivity improvementsn nDemonstrate knowledge of specific techniques for Demonstrate knowledge of specific techniques for continuous improvement a

181、nd use those that are continuous improvement and use those that are appropriateappropriate无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Automotive-Sector-Specific Requirementsn nManufacturing capabilitiesManufacturing capabilitiesn nUse a cross-functional team approach for developing Use a cross-functional t

182、eam approach for developing facilities, processes, and equipment plans during the facilities, processes, and equipment plans during the advanced quality planning processadvanced quality planning processn nDevelop methods for evaluating effectiveness of Develop methods for evaluating effectiveness of

183、 existing operations and processesexisting operations and processesn nUse mistake-proofing methodology when potential Use mistake-proofing methodology when potential sources of nonconforming units are identifiedsources of nonconforming units are identifiedn nProvide resources for tool and gage desig

184、n, fabrication, Provide resources for tool and gage design, fabrication, and full-dimensional inspection; and implement a and full-dimensional inspection; and implement a system for tooling managementsystem for tooling managementn nPermanently mark customer-owned tools and Permanently mark customer-

185、owned tools and equipment so ownership is apparentequipment so ownership is apparent无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Customer-Specific Requirementsn nChrysler-Specific RequirementsChrysler-Specific Requirementsn nSome requirements which go beyond the fundamental Some requirements which go beyond

186、 the fundamental quality system requirements:quality system requirements:l lChrysler suppliers must be third-party Chrysler suppliers must be third-party registered by July 31, 1997registered by July 31, 1997l lShields, Diamonds, and Pentagon Shields, Diamonds, and Pentagon Critical Characteristics

187、GuidelinesCritical Characteristics Guidelinesl lA complete annual inspection layoutA complete annual inspection layoutl lInternal quality system audits conducted at least once per yearInternal quality system audits conducted at least once per yearl lDesign validation/production verification performe

188、d once per Design validation/production verification performed once per model yearmodel yearl lNonconformances addressed with a written corrective action Nonconformances addressed with a written corrective action plan following the “7D” formatplan following the “7D” format无忧资源： 中国最大最全的资源下载网教育新天地：中国最

189、大的学习培训咨询平台Customer-Specific Requirementsn nFord-Specific RequirementsFord-Specific Requirementsn nSome requirements which go beyond the fundamental Some requirements which go beyond the fundamental quality system requirements:quality system requirements:l lFord suppliers are not required toFord supp

190、liers are not required to be third-party registered at this timebe third-party registered at this timel lControl item parts identified with an inverted Control item parts identified with an inverted delta and have special requirements for Control Plans, delta and have special requirements for Contro

191、l Plans, FMEAs, etc.FMEAs, etc.l lCustomer approval of Control Plans and FMEAsCustomer approval of Control Plans and FMEAsl lTeam oriented problem solving (8D)Team oriented problem solving (8D)l lStatistical verification of job set-upsStatistical verification of job set-upsl lQuality Operating Syste

192、m Quality Operating System 无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Customer-Specific Requirementsn nGeneral Motors-Specific RequirementsGeneral Motors-Specific Requirementsn nSome requirements which go beyond the fundamental Some requirements which go beyond the fundamental quality system requirements:

193、quality system requirements:l lGeneral Motors suppliers must be third-partyGeneral Motors suppliers must be third-partyregistered by December 31, 1997registered by December 31, 1997l lNAO suppliers shall verify that NAO suppliers shall verify that they are using the latest version of they are using

194、the latest version of General Motors general procedures General Motors general procedures and other requirements at least annuallyand other requirements at least annuallyl lKey Characteristics Designation SystemKey Characteristics Designation Systeml lProblem reporting and resolution procedureProble

195、m reporting and resolution procedurel lUPC labeling for commercial service applicationsUPC labeling for commercial service applications无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MODULE 3The Audit System无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台The Audit Systemn nThis module will discuss:This module will discus

196、s:n nThe objectives of an audit programThe objectives of an audit programn nTypes of auditsTypes of auditsn nEssential elements which are Essential elements which are necessary for an audit systemnecessary for an audit system to operate effectivelyto operate effectivelyn nFactors which should be con

197、sideredFactors which should be consideredwhen developing an audit schedulewhen developing an audit schedulen nInstances when normally scheduled audits should be Instances when normally scheduled audits should be supplemented with additional auditssupplemented with additional audits无忧资源： 中国最大最全的资源下载网

198、教育新天地：中国最大的学习培训咨询平台Audit System : Management Tooln nProvides formal feedbackProvides formal feedbackn nReports on status and adequacyReports on status and adequacyn nProvides management with confidence in Provides management with confidence in product or serviceproduct or service无忧资源： 中国最大最全的资源下载网教育

199、新天地：中国最大的学习培训咨询平台Assessment and AuditAssessmentA systematic investigation of the documented quality system andthe implementation of the quality system to determineeffectiveness.Documentation ReviewComparison of qualitydocumentation to QS-9000requirements to determineadequacy.On-Site AuditComparison

200、of the qualitydocumentation to theimplementation of thequality system to determineeffectiveness.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit System Objectivesn nTo determine that a quality program has been To determine that a quality program has been developed and documenteddeveloped and documentedn n

201、To verify that the quality program has been To verify that the quality program has been implemented and is being adhered to by the implemented and is being adhered to by the organizationorganizationn nTo evaluate the effectiveness of the quality To evaluate the effectiveness of the quality program i

202、n meeting quality requirements and program in meeting quality requirements and achieving management goalsachieving management goalsn nTo identify nonconformances and program To identify nonconformances and program weaknessesweaknessesn nTo ensure correction of identified or potential To ensure corre

203、ction of identified or potential problemsproblems无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Additional Functions of the Audit Systemn nProvides feedback on regulatory requirements Provides feedback on regulatory requirements and potential and potential litigation issueslitigation issuesn nProvides unbiase

204、d evaluationsProvides unbiased evaluationsn nPromotes communicationsPromotes communicationsn nEvaluates areas not readily Evaluates areas not readily visible to managementvisible to managementn nFormalizes corrective Formalizes corrective actions and process actions and process improvementsimproveme

205、nts无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Classificationsn nINTERNAL AUDITS (first party) n nEXTERNAL AUDITS (second party)n nEXTRINSIC AUDITS (third party)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Classificationsn nAudits may be classified by scope and depth:Audits may be classified by scope and dep

206、th:n nProcess audits Process audits l leffectiveness of the quality system.effectiveness of the quality system.specific process or activityspecific process or activityn nProduct/service audits Product/service audits l lassessment of the quality system.assessment of the quality system.product or serv

207、iceproduct or service无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit System Elementsn nTotal management support, and commitmentTotal management support, and commitmentn nManpower, funding, and facilitiesManpower, funding, and facilitiesn nAuthority, responsibilities, and organizational Authority, respons

208、ibilities, and organizational independenceindependencen nAccess to facilities, documents, and personnelAccess to facilities, documents, and personneln nMethod for reporting resultsMethod for reporting resultsn nAccess to appropriate levels of managementAccess to appropriate levels of managementn nCo

209、rrective/preventive action verificationCorrective/preventive action verification无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Scheduling Auditsn nRegulatory documentsRegulatory documentsn nIndustry standardsIndustry standardsn nCorporate commitmentsCorporate commitmentsn nQA program requirementsQA program re

210、quirementsn nPrevious history of Previous history of performance for the areas performance for the areas to be auditedto be auditedn nIndustry experienceIndustry experience无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Scheduling Audits Additional Scheduling Factorsn nRegularly scheduled based on:Regularly sc

211、heduled based on:n nImportanceImportancen nComplexityComplexityn nStatus of activityStatus of activityn nInitiated early in the life of the activityInitiated early in the life of the activityn nScheduled to assure adequate coverageScheduled to assure adequate coveragen nBreadth and depth of scope Br

212、eadth and depth of scope ensure adequate evaluationensure adequate evaluationn nFrequency adjusted based upon:Frequency adjusted based upon:n nAudit resultsAudit resultsn nManagement directionManagement direction无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Scheduling Audits Supplemental Auditsn nAny time si

213、gnificant changes are made which could Any time significant changes are made which could affect the programaffect the programn nWhen it is suspected that the quality of an item is in When it is suspected that the quality of an item is in jeopardy due to deficiencies in the quality programjeopardy du

214、e to deficiencies in the quality programn nWhen a systematic, independent assessment of When a systematic, independent assessment of program effectiveness is considered necessaryprogram effectiveness is considered necessaryn nIf required, to verify implementation of corrective If required, to verify

215、 implementation of corrective actionsactions无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MODULE 4AuditorQualification无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Auditor Qualificationn nThis module will discuss:This module will discuss:n nIndustry standards which address th requirements for Industry standards which

216、 address th requirements for auditing and auditor qualificationsauditing and auditor qualificationsn nRequirements for qualification of auditors Requirements for qualification of auditors n nHow an auditor may maintain his/her proficiencyHow an auditor may maintain his/her proficiencyn nTraining req

217、uirements for auditorsTraining requirements for auditorsn nEvaluation requirements for auditors Evaluation requirements for auditors 无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台ISO 10011n nThe focus of this course is on the requirements of The focus of this course is on the requirements of ISO 10011. This

218、standard consists of three parts:ISO 10011. This standard consists of three parts:n nISO 10011-1ISO 10011-1l lProvides guidelines for performing an audit of a quality system of an Provides guidelines for performing an audit of a quality system of an organization. It allows users to adjust the guidel

219、ines described to suit organization. It allows users to adjust the guidelines described to suit their needs.their needs.n nISO 10011-2ISO 10011-2l lDescribes the minimum criteria required to qualify audits to ensure Describes the minimum criteria required to qualify audits to ensure that quality sys

220、tems audits are carried out effectively and uniformly. that quality systems audits are carried out effectively and uniformly. It also provides the method by which individual auditors compliance It also provides the method by which individual auditors compliance to the criteria should be judged and m

221、aintained.to the criteria should be judged and maintained.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台ISO 10011n nISO 10011-3ISO 10011-3l lEstablishes a capability to provide overall management of the audit Establishes a capability to provide overall management of the audit process for organizations which

222、have an ongoing need to carry out process for organizations which have an ongoing need to carry out quality system audits.quality system audits.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Auditor Qualificationn nKey element in the audit processKey element in the audit processn nAuditor capabilities directl

223、y impact audit Auditor capabilities directly impact audit resultsresults无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Qualification Criterian nEducation Education n nCompletion of secondary educationCompletion of secondary educationn nCommunication skillsCommunication skillsn nDemonstrated competenceDemonstr

224、ated competencen nTraining Training n nTraining to the extent necessary to ensure competence Training to the extent necessary to ensure competence in skills required for carrying out audits, and for in skills required for carrying out audits, and for managing audits:managing audits:l lKnowledge and

225、understanding of standardsKnowledge and understanding of standardsl lAuditing techniquesAuditing techniquesl lAdditional skills required for managing an auditAdditional skills required for managing an audit无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Qualification Criterian nExamination Examination n nCompe

226、tence should be demonstrated through written or Competence should be demonstrated through written or oral examsoral examsn nExperienceExperiencen nFour years full-time practical workplace experience, at Four years full-time practical workplace experience, at least two years of which should be in qua

227、lity assurance least two years of which should be in quality assurance activitiesactivitiesn nExperience in the entire audit processExperience in the entire audit processn nParticipation in a minimum of four audits of at least Participation in a minimum of four audits of at least twenty audit daystw

228、enty audit days无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Auditor Personal Attributesn nAuditor candidates must:Auditor candidates must:n nBe open mindedBe open mindedn nPossess sound judgement,Possess sound judgement,analytical skills, and tenacityanalytical skills, and tenacityn nPerceive situations rea

229、listicallyPerceive situations realisticallyn nMaintain a broad perspectiveMaintain a broad perspectiven nUnderstand the role of each Understand the role of each individualindividual无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Auditor Abilitiesn nApply these attributes to:Apply these attributes to:n nObtain

230、and assess objective evidence fairlyObtain and assess objective evidence fairlyn nRemain true to audit purposeRemain true to audit purposen nConstantly evaluate the situationConstantly evaluate the situationn nTreat personnel in a way that achieves Treat personnel in a way that achieves audit purpos

231、eaudit purposen nAvoid distractionsAvoid distractionsn nCommit full attention to the auditCommit full attention to the auditn nHandle stressful situationsHandle stressful situationsn nArrive at acceptable conclusionsArrive at acceptable conclusionsn nRemain true to a conclusionRemain true to a concl

232、usion无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Evaluation Paneln nChaired by an individual currently active in Chaired by an individual currently active in managing significant auditing operationsmanaging significant auditing operationsn nEvaluation panel should consist of not less than Evaluation panel

233、should consist of not less than two memberstwo membersn nDetermine that the candidate has acquired Determine that the candidate has acquired necessary knowledge skillsnecessary knowledge skillsn nPeriodically review auditor performancePeriodically review auditor performance无忧资源： 中国最大最全的资源下载网教育新天地：中国

234、最大的学习培训咨询平台Evaluation Paneln nThe panel should use techniques such as:The panel should use techniques such as:n nInterviews with candidateInterviews with candidaten nEvaluations of written workEvaluations of written workn nDiscussions with former employers, Discussions with former employers, colleag

235、ues, etc.colleagues, etc.n nStructured testing for appropriate characteristicsStructured testing for appropriate characteristicsn nRole playingRole playingn nObservations under actual audit conditionsObservations under actual audit conditionsn nRecords of training and related examinationsRecords of

236、training and related examinations无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Maintenance of Competencen nCurrent knowledge of quality systems Current knowledge of quality systems standards and requirementsstandards and requirementsn nCurrent knowledge of auditing procedures and Current knowledge of auditin

237、g procedures and methodsmethodsn nParticipate in refresher trainingParticipate in refresher trainingn nHave performance reviewed at Have performance reviewed at least every three years by least every three years by evaluation panelevaluation panel无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MODULE 5Human Fa

238、ctorsRole in Auditing无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Human Factors Role in Auditingn nThis module will discuss:This module will discuss:n nFactors which can affect the ability of an auditor to Factors which can affect the ability of an auditor to obtain and assess informationobtain and assess i

239、nformationn nWhy an auditor needs to understand human factorsWhy an auditor needs to understand human factorsn nOrganizations or individuals impacted by the results of Organizations or individuals impacted by the results of the auditthe auditn nMethods which may be used by the auditor to deal with M

240、ethods which may be used by the auditor to deal with hostilityhostilityn nFactors which may induce stress on the part of the Factors which may induce stress on the part of the auditor and methods for dealing with eachauditor and methods for dealing with each无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Intro

241、ductionn nAudit results depend upon:Audit results depend upon:n nQUANTITY of informationQUANTITY of informationn nQUALITY of informationQUALITY of informationn nAUDITORs ability to obtainAUDITORs ability to obtainand evaluate informationand evaluate information无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Au

242、dit Resultsn nAudit results are of concern to:Audit results are of concern to:n nManagement of the quality systemManagement of the quality systemn nThe customerThe customern nManagement of the audited organizationManagement of the audited organizationn nThe personnel who accomplish the activitiesThe

243、 personnel who accomplish the activitiesn nRegulatory or licensing agenciesRegulatory or licensing agencies无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Stressn nResults:Results:n nCan reduce auditor effectivenessCan reduce auditor effectivenessn nCan reduce information accessCan reduce information acc

244、ess无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Stressn nReactions:Reactions:n nProgressive hostilityProgressive hostilityl lIncreasingly antagonisticIncreasingly antagonisticl lDefensive reactionDefensive reactionn nSudden hostilitySudden hostilityl lInternal conflictInternal conflictl lFrustrationFr

245、ustrationn nImmediate hostilityImmediate hostilityl lDirect conflictDirect conflictl lAvoidanceAvoidance无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Stressn nConsiderationsConsiderationsn nApproachApproachn nEmpathy and sympathyEmpathy and sympathyn nCompliance with local customsCompliance with local

246、customsn nObjectivity and freedom from biasObjectivity and freedom from biasn nAudit ethicsAudit ethicsn nReasonable doubtReasonable doubtn nImpersonal reportingImpersonal reportingn nValue judgementsValue judgementsn nRapportRapportn nProprietary informationProprietary informationn nInterview setti

247、ngInterview settingn nMinor conditionsMinor conditions无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Common Problem Areasn nResistance to changeResistance to changen nVolunteered information/tip-offsVolunteered information/tip-offsn nInternal conflictsInternal conflictsn nDeceptionDeceptionn nDiversionDiversi

248、on无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Auditor Etiquetten nBe openBe openn nUse two-way communicationUse two-way communicationn nDont emphasize errorsDont emphasize errorsn nDont focus on individualsDont focus on individualsn nWhen wrong admit itWhen wrong admit itn nRespect organizational channelsR

249、espect organizational channelsn nFoster an atmosphere of Foster an atmosphere of seeking to improveseeking to improven nBelieve statements Believe statements but require proofbut require proof无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Auditor Etiquetten nDont hedgeDont hedgen nKeep your disruptions of oth

250、ers to a minimumKeep your disruptions of others to a minimumn nRespect expertiseRespect expertisen nDeal with frustrationDeal with frustrationn nMake auditees responsibilities clearMake auditees responsibilities clearn nBe sure to differentiate between Be sure to differentiate between recommendation

251、s and requirementsrecommendations and requirements无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MODULE 6AuditPlanning无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Planningn nThis module will discuss:This module will discuss:n nActivities which take place during the planning phase Activities which take place dur

252、ing the planning phase of the audit processof the audit processn n“Vertical slice” and “horizontal slice” sampling“Vertical slice” and “horizontal slice” samplingn nUses for an audit checklistUses for an audit checklistn nItems which should be considered orItems which should be considered orconsulte

253、d when preparing for an auditconsulted when preparing for an auditn nMethods for selecting audit samplesMethods for selecting audit samples无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Planningn nIncludes:Includes:n nSelecting an audit teamSelecting an audit teamn nInterfacing with the audited organiza

254、tion to obtain Interfacing with the audited organization to obtain preliminary informationpreliminary informationn nOrienting the audit teamOrienting the audit teamn nDeveloping an audit planDeveloping an audit plann nAssembling a checklistAssembling a checklist无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台T

255、eam Selectionn nNumber of personnel and collective team Number of personnel and collective team experience depends upon:experience depends upon:n nAudit scopeAudit scopen nAvailable personnelAvailable personneln nAvailable time to perform the auditAvailable time to perform the auditn nNeed for speci

256、al skills or expertiseNeed for special skills or expertise无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Benefits of a Knowledgeable Teamn nLess time and effort is required during the Less time and effort is required during the planning phase of the auditplanning phase of the auditn nThe investigation is more

257、 efficient and more The investigation is more efficient and more effectiveeffectiven nReporting is more meaningfulReporting is more meaningfuln nCredibility is established with the audited Credibility is established with the audited organizationorganization无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Team S

258、izen nSingle person team is not recommendedSingle person team is not recommendedn n2 or 3 person team is optimal2 or 3 person team is optimaln nBenefits of multiple-person teams:Benefits of multiple-person teams:n nMore experience and More experience and technical technical expertiseexpertisen nBett

259、er focus on specific areasBetter focus on specific areasn nSynergy/brainstorming,Synergy/brainstorming,“sounding boards”“sounding boards”无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Interfacing With the Audited OrganizationConfirm the auditObtain informationProvide written notification无忧资源： 中国最大最全的资源下载网教育新天

260、地：中国最大的学习培训咨询平台Written Notificationn nTypically includes:Typically includes:n nA brief description of the purpose A brief description of the purpose and scope of the auditand scope of the auditn nIndication of the authority toIndication of the authority toconduct the auditconduct the auditn nOpening

261、 meeting time and dateOpening meeting time and daten nTentative schedule of major Tentative schedule of major audit activitiesaudit activitiesn nIdentification of the audit Identification of the audit team membersteam members无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Team Orientationn nAudit scopeAu

262、dit scopen nAudit team capabilities and team member Audit team capabilities and team member expertiseexpertisen nGround rules for the auditGround rules for the auditn nSpecific issues, problem areas, and Specific issues, problem areas, and management concernsmanagement concernsn nActivities and crit

263、ical areas to be investigatedActivities and critical areas to be investigated无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Plann nDeveloped before document reviewDeveloped before document reviewn nHelps to determine effectivenessHelps to determine effectivenessn nHelps in:Helps in:n nDetermining critic

264、al information and activitiesDetermining critical information and activitiesn nIdentifying samplesIdentifying samplesn nMaximizing use of time and manpower Maximizing use of time and manpower n nProvides an outline for approach Provides an outline for approach n nDeveloped by teamDeveloped by team无忧

265、资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Plan Developmentn nIdentify purpose of the process under Identify purpose of the process under investigation and determine what should be investigation and determine what should be accomplishedaccomplishedn nIdentify customer of the processIdentify customer o

266、f the processn nDetermine customer needs, expectations, Determine customer needs, expectations, expected productexpected productn nIdentify critical informationIdentify critical informationn nDetermine how to obtain information which Determine how to obtain information which provides an indication o

267、f process performance:provides an indication of process performance:n nIn the allotted time In the allotted time n nWith the given audit teamWith the given audit team无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Samplingn nAn audit is a sampling processAn audit is a sampling processn nAudit results are impac

268、ted by the quality and Audit results are impacted by the quality and quantity of information obtainedquantity of information obtainedn nObtaining informationObtaining informationn nObserving activitiesObserving activitiesn nInterviewing personnelInterviewing personneln nReviewing documentationReview

269、ing documentation无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Sample Methodsn nStatisticaln nPopulation sizePopulation sizen nSample sizeSample sizen nSelectiven nProblem areasProblem areasn nComplex activitiesComplex activitiesn nSignificant riskSignificant risk无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Sampling

270、n nHorizontal sliceHorizontal slicen nRelatively large sample sizeRelatively large sample sizen nTypically focuses on one quality Typically focuses on one quality system elementsystem elementn nVertical sliceVertical slicen nRelatively small Relatively small sample sizesample sizen nTypically focuse

271、s on Typically focuses on several quality systemseveral quality systemelementselements无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Checklist Guidancen nUse the QSA checklist as the primary guide Use the QSA checklist as the primary guide all questions that applyall questions that applyn nMake “user friendly

272、”Make “user friendly”n nUse a logical formatUse a logical formatn nAvoid detailed checklistsAvoid detailed checklistsn nAllow for flexibilityAllow for flexibility无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Checklist Functionsn nEnsure audit scope is coveredEnsure audit scope is coveredn nEnsure areas

273、 investigated to an appropriate depthEnsure areas investigated to an appropriate depthn nIdentify audit samples to be takenIdentify audit samples to be takenn nFacilitate team assignmentFacilitate team assignmentn nProvide a means of documenting investigationsProvide a means of documenting investiga

274、tions无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Checklist Functionsn nProvide a method to track progress throughout Provide a method to track progress throughout the auditthe auditn nProvide a method for rapid Provide a method for rapid evaluation of informationevaluation of informationn nFacilitate

275、 writing theFacilitate writing theaudit reportaudit reportn nProvide historical dataProvide historical data无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Developing Checklist Questionsn nDocument reviewDocument reviewn nSpecificationsSpecificationsn nPast performancePast performancen nKnowledge of organizatio

276、nKnowledge of organization无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MODULE 7Audit Performance无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Performancen nThis module will discussThis module will discussn nActivities which occur during performanceActivities which occur during performancen nReasons for intervi

277、ewsReasons for interviewsn nUnderstanding the difference between “open” and “closed” Understanding the difference between “open” and “closed” questionsquestionsn nUse of team meetingsUse of team meetingsn nNonconformance statementNonconformance statementn nAudit reportAudit reportn nPromoting correc

278、tive actionPromoting corrective action无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit PerformanceFive distinct parts:Five distinct parts:Opening meetingAudit investigationAudit team meetingClosing meetingAudit report无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Opening Meetingn nShould include:Should include:n nA

279、ttendance rosterAttendance rostern nDescription of audit purposeDescription of audit purposeand scopeand scopen nIntroduction of audit teamIntroduction of audit teamn nReview of audit methods andReview of audit methods andrulesrulesn nReview of audit agendaReview of audit agendan nVerification of st

280、atus of the Verification of status of the quality systemquality systemn nVerification of status of activitiesVerification of status of activitiesn nEstablishment of lines of communicationEstablishment of lines of communication无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Opening Meetingn nIdentify interfaces

281、Identify interfacesn nMeet counterpartsMeet counterpartsn nSchedule interviewsSchedule interviewsn nEstablish a team meeting areaEstablish a team meeting arean nAnswer questionsAnswer questions无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Opening Meetingn nConducting the meetingConducting the meetingn nBe bu

282、sinesslike and professionalBe businesslike and professionaln nProvide auditee with as much information as possibleProvide auditee with as much information as possiblel lAudit planAudit planl lTimingTimingn nKeep meeting as brief as possibleKeep meeting as brief as possiblen nMake note of problems an

283、d concerns for further investigationMake note of problems and concerns for further investigation无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Investigationn nLimiting factors:Limiting factors:n nTime and number of auditorsTime and number of auditorsn nFactors to closely monitor:Factors to closely monit

284、or:n nEffective audit team managementEffective audit team managementn nFacility tourFacility tourn nProper investigative techniquesProper investigative techniquesn nUse of audit team meetingsUse of audit team meetings无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Team Managementn nTeam leader responsibi

285、lities:Team leader responsibilities:n nPlanning the auditPlanning the auditn nScheduling meetingsScheduling meetingsn nDetermining changes to scope of audit if necessaryDetermining changes to scope of audit if necessaryn nRedirecting manpower to accommodate changing conditionsRedirecting manpower to

286、 accommodate changing conditionsn nKeeping within scheduleKeeping within schedulen nCommunicatingCommunicatingn nWriting final reportWriting final report无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Facility Tourn nCan help to:Can help to:n nUnderstand activity and product flowUnderstand activity and product

287、 flown nEvaluate resources and facilitiesEvaluate resources and facilitiesn nIdentify areas for further examinationIdentify areas for further examinationn nIdentify individuals to interviewIdentify individuals to interviewn nClarify why elements are implemented in a particular Clarify why elements a

288、re implemented in a particular manner manner 无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Investigative Techniquesn nLet problems lead the investigation use the checklist as a Let problems lead the investigation use the checklist as a guideguiden nGet a complete perspective on the problem 6 “ws”Get a comple

289、te perspective on the problem 6 “ws”n nConduct interviewsConduct interviewsn nWhen a problem is not significant move onWhen a problem is not significant move onn nDocument everything you examineDocument everything you examinen nDont neglect off-shiftsDont neglect off-shifts无忧资源： 中国最大最全的资源下载网教育新天地：中国

290、最大的学习培训咨询平台Obtaining Informationn nDocuments/recordsDocuments/recordsn nCustomer requirements (contract)Customer requirements (contract)n nPrevious problems (QRs DMRs PR/Rs)Previous problems (QRs DMRs PR/Rs)n nMaintenance historyMaintenance historyn nRegulatory requirementsRegulatory requirementsn n

291、Observing activitiesObserving activitiesn nSource of most accurate informationSource of most accurate informationn nPrinciples of observationPrinciples of observationn nInterviewsInterviews无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Observingn nWhat actually occursWhat actually occursn nDocumentation accur

292、ately reflects activity Documentation accurately reflects activity n nAdequacy of controlsAdequacy of controlsn nAdequacy of trainingAdequacy of trainingn nCompliance with program requirementsCompliance with program requirementsn nAdequacy of document controlAdequacy of document control无忧资源： 中国最大最全的

293、资源下载网教育新天地：中国最大的学习培训咨询平台Observingn nTaking notesTaking notesn nDate and timeDate and timen nWho Who n nDocumentsDocumentsn nSequence of eventsSequence of eventsn nDifficulties encounteredDifficulties encounteredn nCritical steps if activity is complex Critical steps if activity is complex n nEquipme

294、nt affectedEquipment affectedn nSpecial equipmentSpecial equipment无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Interviewsn nProvide the following information:Provide the following information:n nUnderstanding of program requirementsUnderstanding of program requirementsn nAdequacy of personnel trainingAdequa

295、cy of personnel trainingn nAdequacy of communications and interfacesAdequacy of communications and interfacesn nCommunication of management attitudes and policiesCommunication of management attitudes and policiesn nProblem solving abilitiesProblem solving abilitiesn nInterview information always rep

296、resents the Interview information always represents the interpretation of an activity by the person being interpretation of an activity by the person being interviewedinterviewed无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Communication Techniquesn nNonverbalNonverbaln nBody languageBody languagen nFacial e

297、xpressionsFacial expressionsn nVerbalVerbaln nQuestioning and Questioning and listening skillslistening skills无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Types of Questionsn nOpenOpenn nObtain broad informationObtain broad informationn nGenerally require explanation as a responseGenerally require explanati

298、on as a responsen nClosedClosedn nObtain specific informationObtain specific informationn nGenerally a “yes” or “no” responseGenerally a “yes” or “no” responsen nProvide limited informationProvide limited informationn nProbingProbingn nClarify already obtained informationClarify already obtained inf

299、ormationn nLeading/loadedLeading/loadedn nLeading the answer is obviousLeading the answer is obviousn nLoaded has no correct responseLoaded has no correct responsen nSHOULD BE AVOIDED!SHOULD BE AVOIDED!无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Active Listening Skillsn nParaphrasingParaphrasingn nDid I he

300、ar you correctly?Did I hear you correctly?n nWaitingWaitingn nMake sure they are finishedMake sure they are finishedn nNot interruptingNot interruptingn nDont be impatientDont be impatientn nSummarizingSummarizingn nCorrect any Correct any misunderstandingsmisunderstandings无忧资源： 中国最大最全的资源下载网教育新天地：中国

301、最大的学习培训咨询平台Conducting the Interviewn nGeneral guidelinesGeneral guidelinesn nConduct in a quiet environmentConduct in a quiet environmentn nInterview separatelyInterview separatelyn nUse tape recorders carefullyUse tape recorders carefullyn nIf possible have two people conduct the interviewIf possib

302、le have two people conduct the interviewl lOne to askOne to askl lOne to take notesOne to take notesn nAsk the same questions at different levelsAsk the same questions at different levelsn nBack up interviews with documented evidenceBack up interviews with documented evidence无忧资源： 中国最大最全的资源下载网教育新天地：

303、中国最大的学习培训咨询平台Conducting the Interviewn nPreparationPreparationn nWhat type of informationWhat type of informationn nWho will be interviewedWho will be interviewedn nKey questionsKey questionsn nSchedule time and locationSchedule time and locationn nBrief the intervieweeBrief the interviewee无忧资源： 中国最

304、大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Conducting the Interviewn nConductConductn nIntroduce yourself Why are you here?Introduce yourself Why are you here?n nEvaluate the interviewees attitudeEvaluate the interviewees attituden nBegin with general questionsBegin with general questionsn nAvoid distractionsAvoid

305、 distractionsn nTake notesTake notesn nSummarize major pointsSummarize major pointsn nPost interviewPost interviewn nReview and summarize notesReview and summarize notesn nFollow up on additional investigationsFollow up on additional investigationsn nConduct additional interviewsConduct additional i

306、nterviews无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Document Reviewn nProvides a large portion of the objective evidenceProvides a large portion of the objective evidencen nDetermines the adequacy of the documentation to Determines the adequacy of the documentation to meet requirements of QS-9000meet requ

307、irements of QS-9000无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Adequacyn nAs used in QS-9000 means that the specific supplier As used in QS-9000 means that the specific supplier documentation meets QS-9000 intent given the documentation meets QS-9000 intent given the scope of the suppliers operations.scope

308、 of the suppliers operations.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台System Effectivenessn nSome methods to help evaluate effectiveness:Some methods to help evaluate effectiveness:n nEvaluating management support and interestEvaluating management support and interestn nInterviewing to determine if pers

309、onnel understand their job, Interviewing to determine if personnel understand their job, instructions, quality objectives, customer requestsinstructions, quality objectives, customer requestsn nReviewing the quality cost systemReviewing the quality cost systemn nAssessing aggressiveness and effectiv

310、eness of corrective Assessing aggressiveness and effectiveness of corrective actionsactionsn nObserving and interviewing to determine commitment to Observing and interviewing to determine commitment to management resultsmanagement resultsn nDetermine if end results meet the customers needs and Deter

311、mine if end results meet the customers needs and expectationsexpectations无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Team Meetingsn nAccomplish the following:Accomplish the following:n nAllows team leader to track progressAllows team leader to track progressn nAllows exchange of informationAllows exc

312、hange of informationn nAssists in identifying systemic problemsAssists in identifying systemic problemsn nTakes advantage of technical experience of entire teamTakes advantage of technical experience of entire teamn nTakes advantage of brainstorming and synergyTakes advantage of brainstorming and sy

313、nergyn nProvides a forum for determining nonconformance Provides a forum for determining nonconformance statements, opportunities for improvement, and summarizing statements, opportunities for improvement, and summarizing results for the closing meetingresults for the closing meeting无忧资源： 中国最大最全的资源下

314、载网教育新天地：中国最大的学习培训咨询平台Documenting Nonconformancesn nImportant function of the teamImportant function of the teamn nRarely an isolated caseRarely an isolated casen nUsually in the form of a symptomUsually in the form of a symptomn nTeam needs to look for significance and scopeTeam needs to look for si

315、gnificance and scopen nDoes symptom lead to nonconformance?Does symptom lead to nonconformance?n nMake sure there is adequate investigation prior Make sure there is adequate investigation prior to writing the nonconformanceto writing the nonconformance无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Major Nonco

316、nformancen nThe absence or total breakdown of a system to The absence or total breakdown of a system to meet a requirement of QS-9000.meet a requirement of QS-9000.n nA number of minor nonconformities against one requirement A number of minor nonconformities against one requirement can represent a t

317、otal breakdown of the system and thus be can represent a total breakdown of the system and thus be considered a major nonconformity.considered a major nonconformity.n nAny noncompliance that would result in the Any noncompliance that would result in the probable shipment of a nonconforming probable

318、shipment of a nonconforming product. product. n nA condition that may result in the failure or materially A condition that may result in the failure or materially reduce the usability of the products or services for their reduce the usability of the products or services for their intended purposeint

319、ended purpose. .无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Major Nonconformancen nA noncompliance that judgment and A noncompliance that judgment and experience indicate is likely either to result in experience indicate is likely either to result in the failure of the quality system or to materially the f

320、ailure of the quality system or to materially reduce its ability to assure controlled processes reduce its ability to assure controlled processes and products.and products.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Major Nonconformancen nThe absence or total breakdown of a system to The absence or total b

321、reakdown of a system to meet a requirement of QS-9000:meet a requirement of QS-9000:n nThe quality manual says that final inspection is performed in The quality manual says that final inspection is performed in accordance with QS-9000. The audit identifies that no final accordance with QS-9000. The

322、audit identifies that no final inspection is actually performed.inspection is actually performed.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Major Nonconformancen nAny noncompliance that would result in the Any noncompliance that would result in the probable shipment of nonconforming product:probable shipm

323、ent of nonconforming product:n nWhile visiting the widget manufacturing area, the auditor While visiting the widget manufacturing area, the auditor noticed an unmarked box of widgets near the shipping area. noticed an unmarked box of widgets near the shipping area. He was told that these were reject

324、ed parts and will be He was told that these were rejected parts and will be shipped to a company that can salvage some of the valuable shipped to a company that can salvage some of the valuable materials.materials.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Major Nonconformancen nA noncompliance that judgm

325、ent and A noncompliance that judgment and experience indicate is likely either to result in experience indicate is likely either to result in the failure of the quality system or to materially the failure of the quality system or to materially reduce its ability to assure controlled processes reduce

326、 its ability to assure controlled processes and products:and products:n nAcme fabricates several critical parts with a machining Acme fabricates several critical parts with a machining operation. A Control Plan exists for these parts. The operation. A Control Plan exists for these parts. The documen

327、tation indicates the process is under statistical documentation indicates the process is under statistical control and has been for months. The auditor noticed that control and has been for months. The auditor noticed that many of these parts were rejected over time because they did many of these pa

328、rts were rejected over time because they did not meet specification. Some of the variations were found in not meet specification. Some of the variations were found in characteristics identified as special on the Control Plan. An characteristics identified as special on the Control Plan. An unauthori

329、zed repair operation was used to modify some of unauthorized repair operation was used to modify some of the parts so they would fit; the remaining parts were the parts so they would fit; the remaining parts were scrapped.scrapped.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Minor Nonconformancen nA noncomp

330、liance with QS-9000 that judgment A noncompliance with QS-9000 that judgment and experience indicate is and experience indicate is notnot likely to result in likely to result in the failure of the quality system or reduce its the failure of the quality system or reduce its ability to assure controll

331、ed processes or ability to assure controlled processes or products.products.1. 1.It may be either:It may be either:n nA failure in some part of the suppliers documented A failure in some part of the suppliers documented quality system relative to a quality system requirement, quality system relative

332、 to a quality system requirement, ororn nA single observed lapse in following one item of a A single observed lapse in following one item of a companys quality panys quality system.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Minor Nonconformancen nA failure in some part of the suppliers A failure in some p

333、art of the suppliers documented quality system relative to a QS-9000 documented quality system relative to a QS-9000 requirement:requirement:n nThe auditor was walking through receiving and observed The auditor was walking through receiving and observed the area where incoming material is segregated

334、 until it the area where incoming material is segregated until it has been inspected. While there, he noted that the has been inspected. While there, he noted that the procedure being used to check incoming materials was procedure being used to check incoming materials was SOP-RI-012, Revision 4. He

335、 recalled that when he SOP-RI-012, Revision 4. He recalled that when he visited document control, the revision identified as being visited document control, the revision identified as being in effect was SOP-RI-012, Revision 6.in effect was SOP-RI-012, Revision 6.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平

336、台Minor Nonconformancen nA single observed lapse in following one item of A single observed lapse in following one item of a companys quality system:a companys quality system:n nAn employee-owned gage An employee-owned gage was not entered in the calibration was not entered in the calibration system.

337、system.无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台n nShould include:Should include:n nA clear description of the problemA clear description of the problemn nObjective evidence to supportObjective evidence to supportn nA quote or paraphrase of the requirementA quote or paraphrase of the requirementincludin

338、g the sourceincluding the sourcel lCite closest subelementCite closest subelementn nThe impact or significance ofThe impact or significance ofthe problem, if knownthe problem, if knownNonconformance Statements无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Nonconformance Communicationn nShould be addressed fou

339、r times:Should be addressed four times:n nInitially, Initially, symptomsymptom identified to escort identified to escortn nWhen When nonconformancenonconformance identified, responsible identified, responsible management notifiedmanagement notifiedn nNonconformance identified during closing meetingN

340、onconformance identified during closing meetingn nNonconformance identified in audit reportNonconformance identified in audit report无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Nonconformance Communicationn nRecommendationsRecommendationsn nAssist the audited organizationAssist the audited organizationn nWo

341、nt change the auditees obligationsWont change the auditees obligationsn nBased on information learned during auditBased on information learned during audit无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Closing Meetingn nChaired by team leaderChaired by team leadern nSummary of the teams Summary of the teams a

342、ssessmentassessmentn nEnsures auditedEnsures auditedorganizations management organizations management clearly understands the clearly understands the results of the assessmentresults of the assessment无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Closing Meetingn nShould include the following:Should include t

343、he following:n nAttendance rosterAttendance rostern nIntroduction of team for personnel not at the opening Introduction of team for personnel not at the opening meetingmeetingn nReview of the audit scope and purposeReview of the audit scope and purposen nOverall assessment of the audited areaOverall

344、 assessment of the audited arean nImprovements and good practices Improvements and good practices n nDescription of nonconformances and their Description of nonconformances and their significance/potential impactsignificance/potential impactn nOpportunities for improvement and specific Opportunities

345、 for improvement and specific recommendationsrecommendations无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Reportn nAccomplishes the following:Accomplishes the following:n nFocuses attention/resources on problem areasFocuses attention/resources on problem areasn nPresents the overall assessment of the a

346、udit areaPresents the overall assessment of the audit arean nIndicates the depth and adequacy of investigationsIndicates the depth and adequacy of investigationsn nProvides objective evidence of the assessmentProvides objective evidence of the assessment无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Rep

347、ortn nAudit identification numberAudit identification numbern nIdentification of the audit team membersIdentification of the audit team membersn nAudit datesAudit datesn nReport issue dateReport issue daten nA description of the audit scope/purposeA description of the audit scope/purposen nIdentific

348、ation of groups auditedIdentification of groups auditedn nReference documentsReference documentsn nSignature of the audit team leaderSignature of the audit team leadern nAn assessment of overall conditions of the audited An assessment of overall conditions of the audited areaarean nIdentification of

349、 good practicesIdentification of good practices无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Reportn nIdentification of areas of improvement Identification of areas of improvement n nDescription of problems and weaknessDescription of problems and weaknessn nIdentification of isolated problems Identific

350、ation of isolated problems n nIdentification of actions taken during the audit to Identification of actions taken during the audit to correct problemscorrect problemsn nIdentification of documents reviewed and activities Identification of documents reviewed and activities observed observed n nRecomm

351、endations for improvement Recommendations for improvement n nEnough detail to support conclusionsEnough detail to support conclusionsn nDistribution (may be indicated in cover letter)Distribution (may be indicated in cover letter)无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台MODULE 8Follow-UpActions无忧资源： 中国最

352、大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Follow-Up Actionsn nThis module will discuss:This module will discuss:n nThe corrective action tracking systemThe corrective action tracking systemn nItems that must be included in an audit responseItems that must be included in an audit responsen nWhy “steps to prevent r

353、ecurrence” are critical to the Why “steps to prevent recurrence” are critical to the responseresponsen nHow corrective actions may be verifiedHow corrective actions may be verified无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Auditor Follow-Up Actionsn nCorrective action status trackingCorrective action stat

354、us trackingn nResponse evaluationResponse evaluationn nVerification of corrective actionVerification of corrective action无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Status Tracking System Informationn nNonconformance numberNonconformance numbern nIssue dateIssue daten nOrganization responsible for correcti

355、ve actionOrganization responsible for corrective actionn nResponse due dateResponse due daten nResponse evaluationResponse evaluationn nScheduled corrective action implementation Scheduled corrective action implementation datedaten nVerification dateVerification daten nEscalation activities: new due

356、 date/type of Escalation activities: new due date/type of actionaction无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Audit Responsen nWritten response mandatoryWritten response mandatoryn nMust address root causeMust address root causen nEvaluateEvaluaten nIdentification of Identification of corrective action

357、corrective actionn nPrevention ofPrevention of recurrencerecurrencen nImplementationImplementationscheduleschedule无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Verifying Corrective Actionsn nCloseout should be based upon implementation Closeout should be based upon implementation of effective corrective acti

358、onsof effective corrective actionsn nObjective evidence requiredObjective evidence requiredn nAccomplished by:Accomplished by:n nAcceptance of written response andAcceptance of written response andevaluation of evidenceevaluation of evidencen nVerification of corrective action at Verification of cor

359、rective action at audit locationaudit locationn nRe-auditRe-audit无忧资源： 中国最大最全的资源下载网教育新天地：中国最大的学习培训咨询平台Typical Audit Recordsn nNotification/agenda letterNotification/agenda lettern nAudit checklistAudit checklistn nAudit reportAudit reportn nResponses for identified Responses for identified nonconformancesnonconformancesn nResponse evaluationsResponse evaluationsn nDocumentation of Documentation of verification of corrective actionsverification of corrective actionsn nAuditor qualification recordsAuditor qualification records