Qs9000审核员培训教材ppt课件

1、INTERNAL AUDITING FORQS-9000WelcomeRestroomsBreaksRegistration sheetsPhonesEvaluationsFor assistance after this course.IntroductionsNameCompanyTitle/PositionCurrent responsibilitiesExperience in quality systemsExperience in auditingWhat do you expect to learn from this course?AgendaAuditing fundamen

2、talsThe audit systemHuman factors role in auditingAudit preparationAudit performanceOpening meetingClosing meetingAudit reportFollow-up actionCase studyExamExam (3-1/2 hours)1-1/2 hoursPart 1 (open book)Seven case studiesAnswer as the team leaderIf there is a nonconformance, cite the closest element

3、/subelement of QS-900015 minute break2 hoursPart 2 (closed book)General questions about auditingMultiple choice/fill in the blank/true-falsePart 3 (closed book)QS-9000 requirementsMultiple choice/fill in the blank/true-falseMODULE 1IntroductionIntroductionThis module will discuss:Definition of quali

4、tyCost of nonqualityCost of qualityPrevention costsAppraisal costsQuality systemDefinition of QualityQuality = ?Definitions of QualityDictionaryA characteristic or attribute of something; property; a feature. Excellence; superiority. Degree or grade of excellence.DemingQuality has meaning only in te

5、rms of the customer, his needs, what he is going to use it for. Continuous improvement.Definitions of QualityJuranFitness for use/fitness for purpose as seen by the user. For long-lived items: availability, reliability and maintainability (the “abilities).Regulated IndustriesMeeting specifications o

6、r requirements. Definitions of QualityCrosby Conformance to requirements.IshikawaProducts and services which are economical, most useful, and always satisfactory to the consumer.ISO 8402The totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.Costs of

7、 NonqualityWaste due to scrap or rejected itemsReperformance of workInefficient use of resources Service and warranty costsCustomer loss of confidence Loss of market shareLiability costsCost of QualityPrevention and appraisal costsCosts to prevent nonconformancesCosts to evaluate qualityNonquality c

8、ostsInternal failure costsExternal failure costsVariables Affecting QualityAccuracy in identifying customer requirements and expectationsAdequacy of raw materialsAdequacy of product designCompetency of personnelVariances in process equipmentAdequacy of measures taken to prevent damage to the product

9、 after productionVariables Affecting QualityControl of production conditions, such as cleanliness, humidity, and temperatureControl of changes in design or in customer requirementsControl of production process support systems, such as electric power, compressed air, and waterAdequacy and accuracy of

10、 test and inspection equipmentCorrectly identifying inspection and test criteriaQuality System Definition: “The organizational structure,responsibilities, procedures,processes, and resources needed to implement quality management.ISO 8402 Types of Quality SystemsInternal Quality SystemImplements pol

11、icies and objectivesIncludes quality control functionsIncludes quality assurance activitiesExternal Quality SystemProvides assurance specifically for the customerMODULE 2QS-9000OverviewQS-9000 OverviewThis module will discuss:Quality system documentationThe twenty elements that are ISO basedThe auto

12、motive sector-specific requirementsThe customer-specific requirementsQS-9000 OverviewQuality System Requirements QS-9000 Developed by Chrysler, Ford, General MotorsHarmonizes Chryslers Supplier Quality Assurance Manual, Fords Q-101 Quality System Standard, and GMs NAO Targets for ExcellenceFounded o

13、n ISO 9001:1994, Section 4QS-9000 OverviewQS-9000 applies to all direct internal and external suppliers to OEMs of:Production materialsProduction or service partsHeat treating, painting, plating, or other finishing servicesQS-9000 OverviewQuality system documentationSuppliers must establish, documen

14、t, and implement effective quality systems based on QS-9000All requirements of QS-9000 must be incorporated into the suppliers quality system (see quality system documentation progression)Quality System Documentation ProgressionQS-9000 OverviewQuality system documentation (cont.)Level 1: Quality Man

15、ualDefines managements quality policy and commitment to qualityLevel 2: ProceduresSpecifies who does what, and when it is to be doneLevel 3: InstructionsSpecifies how the work should be performed by one individual or functionLevel 4: Records and Other DocumentationProvides the objective evidence of

16、implementation and resultsComparison of Quality System RequirementsTOPICChryslerFordGMSuppliers quality policyXSuppliers business planXTrainingXXXProcess monitoring instructionsXXXEvaluating subcontractor supply baseXXApproved materialsXXXControl of purchased production materialsXXXQuality PlanningX

17、XX - Resources for quality planningX - Planning for new product launchesXXX - Process flow chartXXX - Feasibility studiesX - Design failure mode & effects analysisXX - Process failure mode & effects analysisXX - Control plans (part specific)XXX - Gage planningX - Preliminary capabilityXXX - Packagin

18、g planningXXX - Prototype quality initiativesXXX - Special characteristics symbologyXXXOngoing capability requirementsXXMeasurement Systems AnalysisXXXIn-process & final inspectionXXXMeasuring & testing equipmentXXXAnnual layoutXXAnnual material & functional testXFunctional (ES) test performanceXXXI

19、ndication of product statusXXXVerification of new set-upsXReworked productsXXXReturned product analysisXXProblem reporting & resolutionXXXScheduled preventive maintenanceXXXLot traceabilityXXXContinuous improvementXXXQuality proceduresXXXRecords retentionXXXDrawing & change controlXXXEngineering App

20、roved Product AuthorizationsXXXProcess ChangesXXXInternal System AuditsXXXQuality System AssessmentsXXXInitial sample approval processXXXColor/grain/texture approvalXXXSupplier performance indicatorsXXContract reviewXSPC requirementsXXXQS-9000 - Quality System RequirementsCONTAINS 23 ELEMENTS THAT C

21、AN BE GROUPED IN FOUR CATEGORIES:Quality management and leadershipQuality system structure and controlProduct and process managementAutomotive sector specific requirementsPlus customer specific requirementsFormat ExampleElement Number Title of ElementRequirements:ISO based requirementsAdditional:Aut

22、omotive interpretationsQuality Management & LeadershipProvides requirements for the effective management of the quality system:Outlines managements responsibility, involvement, and support of the quality systemProvides organizational structure requirements for the support of quality functionsEmphasi

23、zes training of personnel affecting qualityQuality Management & LeadershipElement 4.1 Management ResponsibilityRequirements:Define/communicate quality policy understood at all levelsDefine objectives and commitment to qualityDefine responsibilities and authority for personnel affecting qualityProvid

24、e organizational independence where neededProvide adequate resources/trained personnel (including internal audits)Appoint management representative Review all elements of quality system periodicallyQuality Management & LeadershipElement 4.1 Management Responsibility (cont.)Additional:Manage appropri

25、ate activities during concept development, prototype, and productionUse multidisciplinary decision makingCommunicate information/data in a customer- prescribed formatDocument a formal, comprehensive business planMethods to determine customer expectationsBased on an objective valid process to collect

26、 informationMethods to track, update, and review planDocument trends in quality and operational performance Follow a process for determining, analyzing, and documenting trends in customer satisfaction and dissatisfactionQuality Management & LeadershipElement 4.18 TrainingRequirements:Identify needs

27、and provide training for all personnel affecting qualityQualify personnel on the basis of education, training and/or experience Maintain records Additional:View as a strategic issuePeriodically evaluate effectivenessQuality System Structure & ControlProvides the framework for and control of the qual

28、ity system:Requires a documented quality system be established and maintained Provides controls for documents and dataRequires investigation and corrective action of nonconformancesProvides controls for quality recordsRequires audits of the quality systemQuality System Structure & ControlElement 4.2

29、 Quality SystemRequirements:Establish a documented quality system and effectively implementPrepare quality plansIdentify and acquire required controls, equipment, resources and skills Ensure compatibility of design and production processesUpdate quality control and inspection and test techniquesUpda

30、te measurement systems capabilityIdentify suitable verification activities at appropriate stagesClarify standards of acceptabilityIdentify and prepare quality recordsQuality System Structure & ControlElement 4.2 Quality System (cont.)Additional:Use the Advanced Product Quality Planning and Control P

31、lan reference manual Identify special characteristics Confirm manufacturing feasibility before contractDevelop process FMEAs as a prevention toolCross-functional teams develop control plansprototypeprelaunch productionQuality System Structure & Control Phases of Product Quality Planning (APQP)Qualit

32、y System Structure & ControlElement 4.5 Document and Data ControlRequirements:Ensure that:Documents and data are reviewed and approved for useChanges to the documents are reviewed, approved, and controlledControl external documents (e.g., customer drawings) Additional:Have current releases of refere

33、nced documents availableIdentify special characteristics on documentsTimely review, distribution, and implementation of customer specifications and standards Keep records of the implementation date Quality System Structure & ControlElement 4.14 Corrective and Preventive ActionRequirements:Investigat

34、e nonconformances and take corrective actionsInitiate preventive measures Take measures to prevent nonconformances from occurringEnsure corrective and preventive actions are effectiveAdditional:Use disciplined problem-solving methods Respond in customer prescribed manner for external nonconformances

35、Analyze parts returned by the customer and take action to prevent recurrenceQuality System Structure & ControlElement 4.16 Control of Quality RecordsRequirements:Control records through:Identification Collection, indexing, and access Filing and storageMaintenance and dispositionStore and retain reco

36、rds in a way which makes them:Readily retrievablePrevents deterioration, damage, or lossQuality System Structure & ControlElement 4.16 Control of Quality Records (cont.)Additional:Follow customer or government retention periodsIf none are specified, use the following as minimums:while active plus on

37、e calendar year:PPAP approvals, tooling records, P.O.s, and amendmentsone calendar year after year in which created:quality performance records, e.g., control charts, test resultsthree years:internal quality system audits and management reviewsRetain documents from superseded parts required for new

38、part qualification in new part fileQuality System Structure & ControlElement 4.17 Internal Quality AuditsRequirements:Plan and implement internal quality audits:Verify that activities comply with the quality planDetermine the effectiveness of the quality systemBase the schedule on status/importance

39、of the activityDone by independent personnelRecord and report results to the audited departmentTake timely corrective action Verify the effectiveness of the corrective action with follow-up audits Additional:Include suitable work environment as part of the internal audit processProduct & Process Man

40、agementDescribes the controls necessary for the management of processes, activities, and materials necessary to provide assurance in the product:Requires: a review of contracts before acceptance product identification and traceability test status identification measures to control handling and deliv

41、ery of product identification of statistical techniques neededProduct & Process ManagementProvides controls for:Design activitiesPurchased and customer supplied productProduction processesInspection and testing processesand related equipmentNonconforming productServicing activities (if in contract)P

42、roduct & Process ManagementElement 4.3 Contract ReviewRequirements:Review contracts to ensure that:Customer requirements are adequately defined and documentedVerbal orders are agreed upon before acceptanceDifferences are resolvedSupplier has the capability to meet the requirementsIdentify contract a

43、mendments processMaintain contract review records Additional:Meet all customer requirements (including customer specific)Product & Process ManagementElement 4.4 Design Control (applies to design responsible suppliers only)Requirements:Identify activities, resources, responsibilities, and technical i

44、nterfaces (use qualified personnel with adequate resources)Identify design input requirementsInclude statutory/regulatory requirementsResolve unclear requirementsConsider results of contract reviewsProduct & Process ManagementElement 4.4 Design Control (cont.)Requirements (cont.):Document design out

45、put (verifiable and reviewed before release)Plan and conduct design reviews with appropriate functions/specialistsPerform design verification (ensure design output meets input requirements)Perform design validation (ensure product conforms to user needs)Review, approve, and control design changesPro

46、duct & Process ManagementElement 4.4 Design Control (cont.)Additional:Have ability to use CAD/CAE (unless waived) Design output results from a process that includes:Efforts to simplify, optimize, innovate, and reduce wasteUse of geometric dimensioning and tolerancing as applicableAnalysis of cost/pe

47、rformance/risk trade-offsUse of feedback from testing, production, and the fieldUse of design FMEAsProduct & Process ManagementElement 4.4 Design Control (cont.)Additional (cont.):Have a comprehensive prototype program, using the same production subcontractors, tools, and processes, wherever possibl

48、eInclude product life, reliability, and durability in performance testing; track to monitor timely completion and conformance to requirementsHave written customer approval or waiver on design changesHave customer review proprietary design changesProduct & Process ManagementElement 4.6 PurchasingRequ

49、irements:Evaluate, select, and control subcontractorsMaintain records of acceptable subcontractors Ensure purchasing documents clearly describe the product orderedReview and approve purchasing documentsVerify product at subcontractor or by customerProduct & Process ManagementElement 4.6 Purchasing (

50、cont.)Additional:Use customer approved subcontractorsSatisfy governmental and safety requirements for production materialsDevelop subcontractors using QS-9000Require 100% on-time delivery performance from subcontractors (supplier provides appropriate planning information and purchase commitments)Imp

51、lement a system to monitor delivery performance of subcontractorsProduct & Process ManagementElement 4.7 Control of Customer Supplied ProductRequirements:Establish methods to verify, store, and maintain customer supplied productsRecord and report lost, damaged, or unsuitable product to the customerA

52、dditional:Includes customer owned tooling and returnable packagingProduct & Process ManagementElement 4.8 Product Identification and TraceabilityRequirements:Where appropriate, identify product by suitable means from receipt and during all stages of production and deliveryWhere traceability is a spe

53、cified requirement, provide for unique identification of product and record identificationProduct & Process ManagementElement 4.9 Process ControlRequirements:Document procedures defining manner of productionUse suitable equipment and in a suitable working environmentComply with standards, control pl

54、ans, proceduresMonitor and control key process parameters and product characteristicsApprove processes and equipmentStipulate criteria for workmanshipProvide suitable maintenance of equipmentQualify special processesProduct & Process ManagementElement 4.9 Process Control (cont.)Additional:Have a pro

55、cess to ensure compliance with government safety and environmental regulationsComply with customer requirements for special characteristicsProvide an effective total preventive maintenance system Document process monitoring and operator instructionsPerform preliminary process capability studies and

56、meet customer targets Meet ongoing process performance requirements defined by customer Product & Process ManagementElement 4.9 Process Control (cont.)Additional (cont.):Verify job setups Notify the customer and record effective dates for process changesFor appearance items, provide:Appropriate ligh

57、ting for evaluationMasters for color, grain and texture, as appropriateQualified personnel to make appearance evaluationsProduct & Process ManagementElement 4.10 Inspection and TestingRequirements:Verify incoming product before use according to planIn determining the approach, consider:Amount of con

58、trol at subcontractorRecorded evidence of conformance providedIf product is released prior to verification:Positively identify and recordRecall or replace if found nonconformingInspect and test in-process product according to planHold product until verification is completedProduct & Process Manageme

59、ntElement 4.10 Inspection and Testing (cont.)Requirements (cont.): Inspect and test final product according to planComplete all specified activities and meet requirementsDispatch no product unless all planned activities are completedEstablish records which show the inspection status and inspection a

60、uthorityProduct & Process ManagementElement 4.10 Inspection and Testing (cont.)Additional:Use zero defects for attribute data sampling plansDocument acceptance criteria for other situations Use accredited laboratories when required by the customerUse one or more of the following in the incoming qual