APQP_23_elementsA.ppt

ModuleIntroduction组成部分介绍,IntroductiontotheAPQPProcessAPQP过程介绍,1-1,2,1-2,APQPSystemicFlowAPQP系统流程,1-3-E,APQPSystemicFlowAPQP系统流程,1-3-C,AccessingtheAPQPGuidelines访问APQP指南,BoththeGuidelineandtheformsareavailable.指南和表格均可由此获得。,1-4,APQPGenericProgramGanttChart,1-5,MatrixforQualityPlanning质量策划矩阵,1-6,ModuleIntroduction组成部分介绍,PlanandDefine计划与定义,1-7,ProcessFlow过程流程,1-8,SourcingDecision资源决定,ItisadocumentthatadvisesinternalandexternalsuppliersofkeycontactpersonnelwithinFord(STA,purchasing,engineers,etc.).是内、外部供方与Ford（STA、采购、工程等）协商关键联络人的文件。Itservesasaformalcustomercommitmenttoworkwithallinternalandexternalpartsuppliers,toolingsuppliers,andfacilitysuppliersonaprogram.作为与项目中的内、外部零件供方、工装供方和设施供方共同工作的正式对顾客的承诺。,1-9,SourcingDecisionExpectations资源决定的期望,Allinternalandexternalsuppliersforaprogramareidentified项目所有的内、外部供方已经确定Earlysourcingtargetagreementsareestablishedandsignedbyappropriateareas由适当的区域建立并签署早期资源指标协议Allnon-Q1suppliersareidentified所有非Q1供方已经确定Specialarrangementsfornon-Q1suppliersareidentified非Q1供方的特殊安排已经确定Aprogramtimeline,alignedtoFPDS,isestablishedfromto已经建立了从到的、与FPDS一致的项目时间安排,1-10,SourcingDecisionChecklist资源决定检查清单,1-11,CustomerInputRequirements顾客输入要求,TheCustomerInputRequirementselementensuresthattheprogramteamappropriatelyassessesthepotentialmanufacturing,process,anddesignissuesearlyintheproductdevelopmentphase.顾客输入要求要素为了要让项目小组，在产品开发阶段适当的评估潜在的制造、过程和设计问题。CustomerInputRequirementsarethedesigncriteriaandtheprogramrequirementsnecessarytoinitiatetheAPQPprocess.顾客输入要求是启动APQP过程的必要的设计准则和项目要求。,1-12,CustomerInputRequirementsExpectations顾客输入要求期望,Issuesfromsurrogatecomponentsorplantsareidentifiedandaddressedwithproductandmanufacturing.已经识别了暂时代替的零部件或工厂的问题，并解决了生产和制造问题Componenttargetsandproductassumptionsaredefined.已经定义了零部件指标和产品假设TargetsforTGW,TGR,Warranty,UsefulLifeReliability,andIncomingQualityareestablished.已经建立TGW、TGR、保证、使用寿命可靠性和进货质量指标Capacityplanningvolumesaredefined.生产量策划值已定义,1-13,CustomerInputExpectations(Continued)顾客输入要求期望（续）,Systemcomponentdesignsandspecificationsshouldinclude:系统部件设计和规范应该包括：Productassumptions产品假设Functionalperformance性能表现Dimensions几何尺寸Weight重量Material材料Reliabilityandqualitygoals可靠性和质量目标,1-14,CustomerInputChecklist顾客输入检查清单,1-15,Craftsmanshipisanassessmentofwhatthecustomersees,touches,uses,hears,andsmells.Itaffectsdesignandmanufacturing,anditimprovestheoverallperceptionofvalue.精致工艺是对顾客看到的、感觉到的、使用的、听到的和闻到的评估。影响设计和生产，并改进全面感官的价值。,Craftsmanship精致工艺,1-16,CraftsmanshipExpectations精致工艺期望,ObtainCraftsmanshiptargetsandobjectivestodevelopCraftsmanshipplans获得精致工艺指标和目标以开发精致工艺计划DeveloptheCraftsmanshipstrategy开发精致工艺战略ImplementaplantoachieveCraftsmanshiptargets实施计划以达到精致工艺指标IntegrateplanstosupportthefinalCraftsmanshiptheme整合各项计划以支持最终精致工艺计划EnsurethatthedesignandmanufacturingprocessescomplywithCraftsmanshipstrategyandplans确保设计和制造过程符合精致工艺战略和计划IdentifyandresolveCraftsmanshipissuesthatarise识别并解决发生的精致工艺问题,1-17,CraftsmanshipChecklist精致工艺检查清单,1-18,TeamFeasibilityCommitment小组可行性承诺,TheTeamFeasibilityCommitmentelementdetermineswhethertheproposeddesigncanbemanufacturedwithintheprogramsguidelinesandspecifications.小组可行性承诺要素确定了建议的设计是否能根据项目指南和规范进行制造Thegoalsofthiselementaretoverifythatallofthe:本要素的目的是验证所有：Activitiesagreethattheycanproducetheproductwithinspecifications.活动可以生产符合规范的产品Feasibilityconcernsareresolvedandnecessaryproductandprocesschangesarecompletedbeforefirstproductionprove-outs(1PP).在第一预生产单元建立（1PP）前解决可行性问题和必要的产品和过程更改.,1-19,TeamFeasibilityCommitmentExpectations小组可行性承诺期望,Theprogramteammustestablishaformalfeasibilityprocessanddocument.项目小组必须建立正式的可行性过程和文件。FeasibilitiesaretrackedandmajorfeasibilityconcernscanberesolvedbeforeProductionTrialRun.在产品试生产前追踪可行性，并解决可行性涉及的重要问题。WERSandAIMSconcernsareresolved,andtheproductcanbemanufacturedtomeetCp/Cpkandtolerancerequirements.解决了WERS和AIMS设计的问题，可以在满足Cp/Cpk和公差要求的情况下制造产品。Suppliersandsubsupplierswerepartofthefeasibilityprocess.供方和分承包方式可行性过程的一部分。,1-20,TeamFeasibilityCommitmentChecklist小组可行性承诺检查清单,1-21,ModuleIntroduction组成部分介绍,ProductDesignandDevelopment产品设计和开发,1-22,ProductDesignandDevelopment产品设计和开发,1-23,Elements要素,DesignFMEA设计FMEADVP&R设计验证计划和报告Subcontractor/SubsupplierAPQPStatus分承包方/分供方APQP状态DrawingsandSpecifications图样和规范,1-24,DesignFMEA设计FMEA,Agroupofactivitiesintendedto:一组活动，用于:Identifypotential:识别潜在的:Productfailuremodesearlyintheproductdevelopmentphase产品开发阶段的早期产品失效模式Productdesignsafetyconcerns产品设计安全涉及的问题Significant/critical/specialcharacteristics重要/关键/特殊特性Establishapriorityfordesignimprovementactions为设计改进活动建立优先顺序Documenttherationalebehindproductdesignchangestothedevelopmentoffutureproductdesigns将产品设计变更中的思路文件化，作为未来产品设计的开发的输入,1-25,DFMEAExpectationsDFMEA期望,CompletingDFMEAsthatfocusonwhathaschangedinthedesignanditseffectontheentiresystem完成关注设计中进行的更改及其对整个系统的影响的DFMEACreatingalistofpotentialSpecialCharacteristics(YC,YS)resultingfromDFMEAsorequivalentanalysis建立DFMEA或类似的分析输出的潜在特殊特性(YC,YS)清单Addressinglessonslearnedandqualityissuesfoundinelement2,CustomerInputRequirement解决在要素2，顾客输入要求中发现的质量问题和学到的经验EnsuringthattheDFMEAinfoissenttoPFMEAteams,includingthespecialcharacteristicslist确保将DFMEA信息，包括特殊特性清单传递给PFMEA小组,1-26,DesignFMEAChecklist设计FMEA检查清单,1-27,DVP&R设计验证计划和报告,Liststheengineeringevaluationsandtestsrequiredtoestablishthatadesignisfitforuseintheintendedenvironment列出建立适于在预期的环境中使用的设计所要求的工程评价和试验AssistsProductDevelopment(PD)inverifyinganddocumentingthefunctionality,reliability,anddurabilityofthevehiclesdesignthroughplannedtestsandevaluations协助产品开发（PD）按计划的试验和评价，验证和文件化车辆设计的功能性、可靠性和耐久性DocumentstheplansandreportsforDesignVerificationofagivendesign将对给定设计进行设计验证的策划和报告文件化Identifiestests,acceptancecriteria,samplesizes,andcompletiondatesinastandardformat以标准的形式确定试验、接受准则、样本容量和完成日期,1-28,DVP&RExpectations设计验证计划和报告期望,Correctiveactionplansmustbecompletedforanytestresultthatdoesnotmeetdesignspecandreliabilitygoals必须针对任何没有满足设计期望和可靠性目标的试验结果完成纠正措施计划TheDVP&Rmust:DVP&R必须：AlignwithPQOSdeliverables配合PQOS可交付性Provideinputstocompletereportsandproformas向完成报告和形式提供输入Identifyanyspecifictests,methods,equipment,acceptancecriteria,samplesizes,designlevel,andtiming确定任何特殊的试验、方法、设备、接收准则、样本容量、设计等级和时间安排,1-29,DVP&RChecklist设计验证计划和报告检查清单,1-30,SubcontractorAPQPStatus分承包方APQP状态,TheSubcontractorAPQPStatuselementidentifiesandreportsontheconditionofexternalcontractors(i.e.,suppliers)andsubcontractorsAPQPprocess.分承包方APQP状态要素确定和报告外部承包方（例如供方）和分承包方APQP过程的状况InternalandexternalsuppliersidentifyAPQPrequirementsbycascadingprogramtargetsAPQPrequirementstotheirsubcontractors,andbyconductingAPQPreviews,asappropriate.内部和外部供方通过向分承包方逐级传递项目指标APQP要求和适当时进行APQP评审确定APQP要求,1-31,SubcontractorExpectations分承包方期望,SubcontractorAPQPStatusgeneralexpectationsarethatallinternalandexternalsuppliersmust:分承包方APQP状态的总的期望是所有内部和外部供方必须：AssesstheriskandspecifytheleveloftheirsubcontractorsAPQPparticipation评估风险和确定它们的分承包方参与APQP的等级CascadeAPQPrequirementstotheirsubcontractors向它们的分承包方逐级传递APQP要求HoldregularlyscheduledAPQPreviewmeetingswiththeirsubcontractors有规律的与分承包方会议，进行安排好的APQP评审,1-32,SubcontractorAPQPChecklist分承包方APQP检查清单,1-33,DrawingandSpecifications图样和规范,Thiselementprovidesanevaluationofthedevelopmentoftargetsandspecificationstobeinputtothedesignprocessanddrawings.本要素提供对输入到设计过程和图样的指标和规范的开发的评价。Thesedrawingsincludeallengineeringdrawings,CADdata,materialspecifications,andengineeringspecifications.这些图样包括所有工程图样、CAD数据、材料规范和工程规范。,1-34,DrawingandSpecificationsExpectations图样和规范期望,ProgramNeedDatesarecommunicatedandagreedtobyeffectedareas.项目所需数据由受到影响的区域进行沟通和批准。SCsandCCsareidentifiedonthedrawingsorattacheddocuments.在图样和附带文件中确定SC和CC。Tolerancesandpartspecsarecompatiblewithacceptedmanufacturingstandardsforgaugesandequipment.公差和零件规格与量具和设备的可接受的制造标准一致。Drawingsandspecificationsmustinclude:图样和规范必须包括：Engineeringspecificationtests工程规范试验Productvalidationtestrequirements产品确认试验要求Documentationtosupportprototypebuildandpre-launchcontrolplandevelopment文件化以支持样件制造和试生产控制计划的开发,1-35,DrawingandSpecificationsExpectations(Continued)图样和规范期望（续）,ThedrawinginformationandengineeringspecificationswillbeusedasaprerequisitetothePBCP.图样信息和工程规范将作为样件制造控制计划（PBCP）的先决条件。MaterialusedbythesuppliersorthesubcontractorsmustbeapprovedandincludedintheFordApprovedSourcelist.供方或分承包方使用的材料，必须被批准并包含在福特批准资源清单内。PDandMEpersonnelwillassessdrawingsandspecificationstoensuretheymeettheprogramsABSandqualityrequirements.PD和ME人员将评估图样和规范，以确保满足项目ABS和质量要求。,1-36,DrawingsandSpecificationsChecklist图样和规范检查清单,1-37,ModuleIntroduction组成部分介绍,PrototypeBuild样件制造,1-38,ProcessFlow过程流程,1-39,PrototypeBuildOverview样件制造概述,APQPPrototypeBuildelementssupportthesuccessfulplanningandconstructionofPrototypeBuildunits,whichprovideanunderstandingofthevehicles:APQP样件制造要素支持样件制造单位的成功的策划和构造，提供对于车辆的如下理解：Design设计Functionality功能性Manufacturability可制造性,1-40,PrototypeBuildElements样件制造要素,ThePBCPsupportstheplanningandconstructionofprototypesbydocumentingtheprocessstepsofthePrototypeBuildphase.PBCP通过将样件制造阶段的过程步骤文件化支持样件的策划和构造。ThePrototypeBuildensuresthatthecustomerreceivesCPsmanufacturedandassembledpriorto1PP.样件制造确保顾客在1PP前收到制造和装配好的CP。,1-41,PBCP(PrototypeBuildControlPlan)DefinitionPBCP（样件制造控制计划）定义,ThePBCPdescriptionofthedimensionalmeasurementsandmaterial/functionalteststhatoccurduringtheCPbuild.PBCP描述了发生在CP制造中的尺寸测量和材料/功能试验Itisthefirstsummarydocumentthatindicates:是说明如下事项的摘要文件：ThestepsbetweenPrototypeBuildandPre-LaunchleadingtotheProductionControlPlan产生生产控制计划的样件制造和试生产之间的步骤Theprocessstepstoidentifyandalignboththeproductscharacteristicsanditstargets识别和调整产品特性及其指标的过程步骤,1-42,PBCPGeneralExpectationsPBCP总的期望,Productcharacteristicsarereviewed评审产品特性ThosecharacteristicsrequiredforPBCPsareidentified.确定PBCP所要求的特性。AllpotentialsignificantandcriticalcharacteristicsfromtheDFMEAsmustbeincluded.必须包括DFMEA输出的所有潜在重要和关键特性。Theprocessparameterconditionsmustbedocumented.过程参数条件必须被文件化。Thisincludesallspecialtooling,manufacturing,andassemblyconditions.包括所有特殊工具、制造和装配条件。,1-43,PBCPChecklistPBCP检查清单,1-44,PrototypeBuild样件制造,Definesthemanufactureandassemblyofcomponents,subsystems,systems,andvehiclessuppliedtothecustomerforbuildsoccurringpriortothe1PPtrialrun定义在1PP试运行前的样件制造，以提供给零部件、子系统、系统和车辆的制造和装配。Includesnotonlytheactualbuildprocess,butthepreparationforthebuildsothatCPsaresuppliedtothecustomerpriorto1PP不仅包括实际的制造过程，而且包括为了在1PP前将CP提交给顾客而进行的制造准备,1-45,PrototypeBuildExpectations样件制造期望,PBCPsarefollowed.按照PBCP进行Suppliersreceiveallnecessaryinformationandparticipateaccordingtotheprogramsscheduleandtiming.供方收到所有必要的信息并按照项目时间安排定时参与Thetimingforchangeswillbeinlinewiththenextbuildphase.更改的时间选择应该符合下一个制造阶段。Allprototypematerialsmustmeet100percentofthedimensionalspecificationsandfunctionalrequirementsatdeliverytomeettheCPIn-PlantDate.交付时所有样件材料必须100%满足尺寸规范和功能要求以满足CP进厂日期。,1-46,PrototypeBuildExpectations(Continued)样件制造期望（续）,QualitylevelsarecheckedagainstthePBCP.按照PBCP检查质量等级。Dimensionalandfunctionaldataisavailableforreviewbythecustomeroneachpart.顾客可以获得每个零件的尺寸和功能数据以进行评审。Suppliersprovidecustomerswithanytestingandcheckingrequirementsforprove-outoftheirpartdesign.供方向顾客提供所有试验和检查要求以证明零件设计是适当的。AnActionMatrixisdevelopedtocaptureandresolveallconcernsfoundduringbuildandanysubsequentlab,plant,and/orroadtesting,andallconcernsarereviewedwiththeprogramteamandappropriatemanagement.开发“措施矩阵”以获得和解决在制造和所有试验室、工厂和/或道路试验中并发的问题，和所有项目小组及适当的管理层评审的问题。,1-47,PrototypeBuildChecklist样件制造检查清单,1-48,ModuleIntroduction组成部分介绍,ProcessDesignandDevelopment过程设计和开发,1-49,ProcessFlow过程流程,1-50,Elements要素,Facilities,Tools,andGauges1.设施、工具和量具2.ManufacturingProcessFlow2.制造过程流程3.ProcessFMEA3.过程FMEA4.MeasurementSystemEvaluation4.测量系统评价5.Pre-LaunchControlPlan5.试生产控制计划6.OperatorProcessInstructions6.操作工过程指导书7.PackagingSpecifications7.包装规范,1-51,Facilities,Tools,andGauges(8)设施、工具和量具(8),Thiselementidentifiesthenew,additional,refurbished,andrelocatedfacilitiesandresourcesnecessarytomanufacturethecustomer-specifiedproductatdesignatedquantityandqualitylevels.本要素确定了以规定的数量和质量等级制造顾客指定的产品所需的新的、额外的、更新的和重新部署的设施和资源。Theelementalsoidentifiesthetoolsandgaugesusedinprocessmachinerytotransformrawmaterialintofinishedpartsorassemblies.本要素还确定了用于将原材料转换为完成的零件或组装件的机械加工过程的工具和量具。,1-52,Expectations期望,Theplanningandexecutionofthiselementmustalignwith:tomilestonesPQOSDeliverables本要素的计划和执行必须配合里程碑到PQOS需交付的事务Facilitypermits,planningapproval,drawings,andutilitiesmustbeincludedontheManufacturingTimingPlan.Inaddition,fundingapprovalsmustbecompleted.制造时间计划中必须包括设施许可、计划批准、图样和效用。另外，必须完成资金批准。Theprogramteammustapprovestatisticalrequirementsandacceptancecriteriabeforesourcingoftoolsorgaugescanbemade.在可以进行工具和量具的外包之前，项目小组必须批准统计要求和接收准则。,1-53,Expectations(Continued)期望（续）,AlltoolsandgaugesmustcomplywithToolingandEquipmentSupplementrequirements.所有工具和量具必须符合工装和设备补充要求。Trialrunsshouldoccuratthemachinebuilderslocationtoqualifyalltools.应该在机械制造者的现场进行试运行，以验证所有工具合格。Allcorrectiveactionsforfacilities,tools,andgaugesnotmeetingcustomerrequirementsmustbecompletedbeforetheProductionTrialRun.必须在产品试生产前完成针对不满足顾客要求的设施、工具和量具的所有纠正措施。Toolsandgaugesmustbedelivered,setup,andapprovedintheirspecifiedfacilitiesbeforetheProductionTrialRun.产品试生产前工具和量具必须以制定的设施交付、安装和批准。,1-54,Facilities,Tools,andGaugingChecklist设施、工具和量具检查清单,1-55,ManufacturingProcessFlow(13)制造过程流程（13）,Thiselementisagraphicrepresentationofthecurrentorproposedsequenceofthemanufacturingprocesstoensurethattheprocessdefinition,PFMEA,andControlPlanscanbecreatedandanalyzedintheappropriatesequence.本要素制造过程的当前的或建议的次序的图解表示，以确保以适当的次序建立和分析过程定义、PFMEA和控制计划。,1-56,ManufacturingProcessFlowExpectations制造过程流程期望,ManufacturingProcessFlowgeneralexpectationsarethat:制造过程流程总的期望是：Across-functionalteamledbyVOEngineeringdevelopsaManufacturingProcessflowcharttoserveasaninputtoPFMEAs.由VO工程领导的横向职能小组开发制造过程流程图作为PFMEA的输入。TheprocessflowchartsaredevelopedusingPFMEAsandsurrogateprocessestoserveasinputfornewprocessesandtechnologies.使用PFMEA和替代的过程开发过程流程图，作为新过程和技术的输入。Thecurrentproductionflowchartsmaybemodifiedtoshowrevisionstotheprocessflow.可以修改当前的生产流程图，以显示对过程流程的修改。,1-57,ManufacturingProcessFlowChecklist制造过程流程检查清单,1-58,ProcessFMEA(14)过程FMEA(14),ThePFMEAisasystematicapproachusedbyamanufacturing-responsibleteamtoensurethatpotentialprocess-relatedfailuremodesandtheirassociatedcauseshavebeenconsideredandresolved.PFMEA是制造职责小组使用的确保已经考虑并解决了潜在的与过程相关的失效模式及其相关原因的系统化的方法。,1-59,Expectations期望,AllProcessFMEAsarepreparedbyacross-functionalteamledbyManufacturingEngineeringfollowingthestepsdefinedintheFMEAguideline.所有过程FMEA以制造工程为领导的横向职能小组按照FMEA指南中定义的步骤进行准备。ProcessFMEAsmustbeestablishedanytimethat:当存在如下事项时，必须建立过程FMEA：Newprocesses,technologies,products,orproductfeaturesareintroduced.引入新的过程、技术、产品或产品特征。Qualityrisksareidentifiedthatcannotberesolvedthroughdesignchanges.确定质量风险不能通过设计变更加以解决。Majorqualityconcernshavenotbeenresolvedduringthecurrentproductionmodelyear.在当前的生产模型年中，没有解决重大的涉及质量的问题。,1-60,Expectations(Continued)期望（续）,Listofrecommendedactionsandlessonslearnedisincorporatedintheprocess(continuousimprovement).将列出的“建议措施”和学到的经验和并在过程（持续改进）中。Poke-a-Yokehasbeenusedinaddressingcorrectiveactions.制定纠正措施中使用防错方法（Poke-a-Yoke）。,1-61,ProcessFMEAChecklist过程FMEA检查清单,ProcessFMEA,1-62,MeasurementSystemEvaluation(15)测量系统评价（15）,Thiselementassessesthevariationofthemeasurementsystem,anddetermineswhetheritisacceptableformonitoringtheproductionprocess.本要素评估测量系统的变差，确定是否可以接受测量系统监控生产过程。,1-63,Expectations期望,Correlationstandardsarereachedandagreedtowiththecustomerforduplicategaugesortestequipment.已达到相同的测量或试验设备的相关标准和顾客的批准。Gaugeinstructionsandvisualaidstoensureappropriateuseofgaugeandtestequipmentinproduction.测量指导书和目视辅具确保在生产中适当的使用测量和试验设备。Allmeasurementsystems(gaugesandtestequipment)mustbemodifiedtoreflectthelatestengineeringpartlevelbeforetheProductionTrialRun.在产品试生产前必须修改所有测量系统（测量和试验设备）以反映最新工程零件等级。,1-64,Expectations(Continued)期望（续）,Theuser/customermustbegiventheopportunitytoreviewandconcurwiththegaugesandtestequipmentstudyresultsbeforetheProductionTrialRun.产品试生产前使用者/顾客,必须有机会评审和批准测量和试验设备研究结果。TheMeasurementSystemEvaluationmustberepeatedandapprovedfollowingallgaugeandtestequipmentmodifications.所有测量和试验设备更改后,必须重新进行测量系统评价并获得批准。TheProductionControlPlanmustalignwiththeMeasurementSystemsDevelopmentplan.生产控制计划必须配合测量系统开发计划。GaugeRepeatabilityandReproducibilitystudiesmustbeconductedonallmeasurementsystems.所有测量系统必须进行量具重复性和再现性研究。,1-65,MeasurementSystemEvaluationChecklist测量系统评价检查清单,1-66,Pre-LaunchControlPlan(16)试生产控制计划（16）,Thisisadescriptionofthedimensionalmeasurementsandmaterial/functionalin-processtestsorchecksthatoccurafterprototypebuilds,butbeforefullproduction对发生在样件制造后，全面生产前的尺寸测量、过程中材料/功能试验或检查的描述。,1-67,Expectations期望,Legitimate/appropriateinspectionsamplesizes,frequencies,controlmethod,etc.inclusivetopre-launchphaseofproductionareincluded.在生产的试生产阶段包含合理/适当的检验样本容量、频率、控制方法等。Allproduct&processcharacteristicsforpre-launchcontrolplansareidentifiedandreviewed.确定和评审试生产控制计划的所有产品和过程特性。ResultsfromthePBCPandDFMEAprovidetheoutlineforthePre-LaunchControlPlan.PBCP和DFMEA的结果提供了试生产控制计划的概要。TheProductionControlPlanforthecurrentproductionmodelisusedtoassistinthedevelopmentofthePre-LaunchControlPlanifAPQPElements8and13havenotbeeninitiated.如果APQP要素8和13还未启动，使用当前生产模式的生产控制计划协助开发试生产控制计划。,1-68,Pre-LaunchControlPlanChecklist试生产控制计划检查清单,1-69,OperatorProcessInstructions(17)操作工过程指导书（17）,Thiselementdescribesthedetailsofthecontrolsandactionsthatoperatingpersonnelmustperformtoproducequalityproducts.本要素描述操作人员为生产质量合格的产品所必须执行的控制和措施的详细情况。Theseinstructionsaredividedintotwomajorcomponents:这些指导书分为两个主要部分：Descriptionoftheprocess过程描述Operatorinstructions操作供指导书,1-70,Expectations期望,AcompletedOperatorProcessInstructionspackage.完成的整套操作工过程指导书。Instructionsdevelopedtobeusedduringaproductiontrialruntoensuretheprocessperformsasintended.在产品试生产中使用开发的指导书以确保过程按预期执行。OperatorProcessInstructionsdescribeallprocessstepsnecessarytoproduceaqualityproduct.Thetraininginstructionsmustinclude:操作工过程指导书描述了生产质量合格的产品所需的所有过程步骤。培训指导书必须包括：Detailedinstructions详细的指导书Visualaids目视辅具Anyotherqualitymaterialsnecessarytosupporttheproductionoperator支持生产操作工所需的任何质量材料,1-71,OperatorProcessInstructionsChecklist操作工过程指导书检查清单,1-72,PackagingSpecifications(18)包装规范（18）,Thiselementdescribesthedesignanddevelopmentoftheend-itemshipmentpackaging,includinginteriorpartitions.本要素描述产品最后出货包装的设计与开发，包括包装内部的分隔配置。,1-73,Expectations期望,Pastissuesonsimilarorsurrogatepackagingarediscussedandresolvedbytheteam.小组讨论和解决相似或替代的包装中过去发生的问题。Correctiveactionsexistforanypackagingissuesidentifiedthataffectproductperformanceandcharacteristics.确定对于任何影响产品性能和特性的包装问题的现存纠正措施。Supplie