工艺设计和开发控制程序

PROCEDUREDOCUMENT/程序文件CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT工艺设计和开发控制程序DOCUMENTNO/编号TYQP730115REVISION/版本CHECKEDBY/校对VERIFIEDBY/审核APPROVEDBY/批准CONTROLLEDCONDITION/受控状态DISTRIBUTIONNO/分发号质量管理体系更改记录表RECORDCHARTOFCHANGESINQUALITYMANAGEMENTSYSTEMOFQUALITYMANUALTYQRTQD031A更改单编号CHANGEORDERNUMBER文件编号DOCUMENTNUMBER处数SECTIONCHANGED标志REV更改日期RELEASECHANGE更改人CHANGEEXECUTORNO/编号TYQP730115PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序1CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序1PURPOSE/目的THISPROCEDUREISUSEDTONORMALIZETHEMANAGEMENTOFNEWPRODUCTPROCESSDESIGNANDDEVELOPMENTOFTHECOMPANYSOASTOENSURETHATALLTHETASKSONNEWPRODUCTPROCESSDESIGNANDDEVELOPMENTOFTHECOMPANYAREIMPLEMENTEDEFFECTIVELY本程序为了规范公司新产品工艺设计和开发的管理，确保公司新产品工艺设计和开发的各项工作得到有效实施。2SCOPE/范围THISPROCEDUREISAPPLICABLETOCONTROLOFNEWPRODUCTPROCESSDESIGNANDDEVELOPMENTOFTHECOMPANYTHECONTENTTHECOMPANYDOESNTCOVERTHEPRODUCTDESIGN,JUSTFOCUSINGONPROCESSDESIGNBASEDONCUSTOMERDRAWINGS本程序适用于公司新产品工艺设计和开发的控制。但包括产品进行设计和开发。3TERMS/术语31PROCESSDESIGNOUTPUTTHERESULTOFPROCESSDESIGNTHROUGHTHEPROCESSDESIGNANDDEVELOPMENT,THEBASESOFPROCESSDESIGNARETRANSFORMEDINTOASERIESOFPROCESSTECHNICALDATAOFTHEPROCESSDESIGNOUTPUT/工艺设计输出指工艺或过程设计的结果。通过对工艺设计和开发，将工艺设计的依据转化为工艺设计输出的一系列工艺技术资料。32PROCESSREVIEWTHEPROCESSDESIGNISREVIEWEDFORMALLY,ROUNDLYANDSYSTEMICALLYANDTHEREVIEWRESULTISDOCUMENTED/工艺评审对工艺设计进行的正式、全面和系统的审查，并把审查结果形成文件。33OVERALLPROCESSPROGRAMBASEDONPRODUCTDESIGNREQUIREMENT,PRODUCTIONPROGRAMANDPRODUCTIVITY,THEGUIDANCEDOCUMENTISUSEDTOPUTFORWARDTHETECHNOLOGYANDPREPAREFORCONCRETETASKSANDMEASURES/工艺总方案根据产品设计要求、生产纲领和生产能力，提出工艺技术准备具体任务和措施的指导性文件。PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序234FIRSTARTICLEBATCHINSPECTIONAFTERTHEREADYCONDITIONOFTRIALMANUFACTUREISQUALIFIEDTHROUGHCHECK,THEFIRSTBATCHOFTRIALMANUFACTUREDCOMPONENTSANDPARTSARECHECKEDFOROVERALLPROCESSANDFINISHEDPRODUCTSINACCORDANCEWITHTHEREQUIREMENTSOFPRODUCTDRAWINGSANDTECHNOLOGICALPROCEDURETODETERMINEWHETHERTHEPRODUCTIONPROCESSANDEQUIPMENTSCANGUARANTEETHATTHEPRODUCTSCONFORMINGTODESIGNREQUIREMENTSAREPRODUCED/首件（批）鉴定在生产试制准备状态检查合格后，对首批试制生产的零、部（组）件按产品图和工艺规程的要求进行全面的过程和成品检查，以确定生产工艺和设备能否保证生产出符合设计要求的产品。35PROCESSPLANNINGRESPONSIBILITIESANDAUTHORITIESFORPROCESSDESIGNAREDISTRIBUTEDANDINTERFACEMANAGEMENTATEVERYSTAGEOFPRODUCTPROCESSDESIGNISDEFINEDONTHEBASISOFTECHNICALDOCUMENTSSUCHASPRODUCTDESIGNDRAWINGOFTHECUSTOMERINACCORDANCEWITHSCHEDULESOFPRODUCTDESIGNANDDEVELOPMENT,INORDERTOGUARANTEETHATTHEPROCESSDESIGN,VALIDATION,ETCARECARRIEDOUTASSCHEDULED/工艺策划按照产品设计和开发的进度要求，根据客户产品设计图样等技术文件，对产品工艺设计职责和权限进行分工，明确产品工艺设计各阶段接口管理，保证工艺设计和验证等活动按计划进行。4RESPONSIBILITY/职责41TECHNICALQUALITYDEPARTMENTSHALLBERESPONSIBLEFORCENTRALIZEDMANAGEMENTOFPROCESSDESIGNANDDEVELOPMENTANDHAVINGTHEPROCESSDESIGNANDDEVELOPMENTFORNEWPRODUCTIMPLEMENTED/技术质量部是公司工艺设计和开发过程的归口管理部门；负责公司新产品工艺设计和开发工作的组织实施；42TECHNICALQUALITYDEPARTMENTSHALLBERESPONSIBLEFORBUSINESSMANAGEMENTOFPROCESSDESIGNANDDEVELOPMENTANDHAVINGTHEPROCESSDESIGNANDDEVELOPMENTFORNEWPRODUCTIMPLEMENTED/技术质量部门负责工艺设计和开发过程的业务管理；负责新产品工艺设计和开发工作的组织实施；43ALLTHERELATEDUNITSOFTHECOMPANYSHALLBERESPONSIBLEFORCOOPERATIONINACCOMPLISHINGALLTHETASKSONTHEPROCESSDESIGNANDDEVELOPMENT/公司各有关单位负责配合完成工艺设计和开发过程的各项工作。5WORKINGPROCEDURE/工作程序PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序351PROCESSDESIGNANDDEVELOPMENTPLANNING/工艺设计和开发策划511SOURCEOFPROCESSDESIGNANDDEVELOPMENTPROJECT/工艺设计和开发项目的来源AAFTERTHENEWPRODUCTCONTRACTORTECHNICALAGREEMENTSIGNEDBYMARKETINGDEPARTMENTANDTHECUSTOMER,ORMARKETDEMANDISREVIEWED,MARKETINGDEPARTMENTSHALLFILLINAPPLICATIONFORSETUPOFPROCESSDESIGNANDDEVELOPMENTPROJECTANDSUBMITITTORELATEDDEPARTMENTSANDPERSONNELFORCONFIRMATIONAFTERITISAPPROVEDBYGENERALMANAGER,ITSHALLBEISSUEDTOCHIEFENGINEER/营销部与顾客签订的新产品合同或技术协议，或市场需求，通过评审后，由营销部填写工艺设计开发立项申请书，经相关部门、人员确定后报总经理批准后下发到总工程师。BAFTERRECEIVINGAPPLICATIONFORSETUPOFPROCESSDESIGNANDDEVELOPMENTPROJECT,CHIEFENGINEERSHALLTRANSMITASSIGNMENTBOOKFORPROCESSDESIGNANDDEVELOPMENTTOLOWERLEVELSANDSENDTHETECHNICALDATACONCERNINGNEWPRODUCTTOTECHNICALQUALITYDEPARTMENT/接到工艺设计开发立项申请书后由总工程师下达工艺设计和开发任务书，并将与新产品有关的技术资料转交技术质量部。512CHIEFENGINEERSHALLDETERMINETHEPROJECTLEADERBASEDONTHEABOVEPROJECTSOURCESANDTRANSFORMTHEOUTPUTOFPROCESSDESIGNANDDEVELOPMENTPLANNINGINTOPROCESSDESIGNANDDEVELOPMENTPLANTHEPLANSHALLINCLUDETHEFOLLOWINGCONTENTS/总工程师根据上述项目来源，确定项目负责人，将工艺设计和开发策划的输出转化为工艺设计和开发计划书。计划书内容包括ADIVISIONOFTHESTAGESSUCHASINPUT,OUTPUT,REVIEW,VERIFICATIONANDCONFIRMATIONOFPROCESSDESIGNANDDEVELOPMENTANDMAINWORKCONTENT/工艺设计和开发的输入、输出、评审、验证、确认等各阶段的划分和主要工作内容；BRESPONSIBILITIESANDAUTHORITIESATALLTHESTAGES,REQUIREMENTOFSCHEDULEANDSUPPORTINGUNIT/各阶段人员职责和权限，进度要求和配合单位；CREQUIREMENTFORRESOURCEALLOCATION,EG,PERSONNEL,INFORMATION,EQUIPMENT,FUNDGUARANTEEANDOTHERRELATEDCONTENT/资源配置需求，如人员、信息、PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序4设备、资金保证等及其他相关内容。513THEOUTPUTDOCUMENTOFPROCESSDESIGNANDDEVELOPMENTPLANNINGSHALLBEREVISEDAPPROPRIATELYWITHTHESCHEDULEOFDESIGNANDDEVELOPMENTINACCORDANCEWITHTHERELATEDPROVISIONSOFCONTROLPROCEDUREFORDOCUMENT/工艺设计和开发策划的输出文件随着设计和开发的进展，在适当时予以修改，应执行文件控制程序的有关规定。514INTERFACEMANAGEMENTBETWEENDIFFERENTGROUPSOFPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发不同组别之间的接口管理DIFFERENTGROUPSOFPROCESSDESIGNANDDEVELOPMENTMAYCONCERNDIFFERENTFUNCTIONSORLEVELSOFTHECOMPANY,ANDTHEEXTERIOROFTHECOMPANY工艺设计和开发的不同组别可能涉及到公司不同职能或不同层次，也可能涉及到公司外部。AFORTHECOMMUNICATIONOFIMPORTANTDESIGNANDDEVELOPMENTINFORMATIONBETWEENTHEGROUPS,THEDESIGNANDDEVELOPMENTPERSONNELSHALLFILLINCONTACTFORMFORPROCESSDESIGNANDDEVELOPMENTINFORMATIONAFTERTHECONTACTFORMISAPPROVEDBYTHEPROJECTLEADER,ITSHALLBEISSUEDTOTHEGROUPSIFSOMETASKSNEEDTOBEHARMONIZEDBYTHEDIRECTOROFTECHNICALQUALITYDEPARTMENT,THEYCANNOTBEHARMONIZEDUNTILTHEYAREAPPROVEDBYTHEDIRECTOROFTECHNICALQUALITYDEPARTMENT/对于组别之间重要的设计和开发信息沟通，设计开发人员填写工艺设计开发信息联络单，由项目负责人审批后发给相关组别，需要技术质量部主管进行协调工作的，由技术质量部主管审批后组织协调。BMARKETINGDEPARTMENTSHALLTAKECHARGEOFCONTACTWITHTHECUSTOMERANDINFORMATIONTRANSFERTOTHECUSTOMER/营销部负责与顾客的联系及信息传递。52PROCESSDESIGNANDDEVELOPMENTINPUT/工艺设计和开发输入521THEPROCESSDESIGNANDDEVELOPMENTINPUTSHOULDINCLUDETHEFOLLOWINGCONTENTS/工艺设计开发输入应包括以下内容AMAINCHARACTERISTICSANDPERFORMANCEREQUIREMENTSFORTHEPRODUCTTHESEREQUIREMENTSAREMAINLYFROMTHEDEMANDANDEXPECTATIONOFTHECUSTOMERORPROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序5MARKET,NORMALLYINCLUDEDINTHECONTRACT,ORDERORPROJECTRECOMMENDATION/产品主要特点、性能要求。这些要求主要来自顾客或市场的需求与期望，一般应包含在合同、定单或项目建议书中；BAPPLICABLELAWSANDREGULATIONSANDMANDATORYNATIONALSTANDARDSSHALLBEMET/适用的法律、法规要求，对国家强制性标准一定要满足；CAPPLICABLEINFORMATIONPROVIDEDBYPREVIOUSSIMILARPROCESSDESIGNANDDEVELOPMENT/以前类似的工艺设计和开发提供的适用信息；DOTHERREQUIREMENTSNECESSARYFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发所必须的其他要求。522THEPROCESSDESIGNANDDEVELOPMENTINPUTSHALLBEDOCUMENTED,LISTOFPROCESSDESIGNANDDEVELOPMENTINPUTSSHALLBECOMPLETEDANDALLKINDSOFRELEVANTDATASHALLBEATTACHED/工艺设计和开发的输入应形成文件，填写工艺设计和开发输入清单，并附上各类相关的资料。523THEDIRECTOROFTECHNICALQUALITYDEPARTMENTSHALLARRANGETHERELATEDPROCESSDESIGNANDDEVELOPMENTPERSONNELANDASSOCIATEDDEPARTMENTSTOREVIEWTHEPROCESSDESIGNANDDEVELOPMENTINPUTANDCLARIFYTHEIMPERFECT,VAGUEORINCONSISTENTREQUIREMENTSINORDERTOENSURETHATTHEDESIGNANDDEVELOPMENTINPUTMEETSTHEREQUIREMENTSOFTHEASSIGNMENTBOOK/技术质量部主管组织有关工艺设计和开发人员和相关部门对工艺设计和开发输入进行评审，对其中不完善、含糊或矛盾的要求做出澄清和解决，确保设计开发的输入满足任务书的要求。53PROCESSDESIGNANDDEVELOPMENTOUTPUT/工艺设计和开发的输出531THEPROCESSDESIGNANDDEVELOPMENTPERSONNELSHALLLAUNCHTHEPROCESSDESIGNANDDEVELOPMENTONTHEBASISOFPROCESSDESIGNANDDEVELOPMENTPLANANDTHEPROGRAM,ANDWORKOUTCORRESPONDINGDOCUMENTONPROCESSDESIGNANDDEVELOPMENTOUTPUT,IE,LISTOFPROCESSDESIGNANDDEVELOPMENTOUTPUTS/工艺设计和开发人员根据工艺设计和开发计划书及方案等开展工艺设计开发工作，并编制相应的工艺设计和开发输出文件，即工艺设计和开发输出清单。532THEDOCUMENTONPROCESSDESIGNANDDEVELOPMENTOUTPUTSHOULDBEEXPRESSEDINTHEFORMTHATITCANBEVERIFIEDFORPROCESSDESIGNANDDEVELOPMENTINPUTTOPROVETHATTHEINPUTREQUIREMENTISMETANDTOPROVIDESUITABLEINFORMATIONFORPROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序6THEPRODUCTIONTHEDOCUMENTONPROCESSDESIGNANDDEVELOPMENTOUTPUTSHALLVARYWITHDIFFERENTPRODUCTS,INCLUDINGTHEPARAMETERSANDDOCUMENTSFORPRODUCTIONGUIDANCE,EG,CONVERSIONDRAWING,PROCESSDOCUMENT,PARTLIST,CONTROLPLAN,INSPECTIONANDTESTPLAN,INSPECTIONWORKINSTRUCTIONS,LISTOFPURCHASEDMATERIALSANDDESIGNDRAWINGSOFTOOLINGANDFIXTURES/工艺设计和开发输出文件应以能针对工艺设计和开发输入进行验证的形式来表达，以便于证明满足输入要求，为生产运作提供适当的信息。工艺设计和开发输出文件因产品不同而不同，包括指导生产等活动的参数和文件如转换图纸、工艺文件、零件明细表、控制计划、检验和试验计划、检验作业指导书、物资采购清单、工装夹具设计图纸等。533TECHNICALQUALITYDEPARTMENTSHALLASSIGNAPERSONSPECIALLYFORCHECKINGTHEPROCESSDATA,ESPECIALLYCHECKINGWHETHERTHEPROCESSDATAMEETTHEPRODUCTDESIGNREQUIREMENT,THECONTENTISCOMPLETEANDCORRECT,THEWORKINGPROCESSESAREHARMONIZEDANDTHEPROCESSINGISFEASIBLEANDCHECKABLE/技术质量部指定专人负责校核工艺资料，重点校核工艺资料能否满足产品设计要求；内容完整、正确；工序之间是否协调、加工的可行性和可检查性。534FULLPARTTIMESTANDARDIZATIONPERSONNELOFTECHNICALQUALITYDEPARTMENTSHALLTAKECHARGEOFCHECKINGTHEDATAONPROCESSDESIGNANDDEVELOPMENTOUTPUTFORSTANDARDIZATION/技术质量部门的专（兼）职标准化员负责本部门对工艺设计和开发输出资料标准化检查。535THEPROJECTLEADERSHALLREVIEWTHEPROCESSOUTPUTDOCUMENTANDFILLINLISTOFPROCESSDESIGNANDDEVELOPMENTOUTPUTSTHEOUTPUTDOCUMENTCANNOTBEISSUEDUNTILITISAPPROVEDBYCHIEFENGINEER/由项目负责人对输出工艺文件进行审核并填写工艺设计和开发输出清单，总工程师批准输出文件后才能发放。54REVIEWOFPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发的评审541THESYSTEMICANDCOMPREHENSIVEREVIEWSPROPOSEDBYTHEPROJECTLEADEROFPROCESSDESIGNASUSUALSHOULDBECARRIEDOUTATTHESUITABLESTAGEOFPROCESSDESIGNANDDEVELOPMENT/在工艺设计和开发的适当阶段应系统的、综合的评审，一般由工艺设计项目负责人提出。5411THEINSTRUCTIONPROCESSDOCUMENTSSUCHASPROCESSDESIGNANDDEVELOPMENTPROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序7PLANNING,OVERALLPROCESSPROGRAMPROCESSROUTEANDPRODUCTIONINSTRUCTIONSSHOULDBEPROCESSREVIEWEDBEFORECONCRETEPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发策划、工艺总方案（工艺路线）及生产说明书等指令性工艺文件的工艺评审应在工艺具体设计和开发前进行。5412TECHNOLOGICALPROCEDUREFORNEWPROCESS,KEYARTICLE,IMPORTANTARTICLEANDKEYPROCESSWORKINGPROCESSANDSPECIALPROCESSDOCUMENTSHALLBEREVIEWEDBEFOREFIRSTARTICLEINSPECTION/新工艺，关键件、重要件、关键过程（工序）的工艺规程以及特殊工艺文件的评审在首件鉴定前进行。542REVIEWCONTENT/评审内容5421REVIEWOFOVERALLPROCESSPROGRAM/工艺总方案的评审ATHEOVERALLPROCESSPROGRAMSHALLBEREVIEWEDFORCORRECTNESS,ADVANCEMENT,ECONOMYANDFEASIBILITY/审查工艺总方案的正确性、先进性、经济性和可行性；BTHEOVERALLPROCESSPROGRAMSHALLBEREVIEWEDTODETERMINEWHETHERITMEETSTHEREQUIREMENTSOFPRODUCTDESIGNANDPRODUCTIONPROGRAM/审查工艺总方案是否满足客户产品设计及生产纲领的要求；CTHEPRODUCTPROCESSDIVISIONANDROUTESHALLBEDETERMINEDREASONABLYANDFEASIBLY/产品的工艺分工和工艺路线的确定是否合理、可行；DTHEBASESUSEDTODETERMINESPECIALTOOLINGFACTORSSHALLBEREVIEWED/审查专用工装系数的确定依据；ETHEBASESANDRATIONALITIESFORNEWPROCESS,NEWTECHNIQUEANDNEWEQUIPMENT/新工艺、新技术、新设备采用的依据及合理性；FTHEREQUIREMENTSFORSTANDARDIZATIONOFPROCESSTECHNICALDOCUMENTS/工艺技术文件的标准化要求；GTHEPRINCIPLESFORDETERMINATIONANDCONTROLOFMATERIALCONSUMPTIONQUOTASHALLBEREVIEWED/审查材料消耗定额确定及控制的原则。5422REVIEWOFKEYARTICLEANDIMPORTANTARTICLE/关键件、重要件的评审ATHECONTROLFACTORSANDCONTENTSOFTHEPROCESSDOCUMENTSONKEYPROCESSESWORKINGPROCESSESOFKEYARTICLEANDIMPORTANTARTICLESHALLBEREVIEWEDFORCORRECTNESS,RATIONALITYANDINSPECTABILITY/审查关键件、重要件中关键过程PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序8工序工艺文件的控制因素及内容的正确性、合理性、可检查性；BTHEPROCESSCAPABILITYINDEXOFKEYPROCESSWORKINGPROCESSSHALLBEVERIFIED/核实关键过程工序的工序能力指数；CTHEPROCESSMETHODSANDDETECTIONREQUIREMENTSFORKEYPROCESSESWORKINGPROCESSESOFKEYARTICLEANDIMPORTANTARTICLESHALLBEREVIEWEDFORRATIONALITYANDFEASIBILITY/审查关键件、重要件中关键过程工序的工艺方法、检测要求的合理性和可行性；DTHESETUPOFASSOCIATEDWORKINGPROCEDUREANDINSPECTIONPROCESSRELATEDTOFORMATIONOFQUALITYCHARACTERISTICOFKEYPROCESSWORKINGPROCESSSHALLBEREVIEWEDFORCORRECTNESS,RATIONALITYANDFEASIBILITY/审查与关键过程工序的质量特性形成，涉及的关联工序及检验工序设置的正确性、合理性、可行性；ETHETECHNICALBREAKTHROUGHMEASUREFORKEYPROCESSWORKINGPROCESSSHALLBEREVIEWED/审查关键过程工序的技术攻关措施；FTHECONTENTOFKEYPROCESSWORKINGPROCESSSHALLBEREVIEWEDFORCOMPLETENESS/审查关键过程工序目录的完整性。5431TECHNICALQUALITYDEPARTMENTSHALLISSUETHEREVIEWCONTENTORRELATEDDATATOTHEREVIEWINGUNITS/技术质量部将评审内容或有关的资料送交各参评单位。544ORGANIZATIONANDRESPONSIBILITYOFREVIEW/评审组织及职责5441REVIEWORGANIZATION/评审组织THEPROCESSREVIEWGROUPSHALLBECOMPOSEDOFREVIEWERSOFWHICHTHECHIEFISCOMPETENTTECHNICALLEADERORHIS/HERREPRESENTATIVE由参评人员组成工艺评审组，组长由主管技术领导或由他指定的委托人担任。5442RESPONSIBILITIESOFREVIEWGROUPCHIEF/评审组长职责APRESIDEOVERTHEMEETING/主持会议；BCOLLECTTHEPROBLEMSANDSUGGESTIONSPUTFORWARDINTHEREVIEW,GIVEOPINIONSANDMAKECONCLUSIONS/汇集评审提出的问题和建议，写出评语和结论；CASSIGNARECORDERTOSORTANDWORKOUTTHEPROCESSREVIEWREPORTS/指定记录PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序9人员整理、写出工艺评审报告；5443RESPONSIBILITIESOFREVIEWER/评审人员职责AREADYFORTHEREVIEWINADVANCE/提前做好参评准备；BGIVEOPINIONSFULLY/充分发表意见；545REVIEWSTEPS/评审步骤5451THEREVIEWGROUPCHIEFSHALLDESCRIBETHEMEETINGANDASSIGNARECORDER/评审组组长作会议说明并指定记录人员；5452THEPROCESSDESIGNREPRESENTATIVESHALLINTRODUCETHEPROCESSDESIGN/工艺设计代表介绍工艺设计情况；5453THEREVIEWERSSHALLGIVETHEOPINIONSONTHEREVIEW/参评人员发表评审意见；5454THEREVIEWGROUPCHIEFSHALLDEFINETHEITEMSANDCONTENTSTOBEIMPROVEDONTHEBASISOFCOLLECTEDOPINIONS,ANDSUMMARIZETHEREVIEWRESULTSTOGIVEHIS/HEROPINIONORMAKEACONCLUSION/评审组组长在集中意见的基础上，明确需要改进的项目和改进内容，对评审结果总结形成评语或结论；5455THERECORDERSHALLSORTTHEMEETINGRECORDSANDFILLINREPORTONPROCESSDESIGNANDDEVELOPMENTREVIEW/记录人员整理会议记录，填写工艺设计和开发评审报告。546MEASUREIMPLEMENTATIONANDDATAPERFECTION/落实措施，完善资料TECHNICALQUALITYDEPARTMENTSHALLEARNESTLYANALYZETHEPROBLEMSANDIMPROVEMENTOPINIONSPUTFORWARDINTHEREVIEWMEETING,WORKOUTTHEMEASURES,HAVETHEMTAKENANDPERFECTTHEPROCESSDATA技术质量部认真分析评审会议提出的问题和改进意见，制定并落实措施，完善工艺资料。55FIRSTARTICLEINSPECTION/首件鉴定541TECHNICALQUALITYDEPARTMENTSHALLDRAWUPAFIRSTARTICLEBATCHINSPECTIONPLAN,PROPOSETHEINSPECTIONREQUIREMENT,ASSIGNAPERSONTOARRANGETHETRIALMANUFACTUREINSPECTIONANDARRANGETHEPLANTIMPLEMENTATIONONTHEBASISOFISSUEDNEWPRODUCTTRIALMANUFACTUREPLAN/技术质量部根据下达的新产品试制计划，拟订首件（批）鉴定计划，提出鉴定要求，明确试制鉴定组织人员，并组织实施。PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序10542TRIALMANUFACTUREOFFIRSTARTICLEBATCH/首件（批）试制MANUFACTURINGDEPARTMENTSHALLTRIALMANUFACTURETHEFIRSTARTICLEBATCHONTHEBASISOFNEWPRODUCTTRIALMANUFACTUREPLANANDTHEFOLLOWINGREQUIREMENTS制造部根据新产品试制计划和下列要求组织进行首件（批）试制ATHEPROCESSDEVICE,PRODUCTIONEQUIPMENT,TESTEQUIPMENT,ENVIRONMENTALCONDITION,ETCSHALLMEETTHEPROVISIONSOFPROCESSDOCUMENTS,ANDTHEREADYCONDITIONOFTRIALMANUFACTURESHALLBEQUALIFIEDTHROUGHCHECK/工艺装置、生产设备、试验设备及环境条件等满足工艺文件的规定，并经试制准备状态检查合格；BTHEARTICLESHALLBEPROCESSEDINEACHWORKINGPROCESSSTRICTLYINACCORDANCEWITHTHEREQUIREMENTSOFPROCESSDOCUMENT,ANDTHEPROBLEMSFOUNDDURINGTHETRIALMANUFACTUREINEACHWORKINGPROCESSSHALLBEHANDLEDANDRECORDEDBYTHETECHNICIANINTIME/每道工序应严格按工艺文件的要求加工，技术人员及时处理、记录每道工序试制中的问题；CTHEINSPECTORSHALLCHECKTHEPROCESSEDARTICLEANDMAKERELATEDRECORDS/检验人员进行加工后的检测，做好相关记录。543INSPECTIONFORFIRSTARTICLEBATCHWORKINGPROCESS/首件（批）工序鉴定5431THEARTICLEPARTORCOMPONENTINFIRSTARTICLEBATCHWORKINGPROCESSSHALLBEINSPECTEDSTRICTLYINACCORDANCEWITHISSUEDPROCESSDOCUMENTANDWORKINSTRUCTIONSFORTRIALMANUFACTUREAFTERITISQUALIFIED,THECONDITIONONINSPECTIONFORFIRSTARTICLEBATCHWORKINGPROCESSSHALLBEPOSSESSED/首件（批）工序（零、部）件严格按照下发的试制工艺文件和作业指导书进行检验。合格后才能具备首件（批）工序鉴定条件。5432WHENTHECONDITIONONINSPECTIONFORFIRSTARTICLEBATCHWORKINGPROCESSSHALLBEPOSSESSED,MANUFACTURINGDEPARTMENTSHALLFILLIN“APPLICATIONFORMFORINSPECTIONTYPEAPPROVALOFFIRSTARTICLEBATCHWORKINGPROCESS”ANDSUBMITITTOTECHNICALQUALITYDEPARTMENTTOINSPECTTHEFIRSTARTICLEBATCHWORKINGPROCESS/具备首件（批）工序鉴定条件时，由制造部填写“首件（批）工序（零、部）件鉴定（定型）申请表”交技术质量部门组织对首件（批）的工序实施鉴定。PROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序11544INSPECTIONOFPARTANDCOMPONENTINFIRSTARTICLEBATCHWORKINGPROCESS/首件（批）工序零、部件鉴定5441TECHNOLOGYQUALITYDEPARTMENTSHALLTAKECHARGEOFASSIGNTHEINSPECTORSTOINSPECTTHEPARTANDCOMPONENTINTHEFIRSTARTICLEBATCHWORKINGPROCESS/技术部门负责组织鉴定组成员，进行首件（批）零、部件鉴定。5442THESITUATIONONTHEINSPECTIONFORFIRSTARTICLEBATCHWORKINGPROCESSANDTHEPROCESSINGQUALITYOFTHEWORKINGPROCESSSHALLBESPOTCHECKED,WITHTHEFOLLOWINGCONTENTSVERIFIED/抽查首件（批）工序鉴定情况及工序加工质量，验证以下内容ACOMPLETENESS,CORRECTNESSANDEFFECTIVENESSOFPROCEDUREDOCUMENTANDWORKINSTRUCTIONS/工艺文件、作业指导书的完整、正确、有效性；BCONFIGURATIONOFMEASURINGEQUIPMENTLIKEMEASURINGTOOLANDEFFECTIVENESSOFTHEEQUIPMENTFORPRODUCTQUALITYCONTROL/量具等测量设备的配置及对产品质量控制的有效性；CCONFORMANCEOFPROCESSINGINWORKINGPROCESSTOPROCESSDOCUMENT/工序加工与工艺文件的符合性；DQUALITIESOFRAWMATERIAL,PARTSANDAUXILIARYEQUIPMENTASWELLASBLANK/原材料、配套件、坯件质量；EWHETHERTHEPRECISIONOFPRODUCTIONEQUIPMENTMEETSTHEPROCESSINGREQUIREMENT/生产设备的精度能否满足加工要求。5443THEFINISHEDPARTANDCOMPONENTINTHEFIRSTARTICLEBATCHSHALLBESPOTCHECKEDTOAFFIRMWHETHERTHEYMEETTHEREQUIREMENTSOFTHECUSTOMERSPRODUCTIONDRAWINGS/抽查首件（批）零、部件成品，证实其是否满足客户产品图要求。5444INSPECTIONGROUPSHALLASSESSTHERESULTOFSPOTCHECK,MAKEACONCLUSIONANDFILLTHECONCLUSIONANDFOUNDPROBLEMSINCORRESPONDINGCOLUMNSOFCHECKLISTOFPARTS/COMPONENTSINFIRSTARTICLEBATCHWORKINGPROCESS/鉴定组对抽查结果进行评议，做出鉴定结论并将结论及问题写入首件（批）工序（零、部）件鉴定表相应栏内。545POSTINSPECTIONDISPOSAL/鉴定后的处置5451THEPARTANDCOMPONENTQUALIFIEDTHROUGHTHEINSPECTIONSHALLBECIRCULATEDORPROCEDUREDOCUMENT/程序文件PAGE/页码25SHEETS/共25页CONTROLPROCEDUREFORPROCESSDESIGNANDDEVELOPMENT/工艺设计和开发控制程序12STOREDASREQUIRED/鉴定合格的零、部件按要求流转或保存。5452FORTHEPARTANDCOMPONENTUNQUALIFIEDTHROUGHTHEINSPECTION,THESUBSEQUENTPARTANDCOMPONENTCANBEUSEDFORREINSPECTION/鉴定未通过时，允许用后续产品递补，重新进行鉴定。55VALIDATIONOFDESIGNANDDEVELOPMENT/设计和开发的验证551BASEDONTHEPROCESSDESIGNANDDEVELOPMENTPROGRAMPASSINGTHROUGHTHEREVIEW,TECHNICALQUALITYDEPARTMENTSHALLBERESPONSIBLEFORCITINGTHEAFFIRMEDEVIDENCERELATEDTOSIMILARPROCESSDESIGNANDDEVELOPMENTFORCOMPARISONASTHEBASISFORVERIFICATIONOFTHISDESIGN/根据评审通过的工艺设计和开发方案,技术质量部负责引用已证实的类似工艺设计和开发的有关证据进行比较，作为本次设计的验证依据。552THEPROJECTLEADERSHALLSUMMARIZEALLTHEVERIFICATIONRESULTS,WORKOUTREPORTONVERIFICATIONOFPROCESSDESIGNANDDEVELOPMENT,RECORDTHEVERIFICATIONRESULTSANDTRACEDMEASURESANDREPORTTHEMTOCHIEFENGINEERFORAPPROVALSOASTOENSURETHATEVERYPERFORMANCEINDICATORANDEVERYFUNCTIONALINDICATORINPROCESSDESIGNANDDEVELOPMENTINPUTHAVECORRESPONDINGVERIFICATIONRECORDS/项目负责人综合所有验证结果，编制工艺设计和开发验证报告，记录验证的结果及跟踪的措施，报总工程师批准，确保工艺设计和开发输入中每一项性能、功能指标都有相应的验证记录。56CONFIRMATIONOFDESIGNANDDEVELOPMENT/设计和开发的确认THECONFIRMATIONISINTENDEDTOPROVETHATTHEPRODUCTMEETSEXPECTEDUSEREQUIREMENT,ANDSHOULDBECARRIEDOUTBEFOREBATCHPRODUCTIONASUSUALIFTHECONFIRMATIONNEEDSTOBECARRIEDOUTAFTERTHEP