ProcedureDocument/程序文件ControlProcedureforProcessdesignandDevelopment工艺设计和开发控制程序DocumentNO/编号:TY-QP7.3-01-15Revision/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RecordChartofChangesinQualityManagementSystemofQualityManualTY-QR-TQD-031A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ChangeExecutorControlProcedureforProcessdesignandDevelopment/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Thisprocedureisapplicabletocontrolofnewproductprocessdesignanddevelopmentofthecompany.Thecontent:Thecompanydoesn’tcovertheproductdesign,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3.1Processdesignoutput:theresultofprocessdesign.Throughtheprocessdesignanddevelopment,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。3.2Processreview:theprocessdesignisreviewedformally,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。3.3Overallprocessprogram:basedonproductdesignrequirement,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。3.4Firstarticle(batch)inspection:afterthereadyconditionoftrial-manufactureisqualifiedthroughcheck,thefirstbatchoftrial-manufacturedcomponentsandpartsarecheckedforoverallprocessandfinishedproductsinaccordancewiththerequirementsofproductdrawingsandtechnologicalproceduretodeterminewhethertheproductionprocessandequipmentscanguaranteethattheproductsconformingtodesignrequirementsareproduced./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。3.5Processplanning:responsibilitiesandauthoritiesforprocessdesignaredistributedandinterfacemanagementateverystageofproductprocessdesignisdefinedonthebasisoftechnicaldocumentssuchasproductdesigndrawingofthecustomerinaccordancewithschedulesofproductdesignanddevelopment,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4.1TechnicalQualityDepartmentshallberesponsibleforcentralizedmanagementofprocessdesignanddevelopmentandhavingtheprocessdesignanddevelopmentfornewproductimplemented;/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;4.2TechnicalQualityDepartmentshallberesponsibleforbusinessmanagementofprocessdesignanddevelopmentandhavingtheprocessdesignanddevelopmentfornewproductimplemented;/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;4.3Alltherelatedunitsofthecompanyshallberesponsibleforcooperationinaccomplishingallthetasksontheprocessdesignanddevelopment./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5.1ProcessDesignandDevelopmentPlanning/工艺设计和开发策划5.1.1SourceofProcessDesignandDevelopmentProject/工艺设计和开发项目的来源a)AfterthenewproductcontractortechnicalagreementsignedbyMarketingDepartmentandthecustomer,ormarketdemandisreviewed,MarketingDepartmentshallfillinApplicationforSetupofProcessDesignandDevelopmentProjectandsubmitittorelateddepartmentsandpersonnelforconfirmation.AfteritisapprovedbyGeneralManager,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。b)AfterreceivingApplicationforSetupofProcessDesignandDevelopmentProject,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。5.1.2ChiefEngineershalldeterminetheprojectleaderbasedontheaboveprojectsourcesandtransformtheoutputofprocessdesignanddevelopmentplanningintoProcessDesignandDevelopmentPlan.Theplanshallincludethefollowingcontents:/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:a)Divisionofthestagessuchasinput,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;b)Responsibilitiesandauthoritiesatallthestages,requirementofscheduleandsupportingunit;/各阶段人员职责和权限,进度要求和配合单位;c)Requirementforresourceallocation,e.g.,personnel,information,equipment,fundguaranteeandotherrelatedcontent./资源配置需求,如人员、信息、设备、资金保证等及其他相关内容。5.1.3TheoutputdocumentofprocessdesignanddevelopmentplanningshallberevisedappropriatelywiththescheduleofdesignanddevelopmentinaccordancewiththerelatedprovisionsofControlProcedureforDocument./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。5.1.4InterfaceManagementbetweenDifferentGroupsofProcessDesignandDevelopment/工艺设计和开发不同组别之间的接口管理Differentgroupsofprocessdesignanddevelopmentmayconcerndifferentfunctionsorlevelsofthecompany,andtheexteriorofthecompany.