工艺设计和开发控制程序.docx

ProcedureDOC1.Iment/程序文件Contro1.PrOCedUreforProcessdesignandDeve1.opment工艺设计和开发限制程序DocumentNO/编号:TY-QP7.3-01-15Revision/版本:Checkedby/校对：Verifiedby/审核:Approvedby/批准:Contro1.1.edCOndition/受控状态：DistributionNo./分发号:质量管理体系更改记录表RecordChartofChangesinQua1.ityManagementSystemofQua1.ityManua1.TY-QR-TQD-03IA更改单编号ChangeOrderNumber文件编号DocumentNumber处数SectionChanged标记Rev更改日期Re1.easeChange更改人ChangeExecutor计开发立项中清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. 1.2ChiefEngineersha1.1.determinetheproject1.eaderbasedontheaboveprojectsourcesandtransformtheoutputofprocessdesignanddeve1.opmentp1.anningintoProcessDesignandDeve1.opmentP1.an.Thep1.ansha1.1.inc1.udethefo1.1.owingContents:/总工程师依据上述项目来源，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安排书讥安排书内容包括：a) Divisionofthestagessuchasinput,output,review,verificationandconfirmationofprocessdesignanddeve1.opmentandmainworkContent;/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) Responsibi1.itiesandauthoritiesata1.1thestages,requirementofschedu1.eandsupportingUnit;/各阶段人员职责和权限，进度要求和协作单位：c) Requirementforresourcea1.1.ocation,e.g.,personne1.,information,equipment,fundguaranteeandotherre1.atedContent./资源配置需求，如人员、信息、设备、资金保证等与其他相关内容。5.1.3Theoutputdocumentofprocessdesignanddeve1.opmentp1.anningsha1.1berevisedappropriate1.ywiththeschedu1.eofdesignanddeve1.opmentinaccordancewiththere1.atedprovisionsofContro1.ProcedureforDOCUment./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，应执行文件限制程序的有关规定。5.1.4InterfaceManagementbetweenDifferentGroupsofProcessDesignandDeVe1。PInent/工艺设计和开发不同组别之间的接口管理Differentgroupsofprocessdesignanddeve1.opmentmayconcerndifferentfunctionsor1.eve1.softhecompany,andtheexteriorofthecompany.工艺设计和开发的不同组别可能涉与到公司不同职能或不同层次，也可能涉与到公司外部。a) Forthecommunicationofimportantdesignanddeve1.opmentinformationbetweenthegroups,thedesignanddeve1.opmentpersonne1.sha1.1fi1.1.inContactFormforProcessDesignandDeve1.opmentInformation.Afterthecontactformisapprovedbytheproject1.eader,itsha1.1.beissuedtothegroups.IfsometasksneedtobeharmonizedbythedirectorofTechnica1.Qua1.ityDepartment,theycannotbeharmonizedunti1theyareapprovedbythedirectorofTechnica1.Qua1.ityDePartment./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，须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。b) MarketingDepartmentsha1.1.takechargeofcontactwiththecustomerandinformationtransfertothecustomer./营销部负责与顾客的联系与信息传递。5.2ProcessDesignandDeve1.opmentInPUt/工艺设计和开发输入5.2.1Theprocessdesignanddeve1.opmentinputshou1.dinc1.udethefo1.1.owingContents:/工艺设计开发输入应包括以下内容：a) Maincharacteristicsandperformancerequirementsfortheproduct.Theserequirementsaremain1.yfromthedemandandexpectationofthecustomerormarket,norma1.1.yinc1.udedinthecontract,orderorprojectrecommendation;/产品主要特点、性能要求。这些要求主要来H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：b) App1.icab1.e1.awsandregu1.ationsandmandatorynationa1.standardsShaI1.bemet;/适用的法律、法规要求，对国家强制性标准肯定要满足；App1.icationFormforInspection（TypeApprova1.）ofFirstArtic1.e（Batch）WorkingPrOCeSS/首件（批）工序（零、部）件鉴定（定型）申请表1.OG/SN序号：TY-QR-TQD-098SN/序号ProductNaine/产品名称WorkingProcess/1序名称ProductStatus/产品状态Remarks/备注App1.icationDepartment/申请部门App1.icant/申请人DateofApp1.ication/申请时间ManufacturingDepartment'sOPinion/制造部看法:Signedby/签字：Date/日期:Technica1.Qua1.ityDepartment*sOPiniOn/技术质量部看法:Signedby/签字：Da1.e/日期:Check1.istofParts/ComponentsinFirstArtic1.e（Batch）WorkingProcess首件（批）工序（零、部）件鉴定表1.OG/SN序号:TY-QR-TQD-099ProductName/产品名称DrawingNO./图号No.OfPartZComponentinFirstArtic1.e（BatCh）/首件（批）（零部）件编号Item/项目SN/序号InspectionContenty鉴定内容InspectionReSUIt/鉴定结果Ren1.arkS/备注ProcessQUa1.ity/过程质量ProductQUa1.ity/产品质量1Comp1.eteness,CorrectnessandEffectivenessofProcedureandWorkInstructions/工艺文件、作业指导书的完整、正确、有效性2ConfigurationofMeasurementEquipments1.ikeGaugesandTheirEffectivenessforContro1.ofProductQUaIity/量具等测量设备的配置与对产品质量限制的有效性3WhetherthePrecisionsofToo1.ingandProductionEquipmentsMeettheProcessingReqUirementS/工装、生产设备的精度能否满足加工要求4Imp1.ementationofProcessbyManufacturingDCPar1.mCnt/制造部工艺执行状况5WhethertheProductionConditionsareContro1.1.ed/生产条件是否处于受控状态6WhethertheProductQua1.ityAccordstotheRequirementsoftheCustomer'sDrawings/产品质量是否符合客户图纸要求InspectionConc1.usion/鉴定结论Joint1.ySignedbyMemberS/组员会签Signedby/签字：Date/日期：ChiefEngineer*sOPiniOn/总工程师看法Signedby/签字：Date/日期：Genera1.Manager'SOPiniOn/总经理看法Signedby/签字：Date/日期：ReportonProcessDesignandDeve1.opmentReVieW/工艺设计和开发评审报告1.OG/SN序号：Ty-QR-TQD-100AProductMOdeI/产品型号:ProductName/产品名称:ReviewCategory/评审类别:Pre1.iminaryDesignReVieW/初步设计评审口ProcessProgramReVieW/工艺方案评审口Others/其他：ReVieWMOderator/评审主持人：DateofReVieW/评审时间:ObjeCt/评审对象：COntent/评审内容：Tickinginexpressespassingthroughthereviewandfi1.1.ing"?”inexpressesthesuggestionordoubt/口内打“J”表示通过评审，打“？”表示有建议或疑问。ProcessProgramReview/工艺方案1.ECOnOmy/经济性口2.Rationa1.ityofProcessF1.ow2E艺流程合理性口3.Rationa1.ityofTestMethOd/检测方法合理性口4.Rationa1.ityofQua1.ityContro1.BointPIaCement质控点设置合理性口评审5.WorkingProcessCaPabi1.ity/工序实力6.Rationa1.ityofEquipmentSeIeCtiOn/设备选型合理性口7.Feasibi1ityofPurchasingOUtSOUrCedArtiCIe/选购外协可行性口8.Feasihi1ityofToo1.ingDeSign/工装设计可行性口9.Prob1.emsandSuggestions(forcontentsnotpassingthroughthereview)/存在问题与改进的建议(与评审没通过的内容对应)：ReViewcOnCIUSiOn/评审结论:SignaturesofReVieWerS/评审人签名：Department/部门ReviewedbyDate评审人/日期Tit1.e/职位Department部门ReviewedbyDate评审人/日期Tit1.e/职位PreparedbyDate编制/日期Verifiedby/Date/审核/日期APPrOVedby/Date/批准/日期Va1.idationofImprovementMeasuresProposedinReviewConc1.usion/评审结论中改进措施的验证状况：Va1.idatedby/验证人：Date/验证时间：ReportonVa1.idationofProcessDesignandDeVe1.OPI1.ent/工艺设计和开发验证报告1.OG/SN序号：TY-QR-TQD-101AProductMOde1./产品型号：ProductName/产品名称：Va1.idationUnit/验证单位TestedSamp1.eNo./测试样品编号:TimesofStartandEndofTest/试验起止时间：App1.icab1.eStandardsor1.awsandSgUIatJons/依据1勺标准或法律法规：s序号No.andRev./编号、版本NamesofStandardsor1.awsandReguIations标准或法律法规名称App1.icab1.eChaptersZSections适用章节MainTestInstrumentsandEqUiPmentS/主要试验仪器与设备:SN/序号Nos.ofInstrumentsandEquipments/仪器设备编号NamesofInstrumentsandEquipments/仪器与设备名称PeriodofVa1.idityforMeaSUrement/计量有效期AbstractofTestZ1.nspectionReportandComparisonoDesignInput(Technica1.DesignSpecifics1.ions)/Sta报告内容摘要与其与设计输入(设计技术任务书)/标准。theReportwithndards试验/检测勺比照状况：SN/序号TestItemS/检测项目Actua1.TestVa1.Ues/实际检测值RequiredVa1.uesinDesignInputStandards设计输入/标准的要求值Conc1.usion/结论DesignVa1.idationSUmmary/设计验证总结论：PreparedbyDate编制/VerifiedbyDate审ApprovedbyDate批准日期：核/日期：/日期：Va1.idationofImprovementMeasuresProposedinVa1.idationConc1.usion/验证结论中改进措施的验证状况：Va1.idatedby/验证人：Date/验证时间：