工艺设计和开发控制程序

Procedure Document/程序文件Control Procedurefor Process design and Development工艺设计和开发限制程序Document NO/编号TY-QP

7.3-01-15Revision/版本:Checked by/校对Verified by/审核Approved by/批准Controlled Condition/受控状态Distribution No./分发号:for process design and development inputto prove that theinputrequirement ismet andto providesuitable informationfor theproduction.The document on process design and development outputshallvary withdifferent products,including theparameters anddocumentsfor productionguidance,e.g.,conversion drawing,process document,part list,control plan,inspection andtest plan,inspection work instructions,list ofpurchased materialsand designdrawingsof toolingand fixtures./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，为生产运作供应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、限制安排、检验和试验安排、检验作业指导书、物资选购清单、工装夹具设计图纸等

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3.3Technical Quality Department shallassign aperson speciallyforchecking theprocess data,especially checkingwhether the process datameet the productdesign requirement,the contentis completeand correct,the workingprocessesare harmonizedand the processing isfeasible andcheckable./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

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3.4Full parttime standardizationpersonnel of Technical QualityDepartmentshalltake chargeof checkingthe dataon process design and developmentoutput forstandardization./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

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3.5The projectleader shallreview the process outputdocument and fillin List ofProcess Design and DevelopmentOutputs.The outputdocument cannotbeissued untilit is approved byChief Engineer./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

5.4Review of Process Design and Development/工艺设计和开发的评审

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4.1The systemicand comprehensivereviews proposedby the projectleader of process designas usualshould be carried outat thesuitablestage of process design and development./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

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1.1The instruction process documentssuch asprocess design anddevelopment planning,overall processprogram processroute andproductioninstructions shouldbe process reviewed beforeconcrete processdesign and development./X艺设计和开发策划、工艺总方案工艺路途与生产说明书等指令性工艺文件的工艺评审应在工艺详细设计和开发前进行

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1.2Technological procedurefor new process,key article,importantarticle andkey processworking processand specialprocess documentshall be reviewedbefore first article inspection./新工艺，关键件、重要件、关键过程工序的工艺规程以与特别工艺文件的评审在首件鉴定前进行

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4.2Review Content/评审内容

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2.1Review ofOverall Process Program/工艺总方案的评审a Theoverall processprogram shall be reviewedfor correctness,advancement,economy andfeasibility;/审查工艺总方案的正确性、先进性、经济性和可行性；b Theoverall processprogram shall be reviewedto determine whetherit meetsthe requirements of product design andproduction program;/审查工艺总方案是否满足客户产品设计与生产纲领的要求；c The product processdivision androute shall bedetermined reasonablyand feasibly;/产品的工艺分工和工艺路途的确定是否合理、可行；d Thebases used to determinespecial toolingfactors shall bereviewed;/审查专用工装系数的确定依据；e Thebases andrationalities fornewprocess,new techniqueand newequipment;/新工艺、新技术、新设备采纳的依据与合理性；f Therequirements forstandardization of process technicaldocuments;/工艺技术文件的标准化要求；g Theprinciples fordetermination andcontrol ofmaterial consumptionquotashall be reviewed./审查材料消耗定额确定与限制的原则

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2.2Review ofKey Articleand ImportantArticle/关键件、重要件的评审a Thecontrol factorsand contentsof the process documentson keyprocessesworking processes of key article and important articleshall be reviewedfor correctness,rationality andinspectability;/审查关键件、重要件中关键过程工序工艺文件的限制因素与内容的正确性、合理性、可检查性；b The process capabilityindex ofkey processworking process shallbe verified;/核实关键过程工序的工序实力指数；c The process methodsand detectionrequirements forkey processesworking processesofkey articleandimportant article shall bereviewed forrationality andfeasibility;/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；d Thesetup ofassociated workingprocedure andinspection processrelated to formationof qualitycharacteristic ofkey processworking processshall be reviewedfor correctness,rationality andfeasibility;/审查与关键过程工序的质量特性形成，涉与的关联工序与检验工序设置的正确性、合理性、可行性；e Thetechnical breakthroughmeasure forkey processworking processshall bereviewed;/审查关键过程工序的技术攻关措施；f The content ofkey processworking processshall bereviewed forcompleteness./审查关键过程工序书目的完整性

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3.1Technical Quality Department shallissue thereview contentorrelated datato thereviewing units./技术质量部,各评审内容或有关的资料送交各参评单位

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4.4Organization andResponsibility ofReview/评审组织与职主贝

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4.1Review Organization/评审组织The processreview groupshall becomposed ofreviewers ofwhich thechiefis competenttechnical leaderor his/her representative.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托付人担当

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4.2Responsibilities ofReview GroupChief/评审组长职责a Presideover the meeting;/主持会议；b Collectthe problemsand suggestionsput forwardin thereview,giveopinions and make conclusions;/汇合评审提出的问题和建议，写出评语和结论；c Assigna recorderto sortand work out theprocessreviewreports;/指定记录人员整理、写出工艺评审报告；

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4.3Responsibilities ofReviewer/评审人员职责a Readyfor thereview inadvance;/提前做好参评打算；b Giveopinions fully./充分发表看法；

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4.5Review Steps/评审步骤

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5.1The reviewgroup chiefshall describethe meetingand assignarecorder;/评审组组长作会议说明并指定记录人员；

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5.2The process design representativeshall introducethe processdesign;/工艺设计代表介绍工艺设计状况；

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5.3The reviewersshall givethe opinionson thereview;/参评人员发表评审看法；

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5.4The reviewgroup chiefshall definethe itemsand contentsto beimprovedon the basis ofcollected opinions,and summarizethe reviewresultsto givehis/her opinionor makea conclusion;/评审组组长在集中看法的基础上，明确须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；

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5.5The recordershall sortthemeetingrecords andfill inReporton Process Design and Development Review./t己录人员整理睬议记录，填写《工艺设计和开发评审报告》

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4.6Measure Implementationand DataPerfection/落实措施,完善资料Technical QualityDepartment shallearnestly analyzethe problemsandimprovement opinionsput forwardin thereview meeting,workout themeasures,have themtaken andperfect theprocessdata.技术质量部仔细分析评审会议提出的问题和改进看法，制定并落实措施，完善工艺资料

5.5First ArticleInspection/首件鉴定

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4.1Technical QualityDepartment shalldraw upa first article batchinspectionplan,propose the inspection requirement,assign aperson toarrangethe trial-manufacture inspectionand arrangethe plantimplementationon thebasis ofissued New Product Trial-manufacture Plan./技术质量夸B依据下达的新产品试制安排，拟订首件批鉴定安排，提出鉴定要求,明确试制鉴定组织人员，并组织实施

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4.2Trial-manufacture of First ArticleBatch/首件加匕试制Manufacturing Departmentshal1trial-manufacture the first articlebatchon thebasis ofNewProductTrial-manufacture Planand thefollowingrequirements:制造部依据新产品试制安排和下列要求组织进行首件批试制a The process device,production equipment,test equipment,environmental condition,etc shallmeet theprovisions of processdocuments,and theready conditionof trial-manufacture shall bequalified throughcheck;/工艺装置、生产设备、试验设备与环境条件等满足工艺文件的规定，并经试制打算状态检查合格；b The article shall be processedin each working processstrictly inaccordance with the requirements of process document,and theproblemsfound duringthe trial-manufacture ineachworking processshall behandled andrecorded by the technicianin time;/每道工序应严格按工艺文件的要求加工，技术人员与时处理、记录每道工序试制中的问题；c Theinspector shallcheck theprocessed articleandmakerelatedrecords./检验人员进行加工后的检测，做好相关记录

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4.3Inspection forFirst ArticleBatch Working Process/首件批工序鉴定

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3.1Thearticlepart orcomponent infirst article batch workingprocessshallbeinspected strictlyin accordance with issuedprocessdocument and work instructionsfor trial-manufacture.After itis qualified,the condition on inspection for first article batchworkingprocessshallbe possessed./首件批工序零、部件严格依据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

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3.2When theconditiononinspection forfirstarticlebatch workingprocessshallbepossessed,Manufacturing Department shall fill in“Application Form for InspectionType Approval of First Article BatchWorking Process^and submit it to Technical QualityDepartment toinspectthe firstarticlebatchworkingprocess./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

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4.4Inspection of Part andComponent inFirst ArticleBatch WorkingProcess/首件批工序零、部件鉴定

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4.1Technology QualityDepartment shalltake chargeof assigntheinspectors toinspect thepart and component in the firstarticle batchworkingprocess./技术部门负责组织鉴定组成员，进行首件批零、部件鉴定

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5.2The situation on theinspection forfirstarticlebatch workingprocessand theprocessing qualityof theworkingprocessshallbespotchecked,with thefollowing contentsverified:/抽查首件批工序鉴定状况与工序加工质量，验证以下内容a Completeness,correctness andeffectiveness ofprocedure documentandworkinstructions;/工艺文件、作业指导书的完整、正确、有效性；b Configuration of measuringequipment likemeasuring toolandeffectiveness of the equipmentfor productquality control;/量具等测量设备的配置与对产品质量限制的有效性;c Conformanceof processingin workingprocess toprocess document;/工序加工与工艺文件的符合性；d Qualitiesof rawmaterial,parts andauxiliary equipmentas wellasblank;/原材料、配套件、坯件质量；e Whether the precisionof productionequipment meetsthe processingrequirement./生产设备的精度能否满足加工要求

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4.3The finishedpart andcomponent in the firstarticle（batch）shallbespot checkedto affirmwhether theymeet the requirementsof thecustomer5s productiondrawings./抽查首件（批）零、部件成品，证明其是否满足客户产品图要求

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4.4Inspection Groupshall assessthe resultof spotcheck,makea conclusionandfillthe conclusionand foundproblems incorrespondingcolumns ofChecklist ofParts/Components inFirst Article（Batch）WorkingProcess./鉴定组对抽查结果进行评议，做出鉴定结论并将结论与问题写入《首件（批）工序（零、部）件鉴定表》相应栏内

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4.5Post-inspection Disposal/鉴定后的处置

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5.1The part andcomponentqualified through theinspectionshallbe circulatedor storedas required./鉴定合格的零、部件按要求流转或保存

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5.2For thepart andcomponent unqualified through theinspection,the subsequentpartandcomponent canbe usedfor re-inspection./鉴定未通过时，允许用后续产品递补，重新进行鉴定

5.5Validation ofDesign and Development/设计和开发的验证

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1.1Based on theprocessdesign and development programpassing throughthereview,Technical QualityDepartment shallbe responsibleforciting theaffirmed evidencerelatedtosimilar processdesign anddevelopment for comparisonas thebasis forverification ofthisdesign./依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明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

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1.2The projectleader shallsummarize all the verificationresults,workout Report on Verification of Process Design and Development,recordthe verificationresults andtraced measuresand reportthem to ChiefEngineer forapproval soas to ensure that every performanceindicatorand everyfunctional indicatorin processdesign and developmentinput havecorresponding verificationrecords./项目负责人综合全部验证结果，编制《工艺设计和开发验证报告》,记录验证的结果与跟踪的措施，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

5.6Confirmation ofDesign and Development/设计和开发的确认Theconfirmation isintended toprovethat the product meets expecteduserequirement,and shouldbecarried out beforebatch productionas usual.If the confirmation needsto becarried outafter the product is used bytheuser fora period,it shouldbe realizedlocally withinpossibleapplicable range.Based on the productcharacteristics,one of thefollowing confirmationmethods canbe selected.确认的目的是证明产品能够满足预期的运用要求，通常应在批量生产之前，如需经用户运用一段时间才能完成确认工作的，应在可能的适用范围内实现局部确认，依据产品的特点，可以选择下述几种确认方式之一

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6.1Technical QualityDepartment shall arrange related personnel tocarryoutthefirstarticleinspectionfor theproduct,i.e.,the productprocess design and development isconfirmed;/技术质量部组织相关人员对产品进行首件鉴定，即对产品工艺设计和开发予以确认；

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6.2After theproduct isqualified throughthe acceptance,if itisdelivered byMarketing Departmentto the customer fortryout,MarketingDepartment shall fillinCustomer SatisfactionQuestionnaire toindicatethe customersatisfaction forconformance ofproduct tostandard orcontractrequirement and the assessmentfor applicability,the customersatisfactionrefers to theconfirmation of processdesign and development;/自验收合格的产品，假如须要由营销联系交付顾客试用，由营销部提交《顾客满足度度调查表》，说明顾客对产品符合标准或合同要求的满足程度与对适用性的评价，顾客满足即对工艺设计和开发予以确认；

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6.3Theproductshallbesent tonational orindustrial relatedagencyfor inspection,the reporton qualificationthrough inspectionrefers totheconfirmationof processdesign anddevelopment.The abovereport andrelateddata arethe resultsof theconfirmation.Technical QualityDepartment shall analyzethe results,take correspondingtracing andimprovementmeasures asneeded,fill themin Contact Form for Process Designand Development Informationand submitthe formto relevantdepartmentsfor implementationto ensure that theproductmeetsexpected userequirements./产品送至国家或彳亍业有关机构进行检验，其检验合格报告即为工艺设计和开发的确认上述报告与相关资料为确认的结果，技术质量部对此结果进行分析，依据须要实行相应的跟踪和改进措施，并填写在《工艺设计和开发信息联络单》上传递给相关部门执行，以确保产品满足预期的运用要求

5.7Control of Changes inDesign and Development/设计和开发更改的限制

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7.1The importantchanges ofkeyarticle,importantarticleand specialprocessshallbecarried outafter test,demonstration andreview.The reviewshall includeevaluation on the effectof componentsanddelivered productsbrought bythese changes./关键件、重要件和特种工艺的重要更改，应通过试验、论证、评审后实施审核应包括构成零件和已交货产品的变动效果的评估

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7.2For thechange after the formalprocess document is issued,TechnicalQuality Department shall fillin Application for DocumentChange withrelevant data attached./正式工艺文件下质量管理体系更改记录表Record ChartofChangesin QualityManagement Systemof QualityManualTY-QR-TQD-031A更改单编号文件编号更改日期更改人处数标记Change OrderDocument ReleaseChangeSecti onRevNumberNumber ChangeExecutorChang ed发后的更改应由技术质量部填写《文件更改申请》，并附上相关资料

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7.3Theprocessdocument shallbe changedafter approvalof theManagementRepresentative ifnecessary,such changeshallbereviewedby relevantdepartments andrelatedpersonnel and theinformation onthechange shallbe availableto relevantdepartments,personneland thesupplier intime.All modificationsshallbeidentified andrecorded forfiling./更改工艺文件必需报管理者代表批准后方可进行更改必要时须要相关部门与相关人员进行评审，并确保相关部门、人员、与供应商与时得到更改信息全部变动和修改应予以识别和归档6Relevant Documents/相关文件

6.1TY-QP

4.2-01-15Control Procedurefor DocumentTY-QP

4.2-01-15《文件限制程序》

6.2TY-QP

4.2-02-15Control Procedurefor QualityRecord TY-QP

4.2-02-15《质量记录限制程序》7Annexes/附件

7.1TY-QR-TQD-092Application for Setup of Process Design andDevelopment Project/TY-QR-TQD-092《工艺设计和开发立项申请书》

7.2TY-QR-TQD-093Assignment Bookfor Process Design and DevelopmentTY-QR-TQD-093《工艺设计和开发任务书》

7.3TY-QR-TQD-094Process Design and Development Plan TY-QR-TQD-094《工艺设计和开发安排书》

7.4TY-QR-TQD-095Contact Formfor Process Design and DevelopmentInformation/TY-QR-TQD-095《工艺设计和开发信息联络单》

7.5TY-QR-TQD-096List ofProcess Designand DevelopmentInputsTY-QR-TQD-096《工艺设计和开发输入清单》

7.6TY-QR-TQD-097List ofProcess Designand DevelopmentOutputsTY-QR-TQD-097《工艺设计和开发输出清单》

7.7TY-QR-TQD-098Application Formfor InspectionTypeApproval）ofFirst Article（Batch）Working Process/TY-QR-TQD-098《首件（批）工序（零、部）件鉴定（定型）申请表》

7.8TY-QR-TQD-099Checklist ofParts/Components inFirstArticle（Batch）Working Process/TY-QR-TQD-099《首件（批）工序（零、部）件鉴定表》

7.9TY-QR-TQD100Report onProcess Designand DevelopmentReviewTY-QR-TQD100《工艺设计和开发评审报告》

7.10TY-QR-TQD101Report onVerification ofProcess Design andDevelopment TY-QR-TQD101《工艺设计和开发验证报告》ApplicationforSetup ofProcess Designand DevelopmentProject工艺设计和开发立项申请书L0G/SN序号TY-QR-TQD-092AApplicationApplicant/申请Department/提出人部门Project Name/项Type andSpecs/目名称型号规格Date ofSalesTarget/销Application/申售对象请日期nance,structure,appearance andBasicInformation inchperfornascription,etc/基本要求包括package,technical parameterde参数说明等主要性能、结构、外观包装、技术2Market Forecastand Analysisiincl.market demand,user sexpectation,situationoncomp€3titor,current situationonproduct quality,expected salesof firstbatch,delivery term,ex-factory price,etc/市场预展竞1分析（包括市场需求、用户期望、船争对手状况、产品质量现状、预3首批销量、交货期限、出厂价格）Referable ExistingTechnique/可引用的原有技术Feasibility Analysisincl.technique,purchase,process,cost,etc/可行性分析包括技术、选购、工艺、成本等方面ApprovalofDepartment Leader/部门领导审批Signed by/签名Date/日期VerificationofChief Engineer/总工程师审核Signed by/签名Date/日期Written Instructionof General Manager/总经理批示:Signed by/签名Date/日期Assignment Bookfor Process Designand Development/工艺设计和开发任务书L0G/SN序号TY-QR-TQD-093AProduct Model/产品型号:Product Name/产品名称Dates ofStart andEnd of ProjectTarget Cost/目标成Product Development/产品开发起止日Leader/项本期目负责人Applicable Standards or Lawsand Regulationsincl.name,No.,revision,chapter/section No.,etc）/依据的标准或法律法规（包括名称、编号、版本、章节号等）Description ofProduct Function/产品功能描述:Technical Parameterand PerformanceIndicator/技术参数与性能指标Requirement forProduct Structure/产品结构要求:Special Requirementof Customer/顾客特别要求:□No/无□Yes,please describe/有，详细描述Other Requirements/其它要求:Remarks/备注:Jointly Signed by/会签评审ReviewedReviewedDepartme Title/职Departme Title/职by/Date/评by/Date/评nt/部门位nt/部门位审人/审人/日期日期VerifiedPrepared Approvedby/Date/审by/Date/编by/Date/批核/日制/日期准/日期期Process Designand DevelopmentPlan/工艺设计和开发安排书L0G/SN序号TY-QR-TQD-094AProject Name/项目名称:Project Source/项目来源:Development Period/开发周期General ProjectLeader/项目总负责人Designe DesigneTitle/职Title/Designer/设计人员Title/职位r/设计人r/设计人位职位员员Resource Allocation/资源配置:Responsible LeadeDate ofStage Division/Main Content/阶段划分与Department/责r/责Completion/完成主要内容任部门任人时间Preparation of Application forDesignSetup ofProject/编制立项申请书Developme ntReviewofApplicationforInput/设计SetupofProject/对立项申请开发输入书进行评审Design ofDrawing,Process,Tooling andFixtures/图纸、工艺、Design工装夹具设计Developme ntPreliminaryTechnicalOutput/设计Design Review/初步技术设计评审开发输出Technical DesignDocumentOutput/技术设计文件输出Part Purchase/零部件选购SampleTrial-manManufacture ofTooling andufacture/Fixtures/工装夹具制作Sample Trial-manufacture/样样品试制品试制Sample Test/样品检测Sample Review/样品评审Project Summary/项目总结Developme ntValidationand Review/Project Review/项目评审开发验证、评审Formal Drawing/正式图纸Formal ProcessDocument/正Design式工艺文件Developme ntFormalWork Instructions/正Output/设计式作业指导书开发输出Conversion intoFormalProduct ion/转入正式生产Remarks/备注ApprovedVerifiedPrepared by/Date/by/Date/批by/Date/审编制/日期准/日期核/日期ContactFormfor Process Designand Development Information工艺设计开和开发信息联络单LOG/SN序号:TY-QR-TQD-095AContent/内容Signed by/签字:Date/日期Project Leaders Opinion/项目Related LeadersOpinion/相关主管看法领导看法Signedby/签字:SignedDate/by/签字:日期Date/日期List ofProcess Designand Development Inputs/工艺设计和开发输入清单LOG/SN序号:TY-QR-TQD-096ASN/序号Name/名称Un it/单位Qty/数量Remarks/备注Prepared by/编制Verified by/审核Approved by/批准:Date/日期Date/日期Date/日期List ofProcess DesignandDevelopmentOutputs/工艺设计和开发输出清单LOG/SN序号TY-QR-TQD-097ASN/序号Name/名称Unit/单位Qty/数量Remarks/备Prepared by/编制:Verified by/审核:Approved by/批准:Date/日期Date/日期Approved by/批准:Application Formfor Inspection（Type Approval）of FirstArticle（Batch）WorkingProcess/首件（批）工序（零、部）件鉴定（定型）申请表L0G/SN序号TY-QR-TQD-098AProduct WorkingSN/序Remarks/备注ProductName/产品Process/X号Status/产品名称序名称状态ApplicantDate ofnApplicatio/申请人Applicatio n/Department/申申请时间请部门Signed by/签字:Date/日期:Manufacturing Department5sOpinion/制J造部看法:Signedby/签字:Date/日期:Technical QualityDepartments Opinion/技术质量部看法:Checklist ofParts/Components inFirstArticle（Batch）WorkingProcess首件（批）工序（零、部）件鉴定表LOG/SN序号TY-QR-TQD-099AProduct Name/产Drawing No./图号No.ofPart/Component in品名称FirstArticle（Batch）/首件（批）（零部）件编号SN/InspectionItem/项目Inspection Content/鉴定内容Remarks/备序Result/鉴定注号结果1Completeness,Correctness andEffectivenessof ProcedureandProcessWorkQuality/过程Instructions/工艺文件、作业指导质量书的完整、正确、有效性Product2Quality/产品Configurationof质量Measurement EquipmentslikeGauges andTheirEffectiveness forControl ofProductQuality/量具等测量设备的配置与对产品质量限制的有效性3Whether thePrecisions ofToolingand ProductionEquipmentsMeet theProcessingRequirements/X装、生产设备的精度能否满足加工要求4Implementation ofProcess byManufacturingDepartment/制造部工艺执行状况5Whether theProductionConditions areControlled/生产条件是否处于受控状态6WhethertheProduct QualityAccordsto theRequirements of theCustomers Drawings/产品质量是否符合客户图纸要求InspectionConclusion/鉴定结论JointlySigned bySignedby/签字Date/日期Members/组员会签ChiefEngineersSigned by/签字Date/日期Opinion/总工程师看法GeneralManagersSigned by/签字Date/日期Opinion/总经理看法Report onProcess DesignandDevelopmentReview/工艺设计和开发评审报告L0G/SN序号TY-QR-TQD-100AProduct Model/产品型号Product Name/产品名称Review Category/评审类别□Preliminary DesignReview/初步设计评审□ProcessProgramReview/工艺方案评审□Others/其他Review Moderator/评审主持人DateofReview/评审时间:Object/评审对象:Content/评审内容Ticking in□expresses passing throughthereview andfilling〃？〃in□expresses thesuggestion ordoubt/□内打“J”表示通过评审，打“？”表示有建议或疑问Process

1.Economy/经济性□

2.Rationality ofProcess Flow/I艺流程合理性口

3.Rationality ofTest Method/检测方法合理性□

4.ProgramRationality ofQuality ControlPointReview/工Placement/质控点设置合理性口艺方案评审

5.WorkingProcessCapability/工序实力口

6.Rationality ofEquipmentSelection/设备选型合理性口

7.Feasibility ofPurchasingOutsourced Article/选购外协可行性□

8.Feasibility ofTooling Design/工装设计可行性口

9.Problems andSuggestions forcontents notpassingthroughthereview/存在问题与改进的建议与评审没通过的内容对应Review Conclusion/评审结论Signatures ofReviewers/评审人签名Departm ReviewedReviewedDepartment/Title/Title/ent/部by/Date/评审by/Date/评审人部门职位职位门人/日期/日期Prepared VerifiApproveded by/Datby/Date/编制by/Date/e/审核//日期批准/日期日期Validation ofImprovement MeasuresProposed inReview Conclusion/评审结论中改进措施的验证状况Validated by/验证人:Date/验证时间:ReportonValidation ofProcess DesignandDevelopment/工艺设计和开发验证报告L0G/SN序号TY-QR-TQD-101AProduct Model/产品型号:Product Name/产品名称Validation Unit/验证单位Times ofStart andEnd ofTest/试验起Tested SampleNo./测试样品编号止时间Applicable Standardsor Lawsand Regulations/依据的标准或法律法规:ApplicableSN/序Names ofStandardsorLaws andNo.and Rev.Chapters/Sectio ns/号Regulations/标准或法律法规名称/编号、版本适用章节Main TestInstruments and Equipments/主要试验仪器与设备:Nos.ofPeriod ofValidityInstrument sNames ofInstruments andSN/序afor Measurement/计andEquipmentsEquipments/仪器与设备名称量有效期/仪器设备编号Abstract ofTest/Inspection Reportand Comparisonof theReport withDesign InputTechnicalDesign Specifications/Standards/试验/检测报告内容摘要与其与设计输入设计技术任务书/标准的比照状况Control ProcedureforProcessdesign andDevelopment/工艺设计和开发限制程序1Purpose/目的This procedureisusedto normalizethe managementof new product processdesign anddevelopment of the company soas toensurethat allthe tasks onnew product processdesign anddevelopmentof thecompanyare implementedeffectively.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This procedureis applicableto controlof new productprocess design anddevelopmentof thecompany.Thecontent:The companydoesnt covertheproductdesign,just focusingon processdesign based on customerdrawings.本程序适用于公司新产品工艺设计和开发的限制但包括产品进行设计和开发3Terms/术语

3.1Processdesign output:the resultof processdesign.Through theprocessdesign anddevelopment,the basesofprocessdesign aretransformed intoaseries ofprocess technicaldata oftheprocessdesignoutput./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

3.2Process review:theprocessdesign isreviewed formally,roundly andsystemicallyand thereview resultis documented./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Required ValuesinActual TestDesignSN/序Test Items/检测Conclusion/结Values/实际检测Input/Standards/设号项目论值计输入/标准的要求值Design ValidationSummary/设计验证总结论Prepared by/Date/编制/Verified by/Date/审Approved by/Date/批准日期核/日期/日期Validation ofImprovement MeasuresProposed inValidation Conclusion/验证结论中改进措施的验证状况Validated by/验证人Date/验证时间

3.3Overall processprogram:basedonproductdesignrequirement,production programand productivity,the guidancedocumentisusedtoputforward thetechnology andprepare forconcrete tasksand measures./工艺总方案依据产品设计要求、生产纲领和生产实力，提出工艺技术打算详细任务和措施的指导性文件

3.4First article（batch）inspection:aftertheready conditionoftrial-manufacture isqualifiedthroughcheck,thefirstbatch oftrial-manufactured componentsand partsare checkedfor overallprocessand finishedproducts inaccordancewith therequirementsof productdrawingsand technologicalprocedure todeterminewhetherthe productionprocessand equipmentscan guaranteethat theproducts conformingtodesign requirementsare produced./首件（批）鉴定在生产试制打算状态检查合格后，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

3.5Process planning:responsibilities and authorities for processdesign aredistributed andinterface managementateverystage ofproductprocessdesignis definedonthebasis oftechnical documentssuch asproductdesign drawingofthecustomer inaccordancewithschedules ofproductdesign anddevelopment,in orderto guaranteethattheprocessdesign,validation,etc arecarriedoutas scheduled./工艺策戈lj依据产品设计和开发的进度要求，依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安排进行4Responsibility/职责

4.1Technical QualityDepartmentshallbe responsiblefor centralizedmanagementofprocessdesign anddevelopment andhaving theprocess designanddevelopment fornewproductimplemented;/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；

5.2Technical QualityDepartmentshallbe responsiblefor businessmanagementofprocessdesign anddevelopment andhaving theprocess designanddevelopmentfornewproductimplemented;/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；

6.3All therelated unitsofthecompany shallbe responsibleforcooperation inaccomplishing allthetasksontheprocessdesign anddevelopment./公司各有关单位负责协作完成工艺设计和开发过程的各项工作5Working Procedure/工作程序

5.1Process DesignandDevelopmentPlanning/工艺设计和开发策划

7.

1.1Source ofProcess DesignandDevelopmentProject/工艺设计和开发项目的来源a After the newproduct contractor technicalagreement signedbyMarketing Departmentandthecustomer,or marketdemand isreviewed,Marketing Departmentshall fillin Applicationfor SetupofProcess DesignandDevelopmentProject andsubmititto relateddepartmentsand personnelfor confirmation.After itis approvedbyGeneralManager,it shallbe issuedtoChief Engineer./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 Afterreceiving ApplicationforSetupofProcessDesignandDevelopmentProject,Chief Engineershall transmitAssignmentBook forProcessDesignandDevelopmentto lowerlevels andsendthe technicaldata concerningnewproducttoTechnical QualityDepartment./接至U《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.

1.2ChiefEngineershall determinetheprojectleader basedontheaboveproject sourcesand transformthe outputofprocessdesign anddevelopmentplanning intoProcessDesignandDevelopmentPlan.The planshall includethefollowing contents:/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》安排书内容包括a Divisionofthe stages suchas input,output,review,verificationand confirmationofprocessdesign anddevelopment andmain workcontent;/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,requirementof scheduleand supportingunit;/各阶段人员职责和权限，进度要求和协作单位；c Requirementfor resourceallocation,e.g.,personnel,information,equipment,fund guaranteeand otherrelated content./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.

1.3The outputdocument ofprocessdesign anddevelopmentplanningshall berevised appropriatelywith theschedule ofdesign anddevelopmentin accordancewiththerelated provisionsof ControlProcedure forDocument./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.

1.4Interface Managementbetween DifferentGroups ofProcess DesignandDevelopment/工艺设计和开发不同组别之间的接口管理Different groupsofprocessdesignanddevelopment mayconcerndifferent functionsor levelsofthecompany,andtheexterior ofthecompany.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 Forthe communicationof importantdesignanddevelopmentinformation betweenthe groups,the designand developmentpersonnelshallfillin ContactFormforProcessDesignandDevelopment Information.Afterthecontact formisapprovedby theprojectleader,it shallbe issuedtothegroups.If sometasksneed tobe harmonizedbythedirector of TechnicalQualityDepartment,they cannotbe harmonizeduntil theyare approvedbythe directorofTechnicalQualityDepartment./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 MarketingDepartmentshalltake chargeof contactwith thecustomerand informationtransfer tothecustomer./营销部负责与顾客的联系与信息传递

5.2ProcessDesignandDevelopmentInput/工艺设计和开发输入

5.

2.1Theprocess designanddevelopment input shouldinclude thefollowingcontents:/工艺设计开发输入应包括以下内容a Maincharacteristics andperformance requirementsfortheproduct.These requirementsare mainlyfrom thedemand andexpectation ofthecustomer ormarket,normally includedinthecontract,orderor projectrecommendation;/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；b Applicablelaws andregulations andmandatory nationalstandardsshall bemet;/适用的法律、法规要求，对国家强制性标准肯定要满足；c Applicableinformation providedby previoussimilar processdesignanddevelopment;/以前类似的工艺设计和开发供应的适用信息；d Otherrequirements necessaryforprocessdesignanddevelopment./工艺设计和开发所必需的其他要求

5.

2.2Theprocessdesignanddevelopment inputshallbedocumented,Listof ProcessDesignandDevelopmentInputsshallbecompleted andall kindsofrelevantdatashallbeattached./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

5.

2.3The directorofTechnicalQualityDepartmentshallarrangetherelated processdesignanddevelopment personneland associateddepartmentsto reviewtheprocessdesignanddevelopmentinputand clarifytheimperfect,vague orinconsistent requirementsin ordertoensurethatthe designanddevelopmentinput meetstherequirementsoftheassignmentbook./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、模糊或冲突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

5.

2.43ProcessDesignandDevelopmentOutput/工艺设计和开发的输出

5.

3.1Theprocessdesignanddevelopment personnelshall launchtheprocess designanddevelopment onthebasisofProcessDesignandDevelopmentPlanandthe program,andworkout correspondingdocumentonprocessdesignanddevelopment output,i.e.,ListofProcessDesignandDevelopmentOutputs./工艺设计和开发人员依据《工艺设计和开发安排书》与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》

5.

3.2The documentonprocessdesignanddevelopment outputshould beexpressedintheform thatit canbe verified。