中英对照产品设计和开发控制程序.docx

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1、文件名称：产品设计和开发控制程序文件编号02-03版本号/修订号2/0页码1/51.目的：Purpose规范对各种产品的设计、开发、试制、试验、验证、鉴定、确认、取得专业合格证等过程的控制；实现生产的所有技术准备充分有效，以确保制造的产品能满足顾客的要求。Standardizethecontrolforprocessesofdesign,development,trialproduce,testing,verification,identification,validationandobtainingprofessionalcertificate.Adequacyandeffectivetec

2、hnicalpreparationforproductionrealization,toensurethecompliancetocustomerrequirements.2.适用范围：Applicablescope本程序所指的产品，主要是新产品，即：产品在工作机理、原材料、结构、特性及应用领域等有一个或多个方面的实质性改变的；在尺寸或参数上有显著变更或扩展的、工艺过程有较大变化的产品。重要顾客要求的产品以及公司认定的重要产品可比照为新产品。非新产品从简参照执行。Theproductsmentionedherearemainlynewproducts,thatis,theressubstant

3、ialtransformationononeormoreaspects;obviousalterationorexpandingondimensionsorparameters,greatchangeontechnologicalprocess.Productsorderedbyimportantcustomerandtheimportantproductsidentifiedbycompanycouldbetreatedasnewproducts.Thosenotbelongingtonewproductsshouldimplementbyshort.3.职责:Responsibility3

4、.1总经理最终负责批准产品任务的承接。GeneralManagerisinchargeofthefinalapprovingofproduct.3.2技术副总经理或总经理授权的负责人全面负责产品合同性评审，批准和组织设计和开发的控制。DeputyGeneralManageroftechnologyorauthorizerbyGeneralManagershouldcomprehensivelytakechargeofcontractreview,controlofapprovingandorganizationfordesignanddevelopment.3.3市场部负责新产品开发前和顾客的

5、沟通，保证顾客要求的充分性、有效性。在取得顾客要求的文件(如技术规范书等)或图样后做出任务提交。MarketingDepartmentisinchargeofthecommunicationwiththecustomerbeforenewproductdevelopment,toensuretheadequacyandeffectivenessofcustomerrequirements.Submitthemissionafterobtainingthedocument(liketechnicalspecification)ordrawingrequiredbycustomer.3.4技术部负

6、责产品设计和开发的策划；进行从设计输入及评审到产品确认的设计开发全过程的实施和控制；负责全过程的对顾客的技术跟踪。TechnicalDepartmentisinchargeoftheplanningofproductdesignanddevelopment,implementandcontrolthewholeprocessfromdesigninputandreviewtoproductvalidation,inchargeofthetechnologicaltraceforwholeprocess.3.5质控部负责过程的控制，对完工产品的负责试验、验证，记录并出具报告；负责委托型式试验及获

7、取专业合格证工作。QualityDepartmentisinchargeoftheprocesscontrol,forfinishedproducts,itisresponsibleforinspection,validation,recordingandissuingreport,aswellasauthorizetypetestandobtainprofessionalcertificate.3.6生产部负责试制及试生产的生产技术准备和组织实施。ManufacturingDepartmentisinchargeofthetechnicalpreparationoftrailproducti

8、onandpilotmanufacturing,alsotheorganizationandimplementation.3.7采购部门负责产品制造中所有合格供方可提供材料的采购。PurchasingDepartmentisinchargeofthepurchasingofavailablematerialsfromal1qualifiedsuppliers.3.8车间负责新产品试制以及实施产品生产过程控制Workshopisinchargeofthecontrolfortrailproductionofnewproductandproductionprocess.4.程序：Procedure

9、4.I产品开发中和产品有关要求评审的控制Thecontrolrelatedtoproductandrequiredforreviewinproductdevelopment产品开发中和产品有关要求评审按销售管理制度4.2.1、42.2执行。.Implementasclauses4.2.1and4.2.2ofSalesManagementInStitUtion.4.1.1市场部门及技术部门和顾客沟通要考虑产品技术要求、工况要求、参数规范、标准、交货期、交付要求、数量、价格、付款方式、标志、包装等方面要素，保证沟通尽可能充分、有效。Forthecommunicationwithcustomer,M

10、anagementDepartmentandTechnicalDepartmentshouldconsidertechnicalrequirements,conditionsrequirements,specification,standard,deliverytime,deliveryrequirements,quantity,price,paymentterm,mark,packaging,toensuretheadequacyandeffectivecommunication.4.1.2市场部门在初步确认了顾客要求的文件、图样或样品后，填写“合同要求评审单”，随顾客文件一并提交给技术部门

11、。AfterMarketingDepartmentprimarilyconfirmsthedocument,drawingandsamplerequiredbycustomer,fillinReviewFormforContractRequirements,submittoTechnicalDepartmentwithcustomerdocumentstogether.编制2009/12/28文件名称：产品设计和开发控制程序文件编号-02-03版本号/修订号2/0页码2/54.1.3技术部门在接到市场部提交的文件后，组织实施对和产品有关要求中的技术要求、参数规范、外观要求、交货期、法律法规要求

12、等的可满足性评审。并填写合同评审单。如通过评审，则正式确定合同。合同评审单”由总经理批准。批准后确认为新产品，则市场部门正式下达“新产品设计开发任务单”或“生产通知单”，和顾客文件一起下达到给技术部门。进入设计开发阶段。AfterTechnicalDepartmentreceivesthedocumentsfromMarketingDepartment,organizetoconductthecompliancereviewforproductrelatedrequirementsliketechnicalrequirements,parameters,appearancerequiremen

13、ts,delivery,statutoryandregulatoryrequirements.Ifpassthereview,officiallyconfirmitasacontract.ContractReviewFormisapprovedbyGeneralManager,afterbeingapproved,itcouldbeconfirmedasanewproduct,MarketingDepartmentformallyissuetheDesignandDevelopmentMissionFormofNewProductorProductionNotification7,distri

14、butetoTechnicalDepartmentwithcustomerdocumentstogether.Itgoesintodesignanddevelopmentstage.4.1.4生产部门组织对合同产品生产线及设备工程能力、生产能力、以确保交货期完成的保证性评审，其中采购人员组织采购材料，零部件可能性和进度保证性评审，并填写“合同评审单。ManufacturingDepartmentorganizestoreviewproductionlineofcontractproducts,equipmentengineeringcapacity,productioncapacitytoma

15、kesurethedeliveryterm.PurchasingDepartmentorganizestoreviewpurchasingmaterials,partsandprogressinsurance,andfillinContractReviewForm.4.2产品设计控制Controlofproductdesign4.2.1设计的策划和输入的控制Controlofdesignplanningandinput.4.2.1.1技术部门或项目负责人负责设计的策划和输入评审。主要对顾客图样及产品的技术参数、技术要求可实现性、可满足性和完整性、准确性给予确认。设计输入评审按表记录签字。同时，

16、根据任务性质策划：分解设计和开发的阶段，确定工作内容、进度要求、规定项目人员和责任，编制“产品设计和开发策划及分解任务进度表。TechnicalDepartmentorprojectmanagerisinchargeofthereviewfordesignplanningandinput.Mainlyconfirmtherealizationability,complianceandcompleteness,correctnessforcustomerdrawing,parametersandtechnicalrequirementsofproduct.Designinputreviewsho

17、uldsignforrecordsaccordingtotheform.Meanwhile,planasthepropertyofmissions,breakdowndesignanddevelopmentstages,determinetheworkingcontent,progressrequirements,defineprojectmembersandresponsibility,formulatePlanningandDecompositionMissionProgressFormofProductDesignandDevelopment4.2.1.2顾客产品的技术参数、技术要求，不

18、被确认时认应由技术部门指定的产品项目负责人和顾客进一步沟通。如取得充分且必要的设计输入后，再予以确认。Beforetheconfirmationoftechnicalparameters,technicalrequirementsofcustomerproduct,theprojectmanagerappointedbyTechnicalDepartmentshouldcommunicatewithcustomerfurther.Confirmafterobtainingadequacyandnecessarydesigninput.4.2.1.3产品总体设计方案图原则上应送顾客确认。Over

19、alldesignlayoutofproductshouldbesubmittedtocustomerforconfirmationinprincipal.4.2.2设计输出的控制Controlofdesignoutput4.2.2.1符合4.2.1.1、4.2.1.3条的被确认的图样、技术参数和技术要求由项目负责人进行工程设计和产品图样设计，形成设计输出，用于过程开发的输入。Thedrawing,technicalparametersandtechnicalrequirementscomplyingwith4.2.1.1,4.2.1.3shouldbeusedforengineeringde

20、signandproductdesign,andformthedesignoutputfortheinputofprocessdevelopment.4.2.2.2设计输出文件主要是产品图样(含零件图)、工程设计计算书、安装使用说明书、原材料及外购、外协件清单、产品图样技术文件清单等。根据顾客要求可输出其它设计文件。Designoutputdocumentsmainlyincludeproductdrawing(partdrawing),calculationsheetofengineeringdesign,installationoperationinstruction,listofrawm

21、aterials,outsourcingparts,listofproductdrawingtechnicaldocument.Outputotherdesigndocumentascustomerrequirements.4.2.2.3设计输出必须进行设计输出评审和验证控制Designoutputmustconductdesignoutputreviewandverificationcontrola.通常产品设计输出评审，按图样或文件的设计一绘图一一校对一一工艺一一标准化一一审核一一批准过程进行并责任签字，在适用时作出记录。其中设计、审核、批准为必要过程。Designoutputreview

22、fornormalproductsshouldconductasthefollowingprocess,designasdrawingordocument-drawing-check-techno1ogy-standardization-reviewapprove,relevantresponsiblepersonnelshouldsign,andrecordwhenapplicable.Design,reviewandapprovingarenecessaryprocesses.“设计”：签字者为工程设计计算的设计人员，一般为项目负责人。签字者应确定产品主导结构、参数、尺寸、技术要求及其它标

23、注，对设计规范、图样工程标准等的符合性、完整性、正确性负责。Design:thepersontosignshouldbethedesignerofengineering,normallyitsprojectmanager.Thesignershoulddeterminetheproductmainstructure,parameters,dimensions,technicalrequirementsandothermarks,beresponsiblefortheconformity,completenessandcorrectnessofdesignspecificationanddraw

24、ingengineeringstandard.绘图签字者为通过AUTOCAD或其它手段，将工程设计变为图样文件的设计人员。签字者应对图样反映的产品结构、尺寸、技术要求、其它标注等对工程设计、图样规范标准的符合性、完整性、正确性负责。“绘图”可以和设计”为一人。SignerofdrawingisthedesignerthattransferengineeringdesigntodrawingdocumentbyAUTOCADorothermeans.Signershouldberesponsibleforthecompliance,completenessandcorrectnessofprod

25、uctstructure,dimensions,technicalrequirementsandotherremarkstoengineeringdesignanddrawingspecificationstandard.Drawinganddesigncouldbecompletedbyoneperson.编制日期2009/12/28文件名称：产品设计和开发控制程序文件编号版本号/修订号2/0页码3/5“工艺”：签字者为主管本项目产品过程开发人员。其签字对产品工艺可行性、可保证性负责。Technology:signershouldbetheproductprocessdevelopmentp

26、ersonwhotakechargeofthisproject.Signmeansthatheisresponsibleforfeasibilityandassuranceofproducttechnology.“校对：签字者为产品设计资格人员，其签字和绘图签字者共用承担绘图”款中规定的责任。在某些情况下，“校对”和“审核”合二为一是允许的。Check:signershouldbequalifiedpersonforproductdesign,heshouldberesponsibleforthedutiesregulatedindrawingwithsignerofdrawingtogeth

27、er.Insomeconditions,itspermittedthatcheckandreviewarethesame.标准化”：签字者为(专)、兼职标准化人员，其签字应对图样工程标准、标注标准化、材料、标准件标注引用，技术条件标准引用等的正确性负责。“标准化允许和“校对”为一人。Standardization:signershouldbe(full-time)part-timestandardizationperson,heshouldberesponsibleforthecorrectnessofdrawingengineeringstand,standardizationofremar

28、ks,materials,remarkquoteofstandardparts,quoteoftechnicalrequirementsstandard.Standardizationandcheckarepermittedtobethesame.“审核”：签字者为技术指定人员。其签字应对图样或技术文件的图面表达、标准化、工艺、规范应用等方面的设计的符合性、图面完整性、正确性、工艺可实现性负责。Review:signershouldbesomeoneappointedbyTechnicalDepartment.Heshouldberesponsibleforthecomplianceofexp

29、ressionofdrawingortechnicaldocuments,standardization,technology,specificationapplicationdesign,completeness,correctnessofdrawing,realizationpossibilityoftechnology.“批准：签字者为公司级技术负责人，应对图样及技术文件的可公布性、实施合法性负责。批准”后图样或技术文件方可发放、执行。Approve:signershouldbemanagerofTechnicalDepartment,shouldberesponsibleforthep

30、ublishpossibilityofdrawingandtechnicaldocuments,legalityofimplementation.Afterapprove,drawingandtechnicaldocumentscouldbereleasedandimplemented.b.对特殊的、结构复杂的、技术难度较大的、在全新领域应用的新产品的设计输出，可由公司技术负责人如召集有关人员共同评审，做出设计输出评审书。Forthedesignoutputofnewproductswithspecial,complicatedstructure,difficulttechnologyanda

31、ppliedinnewfield,managerofTechnicalDepartmentcouldcallforrelevantpersonstoreview,completeReviewFormofDesignOutput.4.2.2.4须经顾客确认的产品图样(总图)，应于审核”后，“批准”前提交顾客确认。顾客确认须是书面文件或在被确认图样上签署书面文字确认，并返还。确认文件或被直接确认图样均应按外来技术文件规范管理。Theproductdrawing(overalldrawing)neededtobeconformedbycustomershouldbesubmittedtocustom

32、erafterreviewandbeforeapprove.Customerconformationshouldbewrittendocumentorsigninthedrawingbeenconfirmed,andreturntothecompany.Confirmationdocumentorthedrawingbeenconfirmeddirectlybysigningshouldallbemanagedbytechnicaldocumentspecification.4.2.2.5顾客未确认的图样，结合顾客修正意见，按4.2.1、4.2.2条款规定重新进行设计。以最终获得顾客确认。If

33、customerdoes11,tconfirmthedrawing,combineamendmentsuggestionsofcustomer,redesignasclauses4.2.1and4.2.2,togetthecustomerconfirmationfinally.4.2.2.6产品图样及技术文件必须得到批准，批准后图样和技术文件按规定发放范围发放和保存，并严格执行受控技术文件签收手续，签收的图样和文件由签收人负责控制。Productdrawingandtechnicaldocumenthavetobeapproved,afterbeingapproved,distributean

34、dstoreastheregulatedreleasescopeofdrawingandtechnicaldocuments,strictlyimplementthesigningprocessofcontrolledtechnicaldocuments,signerisresponsibleforthecontrolofdrawingandtechnicaldocumentshesignedandreceived.4.3产品过程开发和制造的控制Controlofproductprocessdevelopmentandmanufacturing4.3.1产品过程开发控制Controlofpro

35、ductprocessdevelopment4.3.1.1产品过程开发控制由技术部门负责。TechnicalDepartmentisinchargeofthecontrolofproductprocessdevelopment.4.3.1.2在产品设计完成后，由项目负责人将新产品图样和技术文件发给项目产品过程开发人员，实施了任务分解下达。Afterfinishingtheproductdesign,projectmanagerisresponsiblefortheissuingofnewproductdrawingandtechnicaldocumentstoproductprocessdev

36、elopmentengineer.4.3.1.3过程开发人员接收任务后进行过程设计编制，输出产品加工（组装）工艺文件并验证评审责任签字。规定其过程顺序、工序内容、工艺参数、技术要求、检验规范、设备及工装要求。Processdevelopmentengineerconductstheproductdesignformulationafterreceivingthemission,outputproductiontechnologicaldocuments,verifyandsign.Defineitsprocesssequence,procedurecontent,technicalparame

37、ters,technicalrequirements,inspectionspecification,equipmentandfabricationrequirements.4.3.1.4过程开发人员依据工装要求”，编制工装清单。由项目负责人向工装设计人员或采购部门下达工装设计或采购任务。Processdevelopmentengineerformulatethefabricationlistaccordingto/zfabricationrequirements.Projectmanagerissuethefabricationdesignorpurchasingmissiontofabri

38、cationdesignerorpurchasingdepartment.4.3.1.5工装设计人员接受工装设计任务后，在充分理解产品要求和工序过程要求后设计工装图样。工装图样按设计一校对一审核一批准过程验证评审责任签字。正式形成有效的，可发放的工装图样。签字责任类同于4.2.2.3a）条款规范，工装图样发放给工装制造班和质控部.Fabricationdesignerreceivesthedesignmission,designfabricationdrawingafterthoroughlyunderstandproductrequirementsandprocessrequirements

39、.Fabricationdrawingshouldbereviewedandsignedaccordingthesequencedesign-CheCk-review-approve.Formallycreatetheeffectiveandissuablefabricationdrawing.Signresponsibilityisthesameasspecificationinclause4.2.2.3a）,thefabricationdrawingshouldbeissuedtofabricationworkshopandQualityControlDepartment.文件名称：产品设

40、计和开发控制程序文件编号-02-03版本号/修订号2/0页码4/54.3.1.6过程开发人员和工装设计人员输出的首轮工艺文件，应加盖“试制”章。过程中应如实记录各工序实际过程及试制工装的全部更改内容。也允许在试制”工艺卡上以档案书写笔划改并标识记录。ProcessdevelopmentengineeranddesigneroutputtheinitialworkmanshipdocumentsandshallputstampTRIAL.Itshallrecordthepracticalfabricationprocessandanychangedcontent.Alsoitisallowedt

41、ousepentodomarkorrecordintheworkmanshipcard.4.3.1.7在产品全部过程结束后，由过程开发人员和工装人员，对试制工艺卡片、试制”工装图样，按更改记录内容进行修改并反馈到设计负责人员处对产品图样修改。修改后进行编制（设计）一一校对一一（工艺）审核一一批准过程的责任签字评审。形成下一轮生产用产品图样和工艺文件。签字责任类同于4.2.2.3a）条款规范。Aftertheproductcompletion,processdevelopmentengineeranddesignershallaccordingtoanychangedcontent,makere

42、visionandputintodrawingfeedback.Thenfollowtheprocedure:editiontoreviewtoapprovetoapprove.SignatureresponsibilityissimiIarwithClause4.2/4.34.3.2产品过程控制Productprocesscontrol4.3.2.1原材料、外购件、外协件采购、进货应按采购技术要求并执行进货检验、验收。按采购控制程序和物资库存管理制度控制。Accordingtotechnicalrequirementinspectionandtestshallbedonetorawmater

43、ials,outsourcingcomponentsandotherproductsbasedonpurchasecontrolprocedureandwarehousingregulations.4.3.2.2各工序按工艺卡片”及过程控制文件内容控制，检查控制责任人为操作者及专职检验员。重要工序的首件要得到质控部门确认。EachprocedureisaccordingtoWorkmanshipCardandothercontroldocuments.Theresponsiblepersonsshallbeoperatorandinspectors.Importantprocedureshal

44、1beconfirmedbyQCdepartment.4.3.2.3产品设计和开发的验证：样品完成后的全项目检验和性能试验（型式试验）由质控部门负责并出具报告以对产品满足规定要求进行验证。报告一式二份，一份提交、一份自存。Productdesignanddevelopmentprove:afterproductcompletionandpropertytest,QCdepartmentshallissuereporttosatisfyregulations.Thereportisinduplicate,oneforsubmitandtheotherisforkeepinginrecord.4.

45、3.2.4产品全项目检验规范按产品相关标准执行。l1itemsofinspectionshal1becarriedoutaccordingtorelevantregulations.4.3.2.5产品过程控制细则按生产作业过程管理办法。ProductcontrolrulesarereferredbyProductionProcessManagementMeasures.4.3.2.6产品专业合格证由技术部负责联络、送样、直至取证。ProdUCtqualificateiscoordinatedbytechnicaldepartmentuntilthecertificateisissued.4.3

46、.3产品的验证和确认VerifiCationandvalidationofproduct4.3.31新产品的确认必要时通过厂内验证和鉴定确认。厂内鉴定由技术负责人召集专题（鉴定）会议进行。一般由技术部负责人、设计和开发人员、检验人员、市场部人员参加。一般产品，质控部验证合格后即对产品初步确认,可出厂交付顾客。Newproductconfirmationifnecessaryshallbeconfirmedatfactory.Responsiblepersonscallmeetings.Normallydesignanddevelopmentengineers,inspectorsandmark

47、etingpersonsallparticipate.Ingeneraloncetheproductisqualified,thenewproductshallbedeliveredtocustomer.4.3.3.2厂内鉴定材料包括：试制产品、顾客提供的产品（如有）、产品图样、试制用工艺卡片、文件更改记录、产品验证的检验报告和试验报告，必要时还需要有试制总结。Appraisedocumentsincludetestproducts,drawings,workmanshipcard,documentchangerecordsandinspectionreports,ifnecessaryand

48、trialsummarydocuments.4.3.3.3厂内鉴定的目的:一是对新产品符合性质量进行工厂确认,二是对图样、文件的有效性确认；三是对产品能够满足规定的使用要求或预期用途及水平评价。厂内鉴定时由技术负责人指定人员完成“新产品工厂鉴定报告，并进行责任签字。Appraisepurpose:1)newproductqualityconfirmation;2)effectiveconfirmationofdrawingsanddocuments;3)usagerequirementorexpectedapplicationwhichcanmeetrequirements.Whendofactoryappraise,personsappointedbytechnicaldepartmentwillfinishNewProductFactoryAppraiseReportanddosignature.文件名称：产品设计和开发控制程序文件编号版本号/修订号2/0页码5/54.3.3.4通过厂内鉴定的