工藝設(shè)計(jì)和開發(fā)控制程序

ProcedureDocument/程序文件ControlProcedureforProcessdesignandDevelopment工藝設(shè)計(jì)和開發(fā)控制程序DocumentNO/編號(hào)：TY-QP7.3-01-15Revision/版本：Checkedby/校對(duì)：Verifiedby/審核：Approvedby/批準(zhǔn)：ControlledCondition/受控狀態(tài)：DistributionNo./分發(fā)號(hào)：.1.4InterfaceManagementbetweenDifferentGroupsofProcessDesignandDevelopment/工藝設(shè)計(jì)和開發(fā)不同組別之間的接口管理Differentgroupsofprocessdesignanddevelopmentmayconcerndifferentfunctionsorlevelsofthecompany,andtheexteriorofthecompany.工藝設(shè)計(jì)和開發(fā)的不同組別可能涉及到公司不同職能或不同層次，也可能涉及到公司外部。Forthecommunicationofimportantdesignanddevelopmentinformationbetweenthegroups,thedesignanddevelopmentpersonnelshallfillinContactFormforProcessDesignandDevelopmentInformation.Afterthecontactformisapprovedbytheprojectleader,itshallbeissuedtothegroups.IfsometasksneedtobeharmonizedbythedirectorofTechnicalQualityDepartment,theycannotbeharmonizeduntiltheyareapprovedbythedirectorofTechnicalQualityDepartment./對(duì)于組別之間重要的設(shè)計(jì)和開發(fā)信息溝通，設(shè)計(jì)開發(fā)人員填寫《工藝設(shè)計(jì)開發(fā)信息聯(lián)絡(luò)單》，由項(xiàng)目負(fù)責(zé)人審批后發(fā)給相關(guān)組別，需要技術(shù)質(zhì)量部主管進(jìn)行協(xié)調(diào)工作的，由技術(shù)質(zhì)量部主管審批后組織協(xié)調(diào)。MarketingDepartmentshalltakechargeofcontactwiththecustomerandinformationtransfertothecustomer./營銷部負(fù)責(zé)與顧客的聯(lián)系及信息傳遞。5.2ProcessDesignandDevelopmentInput/工藝設(shè)計(jì)和開發(fā)輸入5.2.1Theprocessdesignanddevelopmentinputshouldincludethefollowingcontents:/工藝設(shè)計(jì)開發(fā)輸入應(yīng)包括以下內(nèi)容：Maincharacteristicsandperformancerequirementsfortheproduct.Theserequirementsaremainlyfromthedemandandexpectationofthecustomerormarket,normallyincludedinthecontract,orderorprojectrecommendation;/產(chǎn)品主要特點(diǎn)、性能要求。這些要求主要來自顧客或市場(chǎng)的需求與期望，一般應(yīng)包含在合同、定單或項(xiàng)目建議書中；Applicablelawsandregulationsandmandatorynationalstandardsshallbemet;/適用的法律、法規(guī)要求，對(duì)國家強(qiáng)制性標(biāo)準(zhǔn)一定要滿足；Applicableinformationprovidedbyprevioussimilarprocessdesignanddevelopment;/以前類似的工藝設(shè)計(jì)和開發(fā)提供的適用信息；Otherrequirementsnecessaryforprocessdesignanddevelopment./工藝設(shè)計(jì)和開發(fā)所必須的其他要求。5.2.2Theprocessdesignanddevelopmentinputshallbedocumented,ListofProcessDesignandDevelopmentInputsshallbecompletedandallkindsofrelevantdatashallbeattached./工藝設(shè)計(jì)和開發(fā)的輸入應(yīng)形成文件，填寫《工藝設(shè)計(jì)和開發(fā)輸入清單》，并附上各類相關(guān)的資料。5.2.3ThedirectorofTechnicalQualityDepartmentshallarrangetherelatedprocessdesignanddevelopmentpersonnelandassociateddepartmentstoreviewtheprocessdesignanddevelopmentinputandclarifytheimperfect,vagueorinconsistentrequirementsinordertoensurethatthedesignanddevelopmentinputmeetstherequirementsoftheassignmentbook./技術(shù)質(zhì)量部主管組織有關(guān)工藝設(shè)計(jì)和開發(fā)人員和相關(guān)部門對(duì)工藝設(shè)計(jì)和開發(fā)輸入進(jìn)行評(píng)審，對(duì)其中不完善、含糊或矛盾的要求做出澄清和解決，確保設(shè)計(jì)開發(fā)的輸入滿足任務(wù)書的要求。5.3ProcessDesignandDevelopmentOutput/工藝設(shè)計(jì)和開發(fā)的輸出TheprocessdesignanddevelopmentpersonnelshalllaunchtheprocessdesignanddevelopmentonthebasisofProcessDesignandDevelopmentPlanandtheprogram,andworkoutcorrespondingdocumentonprocessdesignanddevelopmentoutput,i.e.,ListofProcessDesignandDevelopmentOutputs./工藝設(shè)計(jì)和開發(fā)人員根據(jù)《工藝設(shè)計(jì)和開發(fā)計(jì)劃書》及方案等開展工藝設(shè)計(jì)開發(fā)工作，并編制相應(yīng)的工藝設(shè)計(jì)和開發(fā)輸出文件，即《工藝設(shè)計(jì)和開發(fā)輸出清單》。Thedocumentonprocessdesignanddevelopmentoutputshouldbeexpressedintheformthatitcanbeverifiedforprocessdesignanddevelopmentinputtoprovethattheinputrequirementismetandtoprovidesuitableinformationfortheproduction.Thedocumentonprocessdesignanddevelopmentoutputshallvarywithdifferentproducts,includingtheparametersanddocumentsforproductionguidance,e.g.,conversiondrawing,processdocument,partlist,controlplan,inspectionandtestplan,inspectionworkinstructions,listofpurchasedmaterialsanddesigndrawingsoftoolingandfixtures./工藝設(shè)計(jì)和開發(fā)輸出文件應(yīng)以能針對(duì)工藝設(shè)計(jì)和開發(fā)輸入進(jìn)行驗(yàn)證的形式來表達(dá)，以便于證明滿足輸入要求，為生產(chǎn)運(yùn)作提供適當(dāng)?shù)男畔?。工藝設(shè)計(jì)和開發(fā)輸出文件因產(chǎn)品不同而不同，包括指導(dǎo)生產(chǎn)等活動(dòng)的參數(shù)和文件：如轉(zhuǎn)換圖紙、工藝文件、零件明細(xì)表、控制計(jì)劃、檢驗(yàn)和試驗(yàn)計(jì)劃、檢驗(yàn)作業(yè)指導(dǎo)書、物資采購清單、工裝夾具設(shè)計(jì)圖紙等。TechnicalQualityDepartmentshallassignapersonspeciallyforcheckingtheprocessdata,especiallycheckingwhethertheprocessdatameettheproductdesignrequirement,thecontentiscompleteandcorrect,theworkingprocessesareharmonizedandtheprocessingisfeasibleandcheckable./技術(shù)質(zhì)量部指定專人負(fù)責(zé)校核工藝資料，重點(diǎn)校核工藝資料能否滿足產(chǎn)品設(shè)計(jì)要求；內(nèi)容完整、正確；工序之間是否協(xié)調(diào)、加工的可行性和可檢查性。Full(part)timestandardizationpersonnelofTechnicalQualityDepartmentshalltakechargeofcheckingthedataonprocessdesignanddevelopmentoutputforstandardization./技術(shù)質(zhì)量部門的專（兼）職標(biāo)準(zhǔn)化員負(fù)責(zé)本部門對(duì)工藝設(shè)計(jì)和開發(fā)輸出資料標(biāo)準(zhǔn)化檢查。TheprojectleadershallreviewtheprocessoutputdocumentandfillinListofProcessDesignandDevelopmentOutputs.TheoutputdocumentcannotbeissueduntilitisapprovedbyChiefEngineer./由項(xiàng)目負(fù)責(zé)人對(duì)輸出工藝文件進(jìn)行審核并填寫《工藝設(shè)計(jì)和開發(fā)輸出清單》，總工程師批準(zhǔn)輸出文件后才能發(fā)放。5.4ReviewofProcessDesignandDevelopment/工藝設(shè)計(jì)和開發(fā)的評(píng)審5.4.1Thesystemicandcomprehensivereviewsproposedbytheprojectleaderofprocessdesignasusualshouldbecarriedoutatthesuitablestageofprocessdesignanddevelopment./在工藝設(shè)計(jì)和開發(fā)的適當(dāng)階段應(yīng)系統(tǒng)的、綜合的評(píng)審，一般由工藝設(shè)計(jì)項(xiàng)目負(fù)責(zé)人提出。Theinstructionprocessdocumentssuchasprocessdesignanddevelopmentplanning,overallprocessprogram(processroute)andproductioninstructionsshouldbeprocessreviewedbeforeconcreteprocessdesignanddevelopment./工藝設(shè)計(jì)和開發(fā)策劃、工藝總方案（工藝路線）及生產(chǎn)說明書等指令性工藝文件的工藝評(píng)審應(yīng)在工藝具體設(shè)計(jì)和開發(fā)前進(jìn)行。Technologicalprocedurefornewprocess,keyarticle,importantarticleandkeyprocess(workingprocess)andspecialprocessdocumentshallbereviewedbeforefirstarticleinspection./新工藝，關(guān)鍵件、重要件、關(guān)鍵過程（工序）的工藝規(guī)程以及特殊工藝文件的評(píng)審在首件鑒定前進(jìn)行。5.4.2ReviewContent/評(píng)審內(nèi)容ReviewofOverallProcessProgram/工藝總方案的評(píng)審Theoverallprocessprogramshallbereviewedforcorrectness,advancement,economyandfeasibility;/審查工藝總方案的正確性、先進(jìn)性、經(jīng)濟(jì)性和可行性；Theoverallprocessprogramshallbereviewedtodeterminewhetheritmeetstherequirementsofproductdesignandproductionprogram;/審查工藝總方案是否滿足客戶產(chǎn)品設(shè)計(jì)及生產(chǎn)綱領(lǐng)的要求；Theproductprocessdivisionandrouteshallbedeterminedreasonablyandfeasibly;/產(chǎn)品的工藝分工和工藝路線的確定是否合理、可行；Thebasesusedtodeterminespecialtoolingfactorsshallbereviewed;/審查專用工裝系數(shù)的確定依據(jù)；Thebasesandrationalitiesfornewprocess,newtechniqueandnewequipment;/新工藝、新技術(shù)、新設(shè)備采用的依據(jù)及合理性；Therequirementsforstandardizationofprocesstechnicaldocuments;/工藝技術(shù)文件的標(biāo)準(zhǔn)化要求；Theprinciplesfordeterminationandcontrolofmaterialconsumptionquotashallbereviewed./審查材料消耗定額確定及控制的原則。ReviewofKeyArticleandImportantArticle/關(guān)鍵件、重要件的評(píng)審Thecontrolfactorsandcontentsoftheprocessdocumentsonkeyprocesses(workingprocesses)ofkeyarticleandimportantarticleshallbereviewedforcorrectness,rationalityandinspectability;/審查關(guān)鍵件、重要件中關(guān)鍵過程(工序)工藝文件的控制因素及內(nèi)容的正確性、合理性、可檢查性；Theprocesscapabilityindexofkeyprocess(workingprocess)shallbeverified;/核實(shí)關(guān)鍵過程(工序)的工序能力指數(shù)；Theprocessmethodsanddetectionrequirementsforkeyprocesses(workingprocesses)ofkeyarticleandimportantarticleshallbereviewedforrationalityandfeasibility;/審查關(guān)鍵件、重要件中關(guān)鍵過程(工序)的工藝方法、檢測(cè)要求的合理性和可行性；Thesetupofassociatedworkingprocedureandinspectionprocessrelatedtoformationofqualitycharacteristicofkeyprocess(workingprocess)shallbereviewedforcorrectness,rationalityandfeasibility;/審查與關(guān)鍵過程(工序)的質(zhì)量特性形成，涉及的關(guān)聯(lián)工序及檢驗(yàn)工序設(shè)置的正確性、合理性、可行性；Thetechnicalbreakthroughmeasureforkeyprocess(workingprocess)shallbereviewed;/審查關(guān)鍵過程(工序)的技術(shù)攻關(guān)措施；Thecontentofkeyprocess(workingprocess)shallbereviewedforcompleteness./審查關(guān)鍵過程(工序)目錄的完整性。TechnicalQualityDepartmentshallissuethereviewcontentorrelateddatatothereviewingunits./技術(shù)質(zhì)量部將評(píng)審內(nèi)容或有關(guān)的資料送交各參評(píng)單位。5.4.4OrganizationandResponsibilityofReview/評(píng)審組織及職責(zé)ReviewOrganization/評(píng)審組織Theprocessreviewgroupshallbecomposedofreviewersofwhichthechiefiscompetenttechnicalleaderorhis/herrepresentative.由參評(píng)人員組成工藝評(píng)審組，組長(zhǎng)由主管技術(shù)領(lǐng)導(dǎo)或由他指定的委托人擔(dān)任。ResponsibilitiesofReviewGroupChief/評(píng)審組長(zhǎng)職責(zé)Presideoverthemeeting;/主持會(huì)議；Collecttheproblemsandsuggestionsputforwardinthereview,giveopinionsandmakeconclusions;/匯集評(píng)審提出的問題和建議，寫出評(píng)語和結(jié)論；Assignarecordertosortandworkouttheprocessreviewreports;/指定記錄人員整理、寫出工藝評(píng)審報(bào)告；ResponsibilitiesofReviewer/評(píng)審人員職責(zé)Readyforthereviewinadvance;/提前做好參評(píng)準(zhǔn)備；Giveopinionsfully./充分發(fā)表意見；5.4.5ReviewSteps/評(píng)審步驟Thereviewgroupchiefshalldescribethemeetingandassignarecorder;/評(píng)審組組長(zhǎng)作會(huì)議說明并指定記錄人員；Theprocessdesignrepresentativeshallintroducetheprocessdesign;/工藝設(shè)計(jì)代表介紹工藝設(shè)計(jì)情況；Thereviewersshallgivetheopinionsonthereview;/參評(píng)人員發(fā)表評(píng)審意見；Thereviewgroupchiefshalldefinetheitemsandcontentstobeimprovedonthebasisofcollectedopinions,andsummarizethereviewresultstogivehis/heropinionormakeaconclusion;/評(píng)審組組長(zhǎng)在集中意見的基礎(chǔ)上，明確需要改進(jìn)的項(xiàng)目和改進(jìn)內(nèi)容，對(duì)評(píng)審結(jié)果總結(jié)形成評(píng)語或結(jié)論；TherecordershallsortthemeetingrecordsandfillinReportonProcessDesignandDevelopmentReview./記錄人員整理會(huì)議記錄，填寫《工藝設(shè)計(jì)和開發(fā)評(píng)審報(bào)告》。5.4.6MeasureImplementationandDataPerfection/落實(shí)措施，完善資料TechnicalQualityDepartmentshallearnestlyanalyzetheproblemsandimprovementopinionsputforwardinthereviewmeeting,workoutthemeasures,havethemtakenandperfecttheprocessdata.技術(shù)質(zhì)量部認(rèn)真分析評(píng)審會(huì)議提出的問題和改進(jìn)意見，制定并落實(shí)措施，完善工藝資料。5.5FirstArticleInspection/首件鑒定5.4.1TechnicalQualityDepartmentshalldrawupafirstarticle(batch)inspectionplan,proposetheinspectionrequirement,assignapersontoarrangethetrial-manufactureinspectionandarrangetheplantimplementationonthebasisofissuedNewProductTrial-manufacturePlan./技術(shù)質(zhì)量部根據(jù)下達(dá)的新產(chǎn)品試制計(jì)劃，擬訂首件（批）鑒定計(jì)劃，提出鑒定要求，明確試制鑒定組織人員，并組織實(shí)施。5.4.2Trial-manufactureofFirstArticle(Batch)/首件（批）試制ManufacturingDepartmentshalltrial-manufacturethefirstarticle(batch)onthebasisofNewProductTrial-manufacturePlanandthefollowingrequirements:制造部根據(jù)新產(chǎn)品試制計(jì)劃和下列要求組織進(jìn)行首件（批）試制：Theprocessdevice,productionequipment,testequipment,environmentalcondition,etcshallmeettheprovisionsofprocessdocuments,andthereadyconditionoftrial-manufactureshallbequalifiedthroughcheck;/工藝裝置、生產(chǎn)設(shè)備、試驗(yàn)設(shè)備及環(huán)境條件等滿足工藝文件的規(guī)定，并經(jīng)試制準(zhǔn)備狀態(tài)檢查合格；Thearticleshallbeprocessedineachworkingprocessstrictlyinaccordancewiththerequirementsofprocessdocument,andtheproblemsfoundduringthetrial-manufactureineachworkingprocessshallbehandledandrecordedbythetechnicianintime;/每道工序應(yīng)嚴(yán)格按工藝文件的要求加工，技術(shù)人員及時(shí)處理、記錄每道工序試制中的問題；Theinspectorshallchecktheprocessedarticleandmakerelatedrecords./檢驗(yàn)人員進(jìn)行加工后的檢測(cè)，做好相關(guān)記錄。5.4.3InspectionforFirstArticle(Batch)WorkingProcess/首件（批）工序鑒定Thearticle(partorcomponent)infirstarticle(batch)workingprocessshallbeinspectedstrictlyinaccordancewithissuedprocessdocumentandworkinstructionsfortrial-manufacture.Afteritisqualified,theconditiononinspectionforfirstarticle(batch)workingprocessshallbepossessed./首件（批）工序（零、部）件嚴(yán)格按照下發(fā)的試制工藝文件和作業(yè)指導(dǎo)書進(jìn)行檢驗(yàn)。合格后才能具備首件（批）工序鑒定條件。Whentheconditiononinspectionforfirstarticle(batch)workingprocessshallbepossessed,ManufacturingDepartmentshallfillin“ApplicationFormforInspection(TypeApproval)ofFirstArticle(Batch)WorkingProcess”andsubmitittoTechnicalQualityDepartmenttoinspectthefirstarticle(batch)workingprocess./具備首件（批）工序鑒定條件時(shí)，由制造部填寫“首件（批）工序（零、部）件鑒定（定型）申請(qǐng)表”交技術(shù)質(zhì)量部門組織對(duì)首件（批）的工序?qū)嵤╄b定。5.4.4InspectionofPartandComponentinFirstArticle(Batch)WorkingProcess/首件（批）工序零、部件鑒定TechnologyQualityDepartmentshalltakechargeofassigntheinspectorstoinspectthepartandcomponentinthefirstarticle(batch)workingprocess./技術(shù)部門負(fù)責(zé)組織鑒定組成員，進(jìn)行首件（批）零、部件鑒定。Thesituationontheinspectionforfirstarticle(batch)workingprocessandtheprocessingqualityoftheworkingprocessshallbespotchecked,withthefollowingcontentsverified:/抽查首件（批）工序鑒定情況及工序加工質(zhì)量，驗(yàn)證以下內(nèi)容：Completeness,correctnessandeffectivenessofproceduredocumentandworkinstructions;/工藝文件、作業(yè)指導(dǎo)書的完整、正確、有效性；Configurationofmeasuringequipmentlikemeasuringtoolandeffectivenessoftheequipmentforproductqualitycontrol;/量具等測(cè)量設(shè)備的配置及對(duì)產(chǎn)品質(zhì)量控制的有效性；Conformanceofprocessinginworkingprocesstoprocessdocument;/工序加工與工藝文件的符合性；Qualitiesofrawmaterial,partsandauxiliaryequipmentaswellasblank;/原材料、配套件、坯件質(zhì)量；Whethertheprecisionofproductionequipmentmeetstheprocessingrequirement./生產(chǎn)設(shè)備的精度能否滿足加工要求。Thefinishedpartandcomponentinthefirstarticle(batch)shallbespotcheckedtoaffirmwhethertheymeettherequirementsofthecustomer'sproductiondrawings./抽查首件（批）零、部件成品，證實(shí)其是否滿足客戶產(chǎn)品圖要求。InspectionGroupshallassesstheresultofspotcheck,makeaconclusionandfilltheconclusionandfoundproblemsincorrespondingcolumnsofChecklistofParts/ComponentsinFirstArticle(Batch)WorkingProcess./鑒定組對(duì)抽查結(jié)果進(jìn)行評(píng)議，做出鑒定結(jié)論并將結(jié)論及問題寫入《首件（批）工序（零、部）件鑒定表》相應(yīng)欄內(nèi)。5.4.5Post-inspectionDisposal/鑒定后的處置Thepartandcomponentqualifiedthroughtheinspectionshallbecirculatedorstoredasrequired./鑒定合格的零、部件按要求流轉(zhuǎn)或保存。Forthepartandcomponentunqualifiedthroughtheinspection,thesubsequentpartandcomponentcanbeusedforre-inspection./鑒定未通過時(shí)，允許用后續(xù)產(chǎn)品遞補(bǔ)，重新進(jìn)行鑒定。5.5ValidationofDesignandDevelopment/設(shè)計(jì)和開發(fā)的驗(yàn)證Basedontheprocessdesignanddevelopmentprogrampassingthroughthereview,TechnicalQualityDepartmentshallberesponsibleforcitingtheaffirmedevidencerelatedtosimilarprocessdesignanddevelopmentforcomparisonasthebasisforverificationofthisdesign./根據(jù)評(píng)審?fù)ㄟ^的工藝設(shè)計(jì)和開發(fā)方案,技術(shù)質(zhì)量部負(fù)責(zé)引用已證實(shí)的類似工藝設(shè)計(jì)和開發(fā)的有關(guān)證據(jù)進(jìn)行比較，作為本次設(shè)計(jì)的驗(yàn)證依據(jù)。Theprojectleadershallsummarizealltheverificationresults,workoutReportonVerificationofProcessDesignandDevelopment,recordtheverificationresultsandtracedmeasuresandreportthemtoChiefEngineerforapprovalsoastoensurethateveryperformanceindicatorandeveryfunctionalindicatorinprocessdesignanddevelopmentinputhavecorrespondingverificationrecords./項(xiàng)目負(fù)責(zé)人綜合所有驗(yàn)證結(jié)果，編制《工藝設(shè)計(jì)和開發(fā)驗(yàn)證報(bào)告》，記錄驗(yàn)證的結(jié)果及跟蹤的措施，報(bào)總工程師批準(zhǔn)，確保工藝設(shè)計(jì)和開發(fā)輸入中每一項(xiàng)性能、功能指標(biāo)都有相應(yīng)的驗(yàn)證記錄。5.6ConfirmationofDesignandDevelopment/設(shè)計(jì)和開發(fā)的確認(rèn)Theconfirmationisintendedtoprovethattheproductmeetsexpecteduserequirement,andshouldbecarriedoutbeforebatchproductionasusual.Iftheconfirmationneedstobecarriedoutaftertheproductisusedbytheuserforaperiod,itshouldberealizedlocallywithinpossibleapplicablerange.Basedontheproductcharacteristics,oneofthefollowingconfirmationmethodscanbeselected.確認(rèn)的目的是證明產(chǎn)品能夠滿足預(yù)期的使用要求，通常應(yīng)在批量生產(chǎn)之前，如需經(jīng)用戶使用一段時(shí)間才能完成確認(rèn)工作的,應(yīng)在可能的適用范圍內(nèi)實(shí)現(xiàn)局部確認(rèn),根據(jù)產(chǎn)品的特點(diǎn),可以選擇下述幾種確認(rèn)方式之一。5.6.1TechnicalQualityDepartmentshallarrangerelatedpersonneltocarryoutthefirstarticleinspectionfortheproduct,i.e.,theproductprocessdesignanddevelopmentisconfirmed;/技術(shù)質(zhì)量部組織相關(guān)人員對(duì)產(chǎn)品進(jìn)行首件鑒定，即對(duì)產(chǎn)品工藝設(shè)計(jì)和開發(fā)予以確認(rèn)；5.6.2Aftertheproductisqualifiedthroughtheacceptance,ifitisdeliveredbyMarketingDepartmenttothecustomerfortryout,MarketingDepartmentshallfillinCustomerSatisfactionQuestionnairetoindicatethecustomersatisfactionforconformanceofproducttostandardorcontractrequirementandtheassessmentforapplicability,thecustomersatisfactionreferstotheconfirmationofprocessdesignanddevelopment;/自驗(yàn)收合格的產(chǎn)品，如果需要由營銷聯(lián)系交付顧客試用，由營銷部提交《顧客滿意度度調(diào)查表》,說明顧客對(duì)產(chǎn)品符合標(biāo)準(zhǔn)或合同要求的滿意程度及對(duì)適用性的評(píng)價(jià)，顧客滿意即對(duì)工藝設(shè)計(jì)和開發(fā)予以確認(rèn)；5.6.3Theproductshallbesenttonationalorindustrialrelatedagencyforinspection,thereportonqualificationthroughinspectionreferstotheconfirmationofprocessdesignanddevelopment.Theabovereportandrelateddataaretheresultsoftheconfirmation.TechnicalQualityDepartmentshallanalyzetheresults,takecorrespondingtracingandimprovementmeasuresasneeded,filltheminContactFormforProcessDesignandDevelopmentInformationandsubmittheformtorelevantdepartmentsforimplementationtoensurethattheproductmeetsexpecteduserequirements./產(chǎn)品送到國家或行業(yè)有關(guān)機(jī)構(gòu)進(jìn)行檢驗(yàn)，其檢驗(yàn)合格報(bào)告即為工藝設(shè)計(jì)和開發(fā)的確認(rèn)。上述報(bào)告及相關(guān)資料為確認(rèn)的結(jié)果，技術(shù)質(zhì)量部對(duì)此結(jié)果進(jìn)行分析，根據(jù)需要采取相應(yīng)的跟蹤和改進(jìn)措施，并填寫在《工藝設(shè)計(jì)和開發(fā)信息聯(lián)絡(luò)單》上傳遞給相關(guān)部門執(zhí)行，以確保產(chǎn)品滿足預(yù)期的使用要求。5.7ControlofChangesinDesignandDevelopment/設(shè)計(jì)和開發(fā)更改的控制5.7.1Theimportantchangesofkeyarticle,importantarticleandspecialprocessshallbecarriedoutaftertest,demonstrationandreview.Thereviewshallincludeevaluationontheeffectofcomponentsanddeliveredproductsbroughtbythesechanges./關(guān)鍵件、重要件和特種工藝的重要更改，應(yīng)通過試驗(yàn)、論證、評(píng)審后實(shí)施。審核應(yīng)包括構(gòu)成零件和已交貨產(chǎn)品的變動(dòng)效果的評(píng)估5.7.2Forthechangeaftertheformalprocessdocumentisissued,TechnicalQualityDepartmentshallfillinApplicationforDocumentChangewithrelevantdataattached./正式工藝文件下發(fā)后的更改應(yīng)由技術(shù)質(zhì)量部填寫《文件更改申請(qǐng)》，并附上相關(guān)資料。5.7.3TheprocessdocumentshallbechangedafterapprovaloftheManagementRepresentative(ifnecessary,suchchangeshallbereviewedbyrelevantdepartmentsandrelatedpersonnel)andtheinformationonthechangeshallbeavailabletorelevantdepartments,personnelandthesupplierintime.Allmodificationsshallbeidentifiedandrecordedforfiling./更改工藝文件必須報(bào)管理者代表批準(zhǔn)后方可進(jìn)行更改（必要時(shí)需要相關(guān)部門及相關(guān)人員進(jìn)行評(píng)審），并確保相關(guān)部門、人員、及供應(yīng)商及時(shí)得到更改信息。所有變動(dòng)和修改應(yīng)予以識(shí)別和歸檔。6RelevantDocuments/相關(guān)文件6.1TY-QP4.2-01-15ControlProcedureforDocumentTY-QP4.2-01-15《文件控制程序》6.2TY-QP4.2-02-15ControlProcedureforQualityRecordTY-QP4.2-02-15《質(zhì)量記錄控制程序》7Annexes/附件TY-QR-TQD-092ApplicationforSetupofProcessDesignandDevelopmentProject/TY-QR-TQD-092《工藝設(shè)計(jì)和開發(fā)立項(xiàng)申請(qǐng)書》TY-QR-TQD-093AssignmentBookforProcessDesignandDevelopmentTY-QR-TQD-093《工藝設(shè)計(jì)和開發(fā)任務(wù)書》TY-QR-TQD-094ProcessDesignandDevelopmentPlanTY-QR-TQD-094《工藝設(shè)計(jì)和開發(fā)計(jì)劃書》TY-QR-TQD-095ContactFormforProcessDesignandDevelopmentInformation/TY-QR-TQD-095《工藝設(shè)計(jì)和開發(fā)信息聯(lián)絡(luò)單》TY-QR-TQD-096ListofProcessDesignandDevelopmentInputsTY-QR-TQD-096《工藝設(shè)計(jì)和開發(fā)輸入清單》TY-QR-TQD-097ListofProcessDesignandDevelopmentOutputsTY-QR-TQD-097《工藝設(shè)計(jì)和開發(fā)輸出清單》TY-QR-TQD-098ApplicationFormforInspection(TypeApproval)ofFirstArticle(Batch)WorkingProcess/TY-QR-TQD-098《首件（批）工序（零、部）件鑒定（定型）申請(qǐng)表》TY-QR-TQD-099ChecklistofParts/ComponentsinFirstArticle(Batch)WorkingProcess/TY-QR-TQD-099《首件（批）工序（零、部）件鑒定表》TY-QR-TQD100ReportonProcessDesignandDevelopmentReviewTY-QR-TQD100《工藝設(shè)計(jì)和開發(fā)評(píng)審報(bào)告》TY-QR-TQD101ReportonVerificationofProcessDesignandDevelopmentTY-QR-TQD101《工藝設(shè)計(jì)和開發(fā)驗(yàn)證報(bào)告》ApplicationforSetupofProcessDesignandDevelopmentProject工藝設(shè)計(jì)和開發(fā)立項(xiàng)申請(qǐng)書LOG/SN序號(hào)：TY-QR-TQD-092AApplicationDepartment/提出部門Applicant/申請(qǐng)人ProjectName/項(xiàng)目名稱TypeandSpecs/型號(hào)規(guī)格SalesTarget/銷售對(duì)象DateofApplication/申請(qǐng)日期BasicInformation(incl.performance,structure,appearanceandpackage,technicalparameterdescription,etc)/基本要求（包括主要性能、結(jié)構(gòu)、外觀包裝、技術(shù)參數(shù)說明等）MarketForecastandAnalysis(incl.marketdemand,user'sexpectation,situationoncompetitor,currentsituationonproductquality,expectedsalesoffirstbatch,deliveryterm,ex-factoryprice,etc)/市場(chǎng)預(yù)測(cè)分析（包括市場(chǎng)需求、用戶期望、競(jìng)爭(zhēng)對(duì)手情況、產(chǎn)品質(zhì)量現(xiàn)狀、預(yù)期首批銷量、交貨期限、出廠價(jià)格）ReferableExistingTechnique/可引用的原有技術(shù)FeasibilityAnalysis(incl.technique,purchase,process,cost,etc)/可行性分析(包括技術(shù)、采購、工藝、成本等方面)ApprovalofDepartmentLeader/部門領(lǐng)導(dǎo)審批：Signedby/簽名：Date/日期：VerificationofChiefEngineer/總工程師審核：Signedby/簽名：Date/日期：WrittenInstructionofGeneralManager/總經(jīng)理批示：Signedby/簽名：Date/日期：AssignmentBookforProcessDesignandDevelopment/工藝設(shè)計(jì)和開發(fā)任務(wù)書LOG/SN序號(hào)：TY-QR-TQD-093AProductModel/產(chǎn)品型號(hào)：ProductName/產(chǎn)品名稱：DatesofStartandEndofProductDevelopment/產(chǎn)品開發(fā)起止日期：ProjectLeader/項(xiàng)目負(fù)責(zé)人：TargetCost/目標(biāo)成本：ApplicableStandardsorLawsandRegulations(incl.name,No.,revision,chapter/sectionNo.,etc)/依據(jù)的標(biāo)準(zhǔn)或法律法規(guī)（包括名稱、編號(hào)、版本、章節(jié)號(hào)等）：DescriptionofProductFunction/產(chǎn)品功能描述：TechnicalParameterandPerformanceIndicator/技術(shù)參數(shù)及性能指標(biāo)：RequirementforProductStructure/產(chǎn)品結(jié)構(gòu)要求：SpecialRequirementofCustomer/顧客特殊要求：□No/無□Yes,pleasedescribe/有，具體描述：OtherRequirements/其它要求：Remarks/備注：JointlySignedby/會(huì)簽評(píng)審：Department/部門Reviewedby/Date/評(píng)審人/日期Title/職位Department/部門Reviewedby/Date/評(píng)審人/日期Title/職位Preparedby/Date/編制/日期Verifiedby/Date/審核/日期Approvedby/Date/批準(zhǔn)/日期ProcessDesignandDevelopmentPlan/工藝設(shè)計(jì)和開發(fā)計(jì)劃書LOG/SN序號(hào)：TY-QR-TQD-094AProjectName/項(xiàng)目名稱：ProjectSource/項(xiàng)目來源：DevelopmentPeriod/開發(fā)周期：GeneralProjectLeader/項(xiàng)目總負(fù)責(zé)人：Designer/設(shè)計(jì)人員Title/職位Designer/設(shè)計(jì)人員Title/職位Designer/設(shè)計(jì)人員Title/職位ResourceAllocation/資源配置：StageDivision/MainContent/階段劃分及主要內(nèi)容ResponsibleDepartment/責(zé)任部門Leader/責(zé)任人DateofCompletion/完成時(shí)間DesignDevelopmentInput/設(shè)計(jì)開發(fā)輸入PreparationofApplicationforSetupofProject/編制立項(xiàng)申請(qǐng)書ReviewofApplicationforSetupofProject/對(duì)立項(xiàng)申請(qǐng)書進(jìn)行評(píng)審DesignDevelopmentOutput/設(shè)計(jì)開發(fā)輸出DesignofDrawing,Process,ToolingandFixtures/圖紙、工藝、工裝夾具設(shè)計(jì)PreliminaryTechnicalDesignReview/初步技術(shù)設(shè)計(jì)評(píng)審TechnicalDesignDocumentOutput/技術(shù)設(shè)計(jì)文件輸出SampleTrial-manufacture/樣品試制PartPurchase/零部件采購ManufactureofToolingandFixtures/工裝夾具制作SampleTrial-manufacture/樣品試制SampleTest/樣品檢測(cè)DevelopmentValidationandReview/開發(fā)驗(yàn)證、評(píng)審SampleReview/樣品評(píng)審ProjectSummary/項(xiàng)目總結(jié)ProjectReview/項(xiàng)目評(píng)審DesignDevelopmentOutput/設(shè)計(jì)開發(fā)輸出FormalDrawing/正式圖紙F(tuán)ormalProcessDocument/正式工藝文件FormalWorkInstructions/正式作業(yè)指導(dǎo)書ConversionintoFormalProduction/轉(zhuǎn)入正式生產(chǎn)Remarks/備注：Preparedby/Date/編制/日期Verifiedby/Date/審核/日期Approvedby/Date/批準(zhǔn)/日期ContactFormforProcessDesignandDevelopmentInformation工藝設(shè)計(jì)開和開發(fā)信息聯(lián)絡(luò)單LOG/SN序號(hào)：TY-QR-TQD-095AContent/內(nèi)容：Signedby/簽字：Date/日期：ProjectLeader'sOpinion/項(xiàng)目主管意見RelatedLeader'sOpinion/相關(guān)領(lǐng)導(dǎo)意見Signedby/簽字：Date/日期：Signedby/簽字：Date/日期：ListofProcessDesignandDevelopmentInputs/工藝設(shè)計(jì)和開發(fā)輸入清單LOG/SN序號(hào)：TY-QR-TQD-096ASN/序號(hào)Name/名稱Unit/單位Qty/數(shù)量Remarks/備注Preparedby/編制：Verifiedby/審核：Approvedby/批準(zhǔn)：Date/日期：Date/日期：Date/日期：ListofProcessDesignandDevelopmentOutputs/工藝設(shè)計(jì)和開發(fā)輸出清單LOG/SN序號(hào)：TY-QR-TQD-097ASN/序號(hào)Name/名稱Unit/單位Qty/數(shù)量Remarks/備注Preparedby/編制：Verifiedby/審核：Approvedby/批準(zhǔn)：Date/日期：Date/日期：Approvedby/批準(zhǔn)：

ApplicationFormforInspection(TypeApproval)ofFirstArticle(Batch)WorkingProcess/首件（批）工序（零、部）件鑒定（定型）申請(qǐng)表LOG/SN序號(hào)：TY-QR-TQD-098ASN/序號(hào)ProductName/產(chǎn)品名稱WorkingProcess/工序名稱ProductStatus/產(chǎn)品狀態(tài)Remarks/備注ApplicationDepartment/申請(qǐng)部門Applicant/申請(qǐng)人DateofApplication/申請(qǐng)時(shí)間ManufacturingDepartment'sOpinion/制造部意見：Signedby/簽字：Date/日期：TechnicalQualityDepartment'sOpinion/技術(shù)質(zhì)量部意見：Signedby/簽字：Date/日期:ChecklistofParts/ComponentsinFirstArticle(Batch)WorkingProcess首件（批）工序（零、部）件鑒定表LOG/SN序號(hào)：TY-QR-TQD-099AProductName/產(chǎn)品名稱DrawingNo./圖號(hào)No.ofPart/ComponentinFirstArticle(Batch)/首件（批）（零部）件編號(hào)Item/項(xiàng)目SN/序號(hào)InspectionContent/鑒定內(nèi)容InspectionResult/鑒定結(jié)果Remarks/備注ProcessQuality/過程質(zhì)量ProductQuality/產(chǎn)品質(zhì)量1Completeness,CorrectnessandEffectivenessofProcedureandWorkInstructions/工藝文件、作業(yè)指導(dǎo)書的完整、正確、有效性2ConfigurationofMeasurementEquipmentslikeGaugesandTheirEffectivenessforControlofProductQuality/量具等測(cè)量設(shè)備的配置及對(duì)產(chǎn)品質(zhì)量控制的有效性3WhetherthePrecisionsofToolingandProductionEquipmentsMeettheProcessingRequirements/工裝、生產(chǎn)設(shè)備的精度能否滿足加工要求4ImplementationofProcessbyManufacturingDepartment/制造部工藝執(zhí)行情況5WhethertheProductionConditionsareControlled/生產(chǎn)條件是否處于受控狀態(tài)6WhethertheProductQualityAccordstotheRequireme