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设计开发管理程序DesignandDevelopmentManagementProcedureDOC.NO.：VER：1.1SHEET：1/10☆☆☆☆☆☆☆☆ISO9001:2015☆☆☆☆☆☆☆☆1.目的Purpose为确保产品设计开发过程中，能有效的管理各个主要活动之输入与输出，以确保产品能符合客户或市场需求。Inordertoensureallmajoractivityinputandoutputintheproductdesignanddevelopmentprocesscanbeeffectivelymanagedandensureallproductscancomplywithcustomerandmarketrequirements.2.范围Scope凡本公司所设计开发及客户委托开发之产品，包括新产品、系列品均属之。ThisProcedureisapplicabletoalltheproductsdesignedanddevelopedbytheCompanyordevelopedunderthecommissionofthecustomer,includingnewproductsandproductseries.3.权责Responsibilities作业内容Description审查Review核准Approval1设计和开发策划Designanddevelopmentplanning项目小组Projectteam副总（含）以上主管DeputyorVicegeneralmanager(inclusive)andabove2设计和开发输入Designanddevelopmentinput项目小组Projectteam业务/客户Business/customer3设计和开发控制Designanddevelopmentreview项目小组Projectteam研发部经理R&Dmanager4设计和开发输出Designanddevelopmentoutput项目小组Projectteam研发部经理R&Dmanager5产品量试Productbatchrun项目小组Projectteam研发部经理R&Dmanager4.定义Definitions4.1项目小组：系指由业务、PM、研发、品管、生管、采购、制造、生技单位之担当人员所组成之设计开发项目小组。Projectteam:Itreferstothedesignanddevelopmentprojectteamconsistingoftheresponsiblepersonsofsuchdepartmentsasbusiness,PM,R&D,QC,productionmanagement,purchase,manufactureandproductiontechnology.4.2新产品：系指设计开发之新系列产品。Newproducts:Thenewseriesofproductsdesignedanddeveloped.设计开发管理程序DesignandDevelopmentManagementProcedureDOC.NO.：VER：1.1SHEET：2/10☆☆☆☆☆☆☆☆ISO9001:2015☆☆☆☆☆☆☆☆4.3系列品：系指同系列产品，唯产品结构、功能型式或外观形式需作适当变化始符合客户（或市场）需求而进行设计之产品。Productseries:i.e.thesameseriesofproductsdesignedthatcannotmeetthecustomer(market)requirementunlesstheproductstructure,functionaltypeorprofileischangedproperly.5.作业内容Content5.1新产品Newproduct5.1.1设计和开发策划：Designanddevelopmentplanning:5.1.1.1业务部门对产品信息收集的方式，可由搜集产品、策略性产品、市场需求信息、国内外展览、相关的研讨会或各种相关刊物等取得，确定客户（或市场）之要求（适当时含客户规格、样品等）..Thebusinessdepartmentshallcollectproductinformationbymeansofcollectedproducts,strategicproducts,marketdemandinformation,domesticandforeignexhibitions,relatedseminarsorvariousmagazinesetcandconfirmcustomer(market)requirements(includingcustomerspecificationsandsamplesetcwhereproper).5.1.1.2PM组织成立项目小组针对产品信息数据进行产品开发可行性评估，分析本公司既有技术能力及产品之市场性并填写《开发可行性评估表》，是否进行产品开发策划，由副总（含）以上主管裁定并指定PM及业务担当开立《新产品开发申请表》。PM/业务根据开发策划阶段达成的对产品要求制订《产品规格书》.ThePMshallorganizeandestablishprojectteamtoevaluatetheproductdevelopmentfeasibilityasperproductinformationanddata,analyzetheexistingtechnicalcapacityandproductmarketabilityoftheCompanyandfillinDevelopmentFeasibilityAssessmentSheet;fortheplanningofwhethertohaveproductdevelopmentplanning,itistheresponsibilityofthedeputygeneralmanager(inclusive)orabovetodetermineandthebusinesspersonnelshallprepareNewProductDevelopmentApplicationForm.PM/businesspersonnelshallestablishProductSpecificationsaccordingtotheproductrequirementsreachedbyPMandthebusinesspersonnelonthedevelopmentplanningstage.5.1.1.3研发部收到《新产品开发申请表》后研发部经理指派研发部工程师承担产品设计任务。研发部工程师依据由项目负责人(PM)提出的《开发计划书》，设计开发管理程序DesignandDevelopmentManagementProcedureDOC.NO.：VER：1.1SHEET：3/10☆☆☆☆☆☆☆☆ISO9001:2015☆☆☆☆☆☆☆☆《产品规格书》作为产品设计开发阶段之依据，并经副总（含）以上主管核准。AftertheR&DdepartmentreceivestheNewProductDevelopmentApplicationForm,theR&DmanagershallappointR&Dengineertoassumeproductdesigntask.TheR&DengineershalltaketheDevelopmentPlanpreparedandProductSpecificationsbytheprojectmanager(PM)asthebasisforproductdesignanddevelopment,whichshallbereviewedandapprovedbythedeputygeneralmanager(inclusive)orabove.5.1.1.4产品开发策划无需进行时，《开发可行性评估》表并同产品信息数据一律由PM管理保存。Whenproductdevelopmentplanningisunnecessary,theDevelopmentFeasibilityAssessmentSheetshallbemanagedandkeptbythePMtogetherwillallproductinformationanddata.5.1.1.5对于ODM、OEM产品,《产品规格书》的内容必须与客户要求一致。ForODMandOEMproducts,thecontentofProductSpecificationsmustbeconsistentwithcustomerrequirements.5.1.2设计和开发输入：Designanddevelopmentinput:5.1.2.1项目负责人提交《产品计划书》和《产品规格书》给业务或客户确认，确认依此进行开发和设计。ThePMshallsubmitProductPlanandProductSpecificationstothebusinessdepartmentorthecustomerforconfirmation,andthedevelopmentanddesignshallbeconductedaccordingtosuchconfirmeddocuments.5.1.2.2PM需复制一份《开发可行性评估表》、《开发计划书》、《产品规格书》及可供研发参考之产品信息数据给予研发部做为该产品开发和设计的依据。ThePMshallcopytheDevelopmentFeasibilityAssessmentSheet,DevelopmentScheme,ProductSpecificationsandtheproductinformationanddataforR&DreferencetotheR&Ddepartmentforitsreferenceduringproductdevelopmentanddesign.5.1.2.3PM应适时跟进和更新《开发计划书》中开发计划及完成状态,定期发放以指导开发进程。ThePMshallinpropertimefollowandupdatethedevelopmentplanandcompletionstateasprovidedintheDevelopmentPlanandregularlyissueittodirectthedevelopmentprogress.设计开发管理程序DesignandDevelopmentManagementProcedureDOC.NO.：VER：1.1SHEET：4/10☆☆☆☆☆☆☆☆ISO9001:2015☆☆☆☆☆☆☆☆5.1.3设计和开发的控制5.1.3.1设计和开发评审Designanddevelopmentreview项目负责人制作《设计评审表》，并召集项目小组人员进行产品设计评审，以及产品失效模式的风险评估；由主管经理核准。ThePMshallmakeDesignReviewFormandconvoketheprojectteampersonneltohaveproductdesignandproductfailuremoderiskassessmentreview,whichshallbeapprovedbythedirector/manager.5.1.3.2设计和开发验证：Designanddevelopmentvalidation:5.1.3.2.1设计和开发验证的目的在验证产品规格与《产品规格书》符合。ThepurposeofdesignanddevelopmentshallbeconsistentwiththespecificationoftheproductbeingvalidatedandtheProductSpecifications.5.1.3.2.2研发部工程师安排制作样品,依测试