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1、生产件批准程序(PPAP)ATLSQE2013-08-05JIMMYZHANG2PPAP定义PPAPdefinesgenericrequirementsforproductionpartapproval.ThepurposeofPPAPistodetermineifallcustomerengineeringdesignrecordandspecificationrequirementsareproperlyunderstoodbytheorganizationandthatthemanufacturingprocessh
2、asthepotentialtoproduceproductconsistentlymeetingtheserequirementsduringanactualproductionrunatthequotedproductionrate.PPAP规定了生产件批准的一般要求,通过组织准备和提交文件、样品,使顾客能够确定:组织是否理解了顾客工程设计记录和规范的所有要求;制造过程是否有潜力在实际生产运行中,按报价时的生产节拍持续生产满足顾客要求的产品。PPAP生产件定义ThisrunofPPAPshallbemanufactur
3、edattheproductionsiteusingthetooling,gaging,process,materials,andoperatorsfromtheproductionenvironment.Partsfromeachuniqueproductionprocess,e.g.duplicateassemblylineand/orworkcell,eachpositionofamultiplecavitydie,mold,toolorpattern,shallbemeasuredandrepresentative
4、partstested.采用正式批量生产所用的工装、量检具、过程,材料、操作员、环境和过程参数生产出的产品。不同的冲模、铸模、工装或模型要分别取样测量验证,并对代表性零件进行试验。3PPAPisaWin-WinActivityPPAP生产件定义ProductforPPAPshallbetakenfromasignificantproductionrun.Thissignificantproductionrunshallbefromonehourtoeighthoursofproduction,andwiththespeci
5、ficproductionquantitytototalaminimumof300consecutiveparts,unlessotherwisespecifiedbySQE.用于PPAP的零件必须取自正式的批量试生产。1小时到8小时的连续生产件。至少300件连续生产,除非SQE另有有规定。Suppliershouldmeetallspecifiedrequirements,designrecord,specification.应满足所有规定要求,如设计记录和技术规范。4PPAP适用项PPAP被运用但不限于:Newpart
6、s,sub-assembliesandtoolspurchasedforclinicaluse.采购新料,部件装配和临床使用工具。Achangetoapart,material,process,manufacturingequipment,manufacturinglocation,inspectionmethod,risklevel,etc.initiatedbyCovidienorthesupplier(SupplierChangeRequest)whenpreviouslyqualifiedbyPPAP.由客户Cov
7、idien或供应商(供应商变更请求)发起的零件、原材料、工艺、生产设备、生产地点、检验方法、风险水平等的变更。5PPAP适用项Productionfromrefurbishedorrepairedtools,dies,molds,patterns,toincludereplacementtoolingcomponentsthatdirectlycontrolkeycharacteristicsand/orrequireaFAT.翻新或修理工装、冲模、铸模、模形,包括直接控制关键特征的工装组件的变更。Correctionof
8、discrepanciesforapreviouslysubmittedPPAP.以前提交的PPAP不符合项的纠正。6PPAP适用项PPAP可能也被认做:Productionfollowingsuspendedshipmentduetoaqualityissue由于质量问题暂缓出货的产品。Supplie