QSB变更管理

QualitySystemsBasicsrevFebruary2011FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWS11.0–变更管理1GlobalPurchasingandSupplyChainQualitySystemsBasicsrevFebruary2011FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWS变更管理目录11.0)导言:目的、范围和职责11.1)益处11.2)变更流程11.3)试生产（PTR）流程11.4)备库流程11.5)临时替代流程11.6)总结，必须2GlobalPurchasingandSupplyChainQualitySystemsBasicsrevFebruary2011FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWS目的：•有一个系统来管理工厂中所有的过程变更。•计划的变更•紧急的变更•在标准化沟通下，建立一个都能接受的试运行流程，完成变更就绪评审和变更后产品质量评审。•为临时替代生产流程定义最低要求。•执行一个受控的备库流程。范围：•可能影响到最终产品的变更。•客户已经批准的生产设备和生产系统。•工厂中的手工和自动化岗位。•通过文件控制而受控的流程。职责：•负责人营运经理生产／技术经理质量经理针对各种异常状况的应急计划变更管理11.0–导言3GlobalPurchasingandSupplyChainQualitySystemsBasicsrevFebruary2011FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWS变更管理11.1–益处•改善在组织中如何通知和通报那些可能导致失控的行为（或变更）。•为通报和执行生产试运行分配职责。•改善备库品质量。•预先定义和批准临时替代流程运作方法和控制手段，以及如何回归原来的生产流程•确保有一个系统的方法来处理所有客户已批准流程的变更。4GlobalPurchasingandSupplyChainQualitySystemsBasicsrevFebruary2011FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWS变更管理所有供应商都应有一个控制工厂过程变更的程序：•所有的变更都需要客户审核和批准•变更应使用文件化的工厂过程变更申请表（PPCR）。（参见PowertrainPPCR例子）•所有过程变更申请表都应由文件控制程序来控制。•此程序应覆盖计划的与紧急的变更（典型例子：因停机，库存耗尽，客户授权的返工，订单的变动等计划外的情况导致临时修改过程/标准化操作）。•除了EWO,BTAB外，任何更改必须提前一个月通知客户/SQE,并得到批准后,才能开始更改。工厂过程变更申请表（PPCR）的目的：•保留所有可能影响到最终产品的变更记录。•追溯对过程可能有负面影响但不一定影响最终产品质量的系统变更。•保证所有关键相关方都清楚变更的要求，并对可能的失控进行管控。11.2–变更流程5GlobalPurchasingandSupplyChainQualitySystemsBasicsrevFebruary2011FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSPPCR用于任何可能对以下项目产生影响的硬件或软件变更：•单件成本或质量•生产设备/生产系统的可靠性•作业指导文件，操作或检具指导文件，控制计划，PFMEA，流程图•培训材料•维修维护程序一些要求使用PPCR例子：•变更校准程序•变更操作指导文件•变更机器设备的设定目标•变更过程控制计划•变更经批准的EWO6GlobalPurchasingandSupplyChain11.2-变更流程（续）变更管理QualitySystemsBasicsrevFebruary2011FRNCPWPOSWI(SOS)OI(JES)SOT(JIT)RiskEPVLPAVSContamSCMMCPSWSRev.Date:10/5/07PLANTPROCESSCHANGEREQUESTPPCRNO.(ALLSHADEDAREASMUSTBECOMPLETED)CONTACT:EXT.5-5391SECTION1:BACKGROUNDINFORMATIONEMERGENCYPPCR?YESNOIFYES,GIVECOPYTOQUALITYPARTNAME(S)IMPACTEDManufacturingProcessBypassed?YESNOMODELYEARANDAPPLICATIONPART#(S)IMPACTEDMFG.DEPT(S)IMPACTEDOPERATION/STATION#PLANNEDCHANGEDATEOPPORTUNITY/PROBLEMSTATEMENT:DESCRIPTIONOFCHANGE/EMERGENCYREACTIONPLAN:WHATISTHEAIMOFTHISCHANGE?WHYSHOULDWEWORKONTHISNOW?EXPLAINTHEMETHODBYWHICHPROPEROPERATIONWILLBEVERIFIED:INITIATORNAMEINITIATINGDEPARTMENTAREAMGR.SIGN.(EMER.ONLY)SECTION2:DETERMINEIFCHANGEREQUIRESPDT/CIT-LEVELORPPAPREVIEWANDAPPROVALCHECKANYOFTHEFOLLOWINGTHATMAYBEAPPLICABLE:CM,PANEWPARTORPRODUCT(i.e.ASPECIFICPART,MATERIALORCOLORNOTPREVIOUSLYSUPPLIEDTOTHESPECIFICCUSTOMER).CM,PPRODUCTMODIFIEDBYANENGINEERINGCHANGETODESIGNRECORDS,SPECIFICATIONSORMATERIALS.CM,PUSEOFANOTHEROPTIONALCONSTRUCTIONORMATERIALTHANWASUSEDINTHEPREVIOUSLYAPPROVEDPART.CM,PPRODUCTIONFOLLOWINGANYCHANGEINPROCESSORMETHODOFMANUFACTUREWHERE,INTHEJUDGEMENTOFTECHNICALEXPERTS,THEPOTENTIALEXISTSTOIMPACTPRODUCTINTEGRITY(e.g.MATERIALPROPERTIES,SURFACEFINISH...ETC.).PPRODUCTIONFOLLOWINGANYCHANGEINPROCESSORMETHODOFMANUFACTURE.PCORRECTIONOFADISCREPANCYONAPREVIOUSLYSUBMITTEDPART.PPRODUCTIONFROMTOOLINGANDEQUIPMENTTRANSFERREDTOADIFFERENTPLANTLOCATIONORFROMANADDITIONALPLANTLOCATION.PPRODUCTIONFOLLOWINGREFURBISHMENTORREARRANGEMENTOFEXISTINGTOOLINGOREQUIPMENT.PCHANGEINSOURCEFORSUBCONTRACTEDPARTS,MATERIALS,DUNNAGEORSERVICES(e.g.HEAT-TREATING,PLATING,PAINTING,ETC.)PPRODUCTRE-RELEASEDAFTERTOOLINGHASBEENINACTIVEFORVOLUMEPRODUCTIONFORTWELVEMONTHSORMORE.PFOLLOWINGACUSTOMERREQUESTTOSUSPENDSHIPMENTDUETOASUPPLIERQUALITYCONCERN.PPRODUCTIONFROMNEWORMODIFIEDTOOLS(EXCEPTPERISHABLETOOLS),DIES,MOLDS,PATTERNS...ETC.,INCLUDINGADDITIONALORREPLACEMENTTOOLING.NOITEMSAPPLICABLECHANGEALREADYPDT/CITAPPROVEDIFYOUCHECKEDANYCMITEM(S):1)DONOTCONTINUETOSECTION3UNTILFURTHERNOTIFIEDBYYOURPDT/CITLEADER.2)FORWARDTHISSHEETTOTHEMANUFACTURINGENGINEERINGCLERK.IFYOUCHECKEDONLYPITEM(S):CONTINUETOSECTION3.COMPLETEPPAPSECTION(MANDATORY).CHANGELEADERNAME(ifdifferentthaninitiator)IFYES,COMPLETEManufacturingProcessBackupWorksheet(inS:\ECO\FORMS)DATEINITIATED(IFEMERGENCY,TIMEALSOREQUIRED)Rev.Date:10/5/07PLANTPROCESSCHANGEREQUESTPPCRNO.SECTION3:DETERMINEWHICHFUNCTIONALGROUPSNEEDTORESPONDTOTHISCHANGECHECKANYITEMSTHATMAYBEAPPLICABLE/IMPACTED:RESPONSEDUEDATE:SAFETY:CONTACT:SIGNATURE:GUARDINGOTHERWORK-FITINSTRUCTIONSMANUFACTURING:CONTACT:SIGNATURE:MAINTENANCEMANUFACTURINGINSTRUCTIONSPRODUCTIONMONITORINGMANUFACTURINGENGINEERING:CONTACT:SIGNATURE:PROCESSROUTINGPROCESSPARAMETERSGAGE(DRAWING,PLAN)TOOLINGANDDRAWINGSPFMEACMM(DRAWING,FIXTURES)PROCESSCONTROLPLANMACHINEDRAWINGS(MECH/ELECT)FLOATSHEETSERRORPROOFINGGAGECHECKSHEETPROCESSFLOWDIAGRAMTOOLINGENGINEERING:CONTACT:SIGNATURE:CUTTINGTOOLS&DRAWINGSCNCPARTPROGRAMTOOLROUTINGINDUSTRIALENGINEERING:CONTACT:SIGNATURE:WORKPLACELAYOUTENGINESEQUENCINGSYSTEMJOBINSTRUCTIONS(SWC/SOS/STS/JES)TAKTTIME/LABORCONTENTCYCLETIME(PARTTOPART)STANDARDIZEDWORKVIDEODUNNAGE(INTERNAL&EXTERNAL)ERGONOMICSGAGE/TOOLCHG/COMP.FREQ.MATERIALHANDLINGJOBDESIGN(METHODCHANGE)VISUALCONTROLSANDONSIGNALINGSYSTEMPLANTENGINEERING:CONTACT:SIGNATURE:ELECTRICAL/CONTROLSSOFTWAREWASHER