過(guò)程能力研究作業(yè)規(guī)范

1.Purpose目的:制SPC的方法；TodefinethemethodfortheplanningandexecutionofStatisticalProcessControl(SPC);1.2確保在SPC過(guò)程中，相關(guān)人員已被清楚地定義了適當(dāng)?shù)慕巧吐氊?zé)；失控時(shí)，各級(jí)職ToensuretherelevantpersonnelinvolvedinSPCarefullydefinedwithproperrolesandresponsibilitiestogetherwiththeirlevelofauthorityinthedecisionmakingofSPCandout-of-controlsituation;1.3建立一個(gè)有效的SPC系統(tǒng)，以達(dá)到最小變差的，穩(wěn)定的和有能力的過(guò)程，在公司中貫徹“質(zhì)TobuildaneffectiveSPCsystemtoachievestableandcapableprocesseswithminimumprocessvariationresultingin“build-inquality”mindsetinthecompany;ToensurethatallcustomerrequirementsinregardstoSPCareadhered;2.Scope范圍:3.Definition定義:3.1SPC:統(tǒng)計(jì)過(guò)程控制StatisticalProcessControl3.2CP:控制計(jì)劃ControlPlan3.3PFMEA:過(guò)程失效模式影響分析3.4Defectivepart:缺陷品沒(méi)有滿足客戶(hù)要求或規(guī)格的產(chǎn)品Item,partorproductthatdoesnotmeetcustomer’srequirementorspecification3.5Defect:缺陷沒(méi)有滿足客戶(hù)要求或規(guī)定的質(zhì)量特性或缺點(diǎn)Flaworqualitycharacteristicthatdoesnotmeetcustomer’srequirementorspecification4.Responsibility職責(zé):4.1.質(zhì)量經(jīng)理／六西格瑪黑帶／或經(jīng)過(guò)培訓(xùn)的有資格的人員QAManager/6SigmaBlackBelt／orqualifiedpersonnel4.1.1負(fù)責(zé)統(tǒng)計(jì)過(guò)程控制的培訓(xùn)Coordinateandconductstatisticalprocesscontroltrainingtoallrelevantlevels.4.1.2負(fù)責(zé)工廠SPC指導(dǎo)和執(zhí)行計(jì)劃DeterminefactorySPCdirectionandimplementationplan.4.1.3與公司管理層評(píng)審SPC執(zhí)行表現(xiàn)ReviewSPCimplementationperformancewithtopmanagement.4.1.4持續(xù)對(duì)全公司宣導(dǎo)SPC的意識(shí)和教育ContinuouslydriveforawarenessandeducationofSPCatalllevels.4.1.5作為SPC執(zhí)行及其附加活動(dòng)的推動(dòng)者ActasfacilitatorontheSPCimplementationandproliferationactivities.4.2.客戶(hù)質(zhì)量工程師CustomerQualityEngineer(CQE)4.2.1依據(jù)控制計(jì)劃／過(guò)程失效模式確認(rèn)當(dāng)前關(guān)鍵控制范圍ReviewthecurrentprocessflowwiththeaidofControlPlan/PFMEAtoidentifycriticalareas.4.2.2依據(jù)現(xiàn)有數(shù)據(jù)和客戶(hù)要求，為統(tǒng)計(jì)過(guò)程控制的執(zhí)行確定關(guān)鍵參數(shù)。記入控制計(jì)劃及檢驗(yàn)計(jì)IdentifythekeyparameterforSPCimplementationusingexistingprocessdataandfollowingcustomerrequirements.RegisterinControlPlanandInspectPlan.4.2.3將工程變更信息傳達(dá)PQE，確保全部任務(wù)的執(zhí)行和過(guò)程能力滿足客戶(hù)要求。PassEngineeringChange(EC)informationtoPQE,ensurealltasksimplementationandprocesscapabilitymeetcustomerrequirements.4.3.過(guò)程控制工程師ProcessQualityEngineer(PQE)4.3.1評(píng)審和利用過(guò)程數(shù)據(jù)，推動(dòng)過(guò)程變更／改善Reviewandutilizetheprocessdataandfacilitateprocesschange/improvement.4.3.2依據(jù)控制計(jì)劃和檢驗(yàn)計(jì)劃執(zhí)行ImplementSPCviaControlPlanandInspectionPlan.啟動(dòng)統(tǒng)計(jì)過(guò)程控制圖的執(zhí)行(計(jì)數(shù)型和計(jì)量型)InitiateSPCchart(attributeandvariable)implementation.評(píng)審和升級(jí)統(tǒng)計(jì)過(guò)程控制限，最少每月一次Reviewandupdatethestatisticalcontrollimitsoncepermonthatleast.利用統(tǒng)計(jì)過(guò)程控制的數(shù)據(jù)判斷過(guò)程變化和改進(jìn)機(jī)會(huì)ReviewandutilizeSPCdatatowardsprocesschangeidentificationandimprovement.4.3.3建立統(tǒng)計(jì)過(guò)程控制過(guò)程(依靠SPC操縱持續(xù)改進(jìn)過(guò)程)Establishstatisticalcontrolprocesses(drivingcontinuousimprovementthroughSPC).確定變化源Identifysourceofvariation.提出改進(jìn)措施，與過(guò)程團(tuán)隊(duì)一起消除在過(guò)程中的異常Requestforcorrectiveactionsandworkwithprocessteamtoeliminatethevariabilityfoundintheprocess.文件化SPC圖中失控的糾正措施Documentcorrectiveactionsontheout-of-controlconditionsonSPCcharts.周期性地計(jì)算和分析過(guò)程能力，以持續(xù)改進(jìn)Calculatesandanalyzeprocesscapabilityperiodicallyforcontinuousimprovement.持續(xù)減少過(guò)程變異Continuouslyreducetheprocessvariability.4.3.4對(duì)新設(shè)備，關(guān)鍵物料，設(shè)計(jì)變更過(guò)程與工藝工程師一起，執(zhí)行過(guò)程能力研究(在新產(chǎn)品檢驗(yàn)過(guò)程中與CQE,FA一起)；Performprocesscapabilitystudyfornewprocesses(togetherwithCQE,FAduringFirstArticleinspection),newequipmentandmajormaterialordesignchangestogetherwiththetechnical/industryengineers.4.3.5建立過(guò)程能力Establishprocesscapability.4.4.QCSupervisor4.4.1了解統(tǒng)計(jì)過(guò)程概念，原理和統(tǒng)計(jì)技術(shù)UnderstandSPCconcept,methodologyandstatisticaltechniques.UsethedataontheSPCchartforprocessimprovementactivities.4.4.3收集和提交完整的SPC控制圖給PQE，以持續(xù)改進(jìn)CollectandsubmitcompletedchartstoPQEforcontinuousimprovement.4.4.4確保正確的和整理的記錄，測(cè)繪和文件化統(tǒng)計(jì)過(guò)程統(tǒng)計(jì)圖(媒體形式)Ensurecorrectandtidyrecords,plottinganddocumentationofSPCcharts(insoftcopies).4.4.5確保失控下的糾正措施。確保文件化糾正措施與SPC平臺(tái)的聯(lián)系Ensurecorrectiveactionsaretakenonalltheout-of-controlconditions.Ensure&documentallcorrectiveactionsatthe“cause&actions”sectionoftheSPCsoftware.4.4.6執(zhí)行每日的評(píng)審和分析(與PQE，如必要)，在調(diào)整過(guò)程前，確定失控是由偶因或異因造成Conductdailyreviewandanalyze(togetherwithPQEifnecessary)whetheroutliersarechanceorassignablebeforeadjustingtheprocess(inordertoavoidprocesstampering).4.4.7識(shí)別過(guò)程問(wèn)題，過(guò)程變異的根本原因，及過(guò)程改進(jìn)的能力。Identifytherootcausesofprocessproblem&processvariationforprocesscontrolandalsoprocesscapabilityimprovement.4.4.8如果有任何失控不能被解決時(shí)，提出停機(jī)要求(通過(guò)生產(chǎn)主管和經(jīng)理，及質(zhì)量經(jīng)理批準(zhǔn))。Requestforequipment/machinestop(ApprovedbyProductionSuperintendent/Manager,andQualityManager)ifthereisanyout-of-controlconditionsshownontheSPCchartthatcan’tberesolved.4.5.QC領(lǐng)班／QC檢驗(yàn)員QCLeader/QCInspector4.5.1接受SPC培訓(xùn)ReceiveSPCtraining.4.5.2監(jiān)視指定過(guò)程Monitortheprocessesasassigned.4.5.3數(shù)據(jù)輸入和繪制SPC圖DataentryduringmeasurementandplotdataonSPCchart(SPCSoftware)4.5.4在數(shù)據(jù)被記錄在SPC軟件后，立即評(píng)審和分析控制圖，確保無(wú)失控情形，規(guī)則如附件;Reviewandanalyzethecontrolchartsimmediatelyafterthedataareplottedtoensureno‘outofcontrol’situationbasedonSPCrulesactivated,refertheannex;InformQCSupervisor/PQE/ProductionSuperintendentonallout-of-controlconditions.4.5.6文件化失控發(fā)現(xiàn)和糾正措施在SPC軟件中。DocumentanyoutofcontrolfindingsandcorrectiveactionsontheunnaturalpatternintotheSPCsoftware.5.Procedure程序:被ThefollowingStatistical/SixSigmaToolsshallbeutilizedwhereapplicableintheprocessofqualification,characterization,andmodificationofproduct,process,equipmentandmaterials,butnotlimit:5.1.1相關(guān)統(tǒng)計(jì)圖表DescriptiveStatistics(中位數(shù)Median,柱狀圖Histogram,箱線圖Dot/BoxPlot).5.1.2正態(tài)性測(cè)試NormalityTest.5.1.3能力研究CapabilityStudy1(Sixpackplot).5.1.4過(guò)程圖ProcessMapping.5.1.5柏拉圖ParetoChart.5.1.6魚(yú)骨圖FishboneDiagram.5.1.7失效模式影響分析FMEA.5.1.8測(cè)量系統(tǒng)分析MSA(GR&R1–CrossedGRR)study.5.1.9測(cè)量系統(tǒng)分析MSA(GR&R2–NestedGRR)study.5.1.10離散圖ScatterPlot.5.1.11親和圖Correlation.5.1.12統(tǒng)計(jì)過(guò)程控制圖SPCcharts(VariableandAttributecharts)CQEshallidentifytheSPCoperationsinprocesslocationsasfollows:5.2.1首件報(bào)告，生產(chǎn)批準(zhǔn)過(guò)程FirstArticle(FA),ProductionApprovalprocess5.2.2過(guò)程質(zhì)量控制In-processQC.5.2.3出貨／批量接收測(cè)試Outgoing/LotAcceptanceTest(LAT).5.2.4DPPM改進(jìn)計(jì)劃，持續(xù)改進(jìn)項(xiàng)目DPPMImprovementPlans,ContinuousImprovementProjects.5.2.5糾正預(yù)防措施CorrectiveandPreventiveAction.5.2.6制造設(shè)計(jì)和修改DesignforManufacturing(DFM)/Debugging.5.3.CQE確定過(guò)程關(guān)鍵參數(shù)和特性CQEidentifyprocesscriticalparametersandcharacteristics:5.3.1CQE需要依據(jù)客戶(hù)要求和內(nèi)部控制要求，確定過(guò)程／產(chǎn)品的關(guān)鍵參數(shù)和特性包括需要控制CQEshallidentifytheprocess/productkeyparametersandcharacteristicsincludingdimensionsforthepurposeofcontrolaccordingtocustomerrequirementsandforinternalcontrolpurposes.5.3.2關(guān)鍵參數(shù)或尺寸的選擇依據(jù)下面要求：Theselectioncriteriaofkeyparametersordimensionsshallberelatedwith:客戶(hù)關(guān)鍵特性尺寸Customercriticalorcharacteristicdimensions.需要控制的過(guò)程性能尺寸Controlledprocesscapabilitydimension.客戶(hù)其他補(bǔ)充要求Customerothercomplementarilyrequest產(chǎn)品可靠性，如果有Reliabilitytestofproductifapplicable.5.4.質(zhì)量控制團(tuán)隊(duì)將對(duì)關(guān)鍵參數(shù)和尺寸執(zhí)行統(tǒng)計(jì)過(guò)程控制。它們是檢驗(yàn)計(jì)劃的一部分TheQualityControlteamshallimplementstatisticalprocesscontrolonallthekeyparametersanddimensionsbeingidentified.ThisshallbeupdatedintothepartGeneralInspectionPlan.5.5.過(guò)程控制工程師和質(zhì)量控制團(tuán)隊(duì)對(duì)關(guān)鍵參數(shù)和尺寸執(zhí)行計(jì)數(shù)型控制圖，計(jì)量型控制圖PQEandqualitycontrolteamshallimplementeither(notlimitedtoonlyone)variablecontrolchart,attributecontrolchart(ifapplicable)onkeyparametersanddimensions.5.6.計(jì)數(shù)型和計(jì)量型控制圖的應(yīng)用(參考附件A)Belowtableshallbeusedtodeterminethecorrectselectionoftheattributeandvariablecontrolcharts.(RefertoappendixA)應(yīng)應(yīng)用場(chǎng)合Applicationintensity,pure,time,shrinkrate,andetc.Samplesizeis2to10.范圍同上，樣本量≥11的場(chǎng)合使用Sameasabove,samplesizeis≥11控制圖ControlChart均值-極差X-R均值-標(biāo)準(zhǔn)差X-s分布Distribution正態(tài)分布Normaldistribution(計(jì)量值)sizeshallbeoddnumber全檢自動(dòng)化測(cè)量的場(chǎng)合，取樣費(fèi)時(shí)、昂貴的場(chǎng)合--流體，液體Measurecouldbeautomatic,highcostortime–liquidetc.測(cè)量樣本組內(nèi)單位不合格率Measurestheproportionofdefectiveunitsinasubgroup.樣本大小可以固定或變化Thesubgroupsizecanbeconstantorvariable測(cè)量樣本組內(nèi)不合格數(shù)Measuresthenumberofdefectiveitemsinasubgroup.樣本大小固定Requiresaconstantsubgroupsize.測(cè)量樣品中的不合格數(shù)Measuresthenumberofdefectsperunitofproduct(DPU).樣本大小固定或變化Thesubgroupsizecanbeconstantorvariable.測(cè)量樣本中的不合格數(shù)，樣本可以是一個(gè)單位的產(chǎn)品Measuresthetotalnumberofdefectsinasubgroup–thesubgroupsizecanbe1unitofproductifweexpecttohavearelativelylargenumberofdefects/unit.樣本大小固定Requiresaconstantsubgroupsize.Me-R單值-移動(dòng)極差X-Rs不合格品率Pchart不合格品數(shù)npchart單位不合格品數(shù)Uchart不合格數(shù)Cchart二項(xiàng)分布Binomialdistribution(計(jì)件值)泊松分布Poissondistribution(計(jì)點(diǎn)值)Oncetheabovedecisionshavebeenset,thePQEshallusethelistedguidelinesforplottingandimplementingthecontrolchart(refertoappendixB):5.7.1采樣準(zhǔn)備Preparationofsampling:確定數(shù)據(jù)收集的合理樣本組大小，周期，平均采樣時(shí)間段IdentifysamplesizeandfrequencyofdatacollectionbystatisticallycalculatingtherationalsubgroupsizeanddeterminingtheAverageRunLength5.7.2數(shù)據(jù)收集Datacollection:指定收集責(zé)任。只有有資格的人員才能輸入數(shù)據(jù)到SPC表格中Assignresponsibilityfordatacollection.OnlycertifiedpersonnelwillbeallowedtoinputdateinSPCfile由SPC表格計(jì)算相關(guān)統(tǒng)計(jì)量：均值，極差，分布，等LettheSPCfilecalculatetherelevantstatistics:mean,range,proportion,etc.5.7.3建立控制圖Constructthecontrolchart:通過(guò)足夠的數(shù)據(jù)，計(jì)算試生產(chǎn)的數(shù)據(jù)中心線和控制限。最少為25組。Calculatethetrialcenterlineandthetrialcontrollimitsfromcollecteddataofsufficientsubgrouppoints.Minimum25groups.由SPC表格繪出過(guò)程的試驗(yàn)性中心線，試驗(yàn)性控制限和圖表LettheSPCfileplotthetrialcenterline,trialcontrollimitsandchart5.7.4分析和解釋Analysis&interpretation:調(diào)查控制圖中失控的點(diǎn)和異常情形Investigatethechartforanyoutofcontrolpointsorabnormalsituation排除失控點(diǎn)，如必要。使用下一組數(shù)據(jù)替換異常的點(diǎn)或失控的點(diǎn)。(這里的工作是為了在試生產(chǎn)過(guò)程時(shí)，確定初步控制限時(shí)采用)Eliminateout-of-controlpointsifnecessary(Thisisforthetrialorstartingperiodonlywhendeterminingtheinitialcontrollimits).Replacetheoutofcontrolpointswithnextcollecteddataandrecalculatethetrialcontrollimits.確定長(zhǎng)期過(guò)程能力。推薦關(guān)鍵參數(shù)或尺寸Cpk≥1.33。Determinelongtermprocesscapabilityfromthedata.Cpk≥1.33isencouragedandshouldbetheaimforthekeyparameterordimension.5.7.5一旦試生產(chǎn)數(shù)據(jù)的控制限確定，使用他作為過(guò)程監(jiān)視的工具：Oncethetrialcontrollimitsareset,usethecontrolchartasaprocessmonitoringtool:使用文件持續(xù)收集并繪制控制圖ContinuedatacollectionandplottingofcontrolchartusingtheSPCfile.確定控制圖失控情形，并采取糾正措施。參考5.8Identifyout-of-controlsituationsandtakecorrectiveaction.Refertosection.5.3當(dāng)5.11中描述的情形發(fā)生時(shí)，新的中心線和控制限需要被重算Ifsituationwhichhadbeendescribedinsection5.11hasoccurred,recalculatethenewcenterlineandcontrollimits.5.8.一旦控制被執(zhí)行，控制圖如果有任何模式的異常，下面的工作必須采?。篛ncethecontrolchartshavebeenimplemented,thefollowingactionsmustbetakenifthereisanynon-random(unnatural)patternshownonSPCcharts:QC主管和相關(guān)生產(chǎn)主管。IPQCshallinformPQE,QCsupervisorandrelevantProductionsupervisoronthefindingsofnon-randompatternsandoutofcontroltriggeringbytheSPCsoftware(appendixC).5.8.2PQC，QC主管應(yīng)當(dāng)負(fù)責(zé)，與生產(chǎn)主管及其他相關(guān)人員一起，通過(guò)根本原因分析，對(duì)其采取糾正措施，并文件化這個(gè)過(guò)程。PQEandQCsupervisorshallrespondtothenon-randompatternthroughinvestigationandrequestingforappropriatecorrectiveactionsfromrelevantpersonnelandthendocumentthefindingsofrootcause,changes,anyabnormalityandcorrectiveactionsintotheSPCsoftware.5.8.3PQC，QC主管依據(jù)“附件C”作為一個(gè)執(zhí)行調(diào)查異常的指導(dǎo)。ThePQE,QCsupervisorshalluse“AppendixC”asaguidetointerpretthenon-randompatternsandperforminvestigation.5.8.4如果嚴(yán)重失控(尺寸，功能，可靠性，安全)，生產(chǎn)部應(yīng)當(dāng)停止生產(chǎn)，由質(zhì)量部經(jīng)理和生產(chǎn)部經(jīng)理批準(zhǔn)(有爭(zhēng)議時(shí)，由總經(jīng)理／運(yùn)營(yíng)經(jīng)理批準(zhǔn))。調(diào)查，根本原因需要確定和分析。只有當(dāng)問(wèn)題被糾正后生產(chǎn)才可以繼續(xù)。Theproductionshallbeshutdown/stoppedifthereisseriousoutofcontrolsituation(size,function,reliability,safety)afternotifyingandobtainingapprovalfromtheQMandProductionManager(GM/OMapprovalifdisputation).Investigationshallbecarriedoutandtherootcauseshallbeidentifiedandanalyzed.Theproductionshallberesumedonlyaftertheproblemhasbeenrectified.5.9.失控和異常模式需要糾正措施。Out-of-controlconditionandnon-randompatternrequiringcorrectiveactionsareasperRules.5.10.應(yīng)用全部或任意一個(gè)規(guī)則，由項(xiàng)目小組與客戶(hù)協(xié)商后確定。TheapplicationofanyoralloftheaboverulesistobedecidedbyProgramteamandcanbeonacasebycasebasisoraspercustomerrequirement.滿足客戶(hù)要求。Propercontrolontherevisionofstatisticalcontrollimits.Shorteningofsamplinginterval/oradditionofzonerulesshallbedonetoensurecustomerrequirementsaremet.PQESPC任何確定的控制限的變更，需要迅速升級(jí)相關(guān)控制圖ThePQEreviewsthedataandthecontrollimitsinSPCchartonamonthlybasis.Anychangeincontrollimitsasdecidedduringthisreviewshallbepromptlyupdatedintotherelevantcontrolcharts.5.11.2可能引起統(tǒng)計(jì)控制限的變更的情況(如適用，由PQE決定)Achangeofstatisticalcontrollimitmayberequired(ifapplicable,asdecidedbytheSPCprojectteam)ifthereis:設(shè)備變更(如設(shè)備重大維修，搬遷)Machinechange(e.g.Majoroverhaul,re-location).模具變更(如重大維修)Toolingchange(e.g.Majoroverhaul).Adjustmentininputparameter).收入材料變更(如供應(yīng)商變更)Incomingmaterialchange(e.g.Changeofsupplier).applicable(e.g.Mayaffectinputparameter).5.12.當(dāng)有嚴(yán)重的過(guò)程變異，可能影響出貨中斷，不合格品出貨至客戶(hù)，質(zhì)量經(jīng)理需要依據(jù)CPQP作。Whentherearesevereprocessdeviations,whichwillresultindeliverystoppage,orbadpartsescapingtoCustomers,QAManagershallfollowCP-QP-8.3-1NonconformingControlprocedureandarrangerelevantwork..PQEshallensureproperSPCdataretentionsystem.5.13.1全部控制圖，糾正措施電子數(shù)據(jù)，每月匯總的電子數(shù)據(jù)應(yīng)當(dāng)保存在電腦中并備份。Allthecontrolcharts,correctiveactionspreadsheet,andmonthlysummaryspreadsheetshallbesavedandfiledproperintheSPCcomputerwithbackupdisk.5.13.2全部控制圖，應(yīng)當(dāng)依據(jù)CP-QP-4.2.4-1《質(zhì)量記錄管理程序》的要求保持。AllcontrolchartsshallbefiledaccordingwiththedemandsinCP-QP-4.2.4-1<QualityRecordmanagementprocedure>.5.14.評(píng)審過(guò)程流程圖Reviewingoftheprocessflow:5.14.1PQE應(yīng)當(dāng)對(duì)當(dāng)前生產(chǎn)過(guò)程進(jìn)行評(píng)審；PQEshallreviewthecurrentprocessflowpracticedatthemanufacturingfloor.5.14.2他們需要排除加工或過(guò)程監(jiān)視中，不增值的部分，通過(guò)FMEA／過(guò)程流程圖，過(guò)程控制圖或?qū)嶒?yàn)設(shè)計(jì)的分析。必要時(shí)通過(guò)客戶(hù)批準(zhǔn)。Theyshalleliminatenon-valueaddedprocessesorprocessmonitors,throughanalysisoftheFMEA/processmapping,processcontrolchart,ordesignofexperiments.Getcustomerapprovalifnecessary.5.15.研究和利用現(xiàn)有的過(guò)程數(shù)據(jù)以建立穩(wěn)定的過(guò)程和能力：Studyingandutilizingtheexistingprocesscontroldatatoestablishtheprocessstabilityandprocesscapability:5.15.1PQE應(yīng)當(dāng)統(tǒng)計(jì)地分析當(dāng)前現(xiàn)有的過(guò)程控制數(shù)據(jù)PQEshallstatisticallyanalyzetheexistingprocesscontroldata.5.15.2他們需要確定過(guò)程常態(tài)和減少過(guò)程變異Theyshallidentifythenormalityofprocessandreducetheprocessvariability.5.15.3控制圖上過(guò)程參數(shù)或尺寸的Cpk需要周期性計(jì)算(最小25組數(shù)據(jù))Cpkoftheparameterordimensionplottedoncontrolchartsshallbecalculatedperiodically(fromsufficientdatapointsofminimum25points).5.15.4如果CPK＜1.33，PQE需要制定計(jì)劃和指定人員以改進(jìn)過(guò)程和能力，使用5.1中提到IftheCPK＜1.33,PQEmustgenerateplansandassigntaskforcetoimprovetheprocessandcapabilityusingtheStatistical/SixSigmaToolsmentionedinsection5.5證明，描述和變更源需要被調(diào)查和解決，并滿足客戶(hù)CPK要求。Identification,characterizationandsourceofvariationsshallbeinvestigatedandresolvedwiththegoalofmeetingcustomerCPKrequirements.5.16.執(zhí)行周期性的審核Performperiodicaudits.5.16.1內(nèi)審小組需要對(duì)SPC的執(zhí)行進(jìn)行每年審核,可包括在內(nèi)審活動(dòng)中.InternalAuditteamshallperformauditsonproperSPCimplementationannually.Couldbeinvolvedinternalauditactivities.5.16.2全部的審核結(jié)果必須文件化和分析Alltheauditresultsmustbedocumentedandanalyzed.5.16.3內(nèi)審小組應(yīng)當(dāng)及時(shí)評(píng)審糾正措施的結(jié)果InternalAuditorreviewstheresultsoftheseauditsandtakesappropriatecorrectiveactionswithoutunduedelaytoaddressallthefindingsfromtheaudit.5.17.為確保全部人員執(zhí)行SPC，需要進(jìn)行SPC培訓(xùn)和認(rèn)證ToensureadequatecompetencyofallpersonneldealingwithSPC,structuralSPCtrainingandcertificationprogramshallbeconducted.5.17.1質(zhì)量經(jīng)理應(yīng)當(dāng)對(duì)各層員工，每年策劃培訓(xùn)的需求和預(yù)算計(jì)劃QMshallmeetyearlytoplanthedetailedtrainingandbudgetplansforalllevelsofstaffinvolvedinSPC.5.17.2質(zhì)量經(jīng)理需要對(duì)QA的重要人員，每年策劃SPC培訓(xùn)和認(rèn)證，確保100%覆蓋QMshallplantheyearlySPCtrainingandcertificationfortheQAsupervisor,leadersandinspectors.5.17.3質(zhì)量經(jīng)理與總部QA應(yīng)當(dāng)完善SPC培訓(xùn)材料和測(cè)試材料；SitePQEandCorpQAshallplananddevelopthein-houseSPCtrainingandcertificationmaterials.5.17.4質(zhì)量經(jīng)理應(yīng)當(dāng)執(zhí)行培訓(xùn)和測(cè)試QA各級(jí)重要人員；QMshallconductthetrainingandtesttheQAleadersandinspectorsaccordingtoth