11QP-0015不合格控制程序

Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3Page:1/7Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3Page:1/7不合格控制程序不合格控制程序Unqualifiedcontrolprogram版本：B3HISTORY:RevisionReleasedatePreparedByDescriptionofChangesA02005/5/20Tom首次發(fā)行A12006/10/26Sandra格式變更A22008/09/08Tom修改部分內(nèi)容B02009/04/01TangXiaojin格式變更&內(nèi)容重新修改B12010/01/08TangXiaojin更換原材料不合格處理表B22010/07/29TangXiaojin4.4.1A中明確原材料讓步接收的判定人B32010/12/24TangXiaojin明確4.4.4超保質(zhì)期產(chǎn)品的處理Approvedby:江濤Reviewedby:呂艷杰Preparedby:MayXuDate:2010.12.24Date: 2010.12.24Date2010.12.24

Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3 Page：2/7Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3 Page：2/7不合格控制程序1、目的1,Purpose對(duì)不合格產(chǎn)品進(jìn)行識(shí)別和控制，防止不合格品流入生產(chǎn)和下道工序及交付顧客。TOidentifyandcontroltheunqualifiedproducts,aswelltopreventnonconformingproductsintoproductionandthenextworkingprocedureandbeingdeliveredtocustomers2、適用范圍Applicability本程序適用于原材料、半成品、成品及交付后的產(chǎn)品發(fā)生的不合格的控制的規(guī)定，同時(shí)適用要求。Thisprocedureisapplicabletotheregulationcontroloftheunqualifiedoftherawmaterials,semi-finishedproducts,finishedproductsandafter-deliveryproducts,aswellapplicabletothe3crequirement.3、職責(zé)Responsibility質(zhì)管部負(fù)責(zé)不合格品識(shí)別，并跟蹤不合格品的處理結(jié)果，采取糾正措施；Qualitycontroldepartmentisresponsiblefornonconformingproductidentification,andtrackingthehandlingresultsofunqualifiedproductsandtakingcorrectivemeasures;質(zhì)管部、研發(fā)部、采購(gòu)部、銷售部負(fù)責(zé)在各自職責(zé)范圍內(nèi)對(duì)不合格品做處理決定；Thequalitycontroldepartment,R&Ddepartment,purchasingdepartmentandsalesdepartmentareresponsibleforhandlingtheunqualifiedproductswithintheirrespectiveduties;倉(cāng)庫(kù)、車間負(fù)責(zé)對(duì)不合格品的標(biāo)識(shí)、隔離；Warehouseandworkshopareresponsiblefortheidentificationandquarantineofnonconformingproduct4、程序

Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3 Page:3/7盒Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3 Page:3/7不合格控制程序Procedure流程圖flowchart詳細(xì)描述detaileddescription責(zé)任部門Responsibleby原材料檢驗(yàn)發(fā)現(xiàn)的不合格品；nonconformingproductfoundbyRawmaterialinspection;生產(chǎn)過(guò)程中出現(xiàn)的不合格品；Nonconformingproductoccurredduringtheproductionprocess;產(chǎn)品交付后，客戶使用過(guò)程中的不合格品；Nonconformingproductappearedwhencustomersuseafterproductdelivery,儲(chǔ)存過(guò)程中產(chǎn)品超過(guò)保質(zhì)期限引起的不合格品；QC車間workshop銷售sales倉(cāng)庫(kù)warehouse技術(shù)部、QC4.1來(lái)源SourceI4.2分類jassiucation4.3標(biāo)識(shí)及隔離Identificationandquarantine1rnonconformingproductcausedbyexpirationofstorage;4.1.53c產(chǎn)品型式檢驗(yàn)過(guò)程中發(fā)生的不合格品；nonconformingproductfoundin3cproducttypetestTechnicalDept)r嚴(yán)重不合格：直接影響產(chǎn)品質(zhì)量、主要功能及技術(shù)性能等的不合格情況；Seriousunqualified:unqualifiedconditionsdirectlyimpactonproductquality,mainfunctionsandtechnicalperformance;一般不合格：個(gè)別或者少量檢測(cè)項(xiàng)目不達(dá)標(biāo)，但是不影響產(chǎn)品質(zhì)量的不合格情況；Generalunqualified:individualorfewtestprograms,arenotuptostandard,butdoesnotaffecttheunqualified;研發(fā)部R&D4.3在發(fā)現(xiàn)原材料、半成品、成品中的不合格品后，倉(cāng)庫(kù)或生產(chǎn)車間應(yīng)立即將其拉出，做明確標(biāo)識(shí)(加貼不合格標(biāo)簽)，然后放入不合格品區(qū)進(jìn)行隔離，并做好相關(guān)記錄；Oncethenonconformingrawmaterialsfoundamongsemi-finishedproductsandfinishedproducts,thewarehouseorworkshopshouldimmediatelydrawitbackandmakeclearidentification(labeledwithunqualifiedlabel),andthenputintothenon-conformingproductareainisolation,anddorelevantrecords;倉(cāng)庫(kù)或生產(chǎn)車間Warehouseandworkshop4.4.1QC在確定原料不合格品后，報(bào)部門主管先進(jìn)行評(píng)審；AfterQCdeterminethematerialnonconforming,reporttothedepartmentmanagertoreview;A、對(duì)于一般不合格品，可作讓步接收處理的，各部門填寫(xiě)完成《原料檢驗(yàn)不合格處理聯(lián)絡(luò)票》后，由QA負(fù)責(zé)人判定，并簽字，然后通知倉(cāng)庫(kù)收貨，記錄存檔；品質(zhì)部QC車間workshop倉(cāng)庫(kù)warehouse研發(fā)部

Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3Page：4/7Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3Page：4/7不合格控制程序Forgeneralnonconformingproduct,concessionscouldbemade. R&Dalldepartmentfirstfilledintheformofrawmaterial 銷售inspectionunqualifiedprocessingcontactticket,thenQA salesmanagerdecideandsign,finallynotifythewarehousereceivingandrecording;B、對(duì)嚴(yán)重不合格品，各部門填寫(xiě)《原料檢驗(yàn)不合格處理聯(lián)絡(luò)票》，通知倉(cāng)庫(kù)拒收，采購(gòu)?fù)?yīng)商聯(lián)系退貨，請(qǐng)其按《供應(yīng)商材料不良改善通知書(shū)》提交原因分析及糾正預(yù)防措施；Forseriousnon-conformingproducts,eachdepartmentfillinthetheformofrawmaterialinspectionunqualifiedprocessingcontactticket,theninformwarehouseofrejecting,ofcontactingwithsupplierstoreturn,andsubmitthereasonandanalysistogetherwithcorrectiveandpreventiveactionsaccordingtothenoticeofsuppliermaterialbadlyimprove;流程圖flowchart 詳細(xì)描述 責(zé)任部門detaileddescriptionResponsibleby4.4評(píng)審及處置Reviewanddisposition4.4.2在確認(rèn)生產(chǎn)過(guò)程中的半成品、成品不合格后，QC相關(guān)部門先進(jìn)行判定能夠進(jìn)行調(diào)整；Uponconfirmationofthesemi-finishedproducts,finishedproductisunqualifiedintheprocessofproduction,QCdeterminetowhetheradjustornot;4.4.2.1對(duì)于能調(diào)整的，將調(diào)整物料名稱、批號(hào)、數(shù)量記錄與生產(chǎn)單相應(yīng)欄，生產(chǎn)人員根據(jù)記錄直接進(jìn)行返工，調(diào)整后的產(chǎn)品再進(jìn)行重新檢測(cè)，合格后按正常程序入庫(kù)；如仍然不合格，交由技術(shù)部門作出處理決定(讓步放行、返工、報(bào)廢)，QC將相關(guān)記錄發(fā)至生產(chǎn)車間及倉(cāng)庫(kù)進(jìn)行相應(yīng)的處理；Forthatcanbeadjusted,recordthematerialname,batchnumber,quantityaccordinglywithproductionsinglebar,andthenproductionpersonneldirectlyredoaccordingtotherecord,andtheproductaftertheadjustmentcanbetestedagain.Ifqualified,putintowarehousingaccordingtonormalprocess;Ifstill,thetechnicaldepartmentdealwiththeproduction(givenconcessions,rework,scrap)andQCwillgivetherelativerecordcorrespondingtotheprocessingproductionworkshopandwarehouse;讓步接收Concessionandreceive退換貨Returnandchange返工reworkJ報(bào)廢scraPe讓步放行Concessionandrelease

Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3Page：5/7Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3Page：5/7不合格控制程序A、讓步放行：技術(shù)部在生產(chǎn)單的不合格檢測(cè)項(xiàng)目處和《不合格品報(bào)告》的相應(yīng)欄簽字批準(zhǔn)后方可放行，必要時(shí)征得客戶認(rèn)可(如現(xiàn)場(chǎng)調(diào)色)，QC保存相關(guān)記錄，以待追蹤；Concedeandrelease:technicalDeptsignedundersingleunqualifieddetectionprojectintheproductionsheetandthecorrespondingcolumnofthenonconformingreportandthencouldbereleased,Ifnecessary,customerconsent(suchasspotcolor)andQCkeeprelevantrecordsfortracking;B、返工：由生產(chǎn)部執(zhí)行，返工的產(chǎn)品重新檢測(cè)，填寫(xiě)相應(yīng)的檢驗(yàn)記錄，復(fù)檢仍不合格時(shí)，填寫(xiě)《不合格品報(bào)告》，化學(xué)師簽字后，通知倉(cāng)庫(kù)標(biāo)識(shí)并放入不合格品區(qū)，QC保存相關(guān)記錄；Rework:performedbytheproductiondepartment,detectreworkproducts,fillinthecorrespondinginspectionrecords,whenthere-inspectionisnotqualified,fillinthenonconformingreport,signedbythechemistryteacher,informwarehouselogoandputintothenon-conformingproductareaandthenQCkeeprelevantrecords;C、報(bào)廢：技術(shù)部寫(xiě)明原因，生產(chǎn)部填寫(xiě)《報(bào)廢單》，倉(cāng)庫(kù)將其放置廢品去，由組織統(tǒng)一處理；Scrap:technicalDeptgivereasons,theproductiondepartmentfillinthescrapformandputitintowarehouse,waitingfororganizationunifiedhandling;4.4.2.2對(duì)于一開(kāi)始就不能進(jìn)行調(diào)整的產(chǎn)品，QC直接填寫(xiě)《不合格品報(bào)告》交由技術(shù)部處理,將相關(guān)記錄存檔。Forthatcanbeadjusted,QCdirectlyfillinthenonconformingreportandhandittothetechnicalforprocessingandrecordinge.4.4.3交付后開(kāi)始使用過(guò)程中發(fā)現(xiàn)的不合格品，按照《客戶投訴流程》進(jìn)行處理，品質(zhì)部確認(rèn)為不合格品后，除執(zhí)行4.4.2條款規(guī)定外，品質(zhì)部采取相應(yīng)的糾正和預(yù)防措施，執(zhí)行《糾正和預(yù)防措施控制程序》有關(guān)規(guī)定，銷售部按《顧客滿意度控制程序》進(jìn)行處理，以滿足顧客正當(dāng)要求。Nonconformingproductfoundintheprocessofuseafterdelivery,processingaccordingtotheprocessofthecustomercomplaintsprocedure,qualitydepartmentidentifiedasnonconformingproduct,exceptforimplementingtheprovisionsofclause4.4.2,qualitydepartmenttakecorrespondingcorrectiveandpreventivemeasures,executetherelevantprovisionsofthe"correctiveandpreventive

Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3 Page:6/7盒Doc.No:QP-02-015ReleaseDate:2010/12/24Rev:B3 Page:6/7不合格控制程序accordingtothe"customersatisfactioncontrolprocedurestosatisfycustomersasrequired.4.4.4儲(chǔ)存過(guò)程中超過(guò)保存期限的不合格品，倉(cāng)庫(kù)將其移出放入不合格品區(qū)，通知品質(zhì)部進(jìn)行重新檢測(cè)，填寫(xiě)檢測(cè)記錄；研發(fā)部根據(jù)檢測(cè)結(jié)果，判定是否能返工，不可返工的產(chǎn)品，倉(cāng)庫(kù)牽頭填寫(xiě)《報(bào)廢單》，加貼報(bào)廢標(biāo)識(shí)后放入報(bào)廢庫(kù)位，組織統(tǒng)一報(bào)廢。對(duì)于可以返工的產(chǎn)品，技術(shù)部出具返工方案，由技術(shù)/PC驗(yàn)證后，生產(chǎn)執(zhí)行返工，QC檢測(cè)返工后的產(chǎn)品，合格后方可包裝出貨。Nonconformingproductbeyondexpiration,wouldbemoveintothenonconformingareainwarehouse,informthequalitydepartmentforre-inspection,fillintestrecord;Researchanddevelopmentdepartmentcandeterminewhetherreworkaccordingtotheresults;warehousefillinthescrapformandlabelwithdiscardedlogo,handedtoorganizationunifiedscrap.Forreworkproducts,technicalDeptissuethereworksolutionafterverificationbythetechnical/PC,performreworkproduction,QCinspectionthereworkproducts,tobequalifiedandpackaged.4.5品質(zhì)部負(fù)責(zé)每月對(duì)不良品進(jìn)行統(tǒng)計(jì)組織相關(guān)部門進(jìn)行原因分析并制定糾正和預(yù)防措施技術(shù)部負(fù)責(zé)提出不良品的處理措施，PC驗(yàn)證處理措施的有效性，生產(chǎn)部B負(fù)責(zé)執(zhí)行。品質(zhì)部跟進(jìn)糾正和預(yù)防措施的執(zhí)行。Qualitydepartmentisresponsibleformonthlystatisticsofdefectiveproduct,organizerelevantdepartmentsanalysisreasonsandmapoutcorrectiveandpreventiveactions,technicaldepartmentisresponsiblefornon-conformingprocessingmeasures,PCvalidatestheef