捷普供應(yīng)商審核表+自評回復(fù)范本OSA for plastics parts

GeneralOn-SiteAssessmentQuestionnaire一般現(xiàn)場評估問卷,,,,,,

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Section1-QualitySystem,,第1部分-質(zhì)量體系,,,,

"Question

Number",Element,Question/Requirement,RatingCriteria,ProbationalMinimumScore,AcceptableMinimumScore,佐證

1,QualityObjective質(zhì)量目標(biāo),"1.1Arethequalityobjectivesestablished?

1.2Doesthequalityobjectivesincludeatleast:RTVDPMfromcustomer,CountofCustomerComplaint,PassYieldinProductionandRTVtosupplier?

1.3Isthereadefinedprocesstoreviewcustomers'qualitytargetexpectation?e.g.,customer'svendorRTVDPMtarget.

1.4Arethequalityobjectivesalignto(orhigherthan)customerexpectations?

1.5Arethequalityobjectivesreviewedbymanagement?

1.6Arethequalityobjectivescommunicatedbymanagementandunderstoodthroughouttheorganization.

1.7Aretheactualqualityperformancemeasuredandmeetcustomerandinternaltarget?Areaccordingcorrectiveactionsbeentakenifdidnotmeettarget?(meetatleastoneofthem)

1.8Doessupplierdriveforcontinuousimprovement?是否建立了質(zhì)量目標(biāo)?質(zhì)量目標(biāo)是否至少包括:RTV，顧客的DPM，顧客投訴數(shù)，生產(chǎn)合格率和供應(yīng)商的RTV?是否有明確的過程來評審顧客的質(zhì)量目標(biāo)期望?例如，客戶的供應(yīng)商RTVDPM目標(biāo)。質(zhì)量目標(biāo)是否符合(或高于)顧客期望?管理層是否對質(zhì)量目標(biāo)進行評審?質(zhì)量目標(biāo)是否由管理層傳達并在整個組織內(nèi)被理解?是否測量了實際的質(zhì)量績效并達到顧客和內(nèi)部目標(biāo)?如果沒有達到目標(biāo)，是否采取了相應(yīng)的糾正措施?(至少滿足其中之一)供應(yīng)商是否推動持續(xù)改進?","Score0-Donotmeetrequirement1.1.

Score1-Meetrequirement1.1.Butdonotmeetrequirement1.2and/or1.3and/or1.4and/or1.5and/or1.6and/or1.7.

Score2-Meetrequirement1.1,1.2,1.3,1.4,1.5,1.6and1.7.Butdonotmeetrequirement1.8.

Score3-Meetallrequirements.得分0-不符合要求1.1。得分1-滿足要求1.1。但不符合規(guī)定1.2及/或1.3及/或1.4及/或1.5及/或1.6及/或1.7。得分2-滿足要求1.1、1.2、1.3、1.4、1.5、1.6和1.7。但不符合要求1.8。得分3-滿足所有要求。",2,3,DCC-WI-005質(zhì)量目標(biāo)管理辦法

2,InternalAudit內(nèi)部審計,"2.1Isinternalauditplanestablished?

2.2Istheinternalauditactuallyconductedperthedefinedfrequency?

2.3Doessupplierdrivecorrectiveactionsforthenon-conformancefoundininternalaudit?

2.4Istheinternalauditreportandcorrectiveactionsreviewedbymanagement?

2.5Istheinternalauditconductedontime?2.1是否制定了內(nèi)部審核計劃?2.2內(nèi)部審核是否按照規(guī)定的頻率進行?供應(yīng)商是否對內(nèi)部審核中發(fā)現(xiàn)的不符合項采取糾正措施?管理層是否審核了內(nèi)部審核報告和糾正措施?2.5內(nèi)部審核是否按時進行?","Score0-Donotmeetrequirement2.1and/or2.2.

Score1-Meetrequirement2.1and2.2.Butdonotmeetrequirement2.3and/or2.4.

Score2-Meetrequirement2.1,2.2,2.3and2.4.Butdonotmeetrequirement2.5.

Score3-Meetallrequirements.得分0-不符合要求2.1和/或2.2。得分1-滿足要求2.1和2.2。但不符合第2.3及/或第2.4條規(guī)定。得分2-滿足要求2.1、2.2、2.3和2.4。但不符合要求2.5。得分3-滿足所有要求。",2,2,HH-QEP-04內(nèi)部審核管理程序

3,ConfidentialAgreement保密協(xié)議,"3.1Areconfidentialagreementssetupwithcustomers?

3.2Areconfidentialagreementssetupwithemployees?3.1是否與客戶訂立保密協(xié)議?3.2是否與員工訂立保密協(xié)議?","Score0-Donotmeetrequirement3.1and/or3.2.

Score3-Meetallrequirements0分-不符合3.1和/或3.2的要求。得分3-滿足所有要求。",3,3,有與客戶和員工簽署保密協(xié)議

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Section2-Facilities,,第2部分-設(shè)施,,,,

"Question

Number",Element,Question/Requirement,RatingCriteria,ProbationalMinimumScore,AcceptableMinimumScore,佐證

1,AccessControl訪問控制,"1.1Doessupplierhaveasystemforaccesscontrolofrestrictedarea?

1.2Areallhighriskareas'accesscontrolled,andarethecontroleffective?

1.3Areallmediumareas'accesscontrolled,andarethecontroleffective?

Notes:

a).Effectivemeansunauthorizedpersoncannotgetthroughtherestrictedaccess.

b).HighRiskAreaincludebutnotlimitedto:designanddevelopmentarea,prototype/NPIbuildarea,manufacturingworkfloor/warehousefortheproductswhichcustomerhavenotpubliclyreleased,etc.

c).MediumRiskAreaincludebutnotlimitedto:documentcontrolarea,manufacturingworkfloor/warehousefortheproductswhichcustomerhavepubliclyreleased,etc.供應(yīng)商是否有限制區(qū)域的進入控制系統(tǒng)?1.2是否對所有高風(fēng)險區(qū)域的出入進行了控制，控制是否有效?1.3所有媒介區(qū)域的出入是否受到控制，控制是否有效?注:a).有效是指未經(jīng)授權(quán)的人不能通過限制的訪問。b).高風(fēng)險區(qū)域包括但不限于:設(shè)計開發(fā)區(qū)域、原型/新產(chǎn)品導(dǎo)入構(gòu)建區(qū)域、客戶未公開放行產(chǎn)品的生產(chǎn)車間/倉庫等。c).中等風(fēng)險區(qū)域包括但不限于:文件控制區(qū)域、客戶已公開放行產(chǎn)品的生產(chǎn)車間/倉庫等。","Score0-Donotmeetrequirement1.1

Score1-Meetrequirement1.1.Butdonotmeetrequirement1.2.

Score2-Meetrequirement1.1,and1.2.Butdonotmeetrequirement1.3.

Score3-Meetallrequirements0分-不符合1.1分1分-符合1.1分。但不符合要求1.2。得分2-滿足要求1.1和1.2。但不符合要求1.3。得分3-滿足所有要求",2,3,C-TPAT-HH-022敏感或重點區(qū)域控制程序

2,Plantsizeandlinelayout工廠規(guī)模和生產(chǎn)線布局,"2.1Isthelinelayoutinthemostefficientwaytominimizethequalityriskinthetransportation?

2.2Istheplantofsufficientsizetolayallthemachine,conveyor,tooling,fixture,WIP,etc.orderly?2.1線路布局是否以最有效的方式將運輸中的質(zhì)量風(fēng)險降至最低?2.2工廠是否有足夠的規(guī)模擺放所有的機器，輸送機，工裝，夾具，在制品等?","Score0-Donotmeetrequirements2.1and2.2.

Score1-Meetrequirement2.2.Butdonotmeetrequirement2.1.

Score2-Meetrequirement2.1.Butdonotmeetrequirement2.2.

Score3-Meetallrequirements得分0-不符合要求2.1和2.2。得分1-滿足2.2要求。但不符合要求2.1。得分2-滿足要求2.1。但不符合2.2要求。得分3-滿足所有要求",2,2,工廠規(guī)模足夠充足，現(xiàn)場查看

3,5S,"3.1Sort:sortout&separatethatwhichisneeded¬neededintheproductionarea?

3.2Straighten:Arrangeitemsthatareneededsothattheyareready&easytouse.Clearlyidentifylocationsforallitemssothatanyonecanfindthem&returnthemoncethetaskiscompleted.

3.3Shine:Cleantheworkplace&equipmentonaregularbasisinordertomaintainstandards&identifydefects.

3.4Standardize:Revisitthefirstthreeofthe5SonafrequentbasisandconfirmtheconditionoftheGembausingstandardprocedures.

3.5Sustain:Keeptotherulestomaintainthestandard&continuetoimproveeveryday.3.1分類:對生產(chǎn)區(qū)域需要和不需要的進行分類和分類。3.2整理:整理需要的物品，使其準(zhǔn)備好并易于使用。清楚地確定所有物品的位置，以便任何人都可以找到它們并在任務(wù)完成后返回它們。3.3清潔:定期清潔工作場所和設(shè)備，以保持標(biāo)準(zhǔn)并發(fā)現(xiàn)缺陷。3.4標(biāo)準(zhǔn)化:經(jīng)常對5S的前三項進行復(fù)查，并按照標(biāo)準(zhǔn)程序確認(rèn)原葉的狀況。3.5持續(xù):遵守規(guī)則，保持標(biāo)準(zhǔn)，每天持續(xù)改進。","Score0-Donotmeetallrequirementsof3.1,3.2,and3.3.

Score1-Meetminimum1itemsof3.1or3.2or3.3.

Score2-Meetallrequirementsof3.1,3.2and3.3.Butdonotmeet3.4and/or3.5.

Score3-Meetallrequirements.得分0-不符合要求2.1和2.2。得分1-滿足2.2要求。但不符合要求2.1。得分2-滿足要求2.1。但不符合2.2要求。得分3-滿足所有要求",2,3,HH-QEP-08工作環(huán)境及6S管理程序

4,Environmentalcontrolformaterialandproductstorage物料和產(chǎn)品儲存的環(huán)境控制,"4.1Isthereanenvironmentcontrolsystemformaterialandproductstorage?

4.2Areallcriticalareascontrolled?

4.3Arethecontrolactivitiesimplementedallthetime.

4.4Arethecontrolrecordmaintained?

Notes:

a).Environmentcontrolactivitiesincludebutnotlimitedto:temperatureandhumiditycontrol,rain-proof,sunlight-proof,airventilation.

b).Criticalareameanstheareastoressensitivematerialsorproductswhichareeasytorust,deteriorate,ordegenerate.4.1是否有物料和產(chǎn)品儲存的環(huán)境控制系統(tǒng)?4.2所有關(guān)鍵區(qū)域是否得到控制?4.3控制活動是否一直在實施?4.4是否保持控制記錄?注:a).環(huán)境控制活動包括但不限于:溫濕度控制、防雨、防陽光、通風(fēng)。b).臨界區(qū)域是指存放易生銹、變質(zhì)或變質(zhì)的敏感材料或產(chǎn)品的區(qū)域。","Score0-Donotmeetrequirement4.1

Score1-Meetrequirement4.1.Butdonotmeetrequirement4.2.

Score2-Meetrequirements4.1and4.2.Butdonotmeetrequirement4.3and/or4.4.

Score3-Meetallrequirements.得分0-不符合要求2.1和2.2。得分1-滿足2.2要求。但不符合要求2.1。得分2-滿足要求2.1。但不符合2.2要求。得分3-滿足所有要求",2,3,HH-QEP-15產(chǎn)品搬運，儲存，包裝與防護管理程序

5,Documentprotectionanddatarecovery文件保護和數(shù)據(jù)恢復(fù),"5.1Aretheredocumentprotectionanddatabackupactivitiesinplaceforbothhardcopyandelectronicfiles?

5.2Aretheseactivitieseffective?

5.3Istheeffectivenessperiodicallyverified?

Notes:

a).Documentprotectionanddatabackupactivitiesincludebutnotlimitedto:hardcopyfilestoragerooms,passwordprotectedcomputer,passwordloginelectronicsystem,electronicfilesanddatabackupinserver,etc.5.1是否對硬拷貝文件和電子文件進行文件保護和數(shù)據(jù)備份?5.2這些活動是否有效?5.3是否定期驗證有效性?注:a).文件保護和數(shù)據(jù)備份活動包括但不限于:硬拷貝文件存儲室、密碼保護計算機、電子系統(tǒng)密碼登錄、服務(wù)器電子文件和數(shù)據(jù)備份等。","Score0-Donotmeetrequirement5.1.

Score1-Meetrequirement5.1.Butdonotmeetrequirement5.2

Score2-Meetrequirement5.1and5.2.Butdonotmeetrequirement5.3.

Score3-Meetallrequirements.得分0-不符合要求2.1和2.2。得分1-滿足2.2要求。但不符合要求2.1。得分2-滿足要求2.1。但不符合2.2要求。得分3-滿足所有要求",2,3,015-數(shù)據(jù)備份管理程序

6,Reliableutilitysource可靠的公用事業(yè)來源,"6.1Doesthesupplier'splanthasreliableutilitysourcestosupportcapacity,

6.2Doesthisutilitysourcewellmaintained?

Notes:Utilitysourcesincludebutnotlimitto:electricity,water,chemicals,etc.6.1供應(yīng)商的工廠是否有可靠的公用資源來支持產(chǎn)能，6.2該公用資源是否得到良好的維護?注:公用事業(yè)來源包括但不限于:電、水、化學(xué)品等。","Score0-Donotmeetrequirement6.1.

Score1-Meetrequirement6.1.Butdonotmeetrequirement6.2.

Score3-Meetallrequirements.得分0-不符合要求6.1。得分1-滿足要求6.1。但不符合6.2要求。得分3-滿足所有要求。",3,3,是

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Section3-DemandManagement第3部分-需求管理,,,,,,

"Question

Number",Element,Question/Requirement,RatingCriteria,ProbationalMinimumScore,AcceptableMinimumScore,佐證

1,Customerdemandmanagement客戶需求管理,"1.1Isthereacustomerdemandmanagementsysteminplace?

1.2Isthereaformalcommittingprocessforcustomerordersinplace?

1.3Istheplanningscheduleactuallyaligntothecommittingtocustomer?

1.4Isthereadefinedandexecutedprocesstonotifycustomersofanychangesinplanningandgetapprovalfromcustomer.1.1是否有客戶需求管理系統(tǒng)?客戶訂單是否有正式的提交流程?計劃進度是否與對客戶的承諾一致?是否有明確的和可執(zhí)行的流程來通知客戶計劃中的任何變更，并得到客戶的批準(zhǔn)。","Score0-Donotmeetrequirement1.1.

Score1-Meetrequirement1.1.Butdonotmeetrequirement1.2and/or1.3.

Score2-Meetrequirements1.1,1.2and1.3.Butdonotmeetrequirement1.4.

Score3-Meetallrequirements.得分0-不符合要求1.1。得分1-滿足要求1.1。但不符合要求1.2及/或1.3。得分2-滿足要求1.1,1.2和1.3。但不符合要求1.4。得分3-滿足所有要求。",2,3,HH-QEP-12訂單評審管理程序

2,Capacityplanningtools容量規(guī)劃工具,"2.1Isthereanytoolutilizedforcapacityplanning?

2.2Doesthecapacityplanningtoolincorporatebothlaborandequipment?

2.3Doesthecapacityplanningtakeintoaccounttheactualachievedcapacityandtheactualpassyield?2.1是否有工具用于容量規(guī)劃?2.2產(chǎn)能規(guī)劃工具是否包括人工和設(shè)備?2.3產(chǎn)能規(guī)劃是否考慮到實際達到的產(chǎn)能和實際合格率?","Score0-Donotmeetrequirement2.1.

Score1-Meetrequirement2.1.Butdonotmeetrequirement2.2.

Score2-Meetrequirements2.1and2.2.Butdonotmeetrequirement2.3.

Score3-Meetallrequirements.",2,3,HH-QEP-16生產(chǎn)計劃和交付管理程序

3,OTD(OnTimeDelivery)準(zhǔn)時交貨,"3.1IstheOTDtocustomerobjectivedefined?

3.2IstheOTDtocustomerobjectivealignto(orhigherthan)customerexpectations?

3.3IstheOTDtocustomerperformancemeasuredandmeetcustomerandinternaltarget?Areaccordingcorrectiveactionsbeentakenifdidnotmeettarget?(meetatleastoneofthem)

3.4Doessupplierdriveforcontinuousimprovement?3.1對顧客的OTD目標(biāo)是否有明確規(guī)定?對顧客目標(biāo)的OTD是否符合(或高于)顧客期望?3.3對顧客績效的OTD是否測量并達到顧客和內(nèi)部目標(biāo)?如果沒有達到目標(biāo)，是否采取了相應(yīng)的糾正措施?(至少滿足其中之一)供應(yīng)商是否推動持續(xù)改進?","Score0-Donotmeetrequirement3.1

Score1-Meetrequirement3.1.Butdonotmeetrequirement3.2and/or3.3

Score2-Meetrequirements3.1,3.2,and3.3Butdonotmeetrequirement3.4.

Score3-Meetallrequirements.",2,3,DCC-WI-005質(zhì)量目標(biāo)管理辦法

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Section4-APQP/NPI,,第4部分-APQP/NPI,,,,

"Question

Number",Element,Question/Requirement,RatingCriteria,ProbationalMinimumScore,AcceptableMinimumScore,

1,NPIprocess,"1.1.IsthereadocumentedprocesstoimplementengineeringreviewinNPIstage?

1.2.Isthereachecklistusedtoensuretheengineeringreviewprocessbeactuallycarriedout?

1.3.Doesthechecklistincludecustomergeneralrequirementsandspecificrequirements?

1.4.DoesthechecklistincludeproductrequirementsinmasterdrawingandGerberfile(PCB)?1.1.在新產(chǎn)品導(dǎo)入階段是否有實施工程評審的文件化流程?1.2.是否有檢查表用于確保工程評審過程的實際執(zhí)行?1.3.清單是否包括顧客的一般要求和特殊要求?1.4.檢查表是否包括主圖紙和Gerber文件(PCB)中的產(chǎn)品要求?","Score0.Donotmeetanyrequirementof1.1,1.2,1.3or1.4.

Score3.Meetingallrequirements.得分為0。不符合1.1、1.2、1.3或1.4的任何要求。分?jǐn)?shù)3。滿足所有要求。

",3,3,HH-QEP-11新產(chǎn)品開發(fā)管理程序

2,"Productqualificationprocess產(chǎn)品確認(rèn)過程

","2.1Isthereadocumentedproductqualificationprocedureinplace?

2.2Doestheproductqualificationtypealigntocustomerrequirements(i.e.,PPAPorFAIqualification?IfPPAPqualificationrequired,whichlevelPPAPexecuted?)

2.3Areproductqualificationcompletedbeforemassproduction?

2.4Aretheproductqualificationreportsapprovedbyauthorizedpeopleandcustomer.

2.5AretheproductqualificationcompletedmeetJabilrequirements(verifysomerealcasessuppliercompleted)?是否有文件化的產(chǎn)品確認(rèn)程序?產(chǎn)品確認(rèn)類型是否符合顧客要求(如PPAP或FAI確認(rèn))?如果PPAP需要確認(rèn)，執(zhí)行哪一級的PPAP?)2.3產(chǎn)品確認(rèn)是否在量產(chǎn)前完成?2.4產(chǎn)品合格報告是否經(jīng)授權(quán)人員和顧客批準(zhǔn)?2.5完成的產(chǎn)品確認(rèn)是否符合捷普公司的要求(驗證一些供應(yīng)商完成的真實案例)?

","Score0-Donotmeetrequirement2.1.

Score1-Meetrequirement2.1.Butdonotmeetrequirement2.2and/or2.3and/or2.4.Orfindmultiplecasesdonotmeetrequirement2.5.

Score2-Meetrequirement2.1,2.2,2.3and2.4,Butfindisolatedcasedonotmeetrequirement2.5.

Score3-Meetallrequirements.得分0-不符合要求2.1。得分1-符合要求2.1。但不符合規(guī)定2.2及/或2.3及/或2.4?；虬l(fā)現(xiàn)多個情況不符合要求2.5。得分2-滿足要求2.1、2.2、2.3和2.4，但發(fā)現(xiàn)個案不符合要求2.5。得分3-滿足所有要求。",2,3,HH-QEP-11新產(chǎn)品開發(fā)管理程序

3,Specialcharacteristicscontrol特殊特性控制,"3.1Isthereaprocessinplacetoidentifyandcontrolthespecialcharacteristics?

3.2Arespecialcharacteristicsidentifiedandcontrolledforallproducts?

Notes:

a).Specialcharacteristicsincludebutnotlimitedto:customerassignedcharacteristicsandproduct'scriticalcharacteristics.

b).1partnumbercountas1case.3.1是否有識別和控制特殊特性的程序?3.2是否對所有產(chǎn)品的特殊特性進行識別和控制?a).特殊特性包括但不限于:顧客指定的特性和產(chǎn)品的關(guān)鍵特性。B).1個零件號計1箱。","Score0-Donotmeetrequirement3.1.

Score1-Meetrequirement3.1.Butfindmultiplecasesdonotmeetrequirement3.2.

Score2-Meetrequirement3.1.Butfindisolatedcasedonotmeetrequirement3.2.

Score3-Meetallrequirements.",2,3,新產(chǎn)品試制試生產(chǎn)控制程序（工程）

4,MeasurableMetricsofNPIprocesseffectiveness新產(chǎn)品導(dǎo)入過程有效性的可測量指標(biāo),"4.1AremeasurablemetricsofNPIprocesseffectivenessbuilt?

4.2Arethismetricscontinuouslymeasured?

4.3ArethesemetricsreviewedtoimprovetheeffectivenessoftheNPIprocess?

Notes:Measurablemetricsincludebutnotlimitedto:ProcessFPY,CustomerReturnRate,CARinNPIstage,Timetomeetthequalitytarget,etc.4.1是否建立了新產(chǎn)品導(dǎo)入過程有效性的可測量指標(biāo)?4.2這些指標(biāo)是否持續(xù)測量?是否對這些指標(biāo)進行了評審，以提高新產(chǎn)品導(dǎo)入過程的有效性?備注:可測量的指標(biāo)包括但不限于:流程效率、客戶回頭率、新產(chǎn)品導(dǎo)入階段的CAR、達到質(zhì)量目標(biāo)的時間等。","Score0-Donotmeetrequirement4.1

Score1-Meetrequirement4.1.Butdonotmeetrequirement4.2.

Score2-Meetrequirements4.1and4.2.Butdonotmeetrequirement4.3.

Score3-Meetallrequirements",2,3,HH-QEP-11新產(chǎn)品開發(fā)管理程序

5,LessonLearn經(jīng)驗教訓(xùn),"5.1IslessonlearnrequirementdefinedinNPIprocess?

5.2DoeslessonlearnprocessimplementattheendofeachNPIproject?

5.3ArethelessonlearnfrompreviousprojectsincorporatedintothenewprojectNPI?5.1在新產(chǎn)品導(dǎo)入過程中是否定義了經(jīng)驗教訓(xùn)要求?5.2在每個新產(chǎn)品導(dǎo)入項目結(jié)束時是否實施經(jīng)驗教訓(xùn)學(xué)習(xí)過程?5.3以前項目的經(jīng)驗教訓(xùn)是否被納入到新項目的NPI中?","Score0-Donotmeetrequirement5.1

Score1-Meetrequirement5.1.Butdonotmeetrequirement5.2

Score2-Meetrequirement5.1and5.2.Butdonotmeetrequirement5.3

Score3-Meetallrequirements.",2,3,DFM

6,Packagingverification包裝驗證,"6.1Isthepackagingverificationprocessinplace?

6.2IsthepackagingverificationactivitiesimplementedtoallNPIproducts?

Notes:Thepackagingverificationmayincludebutnotlimitto:preventproductdamageintransportation,preventproducttravelinsidethecontainer,moisture-proofformoisturesensitiveproducts,ESD-proofforESDsensitiveproducts,etc.6.1包裝驗證程序是否到位?是否對所有新產(chǎn)品導(dǎo)入實施了包裝驗證活動?注:包裝驗證可包括但不限于:防止產(chǎn)品在運輸過程中損壞，防止產(chǎn)品在容器內(nèi)移動，防濕敏感產(chǎn)品防潮，防靜電敏感產(chǎn)品防靜電等。","Score0-Donotmeetrequirement6.1

Score1-Meetrequirement6.1.Butfindmultiplecasesdonotmeetrequirement6.2.

Score2-Meetrequirement6.1.Butfindisolatedcasedonotmeetrequirement6.2.

Score3-Meetallrequirements.",2,3,HH-QEP-11新產(chǎn)品開發(fā)管理程序

7,Newmachines/programs/Softwarevalidationandversioncontrol新機器/程序/軟件的驗證和版本控制,"7.1Isthereanewmachine/program/testingsoftwarevalidationprocessinplace?

7.2Areallnewmachines/programs/testingsoftwarevalidatedbeforeutilizingtoproduction?

7.3Istheversioncontrolinplaceforallprogramandtestingsoftware?是否有新的機器/程序/測試軟件驗證流程?所有新機器/程序/測試軟件在投入生產(chǎn)前是否經(jīng)過驗證?所有的程序和測試軟件是否都有版本控制?","Score0-Donotmeetrequirement7.1.

Score1-Meetrequirement7.1.Butdonotmeetrequirement7.2.

Score2-Meetrequirements7.1and7.2.Butdonotmeetrequirement7.3.

Score3-Meetallrequirements.",2,3,HH-QEP-07設(shè)備設(shè)施管理程序

,,,,,,,

Section5-CorrectiveandPreventiveAction第5部分-糾正和預(yù)防措施,,,,,,

"Question

Number",Element,Question/Requirement,RatingCriteria,ProbationalMinimumScore,AcceptableMinimumScore,佐證

1,CAPAimplementedandclosuretimetracked實施CAPA并跟蹤關(guān)閉時間,"1.1IstheCAPAprocessinplace?

1.2IstheCAPAprocessimplementedtocustomerqualityissue,internalqualityissueandsupplierqualityissue?

1.3IstheCAPAclosuretimetrackedandmeetcustomerrequirements?

Notes:CAPAmeansCorrectiveActionandPreventiveAction.CAPA過程是否到位?是否對客戶質(zhì)量問題、內(nèi)部質(zhì)量問題和供應(yīng)商質(zhì)量問題實施了CAPA程序?1.3CAPA結(jié)束時間是否被跟蹤并滿足客戶要求?注:CAPA是指糾正措施和預(yù)防措施。","Score0-Donotmeetrequirement1.1.

Score1-Meetrequirement1.1.Butdonotmeetrequirement1.2.

Score2-Meetrequirements1.1and1.2.Butdonotmeetrequirement1.3.

Score3-Meetallrequirements.得分0-不符合要求1.1。得分1-滿足要求1.1。但不符合要求1.2。得分2-滿足要求1.1和1.2。但不符合要求1.3。得分3-滿足所有要求。",2,3,HH-QEP-06糾正及持續(xù)改進管理程序

2,EffectivenessofCAPACAPA的有效性,"2.1IstheCAPAeffectivenessverificationprocessinplace?

2.2Istherenonerepeatqualityissuere-occurredwiththesamerootcause?

2.3Forrootcauseanalysis,are3Ways(Occurrence,DetectionandSystematic)5Whys(deepcauseanalysis)approachusedandtherootcausesbeactuallyaddressed?

2.4Areeffectivecontainmentaction,correctiveactionandpreventiveactionplannedandexecuted.(Trainingaloneisnotacceptableforeffectiveness.Effectiveactionsincludebutnotlimitedto:procedure/visualaid/workinstructionupdate,productionline/tooling/fixture/gaugeimprovement,PokeYoke,etc.)

2.5Aretheplannedactionsimplementedontime?

2.6AretheCAPAreportreviewedbyauthorizedperson?補救措施有效性驗證程序是否到位?是否沒有相同根本原因?qū)е碌闹貜?fù)質(zhì)量問題再次發(fā)生?對于根本原因分析，是否使用了3種方法(發(fā)生、檢測和系統(tǒng))5個原因(深層原因分析)方法，并實際解決了根本原因?是否計劃并執(zhí)行了有效的控制措施、糾正措施和預(yù)防措施。(單靠培訓(xùn)是不能提高效率的。有效的措施包括但不限于:程序/視覺輔助/作業(yè)指導(dǎo)書更新，生產(chǎn)線/工裝/夾具/量具改進，PokeYoke等)計劃的措施是否按時實施?2.6CAPA報告是否經(jīng)授權(quán)人員審核?","Score0-Donotmeetrequirement2.1

Score1-Meetrequirement2.1.Butdonotmeetrequirement2.2and/or2.3and/or2.4.

Score2-Meetrequirements2.1,2.2,2.3and2.4.Butdonotmeetrequirement2.5and/or2.6.

Score3-Meeta得分0-不符合要求2.1得分1-符合要求2.1但不符合規(guī)定2.2及/或2.3及/或2.4。得分2-滿足要求2.1,2.2,2.3和2.4。但不符合要求2.5及/或2.6。得分3-滿足所有要求。llrequirements.",2,3,HH-QEP-06糾正及持續(xù)改進管理程序

,,,,,,,

Section6-ProcessControl,,第6節(jié)-過程控制,,,,

"Question

Number",Element,Question/Requirement,RatingCriteria,ProbationalMinimumScore,AcceptableMinimumScore,佐證

1,Processdocuments處理文檔,"1.1Arenecessaryprocessdocumentsavailableontheworkstation?

1.2Aretheactualactivitiesatworkstationalignwiththerequirementsdefinedinprocessdocuments?

1.3Aretheseprocessdocumentsapprovedbyauthorizedpeople?

Notes:

a).Processdocumentsincludebutnotlimitedto:workinstruction,standardoperationprocedure,parametersheet,etc.

b).Availableontheworkstationcanbe:hardcopydocumentsarekeptaroundtheworkstation,orelectronicdocumentsareaccessiblearoundtheworkstation.工作臺上是否有必要的工藝文件?工作站上的實際活動是否符合過程文件中規(guī)定的要求?1.3這些工藝文件是否經(jīng)授權(quán)人員批準(zhǔn)?注:a).工藝文件包括但不限于:作業(yè)指導(dǎo)書、標(biāo)準(zhǔn)操作規(guī)程、參數(shù)表等;b).工位上可獲得的文件有:工位周圍保存的硬拷貝文件或工位周圍可獲取的電子文件。","Score0-Donotmeetrequirement1.1.

Score1-Meetrequirement1.1.Butdonotmeetrequirement1.2.

Score2-Meetrequirement1.1and1.2.Butdonotmeetrequirement1.3.

Score3-Meetallrequirements.得分0-不符合要求1.1。得分1-滿足要求1.1。但不符合要求1.2。得分2-滿足要求1.1和1.2。但不符合要求1.3。得分3-滿足所有要求。",2,3,作業(yè)指導(dǎo)書

2,Inspectioninstructions檢驗指導(dǎo)書,"2.1Arenecessaryinspectioninstructionsavailableontheinspectionstation?

2.2AretheinspectioninstructionalignwithJabilrequirementsand/orcustomerrequirements.

2.3Aretheinspectioninstructionsapprovedbyauthorizedpeople?

Notes:Inspectionstationincludebutnotlimitedto:incominginspection,processinspectionandfinalinspection.2.1檢驗站是否有必要的檢驗指導(dǎo)書?檢驗指導(dǎo)書是否符合捷普公司的要求和/或客戶的要求?2.3檢驗指導(dǎo)書是否經(jīng)授權(quán)人員批準(zhǔn)?注:檢驗站包括但不限于:進貨檢驗、過程檢驗和最終檢驗。

","Score0-Donotmeetrequirement2.1.

Score1-Meetrequirement2.1.Butdonotmeetrequirement2.2.

Score2-Meetrequirement2.1and2.2.Butdonotmeetrequirement2.3.

Score3-Meetallrequirements.",2,3,SIP/QCD-WI-0120原材料進料檢驗指導(dǎo)/QCD-WI-0035首尾件檢查作業(yè)指導(dǎo)書/QCD-WI-0091

IPQC巡檢作業(yè)指導(dǎo)書

3,Keyprocessparametercontrol關(guān)鍵工藝參數(shù)控制,"3.1Arethekeyprocessparametersdefinedintheprocessdocuments?

3.2Areallthekeyprocessparametersmonitored?

3.3Arecorrectiveactionstakenifanykeyparameterisoutofdefinedspec?

3.4Cansupplierdemonstratehowthiskeyprocessparametersaredefined(i.e.bycalculation,byDOE,refertothematerialsupplier'srecommendation,etc.)?3.1關(guān)鍵工藝參數(shù)是否在工藝文件中定義?3.2是否對所有關(guān)鍵工藝參數(shù)進行監(jiān)控?3.3如果任何關(guān)鍵參數(shù)超出規(guī)定的規(guī)格，是否采取糾正措施?3.4供應(yīng)商能否說明這些關(guān)鍵工藝參數(shù)是如何定義的(即通過計算、DOE、參考材料供應(yīng)商的建議等)?","Score0-Donotmeetrequirement3.1

Score1-Meetrequirement3.1.Butdonotmeetrequirement3.2and/or3.3

Score2-Meetrequirement3.1,3.2and3.3.Butdonotmeetrequirement3.4.

Score3-Meetallrequirements.",2,3,作業(yè)指導(dǎo)書/QCD-WI-0035首尾件檢查作業(yè)指導(dǎo)書/QCD-WI-0091

IPQC巡檢作業(yè)指導(dǎo)書

4,Processbuy-off過程收買,"4.1Aretheprocessbuy-offrequirementsdefined?

4.2Aretheprocessbuy-offexecutedbeforeitreleasetomassproduction?

Notes:

a).processbuy-offrequirementsincludebutnotlimitedto:partverification,keyprocessparameterverification,processcapacityverification,processpassyieldverification,etc.

b).1manufacturingprocesscountas1case.4.1是否定義了過程買斷要求?在批量生產(chǎn)前是否進行了工藝驗收?注:a).工藝驗收要求包括但不限于:零件驗證、關(guān)鍵工藝參數(shù)驗證、工藝能力驗證、工藝合格率驗證等。b).1個制造工藝計1例。","Score0-Donotmeetrequirement4.1.

Score1-Meetrequirement4.1.Butfindmultiplecasesdonotmeetrequirement4.2.

Score2-Meetrequirement4.1.Butfindisolatedcasedonotmeetrequirement4.2.

Score3-Meetallrequirements.",2,3,作業(yè)指導(dǎo)書/QCD-WI-0035首尾件檢查作業(yè)指導(dǎo)書/QCD-WI-0091

IPQC巡檢作業(yè)指導(dǎo)書

5,Firstpiecebuy-offinspection首件產(chǎn)品驗收,"5.1Isthefirstpiecebuy-offinspectionrequirementdefined?

5.2Isthefirstpiecebuy-offinspectionexecutedbeforeconsecutiveproduction?

Notes:

a).Iftheproductisproducedpiecebypiece,buy-offinspectionisrequiredforthefirstpiecebeforeconsecutiveproduction.Iftheproductisproducedbatchbybatch,samplingbuy-offinspectionisrequiredforthefirstbatch.

b).1partnumbercountas1case.是否規(guī)定了首件進貨檢驗要求?5.2連續(xù)生產(chǎn)前是否進行首件驗收?注:a).如果產(chǎn)品是單件生產(chǎn)，在連續(xù)生產(chǎn)前需要對第一個件進行驗收。如果產(chǎn)品是分批生產(chǎn)的，第一批需要抽樣驗收。B).1個零件號計1箱。","Score0-Donotmeetrequirement5.1.

Score1-Meetrequirement5.1.Butfindmultiplecasesdonotmeetrequirement5.2.

Score2-Meetrequirement5.1.Butfindisolatedcasedonotmeetrequirement5.2.

Score3-Meetallrequirements.",2,3,QCD-WI-0035首尾件檢查作業(yè)指導(dǎo)書

6,Samplinginspectioninconsecutiveproduction連續(xù)生產(chǎn)的抽樣檢驗,"6.1Isthesamplinginspectionrequirementdefinedforconsecutiveproduction?

6.2Isthesamplinginspectionexecutedinconsecutiveproduction?

Notes:

a).Thesamplingplanforconsecutiveproductioncouldbe:Xpcs/hour,orfollowtheAQLsamplingrequirement.

b).1partnumbercountas1case.6.1是否規(guī)定了連續(xù)生產(chǎn)的抽樣檢驗要求?6.2連續(xù)生產(chǎn)是否有抽樣檢驗?注:a).連續(xù)生產(chǎn)的抽樣計劃可為:X件/小時，或按AQL抽樣要求。B).1個零件號計1箱。","Score0-Donotmeetrequirement6.1.

Score1-Meetrequirement6.1.Butfindmultiplecasesdonotmeetrequirement6.2.

Score2-Meetrequirement5.1.Butfindisolatedcasedonotmeetrequirement6.2.

Score3-Meetallrequirements.",2,3,QCD-WI-0065抽樣計劃說明

7,Lightluxcontrolforcosmeticinspection化妝品檢驗用光照度控制,"7.1Isthelightluxcontrolledforcosmeticinspectionarea?

7.2Arethelightluxinspec?

7.3Isthelightluxperiodicallyre-verified?

Notes:

a).Jabillightluxspec:800-1000Lux,per00-QS60-1000-003.Ifthereiscustomerspecavailable,followcustomerrequirementtoreplaceJabilrequirement.

b).Periodicallyreverifyfrequencycouldbe:monthly,yearly,etc.7.1化妝品檢驗區(qū)域的照度是否有控制?7.2光通量是否符合規(guī)格?7.3照度是否定期重新驗證?注:a).Jabil光勒克斯規(guī)格:800-1000勒克斯，每00-QS60-1000-003。如果有可用的客戶規(guī)格，請按照客戶需求替換Jabil需求。b).定期驗證頻率可為:每月、每年等。","Score0-Donotmeetrequirement7.1

Score1-Meetrequirement7.1.Butdonotmeetrequirement7.2.

Score2-Meetrequirement7.1and7.2.Butdonotmeetrequirement7.3.

Score3-Meetallrequirements.

N/A-Ifthereisnocosmeticinspectionrequiredinsupplier.0分-不符合要求7.1分1分-符合要求7.1但不符合7.2要求。得分2-滿足要求7.1和7.2。但不符合要求7.3。得分3-滿足所有要求。-如果供應(yīng)商不需要進行外觀檢查。",2,3,QCD-WI-0105光照度計使用說明/光照度點檢表

8,"Mastersample,boundarysample,customersample主樣，邊界樣，客戶樣","8.1Ifapplicable,aremastersamplesand/orboundarysamplesand/orcustomersamplesavailable?

8.2Arethesesampleswellstored?

8.3Arethesesamplesclearlyidentified?

8.4Arethesesamplesperiodicallyreviewed?8.1如適用，是否有主樣和/或邊界樣和/或客戶樣?8.2這些樣品是否妥善保存?8.3這些樣品是否有清晰的標(biāo)識?8.4這些樣品是否定期評審?","Score0-Donotmeetrequirement8.1.

Score1-Meetrequirement8.1.Butdonotmeetrequirement8.2and/or8.3.

Score2-Meetrequirement8.1,8.2and8.3.Butdonotmeetrequirement8.4.

Score3-Meetallrequirements.

N/A-Ifnosampleisrequired.0分-不符合8.1分要求。得分1-滿足要求8.1。但不符合要求8.2和/或8.3。得分2-滿足要求8.1,8.2和8.3。但不符合要求8.4。得分3-滿足所有要求。-如果不需要采樣。",2,3,ENG-WI-071各類樣品管理辦法

9,SPCoryieldcontrol產(chǎn)量控制,"9.1DoesSPCoryieldcontroltoolusedforprocesscontrol?

9.2Arecorrectiveactionstakenforoutofcontrolconditions?

9.3Arethecorrectiveactionseffectiveforthequalityimprovement?

Notes:effectivemeanstheprocesscapabilityimprovedtomeetthetarget,ortheprocessyieldimprovedtomeetthetarget.9.1過程控制是否使用SPC或良率控制工具?9.2是否對失控情況采取了糾正措施?9.3質(zhì)量改進的糾正措施是否有效?注:有效是指過程能力的改進以達到目標(biāo)，或過程良率的改進以達到目標(biāo)","Score0-Donotmeetrequirement9.1.

Score1-Meetrequirement9.1.Butdonotmeetrequirement9.2.

Score2-Meetrequirements9.1and9.2.Butdonotmeetrequirement9.3.

Score3-Meetallrequirements.",2,3,SPC統(tǒng)計過程控制程序（品質(zhì)）

10,Traceabilitysystem可追溯性系統(tǒng),"10.1Isthereatraceabilitysysteminplace?

10.2Isthetraceabilitysystemcoveredthewholeprocessfrommaterialincomingtoproductdelivery?

10.3Dotheactualactivitiesfollowthedefinedtraceabilityrequirements?

Notes:actualactivitiesincludebutnotlimitedto:material/product'sidentificationonsite,recordofthetraceability,etc.10.1是否有可追溯系統(tǒng)?10.2追溯系統(tǒng)是否涵蓋從物料入庫到產(chǎn)品交付的全過程?10.3實際活動是否遵循已定義的可追溯性要求?注:實際活動包括但不限于:物料/產(chǎn)品的現(xiàn)場標(biāo)識、追溯性記錄等。","Score0-Donotmeetrequirement10.1

Score1-Meetrequirement10.1.Butdonotmeetrequirement10.2,and/orfindmultiplecasesdonotmeetrequirement10.3.

Score2-Meetrequirement10.1