質(zhì)量體系審核表+自評(píng)回復(fù)范本Quality System Audit Rev15-長(zhǎng)城

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,1:QualitySystemRequirements,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remark

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,55,,Counts:,55,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

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,1.1,"Hasthesupplierdefinedanddocumenteditscorporatequalitypolicyandqualityobjectives？Achievequalityobjectives?

供應(yīng)商是否有明確并文件化的公司質(zhì)量方針和制定質(zhì)量目標(biāo)?質(zhì)量目標(biāo)是否達(dá)標(biāo)？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,"HH-QEM-01質(zhì)量環(huán)境手冊(cè)A>質(zhì)量方針：

群策群力、品質(zhì)至上；精益求精、客戶滿意。D>公司總目標(biāo)

準(zhǔn)時(shí)交貨達(dá)成率、客戶滿意度、進(jìn)料檢驗(yàn)批合格率、客戶投訴和重大SR事故,達(dá)成，見(jiàn)質(zhì)量目標(biāo)統(tǒng)計(jì)表",,,,,

,1.2,"Doesthesupplierconductmanagementreviewsofthesuitabilityandeffectivenessofthequalitymanagementsystematappropriateintervals?(i.e.doesthequalitysystemmeetcustomerrequirements?)Areimplementationofactionitemsfrommanagementreviewtracked?

對(duì)質(zhì)量體系的符合性和有效性是否進(jìn)行定期的管理評(píng)審（如品質(zhì)體系是否滿足客戶要求？）管理評(píng)審的改善行動(dòng)是否實(shí)施？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-03管理評(píng)審管理程序,,,,,

,1.3,"Dotheinternalauditsverifycompliancewithplannedarrangements?Dothefollowupactivitiesincludeverificationoftheactionstakenandthereportingofverificationresults?

內(nèi)部審核是否按計(jì)劃實(shí)施？?jī)?nèi)審問(wèn)題點(diǎn)是否有改善行動(dòng)的確認(rèn)，以及報(bào)告記錄確認(rèn)結(jié)果？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-04內(nèi)部審核管理程序,,,,,

,1.4,"Isthereasystemthatidentifiestrainingrequirementsforallpersonnelaffectingthequalityoftheproduct?Areaccuratetrainingrecordsmaintained?

對(duì)影響產(chǎn)品品質(zhì)的人員是否有明確的培訓(xùn)體系？是否有準(zhǔn)確的培訓(xùn)記錄并保存？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-32人力資源管理程序-人力資源部,,,,,

,1.5,"Isthereaproductenvironmentmanagement(ROHS/REACH,HFetc.)controlfile?Proofofexecution?

是否有產(chǎn)品環(huán)境管理物質(zhì)（ROHS/REACH/無(wú)鹵等）控制文件？執(zhí)行的證據(jù)？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,QC080000-2017手冊(cè)+程序文件,,,,,REACH/無(wú)鹵適用于有要求的產(chǎn)品

,1.6,"DoessupplierhaveISO9001certification?WhetherthereistheimplementationofISO9001-2015version

供應(yīng)商是否有ISO9001認(rèn)可？是否有推行ISO9001-2015版",,,,,,,,,,,,,,,Thresholditems門檻項(xiàng),5,有證書(shū)編號(hào)：16421Q30005R1M，有效期：2023/12/18,,,,,

,1.7,"Isthereamedicalproductriskidentificationandprogramdocumentation?Isthedocumentexecuted?

是否有醫(yī)療產(chǎn)品風(fēng)險(xiǎn)識(shí)別及程序文件？是否依文件執(zhí)行？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-41產(chǎn)品風(fēng)險(xiǎn)管理程序,,,,,適用于醫(yī)療器械產(chǎn)品

,1.8,"DoessupplierhaveISO14001certification?Ifnot,doessupplierhaveaplan/roadmaptoachievethecertification?

供應(yīng)商是否有ISO14001認(rèn)可？是否有推行ISO14001-2015版，如沒(méi)有，是否有認(rèn)可計(jì)劃？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,有證書(shū)編號(hào)：16421E30004R1M，有效期：2023/12/18,,,,,

,1.9,"Ifsuppliersareinthepollutingindustries,suchasplastics,PCB,packagingplants,electroplatingplants,wastedisposalreportsshouldbeprovidedtocheckwhetherenvironmentalpermitsarestillvalid？

供應(yīng)商若屬于污染行業(yè)，如塑料，PCB，包裝廠，電鍍廠，則要提供廢水廢棄處理報(bào)告，檢查環(huán)保許可證是否還有效？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,廢水廢棄物有委托有資質(zhì)的廠商合規(guī)處理，不屬于污染行業(yè)，不需要取得環(huán)保許可證,,,,,

,1.10,"DoessupplierhaveISO13485certification?Ifnot,doessupplierhaveaplan/roadmaptoachievethecertification?

供應(yīng)商是否有ISO13485認(rèn)可？如沒(méi)有，是否有認(rèn)可計(jì)劃？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,有,,,,,適用于醫(yī)療關(guān)鍵部件供應(yīng)商

,1.11,"DoessupplierhaveISO45001certification?Ifnot,doessupplierhaveaplan/roadmaptoachievethecertification?

供應(yīng)商是否有ISO45001認(rèn)可？如沒(méi)有，是否有認(rèn)可計(jì)劃？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,有,,,,,

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,2:DesignControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,20,,Counts:,20,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

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,2.1,"是否已建立以下文件？例如，設(shè)計(jì)文件、技術(shù)標(biāo)準(zhǔn)和圖紙

Istherehavethefollowingdocuments?

suchas,Designdocumentsandtechnicalspec./drawings?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,是，見(jiàn)圖紙,,,,,

,2.2,"Istherearequirementtoverifytheproductmeetsdesignspecificationspriortomassproduction?Istherehaveassessmentreportorcertificationrecords?

在批量生產(chǎn)之前，是否有核實(shí)產(chǎn)品符合設(shè)計(jì)標(biāo)準(zhǔn)的要求（規(guī)定）？是否有評(píng)估報(bào)告或驗(yàn)證記錄？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-11新產(chǎn)品開(kāi)發(fā)管理程序-工程部/ENG-WI-0070產(chǎn)前會(huì)議管理辦法,,,,,

,2.3,"IstherehaveDesignFailureModeandEffectsAnalysisfordesignproducts？

自己設(shè)計(jì)的產(chǎn)品是否DFMEA文件（潛在失效模式分析）",,,,,,,,,,,,,,,Thresholditems門檻項(xiàng),X,無(wú)設(shè)計(jì)，依客戶圖紙制造,,,,,供應(yīng)商自行設(shè)計(jì)的醫(yī)療器械關(guān)鍵部件必須滿足

,2.4,"WhethercancooperatewithcustomerstoprovideFAEsamplesandFAEdocuments？

是否可以配合客戶提供FAE樣品及完整的FAE資料",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,依客戶要求執(zhí)行,,,,,

,2.5,"DoessupplierestablishQMSdocumentorrequirementtoensureitsprovidedmaterialmeetscustomerspecificationordrawingrequirements?e.g.plasticpartmaterialcomposition,dimensionrequirementetc.

供應(yīng)商是否建立質(zhì)量體系文件或要求保證其提供的物料符合客戶規(guī)格或圖紙要求？例如：塑膠物料的物料成分、尺寸要求等",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-11新產(chǎn)品開(kāi)發(fā)管理程序及客戶要求提供物料成分、尺寸等等,,,,,

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,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

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,3:DocumentandRecordControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,40,,Counts:,40,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,3.1,"Doesthesupplierhaveestablishedanddocumentedproceduresfordocument？Thefollowingfileshasbeenestablished?b)Processcontroldocuments?(c)Workinstructions?

供應(yīng)商是否建立并文件控制程序？是否已建立以下文件？工藝控制文件？工作指引？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-35文件、資料和記錄管理程序,,,,,

,3.2,"Doestheprocedureensurethatallobsoletedocumentsarepromptlyremovedfromallpointsofissueoruse?haveusetheoldversionfile?

程序是否確保及時(shí)地從所有發(fā)放和使用地收回廢止的文件？現(xiàn)場(chǎng)是否有使用舊版文件？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-35文件、資料和記錄管理程序,,,,,

,3.3,"Arequalitydocumentsreviewedandapprovedforadequacybyauthorizedpersonnelpriortoissue?

質(zhì)量文件在發(fā)行前是否經(jīng)有權(quán)限的人員審核和批準(zhǔn)？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-35文件、資料和記錄管理程序,,,,,

,3.4,"Isthereaproceduretogovernengineeringchanges？Isthereasystemtoconfirmtherelateddepartmentreceivetheengineeringchangenotice?Engineeringchangeexecutionrecords?

是否有工程變更管理程序？是否有系統(tǒng)來(lái)確認(rèn)相關(guān)部門收到工程變更通知？工程變更執(zhí)行的記錄？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-29工程變更管理程序-工程部,,,,,

,3.5,"Doesnoitifycustomerifanychangedefined？Suchas：a)Changeofrawmaterialsorsuppliers

b)Changeofproductstandardanddesign(includingchangeoftheinspection,packingandotherstandardsrelevanttoProduct)

c)ChangeofProductManagementPlan(PMP)

d)Changeofmainproductionequipmentorkeyindirectmaterials

e)Changeofsiteofmanufacturing

f)Changeofversionsofprocedureandsoftware;

g)AnyotherrelevantchangesthatmayaffectthequalityofProduct

是否有定義工程變更需通知客戶？如以下情況

a.原材料或原材料供應(yīng)商的變更

b.產(chǎn)品的設(shè)計(jì)和標(biāo)準(zhǔn)變更(包括檢驗(yàn)、包裝標(biāo)準(zhǔn)及其它與產(chǎn)品有關(guān)的標(biāo)準(zhǔn)的更改);

c.生產(chǎn)或工藝流程（PMP）的更改;

d.主要生產(chǎn)設(shè)備或關(guān)鍵輔助材料的變更;

e.生產(chǎn)場(chǎng)所變更；

f.程序軟件版本的變更；

g.其它會(huì)影響產(chǎn)品質(zhì)量的相關(guān)變更.",,,,,,,,,,,,,,,Thresholditems門檻項(xiàng),5,HH-QEP-29工程變更管理程序-工程部,,,,,

,3.6,"Areallqualityrecordsidentified,indexed,filed,collected,stored,maintained,anddisposedafterstatedperiod?

所有品質(zhì)記錄是否按規(guī)定的時(shí)間段標(biāo)識(shí)，索引，整理，儲(chǔ)存，保護(hù)以及處理",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-35文件、資料和記錄管理程序,,,,,

,3.7,"Haveretentiontimesofqualityrecordsbeenestablishedandrecorded?

有規(guī)定品質(zhì)記錄的保存時(shí)間和相關(guān)記錄？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,記錄清單,,,,,

,3.8,"Whethertodoqualityrecordkeepingtimeisgreaterthanorequaltotheproductlifecycle,productlifecycleislessthantwoyears,savefortwoyears？

是否做到品質(zhì)記錄的保存時(shí)間大于等于產(chǎn)品壽命周期，產(chǎn)品壽命周期少于兩年的，保存兩年。",,,,,,,,,,,,,,,Thresholditems門檻項(xiàng),5,記錄清單,,,,,針對(duì)醫(yī)療器械供應(yīng)商要求必須做到

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,4:SupplierQualityControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,25,,Counts:,25,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,4.1,"Aresubcontractorsselectedonthebasisoftheirabilitytomeetsubcontractrequirements,includingcost,quality,technologyrequirements?Areup-to-daterecordskeptofacceptable/approvedsubcontractors?

是否有次級(jí)供應(yīng)商選擇評(píng)估的要求，包括成本、品質(zhì)、技術(shù)評(píng)估來(lái)選擇次級(jí)供應(yīng)商？是否有最新的可接受、受批準(zhǔn)供應(yīng)商記錄？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-13供應(yīng)商管理程序-采購(gòu)部,,,,,

,4.2,"Isthesubcontractorappraisedperiodicallybythecriteriaofcost,quality,technologyandservice?

是否有對(duì)次級(jí)供應(yīng)商根據(jù)成本、品質(zhì)、技術(shù)和服務(wù)的標(biāo)準(zhǔn)進(jìn)行定期考核？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-13供應(yīng)商管理程序-采購(gòu)部,,,,,

,4.3,"Doesthepartapprovalincludeverificationof:IsthereaProcesscontrolparameters/documents(GR&R,PFMEA,processmanagementplan,productionflowchart,drawings,etc.)?IsthereaCriticalparameters/dimensionscontrol?(includingcapabilityindexCpk)

部件批準(zhǔn)是否包括以下方面的確認(rèn)？流程控制參數(shù)、文件（重復(fù)性,過(guò)程失效模式分析,制程管理計(jì)劃PMP,生產(chǎn)流程圖,圖紙等)?關(guān)鍵參數(shù)和尺寸控制？（包括能力指數(shù)CPK）",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,HH-QEP-13供應(yīng)商管理程序-采購(gòu)部,,,,,

,4.4,"DoesthesupplierhaveeffectiveRMAcontrolwithsubcontractors?（RMA=ReturnMaterialAuthorization)

供應(yīng)商是否有對(duì)次承包商的有效RMA控制？(RMA=客戶退貨）",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,QCD-WI-0089進(jìn)料檢驗(yàn)指導(dǎo)書(shū),,,,,

,4.5,"DoesthesupplierhaveHazardoussubstances(ROHS,REACH,halogenfree,etc.)controlwithsubcontractors?Requiredtoprovideenvironmentalrequirementstatement,testreport？

供應(yīng)商是否有對(duì)次承包商物料進(jìn)行有害物質(zhì)（ROHS,REACH，無(wú)鹵等）控制，是否要求提供環(huán)保聲明，第三方測(cè)試報(bào)告？",,,,,,,,,,,,,,,Thresholditems門檻項(xiàng),5,HH-QEP-13供應(yīng)商管理程序-采購(gòu)部,,,,,

,4.6,"Doesthesupplierhaveinvestigateitsupstreamresources,andprovidetherelevantinvestigationrecordswhencustomeraudit,ifthecustomerhavethesurveyrequirementsforconflictminerals(canprovidecustomersdemandsurveyform,orneedrelateddeclarationdocuments)？

客戶有礦產(chǎn)沖突調(diào)查需求的，供應(yīng)商是否對(duì)其上游資源進(jìn)行調(diào)查，并在審核時(shí)提供相關(guān)調(diào)查記錄（可提供客戶需求的調(diào)查表格，或者需要相關(guān)聲明資料）",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,有調(diào)查,,,,,適用于客戶有礦產(chǎn)沖突調(diào)查需求的供應(yīng)商

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,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,5:IQCControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,30,,Counts:,30,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,5.1,"IsthetargetofincomingqualitysuchasLARDPPMdefinedindocument?Anycorrectiveactiontakenfortheseun-achievedtarget?

是否有文件定義IQC的來(lái)料品質(zhì)目標(biāo),如LAR,DPPM?未達(dá)標(biāo)的情況有無(wú)改善措施?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,DCC-WI-005質(zhì)量目標(biāo)管理辦法,,,,,

,5.2,"Aretheincominginspectionpersonneltrainedandcertifiedfortheoperations?Dotherecordsevidencethis?

是否來(lái)料檢驗(yàn)人員受過(guò)培訓(xùn),并發(fā)上崗資格證?是否有記錄為證?",,,,,,,,,,,,,,,Generalitems,5,有培訓(xùn)發(fā)上崗證,,,,,

,5.3,"IsthereWIforincominginspectionincludinginspectioncriteria,productsampleplan?

是否有來(lái)料的檢驗(yàn)指引,并包括了檢驗(yàn)標(biāo)準(zhǔn)和抽樣計(jì)劃?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,QCD-WI-0089進(jìn)料檢驗(yàn)指導(dǎo)書(shū),,,,,

,5.4,"IsthereWItodefineprocedureofincominginspection,passed/failedmaterialdispostion,materialstorage?Arethesematerialplacedonspecifiedareaseparately?IsthereanyevidencetoindicatethatIQCfollowstheprocedurecorrectly?

是否有來(lái)指引定義來(lái)料檢驗(yàn)的流程,合格/不合格來(lái)料的處置,物料的存放?并分別放置于指定區(qū)域？是否有證據(jù)顯示IQC正確按指引操作?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,QCD-WI-0089進(jìn)料檢驗(yàn)指導(dǎo)書(shū)/HH-QEP-39不合格品管理程序-品管部,,,,,

,5.5,"DothefailedinspectionresultstriggerCorrectiveActionsbacktothesupplierandrequestCAreport?

對(duì)不合格物料是否要求供應(yīng)商的改善行動(dòng)并要求提供報(bào)告?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,QCD-WI-0089進(jìn)料檢驗(yàn)指導(dǎo)書(shū)/8D報(bào)告,,,,,

,5.6,"IsthereaROHSmeasuringequipment?IsthereIQCtodoROHScontroltheincomingmaterial?

是否有ROHS測(cè)量設(shè)備?IQC是否對(duì)來(lái)料進(jìn)行ROHS控制？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,QCD-WI-0120原物料進(jìn)料檢驗(yàn)指導(dǎo)書(shū)，有ROHS1.0/2.0設(shè)備,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,6:ProcessControl,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,40,,Counts:,40,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,6.1,"Isthereaprocedureordocumenttospecifyallcriticalparametersandproductcharacteristicswhichneedmonitoringorcontrol?PMPfilesorqualitycontrolplan？

是否有流程和文件指定了所有需要監(jiān)控和控制的關(guān)鍵參數(shù)和產(chǎn)品特性?（PMP文件或質(zhì)量控制計(jì)劃）",,,,,,,,,,,,,,,Thresholditems門檻項(xiàng),5,,,,,,

,6.2,"Arethereworkinstructionsdefiningthemannerofproduction,installationsforeachprocess/station?(WI=WorkInstruction)Dotheworkinstructionsclearlyspecifythemachines,fixtures,tools,gaugesandprogramtobeused?Doindicateassemblyspecificationsandmachinesetting?(e.g.,temp,pressure,torquedriversetting,andadjustment/testspecifications)

是否有工作指引定義了生產(chǎn),裝配中每個(gè)崗位的操作?是否工作指引清楚的指定了要使用的機(jī)器,工裝,工具,量具和程序?規(guī)定關(guān)鍵參數(shù)設(shè)置范圍(如溫度,壓力,扭力批的設(shè)置,調(diào)節(jié)/測(cè)試規(guī)格)？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,,,,,,

,6.3,"Arethereproceduresandpracticesinplacetoassureproducttraceabilitythroughallstagesofproduction?Areassembliesproperlymarkedandtrackedthroughtheassemblyprocesstoensurenostepsintheprocessflowaremissed

是否有流程和方法確保產(chǎn)品在整個(gè)生產(chǎn)流程各個(gè)環(huán)節(jié)的可追溯性?是否被裝配的部件在裝配流程中被正確打標(biāo)記和追溯,確保生產(chǎn)流程中沒(méi)有步驟被遺漏?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,,,,,,

,6.4,"IsthereacomprehensivePreventiveMaintenancePlanandrecordformachines,equipment?Accordingtotheplan?

是否有針對(duì)機(jī)器,設(shè)備,的全面預(yù)防性維護(hù)計(jì)劃，是否有保養(yǎng)維護(hù)記錄?是否依計(jì)劃實(shí)施？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,,,,,,

,6.5,"AreallESDsystemsareproperlyinstalledandmaintained?e.g.groundingmainsystem,instrument,fixture…etc.

ESD防護(hù)系統(tǒng)是否被安裝和維護(hù)?如主接地系統(tǒng),儀器,工裝等.",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,,,,,,

,6.6,"Aretheremonitoringsystemsforenvironmentcondition,suchastemperature,humidity,particlecount…etc.?

是否有對(duì)環(huán)境條件如溫度,濕度,空氣微粒數(shù)的監(jiān)控系統(tǒng)?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,,,,,,

,6.7,"Areallcriticalprocessesandparametersunderstatisticalcontrol?(e.g.,controlchart,Cp/Cpkstudy)，Areout-of-controlconditionsnotedoncontrolcharts,withcausesinvestigated,andactionsprovided?

是否所有的關(guān)鍵工序和參數(shù)都在使用統(tǒng)計(jì)方法控制(如控制圖,Cp/Cpk研究)，對(duì)超出控制線的情況是否在控制圖中有標(biāo)注,并提供原因調(diào)查和改善行動(dòng)?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,,,,,,

,6.8,"IfsuppliershaveproductionnonROHScompliantproduct,sononROHScompliantproductanditsproductionequipmentisclearlylabeledwithROHSproductsandproductionequipmentorisolate?

如果供應(yīng)商有生產(chǎn)不符合ROHS的產(chǎn)品，那么不符合ROHS的產(chǎn)品及其生產(chǎn)設(shè)備是否與ROHS產(chǎn)品及其生產(chǎn)設(shè)備做明確標(biāo)示或隔離？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,7:InspectionandTesting/Status,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,30,,Counts:,30,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,7.1,"Doesthesupplierinspect,testandidentifyproductasrequiredbythequalityplanorPMPdocumentedprocedures?

供應(yīng)商是否按要求的品質(zhì)計(jì)劃或PMP文件定義的流程檢驗(yàn),測(cè)量和識(shí)別產(chǎn)品?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,QCP,,,,,

,7.2,"DoesthesupplierutilizeoutgoingproductinspectionandtestingsuchasOutofBoxAudits?Aretherecompleteshipmentreports?

供應(yīng)商是否有出貨檢驗(yàn)和測(cè)試,如開(kāi)箱檢驗(yàn)?是否有完整的出貨報(bào)告？",,,,,,,,,,,,,,,Thresholditems門檻項(xiàng),5,QCD-WI-S1064OQC檢驗(yàn)指導(dǎo)書(shū),,,,,

,7.3,"Doesthesupplierutilizeextendedreliability/regulatorytestsonregularbasis?(e.g.Drop/vibration,EMI,reliability,safety,….)

供應(yīng)商是否有常規(guī)的延伸的可靠性測(cè)試(如跌落,震動(dòng),EMI,可靠性,安全性)?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,QCD-WI-0119可信賴性測(cè)試計(jì)劃說(shuō)明,,,,,

,7.4,"Aretheredocumentedproceduresforcontrolofinspection,measuring,testequipment，Andequipmentmasterlist(referandfillappendix-2)?

是否有檢驗(yàn)，測(cè)量及測(cè)試設(shè)備的的控制程序文件和受控儀器清單(參考并填寫附表-2）？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-18監(jiān)視和測(cè)量裝置控制程序-品管部,,,,,

,7.5,"EquipmentCalibrationscheduleandcalibrationrecord/report

測(cè)量設(shè)備校準(zhǔn)計(jì)劃和校準(zhǔn)報(bào)告/記錄",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,檢測(cè)儀器校準(zhǔn)清單,,,,,

,7.6,"Hasthepersonnelinchargeofcalibrationbeentrainedandformallycertified?

校準(zhǔn)人員有無(wú)經(jīng)過(guò)培訓(xùn)或資格認(rèn)證？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,有內(nèi)校資質(zhì),,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,8:ProductIdentificationandLotTraceability,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,15,,Counts:,15,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,Remarks

,,,,,,,,,,,,,,,,,,,,,,,,,

,8.1,"Arein-stockandin-processmaterialsproperlyidentifiedandcontrolled?

是否在倉(cāng)庫(kù)和生產(chǎn)中的物料能被正確識(shí)別和控制?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-17產(chǎn)品標(biāo)識(shí)和可追溯性管理程序,,,,,

,8.2,"Canallmaterialsin-processandinwarehousebetraceable(includingFIFOmaterials)?（FIFO=FirstInFirstOut)

是否所有在在生產(chǎn)過(guò)程中和在倉(cāng)庫(kù)的物料都能被追溯，倉(cāng)庫(kù)物料是否遵循先進(jìn)先出的原則？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,WH-WI-0003先進(jìn)先出管理制度,,,,,

,8.3,"Isthereanevidencethatkeycomponentsfromsubcontractorcanbetraceable(datecode,lotnumber,...etc.)?

是否有證據(jù)顯示來(lái)自次承包商的部件能被追溯(如日期代碼,批次號(hào)等)?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-17產(chǎn)品標(biāo)識(shí)和可追溯性管理程序,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,9:ControlofNonconformingProduct,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,35,,Counts:,35,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,9.1,"IsthereaMRB（MaterialReviewBoard)proceduretoreviewthedispositionofnonconformingmaterial?(e.g.""useasis"",RTV,scrap,rework)

是否有關(guān)于不合格物料處理審核的MRB(不良物料處理）程序？（讓步接受，退貨，報(bào)廢，返修等）",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-39不合格品管理程序-品管部,,,,,

,9.2,"Arerepairedproductsre-inspectedortestedaccordingtodocumentedprocedure?

是否有返工、返檢或重新測(cè)試的程序文件？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,QCD-WI-S1055產(chǎn)品返工管理規(guī)范,,,,,

,9.3,"DoesthesupplierperformContinuousImprovementProcessfornonconformity?(Dataanalysis,FA,C/Aforworsttopsandtracking)improvementevidence？

對(duì)不合格（品）是否有要求供應(yīng)商的持續(xù)改善的程序及改善證據(jù)？（對(duì)主要不合格項(xiàng)的數(shù)據(jù)分析，失效分析，糾正行動(dòng)及跟蹤）",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,8D報(bào)告,,,,,

,9.4,"ForRMAreturnsorcustomerrejects,aretheappropriatecorrectiveorpreventiveactionsdevelopedtoeliminatethecauseofactualorpotentialnonconformance?

對(duì)RMA物料或客戶拒收產(chǎn)品，是否有適當(dāng)?shù)募m正或預(yù)防行動(dòng)去消除產(chǎn)生不合格的現(xiàn)有或潛在的因素？",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-39不合格品管理程序-品管部/HH-QEP-06糾正及持續(xù)改進(jìn)管理程序-品管部,,,,,

,9.5,"whethertoadopttheappropriateisolationmeasuresforforthematerialsnotconformtotheenvironmental(ROHSetc.)requirements?Andputdistinctlabel？

不符合環(huán)保要求（ROHS等)的物料,是否采取恰當(dāng)?shù)母綦x措施？并有明顯標(biāo)識(shí),",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-39不合格品管理程序-品管部,,,,,

,9.6,"IsfailureanalysisperformedandissueaClosedLoopCorrectiveAction(CLCA)forin-processnonconformity?

制程中不合格品是否進(jìn)行了失效分析，發(fā)出糾正行動(dòng)要求？是否有改善報(bào)告？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-39不合格品管理程序-品管部/HH-QEP-06糾正及持續(xù)改進(jìn)管理程序-品管部,,,,,

,9.7,"Isacorrectiveactionrequestissuedintheeventaunitfailsreliabilitytest?Doesthecorrectiveactionrequestincludelongterm/preventiveaction?

是否對(duì)不良項(xiàng)含（可靠性測(cè)試失效）有糾正行動(dòng)的要求，且改善行動(dòng)要求是否含有長(zhǎng)期措施和預(yù)防行動(dòng)要求？",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,HH-QEP-39不合格品管理程序-品管部/HH-QEP-06糾正及持續(xù)改進(jìn)管理程序-品管部,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,"10:Handling,Packaging,Storage&Delivery",,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,25,,Counts:,25,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,10.1,"Arethereproceduresforhandling,storing,packaginganddeliveryofproductandmaterialsandcontrolrecords?

是否有產(chǎn)品和物料取放,存儲(chǔ),包裝,周轉(zhuǎn)的文件和記錄?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-15產(chǎn)品搬運(yùn)，儲(chǔ)存，包裝與防護(hù)管理程序部,,,,,

,10.2,"AreallESD-sensitivematerialsstoredinanti-staticcontainers?

是否所有ESD敏感物料都被存放于防靜電容器中?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,

,10.3,"Aredefectiveproduct/materialssegregatedtopreventmixing?

不良品（有缺陷的產(chǎn)品/物料）是否被隔離以防混淆?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),5,HH-QEP-39不合格品管理程序-品管部,,,,,

,10.4,"Areappropriateenvironmentcontrol(temperatureandhumidity…),andshelflifedefinedandmonitoredinthesestorageareasonaregularbasis?

在這些存儲(chǔ)區(qū)域,恰當(dāng)?shù)沫h(huán)境控制(溫度和濕度等)和保存期限，是否被定義和定期監(jiān)控?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,ENG-WI-0059物料儲(chǔ)存檢驗(yàn)周期控制指引,,,,,

,10.5,"Aremethodsforverificationanddispositionofmaterialsdefinedwhendeteriorationoroutofshelflifefound?

對(duì)損壞或超出保存期限的情況,是否定義驗(yàn)證和處理該物料的方法?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,ENG-WI-0059物料儲(chǔ)存檢驗(yàn)周期控制指引,,,,,

,10.6,"Arethematerialwithenvironmentalrequirement,flammable,corrosive,andtoxicmaterialsproperlystoredandsegregated?Andputdistinctlabel,storageconditionmeetsperifiedrequirement?Arenecessaryprotectionmeansinplaceforflammable,corrosiveandtoxicmaterials?

有環(huán)保要求的物料,易燃,有腐蝕性,有毒的物料是否恰當(dāng)?shù)拇鎯?chǔ)和隔離,有明顯標(biāo)識(shí),存放條件是否滿足規(guī)定要求?是否有所需的針對(duì)易燃,有腐蝕性,有毒的物料的防護(hù)措施?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),5,存放化學(xué)品倉(cāng),,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,11:CorrectiveAction&PreventionAction,,,,,,,,Self-rating,Avgscore:,,#DIV/0!,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

,,,,,,,,,Self-rating,Subtotal:,,0,,Counts:,0,,,"0,1,2,3,4,5",參考文件名稱&編號(hào),"0,1,2,3,4,5",,,,

,,,,,,,,,,Subtotal:,,0,,Counts:,0,,,N/A=X,或其他依據(jù),N/A=X,,,,

,,,,,,,,,,,,,,,,,,,,,,,,,

,11.1,"是否明確定義改善和預(yù)防措施流程，并建立相應(yīng)的系統(tǒng)快速識(shí)別和改善不利于品質(zhì)的根本因素？

Isthereaprocedurethatdescribesprocessfortakingcorrectiveandpreventiveaction?Isthereasystemofrootcauseimprovementactionsthatcanquicklyidentifyandimprovefactorsthatarenotconducivetoquality?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

,11.2,"如何確保將品質(zhì)異常問(wèn)題或不合格品的有關(guān)信息傳遞到對(duì)保證產(chǎn)品品質(zhì)或預(yù)防出現(xiàn)品質(zhì)問(wèn)題負(fù)有直接責(zé)任的人員？

Isitensuredthatinformationaboutqualityabnormalityornonconformingproductsistransmittedtothosewhoaredirectlyresponsibleforensuringproductqualityorpreventingtheoccurrenceofqualityproblems?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

,11.3,"對(duì)于不良品退貨或者客戶拒收是否進(jìn)行失效分析？是否采取適當(dāng)?shù)募m正和預(yù)防措施消除當(dāng)前的和潛在的不良因素？是否執(zhí)行閉環(huán)改善行動(dòng)？

Istherefailureorrootcauseanalysisconductedfordefectivegoodsreturnedorrejectedbycustomers?Areappropriatecorrectiveandpreventivemeasurestakentoeliminatecurrentandpotentialnegativefactors?Areclosed-loopimprovementactionsimplemented?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

,11.4,"改善行動(dòng)是否包括識(shí)別根本原因、圍堵措施、臨時(shí)&長(zhǎng)期的預(yù)防措施？糾正措施是否能夠防止不良和類似問(wèn)題的再次發(fā)生？

Docorrectiveactionsincludetheidentificationofrootcauses,containmentactions,temporary&long-termpreventivemeasures?Doesthecorrectiveactionspreventtherecurrenceofbadandsimilarproblems?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

,11.5,"如果不良缺陷涉及到次級(jí)供應(yīng)商，是否有定義反饋給IQC采取相應(yīng)行動(dòng)的制度？

Ifdefectsinvolvesub-suppliers,isthereadefinedprocessforfeedbacktoIQCforaction?",,,,,,,,,,,,,,,Generalitems普通項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

,11.6,"是否采用適當(dāng)?shù)慕y(tǒng)計(jì)技術(shù)以發(fā)現(xiàn)重復(fù)出現(xiàn)的質(zhì)量問(wèn)題？

Areappropriatestatisticaltechniquesusedtodetectrecurringqualityproblems?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

,11.7,"是否有流程定義如何跟蹤糾正措施和預(yù)防措施的執(zhí)行狀況？以確保改善行動(dòng)的有效性，且不會(huì)對(duì)最終產(chǎn)品產(chǎn)生不利影響；

Isthereaprocesstodefinehowtotrackthestatusofcorrectiveandpreventiveactions?Toensurethatimprovedactioniseffectiveanddoesnotadverselyaffectthefinalproduct;",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

,11.8,"糾正和預(yù)防的全部措施及結(jié)果是否予以記錄并予以管理審核？是否有將失效分析和改善行動(dòng)反饋給相關(guān)部門的制度？

Areallcorrectiveandpreventiveactionsandoutcomesdocumentedandmanagementreviewed?Isthereaprocedureforfeedbackoffailureanalysisandimprovementactionstorelevantdepartments?",,,,,,,,,,,,,,,Criticalitems關(guān)鍵項(xiàng),X,,,,,,適用于醫(yī)療器械供應(yīng)商

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,FormNo:FM-002-223Rev.15,,,,,,,,,,,,,,,,,,,,,,,

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,12:TradeSecuritySurvey,,,,,,,,Self-rating,Avgscore:,,100%,,,,,Items,Self-rating,RemarkbySupplier,ScorebyKaiFa,,,,Remarks

,,,,,,,,,,Avgscore:,,#DIV/0!,,,,,,供應(yīng)商自評(píng),供應(yīng)商備注,KF評(píng)分,,,,

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