IATF 16949：2016 SIs Oct2019 SI 16-18（英文版）

www.iatfglobaloversight.orgPage1of15SIIATF-InternationalAutomotiveTaskForceIATF16949:2016–SanctionedInterpretationsIATF169491stEditionwaspublishedinOctober2016andwaseffective1January2017.ThefollowingSanctionedInterpretationsweredeterminedandapprovedbytheIATF.Unlessotherwiseindicated,SanctionedInterpretationsareapplicableuponpublication.Revisedtextisshowninblue.ASanctionedInterpretationchangestheinterpretationofaruleorarequirementwhichitselfthenbecomesthebasisforanonconformity.SI1-9issuedinOctober2017,effectiveOctober2017.SI10-11issuedinApril2018,effectiveJune2018.SI8revisedandreissuedinJune2018,effectiveJuly2018.SI10revisedandreissuedinJune2018,effectiveJuly2018.SI12-13issuedinJune2018,effectiveJuly2018.SI14-15issuedinNovember2018,effectiveJanuary2019.SI16-18issuedinOctober2019,effectiveJanuary2020.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage2of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION13.1Termsanddefinitionsfortheautomotiveindustrycustomerrequirementsallrequirementsspecifiedbythecustomer(e.g.,technical,commercial,productandmanufacturingprocess-relatedrequirements,generaltermsandconditions,customer-specificrequirements,etc.)Wheretheauditedorganizationisavehiclemanufacturer,vehiclemanufacturersubsidiary,orjointventurewithavehiclemanufacturer,therelevantcustomerisspecifiedbythevehiclemanufacturer,theirsubsidiaries,orjointventures.Rationaleforchange:Customerrequirementsaredevelopedbyvehiclemanufacturersforapplicationintheirsupplychainbythenatureoftheproductrealizationprocess.Therefore,wherethevehiclemanufacturersarebeingcertified,thevehiclemanufacturesdefinehowcustomerapprovalsand/orinputaremanaged.24.4.1.2ProductsafetyTheorganizationshallhavedocumentedprocessesforthemanagementofproduct-safetyrelatedproductsandmanufacturingprocesses,whichshallincludebutnotbelimitedtothefollowing,whereapplicable:a)–m)(…)NOTE:Specialapprovalofsafetyrelatedrequirementsordocumentsmayberequiredbythecustomerortheorganization’sinternalprocesses.isanadditionalapprovalbythefunction(typicallythecustomer)thatisresponsibletoapprovesuchdocumentswithsafety-relatedcontent.Rationaleforchange:Clarifyanyconfusionrelatedtospecialapprovalreviewforsafetyrelatedrequirementsordocuments.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage3of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION36.1.2.3ContingencyplansTheorganizationshall:a)–b)(…)c)preparecontingencyplansforcontinuityofsupplyintheeventofanyofthefollowing:keyequipmentfailures(alsoseeSection8.5.6.1.1);interruptionfromexternallyprovidedproducts,processes,andservices;recurringnaturaldisasters;fire;utilityinterruptions;cyber-attacksoninformationtechnologysystems;labourshortages;orinfrastructuredisruptions;Rationaleforchange:Organizationsneedtoaddressthepossibilityofacyber-attackthatcoulddisabletheorganization'smanufacturingandlogisticsoperations,includingransom-ware.Organizationsneedtoensuretheyarepreparedincaseofacyber-attack.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage4of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION47.2.3InternalauditorcompetencyTheorganizationshallhaveadocumentedprocess(es)toverifythatinternalauditorsarecompetent,takingintoaccountanyrequirementsdefinedbytheorganizationand/orcustomer-specificrequirements.Foradditionalguidanceonauditorcompetencies,refertoISO19011.Theorganizationshallmaintainalistofqualifiedinternalauditors.Qualitymanagementsystemauditors,manufacturingprocessauditors,andproductauditorsshallallbeabletodemonstratethefollowingminimumcompetencies:a)understandingoftheautomotiveprocessapproachforauditing,includingrisk-basedthinking;b)understandingofapplicablecustomer-specificrequirements;c)understandingofapplicableISO9001andIATF16949requirementsrelatedtothescopeoftheaudit;d)understandingofapplicablecoretoolrequirementsrelatedtothescopeoftheaudit;e)understandinghowtoplan,conduct,report,andcloseoutauditfindings.Additionally,Ataminimum,manufacturingprocessauditorsshalldemonstratetechnicalunderstandingoftherelevantmanufacturingprocess(es)tobeaudited,includingprocessriskanalysis(suchasPFMEA)andcontrolplan.Ataminimum,productauditorsshalldemonstratecompetenceinunderstandingproductrequirementsanduseofrelevantmeasuringandtestequipmenttoverifyproductconformity.WheretrainingisprovidedIftheorganization’spersonnelprovidethetrainingtoachievecompetency,documentedinformationshallberetainedtodemonstratethetrainer’scompetencywiththeaboverequirements.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage5of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION4(cont.)7.2.3InternalauditorcompetencyRationaleforchange:Distinguishcompetencyrequirementsforqualitymanagementsystemauditors,manufacturingprocessauditors,andproductauditors.Clarifiedthetrainercompetencyexpectationsforinternallyprovidedtraining.57.5.1.1QualitymanagementsystemdocumentationThequalitymanualshallinclude,ataminimum,thefollowing:a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions;b)documentedprocessesestablishedforthequalitymanagementsystem,orreferencetothem;c)theorganization’sprocessesandtheirsequenceandinteractions(inputsandoutputs),includingtypeandextentofcontrolofanyoutsourcedprocesses;d)adocument(i.e.,matrixforexample,atable,alist,oramatrix)indicatingwherewithintheorganization’squalitymanagementsystemtheircustomer-specificrequirementsareaddressed.Rationaleforchange:SomeCBsandorganizationswantedclarificationthatamatrixwasnotamandatorydocument.Amatrixisjustoneofmultiplemethodsthatareacceptable.Theformatusedisuptotheorganization.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage6of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION68.3.3.3SpecialcharacteristicsTheorganizationshalluseamultidisciplinaryapproachtoestablish,document,andimplementitsprocess(es)toidentifyspecialcharacteristics,includingthosedeterminedbythecustomerandtheriskanalysisperformedbytheorganization,andshallincludethefollowing:a)documentationofallspecialcharacteristicsintheproductand/ormanufacturingdocumentsdrawings(asrequired),relevantriskanalysis(suchasProcessFMEA),controlplans,andstandardwork/operatorinstructions;specialcharacteristicsareidentifiedwithspecificmarkingsandarecascadedthrougheachofthesedocuments;documentedinthemanufacturingdocumentswhichshowthecreationof,orthecontrolsrequired,forthesespecialcharacteristics;Rationaleforchange:Clarifiesthedocumentationofspecialcharacteristicsintheproductand/ormanufacturingdrawings.78.4.2.1Typeandextentofcontrol-supplementalTheorganizationshallhaveadocumentedprocesstoidentifyoutsourcedprocessesandtoselectthetypesandextentofcontrolsusedtoverifyconformityofexternallyprovidedproducts,processes,andservicestointernal(organizational)andexternalcustomerrequirements.Theprocessshallincludethecriteriaandactionstoescalateorreducethetypesandextentofcontrolsanddevelopmentactivitiesbasedonsupplierperformanceandassessmentofproduct,material,orservicerisks.Wherecharacteristicsorcomponents“passthrough”theorganization’squalitymanagementsystemwithoutvalidationorcontrols,theorganizationshallensurethattheappropriatecontrolsareinplaceatthepointofmanufacture.Rationaleforchange:Clarifytheorganization’sresponsibilitiesforpassthroughcharacteristics.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage7of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION8Revised8.4.2.3SupplierqualitymanagementsystemdevelopmentTheorganizationshallrequiretheirsuppliersofautomotiveproductsandservicestodevelop,implement,andimproveaqualitymanagementsystem(QMS)withtheultimateobjectiveofeligibleorganizationsbecomingcertifiedtothisAutomotiveQMSStandard.Usingarisk-basedmodel,theorganizationshalldefineaminimumacceptablelevelofQMSdevelopmentandatargetQMSdevelopmentlevelforeachsupplier.certifiedtoISO9001,unlessotherwiseUnlessotherwiseauthorizedbythecustomer[e.g.,itema)below],aQMScertifiedtoISO9001istheinitialminimumacceptablelevelofdevelopment.Basedoncurrentperformanceandthepotentialrisktothecustomer,theobjectiveistomovesuppliersthroughthefollowingQMSdevelopmentprogression:withtheultimateobjectiveofbecomingcertifiedtothisAutomotiveQMSStandard.Unlessotherwisespecifiedbythecustomer,thefollowingsequenceshouldbeappliedtoachievethisrequirement:a)compliancetoISO9001throughsecond-partyaudits;b)certificationtoISO9001throughthird-partyaudits;unlessotherwisespecifiedbythecustomer,supplierstotheorganizationshalldemonstrateconformitytoISO9001bymaintainingathird-partycertificationissuedbyacertificationbodybearingtheaccreditationmarkofarecognizedIAFMLA(InternationalAccreditationForumMultilateralRecognitionArrangement)memberandwheretheaccreditationbody’smainscopeincludesmanagementsystemcertificationtoISO/IEC17021;c)certificationtoISO9001withcompliancetoothercustomer-definedQMSrequirements(suchasMinimumAutomotiveQualityManagementSystemRequirementsforSub-TierSuppliers[MAQMSR]orequivalent)throughsecond-partyaudits;d)certificationtoISO9001withcompliancetoIATF16949throughsecond-partyaudits;IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage8of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION8(cont.)revised8.4.2.3Supplierqualitymanagementsystemdevelopmente)certificationtoIATF16949throughthird-partyaudits(validthird-partycertificationofthesuppliertoIATF16949byanIATF-recognizedcertificationbody).NOTE:TheminimumacceptablelevelofQMSdevelopmentmaybecompliancetoISO9001throughsecond-partyaudits,ifauthorizedbythecustomer.Rationaleforchange:Clarifiedtheexpectedsupplierqualitymanagementsystemdevelopmentprogression.Thisapproachsupportsthe“RiskBasedThinking”conceptemphasizedthroughoutSection8.4ofthestandard.Additionalclarificationaddedwith“asapplicable”inthefirstparagraphtoaddressthoseorganizationsthatarenoteligibleforIATF16949certification(examplesincludingbutnotlimitedtothefollowing:scrapmetalsuppliers,truckingcompanieswhoprovidetransportandlogisticssupport,etc.).98.7.1.1CustomerauthorizationforconcessionTheorganizationshallobtainacustomerconcessionordeviationpermitpriortofurtherprocessingwhenevertheproductormanufacturingprocessisdifferentfromthatwhichiscurrentlyapproved.Theorganizationshallobtaincustomerauthorizationpriortofurtherprocessingfor“useasis”andreworkforrepair(see8.7.1.5)dispositionsofnonconformingproduct.Ifsub-componentsarereusedinthemanufacturingprocess,thatsub-componentreuseshallbeclearlycommunicatedtothecustomerintheconcessionordeviationpermit.Rationaleforchange:Clarifyrequirementsandeliminatecontradictioninrelationtocustomerapprovalassociatedwithrework.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage9of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION10revised7.1.5.3.2.ExternallaboratoryExternal/commercial/independentlaboratoryfacilitiesusedforinspection,test,orcalibrationservicesbytheorganizationshallhaveadefinedlaboratoryscopethatincludesthecapabilitytoperformtherequiredinspection,test,orcalibration,andeither:—thelaboratoryshallbeaccreditedtoISO/IEC17025oritsnationalequivalent(e.g.,CNAS-CL01inChina)byanaccreditationbody(Signatory)oftheILACMRA(InternationalLaboratoryAccreditationForumMutualRecognitionArrangement–www.ilac.org)ornationalequivalentandincludetherelevantinspection,test,orcalibrationserviceinthescopeoftheaccreditation(certificate);thecertificateofcalibrationortestreportshallincludethemarkofanationalaccreditationbody;or—thereshallbeevidencethattheexternallaboratoryisacceptabletothecustomer.Rationaleforchange:Someorganizationsfoundthelabaccreditationrequirementsforexternal/commercial/independentlaboratoryfacilitiesusedforinspection,test,orcalibrationservicesconfusingandneededclarification.Clarifiedlabaccreditationrequirementsandexpectations.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage10of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION118.5.6.1.1TemporarychangeofprocesscontrolsTheorganizationshallidentify,document,andmaintainalistoftheprocesscontrols,includinginspection,measuring,test,anderror-proofingdevices.,thatincludestheprimaryprocesscontrolandtheapprovedback-uporalternatemethods.Thelistofprocesscontrolsshallincludetheprimaryprocesscontrolsandtheapprovedback-uporalternatemethods,ifback-uporalternatemethodsexist.Rationaleforchange:Clarifiedthatnoteveryprimaryprocesscontrolhasaback-uporalternatemethod.Clarifiedthatifaback-uporalternatemethodexists,thatthoseback-uporalternatemethodsareincludedonalistmaintainedbytheorganization.Itisnotarequirementtohaveanalternativeprocesscontrolforeveryprimarycontrol.125.1.1.2ProcesseffectivenessandefficiencyTopmanagementshallreviewtheproductrealizationprocesseseffectivenessandefficiencyofthequalitymanagementsystemandsupportprocessestoevaluateandimprovetheireffectivenessandefficiencytheorganization’squalitymanagementsystem.Theresultsoftheprocessreviewactivitiesshallbeincludedasinputtothemanagementreview(seeSection9.3.2.1.).Rationaleforchange:Clarifiedthatnoteveryprocessrequiresanefficiencymeasure.Theorganizationneedstodeterminewhichprocessesrequireefficiencymeasureswithintheirqualitymanagementsystem.Additionally,theorganization’sproblem-solvingprocessesneedtohaveaneffectivenessreviewconductedbytheorganization’smanagement.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage11of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION139.3.2.1Managementreviewinputs–supplementalInputtomanagementreviewshallinclude:a)costofpoorquality(costofinternalandexternalnonconformance);b)measuresofprocesseffectiveness;c)measuresofprocessefficiencyforproductrealizationprocesses,asapplicable;d)productconformance;e)assessmentsofmanufacturingfeasibilitymadeforchangestoexistingoperationsandfornewfacilitiesornewproduct(seeSection7.1.3.1);f)customersatisfaction(seeISO9001,Section9.1.2);g)reviewofperformanceagainstmaintenanceobjectives;h)warrantyperformance(whereapplicable);i)reviewofcustomerscorecards(whereapplicable);j)identificationofpotentialfieldfailuresidentifiedthroughriskanalysis(suchasFMEA);k)actualfieldfailuresandtheirimpactonsafetyortheenvironment.Rationaleforchange:Clarifiedthatnoteveryprocessrequiresanefficiencymeasure.Theorganizationneedstodeterminewhichprocessesrequireefficiencymeasureswithintheirqualitymanagementsystem.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage12of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION149.2.2.2QualitymanagementsystemauditTheorganizationshallauditallqualitymanagementsystemprocessesovereachathree-yearauditcyclecalendarperiod,accordingtoanannualprogramme,usingtheprocessapproachtoverifycompliancewiththisAutomotiveQMSStandard.Integratedwiththeseaudits,theorganizationshallsamplecustomer-specificqualitymanagementsystemrequirementsforeffectiveimplementation.Thecompleteauditcycleremainsthreeyearsinlength.Thequalitymanagementsystemauditfrequencyforindividualprocesses,auditedwithinthethree-yearauditcycle,shallbebaseduponinternalandexternalperformanceandrisk.Organizationsshallmaintainjustificationfortheassignedauditfrequencyoftheirprocesses.Allprocessesarerequiredtobesampledthroughoutthethree-yearauditcycleandauditedtoallapplicablerequirementsintheIATF16949standard,includingISO9001baserequirements,andanycustomer-specificrequirements.Rationaleforchange:Clarifiedthattheauditcycleremainsthreeyearsinlength.DeletedIATF16949FAQ18andputformerFAQ182ndparagraphrequirementsintoSI14.Clarifiedthatallprocessesaretobeauditedduringthethree-yearauditcycle.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage13of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION153.1TermsanddefinitionsfortheautomotiveindustryembeddedsoftwareEmbeddedsoftwareisaspecializedprogrammestoredinanautomotivecomponent(typicallycomputerchiporothernon-volatilememorystorage)specifiedbythecustomer,oraspartofthesystemdesign,tocontrolitsfunction(s).ToberelevantinthescopeofIATF16949certification,thepartthatiscontrolledbyembeddedsoftwaremustbedevelopedforanautomotiveapplication(i.e.,passengercars,lightcommercialvehicles,heavytrucks,buses,andmotorcycles;seeRulesforachievingandmaintainingIATFRecognition,5thEdition,Section1.0EligibilityforCertificationtoIATF16949,forwhatiseligiblefor“Automotive”).NOTE:Softwaretocontrolanyaspectofthemanufacturingprocess(e.g.,machinetomanufactureacomponentormaterial)isnotincludedinthedefinitionofembeddedsoftware.Rationaleforchange:Minimizeconfusionregardingembeddedsoftwareandwhatisapplicable.DeletedIATF16949FAQ10.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage14of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION169.3.2.1Managementreviewinputs–supplementalInputtomanagementreviewshallinclude:a)costofpoorquality(costofinternalandexternalnonconformance);b)measuresofprocesseffectiveness;c)measuresofprocessefficiencyforproductrealizationprocesses,asapplicable;d)productconformance;e)assessmentsofmanufacturingfeasibilitymadeforchangestoexistingoperationsandfornewfacilitiesornewproduct(seeSection7.1.3.1);f)customersatisfaction(seeISO9001,Section9.1.2);g)reviewofperformanceagainstmaintenanceobjectives;h)warrantyperformance(whereapplicable);i)reviewofcustomerscorecards(whereapplicable);j)identificationofpotentialfieldfailuresidentifiedthroughriskanalysis(suchasFMEA);k)actualfieldfailuresandtheirimpactonsafetyortheenvironment;l)summaryresultsofmeasurementsatspecifiedstagesduringthedesignanddevelopmentofproductsandprocesses,asapplicable.Rationaleforchange:Inthesection“8.3.4.1Monitoring”thesummaryresultsofmeasurementsatspecifiedstagesduringthedesignanddevelopmentofproductsandprocesseswasrequiredasaninputtomanagementreview;however,itwasnotdisplayedinthesection9.3.2.1.Measurementsmayconsider,forexample:timing,costs,orfeasibility.IATF-InternationalAutomotiveTaskForceIATF16949:2016---SanctionedInterpretations(SIs)www.iatfglobaloversight.orgPage15of15NUMBERIATF16949REFERENCESANCTIONEDINTERPRETATION176.1.2.3Contingencyplansa)–d)(…)e)periodicallytestthecontingencyplansforeffectiveness(e.g.simulations,asappropriate);cybersecuritytestingmayincludeasimulationofacyber-attack,regularmonitoringforspecificthreats,identificationofdependenciesandprioritizationofvulnerabilities.Thetestingisappropriatetotheriskofassociatedcustomerdisruption;Note:cybersecuritytestingmaybemanagedinternallybytheorganizationorsubcontractedasappropriateRationaleforchange:Cybersecurityisagrowingrisktomanufacturingsustainabilityinallmanufacturingfacilities,includingautomotive.ContingencytestinghasalsobeenidentifiedbyorganizationsandCBsasanareainneedofclarification.Thisupdateprovidesdetailsofwhatistobetestedaspartofacyber-attackcontingencyplanvalidation.187.1.3.1Plant,facility,andequipmentplanningTheorganizationshalluseamultidisciplinaryapproachincludingriskidentificationandriskmitigationmethodsfordevelopingandimprovingplant,facility,andequipmentplans.Indesigningplantlayouts,theorganizationshall:a)optimizematerialflow,materialhandling,andvalue-addeduseoffloorspaceincludingcontrolofnonconformingproduct;andb)facilitatesynchronousmaterialflow,asapplicable;andc)implementcyberprotectionofequipmentandsystemssupportingmanufacturing.Rationaleforchange:Cybersecurityisnotlimitedtothesupportfunctionsandofficeareasusingcomputers.Manufacturingalsousescomputerizedcontrolsandequipmentwhichwouldbeatrisktocyber-attack.Thisadditiondrivestheimplementationofnecessaryprotectionstoensurecontinuedoperationandproductiontomeetcus