Welcome to the seventeenth edition of the Quality Partner newsletter. The newsletter is designed to keep readers up to date with developments in Quality Management Systems. This issue focuses on:

• Effectiveuseoferrorproofing• Sanctionedinterpretations• Customerrequirementsverses

customerspecificrequirements• Whatisaccreditation• Questionsandanswers

Ifyouhaveanyquestionsortopicsforfutureeditions,pleasefeelfreetoemailpaul.hardiman@qualitypartner.co.uk

Iamsure2020willbechallengingformanyofus,butlet’snotfocusonthehappeningswecannotinfluence,butthethingsthatwecan,whichwillincludemaintainingIATF16949certificationandcontinualimprovement.

IATF I6949 certification status

Attheendof2019thereweremorethan74,000IATF16949certifiedsitesglobally.Ofthis,72%ofthesecertificateswereissuedtoorganizationsintheAsiaPacificregion,15%inEurope,8%inNorthAmericaand

5%intherestoftheworld.

China,IndiaandSouthKoreacontinuetobethetop3countriesforcertification.

Regardinganalysisofthemajornonconformitiesraisedin2019,over2500wereraisedagainstnonconformityandcorrectiveaction(10.2.1)orproblemsolving(10.2.3).Thisisnotsurprising,assomeofthesemajornonconformitieswouldhavebeenraisedbecausethecorrectiveactionfromminornonconformitiesfrompreviousvisitshadnotbeeneffectivelyimplemented(wheretherulesmandatethattheminorgetsescalatedtoamajorandanewmajorraisedagainstcorrectiveaction)

Forminornonconformities,clause8.5.1.1,controlplan,wasthenumberone,withover9000nonconformitiesraised,with8.3.5.2,manufacturingprocessdesignoutput,asnumbertwo,withover8000nonconformities.ForMoreInformationVisit

www.qualitypartner.co.uk

Author:PaulHardiman

Quality Partner Newsletter

January 2020

Issue date: January 2020

1

Error proofing

Inthe2016publicationofIATF16949,therewasanincreasedemphasisontheuseoferrorproofingaspartofdefectprevention,witherrorproofingbeingmentioned12timesinthestandard.

TheIATFdefinitionoferrorproofingis:

• “productandmanufacturingprocessdesignanddevelopmenttopreventmanufactureofnonconformingproducts”

AdditionalguidanceonerrorproofingcanbefoundinCQI-18,whereerrorproofingisdefinedas:

• Useofproductcharacteristics,techniques,methodsand/ordevicesduring:• Designphasesoraproductorprocess• Aspartofanimprovementorcorrectiveactionprocess

Toensurethat:

• Theproductwillfunctionasdesiredand/or:• Theproductdesignwillallowtheparttobeassembledormanufacturedonlyaccordingtothedesign

intentand/or• Processerrorswillbedetectedatthesourceanddefectswillbepreventedor,ifdiscovered,willnotbe

passedtothenextprocessstep.Therefore,apotentialdefectwillnotbesenttothecustomer.

Thisdefinitionseemstointimatethatmistake-proofingcanbepartoferrorproofing,wherethemanufactureofadefectmaynotbeabletobeprevented,butasystemisinplacetodetectthedefectinstation,preventingfurtherprocessing.

InIATF16949,requirement8.3.1.1,itstates:

“TherequirementsofISO9001,Section8.3.1,shallapplytoproductandmanufacturingprocessdesignanddevelopmentandshallfocusonerrorpreventionratherthandetection.”

Theorganizationshalldocumentthedesignanddevelopmentprocess”

Thisrequirementfocusesonensuringanorganizationimplementserrorproofingwhenintroducinganewdesign(whichcouldincludeanewproductornewmanufacturingprocess).

IntegraltothisshouldbeidentifyingthepotentialuseoferrorproofingwhendevelopingtheDFMEAorPFMEA.UsingtheconceptsintheAIAG-VDAFMEAhandbook,thiscouldbewherehighactionpriority(AP)rankingsareidentified.Byimplementingerrorproofingthiscouldimpactoccurrenceordetection.

IATFrequirement10.2.3states:

“Theorganizationshallhaveadocumentedprocesstodeterminetheuseofappropriateerror-proofingmethodologies.Detailsofthemethodusedshallbedocumentedintheprocessriskanalysis(suchasPFMEA)andtestfrequenciesshallbedocumentedinthecontrolplan.”

InDFMEA,occurrencecanbescoredas1when“Failureeliminatedthroughpreventioncontrolandfailurecauseisnotpossiblebydesign”anddetectionas1when“Priortestingconfirmedthatfailuremodeorcausecannotoccur,ordetectionmethodsproventoalwaysdetectthefailuremodeorfailurecause.”

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AnexampleisthedesignofaSIMcardforamobilephone,which,duetotheproductdesign,cannotbeassembledthewrongwayinthedevice.

AndinPFMEA,occurrencecanbescoredas1when“Preventioncontrolsareextremelyeffectiveinpreventingfailurecausefromoccurringduetodesign(e.g.partgeometry)orprocess(e.g.fixtureortoolingdesign).Intentofpreventioncontrols–FailureModecannotbephysicallyproducedduetotheFailureCause”,anddetectionas1when“Failuremodecannotbephysicallyproducedasdesignedorprocessed,ordetectionmethodsproventoalwaysdetectthefailuremodeorfailurecause.”

Obviouslytheremaybetechnicaloreconomicconstraintswhendecidingontheuseoferror-proofing,butdecisionsshouldbemadeusingrisk-basedthinking.Step7oftheAIAG-VDAhandbookapproachtodevelopingFMEAgivestheFMEAteamtheopportunitytosummarisetheresultsoftheFMEAactivitytoManagement,includingalistofthehighactionpriorityrisksidentifiedandrecommendedimprovementactions.

Nowlet’slookaterrorproofingdevices:

ThedefinitioninCQI-18is:

• “Useofmechanical,electronicorsoftwaredevicesusedtopreventordetectsomecriticalrequirementfortheproductorprocess.Solutionscanbetechnical(closedloop)orbehavioural(humanreaction)”

ThetermPoke-Yokeisoftenusedintheautomotiveindustry;thedefinitioninCQI-18is:

• “Generallylowcost,devicesusedintheJidoka(prevention)systemthatwillstopprocessinordertopreventtheproductionofpotentiallydefectiveproduct.Thistermissometimesusedinindustrytosignifyalltypesoferrorproofingdevices.”

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OnceerrorproofingisimplementedIATF1694910.2.4requires:

“Theprocessshallincludethetestingoferror-proofingdevicesforfailureorsimulatedfailure.Recordsshallbemaintained.Challengeparts,whenused,shallbeidentified,controlled,verified,andcalibratedwherefeasible.Error-proofingdevicefailuresshallhaveareactionplan.”

TheIATFdefinitionofchallengepartis:

• “part(s)ofknownspecification,calibratedandtraceabletostandards,withexpectedresults(passorfail)thatareusedtovalidatethefunctionalityofanerror-proofingdeviceorcheckfixtures(e.g.,go/no-gogauging)”

Thefrequencyoftestingwilldependonrisk,butthekeythingisthisshouldbedocumentedinthecontrolplan,andrecordsmaintainedtodemonstratethefrequencyhasbeencompliedwith.Intheeventofanissuebeingidentifiedwiththeerrorproofingdevice,operatorsneedtobetrainedinhowtoreact(asdefinedinthereactionplaninthecontrolplan).

So,insummary,errorproofingmethodologyshouldbebuiltintothedocumentedproductandprocessdesignprocess.

Forexistingprocesses,errorproofingmaybeimplementedaspartofongoingcontinualimprovementorbasedoninternalorexternalissueswiththeproductorprocess(reactiveuse).

Thekeythingis,whileitisgreattohaveerrorproofing,itisonlyeffectiveifthefunctioningoftherelevantdevice/instrumentisverifiedasbeingeffective,bycompetentoperators,onanongoingbasis.

What is an IATF 16949 Sanctioned Interpretation and where to find them

So,whatisasanctionedinterpretation?

TheIATFdefinitionis:

“ASanctionedInterpretation(SI)changestheinterpretationofanIATF16949requirementwhichitselfthenbecomesthebasisforanonconformity”SincethepublicationofIATF16949inSeptember2016,interestedpartiestothescheme,includingauditors,clientsandconsultants,havesometimesfedbacktoIATFOversightsthatcertainrequirementsintheIATFstandardforachievingIATFrecognitionarenotclear.

Typically,IATFreviewandreissuethestandardwhenthereisare-publicationofISO9001,normallyevery5-10years.Thatwouldbealongtimetowaittointroduceachange!

OnceachangethroughaSIhasbeenapprovedbyIATF,thechangeispublishedontheIATFGlobaloversightwebsite,intheIATFapprovedgloballanguages:

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https://www.iatfglobaloversight.org/iatf-169492016/iatf-169492016-sis/

EachissuedSIisissuedinastandardformat:

TheSIisgivenanumber,therelevantIATF16949clauseiscited,andthechangetotherequirementisindicatedinblue.So,intheexampleshown,therequirementforacontingencyplantocovercyber-attacksoninformationtechnologyrequirementsisadded.

EachSIincludesarationaleforwhythechangewasmade.

Typically,sanctionedinterpretationsareissuedbyIATF1to3timesperyear.

Byaddingyoure-mailaddressinthesubscribeboxshown,youwillautomaticallybeupdatedwithanynewsanctionedinterpretations.

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Thesubscriptionscreencanbeseenat:https://www.iatfglobaloversight.org/iatf-169492016/iatf-169492016-sis/

So,let’ssummarise:

AnyIATFcertifiedorganizationneedstoreviewanynewsanctionedinterpretationsandmakethenecessarychangestotheirqualitymanagementsystem,inaccordancewiththedefinedtimingspecifiedwhentherelevantSIsarereleased.

Auditors(Internal,secondandthirdparty)alsoneedtobeawareoftheSIsandthechangeswillaffecttheauditcriteria.

Customer requirement verses Customer specific requirement

AquestionIoftengetaskedisthedifferencebetweencustomerrequirementandcustomerspecificrequirement.

TheIATFdefinitionofcustomerrequirementis:

• “Allrequirementsspecifiedbythecustomer,forexampletechnical,commercial,productandmanufacturingprocess-relatedrequirements,generaltermsandconditions,andcustomer-specificrequirements.”

So,usingthisdefinition,customerspecificrequirementsarepartofcustomerrequirements.TheIATFdefinitionofcustomerspecificrequirementsis:• “interpretationsoforsupplementalrequirementslinkedtoaspecificclause(s)ofthisAutomotiveQMS

Standard”

WhereasallIATFmembers,andmanyothervehiclemanufacturersmandateIATF16949certificationoftheirsuppliers,theyalsoaddadditionalqualitymanagementsystemrequirementsthroughcustomerspecificrequirements.

IATFmemberspublishtheircustomerspecificrequirementsontheIATFglobaloversightwebsite.

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https://www.iatfglobaloversight.org/oem-requirements/customer-specific-requirements/

Itisimportantthat,aspartoffeasibilityreview,organizationsreviewanycustomerspecificrequirements,especiallyforanynewcustomer.

Complyingwithcustomerspecificrequirementscanhavesignificantcostimplications.

Someexamples:

• Fordcustomerspecificrequirementsforlayoutinspection(8.6.2)states:

“Theorganizationshallperformannuallyalayoutinspection(toalldimensionalrequirements)onatleast5parts.”

Thiscantakeasignificantamountoftimetocollectandrecordthisdata,especiallyforcomplexparts.

• GMcustomerspecificrequirementsformanufacturingprocessaudit(9.2.2.3)states:

“Theorganizationshallincorporateaninternallayeredprocessauditprocesstoassesscompliancetostandardizedprocesses,toidentifyopportunitiesforcontinuousimprovement,andtoprovidecoachingopportunities.ThelayeredprocessauditisledbyManagementwhoarecompetenttoconducttheaudits.”Again,tosetupandmaintainalayeredprocessauditsystemcantakesignificanttimeandeffort,aswellasinvestmentintherelevanttrainingformanagementandothersupervisorypersonnelwhowillbeinvolvedintheauditprocess.

• VWGroupcustomerspecificrequirementsforsecondpartyaudits(7.2.4and8.4.2.4.1)states:

“Theprocess-auditsinthesupplychainmustbeconductedinaccordancetoFormel-Q-CapabilitybycertifiedVDA6.3auditors(seeauditorqualificationinSection3.2ofFQF8.0).”

TobecomeaVDA6.3certifiedauditor,candidatesmustmeetverystrictentryrequirements,attendfourdaysofsanctionedtrainingfollowedbyonedayofexams(writtenandinterview).Again,thiscanhavesignificantcostimplications.

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QualityPartnerNewsletterJanuary2020

CustomerspecificrequirementsdonotjustapplytoIATFOEMmembers.

Anyorganizationintheautomotivesupplychaincanaddcustomerspecificrequirementsforsuppliers.

Theissueisthesecansometimesbedifficulttofind!

Onepotentialsourceiswww.customerspecifics.com

Thesite,whichisfreetoaccess(onceyouhavesetupausernameandpassword),hasasearchfacilitybyindustry(includingautomotive)andbyaspecificcompanyname.

TheexampleinthescreenshotisforLearAutomotive,whoaccordingtothesite,werelastupdatedinMay2019.Whilethereisnoguaranteethatthisisthelatestversion,atleastitisastartingpoint,especiallyifundertakingafeasibilityreviewforanewcustomer.

InreviewingtheLearrequirementsthisraisesaninterestingquestion.TherequirementsinthedocumentarenotwrittentomatchtheclausesofIATF16949.

Anexample:

16.8ProductionPartApproval

“16.8.1SuppliersarenotauthorizedtobeginproductionorshipmaterialtoLearpriortoobtainingapprovalfromtheLearreceivingfacilitypertherequirementsoftheAIAGProductionPartApprovalProcess(PPAP)Manual,accordingtothelatestrevisionlevel.AnydeviationtothisrequirementmustbeapprovedinadvanceandagreedbyLearinwriting.”

InLearrequirementsthisis16.8,butinIATF16949therelevantclauseis8.3.4.4Productapprovalprocess.

So,isthisacustomerspecificrequirement?

Inmyviewitis,butsomewouldargueitisnotasitisnotspecifically“linked”,asspecifiedinthedefinition:

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• “interpretationsoforsupplementalrequirementslinkedtoaspecificclause(s)ofthisAutomotiveQMSStandard”

Whetherornotthisisacustomerspecificrequirement,therequirementofthecustomer(inthiscaseLear)stillmustbemet,withintheframeworkoftheQualityManagementSystem.

Insummary,manyorganizationsdonotpayenoughattentiontocustomerspecificrequirementsintheircontractreviewprocess,whichcanendupcausingcustomerdissatisfaction,andpossiblesignificantunbudgetedinternalcosts.

What is accreditation and what to look for in ISO9001 supplier certificates?

Oneofthemuch-discussedrequirementsinIATF16949isthecertificationrequirementsforsupplierstoanIATF16949certifiedorganization.

Let’sstartwithbasics:whatisthemeaningofaccreditation?

Ageneraldescriptionis

• “Theactionorprocessofofficiallyrecognizingsomeoneashavingaparticularstatusorbeingqualifiedtoperformaparticularactivity.”

So,whatdoesthismeaninthecontextofIATF16949?

IATFrequirement8.4.2.3Supplierqualitymanagementsystemdevelopmentstates:

a)certificationtoISO9001throughthird-partyaudits;unlessotherwisespecifiedbythecustomer,supplierstotheorganizationshalldemonstrateconformitytoISO9001bymaintainingathird-partycertificationissuedbyacertificationbodybearingtheaccreditationmarkofarecognizedIAFMLA(InternationalAccreditationForumMultilateralRecognitionArrangement)memberandwheretheaccreditationbody’smainscopeincludesmanagementsystemcertificationtoISO/IEC17021;

DetailsofIAFMLAmemberscanbefoundathttps://www.iaf.nu/articles/Accreditation_Body_Members_by_Name/52

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Whenanorganizationreviewsasuppliercertificate,theyshouldlookforevidencethatthecertificatehasdetailsofwhichcertificationbodyissuedthecertificate,whatisthescopeofcertification(thisshouldmatchtheproductorserviceyouarepurchasing),whatistheexpirydateandwhataccreditationmarkisonthecertificate.

Anexampleisshownbelow:

Inthiscertificateexample,thecertificationbodyisaccreditedbyANAB,andANABcanbefoundontheIAFwebsiteasanIAFMLA(InternationalAccreditationForumMultilateralRecognitionArrangement)member.

YouwillfindsomecertificateswheretheIAFlogoisalsoincludedonthecertificate:So,whydidIATFintroducethisrequirement?

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Inaworldofde-regulation,somecertificationbodiesissuecertificateswithoutanynationallyrecognisedaccreditation,andassuch,thiscangivedoubtontheintegrityofthecertification.Forexample,ifnoaccreditation(checking),whochecksthecertificationbodyhasaneffectiveprocesstoallocatecompetentauditorsetc?

AtthistimethereisnoavailablelistingofISO9001IAFcompliantcertificates,althoughIbelievethisisbeingworkedon-watchthisspace!

Ask the expert

Question:InthecontextofIATF16949,whatisamanufacturingprocess?

Answer: FirstweshouldlookatthedefinitionofmanufacturingspecifiedinIATF16949:

Manufacturing

processofmakingorfabricating

• productionmaterials;• productionpartsorserviceparts;• assemblies;or• heattreating,welding,painting,plating,orotherfinishingservice

Nextlet’slookatthedefinitionofaprocess:

• “asetofinterrelatedorinteractingactivitiesthatuseinputstodeliveranintendedresult”

So,anoverallmanufacturingprocessismadeupofanumberofvalue-addedactivitiestotransitionaninput(whichcouldberawmaterials,componentsetc.)toanoutput(forexampleaproduct)thatmeetsanautomotivecustomerspecifiedrequirement.

Inclause8.3.5.2ofIATF16949itrequiresthatanorganizationdefinesa

e)manufacturingprocessflowcharts/layoutTheformatoftheflowchart/layoutisnotspecifiedinIATF16949,butthecustomercouldspecifythisincustomerspecificrequirements.Theflowchartshouldcoverfrommaterialsreceipttoproductdispatch.

Quality Partner’s expert, Paul Hardiman

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Itisimportantforthepersonplanningtheinternalauditprogrammetounderstandthemanufacturingprocesses.

TheIATFrequirement9.2.2.3states:

“Theorganizationshallauditallmanufacturingprocessesovereachthree-yearcalendarperiodtodeterminetheireffectivenessandefficiencyusingcustomer-specificrequiredapproachesforprocessaudits.Wherenotdefinedbythecustomer,theorganizationshalldeterminetheapproachtobeused.”Also,forinternalauditors7.2.3states“Ataminimum,manufacturingprocessauditorsshalldemonstratetechnicalunderstandingoftherelevantmanufacturingprocess(es)tobeaudited,includingprocessriskanalysis(suchasPFMEA)andcontrolplan.”

Question:Acompanymanufacturesonlyoneproductionpartnumberforavehiclemanufacturer.Thevehiclemanufacturerisresponsiblefortheproductdesign.Inthisfactorythereisonlyonemachinetoproducethispart.However,theyalsomanufacturepartsfor2ndand3rdtierautomotivecustomerswheretheydesignthepartsandtools.TheyintendtobecertifiedtoIATF16949.Whatshouldthescopeofcertificationcover?Answer:

ThekeyisallAUTOMOTIVEproductsmustbeincludedinthescope,atwhateverlevelinthesupplychain.So,inthiscaseifthepartstheydesignaregoingtoanautomotivecustomer,thescopemustincludedesign,sothescopemustbethedesignandmanufactureof............

Rememberproductdesignisthedesigningoftheproduct,notthetool;thetooldesigniscoveredbymanufacturingprocessdesign.

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Question:

ItwasidentifiedduringaninternalauditonRecordsManagementthatQAwerenotcomplyingwithIATF16949:20167.5.3.2.1‘Recordretention’requirementasourcalibrationrecordsareonlyretainedfor3years.Theprocessownerhaschallengedthevalidityofthefinding.Canyouclarifywhattheretentiontimeshouldbe?

Answer:

Whenconsideringretentionofrecords,youmusttakeintoaccountcustomerspecificrequirements(ifany),legalandyourownorganizationrequirementsindefiningretentiontimes.

IATF16949clause7.5.3.2.1states:

“Productionpartapprovals,toolingrecords(includingmaintenanceandownership),productandprocessdesignrecords,purchaseorders(ifapplicable),orcontractsandamendmentsshallberetainedforthelengthoftimethattheproductisactiveforproductionandservicerequirements,plusonecalendaryear,unlessotherwisespecifiedbythecustomerorregulatoryagency.”

Thisdoesnotspecificallymentioncalibrationrecords.

So,iftherearenocustomer,legalororganizationrequirements3yearsisenoughtomeetthestandard.However,iftherewasameasurementissueanditresultedinaliabilityclaim,youmaywanttoconsiderkeepingtherecordsofcalibrationlonger.

Question:

Iamwonderingifyoucouldhelpmeinclarifyingtheconditionsforaspecialstatusandtheinitiationofthedecertificationprocess.

Example1:ThecustomerreceivesanotificationfromGMinformingthemtheyhavebeenplacedonNewBusinessHold)

Shouldtheorganizationinformthecertificationbodyin10daysinthiscase?

Example2:

ThecustomerreceivesaLevel0escalationletterfromVW(Level0=Thesupplierhasproblems,thelowestofficialescalationlevelatVWgroup).

Shouldthecustomerinformthecertificationbodyin10daysinthiscase?

Areallescalationlevelsconsideredaspecialstatus,oronlythehighestones(e.g.:newbusinessonhold).

Whatexactlyisyourunderstandingforaspecialstatus?

Answer:

Averyinterestingquestion,that,ifIamhonest,isnotclearintheIATFscheme.

Firstly,thedefinitionofspecialstatusis

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• “Notificationofacustomer-identifiedclassificationassignedtoanorganizationwhereoneormorecustomerrequirementsarenotbeingsatisfiedduetoasignificantqualityordeliveryissue.”

IntheIATFrules,5thedition,itstates:

8.1Initiationofthedecertificationprocess

b)theclientadvisesthecertificationbodyofaspecialstatusconditionfromanIATFOEM.Notificationfromtheclienttothecertificationbodyshalloccurwithinten(10)calendardaysfromreceiptofthespecialstatusconditionorotherwisespecifiedbythecustomer;

Inadditiontothisrequirement,youshouldconsultcustomerspecificrequirements.

IntheExample1GMcustomerspecificrequirementsstate:

“TheorganizationshallnotifytheirCertificationBodywithin5businessdaysofreceivingnoticeofspecialstatusconditionofGMNewBusinessHold–Quality.TheCertificationBodyshalltakethedecisiontoplacetheorganizationonimmediatesuspension*uponreceivingnoticeofGMNewBusinessHold–Quality(NBH).”Inthiscase,thecustomerspecificrequirementsaddaninterpretationtotheIATFrulesandtheorganizationmustinformthecertificationbodywithin5businessdaysandnot10calendardaysasdefinedintherules.Inexample2thisislessclear,asthereisnospecificrequirementrelatedtothisintheVWIATF16949customerspecificrequirements.

InFormelQ,whichisreferencedintheCSRs,itstates:

“Shouldthesemeasuresandimprovementprogrammes,requiredbytheVWgroup,notbeadequatelyimplementedintimeandthisdefectoccurrepeatably,theexistingVWgroupescalationprinciplewillapply.”

So,althoughintheexampleVWhavenotifiedthesupplierofissues,inmyviewthiswouldnotbedeemedasacustomernotificationofsignificantqualityordeliveryissues.

However,inanyaudit,theauditorshouldfollowuponhowtheissueswithVWhadbeenidentifiedandescalatedtoManagementreview.Ifnot,theauditorcanraiseamajornonconformity,whichwouldtriggerthedecertificationandsuspensionprocess.

Question:

Recently,weinternallyhavebeenconfusedwiththedefinitionaboutProductandProcesscharacteristicswithinourinternalauditteam.

Productcharacteristicsonlymeansfinishedproduct;theproductcharacteristicsofprocesswithintheprocessflowchartareProcesscharacteristics.Isitcorrect?

Doyouhaveofficialdefinitionorexplanationaboutproductandprocesscharacteristics?

Answer:

TheIATFdefinitionrelatedtospecialcharacteristicsis:

• “classificationofaproductcharacteristicormanufacturingprocessparameterthatcanaffectsafetyorcompliancewithregulations,fit,function,performance,requirements,orsubsequentprocessingofproduct”

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Ihavealwaysinterpretedthisthataproductcharacteristicissomethingrelatedtoafeatureoftheproduct(thiscouldbeofthefinalproductspecifiedbythecustomer,oracharacteristicoftheproductdefinedinternallyascriticaltoproducingthespecificationsofthecustomer).

Aprocesscharacteristicisnotdirectlyrelatedtotheproductbutisacharacteristicrelatedtothemanufacturingprocess(forexampletemperature,pressure,speedetc.)thatiscriticaltocontroltomeettheproductcharacteristics.