Quality Newsletter January 2020...2020/01/17 · The layered process audit is led by Management who...
Transcript of Quality Newsletter January 2020...2020/01/17 · The layered process audit is led by Management who...
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,[email protected]
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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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.