CQI-30英文审核表格资料

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,SpecialProcess:RubberProcessingSystemAssessment–Mixing&Molding,,,,,,,,,,,,,,,,,,,,

,,,,,,,FacilityName:ArmadaRubberMfg.Co.,,,,,,,,,,,,,,,,,,,,

,,,,,,,Address:24586ArmadaRidgeRoad,,,,,,,,,,,,,,,,,,,,

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

,,,,,,,PhoneNumber:586-784-9135,,,,,,,,,,,,,,,,,,,,

,,,,,,,NumberofMoldingEmployeesatthisFacility:62,,,,,,,Type(s)ofrubberprocessesareperformedatthisFacility:,,,,,,,,,,,,,

,,,,,,,,,,,,,,⃝InjectionMoldingxTransferMolding⃝CompressionMoldingxMixing,,,,,,,,,,,,,

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

,,,,,,,Captivemolderand/ormixer(Y/N):,,,,,,,⃝YesxNoSpecify:,,,,,,,,,,,,,

,,,,,,,CommercialMolderormixer(Y/N):,,,,,,,⃝YesxNoSpecify:,,,,,,,,,,,,,

,,,,,,,DateofAssessment:,,,,,,,10.13.2022,,,,,,,,,,,,,

,,,,,,,DateofPreviousAssessment:,,,,,,,N/A,,,,,,,,,,,,,

,,,,,,,ActionsfromPreviousAssessment(referenceFindingsbelow):,,,,,,,,,,,,,,,,,,,,

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

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

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

,,,,,,,CurrentQualityCertification(s):IATF16949:2016,,,,,,,,,,,,,,,,,,,,

,,,,,,,DateofRe-assessment(ifnecessary):,,,,,,,,,,,,,,,,,,,,

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

,,,,,,,PersonnelContacted:,,,,,,,,,,,,,,,,,,,,

Downloadfrom/forum.php?mod=viewthread&tid=84861,,,,,,,,,,,,,,,,,,,,,,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

More/forum.php?mod=forumdisplay&fid=43,,,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,,,Name:DonEdwards,,,Title:GM,,,,Phone:586-784-9135,,,,,,,,,,,"Email:donedwards@armad

",,

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,,,,,,,Auditors/Assessors:,,,,,,,,,,,,,,,,,,,,

,,,,,,,Name:,,,Company:,,,,Phone:,,,,,,,,,,,Email:,,

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,,,,,,,"Numberof""NotSatisfactory""Findings:0",,,,,,,,,,,,,,,,,,,,

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,,,,,,,"Numberof""NeedsImmediateAction""Findings:0",,,,,,,,,,,,,,,,,,,,

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"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

,,,,,"Section1-General,Pre-AuditSurvey",,,,,,,,,,,,,,,,,,,,,,

,,,,,,,,CompanyName:,,,,,,ArmadaRubberMfg.Co.,,,,,,,,,,,,,

,,,,,,,,CompanyAddress:,,,,,,"24586ArmadaRidgeRoad,Armada,MI48005",,,,,,,,,,,,,

,,,,,,,,Division:,,,,,,,,,,,,,,,,,,,

,,,,,,,,NumberofManufacturingShifts:,,,,,,2,,,,,,,,,,,,,

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

,,,,,,,,,,,,,,CapabilityExistsonSite,,,,,,,,,,,,,

,,,,,,,,Guidance,,,,,,Yes,,,,No,,Observations&Comments,,,,,,,

,,,,,1.1,,,In-HouseManufacturingCapabilities,,,,,,,,,,,,,,,,,,,

,,,,,1.1.1,,,Preppingofelastomers,,,,,,,,,,x,,,,,,,,,

,,,,,1.1.2,,,"Preppingoftextiles(cleaning,priming,forming,shaping)",,,,,,,,,,x,,,,,,,,,

,,,,,1.1.3,,,Calendering/skimcoating,,,,,,,,,,x,,,,,,,,,

,,,,,1.1.4,,,Textilesolutioncoating,,,,,,,,,,x,,,,,,,,,

,,,,,1.1.5,,,Compounding,,,,,,x,,,,,,,,,,,,,

,,,,,1.1.6,,,InjectionMolding,,,,,,x,,,,,,,,,,,,,

,,,,,1.1.7,,,TransferMolding,,,,,,x,,,,,,,,,,,,,

,,,,,1.1.8,,,Coldpot,,,,,,x,,,,,,,,,,,,,

,,,,,1.1.9,,,Traditional,,,,,,x,,,,,,,,,,,,,

,,,,,1.1.2010,,,CompressionMolding,,,,,,,,,,,,,,,,,,,

,,,,,1.1.2011,,,Moldingtextilereinforced,,,,,,,,,,x,,,,,,,,,

,,,,,1.1.2012,,,Moldingcompositearticles(rubber-metal;rubber-plastic),,,,,,,,,,x,,,,,,,,,

,,,,,1.1.2013,,,SubstrateTreatment,,,,,,,,,,x,,,,,,,,,

,,,,,1.2,,,PrincipalCuringMethods,,,,,,,,,,,,,,,,,,,

,,,,,1.2.1,,,Autoclave,,,,,,,,,,x,,,,,,,,,

,,,,,1.2.2,,,In-mold,,,,,,x,,,,,,,,,,,,,

,,,,,1.2.3,,,Oven,,,,,,,,,,x,,,,,,,,,

,,,,,1.3,,,PostCure,,,,,,,,,,,,,,,,,,,

,,,,,1.3.1,,,Aircirculatingovens,,,,,,,,,,x,,,,,,,,,

,,,,,1.3.2,,,E-beam,,,,,,,,,,x,,,,,,,,,

,,,,,1.3.3,,,Deflashing,,,,,,x,,,,,,,,,,,,,

More/forum.php?mod=viewthread&tid=77933,,,,,,,,,,,,,,,,,,,,,,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

1.3.4,,,,PostMoldingTrimming,,,,,,,,,,x,,,,,,,,,,,,,

1.3.5,,,,Inspection/ProductTesting,,,,,,,,,,x,,,,,,,,,,,,,

1.3.6,,,,OutsourcedProcesses/Operations,,,,,,,,,,x,,,,,,,,,,,,,

1.3.7,,,,Testingon-site,,,,,,,x,,,,,,,,,,,,,,,,

1.3.8,,,,Inspectionon-site,,,,,,,x,,,,,,,,,,,,,,,,

1.3.9,,,,QualityConformanceTesting,,,,,,,x,,,,,,,,,,,,,,,,

,,,,Performedinternally,,,,,,,x,,,,,,,,,,,,,,,,

,,,,Performedexternally,,,,,,,,,,x,,,,,,,,,,,,,

,,,,Combinationofboth,,,,,,,,,,x,,,,,,,,,,,,,

1.4,,,,CalibrationCapability,,,,,,,,,,,,,,,,,,,,,,,

1.4.1,,,,Performedinternally(compliantwithISO/IEC17025orISO10012),,,,,,,x,,,,,,,,,,,,,,,,

1.4.2,,,,OutsourcedISO/IEC17025accreditedLaboratory,,,,,,,,,,x,,,,,,,,,,,,,

1.4.3,,,,Combinationofboth,,,,,,,,,,x,,,,,,,,,,,,,

1.5,,,,IsthereacurrentQualityCertification,,,,,,,,,,,,,,,,,,,,,,,

1.5.1,,,,NameofAuditing/CertifyingOrganization,,,,,,,x,,,,,,,NSF,,,,,,,,,

,,,,TypeofCertificate,,,,,,,,,,,,,,IATF16949:2016,,,,,,,,,

1.5.2,,,,CertificateIssueDate,,,,,,,,,,,,,,4.7.2022,,,,,,,,,

1.5.3,,,,CertificationexpirationDate,,,,,,,,,,,,,,4.4.2025,,,,,,,,,

1.5.4,,,,Certificatenumber,,,,,,,,,,,,,,447714,,,,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.1,Thereshallbeadedicatedandqualifiedmoldingprofessionalonsite.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Toensurereadilyavailableexpertise,thereshallbeadedicatedandqualifiedprofessionalonsite.

•Thisindividualshallbeafull-timeemployeeandthepositionshallbereflectedintheorganizationchart.

•Ajobdescriptionshallexistidentifyingthequalificationsforthepositionincludingchemicalandmoldingknowledge.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Whatisthisperson’stitle?,,,,,,,,,,,,,,,,,,,x,,GM,,,,,,

Isthispositionreflectedintheorganizationalchart?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Isthereadocumentedjobdescriptionlistingalltherequiredqualificationsandresponsibilitiesofthisposition?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Describeindetailthisperson’seducationalbackgroundandpracticalexperience.,,,,,,,,,,,,,,,,,,,x,,56yearsexperienceasGM,,,,,,

Howmanyyearsofprocessexperienceatrubbermixing/moldingfacilitydoesthispersonhave?,,,,,,,,,,,,,,,,,,,,,56,,,,,,

Isthisindividualafull-timeemployeeatthelocationbeingaudited?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.2,Thefacilityshallperformadvancedqualityplanning.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Theorganizationshallincorporateadocumentedadvancedproductqualityplanningprocess.

•Afeasibilitystudyshallbeperformedandinternallyapprovedforeachnewpartorprocess.Similarpartscanbegroupedintopartfamiliesforthiseffortasdefinedbytheorganization.

•Afterthepartapprovalprocessisapprovedbythecustomer,noprocesschangesareallowedunlessapprovedbythecustomer.

•Theorganizationshallcontactthecustomerwhenclarificationofprocesschangesisrequired.Thisclarificationofprocesschangesshallbedocumented.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Doesthefacilityuseadocumentedadvancedqualityplanningprocess?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

"Doesthefacilityperformadocumentedinternalfeasibilitystudyforeachpartbeforeprocessing?

Ifno,doesthefacilityperformadocumentedinternalfeasibilitystudyforsimilarparttypesorfamilyofpartsbeforeprocessing?",,,,,,,,,,,,,,,,,,,x,,,,,,,,

WhatistheprocedureforchangingtheprocessafterPPAPorothercustomer-specifiedpart/processapproval?,,,,,,,,,,,,,,,,,,,x,,changeprocess,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.3,ThefacilitiesFMEAsshallbeuptodateandshallreflectthecurrentprocess.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•TheorganizationshallincorporatetheuseofadocumentedFailureModeandEffectsAnalysis(FMEA)andensuretheFMEAsareupdatedtoreflectcurrentpartqualitystatus.

•TheFMEAshallbewrittenforeachpartorpartfamilyortheymaybeprocessspecificandwrittenforeachprocess.

•FMEAsshalladdresseveryprocessstepfrompartreceipttopartshipment.

•Across-functionalteamshallbeusedinthedevelopmentoftheFMEA.

•Allspecialcharacteristics,asdefinedbytheorganizationanditscustomers,shallbeidentified,defined,andaddressedintheFMEA.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

DoesthefacilityhaveadocumentedFailureModeandEffectsAnalysis(FMEA)inuse?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

IdentifythenamesandjobfunctionoftheteammembersusedinthedevelopmentoftheFMEA.,,,,,,,,,,,,,,,,,,,,,"Edwards,Bianchi,Tobey",,,,,,

"IdentifyiftheFMEAiswrittenforeachpart,partfamilyorprocessspecific.",,,,,,,,,,,,,,,,,,,x,,,,,,,,

"AreallFMEAsconsistentwithallassociateddocumentationsuchascontrolplans,workinstructionsandshoptravelers?",,,,,,,,,,,,,,,,,,,x,,,,,,,,

DoallFMEAsincludeeveryprocessstepfrompartreceipttopartshipment?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

"Arespecialcharacteristics,asdefinedbytheorganizationanditscustomers,identified,defined,andaddressedintheFMEAs?",,,,,,,,,,,,,,,,,,,x,,,,,,,,

ProvideevidencethattheFMEAhasbeenupdatedinresponsetoqualityissues.,,,,,,,,,,,,,,,,,,,x,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.4,Theprocesscontrolplansshallbeuptodateandshallreflectthecurrentprocess.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Theorganizationshallincorporatetheuseofadocumentedcontrolplanandensurethecontrolplansareupdatedtoreflectcurrentcontrols.

•Thecontrolplansshallbewrittenforeachpartorpartfamilyortheymaybeprocess-specific.

•Thecontrolplansshalladdressallprocessstepsfrompartreceipttopartshipmentandidentifyallequipmentusedandallkeymoldingprocessparametersasdefinedbytheorganization.

•Across-functionalteamshallbeusedinthedevelopmentofcontrolplans,whichshallbeconsistentwithallassociateddocumentationsuchasworkinstructions,shoptravelers,andFMEAs.

•Allspecialcharacteristics,asdefinedbytheorganizationanditscustomers,shallbeidentified,defined,andaddressedinthecontrolplans.

•Thecontrolplanshalldetailtheproductandprocesscharacteristics,andcontrolsincludingtestingfrequencyandsamplesize.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Doesthefacilityhaveadocumentedcontrolplaninuse?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

"Identifyifthecontrolplaniswrittenforeachpart,partfamilyorprocessspecific.",,,,,,,,,,,,,,,,,,,x,,,,,,,,

Doallcontrolplansincludeeveryprocessstepfrompartreceipttopartshipment?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Doesthecontrolplanidentifyallkeymoldingprocessparameters?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Identifythenamesandjobfunctionoftheteammembersusedinthedevelopmentofthecontrolplan.,,,,,,,,,,,,,,,,,,,,,"Edwards,Bianchi,Tobey",,,,,,

"Arethecontrolplansconsistentwithallassociateddocumentationsuchasworkinstructions,specificationsandFMEAs?",,,,,,,,,,,,,,,,,,,x,,,,,,,,

Provideevidencethatsamplesizesandfrequenciesforevaluationofprocessandproductcharacteristicsareaddressedandconsistentwiththeminimumrequirements.,,,,,,,,,,,,,,,,,,,x,,,,,,,,

"Arespecialcharacteristics,asdefinedbytheorganizationanditscustomers,identified,defined,andaddressedinthecontrolplans?",,,,,,,,,,,,,,,,,,,x,,,,,,,,

"Provideevidencethatthecontrolplanhasbeenupdatedinresponsetoqualityissues,customerrequirementsandprocesschanges.",,,,,,,,,,,,,,,,,,,x,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.5,"Allrubbermixingandmoldingrelatedandreferencedspecificationsshallbeuptodateandavailable.Forexample:SAE,AIAG,ASTM,GeneralMotors,Ford,Stellantis,Toyota,VolvoTruck.",,,,,,,,,,,,,,,,,,,,,,,,,,

"•Adocumentcontrolsystemispertinentforthehandlingandinternaldistributionofreceivedcustomerspecificationsandtokeepuptodatewithnationalorglobalstandardsrelatedtorubbermixingandmoldingprocesses.Toensureallcustomerrequirementsareunderstoodandsatisfied,theorganizationshallhaveallrelatedmoldingandcustomerreferencedstandardsandspecificationsavailableforuseandaprocesstoensurethattheyarecurrent.

•Theorganizationshallhaveaprocesstoensurethetimelyreview,distribution,andimplementationofallcustomerandindustryengineeringstandardsandspecificationsandchangesbasedoncustomerrequiredschedule.Thisprocessshallbeexecutedassoonaspossibleandshouldnotexceedtwoweeks.

•Theorganizationshalldocumentthisprocessofreviewandimplementation,anditshalladdresshowcustomerandindustrydocumentsareobtained,howtheyaremaintainedwithintheorganization,howthecurrentstatusisestablished,andhowtherelevantinformationiscascadedtotheshopfloorwithinthetwoweekperiod.

•Theorganizationshallidentifywhoisresponsibleforperformingthesetasks.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Doestheorganizationhaveallrelatedmoldingandcustomerreferencedstandardsandspecificationsavailableforuse?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Howarestandardsandspecificationsobtained?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Describethesystemandtimingusedtomaintainthestandardsandspecificationstoensurethattheyareuptodate.,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Definethatprocessusedtoreviewandcommunicatewithinthetwoweekperiodupdatedstandardsandspecificationsthroughouttheorganization.Includethenamesandjobfunctionsoftheresponsiblepersonnel.,,,,,,,,,,,,,,,,,,,x,,,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.6,Allmoldingrelatedinternalandexternalbestpracticesshallbedocumentedandmaintained.,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Doestheorganizationhaveadocumentedprocessandsystemformaintainingbestpracticesobtainedthroughlessonslearnedorfromindustryknowledge?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.7,Thereshallbedocumentedprocessinstructions.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Theorganizationshallhavewrittenprocessinstructionsforallactivepartsorfamilyofparts,includingrelevantpartspecificrequirements,andrelevantoperatingparameters.Examplesofoperatingparametersincludeprocesstemperatures,cycletimes,etc.Suchparametersshallnotonlybedefined,theyshallhaveoperatingtolerancesasdefinedbythemolderinordertomaintainprocesscontrol.

•Theseprocessinstructionsmaytaketheformofworkinstructions,jobcard,computer-basedrecipes,orothersimilardocuments.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Doestheorganizationhavewrittenprocessinstructionsforallactivepartsorfamilyofpartsandincludeallrelevantoperatingparameters?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

"Whatformofprocessspecificationisused?

(Thesemaybeintheformofworkinstructions,jobcard,computer-basedrecipes,orothersimilardocuments.)",,,,,,,,,,,,,,,,,,,x,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.8,Avalidproductcapabilitystudyshallbeperformed.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Todemonstrateeachprocessiscapableofyieldingacceptableproduct,theorganizationshallperformproductcapabilitystudiesfortheinitialvalidationofeachprocess,afterrelocationofanyprocessequipment,andafteramajorchangeofanyprocessorequipment.Theorganizationshalldefinewhatconstitutesamajorchange.

•Initialproductcapabilitystudiesshallbeconductedforallmoldingprocessesperlineasdefinedinscopeofworkandinaccordancewithcustomerrequirements.Capabilitystudytechniquesshallbeappropriateforthemoldingproductcharacteristics(e.g.,moldingthickness,andpartweight).

•Anactionplanshallexisttoaddressthestepstobefollowedincasecapabilityindicesfalloutsidecustomerrequirementsorestablishedranges.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Hasaninitialproductcapabilitystudybeenperformed?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Arestudiesconductedforeachmoldingprocessforeachlineinthefacility?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

"Hasanewstudybeencompletedafterrelocationofanyprocessequipment,majorrebuildofanyequipment,oranysignificantchangeinprocesschemistry?",,,,,,,,,,,,,,,,,,,x,,,,,,,,

Howdoestheorganizationdefinewhatconstitutesamajorchange?,,,,,,,,,,,,,,,,,,,x,,drawingchange,,,,,,

Whatstepsarefollowedwhencapabilityindicesfalloutsidespecifiedrequirements?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.9,"Theorganizationshallhaveaprocessinplacetocollect,analyze,andreacttoproductandprocessdataatspecifiedintervals.",,,,,,,,,,,,,,,,,,,,,,,,,,

"•Theanalysisofproductcharacteristicsandprocessesparametersovertimecanyieldvitalinformationfordefectpreventionefforts.

•Methodsofanalysisshallincludeongoingtrendorhistoricaldataanalysisofspecialproductandprocessparameters.

•Theorganizationshalldeterminewhichparameterstoincludeinsuchanalysis.

•Managementormanagementdesigneeshallreviewthemonitoringsystems/logsatspecifiedintervals.

•Theorganizationshallhavereactionplansfornonconformancestoprocessrequirements.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

Whatproductcharacteristicsandprocessparametersareused?,,,,,,,,,,,,,,,,,,,,,dimensionalstudy,,,,,,

Howistheongoingtrendorhistoricaldatareviewedandanalyzed?,,,,,,,,,,,,,,,,,,,,,eachPPAP,,,,,,

Howdoestheorganizationusethisdatatopreventfuturefailuresandimprovethequalitysystem?,,,,,,,,,,,,,,,,,,,,,TBD,,,,,,

Definetheprocessinplacetogatherandreviewthisinformation.,,,,,,,,,,,,,,,,,,,,,PPAP,,,,,,

Identifythemanagerormanagementdesigneereviewingtheprocessrecordsfromthemonitoringsystems/logs.,,,,,,,,,,,,,,,,,,,,,GM,,,,,,

Describereactionplansfornonconformancestothewrittenprocessrequirements.,,,,,,,,,,,,,,,,,,,,,ReportandCorrect,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.10,Allprocesscontrolandtestingrecordsmustberetainedforaminimumofonecalendaryearaftertheyearinwhichtheywerecreated.,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Whatistheprocesstoretaintheserecords?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Whatistheprocessforretentionofcustomerspecificdocumentswithlongerretentiontimes?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.11,Internalassessmentsshallbecompletedataminimumonceevery12monthsusingthelatestrevisionoftheAIAGCQI-30RubberProcessingSystemAssessment–Mixing&Molding.,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

WhatisthedateofthelastAIAGCQI-30RubberProcessingSystemAssessment–Mixing&Molding?,,,,,,,,,,,,,,,,,,,,,TBD,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.12,Thereshallbeaninternalsysteminplacetoauthorizereprocessinganditshallbedocumented.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Thequalitymanagementsystemshallincludeadocumentedprocessforreprocessingthatshallincludeauthorizationfromthequalitymanageroradesignatedindividual.

•Thereprocessingprocedureshalldescribeproductcharacteristicsforwhichreprocessingisallowedaswellasthosecharacteristicsforwhichreprocessingisnotpermissible.

•Allreprocessingactivityshallrequireaseparatereworkspecificprocesscontrolsheetorotheridentificationmethodissuedbyqualifiedtechnicalpersonneldenotingthenecessarymoldingmodifications.

•Recordsshallclearlyindicatewhenandhowanymaterialhasbeenreprocessed.

•Thereworkofmaterialshallcomplywiththecustomer’sspecificationsand/orrequirements.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Describetheprocedureforauthorizingreprocessingofnonconformingmaterial.,,,,,,,,,,,,,,,,,,,,,ResidentChemistcanapprovedeviation,,,,,,

Doesthereprocessingproceduredescribeproductcharacteristicsthatallowornotallowreprocessing?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Didthequalitymanagerormanager’sdesigneeauthorizethereworkanddeterminethereprocessingprocedure?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Howdoyouidentifythatmaterialhasbeenreprocessed?,,,,,,,,,,,,,,,,,,,,,tags,,,,,,

Dotherecordsclearlyindicatewhenandhowanymaterialhasbeenreprocessedincludingthequalitymanager’sauthorizationofrelease?,,,,,,,,,,,,,,,,,,,x,,,,,,,,

Provideevidencethatthereworkcomplieswithyourcustomer'sspecificationsand/orrequirements.,,,,,,,,,,,,,,,,,,,,,Finaltestresults,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.13,"TheQualityDepartmentshallreview,address,anddocumentcustomerandinternalconcerns.",,,,,,,,,,,,,,,,,,,,,,,,,,

"Thequalitymanagementsystemshallincludeaprocessfordocumenting,reviewing,andaddressingcustomerconcernsandanyotherconcernsinternaltotheorganization.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–MixingandMolding

Version1,IssuedAugust2022",,,,,,,,,,,,,,,,,,,,,,,,,,,

Describetheprocedureforreviewingandaddressingexternalcustomerandinternalconcerns.,,,,,,,,,,,,,,,,,,,x,,Qualitymanagerlogsandresponds,,,,,,

Describetheproblemsolvingapproachthatisused.,,,,,,,,,,,,,,,,,,,x,,8D,,,,,,

Describethecommunicationprocessusedtorespondtotheoriginator.,,,,,,,,,,,,,,,,,,,x,,email,,,,,,

Providearecentexampleofthisprocedureinuse.,,,,,,,,,,,,,,,,,,,,,,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.14,Theorganizationshallhaveacontinualimprovementprocess.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Thecontinualimprovementprocessshallbedesignedtoachieveimprovementsinqualityandproductivity.

•Identifiedactionsshallbeprioritizedandshallincludetiming(estimatedcompletiondates).

•Theorganizationshallshowevidenceofprogrameffectiveness.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Describethecontinualimprovementprocessusedtoachieveimprovementsinqualityandproductivity.,,,,,,,,,,,,,,,,,,,x,,monthlymeetingsreportresults,,,,,,

"Providearecentexampleofhowactionsareidentified,prioritizedandcompletiondatesassigned.",,,,,,,,,,,,,,,,,,,,,seeminutes,,,,,,

Describehowtheorganizationmeasurestheeffectiveness.,,,,,,,,,,,,,,,,,,,,,costofquality,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.15,Thereshallbepredefinedpersonnelresponsibleformanagementofmaterialsinquarantinearea.,,,,,,,,,,,,,,,,,,,,,,,,,,

Onlythequalitymanagerordesigneemayauthorizethedispositionofmaterialfromquarantinestatus.,,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Definetheprocessforreleaseofmaterialfromquarantine.,,,,,,,,,,,,,,,,,,,,,redtagmustreflectapproval,,,,,,

Listtheauthorizedpersonnelwithjobtitles.,,,,,,,,,,,,,,,,,,,,,"Edwards,Evely,RandallQualitydept",,,,,,

Reviewevidencethatonlythesepersonsarereleasingmaterialsfromthequarantinearea.,,,,,,,,,,,,,,,,,,,,,seetags,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.16,Thereshallbedocumentedproceduresand/orworkinstructionsforallprocessesandtheyshallbeavailabletoalloftheorganization’spersonnel.,,,,,,,,,,,,,,,,,,,,,,,,,,

"•Thereshallbeproceduresorworkinstructionsavailabletopersonnelcoveringtheirresponsibilities.

•Thesedocumentsshallincludeinstructionsforaddressingpotentialemergencies(suchaspowerfailure),equipmentstart-up,equipmentshut-down,productsegregation(See2.3,2.8),productinspection,andgeneraloperatingprocedures.",,,,,,,,,,,,,,,,,,,,,,,,,,,

Guidance,,,,,,,,,,,,,,,,,,,Yes,No,Observations&Comments,,,,,,

Reviewtheprocedure/workinstructionforprocessstart-upandshut-down.,,,,,,,,,,,,,,,,,,,,,IATF16949certificate,,,,,,

Reviewtheprocedure/workinstructionforprocesscontrolduringoperation.,,,,,,,,,,,,,,,,,,,,,IATF16949certificate,,,,,,

Whatistheprocedureinplacetoaddresspotentialemergencies?(Suchaspoweroutageand/orequipmentfailure).,,,,,,,,,,,,,,,,,,,,,IATF16949certificate,,,,,,

"Reviewtheproceduresforinspectionoftheproduct,inprocessoraftercompletion.",,,,,,,,,,,,,,,,,,,,,IATF16949certificate,,,,,,

Verifythattheseprocedures/workinstructionsareaccessibletopersonnelperformingthejobatalltimes.,,,,,,,,,,,,,,,,,,,,,IATF16949certificate,,,,,,

,Section2-ManagementResponsibility&QualityPlanning,,,,,,,,,,,,,,,,,,,,,,,,,,

2.17,Theorganizationandmanagementshallprovideemployeetraining.,,,,,,,,,,,,,,,,,,,,,,,,,,

"CQI-30

SpecialProcess:RubberProcessingSystemAssessment–Mixing