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"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:,,,,,,,,,,,,,
,,,,,,,,,,,,,,?InjectionMoldingxTransferMolding?CompressionMoldingxMixing,,,,,,,,,,,,,
,,,,,,,,,,,,,,,,,,,,,,,,,,,,
,,,,,,,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
",,
,,,,,,,,,,,,,,,,,,,,,,,,,,,,
,,,,,,,,,,,,,,,,,,,,,,,,,,,,
,,,,,,,Auditors/Assessors:,,,,,,,,,,,,,,,,,,,,
,,,,,,,Name:,,,Company:,,,,Phone:,,,,,,,,,,,Email:,,
,,,,,,,,,,,,,,,,,,,,,,,,,,,,
,,,,,,,,,,,,,,,,,,,,,,,,,,,,
,,,,,,,"Numberof""NotSatisfactory""Findings:0",,,,,,,,,,,,,,,,,,,,
,,,,,,,,,,,,,,,,,,,,,,,,,,,,
,,,,,,,,,,,,,,,,,,,,,,,,,,,,
,,,,,,,"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
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