IATF16949：2016質(zhì)量手冊(cè)英文版模板

XYZCOMPANY

IATF16949QUALITYMANUAL

REV.1 DATE:xx/xx/xx

XYZCOMPANY

IATF16949QUALITYMANUAL

DATE:

REVISION01

UNCONTROLLEDCOPY

CONTROLLEDCOPY

Serial#_________

IssuedTo:___________________________Date:___________

SAMPLE

Note:Thissamplemanualonlycontainspartialtexttherefore,thenumberingisnotconsecutive.

TableofContents

TOC\o"1-4"\f\h\z\t"BodyTextIndent,1"

Introduction

8

1.0 Scope

9

1.1 Productsandservices

9

1.2 Applicability

9

1.3 Qualitypolicystatement

10

2.0 Companyhistoryandcontactinformation

11

3.0 Termsanddefinitions

11

4.0 Contextoftheorganization

12

4.1 Understandingtheorganizationanditscontext

12

4.2 Understandingtheneedsandexpectationsofinterestedparties

12

4.3 Determiningthescopeofthequalitymanagementsystem

13

4.3.1 Determiningthescopeofthequalitymanagementsystem-supplemental

13

4.3.2 Customer-specificrequirements

13

4.4 Qualitymanagementsystemanditsprocesses

13

4.4.1.1 Conformanceofproductsandprocesses

17

4.4.1.2 Productsafety

17

5.0 Leadership

17

5.1 Leadershipandcommitment

17

5.1.1 General

17

5.1.1.1 Corporateresponsibility

18

5.1.1.2 Processeffectivenessandefficiency

18

5.1.1.3 Processowners

19

5.1.2 Customerfocus

19

5.2 Policy

19

5.2.1 Establishingthequalitypolicy

19

5.2.2 Communicatingthequalitypolicy

20

5.3 Organizationalroles,responsibilitiesandauthorities

20

5.3.1 Organizationalroles,responsibilities,andauthorities–supplemental

22

5.3.2 Responsibilityandauthorityforproductrequirementsandcorrectiveactions

22

5.4 Managementresponsibilities

22

5.5 Managementrepresentative

23

6.0 Planning

24

6.1 Actionstoaddressriskandopportunities

24

6.1.1

24

6.1.2

24

6.1.2.1 Riskanalysis

25

6.1.2.2 Preventiveaction

25

6.1.2.3 Contingencyplans

25

6.2 Qualityobjectivesandplanningtoachievethem

27

6.2.1 General

27

6.2.2 Planningtoachievequalityobjectives

27

6.2.2.1 Qualityobjectivesandplanningtoachievethem-supplemental

27

6.2.3 Classificationofqualityobjectives

28

6.2.4 Keyinitiatives

28

6.3 Planningofchanges

28

7.0 Support

29

7.1 Resources

29

7.1.1 General

29

7.1.1.1 Responsibilitiesfordeterminationofrequiredresources

30

7.1.1.2 Provisionofresources

30

7.1.2 People

30

7.1.3 Infrastructure

30

7.1.3.1 Plant,facility,andequipmentplanning

30

7.1.4 Environmentfortheoperationofprocesses

31

7.1.4.1 Environmentfortheoperationofprocesses–supplemental

31

7.1.4.2 Personnelsafetytoachieveproductquality

32

7.1.5 Monitoringandmeasuringresources

32

7.1.5.1 General

32

7.1.5.2 Measurementtraceability

33

7.1.5.3 Laboratoryrequirements

34

7.1.6 Organizationalknowledge

35

7.2 Competence

35

7.2.1 General

35

7.2.2 Competence,awarenessandtraining

36

7.2.2.1 Competence–on-the-jobtraining

36

7.2.3 Internalauditorcompetency

36

7.2.4 Second-partyauditorcompetency

37

7.3 Awareness

37

7.3.1 Awareness–supplemental

38

7.3.2 Employeemotivationandempowerment

38

7.4 Communication

38

7.4.1 General

38

7.4.2 Internalcommunication

39

7.4.3 Externalcommunication

39

7.5 Documentedinformation

39

7.5.1 General

39

7.5.1.1 Qualitymanagementsystemdocumentation

40

7.5.1.2 Qualitysystemmanual

40

7.5.2 Creatingandupdating

40

7.5.3 Controlofdocumentedinformation

40

8.0 Operation

41

8.1 Operationalplanningandcontrol

42

8.1.1 Planningofproductandservicerealization

42

8.1.2 Operationalplanningandcontrol—supplemental

43

8.1.3 Confidentiality

43

8.1.4 Acceptancecriteria

43

8.2 Requirementsforproductsandservices

43

8.2.1 Customercommunication

43

8.2.1.1 Customercommunication—supplemental

44

8.2.2 Determiningtherequirementsrelatedtoproductsandservices

44

8.2.2.1 Determiningtherequirementsforproductsandservices–supplemental

44

8.2.3 Reviewofrequirementsrelatedtoproductsandservices

45

8.2.3.1 Reviewofrequirementsrelatedtoproductsandservices—supplemental

45

8.2.3.2 Customer-designatedspecialcharacteristics

45

8.2.3.3 Organizationmanufacturingfeasibility

45

8.2.4 Changestorequirementsforproductsandservices

46

8.3 Designanddevelopmentofproductsandservices

46

8.3.1 General

46

8.3.1.1 Designanddevelopmentofproductsandservices–supplemental

47

8.3.2 Designanddevelopmentplanning

47

8.3.2.1 Designanddevelopmentplanning–supplemental

47

8.3.2.2 Productdesignskills

48

8.3.2.3 Developmentofproductswithembeddedsoftware

49

8.3.3 Designanddevelopmentinputs

49

8.3.3.1 Productdesigninput

49

8.3.3.2 Manufacturingprocessdesigninput

50

8.3.3.3 Specialcharacteristics

51

8.3.4 Designanddevelopmentcontrols

51

8.3.4.1 General

51

8.3.4.2 Designanddevelopmentreview

51

8.3.4.3 Designanddevelopmentvalidation

52

8.3.4.4 Prototypeprogramme

53

8.3.4.5 Productapprovalprocess

53

8.3.5 Designanddevelopmentoutputs

53

8.3.5.1 Designanddevelopmentoutputs–supplemental

53

8.3.5.2 Manufacturingprocessdesignoutput

54

8.3.6 Designanddevelopmentchanges

55

8.3.6.1 Designanddevelopmentchanges–supplemental

55

8.4 Controlofexternallyprovidedprocesses,productsandservices

55

8.4.1 General

56

8.4.1.1 General-supplemental(undercontrolofexternallyprovidedprocesses,productsandservices)

56

8.4.1.2 Supplierselectionprocess

56

8.4.1.3 Customer-DirectedSources(alsoknownas“Directed–Buy”)

57

8.4.2 Typeandextentofcontrol

57

8.4.2.1 Typeandextentofcontrol–supplemental

58

8.4.2.2 Statutoryandregulatoryrequirements

58

8.4.2.3 Supplierqualitymanagementsystemdevelopment

58

8.4.2.4 Suppliermonitoring

59

8.4.2.5 Verificationofpurchasedproduct

61

8.4.3 Informationforexternalproviders

61

8.4.3.1 Purchasinginformation

61

8.4.3.2 Informationforexternalproviders–supplemental

62

8.5 Productionandserviceprovision

62

8.5.1 Controlofproductionandserviceprovision

62

8.5.1.1 Controlplan

63

8.5.1.2 Standardizedwork–operatorinstructionsandvisualstandards

64

8.5.1.3 Verificationofjobset-ups

64

8.5.1.4 Verificationaftershutdown

64

8.5.1.5 Totalproductivemaintenance

64

8.5.1.6 Managementofproductiontoolingandmanufacturing,test,inspectiontoolingandequipment

65

8.5.1.7 Productionscheduling

66

8.5.1.8 Validationofprocessesforproductionandserviceprovision

66

8.5.2 Identificationandtraceability

67

8.5.2.1 Identificationandtraceability—supplemental

67

8.5.3 Propertybelongingtocustomersorexternalproviders

68

8.5.4 Preservation

68

8.5.4.1 Preservation–supplemental

68

8.5.5 Post-deliveryactivities

69

8.5.5.1 Feedbackofinformationfromservice

69

8.5.5.2 Serviceagreementwithcustomer

69

8.5.6 Controlofchanges

70

8.5.6.1 Controlofchanges–supplemental

70

8.6 Releaseofproductsandservices

71

8.6.1 Releaseofproductsandservices—supplemental

71

8.6.2 Layoutinspectionandfunctionaltesting

72

8.6.3 Appearanceitems

72

8.6.4 Verificationandacceptanceofconformityofexternallyprovidedproductsandservices

72

8.6.5 Statutoryandregulatoryconformity

73

8.6.6 Acceptancecriteria

73

8.7 Controlofnonconformingoutputs

73

8.7.1.1 Customerauthorizationforconcession

74

8.7.1.2 Controlofnonconformingproduct–customerspecifiedprocess

74

8.7.1.3 Controlofsuspectproduct

74

8.7.1.4 Controlofreworkedproduct

74

8.7.1.5 Controlofrepairedproduct

75

8.7.1.6 Customernotification

75

8.7.1.7 Nonconformingproductdisposition

75

9.0 Performanceevaluation

75

9.1 Monitoring,measurement,analysis,andevaluation

76

9.1.1 General

76

9.1.1.1 Monitoringandmeasurementofmanufacturingprocesses

76

9.1.1.2 Identificationofstatisticaltools

77

9.1.1.3 Applicationofstatisticalconcepts

77

9.1.2 Customersatisfaction

77

9.1.2.1 Customersatisfaction–supplemental

78

9.1.3 Analysisandevaluation

78

9.1.3.1 Prioritization

79

9.2 Internalaudit

79

9.2.1.1 Internalauditprogram

80

9.2.1.2 Qualitymanagementsystemaudit

80

9.2.1.3 Manufacturingprocessaudit

81

9.2.1.4 Productaudit

81

9.3 Managementreview

81

9.3.1 General

81

9.3.1.1 Managementreview–supplemental

81

9.3.2 Managementreviewinputs

81

9.3.2.1 Managementreviewinputs–supplemental

82

9.3.3 Managementreviewoutputs

82

9.3.3.1 Managementreviewoutputs–supplemental

83

10.0 Improvement

83

10.1 General

83

10.2 Nonconformityandcorrectiveaction

83

10.2.1

84

10.2.2

84

10.2.3 Problemsolving

84

10.2.4 Error-proofing

85

10.2.5 Warrantymanagementsystems

85

10.2.6 Customercomplaintsandfieldfailuretestanalysis

86

10.3 Continualimprovement

86

10.3.1 Continualimprovement–supplemental

86

InspectionandTestProcedure

88

CorrectiveandPreventiveActionProcedure

92

Introduction

XYZCompanyrecognizesitsresponsibilityasamanufacturerofqualityproducts/providerofqualityservices.Tothisend,XYZCompanyhasdevelopedanddocumentedaqualitymanagementsystem.ThequalitymanagementsystemcomplieswiththeinternationalstandardIATF16949:2016,AutomotiveQualityManagementSystemStandard.ThequalitymanagementsystemiscommonlyreferredtoasthequalitysystemorQMS.

ThisQualityManualappliestositesoftheorganizationwherecustomer-specifiedparts,forproductionand/orservice,aremanufactured,supportingfunctions,whetheron-siteorremoteandthroughouttheentireautomotivesupplychain.

Thepurposeofthismanualistoprovidecomprehensiveevidencetoallcustomers,suppliersandemployeesofwhatspecificcontrolsareimplementedtoensureproduct/servicequality.Thismanualalsogovernsthecreationofqualityrelateddocumentedinformation.Itwillberevised,asnecessary,toreflectthequalitysystemcurrentlyinuse.Itisissuedonacontrolledcopybasistoallinternalfunctionsaffectedbythequalitymanagementsystemandonanuncontrolledcopybasistocustomersandsuppliers.Itmaybeissuedtocustomersonacontrolledcopybasisuponcustomerrequest.

Thismanualisdividedintotenmainsections.Sections4-10aremodeledonthesectionalorganizationoftheIATF16949:2016standard.Sectionsarefurthersubdividedintoseveralsubsectionsrepresentingmainqualitysystemelementsoractivities.

__________________________________

(Name),President

4.4.1.1Conformanceofproductsandprocesses

XYZCompanyensuresthatallproductsandprocessesconformtoallapplicablecustomer,regulatory,statutoryrequirements,andexpectationsofallinterestedparties.Thisincludesoutsourcedprocessesandpartsforservices.Fordetails,refertotheRiskManagementProcedure,ProcessControlProcedure,InspectionandTestProcedure,PurchasingProcedure,ServicingProcedure,InternalAuditsProcedure,andManagementReviewProcedure.

4.4.1.2Productsafety

XYZCompany’shasdevelopedandimplementedaProductSafetyManagementProceduretomanageproductsafety.Design,manufacturing,andservicingprocessesfurthersupportproductsafetyinitiatives.

5.1.1.1Corporateresponsibility

XYZCompanypromotesanethicalbusinesscultureandfocusesonmaintainingintegrityinallofitsbusinessactivities.Tothisend,XYZCompanyhasdevelopedandenforcesdocumentedcorporateresponsibilitypolicies.Fordetails,refertotheAnti-BriberyPolicyandEmployeeCodeofConduct,whichalsoincludesanescalationpolicy.

6.1.2.1Riskanalysis

XYZCompanyperiodicallyreviewslessonslearnedfromproductrecalls,productaudits,fieldreturnsandrepairs,complaints,scrap,rework,andincludestheminriskanalysis.Theeffectivenessoftheseactionsisevaluated,andactionsareintegratedintoXYZCompany’squalitymanagementsystem.Fordetails,refertotheRiskManagementProcedure.

6.2.4Keyinitiatives

ThemanagementofXYZCompanyestablishesannualkeyinitiatives,whichincludequalityobjectives.TheobjectivesareestablishedviatheManagementReviewProcedureandcommunicatedtoalllevelsoftheorganizationforuseinestablishingeachfunction’sandemployee’sannualkeyobjectives.Qualityobjectivesaremeasurable,includebusinessperformanceindicatorsreflectingrequirementsforproducts/services,andareconsistentwiththequalitypolicyincludingthecommitmenttocontinuousimprovement.TheuseofqualityobjectivesforfacilitatingcontinualimprovementisexplainedintheContinualImprovementProcedure.

8.0 Operation

8.1 Operationalplanningandcontrol

8.1.1Planningofproductandservicerealization

XYZCompanyhasestablishedandmaintainsadocumentedProductandServiceRealizationPlanningProceduretoensurethatprocessesandsub-processesareconductedundercontrolledconditions.Planningoftherealizationprocessesisconsistentwiththeotherrequirementsoftheorganization’squalitymanagementsystem.

8.3.2.3Developmentofproductswithembeddedsoftware

XYZCompanymaintainsandfollowsadocumentedasoftwarequalityassuranceprocessforproductswithinternallydevelopedembeddedsoftware.XYZCompanyusesanappropriateassessmentmethodologytoassessitssoftwaredevelopmentprocess.

8.4.1 General

XYZCompanyensuresthatthepurchasingprocessiscontrolledsuchthatpurchasedproductsandsubcontractedservices,whichaffectproduct/servicequality,conformtospecifiedrequirements.

8.4.2.3.1Automotiveproduct-relatedsoftwareorautomotiveproductswithembeddedsoftware

XYZCompanyrequiresuppliersofsoftware-relatedproducts,orproductswithembeddedsoftwaretomaintainsoftwarequalityassuranceprocessforitsproducts,thisincludesasoftwaredevelopmentassessmentmethodology.TherequirementswithinSection8.3.2.3ofthismanualalsoapplytoXYZCompanysuppliers.FordetailsrefertoSection8.3.2.3.

InspectionandTestProcedure

xe"InspectionandTestProcedure"

ReceivingInspectionandTest

Allpurchasedmaterialwhichinfluencesthemanufactureof,orisintendedforuseaspartof,deliverableproductsissubjecttoinspectionand/ortestingbyReceivingInspection.Uponreceiptofproducts,receivingpersonnelverifythequantityofdeliveredunits,checkmarkingandidentificationofpackages,andinspectallpackagesforanysignsoftamperingordamage.Ifallthesechecksandinspectionsaresatisfactory,receivingpersonnelsignsthedeliveryreceipt.Ifnot,anyshortagesordamagesarenotedonallcopiesofthedeliveryreceipts.

Thereceivedcontainersarethenmovedtothedesignatedinspectionarea,acopyofthepurchaseorderisretrieved,andthepackingslipsareremovedfromthecontainers.Uponopeningthecontainers,thegoodsareverifiedagainstthepurchaseorderandthepackingslip,andareexaminedvisuallyforanysignsofdamage.Thepurchaseorderisstamped“RECEIVED”andissignedanddatedbythereceivinginspector.AllreceivinginspectionsareloggedintheReceivingInspectionLog.

Oncriticalpartsandcomponents,asdeterminedbytheQualityManager,aprecisioninspection/testisperformed.Thistypeofinspectionincludesoneormoreofthefollowing:

reviewofmaterialcertificates,supplierinspectionrecords,compliancecertificates,andanyotherrelevantdocumentationdeliveredwiththeproduct

receiptof,andevaluationof,statisticaldata

randomsamplingbasedonstatisticaltechniquespecified

100%Inspection/testingifnecessary

visualinspectiontodetectanydamageorothervisibleproblems

performingmeasurementsandtestingagainstspecifiedrequirements

secondorthirdpartyassessmentsorauditsofsuppliersites,whencombinedwithrecordsofacceptabledeliveredproductquality

partevaluationbyadesignatedlaboratory

anothermethodagreedwiththecustomer

Resultsofsuchinspection/test,includingrecordingthesamplesizeandactualmeasurementsarerecordedontheInspection/Test&AuditReport

Whereitisnotpracticaltoperformreceivinginspectionuponreceipt,provisionsaremadetoperformsourceinspectionatthesupplier’sfacility.

TheQualityManagerdeterminestheextentandscopeofreceivinginspectionbasedontheimportanceoftheitemandthesuppliers’controlmethodsandperformance.TheQualityManagermayrequestthatsuppliersprovideobjectiveevidenceofconformance(i.e.,materialcertifications,certificatesofconformance,testdata,firstarticleinspectionandSPCdata).Objectiveevidenceprovidedbysuppliersmaybeusedasthebasisforreducing/waivingreceivingandsourceinspection.

Uponacceptance,productsareidentifiedwithan“ACCEPT”tag[greensticker]andmovedtostock.Intheeventthatproductwhichisdesignatedforreceivinginspectionisreleasedtoproductionduetourgency,itshallbepositivelyidentifiedandrecordedinreceivinginspectionrecords.

In-processInspectionandTest

In-processinspection/testingisconductedtoensurethattheproduct/processconformstospecifiedrequirements.Theinspection/testingisnormallycarriedoutbyproductionpersonnel.Randomauditsofthein-processinspection/testingprocessareconductedbyqualitycontrolpersonnel.

TheQualityManagerdeterminestheextentandscopeofin-processinspection/testingbasedontheimportanceoftheitem,controlmethods,andpreviousperformance.

FinalInspectionandTest

Foracceptanceofcompletedproducts,finalinspection/testingisutilized.Thisincludesaverificationofsatisfactoryreceivingandin-processinspections/tests,aswellascompletionoftheremaininginspections/teststoassurethatthefinishedproducts/processesconformtospecifiedrequirements.Productsarenotreleased,processesarenotapproveduntilallinspection/testactivitieshavebeensatisfactorilycompletedandtheappropriatedocumentationisavailableandauthorized.AllfinalinspectionsareloggedintheFinalInspectionLog.Oncriticalpartsandcomponents,asdeterminedbytheQualityManager,aFinalInspection/Test&AuditReportiscompleted.

XYZCompanyensurestheplannedarrangement,toverifythattheproductsandservicerequirementshavebeensatisfied,arealignedwiththecontrolplanandaredocumentedasspecifiesinthecontrolplan.

XYZCompanyensuresthattheplannedarrangementsforinitialreleaseofproductsandservicesencompassproductorservicesapproval.

Whenchangesoccurafterinitialrelease,XYZCompanyensuresthatproductorservicesapprovalsareobtainedinaccordancewithsection8.5.6.

Alayoutinspectionandafunctionalverificationtoapplicablecustomerengineeringmaterialandperformancestandardsisperformedforeachproductasspecifiedinthecontrolplans.Thefrequencyoflayoutinspectionsisdeterminedbythecustomer.Resultsareavailableforcustomerreview.

TheQualityManagerdeterminestheextentandscopeoffinalinspection/testingbasedontheimportanceoftheitem,controlmethods,andpreviousperformance.

InspectionandTestRecords

Inspection/testrecords,whichshowclearlywhethertheproduct/processhaspassedorfailedthedefinedacceptancecriteria,areestablishedandmaintained.

NonconformingMaterial/Products

Allmaterial/productsthatarefoundtobenonconformingareidentifiedandsegregatedand/orquarantined,andappropriatelydispositionedpertheControlofNonconformingProductProcedure.

CorrectiveandPreventiveActionProcedure

xe"CorrectiveandPreventiveActionProcedure"

InitiationofCorrective/PreventiveActions

Correctiveactionsmayberequestedwhenacondition,whichisadversetoqualityorwhichhasthepotentialforproduct/processimprovementisidentified.Thisincludesnonconformingmaterialreceivedfromasupplier.

Preventiveactionsmayberequestedwhenpotentialproduct/processproblemsareidentified.

Anyemployeeofthecompanycaninitiateacorrective/preventiveactionrequestbycompletingthetopportionoftheCorrectiveActionRequest(CAR)form,butonlytheQualityManagercanissueaSupplierCorrectiveActionRequest(SCAR).TheQualityManagerrecordsallCARsintheCorrectiveActionStatusLogandSCARsintheSupplierCorrectiveActionStatusLog.

CustomerComplaints

Marketing/Salesisresponsibleforreceiving,processing,andrespondingtocustomercomplaints.AllreceivedcustomercomplaintsarerecordedintheCustomerComplaintsStatusLog.

TheQualityManagerevaluateseverycomplaintandwhenrelevant,requestsimplementationofcorrectiveactionsfromtheresponsiblefunction.TheQualityManager,inconjunctionwiththePresidentandSales,determinestheappropriatecustomerresponse.

FieldfailuresarehandledasdescribedintheServicingProcedure.

AnalysisandApprovals

Athoroughanalysisofallrelatedprocesses,operations,qualityrecordsandspecifications,whichma