QualityAssuranceManual
ZentechManufacturing,Inc.6980TudsburyRoad
Baltimore,Maryland21244Phone:(443)348‐4500www.zentech.com
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1. Purpose&Scope1.1. Purpose
1.1.1. ZENTECHManufacturing,Inc.isanElectronicManufacturingServices(EMS)providerforalltypesofassembliesfortheconsumer,commercial,defense,aerospaceandmedicalindustries.
1.2. Scope1.2.1. ContractDesign,development,assemblyandqualificationofelectricaland
mechanicalsystems,electroniccircuitcards,cableandwiringharnesses,electromechanicalenclosures,RFelectronics,controlsystems,andsystemintegrationfor;government,aerospace,avionics,defense,medical,commercial,consumerproduct,andoriginalequipmentmanufacturers.
1.3. Exclusions1.3.1. ThefollowingareexclusionstotheISO13485:2003Medicaldevices‐‐Quality
managementsystems‐‐Requirementsforregulatorypurposesastheorganizationdoesnotcurrentlyhavethenecessaryfacilities.1.3.1.1. 7.5.1.3Requirementsforsterilemedicaldevices.1.3.1.2. 7.5.2.2Requirementsforsterilemedicaldevices.1.3.1.3. 7.5.3.2.2RequirementsforactiveImplantablemedicaldevices.
2. ApplicableDocuments2.1. PrerequisiteDocuments
2.1.1. ISO9001:2008QualityManagementSystem–Requirements2.1.2. ISO13485:2003MedicalDevices–QualityManagementSystems–Requirementsfor
regulatorypurposes2.1.3. AS9100:2009QualityManagementSystems–RequirementsforAviation,Spaceand
DefenseOrganizations2.2. StatutoryandRegulatoryDocuments
2.2.1. OSHAStandard29CFR1910(GeneralIndustry)2.2.2. ANSI/ESDS20.20‐ProtectionofElectricalandElectronicPartsElectrostaticDischargeControl2.2.3. IPC‐A‐610‐AcceptabilityofElectronicAssemblies2.2.4. IPC‐A‐600–AcceptabilityofPrintedBoards2.2.5. IPC‐A‐620–RequirementsandAcceptanceforCable&Wire2.2.6. J‐STD‐001–RequirementsforSolderedAssemblies2.2.7. J‐STD‐020‐Moisture/ReflowSensitivityClassificationforSurfaceMountDevices2.2.8. J‐STD‐033‐StandardforHandling,Packing,ShippingandUseofMoistureSensitiveDevices
2.3. PeerDocuments2.3.1. 4.2.3ControlofDocumentsProcedure2.3.2. 4.2.4ControlofRecordsProcedure2.3.3. 5.3ZentechQualityPolicy
2.4. SubordinateDocuments2.4.1. 6.2.2Competence,TrainingandAwarenessProcedure2.4.2. 6.4.3ElectrostaticDischarge(ESD)ControlsProcedure
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2.4.3. 6.4.4UniqueWorkEnvironmentProcedure2.4.4. 7.1.2RiskManagementProcedure2.4.5. 7.1.3ConfigurationManagementProcedure2.4.6. 7.2.1ProductRequirementsDeterminationProcedure2.4.7. 7.3.1DesignandDevelopmentControlProcedure2.4.8. 7.3.2DesignandDevelopmentInputsProcedure2.4.9. 7.3.3EngineeringDesignandDevelopmentOutputsProcedure2.4.10. 7.3.4EngineeringDesignandDevelopmentReviewProcedure2.4.11. 7.3.5DesignandDevelopmentVerificationProcedure2.4.12. 7.3.6EngineeringDesignandDevelopmentValidationProcedure2.4.13. 7.3.7DesignandDevelopmentChangesProcedure2.4.14. 7.4.1PurchasingProcedure2.4.15. 7.4.2PurchasingInformationProcedure2.4.16. 7.4.3PurchasedProductsVerificationProcedure2.4.17. 7.4.3_6.0ReceivingInspectionInstruction_PWB2.4.18. 7.4.4CounterfeitComponentMitigationProcedure2.4.19. 7.5.1ControlofProductionandServiceProcedure2.4.20. 7.5.2ValidationofProcessesProcedure2.4.21. 7.5.3IdentificationandTraceabilityProcedure2.4.22. 7.5.4CustomerPropertyProcedure2.4.23. 7.5.5PreservationofProductProcedure2.4.24. 7.6ControlofMonitoringandMeasuringEquipmentProcedure2.4.25. 8.2.1CustomerSatisfactionProcedure2.4.26. 8.2.2InternalAuditsProcedure2.4.27. 8.2.4ProductInspectionandAcceptanceInstruction2.4.28. 8.3ControlofNonconformingMaterialProcedure2.4.29. 8.4AnalysisofDataProcedure2.4.30. 8.5.1.2QualityAlertProcedure2.4.31. 8.5.1.4AdverseEventsAdvisoryNoticeProcedure2.4.32. 8.5.2CorrectiveActionProcedure2.4.33. 8.5.3PreventiveActionProcedure
2.5. TermsandDefinitions2.5.1. Unlessotherwisespecifiedherein,thetermsanddefinitionsincludedinthe
Prerequisitedocuments(above)apply.3. Responsibility
3.1. TheManagementRepresentativesOffice,assignedbytheGeneralManager’sOffice,isresponsiblefortheimplementation,maintenanceandexecutionofthisQualityAssuranceManual,theQualityManagementSystem,andtodefinetheprocessesrequiredtodocument,establishandmaintaintheQualityManagementSystem.
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3.2. AllothermanagementofficeswithintheorganizationshallsupporttheManagementRepresentativesOfficeinthedesign,documentation,implementationandmaintenanceofthisQualityAssuranceManualandtheQualityManagementSystem.
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4. QualityManagementSystem4.1. GeneralRequirements
4.1.1. Theorganizationhasestablished,documented,implementedandmaintainsaqualitymanagementsystemandmaintainsandcontinuallyimprovesitseffectivenessaccordingtothisQualityAssuranceManual,andtheapplicabledocumentsestablishedforthequalitymanagementsystemincludingcustomerandapplicablestatutoryandregulatoryqualitymanagementsystemrequirementsindicated(see2.0,ApplicableDocuments)herein.
4.1.2. TheGeneralManager’sOfficehasappointedamemberoftheorganization’smanagement(ManagementRepresentative)who,irrespectiveofotherresponsibilities,hasbeendelegatedtheresponsibilityandauthoritytoensureprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained.Theorganization’sGeneralManagerreviewstheorganization’squalitymanagementsystem,atplannedintervals(see5.6,ManagementReview),toensureitscontinuingsuitability,adequacyandeffectiveness.4.1.2.1. TheManufacturingManagementOfficemaintainstheManufacturing
Engineeringactivitytoensuretheavailabilityofinformationnecessarytosupporttheoperationoftheidentifiedprocesses.
4.1.2.2. TheProductAssuranceOfficemaintainstheQualityEngineeringactivitytoensuretheeffectivemonitoringoftheidentifiedprocesses.
4.1.2.3. TheHumanResourcesOfficeensurestheavailabilityofqualifiedpersonnelnecessarytosupporttheoperationandmonitoringoftheidentifiedprocesses.
4.1.2.4. TheOperationsManagementOfficeensurestheavailabilityofadequateenvironmentandinfrastructurenecessarytosupporttheoperationandmonitoringoftheidentifiedprocesses.
4.1.2.5. KeyOperatingIndicators,depictingtheeffectivenessoftheidentifiedprocessesfrommeasurementdatacollectedandanalyzedareimplemented,maintainedandreportedtotheGeneralManager’sOfficeatplannedintervals(see5.6,ManagementReview).
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4.1.3. Primaryprocesseswithintheorganizationaredepictedbelow.ThesequenceofinteractionbeginswithdefinedrequirementsestablishedbytheProgramManagementOfficeandpassedontotheSubcontractandProcurementOffice,andtheManufacturingManagementOffice.RawmaterialflowsfromreceivingintoProductRealizationProcesses.Semi‐finishedproductflowsintotheQualityandTestfunctions.CompletedproductisprocessedthroughPackagingandShippingtotheCustomer.Shipping/ReceivingprocessesprovidedatatotheFinanceandAccountingOfficeforaccountingpurposes.4.1.3.1. Eachoftheidentifiedprocessesareassignedtoanappropriatemanagement
officewhoshallensuretheoutcomessatisfytheinterestedpartiesandthatcorrective,preventiveand/orimprovementactions,asrequired,arecarriedout.
4.1.3.2. Outsourcingofprocessesand/orproductshallbecontrolledandverifiedtoconformtoallrequirementsoutlinedintheQualityManagementSystem.ConformanceverificationmaytakeplaceintheformofCertificatesofConformance,on‐siteinspectionand/orreceivinginspectionprocesses.
4.1.4. PrimaryProcessesFlow/BlockDiagram
5.0ManagementResponsibili ty
8.2.2Internal
Audit
4.2.3Control of
Documents
Customers
5.2Customer
Focus
6.0Resource
Management
8.5Improvement
4.2.4Control ofRecords
Act
7.2Customer
Related Process
7.1Planning of
Product RealizationProcedure
4.2.2QualityManual
8.4Analysisof Data
8.3Control of
NonconformingProduct
Do Customers
7.3Design and
Development
7.4Purchasing
7.5Production and
Service Provision
8.2Monitoring andMeasurement
8.2.1Customer
Satisfaction
ProductDesign TDP
7.3.1D & D
Planning
7.3.2D & DInput
7.3.3 & 7.3.4D & D
Output & Review
7.3.5 & 7.3.6D & D
Verification & Validation
7.3.7Control of D & D
Changes
Plan
Che
ck
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4.2. DocumentationRequirements4.2.1. GeneralDocumentationRequirements
4.2.1.1. Thequalitymanagementsystemdocumentationincludesadocumentedqualitypolicy(see5.3QualityPolicy),statementsofqualityobjectives(see5.4.1QualityObjectives),thisqualitymanual(Ref;4.2.2QualityAssuranceManual),documentedprocedures,documentsdeterminedbytheorganizationtobenecessaryandanyotherdocumentationspecifiedbynationalorregionalregulations(see2.0ApplicableDocuments)andrecords(see4.2.4ControlofRecords)requiredbythemanagementsystemtoensuretheeffectiveplanning,operationandcontrolofitsprocesses.
4.2.1.2. Theorganizationensuresthatpersonnelhaveaccessto,andareawareof,relevantqualitymanagementsystemdocumentationandchangesbymakingthepertinentinformationreadilyavailableontheorganizationsdatamanagementsystemandinformationflow‐downthroughmanagementinteraction.
4.2.2. QualityManual4.2.2.1. Theorganizationhasestablishedandmaintainsthisqualitymanual(Ref;4.2.2
QualityAssuranceManual)thatincludesthescopeofthemanagementsystemandthedetailsofanyexclusions(see1.2Scope).
4.2.2.2. Proceduresandotherdocumentsrequiredbythequalitymanagementsystemareincludedin,orreferencedinthisqualitymanual(see2.0ApplicableDocuments).
4.2.3. ControlofDocuments4.2.3.1. TheDocumentControlOfficeisresponsibleforthecontrolofdocuments
requiredbytheQualityManagementSystemaccordingtothe4.2.3ControlofDocumentsProcedure.
4.2.4. ControlofRecords4.2.4.1. TheDocumentControlOfficeisresponsibleforthecontrolofrecordsrequired
bytheQualityManagementSystemaccordingtothe4.2.4ControlofRecordsProcedure.
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5. ManagementResponsibility5.1. ManagementCommitment
5.1.1. ThetopmanagementofZentechManufacturing,Inc.demonstratesitscommitmenttothedevelopment,implementation,maintenanceandcontinualimprovementofthequalitymanagementsystemrepresentedbythisQualityAssuranceManual,andtheapplicabledocumentationreferencedherein,astheonlymanagementsystememployedbytheenterprise.
5.1.2. TheGeneralManager’sOfficedemonstratesandmaintainstheeffectivenessofthismanagementsystembycommunicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirementsthroughoutthismanagementsystem,periodicreviews(see5.6,ManagementReview),establishingtheQualityPolicy(see5.3,QualityPolicy,below,andthepolicy;5.3ZentechQualityPolicy),ensuringobjectivesareestablished(see5.4.1,QualityObjectives,below),conductingperiodicmanagementreviews(see5.6,ManagementReview,below),andensuringtheavailabilityofnecessaryresources(see6.0,ResourceManagement,below).
5.2. CustomerFocus5.2.1. TheProgramManagementOfficeisresponsibletoensurethatcustomer
requirementsaredeterminedandaremetaccordingto7.2CustomerRelatedProcesses(below).
5.2.2. TheProductAssuranceOfficeisresponsibletoensurethatproductconformityandon‐timedeliveryperformancearemeasuredandthatappropriateactionistakenifplannedresultsarenot,orwillnotbe,achievedaccordingto8.2MonitoringandMeasurement(below).
5.3. QualityPolicy5.3.1. Thequalitypolicyismaintainedas5.3ZentechQualityPolicy,acontrolleddocument
includedasanintegralelementofthemanagementsystem(see2.0ApplicableDocuments,above).
5.3.2. TheManagementRepresentativeOffice,assignedbytheGeneralManager’sOffice,isresponsiblefortheimplementationandmaintenanceofthepolicy.
5.3.3. Thispolicyisreviewedannuallyforcontinuingsuitabilitybytopmanagement,asanelementofmanagementreviews(see5.6,ManagementReview,below),toensurethepolicy;isappropriatetothepurposeoftheorganization,includesacommitmenttocomplywiththerequirementsandmaintaintheeffectivenessofthequalitymanagementsystem,providesaframeworkforestablishingandreviewingqualityobjectives,andiscommunicatedandunderstoodwithintheorganization.
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5.4. Planning5.4.1. QualityObjectives
5.4.1.1. TheManagementRepresentativeOffice,assignedbytheGeneralManager’sOffice,isresponsibletoensurethatobjectives,includingthoseneededtomeetrequirementsforproduct(see7.1,PlanningofProductRealization,below),areestablishedatrelevantfunctionsandlevelswithintheorganization.
5.4.1.2. Theobjectivesshallbemeasurableandconsistentwiththequalitypolicy.5.4.1.3. Objectivesareestablishedannuallyasanelementofmanagementreviews(see
5.6,ManagementReview,below).5.4.1.4. Atminimum,objectivesareestablishedforeachoftheorganizationsprimary
processes(see4.1.4,PrimaryProcessesFlow/BlockDiagram,above).5.4.1.4.1. Eachestablishedobjectiveisassignedtooneormoremanagement
office(s)toensuretheobjectiveisdefinedtoincludespecific,measurable,attainable,requiredandtime‐boundelementsthatareconsistentwiththeorganizationsqualitypolicyandguidinggoals.
5.4.1.4.2. TheassignedmanagementofficeshallensurethedefinedobjectiveisreviewedandapprovedbytheGeneralManager’sOffice.
5.4.1.4.3. TheProductAssuranceOfficeshallmaintainmetrics,progressreporting,andobjectivedocumentation(see8.5Improvement,below).
5.4.2. QualityManagementSystemPlanning5.4.2.1. TheManagementRepresentativeOffice,assignedbytheGeneralManager’s
Office,isresponsibletoensurethattheplanningofthequalitymanagementsystemiscarriedoutinordertomeetrequirements(see4.1,QMSGeneralRequirements,above),aswellasthequalityobjectives(see5.4.1,QualityObjectives,above),andtheintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.
5.4.2.1.1. TheManagementRepresentativeOfficeand/ortheProductAssuranceOfficeshallensuretheeffectofproposedchangesonthemanagementsystemisconsideredpriortotheimplementationofchanges,andshallreviewtheactualeffectofchanges,followinganychangeimplementation(see8.5,Improvement,below).
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5.5. Responsibility,AuthorityandCommunication
PMOProgramManager
Office
CMOContract
ManagementOffice
SPOSubcontract &Procurement
Office
MMOManufacturingManagement
Office
OMOOperations
ManagementOffice
MROManagement
RepresentativeOffice
FAOFinance &Accounting
Office
HROHuman
ResourceOffice
PAOProduct
AssuranceOffice
EDDEngineering
& DesignOffice
CCOConfiguration
ControlOffice
DCODocument
ControlOffice
ITOInformationTechnology
Office
MPOManufacturing
PlanningOffice
TBDTo Be
Determined
GMOGeneral
ManagementOffice
5.5.1. ResponsibilityandAuthority5.5.1.1. TheGeneralManager’sOfficehasestablishedaseriesofmanagementoffices
(seediagramabove)anddefinedresponsibilitiesandauthoritiesincludingallelementsandsub‐elementsofthemanagementsystem.
5.5.1.2. TheManagementRepresentativesOfficeannuallycommunicatestotheorganization;thepersonsassignedtoeachmanagementofficeinanAnnualResponsibilitiesandAuthoritiesMemo,publishedtoallemployeesfollowingtheannualmanagementreview(see5.6,ManagementReview,below).
5.5.1.3. Managementofficeresponsibilitiesandauthoritiesaredefinedwithinthisqualityassurancemanual(Ref;4.2.2QualityAssuranceManual)includingapplicabledocuments(see2.0ApplicableDocuments,above).
5.5.1.4. Establishedmanagementofficesperformandverifyworkaffectingquality,havetheindependenceandauthoritynecessarytoperformthesetasks,andparticipateequallyasteammemberstoensurecustomer,statutoryandregulatoryrequirementsaremet.
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5.5.1.5. EstablishedManagementOffices5.5.1.5.1. MRO,ManagementRepresentativeOfficeisresponsibleforallactivities
definedbythemanagementsystemincludingthosespecificallydefinedwithin5.5.2,ManagementRepresentative,below.
5.5.1.5.2. PMO,ProgramManagementOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;ProjectManagement,IntegratedProductDevelopment,ProductLifecycle&Logistics,andCustomerCare&Support.
5.5.1.5.3. FAO,FinanceandAccountingOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;AccountsReceivable,AccountsPayable,PayrollAccounting,andEmployeeBenefits.
5.5.1.5.4. CMO,ContractManagementOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;Marketing,Sales,ContractAdministration,andProjectControls.
5.5.1.5.5. HRO,HumanResourceOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;Recruiting,PerformanceAppraisal,SuccessionPlanning,andSalaryAdministration.
5.5.1.5.6. SPO,SubcontractandProcurementOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;SubcontractManagement,CommodityProcurement,Pack&Ship,andInventoryControl.
5.5.1.5.7. PAO,ProductAssuranceOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;QualityEngineering,QualityControl,TestEngineering,andProductionTest.
5.5.1.5.8. MMO,ManufacturingManagementOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;ProductRealization,ProcessEngineering,PreventiveMaintenance,andProductionControl.
5.5.1.5.9. EDD,EngineeringDesignandDevelopmentisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;Component,Systems,Electronics,Ergonomics,Mechanical,andSoftwareEngineering.
5.5.1.5.10. OMO,OperationsManagementOfficeisresponsibleforallactivitiesdefinedbythemanagementsystemincluding;EnvironmentalHealth&Safety,FacilityMaintenance,andDisasterPreparedness&Recovery.
5.5.1.5.11. CCO,ConfigurationControlOfficeisresponsibletoimplementandmaintaintheconfigurationmanagementprocessincludingplanning,identification,changecontrolandconfigurationstatus.
5.5.1.5.12. DCO,DocumentControlOfficeisresponsibletocontroldocumentsrequiredbythemanagementsystemincludingapproval,identification,changecontrolanddistributioncontrol.
5.5.1.5.13. ITO,InformationTechnologyOfficeisresponsibletomaintaintheorganizationscommunicationandinformationinfrastructure.
5.5.1.5.14. MPO,ManufacturingPlanningOfficeisresponsibletoplan,implementandmaintaintheorganizationsrequirementsplanningsubsystem.
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5.5.2. ManagementRepresentative5.5.2.1. TheGeneralManager’sOfficeappointsamemberoftheorganization's
managementwho,irrespectiveofotherresponsibilities,hastheresponsibilityandauthoritythatincludes;ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained,reportingtotopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,ensuringthepromotionofawarenessofstatutory,regulatoryandcustomerrequirementsthroughouttheorganization,andtheorganizationalfreedomandunrestrictedaccesstotopmanagementtoresolvequalitymanagementissues.
5.5.2.1.1. ThepersonappointedasManagementRepresentativeisincludedintheAnnualResponsibilitiesandAuthoritiesMemo,publishedtoallemployeesfollowingtheannualmanagementreview(see5.6,ManagementReview,below).
5.5.3. InternalCommunication5.5.3.1. TheGeneralManager’sOfficeensuresthatappropriatecommunicationis
flowedtotheestablishedmanagementofficesthatensurenecessaryinformationisflowedtoallemployeeswithintheorganizationincludingcommunicationregardingtheeffectivenessofthequalitymanagementsystem.
5.5.3.1.1. Necessaryinformationflowdownmaybeinanyformortypeofmedium,includingverbalcommunication.
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5.6. ManagementReview5.6.1. General
5.6.1.1. ThepersonwiththeresponsibilityandauthorityfortheGeneralManager’sOfficeandtheManagementRepresentativesOfficeannuallyreviewtheorganization'smanagementsystemtomaintainitscontinuingsuitability,adequacyandeffectiveness.
5.6.1.1.1. Thereviewshallinclude,atminimum,assessingopportunitiesforimprovementandtheneedforchangestothemanagementsystem,includingthequalitypolicyandqualityobjectives.
5.6.1.1.2. Othermembersoftheorganizationmaybeinvited,requestedordirectedtoparticipateinthemanagementreviewbytheGeneralManager’sOffice.
5.6.2. ReviewInput5.6.2.1. Themanagementreviewisprepared,scheduledandconductedbythe
ManagementRepresentativesOffice,andincludes,atminimum:opportunitiesforimprovement,proposedchanges(ifany)tothemanagementsystem,proposedchanges(ifany)tothequalitypolicy,proposedchanges(ifany)tothequalityobjectives,resultsofaudits,customerfeedback,processperformanceandproductconformity,statusofpreventiveandcorrectiveactions,identifiedresourceneeds,follow‐upobjectivesfrompreviousmanagementreviews,andneworrevisedregulatoryrequirements.
5.6.3. ReviewOutput5.6.3.1. RecordsofthemanagementreviewaremaintainedbytheManagement
RepresentativesOfficeaccordingtothe4.2.4ControlofRecordsProcedure,andincludeatminimum;anydecisionsandactionsrelatedto;improvementoftheeffectivenessofthemanagementsystemanditsprocesses,improvementsneededtomaintaintheeffectivenessofthequalitymanagementsystemanditsprocesses,improvementofproductrelatedtocustomerrequirements,resourceneeds,andthereviewandacceptanceoftheQualityPolicy,QualityObjectives,andapprovedAnnualResponsibilitiesandAuthoritiesMemo.
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6. ResourceManagement6.1. ProvisionofResources
6.1.1. TheGeneralManager’sOfficeshalldetermineandprovidetheresourcesneededtoimplementandmaintainthemanagementsystem,maintainandcontinuallyimproveitseffectiveness,andtoenhancecustomersatisfactionbymeetingcustomerandregulatoryrequirements.
6.1.2. Eachresponsiblemanagementofficewithintheorganizationholdstheresponsibilitytoidentifyresourceneeds,andtoincludeinthemanagementreview(see5.6ManagementReview,above)thejustificationforsuchneeds.6.1.2.1. Additionalresourcerequirements,onceapproved,areassignedtothe
appropriatemanagementoffice(s)forimplementation.6.2. HumanResources
6.2.1. General6.2.1.1. TheHumanResourcesOfficeisresponsibleformaintainingsufficienthuman
resourcesrequiredbytheorganization.6.2.1.2. Eachresponsiblemanagementofficewithintheorganizationholdsthe
responsibilitytoidentifyhumanresourceneeds,andtoincludeinthemanagementreview(see5.6ManagementReview,above)thejustificationforsuchneeds.
6.2.2. Competence,trainingandawareness6.2.2.1. Eachresponsiblemanagementofficewithintheorganizationisresponsibleto
ensurepersonnelperformingworkaffectingconformitytoproductrequirementsshallbecompetentonthebasisofappropriateeducation,training,skillsandexperience.
6.2.2.2. Theresponsiblemanagementofficeshalldeterminenecessarycompetenceforitspersonnel,providetrainingasrequiredtoachievenecessarycompetence,evaluatetheeffectivenessofnecessarytraining,andensurethatitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandcontributionstoachievingqualityobjectives.
6.2.2.3. Thisinformation,alongwithanytrainingrenewaland/orexpirationinformation,isconveyedtothehumanresourcesofficeasthebasisforemployeecompetenceandtrainingrecords.
6.2.2.3.1. TheHumanResourcesOfficeisresponsibleformaintainingemployeerecordsaccordingtothe4.2.4ControlofRecordsProcedure.
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6.3. Infrastructure6.3.1. TheOperationsManagementOfficeisresponsibleformaintainingsufficient
infrastructureresourcesrequiredbytheorganization.6.3.2. Eachresponsiblemanagementofficewithintheorganizationholdstheresponsibility
toidentifyinfrastructureresourcesneededtoachieveproductconformity,andtoincludeinthemanagementreviewthejustificationforsuchneeds.6.3.2.1. Infrastructurerequirementsmayincludebuildings,workplaceandassociated
utilities,processequipment,andsupportingservices.6.3.3. Buildings,workplaceandassociatedutilitiesaremaintainedbythirdparty
contractors,managedbytheOperationsManagementOffice,includingconditioningoftheairandprovidinglightsandpowernecessaryforcontrolofproductionprocesses.
6.3.4. Processingequipmentismaintained,includingpreventivemaintenance,accordingtothemaintenancescheduleandlogsustainedbytheOperationsManagementOffice.6.3.4.1. ThemaintenancelogisaqualityrecordmaintainedbytheOperations
ManagementOfficeaccordingtothe4.2.4ControlofRecordsProcedure.6.3.5. Supportingservices,suchastransportofgoods,arecontractedtoathirdpartyas
necessary.6.3.6. TheSubcontractandProcurementOffice(InformationTechnologyActivities)is
responsibleforsupportingservices,suchascommunicationandinformationservicesincludingthemaintenanceandavailabilityofdataprocessingtools,equipmentanddatabaseavailabilityincludingrecords.6.3.6.1. Theorganization’sdatanetworkistherepositoryfordataprocessing
programsandanynecessarydatabase,includingrecords.6.3.6.2. Aduplicateimageofthedatanetworkiscompiledanddown‐loadedtoa
secure,off‐site,locationonadailybasis.6.3.6.3. Thecacheofduplicateimagesmaybeusedtorecovernecessaryrecords
and/orrecovertheentirenetworkintheeventofinadvertentlossordamage.
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6.4. WorkEnvironment6.4.1. TheOperationsManagementOfficeisresponsibleformaintainingthework
environmentrequiredbytheorganizationtoachieveconformitytoproductrequirements.
6.4.2. Eachresponsiblemanagementofficewithintheorganizationholdstheresponsibilitytoidentifyworkenvironmentresourcesneededtoachieveproductconformity,andtoincludeinthemanagementreviewthejustificationforsuchneeds.6.4.2.1. Workenvironmentrelatestothoseconditionsunderwhichworkisperformed
includingphysical,environmentalandotherfactorsincludingtemperature,humidity,lightingandweather.
6.4.3. Thephysicalenvironmentincluding;temperature,humidity,lightingandprotectionfromweatheriscontrolled.Allproductrealizationprocessesareperformedinbuildingsappropriatelyimplementedandmaintainedaccordingto6.3Infrastructure(above).6.4.3.1. Temperatureandhumidityaremaintainedatlevelsthatarecomfortableand
compliantwithIPCspecificationsforcontrolofsolderabilityanddamagetoelectrostaticsensitivedevices.
6.4.3.2. Electrostaticsensitivedevicesareprotectedaccordingtothe6.4.3ElectrostaticDischarge(ESD)ControlsProcedure.
6.4.3.3. Workareasandtoolsaredesignedforeaseofuseandavoidanceofstressduetorepeateduse.Safetyguardsandemergencystopsareincludedwherenecessary.
6.4.3.4. Thefacilityiscompliantwithapplicablestatutoryorregulatoryspecifications.MaterialSafetyDataSheets(MSDS)arereadilyavailableforapplicablechemicalsandcompounds.
6.4.4. TheManufacturingManagementOfficeisresponsibleforuniqueworkenvironments,suchascleanrooms,whererequiredbycustomer,statutoryorregulatoryspecificationaccordingtothe6.4.4UniqueWorkEnvironmentProcedure.
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7. ProductRealization7.1. PlanningofProductRealization
7.1.1. ProjectManagement7.1.1.1. TheProgramManagementOfficeisresponsibletoensureproductrealization
processesareexecutedinastructuredandcontrolledmannertomeetrequirementsatacceptableriskwithinresourceandscheduleconstraintsaccordingtothe7.2.1ProductRequirementsDeterminationProcedure.
7.1.2. RiskManagement7.1.2.1. TheProgramManagementOfficeisresponsiblefortheidentification,
assessment,andmitigationofriskaccordingtothe7.1.2RiskManagementProcedure.
7.1.3. ConfigurationManagement7.1.3.1. TheConfigurationManagementOfficeisresponsibleforconfiguration
managementaccordingtothe7.1.3ConfigurationManagementProcedure.7.1.4. ControlofWorkTransfers
7.1.4.1. TheSubcontractandProcurementOfficeisresponsibletoplanandcontrolthetemporaryorpermanenttransferofwork;fromoneorganizationfacilitytoanother,fromtheorganizationtoasupplier,fromonesuppliertoanothersupplier,andtoverifytheconformityoftheworktorequirementsaccordingtothe;7.4.1PurchasingProcess,7.4.2PurchasingInformationProcedure,and/orthe7.4.3PurchasedProductsVerificationProcedure.
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7.2. CustomerRelatedProcesses7.2.1. DeterminationofRequirementsrelatedtotheProduct
7.2.1.1. TheProgramManagementOfficeisresponsibleforthedeterminationofrequirementsrelatedtotheproductincluding;productrequirementsspecifiedbythecustomer,productrequirementsnotspecifiedbythecustomer,statutoryandregulatoryrequirements,andtheorganization'sproductrequirementsaccordingtothe7.2.1ProductRequirementsDeterminationProcedure.
7.2.2. ReviewofRequirementsrelatedtotheProduct7.2.2.1. TheProgramManagementOfficeisresponsibleforthereviewofrequirements
relatedtotheproductincluding;conductingthereview,timingofthereview,maintainingrecordsofproductrequirementreviews,handlingundocumentedstatementsofrequirementsandchangestoproductrequirements.
7.2.2.2. UponreceiptofasalesordertheProgramManagementOfficereviewsrequirementsstatedbythecustomertoensurethatproductrequirementsaredefinedandthattheorganizationhastheabilitytomeetdefinedrequirements.
7.2.2.2.1. TheProgramManagementOfficeresolvesanyissuesrelatedtotheorderwiththecustomer,andthenarrangesareviewmeetingtoincludenecessarysubjectmatterexpertsfromwithintheorganization.
7.2.2.2.2. Arecordofthereviewandanyassignedactionitemsarerecordedaccordingtothe7.2.1ProductRequirementsDeterminationProcedure.
7.2.3. CustomerCommunication7.2.3.1. TheProgramManagementOfficeisresponsibleforcustomercommunication
including;providingproductinformation,inquiries,contractsandordersandcontractamendments.
7.2.3.1.1. TheProgramManagementOfficeisresponsibleforcustomerfeedbackaccordingtothe8.2.1CustomerSatisfactionProcedure.
7.2.3.1.2. TheProgramManagementOfficeisresponsibletocoordinateresponsetocustomercomplaintsincluding,whereapplicable,theinitiationofcorrectiveactionsaccordingtothe8.5.2CorrectiveActionProcedure.
7.2.3.1.3. TheProgramManagementOfficeisresponsibletocommunicateanyproductqualityconcernsincluding,whereapplicable,thecoordinationofaqualityalertand/oradvisorynoticeaccordingtothe8.5.1.2QualityAlertProcedureand/orthe8.5.1.4AdverseEventsAdvisoryNoticeProcedure.
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7.3. DesignandDevelopment7.3.1. DesignandDevelopmentPlanning
7.3.1.1. TheEngineeringDesignandDevelopmentOffice(Engineering)isresponsiblefortheplanningandcontrolofdesignanddevelopmentincludingmanagingtheorganizationalinterfaces,ensuringplansareupdatedasthedesignprogresses,determiningthestagesofdesign,planningreview/verification/validationactivities,anddeterminingresponsibilitiesandauthorityfordesignanddevelopmentactivitiesaccordingtothe7.3.1DesignandDevelopmentControlProcedure.
7.3.2. DesignandDevelopmentInputs7.3.2.1. Engineeringisresponsibleforthedesign&developmentinputsincluding
determiningandrecordingdesigninputs,andreviewofdesigninputrequirementsaccordingtothe7.3.2DesignandDevelopmentInputsProcedure.
7.3.3. DesignandDevelopmentOutputs7.3.3.1. Engineeringisresponsibleforthedesign&developmentoutputsincluding
documentingthedesignanddevelopmentoutput,andapprovalofdesignoutputsaccordingtothe7.3.3DesignandDevelopmentOutputsProcedure.
7.3.4. DesignandDevelopmentReview7.3.4.1. Engineeringisresponsibleforthedesign&developmentreviewincluding
planningdesignreviews,designreviewparticipants,anddesignrecordsaccordingtothe7.3.4DesignandDevelopmentReviewProcedure.
7.3.5. DesignandDevelopmentVerification7.3.5.1. Engineeringisresponsibleforthedesign&developmentverificationincluding
performingdesignverification,andrecordingdesignverificationresultsaccordingtothe7.3.5DesignandDevelopmentVerificationProcedure.
7.3.6. DesignandDevelopmentValidation7.3.6.1. Engineeringisresponsibleforthedesign&developmentvalidationincluding
performingvalidation,timingofvalidation,andrecordingvalidationresultsaccordingtothe7.3.6DesignandDevelopmentValidationProcedure.
7.3.7. ControloftheDesignandDevelopmentChanges7.3.7.1. Engineeringisresponsibleforthedesign&developmentchangesincluding
identificationandrecordingofdesignchanges,reviewandevaluationofchanges,andverificationandvalidationofdesignchangesaccordingtothe7.3.7DesignandDevelopmentChangesProcedure.
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7.4. Purchasing7.4.1. PurchasingProcess
7.4.1.1. TheSubcontractandProcurementOfficeshallsustainthepurchasingprocessesincludingensuringpurchasedproductconformstospecifiedrequirements,controlofsuppliersandevaluationandselectionofsuppliersincludingresultsofsupplierevaluation,inaccordancewiththe7.4.1PurchasingProcess.
7.4.2. PurchasingInformation7.4.2.1. TheSubcontractandProcurementOfficeshallsustainpurchasinginformation
includingdescribingproductstobepurchasedandadequacyofpurchasingrequirementsinaccordancewiththe7.4.2PurchasingInformationProcedure.
7.4.3. VerificationofPurchasedProduct7.4.3.1. TheProductAssuranceOfficeshallsustainpurchasedproductsverification
includingensuringpurchasedproductmeetsrequirementsandverificationonsupplierpremises,inaccordancewiththe7.4.3PurchasedProductsVerificationProcedure.
7.4.4. CounterfeitComponentMitigation7.4.4.1. TheSubcontractandProcurementOfficeshallpreventtheintroductionof
counterfeitelectroniccomponentsintocustomerproductsaccordingtothe7.4.4CounterfeitComponentMitigationProcedure.
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7.5. ProductionandServiceProvision7.5.1. ControlofProductionandServiceProvision
7.5.1.1. TheManufacturingManagementOfficeisresponsibletoplanandcarryoutproductionandserviceprovisionundercontrolledconditionsaccordingtothe7.5.1ControlofProductionandServiceProcedure.
7.5.2. ValidationofProcessesforProductionandServiceProvision7.5.2.1. TheManufacturingManagementOfficeisresponsibletovalidateany
processesforproductionandserviceprovisionwheretheresultingoutputcannotbeverifiedbysubsequentmonitoringormeasurementaccordingtothe7.5.2ValidationofProcessesProcedure.
7.5.3. IdentificationandTraceability7.5.3.1. TheManufacturingManagementOfficeisresponsibleto,whereappropriate,
identifytheproductbysuitablemeansthroughoutproductrealizationaccordingtothe7.5.3IdentificationandTraceabilityProcedure
7.5.4. CustomerProperty7.5.4.1. TheManufacturingManagementOfficeistoresponsibletoexercisecarewith
customerpropertywhileitisundertheorganization'scontrolaccordingtothe7.5.4CustomerPropertyProcedure
7.5.5. PreservationofProduct7.5.5.1. TheManufacturingManagementOfficeisresponsibleforpreservingthe
conformityofproductduringinternalprocessinganddeliverytotheintendeddestinationaccordingtothe7.5.5PreservationofProductProcedure
7.6. ControlofMonitoringandMeasuringEquipment7.6.1. TheProductAssuranceOfficeisresponsibleforthecontrolofmonitoringand
measuringequipmentaccordingtothe7.6ControlofMonitoringandMeasuringEquipmentProcedure.
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8. Measurement,AnalysisandImprovement8.1. General
8.1.1. TheProductAssuranceOfficeisresponsibletoplanandimplementmonitoring,measurement,analysisandimprovementprocessesneededtodemonstrateproductconformity,ensureconformityofthemanagementsystem,andtomaintainandcontinuouslyimprovetheeffectivenessofthemanagementsystem.8.1.1.1. Productconformitytorequirementsisdemonstratedaccordingto8.2.4
MonitoringandMeasurementofProduct,below.8.1.1.2. Conformity,maintenanceandcontinuousimprovementoftheeffectivenessof
themanagementsystemisensuredthroughtheeffectiveutilizationofdocumentcontrolaccordingto4.2.3ControlofDocuments,above,andinternalauditsaccordingto8.2.2InternalAudits,below.
8.2. MonitoringandMeasurement8.2.1. CustomerSatisfaction
8.2.1.1. TheProgramManagementOfficeisresponsibleformonitoringinformationrelatingtothecustomer’sperceptionoftheorganization’sabilitytomeetrequirementsaccordingtothe8.2.1CustomerSatisfactionProcedure.
8.2.2. InternalAudit8.2.2.1. TheProductAssuranceOfficeisresponsibletoconductinternalauditsat
plannedintervalstodeterminewhetherthequalitymanagementsystemconformstotheplannedarrangements(see7.1),totherequirementsoftheprerequisitestandards(see1.1),tothequalitymanagementsystemrequirementsestablishedbytheorganization,andiseffectivelyimplementedandmaintainedaccordingtothe8.2.2InternalAuditsProcedure.
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8.2.3. MonitoringandMeasurementofProcess8.2.3.1. TheProductAssuranceOfficeisresponsibleformonitoringandmeasuringthe
effectivenessofprimaryprocesses(see4.1.4PrimaryProcessesFlow/BlockDiagram,above)andproductrealizationprocessestodemonstratetheabilityoftheseprocessestoachieveplannedresults.
8.2.3.2. Whereapplicable,pertinentperformancedataforeachoftheindicatedprocessesiscollected,analyzedandreportedtotheorganization.
8.2.3.3. Reportingmetricsincludeobjectivestobeachievedandleadingindicatorsofimprovementopportunities.
8.2.3.4. Corrective,preventiveand/orimprovementactionsareinitiated,wherenecessary,accordingto8.5Improvement(below).
8.2.4. MonitoringandMeasurementofProduct8.2.4.1. TheProductAssuranceOfficeisresponsibletomonitorandmeasureproduct
characteristicstodemonstrateproductconformity.8.2.4.2. Procuredcomponentparts,assemblies,andcustomersuppliedmaterialis
inspectedaccordingtothe7.4.3VerificationofPurchasedProductProcedure.8.2.4.3. Productsareinspectedtoacceptancecriteriafollowingeachproduct
realizationprocessaccordingtothe8.2.4ProductInspectionandAcceptanceInstruction.
8.2.4.4. Acceptanceand/orspecificdiscrepanciesarerecordedintheorganizationsdefecttrackingsystem.
8.2.4.5. Whereapplicable,pertinentperformancedataforeachproductiscollected,analyzedandreportedtotheorganization.
8.2.4.6. Corrective,preventiveand/orimprovementactionsareinitiated,wherenecessary,accordingto8.5Improvement(below).
8.3. ControlofNonconformingProduct8.3.1. TheProductAssuranceOfficeisresponsibletoensurethatproductwhichdoesnot
conformtoproductrequirementsisidentifiedandcontrolledtopreventitsunintendeduseordeliveryaccordingtothe8.3ControlofNonconformingMaterialProcedure.
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8.4. AnalysisofData8.4.1. TheProductAssuranceOfficeisresponsibleforanalysisofdatanecessaryto
demonstratethesuitabilityandeffectivenessofthemanagementsystemaccordingtothe8.4AnalysisofDataProcedure.
8.5. Improvement8.5.1. ContinualImprovement
8.5.1.1. TheManagementRepresentativesOfficeisresponsibletoidentifyandinitiateanychangesnecessarytoensureandmaintainthecontinuedsuitability,improvementandeffectivenessofthequalitymanagementsystem.
8.5.1.1.1. Thekeyoperatingindicatorsandqualityobjectivesaremonitoredtoidentifyopportunitiesforimprovement.
8.5.1.1.2. Themanagementreview,includingqualitypolicyandqualitymanagementsystemreviewscontributetoimprovementopportunities.
8.5.1.1.3. Auditresultsanddataanalysismaycontributeimprovementopportunities.
8.5.1.1.4. Improvementactivitiesareinitiated,monitoredandevaluatedbytheorganization’sseniormanagementtoensuretheeffectivenessofresults.
8.5.1.1.4.1. StaffnotesreportingprogressofimprovementactivitiesareretainedbytheManagementRepresentativesOfficeaccordingtothe4.2.4ControlofRecordsProcedure.
8.5.1.2. TheProductAssuranceOfficeisresponsibleforadvisorynoticestotheorganizationaccordingtothe8.5.1.2QualityAlertProcedure.
8.5.1.3. TheProductAssuranceOfficeisresponsibleforprocessingcustomercomplaintsaccordingtothe8.5.2CorrectiveActionProcedure.
8.5.1.4. Wherenationalorregionalreportingofadverseeventsarerequiredbycontractorregulation,theProductAssuranceOfficeisresponsibleforprocessingsuchreportsaccordingtothe8.5.1.4AdverseEventsAdvisoryNoticeProcedure.
8.5.2. CorrectiveAction8.5.2.1. TheProductAssuranceOfficeisresponsibletoinitiateactiontoeliminatethe
causeofnonconformitiesinordertopreventrecurrenceandrequirestheactionstobeappropriatetotheeffectsofthenonconformitiesencounteredaccordingtothe8.5.2CorrectiveActionProcedure.
8.5.3. PreventiveAction8.5.3.1. TheProductAssuranceOfficeisresponsiblefortheimplementationand
maintenanceofpreventiveactionprocessesaccordingtothe8.5.3PreventiveActionProcedure.