Quality Assurance Manual - Zentech Manufacturing, Inc. · J‐STD‐033 ‐ Standard for Handling...

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QualityAssuranceManual

ZentechManufacturing,Inc.6980TudsburyRoad

Baltimore,Maryland21244Phone:(443)348‐4500www.zentech.com

QAM 4.2.2 Quality Assurance Manual Rev F Page 2 of 24

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

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.

3.2. AllothermanagementofficeswithintheorganizationshallsupporttheManagementRepresentativesOfficeinthedesign,documentation,implementationandmaintenanceofthisQualityAssuranceManualandtheQualityManagementSystem.

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).

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

4.2.3Control of

Documents

Customers

5.2Customer

6.0Resource

Management

8.5Improvement

4.2.4Control ofRecords

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

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.