PHILIPS Design controls process.docx

PHILIPS Design controls process.docx

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PHILIPSDesigncontrolsprocess

Notice

RevisionSummary

UNCONTROLLEDINPRINTEDFORMUNLESSSTAMPEDINRED

Thecurrentdocumentrevisionisdescribedbelow:

Rev.

ChangeSummary（TheCOnumberofthisrevisionisshownintheDMSweb'effectivearea'screenforthisdocument）

Y

∙UpdatedProductSecurityOfficerRiskManagementApprovals（theyonlysignoff,notapprove）

∙MovedACheckpointReview（knownastheProjectPlanCommitmentMilestone-see“REVIEWING”section）mustbeconductedatthebeginningoftheprojectintheDefinitionandPlanningPhase,togetagreementfromentitymanagementontheprojectscope,devicedefinition,andcommitmenttosupporttheproject.Fromsection4.4DesignDevelopmentphaseto6.2CheckpointReview.

oRe-wordListofcross-functionalrepresentationcontributingtoriskmanagementactivity（includingnames,areaofcontributionandfunctions/expertiseofcontributors（seeA-Q2920-00126-F1）.

∙Reworded:

TakesintoconsiderationanyDoDDIACAPrequirementsfromthecustomerto:

oIftheproductissoldtothemilitary,thenDoDDIACAPsecurityrequirementsmayneedtobeaddressed.RequirementsareaddressedbyanalyzingtheproductwiththeDoDDIACAPgolddisk.ContactyourProductSecurityOfficerforadditionalguidance.

o

∙CorrectedOEMreferencecases1-4to1-7.

∙AddedclarificationtofootnotetoCRS（ConsidertheresultsoftheValuePropositionHouse（VPH）（UXW-030410）whichgeneratesandphrasesmeaningful,keyproduct/solutionrequirementsandVoiceoftheCustomer（VOC）UXW-030530&ProductRealizationProcess（UXW-030510&UXW-030510a1）processes）

∙AddedunderSourcingPolicy/SupplierDevelopmentContributionAgreement

∙ForSupplierrelatedissues:

implementanFMEAbeforerelease,tounderstandpotentialfutureQAissuesandimpacts

∙RemovedreferencestoARM,SETrequirementtools.

∙MovedunderCRSConsiderUDIbarcodepackingrequirementsfornew,revisedproductsorlabelchangesaccordingtoUXW-050002.

∙BecauseitisalreadyinTable2,RemovedunderDesignDevelopmentreferencetoCardiacCareSystems（CCS）Q&Rmustbenotifiedpriortoreleasinganynewproducts（beingsoldbyPhilips）sotheymaybeaddedintoDiscovery,APAC/POC,andMercuryatinitialreleaseorwhenadditionalmarketreleaseshappenwhentheyreceiveapprovalsforthoseotherregions.

∙UnderDesignDevelopmentPhase–removedreferencetoPhase1exitmeetingsincephraseisobsolete.

∙.Removedreferenceto:

Maintainabilityincludingthoroughcodedocumentation;

∙Under17.3correctreferencetoProductRealizationProcess.

∙Addedunder17.3‘OR’instatement:

∙Obsolete:

A-Q2920-00402（CATITest&InspectionTemplateGenerationProcess）,pleaserefertotheCSPPprocess.（A-Q2920-40490 Title:

PMCCCustomerServiceProductPlanningProcess）

∙MovedpartofDIACAPgolddiskreferencetosection17.3softwareverification.

∙Addedreferencefortestcoveragetosection17.3DesignVerificationProtocol:

orbasedonadeterminationandrationaleoftestcoveragebasedonRMSandPSRAfindings,andeterminationofadequatetestcoverage.

∙RewordedPeerReviewsectionforimprovedreadability.

∙Removedfootnote5frompage26forIdentificationof（otherPMCC）compatibledevicesbecausetextforfootnoteisundergeneralnotesonnextpage.

UnderISremoved:

∙referencetoTheallocationofrisk-controlmeasuresutilizingbutnotlimitedtotoolssuchasIshikawa,FaultTree,andFMECA.

∙utilizingsuchtoolsasDFSSRecommendedPRPGuidelines/PracticeslocatedinUXT-030530andUXT-030060,PHFailureModeandEffectsAnalysis（FMEA）.

∙andtestingforpreviousdefects;

∙RemovedPeerreviewissufficientaslongasthePeerreviewconductedisconductedsufficiently.

∙Undersection17.3DesignVerificationProtocolremovedreferencestocompilers.

∙Section6.5PeerReviewrewordedlastbullet

∙Undersection17.7TraceabilityMap:

correctedtypoandupdatedittocorrectlanguage‘CommercialRequirementsSpecification,System’

∙UnderDHFRelatedDocumentation:

changedtheworddeliverableto‘change’asfollows:

∙AnydeliverablelistedonTable1beingnewlyaddedorchanged,istobereviewedandapprovedbytheapproverslistedonTable1,priortoimplementationofchange.

∙Under24.3StatementofWork–restoredsecondbullet->Specificexpectationssurroundingstandardscompliance（QS,Safety,EMC,Risk,Biocompatibility,Sterilization,Other

∙UnderTable3–ComplementaryProductsIntegrationFlowbyPhase–changedfirstphasetoProductProposal

UnderPostReleaseSupplierChange–changedwordingto:

BU’sshouldre-evaluatethechanges（notjusttakevendor’stestresults）,implementaFMEAbefore–re-release,tounderstandpotentialfutureQAissuesandimpactsandpossiblyretesttheproducttoensurechangehasnotaffectedenvironmentalconditionsofproductbaseorotherfactors.

Undertransitionchangewordingto:

Thefollowingapplies:

∙IfaprojectispreDesignandImplementationPhase（e.g.,firsttwophases）thenimplementnewversionimmediately.

∙IfaProjectispostDefinitionandPlanningPhase（e.g.,thirdandfourthphase）thenconsultwithyourQ&RManager.

∙ReplacedoldreferencesthroughoutdocumentfromPre-DefinitionandPlanningwithDefinitionandPlanning.

∙UnderCase6–addedback（PreviouslyknownasComplementaryProducts）forclarification.

∙Updatedunder13.KeyComponentsreferencestochapternumbers

∙Under17.1Validationchangedclinicalinvestigationtoclinicalevaluation

∙Under17.3DesignVerificationProtocolrewordedtestcoverageparameters.

∙17.3SoftwareVerificationtookoutreferencetoHALT

∙NewPMCCSystemPatch/VulnerabilityProcessandCustomerNotification（A-Q2920-00528）&template（A-Q2920-00528-F1）,

∙UpdateofClinicalEvaluationProcess（A-Q2920-00182）andnewtemplate（A-Q2920-00182-T1）forClinicalEvaluationReport,

∙UpdateofRiskManagementProcess（A-Q2920-00126）andassociatedtemplatesandforms（A-Q2920-00126-F1,A-Q2920-00126-T1,（new）A-Q2920-00126-T2）

∙Note:

ClinicalEvaluationProcessandRiskManagementprocesseswereupdatedfor62304,60601-1:

20053rdEditionandthenewMDD.

∙PowerpointtrainingforICLprocess（ICS_204_presentation.ppt）

∙ChangetitleofVisiofilefrom204Eflow-1.vsdtoA-Q2920-00204flow-1.vsd

∙UpdateA-Q2920-00204-F1changesfornewMDDchangesandPMCCreferencesandproperwordingofdocumentnames.

∙UpdateofDiscontinuanceProcessA-Q2920-00207withdefaulttimingdates,referencePRPPFPP,referenceforMCS,clarifiedGMSperiod,anddeletedduplicatedphase.

Purpose

ToestablishtherequirementsandprocessesforthedesignanddevelopmentofneworrevisedPMCCproduct.

Scope

ThisisaTier2QualitySystemDocumentoftheelementDesignControls/NewProductDevelopment.

ThisisaQSRdocument:

ThisdocumentappliestoPMCCmedicalandnon-medicalnewproductdesignanddevelopment,aswellastoexistingproductdesign.ThisprocessappliesregardlessiftheproductisPhilipsbrandedornot,oriftheproductisdevelopedinhouseornot.Inaddition,thisprocessappliestoComplementaryProducts.

ThisProcess:

▪Appliestothedesignofpartialproducts（i.e.,items/subassemblies/modules/etc.）thatwillendupincommerciallyavailableproduct.

▪Appliestorevisedproductasdescribedinthe“REVISEDPRODUCT”section.

▪Doesnotapplytoresearchorinvestigationaimedatdeterminingthefeasibilityofaneworrevisedproductorproductuse.

▪IsinalignmentwiththerelevantsectionsofthePMSUXT-030001,PMSProductCreationProcess,andPMSUXW-030510,PMSProductRealizationProcess.

▪DoesnotincorporateCEmarkingrequirementsfortheEMCDirective.NoprocessiscurrentlyprovidedfortheEMCDirective;refertotheEMCDirectivedirectlyforspecificsand/orconsultwithRegulatoryEngineering.

▪ComplieswithFDA’sGuidancefor“GeneralPrinciplesofSoftwareValidation:

FinalGuidanceforIndustryandFDAStaff.

Thisdocumentdealsnotonlywithrequirementsrelatedtoproductquality,butalsowithrequirementstosupportoperationalaspects.Forclarity,operationaldeliverablesarelistedseparately.

DocumentComponents

ThisdocumentcontainsthefollowingadditionalcomponentsinDMS:

Filename

Description

A-Q2920-00204Flow-1.vsd

ProductDevelopment–DesignFlowbyPhase

204dflow-2.ppt

ProductDevelopmentDesignFlow

Note:

WherethewordDeviceisusedwithinthisprocessitissynonymouswiththewordProduct.

TableofContents

1.ProductDevelopmentDesignFlowbyPhaseDiagram7

2.General8

1.1Responsibilities8

3.RevisedProduct9

4.Planning9

4.1ProgramManagementPlan（PMP）9

4.2PMPProgramOverview10

4.3PMPProjectSchedule12

4.4DesignDevelopmentPhases13

5.ProductDevelopment–DetailedDesignFlow14

6.Reviewing15

6.1General15

6.2CheckpointReview15

6.3DesignReviewRequirements,NewDeviceDesign16

6.4DesignReviewResponsibilities17

6.5PeerReviewRequirements17

7.Designing18

7.1.1DesignDevelopment18

8.ProcessDeliverables19

8.1General19

8.2Table1.0ProcessDeliverablesSummary20

8.3OrderofExecution（Verification&Validation）22

9.CommercialRequirementsSpecification（CRS）23

9.1General23

9.2Contents24

10.System/ProductRequirementsSpecification（SRS）26

10.1InstrumentCompatibilitySupplement（ICS）27

11.InternalSpecification（IS）28

12.RiskManagement29

12.1SecurityRiskAssessment29

12.2SafetyRiskManagement29

13.KeyComponent31

13.1Definition31

13.2Implementation31

14.PurchasedPartClassification32

14.1Introduction32

14.2Determiningproperpartclassification32

15.ProductSpecifications33

15.1Product/PartSpecifications33

15.2Purchased