qms質量管理體系-21cfr-820quality system

TITLE21--FOODANDDRUGSCHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICESSUBCHAPTERH--MEDICALDEVICESPART QUALITYSYSTEMSubpartA--GeneralSec.820.1Currentgoodmanufacturingpractice(CGMP)requirementsaresetforthinthisqualitysystemregulation.Therequirementsinthisparternthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,andservicingofallfinisheddevicesintendedforhumanuse.TherequirementsinthispartareintendedtoensurethatfinisheddeviceswillbesafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeticAct(theact).Thispartestablishesbasicrequirementsapplicabletomanufacturersoffinishedmedicaldevices.Ifamanufacturerengagesinonlysomeoperationssubjecttotherequirementsinthispart,andnotinothers,thatmanufacturerneedonlycomplywiththoserequirementsapplicabletotheoperationsinwhichitisengaged.Withrespecttoclaevices,designcontrolsapplyonlytothosedeviceslistedin820.30(a)(2).Thisregulationdoesnotapplytomanufacturersofcomponentsorpartsoffinisheddevices,butsuchmanufacturersareencouragedtouseappropriateprovisionsofthisregulationasguidance.Manufacturersofhumanbloodandbloodcomponentsarenotsubjecttothispart,butaresubjecttopart606ofthischapter.Manufacturersofhumancells,tissues,andcellularandtissue-basedproducts(HCT/Ps),asdefinedin1271.3(d)ofthischapter,thataremedicaldevices(subjecttopremarketreviewornotification,orexemptfromnotification,underanapplicationsubmittedunderthedeviceprovisionsoftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct)aresubjecttothispartandarealsosubjecttothedonor-eligibilityproceduressetforthinpart1271subpartCofthischapterandapplicablecurrentgoodtissuepracticeproceduresinpart1271subpartDofthischapter.Intheeventofabetweenapplicableregulationsinpart1271andinpartsofthischapter,theregulationspecificallyapplicabletothedeviceinquestionshallsupersedethemoregeneral.Theprovisionsofthispartshallbeapplicabletoanyfinisheddeviceasdefinedinthispart,intendedforhumanuse,thatismanufactured,imported,orofferedforimportinanyStateorTerritoryoftheUnitedStates,theDistrictofColumbia,ortheCommonwealthofPuertoRico.justificationInthisregulationtheterm"whereappropriate"isusedseveraltimes.Whenarequirementisqualifiedby"whereappropriate,"itisdeemedjustification當理由otherwise.Arequirementis"appropriate"ifnonimplementationcouldreasonablybeexpectedtoresultintheproductnotmeetingitsspecifiedrequirementsorthemanufacturernotbeingabletocarryoutanynecessarycorrectiveaction.Thequalitysystemregulationinthispartsupplementsregulationsintheeventofabetweenapplicableregulationsinthispartandinotherpartsofthischapter,theregulationsspecificallyapplicable381,383).Thefailuretocomplywithanyapplicableprovisioninthispartrendersadeviceadulteratedundersection501(h)oftheact.Suchadevice,aswellasanyresponsibleforthefailuretocomply,issubjecttoregulatoryaction.Foreignmanufacturers.IfamanufacturerwhooffersdevicesforimportintotheUnitedStatesrefusestopermitorallowthecompletionforthepurposeofdeterminingcompliancewiththispart,itshallappearforpurposesofsection801(a)oftheact,thatthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,suchfacilitythatareofferedforimportintotheUnitedStatesdonotconformtotherequirementsofsection520(f)oftheactandthispartsection501(h)oftheact.Exemptionsorvariances whowishestopetition[p?'t??(?)n]foranexemptionorvarianceofsection520(f)(2)oftheact.Petitionsforanexemptionorvarianceshallbesubmittedaccordingtotheproceduressetforthin10.30ofthistheFoodandDrugAdministration,CenterforDevicesandRadiologicalHealth,DivisionofSmallManufacturers,InternationalandConsumerAssistance,10903NewHampshireAve.,Bldg.66,rm.4613,SilverSpring,MD20993-0002,1- ,FAX: FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhenncydeterminesthatsuchvarianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthneedforthedeviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.[61FR52654,Oct.7,1996,asamendedat65FR17136,Mar.31,2000;FR66636,Nov.7,2000;69FR29829,May25,2005;72FR17399,Apr.2007;75FR20915,Apr.22,Sec.820.3ActmeanstheFederalFood,Drug,andCosmeticAct,asamended(secs.201-903,52Stat.1040etseq.,asamended(21U.S.C.321-394)).Alldefinitionsinsection201oftheactshallapplytotheregulationsinthispart.Complaintmeansanywrittenelectronicororalcommunicationthatallegesdeficienciesrelatedtotheidentityqualitydurability,reliability,safetyeffectivenessorperformanceofadeviceafteritisreleasedfordistribution.Componentmeansanyrawmaterial原材料,substance,piece,part,software,firmware固件labelingorassemblywhichisintendedtobeincludedaspartofthefinished,packaged,andlabeleddevice.Controlnumber譯？meansanydistinctivesymbolssuchasadistinctivecombinationoflettersornumbersorbothfromwhichthehistoryofthemanufacturingpackaginglabelinganddistributionofaunit,lot,orbatchoffinisheddevicescanbedetermined.Designhistoryfile(DHF)meansacompilationofrecordswhichdescribesthedesignhistoryofafinisheddevice.Designinputmeansthephysicalandperformancerequirementsofadevicethatareusedasabasisfordevicedesign.Designoutputmeanstheresultsofadesigneffortateachdesignphaseandat ofthetotaldesigneffort.Thefinisheddesignoutputisthebasisforthedevicemasterrecord器械主記錄？.Thetotalfinisheddesignoutputconsistsofthedeviceitspackagingandlabelingandthedevicemasterrecord.Designreview設計評審meansa ed,comprehensive,systematicexaminationofadesigntoevaluatetheadequacyofthedesignrequirements設計要求,toevaluatethecapabilityofthedesigntomeettheserequirements,andtoidentifyproblems.Devicehistoryrecord(DHR)meansacompilationofrecordscontainingtheproductionhistoryofafinisheddevice生產記錄.theprocedures程序andspecifications規(guī)范forafinisheddevice.Establishmeansdefine, Finisheddevicemeansanydeviceoraccessory配件toanydevicethatissuitableforuseorcapableoffunctioning,whetherornotitispackaged,labeled,orsterilized.Lotorbateansoneormorecomponentsorfinisheddevicesthatconsistofasingletypemodel模型classsizecomposition組成/組合,orsoftwareversionthataremanufacturedunderessentiallythesameconditionsandthatareintendedtohaveuniformcharacteristicsandqualitywithinspecifiedlimits.Managementwithexecutiveresponsibilitymeansthosesenioremployeesofamanufacturerwhohavetheauthoritytoestablishormakechangestothemanufacturer'squalitypolicyandqualitysystem.Manufacturermeansany whodesigns,manufactures,fabricates制造,assembles,orprocessesafinisheddevice.Manufacturerincludesbutisnotlimitedtothosewhoperformthefunctionsofcontractspecificationdevelopment,andinitialdistributorsofforeignentities['ent?ti /實體performingthesefunctions.tofacilitatethemanufacturingprocess,a itantconstituent伴隨成分,orabyproductconstituent副產品成分producedduringthemanufacturingprocesswhichispresentinoronthefinisheddeviceasaresidue'rez?du]剩余物orimpurity雜志notbydesignorintentoftheNonconformitymeansthenonfulfillmentofaspecifiedProductmeanscomponentsmanufacturingmaterialsinprocessdevices,finisheddevices成品,andreturneddevices.Qualitymeansthetotalityoffeaturesandcharacteristicsthatbearontheabilityofadevicetosatisfyfitness-for-use適用性includingsafetyandperformance.Qualityauditmeansasystematic,independentexaminationofamanufacturer'squalitysystemthatisperformedatdefinedintervalsandatsufficientfrequencytodeterminewhetherbothqualitysystemprocedures,thattheseproceduresareimplementedeffectively,andthattheseproceduresaresuitabletoachievequalitysystemobjectives.Qualitypolicy質量手meanstheoverallintentionsanddirectionofananizationwithrespecttoqualityasestablishedbymanagementwithexecutiveresponsibility.Qualitysystemmeansthe procedures,processes,andresourcesforimplementingqualityRemanufacturer再生商譯？meansany renovates['ren?.ve?t]修復,repackages,restores,ordoesanyotheractafinisheddevicethatsignificantlychangesthefinisheddevice'sperformanceorsafetyspecifications,orintendeduse.Rework返工meansactiontakenonanonconformingproductsothatitwillfulfillthespecifiedDMRrequirementsbeforeitisreleasedfordistribution.Specificationmeansanyrequirementwithwhichaproduct,process,service,orotheractivitymustconform.Validation驗證meansconfirmationbyexaminationandprovisionofobjectiveevidence客觀thattheparticularrequirementsforaspecificintendeduse預期用途canbeconsistentlyfulfilled.Processvalidation過程檢驗meansestablishingbyobjectiveevidencethataprocessconsistentlyproducesaresultorproductmeetingitspredeterminedspecifications.specificationsconformwithuserneeds使用需求andintendeduse(s).(aa)VerificationmeansconfirmationbyexaminationandprovisionofobjectiveevidencethatspecifiedrequirementshavebeenSec.820.5QualityEaanufacturershallestablishandmaintainaqualitysystemthatisappropriateforthespecificmedicaldevice(s)designedormanufactured,andthatmeetstherequirementsofthispart.SubpartB--QualitySystemSec.820.20ManagementQualitypolicy.Managementwithexecutiveresponsibilityshallestablishitspolicyandobjectivesfor,andcommitmentto,quality.Managementwithexecutiveresponsibilityshallensurethatthequalityofthe anization.Ea anufacturershallestablishandmaintainan producedinaccordancewiththerequirementsofthispart.Responsibilityandauthority.Ea anufacturershallestablishtheappropriateresponsibility,authority,andinterrelationofallnelwhomanageperformandassessworkaffectingquality,andResources.Ea anufacturershallprovideadequateresources,includingtheassignmentoftrained nel,formanagement,performanceofwork,andassessmentactivities,includinginternalqualityaudits,tomeettherequirementsofthispart.ManagementrepresentativeManagementwithexecutiveresponsibilityshallappointandsuchappointmentofamemberofmanagementwhoirrespectiveofotherresponsibilitiesshallhaveestablishedauthorityoverandresponsibilityfor:Ensuringthatqualitysystemrequirementsareeffectivelyestablishedandeffectivelymaintainedinaccordancewiththispart;andReportingontheperformanceofthequalitysystemtomanagementwithexecutiveresponsibilityforreview.Managementreview.Managementwithexecutiveresponsibilityshallreviewthesuitabilityandeffectivenessofthequalitysystematdefinedprocedurestoensurethatthequalitysystemsatisfiestherequirementsofthispartandthemanufacturer'sestablishedqualitypolicyandobjectives.ThedatesandresultsofqualitysystemreviewsshallbeQualityplanning.Ea anufacturershallestablishaqualityplantodevicesthataredesignedandmanufactured.Themanufacturershallestablishhowtherequirementsforqualitywillbemet.Qualitysystemprocedures.Eaanufacturershallestablishqualitysystemproceduresandinstructions.AnoutlineofthestructureoftheationusedinthequalitysystemshallbeestablishedwhereSec.820.22Quality anufacturershallestablishsuchauditstoassurethat

proceduresproceduresforqualityauditsthequalitysystemisinwiththeestablishedqualitysystemrequirementsandtodeterminetheeffectivenessofthequalitysystemQualityauditsshallbeconductedbyindividualswhodonothavedirectresponsibilityforthemattersbeingaudited.Correctiveaction(s)糾正措施includingareauditofdeficientmattersshallbetakenwhennecessaryAreportoftheresultsofeachqualityauditandreaudit(swheretaken,shallbemadeandsuchreportsshallbereviewedbymanagementhavingresponsibilityforthemattersaudited.ThedatesandresultsofqualityauditsandreauditsshallbeSec.820.25General.Eaanufacturershallhavesufficientnelwiththenecessaryeducation,background,training,andexperiencetoassurethatallactivitiesrequiredbythispartarecorrectlyperformed.Training.Ea trainingneedsandensurethat

aretrainedto performtheirassignedresponsibilities.Trainingshall Aspartoftheirtraining, nelshallbemadeawareofdevicedefect缺陷swhi ayoccurfromtheimproperperformanceoftheirspecificjobs.nelwhoperformverificationandvalidationactivitiesshallbemadeawareofdefectsanderrorsthatmaybeencounteredaspartoftheirjobfunctions.SubpartC--DesignControlsSec.820.30Designcontrols. anufacturerofanyclassIIIorclassIIdevice,andtheclassthatspecifieddesignrequirementsare

Thefollowing evicesaresubjecttodesignDevicesautomatedwithcomputersoftware;ThedeviceslistedinthefollowingCatheter,TracheobronchialGlove,Restraint,System,Applicator,Radionuclide,Source,RadionuclideDesignanddevelopmentplanning.Ea identifyanddescribetheinterfaceswithdifferentgroupsoractivitiesthatprovideorresultininputtothedesignanddevelopmentprocess.Theplansshallbereviewed,updated,andapprovedasdesignanddevelopmentevolves更新.Designinput. anufacturershallestablishandproceduresprocedurestoensurethatthedesignrequirementsrelatingtoaareappropriateandaddresstheintendeduseofthedevice,includingtheneedsoftheuserandpatient.Theproceduresshallincludeamechanism['mek?.n?z?m]機理方法foraddressing plete,ambiguous,oringrequirements.Thedesigninputrequirementsshallbeedandshallbereviewedandapprovedbyadesignatedindividual(s).Theapproval,includingthedateandsignatureofindividual(s)approvingtherequirements,shall Designoutput. anufacturershallestablishand.Designoutputproceduresshallcontainormakereferencetoacceptancecriteriaandfortheproperfunctioningofthedeviceareidentified.Designoutputshallbeed,reviewed,andapprovedbeforerelease.Theapproval,includingthedateandsignatureoftheindividual(s)approvingtheoutput,shallbeed.Designreview. anufacturershallestablishand atappropriatestagesofthedevice'sareplannedandstagebeingreviewedandanindividual(s)whodoesnothavedirectresponsibilityforthedesignstagebeingreviewed,aswellasanyspecialistsneeded.Theresultsofadesignreview,includingidentificationofthedesign,thedate,andtheindividual(s)performingthereview,shallbe edinthedesignhistoryfile(theDHF).Designverification.Ea anufacturershallestablishandmaintainproceduresforverifyingthedevicedesign.Designverificationshallconfirmthatthedesignoutputmeetsthedesigninputrequirements.Theresultsofthedesignverification,includingidentificationofthedesign,method(s),thedate,andtheindividual(s)performingtheverification,shallbe edintheDHF.Designvalidation.Ea anufacturershallestablishandmaintainproceduresforvalidatingthedevicedesign.Designvalidationshallbelots,orbatches,ortheirequivalents.Designvalidationshallensurethatdevicesconformtodefineduserneedsandintendedusesandshallincludetestingofproductionunitsunderactualorsimulateduse ysis,whereappropriate.Theresultsofthedesignvalidation,includingidentificationofthedesign,method(s),thedate,andtheindividual(s)performingthevalidation,shallbe Designtransfer. anufacturershallestablishandproductionDesignchanges. anufacturershallestablishandproceduresproceduresforthe ation,validationortheir.Designhistoryfile.Ea foreachtypeofdevice.TheDHFshallcontainorreferencetherecordstheapproveddesignplanandtherequirementsofthispart.SubpartD--Sec. anufacturershallestablishandmaintainprocedurestocontrolallsthatarerequiredbythispart.Theproceduresshallfortheapprovalanddistribution.Ea anufacturershalldesignate['dez?ɡn?t]指定anindividual(s)toreviewforadequacyandapprovepriortoissuanceall sestablishedtomeettheoftheindividual(s)approvingthe ,shallbe sestablishedtomeettherequirementsofthispartshallbeavailableatalllocationsforwhichtheyaredesignated,used,orotherwisenecessary,andallobsolete[.ɑbs?'lit] sshallbepromptlyremovedfromallpointsofuseorotherwisepreventedfromunintendeduse.changes.Changesto sshallbereviewedandapprovedbyanindividual(s)inthesamefunctionor anizationthatperformedtheoriginalreviewandapproval,unlessspecificallydesignatedotherwise.Approvedchangesshallbecommunicatedtothe nelinatimely及時的manner.Ea anufacturershallmaintainrecordsofchangesto s.Changerecordsshallincludeadescriptionofthechange,identificationoftheaffected thechange eseffective.SubpartE--PurchasingSec.820.50Purchasing anufacturershallestablishandmaintainprocedurestoensurethatallpurchasedorotherwisereceivedproductandservicesconformtospecifiedrequirements.Evaluationofrs,contractors承包商,andconsultants.Eachmanufacturershallestablishandmaintaintherequirements,includingqualityrequirements,thatmustbemetbyrs,contractors,andconsultants.Ea anufacturershall:Evaluateandselectpotentialrs,contractors,andconsultantsonthebasisoftheirabilitytomeetspecifiedrequirements,includingqualityrequirements.Theevaluationshallbeed.Definethetypeandextent范圍程度ofcontroltobeexercisedovertheevaluationresults.andconsultants.Purchasingdata.Ea thatclearlydescribeorreferencethespecifiedrequirements,includingqualityrequirementsforpurchasedorotherwisereceivedproductandservices.Purchasing sshallinclude,wherepossible,anagreement協(xié)議thatthers,contractors,andconsultantsagreetonotifythemanufacturerofchangesintheproductorservicesothatmanufacturersmaydeterminewhetherthechangesmayaffectthequalityofafinisheddevicePurchasingdatashallbeapprovedinaccordancewithSubpartF--IdentificationandSec.820.60 productduringallstagesofreceipt,production,distribution,andinstallationtopreventmixups.Sec.820.65 anufacturerofadevicethatisintendedforsurgicalimplantintothebodyortosupportorsustainlifeandwhosefailuretoperformwhenproperlyusedinaccordancewithinstructionsforuseprovidedinthelabelingcanbereasonablyexpectedtoresultinasignificantinjurytotheusershallestablishandmaintainproceduresforidentifyingwithacontrolnumbereachunit,lot,orbatchoffinisheddevicesandwhereappropriatecomponents.Theproceduresshallfacilitatecorrectiveaction.Suchidentificationshallbe edintheDHR.SubpartG--ProductionandProcessSec.820.70ProductionandprocessGeneral. anufacturershalldevelop,conduct,control,monitorproductionprocessestoensurethatadeviceconformstoitsspecifications.Wheredeviations偏差fromdevicespecificationscouldoccurasaresultofthemanufacturingprocess,themanufacturershallestablishandmaintainprocesscontrolproceduresthatdescribeanyprocesscontrolsnecessarytoensureconformancetospecifications.Whereprocesscontrolsareneededtheyshallinclude: methodsthatdefineandcontrolthemannerofproduction;Monitoringandcontrolofprocessparametersandcomponentanddevicecharacteristicsduringproduction;CompliancewithspecifiedreferencestandardsorTheapprovalofprocessesandprocessequipment;Criteriaforworkmanship工藝whichshallbeexpressedin Productionandprocesschanges.Ea anufacturershallestablishandmaintainproceduresforchangestoaspecification,method,process,orprocedure.Suchchangesshallbeverifiedorwhereappropriate Environmentalcontrol.Whereenvironmentalconditionscouldreasonablybeexpectedtohaveanadverseeffectonproductquality,themanufacturershallestablishandmaintainprocedurestoadequa shallbeperiodicallyinspectedtoverifythatthesystem,includingnecessaryequipment,isadequateandfunctioningproperly.Theseactivitiesshallbe edandreviewed.nel.Ea anufacturershallestablishandmaintainrequirementsforthehealth,cleanliness, alpractices,andclothingof nelifcontactbetweensuch nelandproductorenvironmentcouldreasonablybeexpectedtohaveanadverseeffectonnelwhoarerequiredtoworktemporarily暫時underenvironmentalconditionsareappropria ytrainedorsupervisedbyatrainedindividual.Contaminationcontrol.Ea anufacturershallestablishandmaintainprocedurestopreventcontaminationofequipmentorproductbysubstancesthatcouldreasonablybeexpectedtohaveanadverseeffectonproductquality.Buildings.Buildingsshallbeofsuitabledesignandcontainsufficientspacetoperformnecessaryoperations,preventmixups,andassureorderlyEquipment.Ea themanufacturingprocessmeetsspecifiedrequirementsandis maintenance,adjustment,cleaning,anduse.Maintenanceschedule.Ea schedulesfortheadjustment,cleaning,andothermaintenanceofequipmenttoensurethatmanufacturingspecificationsaremet.themaintenanceactivities,shallbe Inspection.Eaanufacturershallconductperiodicinspectionsinaccordancewithestablishedprocedurestoensureadherencetoapplicableequipmentmaintenanceschedules.Theinspections,includingthedateandindividual(s)conductingtheinspections,shallbeed.Adjustment.Ea anufacturershallensurethatanyinherentlimitationsorallowabletolerancesarevisiblypostedonornearequipmentrequiringperiodicadjustmentsorarereadilyavailabletonelperformingtheseManufacturingmaterial.Whereamanufacturingmaterialcouldreasonablybeexpectedtohaveanadverseeffectonproductquality,themanufacturershallestablishandmaintainproceduresfortheuseandremovalofsu anufacturingmaterialtoensurethatitisremovedorTheremovalorreductionofsu anufacturingmaterialshallbeAutomatedprocesses.Whencomputersorautomateddataprocessingsystemsareusedaspartofproductionorthequalitysystem,themanufacturershallvalidatecomputersoftwareforitsintendeduseaccordingtoanestablishedprotocol['pro?t?.k?l]議定書Allchangesshallbevalidatedbeforeapprovalandissuance.Thesevalidationactivitiesandresultsshallbe Sec.820.72Inspection,measuring,andtestControlofinspection,measuring,andtestequipment.Eachmanufacturershallensurethatallinspection,measuring,andtesttestequipment,issuitableforitsintendedpurposesandiscapableofproducingvalidresults.Ea anufacturershallestablishandmaintainprocedurestoensurethatequipmentisroutinelycalibrated['k?l?.bre?t]定標,inspected,checked,andmaintained.Theproceduresshallincludeprovisionsforhandling,preservation,andstorageofequipment,sothatitsaccuracyandfitnessforusearemaintained.Theseactivitiesshall andlimitsforaccuracyandprecision.Whenaccuracyandprecisionlimitsarenotmet,thereshallbeprovisionsforremedialaction補救措施toreestablishthelimitsandtoevaluatewhethertherewasanyadverseeffectonthedevice'squality.Theseactivitiesshallbe Calibrationstandards.Calibrationstandardsusedforinspection,measuring,andtestequipmentshallbetraceabletonationalorpracticaloravailable,themanufacturershalluseanindependentshallestablishandmaintainanin-house機構的standard.theindividualperformingeachcalibration,andthenextcalibrationdateshallbe ed.Theserecordsshallbedisplayedonorneareachpieceofequipmentorshallbereadilyavailabletothe nelusingsuchequipmentandtotheindividualsresponsibleforcalibratingtheSec.820.75Processinspectionandtest,theprocessshallbevalidatedwithahighdegreeofassurance擔保andapprovedaccordingtoestablishedprocedures.Thevalidationactivitiesandresults,includingthedateandsignatureoftheindividual(s)approvingthevalidationandwhereappropriatethemajorequipmentvalidated,shallbe anufacturershallestablishandmaintainproceduresformonitoringandcontrolofprocessparametersforvalidatedprocessestoensurethatthespecifiedrequirementscontinuetobemet. byqualifiedindividual(s).Forvalidatedprocesses,themonitoringandcontrolmethodsanddata,thedateperformed,and,whereappropriate,theindividual(s)performingtheprocessorthemajorequipmentusedshallbeed.Whenchangesorprocessdeviationsoccur,themanufacturershallreviewandevaluatetheprocessandperformrevalidationwhereappropriate.Theseactivitiesshallbe SubpartH--AcceptanceActivitiesSec.820.80Receiving,in-process,andfinisheddeviceGeneral.Eaanufacturershallestablishandmaintainproceduresforacceptanceactivities.Acceptanceactivitiesincludeinspections,tests,orotherverificationactivities.Receivingacceptanceactivities.Ea maintainproceduresforacceptanceof ingproduct. ingproductshallbeinspected,tested,orotherwiseverifiedasconformingtospecifiedrequirements.Acceptanceorrejectionshallbe In-processacceptanceactivities.Ea anufacturershallestablishandmaintainacceptanceprocedures,whereappropriate,toensurethatspecifiedrequirementsforin-processproductaremet.Suchproceduresshallensurethatin-processproductiscontrolleduntiltherequiredornecessaryapprovalsarereceived,andare Finalacceptanceactivities.Ea anufacturershallestablishandmaintainproceduresforfinisheddeviceacceptancetoensurethateachproductionrun,lot,orbatchoffinisheddevicesmeetsacceptancecriteria.Finisheddevicesshallbeheldin ['kw?r?n.tin]檢疫orotherwise ycontrolleduntilreleased.FinisheddevicesnotbereleasedfordistributionTheactivitiesrequiredintheDMRaretheassociateddata ationisthereleaseisauthorizedbythesignatureofadesignatedindividual(s);andtheauthorization/批準isAcceptancerecords.Ea anufacturershall activitiesrequiredbythispart.Theserecordsshallinclude:Theacceptanceactivitiesthedatesacceptanceactivitiesarethethesignatureoftheindividual(s)conductingtheacceptanceactivities;andtheDHR.Sec.820.86AcceptanceEaanufacturershallidentifybysuitablemeanstheacceptancestatusofproduct,toindicatetheconformanceornonconformanceofproductwithacceptancecriteria.Theidentificationofacceptancestatusshallbeandservicingoftheproducttoensurethatonlyproductwhichhaspassedtherequiredacceptanceactivitiesisdistributed,used,orinstalled.SubpartI--NonconformingSec.820.90NonconformingControlofnonconformingproduct.Ea anufacturershallestablishandmaintainprocedurestocontrolproductthatdoesnotconformtoation,evaluation,segregation,anddisposition排列determinationoftheneedforaninvestigationandnotificationofthesor anizationsresponsibleforthenonconformance.Theevaluationandanyinvestigationshall Nonconformityreviewanddisposition.(1)Ea anufacturershallestablishandmaintainproceduresthatdefinetheresponsibilityforreviewandtheauthorityforthedispositionofnonconformingproduct.Theproceduresshallsetforththereviewanddispositionprocess.Dispositionofnonconformingproductshallbe signatureoftheindividual(s)authorizingtheuse.(2)Ea toincluderetestingandreevaluationofthenonconformingproductafterrework,toensurethattheproductmeetsitscurrentapprovedspecifications.Reworkandreevaluationactivities,includingadeterminationofanyadverseeffectfromthereworkupontheproduct,shallbe edintheDHR.SubpartJ--CorrectiveandPreventiveAction糾正和預防措Sec.820.100Correctiveandpreventive anufacturershallestablishandmaintainproceduresforimplementingcorrectiveandpreventiveaction.Theproceduresshallincluderequirementsfor:yzingprocessesworkoperationsconcessions妥協(xié)/特許qualityauditreportsqualityrecordsservicerecordscomplaintsreturnedproduct,andothersourcesofqualitydatatoidentifyexistingandpotentialcausesofnonconformingproduct,orotherqualityproblems.detectrecurringqualityproblems;Investigatingthecauseofnonconformitiesrelatingtopro