通风橱风险评估 Risk Assessment for Fume Hood

通风橱风险评估RiskAssessmentforFumeHood作者Author姓名PrintName职务Occupation签名Signature日期Date审核Reviewer姓名PrintName职务Occupation签名Signature日期Date批准Approver姓名PrintName公司/部门Company/Department签名Signature日期Date风险级别RiskPriority检测可能性低LowProbabilityofDetection检测可能性中等MediumProbabilityofDetection检测可能性高HighProbabilityofDetection风险类别1RiskClass1风险级别高HighRiskPriority风险级别高HighRiskPriority风险级别中等MediumRiskPriority风险类别2RiskClass2风险级别高HighRiskPriority风险级别中等MediumRiskPriority风险级别低LowRiskPriority风险类别3RiskClass3风险级别中等MediumRiskPriority风险级别低LowRiskPriority风险级别低LowRiskPriority评估的目的，是每个关键部件和功能将根据其所执行的功能而确定其最高的风险级别，而后采用风险级别高低来决定适宜的控制方法并确定验证工作的范围。风险级别为中高级必须给出合理建议，并确定适宜的控制方法。Thepurposeofevaluationistodeterminethehighestrisklevelofeachkeycomponentandfunctionbasedonitsexecutedfunction,andthenusethelevelofrisktodeterminetheappropriatecontrolmethodanddeterminethescopeofverificationwork.Reasonablesuggestionsmustbegivenandappropriatecontrolmethodsmustbedeterminedwhentherisklevelismediumtohigh.7.3关键性部件和功能高/中风险评估CriticalComponentandFunctionHigh/MediumRiskAssessment根据关键性部件和功能风险评估的结果，对关键性功能和部件的高/中风险要继续进行风险评估。Continuetoassessthehigh/mediumriskofcriticalcomponentandfunction,accordingtotheresultofCriticalComponentandFunctionRiskAssessment.风险分析和评价表达使用定性描述。和7.2项同样的方法再次用于评估关键性功能和部件高/中风险的建议措施。Riskwillbeexpressedusingqualitativedescriptors.Thesamemethodofitem7.2isusedfortherecommendationofhigh/mediumriskofcriticalcomponentandfunctionagain.建议措施被采用后，关键性部件和功能风险的级别应当降到低级。Therisklevelofcriticalcomponentandfunctionshouldbedecreasedtolowwhentherecommendationswereadopted.通风橱风险评估RiskAssessmentforFumeHood文件编号/Code.版本号/Version页码/Page0111/158. 功能/部件关键性评估Criticalevaluationoffunctions/components8.1功能/部件关键性矩阵Function/componentcriticalmatrix序号功能/部件组件功能问题Problem关键CriticalNO.Function/ComponentComponentfunctionsABCDEFG是/否（Yes/NO）1箱体Box箱体为PP材质TheboxismadeofPPmaterialNNNNNNYYES2内衬Lining提供洁净环境ProvideacleanenvironmentNNNNYNYYES3控制面板Controlpanel设备控制界面，设备基本操作由控制面板操作运行Equipmentcontrolinterface.ThebasicoperationoftheequipmentisoperatedbythecontrolpanelNNNNNNYYES4照明lighting提供照明，利于操作人员进行正确的操作ProvidelightingtofacilitatethecorrectoperationofoperatorsNNNNNNYYES5插座Socket电源接口ThepowerinterfaceNNNNNNYYES6卷帘Rollershutter提供操作空间ProvideoperatingspaceNNNNNNYYES通风橱风险评估RiskAssessmentforFumeHood文件编号/Code.版本号/Version页码/Page0112/158.2关键性部件/功能风险评估CriticalComponent/FunctionRiskAssessment序号NO.功能/关键部件Functional/keycomponents说明/任务Description/Tasks失效事件Failureevents最差情况影响Worst-caseimpactSPD风险优先性RPN1箱体Box箱体为PP材质TheboxismadeofPPmaterial选材不当，外观不平整，有划痕Impropermaterialselection,unevenappearance,andscratches洁净度不合格，洁净环境受到污染，不易于清洁Thecleanlinessisunqualified,thecleanenvironmentispolluted,anditisnoteasytocleanMMMM2内衬Lining提供洁净环境Provideacleanenvironment选材不当Impropermaterialselection影响洁净室环境ImpactoncleanroomenvironmenMMMM3控制面板Controlpanel设备控制界面，设备基本操作由控制面板操作运行Equipmentcontrolinterface.Thebasicoperationoftheequipmentisoperatedbythecontrolpanel控制面板失灵Controlpanelmalfunction影响设备正常使用AffectthenormaluseoftheequipmentHLMH4照明lighting提供照明，利于操作人员进行正确的操作Providelightingtofacilitatethecorrectoperationofoperators选型错误照度达不到要求Wrongtypeselection,illuminationfailstomeettherequirements工作区照度不符合要求TheilluminationintheworkingareadoesnotmeettherequirementsMMMM5插座Socket提供电源Providepowersupply类型错误，安装错误Typeerror,installationerror设备无法正常使用ThedeviceisnotworkingproperlyMMMM6卷帘Rollershutter提供操作空间Provideoperatingspace材质不符合Mtilerialdoesnotmatch材质脱落腐蚀，影响洁净室环境Materialsheddingcorrosion,affectingthecleanroomenvironmentMMMM通风橱风险评估RiskAssessmentforFumeHood文件编号/Code.版本号/Version页码/Page0113/158.3关键性部件和功能风险控制矩阵CriticalComponentandFunctionRiskControlMatrix序号NO.功能/关键部件Functional/kevcomponentsRisklevel风险级别(beforetakecontrolaction)(采取控制措施之前)Recommendedcontrolaction建议控制措施SPD风险优先性RPNRiskacceptable?风险可接受？YES/NO1箱体BoxMIQ确认中检查材质证明，目视检查MaterialcertificationandvisualinspectionduringIQconfirmationMMHLYES2内衬LiningMIQ确认中检查材质证明，目视检查MaterialcertificationandvisualinspectionduringIQconfirmationMMHLYES3控制面板ControlpanelHIQ确认中目视检查DesignconfirmationinDQandvisualinspectioninIQHLHLYES4照明lightingMIQ阶段对部件安装情况进行检查，OQ阶段进行房间照度的测试InspecttheinstallationofcomponentsduringtheIQphase,ConductroomilluminationtestingduringtheOQphaseMMHLYES5插座SocketMIQ中进行目视检查，制定SOP定期维护ConductvisualinspectioninIQanddevelopSOPforregularmaintenanceMMHLYES6卷帘RollershutterMIQ确认中检杳材质证明，目视检查MaterialcertificationandvisualinspectionduringIQconfirmationMMHLYES9.结论Conclusion通风橱风险评估RiskAssessmentforFumeHood文件编号/Code.版本号/Version页码/Page0114/15风险评估结论如下：TheRiskAssessmentconclusiondescribedasbelow:质量风险管理已被适当的实施；-Qualityriskmanagementhasbeenproperlyimplemented;已有适当方法控制风险；-Appropriatemethodsareinplacetocontrolrisks;剩余风险是可接受的。-Residualriskisacceptable.应注意，如果详细设计发生了变更，必须重新按照风险评估的方法对系统、功能和部件进行关键性评估。Itshouldbenotedthatifthedetaileddesignchanges,criticalevaluationsofsystems,functionsandcomponentsmustberedoneinaccordancewiththeriskassessmentmethodology通风橱风险评估RiskAssessmentforFumeHood文件编号/Code.版本号/Version页码/Page0115/1510.修订历史RevisionHistory版本号VersionNO.修订内容/修订原因RevisionContent/RevisionReasons生效日期AvailabilityDate01新建文件Newdocuments见签批页批准日期Seeapprovaldateonthesignatureandapprovalpage目录IndexTOC\o"1-5"\h\z\o"CurrentDocument"目的Propose 3\o"CurrentDocument"范围Scope 3\o"CurrentDocument"职责Responsibilities 3供应商职责()Responsibilities 3业主职责()Responsibilities 3参考文件及规范ReferenceandRegulation 4术语和缩略语Abbreviations 5\o"CurrentDocument"系统描述SystemDescription 6评估方法Assessmentmethods 7\o"CurrentDocument"功能/部件关键性的确认CriticalConfirmationofFunction/Component 7\o"CurrentDocument"关键性部件和功能风险评估RiskAssessmentofCritical ComponentsandFounction 8关键性部件和功能高/中风险评估CriticalComponentandFunctionHigh/MediumRiskAssessment10功能/部件关键性评估Critical evaluationoffunctions/components 11功能/部件关键性矩阵Function/componentcriticalmatrix 11关键性部件/功能风险评估CriticalComponent/FunctionRiskAssessment 12关键性部件和功能风险控制矩阵CriticalComponentandFunctionRiskControlMatrix 13结论Conclusion 13修订历史RevisionHistory 15.目的Propose本文件将概括基于产品要求的潜在风险并采用系统化的分析或工具提供风险管理措施，同时将作为定义后续确认活动内容的依据。Thisdocumentwilloutlinepotentialrisksbasedonproductrequirementsandprovideriskmanagementmeasuresusingasystematicanalysisortool.Itwillalsoserveasabasisfordefiningthecontentofsubsequentvalidationactivities..范围Scope本风险分析范围车间通风橱。ThescopeofthisriskanalysisistheventilationcabinetoftheGMProworkshopinthecleanworkshopo通风橱信息如下表：Theinformationofthefumehoodisshowninthetablebelow:通风橱编号FumeHoodNO.位置Location尺寸SizeZJBDP235300451850（长）X1550（宽）x2495（高）mm.职责Responsibilities供应商职责。Responsibilities风险评估报告的编写。Preparationoftheriskassessmentreport..提供为报告编写所需要的资料。Providetheinformationrequiredtopreparethisreport.业主职责。Responsibilities报告的审核和批准。Reviewandapprovalofreports4. 参考文件及规范ReferenceandRegulation编号No.文件/规范名称Document/RegulationName文件/规范编号Document/RegulationNumber版本Version文件/Document153#楼GMPro车间通风橱用户需求说明(GPURS-#53-030)UserRequirementsSpecificationforFumeHoodofGMProworkshopin53#Building(GPURS-#53-030)规范/Regulation2中国GMP2010版ChinaGMP2010version3医药工业洁净厂房设计规范Standardfordesignofpharmaceuticalindustrycleanroom.4质量风险管理QualityRiskManagement5基于风险分析的药品生产Risk-BasedManufactureofPharmaceuticalProducts.6基于风险分析的调试和确认AppliedRiskManagementforCommissioningandQualification.7风险管理风险评估技术Riskmanagement-riskassessmenttechniques8ISPE基于科学和风险的设施、系统和设备的交付ISPEScienceandRisk-BasedApproachfortheDeliveryofFacilities,Systems,andEquipment9ISPE卷3无菌生产设施第3版ISPEVolume3SterileProductManufacturingFacilitiesThirdEdition10ISPE基准指南卷5调试与确认第一版ISPEBaselineguidevol5:Commissioning&qualificationFirstedition11洁净室及相关受控环境(ISO14644-2)cleanroomandassociatedcontrolledenvironments(ISO14644-2)5.术语和缩略语Abbreviations缩写Abbreviations描述DescribeVMP验证主计划ValidationMasterPlanRA风险评估RiskAssessmentDQ设计确认DesignQualificationEHS环境健康安全EnvironmentHealthSafetySOP标准操作规程StandardOperatingProcedureURS用户需求说明UserRequirementsSpecificationGMP药品生产质量管理规范GoodManufacturingPracticeIQ安装确认InstallationQualificationOQ操作确认OperationalQualificationChp中国药典ChinesePharmacopoeia.系统描述SystemDescription通风橱采用负压式工作方式，排风经过定风量阀进行控制，使工作区形成相对于背景区的负压，保证了粉尘不会扩散至背景区，起到保护外部环境的作用。排出的风经过活性炭处理排至大气。Thefumehoodadoptsanegativepressureworkingmethod,andtheexhaustairiscontrolledbyaconstantairvolumevalvetoformanegativepressurerelativetothebackgroundareaintheworkingarea,ensuringthatdustdoesnotdiffusetothebackgroundareaandprotectingtheexternalenvironment.Thedischargedairistreatedwithactivatedcarbonanddischargedintotheatmosphere..评估方法Assessmentmethods功能/部件关键性的确认CriticalConfirmationofFunction/Component根据功能和部件对产品质量的影响来评估其GMP关键程度。EvaluatetheGMPcriticaldegreeaccordingtothefunctionandcomponent'simpactonproductquality.功能和部件的GMP影响评估以产品的5个质量参数为基础(功效、特性、安全、纯度、质量)。TheGMPimpactassessmentoffunctionsandcomponentsisbasedonthefivequalityparametersoftheproduct(efficacy,characteristics,safety,purity,quality).对于每一项会对产品质量产生影响的功能、所有提供该功能的设备、部件或仪表都归类为关键和非关键两种，这种归类将根据下列问题进行。Foreachfunctionthathasanimpactonthequalityoftheproduct,andforallequipment,componentsorinstrumentsthatprovidethefunction,theclassificationwillbecriticalornon-criticalbasedonthefollowingquestions:A.部件是否用于证明符合所注册工艺的规定？Arecomponentsusedtodemonstratecompliancewiththerequirementsoftheregisteredprocess?.功能/部件是否用于控制一个关键工艺参数？Arefunctions/componentsusedtocontrolakeyprocessparameter?C.功能/部件的正常操作或控制对产品质量或功效具有直接的影响？Doesthenormaloperationorcontroloffunctions/componentshaveadirectimpactonproductqualityorefficacy?D.从功能/部件获取的信息被记录为批记录、批放行数据或其它GMP相关文件的一部分？Isinformationobtainedfromfunctions/componentsrecordedaspartofbatchrecords,batchreleasedataorotherGMP-relateddocuments?E.部件是否与产品、产品成分或产品内包材直接接触？Isthecomponentindirectcontactwiththeproduct,productingredientsorproductinnerpackingmaterial?F.功能/部件是否用于获得，维护，测量或控制可以影响产品质量的关键工艺参数，而对控制系统性能无独立的验证？Arefunctions/componentsusedtoobtain,maintain,measureorcontrolkeyprocessparametersthatcanaffectproductqualitywithoutindependentverilicationoftheperformanceofthecontrolsystem?G.功能陪B件是否用于创建或保持某种系统的关键状态？Arefeatures/componentsusedtocreateormaintainacriticalstateofasystem?七个问题中只要有一个问题的答案是“Yes”，就将该功能/部件归类为关键的功能/部件。Iftheanswertooneofthesevenquestionsis“Yes"，thefeature/partisclassifiedasacriticalfeature/part.“Y”：是“N"：否"N/A”：不适用：YesHNn:No“N/A"：Notapplicable7.2关键性部件和功能风险评估RiskAssessmentofCriticalComponentsandFounction风险确认：可能影响产品质量、产量、工艺操作或数据完整性的风险；Riskidentification:risksthatmayaffectproductquality,yield,processoperationordataintegrity;风险判定：包括评估先前确认风险的后果，其建立在严重程度、可能性及可检测性上；Riskdetermination:includesassessingtheconsequencesofpreviouslyidentifiedrisksbasedonseverity,likelihoodanddetectability;严重性(S)Severity对失效可能造成的影响进行描述(即失效发生的严重性)。Describethepossibleimpactofthefailure(i.e.theseverityofthefailure).严重性Severity(S)描述Describe低Low预期具有较小的负面影响。所导致可预期的危害具有非常微小即为短期的有害影响。Smallnegativeeffectsareexpected.Theresultingpredictableharmhasverysmall,orshort-term,harmfuleffects.中Medium预期具有中等的影响。可预期的影响即为中度的有害影响。Moderateeffectsareexpected.Theexpectedeffectsaremoderatelyharmful.高High预期将具有非常显著的负面影响。可预期的影响具有显著的长期影响和/或可能是灾难性的短期影响。Itisexpectedtohaveaverysignificantnegativeimpact.Foreseeableeffectshavesignificantlong-termeffectsand/orpotentiallycatastrophicshort-termeffects.可能性Probability(P)描述失效发生的可能