洁净室风险评估 Risk Assessment of Clean Room

洁净室风险评估RiskAssessmentofCleanRoom作者Author姓名PrintName公司Company签名Signature日期Date审核Reviewer姓名PrintName公司/部门Company/Department签名Signature日期Date批准Approver姓名PrintName公司/部门Company/签名Signature日期Date中Medium(2)认为缺陷状况的检测是很可能的(例如，在每发生2次检测到1次)。Itisconsideredpossibletodetectdefectconditions(forexample,1inevery2occurrences).高High(1)认为缺陷状况的检测是非常可能的(例如，每次发生可检测到1次)。Thedetectionofdefectconditionsisconsideredhighlyprobable(forexample,itcanbedetected1timeperoccurrence).风险优先性计算为将各不同因素进行相乘：公式为风险优先性=严重性*可能性*可检测性。TheRPNiscalculatedbymultiplyingdifferentfactors:theformulaisRPN=S*P*D.风险优先性（RPN）描述Describe当RPN>9WhenRPN>9身风险水平：此为不可接受风险。必须尽快米用控制措施，通过提高可检测性及降低风险产生的可能性来降低最终风险水平。验证应先集中于确认已采用控制措施且持续执行。Highrisklevel:Thisisanunacceptablerisk.Controlmeasuresmustbeadoptedassoonaspossibletoreducethefinallevelofriskbyincreasingdetectabilityandreducingthelikelihoodofriskgeneration.Validationshouldinitiallyfocusonconfirmingthatcontrolmeasuresareinplaceandarebeingcontinued.当6<RPN<9When6<RPNW9中等风险水平：此风险要求米用控制措施，通过提图可检测性及(或)降低风险产生的可能性来降低最终风险水平。Moderatelevelofrisk:Thisriskrequirestheuseofcontrolmeasurestoreducetheultimatelevelofriskbyincreasingdetectabilityand/orreducingthelikelihoodthattheriskwillarise.当RPN<6WhenRPN<6低风险水平：此风险水平为可接受，无需采用额外的控制措施。Lowlevelofrisk:Thislevelofriskisacceptableanddoesnotrequireadditionalcontrolmeasures.评估的目的，是每个关键部件将根据其所执行的功能而确定其最高的风险优先级别。当风险优先性小于6时为风险可控，则不再给出建议措施。风险优先性大于等于6必须给出合理建议，并决定适宜的控制方法。Thepurposeoftheassessmentisthateachcriticalcomponentwilldetermineitshighestriskprioritybasedonthefunctionitperforms.Whentheriskpriorityislessthan6,theriskiscontrollable,andnorecommendedmeasuresaregiven.ReasonablesuggestionsmustbemadeandappropriatecontrolmethodsshouldbedeterminedfortheRPN26.给出建议措施之后再次对可能性、严重性和可检测性进行评估，得到风险优先性。Aftertheproposedmeasuresaregiven,thelikelihood,severityanddetectabilityareevaluatedagaintoobtaintheriskpriority.需对建议风险控制措施进行评论。Suggestedriskcontrolmeasuresshouldbecommentedon.文件编号/Code.版本号/Version页码/PageRA-CR-010111/338.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NO.功能/部件Function/Component组件功能Componentfunctions问题Problem关键Critical是/否（Yes/NO）ABCDEFG1组合式空调机箱Combinedairconditioningcase提供送风功能段框架结构ProvideairsupplyfunctionsectionframestructureNNNNNNNNO2加湿蒸汽Wetsteam为洁净室空调加湿Humidifythecleannx）mairconditionerNNYYNNYYES3空调热水Airconditioninghotwater用于空调系统温度调节UsedfbrlemperatureregulationofairconditioningsystemNNYYNNYYES4空调冷水Airconditionin®coldwater用于空调系统温度调节UsedfortemperatureregulationofairconditioningsystemNNYYNNYYES5电力供应Powersupply为空调系统提供动力PowertheairconditioningsystemNNYYNNYYES6开关Switch实现电器的启停RealizethestartandstopofelectricalappliancesNNNNNNNNO7插座Socket电源接口ThepowerinterfaceNNNNNNNNO8洁净灯具Cleanlampsandlanterns为生产区域提供照明ProvidelightingfbrproductionareaNNNNNNYYES9应急灯Emergencylight洁净室人员安全要求CleanroompersonnelsafetyrequirementsNNNNNNNNO洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010112/33序号NO.功能/部件Function/Component组件功能Componentfunctions问题Problem关键Critical是/否（Yes/NO）ABCDEFG10墙面和吊顶彩钢板Wallandceilingcolorsteelplate洁净室功能分割CleanroomfunctionsegmentationNNNNNNYYESil洁净室门、窗户和安全门Cleanroomdoors,Windowsandsecuritydoors洁净室内人员流动和观察CleanroompersonnelflowandobservationNNNNNNYYES12地面Ground洁净室地面要求CleanroomfloorrequirementsNNNNNNYYES13地漏Floordrain用于洁净室内排水，隔绝空气防止下水道中空气反流入洁净室ItisusedfordeanroomdniinagetoisolateairandpreventairfromsewerfromflowingbackintocleanroomNNNNNNYYES14密封Seal用于密封洁净室内缝隙UsedforsealingcracksincleanroomsNNNNNNYYES15高效过滤器Higliefficiencyfilter用于洁净送风过滤净化，保证房间满足净化要求Usedforcleanairfiltrationandpurification,toensurethattheroommeetstherequirementsofpurificationNYYYNNYYES16送、回、排风口Send,return,exhaustairoutlet保证房间满足洁净度，压差及自净的设计要求Ensurethattheroommeetsthedesignrequirementsofcleanliness,differentialpressureandself-cleaning.NNNNNNYYES17排风机箱Exhaustfanbox提供排风功能段框架结构ProvidestheexhaustfunctionsectionframestructureNNNNNNNNO文件编号/Code.版本号/Version页码/PageRA-CR-010113/33序号NO.功能/部件Function/Component组件功能Componentfunctions问题Problem关键Critical是/否（Yes/NO）ABCDEFG18风管Duct为洁净室送、回、排风需要Forcleanroomtosend,return,exhaustairneedsNNNNNNYYES19风管保温Ductinsulation用于避免结露或热损耗的风险ToavoidtheriskofcondensationorheatlossNNNNNNYYES20风阀，包括定风量调节阀、变风量调节阀和手动调节阀Theairvalvecomprisesaconstantairvolumeregulatingvalve,avariableairvolumeregulatingvalveandamanualregulatingvalve用于调节风量UsedforregulatingairvolumeNNYYNNYYES21高效过滤器静压箱Plenumchamberforhighefficiencyfilter用于洁净送风及送风均匀UsedforcleanairsupplyanduniformairsupplyNYNYNNYYES功能Function22温湿度Temperatureandhumidity控制洁净室温湿度ControlcleanroomtemperatureandhumidityNYYNYNYYES23压差Differentialpressure控制洁净室压差ControlthedifferentialpressureinthecleanroomNYYNYNYYES24换气次数Airchanges控制洁净室的自净能力Controltheself-cleaningcapacityofthecleanroomNYYNNNYYES25悬浮粒子、微生物（沉降菌、浮游菌/表面微生物）Suspendedparticles,控制洁净室洁净度和微生物环境ControlcleanroomcleanlinessandmicrobialenvironmentNYYNYNYYES文件编号/Code.版本号/Version页码/PageRA-CR-010114/33序号NO.功能/部件Function/Component组件功能Componentfunctions问题Problem关键Critical是/否(Yes/NO)ABCDEFGmicroorganisms(sedimentationbacteria,plankton/surfacemicroorganisms)26噪音Noise保护操作人员听力安全，保证生产过程中的正常沟通ToprotectthehearingsafetyofoperatorsandensurethenormalcommunicationduringproductionNNNNNNYYES27照度Illumination为洁净室房间提供照明亮度，保证生产人员的视线ProvideilluminationforcleanroomroomandensurethelineofsightofproductionpersonnelNNNNNNYYES文件编号/Code.版本号/Version页码/PageRA-CR-010115/338.2关键性部件/功能风险评估和控制矩阵Criticalcomponent/functionriskassessmentandcontrolmatrix关键性部件/功能风险评估矩阵Criticalcomponent/functionriskassessmentmatrix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加湿蒸汽Wetsteam为洁净室空调加湿Humidifythecleanroomairconditioner蒸汽压力不满足要求ThesteampressuredoesnotmeettherequirementsPressureisnotenough影响洁净室的湿度Affectsthehumidityinthecleanroom322122空调热水Airconditioninghotwater用于空调系统温度调节Usedfortemperatureregulationofairconditioningsystem压力不满足要求Pressureisnotenough影响洁净室的温湿度Affectsthetemperatureandhumidityofthecleanroom39212温度不满足要求Thetemperaturedoesnotmeettherequirements影响洁净室的温湿度Affectsthetemperatureandhumidityofthecleanroom322123空调冷水Airconditioningcoldwater用于空调系统温度调节Usedfbrtemperatureregulationofairconditioningsystem压力不满足要求Pressureisnotenough影响洁净室的温湿度Affects(hetemperatureandhumidityofthecleanroom32212温度不满足要求Thetemperaturedoesnotmeettherequirements影响洁净室的温湿度Affectsthetemperatureandhumidityofthecleanroom392124电力供应Powersupply为空调系统提供动力Powertheairconditioningsystem电压过低/高Voltageistoolow/high超过变频器工作范围的电压波动可能导致变频器和电机的损坏或无法正常使用Voltagefluctuationsbeyondtheoperatingrangeofthefrequencyconvertermaycausedamagetothefrequencyconverterandmotororfailuretooperateproperly22285洁净灯具Cleanlampsand为生产区域提供照明Providelightingfor洁净灯具不合格或布局不合理造成房间照度不足房间照度不足，影响操作人员的操作精度2228洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010116/33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RPNlanternsproductionareaCleanlampsareunqualifiedorunreasonablelayoutresultingininsufficientroomilluminationRoomilluminationisinsufficient,affectingtheoperationaccuracyoftheoperator6墙面和吊顶彩钢板Wallandceilingcolorsteelplate洁净室功能分割Cleanroomfunctionsegmentation材质不符合Materialdoesnotmatch材质脱落腐蚀，影响洁净室环境Materialsheddingcorrosion,affectingthecleanroomenvironment299AM8墙板和顶板等连接处等未使用导角或过渡材料NoguideAngleortransitionmaterialisusedatthejointssuchaswallpanelandtopplate存在缝隙，容易滋生微生物，引起环境污染Theexistenceofgaps,easytobreedmicroorganisms,causeenvironmentalpollution22287洁净室门、窗户和安全门Cleanroomdoors,Windowsandsecuritydoors洁净室内人员流动和观察Cleanroompersonnelflowandobservation材质不符合要求Thematerialdoesnotmeettherequirements材质脱落腐蚀，影响洁净室环境Materialsheddingcorrosion,affectingthecleanroomenvironment22288地面Ground洁净室地面要求Cleanroomfloorrequirements材质不符合要求Thematerialdocsnotmeettherequirements材质脱落，易被腐蚀，影响洁净室环境Thematerialfallsoffandiseasytobecorroded,affectingthecleanroomenvironment22289地漏Floordrain用于洁净室内排水，隔绝空气防止下水道中空气反流入洁净室Itisusedforcleanroomdrainagetoisolateairandpreventairfromseweriromflowingbackintocleanroom材质不符合要求Thematerialdoesnotmeettherequirements洁净室微生物滋生，影响洁净室环境，进而影响产品质量Cleanroommicrobialbreeding,affectthecleanroomenvironment,andthenaffectthequalityofproducts2228水封能力不住Insufficientwaterscalingcapacity地面积水，滋生微生物，影响洁净环境Wateraccumulationontheground,breedingmicroorganisms,andaffectingthecleanenvironment2228洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010117/33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RPN10密封Seal用于密封洁净室内缝隙Usedfbrsealingcracksincleanrooms材质不符合要求Thematerialdoesnotmeettherequirements影响洁净室环境Affectthecleanroomenvironment32212密封破损Sealthedamage引起污染或交叉污染Causecontaminationorcrosscontamination3221211高效过滤器Highefficiencyfilter用于洁净送风过滤净化，保证房间满足净化要求Usedforcleanairfiltrationandpurification,toensurethattheroommeetstherequirementsofpurification过滤器选型不满足Filterselectionisnotsatisfied过滤器过滤效率不满足要求Filterefficiencydoesnotmeettherequirements影响洁净室环境Affectsthecleanroomenvironment32212过滤器过滤效率不满足要求Filterefficiencydoesnotmeettherequirements近滤器在生产或安装中被损坏Thefilterisdamagedduringproductionorinstallation过滤效率不能满足要求，影响洁净室环境Filtrationefficiencycannotmeettherequirements,affectingthecleanroomenvironment32212过滤器在生产或安装中被损坏Thefilterisdamagedduringproductionorinstallation严密性不足Lackofrigor漏风严重，空气未经过高效过滤进入洁净房间影响环境Airleakageisserious,theairisnotfilteredintothecleanroom,affectingtheenvironment3221212送、回、排风口Send,return,exhaustairoutlet保证房间满足洁净度，压差及自净的设计要求。Ensurethattheroommeetsthedesignrequirementsofcleanliness,differentialpressureandself-cleaning.材质不符合要求Thematerialdoesnotmeettherequirements材质脱落腐蚀，影响洁净室环境Thematerialfallsoffandcoirodes,affectingthecleanroomenvironment3126安装位置和大小错误Incorrectinstallationlocationandsize影响房间的正常空气循环，无法保证洁净环境Affectsthenormalaircirculationoftheroomandcannotguaranteeacleanenvironment32212文件编号/Code.版本号/Version页码/PageRA-CR-010118/33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RPN13风管Duct为洁净室送、回、排风需要Forcleanroomtosend,return,exhaustairneeds材质不符合要求Thematerialdoesnotmeettherequirements材质脱落腐蚀，堵塞过滤器Materialpeelingcorrosion,cloggingfilter2228风管安装不符合Airductinstallationdoesnotconform风管泄漏，洁净室送风量不足Airductleakage,cleanroomairsupplyisinsufficient222814风管保温Ductinsulation用于避免结露或热损耗的风险Toavoidtheriskofcondensationorheatloss材质不符合要求Thematerialdoesnotmeettherequirements产生热损耗Heatlossgeneration2228安装不符合Installationnonconformity导致结露滴水Itcausesdewtodrip222815风阀，包括定风量调节阀、变风量调节阀和手动调节阀Theairvalvecomprisesaconstantairvolumeregulatingvalve,avariableairvolumeregulatingvalveandamanualregulatingvalve用于调节风量Usedforregulatingairvolume材质不符合要求Thematerialdocsnotmeettherequirements材质脱落腐蚀，无法实现风量的稳定及调节功能Materialfalloffcorrosion,unabletoachievethestabilityandregulationofairvolumefunction2228安装位置错误Incorrectinstallationlocation无法正常调节风量以实现房间的正常风量平衡Theairvolumecannotbeadjustedproperlytoachievethenormalairvolumebalanceoftheroom222816高效过滤器静压箱Plenumchamberforhighefficiencyfilter用于洁净送风及送风均匀Usedforcleanairsupplyanduniformairsupply材质不符合要求Thematerialdoesnotmeettherequirements材质脱落腐蚀，影响洁净室环境Thematerialfallsoffandcoirodes,affectingthecleanroomenvironment32212严密性不足Lackofrigor漏风严重，空气未经过高效过滤进入洁净房间影响环境Airleakageisserious,theairisnotfilteredintothecleanroom,affectingtheenvironment32212功能Function文件编号/Code.版本号/Version页码/PageRA-CR-010119/33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RPN17温湿度Temperatureandhumidity控制洁净室温湿度Controlcleanroomtemperatureandhumidity洁净室温湿度超标Cleanroomtemperatureandhumidityexceedstandard影响洁净室生产环境，进而影响产品质量及人员舒适性Affectsthecleanroomproductionenvironment,andthenaffectstheproductqualityAffectcleanroomproductionenvironment,andthenaffectproductqualityandpersonnelcomfort3221218压差Differentialpressure控制洁净室压差Controlthedifferentialpressureinthecleanroom洁净室压差不符合Pressuredifferenceincleanroomdoesnotmeet影响洁净室气流流向，引起污染或交叉污染Affectstheflowdirectionofthecleanroom,causingcontaminationorcrosscontamination3221219换气次数Airchanges控制洁净室的自净能力Controltheself-cleaningcapacityofthecleanroom换气次数不符合Thefrequencyofventilationisnotconsistent影响洁净室的自净能力Affectstheself-purificationabilityofthecleanroom3221220悬浮粒子、微生物(沉降菌、浮游菌、表面微生物)Suspendedparticles,microorganisms(settlingbacteria,plankton,surfacemicroorganisms)控制洁净室洁净度和微生物环境Controlcleanroomcleanlinessandmicrobialenvironment洁净室设计不满足Cleanroomdesignisnotsatisfied影响洁净室环境，从而影响产品质量Affectsthecleanroomenvironment,therebyaffectingproductquality3221221噪音Noise保护操作人员听力安全，保证生产过程中的正常沟通Toprotectthehearingsafetyofoperatorsandensurethenormalcommunicationduringproduction洁净室噪音超标Excessivenoiseincleanrooms不满足EHS要求影响人员正常操作AffectingthenormaloperationofpersonnelEHSrequirementsarenotmet32212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 4（供应商）安装职责Responsibilities 4（业主）IRMResponsibilities 4参考文件及规范ReferenceandRegulation 5术语和缩略语Abbreviations 6\o"CurrentDocument"系统描述SystemDescription 7评估方法Assessmentmethods 8\o"CurrentDocument"功能/部件关键性的确认Criticalconfirmationoffunction/component 8\o"CurrentDocument"关键’性部件风险评估Riskassessmentofcriticalcomponents 9功能/部件关键性评估Criticalevaluationoffunctions/components 11功能/部件关键性矩阵Function/componentcriticalmatrix 11关键性部件/功能风险评估和控制矩阵Criticalcomponent/functionriskassessmentandcontrolmatrix15结论Conclusion 32彳修订历史RevisionHistory 33洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010120/33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RPN22照度Illumination为洁净室房间提供照明亮度，保证生产人员的视线Provideilluminationforcleanroomroomandensurethelineofsightofproductionpersonnel洁净室照度不足Insufficientlightincleanroom影响人员正常操作Affectingthenormaloperationofpersonnel32212文件编号/Code.版本号/Version页码/PageRA-CR-010121/33关键性部件/功能风险控制矩阵Criticalcomponent/functionriskcontrolmatrix序号NO.功能/关键部件Functional/keycomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPN1加湿蒸汽Weisteam蒸汽压力不满足要求Thesteampressuredoesnotmeettherequirements压力不满足要求Pressureisnotenough12通过在IQ阶段进行蒸汽管道压力表压力口视检查提高失效事件发生的可检测性；编制SOP定期检查维修，定期进行仪表校准检验降低失效事件发生的可能性并提高失效事件的可检测性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthepressureofsteampipelinepressuregaugesduringtheIQstage;DevelopSOPforregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.31132空调热水Airconditioninghotwater压力不满足要求Pressureisnotenough12通过在IQ阶段进行空调热水压力表压力口视检查提高失效事件发生的可检测性；编制SOP定期检查维修，定期进行仪表校准检验降低失效事件发生的可能性并提高失效事件的可检测性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthepressureoftheairconditioninghotwaterpressuregaugeduringtheIQstage;DevelopSOPforregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3113温度不满足要求Thetemperaturedocsnotmeettherequirements12通过在IQ阶段进行空调热水温度计温度口视检查提高失效事件发生的可检测性；编制SOP定期检查维修，定期进行仪表校准检验降低失效事件发生的可能性并提高失效事件的可检测性。3113洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010122/33序号NO.功能/关键部件Functional/kevcomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPNImprovethedetectabilityoffailureeventsbyvisuallyinspectingthetemperatureofairconditioninghotwaterthermometersduringtheIQstage;DevelopSOPfbrregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3空调冷水Airconditioningcoldwater压力不满足要求Pressureisnotenough12通过在IQ阶段进行空调热水压力表压力目视检查提高失效事件发生的可检测性；编制SOP定期检杳维修，定期进行仪表校准检验降低失效事件发生的可能性并提高失效事件的可检测性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthepressureoftheairconditioninghotwaterpressuregaugeduringtheIQstage;DevelopSOPfbrregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3113温度不满足要求Thetemperaturedoesnotmeettherequirements12通过在IQ阶段进行空调热水温度计温度目视检查提高失效事件发生的可检测性；编制SOP定期检杳维修，定期进行仪表校准检验降低失效事件发生的可能性并提高失效事件的可检测性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthetemperatureofairconditioninghotwaterthermometersduringtheIQstage;DevelopSOPfbrregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3113文件编号/Code.版本号/Version页码/PageRA-CR-010123/33序号NO.功能/关键部件Functional/kevcomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPN4电力供应Powersupply电压过低/高Voltageistoolow/high8通过在OQ阶段进行机组供电电压测试提高失效事件的可检测性；ThepossibilityoffailureeventscanbereducedanditsdetectabilitycanbeimprovedbytestingthepowersupplyvoltageoftheunitinOQstage;22145洁净灯具Cleanlampsandlanterns洁净灯具不合格或布局不合理造成房间照度不足Cleanlampsareunqualifiedorunreasonablelayoutresultingininsufficientroomillumination8通过在DQ阶段进行布局合理性检查降低失效事件的可能性：通过IQ阶段对洁净灯具合格证书进行检查及OQ阶段进行照度测试降低失效事件发生的可能性并提高其可检测性。ReducethelikelihoodoffailureeventsbyconductinglayoutrationalitychecksduringtheDQphase;CheckthequalificationcertificateofcleanlampsthroughIQstagetoreducethepossibilityoffailureeventsandimproveitsdetectabilityCleanluminairecertificateinspectionandcleanluminairelayoutinspectionthroughIQstageandilluminanceinspectiontestingthroughOQstagereducethepossibilityoffailureeventsandimprovetheirdetectability21126墙面和吊顶彩钢板Wailandceilingcolorsteelplate材质不符合Materialdoesnotmatch8通过在IQ阶段检查彩钢板的材质证明降低失效事件发生的可能性并提高其可检测性ItisprovedthatthepossibilityoffailureeventscanbereducedanditsdetectabilitycanbeimprovedbycheckingthematerialofcolorsteelplateinIQstage2112墙板和顶板灯等连接处等未使用导角或过渡材料NoguideAngleortransitionmaterialisusedatthejointssuchaswallpanelandtopplateNoguideAngleortransitionmaterialisusedatthe8通过在IQ阶段检查彩钢板安装符合性降低失效事件发生的可能性并提高其可检测性ReducethepossibilityoffailureeventsandimproveitsdetectabilitybycheckingthecomplianceofcolorsteelplateinstallationduringIQstage2112文件编号/Code.版本号/Version页码/PageRA-CR-010124/33序号NO.功能/关键部件Functional/kevcomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPNjunctionbetweenthewallpanelandthetoplight7洁净室门、窗户和安全门Cleanroomdoors,Windowsandsecuritydoors材质不符合要求Thematerialdoesnotmeettherequirements8通过在IQ阶段检查洁净室门和窗户材质降低失效事件发生的可能性并提高其可检测性ReducethelikelihoodoffailureeventsandimprovedetectabilityofcleanroomdoorandwindowmaterialsbycheckingthemduringtheIQphase21128地面Ground材质不符合要求Thematerialdoesnotmeettherequirements8通过IQ阶段检查地面的材质证明降低失效事件发生的可能性并提高其可检测性CheckthematerialofthefloorthroughtheIQstagetoprovetoreducethepossibilityoffailureeventsandimproveitsdetectability21129地漏Floordrain材质不符合要求Thematerialdoesnotmeettherequirements8通过在IQ阶段检查地漏材质证明降低失效事件发生的可能性并提高其可检测性ByexaminingfloordrainmaterialduringtheIQstage,itisprovedthatthepossibilityoffailureeventsisreducedanditsdetectabilityisimproved2112水封能力不足Insufficientwatersealingcapacity8通过在IQ阶段检查地漏安装符合性降低失效事件发生的可能性并提高其可检测性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybycheckingthecomplianceoffloordraininstallationduringtheIQphase211210密封Seal材质不符合要求Thematerialdoesnotmeettherequirements12通过IQ阶段进行检查密封材质证明降低失效事件发生的可能性并提高其可检测性CheckingthesealmaterialthroughtheIQstageprovestoreducethelikelihoodoffailureeventsandimproveitsdetectability3113密封破损Sealthedamage12通过IQ阶段对房间的密封情况进行检查降低失效事件发生的可能性并提高其可检测性CheckthesealingconditionoftheroomthroughtheIQstagetoreducethepossibilityoffailureeventsand3113洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010125/33序号NO.功能/关键部件Functional/kevcomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPNimproveitsdetectability通过编制洁净室SOP针对密封进行定期检查维修降低失效事件发生的可能性并提高其可检测性ReducethepossibilityoffailureeventsandimproveitsdetectabilitybypreparingcleanroomSopsforperiodicinspectionandmaintenanceofseals11高效过滤器Highefficiencyfilter过滤器选型不满足Filterselectionisnotsatisfied12通过DQ阶段进行过滤器选型检查降低失效事件发生的可能性ReducethelikelihoodoffailureeventsbyconductingfilterselectionchecksduringtheDQphase通过在IQ阶段进行过滤器的证明文件检查降低失效事件发生的可能性并提高其可检测性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybyverifyingdocumentationoffiltersduringtheIQphase3113过滤器过滤效率不满足要求Filterefficiencydoesnotmeettherequirements12通过在IQ阶段进行过滤器出厂检测报告检查降低失效事件发生的可能性并提高其可检测性ReducethepossibilityoffailureeventsandimprovethedetectabilityoffiltersbycheckingtheirfactoryinspectionreportsduringtheIQphase通过编制洁净室SOP针对高效过滤器进行定期的检测、更换降低失效事件发生的可能性并提高其可检测性ThroughthepreparationofcleanroomSOP,thehePAfilterisregularlytestedandreplacedtoreducethepossibilityoffailureeventsandimproveitsdetectability3113过滤器在生产或安装中被损坏Thefilterisdamagedduringproductionorinstallation12通过在OQ阶段进行高效检漏测试提高失效事件发生的可检测性Improvethedetectabilityoffailureeventsbyconductingefficientleakdetectiontestingduringthe3113洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010126/33序号NO.功能/关键部件Functional/kevcomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPNOQphase通过编制洁净室SOP针对高效过滤器进行定期的检测、更换降低失效事件发生的可能性并提高其可检测性ThroughthepreparationofcleanroomSOP,thehePAfilterisregularlytestedandreplacedtoreducethepossibilityoffailureeventsandimproveitsdetectability12送、回、排风口Send,return,exhaustairoutlet材质不符合要求Thematerialdoesnotmeettherequirements6通过在IQ阶段进行送、回、排风口的证明文件检查降低失效事件发生的可能性并提高其可检测性Reducethepossibilityoffailureeventsandimprovetheirdetectabilitybycheckingthedocumentationofthefeed,returnandexhaustventsduringtheIQstage3113安装位置和大小错误Incorrectinstallationlocationandsize12通过在IQ阶段进行送、回、排风口的位置及大小进行目视检查降低失效事件发生的可能性并提高其可检测性Reducethepossibilityoffailureeventsandimprovetheirdetectabilitybyvisualinspectionofthepositionandsizeoffeed,returnandexhaustventsinIQstage311313风管Duct材质不符合要求Thematerialdoesnotmeettherequirements8通过在IQ阶段进行风管材质证书检查降低失效事件发生的可能性并提高其可检测性ReducethepossibilityoffailureeventsandimproveitsdetectabilitythroughairductmaterialcertificateinspectioninIQstage2112风管安装不符合Airductinstallationdocsnotconform8通过在IQ阶段进行安装目视检查，并检查漏光及漏风量测试记录降低失效事件发生的可能性并提高其可检测性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybyconductingvisualinspectionofinstallationsduringtheIQphaseandcheckingforlightleakageandairleakagetestrecords2112文件编号/Code.版本号/Version页码/PageRA-CR-010127/33序号NO.功能/关键部件Functional/kevcomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPN14风管保温Ductinsulation材质不符合要求Thematerialdoesnotmeettherequirements8通过在IQ阶段进行风管保温材质证书检查降低失效事件发生的可能性并提高其可检测性ReducethepossibilityoffailureeventsandimproveitsdetectabilitythroughairductinsulationmaterialcertificateinspectioninIQstage2112安装不符合Installationnonconformity8通过在IQ阶段进行风管保温目视检查降低失效事件发生的可能性并提高其可检测性VisualinspectionofductinsulationduringIQstagecanreducethepossibilityoffailureeventsandimproveitsdetectability211215风阀，包括定风量调节阀、变风量调节阀和手动调节阀Theairvalvecomprisesaconstantairvolumeregulatingvalve,avariableairvolumeregulatingvalveandamanualregulatingvalve材质不符合要求Thematerialdoesnotmeettherequirements8通过在IQ阶段进行风阀，包括定风量调节阀、变风量调节阀和手动调节阀材质证书检查降低失效事件发生的可能性并提高其可检测性Thepossibilityoffailureeventscanbereducedandthedetectabilitycanbeimprovedbycheckingthematerialcertificateofairvalve,includingconstantairvolumecontrolvalve,variableairvolumecontrolvalveandmanualcontrolvalveinIQstage2112安装位置错误Incorrectinstallationlocation8通过在IQ阶段进行安装目视检查降低失效事件发生的可能性并提高其可检测性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybyperforminginstallationvisualinspectionduringtheIQphase211216高效过滤器静压箱Plenumchamberforhighefficiencyfilter材质不符合要求Thematerialdoesnotmeettherequirements12通过在IQ阶段进行过滤器静压箱的证明文件检查降低失效事件发生的可能性并提高其可检测性ReducethepossibilityoffailureeventsandimprovedetectabilitybyverifyingthedocumentationofthefilterplenumduringtheIQphase3113严密性不足Lackofrigor12通过在OQ阶段进行高效过滤器及边框的完整性测试提高提高失效事件发生的可检测性通过编制洁净室SOP针对高效过滤器及边框进行3113洁净室风险评估RiskAssessmentofCleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010128/33序号NO.功能/关键部件Functional/kevcomponents失效事件Failureevents风险优先性RPN建议采取措施SuggestmeasurestobetakenSPD风险优先性RPN定期的检测降低失效事件发生的可能性并提高其可检测性ImprovethedetectabilityoffailureeventsbyconductingefficientfilterandborderintegritytestingduringtheOQphaseReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybydevelopingacleanroomSOPforregulartestingofhigh-efficiencyfiltersandframes功能Function17温湿度Temperatureandhumidity洁净室温湿度超标Cleanroomtemperatureandhumidityexceedstandard12通过EMS/BMS的调试和确认阶段进行洁净室温湿度测试降低失效事件的可能性并提高其可检测性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitythroughcleanroomtemperatureandhumiditytestingduringthedebuggingandconfirmationphaseofEMS/BMS通过在OQ/PQ阶段进行洁净室温湿度测试降低失效事件发生的可能性并提高其可检测性ThepossibilityoffailureeventsisreducedanditsdetectabilityisimprovedbycleanroomtemperatureandhumiditytestinginOQ/PQphase通过建立温湿度监测规程针对温湿度进行定期测试在线监测系统(EMS)在线监测，降低失效事件发生的可能性并提高其可检测性Thepossibilityoffailureeventsca