潔凈室風(fēng)險(xiǎn)評(píng)估 Risk Assessment of Clean Room

潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom作者Author姓名PrintName公司Company簽名Signature日期Date審核Reviewer姓名PrintName公司/部門Company/Department簽名Signature日期Date批準(zhǔn)Approver姓名PrintName公司/部門Company/簽名Signature日期Date中Medium(2)認(rèn)為缺陷狀況的檢測(cè)是很可能的(例如，在每發(fā)生2次檢測(cè)到1次)。Itisconsideredpossibletodetectdefectconditions(forexample,1inevery2occurrences).高High(1)認(rèn)為缺陷狀況的檢測(cè)是非常可能的(例如，每次發(fā)生可檢測(cè)到1次)。Thedetectionofdefectconditionsisconsideredhighlyprobable(forexample,itcanbedetected1timeperoccurrence).風(fēng)險(xiǎn)優(yōu)先性計(jì)算為將各不同因素進(jìn)行相乘：公式為風(fēng)險(xiǎn)優(yōu)先性=嚴(yán)重性*可能性*可檢測(cè)性。TheRPNiscalculatedbymultiplyingdifferentfactors:theformulaisRPN=S*P*D.風(fēng)險(xiǎn)優(yōu)先性（RPN）描述Describe當(dāng)RPN>9WhenRPN>9身風(fēng)險(xiǎn)水平：此為不可接受風(fēng)險(xiǎn)。必須盡快米用控制措施，通過(guò)提高可檢測(cè)性及降低風(fēng)險(xiǎn)產(chǎn)生的可能性來(lái)降低最終風(fēng)險(xiǎn)水平。驗(yàn)證應(yīng)先集中于確認(rèn)已采用控制措施且持續(xù)執(zhí)行。Highrisklevel:Thisisanunacceptablerisk.Controlmeasuresmustbeadoptedassoonaspossibletoreducethefinallevelofriskbyincreasingdetectabilityandreducingthelikelihoodofriskgeneration.Validationshouldinitiallyfocusonconfirmingthatcontrolmeasuresareinplaceandarebeingcontinued.當(dāng)6<RPN<9When6<RPNW9中等風(fēng)險(xiǎn)水平：此風(fēng)險(xiǎn)要求米用控制措施，通過(guò)提圖可檢測(cè)性及(或)降低風(fēng)險(xiǎn)產(chǎn)生的可能性來(lái)降低最終風(fēng)險(xiǎn)水平。Moderatelevelofrisk:Thisriskrequirestheuseofcontrolmeasurestoreducetheultimatelevelofriskbyincreasingdetectabilityand/orreducingthelikelihoodthattheriskwillarise.當(dāng)RPN<6WhenRPN<6低風(fēng)險(xiǎn)水平：此風(fēng)險(xiǎn)水平為可接受，無(wú)需采用額外的控制措施。Lowlevelofrisk:Thislevelofriskisacceptableanddoesnotrequireadditionalcontrolmeasures.評(píng)估的目的，是每個(gè)關(guān)鍵部件將根據(jù)其所執(zhí)行的功能而確定其最高的風(fēng)險(xiǎn)優(yōu)先級(jí)別。當(dāng)風(fēng)險(xiǎn)優(yōu)先性小于6時(shí)為風(fēng)險(xiǎn)可控，則不再給出建議措施。風(fēng)險(xiǎn)優(yōu)先性大于等于6必須給出合理建議，并決定適宜的控制方法。Thepurposeoftheassessmentisthateachcriticalcomponentwilldetermineitshighestriskprioritybasedonthefunctionitperforms.Whentheriskpriorityislessthan6,theriskiscontrollable,andnorecommendedmeasuresaregiven.ReasonablesuggestionsmustbemadeandappropriatecontrolmethodsshouldbedeterminedfortheRPN26.給出建議措施之后再次對(duì)可能性、嚴(yán)重性和可檢測(cè)性進(jìn)行評(píng)估，得到風(fēng)險(xiǎn)優(yōu)先性。Aftertheproposedmeasuresaregiven,thelikelihood,severityanddetectabilityareevaluatedagaintoobtaintheriskpriority.需對(duì)建議風(fēng)險(xiǎn)控制措施進(jìn)行評(píng)論。Suggestedriskcontrolmeasuresshouldbecommentedon.文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010111/338.功能/部件關(guān)鍵性評(píng)估Criticalevaluationoffunctions/components8.1功能/部件關(guān)鍵性矩陣Function/componentcriticalmatrix序號(hào)NO.功能/部件Function/Component組件功能Componentfunctions問(wèn)題Problem關(guān)鍵Critical是/否（Yes/NO）ABCDEFG1組合式空調(diào)機(jī)箱Combinedairconditioningcase提供送風(fēng)功能段框架結(jié)構(gòu)ProvideairsupplyfunctionsectionframestructureNNNNNNNNO2加濕蒸汽Wetsteam為潔凈室空調(diào)加濕Humidifythecleannx）mairconditionerNNYYNNYYES3空調(diào)熱水Airconditioninghotwater用于空調(diào)系統(tǒng)溫度調(diào)節(jié)UsedfbrlemperatureregulationofairconditioningsystemNNYYNNYYES4空調(diào)冷水Airconditionin?coldwater用于空調(diào)系統(tǒng)溫度調(diào)節(jié)UsedfortemperatureregulationofairconditioningsystemNNYYNNYYES5電力供應(yīng)Powersupply為空調(diào)系統(tǒng)提供動(dòng)力PowertheairconditioningsystemNNYYNNYYES6開(kāi)關(guān)Switch實(shí)現(xiàn)電器的啟停RealizethestartandstopofelectricalappliancesNNNNNNNNO7插座Socket電源接口ThepowerinterfaceNNNNNNNNO8潔凈燈具Cleanlampsandlanterns為生產(chǎn)區(qū)域提供照明ProvidelightingfbrproductionareaNNNNNNYYES9應(yīng)急燈Emergencylight潔凈室人員安全要求CleanroompersonnelsafetyrequirementsNNNNNNNNO潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010112/33序號(hào)NO.功能/部件Function/Component組件功能Componentfunctions問(wèn)題Problem關(guān)鍵Critical是/否（Yes/NO）ABCDEFG10墻面和吊頂彩鋼板Wallandceilingcolorsteelplate潔凈室功能分割CleanroomfunctionsegmentationNNNNNNYYESil潔凈室門、窗戶和安全門Cleanroomdoors,Windowsandsecuritydoors潔凈室內(nèi)人員流動(dòng)和觀察CleanroompersonnelflowandobservationNNNNNNYYES12地面Ground潔凈室地面要求CleanroomfloorrequirementsNNNNNNYYES13地漏Floordrain用于潔凈室內(nèi)排水，隔絕空氣防止下水道中空氣反流入潔凈室ItisusedfordeanroomdniinagetoisolateairandpreventairfromsewerfromflowingbackintocleanroomNNNNNNYYES14密封Seal用于密封潔凈室內(nèi)縫隙UsedforsealingcracksincleanroomsNNNNNNYYES15高效過(guò)濾器Higliefficiencyfilter用于潔凈送風(fēng)過(guò)濾凈化，保證房間滿足凈化要求Usedforcleanairfiltrationandpurification,toensurethattheroommeetstherequirementsofpurificationNYYYNNYYES16送、回、排風(fēng)口Send,return,exhaustairoutlet保證房間滿足潔凈度，壓差及自凈的設(shè)計(jì)要求Ensurethattheroommeetsthedesignrequirementsofcleanliness,differentialpressureandself-cleaning.NNNNNNYYES17排風(fēng)機(jī)箱Exhaustfanbox提供排風(fēng)功能段框架結(jié)構(gòu)ProvidestheexhaustfunctionsectionframestructureNNNNNNNNO文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010113/33序號(hào)NO.功能/部件Function/Component組件功能Componentfunctions問(wèn)題Problem關(guān)鍵Critical是/否（Yes/NO）ABCDEFG18風(fēng)管Duct為潔凈室送、回、排風(fēng)需要Forcleanroomtosend,return,exhaustairneedsNNNNNNYYES19風(fēng)管保溫Ductinsulation用于避免結(jié)露或熱損耗的風(fēng)險(xiǎn)ToavoidtheriskofcondensationorheatlossNNNNNNYYES20風(fēng)閥，包括定風(fēng)量調(diào)節(jié)閥、變風(fēng)量調(diào)節(jié)閥和手動(dòng)調(diào)節(jié)閥Theairvalvecomprisesaconstantairvolumeregulatingvalve,avariableairvolumeregulatingvalveandamanualregulatingvalve用于調(diào)節(jié)風(fēng)量UsedforregulatingairvolumeNNYYNNYYES21高效過(guò)濾器靜壓箱Plenumchamberforhighefficiencyfilter用于潔凈送風(fēng)及送風(fēng)均勻UsedforcleanairsupplyanduniformairsupplyNYNYNNYYES功能Function22溫濕度Temperatureandhumidity控制潔凈室溫濕度ControlcleanroomtemperatureandhumidityNYYNYNYYES23壓差Differentialpressure控制潔凈室壓差ControlthedifferentialpressureinthecleanroomNYYNYNYYES24換氣次數(shù)Airchanges控制潔凈室的自凈能力Controltheself-cleaningcapacityofthecleanroomNYYNNNYYES25懸浮粒子、微生物（沉降菌、浮游菌/表面微生物）Suspendedparticles,控制潔凈室潔凈度和微生物環(huán)境ControlcleanroomcleanlinessandmicrobialenvironmentNYYNYNYYES文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010114/33序號(hào)NO.功能/部件Function/Component組件功能Componentfunctions問(wèn)題Problem關(guān)鍵Critical是/否(Yes/NO)ABCDEFGmicroorganisms(sedimentationbacteria,plankton/surfacemicroorganisms)26噪音Noise保護(hù)操作人員聽(tīng)力安全，保證生產(chǎn)過(guò)程中的正常溝通ToprotectthehearingsafetyofoperatorsandensurethenormalcommunicationduringproductionNNNNNNYYES27照度Illumination為潔凈室房間提供照明亮度，保證生產(chǎn)人員的視線ProvideilluminationforcleanroomroomandensurethelineofsightofproductionpersonnelNNNNNNYYES文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010115/338.2關(guān)鍵性部件/功能風(fēng)險(xiǎn)評(píng)估和控制矩陣Criticalcomponent/functionriskassessmentandcontrolmatrix關(guān)鍵性部件/功能風(fēng)險(xiǎn)評(píng)估矩陣Criticalcomponent/functionriskassessmentmatrix序號(hào)NO.功能/關(guān)鍵部件Functional/keycomponents說(shuō)明/任務(wù)Description/Tasks失效事件Failureevents最差情況影響Worst-caseimpactSPD風(fēng)險(xiǎn)優(yōu)先性RPN1加濕蒸汽Wetsteam為潔凈室空調(diào)加濕Humidifythecleanroomairconditioner蒸汽壓力不滿足要求ThesteampressuredoesnotmeettherequirementsPressureisnotenough影響潔凈室的濕度Affectsthehumidityinthecleanroom322122空調(diào)熱水Airconditioninghotwater用于空調(diào)系統(tǒng)溫度調(diào)節(jié)Usedfortemperatureregulationofairconditioningsystem壓力不滿足要求Pressureisnotenough影響潔凈室的溫濕度Affectsthetemperatureandhumidityofthecleanroom39212溫度不滿足要求Thetemperaturedoesnotmeettherequirements影響潔凈室的溫濕度Affectsthetemperatureandhumidityofthecleanroom322123空調(diào)冷水Airconditioningcoldwater用于空調(diào)系統(tǒng)溫度調(diào)節(jié)Usedfbrtemperatureregulationofairconditioningsystem壓力不滿足要求Pressureisnotenough影響潔凈室的溫濕度Affects(hetemperatureandhumidityofthecleanroom32212溫度不滿足要求Thetemperaturedoesnotmeettherequirements影響潔凈室的溫濕度Affectsthetemperatureandhumidityofthecleanroom392124電力供應(yīng)Powersupply為空調(diào)系統(tǒng)提供動(dòng)力Powertheairconditioningsystem電壓過(guò)低/高Voltageistoolow/high超過(guò)變頻器工作范圍的電壓波動(dòng)可能導(dǎo)致變頻器和電機(jī)的損壞或無(wú)法正常使用Voltagefluctuationsbeyondtheoperatingrangeofthefrequencyconvertermaycausedamagetothefrequencyconverterandmotororfailuretooperateproperly22285潔凈燈具Cleanlampsand為生產(chǎn)區(qū)域提供照明Providelightingfor潔凈燈具不合格或布局不合理造成房間照度不足房間照度不足，影響操作人員的操作精度2228潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010116/33序號(hào)NO.功能/關(guān)鍵部件Functional/keycomponents說(shuō)明/任務(wù)Description/Tasks失效事件Failureevents最差情況影響Worst-caseimpactSPD風(fēng)險(xiǎn)優(yōu)先性RPNlanternsproductionareaCleanlampsareunqualifiedorunreasonablelayoutresultingininsufficientroomilluminationRoomilluminationisinsufficient,affectingtheoperationaccuracyoftheoperator6墻面和吊頂彩鋼板Wallandceilingcolorsteelplate潔凈室功能分割Cleanroomfunctionsegmentation材質(zhì)不符合Materialdoesnotmatch材質(zhì)脫落腐蝕，影響潔凈室環(huán)境Materialsheddingcorrosion,affectingthecleanroomenvironment299AM8墻板和頂板等連接處等未使用導(dǎo)角或過(guò)渡材料NoguideAngleortransitionmaterialisusedatthejointssuchaswallpanelandtopplate存在縫隙，容易滋生微生物，引起環(huán)境污染Theexistenceofgaps,easytobreedmicroorganisms,causeenvironmentalpollution22287潔凈室門、窗戶和安全門Cleanroomdoors,Windowsandsecuritydoors潔凈室內(nèi)人員流動(dòng)和觀察Cleanroompersonnelflowandobservation材質(zhì)不符合要求Thematerialdoesnotmeettherequirements材質(zhì)脫落腐蝕，影響潔凈室環(huán)境Materialsheddingcorrosion,affectingthecleanroomenvironment22288地面Ground潔凈室地面要求Cleanroomfloorrequirements材質(zhì)不符合要求Thematerialdocsnotmeettherequirements材質(zhì)脫落，易被腐蝕，影響潔凈室環(huán)境Thematerialfallsoffandiseasytobecorroded,affectingthecleanroomenvironment22289地漏Floordrain用于潔凈室內(nèi)排水，隔絕空氣防止下水道中空氣反流入潔凈室Itisusedforcleanroomdrainagetoisolateairandpreventairfromseweriromflowingbackintocleanroom材質(zhì)不符合要求Thematerialdoesnotmeettherequirements潔凈室微生物滋生，影響潔凈室環(huán)境，進(jìn)而影響產(chǎn)品質(zhì)量Cleanroommicrobialbreeding,affectthecleanroomenvironment,andthenaffectthequalityofproducts2228水封能力不住Insufficientwaterscalingcapacity地面積水，滋生微生物，影響潔凈環(huán)境Wateraccumulationontheground,breedingmicroorganisms,andaffectingthecleanenvironment2228潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010117/33序號(hào)NO.功能/關(guān)鍵部件Functional/keycomponents說(shuō)明/任務(wù)Description/Tasks失效事件Failureevents最差情況影響Worst-caseimpactSPD風(fēng)險(xiǎn)優(yōu)先性RPN10密封Seal用于密封潔凈室內(nèi)縫隙Usedfbrsealingcracksincleanrooms材質(zhì)不符合要求Thematerialdoesnotmeettherequirements影響潔凈室環(huán)境Affectthecleanroomenvironment32212密封破損Sealthedamage引起污染或交叉污染Causecontaminationorcrosscontamination3221211高效過(guò)濾器Highefficiencyfilter用于潔凈送風(fēng)過(guò)濾凈化，保證房間滿足凈化要求Usedforcleanairfiltrationandpurification,toensurethattheroommeetstherequirementsofpurification過(guò)濾器選型不滿足Filterselectionisnotsatisfied過(guò)濾器過(guò)濾效率不滿足要求Filterefficiencydoesnotmeettherequirements影響潔凈室環(huán)境Affectsthecleanroomenvironment32212過(guò)濾器過(guò)濾效率不滿足要求Filterefficiencydoesnotmeettherequirements近濾器在生產(chǎn)或安裝中被損壞Thefilterisdamagedduringproductionorinstallation過(guò)濾效率不能滿足要求，影響潔凈室環(huán)境Filtrationefficiencycannotmeettherequirements,affectingthecleanroomenvironment32212過(guò)濾器在生產(chǎn)或安裝中被損壞Thefilterisdamagedduringproductionorinstallation嚴(yán)密性不足Lackofrigor漏風(fēng)嚴(yán)重，空氣未經(jīng)過(guò)高效過(guò)濾進(jìn)入潔凈房間影響環(huán)境Airleakageisserious,theairisnotfilteredintothecleanroom,affectingtheenvironment3221212送、回、排風(fēng)口Send,return,exhaustairoutlet保證房間滿足潔凈度，壓差及自凈的設(shè)計(jì)要求。Ensurethattheroommeetsthedesignrequirementsofcleanliness,differentialpressureandself-cleaning.材質(zhì)不符合要求Thematerialdoesnotmeettherequirements材質(zhì)脫落腐蝕，影響潔凈室環(huán)境Thematerialfallsoffandcoirodes,affectingthecleanroomenvironment3126安裝位置和大小錯(cuò)誤Incorrectinstallationlocationandsize影響房間的正常空氣循環(huán)，無(wú)法保證潔凈環(huán)境Affectsthenormalaircirculationoftheroomandcannotguaranteeacleanenvironment32212文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010118/33序號(hào)NO.功能/關(guān)鍵部件Functional/keycomponents說(shuō)明/任務(wù)Description/Tasks失效事件Failureevents最差情況影響Worst-caseimpactSPD風(fēng)險(xiǎn)優(yōu)先性RPN13風(fēng)管Duct為潔凈室送、回、排風(fēng)需要Forcleanroomtosend,return,exhaustairneeds材質(zhì)不符合要求Thematerialdoesnotmeettherequirements材質(zhì)脫落腐蝕，堵塞過(guò)濾器Materialpeelingcorrosion,cloggingfilter2228風(fēng)管安裝不符合Airductinstallationdoesnotconform風(fēng)管泄漏，潔凈室送風(fēng)量不足Airductleakage,cleanroomairsupplyisinsufficient222814風(fēng)管保溫Ductinsulation用于避免結(jié)露或熱損耗的風(fēng)險(xiǎn)Toavoidtheriskofcondensationorheatloss材質(zhì)不符合要求Thematerialdoesnotmeettherequirements產(chǎn)生熱損耗Heatlossgeneration2228安裝不符合Installationnonconformity導(dǎo)致結(jié)露滴水Itcausesdewtodrip222815風(fēng)閥，包括定風(fēng)量調(diào)節(jié)閥、變風(fēng)量調(diào)節(jié)閥和手動(dòng)調(diào)節(jié)閥Theairvalvecomprisesaconstantairvolumeregulatingvalve,avariableairvolumeregulatingvalveandamanualregulatingvalve用于調(diào)節(jié)風(fēng)量Usedforregulatingairvolume材質(zhì)不符合要求Thematerialdocsnotmeettherequirements材質(zhì)脫落腐蝕，無(wú)法實(shí)現(xiàn)風(fēng)量的穩(wěn)定及調(diào)節(jié)功能Materialfalloffcorrosion,unabletoachievethestabilityandregulationofairvolumefunction2228安裝位置錯(cuò)誤Incorrectinstallationlocation無(wú)法正常調(diào)節(jié)風(fēng)量以實(shí)現(xiàn)房間的正常風(fēng)量平衡Theairvolumecannotbeadjustedproperlytoachievethenormalairvolumebalanceoftheroom222816高效過(guò)濾器靜壓箱Plenumchamberforhighefficiencyfilter用于潔凈送風(fēng)及送風(fēng)均勻Usedforcleanairsupplyanduniformairsupply材質(zhì)不符合要求Thematerialdoesnotmeettherequirements材質(zhì)脫落腐蝕，影響潔凈室環(huán)境Thematerialfallsoffandcoirodes,affectingthecleanroomenvironment32212嚴(yán)密性不足Lackofrigor漏風(fēng)嚴(yán)重，空氣未經(jīng)過(guò)高效過(guò)濾進(jìn)入潔凈房間影響環(huán)境Airleakageisserious,theairisnotfilteredintothecleanroom,affectingtheenvironment32212功能Function文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010119/33序號(hào)NO.功能/關(guān)鍵部件Functional/keycomponents說(shuō)明/任務(wù)Description/Tasks失效事件Failureevents最差情況影響Worst-caseimpactsPD風(fēng)險(xiǎn)優(yōu)先性RPN17溫濕度Temperatureandhumidity控制潔凈室溫濕度Controlcleanroomtemperatureandhumidity潔凈室溫濕度超標(biāo)Cleanroomtemperatureandhumidityexceedstandard影響潔凈室生產(chǎn)環(huán)境，進(jìn)而影響產(chǎn)品質(zhì)量及人員舒適性Affectsthecleanroomproductionenvironment,andthenaffectstheproductqualityAffectcleanroomproductionenvironment,andthenaffectproductqualityandpersonnelcomfort3221218壓差Differentialpressure控制潔凈室壓差Controlthedifferentialpressureinthecleanroom潔凈室壓差不符合Pressuredifferenceincleanroomdoesnotmeet影響潔凈室氣流流向，引起污染或交叉污染Affectstheflowdirectionofthecleanroom,causingcontaminationorcrosscontamination3221219換氣次數(shù)Airchanges控制潔凈室的自凈能力Controltheself-cleaningcapacityofthecleanroom換氣次數(shù)不符合Thefrequencyofventilationisnotconsistent影響潔凈室的自凈能力Affectstheself-purificationabilityofthecleanroom3221220懸浮粒子、微生物(沉降菌、浮游菌、表面微生物)Suspendedparticles,microorganisms(settlingbacteria,plankton,surfacemicroorganisms)控制潔凈室潔凈度和微生物環(huán)境Controlcleanroomcleanlinessandmicrobialenvironment潔凈室設(shè)計(jì)不滿足Cleanroomdesignisnotsatisfied影響潔凈室環(huán)境，從而影響產(chǎn)品質(zhì)量Affectsthecleanroomenvironment,therebyaffectingproductquality3221221噪音Noise保護(hù)操作人員聽(tīng)力安全，保證生產(chǎn)過(guò)程中的正常溝通Toprotectthehearingsafetyofoperatorsandensurethenormalcommunicationduringproduction潔凈室噪音超標(biāo)Excessivenoiseincleanrooms不滿足EHS要求影響人員正常操作AffectingthenormaloperationofpersonnelEHSrequirementsarenotmet32212目錄IndexTOC\o"1-5"\h\z\o"CurrentDocument"目的Propose 3\o"CurrentDocument"范圍Scope 3\o"CurrentDocument"職責(zé)Responsibilities 4（供應(yīng)商）安裝職責(zé)Responsibilities 4（業(yè)主）IRMResponsibilities 4參考文件及規(guī)范ReferenceandRegulation 5術(shù)語(yǔ)和縮略語(yǔ)Abbreviations 6\o"CurrentDocument"系統(tǒng)描述SystemDescription 7評(píng)估方法Assessmentmethods 8\o"CurrentDocument"功能/部件關(guān)鍵性的確認(rèn)Criticalconfirmationoffunction/component 8\o"CurrentDocument"關(guān)鍵’性部件風(fēng)險(xiǎn)評(píng)估Riskassessmentofcriticalcomponents 9功能/部件關(guān)鍵性評(píng)估Criticalevaluationoffunctions/components 11功能/部件關(guān)鍵性矩陣Function/componentcriticalmatrix 11關(guān)鍵性部件/功能風(fēng)險(xiǎn)評(píng)估和控制矩陣Criticalcomponent/functionriskassessmentandcontrolmatrix15結(jié)論Conclusion 32彳修訂歷史RevisionHistory 33潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010120/33序號(hào)NO.功能/關(guān)鍵部件Functional/keycomponents說(shuō)明/任務(wù)Description/Tasks失效事件Failureevents最差情況影響Worst-caseimpactSPD風(fēng)險(xiǎn)優(yōu)先性RPN22照度Illumination為潔凈室房間提供照明亮度，保證生產(chǎn)人員的視線Provideilluminationforcleanroomroomandensurethelineofsightofproductionpersonnel潔凈室照度不足Insufficientlightincleanroom影響人員正常操作Affectingthenormaloperationofpersonnel32212文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010121/33關(guān)鍵性部件/功能風(fēng)險(xiǎn)控制矩陣Criticalcomponent/functionriskcontrolmatrix序號(hào)NO.功能/關(guān)鍵部件Functional/keycomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPN1加濕蒸汽Weisteam蒸汽壓力不滿足要求Thesteampressuredoesnotmeettherequirements壓力不滿足要求Pressureisnotenough12通過(guò)在IQ階段進(jìn)行蒸汽管道壓力表壓力口視檢查提高失效事件發(fā)生的可檢測(cè)性；編制SOP定期檢查維修，定期進(jìn)行儀表校準(zhǔn)檢驗(yàn)降低失效事件發(fā)生的可能性并提高失效事件的可檢測(cè)性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthepressureofsteampipelinepressuregaugesduringtheIQstage;DevelopSOPforregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.31132空調(diào)熱水Airconditioninghotwater壓力不滿足要求Pressureisnotenough12通過(guò)在IQ階段進(jìn)行空調(diào)熱水壓力表壓力口視檢查提高失效事件發(fā)生的可檢測(cè)性；編制SOP定期檢查維修，定期進(jìn)行儀表校準(zhǔn)檢驗(yàn)降低失效事件發(fā)生的可能性并提高失效事件的可檢測(cè)性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthepressureoftheairconditioninghotwaterpressuregaugeduringtheIQstage;DevelopSOPforregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3113溫度不滿足要求Thetemperaturedocsnotmeettherequirements12通過(guò)在IQ階段進(jìn)行空調(diào)熱水溫度計(jì)溫度口視檢查提高失效事件發(fā)生的可檢測(cè)性；編制SOP定期檢查維修，定期進(jìn)行儀表校準(zhǔn)檢驗(yàn)降低失效事件發(fā)生的可能性并提高失效事件的可檢測(cè)性。3113潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010122/33序號(hào)NO.功能/關(guān)鍵部件Functional/kevcomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPNImprovethedetectabilityoffailureeventsbyvisuallyinspectingthetemperatureofairconditioninghotwaterthermometersduringtheIQstage;DevelopSOPfbrregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3空調(diào)冷水Airconditioningcoldwater壓力不滿足要求Pressureisnotenough12通過(guò)在IQ階段進(jìn)行空調(diào)熱水壓力表壓力目視檢查提高失效事件發(fā)生的可檢測(cè)性；編制SOP定期檢杳維修，定期進(jìn)行儀表校準(zhǔn)檢驗(yàn)降低失效事件發(fā)生的可能性并提高失效事件的可檢測(cè)性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthepressureoftheairconditioninghotwaterpressuregaugeduringtheIQstage;DevelopSOPfbrregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3113溫度不滿足要求Thetemperaturedoesnotmeettherequirements12通過(guò)在IQ階段進(jìn)行空調(diào)熱水溫度計(jì)溫度目視檢查提高失效事件發(fā)生的可檢測(cè)性；編制SOP定期檢杳維修，定期進(jìn)行儀表校準(zhǔn)檢驗(yàn)降低失效事件發(fā)生的可能性并提高失效事件的可檢測(cè)性。ImprovethedetectabilityoffailureeventsbyvisuallyinspectingthetemperatureofairconditioninghotwaterthermometersduringtheIQstage;DevelopSOPfbrregularinspectionandmaintenance,conductregularinstrumentcalibrationinspectionstoreducethelikelihoodoffailureeventsandimprovethedetectabilityoffailureevents.3113文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010123/33序號(hào)NO.功能/關(guān)鍵部件Functional/kevcomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPN4電力供應(yīng)Powersupply電壓過(guò)低/高Voltageistoolow/high8通過(guò)在OQ階段進(jìn)行機(jī)組供電電壓測(cè)試提高失效事件的可檢測(cè)性；ThepossibilityoffailureeventscanbereducedanditsdetectabilitycanbeimprovedbytestingthepowersupplyvoltageoftheunitinOQstage;22145潔凈燈具Cleanlampsandlanterns潔凈燈具不合格或布局不合理造成房間照度不足Cleanlampsareunqualifiedorunreasonablelayoutresultingininsufficientroomillumination8通過(guò)在DQ階段進(jìn)行布局合理性檢查降低失效事件的可能性：通過(guò)IQ階段對(duì)潔凈燈具合格證書進(jìn)行檢查及OQ階段進(jìn)行照度測(cè)試降低失效事件發(fā)生的可能性并提高其可檢測(cè)性。ReducethelikelihoodoffailureeventsbyconductinglayoutrationalitychecksduringtheDQphase;CheckthequalificationcertificateofcleanlampsthroughIQstagetoreducethepossibilityoffailureeventsandimproveitsdetectabilityCleanluminairecertificateinspectionandcleanluminairelayoutinspectionthroughIQstageandilluminanceinspectiontestingthroughOQstagereducethepossibilityoffailureeventsandimprovetheirdetectability21126墻面和吊頂彩鋼板Wailandceilingcolorsteelplate材質(zhì)不符合Materialdoesnotmatch8通過(guò)在IQ階段檢查彩鋼板的材質(zhì)證明降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ItisprovedthatthepossibilityoffailureeventscanbereducedanditsdetectabilitycanbeimprovedbycheckingthematerialofcolorsteelplateinIQstage2112墻板和頂板燈等連接處等未使用導(dǎo)角或過(guò)渡材料NoguideAngleortransitionmaterialisusedatthejointssuchaswallpanelandtopplateNoguideAngleortransitionmaterialisusedatthe8通過(guò)在IQ階段檢查彩鋼板安裝符合性降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethepossibilityoffailureeventsandimproveitsdetectabilitybycheckingthecomplianceofcolorsteelplateinstallationduringIQstage2112文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010124/33序號(hào)NO.功能/關(guān)鍵部件Functional/kevcomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPNjunctionbetweenthewallpanelandthetoplight7潔凈室門、窗戶和安全門Cleanroomdoors,Windowsandsecuritydoors材質(zhì)不符合要求Thematerialdoesnotmeettherequirements8通過(guò)在IQ階段檢查潔凈室門和窗戶材質(zhì)降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethelikelihoodoffailureeventsandimprovedetectabilityofcleanroomdoorandwindowmaterialsbycheckingthemduringtheIQphase21128地面Ground材質(zhì)不符合要求Thematerialdoesnotmeettherequirements8通過(guò)IQ階段檢查地面的材質(zhì)證明降低失效事件發(fā)生的可能性并提高其可檢測(cè)性CheckthematerialofthefloorthroughtheIQstagetoprovetoreducethepossibilityoffailureeventsandimproveitsdetectability21129地漏Floordrain材質(zhì)不符合要求Thematerialdoesnotmeettherequirements8通過(guò)在IQ階段檢查地漏材質(zhì)證明降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ByexaminingfloordrainmaterialduringtheIQstage,itisprovedthatthepossibilityoffailureeventsisreducedanditsdetectabilityisimproved2112水封能力不足Insufficientwatersealingcapacity8通過(guò)在IQ階段檢查地漏安裝符合性降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybycheckingthecomplianceoffloordraininstallationduringtheIQphase211210密封Seal材質(zhì)不符合要求Thematerialdoesnotmeettherequirements12通過(guò)IQ階段進(jìn)行檢查密封材質(zhì)證明降低失效事件發(fā)生的可能性并提高其可檢測(cè)性CheckingthesealmaterialthroughtheIQstageprovestoreducethelikelihoodoffailureeventsandimproveitsdetectability3113密封破損Sealthedamage12通過(guò)IQ階段對(duì)房間的密封情況進(jìn)行檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性CheckthesealingconditionoftheroomthroughtheIQstagetoreducethepossibilityoffailureeventsand3113潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010125/33序號(hào)NO.功能/關(guān)鍵部件Functional/kevcomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPNimproveitsdetectability通過(guò)編制潔凈室SOP針對(duì)密封進(jìn)行定期檢查維修降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethepossibilityoffailureeventsandimproveitsdetectabilitybypreparingcleanroomSopsforperiodicinspectionandmaintenanceofseals11高效過(guò)濾器Highefficiencyfilter過(guò)濾器選型不滿足Filterselectionisnotsatisfied12通過(guò)DQ階段進(jìn)行過(guò)濾器選型檢查降低失效事件發(fā)生的可能性ReducethelikelihoodoffailureeventsbyconductingfilterselectionchecksduringtheDQphase通過(guò)在IQ階段進(jìn)行過(guò)濾器的證明文件檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybyverifyingdocumentationoffiltersduringtheIQphase3113過(guò)濾器過(guò)濾效率不滿足要求Filterefficiencydoesnotmeettherequirements12通過(guò)在IQ階段進(jìn)行過(guò)濾器出廠檢測(cè)報(bào)告檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethepossibilityoffailureeventsandimprovethedetectabilityoffiltersbycheckingtheirfactoryinspectionreportsduringtheIQphase通過(guò)編制潔凈室SOP針對(duì)高效過(guò)濾器進(jìn)行定期的檢測(cè)、更換降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ThroughthepreparationofcleanroomSOP,thehePAfilterisregularlytestedandreplacedtoreducethepossibilityoffailureeventsandimproveitsdetectability3113過(guò)濾器在生產(chǎn)或安裝中被損壞Thefilterisdamagedduringproductionorinstallation12通過(guò)在OQ階段進(jìn)行高效檢漏測(cè)試提高失效事件發(fā)生的可檢測(cè)性Improvethedetectabilityoffailureeventsbyconductingefficientleakdetectiontestingduringthe3113潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010126/33序號(hào)NO.功能/關(guān)鍵部件Functional/kevcomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPNOQphase通過(guò)編制潔凈室SOP針對(duì)高效過(guò)濾器進(jìn)行定期的檢測(cè)、更換降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ThroughthepreparationofcleanroomSOP,thehePAfilterisregularlytestedandreplacedtoreducethepossibilityoffailureeventsandimproveitsdetectability12送、回、排風(fēng)口Send,return,exhaustairoutlet材質(zhì)不符合要求Thematerialdoesnotmeettherequirements6通過(guò)在IQ階段進(jìn)行送、回、排風(fēng)口的證明文件檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性Reducethepossibilityoffailureeventsandimprovetheirdetectabilitybycheckingthedocumentationofthefeed,returnandexhaustventsduringtheIQstage3113安裝位置和大小錯(cuò)誤Incorrectinstallationlocationandsize12通過(guò)在IQ階段進(jìn)行送、回、排風(fēng)口的位置及大小進(jìn)行目視檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性Reducethepossibilityoffailureeventsandimprovetheirdetectabilitybyvisualinspectionofthepositionandsizeoffeed,returnandexhaustventsinIQstage311313風(fēng)管Duct材質(zhì)不符合要求Thematerialdoesnotmeettherequirements8通過(guò)在IQ階段進(jìn)行風(fēng)管材質(zhì)證書檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethepossibilityoffailureeventsandimproveitsdetectabilitythroughairductmaterialcertificateinspectioninIQstage2112風(fēng)管安裝不符合Airductinstallationdocsnotconform8通過(guò)在IQ階段進(jìn)行安裝目視檢查，并檢查漏光及漏風(fēng)量測(cè)試記錄降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybyconductingvisualinspectionofinstallationsduringtheIQphaseandcheckingforlightleakageandairleakagetestrecords2112文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010127/33序號(hào)NO.功能/關(guān)鍵部件Functional/kevcomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPN14風(fēng)管保溫Ductinsulation材質(zhì)不符合要求Thematerialdoesnotmeettherequirements8通過(guò)在IQ階段進(jìn)行風(fēng)管保溫材質(zhì)證書檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethepossibilityoffailureeventsandimproveitsdetectabilitythroughairductinsulationmaterialcertificateinspectioninIQstage2112安裝不符合Installationnonconformity8通過(guò)在IQ階段進(jìn)行風(fēng)管保溫目視檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性VisualinspectionofductinsulationduringIQstagecanreducethepossibilityoffailureeventsandimproveitsdetectability211215風(fēng)閥，包括定風(fēng)量調(diào)節(jié)閥、變風(fēng)量調(diào)節(jié)閥和手動(dòng)調(diào)節(jié)閥Theairvalvecomprisesaconstantairvolumeregulatingvalve,avariableairvolumeregulatingvalveandamanualregulatingvalve材質(zhì)不符合要求Thematerialdoesnotmeettherequirements8通過(guò)在IQ階段進(jìn)行風(fēng)閥，包括定風(fēng)量調(diào)節(jié)閥、變風(fēng)量調(diào)節(jié)閥和手動(dòng)調(diào)節(jié)閥材質(zhì)證書檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性Thepossibilityoffailureeventscanbereducedandthedetectabilitycanbeimprovedbycheckingthematerialcertificateofairvalve,includingconstantairvolumecontrolvalve,variableairvolumecontrolvalveandmanualcontrolvalveinIQstage2112安裝位置錯(cuò)誤Incorrectinstallationlocation8通過(guò)在IQ階段進(jìn)行安裝目視檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybyperforminginstallationvisualinspectionduringtheIQphase211216高效過(guò)濾器靜壓箱Plenumchamberforhighefficiencyfilter材質(zhì)不符合要求Thematerialdoesnotmeettherequirements12通過(guò)在IQ階段進(jìn)行過(guò)濾器靜壓箱的證明文件檢查降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ReducethepossibilityoffailureeventsandimprovedetectabilitybyverifyingthedocumentationofthefilterplenumduringtheIQphase3113嚴(yán)密性不足Lackofrigor12通過(guò)在OQ階段進(jìn)行高效過(guò)濾器及邊框的完整性測(cè)試提高提高失效事件發(fā)生的可檢測(cè)性通過(guò)編制潔凈室SOP針對(duì)高效過(guò)濾器及邊框進(jìn)行3113潔凈室風(fēng)險(xiǎn)評(píng)估RiskAssessmentofCleanRoom文件編號(hào)/Code.版本號(hào)/Version頁(yè)碼/PageRA-CR-010128/33序號(hào)NO.功能/關(guān)鍵部件Functional/kevcomponents失效事件Failureevents風(fēng)險(xiǎn)優(yōu)先性RPN建議采取措施SuggestmeasurestobetakenSPD風(fēng)險(xiǎn)優(yōu)先性RPN定期的檢測(cè)降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ImprovethedetectabilityoffailureeventsbyconductingefficientfilterandborderintegritytestingduringtheOQphaseReducethelikelihoodoffailureeventsandimprovetheirdetectabilitybydevelopingacleanroomSOPforregulartestingofhigh-efficiencyfiltersandframes功能Function17溫濕度Temperatureandhumidity潔凈室溫濕度超標(biāo)Cleanroomtemperatureandhumidityexceedstandard12通過(guò)EMS/BMS的調(diào)試和確認(rèn)階段進(jìn)行潔凈室溫濕度測(cè)試降低失效事件的可能性并提高其可檢測(cè)性ReducethelikelihoodoffailureeventsandimprovetheirdetectabilitythroughcleanroomtemperatureandhumiditytestingduringthedebuggingandconfirmationphaseofEMS/BMS通過(guò)在OQ/PQ階段進(jìn)行潔凈室溫濕度測(cè)試降低失效事件發(fā)生的可能性并提高其可檢測(cè)性ThepossibilityoffailureeventsisreducedanditsdetectabilityisimprovedbycleanroomtemperatureandhumiditytestinginOQ/PQphase通過(guò)建立溫濕度監(jiān)測(cè)規(guī)程針對(duì)溫濕度進(jìn)行定期測(cè)試在線監(jiān)測(cè)系統(tǒng)(EMS)在線監(jiān)測(cè)，降低失效事件發(fā)生的可能性并提高其可檢測(cè)性Thepossibilityoffailureeventsca