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1、....CausalAnalysisReport/因果分析報告EventDescription/事件描述ThedetergentresultofGlattGranulationtrain(SampleNo.37.2)incleaningperiodicrevalidationforXelodawasoutofacceptancecriteria.希羅達周期性清潔再驗證中，Glatt制粒干燥系統(tǒng)的清潔劑結(jié)果（樣品編號37.2）超出接受標(biāo)準(zhǔn)。DiscrepancyIDnumber/差異ID號碼TW1079413CausalAn
2、alysisTeamParticipants/因果分析小組成員Function/職能Name/姓名QALilyZhou/周玲潔QVLilyLi/李志珍Prod-SMEZhaoBin/趙斌Prod-SMEXuFeng/徐鋒Prod-SMEAlexYu/郁昊MSAT-SMEChenJie/陳潔Documentationofallinformation/dataavailablefromtheinitialInvestigation/初步調(diào)查中獲取的所有信息/數(shù)據(jù)的記錄1.RCA/因果分析—Fishbonediagram/因果分
3、析——魚骨圖1.1Material/物料方面：lPossiblecause1:CitricAcid可能原因1：檸檬酸Thesupplierforcitricacidisnotchangedsincelastcleaningvalidation(2013.01)自從上次清潔驗證（2013.01）至今，檸檬酸的供應(yīng)商未發(fā)生過變更。Thequantityofcitricacidwasweighedbytwooperatorsandformulationofcitricacidsolutionwasperformedbytwoop
4、erators.Citricacidsolutionwaspumpedintodetergentstoragecontainerforuse.Operatorcheckedthesetpointofdosingpumpwascorrect.DuringWIPprocess,operatorwasalwaysbesidethedetergentstoragecontainerandconfirmedallcitricacidsolutionwasusedup.Noremarkofabnormitywasfoundonlogb
5、ook.檸檬酸由雙人稱量，檸檬酸溶液由雙人配制。使用前，檸檬酸溶液被吸入清潔劑儲罐中待用。員工檢查計量泵的設(shè)定值正確。在WIP期間，員工始終在清潔劑儲罐旁邊并確保所有檸檬酸溶液用盡。查看相關(guān)日志，沒有發(fā)現(xiàn)異常情況。Outcome:No.結(jié)果：不是可能原因。lPossiblecause2:CIP100資料整理11/11....可能原因2：CIP100ThesupplierforCIP100isnotchangedsincelastcleaningvalidation(2013.01)自從上次清潔驗證（2013.01）至今，C
6、IP100的供應(yīng)商未發(fā)生過變更。TwowholedrumsofCIP100areusedforWIP.CIP100ispumpedintodetergentstoragecontainerforuse.Operatorcheckedthesetpointofdosingpumpwascorrect.DuringWIPprocess,operatorwasalwaysbesidethedetergentstoragecontainerandconfirmedallCIP100wereusedup.Noremarkofabno
7、rmitywasfoundonlogbook.兩整桶CIP100用于WIP。CIP100被吸入清潔劑儲罐中待用。員工檢查計量泵的設(shè)定值正確。在WIP期間，員工始終在清潔劑儲罐旁邊并確保所有CIP100用盡。查看相關(guān)日志，沒有發(fā)現(xiàn)異常情況。Outcome:No.結(jié)果：不是可能原因。lPossiblecause3:Glove(forcleaning)可能原因3：手套（用于清潔）Thesupplierforrubbergloveisnotchangedsincelastcleaningvalidation(2013.01)自從上
8、次清潔驗證（2013.01）至今，手套的供應(yīng)商未發(fā)生過變更。Rubbergloveissingleused.70%Ethanolisonlyusedduringgowningbeforeenteringgranulationroom.No70%ethanolisusedduringmanualclean
