偏差处理案例分析报告

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1、....CausalAnalysisReport/因果分析报告EventDescription/事件描述ThedetergentresultofGlattGranulationtrain(SampleNo.37.2)incleaningperiodicrevalidationforXelodawasoutofacceptancecriteria.希罗达周期性清洁再验证中，Glatt制粒干燥系统的清洁剂结果（样品编号37.2）超出接受标准。DiscrepancyIDnumber/差异ID号码TW1079413CausalAn

2、alysisTeamParticipants/因果分析小组成员Function/职能Name/姓名QALilyZhou/周玲洁QVLilyLi/李志珍Prod-SMEZhaoBin/赵斌Prod-SMEXuFeng/徐锋Prod-SMEAlexYu/郁昊MSAT-SMEChenJie/陈洁Documentationofallinformation/dataavailablefromtheinitialInvestigation/初步调查中获取的所有信息/数据的记录1.RCA/因果分析—Fishbonediagram/因果分

3、析——鱼骨图1.1Material/物料方面：lPossiblecause1:CitricAcid可能原因1：柠檬酸Thesupplierforcitricacidisnotchangedsincelastcleaningvalidation(2013.01)自从上次清洁验证（2013.01）至今，柠檬酸的供应商未发生过变更。Thequantityofcitricacidwasweighedbytwooperatorsandformulationofcitricacidsolutionwasperformedbytwoop

4、erators.Citricacidsolutionwaspumpedintodetergentstoragecontainerforuse.Operatorcheckedthesetpointofdosingpumpwascorrect.DuringWIPprocess,operatorwasalwaysbesidethedetergentstoragecontainerandconfirmedallcitricacidsolutionwasusedup.Noremarkofabnormitywasfoundonlogb

5、ook.柠檬酸由双人称量，柠檬酸溶液由双人配制。使用前，柠檬酸溶液被吸入清洁剂储罐中待用。员工检查计量泵的设定值正确。在WIP期间，员工始终在清洁剂储罐旁边并确保所有柠檬酸溶液用尽。查看相关日志，没有发现异常情况。Outcome:No.结果：不是可能原因。lPossiblecause2:CIP100资料整理11/11....可能原因2：CIP100ThesupplierforCIP100isnotchangedsincelastcleaningvalidation(2013.01)自从上次清洁验证（2013.01）至今，C

6、IP100的供应商未发生过变更。TwowholedrumsofCIP100areusedforWIP.CIP100ispumpedintodetergentstoragecontainerforuse.Operatorcheckedthesetpointofdosingpumpwascorrect.DuringWIPprocess,operatorwasalwaysbesidethedetergentstoragecontainerandconfirmedallCIP100wereusedup.Noremarkofabno

7、rmitywasfoundonlogbook.两整桶CIP100用于WIP。CIP100被吸入清洁剂储罐中待用。员工检查计量泵的设定值正确。在WIP期间，员工始终在清洁剂储罐旁边并确保所有CIP100用尽。查看相关日志，没有发现异常情况。Outcome:No.结果：不是可能原因。lPossiblecause3:Glove(forcleaning)可能原因3：手套（用于清洁）Thesupplierforrubbergloveisnotchangedsincelastcleaningvalidation(2013.01)自从上

8、次清洁验证（2013.01）至今，手套的供应商未发生过变更。Rubbergloveissingleused.70%Ethanolisonlyusedduringgowningbeforeenteringgranulationroom.No70%ethanolisusedduringmanualclean