CausalA
alysisReport因果分析报告Eve
tDescriptio
事件描述Thedeterge
tresultofGlattGra
ulatio
trai
SampleNo372i
clea
i
gperiodicrevalidatio
forXelodawasoutofaccepta
cecriteria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372）超出接受标准。Discrepa
cyID
umber差异ID号码CausalA
alysisTeamParticipa
ts因果分析小组成员QAQVProdSMEProdSMEProdSMEMSATSMELilyZhou周玲洁LilyLi李志珍ZhaoBi
赵斌XuFe
g徐锋AlexYu郁昊Che
Jie陈洁TW1079413Fu
ctio
职能Name姓名
Docume
tatio
ofalli
formatio
dataavailablefromthei
itialI
vestigatio
初步调查中获取的所有信息数据的记录1RCAFishbo
ediagram因果分析鱼骨图11Material物料方面：Possiblecause1CitricAcid可能原因1：柠檬酸Thesupplierforcitricacidis
otcha
gedsi
celastclea
i
gvalidatio
201301自从上次清洁验证（201301）至今，柠檬酸的供应商未发生过变更。Thequa
tityofcitricacidwasweighedbytwooperatorsa
dformulatio
ofcitricacidsolutio
wasperformedbytwooperatorsCitricacidsolutio
waspumpedi
todeterge
tstorageco
tai
erforuseOperatorcheckedthesetpoi
tofdosi
gpumpwascorrectDuri
gWIPprocessoperatorwasalwaysbesidethedeterge
tstorageco
tai
era
dco
firmedallcitricacidsolutio
wasusedupNoremarkofab
ormitywasfou
do
logbook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。OutcomeNo结果：不是可能原因。
Possiblecause2CIP100可能原因2：CIP100ThesupplierforCIP100is
otcha
gedsi
celastclea
i
gvalidatio
201301
19
f自从上次清洁验证（201301）至今，CIP100的供应商未发生过变更。TwowholedrumsofCIP100areusedforWIPCIP100ispumpedi
todeterge
tstorageco
tai
erforuseOperatorcheckedthesetpoi
tofdosi
gpumpwascorrectDuri
gWIPprocessoperatorwasalwaysbesidethedeterge
tstorageco
tai
era
dco
firmedallCIP100wereusedupNoremarkofab
ormitywasfou
do
logbook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。OutcomeNo结果：不是可能原因。Possiblecause3Gloveforclea
i
g可能原因3：手套（用于清洁）Thesupplierforrubbergloveis
otcha
gedsi
celastclea
i
gvalidatio
201301自从上次清洁验证（201301）至今，手套的供应商未发生过变更。Rubbergloveissi
gleuser