偏差处理案例

1、SummaryDescription/描绘TheproducttemperaturesensorinGlattfluidbeddriercannotbecalibratedbeforeremovingfromthesystem,discrepancywasinitiatedaccordingtoSOP-0102619section6.1.7Adiscrepancymustbeinitiatedwhenacalibrationfailsornoasfoundreadingscanbetakenbeforethesensorremovedfromthecalibrationschedule.Gla

2、tt制粒机里的产品温度传感器在从系统删除前没法做校验，依据SOP-0102619步骤“校准失败或当仪表从校准计划中删除没法获取前校数据时，一定启动差别办理程序”启动误差。1.Deviation/Actions/误差行动Productionstaffobservedtheproducttemperaturesensorwasbrokenon2015.11.24,maintenanceteamreplacedthebrokenproducttemperaturesensorwithanewimprovedoneon2015.11.26.WorkorderreferstoattachmentTW11

3、18464-01.生产部职工日产品温度传感器破坏，维修团队于日改换了新的经过改良的产品温度传感器。工单见附件TW1118464-01。2.CausalAnalysis/因果剖析5Whystoolwasusedtodothecauseanalysis.5WhysdiagramreferstoattachmentTW1118464-02.用了5Whys工具进行原由剖析。5Whys表示图拜见附件TW1118464-02。1stWhythetemperaturesensorcouldnotbecalibrated?/为何温度探头没法进行校验？（endat22:50on）,alarm101-7”Prod

4、uctTemperatureFBD(T202010)-BrokenWire”occurred,operatorcheckedthealarmandfoundthatthepartofFBDproducttemperaturesensorholderinstalledoutofthechamberwasbroken.Electricalengineerwasinformedandconfirmedthatthesensorwasbroken.夜晚23：32左右在结束希罗达SH2105批次后(2015.11.24,22:50结束），Glatt系统发生报警101-7“物料温度（T202010）-断线

5、”，职工检查发现安装在FBD产品温度探头的腔体外面分连杆处断裂。通知了电工，电工确认该温度探头破坏。Calibrationteamcheckedthesensorandevaluatedthesensorcouldnotbecalibratedasthethermocouplemeltingpointofthesensorfelloffandnooutputsignaldetectedfromsensor.校验小组对探头进行了检查，评估该探头没法进行校准，因为探头热电偶熔点掉落且没有检测到信号输出。ThebrokenpartwasinstalledoutsideoftheFBDchamber,

6、pictureofbrokenproducttemperaturesensorreferstoattachmentTW1118464-03.Thebrokenpointwasmarkedwitharrow伤害的部分在FBD墙体外面，破坏的产品温度探头图见附件TW1118464-03。箭头标明了断裂点。Aboveall,damageofFBDproducttemperaturesensorcausedthatthesensorcannotbecalibrated.综上，FBD的产品温度探头破坏致使该探头没法进行校准。2nd-WhytheFBDproducttemperaturesensorwas

7、broken?/为何FBD温度探头被破坏？Bycheckingthebrokenproducttemperaturesensor,thethicknessoftemperaturesensorholderbrokenpointwasabout1mm,madeof316Lstainless.Theendoftheholderwasajunctionboxusedtoinstalltemperaturetransmitter,anditisabitheavy.经过查察破坏的产品温度探头，Glatt产品温度传感器连杆的断裂处壁厚约为1毫米，为316L不锈钢材质，后来部为接线盒，此接线盒用于安装温度变

8、送器，较重。Itispossiblethethinnerstainlessoftemperaturesensorholdercombiningtheheavierjunctionboxintheendledtomechanicalfatigueovertimeandcausedtheholderbrokeintwo.Aftertheholderbroke,thejunctionboxfelldownunderthegravity,pulledthetemperaturesensorandcausedthatthethermocouplemeltingpointofthesensorfellof

9、f.可能因为温度传感器连杆的不锈钢厚度较薄，而且后来端的接线盒较重，所以使用中简单造成材质的机械疲惫，发生断裂。连杆断裂后，接线盒因为重力作用下坠，拉扯温度探头，致使温度探头热电偶熔点掉落。ThebrokentemperaturesensorpassedthecalibrationbeforeinstalledontheFBD,thecalibrationcertificatereferstoTW1118464-05(TT-00142-PRO).Afterthediscrepancyoccurred,calibrationteaminitiatedthecalibrationdecommiss

10、ionforit.SeeattachmentTW1118464-05(TT-00142-PROCCAF-decommission).已破坏的温度探头在安装到制粒机前校准合格，校准证书见附件TW1118464-05(TT-00142-PRO)。此误差发生后，校验小组对该探头进行了报废，详见附件TW1118464-05(TT-00142-PROCCAF-decommission)。SimilarcaseoccurredinJuly2015,thedeviationreportnumberwasTW1062179,therootcausewassameasTW1118464.Followingrem

11、ediationactionwasdefinedinTW1062179followedaspostclosureactionTW1069248:contactSupplier,strengththetemperaturesensorholder,addthicknessupto2mm,andreplacethewiringinthejunctionboxintheendby2meterofflexiblecorddirectly.Thesupplierrespondeditwouldtaketimetochangethedesignofthesensor,thetargetcompletion

12、dateforthisactionis20015.07月发生过近似事件，详见误差TW1062179。误差TW1062179拟订了后续行动以封闭后行动TW1069248追踪：联系供给商，加厚温度传感器连杆壁厚至2毫米，同时后端接线盒接线方式改为直接2米软线引出。供给商答复因为改这个感觉器的设计需要花必定的时间，所以该行动的估计达成日期为。Whenthediscrepancy(TW1118464)occurredon2015.11.24,maintenanceteamjustreceivedthenewsensorandthecalibrationwasnotcompletedyet.本误差（TW

13、1118464）在日发生时，保护小组刚收到新的感觉器，还没有做校验。Causeconclusion/原由总结Thethicknessoftemperaturesensorholderwasabout1mm,madeof316Lstainless.Theendoftheholderwasajunctionboxusedtoinstalltemperaturetransmitter,anditisabitheavy.Itispossiblethethinnerstainlessoftemperaturesensorholdercombiningtheheavierjunctionboxinthee

14、ndledtomechanicalfatigueovertimeandcausedtheholderbrokeintwo.Aftertheholderbroke,thejunctionboxfelldownduetogravity,pulledthetemperaturesensorandcausedthatthethermocouplemeltingpointofthesensorfelloff,andthecalibrationcannotbeconducted.Glatt产品温度传感器连杆的断裂处壁厚约为1毫米，316L不锈钢材质，后来部为接线盒，此接线盒用于安装温度变送器，较重。推断因

15、为温度传感器连杆的不锈钢厚度较薄，而且后来端的接线盒较重，所以使用中跟着时间的推移简单造成材质的机械疲惫，发生断裂。连杆断裂后，接线盒因为重力作用下坠，拉扯温度探头，致使温度探头热电偶熔点掉落，没法进行校准。Recurringdiscrepancyassessment/重复发生的差别的评估（DateClosed）时间框架：查问的时间段从2013.11.19(Trackwise中gDMS在上海上线的日期)到（封闭时间）Assignedsite/工厂:ShanghaiResponsibleOperationalArea/操作地区：productionEquipmentID/设施编号:SH_SHiP

16、-GranulationsystemSearchingperfieldonRectextwith（allthesewords）/在每个可输入文字的地区搜寻重点词(全部这些字):ProductTemperatureSensorResult:tworecordswerefound,TW864400&TW1062179.TW864400wasrelatedtoLODofCellceptCapoutofacceptancelimit.TW1062179wassameasthenewdiscrepancy.Sothetrendstatusisrecurring.结果：搜寻到2个记录，TW864400&T

17、W1062179。TW864400是对于骁悉胶囊干燥失重超限。此中TW1062179和此差别一致，所以趋向状态为“重复”。.RemediationactionhasbeendefinedinTW1062179,therecordNo.wasTW1069248,tocontactsupplier,strengththetemperaturesensorholder,addthicknessupto2mm,andreplacethewiringinthejunctionboxintheendby2meterofflexiblecorddirectly.在TW1062179中已定义挽救举措：联系供给

18、商，加厚温度传感器连杆壁厚至2毫米，同时后端接线盒方式接线改为直接2米软线引出.新的产品温度感觉器已于安装上。3.RemediationActions/挽救行动TW1118464-05(TT-00145-PRO)forCalibrationCertificate.Afterthecalibrationresultpassed,electricalengineerchangedthenewtemperaturesensorfortheFBD,seeattachmentTW1118464-01forreplacementworkorder.(Done，2015.11.26)，校验小组对新的温度传感

19、器进行了校验。校准证书见附件TW1118464-05(TT-00145-PRO)。校验合格后，电工改换了新的温度探头，工单见附件TW1118464-01。（已达成，）Thethicknessofthenewoptimizedtemperaturesensorholderhasbeenaddedupto2mm,andthewiringinthejunctionboxwasreplacedby2metersflexiblecorddirectly.改良的温度传感器连杆壁加厚至至2毫米，同时后端接线盒接线方式改为直接2米软线引出。4.ImpactAnalysis/影响剖析Withtimelychec

20、kafterdetectionofbrokenFBDproducttemperaturesensorholder,itwasconfirmedthatthebrokenpartwasoutoftheFBDchamberandtherewasnometalfragments.Theimpactonproduct/processwasexcludedimmediately.在发现FBD产品温度传感器连杆处断裂后实时检查，确认断裂处位于FBD锅体外面且没有金属碎屑产生。立刻清除了对产品/工艺的影响。XelodaTabSH2105wasthe4thbatchofthiscampaign,thegran

21、ulationprocessofbatchSH2105wasendat22:50on2015.11.24,andthealarmoccurredatabout23:32on2015.11.24.ReviewtheXelodaTabSH2102-SH2105GranulationReportdata,therewasnoalarminformation,andnoabnormalshownontemperaturecurve,seedetailsinAttachmentTW1118464-04.希罗达片剂SH2105为这个连续批次的第4个批号，SH2105批次制粒在夜晚22:50分结束，该报警发生在夜晚23：32分左右。回首XelodaTabSH2102-SH2105制粒报告数据，没有该温度传感器的报警信息，产品温度曲线数据没有异样，详见附件TW1118464-04。TheFBDwasusedforXelodatabletandCellceptcapsule,theproducttemperatureisamonitoringvalue,thegranulesqualityisevaluatedbytheLOD,therewasnoabnormalLODreportedduringtheu