偏差处理案例

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1、SummaryDescription/描述Theproducttemperaturesensor inGlattfluidbeddriercannotbecalibratedbeforeremovingfromthesystem,discrepancywasinitiatedaccordingtoSOP-0102619section6.1.7 "Adiscrepancymustbeinitiatedwhenacalibrationfailsornoasfoundreadingscanbetakenbeforethesensorremovedfromthe

2、calibrationschedule".Glatt制粒机里的产品温度传感器在从系统删除前无法做校验，根据SOP-0102619步骤6.1.7“校准失败或当仪表从校准计划中删除无法获得前校数据时，必须启动差异处理程序”启动偏差。1.Deviation/Actions/偏差行动Productionstaffobservedtheproducttemperaturesensorwasbrokenon2015.11.24,maintenanceteamreplacedthebrokenproducttemperaturesensorwithanewimprov

3、edoneon2015.11.26.WorkorderreferstoattachmentTW1118464-01.生产部员工2015.11.24日产品温度传感器损坏，维修团队于2015.11.26日更换了新的经过改进的产品温度传感器。工单见附件TW1118464-01。2.CausalAnalysis/因果分析5Why’stoolwasusedtodothecauseanalysis.5Why’sdiagramreferstoattachmentTW1118464-02.用了5Why’s工具进行原因分析。5Why’s示意图参见附件TW1118464-0

4、2。1st–Whythetemperaturesensorcouldnotbecalibrated?/为什么温度探头无法进行校验？Atabout23:32on2015.11.24aftercompletionthebatchofXeldoaSH2105（endat22:50on2015.11.24）,alarm101-7”ProductTemperatureFBD(T202010)-BrokenWire”occurred,operatorcheckedthealarmandfoundthatthepartofFBDproducttemperaturese

5、nsorholderinstalledoutofthechamberwasbroken.Electricalengineerwasinformedandconfirmedthatthesensorwasbroken.2015.11.24晚上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”，员工检查发现安装在FBD产品温度探头的腔体外部分连杆处断裂。通知了电工，电工确认该温度探头损坏。Calibrationteamcheckedthesensorand

6、evaluatedthesensorcouldnotbecalibratedasthethermocouplemeltingpointofthesensorfelloffandnooutputsignaldetectedfromsensor.校验小组对探头进行了检查，评估该探头无法进行校准，因为探头热电偶熔点掉落且没有检测到信号输出。ThebrokenpartwasinstalledoutsideoftheFBDchamber,pictureofbrokenproducttemperaturesensorreferstoattachmentTW11184

7、64-03.Thebrokenpointwasmarkedwitharrow损害的部分在FBD墙体外面，损坏的产品温度探头图见附件TW1118464-03。箭头标注了断裂点。Aboveall,damageofFBDproducttemperaturesensorcausedthatthesensorcannotbecalibrated.综上，FBD的产品温度探头损坏导致该探头无法进行校准。2nd-WhytheFBDproducttemperaturesensorwasbroken?/为什么FBD温度探头被损坏？Bycheckingthebrokenpro

8、ducttemperaturesensor,thethicknessoftemp