偏差处理案例.doc

SummaryDescription/描述The product temperature sensorin Glatt fluid bed drier cannot be calibrated before removing from the system, discrepancy was initiated according to SOP-0102619 section 6.1.7A discrepancy must be initiated when a calibration fails or no as found readings can be taken before the sensor removed from the calibration schedule.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Production staff observed the product temperature sensor was broken on 2015.11.24, maintenance team replaced the broken product temperature sensor with a new improved one on 2015.11.26. Work order refers to attachment TW1118464-01.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. Causal Analysis / 因果分析5 Whys tool was used to do the cause analysis. 5 Whys diagram refers to attachment TW1118464-02.用了5 Whys工具进行原因分析。5 Whys示意图参见附件TW1118464-02。1st Why the temperature sensor could not be calibrated? /为什么温度探头无法进行校验？At about 23:32 on 2015.11.24 after completion the batch of Xeldoa SH2105（end at 22:50 on 2015.11.24）, alarm 101-7”Product Temperature FBD(T202010)- Broken Wire” occurred, operator checked the alarm and found that the part of FBD product temperature sensor holder installed out of the chamber was broken. Electrical engineer was informed and confirmed that the sensor was broken. 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。Calibration team checked the sensor and evaluated the sensor could not be calibrated as the thermocouple melting point of the sensor fell off and no output signal detected from sensor. 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。The broken part was installed outside of the FBD chamber, picture of broken product temperature sensor refers to attachment TW1118464-03.The broken point was marked with arrow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。Above all, damage of FBD product temperature sensor caused that the sensor cannot be calibrated.综上，FBD的产品温度探头损坏导致该探头无法进行校准。2nd- Why the FBD product temperature sensor was broken? / 为什么FBD温度探头被损坏？By checking the broken product temperature sensor, the thickness of temperature sensor holder broken point was about 1mm, made of 316L stainless. The end of the holder was a junction box used to install temperature transmitter, and it is a bit heavy.通过查看损坏的产品温度探头，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，其后部为接线盒，此接线盒用于安装温度变送器，较重。It is possible the thinner stainless of temperature sensor holder combining the heavier junction box in the end led to mechanical fatigue over time and caused the holder broke in two. After the holder broke, the junction box fell down under the gravity, pulled the temperature sensor and caused that the thermocouple melting point of the sensor fell off.可能由于温度传感器连杆的不锈钢厚度较薄，并且其后端的接线盒较重，因此使用中容易造成材质的机械疲劳，发生断裂。连杆断裂后，接线盒由于重力作用下坠，拉扯温度探头，导致温度探头热电偶熔点掉落。The broken temperature sensor passed the calibration before installed on the FBD, the calibration certificate refers to TW1118464-05(TT-00142-PRO). After the discrepancy occurred, calibration team initiated the calibration decommission for it. See attachment TW1118464-05 ( TT-00142-PROCCAF-decommission). 已损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)。此偏差发生后，校验小组对该探头进行了报废，详见附件TW1118464-05 (TT-00142-PROCCAF-decommission)。Similar case occurred in July 2015, the deviation report number was TW1062179, the root cause was same as TW1118464. Following remediation action was defined in TW1062179 followed as post closure action TW1069248: contact Supplier, strength the temperature sensor holder, add thickness up to 2mm, and replace the wiring in the junction box in the end by 2 meter of flexible cord directly. The supplier responded it would take time to change the design of the sensor , the target completion date for this action is 2015.12.31. 2015.07月发生过类似事件，详见偏差TW1062179。偏差TW1062179制定了后续行动以关闭后行动TW1069248跟踪：联系供应商，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。供应商回复因为改这个感应器的设计需要花一定的时间，所以该行动的预计完成日期为2015.12.31。When the discrepancy (TW1118464) occurred on 2015.11.24, maintenance team just received the new sensor and the calibration was not completed yet.本偏差（TW1118464）在2015.11.24日发生时，维护小组刚收到新的感应器，还没有做校验。Cause conclusion/原因总结The thickness of temperature sensor holder was about 1mm, made of 316L stainless. The end of the holder was a junction box used to install temperature transmitter, and it is a bit heavy. It is possible the thinner stainless of temperature sensor holder combining the heavier junction box in the end led to mechanical fatigue over time and caused the holder broke in two. After the holder broke, the junction box fell down due to gravity, pulled the temperature sensor and caused that the thermocouple melting point of the sensor fell off, and the calibration cannot be conducted.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，其后部为接线盒，此接线盒用于安装温度变送器，较重。推测由于温度传感器连杆的不锈钢厚度较薄，并且其后端的接线盒较重，因此使用中随着时间的推移容易造成材质的机械疲劳，发生断裂。连杆断裂后，接线盒由于重力作用下坠，拉扯温度探头，导致温度探头热电偶熔点掉落，无法进行校准。Recurring discrepancy assessment/重复发生的差异的评估Timeframe: From 2013.11.19(gDMS in Trackwise go-life in Shanghai site) till 2015.12.09（Date Closed）时间框架：查询的时间段从2013.11.19(Trackwise 中gDMS在上海上线的日期)到2015.12.09（关闭时间）Assigned site/工厂: ShanghaiResponsible Operational Area/操作区域：productionEquipment ID / 设备编号: SH_SHiP-Granulation systemSearching per field on Rec text with（all these words）/在每个可输入文字的区域搜索关键词(所有这些字): Product Temperature SensorResult: two records were found, TW864400 & TW1062179. TW864400 was related to LOD of Cellcept Cap out of acceptance limit. TW1062179 was same as the new discrepancy. So the trend status is recurring.结果：搜索到2个记录，TW864400 & TW1062179。TW864400是关于骁悉胶囊干燥失重超限。其中TW1062179和此差异一致，因此趋势状态为“重复”。 Remediation action has been defined in TW1062179, the record No. wasTW1069248, to contact supplier, strength the temperature sensor holder, add thickness up to 2mm, and replace the wiring in the junction box in the end by 2 meter of flexible cord directly. 在TW1062179中已定义补救措施：联系供应商，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.The new product temperature sensor was received as installed on 2015.11.26新的产品温度感应器已于2015.11.26安装上。3. Remediation Actions / 补救行动The calibration team calibrated a new temperature sensor on 2015.11.25. See attachment TW1118464-05 (TT-00145-PRO) for Calibration Certificate. After the calibration result passed, electrical engineer changed the new temperature sensor for the FBD, see attachment TW1118464-01 for replacement work order. (Done，2015.11.26)2014.11.25，校验小组对新的温度传感器进行了校验。校准证书见附件TW1118464-05(TT-00145-PRO)。校验合格后，电工更换了新的温度探头，工单见附件TW1118464-01。（已完成，2015.11.26）The thickness of the new optimized temperature sensor holder has been added up to 2mm, and the wiring in the junction box was replaced by 2 meters flexible cord directly.改进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. Impact Analysis/ 影响分析With timely check after detection of broken FBD product temperature sensor holder, it was confirmed that the broken part was out of the FBD chamber and there was no metal fragments. The impact on product/process was excluded immediately. 在发现FBD产品温度传感器连杆处断裂后及时检查，确认断裂处位于FBD锅体外部且没有金属碎屑产生。立即排除了对产品/工艺的影响。Xeloda Tab SH2105 was the 4th batch of this campaign, the granulation process of batch SH2105 was end at 22:50 on 2015.11.24, and the alarm occurred at about 23:32 on 2015.11.24. Review the Xeloda Tab SH2102-SH2105 Granulation Report data, there was no alarm information, and no abnormal shown on temperature curve, see details in Attachment TW1118464-04. 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2015.11.24晚上22:50分结束，该报警发生在2015.11.24晚上23：32分左右。回顾Xeloda Tab SH2102-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常，详见附件TW1118464-04。The FBD was used for Xeloda tablet and Cellcept capsule, the product temperature is a monitoring value, the granules quality is evaluated by the LOD, there was no abnormal LOD rep