偏差处理案例.docxVIP

SummaryDescription/描述The product temperature sensor?in Glattfluid bed drier cannot be calibrated before removing from the system, discrepancy was initiated according to SOP-0102619 section 6.1.7?A 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 staffobserved the product temperature sensor wasbroken on 2015.11.24, maintenance team replaced the broken product temperature sensor with a new improvedone 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 Why’s tool was used to do the cause analysis.5 Why’s diagram refers to attachment TW1118464-02.用了5 Why’s工具进行原因分析。5 Why’s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 holderinstalled 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 notbe calibratedas the thermocouple melting point of the sensor felloff 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 o