-
Summary
Description/
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
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
improved
one on 2015.11.26.
Work
order refers to attachment
TW1118464-01.
生产部员工
2015.11.2
4
日产品温度传感器损坏，维修团队于
2015.11.26<
/p>
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 w
as
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
TW1118
464-02
。
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<
/p>
101-7
“物料温度（
T202010
）
-
断线”，员工检查发现安装在<
/p>
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
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
holderbroken point
was about 1mm,made of 316L stainless. The end of
the holderwas 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 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
TW1118
464-05 (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-001
42-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
supplier
responded it would take time to change the design
of the sensor , the target
completion
date for this action is 2015.12.31.
20
15.07
月发生过类似事件，详见偏差
TW1062179<
/p>
。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<
/p>
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
2015.1
1.24
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
holderwas about 1mm, made of 316L stainless. The
end of the
holderwas a junction box
used to install temperature transmitter, and it is
a bit 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 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<
/p>
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<
/p>
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
: Shanghai
Responsible Operational
Area/
操作区域：
production
Equipment ID /
设备编号
: SH_SHiP-Granulation
system
Searching per field on Rec text
with
（
all these words
< br>）
/
在每个可输入文字的区域搜索关键词
(
所有这些
字
):Produ
ct Temperature Sensor
Result: two records were found,
TW864400 & TW1062179. TW864400 was related to LOD
of
Cellcept Cap out of acceptance
1062179 was same as the newdiscrepancy. So the
trend
status is recurring.
结
果：搜索到
2
个记录，
TW86440
0 & 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”。
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