偏差處理案例

1、SummaryDescription/ 描述The product temperature sensor?in Glatt fluid bed drier cannot be calibrated before removing from the system, discrepancy was initiated according to SOP-0102619 section ?"A discrepancy must be initiated when a calibration fails or no as found readings can be taken before t

2、he sensor removed from the calibration schedule".Glatt制粒機(jī)里的產(chǎn)品溫度傳感器在從系統(tǒng)刪除前無法做校驗(yàn),根據(jù) SOP-0102619步驟“校準(zhǔn)失敗或當(dāng)儀表從校準(zhǔn)方案中刪除無法獲得前校數(shù)據(jù)時(shí),必須啟動(dòng)差異處理程序啟動(dòng)偏差.1. Deviation/ Actions /偏差行動(dòng)Production staff observed the product temperature sensor was broken on maintenance teamreplaced the broken product temperature sens

3、or with a newimproved one on Work order refers toattachment TW1118464-01.生產(chǎn)部員工日產(chǎn)品溫度傳感器損壞,維修團(tuán)隊(duì)于日更換了新的經(jīng)過改良的產(chǎn)品溫度傳感器.工單見附件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工具進(jìn)行原因分析.5 Why' s示意圖參

4、見附件 TW1118464-02 .1st Why the temperature sensor could not be calibrated? /為什么溫度探頭無法進(jìn)行校驗(yàn)？At about 23:32 on after completion the batch of Xeldoa SH2105(end at 22:50 on ) , alarm 1017 "Product Temperature FBD(T202222)- Broken Wire" occurred, operator checked the alarm andfound that the part

5、of FBD product temperature sensor holder installed out of the chamber was broken. Electrical engineer was informed and confirmed that the sensor was broken.晚上23: 32左右在結(jié)束希羅達(dá)SH2105批次后22:50結(jié)束),Glatt系統(tǒng)發(fā)生報(bào)警101-7 “物料溫度(T202222 )-斷線,員工檢查發(fā)現(xiàn)安裝在FBD產(chǎn)品溫度探頭的腔體外局部連桿處斷裂.通知了電工,電工確認(rèn)該溫度探頭損壞.Calibration team checked t

6、he 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. 校驗(yàn)小組對(duì)探頭進(jìn)行了檢查,評(píng)估該探頭無法進(jìn)行校準(zhǔn),由于探頭熱電偶熔點(diǎn)掉落且沒有檢測到信號(hào)輸 出.The broken part was installed outside of the FBD chamber, picture of broken product temperatu

7、re sensor refers to attachment broken point was marked with arrow 損害的局部在FBD墻體外面,損壞的產(chǎn)品溫度探頭圖見附件TW1118464-03 .箭頭標(biāo)注了斷裂點(diǎn).Above all, damage of FBD product temperature sensor caused that the sensor cannot be calibrated.綜上,FBD的產(chǎn)品溫度探頭損壞導(dǎo)致該探頭無法進(jìn)行校準(zhǔn).2nd- Why the FBD product temperature sensor was broken? /為什么

8、FBD 溫度探頭被損壞？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.通過查看損壞的產(chǎn)品溫度探頭,Glatt產(chǎn)品溫度傳感器連桿的斷裂處壁厚約為1毫

9、米,為316L不銹鋼材質(zhì),其后部為接線盒,此接線盒用于安裝溫度變送器,較重.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 t

10、he temperature sensor and caused that the thermocouple melting point of the sensor fell off.可能由于溫度傳感器連桿的不銹鋼厚度較薄,并且其后端的接線盒較重,因此使用中容易造成材質(zhì)的機(jī) 械疲勞,發(fā)生斷裂.連桿斷裂后,接線盒由于重力作用下墜,拉扯溫度探頭,導(dǎo)致溫度探頭熱電偶熔點(diǎn) 掉落.The broken temperature sensor passed the calibration before installed on the FBD, the calibration certificate ref

11、ers 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).已損壞的溫度探頭在安裝到制粒機(jī)前校準(zhǔn)合格,校準(zhǔn)證書見附件TW1118464-05 (TT-00142-PRO).此偏差發(fā)生后,校驗(yàn)小組對(duì)該探頭進(jìn)行了報(bào)廢,詳見附件TW1118464-05 (TT-00142-PRO

12、CCAF-decommission).Similar case occurred in July 2022, 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 thick

13、ness 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 月發(fā)生過類似事件,詳見偏差TW1062179.偏差TW1062179制定了后續(xù)行動(dòng)以關(guān)閉后行動(dòng)TW1069248跟蹤：聯(lián)系供給商,加厚

14、溫度傳感器連桿壁厚至2毫米,同時(shí)后端接線盒接線方式改為直接2米軟線引出.供給商回復(fù)由于改這個(gè)感應(yīng)器的設(shè)計(jì)需要花一定的時(shí)間,所以該行動(dòng)的預(yù)計(jì)完成日期 為.When the discrepancy (TW1118464) occurred on maintenance team just received the new sensor and the calibration was not completed yet.本偏差(TW1118464 )在日發(fā)生時(shí),維護(hù)小組剛收到新的感應(yīng)器,還沒有做校驗(yàn).Cause conclusion/ 原因總結(jié)The thickness of temperature

15、 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 ove

16、r 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 thethermocouplemelting point of the sensor fell off, and the calibration cannot be conducted.Glatt產(chǎn)品溫度傳感器連桿的斷裂處壁厚約為1毫米,316L不銹鋼材質(zhì),其后部為接線盒,此接線盒用于安

17、裝溫度變送器,較重.推測由于溫度傳感器連桿的不銹鋼厚度較薄,并且其后端的接線盒較重, 因此使用中隨著時(shí)間的推移容易造成材質(zhì)的機(jī)械疲勞,發(fā)生斷裂.連桿斷裂后,接線盒由于重力作用下 墜,拉扯溫度探頭,導(dǎo)致溫度探頭熱電偶熔點(diǎn)掉落,無法進(jìn)行校準(zhǔn).Recurring discrepancy assessment/重復(fù)發(fā)生的差異的評(píng)估Timeframe: From in Trackwise go-life in Shanghai site) till( Date Closed )時(shí)間框架：查詢的時(shí)間段從中g(shù)DMS在上海上線的日期)到(關(guān)閉時(shí)間)Assigned site/ 工廠:Shanghai Resp

18、onsible Operational Area/ 操作區(qū)域： production Equipment ID / 設(shè)備編號(hào):SH_SHiP-Granulation systemSearching per field on Rec text with (all these words ) /在每個(gè)可輸入文字的區(qū)域搜索關(guān)鍵詞(所有這些字)：Product Temperature SensorResult: two records were found, TW864400 & TW1062179. TW864400 was related to LOD of Cellcept Cap ou

19、t of acceptance limit. TW1062179 was same as the new discrepancy. So the trend status is recurring.結(jié)果：搜索到 2個(gè)記錄,TW864400 & TW1062179 o TW864400是關(guān)于驍悉膠囊枯燥失重超限.其中 TW1062179和此差異一致,因此趨勢狀態(tài)為“重復(fù).Remediation action has been defined in TW1062179, the record No. wasTW1069248, to contact supplier, strength t

20、he 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中已定義補(bǔ)救舉措：聯(lián)系供給商,加厚溫度傳感器連桿壁厚至2毫米,同時(shí)后端接線盒方式接線改為直接 2米軟線引出.The new product temperature sensor was received as installed on新的產(chǎn)品溫度感應(yīng)器已于安裝上.3. Remediati

21、on Actions / 補(bǔ)救行動(dòng)The calibration team calibrated a new temperature sensor on 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 w

22、ork order.(Done ,校驗(yàn)小組對(duì)新的溫度傳感器進(jìn)行了校驗(yàn).校準(zhǔn)證書見附件TW1118464-05(TT-00145-PRO) o校驗(yàn)合格后,電工更換了新的溫度探頭,工單見附件 TW1118464-01 .(已完成,)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.改良的溫度傳感器連桿壁加厚至至2

23、毫米,同時(shí)后端接線盒接線方式改為直接2米軟線引出.4. Impact Analysis?/ 影響分析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.在發(fā)現(xiàn)FBD產(chǎn)品溫度傳感器

24、連桿處斷裂后及時(shí)檢查,確認(rèn)斷裂處位于FBD鍋體外部且沒有金屬碎屑產(chǎn)生.立即排除了對(duì)產(chǎn)品/工藝的影響.Xeloda Tab SH2105 was the 4th batch of this campaign, the granulation process of batch SH2105 was end at 22:50 on and the alarm occurred at about 23:32 on Review the Xeloda Tab SH2102- SH2105 Granulation Report data, there was no alarm information, a

25、nd no abnormal shown on temperature curve, see details in Attachment TW1118464-04.希羅達(dá)片劑SH2105為這個(gè)連續(xù)批次的第 4個(gè)批號(hào),SH2105批次制粒在晚上 22:50分結(jié)束,該報(bào)警 發(fā)生在晚上23: 32分左右.回憶 Xeloda Tab SH2102-SH2105制粒報(bào)告數(shù)據(jù),沒有該溫度傳感器的報(bào)警信息,產(chǎn)品溫度曲線數(shù)據(jù)沒有異常,詳見附件TW1118464-04 oThe 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 r