偏差處理案例分析-文庫吧資料
2025-04-22 23:01本頁面
【正文】 room is within acceptance criteria during clearance according to printout of BMS system.根據(jù)BMS系統(tǒng)打印記錄，在清場期間制粒間的溫濕度和壓差均在可接受標(biāo)準(zhǔn)內(nèi)。維護(hù)行動按照維護(hù)計(jì)劃進(jìn)行。Oute: No.結(jié)果：不是可能原因。Oute: YES結(jié)果：是可能的原因。The last step of WIP process is drying. So, drinking water in space between the upper seal and FBD bowl rim was evaporated, but residue of CIP100 was on upper seal and FBD bowl rim.WIP程序的最后一步為干燥。When the alarms occurred, WIP process was during drinking water washing/rinse after CIP100 washing. There might be some CIP100 residue in drinking water in the space between the upper seal and FBD bowl rim.報(bào)警發(fā)生時(shí)，WIP程序處于CIP100清洗后的飲用水清洗/淋洗步驟中。供應(yīng)商對1383報(bào)警原理的解釋見附件01。Alarm 1383 will occur when the seal pressure of FBD lower seal is min. Confirmed by supplier, this alarm will cause upper seal and lower seal deflate together. Pls. see attachment01 for Explanation for the principle of alarm 1383 provided by the supplier. Moreover, Simulation run and supporting test was performed after the discrepancy occurred: When intentionally stopping the pressed air supply to lower seal, Alarm 1383 occurred, and the upper seal was found deflated at the same time. When intentionally stopping the pressed air supply to upper seal, Alarm 1393 occurred, and the lower seal was also found deflated at the same time.1383報(bào)警為FBD碗形腔體的下密封圈的壓力最小值時(shí)發(fā)生的報(bào)警。重新充氣。該報(bào)警是由于壓縮空氣管道漏氣導(dǎo)致的。During stopping period of machine, alarm 1383 “Product container sealleak” occurred and caused the upper seal of FBD deflated. At that time, drinking water might enter the gap between upper seal and FBD bowl rim. The alarm was caused by leakage of pressed air duct. The duct was replaced and alarm was removed after about 16min and the upper seal inflated. Some drinking water might residue in the space between the upper seal and FBD bowl rim.在設(shè)備停止期間，1383報(bào)警“Product container sealleak”發(fā)生并導(dǎo)致FBD上上密封圈泄氣，這里是否只寫FBD密封圈泄氣更合適??？密封圈放氣。在“警的發(fā)暫?！辈襟E前，7步飲用水清洗/淋洗（4步VG，3步FBD）已完成，剩余3步飲用水清洗/淋洗（21步VG，12步FBD）還未進(jìn)行。在暫停”步驟，對Glatt的清洗暫停，飲用水儲罐正在補(bǔ)水。 Measure/測量方面l Possible cause 1: alarms during WIP可能原因1：WIP期間的報(bào)警Checking printout of WIP process, it was found that at 10:16 , alarm 54521”Tank loop water flowactual valuemin” occurred in “WIP STOP” step. In “WIP STOP” step, washing for Glatt paused and water replenishing of drinking water tank was inprocess. It caused the alarm 54521 that the value of water flow for replenishing drinking water was too low. Before “WIP STOP” step, 7 steps for drinking water washing/rinse (4 steps for VG and 3 steps for FBD) had pleted and 3 steps for drinking water washing/rinse (1 step for VG and 2 steps for FBD) 中英文不一致，確認(rèn)一下！was not performed. And, steps for drinking water washing/rinse were after CIP100 washing.查看WIP程序的打印報(bào)告， 上午10：16，54521報(bào)警”Tank loop water flowactual valuemin”發(fā)生在“生在“暫?！辈襟E。l Possible cause 2: Qualification for sampling staff 可能原因2：取樣員工的資質(zhì)Sampling person is trained and qualified, and have taken CV samples for almost 3 years.取樣員工受過培訓(xùn)過，是有資質(zhì)的，且已進(jìn)行近3年的清潔驗(yàn)證取樣。他們均有手工清潔的資質(zhì)認(rèn)證證書。Oute: No.結(jié)果：不是可能原因。Oute: No.結(jié)果：不是可能原因。l Possible cause 7: Purified water可能原因7：純水The quality monitoring parameters (ozone and conductivity) are all within acceptance criteria during clearance according to printout of SHiP PUW system. And, no abnormal tren
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