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1. To
ensure that all OOS/OOT/OOAL/OOAC of laboratory have been investigated and
handled timely.


確保所有OOS/OOT/OOAL/OOAC已經(jīng)過調(diào)查并得到及時處理。


2. Maintenance
Deviation handling system. Coordinate risk assessment for deviation and
review corrective actions for deviation. Ensure close deviation in time.


維護(hù)偏差處理系統(tǒng)。協(xié)調(diào)偏差風(fēng)險評估，審查偏差糾正措施。確保及時關(guān)閉偏差。


3. Maintenance
CAPA system. Follow up CAPA status. Ensure close CAPA in time.


維護(hù)CAPA系統(tǒng)，跟蹤C(jī)APA狀態(tài)。確保及時關(guān)閉CAPA.


4. To review
the change controls related to the quality control.


審核關(guān)于QC的變更。


5.
Control
Documents and records, ensure effective version for QC and MICRO.


正確及時有效地執(zhí)行對文件的管理以保證和理化和微生物實驗室使用正確的文件和記錄。


6.
Issue QMS number and documents, maintain the logbooks,
and finish the trend of non-conforming events every year.


發(fā)放QMS文件編號和文件，維護(hù)臺賬，每年進(jìn)行不符合事件的趨勢回顧分析。


1.Review laboratory documentation
such as test records, audit trail, electronic data, analytical methods, specifications, SOPs and Non-conformity
investigation reports to ensure compliance.


對實驗室文件，如測試記錄，審計追蹤，電子數(shù)據(jù)，分析方法，質(zhì)量標(biāo)準(zhǔn)，SOP，不符合項調(diào)查報告等進(jìn)行審核，確保文件的合規(guī)性。


2. Follow up all instrument calibration plan,
maintenance plan, water sampling plan, environmental monitoring plan, gas
detection plan, dressing qualification verification plan, clock calibration
plan, stability sampling plan, etc., to ensure that the activities are
completed as planned and on time.


跟蹤所有儀器校驗計劃、維保計劃、水的取樣計劃、環(huán)境監(jiān)控計劃、氣體檢測計劃、更衣資質(zhì)確認(rèn)計劃、時鐘校準(zhǔn)計劃、穩(wěn)定性取樣計劃等，確保活動按計劃按時完成。