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e d p u m p run n i n g d ryT e m p e ratu re h i g h … …… …V101 P101 L101 進(jìn)料 feed 故障模型和失效影響分析 FMEA 工藝參數(shù) 變量 原因 影響 Introduction of Safety Review ? page 13 ? March, 2022 頂事件是最終的影響 Top event is the final EFFECT P=Pev1xPev2 + Pev2xPev3xPev4 + Pev5 頂事件 Top event Ev Ev 2 Ev 1 Ev 5 Ev 4 Ev 3 Ev 2 Ev Ev and and or Ev or 故障樹分析 Fault Tree Analysis Introduction of Safety Review ? page 14 ? March, 2022 PROBABILITY OF THE EVENT HIGH MEDIUM LOW SEVERITY OF THE EVENT RISK CLASSIFICATION=PROBABILITYx SEVERITY PROBABILTY OF THE EVENT LOW MEDIUM HIGH SEVERITY HIGH Medium Risk High Risk High Risk MEDIUM Low Risk Medium Risk High Risk LOW Low Risk Low Risk Medium Risk 在考慮“有多少控制措施”的基礎(chǔ)上,可能性可以憑經(jīng)驗(yàn)估計(jì)。所以建議僅使用該方法用于評估非常復(fù)雜和危險(xiǎn)的工藝。風(fēng)險(xiǎn)分析方法 Risk analysis approach 拜耳醫(yī)藥保健有限公司北京工廠 BHC Product Supply Beijing Site 2022年 3月 March, 2022 Introduction of Safety Review ? page 2 ? March, 2022 概念 范圍 Concept Scope 風(fēng)險(xiǎn)分析是為了找出 The scope of the risk analysis is to find out 1) 任何種類的活動(非活動)可能的錯誤。 It is suggested to start from the easiest (usually FMEA) then, if needed, use the most precise (Fault T