Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 6 ICH Q9 QUALITY RISK MANAGEMENT I.6: Hazard Operability Analysis (HAZOP) DeviationCausesConsequencesSafeguardsRecommend High temperature in blender Steam heating control malfunction Feed material #1 reaches decomposition temperature Violent reaction with toxic gas generation Personnel exposure/ injury Equipment damage Diverse high temp.
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