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Annex I.6

Annex I.6. Hazard Operability Analysis (HAZOP). I.6: Hazard Operability Analysis (HAZOP). ( IEC 61882 ) A theory that assumes that risk events are caused by deviations from the design or operating intentions Identify potential deviations from normal use

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Annex I.6

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  1. Annex I.6 Hazard Operability Analysis (HAZOP)

  2. I.6: Hazard Operability Analysis (HAZOP) (IEC 61882) • A theory that assumes that risk events are caused by deviations from the design or operating intentions • Identify potential deviations from normal use How to perform?A systematic brainstorming technique for identifying hazards using so-called “guide-words” applied to relevant parameters: • No, More, Other Than, None ICH Q9

  3. I.6: Hazard Operability Analysis (HAZOP) Concept • Focus team discussions by applying “deviations” to specific nodes • Deviations are generated by applying Guidewords to process parameters • Examine the process by discussing causes of each deviation • Identify consequences • Evaluate risk and safeguards • Make recommendations, if necessary • Include all parts of the process Source: Hazard and Operability Studies in Solid Dosage Manufacture. Nail L. Maxson. (2004).

  4. I.6: Hazard Operability Analysis (HAZOP) Potential Areas of Use(s) • Manufacturing processes • Equipment and facilities • Evaluating process safety hazards • Primarily as starter of a HACCP • Operator error (“use error”) ICH Q9

  5. I.6: Hazard Operability Analysis (HAZOP) Nail L. Maxson. (2004).

  6. EXAMPLE I.6: Hazard Operability Analysis (HAZOP) Nail L. Maxson. (2004).

  7. I.6: Hazard Operability Analysis (HAZOP) Experiences • Ease of applicability of the model? • Simplifies decision making • Allows uniformity of analysis across sites • Process steps guided (“guide words”, if available) • Limitations of the model • Applies to specific situations only • May need to use other models for quantifying risk • Not a structured approach • Not designed for quantifiable risk assessment • Complex output

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