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Annex I.6

HAZOP is a systematic brainstorming technique used to identify hazards by applying guide words to process parameters. This concept focuses on deviations, causes, consequences, and risk evaluation. It is valuable in manufacturing, process safety, HACCP, and identifying operator errors. This approach simplifies decision-making, promotes uniformity, but may require additional risk quantification models.

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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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