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  • cef3 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 8 years, 5 months ago

    Two other methods are:
    Hazard Operability Analysis (HAZOP) – Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide words. Guide words (e.g., No, More, Other Than, Part of) are applied to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions. HAZOP often uses a team of people with expertise covering the design of the process or product and its application.
    Preliminary Hazard Analysis (PHA) – a tool of analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that might cause harm, as well as to estimate their probability of occurrence for a given activity, facility, product, or system. The tool consists of: (1) the identification of the possibilities that the risk event happens, (2) the qualitative evaluation of the extent of possible injury or damage to health that could result, (3) a relative ranking of the hazard using a combination of severity and likelihood of occurrence, and (4) the identification of possible remedial measures

    See: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073511.pdf