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Attach I.7

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  1. Annex I.7 Preliminary Hazard Analysis (PHA)

  2. I.7: Preliminary Hazard Analysis (PHA) (ISO14971) • Analysis based on applying prior experience or knowledge of a hazard or failure to identify future hazards, hazardous situations and events that can cause harm • In estimating their probability of occurrence for a given activity, facility, product or system How to perform? • Identification of the possibilities that the risk event happens • Qualitative evaluation of the extent of possibleinjury or damage to health that could result • Identification of possible remedial measures ICH Q9

  3. EXAMPLE I.7: Preliminary Hazard Analysis (PHA) The steps • Risk Matrix Form • List known potential hazards • Literature • Previous projects • Reportable events • Complaints • Severity rankings • Frequency codes and estimates risk codes • Once established should remain same for similar product classes

  4. EXAMPLE I.7: Preliminary Hazard Analysis (PHA)

  5. I.7: Preliminary Hazard Analysis (PHA) Potential Areas of Use(s) • Analyzing existing systems • Prioritizing hazards • Evaluate the types of hazards for the general product type, then the product class and finally the specific product • Early in the development: little information on design details or operating procedures will often be a precursor to further studies • For product, process and facility design • Further assessed with other risk management tools ICH Q9