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Risk Mitigation: Preliminary Hazard Analysis (PHA) Guide

Utilize PHA to identify potential hazards, evaluate risks, and recommend remedial measures in product design and development. This guide outlines steps, tools, and assessment methods for hazard analysis based on past experiences to enhance safety and quality.

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Risk Mitigation: Preliminary Hazard Analysis (PHA) Guide

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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

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