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

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Annex I.7

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Annex i 7

Annex I.7

Preliminary Hazard Analysis (PHA)


I 7 preliminary hazard analysis pha

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


I 7 preliminary hazard analysis pha1

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


I 7 preliminary hazard analysis pha2

EXAMPLE

I.7: Preliminary Hazard Analysis (PHA)


I 7 preliminary hazard analysis pha3

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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