Preliminary Hazard Analysis is 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.
Pros:
•Helps ensure that the system is safe
•Modifications are less expensive and easier to implement in the earlier stages of design
•Decreases design time by reducing the number of surprises
Cons:
•Hazards must be foreseen by the analysts
•The effects of interactions between hazards are not easily recognized
Resource– http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073511.pd