Risk Analysis

There are many tools available for risk analysis and assessment.  The use of risk analysis is becoming more frequent in the pharmaceutical industry as the FDA seeks to enhance current quality assurance programs.  The various approaches to risk analysis are outlined below:

FMEA or Failure Mode Effects Analysis which assumes a failure for a given piece of equipment and assesses the effect of such a failure and proposes a solution.

FTA or Fault Tree Analysis is the opposite approach to FMEA where a safety hazard is assumed and then there is an attempt is made to identify all the potential failures that can create the hazard.

PrHA or Preliminary Hazard Assessment which is similar to FMEA except that systems or processes are evaluated on a “what-if” basis.  Then a hazard level is assigned, with follow-up action to address the hazard.

HAZOP or HAZard and OPerability study usually follows the PrHA and is conducted when the process documentation is 95% complete and a detailed analysis can be conducted over each component of a given system.  The list of action items from the PrHA is checked to see if they were addressed in the final design.

Although there are many approaches - risk analysis efforts seek the same goal - identify the risk, manage the risk, and communicate the risk.  The Pivotal Point Group can conduct multidisciplinary hazard and risk assessments to serve our client’s needs.  To review an example of how a PrHA would be conducted click here.

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