Risk Management Process and ISO 14971

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HAZARD ANALYSIS OBJECTIVES

The purpose for conducting a Hazard Analysis on medical devices can be summed up by several distinct processes.

The recognition and evaluation of known potential hazards and there effects on the patient, user and others
The identification of actions that could eliminate the potential failures or reduce their chances of occurring
And, the documentation of the recognition, evaluation and corrective activities so that the product quality continuously improves over time.

Over time, products do end up changing. These changes are the results of improvements or to correct a deficiency – in all instances the manufacturer is responsible to evaluate the change as part of the product’s hazard evaluation. Why? Consider this scenario the product undergoes a manufacturing or development change and you do not analyze the risk of the change. Now, let’s say something goes wrong in the field that results in injury or death. The ramifications of not having done an appropriate Hazard Analysis will now put your company at greater risk for law suits and possible Agency action. Not to mention some person may have been injured or even worst killed as a result of your companies neglect to conduct an appropriate evaluation.

WHO SHOULD PARTICIPATE IN A HAZARD EVALUATION?

The ultimate make-up of the hazard evaluation team will be different depending on your particular device. The recommendation is to have at least the following experts participate:

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