Failure Mode and Effects Analysis

FMEA is a risk assessment method based on the simultaneous analysis of failure modes, their consequences, and their associated risk factors. Since the 1960s, FMEA has been used most extensively in areas characterized by high risk, such as nuclear power plant operations, or by high cost, such as the aerospace industry.

In the pharmaceutical and healthcare industry, FMEA can be used to identify areas of potential failure when products are introduced into the complicated medication use system. In the US Food and Drug Administration (FDA) guidance entitled, “Guidance for Industry: Premarketing Risk Assessment,” FMEA is cited as one technique that can be helpful in assessing and preventing medication errors.