What is Failure Mode and Effects Analysis (FMEA)?
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 weapons and
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 existing in our healthcare community today. In an
FDA Guidance entitled, "Guidance for Industry: Premarketing Risk Assessment,"
FMEA is cited as one technique that can be helpful in assessing and preventing
To minimize the risk of error and to provide recommendations and error-reduction
strategies for specific aspects of a product, Med-ERRS has developed our