Abstract

Failure mode and effects analysis (FMEA) is a useful risk analysis tool, but is not sufficient by itself to manage risk. The U.S. Food and Drug Administration has issued guidelines on the use of FMEAs. An effective FMEA consists of three tools: a process map, a cause and effects matrix, and the FMEA proper. This FMEA identifies preventive actions an organization can take to eliminate risks. When failures do occur, a corrective action and preventive action (CAPA) system can be informed by the FMEA to allow the organization to quickly respond to the failure. The CAPA should then inform the FMEA, further improving the overall risk management system. An FMEA which is not integrated with performance measures or lacks definitions for severity, occurrence, or detectability, can perpetuate quality problems.