Failure mode and effects analysis (FMEA) (ie, prospective risk analysis) involves close examination of high-risk processes to identify needed improvements that will reduce the chance of unintended adverse events. This risk assessment process is used in other industries (ie, manufacturing, aviation) to evaluate system safety. Health care organizations now are using it to evaluate and improve the safety of patient care activities. The FMEA process promotes systematic thinking about the safety of patient care processes (ie, what could go wrong, what needs to be done to prevent failures.) The steps of the FMEA process are described and applied to a high-risk perioperative process.