Failure mode and effects analysis (FMEA) is one method hospitals can use to comply with the requirement by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) that they conduct at least one proactive risk assessment of a high-risk process each year. While it is not the only means of satisfying the requirement, FMEA is an established and widely used procedure and is the model suggested by JCAHO. FMEA is not, however, a simple procedure. To help our readers better understand the challenges involved, ECRI conducted its own FMEA as an exercise. The high-risk process we analyzed was setting up and programming infusion pumps for intravenous delivery of medications. In this article, we describe each step we carried out, the principles underlying our decision making along the way, and the lessons we learned. After reviewing our account, the reader should understand what an FMEA is and what it should accomplish, know how to choose and define a process for analysis, and grasp the key elements of a successful FMEA from start to finish.