The authors describe their adaptation of failure mode and effects analysis, a prospective risk assessment tool originally developed in the manufacturing industry, to processes in health care. Their system, Health Care Failure Mode Effects Analysis (HFMEA), is documented in detail, including a complete illustrated example. The system includes tools to prospectively identify process risks in an organization, analyze the ways in which the process can fail, prioritize those failure modes, and take corrective action before failures have occurred. The authors describe the initial deployment of HFMEA in the Veterans Administration health care facilities.