Failure Modes and Effects Analysis

Failure Modes and Effects Analysis (FMEA) is a tool for conducting a systematic, proactive analysis of a process in which harm may occur. In an FMEA, a team representing all areas of the process under review convenes to predict and record where, how, and to what extent the system might fail. Then, team members with appropriate expertise work together to devise improvements to prevent those failures — especially failures that are likely to occur or would cause severe harm to patients or staff.

The FMEA tool prompts teams to review, evaluate, and record the following:

  • Steps in the process
  • Failure modes (What could go wrong?)
  • Failure causes (Why would the failure happen?)
  • Failure effects (What would be the consequences of each failure?)

Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process.


QI Essentials Toolkit by the Institute for Healthcare Improvement.