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Failure Modes and Effects Analysis (FMEA) Tool

A systematic, proactive method for evaluating a process or product to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change.


  • FMEA tool instructions, example, and template

Note: Spanish and Portuguese translations of this tool also available for download.

Failure Modes and Effects Analysis (FMEA) includes review of 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.

*NOTE: Before filling out the templates, first save the PDF files to your computer. Then open and use that version of the tool. Otherwise, your changes will not be saved.

FMEA Tool Overview

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