Failure Modes and Effects Analysis (FMEA) is a systematic, proactive method for evaluating a process 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 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.

Failure Modes and Effects Analysis (FMEA) was developed outside of health care and is now being used in health care to assess risk of failure and harm in processes and to identify the most important areas for process improvements. FMEA has been used by hundreds of hospitals in a variety of Institute for Healthcare Improvement programs, including Idealized Design of Medication Systems (IDMS), Patient Safety Collaboratives, and Patient Safety Summits.

Download the tool for complete instructions. The tool contains:

• Background
• General Instructions
• FMEA Matrix

NOTE: There is also an interactive FMEA Tool available on IHI.org.

Related Measures
Risk Priority Number (from FMEA)

Related Changes
Improve Core Processes for Ordering Medications
Improve Core Processes for Dispensing Medications
Improve Core Processes for Administering Medications