Summary of FMEA/HFMEA Process


In conducting a health care FMEA (HFMEA®) the basic steps are:

  • Identify the process to be examined.
  • Assign FMEA team members, team leader and team facilitator.
  • Explain the methodology to the team.
  • Develop either a flowchart or detailed process flow (outline format) of the process under analysis. All steps in the process should be included.
  • Designate which of the steps in the process constitute “Functions.”
  • Determine which Functions represent potential “Failure Modes” or points of potential failure. Determine the worst potential adverse consequence or “Effect” of each of the Failure Modes.
  • Determine the “Contributory Factors” for each Failure Mode. One or more Root Cause Analyses may be necessary to complete this step. Note that we advocate the use of the term “Contributory Factor” rather than “Cause.”
  • Identify any “Controls” in the process. Controls are components of the process which (a) reduce the likelihood of a Contributory Factor or a Failure Mode, (b) reduce the severity of an Effect, or (c) detect the occurrence of a Failure Mode or Contributory Factor before it leads to the adverse outcome (Effect).
  • Rate the Severity of each Effect (usually on a scale of 1–10, with 10 being the most severe). The impact of Controls that ameliorate the severity of an Effect are reflected in this rating as well.
  • Rate the Occurrence (likelihood) of each Contributory Factor (usually on a scale of 1–10, with 10 being the most frequent, or “certain to occur”). The impact of Controls that reduce the likelihood of occurrence of a Failure Mode or Contributory Factor are reflected in this rating as well.
  • Rate the effectiveness of each “Detection Control” (usually on a scale of 1–10, with 10 being the lack of a Detection Control, or the presence of a wholly ineffective one, and 1 being a 100% flawless detection system).
  • Multiply the three ratings by one another for each Contributory Factor and the corresponding Effect and Detection Controls. The range of these products will be from 1 to 1,000. The resultant number is the Risk Priority number (RPN) for that Contributory Factor.
  • Rank-order the Contributory Factors according to the Risk Priority Numbers.
  • Use a Pareto Chart with the traditional 80% rule to determine which contributory Factors should be addressed first.
  • Add to the above listing ALL Contributory Factors which result in an Effect with Severity of 10, irrelevant of RPN.
  • Develop a plan addressing how the selected Contributory Factors will be addressed, by whom, when, how the improvement will be assessed, etc.
  • Continue the improvement process.

HFMEA is a registered trademark of CCD Health Systems.


Tell us what you think