The Basic Steps of Conducting a Healthcare FMEA
- 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. A 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 © 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.
參考資料: CCD Health System