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professional:hqic:fmea:steps [2013-04-22 04:20]
doctor
professional:hqic:fmea:steps [2020-07-27 09:53] (目前版本)
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 +====== 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 (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.
  
 +參考資料: [[https://ccdsystems.com/summary-hfmea-process/|CCD Health System]]