; Quality-Criteria
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									FMEA Quality Criteria FMEA Steps STEP 1: Define the HFMEA Topic STEP 2: Assemble the Team STEP 3: Graphically Describe the Process Criteria Did they define the scope? Including the limits? Did they develop the flow diagram (this is a process vs. chronological diagram)? including all sub processes under each block of this flow diagram? Did the team include people with appropriate knowledge of the topic? Did they walk down the healthcare process being analyzed? Did they develop the flow diagram (this is a process vs. chronological diagram). Yes/No Quality (1=highest,

Did they verify the flow diagram Was a set of criteria developed/used for assessment of likelihood, outcome, and risk for each failure mode?

Did they list all possible/potential failure modes and assess the risk of each? Did they include consideration of institutional STEP 4: Conduct a Hazard failure/incident experience? healthcare industry data? other data sources? Analysis Did they explicitly address process safeguards? the impact of safeguards on risk? Did they rank the failures by risk significance?

Did they identify measures to reduce risk?

STEP 5: Actions and

Did they identify a description of each risk reduction measure? identify the reduction in risk? STEP 5: Actions and Outcome Measures Did they determine if they wanted to “eliminate,” “control,” or “accept” the failure mode cause? Did they identify a Description of Action for each failure mode that will be eliminated or controlled? Did they identify outcome measures that will be used to analyze and test the redesigned process? Did they identify a single, responsible individual by title to complete the recommended action?


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* Yes No

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