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Quality and Risk Management in the IVF Laboratory
Table 7.1 The generic steps involved in performing a Failure Modes and Effects Analysis (FMEA) Procedural step
Explanation
Examine and map the process Identify Failure Modes Determine the Effects Identify Contributory Factors
Identify all the Functions that are expected to occur. Identify any ways in which any of the Functions might go wrong. Establish the consequences of each Failure Mode. Identify the underlying causes for each Failure Mode (one or more RCAs might be required for this). Estimate, using standardized rating schemes (see Tables 7.2 and 7.3), the frequency or likelihood of occurrence of each Failure Mode or Contributory Factor, and rank each Effect in terms of the possible severity of its consequences. These values are calculated by multiplying the likelihood and severity ranks together. Analyze the process map, identify any monitoring or detection systems, mitigation systems, etc, and assess their impact on the assigned Criticality scores. Identify courses of action and establish how these actions will be assessed for impact upon the process.
Rate the likelihood and severity of each Failure Mode
Calculate the Criticality of each Failure Mode (i.e. each risk) Identify any existing Controls
Prepare an Action Plan
Table 7.2 Suggested list of likelihood ratings for FMEA Failure Modes (“risks�). The real range that might be encountered is 1 to 9 because anything rated as impossible is not a real risk, and therefore irrelevant to the FMEA, and anything rated as 10 should never be encountered in a real-world situation Likelihood
Rating
Comments
0 1 2 4 6 8 10
Impossible Very unlikely Unlikely Possible Likely Very likely Certain
Can never happen, hence it is not a real risk.
This circumstance should never exist in a real world situation.