Failure Mode and Effect Analysis (FMEA)

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Failure Mode and Effect Analysis (FMEA)


While Root Cause analyses are usually involved in the investigation of sentinel and near miss events, failure mode and effect analyses are used before an event occurs. FMEA is a systematic method of identifying and preventing process problems before they occur. FMEAs are focused on preventing defects, enhancing safety, and increasing customer satisfaction.


Failure Mode and Effect Analysis (FMEA)
Description and Definition:

While Root Cause analyses are usually involved in the investigation of sentinel and near miss events, failure mode and effect analyses are used before an event occurs. FMEA is a systematic method of identifying and preventing process problems before they occur. FMEA sare focused on preventing defects, enhancing safety, and increasing customer satisfaction.

Ways in which a process can fail are called failure modes. Each failure mode has a potential effect, and some effects are more likely to occur than others. In addition, each potential effect has a relative risk associated with it. The FMEA process is a way to identify the failures, effects, and risks within a process and then eliminate or reduce them.

The relative risk of a failure and its effects is determined by three factors (See Tables, 1, 2, 3):

  • Severity – the consequence of the failure should it occur.
  • Occurrence –the probability or frequency of the failure occurring.
  • Detection – the probability of the failure being detected before the impact of the effect is realized.

Procedure: A failure mode and effect analysis includes the following steps.

  1. Select a high-risk process.
  2. Define the process/procedure as designed and actual implementation of the process/procedure by completion of a flowchart.
  3. Identify discrepancies between designed and actual processes. For each process step in the flowchart determine:
    Failure Mode: What can go wrong with this step? (All possible failure modes.)
    Cause of Failure: Why would this failure mode occur? (Reason for variation.)
    Effects of Failure: What could happen if this failure mode occurred? (Effect inpatient.)
  4. Assess the Risk Priority Number (RPN) for each failure mode
    Using data and knowledge of the process, each potential failure mode and effect is rated in each of these three factors on a scale ranging from 1 to 10, low to high. By multiplying the rating for the three factors (severity x occurrence x detection), a risk priority number or RPN is determined for each potential failure mode and effect.
    Occurrence (Occ):
    What is the likelihood that this failure would occur?
    (0 = never, 10 = could easily happen)
    Severity (SV):
    If this failure occurred, how severe is the effect?
    (0 = no harm, 10 = possible death)
    Delectability (DT):
    If this failure occurs, how likely is it that it would go through undetected?
    (0 = certain detection, 10 = it would never be noticed)
  5. Identify why variation occurred leading to the effect (root cause analysis).
  6. Redesign the process to minimize the failure mode (Solutions for Improvement).
  7. Test and implement redesigned processes.
  8. Measure effectiveness of the process change and implement strategies to maintain overtime i.e. if effective the Risk Priority Number should be reduced.

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