Failure mode and effect analysis (FMEA) is a systematic method for identifying potential problems and their impact on a process.
Regarding the failure that has been identified, how severe could the resulting harm be if it is not stopped? Would the harm be:
- Minor – the patient does not need any additional care
- Moderate – the patient needs some additional care
- Major – permanent physical or psychological injury to the patient, the patient needs surgical intervention, or additional care is needed for multiple patients
- Catastrophic – where death or major injury would be expected to occur.
The respective rating, on a scale of 1 to 4, gives the severity, or S.
Next, how likely is it that each failure would occur?
- Remote – sometime in five to 30 years
- Uncommon – sometime in two to five years
- Occasional – several times in one to two years
- Frequent – several times in one year.
This rating, on a scale of 1 to 4, gives the likelihood, or L.
Then, how likely is it that each failure would be detected in time to prevent any harm?
- Very likely – would always be detected
- Likely – would be detected on most occasions
- Unlikely – would be detected on only a few occasions
- Not at all likely – would never be detected.
This rating, on a scale of 1 to 4, gives the detectability, or D.