Failure Mode and Effects Analysis [FMEA]

A Failure Modes and Effects Analysis (FMEA) can be used to anticipate potential problems that may result from the change in the process and to take counter-measures to reduce or eliminate the risks.

For each potential failure mode, the FMEA provides a Risk Priority Number (RPN) which is the product of the likeliness of the three factors:

• severity of the failure mode (a high severity is given a high number)
• occurrence of the potential causes of the failure mode (a high likeliness of occurrence is given a high number)
• detection of the potential causes (a low likeliness of detection is given a high number)