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The FMEA Process

The objective of a FMEA is to look for any and all ways a product or process can fail. It starts with the assumption that something can and will go wrong, so let's fix it before it does. Even the simplest products can fail, or the user can make a mistake.

Failure modes are ways in which a process or product can fail. Each failure mode has a potential effect, and some are more likely to occur than others. Each potential effect has an associated relative risk. The FMEA process is a way to identify the failures, effects, and risks, and then reduce or eliminate them.

Three factors determine the relative risk of a failure and its effects. First is severity of the consequence of failure, should it occur. Second is the probability or frequency of the failure occurring, or occurrence. Third is detection, or the probability of the failure being detected before a negative impact is realized.

  Related Links

  - FDA
  - FDA MedWatch
  - FDA (AERS)
  - USP
  - Health Canada
  - EMEA
  - NCC MERP