FMEA

In general

Failure Mode and Effects Analysis (FMEA) is used to avoid faults in products or systems and to increase their reliability. It is primarily used in the automotive and automotive supply industry as well as in the aerospace industry. It can also be used in other industries.

How to proceed

As the correction of errors in early stages of development is less costly than in later stages, FMEA should be used as early as possible.

The product is analysed for possible defects by a team from different disciplines such as development, production, quality assurance and others. The probability of occurrence, the severity of the defect and the probability of detection are weighted in categories from 1 to 10 and these values are multiplied together. The result is the so-called risk priority number. In the simplest case, this number is used to prioritise the remedial measures.

As different combinations of probability of occurrence, severity of the error and probability of detection can lead to the same risk priority number, it makes sense to first consider significance and then the product of probability of occurrence and severity of the error for prioritisation.

This method was developed around 1960 by NASA for the Apollo space programme in order to minimise risks for the astronauts.

Originally, a distinction was made between

• Design FMEA
• System FMEA
• Hardware FMEA
• Software FMEA
• Prozess FMEA

In the automotive sector, the first four were summarised as product FMEA.

FMEA in medical technology

FMEA is also a method for analysing risks in medical technology. It is sensibly combined with harm analysis.

For certain product groups at least, it is possible that pure FMEA is no longer recognised.