What is FMEA and in what situations is it used?

Purpose

Failure Mode and Effects Analysis (FMEA) is basically a preventive action technique for assessing risks and defining action to eliminate, reduce and contain potential modes of failure.

When designing products and processes it is necessary to take into consideration the possibility of failure and either take action to eliminate the cause or minimise the effects.

FMEA has the following features:

Performed during product/process development stage
Also performed when seeking any subsequent improvement
Identifies what could go wrong
Records the effects of potential failure
Ranks the severity of failure effects and so serves to prioritise action
Records the cause of failure and the frequency of occurrence
Identifies existing controls to prevent or detect the cause and their probability of detecting, containing or eliminating failure
Computes a Risk Priority Number (Severity x Occurrence x Detection)
Records additional actions needed to reduce the risk (e.g. risk can be reduced by increasing probability of detection while decreasing severity and probability of occurrence)
Records responsibility for action
Used to track results of actions taken

Problems in its application

Typical problems that arise in the use of FMEA are

The recommendations are not acted upon
The analysis is performed too late and results in it being a record of the status quo and not an aid to improvement
Often treated as a tick in the box – We’ve done an FMEA rather than we have improved the product/process design
The rankings are subjective and inject bias
The analysis is not performed by the designer and thus does not drive the design
The analysis is not repeated when changes are made
The analysis is not used when actual failures occur to discover why they were not detected
It is only used when required by contract and not as a useful tool for risk reduction

Limitations

FMEA is unsuitable where

the product is human because unlike inanimate objects, humans can exercise choice (i.e. they can choose to do things or react in certain ways)
the service primarily consists of human activity (e.g. education)
the process is exploratory i.e. the objectives, inputs, activities and resources cannot be predetermined (e.g. strategic planning process).

Transition Support

A flexible approach to business improvement