“Everything that can fail, shall fail”
This is known as Murphy’s Law and is one of the main reasons behind the FMEA technique.

Consequently, during the design of a system or product, the designer must always think in terms of:

  • What could go wrong with the system or process?
  • How badly might it go wrong?
  • What needs to be done to prevent failures?

Definition of FMEA

FMEA is a methodology for identifying potential risks early in the design and development and/or manufacture of the product, where actions can still be taken to reduce or prevent those from happening.

History of FMEA

This type of thinking has been around for a while, but was first formalised in a procedure in 1949.

  • 1949 – The first FMEA procedure was developed and documented by the US Military to determine the effect of system and equipment failures in the military.
  • 1960’s – NASA adopted the process and used it first time on Apollo.
  • 1970’s – Ford introduces FMEA to the automotive industry.
  • Today – FMEA methodology is extensively used in a variety of industries including semiconductor processing, food service, plastics, software, healthcare etc.

Timing of the FMEA

One of the most important factors for the successful implementation of an FMEA program is timeliness. It is meant to be a “before-the-event” action, not an “after-the-fact” exercise.
Actions from an FMEA can reduce or eliminate the chance of implementing a change that would create an even larger concern.

When is FMEA used?

  • When a process or product is being designed or redesigned
  • When an existing process or product is being applied in a new way.
  • Before developing control plans for a new or modified process.
  • When analysing failures of an existing process or product.

Two Common Types of FMEA’s

  • DFMEA – is the Design FMEA which identifies failures in the specification of the design. It start early in the development process, and before any tooling is initiated. It will uncover problems that will result in potential failures within the new product or any design changes.
  • PFMEA – is the Process FMEA which identifies potential failures in the manufacturing process. It starts as soon as basic manufacturing methods have been discussed and should be completed prior to finalising production plans and releasing for production.

If you are interested in Continuous Improvement and implementing preventive rather than reactive approach in your organisation, then our FMEA Training might be interesting for you, as it is one of the quality tools that focus on preventive maintenance.

Alternatively you can continue to our quality training page for an overview of the training we provide.

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FMEA Rule of ten

FMEA Example