Design and Process FMEA

Similar principles and steps are followed for both design and process FMEAs.

Design-FMEAs

The primary objective of a Design-FMEA is to uncover potential failures associated with the product that could cause:

 Product malfunctions.
 Shortened product life.
 Safety hazards while using the product.

Design-FMEAs should be used throughout the design process—from preliminary design until the product goes into production.

Process-FMEAs

Process-FMEAs uncover potential failures that can:

 Impact product quality.
 Reduce process reliability.
 Cause customer dissatisfaction.
 Create safety or environmental hazards.

Ideally, Process-FMEAs should be conducted prior to start-up of a new process, but they can be conducted on existing processes as well.

However, since a FMEA is intended to be a preventive action it should be completed before the product design is released for production or the production process starts. If a problem is detected after the product is released for production and production is started it becomes a corrective action and not preventive. effective problem solving along with a FMEA may be required.

The first problem needing to be solved is why wasn't the FMEA completed before and/or why didn't the FMEA process identify the potential problem.