Six Sigma and Beyond: Design for Six Sigma, Volume VI

Regardless of the type, all FMEAs should be conducted as early as possible. FMEA studies can be carried out at any stage during the development of a product or process. However, the ideal time to start the FMEA is:

• When new systems, designs, processes, or machines are being designed, but before they are finalized

• When systems design, process, or machine modifications are being contemplated

• When new applications are used for the systems, designs, processes, or machines

• When quality concerns become visible

• When safety issues are of concern

Therefore:

• "FMEA-type thinking" is central to reliability and continual improvement in products and manufacturing processes to remain competitive in our global marketplace . It must be understood that an FMEA conducted after production serves as a reactive tool, and the user has not taken full advantage of the FMEA process.

• A typical system FMEA should begin even before the program approval stage. The design FMEA should start right after program approval and continue to be updated through prototypes. A process FMEA should begin just before prototypes and continue through pilot build and sometimes into product launching. As for the MFMEA, it should also start at the same time as the design FMEA. It is imperative for a user of an FMEA to understand that sometimes information is not always available. During these situations, users must do the best they can with what they have, recognizing that the document itself is indeed a living document and will change as more information becomes available.

• History has shown that a majority of product warranty campaigns and automotive recalls could have been prevented by thorough FMEA studies.