Authors: Khalid S. Mekki
Addresses: Baxter Healthcare Corporation, Corporate Reliability Department, Baxter International, Inc., 302 Hunters Way, Hainesville, IL 60030, USA
Abstract: Mode and Effects Analysis (FMEA) is a methodology that has been used in most industries for many years. Typically, the Design FMEAs are developed early in the product development cycle, in conjunction with the product risk analysis, product architecture and product requirements. Robust Design FMEA, the subject of this paper, is an enhancement to the currently in use Design FMEA by anticipating safety and reliability failure modes through the use of a Parameter Diagram (P-Diagram). The Design FMEAs have gone through a metamorphosis of sorts in the last decade, as a focus on severity and occurrence has replaced Risk Priority Number- (RPN-) driven activities. In large part this is due to the measurement of risk outcomes, resulting from associated RPNs being misinterpreted. As so many practitioners of the Design FMEA believe that the RPN is the most important outcome. However, the Design FMEA methodology must consider taking actions as soon as it is practical.
Keywords: robust design; failure mode and effects analysis; FMEA; design for six sigma; DFSS; six sigma; risk priority number; RPN; parameter diagram; P-diagram; risk analysis; system architecture; product requirements; safety characteristics; reliability characteristics; design controls; failure classification; product development.
International Journal of Product Development, 2006 Vol.3 No.3/4, pp.292 - 304
Published online: 01 Jun 2006 *Full-text access for editors Access for subscribers Purchase this article Comment on this article