FMEAs: Helping You Practice Safe Lean Six Sigma
Dr. Richard J. Titus, Ph.D., Principal and Adjunct Faculty, Titus Consulting and Lehigh University, Bethlehem, PA, USA
Keywords: FMEA, Quality Functional Deployment, Advanced Product Quality Planning
The origin of Failure Mode and Effects Analysis (FMEAs) dates back to the 1960’s with NASA applying this qualitative tool to the Apollo program. The Navy and the auto industry followed utilizing FMEAs in the 1970s with the focus on minimizing design and process failures. Today, many industries require the creation of both Design (DFMEAs) and Process (PFMEAs) Failure Mode and Effects Analysis including automotive, medical and aerospace. This powerful qualitative tool can help organizations practice safe Lean Six Sigma by assessing risk through a deliberate, focused, in-depth analysis of product design and process.
Automotive’s Advanced Product Quality Planning (APQP and the related Quality Functional Deployment (QFD) utilizes the DFMEA to link design parameters to key product characteristics. The PFMEA then links these key product characteristics to process parameters bridging the gap between design and process execution. When used properly, FMEAs help companies execute new and improved designs or processes minimizing common implementation pitfalls, delays or problems. A number of FMEA implementations and results will be examined highlighting proper use and benefits. FMEA’s can also respond to customer quality issues, showing how the process or design has been changed improving performance. Ideally FMEAs should be linked to the Control and Reaction Plan acting as key components in a living and breathing quality system. When an unanticipated quality issue occurs, the Control and Reaction Plan and FMEAs should be examined and, if necessary, revised to include this failure mode.
While FMEAs can add value and help manage and assess risk, there is the dark side of “pencil” whipped FMEAs. These ill created Failure Mode and Effects results in unnecessary and unplanned quality, process and design issues giving FMEAs a bad name
While FMEA’s don’t get the headlines of DOE’s, ANOVA’s, Regression and Process Capability and other “cool” Lean Six Sigma tools they help build a solid foundation for designs and processes.