The Most Common FMEA Mistakes and How to Avoid Them – Part I
Join Carl and Fred as they discuss common FMEA mistakes and how to turn them into quality objectives.
In this episode, they discuss 4 common mistakes and the corresponding quality objectives. In the next podcast, 6 other common mistakes are discussed.
Mistake No. 1: design/process improvements
A review of FMEA applications across industries shows some FMEAs drive ineffective actions or no action at all.
Some design FMEAs drive mostly testing, while some process FMEAs drive mostly controls. FMEA’s failure to drive product or process improvements is a mistake.
FMEA quality objective No. 1: The FMEA drives design improvements (design FMEA) or manufacturing or assembly process improvements (process FMEA) as the primary objective.
Mistake No. 2: design verification or process control plans
Some organizations miss the opportunity to improve their design verification plan (DVP) or process control plan (PCP) based on the failure modes or causes from the FMEA.
The result is inadequate product testing or PCPs. Failure of the FMEA to improve test and control plans is a mistake.
FMEA quality objective No. 2: The DVP considers the failure modes from the design FMEA. The PCP considers the failure modes from the process FMEA.
Mistake No. 3: interfaces
Empirical data show at least 50% of field problems can occur at interfaces between parts and subsystems or between the system and environment.
Similarly, many manufacturing or assembly problems occur at the interface between operations or beyond operations, such as while transporting materials, receiving incoming parts or shipping.
Some practitioners miss these interfaces. Not including interfaces in design or process FMEAs is a mistake.
FMEA quality objective No. 3: The scope of the design FMEA includes interface failure modes in both FMEA block diagram and analysis. The scope of the process FMEA includes inter-operation failure modes, such as transfer devices, and incoming parts and shipping, in both process flow diagram and analysis.
Mistake No. 4: lessons learned
“Those who don’t know history are destined to repeat it.” Edmund Burke
Some organizations do not provide links between FMEAs and field data (in design FMEAs) or manufacturing data (in process FMEAs). It takes concerted effort to integrate problem resolution databases with the FMEA. A lack of integration can cause serious problems to be repeated. Disconnect between the FMEA and information from the field or plant is a mistake.
FMEA quality objective No. 4: The FMEA considers all major lessons learned (from in-service warranties, customer service databases, recall campaigns, prior manufacturing or assembly problems and others) as inputs to failure mode identification.
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Join us as we discuss topics ranging from design for reliability techniques to field data analysis approaches.
Carl’s FMEA website with many articles on FMEA and downloadable FMEA aids: www.effectivefmeas.com
Article: Practice Auditing an Actual FMEA