27. Failure Mode & Effect Analysis
Failure Mode & Effect Analysis (FMEA) is applied when potential failure mode needs to be identified and prevented throughout operation processes, the appropriate timing for FMEA implementation is during New Product/Design Introduction phase or existing product’s modification/improvement phase.
FMEA can be applied (but not limited) to the following perspectives
Design
Process
System
Software
FMEA’s benefits can be listed below:
By identifying potential improvement for design/process in development phase
Ensure more robust and consistent process is implemented for design/production, this is to prevent rushed corrective actions and changes within process.
Reduce potential opportunity of failure occurred within operation or product function, while minimize potential safety risks for product users.
In general, FMEA format can be break down to the following section.
Each failure mode will have respective process steps and corresponding elements (whether it’s parameter or other factors), and each of them could have failure mode and effects to be analyzed. The severity will be one of the critical factors to calculate the failure mode’s risk priority number (RPN) along with the occurrence based on the existing prevention method and respective detection technique.
RPN is calculated as below:
RPN = Severity (S) x Occurrence (O) x Detection (D)
Each factors ranges from 1 to 10, and always prioritize the failure mode with HIGHER SEVERITY score when 2 failure mode’s RPN is the same.
Once identified the current limitation for the failure mode, opportunities can be found for potential improvement to minimize the risk priority number by improving detection method or preventive actions (reduce occurrence).