The FMEA (Failure Mode and Effect Analysis) could be the most abused tool in Lean Six Sigma.
I am using four kinds of FMEA: Concept FMEA, Design FMEA, Process FMEA and Test FMEA in both the Lean Six Sigma and the DFSS projects. Each FMEA has a hierarchy from the system level to the detailed level. So many FMEAs exist in a single project. The reason why the FMEA is so abused is that it could prevent or mitigate a potential risk before happening. And that’s why the percentage of risk management in the Lean Six Sigma is pretty high.
Although the FMEA is a great tool, there are some issues in the effective utilization of the FMEA. The most obvious issues could be “No Follow-up”. Team members create FMEA to identify the potential risks and the possible action items to prevent (or mitigate) the risks. But they satisfy with the FMEA form which they created. They neither update the FMEA nor follow the action items after the creation of FMEA.
The FMEA creation is very expensive. If ten people spend a half day (four hours) to create a FMEA, the FMEA could cost $4,000 (i.e., $100 person/hour x 10 people x 4 hours). If they don’t use the FMEA for the risk management, what’s the point of FMEA? The FMEA with “No Follow-up” is a typical failure mode in FMEA.
To prevent the “No Follow-up” FMEA, I create a summary table with the action items which are identified in the FMEA.
The action items identified in the hierarchically created FMEAs in the different forms (i.e., Concept, Design, Process and Test FMEA) are duplicated in many cases, and can be summarized by removing the duplication. Then the number of action items in the summary table become the manageable size.
The action items in the summary table have another benefit. If an action in the summary table is made, it effects on many FMEA items. The project management uses the summary table and updates the status of each action items in regular basis in the process of PDCA (Plan, Do, Check, Adjust). If an action could not prevent (or mitigate) a risk, then the risk could be escalated and managed in the risk register.
