Today, we’ll discuss Process FMEA, risk management of process improvement.
[Intro Video]
Hi, this is Mike Negami, Lean Sigma, Black Belt.
Today, our topic is related to Lean Sigma, which we haven’t talked about in a long
time.
It’s about FMEA, “Failure Modes and Effects Analysis”.
We conduct FMEA after designing a new product, new service or new process in a Kaizen project.
In DMAIC, it’s usually done at an early stage of the Improve Phase.
In order to increase the probability of success, with FMEA, we can identify potential problems
at the design stage and prevent those problems beforehand.
Originally FMEA was developed by the US Army in the 1950s, and it began to be used in the
aerospace industry and manufacturing industry where failures are not allowed.
Now it’s used in many industries because of Lean Sigma.
You can also use it in process improvement projects for service operations.
Try using it in projects which are spending a lot of time and cost or where failures are
not allowed.
Since we have a template for this, it’s not difficult to do.
There are a few kinds of FMEA used in the manufacturing industry, but today we’ll
focus on the ‘Process FMEA’ that can be used to improve service operations.
This is the Process FMEA template and there are the instructions next to it.
The first column is a column for writing the name of each step of the designed process.
In the next column, list potential failures that could occur in each step.
We call it ‘Failure Mode’.
I made a video about human errors in the past.
Since it will be helpful for you to think of workers’ possible failures, please watch
the video by clicking the link above.
Other than human error, write other failure modes related to tools, equipment or environmental
factors.
Next, write all ‘Impacts when it happens’ in the next column.
With this answer, you can quantify the ‘Severity’ of each failure mode.
For normal FMEA, the measurement is 1 to 10, but since this template is a simplified version,
please put a number from 1 to 5.
5 is the most severe.
Next, you’ll write ‘Possible Causes’ that would cause each failure mode.
This is for estimating the ‘Occurrence’ in the next column.
This will also be quantified from 1 to 5.
The highest occurrence is 5.
Next, consider whether there is ‘Current Preventive Measures’, and if so, write the
preventive measures.
By referring to this, you can quantify ‘Detection‘, which is how difficult you can detect each
occurrence from 1 to 5.
The most difficult to detect is 5.
When you entered ‘Severity, Occurrence, Detection’, the value multiplied by the
three will appear in the ‘RPN’ column, which stands for ‘Risk Priority Number’.
The higher the RPN, the higher the priority.
If there are many failure modes, it’s more efficient to deal with those that are higher
priority.
Therefore, after listing all failure modes, sort the whole table by the RPN column in
descending order.
Then, input ‘Recommended Measures and Deadlines’ and ‘Person in Charge’ from the highest
priority failure modes.
Have them report each completion and record ‘Actions Taken and Completed Date’ in
the next columns.
Once you have done up to this point, you have taken many preventive measures, but you only
did P and D of the PDCA Cycle.
In order to ensure all preventive measures are executed, let's also do C, which is the
check step.
After recording the completion reports, reevaluate ‘Severity, Occurrence, Detection’ and
look at the ‘Risk Priority Number’ again.
If further actions are needed, write them in the remark column and conduct them.
As you can see, you can rotate an effective PDCA Cycle on this piece of paper.
I also introduced the template for Risk Management in the past, and this FMEA is similar to it.
The previous one was for risk management of project management and this one is for risk
management of a newly designed process.
Thank you very much for viewing.
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