Forget Lean and Six Sigma – Go FMEA

Process improvement consulting and business management advice tends to fall into two categories: lean and Six Sigma. Lean engineering concepts seek to do more with less. You optimize and simplify, so you can create more product with fewer people or without having to add more equipment. Six Sigma seeks to make your process nearly perfect. There are applications like healthcare and IT security where you want nearly 100 percent perfection, but that’s rare. And you may not be able to charge more for that nearly perfect process. But instead of debating between Six Sigma and Lean, let’s look at the engineering tool you may not have heard of but desperately need – FMEA. 

What Is FMEA? 

FMEA stands for Failure Mode and Effects Analysis. It is one of the most commonly used process analysis tools. You outline all the different ways or “modes” that something could fail. These can range from obvious, known causes to unlikely or unusual methods. 

How Is FMEA Used? 

FMEA lets you determine every possible way a process could fail. This can lead you to the sources of variation or defects in your process so that you can resolve them. You can also assign probabilities to each failure mode or incident rate. Now you can determine the defects per million opportunity rate and target the failures or quality defects that account for most of your quality problems per Pareto’s rule. You could target the 20 percent of root causes that are responsible for 80 percent of the defects or cause the most expensive defects to correct. 

FMEA can be used in risk management. Identify the ways the product could fail. Assign an estimated probability of that happening, if you don’t have hard data on the failure rate. Assign an estimated cost associated with each failure. Multiply the two values across the board, and you can identify those failures that need to be prevented because of the high cumulative cost to the organization. It gives you a way to prioritize failure modes to be prevented through design changes or built-in fail safes. You retain the ability to decide that certain failures are unacceptable, such as a pacemaker accidentally shocking a patient or a car’s brakes not working. 

FMEA can be the basis for product improvements. Simulate product field failures and determine ways you can prevent it or reduce the damage it causes. 

FMEA expertise is necessary to meet supplier competency requirements under IATF 16949. 

Where Can You Get FMEA Training? FMEA is covered in engineering programs along with other troubleshooting methods like the 5 Whys. FMEA may be covered in Six Sigma and other quality management programs as one tool out of many you can use to find root causes to be addressed. Yet you can take FMEA specific training from a few organizations, such as this website here. By taking only the FMEA course, you learn what you need to know to solve design and process problems in one of the most effective ways. And you don’t waste time learning about how to sell the continuous process improvement ideology to stakeholders or studying the benefits of a clean, organized workplace.