MEDICAL DEVICE RISK MANAGEMENT – ISO 14971 WORKSHOP
KAIZEN CASE: Medtronic
At Medtronic’s Jacksonville, Florida, plant, you won’t find performance ratings on a spreadsheet—
they are posted throughout the plant for all to see. This simple and surprisingly open visual
approach to information flow has been extremely successful both financially and in building an
engaged workforce. Here Emmanuel Dujarric, senior director of Medtronic Surgical Technologies,
explains how kaizen values are lived at Medtronic:
Our plant in Jacksonville, Florida, employs approximately 500 in the manufacture of
medical devices. Our approach to kaizen, which we introduced in 2003, is to keep things very
simple and very visible so [that] everybody can understand them. We have replaced most
electronic information with visual information, to the point where our plant could now run without
computers. Our approach has been, “Don’t give me a big spreadsheet. We’ll just say that if it’s
bad, it’s red; if it’s in trouble, it’s yellow; and if it’s okay, it’s green. I don’t need to know anything
else.” We manage at all levels by those three colors, and instead of entering the information into
a system, we post everything on the walls. If it’s green, we don’t talk about it. The reds and
yellows—the abnormalities—are what we’re concerned with. So our walls are covered with entries
of how we go about solving each problem. That’s what managers of any operating area need to
pay attention to. If an order wasn’t delivered, or there is a quality issue or a staffing issue, or we
are not meeting our safety target, we make all these visible. So when visitors come and see all the
problems on the walls, they say, “How come you have so many problems?” We answer that we
are problem fixers and problem preventers, and the wall shows us what we need to do. The other
option would be to put everything on a spreadsheet that nobody looks at.
Every six months, we align our targets according to the direction of the corporation and
post them. We do this for every function, including the HR and finance departments, and the
process that guides the direction of the company. My personal performance goals are posted as
well. Of course, the finance people are pretty happy with our results, or we wouldn’t still be doing
this. We’ve also made our work order process completely visual by moving several manufacturing
lines into the distribution center. There, we have shelves full of finished goods. When an order is
shipped to a customer, this creates a visual signal, and since the line is close by, people
immediately know what they need to build. There is nobody sitting at a desk analyzing demand
and creating work orders—that function no longer exists. The other side of this is that we challenge
all of our employees to take part in kaizen on a regular basis. There’s no bureaucracy around this,
and kaizen are conducted without any management oversight. Any employee has the ability
and the authority to stop working and make an improvement on the floor whenever they feel
they have to do it. Then, every Friday, we get all the employees in the room, and they have the
opportunity to present what improvement they have done in the last week.
We get about 500 kaizens every quarter. We don’t rely on classroom training for kaizens.
People learn by doing, and if somebody needs help, they can grab a couple of other people
who know how to use the tools. Of course, people make mistakes, but we encourage them to
learn from that and move on. Some of our people are becoming excellent running kaizens and
are climbing the ranks of our company. We have also eliminated titles when we are doing kaizens
it doesn’t matter if you are an employee in the line or a director. And when we look back on
results, it’s been proven over and over again that the biggest breakthroughs we have had at
Jacksonville came from line employees. People who work in manufacturing know about waste,
and they know what improvements can do.
As managers, we have to remain humble. In fact, we consider it our job—our only job—to
serve the workers on the line. This is an excellent illustration of how Medtronic has found a recipe
for success in aligning people with the goals of the organization, making it safe and easy to
expose problems, giving people support, connecting processes and removing barriers between
people, giving people opportunities and the needed respect to make the improvements
necessary to meet the challenges, and allowing people to attain a sense of satisfaction and
engagement.
Source: R.E. McDermott, R.J. Mikulak and M.R. Beauregard. The Basics of FMEA, 2nd Edition, 2009.
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