All Features
Taha A. Kass-Hout, Jeffrey Shuren
In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but…
Jeff Hajek
In any field, there are a handful of common mistakes. Continuous improvement is no different. Some of these errors come as a result of ignorance about the proper way of doing things. Some are the result of habit. And a handful come as a function of taking the path of least resistance.
Regardless…
Michael Causey
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.
As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use…
Ryan E. Day
'Pssst! Hey kid, ya wanna be a metrologist?"..."Uh, what's a metrologist?"... "Ya get paid to measure stuff."..."Sounds kinda boring." So it goes at colleges and universities all across the United States.
The fields of science, technology, engineering, and mathematics—collectively known as STEM—…
The Un-Comfort Zone With Robert Wilson
Albert Einstein once said, “If I were given one hour to save the planet, I would spend 59 minutes defining the problem and one minute resolving it.”
On September 4 in 1957, amid great fanfare, Ford Motor Co. introduced the Edsel line of automobiles to the American public. It immediately stalled.…
Mike Richman
Anyone, in any business, wants to have a culture of quality, and everyone, in a sense, does. But is that quality good or bad? Even more to the point, especially for top managers trying to inculcate excellence within the organization, how do you know the difference? How have leading quality-centric…
MIT News
In the age of big data, visualization tools are vital. With a single glance at a graphic display, a human can recognize patterns that a computer might fail to find even after hours of analysis.
But what if there are aberrations in the patterns? Or what if there’s just a suggestion of a visual…
Quality Transformation With David Schwinn
Last evening my wife, Carole, and I attended a celebratory dinner for the family of one of my former students. Luca, my student, originally from Italy, brought his wife, Olivia, and his young daughter, Kendra.
Olivia, originally from Uganda, is a family physician working primarily with…
Rick Gehrke
The International Labour Organization estimates that more than 2 million deaths every year can be attributed to work activities. This single statistic clearly indicates the pressing need for occupational health and safety regulations, and the importance of a single standard to help organizations…
Lean Math With Mark Hamel
In the words of my friend and colleague Larry Loucka, “Graphs are math.”
Graphs often serve as effective visual process performance tools. Typically, these types of graphs fall into the metric category. As reflected in the supporting concepts of the fourth dimension of the Shingo Prize model,…
William A. Levinson
Can something as simple as a toilet support LEED (Leadership in Energy and Environmental Design)? We take this basic sanitation device for granted, and while it makes the obvious wastes disappear very cleanly, another form of waste hides in plain view.
LEED already promotes the use of greywater,…
Jim Clifton
The Middle East has collapsed into a state of chaos, conflict, and suffering that was unimaginable and unforeseen just four years ago. Hardly any experts or institutions predicted the wars and revolutions that have engulfed the region, and those same experts who missed the coming catastrophe…
Jennifer Havens
Managing operational efficiency in a manufacturing setting requires detailed knowledge of how each cell works to produce a finished good. All the individual processes must connect to materialize a finished product in the most efficient and cost-effective way, all the while maintaining employee…
Dawn Bailey
In a recent column, I shared insights from the 2013 Baldrige Award recipients’ leaders as they fielded questions related to their journeys to excellence. There was so much thoughtful reflection that it couldn’t fit into just one column.
More answers to questions follow:
How did you convey to…
The use of optical 3D shape measurement devices are rapidly gaining importance, allowing the reconstruction of real 3D objects efficiently. The 3D shape and texture can be obtained from stereo images acquired with a freely moving camera. This approach measures the image displacement from the…
Cathy Hayat
Finance professional Joe Fabiani never imagined his love of exotic cars would develop into a full-time career. It began when he searched for an improved exhaust for his Porsche 993 but was at a loss to find one that conformed to the specifications he had in mind. Frustration with OEM stock…
Ron Rode
“So what’s the weather gonna do today?” I am sure that we have all been asked that after answering the first question (about what we do for a living) with: “Metrology.”
Metrology or meteorology? Both are studies of a particular science but are two words that are easily mistaken or misinterpreted…
NASA
Thanks to NASA’s Kepler and Spitzer Space Telescopes, scientists have made the most precise measurement ever of the radius of a planet outside our solar system. The size of the exoplanet, dubbed Kepler-93b, is now known to an uncertainty of just 74 miles (119 km) on either side of the planetary…
Bruce Hamilton
While I am an unabashed proponent of learning by doing, I have a list of books that have been essential to me over the years as a framework for experiential learning.
Most of these books were written before 1990, and one of the most insightful, Managerial Engineering (Productivity Press, 1983) by…
Jesse Lyn Stoner
Today begins my last week as executive director of the Berrett-Koehler Foundation. This is the second time I’ve done this with an organization—served as executive director during the startup phase—and I’ve learned many lessons along the way.
My involvement began two years ago when Steve Piersanti…
Mike Figliuolo
Repeat after me: “No.”
Try it again. This time with conviction: “NO.”
Strategy is inherently about saying no. It’s about the choices we make, and the ones we don’t make. I’ve seen plenty of strategies completely derailed due to an inability to say no to that incremental initiative that’s kind of…
Harry Hertz
‘It must be remembered that there is nothing more difficult to plan, more doubtful of success, nor more dangerous to manage, than the creation of a new system.” This quote is not taken from the words of a modern-day CEO, although he or she might have said it, but from Niccolò Machiavelli in the…
Akhilesh Gulati
Editor’s note: This article continues the series exploring structured innovation using the TRIZ methodology, a problem solving, analysis, and forecasting tool derived from studying patterns of invention found in global patent data.
The TRIZ executive council group had taken a break during summer…
Davis Balestracci
In my last column, I showed the power of process-oriented thinking with a safety scenario. A simple run chart demonstrated that, despite meeting an aggressive 25-percent reduction goal (i.e., 45 accidents during the first year, and 32 the following year), the process that produced the 32 was no…
Michelle LaBrosse
Are you feeling stuck in your job? Although an all-out career change may be a good choice for some, you don’t need to make such a drastic move to breathe new life into your current position.
Developing skills in project management, even if you’re not a project manager, empowers you to make the…
