All Features
Owen Faris, Jeffrey Shuren
At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but also present the greatest risk to patients.
During the past year, we saw…
Ron Rode
The upcoming 2015 Coordinate Metrology Systems Conference (CMSC) will be held “beachside” this year in Hollywood, Florida, from July 20–24. Not only will you be able to swim in the beautiful Atlantic Ocean just steps away from the hotel, you will also be able to “swim” your way through the vast,…
Bruce Hamilton
For a few years—back in the early ‘80s—I fell prey to information automation fascination. I managed an IT department transitioning from a basic accounting system managed by an external service bureau to a batch inventory-control system to an order-processing and manufacturing-control system running…
Denise Robitaille
ISO 9001 continues to wend its way through the revision process, and as it does so there have been lots of discussions and prognostications over the impending changes. All the wringing of hands and ongoing debate will not hurry the process or change the outcome.
The standard is still on track to…
Ultrasonic thickness gauging is a widely used nondestructive test technique for measuring the thickness of a material from one side. It's fast, reliable, and versatile, and unlike a micrometer or a caliper it requires access to only one side of the test piece. The first commercial ultrasonic gauges…
Chip Bell
Disclaimer: I love John Coltrane, Billie Holliday, and Count Basie. Great jazz, to me, ranks right up there with Einstein’s theory of relativity and Newton’s laws of motion in terms of insightful genius. Smooth jazz with a glass of wine and a roaring fire can be the catalyst for a special evening…
Alan Nicol
What relationship do the various functions and personnel in your organization have with your quality group? Is it collaborative, adversarial, or one of total domination? It can be a slippery slope that runs from successful to disastrous. Is your organization climbing or slipping?
Each time we make…
Michael Causey
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according to ancient historians, but it must be remembered…
Patrick Runkel
If you’re not a statistician, looking through statistical output can sometimes make you feel a like you’ve wandered into Alice in Wonderland. Suddenly, you find yourself in a fantastical world where strange and mysterious phantasms appear out of nowhere. For example, consider the T and P in your t…
Arun Hariharan
Recently, I paid for a magazine subscription with a check. A few days later, a person from the magazine’s office phoned me to say that my check had been returned unpaid by my bank. I wondered what the reason could be, as I had enough money in my account.
When I phoned my bank, the bank rep…
Donald J. Wheeler
Whenever the original data pile up against a barrier or a boundary value, the histogram tends to be skewed and non-normal in shape. Last month in part one we found that this doesn’t appreciably affect the performance of process behavior charts for location. This month we look at how skewed data…
Jesse Lyn Stoner
Does your vision sound something like this? “Our vision is to provide aggressive strategic marketing with quality products and services at competitive prices to provide the best value for consumers.”
Bad news. You have a blah, blah, blah vision. Do yourself and everyone on your team a favor: Take…
There was a time when connectivity was oriented to location, with stationary computers communicating with one another across the Internet. With the advent of smart phones, the Internet tied people, not places, together as users accessed the Internet on the move. Now, the next great shift is…
Dirk Dusharme @ Quality Digest
At roughly 7 a.m. every Monday through Friday, I fire up my Lenovo T520 laptop and wait for email, chat, Google Drive, Google Hangout, Skype, remote desktop, an FTP program, two different browsers, and depending where I’m at, my voice over IP applications to load. It may have an Intel 2.5 GHz…
Thomas R. Cutler
This is the last in a series about how lean manufacturing has affected the people and the companywide culture at Hytrol Conveyors, a designer and manufacturer of advanced conveyor systems. As described in part 1 and part 2, dozens of interviews were conducted with a wide range of employees at the…
Barbara A. Cleary
When my mother looked at the prices of new hats, studied their features, and then went home and tried to remodel her old hat with feathers or lace to look like those fancier models, I saw the value of doing things yourself—for my mother, an attitude perhaps shaped by her own parents and their…
Bob Emiliani
Books and their authors can be very influential. They can initiate widespread awareness of a subject and maintain loyal followings long after the publication of their best works. However, when you read books about lean management, or follow influential lean authors, how confident are you that the…
William A. Levinson
Isaac Asimov’s mystery stories often begin with a guest of the Black Widowers being asked, “How do you justify your existence?” On a darker note, George Bernard Shaw said of the concept of eugenics, “If you can’t justify your existence, if you’re not pulling your weight in the social boat, if you’…
Jim Clifton
The United States now ranks not first, not second, not third, but 12th among developed nations in terms of business startup activity. Hungary, Denmark, Finland, New Zealand, Sweden, Israel, and Italy all have higher startup rates than does the United States.
Our single most serious economic…
Dawn Keller
I really can’t make this stuff up.
I wrote a post a couple of years ago titled: “How to Talk to Your Kids About... Quality Improvement,” in which I lamented about Community Hero Day in my daughter’s first-grade class and the need to explain to her why I wasn’t at the “community-hero level” of…
Quality Transformation With David Schwinn
My wife, Carole, and I recently saw And So It Goes, a film with Michael Douglas and Diane Keaton. Michael Douglas’ behavior in the movie reminded me of one of Stephen R. Covey’s classic habits in The 7 Habits of Highly Effective People (Simon & Schuster, anniversary edition 2013). The habit…
Davis Balestracci
I've been presenting at the Institute for Healthcare Improvement (IHI) annual forum for 21 consecutive years. Maybe the biggest surprise from these two decades has been the awesome power of simply "plotting the dots," i.e., plotting important organizational data in their naturally occurring time…
Annette Franz
On the eve (sort of) of the biggest day of the year for the advertising industry (for commercials, anyway... love those Super Bowl commercials), I’d like to share some thoughts about the common disconnect between advertising and the customer experience.
Or, as Robert Stephens, co-founder of Geek…
Taran March @ Quality Digest
Ah, the ubiquitous cell phone. So versatile. So indispensable. So short-lived. We make one billion of them every year because we can’t live without them, yet we cast them aside every 18 months on average. They collect in heaps and shipping containers around the world, their once-coveted designs…
Jack Dunigan
On January 24, 1848, James W. Marshall found gold in Sutter’s Creek next to John Sutter’s Mill in Coloma, California. By 1849, the gold rush was reaching full steam. Some 300,000 gold seekers (called 49ers because of the year in which they travelled) made the journey across the continent or around…