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Meeting the Requirements of ISO 9001:2015
Timothy Lozier
The ISO 9001:2015 standard may still be in draft form, not quite set to replace the existing standard until the end of 2015, but it’s important to keep apprised of these changes and what they will mean for you when complying with the new standard. So what changes lie ahead? In this article we’ll…
Why Doctors Should Help Their Local Hospitals Improve
Thomas Prewitt Jr.
As we begin the journey to value-based healthcare, the relationships between a hospital and its medical staff are changing. For decades, these relationships were straightforward: Doctors admitted patients to the hospital, performed procedures and delivered therapies, and at some point, sent the…
Measuring Risk Management Outcomes
Rod Farrar
In his book Decision Making: Risk Management, Systems Thinking, and Situation Awareness (Argos Press, 2003), Alan McLucas introduces the concept of the risk management paradox. “If risks are being effectively managed as a matter of routine, there will be very few surprises,” he writes. “Nobody…
Six Ways to Maintain Quality Chinese Manufacturers
John Niggl
What are the best ways for a foreign company to monitor quality at a contract Chinese manufacturer? What groundwork should you lay before working with a Chinese supplier? It should come as no surprise that China remains a major manufacturing hub for buyers abroad. As of 2013, Chinese suppliers…
FDA Gives the MDDS World a Big Break
Michael Causey
Sometimes it’s nice to be told what the U.S. Food and Drug Administration (FDA) isn’t going to do. The agency issued a guidance last month that should make anyone building or working with a medical device data system (MDDS) happy and relieved. Can you hear the collective sigh? FDA defines MDDS as…
The Roots of Success
Arun Hariharan
When I was a child, my grandfather used to take me to a garden. On one such visit, I saw the gardener watering and tending the plants and trees. I noticed that he took care to water them at the roots. Out of childish curiosity, I asked him, “Why do you water only the roots? Why don’t you water the…
Training and Qualification: Work Smarter, Not Harder
Mary McAtee
One of those pronouncements that are widely accepted despite a murky link to facts or origin concerns proficiency. “They” say it takes repeating a task 1,000 times before you become an expert. I guess I can understand why they might take this position. Clearly, repetition fixes memory. But I’m…
The Customer Experience Proof Is in the (Diet) Pudding
Annette Franz
I have a few questions for you about your company: Are you focusing on acquisition or retention? Are you rebranding your image or are you reinventing the customer experience? What are your priorities? I recently wrote some articles about how companies have this misguided focus on anything but the…
Meetings: Decide What Matters and Who Cares
Paul Axtell
There is a difference in life between acting out of obligation or inspiration. Inspiration is shaped by having some possibility in mind—seeing the connection between how you are spending your time and a desirable future that doesn’t exist right now. There’s a story about golf pro Byron Nelson,…
Are You Unknowingly Reacting to the Data Process?
Davis Balestracci
In my last column, I discussed how even a well-designed study with a statistically significant result doesn’t necessarily mean viability in the real world. Post-study, one must study the manifestations of variation on the result in any environment in which the result is applied—and each…
Understanding Design of Experiments
Matt Treglia
Design of experiments (DOE) is an approach used in numerous industries for conducting experiments to develop new products and processes faster, and to improve existing products and processes. When applied correctly, it can decrease time to market, decrease development and production costs, and…
Do You Enable Your Team’s Poor Performance?
Mike Figliuolo
If you’re frustrated with your team members not delivering high-quality work, you might be the root cause of the problem. It’s time to stop being an enabler of their bad behaviors. Alan leads a team of highly intelligent scientists. Although most of their time is spent on scientific work, a…
New NIST Tools to Help Boost Wireless Channel Frequencies and Capacity
NIST
Smartphones and tablets are everywhere, which is great for communications but a growing burden on wireless channels. Forecasted huge increases in mobile data traffic call for exponentially more channel capacity. Boosting bandwidth and capacity could speed downloads, improve service quality, and…
Creating a New Metric With Gauge R&R, Part 2
Eston Martz
In part one of this column, I showed you how to set up data collection for a gauge R&R analysis using the Assistant in Minitab 17. In this case, the goal of the gauge R&R study is to test whether a new tool provides an effective metric for assessing resident supervision in a medical…
How Do You Make People Think?
Scott Berkun
The worst, and most common, way to try to make people think is to use force. When people ask the question, “How can I make people think?” they usually mean, “How can I get other people to think the way I do?” They don’t precisely want more people to think well, since free thinking is unpredictable…
Process Performance Indices for Non-Normal Distributions
William A. Levinson
‘I’m shoveling two feet of your partly cloudy off my sidewalk” is an old joke about what happens when meteorologists get the forecast wrong, and there is a similar running joke among quality practitioners. “Your centered Six Sigma process is delivering 580 defects per million opportunities!” That’…
A Mommy’s Look at Scoliosis
Dawn Keller
Juvenile idiopathic scoliosis. That was the diagnosis given to my then 8-year-old daughter last January. In short, it means that she’s young (under 10), she exhibits an abnormal amount of spinal curvature, and there’s no identified cause (aside from some bad luck). Emilia’s X-rays indicated an S-…
National Network for Manufacturing Innovation: It’s Working
Good ideas—for new products, new processes, or new services—are terrible things to waste. Yet time and time again, inventions and discoveries that first sprouted in the United States have taken root in the factories and economies of other nations. Think of computer-controlled machine tools, solar…
Deming’s 14 Points and Their Influence on ISO/FDIS 9001, Part 1
Peter Theobald
In 1982 the late, great W. Edwards Deming condensed more than 50 years of innovation and experience into a book designed to be a wake-up call for U.S. industry. That book was called Out of the Crisis (MIT reprint, 2000). At that point in his career Deming’s legacy as a mathematical physicist,…
How Moral Values Boost Innovation
Paul Sloane
In 1959 Nils Bohlin, an engineer at the Swedish car manufacturer Volvo, invented the first three-point safety belt. It was far more effective than the standard lap belt, like the ones still used on airplanes. Volvo, realizing the importance of this invention, chose not to patent it but rather…
Playing to Win
Matthew E. May
My friend Roger Martin (No. 3 on Thinkers50 ranking in 2013) penned a terrific article in The European Business Review on how Tennis Canada, the national governing body for the sport within that country, rose from recent oblivion to now boasting two young players ranked well inside the top 10 on…
There’s No Such Thing as HIPAA Certification
As more physicians are integrating their patient electronic medical records (EMRs) with third-party patient portals, they’re looking for clarifications on many issues to stay within the various regulations boundaries and to be meaningful use-attested. It can be difficult to differentiate fact from…
Imaginary Customers
Bob Emiliani
Most professors and many administrators have great difficulty accepting the idea of students as customers. Some put great effort into finding ways to describe students as anything but customers, preferring such terms as “partners,” “empowered learners,” “producers,” and so on. The resistance to…
How Mobility Has Revolutionized Technology
Emily Ysaguirre
With the evolution of technology, experts have been able to transform and develop equipment into ways that no one ever thought possible. For example, most people no longer use paper maps as a guide for travel, or phone calls as a means of communication. These have been replaced with portable…
Lean Coffee Through the Deming Lens
Jim Benson
This is a geeking out on the intersection of W. Edwards Deming and our Lean Coffee format. It is brief and assumes some prior knowledge of the System of Profound Knowledge and Deming’s 14 Points for Management. If you don’t know these yet, please go to the sources. Deming’s writings have had a…

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