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Challenges and Insights for Excellent Processes
Dawn Bailey
What are the challenges of incorporating—and maintaining—process excellence in an organization’s culture? The Process Excellence (PEX) Network, a division of the International Quality and Productivity Center, recently released its 12 Days of PEX-MAS with the top challenges and strategies to…
Four Leadership Lessons We Can Learn From Sports
Christine Riordan
I recently watched a high school state track and field championship. At the beginning of the evening, the excitement among the athletes was palpable. Each athlete and team had such determination and grit—but, of course, not all of them were going to win their events or the meet. At the end of the…
Improving Your Brain Health by How You Relate to Others
Michelle LaBrosse
How well your brain works is affected by how you relate to other people. When doing the research for Cheetah’s “Happy Aging Project” program, we synthesized two important bodies of knowledge from leading research on brain health and performance. In his book, Buddha’s Brain (New Harbinger…
Study: FDA 510(k) Approval Process Now Averages Six Months
Michael Causey
If you’ve got six months—and nerves of steel—here’s some good news: You have a 61-percent chance of getting your medical device approved by the Food and Drug Administration (FDA). That’s one nugget of interesting data to be found in a recent Emergo Group report that analyzed some 15,000 device…
Small Data Are Key to Healthcare
Thomas Prewitt Jr.
Big data seem to be all the rage in healthcare, but from the perspective of a frontline clinician, they miss the mark. The clinical enterprise is the realm of small data. That’s because small data are directly related to patient care. Examples of small data include: • Missed clinic appointments…
Finding Hidden WIP
Jim Benson
Limiting work in process (WIP) isn’t easy. Our work is largely invisible, which means it’s hard to notice. It just walks right up, bold and unabashed. It doesn’t have to sneak; we’re simply blind to it. Then, one day, we notice it’s there. During the last three weeks the Modus Cooperandi team…
Ultra-Stable JILA Microscopy Technique Tracks Tiny Objects for Hours
NIST
(NIST: Gaithersburg, MD) -- JILA researchers have designed a microscope instrument so stable that it can accurately measure the 3D movement of individual molecules over many hours—hundreds of times longer than the current limit measured in seconds. The technology was designed to track the…
Five Characteristics of Talented Managers
Chris Groscurth
Globally, companies are scrambling to reengineer their performance management processes. Unfortunately, many of these initiatives have the wrong priorities. Too many leaders rely on convoluted human resources processes and rigid rating systems that are time-consuming and disengaging for managers…
How Major League Baseball Fails to Protect Pitchers
Joel Smith
Last month, the ESPN series Outside the Lines reported on baseball pitchers suffering serious injuries from being struck in the head by line drives, and the efforts that Major League Baseball (MLB) is making toward having protective gear developed for pitchers. You can view the report here if you…
ISO 9001:2015’s Customer Requirements
Mary McAtee
Everyone is gearing up for the challenge of updating their compliance to the requirements of the 2015 version of ISO 9001. Most quality professionals I speak with seem to have digested the new requirements as something very different than past versions. Personally, I don’t see it in quite the same…
More Golf, Statistically
Davis Balestracci
This is a continuation of my last column, which I’ve written to honor my late dad who loved golf. As promised, let’s look at the Masters golf tournament final four-round scores for the 55 players who survived the cut. We’ll analyze and then give it a twist based on the ongoing enumerative vs.…
What Can You Get From a 3D Scanner?
Dan Perreault
To make 3D scanning useful, you really need to understand the types of data files that can be exported or saved from the process. This is particularly important if you’re considering the purchase of a 3D scanner, or are paying for 3D scanning services. If you’re paying for a service, you might…
For Manufacturers, Baldrige Could Be ‘Cure’ for an Uncertain Future, Part 2
Dawn Bailey
In the first part of this series, we looked at how two manufacturers used the Baldrige Criteria to survive the Great Recession and transform their companies. Here we learn more about how the Baldrige can help organizations achieve competitive advantage. Baldrige Award recipient Lockheed Martin…
Turning Audits Into Improvements
Rob Harrison
During a recent interview with Clint Belinsky, vice president of global quality at Jabil, LNS Research discussed revolutionizing quality management and some of the keys to achieving excellence. Streamlined processes, systems, and technology are important, but without the right people and quality-…
Six Benefits of Cloud-Based Quality Management Systems
Brenda Percy
When looking for the best quality management system (QMS) for your business, there are certain traits to take into consideration to ensure you get the most value out of the system in the long run. Here are six of them. 1. Flexibility to make the system your own Flexibility is an important aspect…
For Manufacturers, Baldrige Could Be ‘Cure’ for an Uncertain Future, Part 1
Dawn Bailey
When the recession hit during the early 2000s, Michael Garvey left his fast-paced life trading equities on the floor of the New York Stock Exchange to help save the “family farm,” a bronze foundry in Youngstown, Ohio. Garvey said his parents and many other manufacturers got caught in the “perfect…
FDA’s Shuren Works to Ensure Medical Device Industry Innovators
Michael Causey
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approval of new medical devices by, in part, placing more stress on patient needs when looking at high-risk devices. If…
What Good Is It?
Jack Dunigan
What good is it? Often the mantra of the obsessively practical or the hopelessly cynical, a “what good is it?” response typically indicates disgust, disappointment, or disdain—maybe all three. Obsessively practical leaders seem to become, well, obsessed, with efficiency. Every act, every task,…
Top Three Document Management Tips for Medical Device Companies
Alex Morris, Jon Speer
In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain documentation. We’re talking documentation to demonstrate you have a compliant quality management system, that you design and develop products to meet design controls, and that you’re addressing…
Four Steps to Get Your EQMS Implementation Right From Day One
Rob Harrison
There’s no doubt that the world becomes more interconnected and technology-centered as each day passes. Driverless cars have taken to the road in pilot projects in several countries; modes of communication are instant and global, whether they’re under 140 characters or above; and medical…
How Are Your Processes Really Performing?
Paul Adams
I love my car. Recently, I had to get some major repairs done on it (luckily, they were covered by the warranty). Because it was going to take a while, they provided me with a loaner. This was a really nice car—only 1,200 miles, new-car smell, sunroof, super-quiet, drove like a dream. It made me…
Precisely Wrong
Bruce Hamilton
June 11, 2015, marked the fourth anniversary of the passing of someone who, although not typically credited as a “lean” thinker, nevertheless had a profound effect on many lean implementers. Eliyahu Goldratt, or Eli, was an Israeli physicist whose Ph.D. thesis on queuing theory led him and many…
Work
John Shook
We need to think about redefining work. Until we—anyone who wishes to bring about organizational change—redefine the actual value-creating work of the business, we haven’t made any changes that are meaningful. You may be able to create wealth through a variety of business models or ways of…
Systematic Handling of Organizational Knowledge
Ulrich Wegner
The new ISO 9001, scheduled for publication in late 2015, introduces the term “knowledge.” As knowledge was not addressed by the previous version of ISO 9001, the depth of this topic and the approach to it are new. The international standard ISO/DIS 9001:2015—“Quality management systems—…
Customer Problem Resolution
Matthew Barsalou
I know that the customer should be involved when performing a root cause analysis (RCA) as the result of a complaint. However, in a meeting, the manager of problem resolution and statistical methods told our team that we should view customer-related problem resolution as a “shared journey of…

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