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Why ISO 13485:2003 Is Important
ISO
With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices,…
Escape From Eden
The Un-Comfort Zone With Robert Wilson
Last weekend, as I was clearing clutter, I found a copy of H. G. Wells’ The Time Machine. As I thumbed through it, I recalled that Wells, in his future world, describes man’s descendants as evolving into two distinct species: the Eloi and the Morlock. The Eloi live in an Eden-like setting where…
The Short-Term and Long-Term Confusion
John Flaig
Sometimes when authors try to make a technical concept more understandable, it’s simplified but unfortunately, less accurate. For example, when the developers of Six Sigma wanted to explain control charts and process capability analysis, they needed to include how the signal can be separated from…
The One Quality Every Leader Needs to Succeed
Lolly Daskal
If you are going to be a leader or hold a leadership position, there’s one quality you absolutely require to be successful. You need to be a seeker. A seeker is someone who is always searching. Seekers bypass mediocrity and are not content to settle for the status quo. They search for excellence…
Weighing My Career As a Metrologist
Carol Hockert
As happened with most every metrologist I know, I fell into metrology (the science of measurement) quite by accident. My degree was in chemical engineering, and I was probing the world around me to see what kind of work was out there for someone with my skills and interests. I learned of an…
Why Does It Take So Long to Produce New Car Colors?
Tim Mouw
Detroit recently hosted The North American International Auto Show. It’s an exciting event for consumers who want a sneak peek at what’s on the horizon in the automotive industry: energy efficiency, new gadgets, enhanced comfort, and of course, the latest paint colors and special-effect finishes…
Quality Manuals Need Not Apply
Stephen Mundwiller
One of the more enjoyable discussions I’ve seen on the Internet recently has to be about what to do with the quality manual. A common question is, “So what do I call this thing I put all the procedures in, now that we can’t have a quality manual?” It’s part of the panic brewing among quality…
Volume and Value in Healthcare Models
Katherine Watts
Bundled payments. Volume-to-value. Cost accounting. Process improvement. Patient engagement. Population health. Organizational leadership. These are more than just the newest industry buzzwords: They’re the trends that will compel the healthcare industry to transform its business model. They will…
Data in Everyday Life: Gas Prices
Beth Savage
Out-of-control gas prices reported in the news have our attention. Nearly every media outlet, from the small-town daily news to The Wall Street Journal, has a gas price story on a weekly basis: “Gas Prices Are Plunging,” and “How Low Will Gas Prices Go?” It’s news when they rise and news when they…
Are You Losing Opportunities for Improvement?
Arun Hariharan
The other day, I visited a retail outlet of a wireless services provider to get information about its international roaming packages. The company has a few thousand outlets nationwide; they’re called “relationship centers” staffed with half a dozen employees who try to up-sell products and…
Objective Auditing Meets ISO 9001:2015
Inderjit Arora
Objective auditing has always been a challenge, and this is especially true now for ISO 9001:2015 audits. To better meet customer expectations, fundamental changes have been introduced to the standard to address current business realities and advancements in technology. Much of the responsibility…
Mind the Gap
Greg Fox
Mind the gap. It’s is an important concept to bear in mind when traveling on the Tube in London, the T in Boston, the Metro in Washington, D.C., and other subways. But how many of us remember to mind the gap when we create an interval plot in Minitab Statistical Software? Not too many of us, I’d…
Setting Up a Productive Workspace
Michelle LaBrosse
Your project teams seem to have all the right pieces—team members with technical proficiency, good internal communication, an organized project manager—but something still isn’t quite right. Your team still struggles to get projects done on time and isn’t as productive as it could be. What’s going…
Connecting the Big Dots to the Little Dots—Without Math
Davis Balestracci
This article is based on some ideas from my respected colleague Mark Hamel. Despite the lean framework, these ideas apply to any improvement approach—all of which come from the same theory, lean included. During the past 35 years, quality has evolved from the necessary evil of quality control to…
Consulting and Learning Are Mutually Inclusive
Jim Benson
When you are a consultant, or worse yet, seen as a thought leader, people hire you expecting that you’ll know “the answers.” At best, what you actually know are paths to make sense of problems, communicate them, and then solve them. No consultant should ever arrive knowing the answers. If they do…
Better Accuracy Out of Thin (or Thick) Air
NIST
NIST scientists have devised and improved a prototype instrument the size of a loaf of bread that can substantially increase the accuracy of length measurements in commerce. Perhaps surprisingly, it does so by achieving the most accurate measure of the refractive index of air reported to date. An…
Pinpointing the User Experience
Knowledge at Wharton
Today, design has a seat at the table. With the success of products like the iPod and the iPhone, businesses have realized that a good user experience is key for improving the bottom line. Yet even with this determined focus on design, most digital experiences fall short of user expectations. Of…
Why Strategy Isn’t Dead
Elisabet Lagerstedt
A few years back, a searing pain in my elbow sent me to the doctor, who diagnosed me with olecranon bursitis. Apparently, all that time spent leaning forward on hard desks in different meeting rooms during my team’s frequent marathon strategic planning sessions was putting too much stress on my…
Call and Response
Bill Kalmar
Isn’t caller ID wonderful?! Every day we get calls that are listed as “unavailable,” “out of area,” “name not found,” “anonymous,” and “toll-free caller.” Most of the calls are scams and generally we don’t answer. But on occasion, when I want to have some fun, I relent and pick up the phone.…
Bump and Grind
Bruce Hamilton
Here’s a personal reflection from my distant past that might describe a current state for some of you. When I began working in manufacturing during the pre-lean era, the quoted lead time for my company’s products averaged 12 to 16 weeks. By the 1980s, however, many customers began to routinely…
Warning Signs That Your Supplier Is a Problem
Manufacturing Extension Partnership MEP
Whether it’s for performance management or for risk, it’s important to know who your suppliers are and have a close business relationship with them. It’s a given you should already have a strong relationship with your key suppliers, but how often does your supplier request the following items? •…
A Stake in Innovation
Peter Dizikes
Want to encourage innovation? A new study co-authored by an MIT professor finds that little-known state laws called “constituency statutes” have significant effects on the quantity and quality of innovative business actions. The statutes, which allow companies to prioritize the interests of “…
‘Ingaged’ Leadership: A New Path to Organizational Success
Evan Hackel
I had a call from one of my clients, a franchise brand. I can’t mention the company’s name here, but you know them. They have branded walk-in locations in hundreds of cities and towns across America—probably near where you live. The call explained that the company had a very specific problem it…
Corrective Action Means Opportunity
Paula Oddy
Sponsored Content As an auditor of quality management systems, I can tell you from firsthand experience that most auditees dislike corrective actions. Corrections are tied to findings of nonconformance; understandably, people generally want to emerge from an audit without any significant findings…
How B2B Companies Become Customer Experience Leaders
Annette Franz
When I go to customer experience conferences, B2B companies are underrepresented, both in attendees and speakers. When clients look for benchmark data, B2B reports are few and far between. These are just two examples of why I want to revisit a question I posed in a post I wrote two years ago: If…

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