All Features
Grant Ramaley
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the illusory hope that the Medical Device Single Audit Program (MDSAP) will remedy this.
There just aren…
Paul Leavoy
You’re a corporate quality director at a multisite enterprise with operations spread across the country or around the globe. At some point, you’re going to face the question: How do I keep my local quality leaders engaged, and on the same page?
It’s a question we’d be excused for thinking is only…
Mika Javanainen
It is human nature—people aiming for a goal typically look for the path of least resistance. And when staffing cutbacks and slashed budgets redefine “normal” modes of operation, it is only natural that employees are looking more fervently for efficiencies and ways to circumvent any process that…
Joel Smith
A couple of years ago, I wrote a blog post titled "What I Learned From Treating Childbirth as Failure" that conveniently ended up getting published the day before my daughter was born. You should read it first, but to summarize, it demonstrates how we can predict the odds of an event happening…
Lynda Chervil
Just as intended, the 44th annual celebration of Earth Day will prompt talk about our environment, our impact on it, and what we can do to better live in harmony with it. More of us are realizing that, if we all do what we can every day, collectively we will make a tremendous difference.
People…
Dan Nelson
The process approach is a concept crucial to proper quality management. This concept is not new. In fact, it’s how ISO 9001 was designed to work from the very beginning.
A process approach allows businesses to realize the full benefit of a management system by viewing and managing real processes…
Annette Franz
Do you really know who your customers are? Do you take a 30,000-foot view or a more granular, zoomed-in view in understanding and describing them?
I did several workshops this week on personas and journey mapping. The two are intimately intermingled, and that’s an important point to remember.
But…
John Millican
What could go wrong? As an information security manager, I am often asked that question. But, there are two ways it is asked.
The first is my preferred way. It is a genuine effort to identify and evaluate the risk associated with the item at hand. That is a conversation I want to have. That is a…
Mark Schmit
This is a story about U.S. manufacturing, honoring heroes past and present, and teaching children in ways that textbooks and rote regurgitation cannot. This is a story about why I am optimistic about the future.
This is also a story about Kylan. He’s 8. Before I tell his story, though, I need to…
Nick O’Donohoe
Wayward and capricious, the wind has long been used as a metaphor for constant change. Wind turbine engineers deal with that changeability every day, along with a host of other challenging factors.
Turbines must operate in desert sandstorms and corrosive saltwater. The ambient temperature at the…
Dan Nelson
When we think of plan-do-check-act (PDCA), W. Edwards Deming might spring to mind… and Walter Shewhart, maybe Kaoru Ishikawa as well. But the thinking that results from PDCA today can most always be traced to Shewhart’s 1939 book, Statistical Method From the Viewpoint of Quality Control; these…
NIST
JILA researchers have engineered a short, flexible, reusable probe for the atomic force microscope (AFM) that enables state-of-the-art precision and stability in picoscale force measurements. Shorter, softer, and more agile than standard and recently enhanced AFM probes, the JILA tips will benefit…
Davis Balestracci
Critical thinking does not necessarily result from using a practitioner’s toolbox framed within a formal improvement structure such as Six Sigma, lean, lean Six Sigma, or the Toyota Production System. It’s very easy to get seduced by all the fancy tools, acronyms, and Japanese terminology—and…
Scott Berkun
Status quo is a powerful beast. No matter the organization, once people are in powerful roles they tend to want to change as little as possible out of fear of losing that power. Despite all of their rhetoric about progress and change, most bosses are hard to convince to try new things.
It’s human…
Kevin Meyer
I’ll preface this article by saying that yes, I’m from crazy California. I eat granola with fruits and nuts in the morning, am vegetarian (well, pescatarian), dislike wearing shoes, and practice yoga. At least I don’t have dreadlocks—yet. So there—now you’re warned.
I’m currently winging my way…
William A. Levinson
In their article “Deconstructing Inherently Safe Technology,” authors Glenn Hess and Jeff Johnson warn of the risks that result from high inventories of hazardous chemicals, and cite four approaches to inherently safer technology (IST): 1. Minimize inventories of hazardous chemicals 2. Replace…
Mike Micklewright
Years ago, there was a memorable TV commercial of a toaster waffle that had this very memorable tag line: “Leggo my Eggo.” Today, this product still exists, as does the tag line, but the tag line is much more obscure than it once was.
Today, CEOs and top executives everywhere are quaking in their…
Chet Marchwinski
Companies don’t last for 100-plus years unless they do a lot of things right. But Ingersoll Rand, the 143-year-old home of such iconic brands as Club Car, Thermo King, and Trane, thought it could do even better when it launched a lean transformation about four years ago. As part of that effort, it…
Patti Arms
When you consider rising energy costs, the uncertain nature of foreign fuel sources (regardless of the country in which you operate), and the environmental impact associated with many fuels, then any system that helps you wisely manage your energy consumption and improve your energy performance…
Quality Transformation With David Schwinn
My wife, Carole, and I decided to get out of town to get warm during my recent spring break. While at our destination, Carole decided to look on the Internet for a restaurant that was new to us, had a great view, and a great reputation for food and service. Carole, always value conscious, also…
Grant Ramaley
Electrically powered medical equipment will soon be subject to the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.
As of July 22, 2014, most powered equipment sold within the European Union (EU) must not contain more than the allowed quantities for each homogeneous material…
Dave K. Banerjea
Story update 4/24/2014: We bumped up the cost of accreditation based on comments that the original article was on the low side. We also added references to ILAC as well as additional accreditation bodies that operate in the United States (ACLASS, NVLAP, L.A.B.)
Getting calibration accreditation is…
Bruce Hamilton
An old TV series I watched recently reminded me of an experience I’ve had many times in my work. In this I Love Lucy episode, Lucy is ordered by Ricky to create a schedule to make her “more efficient.” A schedule board, posted in their home, is a “best practice,” but without the best intent. The…
Christine Schaefer
On April 6, 2014, U.S. Secretary of Commerce Penny Pritzker presented two U.S. organizations with the Malcolm Baldrige National Quality Award, the nation’s highest honor for organizational innovation and performance excellence.
The 2013 award recipients are: • Pewaukee School District in Pewaukee…
Dawn Bailey
Why should an organization integrate lean methodology with the Baldrige Criteria for Performance Excellence? And how should it go about doing that?
When I asked Pattie Skriba, vice president of Business Excellence at Advocate Good Samaritan Hospital, a 2010 Baldrige Award recipient, she said that…
