All Features
Dave K. Banerjea
In most industries, maintenance and calibration management departments are separate operations that rarely, if ever cross paths. However, in some industries, such as pharmaceutical and medical device manufacturing, maintenance and calibrations are often performed on the same assets. As a result,…
Stacey Jarrett Wagner
In college I learned about chaos theory, sometimes called the butterfly effect, in which small differences in an initial condition result in divergent outcomes in dynamic systems. In layman’s terms, my fellow students and I were fond of saying that when a butterfly flutters its wings over your…
BDO USA
The manufacturing industry is poised for growth in 2014. Still, the second annual BDO USA LLP analysis of risk factors listed in the most recent 10-K filings of the largest 100 publicly traded U.S. manufacturers found that they will contend with a number of challenges as they work to capitalize on…
MIT Management Executive Education
We’ve all been there—staring down the week’s to-do list with the best of intentions, only to find, at the end of the week, that we didn’t accomplish everything that was required of us. Our tasks get carried over into the following week, and before we know it, we’re caught in the paradox of being…
Donald J. Wheeler
One thing burned into the brains of those who survive a statistics class is that you have to specify an alpha-level before you do anything statistical. And when it comes to statistical inference, they are correct. But just what does the alpha-level represent? What does it mean in practice? Read on…
Robert Fangmeyer
What does healthcare in the United States need? Well, according to a report released May 29, 2014, by the President’s Council of Advisors on Science and Technology (PCAST), U.S. healthcare organizations need “systems engineering.”
In their letter to President Obama, PCAST co-chairs John Holdren…
Jens R. Woinowski
I recently stumbled upon the book by S.J. Scott, Habit Stacking: 97 Small Life Changes That Take Five Minutes or Less (Archangel Ink, 2014). The concept is very simple, but powerful. Instead of a classical review, this is an “in a nutshell” version.
The idea of habit stacking is this: 1. You can…
Jack Dunigan
R ecently I shared five reasons why hope is not an effective strategy, but hope is, nonetheless, an essential attitude. What do you think influences that attitude? Let’s take a look.
There’s a difference between hope and hope so. The former is certain, expectant, optimistic. The latter is…
Mike Richman
The foundations of the quality industry go back decades, centuries, even millennia. In that course of time, men and women of various backgrounds and nationalities contributed wisdom distilled from their hard-earned experiences to help develop the tools and techniques that help good organizations…
MIT Management Executive Education
What stands between you and the more productive version of you—the person who meets personal and professional goals on a daily, monthly, and yearly basis?
Robert Pozen provides concrete answers to this question in his new course, Maximizing Your Personal Productivity, offered July 15–16, 2014, by…
Sonal Sinha
While public U.S. companies were preparing to meet their first conflict minerals reporting deadline, their European counterparts were taking their first steps toward implementing a conflict minerals law.
On March 5, 2014, the European Commission proposed a draft regulation to stop the sale and…
Carly Barry
It’s all too easy to make mistakes involving statistics. Powerful statistical software can remove a lot of the difficulty surrounding statistical calculation, reducing the risk of mathematical errors, but correctly interpreting the results of an analysis can be even more challenging.
No one knows…
Mike Richman
The wisdom of Joseph M. Juran continues to inform and enlighten the quality industry here in the United States and around the world. Juran, who passed away at the age of 103 in 2008, stands as one of the true giants in the modern world of quality and performance excellence.
Joseph DeFeo worked…
Miriam Boudreaux
I frequently get asked questions from clients and readers about how to handle the everyday maintenance of a useful and compliant ISO 9001 quality management system (QMS). I thought I’d address a couple of those questions that I feel many people can relate to.
Numbering schemes: would a document…
David Fenn
For those who have already heard of Disney’s creative strategy, you may not be aware that the romantic notion of it coming directly from Walt Disney himself is actually untrue. The first mention of the dreamer, the realist, and the critic was taken from an interview with two of Disney’s original…
Bruce Hamilton
Aconversation with a lean friend reminded me of a story that I shared four years ago. It dealt with the consequences of crazy measures and how lack of management oversight will allow these measures to persist indefinitely. Absentee decision makers passing down absurd directives... sound familiar…
Lean Math With Mark Hamel
The plan vs. actual chart is one of the most powerful and simple visual process performance metrics. In fact, it’s a sort of Swiss Army knife of charts in that it not only provides insight into process performance but also, by the virtue of its comment field, begs and shares information as to when…
Jack Dunigan
I have always loved working with military people. Their training firmly builds within them a “can do” mentality and a fixation on mission objectives.
One of the best employee associates I ever had was a retired Air Force lieutenant colonel. He could always be depended on to get jobs out the door…
Patrick Runkel
These days, my memory isn’t what it used to be. Besides that, my memory isn’t what it used to be. But my incurable case of CRS (can’t remember stuff) is not nearly as bad as that of the exponential distribution.
When modeling failure data for reliability analysis, the exponential distribution is…
Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.
In Annex 1 of the “Medical Device Directive 93/42/EEC—Essential Requirements—Section 2,” the…
University of Arizona
More than 25 years ago, an abandoned NASA spacecraft fulfilled its mission, fell silent, and has since been hurtling around the sun, somewhere between the orbits of Earth and Mars. Now, a University of Arizona engineering student is trying to wake it up.
Jacob Gold, an undergraduate student…
Michael A. Hughes
Your quality management system (QMS) documents for AS9100, ISO 9001 or any other standard for that matter, do not have to be complicated. Why create volumes of wordy procedures that employees will probably never read? And even if they do, they certainly won’t understand.
As auditors and quality…
Georgia Manufacturing Extension Program
In 1963, two paintbrush salesmen changed the process for coating artist canvases. They went from preparing the canvas by hand to a mass production process. By purchasing a textile machine, rolling the fabric, and applying gesso to the fabric continuously instead of sheet by sheet, Tara Materials…
Matthew E. May
It’s been well over a decade since Dan Pink predicted that the macro trend of automation would change the nature of just about everything in his bestselling book A Whole New Mind (Riverside Books, 2006 edition). The context of his message revolved around work, with the central idea being to take a…
Kevin Meyer
I’ve been following the panting exuberance of big data apostles for the past few years, rolling my eyes at most of it. Sure, it can be interesting, but maybe my age is showing when I say, “So what?” to most of it.
What finally pushed me over the edge enough to comment on it was a tweet I saw from…
