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(marcus evans: London) -- Pharmaceutical quality systems have shifted in recent years from a traditional model to a more global, dynamic, and risk-based approach, enhanced especially by regulatory authorities and economic environment. marcus evans is organizing the conference, “Quality Risk…
My recent beach vacation began with the kind of unfortunate incident that we all dread: killing a distant relative.
It was about 3 a.m. Me, my two sons, and our dog had been on the road since about 7 p.m. the previous day to get to our beach house on Plum Island, Massachusetts. Google maps said…
As I peer into the cardboard box NIST researcher Amanda Forster holds out for me, I can’t help thinking that this mild-mannered materials scientist has an impressive collection of shivs.
Forster’s collection of handmade prison weapons include a ballpoint pen with a razor embedded in the shaft and…
As I was researching the remarkable similarities between lean and Zen for my book, The Simple Leader (Gemba Academy, 2016) one of the most interesting—and meaningful—was the concept of the beginner’s mind.
Taiichi Ohno said, “Observe… without preconceptions and with a blank mind.”
Zen master…
New technologies have empowered customers to seek out the best products and services at the lowest cost and shortest delivery times. Customers can compare price and delivery information as well as reviews about product quality. Thus, the importance of sustaining outstanding quality in order to…
New technologies have empowered customers to seek out the best products and services at the lowest cost and shortest delivery times. Customers can compare price and delivery information as well as reviews about product quality. Thus, the importance of sustaining outstanding quality in order to…
(Productivity Press: New York) -- You likely don’t need any more tools, programs, or workshops to improve your hospital. What you need is a simple and consistent approach to manage problem-solving. Filling this need, Lean Daily Management for Healthcare: A Strategic Guide to Implementing Lean for…
Here’s a stat that might surprise you—according to LNS Research, 50 percent of manufacturers have implemented or will be implementing cross-functional groups to support their operational excellence journeys within a year. At the same time, only 18 percent have software or processes in place to…
Summer is a great time to catch up on reading. I suppose that’s why there’s such a thing as “summer reading,” which starts in grade school and extends a lifetime (or so goes the theory).
My initial attempt at summer reading this year was complemented by a July 4th military flyover of two F-16…
I hope this little diversion into design of experiments (DOE) that I’ve explored in my last few columns has helped clarify some things that may have been confusing. Even if you don’t use DOE, there are still some good lessons about understanding the ever-present, insidious, lurking cloud of…
(FDA: Washington, DC) -- During the last few months, we’ve shared what the FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through lean mapping of the combination product review…
I was honored recently to be a guest on Innochat, a weekly Twitter chat that takes place every Thursday at noon Eastern time. The show is about innovation and covers a wide range of topics and angles. If you love talking innovation, make time for this chat every Thursday.
The topic on July 21 was…
It all started as a normal day for traders David and John (not their real names). Out of the blue, their company’s audit and compliance team called them, seeking clarifications about some of their recent trades. Shortly afterward, David and John realized they had just become victims of the rise of…
It all started as a normal day for traders David and John (not their real names). Out of the blue, their company’s audit and compliance team called them, seeking clarifications about some of their recent trades. Shortly afterward, David and John realized they had just become victims of the rise of…
Elon Musk, CEO of Tesla Motors, recently revealed the second part of his master plan for the company, and it’s a doozy. Not content with producing sleek electric cars (which to be fair, were only a stepping stone to greater things), Musk wants to fundamentally change how we live our lives. But the…
Ever waited way too long at your doctor’s office for an appointment to start? Those long waits may soon be over. A schedule-optimizing software developed by MIT spinout Arsenal Health gets more patients seen more quickly and could soon be used by thousands of healthcare providers across the…
Today I’d like to take a look at a lesson from Taiichi Ohno regarding the pursuit of quality. His comment, “The pursuit of quantity cultivates waste, while the pursuit of quality yields value,” struck a chord with me. Among other things, he's referring to the importance of resisting mass-…
(ASTM: West Conshohocken, PA) -- A new ASTM standard, E3012—“Guide for characterizing environmental aspects of manufacturing process,” will help manufacturers incorporate more sustainable practices into production. The standard, developed by ASTM International Committee E60 on Sustainability, will…
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For more than 30 years, Hendrick Motorsports has consistently been one of NASCAR’s most successful teams. In the course of winning a record 11 Sprint Cup Series championships, Hendrick Motorsports has learned that it must innovate constantly to stay ahead of the competition.…
(ANSI: Washington, D.C.) -- World Standards Day is celebrated annually around the world to increase awareness of the role that standards play in the global economy. To help celebrate the importance of standards, SES—The Society for Standards Professionals and the U.S. Celebration of World…
Have you seen the recent commercial where a young son tells his parents that he’s going to work for GE—as a software developer? Their response was one of bewilderment. In their minds, GE is a manufacturer. The commercial exemplifies the idea that the mental models of leaders—their attitudes,…
This may be stating the obvious, but engineers are generally very analytical. One of the areas where this trait comes to the fore is in evaluating all the ways things can go wrong. This includes exposure and using tools like failure mode and effects analysis (FMEA).
As an engineer, there’s a good…
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M
ost of us are good leaders. Most of us aspire to be great leaders. Few are. What does it take to transcend “good” and become “great?” What’s the secret?
There isn’t one.
The differences between a good leader and a great one boil down to a handful of traits that inspire people…
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A simple fact in manufacturing is that everyone has to measure. However, when precision is the ultimate goal, measurement is not simply about inspection, it’s about process control. Manufacturers need the right tools to increase quality, maximize productivity, and, ultimately, to…
The great physicist Richard Feynman is best known—at least among laypeople—as the person who solved the mystery of the Challenger space shuttle explosion more than two decades ago.
Many of us remember the image of an O-ring suspended in a glass of ice water sitting on a conference table…
