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Bruno Scibilia
Ionce worked in the manufacturing industry. Some processes were so complex that even a very experienced and competent engineer would not necessarily know how to identify the best settings for the manufacturing equipment.
You could make a guess using a general idea of what should be done regarding…
A leader’s ability to communicate is fundamental to building trust and forming a cohesive team. Transparency has become a necessary element of team support. It may be scary to share everything, but the benefits are undeniable.
As I was walking back from the gym one morning, I passed by the local…
Argonne National Laboratory
The search for a truly revolutionary engine design that can make dramatic gains in efficiency requires deep scientific understanding and tools. Lots and lots of tools.
In the past, tools were needed to make prototypes, requiring repeated testing and retrofitting along with a healthy dose of…
Patrick Runkel
About a year ago, a reader asked if I could try to explain degrees of freedom in statistics. Since then, I’ve been circling around that request very cautiously, like it’s some kind of wild beast that I’m not sure I can safely wrestle to the ground.
Degrees of freedom aren’t easy to explain. They…
Amy Williams
My first exposure to manufacturing was nearly 21 years ago. My on-the-job training was brief and mainly consisted of general safety, machine operating, and maintenance instructions with little focus on problematics or quality requirements. After all, I wasn’t forming sheet metal for an airplane; I…
Tim Lozier
When we look at business dynamics, regardless of industry, we see an increasing rate of change in products, processes, and regulations. One process affects the next, and with a growing focus on regulations and standards, complexity becomes an ever-expanding theme, whether related to quality…
NIST
They activate airbags. Keep aircraft correctly positioned in flight. Detect earthquakes or sudden vibrations in failing machinery. Guide military hardware. Monitor falls in elderly individuals and initiate calls for help. They rotate the display on a smartphone from vertical to horizontal, and…
Michelle LaBrosse
Most people begin with the great intentions to eat well, exercise, do their best at work, and get along with co-workers. Unfortunately, good intentions don’t always impel us to actually do what we say we’ll do. Why is this? Let’s explore the answers to this question and how to align our actions…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Marc Silverstein
Every day, new technology creates smaller and smaller materials and components. In many industries these parts require high magnification, sometimes up to 1,000X, to see submicron features. This is accomplished using a compound or upright microscope, where the user can select the objective lens.…
Ken Miller
Please pardon me, but I feel a little like a modern-day Paul Revere alerting you to the start of the second wave of Health Insurance Portability and Accountability (HIPAA) compliance audits.
Last week, Jocelyn Samuels, director of the Health and Human Services’ Office of Civil Rights (OCR),…
Jesse Lyn Stoner
Traditionally, career paths have been based on the idea of “moving up the ladder.” Success is measured by how high you get. A lateral move is usually not seen as a smart career move. Even when changing jobs to increase your skills, the expectation is the new position will be a step higher up the…
April Lemois
Whether it’s budgeting season, or you’re preparing for the future, you need to make strategic decisions about where your allocations will go. As planning commences to replace your current coordinate measuring machine (CMM) or to add a new one, important business considerations such as prior-year…
Ken Levine
One poorly understood concept in lean Six Sigma is how much to “stretch” when setting S.M.A.R.T. goals. These letters are defined as S—specific; M—measureable; A—assignable, attainable, or achievable; R—realistic, reasonable, or relevant; and T—time-based or time-bound. Regardless of the different…
Bruno Scibilia
Sponsored Content
Suppose that on your way to a summer holiday resort (a very distant place), your car breaks down. You might just call roadside assistance and wait for your car to be towed to a repair shop. But suppose that you think you’re smarter than that, and you would like to solve the issue…
Kimberly Watson-Hemphill, Kristine Nissen Bradley
Editor’s note: This is an excerpt from the new book, Innovating Lean Six Sigma, by Kimberly Watson-Hemphill and Kristine Nissen Bradley.
Like every company, healthcare businesses do their work through processes, and any process can be studied and improved using basic lean Six Sigma methods. Figure…
Duke University
Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients.
A new report from the planning board for a national medical device evaluation system (NMDES) describes how the…
NIST
Researchers at the National Institute of Standards and Technology (NIST) have developed the first widely useful standard for magnetic resonance imaging (MRI) of the breast, a method used to identify and monitor breast cancer.
The NIST instrument—a “phantom”—will help standardize MRIs of breast…
Manfred Kets de Vries
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wenty-five years ago, corporations and business schools were preoccupied with models of the rational economic man, not realizing that executives are anything but rational decision makers. The emotional aspects of leadership and the importance of corporate culture were all but ignored. At that…
Joby George
Driven by market expansion, financial pressures, and the need to accelerate innovation, today’s manufacturers have expanded their global operations and supply partners. This evolution has only amplified the manufacturer and supply-chain relationship, which is often characterized by a delicate…
GBMP
Hub Pen Co., located in Braintree, Massachusetts, imports specialty writing instruments and imprints them with company logos and other customized inscriptions. In 2013, the company received a grant for training in lean and continuous improvement, which was delivered by the Greater Boston…
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
Davis Balestracci
In part one yesterday, we looked at stats of the Boston Red Sox bullpen, a typical example of baseball’s tendency to find special cause in just about anything. The Boston Globe article on which these two columns are based has been a gold mine for teaching many useful, basic concepts about…
Davis Balestracci
In honor of baseball season, I’m going to apply some simple statistical thinking to my favorite sport in a two-part series today and tomorrow. I want anyone to be able to enjoy this, so I’ll mark any technical statistics as optional reading. For those of you interested only in the interpretations…
Giles Hutchins
Globalization, disruptive technologies, pressure on finite resources, increasing social disparity, and demand for business transparency: Enter the age of uncertainty. These transformative times are reshaping the workplace in profound ways, demanding the crossing of thresholds at myriad levels. …
