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Swapnil Srivastav
Mandatory reporting requirements for regulations such as Europe’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) legislation have increased the focus on environmental compliance and ethical sourcing across the globe.…
Jim Benson
Prioritization is stressful. We find ourselves prematurely making value decisions about what to pull and when (right now!).
Recently a client asked, “How can I prioritize my work when there is no clear priority? Everything seems equally important.”
This is a deeper issue than simply being…
InfinityQS
What do you feel when you imagine your next regulatory audit? Stress? Anxiety? Overwhelming dread? The average recall can cost a manufacturer as much as $10 million, making compliance important to your brand as well as your bottom line.
As you manage the daily ins and outs of your quality…
Annette Franz
Last month, I wrote about the concept of lean management and what that means not only for your company but also for your customers.
If company leadership wants to transform the culture of the organization and become a lean company, they’ve first got to understand what comprises lean leadership,…
James Warren
Creating a new material has long been either an accident or a matter of trial and error. Steel, for instance, was developed over hundreds of years by people who didn’t know why what they were doing worked (or didn’t work). Generations of blacksmiths observed that iron forged in charcoal was…
British Assessment Bureau BAB
There are hundreds of security breaches that happen every day but in the end, they fall into three main groups: malicious, intentional, or criminal; system glitches; and human error.
The IBM “2015 Cost of Security Breach Survey” conducted by Ponemon Research, catalogs 49 percent of the breaches…
Harish Jose
Uncertainty is all around us. A lean leader’s main purpose is to develop people so they can tackle uncertainty. There are two ways to tackle uncertainty: One is genchi genbutsu (go and see, or seeing for yourself), and the other is to employ the plan-do-check-act (PDCA) cycle, a method for…
Thinh Nguyen, Rachel E. Sherman
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA component will regulate it.
One way sponsors may…
Barbara A. Cleary
In a rapidly changing business environment, it’s sometimes hard just to keep up with everyday demands—never mind having time to develop new and better approaches to changing requirements, needs, or markets. Staying ahead of the curve sounds as if it might demand working longer hours, hiring more…
William A. Levinson
ISO 9001:2015 clause 4.2—“Understanding the needs and expectations of interested parties” requires the organization to determine the “requirements of these interested parties that are relevant to the quality management system.” The recent two-day conflict that Facebook lost to F.B. (Fluff Busting…
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?
Then I spoke with a…
NIST
A new publication from the National Institute of Standards and Technology (NIST) provides a basic model aimed at helping researchers better understand the internet of things (IoT) and its security challenges.
Examples of IoT systems include a smart electric grid, a home controlled by sensors,…
David Schwinn
It’s hard these days to miss the passion of people who support Donald Trump or Bernie Sanders, the steadfastness of the Tea Party, the outrage of the Occupy Wall Street group, and the frustration of young people who have so given up on the system that they choose not to vote. Most grievous is the…
Bruce Hamilton
A friend and colleague remarked to me that “the lean market has become mature,” implying a depth and breadth of lean understanding in industry that I have rarely seen myself.
Standardized work, for example, almost always looks like time setting to me, an occasional and cursory exercise by…
Peter J. Sherman
As organizations become successful and grow, uncertainty is generally the enemy. Thriving organizations seek to eliminate variation and increase efficiency. They identify best practices and policies, and design standard operating procedures. Such efforts can make a business wildly efficient at…
Greg Fox
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…
Jennifer Huergo
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…
Kevin Meyer
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…
Afaq Ahmed, Yves Van Nuland
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…
Steve Garbrecht
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…
Gilles Hilary, Sivakumar Viswanathan
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…
Andrew Maynard
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…
Harish Jose
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-…
Eugene Daniell
Sponsored Content
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.…
Jesseca Lyons
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…