All Features
Laurel Thoennes @ QD
Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?
1988: Food and Drug Administration ActOfficially establishes the FDA as an agency of the Department of Health and Human Services…
Dirk Dusharme
As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.
The goal of any honest pharmaceutical company is to make…
Taran March @ Quality Digest
It’s been a year and a month since Stephen McCarthy switched C suites, moving from Johnson & Johnson, where he served as vice president of quality system shared services, to Sparta Systems, where he’s now vice president of digital innovation. His focus has switched as well.
At J&J, he…
Zac Cooper
The role of quality starts with product design and moves rapidly across the supply chain to the selling and buying experience, which includes the bidding process. When operating a formal continuous process improvement program, nearly all manufacturing engineers are tasked with some level of quality…
Dirk Dusharme
We interview Stanley Chao, author of Selling to China: A Guide for Small and Medium-Sized Businesses (iUniverse, 2018), about the impact of the current U.S.-China trade war. Does China really care, and where do U.S. multinationals go from here? Also, a quick look at Conformance Manager, a web-based…
Stanley Chao
This past year has created havoc for Western companies purchasing raw materials, furniture, high-tech components, auto parts, and power tools from China. And the rocky relationship continues into 2019 as both countries continue to negotiate while kicking the can down the road toward a new March 1,…
Jeffrey Phillips
I recently wrote an article about innovation during 2018, and in it I made some disparaging remarks about Apple, which may or may not have caused it to lose a tremendous amount of market capitalization. Or perhaps the stock was overvalued, and Apple has become more interested in margin than in…
Richard Harpster
On Oct. 13, 2018, the Automotive Industry Action Group (AIAG) sponsored a webinar on the status of the AIAG Core Tools Software (AIAG CTS). John Cachat, AIAG project manager for the AIAG CTS project, was the presenter for the webinar. The presentation provided information on why the AIAG was…
Dirk Dusharme
We tied up last year in a neat little bow, talking about how stories define ourselves and our work; waste is waste, no matter your political leanings; and putting numbers from the news in context.
“The Gift of Being Small” This article by Quality Digest’s Taran March wonderfully illustrates how we…
Matt Krupnick
When graduate student Atis Degro got an email about a George Mason University course in resilience last year, he had to look up what that meant.
He was also curious about the credential being offered for successfully completing the course: not a conventional degree or a certificate, but a “badge…
Steven Barrett
Since their invention more than 100 years ago, airplanes have been moved through the air by the spinning surfaces of propellers or turbines. But watching science fiction movies like the Star Wars, Star Trek, and the Back to the Future series, I imagined that the propulsion systems of the future…
Mark Schmit, Ken Voytek
Manufacturers throughout the United States are facing a new set of challenges and exciting growth opportunities. Given the manufacturing industry’s important role in providing both direct and indirect jobs, how firms react to these changing conditions is critical not only to the companies…
Aytekin Tank
A giant engine in a factory fails. Concerned, the factory owners call in technicians, who arrive with bulging toolkits. None of them can work out what the problem is. The issue persists.
One day, an old man shows up who’s been fixing engines his whole life. After inspecting it for a minute, he…
Wudan Yan, Knowable Magazine
Nearly every month, it seems, comes a new report. In March 2018, there was news of contaminated romaine lettuce, which eventually led to five deaths and sickened more than 200 people across the United States and Canada. In May 2018, about 100 people in California got sick after eating raw oysters…
Ariana Tantillo
The ability to program computers is crucial to almost all modern scientific experiments, which often involve extremely complex calculations and massive amounts of data. However, scientists typically have not been formally trained in science-specific programming to develop customized computational…
Devshree Golecha
In this era of artificial intelligence, where bots can mimic human minds and outperform humans, a new-age process automation tool called “robotic process automation” (RPA) has been creating a lot of buzz. It is highly versatile and can be used by every industry to streamline and optimize their…
Dirk Dusharme
The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
John Bell
To most of us, the phrase “work that matters” infers job satisfaction. The outcome is lower stress, lower turnover, and higher productivity—in business, a win-win for employees, customers, and shareholders. The logic is infallible. So, I ask you, why is there such a gap between the theory and the…
Scott Berkun
To ask a good question requires two things: insight and gumption. The root of all worthy questions is a desire to fill in a gap in your understanding of something. The insight in good questions comes from seeing that gap, exploring its edges, and forming a question that can serve as an invitation…
M. Mitchell Waldrop, Knowable Magazine
This story was originally published by Knowable Magazine.
Back in the 1990s, when U.S. banks started installing automated teller machines in a big way, the human tellers who worked in those banks seemed to be facing rapid obsolescence. If machines could hand out cash and accept deposits on their…
Brian Maskell
If you are a CEO of a manufacturing company with many value streams, it’s impractical to think that you have the time to review all the performance measures of every value stream in your company. Yet you need to know the operational impact of lean on your entire organization.
The traditional…
Jeffrey Phillips
It finally came to me last week. For more than a decade I’ve been working with corporations, trying to help them accelerate their ability to generate new, interesting ideas to market as viable products and services. In some instances we’ve been successful, and in other instances there were…
Anthony Chirico
In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units. In the second article, the process control properties of MIL-STD-105 c>0 sampling plans were…
Mike Richman
One of the highlights on our calendar each year is the first Friday in October, which is Manufacturing Day here in the United States. This event offers us the perfect opportunity to celebrate the centrality of manufacturing as a driver of the economy, innovation, automation, education, and lots…
Anthony Chirico
In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate sample size, and it was illustrated that twice the inspection does not provide twice the consumer…