All Features
Stephen McCarthy
I am thrilled to introduce Quality Digest’s special report, “Unlocking the Future of Life Sciences.” This series explores the last several decades of quality management within the life sciences industry. It begins with the genesis of early regulations, shows us how that led to the current state of…
Mike Richman
Great quality is pretty much the same everywhere, but the cost of poor quality is not equivalent from industry to industry. For example, it’s conceivable (but I hope not probable) that this article may turn out to be a real bomb, or worse, a complete snoozer. What’s the cost of that poor quality?…
Quality Digest
Within the life science industry, federal and industry regulations have prompted the need for compliance, and that trend has only increased in magnitude and complexity. Along with that has come technological solutions to enable both compliance and efficiency, without which life science…
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 @ Quality Digest
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…
Graham Freeman
Many industries have no clear boundary between safety and quality culture. In fact, they are often closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries…
Scott A. Hindle
‘Process Capability: What It Is and How It Helps,” parts one, two, three, and four, discussed Alan’s development in the field of process capability1 He’d learned about the mistakes that can be made and how to avoid them in practice to become better at his job. Alan had since passed on his learning…
Steve McKee
Your business does not have a brand; your brand has a business. That may sound odd, backward, even heretical, but it’s true.
Consider the smartphone on which you may be reading this. When it was fresh out of the box and had gigabytes of memory to spare, it weighed roughly 6 ounces, depending on…
Jack Dunigan
Graham was a salesman of specialty products with a proven record of success. His many years of experience had yielded a high degree of confidence in himself and the products he sold, and an advanced level of competence in his craft as a personable, trust-inspiring, responsible salesman.
The retail…
Wendy White
Starting a new facility in the food-processing industry is an enormous undertaking. There are thousands of things that must be accomplished, from hiring and training new staff to ordering and installing equipment. This scenario is a perfect example of “too much to do and not enough time to do it…
Henrik Bresman, Deborah Ancona
A leading supermarket chain in an eastern European Union country feared an 8-percent drop in sales as discounting giant Lidl was about to enter its market. So, in collaboration with researchers, it decided to run a randomized controlled experiment. The goal was to reduce its costly personnel…
Eric Stoop
In 1982, W. Edward Deming’s Out of the Crisis (MIT Press, 2000 reprint) outlined 14 points by which companies could learn from his success in helping to drive the industrial boom of post-World War II Japan.
The idea that quality pays was revolutionary at the time. Today, another revolution is…
Kevin Meyer
When legendary CEO Herb Kelleher of Southwest Airlines passed away Jan. 3, 2019, many articles memorialized him, including this one by Bill Taylor in the Harvard Business Review and this one by Mark Graban, but I’d like to reinforce a couple attributes that are important to me.
The key to Kelleher…
Lolly Daskal
When we think of leaders, we don’t often think of failures, but one of the hallmarks of the best leaders is knowing how to fail well.
Successful people are those who have failed at something—and in some cases, many things—but without ever regarding themselves as failures. They take risks, and…
Donald J. Wheeler
With the click of your mouse you can turn a list of values into a bubble plot. No thought or effort is required. Simply sit back and let the software gods do the heavy lifting of transforming your list of numbers into a fancy graph. What could possibly go wrong?
In the Dec. 22, 2018, issue of…
Brad Egeland
In case you haven’t heard this one before, “I’m big in Japan” is a way of boosting yourself in some unverifiable fashion. Specifically, it means, “To say or pretend you are someone of stature somewhere else, which is meaningless and not verifiable where you currently are.”
Many are guilty, at…
Teresa Purzner
Developmental biologist Matthew Scott and I went from purely basic biological research in our lab at Stanford University, to discovering a target for drug development, to identifying a drug for a pediatric brain cancer called medulloblastoma, to a clinical trial—all within five years and for just $…
Harish Jose
The TV show The Walking Dead, about survival in a post-apocalyptic zombie world, is one of the top-rated currently. I’ve written previously about the show, but today I want to briefly look at the complex adaptive systems (CAS) in the show’s plot structure. A CAS is an open, nonlinear system with…
Tom Siegfried, Knowable Magazine
If Fyodor Dostoyevsky had been a mathematician, he might have written a book called Crime and Statistics. However, since “statistics” doesn’t have quite the same ring as “punishment,” it wouldn’t have sold as well.
But such a book would make a better guide for formulating crime-fighting policy.…
Innovalia Metrology
Industry 4.0 has catapulted industrial production processes into new realms of advanced manufacturing, in some cases leaving quality control scrambling to catch up. The trend of industrial quality management is to implement lean and accurate production systems; however, for many enterprises, using…
Hamish Knox
Have you ever heard a leader say, “I thought they knew what they were supposed to do?” Have you ever said that about those you lead? Either situation should make us cringe.
Leaders’ No. 1 job is to create clarity in their organizations. Lack of clarity leads to lack of accountability and,…
Chip Bell
Visioning beyond the customer is the responsibility of every person interested in a competitive advantage.
What do Bill Marriott, Ray Kroc, and Al Hopkins have in common?
No, they are not all people of wealth and fame. In fact, Hopkins is a small-town accountant and part-time preacher. They all…
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 @ Quality Digest
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…
