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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…
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…
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…
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…
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…
Bruce Hamilton
December was a busy month for everyone at GBMP. In addition to all of the usual activities to close out the year, we were packing to relocate from Newton, Massachusetts, to our new office in Boston. We were also tossing a whole lot of stuff, something we’d previously neglected to do.
As promoters…
Brian Strzempkowski, Shawn Pruchnicki
When Amelia Earhart took off in 1937 to fly around the world, people had been flying airplanes for only about 35 years. When she tried to fly across the Pacific, she—and the world—knew it was risky. She didn’t make it and was declared dead in January 1939.
In the 80 years since then, many other…
Wolfgang Ulaga
Offering free services may seem like a good way to keep customers happy, but how much money is your business leaving on the table? By redefining freebies as paid opportunities, B2B firms can generate new sources of income and secure long-term growth.
This not to say that companies should stop…
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,…
Shobhendu Prabhakar
Why do we waste our time and effort completing checklist after checklist for tasks that we can complete even when half awake? Do we not have better things to do than complete checklists?
Good question! And the answer is simple: If there is a checklist, it exists for a reason, and we need to follow…
Stephen Fankhauser, Matt Ebbatson
The world is running out of experienced pilots. Supply is not keeping up with the growing demand for air travel. In Australia, the effects are already starting to bite. Even flagship carrier Qantas is having problems. In recent months it has had to perform a very nimble tap dance to crew its vast…
Eric Cooper
Due dates. Whether it’s building a house or implementing an enterprise quality management software (QMS) solution, everyone has them, everyone wants them. What does home construction have to do with going live with a new QMS solution? There are actually quite a few similarities.
Create realistic…
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…
Mike Richman
Happy New Year one and all! For our first QDL of 2019, we were pleased to present some thought-provoking content on the benefits of compromise, the dangers of rhetorical trickery, and the meaning of Chekhov’s gun. Let’s take a closer look:
Ripped from the headlines Can’t anyone here get along?…
Harish Jose
One of my favorite things to do when I learn new and interesting information is to apply it to a different area to see if I can gain further insight. Here, I am looking at the principle, “Chekhov’s gun,” named after the famous Russian author, Anton Chekhov (1860–1904), and how it relates to gemba…
Dirk Dusharme @ Quality Digest
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…
Bretta Kelly
Back in January 2009, I wrote an article for Quality Digest titled “ISO 9001 Documentation Is Like a Box of Chocolates.” Here we are, almost 10 years later, all of the ISO 9001 and related standards have been updated, yet companies still misunderstand what to document, how to document, or why to…
Dr T Burns, Michael McLean
The control chart is at the heart of the very definition of quality. It is central to building, maintaining, and predicting quality into the future. However, control charts today, more often than not, are misused and misunderstood. The aim of this article is to show not only how control charts are…