Brian S. Smith
Throughout my career, I have been a member of several trade organizations. I believe that standards have meaning, in every field. When I become a member of an organization, I endeavor to learn as...
Ryan E. Day
According to the International Labor Organization, around the world every day 7,600 people die from work-related accidents or diseases—that’s more than 2.78 million people every year. To address the...
Tom Taormina
Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes...
Chad Kymal
When we think about IT security, we typically think about the large hacks that were reported in the press. When viewed as a whole, we can understand the magnitude of lost data. It’s no surprise that...
Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food...
Ryan E. Day
I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change...
Donald J. Wheeler
Managers the world over want to know if things are “in control.” This usually is taken to mean that the process is producing 100-percent conforming product, and to this end an emphasis is placed upon...
William A. Levinson
The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001...
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...
Laurel Thoennes @ Quality Digest
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...
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...
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...
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...
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.
“...
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...
William A. Levinson
The U.S. government’s Fourth National Climate Assessment warns that climate change “creates new risks and exacerbates existing vulnerabilities in communities across the United States, presenting...
NIST
A convocation of delegates representing 60 countries voted last month in Versailles, France, to implement the most significant change to the International System of Units (SI) in more than 130 years...
NIST
The U.S. Department of Commerce announced that the 2018 Malcolm Baldrige National Quality Award will be given to two educational institutions, an organ donor group, a hospital, and a project...
Dirk Dusharme @ Quality Digest
In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.
“GE’s Lessons Won’t Determine Whether You...
Ryan E. Day
BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood...
