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...
Taran March @ Quality Digest
These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S. Food and Drug Administration is no exception, and this year especially it has...
Dirk Dusharme @ Quality Digest
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...
Mike Richman
The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That...
Ryan E. Day
One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with...
