Quality Features

Amy Mahn's picture
Amy Mahn
The NIST Cybersecurity Framework consists of standards, guidelines, and best practices to manage cybersecurity-related risk. The framework’s prioritized, flexible, and cost-effective approach...
Ryan E. Day's picture
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's picture
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's picture
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's picture
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's picture
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...
Matthew M. Lowe's picture
Matthew M. Lowe
Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage...
Mike Richman's picture
Mike Richman
Technological breakthroughs tend to change the way users perceive of a problem, offering a solution that, in retrospect, comes to seem obvious and apparent. So it is with the new FARO 8-Axis Quantum...
David Currie's picture
David Currie
This is the second article in a three-part series to help readers distinguish good metrics from bad. In part one we discussed good metrics. Here, we will look at a bad metric and...
Jesse Lyn Stoner's picture
Jesse Lyn Stoner
Confused about the difference between mission and vision? Or between purpose and mission? You’re not alone. I am frequently asked about the difference between mission, vision, purpose, strategy, and...
Dan Jacob's picture
Dan Jacob
What a difference a year and a half make. In mid-2017, LNS Research coined the term “Quality 4.0” and published definitive research on the topic. At that time, an early but large group of...
Donald J. Wheeler's picture
Donald J. Wheeler
In Part One and Part Two of this series we discovered some caveats of data snooping. In Part Three we discovered how listening to the voice of the process differs from the model-based approach...
William A. Levinson's picture
William A. Levinson
Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent...
James daSilva's picture
James daSilva
The news that General Electric ousted CEO John Flannery was surprising to many of us, and it certainly matters to investors, analysts, employees, and competitors (and probably, historians...
Anthony Chirico's picture
Anthony Chirico
Perhaps the reader recognizes d2 as slang for “designated driver,” but quality professionals will recognize it as a control chart constant used to estimate short-term variation of a process. The...
The Un-Comfort Zone With Robert Wilson's picture
The Un-Comfort Zone With Robert Wilson
Last year I was invited to give a lecture on critical thinking to the U.S. Navy. I opened my presentation with a story I’d read in Reader’s Digest magazine as a child. It’s an old story you may have...
John Bell's picture
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...
Mike Richman's picture
Mike Richman
Our industry embodies many aspects, but “Big Q” quality generally involves issues affecting management, measurement, and methodologies. This week on QDL, we covered all of them, and more. Let’s look...
Scott Berkun's picture
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...
Eric Gasper's picture
Eric Gasper
Measurement devices in manufacturing facilities are as ubiquitous as Skittles in trick-or-treat bags. Some companies have thousands of devices in their inventories and depend on them to provide...