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
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...
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...
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
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...
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...
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...
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...
Mike Richman
For manufacturers in diverse sectors such as automotive, aerospace, electronics, and medical device, there’s little question that ensuring great quality would be impossible without the proper testing...
Anthony Chirico
In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units. In the...
Andreas Engelhardt
An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–...
Anthony Chirico
In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate...
Dan Jacob
LNS Research published its research, “Driving Operational Performance With Digital Innovation: Connecting Risk, Quality, and Safety for Superior Results” to address fundamental challenges quality and...
Anthony Chirico
Aerospace standard AS9138—“Quality management systems statistical product acceptance requirements” was issued this year (2018), a few years after its accompanying guidance materials in section 3.7 of...
Gary Marchionini
As millions of people came online iduring the late 1990s, they needed help figuring out what each web page was about, and how to find what they were looking for. Web indexes and search engines sprang...
Bita Kash
Can you imagine a future where the question, “Did you bring a copy of your test results?” becomes entirely unnecessary? That could happen, but the methods that most healthcare providers use to...
Mike Richman
This week’s show contained a range of fun and interesting content from some of our favorite corners of the world of quality. Here’s what we covered:
“More Unidentified Museum Objects”
The...
Eryn Brown
Alan Colquitt is a student of the ways people act in the workplace. In a corporate career that spanned more than 30 years, the industrial-organizational psychologist advised senior managers and human...
Nicole Radziwill
ISO 31000 defines risk as “the effect of uncertainty on outcomes.” Identifying risks and determining ways to respond to them help you learn about your processes, your organization, and the...
Manfred Kets de Vries
A certain amount of stress is needed for us to function effectively. Stress is very much a part of the human condition. We all face disappointments, setbacks, losses and pain. But to live a rich and...
