All Features
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 growing challenges to human health and safety, quality of life, and the rate of economic growth.” The…
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. For the first time, all measurement units will be defined by natural phenomena rather than by…
Wudan Yan, Knowable Magazine
Nearly every month, it seems, comes a new report. In March 2018, there was news of contaminated romaine lettuce, which eventually led to five deaths and sickened more than 200 people across the United States and Canada. In May 2018, about 100 people in California got sick after eating raw oysters…
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 management firm. A presidential-level honor, the award recognizes exemplary U.S. organizations and…
Dirk Dusharme
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 Succeed or Fail”
Does the success or failure of GE’s CEO really matter that much when it comes to how most…
Mike Richman
This Thursday, for the first Thanksgiving in decades, I won’t be watching football, drinking beer, and stuffing myself into oblivion. Instead, I’ll be serving the homeless, giving clothes, and making myself useful.
Thanksgiving is always a time to give thanks—I mean, it’s right there in the holiday…
Paul Foster
Next to defining a problem accurately, root cause analysis is one of the most important elements of problem-solving in quality management. That’s because if you’re not aiming at the right target, you’ll never be able to eliminate the real problem that’s hurting quality.
So which type of root cause…
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 helps to promote the protection and resilience of critical infrastructure and other sectors important to…
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 components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life…
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 challenged itself to find ways to enhance efficiency and update old regulations. Quality Digest has…
Dirk Dusharme
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 certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell…
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’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political…
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 the agency for at least five years. The FDA has broad jurisdiction to regulate all health products,…
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 current industry players to blaze new trails. Whether new or established, life science companies…
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 framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an…
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 heard before, but it’s a perfect introduction to the importance of critical thinking. Here’s how it…
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 closer:
“Ripped from the Headlines: Tariff Fallout” U.S. manufacturers are currently dealing with…
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 of materials. And proper material testing applications begin with reliable and repeatable…
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–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other…
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 second article, the process control properties of MIL-STD-105 c>0 sampling plans were…
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 sample size, and it was illustrated that twice the inspection does not provide twice the consumer…
Chad Kymal
Omnex began working in the automotive industry by assisting Ford powertrain suppliers in 1986. The U.S. automotive industry’s Big Three used GM’s Targets for Excellence, Ford’s Q 101, and Chrysler’s SQA standards to qualify its supply bases. The automotive industry was making deep reductions in its…
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 safety leaders face today.
If quality and safety are separate functions in your organization (…
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 the International Aerospace Quality Group’s (IAQG) Supply Chain Management Handbook. The new…
Mike Richman
IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want. Plus, we brought you a live interview with author Mark Graban, and one on tape from Burt Mason of…