All Features
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…
Minitab LLC
Process validation is vital to the success of companies that manufacture pharmaceutical drugs, vaccines, test kits, and a variety of other biological products for people and animals. According to FDA guidelines, process validation is “the collection and evaluation of data, from the process design…
Chip Bell
I recently had eye surgery that required me to sleep on my back for two weeks following the operation. I have always slept on my side, ever since I was a kid. My back-sleeping attempts are so challenging, I am never able to nap on those United States to Europe flights. I usually end up burning a…
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 @ 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 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…
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 ScanArm and FaroArm.
“This is such an obvious solution to a challenge that every single portable-arm…
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 consider how to change it into a useful, good metric. A bad metric is one that fails in one or more of the attributes of…
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 goals, and where do values fit?
Many people don’t care about definitions, and that’s unfortunate.…
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 manufacturers started to make Quality 4.0 one of their top digital transformation initiatives. This continues…
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 and how it also provides a way to understand when our models do and do not work. Here we conclude the…
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…
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). But does the success or failure of GE’s CEO really matter that much when it comes to how most of us lead,…
Bruker Corp.
(Bruker Nano Surfaces: San Jose, CA and Detroit) -- Bruker Nano Surfaces has announced a partnership with Greening Testing Laboratories of Detroit to provide convenient and cost-effective benchtop friction test and particle-screening capabilities to developers of friction materials. Under this…
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 basic formula shown below is widely used in control charting for estimating the short-term variation…
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…
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 shareholders. The logic is infallible. So, I ask you, why is there such a gap between the theory and the…
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…
ISO
(ISO: Geneva) -- New technologies, from robotics to machine learning, are ushering in a period of rapid change and development. While the aviation industry is working to reap the benefits of this industrial automation, standards, especially those of the International Organization for…
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 from seeing that gap, exploring its edges, and forming a question that can serve as an invitation…
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 accurate information. This is why timely calibration of all measurement devices is critical to…
