All Features
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…
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…
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…
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…
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 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…
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…
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 up. When Google was founded in September 1998, it had to compete with the information retrieval…
Bita Kash, Stephen L. Jones
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 exchange healthcare information are little different than they were 5,000 years ago, when physicians…
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 National Institute of Standards and Technology has a wealth of crazy old artifacts from measurement days of…
Eryn Brown, Knowable Magazine
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 resources departments about how to manage talent—always striving to “fight the good fight,” he says…
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 environment you’re operating within. It also raises your awareness of how any of these things might change in…
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 meaningful life, we must learn to deal in a constructive way with life’s challenges.
Stress evolved…
Oscar Combs
ISO 9001:2015, clause 6.1 requires an organization to identify its risks and take actions to address identified risks. It is very tempting to start with a huge list of potential risks for the organization, but is the organization focusing on the actual risks that have an effect on its operations?…
Richard Wilkinson
Whether it’s the effort to redefine the kilogram or researching the Harry Potter realm of quantum mechanics where things can somehow be in two or more places at one time, quite a bit of the science carried out at the National Institute of Standards and Technology (NIST) can be hard for the average…
Michael Jarrett
Transformational leaders are the exception, not the rule.
A consistent picture emerges from lists of top CEOs. In Harvard Business Review’s Best-Performing CEOs ranking, Pablo Isla of Inditex, the parent company of Zara; Ajay Banga of Mastercard; and Bernard Arnault of LVMH stand out for both…
