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Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements
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…
Use ISO 45001 to Support OSHA VPP Star Status
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…
A Survival Guide for the Era of ‘Alternate Facts’
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…
Inside Quality Digest Live for Nov. 2, 2018
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…
Preparing for Quality
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…
Applying the Procedures of MIL-STD-105 to Imaginary Limits
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…
Occupational Health and Safety: A Standard Approach
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…
Using MIL-STD-105 As a Process Control Procedure
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…
Safety Plus Quality: Why Join Forces Now?
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 (…
The Paradox of Acceptance Sampling
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…
How Will Google’s Innovation Continue Beyond Its 20th Year?
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…
It’s 2018. Do You Know Where Your Medical Records Are?
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…
Inside Quality Digest Live for Aug. 31, 2018
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…
Is It Time to Bring Data to Managing?
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…
Taming Uncertainty in Your QMS With Risk-Based Thinking and ISO 9001:2015
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…
The 10-Point Stress Audit
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…
How Uncertainty Affects Risk
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?…
A Matter of Schlepping
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…
Six Reasons Why CEOs Fail
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…
You’ve Been Phished!
NIST
Organizations worldwide stand to lose an estimated $9 billion in 2018 to employees clicking on phishing emails. We hear about new phishing attacks regularly from the news and from our friends. So why do so many people still click? NIST research has uncovered one reason, and the findings could help…
Inside Quality Digest Live for August 10, 2018
Mike Richman
‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will overcome a poor culture. Do you know which you have? We explored these issues during the Aug. 10,…
Skillscape: How Skills Affect Your Job Trajectory
Morgan Ryan Frank, Iyad Rahwan
How do workers move up the corporate ladder, and how can they maximize their career mobility? Increased wealth disparity, increased job polarization, and decreases in absolute income mobility (i.e., the fraction of children who earn more than their parents) all suggest that upward mobility is…
Investing in Advanced Domestic Drug Manufacturing
Scott Gottlieb
There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the U.S. Food and Drug Administration (FDA), we’re focused on propelling these innovations, collectively referred to as…
Proactively Dealing with Regulatory Changes to Keep Your Business Safe
Mike Figliuolo
Legislative and regulatory changes can cause massive upheaval for your strategic plan. Elections happen all the time. New rules and regulations are proposed, implemented, or repealed on a daily basis. Court cases can change an entire industry landscape. To stay on top of all these changes and to…
Dow(n) and Out: Can General Electric Reclaim Its Legacy?
Mark Miller, Lucas Conley
Recently, General Electric—the last remaining member of the Dow Jones Industrial Average’s original 1896 index—was removed from the world’s most prestigious equity benchmark. News of the venerable brand’s dismissal from the Dow, the index of 30 large, publicly traded U.S. brands reflecting the…

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