All Features
Martin R. Voelk
In just a few short months, the European Union’s General Data Protection Regulation (GDPR) will take effect. The regulation, which replaces the EU’s 20-year-old Data Protection Directive, imposes new and more rigorous requirements on any entity that collects or maintains personal consumer data,…
Scott Gottlieb, Jeffrey Shuren
In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.
For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance…
Donald J. Wheeler, James Beagle III
Whenever we make a measurement, we have to decide how many digits to record. Traditional answers for this question are often little more than guesswork glorified by time. And with digital readouts, are all the displayed digits real? This column provides a sound and practical answer to these…
Jun Nakamuro
The sad truth is that the word “engagement” is not very engaging. It’s one of those fluffy, ambiguous terms that have become all too familiar around the business world, like “empowerment” and “respect.” What does engagement really mean, and how do you, as a leader, engage your workforce? The…
Rob Matheson
Liquid-liquid separation and chemical extraction are key processes in drug manufacturing and many other industries, including oil and gas, fragrances, food, wastewater filtration, and biotechnology.
Three years ago, MIT spinout Zaiput Flow Technologies launched a novel continuous-flow liquid-…
Christopher Martin
My youngest son entered first grade this year with great excitement. As a high-functioning autistic, his obsession from an early age has been numbers and letters. He memorizes license plates at a glance, can count to the millions (and break down the digits), and tell you how many minutes he has…
Harish Jose
It’s not easy to find topics to write about, and even if I find good topics, it has to pass my threshold level. As I was meditating on this, I started to think about procrastination and ambiguity. So my column today is about the importance of “fuzzy concepts.” I am using the term in a loose sense…
Jennifer Lauren Lee
The “inconstant moon,” as Shakespeare called it in Romeo and Juliet, is more reliable than his pair of star-crossed lovers might have thought. Now researchers at the National Institute of Standards and Technology (NIST) plan to make the Moon even more reliable with a new project to measure its…
Brian Rogers, Karel Cool, Christophe Angoulvant
Disruptive ventures arise from mobile device ubiquity, data-powered AI, and digital platforms that connect buyers and suppliers in new ways. They are reshaping industries such as transportation (e.g., Uber, Lyft, and Didi Chuxing), hospitality (e.g., Airbnb and FlipKey), payment services (e.g.,…
Sparta Systems Inc.
(Sparta Systems: Hamilton, NJ) -- A recent survey sponsored by Sparta Systems and conducted by Pharmaceutical Technology, found that while compliance remains the top objective in 2018 among 73 percent of pharmaceutical executives, performance-oriented objectives were nearly as critical for the…
Richard Harpster
Richard Harpster's op-ed is in response to a recent Quality Digest article and webinar discussing the benefits of the draft AIAG-VDA FMEA Handbook. As he points out at the end of this article, the AIAG has provided a means to solicit comments, pro or con, on the handbook. We encourage interested…
Michael Lynn
Some journalists and other social commentators have in recent years called for the abolition of restaurant tipping, primarily because they argue that it hurts workers. Several restaurateurs have even replaced tipping at their restaurants with automatic service charges or inclusive pricing.…
L.S. Starrett Co.
(L.S. Starrett: Athol, MA) -- The L.S. Starrett Co. has introduced a comprehensive line of innovative, entry-level computer-based force testing solutions for applications ranging from load limit and distance testing to break limit, time average, cyclic count and duration testing, constant hold,…
Mike Figliuolo
When you set goals, there’s commonly two types: quantitative and qualitative. By setting both types of goals for your organization, you can achieve a balance of results driven by people focusing on the behaviors that matter.
Quantitative goals and driver metrics
When you set quantitative goals,…
Jon Speer
Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going on once a medical device has reached the market, and it can be challenging to keep up with…
Andrew Hwang
National discussions of crucial importance to ordinary citizens—such as funding for scientific and medical research, bailouts of financial institutions, and revised tax laws—inevitably involve dollar figures in the millions, billions, and trillions. Unfortunately, math anxiety is widespread even…
Eric Stoop
With only a handful of aerospace original equipment manufacturers (OEMs) as potential customers, aerospace suppliers have to hustle to make sure they’re selected. Stand out for the right reasons, and you could solidify 20 years worth of business. Make the wrong impression, and you could miss out…
Annet Aris
After an initial phase of euphoria about how the digital world improves our daily life with virtual assistants, among other gadgets and services, slowly but surely, we're coming firmly back to earth. Post-honeymoon, the breakneck speed of digital development has created an increasing number of…
ISO
Ageing wastewater systems are under threat from growing populations, urbanization, pollution. and climate change, not to mention human behavior. However, despite these challenges and fears for health and safety, the new ISO 24516 series is playing a key role in turning what many consider a burden…
Eric Cooper
You’re in the market to build a new house. Would you tell the builder what you’re looking for, or would you just tell him to build “something?” If the latter, what’s the likelihood that the house you end up with is going to be what you want? Documenting your requirements should be obvious, right…
Bruce Bolger
HighlightsThe New Focus on People Overview of ISO 9001:2015 Standards and the ISO 10018 Certification How This Microsite Helps Quality Management, Auditors, and Solution Providers Articles ResourcesOther Articles In This Series
This Month's Featured ArticleAccumold Starts With the Why
Can the…
Kevin Meyer
Ever since I visited Italy more than a decade ago my inner geek has had a fascination with traffic engineering. If you’ve visited Italy, or many similar places, you probably know why. Traffic appears chaotic, thanks in part to what appears at first glance to be a lack of signals and other controls…
Jack Barkenbus
Every day about 100 people die in car crashes on U.S. roads. That death toll is a major reason why both Congress and the Trump administration are backing automotive efforts to develop and deploy self-driving cars as quickly as possible.
However, officials’ eagerness far exceeds the degree to…
Robert Means
Manufacturing is an industry in flux. Characterized by increasing pressure from global competitors, the impact of new technologies, Industry 4.0, and the “smart factory,” the face of manufacturing is changing drastically for the better. In a recent manufacturing outlook survey from the National…
Kostya Kimlat
A sale, like a great magic trick, occurs inside the customer’s mind. And it is there where it is replayed, remembered, and redefined continually afterward. Because magicians are masters of perception, they understand how to get into the heads of their prospects better than anyone else. That’s why…
