Quality Features

Jon Speer's picture
Jon Speer
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized...
Jason Furness's picture
Jason Furness
One of my hobbies is building and flying radio-controlled model aircraft. Not the small foam ones from Kmart but larger 2-m wingspan craft. It is a lot of fun and usually very relaxing. My birthday...
Annet Aris's picture
Annet Aris
Even tedious jobs like cleaning out archives can sometimes lead to great insights. Sifting through my old files recently, I was pleasantly surprised to find a treasure trove of old memories and...
James daSilva's picture
James daSilva
When you think about Domino’s, you think about getting pizza quickly—30 minutes or less. Domino’s has also become known for technology, including flashy and fun concepts such as the Associated Talent...
Larry Hardesty's picture
Larry Hardesty
MIT researchers have developed a computer interface that can transcribe words that the user verbalizes internally but does not actually speak aloud. The system consists of a wearable device and...
The Un-Comfort Zone With Robert Wilson's picture
The Un-Comfort Zone With Robert Wilson
Many people are writing about innovation. Yet, the more I read, the more confusing the term becomes. Some have said an innovation is an idea. Others have said an idea isn’t an innovation until it...
Jody Muelaner's picture
Jody Muelaner
Whether we like it or not, manufacturing is becoming digitized and connected. Industry increasingly connects production machinery with internet of things (IoT) devices, gathers multiple real-time...
James Beagle III's picture
James Beagle III
In Parts One and Two we defined the equivalence of instruments in terms of bias and measurement error based on studies using a single standard. Here we look at comparing instruments for differences...
Jeremy Marvel's picture
Jeremy Marvel
I was told there would be robots. We are living in a world in which we are surrounded by technology tailored to our needs. Our clothes are treated with nanoparticles to resist wrinkles and stains....
Anonymous's picture
Rick Gould
Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new...
Innovating Service With Chip Bell's picture
Innovating Service With Chip Bell
Many years ago, I worked for the president of a bank famous for aggressive bank acquisitions and rapid growth in the financial services space. The bank ultimately became the Bank of America, and the...
Matthew M. Lowe's picture
Matthew M. Lowe
While most business sectors have welcomed the efficiencies and benefits that cloud technologies and software-as-a-service (SaaS) offerings bring, the life sciences industry has been slow to embrace...
Quality Transformation With David Schwinn's picture
Quality Transformation With David Schwinn
As some of you already know, I was in Ford Motor Co.’s corporate quality office during the early 1980s when, just after “If Japan Can, Why Can’t We” aired on NBC, we pleaded with W. Edwards Deming to...
David Dubois's picture
David Dubois
Faced with a growing range of tech solutions in marketing, from AI to big data to blockchain, business-to-business (B2B) companies too often choose the status quo. Recent evidence suggests the divide...
Kevin Meyer's picture
Kevin Meyer
My favorite part of a recent podcast with James Clear, author of Atomic Habits (Avery, 2018), was the last five minutes, when he talked about a potential downside of good habits. When we decide to...
Jon Speer's picture
Jon Speer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for...
Jay Arthur—The KnowWare Man's picture
Jay Arthur—The KnowWare Man
When I first learned quality improvement back in 1989 at Florida Power and Light, the consultants who trained us taught a very specific way to draw a Pareto chart. They’d been trained in Japan, the...
Jessica Thiefels's picture
Jessica Thiefels
A leader’s job is to keep the team on track. You focus on hitting deadlines and executing projects without losing focus or getting lost in the weeds of decisions, communications, and logistics. The...
James J. Kline's picture
James J. Kline
The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for...
Nicole Radziwill's picture
Nicole Radziwill
As early as 2015, McKinsey’s “Digital America” report projected that adoption of Industry 4.0 technologies in manufacturing alone was expected to increase domestic GDP by more than $2 trillion by...