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All Features

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…
MDSAP: When Is a Certificate Not a Certificate?
Grant Ramaley
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485…
Inside Quality Digest Live for September 12, 2018
Mike Richman
With more than 110,000 expected attendees, IMTS is Chicago’s hottest suburb this week. (I like to refer to it as “Manufactureville.”) Here’s what we covered during our second show of the week, from the booth of today’s sponsor, Q-Mark Manufacturing: “Tapping Your Employee’s Knowledge” It’s no…
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…
FDA Advances Efficient Approaches to Designing and Conducting Cancer Clinical Trials
Richard Pazdur
During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large in magnitude or response durations prolonged in early…
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?…
Silver Toaster Spirit
Bruce Hamilton
Bob C. was a frontline employee with 25 years of experience. His day was spent operating a machine that stripped and terminated leadwire assemblies. Problem was, there were more than 1,000 different assemblies, and it seemed that, while the machine was always busy, it was always behind schedule.…
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…
‘It’s Hard to Learn if You Already Know’
Mark Rosenthal
During a TED talk, Amy Edmondson, the Novartis Professor of Leadership and Management at Harvard Business School, talks about “How to turn a group of strangers into a team.” Although long-standing teams are able to perform, our workplaces today require ad-hoc collaboration between diverse groups.…
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…
Finding Success With 6S
Jared Evans
Implementing 6S, the lean strategy for reducing waste and optimizing efficiency in a manufacturing environment, is more than just creating work protocols that people must follow. Because that’s the thing about people: If they don’t know the “why,” they are less likely to buy in to any initiative,…
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…
Four Fundamentals of Requirements Management
Jama Software
Requirements are the information that best communicates to an engineer what to build, and to a quality-assurance manager what to test. A requirement has three functions: • Defines what you are planning to create • Identifies what a product needs to do and what it should look like • Describes the…
Thinking About Thinking
Kevin Meyer
For the past several years, I’ve been fascinated by how we think—and how that affects us, our leadership, and the organizations we’re a part of. A couple years ago I wrote about the beginner’s mind and the various forms of bias, particularly confirmation bias. During the past couple months, I’ve…
How Load Cell Stability Can Kill Your Uncertainty Budget
Henry Zumbrun
Load cells are a combination of metal, strain gauges, glue, and more. Over time, fatigue ensures that there will be some instability in the system. Load cell stability or drift is usually assumed to be the amount of change in the entire cell system from one calibration cycle to the next. It is the…
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,…
Identity of an Organization: ISO 9004:2018’s Most Important Feature
William A. Levinson
ISO 9004:2018—“Quality of an organization—Guidance to achieve sustained success” expands considerably on the former (2009) revision. It introduces the important concept of “quality of an organization” (Clause 4.1), which makes excellent sense. If the organization’s processes are of high quality, we…
ESPRIT Helps BRAKO Create 2,000 Machining Programs in One Year…
Hélène Horent
Founded in 1947, in Veles, Macedonia, BRAKO produces parts and components used in medical devices, road sweeper trucks, airport ground equipment, forklift accessories, metal-welded constructions, small hydro plants, telecommunications shelters, and antenna towers. The company also makes various…
Lean Manufacturing and the Smart Factory
Ryan E. Day
As manufacturing finds its way through the 21st century, there’s a groundswell change emerging. Organizations are jockeying for competitive position as they endeavor to describe this phenomenon. Industry 4.0, the fourth industrial revolution, and the industrial internet of things (IIoT) are a few…
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…
Integrating and Standardizing QMS, EMS, and OHSMS Management Systems
Chad Kymal
There is a proliferation of management system standards and requirements globally. These management system standards are either customer or industry mandated. Many standards are becoming a requirement for doing business. For example, ISO 9001 is a quality management system (QMS) standard with…
If You’re Only Relying on Data From SPC, You’re Doing It Wrong
Ryan E. Day
‘In God we trust; all others bring data.” “Follow the data.” “Let the data talk.” Nice clichés, but there’s one problem... data can’t talk. In fact, data don’t say a darn thing. Data are bits of raw information. If you want to reduce product variation, improve your manufacturing processes, and…

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