All Features
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…
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…
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…
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…
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…
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…
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…
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…
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,…
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…
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…
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…
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…
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…
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…
AssurX
Proposed in 2012 and now in effect, the general data protection regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to better protect personal data of individuals in the European Union (EU) by making companies more accountable for how…
Vanessa Burrows, Suzanne Junod, John Swann
During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.
A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in fact…
Dirk Dusharme
If asked whether you guard your company’s secrets, most of us would say, “Well, of course I do.” But I’m guessing that if you are a remote worker, or do any work while on the road, you are blithely handing out company secrets and don’t even know it. If nothing bad has happened yet, it’s only…
Thomas R. Cutler
Although automation has been successful in replacing repetitive, simple tasks, the human workforce still plays a critical role in manufacturing. Even the most sophisticated and automated manufacturing operations rely on human operators to configure, run, and properly maintain production equipment…
Fred Schenkelberg
Reliability activities serve one purpose: to support better decision making. That is all they do. Reliability work may reveal design weaknesses, which we can decide to address. Reliability work may estimate the longevity of a device, allowing decisions when compared to objectives for reliability.…