All Features
Chad Kymal
When Philip Crosby announced zero defects as a philosophy during the 1970s, it was met with incredulity. There were already many articles written on the fallacy of such a strategy and the enormous costs of moving toward zero defects. Fast forward 40+ years, and zero defects has become a reality.…
Therese Graff
Medical device companies use ISO 14971 to identify and manage user risks with their devices. However, we often find these same companies do not manage their project risks well.
What is project risk management?
The Guide to the Project Management Body of Knowledge (Project Management Institute,…
Roy Swift
Certificates, certifications, badges, and licenses: What are they worth to the workforce? The last decade has seen huge growth in the number and variety of credentials, and this explosion has fueled a great deal of confusion among students, workers, job seekers, employers, and others.
Job seekers…
Olympus
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Restriction of hazardous substances (RoHS) regulations help protect the public from dangerous or toxic materials in consumer products and electronics. Beyond public health and safety concerns, noncompliance represents significant potential costs, including fines, product recalls…
Ben Snedeker
Storms like Hurricanes Irma and Maria as well as other natural disasters bring with them lots of uncertainty: Where will they go? How much damage will they cause? What is certain is that no matter where they strike, natural disasters knock out power.
And no power means no internet for thousands…
Knowledge at Wharton
NASA Chief Astronaut Chris Cassidy has lived for months on the International Space Station and has performed six spacewalks. “Imagine hanging out with a glass bubble on your head, one hand on a hunk of metal, Earth going beneath your feet at five miles a second, and the whole world listening to…
Ann Cleland
If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017, security advisory from the company.
The Industrial Control System Cyber Emergency Response Team (ICS-CERT…
William A. Levinson
Some ISO 9001 users complain that the standard does not improve performance or deliver bottom-line results, while others are delighted by the standard as a framework for effective quality management systems. I pointed out previously that ISO 9001:2015 does not address, at least not explicitly, the…
Mike Richman
Our most recent episode of QDL from Friday, Sept. 29, 2017. featured news, technology, and two great interviews. Let’s have a closer look:
“Domestic Cars Fail to Keep Up With International Competition”
The most recent American Customer Satisfaction Index (ASCI) survey took a look at people’s…
Jack Phillips, Patti Phillips
According to W. Edwards Deming, “Every system is perfectly designed to achieve exactly the results it gets.” This applies to any quality initiative and any other activity, including learning and development. Yet, according to an ATD/ROI Institute study, only 8 percent of CEOs see the results most…
Anna Abram
We’re at a moment of extraordinary opportunity to improve public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets and products that can expand…
Arun Hariharan
In my October 2013 column, “Standardize to Improve,” I dealt with business process mapping in detail. Business process management systems (BPMS) comprise the entire gamut of documenting process steps, assigning ownership to process owners, and often, process-compliance audits to check whether you…
Mary McAtee
True to my profession as an engineer, I am a total geek at heart and proud of it. Spending time in automobile museums always fascinates me. It excites me to see a prescient innovator from the past come up with an idea like headlights. The first ones were Limelight carbide models that had a nasty…
Thomas Kochan, Lee Dyer
The technologies driving artificial intelligence (AI) are expanding exponentially, leading many technology experts and futurists to predict that machines will soon be doing many of the jobs that humans do today. Some even predict humans could lose control over their future.
While we agree about…
Jacqueline Calhoun
Which cybersecurity-related activities are most important to your business strategy and critical service delivery? How do you assess the effectiveness and efficiency of your use of cybersecurity standards, guidelines, and practices? To answer these questions and build excellence in your…
Joshua Fairfield
Internet-enabled devices are so common, and so vulnerable, that hackers recently broke into a casino through its fish tank. The tank had internet-connected sensors measuring its temperature and cleanliness. The hackers got into the fish tank’s sensors and then to the computer used to control them…
Peter Merrill
ISO 9001:2015 has significant structural changes that differentiate it from the previous standard. The new high-level structure is common to all ISO management system standards (i.e., quality, environmental, IT security) and enables us to start looking at integration of these systems. There is a…
Joe Bollard
As of Sept. 14, 2018, ISO/TS 16949 certificates are longer valid, which means automotive suppliers must certify to the new version, IATF 16949. Transition audits are underway and will continue into next year, but many companies still have a long way to go to prepare.
Let’s look at some of the…
Mary Drotar
A recent article in MIT Sloan Management Review, “Using Scenario Planning to Reshape Strategy,” indicated a resurgence of scenario planning that initially gained recognition during the 1960s and ’70s. Royal Dutch/Shell has been the “poster child” of success ever since it used scenario planning to…
Dirk Dusharme
Our Sept. 8, 2017, episode of QDL examined a different way to conduct clinical trials, discussed fixing problems before they occur, and in the aftermath of Hurricane Harvey looked at resources for building a more resilient and sustainable infrastructure.
“A Better Way to Design Clinical Trials”
A…
Laurel Thoennes @ QD
There’s nothing like a splash of cold water to wake you up. Imagine what a 33-trillion-gallon splash would do. Maybe 24 hours of wind at 185 miles per hour would sweep you onto your feet. Hurricanes Harvey and Irma said, “Wakey wakey,” and we can’t afford to nod off.
How do you recover from…
Arun Hariharan
In the last week of August 2017, two extreme weather events occurred on opposite sides of the world. Hurricane Harvey brought record-breaking rain and catastrophic flooding to Houston, Texas, causing loss of life, mass evacuation of people, and damage estimated to be in billions of dollars. Around…
Greg Hutchins
I live in the Northwest of the United States. We are now the small business and startup mecca of the country. Why? San Francisco and Silicon Valley are too expensive. So, folks are moving in droves to Portland and Seattle; one-third of the license plates in my hood are out of state.
But there are…
DNV GL
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A new report by Jupiter Research says $8 trillion will be the price tag—within the next five years—of cyber attacks against businesses around the world. Hacks and other forms of digital theft are accelerating despite what would seem to be nonstop efforts by corporations to harden…
Stephen Chick
Value has found a place at the heart of healthcare innovation. For money-conscious governments and other actors in the system, it’s not enough that a new treatment be beneficial and safe. It also needs to be cost effective.
This emphasis on value is even changing the profile of the pharmaceutical…