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Improving Online Data Security
Ken Miller
Your employees are your greatest asset—and your greatest cybersecurity risk. That statement may sound harsh, but hackers often prey on unwary employees because employees can provide easy access to otherwise secure systems. Remember the Anthem breach earlier this year? Hackers gained access to…
When Inspections and Regulations Leave Quality Lacking, Try This
Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
Are You Wearing ISO 9001’s Risk-Based Thinking Cap?
Mika Javanainen
With more than one million certifications issued, ISO 9001 is the world’s most widely adopted framework for quality management systems, helping companies achieve conformity of products and services to meet customer expectations and regulatory compliance. The ISO 9001 standard has become synonymous…
Opening Soon: World-Class Facility for Infrared Calibrations
NIST
The National Institute of Standards and Technology (NIST) is about to open the world’s most accurate facility for calibrating infrared (IR) detectors. What makes this possible is an extremely precise reference scale based on NIST’s newly developed standard detectors with sensitivities two orders…
Three Metrics to Measure On-Site Training Effectiveness
Michelle LaBrosse
Project managers, and especially certified project managers, know firsthand the value of quality training for their own professional development and effectiveness. Being a project management professional (PMP), after all, requires project managers to pursue ongoing education to maintain their…
The Secret Foundation of Statistical Inference
Donald J. Wheeler
When industrial classes in statistical techniques began to be taught by those without degrees in statistics it was inevitable that misunderstandings would abound and mythologies would proliferate. One of the things lost along the way was the secret foundation of statistical inference. This article…
Fundamental Constants: The Latest—and the Last?
NIST
In a world of incessant change, some things have to stay the same. One is the set of values for the fundamental physical constants—such as the speed of light or the charge of the electron—that underlie precision measurements in industry, science, and medicine worldwide. Yet even the constants…
More Data Don’t Always Mean Better Insights
Gallup
As technology advances, it’s tempting for companies to believe that gathering more data and crunching more numbers will consistently lead to better customer insights. But Gallup finds that’s not always the case, particularly in the business-to-business (B2B) arena. Here’s why: For B2B companies,…
Developing Cross-Functional Accountability
Mark Rosenthal
It's a typical staff meeting. The function heads sit around the table with the boss. One of them describes a hiccup or problem he's encountering that's outside of his control because it originates in another department. An action item is assigned, and we move on to the next topic. Good to go,…
Know Your Distribution
William A. Levinson
The Shewhart control chart is relatively insensitive to non-normal distributions, and the worst foreseeable consequences of a wrong decision involve searching for an assignable or special cause when none is present. The economic consequences depend on the time wasted, and whether unnecessary…
Happiness Starts in the Head
The Un-Comfort Zone With Robert Wilson
During the late 1970s when I was a college psychology student, I worked in two different psychiatric hospitals. I was enthralled with my studies and loved learning what made people tick. Especially what motivated them. At the same time I was disturbed by the therapy I was witnessing. Depressed…
We’re Not Alone, Children Remind Us
Quality Transformation With David Schwinn
This month’s column results from my wife, Carole, asking me to “watch this.” This was a short video on her computer showing two young children brilliantly and inspirationally singing, “You Raise Me Up.” I was dumbstruck. Their song immediately took me to many places. I was reminded of the wisdom…
The Boss and the Innovator
Harry Hertz
I feel like I should start this article with something like: “An innovator and a boss walk into a bar....” But I don’t have a punch line to follow it, so I’ll stick to the facts. I recently read a blog post titled, “Think Like an Author, Not an Owner.” I felt the story should be more accurately…
Improving FDA Reviews of Combination Products
Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…
Forget Winning; Think Improving
Dawn Bailey
I recently had the great experience of speaking as part of a panel on the value of the Baldrige Excellence Framework, but what meant the most to me was the chance, I hope, to dispel some common misconceptions about what the Baldrige is actually all about. And, no, it’s not just an “excellence…
How to Create a Culture of Continuous Improvement
John Hunter
I have discussed steps to take to build a culture of continuous improvement in numerous posts on my Curious Cat Management Improvement blog. What it boils down to is building a system that supports that culture. Your culture is the result, not your aim. David Heinemeier Hansson put it well…
Lazy Lean Guy
Bruce Hamilton
In 1987, shortly after I became a manufacturing manager, the shop foreman at the time warned me about a young assembler. “Watch out for Michael,” the foreman said. “He tends to bend the rules. You may need to talk to him.” In fact, I did watch Michael, and it did appear that he approached his…
So Why Is It Called ‘Regression,’ Anyway?
Patrick Runkel
Did you ever wonder why statistical analyses and concepts often have such weird, cryptic names? One conspiracy theory points to the workings of a secret committee called the International Committee for Sadistic Statistical Nomenclature and Numerophobia (ICSSNN), which was formed solely to befuddle…
The CEO’s Role in Knowledge Management
Arun Hariharan
I do not presume to preach to business leaders (CEOs and other senior managers). However, having helped a number of organizations and their leaders with knowledge management (KM), I’ve observed certain leaders who are able to achieve greater and more sustainable results from KM than others,…
Is Customer Experience Really Everyone’s Job?
Annette Franz
Pundits and experts alike say that ensuring a good customer experience (CX) is everyone’s job. In fact, if you Google “customer experience is everyone’s job” or “customer service is everyone’s job,” you’ll find endless articles, blogs, and webinars with that very title. It’s true. Technically, it…
FDA Eases Up a Bit on Enforcement Gas Pedal
Michael Causey
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the U.S. Food and Drug Administration (FDA). The number of medical device-related warning letters dipped to 121 during calendar year (CY) 2014, compared to 144 during the…
Ten Mistakes Great Leaders Avoid in Building Work Culture
Shawn Murphy
Culture eats strategy for breakfast. It doesn’t matter how great your plans to introduce a new product to the market are if your culture weakens execution. Culture is how things get done around a company. Great leaders focus on the work culture their leadership helps create as much as they focus…
Fitness Test for Old Pipes
Artec 3D
Thames Water is the United Kingdom’s largest water and wastewater services provider with more than 15 million customers. As part of its business, Thames Water delivers an average of 2,600 million liters of drinking water every day. The company’s cast-iron water mains in many areas of London and…
How Many Episodes Does It Take to Get Hooked on a TV Show?
Michelle Paret
I have two young children, and I work full-time, so my adult TV time is about as rare as finding a Kardashian-free tabloid. So I can’t commit to just any TV show. It better be a good one. I was therefore extremely excited when Netflix analyzed viewer data to find out at what point watchers get…
How to Prepare Your Team for Customer Service Training
Jeff Toister
You’re ready to send your team to customer service training. The big question is whether your team is ready. Chances are, they’re not. A 2010 McKinsey & Co. survey revealed that approximately 75 percent of training programs failed to measurably improve business performance. A lack of…

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