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How to Structure Your Medical Device Technical File
Jon Speer
The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must…
How Do You Get the CEO to Care About Customers?
Chip Bell
Iam often asked by customer service leaders how to get the CEO to care about customers. They are convinced there is a missed tactic that, if implemented, would have the C-suite camping out in the contact center and inviting customers to board meetings. When I outline a number of possible approaches…
Counting Queries: Extracting Key Business Metrics From Datasets
David Darais, Joseph Near
How many people drink pumpkin spice lattes in October, and how would you calculate this without learning specifically who is drinking them, and who is not? Although they seem simple or trivial, counting queries are used extremely often. Counting queries such as histograms can express many useful…
Quality Management Can’t Be Optional Anymore
Graham Freeman
Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable. Although there have been some admirable successes, such as the food and beverage organizations that have ensured the continued safe delivery of food supplies to most…
Growing a More Resilient Global Food System
Bob Holmes, Knowable Magazine
This story was originally published by Knowable Magazine. Most of us won’t soon forget that disconcerting moment last spring when grocery store shelves were suddenly bare where the flour, pasta, and other staples should have been. The news told of farmers dumping milk—nearly four million gallons a…
Three Ways Employers Could Help Fight Vaccine Skepticism
Rita Men
Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or even 80 percent to 90 percent of a population. With some 30 percent of Americans telling pollsters they have no interest in getting vaccinated, that’s cutting it a bit close. The numbers are even worse in many other…
Food Processing: Selecting a Conveyor to Minimize Dust Explosion Risk
Del Williams
On conveyor systems in the food processing industry, some powdered and bulk solid materials such as grains, sugar, and creamer are ignition-sensitive in specific concentrations, particularly when exposed to static electricity discharge. Key concerns are conveyor-system connection points such as…
Quality Professionals Need Better Tools to Handle Their Expanded Duties
Dirk Dusharme @ Quality Digest
Quality professionals no longer focus solely on product or service quality. Today, the quality function is involved in almost every aspect of a company, from customer interactions and compliance management to environmental health and safety, supply chain management, risk management, and more. A…
Threat Models for Differential Privacy
Joseph Near, David Darais
It’s not so simple to deploy a practical system that satisfies differential privacy. Our example in the last post was a simple Python program that adds Laplace noise to a function computed over the sensitive data. For this to work in practice, we’d need to collect all the sensitive data on one…
Cost of Quality: What Is It, and Why Is It Important?
Michael Mallen
The concept of cost of quality (COQ) has been around for decades, but applying it to business is difficult. The adage “quality is free” (coined by Philip B. Cosby in his book by the same title) does not simply mean that you don’t have to pay for it. It means that you are likely already paying to…
Biased AI Can Be Bad for Your Health
Sharona Hoffman
Artificial intelligence holds great promise for improving human health by helping doctors make accurate diagnoses and treatment decisions. It can also lead to discrimination that can harm minorities, women, and economically disadvantaged people. The question is, when healthcare algorithms…
Detecting Abnormal Cyber Behavior Before a Cyberattack
Michael P. Powell
The promise of advanced manufacturing technologies—also known as smart factories or Industry 4.0—is that by networking our machines, computers, sensors, and systems, we will (among other things) enable automation, improve safety, and ultimately become more productive and efficient. And there is no…
How to Tame a Belligerent Colleague
Manfred Kets de Vries
Serge faced a conundrum. One of his business partners was in a legal dispute with Serge’s father, Charlie, and asked for his help. Serge knew that his father was prone to suing everyone who crossed his path—including family members. The business partner had repeatedly tried to end this legal fight…
Backlash Against Johnson & Johnson’s Covid-19 Vaccine Is Real and Risky
Tinglong Dai, Christopher Tang, Ho-Yin Mak
More than 50 million Americans have received at least one dose of either the Pfizer or Moderna Covid-19 vaccine. So far, Americans have been largely brand-agnostic, but that’s about to change as the Johnson & Johnson vaccine rolls out. The vaccine has been hailed as a game changer. It requires…
Differential Privacy for Privacy-Preserving Data Analysis
Joseph Near, David Darais, Kaitlin Boeckl
Does your organization want to aggregate and analyze data to learn trends, but in a way that protects privacy? Or perhaps you are already using differential privacy tools, but want to expand (or share) your knowledge? In either case, NIST’s blog series on differential privacy is for you. Why are…
How to Pressure Test Your Strategic Vision
Theodore Kinni
There is no shortage of advice regarding the art and craft of business strategy. Yet, in 2019, when the consulting firm Strategy& surveyed 6,000 executives, only 37 percent said their companies had well-defined strategies, and only 35 percent believed that their strategies would lead to success…
Long-Lasting Impact of Pandemic on Supply Chain Quality
Sébastien Breteau
It’s been about one year since the Covid-19 impact intensified from a seemingly isolated health scare to a worldwide, ubiquitous tragedy that has upended daily life as we know it. Ever since consumers first faced widespread product shortages of essential items during the early days of the pandemic…
Taking a Qualitative Approach to a Data-Driven Market
Nate Burke
Undeniably, the power of data is unmatched. With an abundance of data collection opportunities available online, and with an increasing number of businesses taking them, the potential and value of such information is richer than ever before. And businesses are benefiting. Particularly where data…
Pandemic Makes Plain the Need for Manufacturing Workforce
Mark Schmit
During the Sept. 18, 2020, session of the “National Conversation with Manufacturers,” our three West Coast manufacturing leaders on the panel kept coming back to their critical need for skilled workers. The conversation was one in a series of 11 virtual listening sessions hosted by the National…
Bendable Concrete and Other CO2-Infused Cement Mixes Could Dramatically Cut Global Emissions
Lucca Henrion, Duo Zhang, Victor Li, Volker Sick
One of the big contributors to climate change is right beneath your feet, and transforming it could be a powerful solution for keeping greenhouse gases out of the atmosphere. The production of cement, the binding element in concrete, accounted for 7 percent of total global carbon dioxide emissions…
What Is Your True Cost of Quality?
James Wells
When is a product “good enough” to accept? This is the classic challenge of quality. High customer expectations demand that suspect products be thoroughly scrutinized and a high standard set for their release. Customers expect this, and quality staff strive to achieve it. The other side of the tug…
Benefits of Workflow Automation in B2B E-Commerce
Yoav Kutner
Like business-to-consumer (B2C) e-commerce, business-to-business (B2B) e-commerce allows customers to purchase parts and supplies via an online portal. The difference is that in B2B e-commerce, both the customers and suppliers are businesses, and the customers may or may not be the end users of the…
What Ails Corporate Executive Committees?
Jose Luis Alvarez
Alexander Hamilton, one of the United States’ founding fathers, famously called energy the most important characteristic of the executive branch of government. “A feeble Executive implies a feeble execution of the government,” he said in the Federalist Papers. “A feeble execution is but another…
Why Your Negotiations As a Quality Professional Are Doomed
Gleb Tsipursky
Negotiators, even professional ones, make surprisingly many wrong decisions that doom negotiations that should have succeeded. Many of these mistakes relate to overestimating how well they can read the feelings and thoughts of other parties in the negotiation, as well as the extent to which the…
Overcoming Barriers to Supply Chain Agility
Aarti Gumaledar, Sameer Hasija, V. Paddy Padmanabhan
Globalization of trade and decades-long innovation in supply chain networks have resulted in significant benefits for all stakeholders—greater efficiencies, lower costs, and greater access to markets, to name just a few. Yet Covid-19 has exposed vulnerabilities in global supply chains. Dispersed…

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