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Mismanaged Cloud Services Put User Data at Risk
Eric Pauley
Organizations’ failure to properly manage the servers they lease from cloud service providers can allow attackers to receive private data, as research my colleagues and I conducted has shown. Cloud computing allows businesses to lease servers the same way they lease office space. It’s easier for…
Editorial Quality Assurance the Old-Time Way
Mark Hembree
As a late Boomer, I can say my particular age group is better positioned than any to marvel at and bemoan what’s become of journalism and publishing in the last 40 years. Not that I’m a Luddite. The advent of word processors was a boon to ham-fisted typists like me. A word processor that actually…
Everything You Need to Know About Root Cause Analysis
Brittney McIver
At some point, every medical device company will encounter an issue that requires an internal investigation. Whether it’s due to a nonconformance, complaint, CAPA, or an audit issue, you’ll have to conduct a failure or root cause investigation to pinpoint why the issue occurred in order to resolve…
New Regulations Will Tighten Companies’ ESG Disclosures
Marc Lepere
As the war in Ukraine rages, finance professionals on Wall Street and in Europe recently attracted outrage by suggesting that investing in arms manufacturers should be treated as ethical investing. In the fight against tyranny, they argued that such an investment “preserves peace and global…
How to Have More Successful Conversations
Knowledge at Wharton
Negotiating a salary increase or a job promotion ranks high on the list of hard conversations to have at work, and it doesn’t get any easier without a plan. “People think, ‘I’m just going to knock on their door, sit down with them, and noodle around and see where this goes.’ That’s not a plan,”…
Intermediaries Must Produce or Get Out
William A. Levinson
Ryan Day1 describes how the rise of independent auto dealers is a “gray swan” event for the automobile industry. This was not only bound to happen, as observed by the author, but also long overdue. The article states, “...current state laws prohibit OEMs from selling new vehicles directly to…
How Standards Can Help Catch Climate Change Cheats
ISO
After lengthy wrangling, the 2021 COP26 climate summit ended with 197 parties agreeing to the new Glasgow Climate Pact. It will get countries to strengthen their CO2 emissions-cutting targets for 2030 by the end of next year, and formally recognize the need to reduce global greenhouse gas emissions…
Software Bill of Materials for Medical Devices
Wade Schroeder
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product. Given that…
Too Happy Too Soon
Bruce Hamilton
The level of excitement was high in our machine shop as we drew closer to our goal of less than 9-minute changeovers on the BNC lathe. (See Part One of this story for how we got there.) Setup improvements had so far reduced changeover time to 20 minutes, cutting the economic order quantity from…
Why Sometimes You Need to Source Locally
Jonathan Gilpin
The world of procurement is often tricky. It involves choosing one appropriate candidate, ultimately benefiting them while rejecting and disadvantaging others. That said, it isn’t just the businesses picked that will profit from winning the contracts; it’s also their supply chain, their local…
Sanctions on Top of Covid: Trouble Ahead for Global Supply Chains
Tinglong Dai
Francis Fukuyama, the U.S. political scientist who once described the collapse of the Soviet Union as the “end of history,” suggested that Russia’s invasion of Ukraine might be called “the end of the end of history.” He meant that Vladimir Putin’s aggression signals a rollback of the ideals of a…
Managing Medical Device Vulnerabilities With Compensating Controls
Dennis Fridrich
As the number of networked medical devices grows, so too will online threats and vulnerabilities. In this era of interconnectivity, healthcare systems must prioritize medical device security and patient safety. The heightened risk is drawing the attention of federal regulators, who warn that “it…
Do Your Job
Bruce Hamilton
We had been working with the Toyota Production System Support Center (TSSC) for two years to build a model line in our assembly department. As we moved from small batch production to one-by-one, the results had been astounding: Customer lead time reduced from two weeks to one day, crew size cut in…
Data Science Paves the Way for Road Safety
Danielle Underferth
As municipalities clamor for a slice of President Biden’s $1.2 trillion infrastructure spending bill, one Johns Hopkins scientist is re-examining one of the basic elements of road-building: Determining the width of road lanes. But determining the width that provides the highest level of safety,…
Safely Studying Dangerous Infections Just Got a Lot Easier
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years. Now,…
How Do You Know You’re Getting What You Pay For at the Grocery Store?
NIST
Whether it’s bananas, olives, potato salad, or cereal, many products are priced according to their weight. That weight is likely determined on a scale tested and certified by a specially trained state or local inspector. Weights and measures underpin approximately half of the United States gross…
A Security Technique to Fool Would-Be Cyber Attackers
Adam Zewe
Multiple programs running on the same computer may not be able to directly access each other’s hidden information. But because they share the same memory hardware, their secrets could be stolen by a malicious program through a “memory timing side-channel attack.” This malicious program notices…
Ninety Percent of Drugs Fail Clinical Trials
Duxin Sun
It takes 10 to 15 years and around $1 billion to develop one successful drug. Despite these significant investments in time and money, 90 percent of drug candidates in clinical trials fail. Whether because they don’t adequately treat the condition they’re meant to target or the side effects are too…
Important Factors in Implementing an Effective HACCP
Violetta Njunina
According to the CDC, approximately one out of six Americans are diagnosed with foodborne diseases each year. Out of this, about 128,000 are hospitalized, and as many as 3,000 lose their lives. These sorry statistics show why food safety is paramount and why more effort should be put into reducing…
Use the Context in Your Data to Enable Process Improvement
Scott A. Hindle
In 2010, new to the world of statistical process control (SPC), I was intrigued by Don Wheeler’s statement that “No data have meaning apart from their context” (from his book, Understanding Variation—The Key to Managing Chaos, SPC Press, 2000, available on Amazon). For a while, I didn’t really get…
The Answer to Manufacturing’s Waste Problem is Hidden in Data
V R Vijay Anand
As the world moves toward a new, post-pandemic normal, industries must leverage digital transformation at an accelerated pace. This is already happening. According to IBM, 67 percent of manufacturers have accelerated digital projects since Covid-19. Although improved operational efficiency is…
Signs of Spring
Bruce Hamilton
Every February, there are welcome reminders that spring is on the way. The first for me is a witch hazel bush in my front yard that defies subfreezing weather to produce fragrant yellow flowers. Then, a few weeks later, crocuses and winter aconites will emerge from the snow. The cycle continues…
Analyzing Experimental Data
Donald J. Wheeler
Last month we looked at analyzing observational data. Here we will consider experimental data and discover a weakness in the way they are obtained that can contribute to the problem of nonreproducible results. Background The discipline of statistics grew up in agricultural and biomedical research…
Bad Management, Burnout, and Health Fears
Andrew Moreo, Imran Rahman, Lisa Cain, Trishna Mistry
About 3.5 million people have at least temporarily left the U.S. workforce since March 2020. More than one-third of them—1.2 million—are in the leisure and hospitality industry. This has created huge problems for restaurants, hotels, and other leisure and hospitality businesses that have struggled…
How to Translate Lean Principles Into Your Office Functions
Keith Groves
The lean manufacturing movement evolved from a desire to reduce waste and inefficiencies and improve productivity on the shop floor. Many manufacturers have also benefited from the resulting continuous improvement mindset as engaged employees became empowered to change things for the better.…

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