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Stephanie Hinton
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this as one of…
Bruce Hamilton
I’ll admit it: After five decades watching U.S. companies turning to simplistic accounting tricks to remain profitable, I’m discouraged.
I was a kid when I first discovered the Toyota Production System (TPS). My eyes were opened to the immense amount of waste in our production and business…
Stephanie Ojeda
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey.
This occupational health and safety standard is especially prevalent in manufacturing, where managing safety incidents is a core concern from the perspective of protecting workers,…
Donald J. Wheeler
Many articles and some textbooks describe process behavior charts as a manual technique for keeping a process on target. For example, in Norway the words used for SPC (statistical process control) translate as “statistical process steering.” Here, we’ll look at using a process behavior chart to…
William A. Levinson
The difference between common (or random) cause and special (or assignable) cause variation is the foundation of statistical process control (SPC). An SPC chart prevents tampering or overadjustment by assuming that the process is in control, i.e., special or assignable causes are absent unless a…
Mike Figliuolo
Meetings give me a rash. A really bad one. One that not even calamine lotion can soothe. The only things worse than meetings are reports. Standard daily reports, weekly reports, hourly reports. Reports on the status of reports. If I wasn’t already insane, these things would drive me insane.
Take a…
Daniel Marzullo
If you could experience the perfect workday, what would you be doing? Have you ever taken the time to think about it?
Whether you’re an entrepreneur climbing the corporate ladder or you’re selling donuts out of the back of your car, it’s essential to pause and reflect periodically on the work you…
Peter Nathanial, David Zuluaga Martínez, Theodoros Evgeniou, Francois Candelon
Last month, the heads of seven major American AI companies emerged from the White House with an agreement on “self-regulation.” On the other side of the Atlantic, Europeans debate the long-awaited EU AI Act, the next major digital regulation following the EU’s Digital Services Act (DSA). The DSA is…
William A. Levinson
Inflation is a serious national issue. Credit agency Fitch Ratings just downgraded the U.S. credit rating—as in the “full faith and credit of the United States”—from AAA to AA+.1 This doubtlessly reflects the fact that our national debt exceeds $31 trillion, or almost $100,000 for every American,…
Stephanie Ojeda
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Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their employer’s approach to safety.
There are also huge risks to companies themselves, which face…
Mark Graban
I can’t count how many times during the past 20 years I’ve heard executives complain that their people aren’t enthusiastically participating in their lean program. Leaders lament that while the company has spent a small fortune to put everybody through continuous improvement training, hardly…
Kobi Leins, ISO
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In everyday life, the most common conversation about artificial intelligence (AI) goes along the lines of, “I used ChatGPT, and it did x.” Corporate leaders, governments, and international organizations, however, are having a very different conversation. Theirs is about how the…
Andrey Koptelov
In this age of rapid technological innovation, the introduction of sophisticated technologies in various industries has raised complex ethical dilemmas. As businesses strive to achieve financial goals and keep stakeholders happy, they also have to mitigate the adverse effects of technology…
Donald J. Wheeler
As we learned last month, the precision to tolerance ratio is a trigonometric function multiplied by a scalar constant. This means that it should never be interpreted as a proportion or percentage. Yet the simple P/T ratio is being used, and misunderstood, all over the world. So how can we properly…
Matthew M. Lowe
Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of smart technologies. Where Industry 5.0 is more values-driven, it will require the technology of…
Chandrakant Isi
An increasing number of engineers are embracing design for manufacturing (DFM) to streamline their production workflow. Industry leaders such as Apple, GE, and Samsung have already adopted DFM as part of their standard practices. If you’re using the “over the wall” engineering strategy—one where…
Harish Jose
The success run theorem is one of the most common statistical rationales for sample sizes used for attribute data.
It goes in the form of:
Having zero failures out of 22 samples, we can be 90% confident that the process is at least 90% reliable (or at least 90% of the population is conforming).
Or…
engineering.com
In the era of the industrial internet of things (IIoT), assets of both information technology (IT) and operational technology (OT) are becoming more sophisticated—and they both generate and use more data. As a result, it’s increasingly important for manufacturers to mesh the IT and OT sides of…
Jeffrey Lewis
I’ve observed that ISO management system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011. Auditors are still using clause-based auditing, despite ISO 19011:2018’s direction to take a risk-based approach.…
Kurt Kleiner, Knowable Magazine
When a Manhattan parking garage collapsed in April 2023, rescuers were reluctant to stay in the damaged building, fearing further danger. So they used a combination of flying drones and a doglike walking robot to inspect the damage, look for survivors, and make sure the site was safe for human…
Polina Marinova Pompliano
Mental toughness is a quality that sets extraordinary individuals apart from the rest, enabling them to endure discomfort and uncertainty for extended periods. But what exactly is mental toughness? Can it be achieved without undergoing severe stress and trauma? Why do some people seem to possess it…
Emily Newton
Solving problems goes beyond noticing the symptoms and wanting to resolve them. It’s also necessary to perform a root cause analysis, pinpointing the factors likely to have made an issue occur. It’s only then that leaders can create concrete solutions for lasting changes. However, root cause…
Bruce Hamilton
Peter Drucker, celebrated by BusinessWeek magazine in 2005 as “the man who invented management,” is credited with a concept that has created confusion for me throughout my work life: the distinction between knowledge work and manual work.
In his 1959 book The Landmarks of Tomorrow (latest edition…
Lindsey Walker
In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological advancements. One particularly revolutionary option is computerized maintenance management system (CMMS)…
Ujjwal Parwal
Risk analytics is a vital component of risk management that uses statistical models, data analysis, and predictive modeling techniques to assess, quantify, and mitigate risks in various domains. This article will delve into the definition of risk analytics, discuss its importance, and explore its…