All Features
Quality Digest, Jason Chester
Today, manufacturing is largely shaped by supply chain volatility, complex labor dynamics, and—like most global industries—the rise of AI. Adopting AI technologies on the shop floor can help manufacturers minimize operational costs, mitigate risk, and optimize processes, which drives efficiency and…
Oak Ridge National Laboratory
Simulations still can’t predict precisely when an earthquake will happen. Still, with the incredible processing power of modern exascale supercomputers, they can now predict how they will happen and how much damage they will likely cause.
Imagine a colossal earthquake strikes the California coast…
Walter Nowocin
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.
One notable…
Judy Fainor
What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?
It’s a compelling vision—and one that’s becoming increasingly achievable through AI-enabled automation. But let’s be clear: We’re not there yet. What we do have is…
Mike Regan
In July 2024, CrowdStrike rolled out a software update that crashed more than 8 million Windows systems worldwide. The faulty release disrupted hospitals, grounded flights, halted banking operations, and affected government services. Comparable to a major cyberattack, the incident caused more than…
William A. Levinson
A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…
Cindy Mielke
Over the years, there have been many developments in systems and technologies that have helped industries redefine how businesses are structured. These changes, especially in sectors like manufacturing and distribution, have led to new roles and responsibilities for employees.
However, often with…
Jake Walton
Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam. Better still, you can also find a posted list of common…
Sachin Waikar
Take two aspirin and call me in the morning: If only prescribing medications were as simple as that.
In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct drug and dosage.
“…
Dottie DeHart
Work-life balance is tough, and for most of us, it’s starting to feel like a thing of the past. Companies are demanding longer hours and increased productivity. Remote workers are being called back to the office, and the ones still at home are stuck in “always on” mode. With layoffs happening left…
ISO
Security configuration management (SCM) is a critical concern for organizations and a fundamental part of many cybersecurity frameworks. Consider this scenario: A team member tweaks a hardware setting on their personal laptop to boost software performance. However, this change causes unforeseen…
Kamran Sayrafian
A few years ago, I heard on the news that many people were being hospitalized with a condition of excess fluid in the lungs, called pulmonary edema. It’s common in elderly patients. Pulmonary edema is dangerous and can lead to breathing difficulties and lung failure. Because it has the potential to…
Kristin Burnham
Companies that adopt industrial artificial intelligence see productivity losses before longer-term gains, according to new research.
Organizations have long viewed artificial intelligence as a way to achieve productivity gains. But recent research about AI adoption at U.S. manufacturing firms…
Lexi Sharkov
They may seem simple, but SOPs (standard operating procedures) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right?
In reality, there are a lot of requirements for writing a good SOP, and auditors have a…
FOCO
Metal foundries are under intense pressure. Soaring energy bills now eat more than 30% of production budgets. Tough carbon regulations, such as the EU’s Carbon Border Adjustment Mechanism, reduce profit margins.
Foundries also struggle with costly scrap loss through melting and meeting tough…
FOBA
In medical technology, safety is paramount. Every step in the manufacturing process must meet the highest standards, from patient protection to regulatory compliance. Because direct part marking plays a key role in ensuring traceability and unique device identification (UDI) conformity, it’s…
NIST
A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the…
Stephanie Ojeda
Global-scale events have tested the bounds of supply chain systems. The coronavirus, for example, made it clear how critical an efficient supply chain is for continuity and survival. It’s a real-world example of how important it is to have an enterprisewide system that uses a quality management…
Nimax
Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices had…
Robyn Coward
In life sciences, every decision carries weight—and speed to market is an ever-present consideration. Scientific innovation is moving faster than ever, yet regulatory demands are growing more complex, and supply chain fragility has become the new normal. Within this volatile landscape, the role of…
Jennifer King
Although patient safety is paramount in healthcare settings, about 1 in 10 patients is harmed in healthcare, and more than 3 million deaths occur due to unsafe care, says the World Health Organization (WHO). The reality is hospitals and healthcare facilities face numerous challenges in managing…
Etienne Nichols
Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device companies outsource the manufacturing of their device to a…
Akhilesh Gulati
Complacency won’t show up on a control chart. But its damage is real. Can AI and systems thinking help us detect it and respond before trust is lost?
As customer expectations evolve, one question remains: Are customers still at the core of your company’s operations?
Back in 1999, a simple but…
Harish Jose
I’m further exploring the notion of models and mental models. We often speak of mental models as though they’re neat packages of knowledge stored somewhere in the mind. These models are typically treated as internal blueprints and as simplified representations of the world that help us navigate and…
John Tschohl
Why do customers patronize one company over another? Many of you might say that the quality and price of the products or services are key factors. But while those things might play into a purchasing decision, they aren’t the most important consideration.
So, what is? Customer service. How you and…