All Features
Fabrizio Maniglio
Most discussions about generative AI in life sciences start with the technology. Quality professionals should start somewhere else—with the record.
Our job has never been to produce documents. It has been to produce evidence that decisions were made correctly, by the right people, on the right…
Radhika Kumar
When hospitals treat device downtime as isolated, one-off incidents, they miss a critical opportunity to improve system reliability, manage long-term costs, and safeguard patient care. Downtime patterns often reveal far more than a single equipment failure; they point to the underlying condition of…
Stephanie Ojeda
A longtime raw-material supplier exits the market, and a manufacturer needs a replacement quickly. The new supplier completes a questionnaire, receives approval, and begins shipping. Months later, delivery slips and defects increase. A broad audit produces a passing score, but the problems continue…
Neeta Verma
Manufacturing Day fell on Oct. 2 this year. Manufacturers opened their doors and showed the public what modern manufacturing looks like, and, hopefully, built some interest in manufacturing careers.
Visitors saw robots, sensors, software, and connected production systems. What they may not have…
CheeYee Tang, Robert Stea, John Wiltberger
Recent cyberattacks on U.S. water and wastewater systems (WWS) are highlighting the escalating threat to our nation’s critical infrastructure and the practical challenges of securing it.
These incidents underscore an important challenge: The connectivity that utilities depend upon must be designed…
Katie Gilbert
William Overman began his Ph.D. program at Stanford Graduate School of Business at an auspicious moment—just two months before ChatGPT publicly launched in November 2022, exploding widely held understandings of what machines can do.
Even as Overman began enlisting AI for his research, he grew wary…
William A. Levinson
Leadership responsibility is included in ISO 9001:2026, Clause 5.1.1, to promote quality culture and ethical behavior. A strong argument could be made for adding safety as well.
Ethics has a very wide range of applications, including the need to avoid conflicts of interest (like recommending a…
Megan Wallin-Kerth, Greg Hutchins
Given that AI has been this century’s biggest disruptor for nearly every industry in the world, it has been met with justifiable levels of angst, anger, questioning, and skepticism. It’s as if our world has essentially been turned into a version of Jurassic Park, where, instead of dinosaurs, we…
Santoshi Muriki
As food companies stand up digital traceability platforms to meet FSMA 204 requirements—now due by July 2028 after the compliance date extension—a quieter problem is showing up behind the deadline itself.
Most of these platforms are being deployed alongside existing quality management systems (QMS…
Neeta Verma
ISO 9001:2026, the sixth edition of the quality management systems standard, was published on Sept. 16, 2026, replacing ISO 9001:2015. ISO lists the new edition as Edition 6, 2026-09. ISO/TC 176 confirmed that the Final Draft International Standard (FDIS) was approved ahead of publication.
However…
Oak Ridge National Laboratory
(ORNL: Oak Ridge, TN) -- As much as 15.2 terawatt-hours of electricity could be generated annually at nonpowered dams—enough to supply more than 1.4 million homes, according to an updated assessment of hydropower technical potential across the nation compiled by researchers at the U.S. Department…
Winnie Jiang, Nicolas Bastoli, Henrike Gueth
When former United States secretary of state Madeleine Albright said, “There is a special place in hell for women who don’t help each other,” that quip captured a widespread expectation that women who reach the top should pull others up behind them. Yet it’s not uncommon for junior female employees…
Oliver Trabert
Manufacturing in the U.S. is seeing its fastest growth in more than four years, driven in large part by rising demand for AI infrastructure. That expansion is arriving alongside severe supply shortages and higher input costs.
Manufacturers look to AI to increase capacity and operate more…
Kendall Kunz
On March 3, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Tentamus India Private Limited. The inspection it describes started the way most do, with one difference. At the initiation of the inspection, the agency’s investigator observed the firm attempting to remove…
Candace Orbaugh
At first glance, the next version of RC14001, the management standard for the chemical industry, looks like a simplification. In practice, it gives organizations more flexibility but also more responsibility. The revised standard no longer hands organizations a predefined list of stakeholder groups…
Stephanie Ojeda
A quality team’s supplier toolbox is deep. Supplier questionnaires, PPAP, supplier scorecards, incoming inspection, audits, corrective action—the list goes on.
In my years of experience as a quality leader, the challenge I see is matching each one to the right stage in the supplier process and the…
Sachin Bhandari
On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No qualified…
Neeta Verma
Extreme heat, drought, wildfires, floods, record-low rivers, and rising energy demand have defined much of the summer of 2026. But for businesses, the important story isn’t simply that weather records are being broken. It’s where those physical changes enter the operating system of a company.
A…
Neeta Verma
The European Commission’s latest Joint Actions on Compliance of Products (JACOP) project offers a useful starting point for understanding why products can still fail environmental compliance checks even when manufacturers have established compliance programs.
Published in June 2026, the JACOP…
Etienne Nichols
Ask a premarket team where corrective and preventive action (CAPA) sits on the priority list, and it usually lands below design controls, risk management, and the submission itself. The reasoning is easy to follow. Nothing has shipped, so there are no complaints to investigate, no returned product…
Grant Ramaley
Medical device companies selling into multiple countries don’t answer to one global regulator. They navigate a patchwork of national requirements that two organizations are trying to align in very different ways.
The International Medical Device Regulators Forum (IMDRF) and the Global…
Cornelia C. Walther
A CEO doesn’t need to read every AI law to understand why regulation matters. It shows up in subtler ways: a sales team using a chatbot with client data, a hiring manager testing an AI screening tool, a board member asking whether the company has an AI policy. AI governance has moved from the…
Neeta Verma
Product compliance is moving beyond certificates and restricted-substance checks. PFAS restrictions, digital product passports, artificial intelligence, supply-chain transparency, and sustainability increasingly require manufacturers to connect regulatory knowledge with reliable product, material,…
Pascal Terrien
In the electrotechnology sector, we know one thing for certain: Trust can’t be imposed; it must be built. Standardization enables us to build it every day. As the world grapples with climate, digital, and societal challenges, manufacturers, electricity producers, grid operators, conformity…
Stephanie Ojeda
The recent multistate outbreak of cyclosporiasis is a powerful reminder that food quality involves more than appearance, consistency, and shelf life. It requires an integrated approach to food safety, supplier control, traceability, risk management, and continuous improvement.
By mid-July 2026,…