All Features
Gabriel Popkin
When we hear that the metric system is based on seven base units, or seven fundamental constants, it gives the impression that there’s something obviously unique and special that sets these seven quantities apart.
But when we delve deeper, it turns out that there’s nothing special about the number…
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…
Megan Wallin-Kerth, Vick Vaishnavi
Octave is taking AI-driven innovation seriously: That much was clear from its OctaveLive keynote this summer in Austin, Texas, where the focus remained on amplifying human capability as well as hiring more people, not fewer, to maintain quality.
Vick Vaishnavi, the head of Octave Reliance, took…
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…
Paras Kharwal
On Sept. 16, 2026, ISO published the sixth edition of ISO 9001. Within days, the summaries arrived: what changed in Clause 5, what the new Annex A says, how the 2024 climate amendment carries forward. They’re useful, but they answer the questions certified organizations ask least often. The…
Etienne Nichols
Most early-stage medical device companies never decide to skip a quality management system (QMS). They just never decide to buy one. The founding team opens a shared drive, builds a spreadsheet for design inputs and outputs, starts a document register in another tab, and agrees to sort out the real…
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…
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…
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…
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…
Laura Lindsay
Consider an AI tool that delivers consistently accurate results and demonstrates impressive capabilities. If the people who are expected to rely on it can’t understand how decisions are reached or challenge outcomes that appear wrong, why would they trust it with an important decision? Would an…
Sam Somerville
Trust is the foundation of business and commerce. Every transaction, partnership, and working relationship depends, to some degree, on confidence that others will deliver on their commitments.
In business, we often focus on customer trust that products and services will meet their needs and…
Rick Heilshorn
Manufacturing has a people problem, but not in the way we usually talk about it.
We talk about the skilled-labor shortage. We talk about retirements. We talk about doing more with fewer people. Usually those are treated as separate problems.
They aren’t. Rather, they are compounding.
Deloitte and…
Josh Peterson
Quality management system software helps life sciences organizations manage documents, training, quality events, change controls, audits, and other regulated processes in one controlled environment.
Most electronic quality management systems (eQMS) offer some version of these core capabilities.…
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…
Marc Schaeffers
With the publication of the new VDA AIAG SPC Manual in July 2026, one of the most significant changes to statistical process control (SPC) in decades has been introduced. While much attention has been given to the new process capability indices, an equally important change is the introduction of a…
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…
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,…
Steve Romig
Quality teams throughout the food manufacturing industry face increasingly difficult obstacles and risks while keeping our food safe. A team can discover a positive Listeria result on a slicer component inside a ready-to-eat production zone after earlier environmental monitoring signals in the area…