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...
Kobi Leins
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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...
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...
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system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011.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...
NIST
Static force, such as the weight of a person standing motionless on a bathroom scale or the force that an office full of equipment exerts on a high-rise floor, can be easily determined using scales,...
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the...
Ian Wright
It’s been a long and arduous road, but you’re almost ready for that first production run. You made it through supplier selection, your designs and production processes have been finalized,...
Stephanie Ojeda
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.
Consider, for example, an electronics...
Etienne Nichols
Your company probably has an internal process for a large purchase like an eQMS. In midsize-to-large medtech companies, you’ll likely find this process in the finance department, or perhaps in a...
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be...
Megan Wallin-Kerth
Business owners and employees alike have long debated over how best to achieve quality standards and what those standards ought to be. However, as much as linear thinking may help when measuring...
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that...
ISO
Net zero is our strongest tool yet against the climate crisis. The transition to net-zero emissions presents a compelling solution that offers not only environmental benefits but also economic,...
Sébastien Breteau
Supply chain quality control is a demanding job. Ensuring that products meet specific standards and expectations for safety and customer satisfaction by monitoring and managing the entire supply...
Ian Wright
‘I have a cellphone that doesn’t behave like a phone: It behaves like a computer that makes calls. Computers are becoming an integral part of daily life. And if people don’t start designing them to...
Jessie MacAlpine
Despite rigorous vehicle safety testing, current evaluations fail to adequately protect women in the case of an accident. In 2021, a study published by the Insurance Institute of Highway Safety found...
Harish Jose
I’m looking at a topic in statistics. I’ve had a lot of feedback on one of my earlier posts on OC curves and how one can use them to generate a reliability/confidence statement based on sample size (...
Phanish Puranam
It’s no secret that there are no universally applicable organization designs. What works in one context may not work in another because each organization has a different history, culture, and cast of...
William A. Levinson
I wrote previously1 that environmental, social, and governance (ESG) metrics are often dysfunctional because they prioritize the wrong things and thus deliver the wrong results.
The recent failure...
Grant Ramaley
As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the...
