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Are Your Audits Clause-Based or Risk-Based?

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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system audits have remained largely unchanged, even after the advent of ISO 19011:2018, the auditing standard that superseded ISO 19011:2011.

A Faster Way to Teach a Robot

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Credits: Jose-Luis Olivares/MIT with images from iStock and The Coop

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Imagine purchasing a robot to perform household tasks. This robot was built and trained in a factory on a certain set of tasks and has never seen the items in your home.

Defining Your Leadership Philosophy on One Piece of Paper

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We make leadership way too difficult. We write entire books on it. We teach it in universities and MBA programs. We dedicate entire fields of study to it. We create massive corporate programs to foster it. Here’s the thing: It’s really not that hard.

What FDA QSR and ISO 13485 Harmonization Means

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Photo by Piron Guillaume on Unsplash

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On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).

Using Active Listening to Transform Manufacturing Workplace Environments

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While recent economic reports on inflation have signaled positive signs for the future, frontline industry turnover rates remain high.

First Article Inspections: What Engineers Need to Know

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Photo by Gavin Allanwood on Unsplash

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It’s been a long and arduous road, but you’re almost ready for that first production run.

What Machine Learning Reveals About Forming a Healthy Habit

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Photo by Victor Freitas on Unsplash
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Wharton experts used machine learning to help uncover the secret formula for successful healthy habit formation, and it turned out there’s no one formula.

One Question That Keeps You Out of Trouble

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You folks know I love asking questions.

A Holistic Approach to Navigating the New Workplace

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Photo by Dylan Gillis on Unsplash
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The end of Covid-19 workplace disruptions has ushered in a fresh set of challenges for organizations.

If Getting the Facts Means Having to Ask

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Jack Webb as Sgt. Joe Friday, and Harry Morgan as Officer Bill Gannon, Dragnet. Credit: Public domain, Wikipedia.

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Pick a problem—any problem. As soon as you have one without an immediate answer, we can begin.

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