Lean
Dr. Donald J. Wheeler has been one of Quality Digest’s most highly read authors for decades. His teaching on the use of control charts in industrial settings has long been considered the gold standard. He has conducted more than 1,100 seminars in 17 countries on six continents, and his books…
As director of quality at a manufacturing plant, James faced the reality of shift every day. As the plant embraced new technologies and adapted to changing global dynamics, he knew that quality management could no longer be reactive. The question was whether he could turn these shifts into…
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those…
Once hailed as both an ethical mandate and a strategic necessity after the upheaval of 2020, diversity, equity, and inclusion (DEI) initiatives now face intense scrutiny and pushback. Major corporations—ranging from Walmart to Google—are quietly retreating from these programs amid escalating…
The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation and nonconformance. Often, this leads to confusion about how events should be classified and managed.
This article explains the difference between a deviation and a…
Keeping quality high in today’s fast-moving production world is a big challenge. Traditional quality checks have worked well, but they can be slow, require a lot of work, and are prone to mistakes.
AI could change this by making quality control faster, more accurate, and easier to…
