Mike Richman’s picture

By: Mike Richman

The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand. That’s the unfortunate reality for weather forecasters, stockbrokers, sports bookmakers, political pundits, and writers of science fiction. Yet people keep trying to project trend lines and read tea leaves, maybe because we like to wonder about the moral and ethical choices that some future state will force us into. Or maybe these kinds of stories just make good copy.

Ryan E. Day’s picture

By: Ryan E. Day

One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products, and it also has the freedom to not exercise that authority (enforcement discretion) as it sees fit.

Matthew M. Lowe’s picture

By: Matthew M. Lowe

Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies share a common need as a prerequisite to success: regulatory compliance.

William A. Levinson’s picture

By: William A. Levinson

Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an OHS management system.

Anthony Chirico’s picture

By: Anthony Chirico

In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units.

Andreas Engelhardt’s picture

By: Andreas Engelhardt

An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other management system approaches, including ISO 14001 and ISO 9001, and can help organizations develop a framework that improves safety, reduces workplace risks, and creates safer working conditions.

Anthony Chirico’s picture

By: Anthony Chirico

In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate sample size, and it was illustrated that twice the inspection does not provide twice the consumer protection.

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Chad Kymal’s picture

By: Chad Kymal

Omnex began working in the automotive industry by assisting Ford powertrain suppliers in 1986. The U.S. automotive industry’s Big Three used GM’s Targets for Excellence, Ford’s Q 101, and Chrysler’s SQA standards to qualify its supply bases. The automotive industry was making deep reductions in its supply bases based on the results of these assessments and other factors. Though many on the Omnex team at that time came from General Motors, Ford’s Q 101 was the standard that really received our attention.

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Anthony Chirico’s picture

By: Anthony Chirico

Aerospace standard AS9138—“Quality management systems statistical product acceptance requirements” was issued this year (2018), a few years after its accompanying guidance materials in section 3.7 of the International Aerospace Quality Group’s (IAQG) Supply Chain Management Handbook.

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Mike Richman’s picture

By: Mike Richman

IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want. Plus, we brought you a live interview with author Mark Graban, and one on tape from Burt Mason of Hexagon Manufacturing Intelligence captured at IMTS. Let’s take a look:

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