Quality Creates Perspective

A QMS Resource for Quality Champions: news, perspective and commentary on hot issues in quality and quality management.



Fighting The Fakes: Why Counterfeits In The Supply Chain Is A Quality Problem

Companies that are not confronting the potential quality issues generated by counterfeits or bogus products in their supply chain ecosystem are leaving themselves open to a world of pain. Logistics Management reported that the prospect of counterfeits in the supply chain is an ever-growing threat, with numerous industry sectors worried about the impact that a fake could have on both consumer confidence and overall product quality. Counterfeiting is already a billion-dollar business, and it is reportedly becoming harder to differentiate the fake from the real thing.

By David Bolton on September 19, 2019
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FDA Cleared vs. FDA Approved: Why the 510(k) System Is Broken and How Medical Device Manufacturers Can Reduce Risk

Nearly every day, the public is bombarded with stories of medical device failures. There was the recall of 6 million defective endotracheal tubes used to keep patients breathing during surgery. Or, how about the FDA’s total shutdown of pelvic mesh sales after discovering that the concept didn’t translate well from similar-but-different hernia mesh, instead causing bleeding, infection and even punctured organs in some patients. Maybe you heard about the duodenoscopes used extensively for diagnosing and treating upper digestive tract problems that have sickened hundreds of patients and can even transmit antibiotic-resistant superbugs, that was reported by the New York Times.

By ETQ on September 17, 2019
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HACCP 101: What Food Manufacturers Need to Know

It’s been over 10 years since the multi-state peanut butter salmonella outbreak in 2008 and 2009 that killed nine and sickened over 700 people, leading to one of the largest recalls in U.S. history. Details of the investigation and criminal case tell a disturbing story of food safety gone awry, complete with fraud, lies to federal prosecutors and knowingly selling products that tested positive for contamination.

By ETQ on September 10, 2019
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Report: 52% Of Children’s Product Recalls Are Not Publicized On Social Media

A study by consumer advocacy organization Kids In Danger (KID) said that digital information about child-related product recalls is often hard to find, with brands making a conscious decision to limit consumer awareness of potential safety or compliance issues with children’s products. As a result, and according to KID’s “Recalls Online: Missed Opportunities for Engagement” report, transparency around a product recall process is very much a hit-and-miss affair, especially in terms of what the customer needs to do next.

By David Bolton on July 12, 2019
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