Risk Management Article

Wudan Yan’s picture

By: Wudan Yan

Nearly every month, it seems, comes a new report. In March 2018, there was news of contaminated romaine lettuce, which eventually led to five deaths and sickened more than 200 people across the United States and Canada. In May 2018, about 100 people in California got sick after eating raw oysters shipped from British Columbia. Then, at the end of July 2018, the baking company Pepperidge Farm issued a recall for a few flavors of its seemingly innocuous, kid-friendly snack, Goldfish crackers.

Amy Mahn’s picture

By: Amy Mahn

The NIST Cybersecurity Framework consists of standards, guidelines, and best practices to manage cybersecurity-related risk. The framework’s prioritized, flexible, and cost-effective approach helps to promote the protection and resilience of critical infrastructure and other sectors important to the economy and national security. We spoke with Amy Mahn, an international policy specialist in the NIST Applied Cybersecurity Division, about the framework, who can use it, and how it’s evolving.

Ryan E. Day’s picture

By: Ryan E. Day

BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapies. Organizations in the life science industry, like BBG, operate in a heavily regulated environment. This is the story of how one company delivers world-class products and stays on the right side of compliance while doing it.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada. On that day, any company that sells medical devices to Canada will either need to hold an MDSAP certificate or show proof that they are on track to be MDSAP certified, or they won’t be able to sell their products in Canada. This mandate could have consequences for Canadian citizens.

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.

[Read More]

Mike Richman’s picture

By: Mike Richman

Our industry embodies many aspects, but “Big Q” quality generally involves issues affecting management, measurement, and methodologies. This week on QDL, we covered all of them, and more. Let’s look closer:

[Read More]

Mike Richman’s picture

By: Mike Richman

For manufacturers in diverse sectors such as automotive, aerospace, electronics, and medical device, there’s little question that ensuring great quality would be impossible without the proper testing of materials. And proper material testing applications begin with reliable and repeatable preparation methods.

[Read More]

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.

[Read More]

Syndicate content