February 2014

For Quality Companies

"3 Loops in 1" as Reflected in FDA Warning Letters

by Cindy Fazzi, MasterControl Inc.

Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

Many of the citations could have been avoided, or at least mitigated, with the help of a closed-loop or “three loops in one” CAPA process. What is it and why is it critical?

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Collaboration is More Than Just a Buzzword

by Marty Jackson, MasterControl Inc.

Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

Indeed Merriam Webster offers this definition: “to work jointly with others or together especially in an intellectual endeavor.”

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How Dole Uses Technology To Save Time, Money

by Nye Joell Hardy, Dole Fresh Vegetables

At Dole Fresh Vegetables, food safety is our first priority, so we have a full-time staff that ensures all our suppliers – growers, harvesters, coolers, and packing sheds – meet rigorous food safety standards before product can be received in our facilities. For that reason, food safety needs to be extraordinarily proactive: we need to identify potential food safety risks and mitigations as early as we can to ensure production continues safely and smoothly.

That is easier said than done.

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