Having to conduct a recall is one of the most trying experiences in any organization mandated by the Food and Drug Administration (FDA). If it is determined that a recall is the only available course of action, it is imperative for an organization to have a system in place to guide them through the recall process from beginning to end, ensuring it is completed as quickly and efficiently as possible and nothing is left out of the quality loop.

The FDA website states, “A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.1” This paper will describe why Recall Management is a necessity in businesses today and how an automated Quality Management System (QMS) can streamline the process by enabling seamless compliance with the best practices of Recall Management.