Dollase and Rozembajgier have each accumulated extensive experience in how to put together an effective recall plan, and they both emphasize the importance of testing it often.
As a general guideline, Rozembajgier advises companies to execute mock recalls every 12 to 18 months to identify any potential gaps and correct them. However, if a series of gaps are evident, “you don’t want to wait a full year to conduct a mock recall again,” he cautions. “Overall, it’s something that you want to make sure you’re doing on a frequent basis, that you’re taking action, and that you’re documenting it.”
Inmar’s Dollase offers a similar timeframe. “Low probability, high consequence situations like a recall can sometimes catch companies off guard. Executing a mock recall annually is a best practice for recall preparation.”
In addition, it’s critical to look outside “your own four walls,” suggests Rozembajgier, “which means having conversations with your suppliers and understanding what plans they have in place relative to recalls and how often they’re testing them.”
Rozembajgier says there are a lot of “common denominators” when it comes to recalls, regardless of the industry. “Certainly, food recalls have an inherent sense of urgency, but in our experience a successful recall comes down to preparedness and the ability to respond in rapid fashion.”
For instance, “If you’re going to launch a food recall, make sure the appropriate Web site is up and the information is timely and accurate, and the phone lines are working and they’re not going to go down. And, if you launch a recall on a Friday, make sure it’s being monitored and that you’re responding accordingly as new information becomes available.”
Not surprisingly, both executives see the value in consulting with outside experts when companies initially develop their recall strategy, especially if the company has not encountered a recall previously.
“The benefit in using the services of an outside expert is the client company can work with someone who can tap into the experience we’ve acquired handling recalls for other industries,” says ExpertRECALL’s Rozembajgier. “We do thousands of recalls in all the major industries, whether it’s food, pharma, medical devices and so on, and there are lessons learned that we can apply to the food sector.”
Inmar’s Dollase concurs. “As part of the recall team, a third-party vendor like Inmar can help establish a plan for recall execution and compliance with governing regulatory requirements, as well as compliance monitoring and adverse event reporting. The less experience a company has with recalls, the more it can benefit from third-party support.”
He adds that, “A third party can help a quality team for continuous monitoring of GMP (Good Manufacturing Practices) within company facilities and those of its vendors. This may include a process that allows continual review of the information and resources available to quickly execute independent testing and research, if an issue is encountered. Moreover, partners like Inmar often provide rapid response field services for product withdrawal. Understanding how to best leverage these capabilities can be an integral part of a mock recall.”