As COVID-19 begins to subside, the U.S. Food and Drug Administration (FDA), like other federal agencies is shifting its focus away from the pandemic and back toward more routine issues.
As an example, the FDA recently published its final guidance outlining steps companies should take to develop recall policies and procedures that include training, planning, and record-keeping to reduce the time a recalled product remains on the market.
The FDA guidance warrants close study. In it, the agency describes an array of best practices for creating, testing, and executing a recall plan. Because of the FDA’s heightened expectations, along with the greater risk and complexity involved in today’s recalls, training – including regular mock recall exercises – has become an essential part of the recall preparation process.
The Food Safety Modernization Act contains a Preventive Controls rule which specifies that any company identifying a potential hazard in its operations must have a written recall plan. A mock recall is necessary to determine the effectiveness of your recall plan and to shine a spotlight on the areas that may need improvement.
While there is no formal regulatory requirement for mock recalls, most leading companies in the food, drug, consumer product, automotive, and medical device industries perform them on an annual or semi-annual basis. Mock recalls prepare them for an actual event so that execution of the plan is as efficient and seamless as possible, and publicity and litigation risks can be greatly reduced.
Most mock recalls involve two general phases:
- Identifying the item to be recalled.
- Retrieving the product from the market.
If you are unable to trace a product through your supply chain, then a successful recall will be impossible. An effective traceability system should identify the unit to be traced (a lot, batch, or single product unit) and account for all processes that may have altered the unit across the supply chain.
Without fail, companies with a tested product recall plan recover and restore full operation sooner than those without one. That’s because a sound product recall plan enables companies to comply more efficiently with government regulations, sustain internal organizational structure, maintain trust with customers and consumers, whilst substantially lowering the financial cost of the event itself.
At Sedgwick, we help companies manage mock recalls to help them mitigate any risk before a recall may occur. Because recalls can affect the entire supply chain, it is important for all companies to strongly consider mock recalls so that they – and their suppliers – remain ready to execute a recall as smoothly as possible.
For more information on mock recalls and how to prepare for a recall event, visit our website.