Recalls are usually thought of as a manufacturing issue. However, wholesalers frequently conduct recalls due to their position in the supply chain. Traditionally the wholesaler's responsibility has been a traceability exercise where the wholesaler would receive recall notices from the recalling firm and subsequently perform a sub recall. In recent years a number of trends have set the stage for an environment where the recall risk profile has evolved and trickled down to all members of the supply chain. Wholesalers, with their unique position in the supply chain, carry a new burden of responsibility to ensure that their business processes related to recalls have been updated to account for and accommodate these changes in the marketplace and enforcement environment.
Trends have emerged that have impacted the way wholesalers look at recalls:
- The Food Safety Modernization Act (FSMA) sets the stage for FDA to apply more additional quality standards to the food market.
- A renewed focus on environmental regulation at the state level is impacting the disposition and destruction options for products typically disposed of on-site at a retail level (food products, liquids, etc). California is leading this trend with many other states following suit.
- International sourcing creates a more common transfer of recall execution requirements to domestic organizations.
- Publication of most recalls on the internet effectively makes all recalls consumer level events, adding to the scope of recall management today.
Wholesalers are under pressure from both their vendors and customers in recall situations. In many cases, vendor expectations and customer expectations may conflict. Wholesalers need to appropriately balance and manage these conflicting expectations, adding to the complexity of how a wholesaler meets its obligations in a recall situation.
All wholesalers should be engaging in projects to identify areas of vulnerability and building the necessary infrastructure to ensure their ability to conduct an effective recall using appropriate risk-based processes. The business processes and infrastructure built to comply with the expectations and requirements of the past may not provide the level of assurance and accommodation that is needed in today's complex environment.