By EAS Senior Consultant Dan Okenu, Ph.D.
Product recalls are a fact of life in the food industry. Recalls occurred an average of 12 times per week. Allergens remain the largest cause of recalls, due to mislabeling, cross-contamination or being undeclared. Large recalls of peanut products, eggs, ground beef and cantaloupe in recent years remind us of the potentially devastating impact of food recalls on the food industry. The good news is that there are measures the food industry can implement to significantly reduce or prevent situations which require product recalls. According to Dan Sowards, senior consultant at EAS Consulting Group, due diligence is critical in protecting against recalls.
On the issue of food safety, Willie Bryant, senior EAS consultant, points out that having the authority to order a food recall gives the FDA leverage over firms hesitant to initiate a recall voluntarily. This is a new authority of FSMA that did not exist during Willie’s 33 years of working in recall operations at the FDA.
It is highly unlikely that an FDA-regulated food firm would fail to protect the public, the company and its brand by refusing to take a recall action after receiving notification from FDA that a recall action is necessary. If the firm takes the action based on the notification by FDA and an FDA order to recall is not required, the recall is still considered “voluntary”, as are all other class I, II, or III recalls.
FDA’s enforcement power for FSMA’s provision for a foreign supplier verification program mandates an approved food safety plan, requires extensive documentation, and audits to satisfy the new proactive science-based preventive control measures. These regulatory provisions will have far reaching implications for recall, shipment tracking and traceability requirements for imported food products including private-label foods manufactured outside the United States. Compliance with FSMA requirements will require smart innovations by the food industry to keep costs down.
Effective product tracking and traceability are vital for speedy trace-back or trace-forward to identify affected products and to remove them from suppliers’ warehouses, retailers’ shelves and consumers’ refrigerators and pantries. A centralized, electronic system that can quickly trace UPC/SKU product codes linking all material ingredients, rework, process conditions and the customers is desirable in any traceability system.
Effective product tracing is an important piece of the puzzle during recalls or foodborne illness outbreaks. In addition to helping to quickly remove adulterated products from the food supply, it assists in pinpointing the problem area within the food production system so corrective action can be taken. A traceability system also provides good record keeping compliance for food defense in case of bioterrorism or economic-motivated adulteration. The effectiveness of the system should be validated annually through mock recalls and traceability testing to ascertain the preparedness of the recall protocol and the recall implementation team.
Staff training is critical at every level of the operational process. Companies should invest in a quality program that evaluates and updates its recall implementation capabilities. From there, your organization can plug in the gaps and protect your business against recalls, reduce recall operational costs, and protect your business brand.
It makes a lot of business sense to invest in proper training of staff and preparedness for a multi-disciplinary recall team that is ready to roll at a moment’s notice. To put the cost of recall readiness or the cost of recall reduction strategies in perspective, managers should consider the colossal cost of implementing a recall and the added cost of recovering from such a huge exercise, including brand image laundering to regain the eroded customer confidence.
EAS can provide specialized training that deals with the nuts and bolts of effective recall and traceability system, emphasizing FDA roles and requirements, best practices for trace-back and trace-forward, legal and regulatory challenges, the recall decision making process, risk assessment/testing, and time management before and after recalls. Other training modules include effective risk communication and media management, creation and preparedness of a multi-disciplinary recall team, and recall reduction strategies. The training highlights specific steps that companies can take to avoid situations that may lead to recalls or to minimize the extent of a recall and its impact on the business.