There were more than 300 food recalls and 17 multistate foodborne investigations in the United States in 2019. (ref: Food Safety magazine) The recall process in the food industry averages more than $10 million in associated costs, according to Food Safety Tech.
In order to address such public health issues and protect the consumers, the Food and Drug Administration (FDA) introduced the Food Safety Modernization Act (FSMA) which was signed by the President in 2011. FSMA enables FDA and food manufacturers to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards. The law also holds imported foods to the same standards as domestic foods.
When looked at holistically, food manufacturers are discovering that implementing the culture of food safety makes good business sense. In many ways, it is a road map to drive efficiency and process innovation.
Food safety compliance relates to the bottom line in ways similar to operational safety, lean practices and even wellness initiatives. Companies with a food safety culture are more likely to have long-term compliance, understand their role in carrying out preventive controls and have buy-in among staff and managers. In fact, these are common traits of not just food safety culture but also well-run companies:
The FDA is the federal oversight body for the food manufacturing industry responsible for implementing the FSMA, a sweeping set of regulations which created challenges to many small and medium-sized manufacturers (SMMs). As a result, the schedule for compliance to FSMA standards was extended until 2017. Some small food manufacturers are still struggling with compliance and are in the process of developing training programs and processes to digitize appropriate recordkeeping.
The FDA in 2019 introduced a “New Era of Smarter Food Safety,” in part to help SMMs find sustainable paths to compliance and address processes and behaviors. The four pillars of FDA’s Smarter Food Safety are:
FSMA has been a centerpiece of FDA’s work to help ensure food safety and prevent foodborne illnesses. To further build on FSMA, FDA has recently introduced a blueprint for the New Era of Smarter Food Safety. It outlines the benefits of enhanced traceability and Smarter Tools and Approaches for Prevention and Outbreak Response especially in light of growing trends in new business models such as on-line purchase of food.
In order to be compliant with FSMA, food manufacturers must have a Food Safety Plan which includes various aspects pertaining to food safety including dealing with a possible outbreak for Salmonella, Listeria monocytogenes, E. coli contaminations and undeclared allergens. The plan must include among other facets, a Hazard Analysis, Recall plan and a Risk-Based Preventive Controls Plan.
The food manufacturer must have uniform data and a system of preventive controls they employ throughout their processes. This includes the precise makeup of the final product, the details of every step in the process and the ability to trace the sourcing of every ingredient and whichever staff members were involved in the production.
These preventive controls are subject to inspections and system audits. In the event of a food safety recall, the FDA requires food manufacturers to be able to trace the issue back through its processes and supply chain. For example, outbreaks have been traced to contaminants in the soil where lettuce was grown or to a single sick employee exposing the food processing line while on the job.
One of the primary benefits of a food safety culture is the use of incentives for manufacturers and suppliers to take what is learned from these outbreaks and apply appropriate preventive measures. A root cause analysis from an outbreak traced to ill food workers would try to determine what environmental factors contributed to ill workers deciding to come to work. Or, an analysis might address what contributed to the contamination of the soil in a produce-related outbreak.
Third-party qualifications are a significant incentive for food manufacturers and are increasingly required of suppliers by the largest food and beverage manufacturers. The Global Food Safety Initiative (GFSI) is an industry-driven initiative for the development of food safety management systems to ensure food facilities are processing safe food for consumers. GFSI oversees and approves different auditing organizations who meet their criteria for following safety audits. One such organization active in the USA is Safe Quality Food (SQF). SQF’s food safety management certification is recognized by many regulatory agencies, in addition to GFSI. Almost one in four food companies requires that their suppliers have SQF certification. SQF is rigorous — it can take a year or more to complete all three levels of certification — but it opens up opportunities to supply parts or ingredients to large food manufacturers and processing companies. SQF certification is dependent on Statistical Process Control (SPC), a methodology for measuring and controlling quality during a manufacturing process.
Knowing the precise product and process measurements allows manufacturers to establish baseline controls, which helps identify variations and problems. Alerts help operators take remedial action early on, preventing unsafe or poor-quality food from entering the supply chain and possibly triggering a recall.
The SPC analysis used in SQF certification can be a competitive differentiator by providing food suppliers with tools and data for actionable insights. Manufacturers can analyze products and processes to address quality, consistency and efficiency, such as reducing scrap and below quality products. So, while the SQF certification can increase market share, SPC drives process improvements.
Aren’t sure where to start when it comes to FSMA compliance? Food safety experts at your local MEP Center can help you align with FSMA and state and local food laws. Connect with them for advice on how to build a sustainable food safety culture. In addition, your MEP trusted advisor can assist you with overall operational optimization, new product development, market penetration and workforce development resulting in an improved bottom-line.