How LIMS Enables the Traceability Required to Protect Food Brands
By Paula Hollywood and Colin Thurston
The food supply chain has become a complex global system consisting of small to large domestic and foreign manufacturers, processors, packers, distributors and transporters with few common business practices. Consumers now expect year-round supplies of fresh fruits and vegetables as well as more exotic foods. This has increased the risk of a major food safety incident. Compliance with differing government regulations and enforcement policies adds to the complexity. With such a convoluted value chain with multifaceted reporting requirements, how can consumer-facing suppliers demonstrate regulatory compliance and protect their brands? Laboratory information management systems (LIMS) play a key role in brand protection by facilitating end-to-end traceability of products and all associated laboratory processes.
What’s at Risk?
According to the Grocery Manufacturers Association, the voice of the consumer packaged goods industry in the U.S., ensuring product safety is the industry’s single most important goal. While this may be true, for producers, brand protection is also critical. Product recalls can cost hundreds of millions of dollars and lost sales due to brand damage can be even more devastating.
The Peanut Corporation of America (PCA)—a supplier of peanuts, peanut butter, peanut meal and peanut paste—provides a case in point. In 2008, the U.S. Food and Drug Administration (FDA) determined that one of the company’s processing facilities was the source of the worst salmonella outbreak in U.S. history, killing nine and sickening hundreds. Not only was PCA forced into bankruptcy, sources estimate the cost of the incident to the peanut industry at $1 billion in lost product and sales. The domino effect throughout the food industry involved the recall of about 1,000 different products. A single incident at one company wreaked havoc on an entire industry.
This incident alone demonstrates the expression that “an ounce of prevention is worth a pound of cure.” In other words, it is far better to avoid problems in the first place than to fix them later. Experts cite the PCA incident as the impetus behind the Food Safety Modernization Act (FSMA).
FSMA Emphasizes Prevention
The cornerstone of the FSMA is to prevent incidents based upon risk assessment, as opposed to rapid response to an incident. The Act requires facilities to write, implement, document and demonstrate a food safety plan. It also requires facilities to go deeper into the supply chain than the current “one up and one down” regulations.
For food processors, more stringent controls are required, enabling a more proactive approach to quality. At minimum, preventive controls require new practices with more control points and additional requirements for corrective action and preventive action, root cause analysis and more continuous documentation. Producers must also demonstrate crisis management preparedness, product traceability, batch coding and Hazard Analysis and Critical Control Points (HACCP) plans. To improve effectiveness, these systems must interact with many applications throughout the manufacturing process so that the information can be quickly accessed to contain the scope of a recall in the event of an incident. Plans differ from facility to facility based upon the level of risk to food safety.
Technology in the Lab and the Field
Globalization of the food supply chain has not only increased the availability of more exotic foods, it has also increased the number of pathogens. FDA has reported that there are five times more identified pathogens today than 50 years ago. Traceability of each product from raw material through production and packaging dictates that more pervasive use of laboratory technology in the field will be necessary.
To minimize risk, food processors must produce detailed and accurate records that identify the quality, quantity, disposition and handling of products at each handover point. Raw material testing and identity verification at each handover point are critical to traceability and quality management. A soft drink company, for example, would use Fourier transform infrared (FTIR) spectroscopy to show that dry ingredients are unadulterated. For beverages with sugar added, high-performance liquid chromatography confirms that fructose has not been diluted by a supplier. Water would be tested for pesticides using gas chromatography/mass spectrometry and cyanide using ion chromatography. These and many other test results are transmitted to the LIMS automatically, ensuring data integrity. The LIMS then provides a platform to process, store, analyze and transmit this information to relevant decision makers throughout the company.
Food producers now also have access to portable optical analysis tools that bring some of these laboratory services to the field for fast, accurate material identity verification. Handheld Raman, near-infrared (NIR) and FTIR spectrometers can help users quickly verify raw material identification to determine suitability for further processing. These handheld devices require little to no sample preparation, enabling technologies previously restricted to the laboratory to be used in the field, speeding up raw material identification and data synchronization. The ability to locate the source of a problem through good traceability can minimize the time to recover and avoid extensive damage to the brand and company reputation.
LIMS Secures the Data Environment
The increased traceability requirements mandated by FSMA don’t just require greater amounts of data, they mandate the transition of data into useful information. A LIMS, like Thermo Scientific SampleManager can manage samples, act as a repository for records data and test results and provide increased traceability and full chain of custody to help ensure regulatory compliance. For producers, a LIMS can help verify that product quality meets regulatory standards while recording data for subsequent inspections. For auditors, a LIMS facilitates review of compliance reports and related certificates of inspection stored with the LIMS to verify safety. Integrating LIMS with enterprise systems, such as enterprise resource planning, personal information manager and manufacturing execution software, enables organizations to share information throughout the enterprise for improved decision making.
FSMA increases the stakes to the point where home-grown systems and paper-based tracking methods could place food producers and processes at greater risk for non-compliance, which in turn could jeopardize a brand’s entire operation. Commercial LIMS such as Thermo Scientific SampleManager, which are specifically designed to help organizations comply with regulations such as Good Manufacturing Practices, Good Laboratory Practices, HACCP, CODEX and 21 CFR Part 11, are likely to prove indispensable under the FSMA, since they provide a secure audit trail and document corrective actions. While the emphasis is on prevention, the ability to quickly react to a contamination incident minimizes recall costs and potentially protects brand reputation.
The current food supply chain not only increases consumer access to year round supplies of fruits and vegetables, it also increases the number of pathogens that could cause contamination. FSMA requires tools that focus on prevention and provide a framework for regulatory compliance. LIMS provides a secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods in the complex food supply chain. As the centralized system for collecting, storing, processing and reporting all food lab-generated data, LIMS provides a complete overview of product quality in accordance with regulatory requirements.
Paula Hollywood is with ARC Advisory Group and Colin Thurston is with Thermo Fisher Scientific. Please visit www.thermofisher.com for more information.