LIMS: A Hub for Compliance

Among the many powers granted to the FDA under the Food Safety Modernization Act (FSMA) is the “authority to order a recall of food.” It can also “suspend,” “detain,” or otherwise disrupt product distribution if it suspects the public is at risk. And European Union (EU) Directive 178/2002 is no less restrictive.

While FSMA and EU directives represent a major shift by the regulators to move from response to prevention, the reality is that contamination does occur. As of this writing, contaminated sausage has been linked to an outbreak of listeriosis that killed 12 people in Denmark. This provides yet another stark reminder that prevention is critical, as peoples’ lives depend on proper response. The solution lies in effective tracking and traceability.

Piloting Track and Trace

In 2011, the FDA tasked the Institute of Food Technologists (IFT) to execute product tracing pilots in collaboration with the USDA, state departments of agriculture, and nearly 100 other organizations. This led to two pilots intended to identify methods for improving tracing of foods across supply chains and develop ways to address foodborne illness outbreaks.

No surprise that the pilots showed the process of product tracking was exceedingly complex and “often times confusing.” IFT highlighted inconsistencies in terminology, numbering systems, formatting, and legibility. While many pilot participants had instruments and processes to capture track and trace level data, performance ultimately came down to “the systems and processes in place within a firm to capture, store, and report this information.” (“Pilot Projects for Improving Product Tracing along the Food Supply System—Final Report,” August 2012, IFT).

IFT’s conclusion was that “uniformity and standardization, improved recordkeeping, enhanced planning and preparedness, better coordination and communication, and the use of technology” were key to rapidly handling “tracebacks” and “traceforwards” in the face of contamination and/or recall.

More Than Tracking and Tracing

The IFT pilots put a point on standardization, recordkeeping, planning, and coordination. These are hallmarks of a modern laboratory information management system (LIMS). But its strength in these areas goes far beyond track and trace—its value starts much earlier in the process.

The starting point for many manufacturers is a “preventive controls plan,” which is based on the Hazard Analysis and Critical Control Points (HACCP) methodology. Developing this plan is not easy, but there’s a reason for that—it’s one of the most important steps a modern food or beverage manufacturer must take as society works to reestablish, or, in some cases, build, public trust in our food supply.

LIMS excels at managing data. Its role in collecting data—from many different instruments and other data sources—is obvious, but it’s the data management role that’s most important, especially in tracking and tracing. A LIMS can be central to effective monitoring and recording at the batch level, creating a record that traces the journey of a batch as it moves from farms through various stages of production to packaging. This end-to-end visibility is possible because a modern LIMS is—or should be—tightly integrated with other enterprise management systems.

The ability of a LIMS to be a hub for track and trace starts with the preventive controls plan, and that plan comprises five steps: evaluating the hazards, specifying preventive steps, specifying how the facility will monitor its controls, maintaining monitoring records, and specifying corrective actions to correct problems.

LIMS and Preventive Controls

1. Evaluating the Hazards. Hazards most often occur in obvious places: where materials are added, where vessels are opened, and where products are packaged. Each of these steps in production, and countless more, requires human or machine intervention, and this opens the door for misstep. What’s more, in multi-ingredient processes, the source of each ingredient is essential as well. This is the complex environment where manufacturers “traceback” when an incident occurs.