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.
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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.
Because it can map these process “pinch points” (changes and hand-offs in the process flow) and then manage the flow of information using metadata such as serial numbers, supplier information, etc., it’s clear why a LIMS is truly a hub for FSMA. First it helps establish the most efficient and safest route to follow from a HACCP standpoint and then, once monitoring begins, it not only oversees the flow of data—massive amounts of it—it can also alert producers to problems before they escalate and provide standardized operating procedures for when they do.
2. Specifying Preventive Steps. Operators make mistakes during production. Equipment becomes outdated or begins to perform poorly. New materials are introduced. There are many fail points in a process, with new ones introduced regularly, so controlling each step requires discipline and structure. A LIMS provides this.
Quality, integrity, and competency must be controlled at every stage during production. When the steps necessary to do this are already codified in software, the likelihood of adherence increases dramatically. A LIMS can, for example, structure operator training requirements for employees both inside and outside of a food production lab. If employees fall behind on training, they cannot rejoin the workflow until they are properly certified or retrained. Likewise, if a sampling instrument is due for maintenance, the LIMS can ensure it’s taken offline until the work is finished and formally documented.
The LIMS can also prevent raw materials or in-process product from reaching the next production stage if pre-established quality thresholds are unmet, and this creates stage gates at critical hazard points. And all of this—from training and instrument calibration to materials assessment—is automated and linked to communications systems, alerting key stakeholders inside and outside the lab to non-conformance as it happens.
3. Monitoring Controls. Without an effective sampling plan and related data management, adherence to a preventive controls plan, as well as future track and trace responsiveness, is nearly impossible. The LIMS ensures that sampling occurs at all necessary control points, that alert thresholds are set, and that data is available for rapid analysis and retrieval.
Sampling plans for control points can be managed as a group, enabling producers to use consistent protocols for each stage of production. Management can compare data from one batch to another and data is available on-demand whenever it’s required—whether for routine quality control or compliance or if an actual hazard is detected.
4. Maintaining Records. Recordkeeping is often seen as audit-related activity, but it’s much more. A LIMS does simplify the process of storing and retrieving data in a paperless environment, but this downplays the value of the information. Records stored within the LIMS are searchable, secure, and authenticated by electronic signatures and audit trails, which significantly streamline routine compliance, but the same data is indispensable following a control point breach. If a hazard is contained, the data can inform future process changes. If the contaminated product has already left the facility, the LIMS will play an important role in isolating the contamination and ensuring a rapid and thorough response.
5. Specifying Corrective Actions. As mentioned above, when a food safety incident occurs, a LIMS will likely be the first place a producer turns to begin corrective action. Fortunately, these steps will be clearly defined in advance and each member of an extended enterprise team will have a specific role. As the IFT pilots made clear, it’s during this critical time that “the systems and processes in place within a firm to capture, store, and report this information” are most important. There’s little time to search, compile, and report critical batch information. FDA will expect rapid analysis that can trace contamination to the source, whether it’s a control point within a facility or a raw material producer downstream.
Law of Unintended Consequences
Many manufacturers are learning that by taking a disciplined, data-driven look at their process control points they’re also achieving new efficiency and productivity gains. Even the relatively straightforward task of automating processes such as training and equipment maintenance scheduling can deliver demonstrable productivity gains. Couple that with data that provides insights into raw materials management, process speed, and costly errors and it’s clear how the benefits of LIMS extend far beyond FSMA compliance alone.
For many, the impetus for change may be FSMA, but the outcomes—with a LIMS in place—are much broader and can impact quality, efficiency, and long-term profitability.
While easing compliance burden and identifying greater efficiencies are benefits that resonate loudly with food and beverage manufacturers, the hard costs of recalls are even more resounding. Even a small recall is expensive, and the longer it goes on the more costly it becomes. The investment made in better information management today pales in comparison to the costs of handling a recall with an inefficient management system.
A data management system, especially one as comprehensive as a LIMS, could be the unsung hero of FSMA compliance.
But FSMA continues to evolve. Consider a recent amendment that requires changes to the Reportable Food Registry, an FDA portal that’s been in place since 2009 to gather data about threats to the food supply. Designed as a first line of protection for consumers, FDA now envisions a more far-reaching purview. Notice requirements under the amendments would put an onus on manufacturers to prepare plans in advance that demonstrate rapid response procedures. So clearly we should expect more oversight in future, not less.
Rapid response, remaining compliant, and discovering avenues for greater efficiency are areas where mastery of data management and a system to do so is required. And when it comes to data and managing lab testing, analysis, and reporting—especially in support of something as far-reaching as FSMA—LIMS is a platform suited to the task.
Thurston is the project director for Thermo Fisher Scientific. Reach him at +44-161-942-3000.