LIMS facilitates FSMA compliance

FOR a long time, the food and beverage industry relied on manual processes and paper-based data management systems to monitor sample testing, quality control and distribution. However, the recent years have proven that traceability of all aspects of food production is now the norm, and utilising manual or paper-based processes to provide traceability reports to any type of regulatory authority is a thing of the past. Now food producers must be able to rapidly trace the origins of any contamination to prevent product recalls and more importantly, to prevent harming the public. Both events will have repercussions for that food producer, including loss of revenue and possibly loss of consumer confidence in the brand. 

The introduction of Food Safety Modernization Act (FSMA) in the United States has brought about the need for greater scrutiny, which means that food and beverage producers around the world shipping product to the U.S. will have to think about how they manage their laboratory data with a view to compliance with U.S. regulations. Food is global now, with choices available every day from food producers far removed from the consuming public. With the passing of the FSMA, food importers will be required to produce certificates of compliance to the new standards and ensure that accredited laboratories conduct proper testing. If certificates of compliance are not available to U.S. food inspectors, those food items will be refused entry to the United States. The EU Directive 178/2002 is no less restrictive. These regulations and legislation are pressing companies to use a secure electronic data environment, increasing the need for laboratory information management systems (LIMS). 

Whilst 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, an outbreak of listeriosis caused by contaminated sausage had resulted in the death of 12 people in Denmark. This provides yet another stark reminder that prevention is critical, but peoples’ lives depend on proper response. The key to response is effective tracking and traceability. This article explores the industry’s experience to date and how a LIMS is much more than a data management tool – it’s a platform for coordinating prevention and managing timely, effective response.

Discovering the challenges of product tracking

In 2011, the FDA tasked the Institute of Food Technologists (IFT) to execute product tracing pilots in collaboration with the U.S. Department of Agriculture, state departments of agriculture and nearly 100 other organisations. This led to two pilots intended to identify methods for improving tracing of foods across supply chains and develop methods to rapidly address foodborne illness outbreaks caused by food contamination.

No surprise that the pilots showed that the process of product tracking was exceedingly complex and “often times confusing.” IFT highlighted inconsistencies in terminology, numbering systems, formatting and legibility. Whilst many pilot participants had instruments and processes necessary 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 final conclusion was that “uniformity and standardisation, 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. 

LIMS enables tracking, tracing and more, for manufacturers 

The IFT pilots put a point on standardisation, record-keeping, planning and coordination. These are hallmarks of a modern 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” (as described in FSMA Section 103 – Hazard Analysis and Risk-Based Preventive Controls), which is based on the rigorous 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 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, including ERP and MES. 

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 can be central to effective monitoring and recording at the batch level, creating a record that traces the journey of the batch as it moves from farms through various stages of production to packaging 

LIMS and HACCP Implementation 

1. Evaluating Potential Hazards You must know your processes. 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 – require human or machine intervention, and this opens the door for misstep. What’s more, in multi-ingredient processes, the source of each ingredient is important as well. This is the complex environment into which manufacturers must “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 SOPs for when they do.

2. Specifying Preemptive 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 of these steps 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 an employee falls behind on training, they cannot rejoin the workflow until they are properly certified or retrained. Likewise, if a sampling instrument is due for routine maintenance, the LIMS can ensure that it is taken offline until required 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. The new control system, systematically managed by the LIMS, is designed from start to be comprehensive and highly responsive.

3. Monitoring Control Points 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. Establishing Paperless Record-Keeping  Record-keeping is often seen as audit-related activity, but it’s much more. A LIMS does greatly 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 streamlines 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 production facility, the LIMS will play an important role in isolating the contamination and ensuring a rapid and thorough response.

5. Defining Response Protocol 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 is little time to search, compile and report critical batch information. FDA will expect rapid analysis that can trace contamination to the source, whether that’s a control point within a facility or a raw material producer downstream. 

The middle of a food safety incident is not the time to develop procedures for tracing fail points in a production process – at this point what’s needed is very specific information and clear protocols to contain the problem as quickly as possible. 

Inadvertent benefits

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.

Conclusion

Whilst 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, especially if one’s in place during a recall crisis. Considering that the FDA estimates that one in six Americans is plagued by foodborne illnesses each year, the need is clear and present.

But FSMA continues evolve. Consider a recent amendment that requires changes to the Reportable Food Registry (RFR), an FDA portal that has been in place since 2009 gathers information about real 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 proposed 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 coming years, not less.

Rapid response, remaining compliant and discovering avenues for greater efficiency are all areas where mastery of data management, and a system to do so, is required. And when it comes to data and managing the complexity of lab testing, analysis and reporting—especially in support of something as far-reaching as FSMA—no platform is more suited to the task than LIMS. 

*Colin Thurston is project director at Thermo Fisher Scientific.