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.
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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 Equipment becomes outdated or begins to perform poorly.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.