An Ounce of Prevention for Food Safety Labs

Inventory can be easily tracked and proactively replenished, but it requires commitment and technology that is capable of supporting high-throughput testing. A laboratory information management system (LIMS) can not only track inventory as it’s used, it can also be programmed

to generate alerts that warn of waning stock levels. Knowing that a reagent is almost out of stock seems trivial until hours into the latest stoppage when you realize how valuable that information would have been two days ago.

SOPs

In writing about its most recent “Reportable Food Registry” annual report (2014), the FDA observed that “The most important lesson learned from this analysis of food allergen recalls and reportable foods is that many of these recalls were caused by simple problems and could have been easily avoided.” It advocated for regular reviews of processes, from raw material acceptance to packaging, to identify procedural changes that could help avoid future recall problems.

Nowhere are SOPs more important than in the lab. Increasingly, labs are going a step further, relying on electronic SOPs (ESOPs) as a defense against risk. Productivity also hangs in the balance, and inconsistency can lead to costly delays that erode trust that must exist between labs and the larger manufacturing enterprise.

But creating ESOPs is only part of the story and a LIMS, such as Thermo Fisher Scientific’s SampleManager, can simplify this process, defining stepwise workflows along with technical corrective actions to ensure consistency and adherence to protocol. Beyond the discipline offered by software such as LIMS, labs must consider many things as they develop ESOPs including thoroughness, standardization, distribution, user compliance and, as the FDA assessment indicates, learnings.

This last consideration, learnings, reflects the fact that SOPs must always be part of a feedback loop. Yes, SOPs are standard, but regulations change and processes are updated—as this happens, the lab must reassess its procedures and then roll out changes effectively. With a LIMS, this happens rapidly and thoroughly with little if any disruption to production. In fact, there may even be opportunities to further streamline laboratory procedures by proactively identifying productivity gains through software.

Aiding proactive discovery in labs is statistical quality control (SQC), a capability that is now standard in some LIMS. With SQC, technicians can detect nonconformance trending before it reaches pre-defined thresholds. This gives labs real-time monitoring capability that relies on statistical algorithms: the lab is observing data trends while the analysis is running, not weeks later.

Think of this as a failsafe for SOPs, another way to catch errors that can cost thousands before they become productivity issues. If data goes out of spec—something that may be impossible for a human to detect—the LIMS can provide warning. The technician is able to address the issue proactively, and this could mean the difference between a rapid batch clearing result or a costly delay in production.

Result Traceability

Nothing can grind a lab to a halt faster than having to defend a result. Was there something wrong with the consumables or instrument? What was the source of the sample? Was the analyst recently certified on the gas chromatography? These are just some of the questions that must be answered if a result is questioned. Until that happens, productivity will likely suffer.

Without a documented and unbroken chain between data and sample, a result is indefensible, it’s that simple. From barcoding through final reporting, each step must be recorded (according to SOPs) in a manner that makes it easy to trace the pathway of a sample. Now multiply this by hundreds, if not thousands of samples, and it’s clear how onerous this process can be.