Over $93 billion a year. That, according to a new Ohio State University study published in the Journal of Food Protection, is the estimated cost of foodborne illness in the U.S. alone. This doesn’t look at the cost to industry, but rather it considers the cost to treat those affected by these illnesses.
What concerns those in the food industry most about staggering estimates like this is the increased scrutiny it brings from policy makers. In fact, the author of the study, Robert Sharff, hopes that his data, which looks at foodborne illness on a state-by-state basis, will “give policymakers a tool to determine whether a particular intervention they’re using makes sense.”
Increasing pressure from regulators is only part of the story for the food industry. According to “Food Safety in a Globalized World,” a study done by global reinsurer Swiss Re, “52 percent of all food recalls cost affected U.S. companies more than $10 million each and losses of more than $100 million are possible.” These estimates exclude any costs of reputational damage, so the ultimate number is much larger.
The significant costs of recalls and more onerous regulatory oversight are enough to justify even greater rigor for labs operating inside food manufacturers. But there’s an obvious drawback to thinking only about recalls and other risks when outfitting and running a food industry lab—this is, after all, a for-profit business. Labs must balance their critical safety net role with a business imperative to drive higher and higher productivity and eke out larger margins wherever possible.
From a food safety and quality standpoint, there are many fail points within a typical food manufacturer that must be understood and closely tracked. This can quickly become overwhelming, and many labs soon become known for their bottlenecks instead of their benefits. From the way they accept raw materials to batch release speed, labs can have an outsized influence on production speed and efficiency.
The potential for labs to disrupt manufacturing productivity can put them squarely in management’s crosshairs, which is why it’s so important to leave nothing to chance, even the smallest process step. Yes, there’s significant pressure to meet regulatory requirements, such as ISO 22000 and Hazard Analysis and Critical Control Points, and the specter of a recall is ever-present, but the answer isn’t to slow operations to a more manageable crawl. That simply isn’t an option.
The modern food industry lab must cast a wider net when it comes to safety and quality fail points, but technology can ensure that this happens with increasing alacrity. This isn’t accomplished by relaxing standards and letting more pass by. In fact, it’s quite the opposite: the best approach is to break down all the fail points, account for them in software and manage as if even the most insignificant problem could snowball into a costly issue.
While there are many places that labs could begin as they look for common fail points, three isolated common areas where an ounce of prevention could yield a pound of cure are inventory, standard operation procedures (SOPs), and traceability. These areas may seem obvious, but few labs approach them with the rigor believed is necessary, so let’s explore them in greater detail.
Inventory
Culture media, reagents, and even vials for gas chromatographs—just some of the everyday items in a food lab that often go out of stock. But why? Most labs operate fairly routinely, running the same workflow test after test with a normal cadence. It shouldn’t be difficult to manage rotating stock with that information at your fingertips.
The problem is that it’s not always at the fingertips. Inventory may not even be tracked electronically, so what looks to be in stock may actually be unavailable. This isn’t something you want to learn as the product team is eagerly awaiting your approval to release a batch. Perhaps the batch is held, which stalls production altogether, or batches move through but eventually need to be discarded. In either case, a seemingly mundane issue—can’t/don’t track inventory in real time—jeopardizes productivity, and, in this case, blame falls squarely on the lab.
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.
When a lab is holding up a batch release, for example, so much must fall into place for it to quickly test and confirm results according to strict formulation and safety parameters. If it still relies on paper-based systems, excessive time is likely required. Even if it has mostly automated data entry, it still must adhere to guidelines that if not codified in software will also require valuable time. And within a food manufacturer, time is always associated in some way with margin.
Without an integrated informatics solution, adhering to these procedures, defending the quality of the data, and making it usable would be nearly impossible. This is why data management through software isn’t just about reporting for auditing purposes. It’s about accelerating results delivery so that production can continue uninterrupted and efficiently, making the lab a demonstrable driver for higher productivity and margin, not an impediment.
Small Steps Create Big Changes
There are many fail points within a typical food manufacturer, and labs are a critical line of defense to ensure failure doesn’t occur. But this can thrust them into a position of productivity impediment instead of driver. When it comes to product quality and consumer safety, some bottlenecks are inevitable, almost necessary. After all, regulation seeks to control certain points that are known to engender risk. But management doesn’t want to hear that control must always equal productivity drain and revenue loss.
From the way they accept raw materials to batch release speed, labs can make demonstrable contributions to productivity and profitability. But only if they accept the notion that ounces of prevention—with data as the measure—can add up to pounds of cure, which in this case would equal more efficient operations and higher profits.
When a lab disrupts manufacturing, it should be to increase productivity, not impede it, and with LIMS and some added discipline this is possible. When this happens, a lab may still be in management’s crosshairs, but this time it will be for all the right reasons.
Meek is the director of product strategy and senior marketing manager for informatics and chromatography software for Thermo Fisher Scientific. She has been with Thermo Fisher in product management, product marketing, sales, and support of software solutions for the past 17 years. Reach her at [email protected].
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