Smart Labs Need to Focus on Predicting and Preventing Errors
While no company would ever put profits ahead of the safety and satisfaction of its customers, tension does exist in some companies when labs are viewed as impediments to increased productivity. It doesn’t have to be this way.
When a lab is responsible for product quality and safety, it fulfills a critical role, but it can also create bottlenecks: lab tests can stand in the way of the raw material acceptance, batch release, and mid- or post-production cleaning, for example. A lab is, in fact, part of a much larger, highly integrated process that includes enterprise resource planning (ERP) software, packaging systems, cold chain, and much more. With all these interdependencies, any inefficiency, from a laboratory informatics standpoint, is magnified.
While labs fulfill a critical data management role when it comes to regulatory compliance, from ISO 22000 to HACCP, at the heart they are part of a production process where even small oversights or inefficiencies can lead to diminished productivity and profit loss. So gaining control over these seemingly insignificant “everyday” problems can mean the difference between profit and loss for the company as a whole. The food and beverage industry is based on high volume, low cost, and small margins, making production efficiency high on the list of priorities alongside product quality and safety.
In the search for greater lab productivity and efficiency, many overlook the small, everyday issues. This is a mistake. By focusing on the common problems below, you’ll have an opportunity to make immediate and demonstrative changes that position your lab as a productivity and profitability driver.
Poor inventory management
Expediting shipments of out-of-stock consumables to a lab—perhaps overpaying as a result—is sometimes called “hot shotting,” and it’s problematic. It’s symptomatic of laboratory mismanagement. Inventory is fairly predictable within a single lab running certain tests and using consistent workflows, so failure to anticipate future need is unacceptable.
Consider a consumable such as vials for gas chromatography (GC). Because of high demand, technicians will store extra vials near their workstations. Because the item is no longer in inventory, a critical batch release may be delayed until a technician can hot-shot what’s needed. Imagine a large dairy where a testing delay is a reason that milk with higher, more expensive fat content moves through production for hours. The lab would be responsible for loss of profit margin for that batch, and it could have been avoided.
Better budgeting and tracking are obvious remedies for inventory mismanagement. A laboratory information management system (LIMS) can enable labs to carefully track inventory as part of a comprehensive lab management program. It’s even possible to create alerts about stock levels. The bottom line is that there is a bottom line: manage it better and you’ll not only avoid waste, you’ll avoid costly production delays that poorly position the lab within the overall enterprise.
Inability to recognize analytical trends
Laboratory errors can be an early warning system. While many labs address errors after the fact, smart labs focus on predicting and preventing errors that mask QA/ QC problems. But with analysts running hundreds of tests each week—many still using paper spreadsheets— this can be nearly impossible.
Today, more and more labs are turning to statistical quality control. The SampleManager LIMS, for example, includes this capability, enabling technicians to detect nonconformance trending before it reaches predefined 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.
Related Article: Informatics Infrastructure in the QA/QC Lab
One missed error can cost thousands or more in lost productivity, product recalls, consumable waste, and, much worse, contaminated batches that sicken customers. Finding minor errors as they occur—because a LIMS-enabled standard operating procedure (SOP) requires you to spot-check data at certain intervals—can mean the difference between profit and loss. And human beings alone simply cannot provide this analytical rigor.
Laboratories are at risk from inconsistent application of procedures, even “innovative workarounds” that show promise as time savers. There is only room for innovation in a lab if, and only if, it passes through the rigor of the SOP process.
Electronic SOPs (ESOPs) are the lab’s defense against risk and the inevitable productivity declines that result from inconsistent procedures. With ESOPs defined in the LIMS, for example, there’s a rigid workflow with clearly defined technical corrective actions to ensure consistency and adherence to protocol. Without this, it’s too easy to make unintended errors.
Four considerations are important when developing ESOPs: thoroughness, standardization, distribution, and compliance. Lab performance, defensibility, and so much more depend on how successfully a lab addresses each of these imperatives. Fortunately, LIMSs have evolved to make management of SOPs easier and more efficient. This brings consistency that not only keeps productivity on track but also helps with compliance with ISO 17025 and other requirements.
Lack of traceability
A single laboratory may be responsible for hundreds of tests each week. And a test is not simply a test, it’s the sum of many parts. Where did a sample originate? What is the maintenance history of the instrument used? What are the reagents and standards used for the test? When was the analyst last certified? Which vendor supplied the consumables? Answering these questions retrospectively can be time-consuming—and that time can sap productivity.
Related Article: Making Research More Traceable
Analysts routinely spend a quarter of their productive time simply collecting data to defend a result. This can take away from time that should be spent contributing to productivity and profitability. But defending data isn’t optional. And this is yet another area where data management software is about more than just data collection and reporting— it’s about enabling productivity. It’s about quickly returning to the job at hand—rapidly, efficiently, and accurately delivering results across the business that enable production to continue uninterrupted.
Today, a LIMS can reach across an enterprise: it still sits in the lab, but it integrates with data in materials requirement planning, ERP, and other enterprise systems in ways that directly impact defensibility. No more searching in multiple places, often a combination of handwritten notes, spreadsheets, and reports: everything required to defend a result is aggregated and organized for rapid analysis and reporting.
When many labs think of trend analysis, they don’t often associate it with instrument maintenance, but that’s a mistake. This reflects a misunderstanding of the importance of maintenance, especially preventive maintenance.
Data such as area counts, baseline conductivity, and retention time provide valuable evidence that, if trended and analyzed, can reveal much about the health of an instrument. Some LIMSs actually offer capabilities that allow users to monitor instrument health so that work can be assigned more effectively on a regular maintenance schedule. Users are notified of upcoming maintenance—even of wear-part failure—so that maintenance can be scheduled before failure becomes an issue.
Analysts will tell you that they “get to know” their instruments, but sometimes signs are too subtle to sense the failure before it occurs and the instrument goes down. And with many new graduates, transfers, and others cycling through who are unfamiliar with various instrument types, there is simply too much margin for error. To understand what an instrument is telling them, it’s much smarter for labs to rely on data; by simply setting a sample point and watching for deviation, labs can effectively give themselves an early warning system. And this can be easily done using a LIMS.
Does instrument downtime seem trivial? It better not, because when a GC goes down, for example, it can impact batch delivery and much more. And looking backward after a production stoppage or slowdown hardly solves the problem today. No, it’s more important than ever for labs to demonstrate that they can play a proactive role in driving productivity and profitability. But it’s hard to make that case when instruments are down or poorly calibrated and your lab is what stands between a business being fully operational and standing still.
Small steps create big changes
Labs are so important to productivity and profitability in the food and beverage industry. Yet too often, little problems—everyday problems that are often seen as trivial—are preventing them from reaching their full potential. And the pace of business today is more frenetic than ever, demanding more and more of managers and analysts who are already overworked.
Everyday problems have a tendency to fly below the radar and escape notice, especially in labs that still rely on paper to manage operations. This must not continue, as food and beverage companies and their labs face even greater scrutiny, exposing gaps that affect not only productivity and profitability, but also the ability to comply with increasingly more rigorous regulatory requirements.
A modern lab should be a productivity partner, capable of not only driving greater efficiency and profitability but also of mitigating future risk. Recalls are expensive, but better, more proactive management can help. Likewise, better data management can help with regulatory compliance, planning, R&D innovation, and so much more. In this regard, the LIMS should be seen as a catalyst for an entire enterprise, not simply a tool for managing a lab. Then the lab can be positioned in a totally different light, as a driver of—not an impediment to— productivity and profitability.