Few consumers realize how many data bytes go into what they bite. Across laboratories worldwide, technicians process hundreds of thousands of samples—from raw ingredients to the finished products shipped to consumers. The data generated is vital to everything from quality control to traceability.
You Might Also Like
Explore This IssueAugust/September 2015
Also By This Author
With so much riding on the accuracy and timeliness of data, few in the industry pause to consider data defensibility. But it’s as important in food labs as it is in any industry: Scientists stand behind results and the steps taken to generate them. But the requirement that data be defensible shouldn’t conflict with constant demands for rapid throughput, efficiency, and greater productivity.
For many in the food industry, a proven pathway to ensure that data is reliable and defensible is to follow guidelines outlined by industry groups or by global standards organizations like ISO. In particular ISO 17025 sets out standards for the management of testing and calibration laboratories, and outlines guidance for the proper calibration of lab equipment and instruments, maintenance schedules, user training, etc. Adherence to a globally accepted set of standards like ISO is a first step for many labs in pursuit of defensible data. But while this standard has been in place for more than 15 years, compliance hasn’t always been easy: Setting up to comply with the standard, especially in a lab that still relies on paper records, is challenging.
The Importance of Data Management
Depending on the food produced, a single laboratory may be responsible for hundreds of tests each week. And no test is just a test; it’s the sum of many parts, from the information about where the sample originated to the maintenance records of the instrument used to conduct the test and the technician’s training history. The data accompanying a single test is significant, and all of it is equally important in a paradigm of defensibility.
Historically, defending data has been onerous. In the case of a disputed result, lab employees would painstakingly collect and aggregate data from multiple sources, including handwritten notes from fellow technicians. It’s not uncommon for technicians to spend a quarter of their productive time simply collecting data to defend a result. Sure, the effort is vital given that public health could be at risk, but these are still hours that could be better spent on activities that are tied to top-line business growth, not time-consuming manual activities, even for something as important as quality assurance or regulatory compliance. Defending data is hard, but it’s also not optional.
Like nearly every industry, the food industry is being transformed by technology. And nowhere is this truer than in the lab and with software. In the age of “big data,” comprehensive data management software is a big deal, and it is one reason that labs are finding it’s easier and less time-consuming to defend their data. Defending may not be as hard after all.
Laboratory information management systems (LIMS) have been around in food safety and quality labs for years. And while the legacy of LIMS may be basic sample management and data reporting, today the capabilities are much more far-reaching across an enterprise: The lab is still where the LIMS sits, but it integrates with data in material requirements planning, enterprise resource planning, and other enterprise systems in ways that enable unprecedented visibility and, most important here, rapid, comprehensive and highly efficient defensibility.
Food manufacturers are concerned with physical, biological, and chemical contaminants. In the case of chemical contaminants, many analytical techniques exist to quantify known chemical contaminants in complex food matrices at very low levels, as is often required by regulation. More advanced instruments and techniques can also be used to identify unexpected chemical contaminants such as advanced agrochemicals, pesticides, and veterinary drugs.
Today it’s not uncommon for a food lab to use complex workflows that feature mass spectrometry (MS) and gas chromatography (GC) working in tandem to dramatically increase selectivity and sensitivity. And the more complex the workflow, the more reasons to automate the workflow and integrate the lab’s instruments with the LIMS, allowing data defensibility to rest in an automated process, and eliminating the errors that can result from manual data handling.
Case Study: Strawberry Jam and GC-MS/MS
For pesticides, many regulations set maximum residue levels (MRLs) at extremely low levels. Many of these MRLs are set at a default value of 0.01 milligram (mg)/kilogram (kg), which is the typical limit of determination of routine analytical methods. This means that some laboratories must test a wide array of foods for a large number of pesticides at concentrations at or below 0.01 mg/kg, doing so with low costs and fast turnaround times.
So let’s say that you wanted to test strawberry jam for pesticides. Once you extract the sample and prepare it according to a detailed sample prep workflow, you’d inject it into a GC-MS/MS system and begin your analysis. This is certainly an over-simplified anecdote, but the point isn’t to discuss the merits of using GC-MS/MS to analyze complex food matrices. This example merely illustrates how much variability there is in the food testing process. Complex instruments, consumables, technicians, samples, etc.—all part of an eventual defensibility exercise.
So knowing that defensibility is both a requirement and a challenge, what’s a forward-thinking lab to do? Engineer defensibility into their processes, of course. But that’s easier said than done. Unless, of course, data is already collected and managed in a disciplined fashion. Even better, so much of the larger data collection process has already been automated thanks to LIMS, so all that’s required when defending a result is a few relatively easy steps.
At a high level, labs must address two main areas: technical quality—including consumable integrity and instrument maintenance and calibration—and staff performance. And much can “go wrong” in these areas if discipline is lacking.
1. Technical quality. Technical quality data includes everything involved with producing an accurate result from an instrument. This presumes flawless staff execution and strict adherence to standard operating procedures (SOPs).
For the strawberry jam analysis above, relevant technical quality data would include reference material certificates, records of approved suppliers, maintenance records, and more. Seems straightforward until one imagines how many times an experiment like this takes place across a busy food lab. The only way to ensure that no misstep compromises a final result is to capture everything within a LIMS as it happens.
Suppliers. From stock solutions to carrier gases, what comes into a lab could affect a result as much as what happens inside the lab. But labs can’t afford to test each shipment of consumables, so they often rely on “approved” suppliers that have earned a reputation for—or can document—quality.
But to defend a result, a technician must use consumables from those pre-approved suppliers. And a LIMS can ensure that they do so on every run. Barcoded materials can be tracked as they arrive, associating them with each supplier and linking the instrument running the test and the materials used to do so. During defense of a test result, a technician need only verify within the LIMS that all consumables originated from approved suppliers. If so, consumables are unlikely to be the fail point.
Consumable quality. The origin of a consumable only tells part of the story. Consumables can, after all, go out of specification during storage or use. The LIMS is indispensable here as well: Lab administrators can configure the system to automatically alert staff when a periodic check is required. This capability significant reduces the likelihood that staff will inadvertently use an out-of-specification consumable that would make the test result indefensible.
Instrument maintenance and calibration. Routine maintenance and workflow-related calibration play an important role in defensibility. And keeping track of what was done, when, and by who is time-consuming and error-prone. But not with a LIMS. Lab managers can organize and retrieve maintenance and calibration records by instrument, time period, and even staff member, and they can proactively set alerts to ensure maintenance occurs on a pre-defined schedule.
For calibrations, the LIMS can easily track reference materials as it tracks the data from the calibrations. If there is an issue with a reference material or an out-of-specification instrument, this will be quickly revealed during the gathering of defensibility data.
2. Staff performance. Human error is just as troublesome in the lab as instrument error. Fortunately, the LIMS is designed to help here as well, addressing issues that arise in each of three broad categories: training, process, and data management. Labs should be able to document adherence to policies and procedures across each of these categories.
Staff training. Training is an important function in any food lab. New staff may be unfamiliar with new instruments or workflows and existing staff are confronted with constant change. Training is dynamic enough to warrant greater discipline and rigorous documentation. And whenever discipline and rigor are required, a LIMS is a wise choice. And this is especially true in a laboratory environment where training and certifications can be different instrument to instrument and process to process. Something as simple as a lapsed certification on a GC- MS/MS instrument can be all it takes to negate a test result and cause a costly production slowdown.
Process quality assurance. Workflows are fundamental to laboratory productivity and quality. There are no shortcuts and variation is unacceptable. So what takes place, by whom, and in what order is critical and must be tracked. A LIMS
can help in two ways: it stores the SOPs, automating as much as possible, and it stores the adherence to these SOPs. There is no room for error-causing interpretation. And if a step is missed, the LIMS records that misstep in real-time, perhaps preventing a future indefensible result before it its memorialized as a record of failure.
For labs looking to engineer defensibility into the process, it’s almost possible to monitor process quality in real time—the LIMS is constantly looking for exceptions that violate the rule. And it doesn’t matter how many different processes and rules are in place, the LIMS is adaptable and can store as many SOPs as a food lab has tests and results to defend.
Data entry and transcription. Manual data entry errors are a well-documented cause for data indefensibility. Even when processes are entirely automated, just a single—even minor—error can cause a bad result downstream. With a LIMS, however, nearly every step can be automated and the resulting data integrated, even from instruments from different vendors. For labs that aspire to engineer defensibility into their processes, there’s no question that a LIMS can be the system of record for “designing out” manual entry errors and using automation to close the loop on unintended transcription or other errors.
Visibility Leads to Defensibility
Whether a food safety lab is analyzing complex matrices with GC-MS/MS or using high-performance liquid chromatography to analyze carbohydrates in foods and beverages, there are many fail points. And without a way to ascertain where a result went wrong, it’s nearly impossible to defend it.
By engineering defensibility into the process, a lab can take a proactive stance. Upfront work may be required, but the long-term savings in time, aggravation, and cost are immeasurable. And with increasing oversight necessary, thanks to the Food Safety Modernization Act and even stricter European Union regulations, manufacturers will require even more visibility into production processes and related quality assurance and control procedures.
Defensibility is part of working in a lab. And with tougher oversight and the need to defend brands against costly breaches and recalls, the demand will certainly grow. But there is an answer, and a LIMS is the means to achieve it—settle for nothing less than complete visibility. Instruments, consumables, and workflows are among the many parts of a dynamic whole, and once the interrelationships are reconciled it’s possible to engineer in defensibility so that it’s not an extra burden but instead is an extra measure of protection.
Meek is director of product strategy, informatics, at Thermo Fisher Scientific. Reach her at firstname.lastname@example.org.