LIMS FAQ:What are the key elements of a LIMS for food and beverage testing?
Title: What are the key elements of a LIMS for food and beverage testing?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: September 2022
A food and beverage laboratory may analyze anything from ingredients and additives to finalized food and beverage products, and many things in between. The types of analyses associated with these and other substrates and matrices can be equally diverse, depending on the role the food and beverage laboratory is playing in the overall larger framework of the industry. As has been noted in other work, the laboratory workflow of the research and development (R&D) role, for example, may look different than that of the food and beverage lab conducting activities in the pre-manufacturing/manufacturing role and the post-production regulation and security role.
Among all these activities is the driving goal of better ensuring a safer, more high-quality food and beverage product for consumers. This goal is furthered by the industry's past lessons and regulatory considerations that were made as a result of those lessons. However, these regulatory requirements place an additional burden on labs trying to meet this common goal, as well as their own internal goals towards quality and excellence. This broad array of analytical techniques and set of regulatory considerations means such labs will continue to turn to informatics solutions like the laboratory information management system (LIMS) and other food safety software, in turn requiring those information management solutions reliably meet the unique needs of their lab.
This brief topical article will examine the typical food and beverage lab's operations and workload, and suggest a base set of LIMS functionality (i.e., system requirements) that is critical to fulfilling the information management and workflow requirements of this lab type. Additional unique requirements will also be briefly discussed.
Note: Any citation leading to a software vendor's site is not to be considered a recommendation for that vendor. The citation should however still stand as a representational example of what vendors are implementing in their systems.
Food and beverage laboratory workflow, workload, and information management
An earlier work looked at the type of testing occurring in food and beverage labs. That examination revealed a wide array of activities going on within the industry, depending on the role the lab plays within the industry, including analyses for innovative improvement, aroma/flavor, nutritional reformulation, stability, packaging safety, labeling, quality control, authenticity, and accreditation. For example, improving the flavor of plant-based meat substitutes comes with somewhat different analytical techniques and disciplinary requirements than improving the three-dimensional food printing of said meat substitutes. Further, both of these R&D workflows likely differ significantly from the food and beverage lab testing for contaminants in a finished product. When you also take into consideration that "[e]very food supply chain will have its own set of product specifications and QC parameters," the workflow picture gets even more complex. Undoubtedly, this means a significant diversity in workflow and workload considerations for the wide variety of industry labs out there.
What is more certain about all these labs' workflows and workloads is the need for quality and consistency to be woven into them in the name of consumer safety and satisfaction, as well as regulatory compliance. At every step of the way—despite any differences in analyses, substrates, and instrumentation among these labs—is this common need to ensure safety, quality, and compliance as part of the end result of operations. The lab attempting to improve the flavor profile of a blended wine may depend on a variety of complex chemical analyses to monitor acids, while the lab attempting to verify the heavy metal content in spinach will use a different set of analytical technique and equipment; however, both labs are focused on performing the activities with some form of safety, quality, and compliance in mind. As such, this article won't look further at specific workflows but rather look more broadly at ensuring those workflows are more optimal, especially through the effective use of information management solutions like a LIMS.
The use of LIMS in food production facilities and labs is not a new concept. However, little information can be found as to the percentage of today's food and beverage laboratories using a LIMS in their workflow. Several surveys from 2020, however, hint that LIMS are important to these types of labs. A survey of 135 professionals—nine percent of them from the food and beverage industry—from laboratory consultancy Astrix Technology found that more than 77 percent of respondents had at least one LIMS implemented in their organization. A separate survey from Lab Manager about analytical instrument use among readers found that more than 16 percent of them were using instruments for food and beverage analysis. Combined, these surveys suggest that the food and beverage industry is not trivially represented among labs. By extension—and particularly given the importance of integrating instrumentation and their produced data in such an environment—a LIMS or other informatics solution appears to be increasingly critical to eliminating manual processes, improving sample management, increasing productivity, and improving regulatory conformance. This, of course, lends to the food and beverage lab's focus on safety, quality, and compliance.
A LIMS can improve laboratory workflows and workloads while enhancing safety, quality, and compliance in a number of ways. A fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to ingredients, additives, quality control samples, standard operating procedures (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of food and beverage production. A well-implemented LIMS can reduce the silos of information and data, while at the same time make that information and data more secure and readily accessible. Given the regulatory demands for providing rapid proof of traceable product movement and relevant quality control data, the LIMS acts as the central integrator and audit trail for that information. Because the LIMS improves traceability—including through its automated interfaces with instruments and other data systems—real-time monitoring of supply chain issues, quality control data, instrument use, and more is further enabled, particularly when paired with configurable dashboards and alert mechanisms. By extension, food and beverage producers can more rapidly act on insights gained from those real-time dashboards. This is also means that the food and beverage testing lab can react more rapidly to issues that compromise compliance with certification to the ISO 17025 standard or Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) requirements. Finally, many modern LIMS tailored to the food and beverage industry come pre-configured out of the box with analytical and quality control workflow support tools that can be further optimized to a lab's unique workflow.
Other informatics options
As an aside, it must be noted that the LIMS is not the sole information management solution for food and beverage producers and laboratories. Software-based information management solutions are being marketed to food and beverage labs in other ways. Some vendors have taken to marketing the somewhat related laboratory execution system (LES), which tends to focus more on laboratory test method execution at the process level while integrating other R&D functionalities found in, for example, electronic laboratory notebooks (ELNs). Other vendors have moved away from the "LIMS" and "LES" moniker completely, referring to their software as simply "food safety software." These offerings appear to focus on helping a producer do more than manage laboratory testing output by addressing other organizational needs such as developing regulatory-driven safety plans, generating schedules for environmental testing, improving communication and compliance, improving reaction time to non-conformances, improving audit readiness and reporting, ensuring greater compliance, and identifying trends across the entire enterprise. In comparison, some LIMS may or may not address these issues; this functionality will be discussed further in the section on specialty LIMS requirements.
Base LIMS requirements
Given the above, it's clear LIMS adoption and use is important to the continued success of food and beverage labs. However, in most cases, a generic LIMS won't do; it's imperative the lab find a solution that meets all or most of its workflow requirements. This more often than not requires a configurable solution that enables trained users to quickly make the changes they need, if those changes make sense within the overall data structure of the LIMS.
What follows is a list of system functionality important to most any food and beverage laboratory, with a majority of that functionality found in many vendor software solutions.
Test, sample and result management
- Sample log-in and management, with support for unique IDs
- Sample batching
- Barcode and RFID support
- End-to-end sample and inventory tracking
- Pre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), drug residues (i.e., pharmaceutical chemistry), and other substances
- Pre-defined and configurable industry-specific workflows
- Configurable screens and data fields
- Specification management
- Test, sampling, instrument, etc. scheduling and assignment
- Test requesting
- Data import and export
- Robust query tools
- Analytical tools, including data visualization, statistical analysis, and data mining tools
- Document and image management
- Version control
- Project management
- Method and protocol management
- Investigation management
- Facility and sampling site management
- Storage management and monitoring
Quality, security, and compliance
- Quality assurance / quality control mechanisms
- Mechanisms for compliance with ISO 17025 and HACCP, including support for critical control point (CCP) specifications and limits
- Result, method, protocol, batch, and material validation, review, and release
- Data validation
- Trend and control charting for statistical analysis and measurement of uncertainty
- User qualification, performance, and training management
- Audit trails and chain of custody support
- Configurable and granular role-based security
- Configurable system access and use (i.e., authentication requirements, account usage rules, account locking, etc.)
- Electronic signature support
- Data encryption and secure communication protocols
- Archiving and retention of data and information
- Configurable data backups
- Status updates and alerts
- Environmental monitoring support
- Incident and non-conformance notification, tracking, and management
Operations management and reporting
- Configurable dashboards for monitoring, by product, process, facility, etc.
- Customizable rich-text reporting, with multiple supported output formats
- Custom and industry-specific reporting, including certificates of analysis (CoAs)
- Industry-compliant labeling
- Email integration
- Instrument interfacing and data management
- Third-party software interfacing (e.g., LES, scientific data management system [SDMS], other database)
- Data import, export, and archiving
- Instrument calibration and maintenance tracking
- Inventory and material management
- Supplier/vendor/customer management
- Integrated (or online) system help
Specialty LIMS requirements
As noted previously, some software vendors are addressing food and beverage processor needs beyond the basic laboratory through their food safety software. A standard LIMS tailored for the food and beverage industry may already contribute to some of these wider organizational functions, as well as more advanced laboratory workflow requirements, but many may not, or may vary in what additional functionality they provide. In that regard, a food and beverage LIMS vendor may also include specialized functionality that helps the food and beverage producer and its laboratory:
- Manage stability studies: Just as with the pharmaceutical industry, stability studies play an important role in food and beverage safety. These studies require careful statistical analysis, predictive modelling, sensory analysis, quantitative descriptive testing, discrimination testing, microbiology testing, and more. This translates to a need for a wide variety of analytical and visualization tools, as well as LIMS support for a wide variety of test methods and limits. A robust LIMS should have these abilities, but not all do.
- Manage recipes, as well as master and batch production records: This functionality is more in the domain of the LES or manufacturing execution system (MES). However, a few LIMS vendors may extend their LIMS to provide these features. Given that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some food and beverage facilities testing batches and manufacturing materials may appreciate support in this regard.
- Support molecular biology workflows: Molecular biology is an important tool in the research of improving foods, beverages, and their ingredients. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, and genotyping. A lab using such techniques may have to do extra due diligence in finding a food and beverage LIMS that also supports these workflow tasks.
- Take advantage of ELN functionality: Given the level of R&D to be found in a food and beverage facility, the ELN is a familiar companion to other informatics systems. A few LIMS vendors may have a built-in ELN with their LIMS or offer an ELN that comes readily integrated with the LIMS. Some elements of ELN functionality may even be found in a few solutions. At a minimum—and nodded to in the base functionality above—the LIMS should support ELN functionality through its ability to effectively connect to a third-party ELN.
- Develop regulatory-driven safety plans: The Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for food and testing labs (and is an influence on ISO 17025). Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a visualization tool.
- Generate schedules for environmental testing: While a LIMS can help assign and schedule a variety of laboratory tasks, broader organizational goals of testing the production environment on a scheduled, reportable basis may not be so straightforward, particularly without facility and sampling site management functionality that allows for highlighting specific test points in the facility. Even offsite or randomized testing may not be fully supported by a generic LIMS, requiring a LIMS flexible enough to compensate for the need for broader scheduled and randomized testing and retesting.
- Improve reaction time to non-conformances: Many LIMS will have some basic form of non-conformance and incident management tools, but the robustness and extensibility of that functionality may be lacking. Can it send an SMS or email to the appropriate supplier in real-time when a pre-defined set of circumstances concerning that supplier's ingredients occurs? Can it re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident? This is a useful area of functionality for the potential LIMS buyer to confirm with a vendor.
- Improve audit readiness and reporting: A LIMS worth its weight will have a robust audit trail, to be sure. But can your LIMS help you audit your suppliers? Can it capture internal audit data on-demand and directly from the facility floor via mobile-friendly forms? Can HACCP- and audit-related data be flagged as such to make retrieval more efficient for audit purposes? These and other considerations may be important to a food and beverage facility, and not all food and beverage LIMS can provide.
This brief topical article sought to answer "what are the key elements of a LIMS for food and beverage testing??" It notes that despite a common goal of making safer, more high-quality foods and beverages, the workflows associated with food and beverage testing can vary, sometimes significantly, depending on the role it plays within the producer's operations. From making a better plant-based meat substitute to verifying the heavy metal content of a crop, the diversity of activities within the various food and beverage labs is definite. When also considering the regulatory and credentialing pressures placed on producers, it becomes clearer that an informatics solution like a LIMS plays a pivotal role in meeting that common goal of safety, quality, and compliance. In turn, such an informatics solution must be flexible enough to cover the many varying needs of the industry.
For many, the ideal solution may be a LES, MES, "food safety software," or even a LIMS. In particular, the well-developed LIMS for the food and beverage industry has played an important role in meeting safety, quality, and compliance goals for decades. A solid set of base functionality has been solidified over time, including audit trails, document management, trend and control charting, non-conformance tracking and alerting, and configurable dashboards that unify data views. However, as industry competition increases, profit margins become thinner, and regulations become more rigorous, the demand for more out of a LIMS increases. A need for unifying data and information flows—in turn making test results, audit data, P&P documents, methods, and more rapidly available—and integrating workflows places further onus on LIMS vendors to provide a more robust solution. In some cases, even more specialized functionality such as support for recipe and batch management, molecular biology workflows, on-demand environmental testing, and incident management is finding its way into a LIMS, giving producers and their labs even more control over and insight into their operations.
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