User:Shawndouglas/sandbox/sublevel5

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

Introduction

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 lab work 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.

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.

• Data management systems in the food industry: https://link.springer.com/chapter/10.1007/978-1-4939-0311-5_3
• Manufacturing execution system in food and beverage: https://www.sciencedirect.com/science/article/abs/pii/S0260877420300315
• LES: https://hs.iles.cloud/en/food-and-beverages-lab-execution

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, heavy metals, drug residues, and other contaminants
• Pre-defined and configurable industry-specific workflows
• Test, sampling, instrument, and other event scheduling
• Test requesting
• Configurable screens and data fields
• Analytical tools, including data visualization, statistical analysis, and data mining tools
• Data import and export
• Data analysis tools
• Robust query tools
• Document and image management
• Version control
• Project management
• Investigation management
• Configurable dashboards for monitoring, by product, process, facility, etc.

Quality, security, and compliance

• Quality assurance / quality control mechanisms
• Mechanisms for compliance with ISO 17025 and HACCP, including critical control point (CCP) specifications and limits
• Results, method, protocol, batch, and material validation, review, and release
• Data validation
• Trend and control charts for 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 (log-in 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
• Incident and non-conformance tracking and management

Operations management and reporting

• 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
• Software interfacing (e.g., LES, scientific data management system [SDMS])
• Instrument calibration and maintenance tracking
• Inventory and material management
• Supplier/vendor/customer management
• Third-party software and database interfacing
• Integrated (or online) system help
• Turnaround time calculation (?)

Specialty LIMS requirements

As noted previously, some software vendors are addressing food and beverage processor needs beyond the 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, 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:

• Develop regulatory-driven safety plans: The Hazard Analysis and Critical Control Points (HACCP) quality control method is recommended or required for...
• Generate schedules for environmental testing:
• Improve communication and compliance:
• Improve reaction time to non-conformances:
• Improve audit readiness and reporting:
• Ensure greater regulatory compliance:
• Manage stability studies
• Manage recipes and batches

LIMS and agriculture genotyping workflows: https://pubmed.ncbi.nlm.nih.gov/16914063/

Conclusion

This brief topical article sought to answer "what are the key elements of a LIMS for food and beverage testing??" It notes that ...