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Title: What are the key elements of a LIMS for animal feed testing?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: May 2024

Introduction

Safe, nutritional food is important all across the food chain, including for those animals we may eventually consume. As such, quality is a significant concept in feed-based organizations. Quality can be measured in a number of ways (e.g., is the feed nutritionally balanced and largely free of heavy metals?), but undoubtedly the laboratory plays a vital role in these efforts. With regulations tightening and demands for safer food and feed increasing, these labs find themselves needing to put a greater emphasis on traceability of produced feeds and their raw ingredients, necessitating software-based solutions like the laboratory information management system (LIMS) which can improve traceability.

This brief topical article will make a cursory examination of feed testing as found within three major contexts: production, R&D, and public health. A core set of functionality found in a LIMS developed for the industry will be described, as well as specialty functionality that LIMS developers may or may not address in their solutions.

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.

Feed testing laboratories, their roles, and information management

A feed testing laboratory can operate within a number of different production, research and development (R&D; academic and industry), and public health contexts. They can:

• act as a third-party consultant, interpreting analytical data;
• provide research and development support for new and revised formulations;
• provide analytical support for nutrition and contaminant determinations;
• provide development support for analytical methods;
• ensure quality to specifications, accreditor standards, and regulations;
• develop informative databases and data libraries for researchers;
• manage in-house and remote sample collection, labeling, and registration, including on farms; and
• report accurate and timely results to stakeholders, including those responsible for monitoring public health.

This wide variety of roles further highlights the already obvious cross-disciplinary nature of analyzing animal feed ingredients and products, and interpreting the resulting data. The human biological sciences, veterinary sciences, environmental sciences, chemistry, microbiology, radiochemistry, botany, epidemiology, and more may be involved within a given animal feed analysis laboratory. Given this significant cross-disciplinarity, it's arguably more challenging for software developers to create laboratory informatics solutions like a laboratory information management system (LIMS) that have the breadth to cover the production, R&D, and public health contexts of animal feed testing. In fact, an industry lab performing quality control (QC) work for a company will likely have zero interest in public health-driven reporting functionality (e.g., as per the Food and Drug Administration's Animal Food Regulatory Program Standards [AFRPS]), and a LIMS that focuses on QC workflows may be more highly desirable.

That said, this Q&A article will examine LIMS functionality that broadly addresses the needs of all three contexts for animal feed analyses. Understand that the LIMS solution your feed lab may be looking for may not require some of the functionality addressed here, particularly in the specialty LIMS requirements section. But also understand the broader context of feed testing and how it highlights some of the challenges of finding a feed testing LIMS that is just right for your lab. This search may be further complicated by other informatics options. In a few cases, standalone formulation and enterprise resource planning (ERP) solutions for the feed industry exist. Some LIMS may have these sorts of features built-in already, so the choice of whether or not to adopt a LIMS in conjunction with other standalone solutions or find a LIMS that incorporates those formulation and ERP functions will have to be carefully considered. Also worth mentioning are systems such as the electronic laboratory notebook (ELN), laboratory execution system (LES), and manufacturing execution system (MES), which play a role in feed-based R&D and production contexts. Even here we find some cross-compatibility with LIMS functionality, and the question of integrating multiple systems or reducing IT and personnel overhead with a greater one-size-fits-all solution arises again. Ultimately it will be up to the organization to determine its needs and find an approach that works for them. Going forward, we'll focus on the LIMS, however.

Base LIMS requirements for animal feed testing

Through its workflow management and traceability mechanisms, thoughtful implementation of a LIMS by the feed-based organization can provide a number of benefits to process management, stakeholder interactions, traceability of raw ingredients, and much more. Given the importance of ISO/IEC 17025's concepts to feed testing laboratories (whether accredited to the standard or not), a feed testing LIMS that provides functionality to assist with ISO/IEC 17025 criteria (as found in Appendix A of the Association of Public Health Laboratories' [APHL's] best practices guide for food and feed testing) provides even more benefits to the feed-based organization.

What follows is a list of system functionality important to most any feed testing laboratory, with a majority of that functionality—including supportive ISO/IEC 17025 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, through to reporting and disposition
• Pre-defined and configurable industry-specific test and method management, including for bacteria (i.e., microbiology), heavy metals (i.e., chemistry), radionuclides (i.e., radiochemistry), and other substances such as micronutrients
• Pre-defined and configurable industry-specific workflows, including for production, R&D, and public health contexts
• Configurable screens and data fields
• Specification management
• Test, sampling, instrument, etc. scheduling and assignment
• Test requesting
• Data import and export
• Raw data management
• Robust query tools
• Analytical tools, including data visualization, statistical analysis, and data mining tools
• Document and image management
• ELN support or functionality for R&D efforts
• Version control
• Project and experiment management
• Method and protocol management
• Investigation management
• Multi-facility and -sampling site management
• Storage management and monitoring

Quality, security, and compliance

• Quality assurance / quality control mechanisms
• Mechanisms supporting compliance with ISO/IEC 17025, hazard analysis and critical control points (HACCP), AFRPS, and the Association of American Feed Control Officials (AAFCO) Official Publication (OP)
• 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 output formats that support state and local sample and field inspection reporting requirements from, e.g., AFRPS
• Custom and industry-specific reporting, including certificates of analysis (CoAs)
• Industry-compliant labeling
• Email integration and other communication support for internal and external stakeholders
• Instrument interfacing and data management, particularly for near-infrared spectroscopy (NIRS) instruments
• Third-party software interfacing (e.g., LES, scientific data management system [SDMS], other databases)
• Data import, export, and archiving
• Instrument and equipment management, including calibration and maintenance tracking
• Inventory and material management, including raw materials
• Supplier/vendor/customer management
• Flexible but secure client portal for pre-registering samples, printing labels, and viewing results
• Integrated (or online) system help

Specialty LIMS requirements

To be sure, a LIMS designed for animal feed testing must have pre-loaded and configurable tests and methods unique to the industry (mentioned above), making workflow management simpler for these labs, whether affiliated with production, R&D, or public health contexts. (Though, as mentioned prior, finding a LIMS that meets all the test and method needs of these three contexts may be more challenging.) However, there are other aspects of organizations testing animal feed that, with a few exceptions (e.g., the closely related food and beverage industry), are somewhat unique to their efforts. What follows are some of the specialty considerations LIMS developers may take with their feed testing LIMS.

• Manage recipes, as well as master and batch production records: This functionality is more in the domain of the LES or MES. However, a few LIMS vendors may extend their LIMS to provide these formulation features. Given that the HACCP rules, in particular, mandate the creation and management of batch production and in-process manufacturing material records, some feed production facilities testing batches and manufacturing materials may appreciate support for formula optimization, ingredient management, batch management, and more.

• Support molecular biology and nutritional testing workflows: Molecular biology and nutritional testing are important tools in the research of improving animal feeds and their ingredients, as well as managing their quality. However, not all LIMS are ideally equipped to handle related workflow aspects such as nucleic acid extraction, protein and cell isolation, gene expression, and genotyping. A lab using such techniques may have to do extra due diligence in finding a feed testing LIMS that also supports these workflow tasks.

• Provide a web-based portal for internal and external stakeholders: Whether producing feed or conducting surveillance testing of feed, many stakeholders come into play, and giving them secure, ready access to aspects of the workflow (e.g., from pre-registering samples to checking final results) is useful. A secure web-based portal that allows authorized stakeholders role-based access to sections of the LIMS can further improve workflow efficiency and communication patterns for the feed testing lab.

• Develop and/or support regulatory-driven safety plans: The HACCP quality control method is recommended or required for feed mills and other producers, and the integration of HACCP methods into the labs testing those feeds may also have value. (HACCP is also an influence on ISO/IEC 17025, which is a major accreditation standard for feed testing laboratories.) 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. However, even if HACCP diagraming isn't integrated into a LIMS and its workflow tools, the LIMS should at least recognize HACCP-related testing as a specific test category, with its own requirements, including support for critical control point (CCP) specifications and limits.

• Provide mechanisms to make data and information more FAIR: Like many other disciplines, modern academic and industrial research of feed ingredient selection, feed formulation, and feed production is plagued by interdisciplinary research data and information (i.e., objects) "in a broad range of [heterogeneous] information formats [that] involve inconsistent vocabulary and difficult‐to‐define concepts." This makes attractive data discovery options such as text mining, cluster searching, and artificial intelligence (AI) methods less effective, in turn hampering innovation, discovery, and improved health outcomes. As such, research labs of all sorts are increasingly turning to the FAIR principles, which encourage processes that make research objects more findable, accessible, interoperable, and reusable. A handful of software developers have become more attuned to this demand and have developed or modified their systems to produce research objects that are produced using metadata- and semantic-driven technologies and frameworks. Producing FAIR data is more important to the academic research and public health contexts of feed testing, but can still be useful to other industrial contexts, as having interoperable and reusable data in industry can lead to greater innovation and process improvement. Of course, all animal feed testing labs can benefit from software systems that generate FAIRer data. For example, FAIR-driven, internationally accepted vocabulary and data descriptors for mycotoxin contamination data can be used in research and laboratory software, making that data more interoperable and reusable. This leads into...

• Support standardized and controlled vocabularies: By extension, this gets into the matter of improved interoperability of feed testing results from different laboratories, particularly government labs in different jurisdictions responsible for monitoring contaminates in animal feed. The AAFCO Strategic Affairs Committee (SAC) highlights this in their Strategic Plan for 2023–2025, stating that in order to "promote and integrate laboratory technology, methods, quality systems, and collaboration in support of animal food safety systems," the different LIMS used across various states demand a more integrated IT environment where "comparable results from different labs" can effectively be made. As of 2024, a standardized, internationally recognized controlled vocabulary for animal feed isn't fully apparent. However, efforts such as the AAFCO Ingredient Definitions Committee (with their results published in the AAFCO OP), FEED, Feedipedia, FoodOn, and MYTOX-SOUTH have made inroads into the area of developing or extending controlled vocabularies that apply to feed testing, and a LIMS vendor that taps into one or more these works arguably has a leg up on vendors that do not.

• Provide tools that support quality management system (QMS) initiatives: In the same AAFCO-SAC Strategic Plan is the recognition of the importance of a QMS to the feed testing lab, in particular in regards to how it should be integrated with laboratory technology such as LIMS and the workflows the LIMS can improve. As such, a LIMS developed with feed testing in mind will ideally have a variety of tools and functionality that help the lab better achieve its QMS goals. At the farthest end of the scale could be a feed testing LIMS that essentially provides the full set of functionality of an electronic QMS so as to limit data duplication and extra integration considerations that come with using multiple electronic systems. This includes the LIMS providing document management, training management, equipment and maintenance management, workflow and method management, quality control and assessment tools, out-of-specification and incident management, batch management, qualification management, and other functionality. Most of this functionality is listed in the base LIMS requirements above, but the combination of them all better supports the QMS needs of a feed testing lab compared to a system that only provides a few of those functionalities.

Conclusion

Animal feed-related entities in the production, R&D, or public health contexts have many incentives to produce, develop, and monitor feed and ingredients that are safe for not only direct animal consumption but also for indirect human consumption. This safety is in large part ensured by the analytical testing of feed and raw ingredients. As regulations have tightened and demand for safer products has increased, paper-based systems have in part given way to electronic systems such as LIMS, ELN, LES, MES, and even the electronic QMS. The LIMS in particular is of high importance to laboratories conducting feed testing, requiring functionality that meets the essential and specialty needs of the industry. From industry-specific tests, methods, and workflows to clear and standardized reporting, a well-designed feed testing LIMS will address the essentials in most cases. However, specialty functionality such as support for molecular biology and nutritional testing workflows, HACCP planning, and full-featured quality management may not be found in every solution. Feed-related entities seeking such a LIMS would be wise to take a thoughtful approach to choosing a feed testing LIMS given the complexities of these three contexts, especially while recognizing the distinct multi-disciplinarity of the industry and its analytical obligations to quality.