LIMS Q&A:How does a LIMS help a food and beverage business improve HACCP compliance?

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Title: How does a LIMS help a food and beverage business improve HACCP compliance?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: March 2024

Introduction

As national and international demand for safer, higher-quality foods and beverages increases, modern food and beverage businesses are finding themselves more inclined to adopt (or pressured to adopt, due to regulations) good industry practices and strong cultures of food safety. Part of that equation involves the hazard analysis and critical control points (HACCP) principles, which when researched and adopted properly stand to help the business limit risks and hazards to its product-specific operations. Laboratories are also part of that equation, with their means of verifying the effectiveness of a given HACCP-based food safety plan and improving the speed with which corrective action is performed. A laboratory information management system (LIMS) is also in the mix, and its functionality can assist the lab (and greater food and beverage business) address the seven core principles of HACCP.

This brief topical article will look at HACCP in the scope of the food and beverage industry, and it will examine a few of the ways a laboratory and its LIMS can benefit HACCP implementations for businesses in the industry.

HACCP and the food and beverage industry

The hazard analysis and critical control points (HACCP) principles, as applied to a food safety management system, help the implementing business identify and procedurally better control a wide variety of identified risks or hazards to food, beverage, and ingredient safety. The HACCP principles essentially say "if the hazards are well understood and measures are put in place to control them," then your HACCP-driven food safety management system has a better chance of being successful in its goals towards safer, higher-quality foods and beverages.[1]

The international standard ISO 22000 Food safety management—first published in 2005—was originally designed to be aligned with quality management standards like ISO 9001 and the HACCP principles, as adopted by the Codex Alimentarius.[2] However, the concept of HACCP has been around for much longer, dating back to efforts in the late 1960s by Pillsbury Company and U.S. government elements towards safer foods for American astronauts.[1][2] This more comprehensive, standardized approach towards HACCP by the International Organization for Standardization (ISO), in conjunction with tangential efforts by the Global Food Safety Initiative (GFSI) and other entities, has ultimately strengthened food and beverage business' approach to food safety over the years. (It should be noted, however, that with only a few exceptions around the world, federal mandates for ISO 9001 and ISO 22000 certification rarely exist. However, some legal mandates for HACCP compliance—along with meeting customer, industry, or other stakeholder demand—may push such businesses to adopt those standards, along with their HACCP components.)[2]

Successfully implementing HACCP principles in the food safety management plan requires intimate knowledge of the product needing to be produced, as well as the risks or hazards associated with the various processes incorporated into that production, including pre- and post-production activities. Without this deep knowledge, any implemented HACCP-based plan can still fail to fully meet its intended purpose (and the lack of this kind of deep knowledge indeed can be problematic for smaller producers with fewer personnel and tighter budgets). These problems can be compounded if the business fails to promote and implement the environmental and operational (i.e., factory) conditions necessary for success, and doesn't already fully subscribe to good hygiene, agricultural, and manufacturing practices.[1]

HACCP is a complicated framework to fully describe in a brief article such as this, but it's set of seven principles should be mentioned at this juncture[1][2]:

  1. Conduct hazard analyses and identify control measures for a given product and its ingredients.
  2. Determine the critical control points (CCPs) along the production chain to better ensure control measures are most effective.
  3. Establish validated critical levels (with quantifiable and qualifiable parameters) that clearly separate acceptability from unacceptability.
  4. Establish and maintain the appropriate monitoring methods for the identified CCPs.
  5. Establish the set of corrective actions that will be enacted when validated critical levels have been identified as violated through the monitoring system.
  6. Validate the overall HACCP plan before implementation, and establish procedures to confirm the plan is working as intended.
  7. Document, archive, and make available as appropriate all procedures, corrective action, etc. appropriate to the HACCP principles and their application.

HACCP alone, however, isn't enough to guarantee success to the food and beverage business. As mentioned, it's development and implementation is largely only as good as the knowledge and work that was put into it. Secondarily, a strong culture of food safety and the drive to implement, train on, monitor, and enforce the HACCP principles is also important.[1] Additionally, a laboratory staffed with personnel having a strong analytical and diagnostic background in foodborne-disease and equipped with sufficient equipment for that work—which will include providing the verification testing to ensure the HACCP plan is working as intended—is essential.[3] In order to improve aspects of that work, such a lab will likely use electronic information management tools like a laboratory information management system (LIMS).

The intersection of LIMS and HACCP compliance

While making the most of any implemented HACCP plan requires deep industry knowledge and an ownership-driven culture of food safety, the role the laboratory—whether in-house or third-party—has in that effort can't be understated. However, a largely paper-based approach to performing the verification testing demanded by HACCP will not do with these labs. A fragmented mix of paper-based and electronic information sources can be a detriment to the traceability of or rapid accessibility to ingredient, additive, and QC sample data and information, as well as standard operating procedure (SOPs), environmental monitoring data, chain of custody data, and other vital aspects of food and beverage production. As such, mindful LIMS implementation has the potential to improve laboratory workflows and workloads while enhancing food and beverage safety, quality, and compliance in a number of ways. 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 QC data, the LIMS can act as the central integrator and audit trail for that information.[4][5][6] Because the LIMS improves traceability—including through its automated interfaces with instruments and other data systems—real-time monitoring of supply chain issues, QC 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.[4] 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/IEC 17025 standard, compliance with Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) requirements, and compliance with the in-house HACCP principles and food safety plan.[7][8][9][10][11] Finally, many modern LIMS tailored to the food and beverage industry come pre-configured out of the box with analytical and QC workflow support tools that can be further optimized to a lab's unique workflow.[11]

These touch points of a LIMS with the food and beverage lab's activities help the associated business get the most out of their HACCP activities in multiple ways, directly and indirectly. First, hundreds or even thousands of data points can be generated as part of HACCP- and food safety-related action in the manufacturing facility. A LIMS with strong interfacing and integration capability can gather most if not all of these data points and help the lab automate its verification tasks, while providing timely alerts when critical levels are breached.[11] This type of interfacing isn't easy (especially in a growing trend towards Industry 4.0 methods in manufacturing), however, and not all LIMS are created equal in this department.[12] This interfacing is further complicated by sample point and CCP locations in the facility, as well as general difficulties with interfacing inline monitoring devices such as particle counters and endotoxin detection systems, requiring some sort of middleware solution that can collect the data from those instruments and send it over a network that is rock-solid and highly available to the LIMS or some instrument data system (IDS) or manufacturing execution system (MES) integrated to the LIMS.[13][14]

Second, the previously mentioned audit trail, preloaded and configurable workflows and methods, and instrument interfacing, along with the LIMS' inherent data visualization, reporting, and data warehousing and archiving abilities, help the food and beverage business better meet many of the seven principles of HACCP. Principles four and five, which address monitoring and corrective action, fall firmly in the wheelhouse of the lab and its verification testing. Pulling relevant data from the LIMS, CCPs can be more readily visualized and monitored, while flagging and notifying key personnel when out-of-trend or out-of-limit results appear, who in turn can more rapidly address the problem and limit future breaches of critical levels. The document and data maintenance aspects of the seventh HACCP principle are also readily addressed through the LIMS. From document management with version control tools to audit trails that maintain a record of every action, including approval and electronic sign-off of the results, the LIMS helps the food and beverage business ensure better HACCP compliance. It can also track training activities and instrument maintenance, ensuring only qualified personnel use calibrated instrumentation to better ensure analytical results are of high quality.[11]

Finally, some LIMS provide tools that directly allow the laboratory to map CCPs to scheduled and randomized sample and data collection, while providing data visualization tools to view the touch points of HACCP with the laboratory's workflow. In turn, collected samples can easily be linked to specific CCP test limits and methods, as well as the personnel qualified to run those test methods.[11][15] This requires the LIMS to support location management so that personnel can readily associate sample data—or practically any other type of data—to a location or CCP.

Conclusion

This brief Q&A article sought to find ways in which a LIMS can help the food and beverage business better comply with its HACCP-driven food safety plan. We found that the HACCP principles have been around a long time, though their greater incorporation and expansion into international standards and best industry practices has been more recent. The seven core HACCP principles help the business to better identify, understand, and measure the hazards facing the production of a specific food or beverage product, and the implementation of these principles requires deep industry knowledge and an authentic cultural commitment to food safety. It also requires well-staffed and -equipped laboratories, ideally using a validated LIMS tailored to the food and beverage industry. Various pieces of LIMS functionality, from audit trails and training management to robust integration and location management, help the laboratory better perform its verification procedures in sympathy with the HACCP principles. However, not all LIMS are the same, and food and beverage labs would be wise to scrutinize LIMS functionality that helps the business better achieve its HACCP goals.

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 Ferris, Iain M. (1 November 2022). "10. Hazard analysis and critical control points (HACCP)". In Wernaart, Bart; van der Meulen, Bernd. Applied Food Science. Wageningen Academic Publishers. pp. 187–213. doi:10.3920/978-90-8686-933-6_10. ISBN 978-90-8686-933-6. https://brill.com/view/book/9789086869336/BP000011.xml. 
  2. ↑ 2.0 2.1 2.2 2.3 Holah, John (2023), "Principles of Hygienic Practice in Food Processing and Manufacturing" (in en), Food Safety Management (Elsevier): 587–613, doi:10.1016/b978-0-12-820013-1.00029-2, ISBN 978-0-12-820013-1, https://linkinghub.elsevier.com/retrieve/pii/B9780128200131000292 
  3. ↑ Owusu-Apenten, Richard; Vieira, Ernest (2023), Owusu-Apenten, Richard; Vieira, Ernest R., eds., "Food Safety Management, GMP & HACCP" (in en), Elementary Food Science (Cham: Springer International Publishing): 217–236, doi:10.1007/978-3-030-65433-7_10#doi, ISBN 978-3-030-65433-7, https://doi.org/10.1007/978-3-030-65433-7_10. Retrieved 2024-03-01 
  4. ↑ 4.0 4.1 Smith, K. (2 July 2019). "Integrated Informatics: Optimizing Food Quality and Safety by Building Regulatory Compliance into the Supply Chain". Food Safety Tech. https://foodsafetytech.com/feature_article/integrated-informatics-optimizing-food-quality-and-safety-by-building-regulatory-compliance-into-the-supply-chain/. Retrieved 01 March 2024. 
  5. ↑ McDermott, P. (31 July 2018). "How Digital Solutions Support Supply Chain Transparency and Traceability". Food Safety Tech. https://foodsafetytech.com/column/how-digital-solutions-support-supply-chain-transparency-and-traceability/. Retrieved 01 March 2024. 
  6. ↑ Evans, K. (15 November 2019). "The Digital Transformation of Global Food Security". Food Safety Tech. https://foodsafetytech.com/feature_article/the-digital-transformation-of-global-food-security/. Retrieved 01 March 2024. 
  7. ↑ Apte, A. (20 October 2020). "Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit?". Food Safety Tech. https://foodsafetytech.com/column/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit/. Retrieved 01 March 2024. 
  8. ↑ Paszko, C. (19 August 2015). "Traceability: Leveraging Automation to Satisfy FSMA Requirements". Food Safety Tech. https://foodsafetytech.com/feature_article/traceability-leveraging-automation-to-satisfy-fsma-requirements/. Retrieved 01 March 2024. 
  9. ↑ Paszko, C. (26 October 2015). "How LIMS Facilitates ISO 17025 Certification in Food Testing Labs". Food Safety Tech. https://foodsafetytech.com/feature_article/how-lims-facilitates-iso-17025-certification-in-food-testing-labs/. Retrieved 01 March 2024. 
  10. ↑ Daniels, T. (22 March 2017). "Using LIMS to Get In Shape for FDA’s Visit". Food Safety Tech. https://foodsafetytech.com/column/using-lims-get-shape-fdas-visit/. Retrieved 01 March 2024. 
  11. ↑ 11.0 11.1 11.2 11.3 11.4 Ingalls, E. (6 August 2020). "How Advanced LIMS Brings Control, Consistency and Compliance to Food Safety". Food Safety Tech. https://foodsafetytech.com/feature_article/how-advanced-lims-brings-control-consistency-and-compliance-to-food-safety/. Retrieved 01 March 2024. 
  12. ↑ Douglas, S.E. (February 2024). "LIMS Q&A:What role does interoperability and systems integration play in the laboratory, and why is this important to address?". LIMSwiki. https://www.limswiki.org/index.php/LIMS_Q%26A:What_role_does_interoperability_and_systems_integration_play_in_the_laboratory,_and_why_is_this_important_to_address%3F. Retrieved 01 March 2024. 
  13. ↑ Kelley, R. (2019). "MODA Solution - The Gap Between LIMS Capabilities and QC Microbiology Needs" (PDF). Lonza Wayne, Inc. https://www.lonzabioscience.com.au/wp-content/uploads/2022/05/MODA-The-gap-between-LIMS-and-QC.pdf. Retrieved 01 March 2024. 
  14. ↑ "LIMS in a Shop Floor IT Landscape". FrontWell Solutions GmbH. 4 June 2023. https://www.frontwell-solutions.com/blog/lims-3/lims-in-a-shop-floor-it-landscape-21. Retrieved 09 February 2024. 
  15. ↑ "Optimizing Food Safety with LIMS HACCP Integration". LabWare, Inc. 10 January 2022. https://www.labware.com/blog/lims-7-steps-of-haccp. Retrieved 01 March 2024. 
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