How does a food and beverage laboratory LIMS handle incident management and corrective action?

Question

Accepted Answer

Quality and safety are ideally major priorities for any food and beverage manufacturer. However, despite every best effort to maintain such safety and quality, incidents and near-misses can and do happen from time to time. This requires the manufacturer to quickly be able to not only identify the incident or near-miss, but also make the corrective actions required (and verify their effectiveness) in order to ensure such risks don’t re-emerge. A laboratory plays an important role in this effort, through its verification activities driven by top-level business goals, regulations, and best industry practices. In turn, the laboratory’s laboratory information management system (LIMS) can be a difference-maker in how effectively the manufacturer identifies and reacts to incidents.

This brief article is a surface-level examination of incident and corrective action management in the food and beverage industry, and identifies ways that a LIMS can aid in this management.

Incident management and corrective action in general

From medical cannabis microbiology testing to food and beverage safety testing, the laboratory plays an important role in ensuring safe, quality outcomes and properly addressing non-conformances and incidents. Numerous national and global regulations, standards, recommendations, and guidelines make clear that incident management and corrective action must be addressed by businesses in multiple industries including the food and beverage industry, not only within their workflows and processes but also within the information systems they use to manage those workflows and processes. Examples include:

9 CFR Part 417 – Hazard Analysis and Critical Control Point (HACCP) Systems^[1]
21 CFR Part 225 – Current Good Manufacturing Practice for Medicated Feeds^[2][3]
42 CFR Part 493, Subpart K – Quality System for Nonwaived [Clinical] Testing^[4][5]
A2LA C211 – Specific Checklist, Combined ISO-IEC 17025-2017 and Veterinary Laboratory Accreditation Program^[6]
ASTM E1578-18 – Standard Guide for Laboratory Informatics^[7]
BRC Global Standard Food Safety^[8]
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition^[9]
U. Commission Directive Commission Directive (EU) 2017/1572 … as regards the principles and guidelines of good manufacturing practice for medicinal products for human use^[10]
FDA HACCP Principles & Application Guidelines^[11]
GFSI Benchmarking Requirements, Version 2020.1^[12]
NYSDOH ELAP and LEB Medical Marijuana Microbiology Guidance^[13]
NIST 800-53, Rev. 5 – Security and Privacy Controls for Information Systems and Organizations^[14]
SQF Institute Food Safety Code, Food Manufacturing, Pet Food Manufacturing, and Manufacture of Food Packaging^[15]
WHO Technical Report Series, #986, Annex 2 – WHO good manufacturing practices for pharmaceutical products: Main principles^[16]

But what qualifies as an incident within the scope of the incident management and corrective action these and other such documents prescribe? An incident is typically represented as a deviation from a standard operating procedure (SOP) or standardized method that leads to an outcome that is less than ideal. In the clinical diagnostic or infectious disease laboratory, this could be represented by a specimen collection process going wrong, negatively impacting analyses of those specimens. For the food and beverage industry, which this article is addressing, an incident may take the form of a substandard or injurious product before or after distribution to the customer or consumer, a low-quality or poor-tasting product that causes customer or consumer dissatisfaction, a product demonstrating regulatory non-compliance, or a product with generally perceived food safety issues.^[17]

As part of preventing incidents, the food and beverage manufacturer must not only ensure a well-designed and operational food safety system but also that it is able to monitor unsatisfactory or near-miss situations, analyze their trends and consequences, and investigate their root causes to better enable corrective and preventative action.^[17] The laboratory—whether in-house or third-party—plays an important role in these processes. The areas where the food and beverage laboratory has the greatest impact in identifying potential and real incidents is through regular and/or randomized testing (often couched as “food safety testing”) to ensure hazard analysis and critical control points (HACCP) critical limits aren’t violated, as well as other varieties of verification testing (e.g., raw material monitoring, environmental monitoring, end-product quality control (QC) testing, or even investigation of employee-reported issues) at various points along the manufacturing chain.^[17][18] This is usually done in-house or with a contracted third-party laboratory, but in the case of incident management where testing doubts arise, some other independent accredited laboratory may be needed to perform testing.^[17]

Increasingly common in modern laboratories, a laboratory information management system (LIMS) can prove useful in these matters. Not only does the modern LIMS help these types of labs manage food and beverage testing activities, it can also provide functionality that assists with the overall business effort towards better incident and corrective action management. The next section explains how.

How can a LIMS help?

A modern LIMS for food and beverage laboratories is able to address a wide variety of needs for the food and beverage lab, from sample reception, testing, tracking, and results management to quality, security, compliance, operations, and report management.^[19] Some of that LIMS functionality is driven by regulations, standards, recommendations, and guidelines like those outlined in the previous section, as well as by industry players looking for specific functionality in their informatics solutions like LIMS. In particular, some LIMS vendors have even incorporated some basic form of non-conformance and incident management tools in their LIMS, but the robustness and extensibility of that functionality may vary from solution to solution.

The ideal LIMS might help food and beverage businesses directly or indirectly with incident management and corrective action in a number of ways. The LIMS, for example, can^{[7][17][19][20][21]}:

provide tools for setting up and implementing HACCP QC methods, for example, by providing integrated support for building HACCP steps into laboratory workflows, even allowing the user to diagram HACCP in their lab or facility as a visualization tool;
automatically send an SMS, email, or alert to the appropriate supplier (or in-house business contact) in real-time when a pre-defined set of limit-breaking or non-conforming testing circumstances concerning that supplier’s ingredients occurs in the LIMS;
re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident;
manage and track samples and results related to and maintain audit records of all HACCP critical limit and other verification testing, allowing more rapid identification of batches or lots related to any potential incident;
maintain all data and information in the LIMS, from R&D to final product QC, while leveraging a robust set of query tools to allow for more rapid examination of records for signs of deviation in a process or workflow;
maintain records on recipes, as well as master and batch production records (though this functionality is more often the domain of a laboratory execution system [LES] or manufacturing execution system [MES]; a handful of LIMS may address this need, particularly since it’s driven by HACCP rules^[19]); and
provide a complete set of incident management and corrective action tracking tools that allow specific samples, analyses, personnel, batch numbers, suppliers, training events, and locations to be flagged as being tied to a particular incident file and corrective action plan, while also tracking and audit trailing all laboratory actions associated with the incident from start to completion.

These and other such LIMS functions should improve reaction time to non-conformances across the business, either directly through the LIMS ability to manage and make available analytical results, or indirectly through, for example, LIMS batch production management, making it easier to trace a compromised product to a batch run or lot. In the case of incident management functionality itself in the LIMS, while it may be more suited for managing incidents that occur specifically in the laboratory, the LIMS vendor that has developed a purpose-built solution will also have likely recognized that incidents and related corrective action in the food and beverage industry extend beyond the laboratory’s doors.^[19][21]

Conclusion

This brief article sought to address how the deployment and use of a LIMS in a food and beverage business can enhance incident and corrective action management. Numerous regulations, standards, recommendations, and guidelines demand proper incident and corrective action procedures for all industries, including the food and beverage industry. We found that the laboratory and its wide variety of verification testing plays an important role in how it verifies and manages incidents or near-misses inside and outside the factory floor. Labs in the food and beverage industry are increasingly using a LIMS, which makes those labs more agile in their abilities. Through a variety of LIMS functionality like sample management and tracking, audit trails, and direct incident management tools, the LIMS can directly or indirectly increase the food and beverage business’ nimbleness and improve how it identifies, reacts, corrects, and prevents such future incidents.

References

“9 CFR Part 417 – Hazard Analysis and Critical Control Point (HACCP) Systems”. Legal Information Institute. Cornell Law School. 25 July 1996. Retrieved 23 February 2024. https://www.law.cornell.edu/cfr/text/9/part-417
“21 CFR Part 225.58 – Current Good Manufacturing Practice for Medicated Feeds – Laboratory controls”. Legal Information Institute. Cornell Law School. 19 November 1999. Retrieved 23 February 2024. https://www.law.cornell.edu/cfr/text/21/225.58
“21 CFR Part 225.158 – Current Good Manufacturing Practice for Medicated Feeds – Laboratory assays”. Legal Information Institute. Cornell Law School. 19 November 1999. Retrieved 23 February 2024. https://www.law.cornell.edu/cfr/text/21/225.158
“42 CFR Part 493.1282 – Quality System for Nonwaived [ClinicalTesting – Standard: Corrective actions”]. Legal Information Institute. Cornell Law School. 22 August 2003. Retrieved 23 February 2024. https://www.law.cornell.edu/cfr/text/42/493.1282
“42 CFR Part 493.1289 – Quality System for Nonwaived [ClinicalTesting – Standard: Analytic systems quality assessment”]. Legal Information Institute. Cornell Law School. 22 August 2003. Retrieved 23 February 2024. https://www.law.cornell.edu/cfr/text/42/493.1289
A2LA (9 December 2011). “C211 – Specific Checklist, Combined ISO-IEC 17025-2017 and Veterinary Laboratory Accreditation Program”. USLegal. Retrieved 23 February 2024. https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation
“Standard Guide for Laboratory Informatics”. ASTM International. 23 August 2019. Retrieved 23 February 2024. https://www.astm.org/e1578-18.html
“Food Safety”. BRC Trading Limited. 2024. Retrieved 23 February 2024. https://www.brcgs.com/our-standards/food-safety/
Centers for Disease Control and Prevention; National Institutes of Health (June 2020). “Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition”. Retrieved 23 February 2024. https://www.cdc.gov/labs/BMBL.html
European Commission (15 September 2017). “Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use”. EUR-Lex. Retrieved 23 February 2024. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32017L1572
S. Food and Drug Administration (25 February 2022). “HACCP Principles & Application Guidelines”. Retrieved 23 February 2024. https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines
Global Food Safety Initiative (2020). “GFSI Benchmarking Requirements, Version 2020.1”. Retrieved 23 February 2024. https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications
New York State Department of Health – Wadsworth Center (3 December 2020). “Procedure on How to Perform an Initial Demonstration of Capability (iDOC) for Medical Marijuana Microbiology”(PDF). Retrieved 23 February 2024. https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf
National Institute of Standards and Technology (10 December 2020). “NIST 800-53, Rev. 5 – Security and Privacy Controls for Information Systems and Organizations”. Retrieved 23 February 2024. https://csrc.nist.gov/pubs/sp/800/53/r5/upd1/final
“Library of Codes – SQF Food Safety Codes”. SQF Institute. 2024. Retrieved 23 February 2024. https://www.sqfi.com/the-sqf-code/choose-your-code/library-of-codes
“WHO Technical Report Series”. Prequalification of Medical Products. World Health Organization. 2014. Retrieved 23 February 2024. https://extranet.who.int/prequal/medicines/who-technical-report-series
Wallace, Carol A.; Motarjemi, Yasmine (2023), “Incident Management and Root Cause Analysis”(in en), Food Safety Management(Elsevier): 957–970, doi:1016/b978-0-12-820013-1.00040-1, ISBN 978-0-12-820013-1. https://linkinghub.elsevier.com/retrieve/pii/B9780128200131000401
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