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[[File:|right|400px]] Title: How can a LIMS help a food and beverage laboratory better handle incident management and corrective action?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: February 2024

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 not only ensuring safe, quality outcomes but also that non-conformances and incidents in the industries those laboratories serve are properly addressed. In fact, 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, not only within their workflows and processes but also within the information systems they use to better manage those workflows and processes. (Or course, this includes the food and beverage industry.) Examples include:

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

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 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.

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. 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 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 process. 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.

Increasingly common in modern laboratories, a laboratory information management system (LIMS) can prove useful in these matters. 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 lab, from sample reception, testing, tracking, and results management to quality, security, compliance, operations, and report management. Some of that functionality is driven by regulations, standards, recommendations, and guidelines like those outlined in the previous section. In particular, some LIMS vendors have incorporated some basic form of non-conformance and incident management tools, 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:

• provide tools for setting up and implementing hazard analysis and critical control points (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;
• re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident;
• 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, 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); 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 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.