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Title: How does a LIMS benefit microbiological sampling and testing in the food and beverage industry?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: January 2024
Introduction
Sampling, the sampling plan, and LIMS
In the world of microbiological testing of foods, beverages, and their processing environment, the importance of proper sampling practices—including having a sound sampling plan—rarely gets understated.[1][2][3][4][5]
Sampling plans
Sampling plans essentially take identified sampling points within a controlled environment and define the frequency at which those sampling points are monitored and drawn from, while linking those collected samples to one or more specific standardized test methods and analyses. The frequency may be daily, monthly, quarterly, annual, or custom-defined (or even randomized[6]), with each sampling point having it's own requirements, often different from sample point to sample point.
Despite the wide variability that can be found in a sample plan, they tend to fall into two categories: attributes plans and variables plans. Broadly speaking, attributes plans are useful when little or no information is known about a food processing method or the past performance of a food or beverage producer but presence/absence testing is required; this is common for regulated testing at points of entry, as found with adulteration testing. Variables sampling plans, on the other hand, are useful where the frequency distribution of microorganisms within a given food or beverage lot is known or can easily be assumed. This type of sample plan is more applicable to food and beverage manufacturers conducting verification and end-point testing in their production processes.[7]
A LIMS can make enacting a lab's sampling plan easier in a number of ways. First, resource planning and quality control (QC) within the lab are important to accurate high-volume sampling and analyses, which better ensures resources such as instruments, equipment, and personnel are more efficiently scheduled, maintained, and put to positive use, and that sampling and analytical procedures are true to standardized methods and standard operating procedures.[8] Given the variable frequency, and the differences of sampling and analytical methods at differing sampling points, a LIMS' ability to manage schedules, enforce standardized methods and workflows, and send alerts further helps the lab enact its sampling plan. In some cases, microbiological sampling and analyses may be required outside the manufacturing plant, for example at a point of distribution or at an ingredient or raw food supplier's facility. In this case, a well-developed LIMS that has strong mobile support, as well as scheduling of samplers and analysts to remote locations, can better allow for field sampling and the management of on-site microbiological test results, in turn supporting any field-based sampling plans.[6] In summation, a LIMS' ability to handle numerous aspects of sample and resource management, from scheduling to final analysis and reporting, streamlines sampling workflows and enhances the accuracy of results, bolstering any microbiology lab's sampling plan.
Second, a sampling plan is further enhanced by a LIMS' ability to improve the scientifically and legally defensible nature of sampling data. For example, a LIMS that supports barcoded and RFID sample management will minimize hand-entered sample IDs (and in turn reduce errors in sample receipt, scheduling, and tracking) and better ensure proper metadata (e.g., time, date, sampler) are associated with each sample. When properly entered into the system as such, the LIMS can then quickly and accurately move it to the next step of workflow, or it can identify an abnormality or missing metadata and flag or alert it for immediate action so that the timely nature of sampling and analysis and can be maintained. Of course, the audit trail of the LIMS itself also aids in the defensibility of sampling data, as when implemented properly, it will document every step of the process, including any modifications, overrides, or approvals of results. The LIMS can also enforce hold times and requirements for blanks, and some even allow for environmental monitoring of sample preservation locations (e.g., tracking of ambient and storage temperature) to ensure regulatory requirements are being met.[9]
Pg 865: "Although statistically limited, finished product and raw material testing may be conducted where there is limited information available about the hygienic status of a product lot (for example, a regulator’s analysis of imported product or a food producer’s analysis of raw materials). Testing may also be used for the evaluation of the suitability of finished products or raw materials where there is information from other verification activities that indicates an increased risk of contamination.
The development and application of acceptance criteria for finished products and raw materials is discussed extensively by the ICMSF, 2002. Lot acceptance criteria are expressed in sampling plans outlining the pathogen or indicator organism(s) of concern, the number of samples to be taken from a lot (n), the limits of acceptance (c, m and M) and the methodology to be used in verifying conformance. Sampling plans in specifications are most often defined as two-class attributes plans (acceptable and unacceptable) and three-class attributes plans (acceptable, marginally acceptable and unacceptable). Two-class attributes plans are defined by m, the level separating acceptable from unacceptable and c, the maximum allowable number of sample units yielding a result greater than m. For pathogens m is often set at 0, indicating an absence of the organism in the analytical unit tested. Three-class attributes plans are defined by m, the level separating acceptable from marginally acceptable, M, the level separating marginally acceptable from unacceptable, and c, the maximum allowable number of sample units yielding a result greater than m and less than M. If any sample is above M in a three-class plan the lot is rejected. Three-class plans are most often applied in criteria for quantitative hygienic indicator organisms as they account for variability in levels and allow identification and correction of trends before levels exceed criteria that would result in lot rejection."
Pg 869: "Sampling for field testing may incorporate the sampling plans and operating characteristic curves used for finished product or ingredient testing, with the testing “lot” as the sampled area of the field or production block. Samples may be taken using a variety of approaches to obtain a samples representative of the field (UF, 2010; Western Growers, 2021). Xu and Buchanan (2019) compared the performance of three field collection methods, including random sampling, stratified random sampling, and sampling using a Z collection pattern ...
Development of Microbiological Specifications for Finished Products
Finished product specifications take into account relevant regulatory or customer requirements, the hazards that may be present in raw materials and the environment, the nature of the product and process, and intended use of the material as determined in the HACCP study. Specifications include pathogens of concern as well as relevant indicator organisms, defined sampling plans and methodology. Sampling plans included in specifications should follow ICMSF format, with stringency based upon the severity of the pathogen of concern, the use of the product and the sensitivity of the consumer. Stringency may also be increased for new products or production lines, or where prior history of the product or process indicates a heightened concern. Sampling plan limits for m and M should be based upon an understanding of the raw materials and processes and ideally the results of testing of products manufactured under good conditions on a variety of production days." [1]
Pg 3: Sampling plan[2]
Sampling plan and LIMS for food: https://www.csolsinc.com/blog/use-samplemanager-lims-stop-food-borne-pathogens/
Sampling plan and LIMS for food: https://foodsafetytech.com/tag/laboratory-information-management-system/
Sampling plan and LIMS: https://eudl.eu/pdf/10.4108/eai.24-2-2023.2330696
Sampling plans and an optimal risk-based monitoring plan for microbiological hazards[3]
Sampling for food safety: https://www.campdenbri.co.uk/blogs/sampling-for-safety.php
Effective sampling plans during pandemic: https://www.dksh.com/global-en/lab-solutions/insights/how-effective-sampling-plans-can-improve-quality-assurance-and-food-safety-during-a-pandemic#accordion-1578360548811-0-collapse
Implementation of Food Safety Management Systems along with Other Management Tools: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8468768/
Sampling and testing: What are the objectives[4]
LIMS in a Shop Floor IT Landscape + sample plans: https://www.frontwell-solutions.com/blog/lims-3/lims-in-a-shop-floor-it-landscape-21
LIMS and microbiological analysis of foods and beverages
Microbiological testing: what food businesses need to know: https://www.safefood.net/professional/food-safety/laboratories/micro-food-testing
Sampling and testing: What are the objectives[4]
Conclusion
References
- ↑ 1.0 1.1 Jackson, T. (2023). "Management of Microbiological Hazards: Role of Testing as Verification". In Andersen, V.; Lelieveld, H.; Motarjemi, Y.. Food Safety Management: A Practical Guide for the Food Industry (2nd ed.). Elsevier, Inc. pp. 851–72. ISBN 9780128200131. https://books.google.com/books?id=3TpwEAAAQBAJ&printsec=frontcover.
- ↑ 2.0 2.1 Erkmen, Osman (2022). "Practice 1: Sampling and sample preparation techniques". Microbiological analysis of foods and food processing environments. London San Diego, CA Cambridge, MA Kidlington, Oxford: Academic Press, an imprint of Elsevier. pp. 3–12. ISBN 978-0-323-91651-6. https://books.google.com/books?id=6kU6EAAAQBAJ&printsec=frontcover.
- ↑ 3.0 3.1 Focker, M.; van Asselt, E.D.; van der Fels-Klerx, H.J. (2023). "Designing a risk-based monitoring plan for pathogens in food: A review" (in en). Food Control 143: 109319. doi:10.1016/j.foodcont.2022.109319. https://linkinghub.elsevier.com/retrieve/pii/S0956713522005126.
- ↑ 4.0 4.1 4.2 De Loy-Hendrickx, A.; Vermeulen, A.; Jacxxens, L. et al. (2018). "Part II: Sampling". In Mieke, U.. Microbiological Guidelines: Support for Interpretation of Microbiological Test Results of Foods. Die Keure. pp. 95–136. ISBN 9782874035036. https://books.google.com/books?id=pG1UDwAAQBAJ&pg=PT108.
- ↑ International Commission on Microbiological Specifications for Foods (2018). Microorganisms in Foods 7: Microbiological Testing in Food Safety Management (2nd ed.). Springer International Publishing. doi:10.1007/978-3-319-68460-4. ISBN 978-3-319-68458-1. http://link.springer.com/10.1007/978-3-319-68460-4.
- ↑ 6.0 6.1 "Autoscribe Integrates Field Sample Planning and Scheduling Management". Autoscribe Blog. Autoscribe Informatics, Inc. 28 April 2020. https://www.autoscribeinformatics.com/resources/blog/autoscribe-integrates-field-sample-planning-and-scheduling-management. Retrieved 09 February 2024.
- ↑ International Commission on Microbiological Specifications for Foods (2018). "Chapter 7: Sampling Plans". Microorganisms in Foods 7: Microbiological Testing in Food Safety Management (2nd ed.). Springer International Publishing. pp. 145–64. doi:10.1007/978-3-319-68460-4. ISBN 978-3-319-68458-1. http://link.springer.com/10.1007/978-3-319-68460-4.
- ↑ "High Volume Environmental Monitoring: LabWare LIMS Solutions". LabWare blog. LabWare, Inc. 6 April 2021. https://www.labware.com/blog/meet-challenges-high-sample-volumes-environmental-monitoring. Retrieved 09 February 2024.
- ↑ Tyer, M.. "How to Ensure Environmental Sampling Data Are Scientifically Sound and Legally Defensible". Hargis & Associates Blog. Hargis & Associates, Inc. https://www.hargis.com/blog/how-to-ensure-environmental-sampling-data-are-scientifically-sound-and-legally-defensible/. Retrieved 09 February 2024.
