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Sampling plans are a critical component of microbiological sampling and testing practices in the food and beverage industry. Sampling plans essentially take identified sampling points within a controlled manufacturing 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<ref name="AIAutoInt20">{{cite web |url=https://www.autoscribeinformatics.com/resources/blog/autoscribe-integrates-field-sample-planning-and-scheduling-management |title=Autoscribe Integrates Field Sample Planning and Scheduling Management |publisher=Autoscribe Informatics, Inc |work=Autoscribe Blog |date=28 April 2020 |accessdate=09 February 2024}}</ref>), with each sampling point having it's own requirements, often different from sample point to sample point. | Sampling plans are a critical component of microbiological sampling and testing practices in the food and beverage industry. Sampling plans essentially take identified sampling points within a controlled manufacturing 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<ref name="AIAutoInt20">{{cite web |url=https://www.autoscribeinformatics.com/resources/blog/autoscribe-integrates-field-sample-planning-and-scheduling-management |title=Autoscribe Integrates Field Sample Planning and Scheduling Management |publisher=Autoscribe Informatics, Inc |work=Autoscribe Blog |date=28 April 2020 |accessdate=09 February 2024}}</ref>), with each sampling point having it's own requirements, often different from sample point to sample point. | ||
Microbiological sampling plans are driven in part by regulatory bodies like the U.S. Food and Drug Administration (FDA) <ref name=FDASampling23">{{cite web |url=https://www.fda.gov/food/compliance-enforcement-food/sampling-protect-food-supply |title=Sampling to Protect the Food Supply |publisher=U.S. Food and Drug Administration |date=13 June 2023 |accessdate=09 February 2024}}</ref><ref name="FDAHACCP22">{{cite web |url=https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines |title=HACCP Principles & Application Guidelines |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=09 February 2024}}</ref>, as well as compulsion or requirement to conform or be accredited to standards such as ISO 2859 ''Sampling procedures for inspection by attributes''.<ref name="ISO2859">{{cite web |url=https://www.iso.org/standard/1141.html |title=ISO 2859-1:1999 ''Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection'' |publisher=International Organization for Standardization |date=November 1999 |accessdate=09 February 2024}}</ref> | Microbiological sampling plans are driven in part by regulatory bodies like the U.S. Food and Drug Administration (FDA) <ref name=FDASampling23">{{cite web |url=https://www.fda.gov/food/compliance-enforcement-food/sampling-protect-food-supply |title=Sampling to Protect the Food Supply |publisher=U.S. Food and Drug Administration |date=13 June 2023 |accessdate=09 February 2024}}</ref><ref name="FDAHACCP22">{{cite web |url=https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines |title=HACCP Principles & Application Guidelines |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=09 February 2024}}</ref>, as well as compulsion or requirement to conform or be accredited to standards such as ISO 2859 ''Sampling procedures for inspection by attributes''.<ref name="ISO2859">{{cite web |url=https://www.iso.org/standard/1141.html |title=ISO 2859-1:1999 ''Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection'' |publisher=International Organization for Standardization |date=November 1999 |accessdate=09 February 2024}}</ref> Despite the wide variability that can be found in a sampling 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.<ref name="JacksonManage23" /><ref name="ErkmanSamp22" /><ref name="ICMSFMicro18-C7">{{cite book |url=http://link.springer.com/10.1007/978-3-319-68460-4 |title=Microorganisms in Foods 7: Microbiological Testing in Food Safety Management |chapter=Chapter 7: Sampling Plans |author=International Commission on Microbiological Specifications for Foods |publisher=Springer International Publishing |year=2018 |edition=2nd |pages=145–64 |doi=10.1007/978-3-319-68460-4 |isbn=978-3-319-68458-1}}</ref> | ||
Despite the wide variability that can be found in a sampling 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.<ref name="ICMSFMicro18-C7">{{cite book |url=http://link.springer.com/10.1007/978-3-319-68460-4 |title=Microorganisms in Foods 7: Microbiological Testing in Food Safety Management |chapter=Chapter 7: Sampling Plans |author=International Commission on Microbiological Specifications for Foods |publisher=Springer International Publishing |year=2018 |edition=2nd |pages=145–64 |doi=10.1007/978-3-319-68460-4 |isbn=978-3-319-68458-1}}</ref | |||
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.<ref name="JacksonManage23" /><ref name="LWHighVol21">{{cite web |url=https://www.labware.com/blog/meet-challenges-high-sample-volumes-environmental-monitoring |title=High Volume Environmental Monitoring: LabWare LIMS Solutions |publisher=LabWare, Inc |work=LabWare blog |date=06 April 2021 |accessdate=09 February 2024}}</ref> 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.<ref name="AIAutoInt20" /> 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 and analytical 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.<ref name="JacksonManage23" /><ref name="TyerHowToEnsure">{{cite web |url=https://www.hargis.com/blog/how-to-ensure-environmental-sampling-data-are-scientifically-sound-and-legally-defensible/ |title=How to Ensure Environmental Sampling Data Are Scientifically Sound and Legally Defensible |author=Tyer, M. |work=Hargis & Associates Blog |publisher=Hargis & Associates, Inc |accessdate=09 February 2024}}</ref><ref name=PFPLTGFoodFeed13">{{cite web |url=https://www.fda.gov/media/88973/download |format=PDF |title=Food/Feed Testing Laboratories Best Practices Manual (Draft) |author=Partnership for Food Protection Laboratory Task Group |date=01 November 2013}}</ref><ref name="PFPLSWHumanAnim18">{{cite web |url=https://www.aphl.org/programs/food_safety/APHL%20Documents/LBPM_Dec2018.pdf |format=PDF |title=Human and Animal Food Testing Laboratories Best Practices Manual |author=Partnership for Food Protection Laboratory Science Workgroup |date=December 2018}}</ref> | |||
Revision as of 18:55, 9 February 2024
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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
LIMS and microbiological sampling and analysis of foods and beverages
In the world of microbiological testing of foods, beverages, and their processing environment, the importance of proper sampling and analytical practices—including having a sound sampling plan—can't be understated.[1][2][3][4][5] The production of properly tasting foods and beverages that are safe to consume are paramount to both the consumer and producer, which is in strong part built upon solid verification and end-point sampling and testing practices throughout the entire process, from ingredient acquisition to shipping the final product.
Sampling plans are a critical component of microbiological sampling and testing practices in the food and beverage industry. Sampling plans essentially take identified sampling points within a controlled manufacturing 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.
Microbiological sampling plans are driven in part by regulatory bodies like the U.S. Food and Drug Administration (FDA) [7][8], as well as compulsion or requirement to conform or be accredited to standards such as ISO 2859 Sampling procedures for inspection by attributes.[9] Despite the wide variability that can be found in a sampling 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.[1][2][10]
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.[1][11] 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 and analytical 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.[1][12][13][14]
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
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 1.2 1.3 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.
- ↑ "Sampling to Protect the Food Supply". U.S. Food and Drug Administration. 13 June 2023. https://www.fda.gov/food/compliance-enforcement-food/sampling-protect-food-supply. Retrieved 09 February 2024.
- ↑ "HACCP Principles & Application Guidelines". U.S. Food and Drug Administration. 25 February 2022. https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines. Retrieved 09 February 2024.
- ↑ "ISO 2859-1:1999 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection". International Organization for Standardization. November 1999. https://www.iso.org/standard/1141.html. 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.
- ↑ Partnership for Food Protection Laboratory Task Group (1 November 2013). "Food/Feed Testing Laboratories Best Practices Manual (Draft)" (PDF). https://www.fda.gov/media/88973/download.
- ↑ Partnership for Food Protection Laboratory Science Workgroup (December 2018). "Human and Animal Food Testing Laboratories Best Practices Manual" (PDF). https://www.aphl.org/programs/food_safety/APHL%20Documents/LBPM_Dec2018.pdf.