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| '''Title''': ''How can a LIMS help a food and beverage laboratory better handle incident management and corrective action?''
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| '''Author for citation''': Shawn E. Douglas
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
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| '''Publication date''': February 2024
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| ==Introduction==
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| ==Incident management and corrective action in general==
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| Numerous 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. Examples include:
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| *9 CFR Part 417 - Hazard Analysis and Critical Control Point (HACCP) Systems[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3]
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| *21 CFR Part 225 - Current Good Manufacturing Practice for Medicated Feeds [https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)][https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]
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| *42 CFR Part 493, Subpart K - Quality System for Nonwaived [Clinical] Testing [https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282][https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]
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| *A2LA C211 - Specific Checklist, Combined ISO-IEC 17025-2017 and Veterinary Laboratory Accreditation Program[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.8 and 4.11]
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| *ASTM E1578-18 - Standard Guide for Laboratory Informatics[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5]
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| *BRC Global Standard Food Safety[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.3][https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2][https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]
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| *CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]
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| *E.U. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]
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| *FDA HACCP Principles & Application Guidelines[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]
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| *GFSI Benchmarking Requirements, Version 2020[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22]
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| *NYSDOH ELAP Medical Marijuana Microbiology Guidance[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]
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| *NIST 800-53, Rev. 5 - Security and Privacy Controls for Information Systems and Organizations[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)][https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5][https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4]
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| *SQF Institute Food Safety Code, Food Manufacturing, Pet Food Manufacturing, and Manufacture of Food Packaging[https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_foodmanufacturing_v3-2-final-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.3][https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_petfood_v3-2-final-w-links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.3][https://www.sqfi.com/docs/sqfilibraries/code-documents/edition-9/code-pdfs/20227fmin_foodpackaging_v3-2-final-w-links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.3]
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| *WHO Technical Report Series, #986, Annex 2 - WHO good manufacturing practices for pharmaceutical products: Main principles[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)][https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
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| An incident is typically represented as a deviation from a standard operating procedure or standardized method that leads to a product outcome that is less than ideal, such as a substandard or injurious product before or after distribution, 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.<ref name="WallaceIncident23">{{Citation |last=Wallace |first=Carol A. |last2=Motarjemi |first2=Yasmine |date=2023 |title=Incident Management and Root Cause Analysis |url=https://linkinghub.elsevier.com/retrieve/pii/B9780128200131000401 |work=Food Safety Management |language=en |publisher=Elsevier |pages=957–970 |doi=10.1016/b978-0-12-820013-1.00040-1 |isbn=978-0-12-820013-1}}</ref>
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| 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.<ref name="WallaceIncident23" />
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| The areas where the laboratory has the greatest impact in identifying potential and real incidents is through regular and/or randomized 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 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.<ref name="WallaceIncident23" />
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| ==How can a LIMS help?==
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| ==Conclusion==
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| ==References==
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| {{Reflist|colwidth=30em}}
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