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| <div class="nonumtoc">__TOC__</div> | | <div class="nonumtoc">__TOC__</div> |
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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 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. Examples include:
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| *9 CFR Part 417 - Hazard Analysis and Critical Control Point (HACCP) Systems<ref name="CLS9CFRPart417">{{cite web |url=https://www.law.cornell.edu/cfr/text/9/part-417 |title=9 CFR Part 417 - Hazard Analysis and Critical Control Point (HACCP) Systems |work=Legal Information Institute |publisher=Cornell Law School |date=25 July 1996 |accessdate=23 February 2024}}</ref>
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| *21 CFR Part 225 - Current Good Manufacturing Practice for Medicated Feeds<ref name="CLS21CFR225.58">{{cite web |url=https://www.law.cornell.edu/cfr/text/21/225.58 |title=21 CFR Part 225.58 - Current Good Manufacturing Practice for Medicated Feeds - Laboratory controls |work=Legal Information Institute |publisher=Cornell Law School |date=19 November 1999 |accessdate=23 February 2024}}</ref><ref name="CLS21CFR225.158">{{cite web |url=https://www.law.cornell.edu/cfr/text/21/225.158 |title=21 CFR Part 225.158 - Current Good Manufacturing Practice for Medicated Feeds - Laboratory assays |work=Legal Information Institute |publisher=Cornell Law School |date=19 November 1999 |accessdate=23 February 2024}}</ref>
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| *42 CFR Part 493, Subpart K - Quality System for Nonwaived [Clinical] Testing<ref name="CLS42CFR493.1282">{{cite web |url=https://www.law.cornell.edu/cfr/text/42/493.1282 |title=42 CFR Part 493.1282 - Quality System for Nonwaived [Clinical] Testing - Standard: Corrective actions |work=Legal Information Institute |publisher=Cornell Law School |date=22 August 2003 |accessdate=23 February 2024}}</ref><ref name="CLS42CFR493.1289">{{cite web |url=https://www.law.cornell.edu/cfr/text/42/493.1289 |title=42 CFR Part 493.1289 - Quality System for Nonwaived [Clinical] Testing - Standard: Analytic systems quality assessment |work=Legal Information Institute |publisher=Cornell Law School |date=22 August 2003 |accessdate=23 February 2024}}</ref>
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| *A2LA C211 - Specific Checklist, Combined ISO-IEC 17025-2017 and Veterinary Laboratory Accreditation Program<ref name="USLegalC211_11">{{cite web |url=https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation |title=C211 - Specific Checklist, Combined ISO-IEC 17025-2017 and Veterinary Laboratory Accreditation Program |author=A2LA |work=USLegal |date=09 December 2011 |accessdate=23 February 2024}}</ref>
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| *ASTM E1578-18 - Standard Guide for Laboratory Informatics<ref name="ASTME1578-18">{{cite web |url=https://www.astm.org/e1578-18.html |title=Standard Guide for Laboratory Informatics |publisher=ASTM International |date=23 August 2019 |accessdate=23 February 2024}}</ref>
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| *BRC Global Standard Food Safety<ref name="BRCGSFoodSafety">{{cite web |url=https://www.brcgs.com/our-standards/food-safety/ |title=Food Safety |publisher=BRC Trading Limited |date=2024 |accessdate=23 February 2024}}</ref>
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| *CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<ref name="CDCBiosafety20">{{cite web |url=https://www.cdc.gov/labs/BMBL.html |title=Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition |author=Centers for Disease Control and Prevention; National Institutes of Health |date=June 2020 |accessdate=23 February 2024}}</ref>
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| *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<ref name="EurLEXCommDir2017-1572">{{cite web |url=https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32017L1572 |title=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 |author=European Commission |work=EUR-Lex |date=15 September 2017 |accessdate=23 February 2024}}</ref>
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| *FDA HACCP Principles & Application Guidelines<ref name="USFDAHACCP22">{{cite web |url=https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines |title=HACCP Principles & Application Guidelines |author=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=23 February 2024}}</ref>
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| *GFSI Benchmarking Requirements, Version 2020.1<ref name="GFSIBenchReqs20">{{cite web |url=https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications |title=GFSI Benchmarking Requirements, Version 2020.1 |author=Global Food Safety Initiative |date=2020 |accessdate=23 February 2024}}</ref>
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| *NYSDOH ELAP and LEB Medical Marijuana Microbiology Guidance<ref name="NYSDOHMMMGuid20">{{cite web |url=https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf |format=PDF |title=Procedure on How to Perform an Initial Demonstration of Capability (iDOC) for Medical Marijuana Microbiology |author=New York State Department of Health – Wadsworth Center |date=03 December 2020 |accessdate=23 February 2024}}</ref>
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| *NIST 800-53, Rev. 5 - Security and Privacy Controls for Information Systems and Organizations<ref name="NIST800-53Rev5_20">{{cite web |url=https://csrc.nist.gov/pubs/sp/800/53/r5/upd1/final |title=NIST 800-53, Rev. 5 - Security and Privacy Controls for Information Systems and Organizations |author=National Institute of Standards and Technology |date=10 December 2020 |accessdate=23 February 2024}}</ref>
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| *SQF Institute Food Safety Code, Food Manufacturing, Pet Food Manufacturing, and Manufacture of Food Packaging<ref name="SQFILibrary">{{cite web |url=https://www.sqfi.com/the-sqf-code/choose-your-code/library-of-codes |title=Library of Codes - SQF Food Safety Codes |publisher=SQF Institute |date=2024 |accessdate=23 February 2024}}</ref>
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| *WHO Technical Report Series, #986, Annex 2 - WHO good manufacturing practices for pharmaceutical products: Main principles<ref name="WHOTechRepSer">{{cite web |url=https://extranet.who.int/prequal/medicines/who-technical-report-series |title=WHO Technical Report Series |work=Prequalification of Medical Products |publisher=World Health Organization |date=2014 |accessdate=23 February 2024}}</ref>
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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 (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.<ref name="WallaceIncident23" />
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| Increasingly common in modern laboratories, a [[laboratory information management system]] (LIMS) can prove useful in these matters. The next section explains how.
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| ==How can a LIMS help?==
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| 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.<ref name="DouglasKeyElementsFoodLIMS22">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:What_are_the_key_elements_of_a_LIMS_for_food_and_beverage_testing%3F |title=What are the key elements of a LIMS for food and beverage testing? |author=Douglas, S.E. |work=LIMSwiki |date=September 2022 |accessdate=23 February 2024}}</ref> 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.
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| 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<ref name="ASTME1578-18" /><ref name="WallaceIncident23" /><ref name="DouglasKeyElementsFoodLIMS22" /><ref name="DouglasLIMSFBCorePrin24">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:How_does_a_LIMS_help_a_food_and_beverage_business_better_address_the_core_principles_of_quality_and_safety_management%3F |title=LIMS FAQ:How does a LIMS help a food and beverage business better address the core principles of quality and safety management? |author=Douglas, S.E. |work=LIMSwiki |date=January 2024 |accessdate=23 February 2024}}</ref>:
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| * 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;
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| * 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;
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| * re-prioritize or pause other related activities that are scheduled due to the identified non-conformance or incident;
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| * 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;
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| * 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;
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| * 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<ref name="DouglasKeyElementsFoodLIMS22" />); and
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| * 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.
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| These and other such LIMS functions should improve reaction time to non-conformances across the business.
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| ==Conclusion==
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| ==References==
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| {{Reflist|colwidth=30em}}
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| <!---Place all category tags here-->
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