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| '''Title''': ''How does a LIMS help a food and beverage business better address the core principles of quality and safety management?''
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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''': January 2024
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| ==Introduction==
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| ==The core principles of food and beverage quality and safety management==
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| [[Hazard analysis and critical control points]] (HACCP) methods remain one of the obvious go-to tools for food and beverage businesses.
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| In the 2023 book ''Food Safety Management: A Practical Guide for the Food Industry'', Overbosch and Blanchard break down the concept of food and beverage quality and safety management into a set of principles that must be applied in order to best achieve it<ref name="OverboschPrinc23">{{cite book |last=Overbosch, P.; Blanchard, S. |year=2023 |editor-last=Andersen, V.; Lelieveld, H.; Motarjemi, Y. |title=Food Safety Management: A Practical Guide for the Food Industry |url=https://books.google.com/books?id=3TpwEAAAQBAJ&printsec=frontcover |chapter=Principles and Systems for Quality and Food Safety Management |edition=2nd |publisher=Elsevier, Inc |pages=497–512 |isbn=9780128200131}}</ref>:
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| *Hygiene in the workplace,
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| *Prevention and reduction of risks (through HACCP),
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| *Reliability of processes and equipment,
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| *Consistency of products and processes to their specifications,
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| *Traceability of products and ingredients,
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| *Relevance of products to the customer or consumer, and
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| *Transparent and accountable integrity of products and ingredients.
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| For the purposes of food and beverage quality and safety management, hygiene management can be understood as the process of identifying and shrinking down the list of "realistic hazards" in development, production, and packaging into a manageable yet robust set of preventable and eliminable risks that either get addressed up-front (the easier risks) or individually identified and managed through HACCP (the more difficult risks).<ref name="OverboschPrinc23" /> Preventing illness, the introduction of foreign material, and the introduction of allergens are generally the domain of hygiene management, backed by standardized approaches found with, for example, ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety - Part 1: Food manufacturing'', EN 15593:2008 ''Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements'', and Codex Alimentarius CXC 1-1968 ''General Principles of Food Hygiene''.<ref name="OverboschPrinc23" /><ref name="AriostiManag16"">{{cite book |year=2016 |editor-last=Lelieveld |editor-first=Huub |editor2-last=Holah |editor2-first=John |editor3-last=Gabrić |editor3-first=Domagoj |author=Ariosti, A. |chapter=Chapter 11: Managing Contamination Risks from Packaging Materials |title=Handbook of hygiene control in the food industry |url=https://www.worldcat.org/title/mediawiki/oclc/959892242 |series=Woodhead Publishing in food science, technology and nutrition |edition=Second edition |pages=147–177 |publisher=Woodhead Publishing is an imprint of Elsevier |place=Amsterdam |isbn=978-0-08-100155-4 |oclc=959892242}}</ref>
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| While addressing hygiene management is in part a matter of addressing a specific set of risks, more broadly food and beverage businesses must address a wide variety of other risks beyond hygiene. This is where HACCP fully comes into play. The [[Food and Drug Administration|U.S. Food and Drug Administration]] (FDA) describes HACCP as "a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product."<ref name="FDAHACCP22">{{cite web |url=https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/hazard-analysis-critical-control-point-haccp |title=Hazard Analysis Critical Control Point (HACCP) |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=19 January 2024}}</ref> As the definition notes, this systems is meant to address a variety of risks from start to finish. However, standards like ISO 22000 that dictate certification to HACCP don't necessarily point to specific hazards; this is left up to the implementers of HACCP systems to do their due diligence and select the most appropriate hazards (i.e., having appropriate specificity and relevancy) and describe how they will be measured and enforced. (In other words, just because HACCP is in place doesn't mean it will be effective.)<ref name="OverboschPrinc23" />
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| Processes and equipment must perform in a predictable manner, with attention paid to their regular review and maintenance. Deficiencies here can originate from lack of appropriate preventive maintenance, non-thorough process design that doesn't imagine "worst case scenarios," and insufficient controls to demonstrate processes and equipment are working as they should.<ref name="OverboschPrinc23" /> A lack of focuse on reliability can lead to inefficiencies, spoilage, and decreased production.<ref>{{Cite journal |last=Tsarouhas |first=Panagiotis |date=2012-11 |title=Reliability, availability and maintainability analysis in food production lines: a review |url=https://ifst.onlinelibrary.wiley.com/doi/10.1111/j.1365-2621.2012.03073.x |journal=International Journal of Food Science & Technology |language=en |volume=47 |issue=11 |pages=2243–2251 |doi=10.1111/j.1365-2621.2012.03073.x |issn=0950-5423}}</ref> The focus on reliability can also tie into the prior principle of risk prevention and reduction, whereas risk and reliability modelling can go hand-in-hand. Proper modelling around a framework that identifies critical equipment with high failure rates and modifies maintenance plans to address those rates can in turn improve quality, safety, and availability.<ref>{{Cite journal |last=Soltanali |first=Hamzeh |last2=Khojastehpour |first2=Mehdi |last3=Torres Farinha |first3=José |date=2023-03-04 |title=An improved risk and reliability framework-based maintenance planning for food processing systems |url=https://www.tandfonline.com/doi/full/10.1080/16843703.2022.2093565 |journal=Quality Technology & Quantitative Management |language=en |volume=20 |issue=2 |pages=256–278 |doi=10.1080/16843703.2022.2093565 |issn=1684-3703}}</ref>
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| Product and process consistency—such that variation from the proper specification is limited—is also important to the food and beverage business. Of course, consistency borne from specification and adherence to it requires that the specification is relevant, specific, precise, and realistic to the intended product or process, while maintaining appropriate goals and symmetrical limits, as well as ensuring process capability. Without these considerations in place, consistent product and process control is unachievable.<ref name="OverboschPrinc23" /> When they are properly enacted in a careful and systematic way to reduce variability, waste reduction, higher quality, and increased customer satisfaction are real outcomes. Laboratories and [[quality control]] testing play an obvious role here.
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| Traceability is a vital principal, especially in the scope of regulatory compliance. From edible products derived from ''[[Cannabis]]'' constituents to bottled water, an approach to traceability that consider "where did it come from, where is it within our premises, and where did it go?" is required to better ensure public safety. Labels that state the region or country of origin involve traceability aspects, as do product recalls and withdraws. Again, laboratory testing that involves durable [[chain of custody]] plays an important role here, particularly in maintaining certified marks for characteristics like "organic" of "GMO-free."<ref name="OverboschPrinc23" /> The U.S. FDA's Food Safety Modernization Act places additional record-keeping demands on food and beverage businesses<ref name="FDATracking 22">{{cite web |url=https://www.fda.gov/food/new-era-smarter-food-safety/tracking-and-tracing-food |title=Tracking and Tracing of Food |publisher=U.S. Food and Drug Administration |date=15 November 2022 |accessdate=19 January 2024}}</ref>, making the principle of traceability practically unavoidable.
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| When discussing the principle of "relevance," the adage of "listen to your customer" comes to mind. In the scope of R&D, this represents the intended audience, from which surveys, panels, and laboratory techniques work towards developing a product that the intended customer has multi-faceted interest in consuming. In the scope of already released product, customer feedback in the form of satisfaction surveys and directed complaint (and compliment) collection systems are used (though failure rates and relative indifference to shortcomings can't necessarily be effectively gleaned from such tools).<ref name="OverboschPrinc23" /> Inevitably, whether a new product or current one, staying in touch with consumer expectations (which increasingly see consumers looking for safer foods with recognizable traceability statements, certification marks, and laboratory-based [[Certificate of analysis|certificates of analysis]])<ref>{{Cite journal |last=Lin |first=Paohui |last2=Tsai |first2=Hsientang |last3=Ho |first3=Tzuya |date=2020-08-31 |title=Food Safety Gaps between Consumers’ Expectations and Perceptions: Development and Verification of a Gap-Assessment Tool |url=https://www.mdpi.com/1660-4601/17/17/6328 |journal=International Journal of Environmental Research and Public Health |language=en |volume=17 |issue=17 |pages=6328 |doi=10.3390/ijerph17176328 |issn=1660-4601 |pmc=PMC7503573 |pmid=32878088}}</ref> is a strong aspect of the principle of relevance.
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| Finally, customers and consumers demand quality from food and beverage products and their ingredients, and transparent and accountable integrity begets quality.<ref>{{Cite book |last=Weiner |first=Edith |last2=Brown |first2=Arnold |date= |year=2006 |title=Future think: How to think clearly in a time of change |url=https://www.oreilly.com/library/view/future-think-how/013185674X/ |chapter=Chapter 8: Integrity Begets Quality |publisher=Pearson Prentice Hall |place=Upper Saddle River, NJ |pages=105–16 |isbn=978-0-13-185674-5}}</ref> In the scope offood and beverage development and production, Overbosch and Blanchard says that this focus on transparent and accountable integrity "means that an acceptable level of transparency must be provided about all relevant parameters and conditions, related to the [other] principles mentioned above, batch by batch."<ref name="OverboschPrinc23" /> This level of transparency is also linked to traceability; traceability systems will fail without the appropriate level of transparency. The deeply proprietary nature of some processes and such may seemingly get in the way of transparency, and as a result a direct-to-the-source approach may emerge, giving the organization less complexity and a clearer route to accountability to its customers.<ref name="OverboschPrinc23" />
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| ==How a LIMS contributes to better addressing these principles==
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| Upon reviewing those seven principles of food and beverage quality and safety management, it's clear that they are largely enterprise-wide principles affecting the multiple departments and branches of the enterprise, including any in-house laboratory. Additionally, it's somewhat difficult to tie each principle to the laboratory-based activities of the industry. (This is particularly true of businesses that subcontract out laboratory work to a third-part. However, that food and beverage business will likely want to vet any third-party laboratory to ensure it's capable of operating in sympathy with the seven principles of quality and safety management). To be sure, a [[laboratory information management system]] (LIMS) is a laboratory-specific piece of software that, when purpose-built, can still have some broader enterprise applicability, yet it's not a "does everything" type of [[informatics]] solution.
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| Keeping in mind the intended function of a LIMS, as well as the diverse approaches to laboratory-based R&D and quality testing of food and beverages, there are undoubtedly ways that a LIMS can help a food and beverage laboratory—and the overall business that employs it—address the seven principles of food and beverage quality and safety management. One example of LIMS functionality that can help the lab and overall business better address all the principles is the LIMS' document management tools. From [[quality management system]]s (QMSs) and food safety management systems (FSMSs) to policy and procedure (P&P) and laboratory safety manuals, a wide variety of documents must be created, distributed, maintained, and updated. These documents will need to be highly available to not only laboratory personnel but also other stakeholders in the laboratory's R&D and analytical processes. They will also need to be version controlled and archivable for both internal policy and external regulatory and accreditation requirements. A well-developed LIMS provides this functionality and more to ensure documentation is secure and available to authorized personnel in a timely fashion.
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| A LIMS can help the lab and overall business better address these principles in other ways:
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| * '''Hygiene''': As noted prior, hygiene management is backed by a number of standards. ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety - Part 1: Food manufacturing'' makes numerous requests of the food manufacturer, including its laboratories. It asks that "test facilities shall be controlled to minimize risk of product contamination," and that specifically microbiology labs "be designed, located and operated so as to prevent contamination of people, plant and products."<ref name="ISO/TS2202-1_09">{{cite web |url=https://www.iso.org/standard/44001.html |title=ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety - Part 1: Food manufacturing'' |publisher=International Organization for Standardization |date=December 2009 |accessdate=19 January 2024}}</ref> The control and operation of these labs is in some capacity up to the business or laboratory manager, but the LIMS can assist the lab in these efforts by housing appropriate documentation, maintaining training records, logging metadata for laboratory activities, and enforcing process steps in the analytical workflow that are standardized to limit contamination.
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| * '''Risk management via HACCP''':
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| * '''Reliability''':
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| * '''Consistency''':
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| * '''Traceability''':
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| * '''Relevance''':
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| * '''Transparent and accountable integrity''':
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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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