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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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| "Quality" and "safety" are two words that should invariably show up in the vocabulary of every food and beverage business. Stakeholders at every point of that business' operations ideally expect the final product to have a high level of quality and be safe to consume, especially the final consumers of the product. As such, quality and safety management are important components of business operations, and the various nuances or "principles" of doing it well must fully be addressed, including in the business' associated laboratories. Those laboratories play a critical role in not only product development (R&D) but also quality control (QC) across the business' operations. Sure, the laboratory operations could be handled by hand, using paper notebooks and spreadsheets, but given the highly regulated nature of the industry, electronic systems such as [[electronic laboratory notebook]]s (ELNs) and [[laboratory information management system]]s (LIMS) are increasingly important.
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| The rest of this brief article will address the role of the LIMS in food and beverage laboratories and their overarching manufacturing entities, particularly in the scope of seven important quality and safety management principles. Those seven principles will be described in further detail, and the intersection of a LIMS with those priniciples will also be addressed.
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| ==The core principles of food and beverage quality and safety management==
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| Proper management of food and beverage [[Quality (business)|quality]] and safety is vital for not only the manufacturer but also the consumer. [[Hazard analysis and critical control points]] (HACCP) methods (described later) remain one of the obvious go-to tools for food and beverage businesses, as it allows them to, when properly implemented, reduce risks to the business and its products. However, there are other considerations outside of [[risk management]] and HACCP that food and beverage businesses must consider.
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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 seven principles that must be applied in order to best achieve it. These seven principles address<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 and other methods),
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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 focus 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 modeling can go hand-in-hand. Proper modeling 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, then 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 considers "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 of food 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 a business that subcontracts out laboratory work to a third-party. 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 and mindfully used, 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 seven 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 achievable 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 too:
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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. Additionally, any environmental control test results (per the standard, "the effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed"<ref name="ISO/TS2202-1_09" />) and certificates of analysis associated with product batches can be managed, maintained, and audited from within the LIMS.
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| *'''Risk management via HACCP''': The HACCP method of risk management is critical to modern food and beverage businesses (and is an influence on [[ISO/IEC 17025|ISO/IEC 17025:2017]] ''General requirements for the competence of testing and calibration laboratories''). While HACCP addresses risk beyond those posed from within and adjacent to the laboratory, as the prior mentioned ISO/TS 22002-1:2009 alludes to, the control and operation of labs to minimize product contamination risk is indeed a strong risk to consider. The lab's activities within, as well as its analyses related to what happens elsewhere in the research or manufacturing facility, are impacted by HACCP. Some LIMS vendors have recognized this and integrated support for building HACCP steps into laboratory workflows. In some cases this may be as sophisticated as allowing the user to diagram HACCP in their lab or facility as a [[Data visualization|visualization]] tool.<ref name="LWOptimizing22">{{cite web |url=https://www.labware.com/blog/lims-7-steps-of-haccp |title=Optimizing Food Safety with LIMS HACCP Integration |publisher=LabWare, Inc |date=10 January 2022 |accessdate=19 January 2022}}</ref>
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| *'''Reliability''': Of course, a manufacturing facility's entire set of automated and semi-automated manufacturing systems isn't going to be fed into a LIMS. However, reliability of processes and equipment doesn't stop at the laboratory's entrance; the food and beverage laboratory must also have a strong focus on this principle. Here a LIMS shines, allowing the lab to integrate most of its analytical equipment with the LIMS to "talk" with the equipment. Errors and failure of integrated instruments can be logged and tracked in the LIMS, and any faulty instrument can even be made unavailable from current and future testing from within the LIMS. Additionally, maintenance records can be kept and made reviewable by personnel and auditors. And in a growing trend of incorporating some elements of [[artificial intelligence]] or [[machine learning]] tools into a LIMS, predictive maintenance routines can be run to better limit analytical downtime.<ref>{{Cite journal |last=Karthik |first=T S |last2=Kamala |first2=B |date=2021-10-01 |title=Cloud based AI approach for predictive maintenance and failure prevention |url=https://iopscience.iop.org/article/10.1088/1742-6596/2054/1/012014 |journal=Journal of Physics: Conference Series |volume=2054 |issue=1 |pages=012014 |doi=10.1088/1742-6596/2054/1/012014 |issn=1742-6588}}</ref> Finally, the safety and quality of a developed, manufactured, or reformulated food or beverage product is only as good as the analytical and quality control testing behind it. The accuracy and reliability of the lab's results are paramount, and a purpose-built LIMS used by properly trained personnel can positively benefit in better ensuring result reliability and accuracy.<ref>{{Citation |last=Famili |first=Parsa |last2=Cleary |first2=Susan |date=2022-03-09 |editor-last=Huynh‐Ba |editor-first=Kim |title=Laboratory Information Management System (LIMS) and Electronic Data |url=https://onlinelibrary.wiley.com/doi/10.1002/9781119680475.ch10 |work=Analytical Testing for the Pharmaceutical GMP Laboratory |language=en |edition=1 |publisher=Wiley |pages=345–373 |doi=10.1002/9781119680475.ch10 |isbn=978-1-119-12091-9 |accessdate=2024-01-19}}</ref><ref>{{Cite journal |last=Zhang |first=Ping |last2=Liu |first2=Binjie |date=2023 |title=Design and Implementation of LIMS System for Small and Medium-sized Discrete Manufacturing Enterprise |url=http://eudl.eu/doi/10.4108/eai.24-2-2023.2330696 |journal=Proceedings of the 2nd International Conference on Engineering Management and Information Science, EMIS 2023, February 24-26, 2023, Chengdu, China |language=en |publisher=EAI |place=Chengdu, People's Republic of China |doi=10.4108/eai.24-2-2023.2330696 |isbn=978-1-63190-405-9}}</ref>
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| *'''Consistency''': As noted above, laboratories play an important role in the overall food and beverage business' goal towards more consistent products and processes. Through their quality testing of ingredients and products at various points along the manufacturing chain, a laboratory's testing can identify unexpected contaminants or deficiencies in a manufacturing process. Tangentially, the laboratory conducting this quality testing—as well as the R&D laboratory attempting to get its formulations right in as few steps as possible—ideally desires its processes and products (i.e., their analytical results) to also be consistent. Here, a LIMS helps by enforcing workflow steps within the laboratory based on a standard method, enforcing specification limits on results, providing mandatory review stops on an analysis, and validating results. Labs compliant to ISO/IEC 17025 and using a LIMS that [[LIMS FAQ:What are the key elements of a LIMS to better comply with ISO/IEC 17025?|addresses the needs of an ISO/IEC 17025 lab]] should—by extension of ISO/IEC 17025 addressing consistent operations as a core requirement of meeting the standard<ref name="DouglasHowDoesISO23">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:How_does_ISO/IEC_17025_impact_laboratories%3F |title=LIMS FAQ:What are the key elements of a LIMS to better comply with ISO/IEC 17025? |author=Douglas, S.E. |work=LIMSwiki |date=January 2023 |accessdate=24 January 2024}}</ref> —have a leg up on ensuring their lab is tapping into the principle of consistency.<ref name="DouglasHowDoesISO23" /><ref name="IngallsHowAdv20">{{cite web |url=https://foodsafetytech.com/feature_article/how-advanced-lims-brings-control-consistency-and-compliance-to-food-safety/ |title=How Advanced LIMS Brings Control, Consistency and Compliance to Food Safety |author=Ingalls, E. |work=Food Safety Tech |date=06 August 2020 |accessdate=24 January 2024}}</ref>
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| *'''Traceability''': From the perspective of regulatory agencies such as the U.S. FDA, the concept of traceability for food safety addresses the entire food supply chain, from farm to table (or at least the "last mile" before the consumer acquires the final product).<ref name="FDAFSMAFinal23">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods |title=FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods |publisher=U.S. Food and Drug Administration |date=21 November 2023 |accessdate=24 January 2024}}</ref> The manufacturing or R&D laboratory is not exempt from this accountability chain, and in fact most food and beverage labs will play an important role through their analyses and corresponding documentation. This extends beyond the traceability of a given ingredient or production batch in the production facility to traceability of samples in the lab, complete with all the appropriate [[metadata]] that helps paint a clearer picture of the ingredient or product batch being tested. A purpose-built LIMS for food and beverage will incorporate an [[audit trail]] that records the who, what, when, where, and why of a process step, as well as a [[chain of custody]] mechanism, sample tracking mechanisms, electronic signatures, robust query tools, and data archiving tools to support not only day-to-day operations but also auditing and other regulatory activities.<ref name="DouglasHowDoesISO23" />
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| *'''Relevance''': For the greater food and beverage business, relevancy of its products to the business' stakeholders is a critical principle to be followed. The in-house or third-party food and beverage lab helps with this effort by providing accurate and timely analytical results, which are tied to standardized methods and well-vetted procedures. Customers' safety and desire for a delicious product demand the R&D or quality control lab conduct the right analyses in the right way at the right time, in turn helping the overall business maintain its product's and own relevancy. While a LIMS doesn't necessarily directly contribute to a product's relevancy, it indirectly does so by providing many of the mechanisms mentioned above in the other principles. The lab's own relevancy is also at stake, and it's in its best interest to move beyond, for example, paper-based methods that don't provide the same level of reliability, traceability, and consistency of operations and data that a LIMS does.<ref name="WHOInfoManage09">{{cite web |url=https://extranet.who.int/hslp/who-hslp-download/package/501/material/316 |title=Information Management |publisher=World Health Organization |format=PPT |date=19 May 2009 |accessdate=24 January 2024}}</ref>
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| *'''Transparent and accountable integrity''': Earlier, it was stated that transparent and accountable integrity begets quality, and quality should be strived for by the food and beverage business and any associated laboratories. By engaging in traceable activities, transparently maintaining and producing the results of those activities, and holding those responsible for failures or misinterpretations of those activities properly accountable, quality of both the final product—whether it's a bag of potato chips or a set of laboratory results—should be the end result. As noted prior, traceability is an important player in the principle of integrity, and the purpose-built LIMS is more than capable in this endeavor. Not only are its audit trail and sample tracking tools critical here, but also the LIMS' mechanisms for better ensuring [[data integrity]] limit the risk of facility shutdowns, product recalls, and loss of brand value.<ref name="HenningEnhanc23">{{cite web |url=https://www.foodmanufacturing.com/safety/article/22879049/enhancing-quality-control-in-food-beverage-the-smart-path-to-lims-consolidation |title=Enhancing Quality Control in Food & Beverage: The Smart Path to LIMS Consolidation |author=Henning, B. |wor=Food Manufacturing |date=10 November 2023 |accessdate=24 November 2024}}</ref>
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| ==Conclusion==
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| This brief informational article sought to answer the question "How does a LIMS help a food and beverage business better address the core principles of quality and safety management?" Recognizing the importance of quality and safety management at all levels of the enterprise, seven principles are discussed that the food and beverage business must address as part of their operations. These seven principles of hygiene in the workplace, risk prevention, process and equipment reliability, product and process consistency, product and ingredient traceability, product relevance, and product and ingredient integrity are described, highlighting how they relate to overall quality and safety in the enterprise, including in any associated laboratories. Those laboratories play a critical role in helping the business better address these principles, as well as address the principles within their own operations. A LIMS can be a vital component to an overall quality and safety management plan, both directly and indirectly addressing the mentioned seven principles. The end results of mindful LIMS implementation and use are improved quality and safety while minimizing risks, at least within the laboratory, if not beyond its walls.
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| ==References==
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| {{Reflist|colwidth=30em}}
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