View source for LIMS Q&A:How can a LIMS assist food and beverage industry compliance with ISO 22000 and ISO/IEC 17025?

[[File:Food Safety Lab (Gibson).jpg|right|300px]]
'''Title''': ''How can a LIMS assist food and beverage industry compliance with ISO 22000 and ISO/IEC 17025?''

'''Author for citation''': Shawn E. Douglas

'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]

'''Publication date''': December 2023

==Introduction==
Maintaining food safety requires a concerted, worldwide effort, particularly as trade of food supplies continues to become more international. Despite a diverse regulatory landscape for food safety from country to country, international standards such as [[ISO 22000]] and [[ISO/IEC 17025]] give food and beverage companies a more globally approved approach to managing food safety and quality within their operations. Complying with these standards, however, can involve the collection, maintenance, and reporting of large quantities of data, which is more difficult than ever to manage with paper- and spreadsheet-based system. This is where a [[laboratory information management system]] (LIMS) comes into play.

This brief, topical article examines ISO 22000 and ISO/IEC 17025, how they relate to the food and beverage industry, and how informatics approaches such as LIMS may prove useful. Examples of functionality of a food and beverage LIMS that helps address compliance with these standards are also given.

==International food and beverage safety through regulatory-driven operational standardization==
When discussing the landscape of food and beverage safety and it regulation, it's difficult not to mention standards like ISO 22000 and ISO/IEC 17025. Most competitive and well-established food and beverage companies will already be accredited to the ISO 22000:2018 standard, and if they have an in-house research and development (R&D) or quality testing [[laboratory]], to the ISO/IEC 17025:2017 standard. Both are internationally recognized standards that attempt to globally harmonize approaches to both food safety management and laboratory quality management.

ISO 22000—first published in 2005—was originally designed to be aligned with quality management standards like [[ISO 9000|ISO 9001]] and the Hazard Analysis and Critical Control Points (HACCP) principles, as adopted by the ''Codex Alimentarius''.<ref name="HolahPric23">{{Citation |last=Holah |first=John |date=2023 |title=Principles of Hygienic Practice in Food Processing and Manufacturing |url=https://linkinghub.elsevier.com/retrieve/pii/B9780128200131000292 |work=Food Safety Management |language=en |publisher=Elsevier |pages=587–613 |doi=10.1016/b978-0-12-820013-1.00029-2 |isbn=978-0-12-820013-1 |accessdate=}}</ref> And while ISO 9001 wasn't exclusively directed at laboratories, over the years laboratories have adopted that standard, along with other non-laboratory businesses. With ISO/IEC 17025 having significant alignment with ISO 9001 (while being specifically designed for analytical and calibration laboratories)<ref>{{Cite journal |last=Miguel |first=Anna |last2=Moreira |first2=Renata |last3=Oliveira |first3=André |date=2021 |title=ISO/IEC 17025: HISTORY AND INTRODUCTION OF CONCEPTS |url=http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf |journal=Química Nova |doi=10.21577/0100-4042.20170726}}</ref> and ISO 22000 having alignment with ISO 9001, it's not surprising there is occasional minor confusion between ISO 22000 and ISO/IEC 17025, as well as their impacts on the food and beverage industry.

ISO 22000:2018 ''Food safety management systems - Requirements for any organization in the food chain'' specifies how any food and beverage-related business can develop and implement a food safety management system that addresses interactive communication requirements, system management requirements, prerequisite programs, and HACCP requirements.<ref name="HolahPric23" /> On the other hand, ISO/IEC 17025:2017 ''General requirements for the competence of testing and calibration laboratories'' specifies how an analytical or calibration laboratory—including a food and beverage lab—can take a quality system approach to their operations while demonstrating competency, impartiality, and consistency.<ref name="ISO17025_17">{{cite web |url=https://www.iso.org/standard/66912.html |title=ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories |publisher=International Organization for Standardization |date=November 2017 |accessdate=05 December 2023}}</ref> While both share aspects of ISO 9001, the intended audiences are different, and ISO 22000 doesn't address things like the measurement aspects of analyses and the management of proficiency testing records.<ref name="PerovicISO22000_08">{{cite web |url=https://www.ifsqn.com/forum/index.php/topic/30137-the-extent-of-iso-17025-implementation-for-fssc-22000/ |title=ISO 22000 and accredited laboratory |author=Perovic, S. |work=The Elsmar Cove |publisher=XenForo Ltd |date=04 February 2008 |accessdate=05 December 2023}}</ref><ref name="Lurah11Extent17">{{cite web |url=https://elsmar.com/elsmarqualityforum/threads/iso-22000-and-accredited-laboratory.25754/ |title=The Extent of ISO 17025 implementation for FSSC 22000 |author=lurah11 |work=International Safety & Quality Network Forums |publisher=International Safety & Quality Network |date=21 July 2017 |accessdate=05 December 2023}}</ref> The most likely crossover between the two in a food and beverage business is where a food manufacturer adopts ISO 22000 or its HACCP practices, and an affiliated laboratory accredited to the ISO/IEC 17025 standard conducts a wide variety of testing, including the identification and monitoring of physical, chemical, and biological hazards as part of HACCP.

Though some countries may have legal requirements for food manufacturers to adopt the HACCP principles enshrined in ISO 22000—which encourage the identification and controlling of potential hazards throughout the manufacturing process to better ensure the quality and safety of food and beverages<ref name="HolahPric23" />—other countries may not have such requirements, leaving ISO 9001, 17025, and 22000 adoption voluntary. However, the clientele of a given food manufacturer may demand they be accredited to one or more of these standards, or even audited to the requirements of the likes of the Global Food Safety Initiative (GFSI).<ref name="HolahPric23" /> Additionally, with food safety regulations growing in number (though differing, sometimes greatly, among countries), and many of those regulations requiring conformance to one or more national and international standards,<ref name="MahmoudAnHist20">{{cite web |url=https://www.food-safety.com/articles/6448-an-historical-food-safety-approach-for-the-world-we-want |title=An Historical Food Safety Approach for the World We Want |author=Mahmoud, B. |work=Food Safety Magazine |date=04 February 2020 |accessdate=05 December 2023}}</ref> food and beverage companies of all types are increasingly finding they need to not only meet the requirements of clientele but also stay ahead of the changing regulatory landscape by getting accredited to an international standard. The data collection and management requirements of standards like ISO 22000 and ISO/IEC 17025 in particular demand something better than a paper- or spreadsheet-based methodology. This is where a LIMS comes into play.

==A LIMS' role in complying with ISO 22000 and ISO/IEC 17025==
The "Vs" of data and information involved with complying with food safety regulations and standards compliance continue to grow, requiring an advanced [[Informatics (academic field)|informatics]] solution that can securely capture, store, trace, archive, and report that data and information in a defensible manner.<ref name="RumpfLever07">{{cite web |url=https://www.labware.com/blog/labware-supports-food-beverage-regulations |archiveurl=https://web.archive.org/web/20210303200830/https://www.food-safety.com/articles/3973-leveraging-food-safety-data-to-improve-operations |title=Leveraging Food Safety Data to Improve Operations |author=Rumpf, A |work=Food Safety Magazine |date=01 August 2007 |archivedate=03 March 2021 |accessdate=06 December 2023}}</ref><ref name="BratagerTheFut22">{{cite web |url=https://foodsafetytech.com/column/the-future-of-food-safety-is-data-driven/ |title=The Future of Food Safety Is Data Driven |author=Bratager, S |work=Food Safety Tech |date=27 July 2022 |accessdate=06 December 2023}}</ref><ref name="ThurstonISO22000_15">{{cite web |url=https://assets.thermofisher.com/TFS-Assets/CMD/Reference-Materials/ar-lims-iso-22000-informatics-labmanager0515-en.pdf |format=PDF |title=ISO 22000 and Integrated Informatics: Business Best Practices to Meet Global Food Safety Regulatory Challenges |author=Thurston, C. |work=Lab Manager |date=May 2015 |accessdate=06 December 2023}}</ref> In a 2021 journal article published in ''Frontiers in Microbiology'',  Donaghy ''et al.'' clearly elaborate on this trend<ref>{{Cite journal |last=Donaghy |first=John A. |last2=Danyluk |first2=Michelle D. |last3=Ross |first3=Tom |last4=Krishna |first4=Bobby |last5=Farber |first5=Jeff |date=2021-05-21 |title=Big Data Impacting Dynamic Food Safety Risk Management in the Food Chain |url=https://www.frontiersin.org/articles/10.3389/fmicb.2021.668196/full |journal=Frontiers in Microbiology |volume=12 |pages=668196 |doi=10.3389/fmicb.2021.668196 |issn=1664-302X |pmc=PMC8177817 |pmid=34093486}}</ref>:

<blockquote>Food safety related data, acquired throughout the food chain, is required for real-time food safety decision-making by all stakeholders, including risk assessors, managers, and communicators ... The ability to collect, analyze, and convey digital data at all stages of the food value chain has seen an exponential increase in the volume, velocity, variety, and veracity of data available. Data sources impacting food safety include food production, food consumption, public health, agriculture, environmental conditions logistics, social media, etc., containing structured and unstructured formats. The ability to extract value from these data, while ensuring the interoperability of different sources to assure food safety and quality, is the future challenge.</blockquote>

A variety of electronic systems have evolved to better address the growing needs of food and beverage companies complying with ISO 22000 and ISO/IEC 17025, including electronic HACCP (e-HACCP) systems, food safety and quality management systems, plant management systems, and LIMS. In particular, where laboratory testing (R&D, quality, or otherwise) intersects with HACCP management, you'll likely find a LIMS. The software is able to record and track operational tasks such as sampling, analysis, training, maintenance, and much more, from delivery of raw materials to approval of the final product, leaning on [[audit trail]]s and role-based security to ensure all recorded data and information is accurate and defensible. Both expected and unexpected or undesirable results should be captured, including non-conformances that if not caught early could have a dramatic impact on the future value of a brand, or the reputation of the manufacturer. That HACCP dictates hazard evaluation, prevention management, monitoring control, record maintenance, and corrective action documentation, it becomes clearer that a LIMS further lends to better tracking the analyses and documents associated with the HACCP activities of the company. This is especially useful when manufacturing and testing operations are spread out across multiple locations nationally and internationally; a web-based LIMS provides consistency and limits complexity of HACCP and laboratory quality management across the entire organization.<ref name="ThurstonISO22000_15" /><ref name="ThermoHowLIMS20">{{cite web |url=https://assets.thermofisher.com/TFS-Assets/DSD/brochures/ISO17025-food-beverage-lims-ebook.pdf |format=PDF |title=How LIMS enables compliance with ISO 17025 |publisher=Thermo Scientific |date=2020 |accessdate=06 December 2023}}</ref>

In particular, the functionality of a food and beverage LIMS that better addresses the needs of ISO 22000 and ISO/IEC 17025 compliance includes robust tools for<ref name="DouglasWhatAre17025_23">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:What_are_the_key_elements_of_a_LIMS_to_better_comply_with_ISO/IEC_17025%3F |title=LIMS FAQ:What are the key elements of a LIMS for food and beverage testing? |work=LIMSwiki |author=Douglas, S.E. |date=September 2022 |accessdate=06 December 2023}}</ref><ref name="DouglasWhatAreFood22">{{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=LIMS FAQ:What are the key elements of a LIMS to better comply with ISO/IEC 17025?|work=LIMSwiki |author=Douglas, S.E. |date=January 2023 |accessdate=06 December 2023}}</ref>:

* Capturing in total a registered sample's data and metadata;
* Providing preloaded and configurable sample types and analytical test methods of the food and beverage industry;
* Validating of sampling and test methods, as well as analytical results;
* Maintaining training and certification records;
* Mapping professional requirements to existing system tasks, sample types, and methods;
* Managing documents, images, and attachments, with versioning and release controls;
* Archiving and retaining data and information;
* Maintaining a calibration and maintenance audit trail;
* Creating statistical trending and control charts;
* Generating certificates of analysis or similar verification documents;
* Developing regulatory-driven safety plans, including building HACCP steps into laboratory workflows;
* Improving reaction time to non-conformances, including automatically messaging suppliers and re-prioritizing or pausing related activities; and
* Improving audit readiness and reporting by supporting supplier audits, capturing internal audit data on-demand and directly from the facility floor, and flagging/alerting HACCP- and audit-related data.

==Conclusion==
Maintaining compliance with the regulatory-driven operational standards affecting food and beverage companies is an increasingly complex task, with large amounts of data and information needing to be captured in the process. Not only is recording this data for compliance important, but it should also be actionable for improving overall operations. In particular, compliance to standards like ISO 22000 and ISO/IEC 17025 drives the need for an informatics tool such as a laboratory information management system (LIMS), which can better empower the food and beverage company (and its laboratory) to comply with and gain insight from regulations and standards affecting their activity.

==References==
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