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LIMS in Food Safety Traceability Efforts
System to gather, manage data helps ensure quality
by Colin Thurston
Globalization of the food supply chain is a driving factor behind the increasing number of food safety incidents. Producers and importers must perform precise, real-time product safety testing at all stages of production, processing, and distribution to ensure quality and compliance with food safety legislation. Each step in the food chain has its own challenges. Laboratory information management systems (LIMS) play a critical role in the workflow of food producers, ensuring that test data from all parts of the delivery chain are captured and analyzed to guarantee consumer safety.
The U.S. Food and Drug Administration and the European Food Law guide major food producers importing and exporting from the United States and Europe. Batch traceability is key for monitoring product quality and effectively managing recalls with limited product loss.
Traceability in European Food Law (EC#178/2002) is defined as the ability to trace and follow a food, feed, food-producing animal, or substance intended to be or expected to be incorporated into a food or feed, through all stages of production, processing, and distribution. Ideally, any substandard components should be detected during the crop growing, raw materials collection, or processing stages, preventing unfit products from reaching the public. In cases when substandard products have been released, traceability of affected product batches can lead to a more effective recall and prevention program, thereby limiting the manufacturer’s exposure to costs and possible litigation.
LIMS in the Food Industry
Sophisticated LIMS solutions are designed to efficiently manage batch relationships among raw materials, processed materials, and packaged goods, enabling analysts to identify the batches affected by contamination and automatically suspend release of a product during investigation. LIMS are designed to manage and control the quality assurance process, organizing and storing analytical data and facilitating the conversion of data to information. This process is fully automated, ensuring that the majority of sample results will be within acceptable limits, filtering and highlighting failures to initiate follow-up investigation. The LIMS workflow schedules analytical work-up for samples with positive results, addressing the need for rapid screening techniques to identify potential contaminants.
Food analysis techniques produce large quantities of different types of data. LIMS automatically gather, store, manage, and report on these data, including sample preparation data, instrument-generated data, standards, reagents and media, reference data for users, and management and metrics reports.
Food samples used for safety testing are often time and condition sensitive, requiring fast turnaround or storage in suitable conditions. LIMS can identify each sample; uniquely generate labels, bar codes, and hazard data; store metadata; and sample life cycle transactions. Freeze/ thaw cycles and preparation steps are logged, sample inventory maintained, and work for laboratory staff prioritized. Overall, the use of LIMS in the food safety workflow ensures that samples are handled correctly and processed within allowed time frames.
Food producers and importers face strict penalties for noncompliance with food safety legislation. At the same time, food recalls are expensive both financially and in terms of damage to brand or company reputation. The ability to trace the components used at any point in the food manufacturing and supply chain is a function that is critical to ensure product quality and regulatory compliance.
Batch traceability can be easily and effectively achieved using a LIMS solution. A LIMS can control the sample chain of custody, automate data collection from instruments and analyzers, manage data by exception, and facilitate certification. A LIMS will collect results directly from instruments and determine whether they are within acceptable limits, making the system ideal for managing data for food producers and importers.
Implementing LIMS for Yogurt Producer
One of the world’s leading dairy product manufacturers needed a LIMS capable of ensuring optimum quality control in its yogurt products. Making the transition from a paper-based manual system to one that automates almost every quality control (QC) sample check and reporting process is a major undertaking for any company. With U.K. production at over 1.8 billion containers of yogurt per year, the time was ripe for change at Müller. They chose Thermo Fisher Scientific to provide a solution.
Molkerei Alois Müller (U.K.) is a market leader in European dairy products. The Müller U.K. site specializes in yogurt products, from low-fat yogurt to yogurt and cereal combinations. Müller U.K. sales have increased annually since the company entered the U.K. market because of its focus on quality and innovation. In fact, the state-of-the-art production facility at Market Drayton that opened in 1992 has expanded significantly several times to add more manufacturing, warehouse, and distribution capability. Today, Müller’s Market Drayton factory produces more than a third of all yogurt eaten in the U.K.
The Müller U.K. labs are mainly focused on production QC, but they also test product from the start of the process. Milk from farms arrives by tanker and is passed by pumps into silos, then separated into skim milk and cream, with some skim into concentrate. Yogurt mixes are made in tanks and batch sterilized. If the batch meets specifications, it is processed through a heat exchanger, cooled, and placed in an incubation tank where culture is added. Every step in the process undergoes quality checks. During incubation, the pH is monitored and checked every two hours. After eight to nine hours of incubation, the pH has dropped, and a final pH check is made when the yogurt is cooled. Given the manual testing and recording being used, there were many places a LIMS could automate and expedite QC tasks.
Batch traceability can be easily and effectively achieved using a LIMS solution. A LIMS can control the sample chain of custody, automate data collection from instruments and analyzers, manage data by exception, and facilitate certification.
The decision to implement a LIMS was driven by the increase in production demand and justified by the need to increase the lab’s efficiency. Müller U.K.’s paper-based system for tracking and reporting QC data was supplemented by Microsoft Excel spreadsheets. A LIMS would dramatically reduce the amount of error-prone paperwork while expediting testing. The LIMS was also expected to assist real-time monitoring of Müller’s production processes and play a pivotal role in ensuring quality control for finished product. By using a LIMS, Müller would be able to trend all data and make decisions and necessary improvements much faster.
Müller U.K. selected the LIMS to manage QC data for raw materials, in process, and finished dairy desserts. Integrating the LIMS with as many pieces of lab equipment as possible allows for automated data transfer and additional efficiencies. The milk reception processes managed by the LIMS were developed to include bar-coding samples from the tankers upon receipt, checking the milk for antibiotics, and checking the milk composition for fats, protein, lactose, and solids. Any out-of-specification parameters can be reported automatically. For example, if a tank fails antibiotics, it is rejected outright. The LIMS flags the result as being out of specification and automatically creates a report.
The milk reception processes managed by the LIMS were developed to include bar-coding samples from the tankers upon receipt, checking the milk for antibiotics, and checking the milk composition for fats, protein, lactose, and solids.
Involving the IT Team
Müller U.K.’s Information Technology (IT) team worked closely with the lab team to select and implement the LIMS. A dedicated IT person ensures the integrity of the solution. IT reviewed distribution of all the QC information; people were asked for their requirements, and they were provided with the appropriate reports. With the LIMS, IT determined the access privileges to the data, which included sample reports, daily averages, and moving averages. These are all read-only reports, and certain reports, such as sales, are restricted to a for-your-eyes-only status that can only be accessed by levels with the authority to do so. The reports are more accurate and stay consistent within the system. Interfaces to various instruments and lots now ensure that there are no input or copying errors.
An enterprise-wide standardization on LIMS can provide immediate benefits to productivity, information sharing, accelerated sample processing, and electronic reporting. Implementing a LIMS has helped Müller U.K.’s lab meet production demands with equanimity and has positioned it to meet future challenges. The LIMS has the potential for integration with other business systems. With a LIMS in place, the lab is confident that it can meet any future challenges.
Food companies need to conduct accurate, continuous testing and have data readily available to comply with regulations. Offering the flexibility to accommodate various workflows, laboratory types, and user communities across the organization, enterprise-wide LIMS solutions can help food companies achieve fast and reliable results. ■