Getting Ready for FSMA: How a Laboratory Information Management System Can Help

Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.

Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.

In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.

In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.

Employing a LIMS to meet the demanding FSMA requirements

The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

  • Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
  • A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
  • A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
  • Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
  • Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.

For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.

Case Studies: LIMS providing traceability for food worldwide

Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.

Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

This article has been adapted from a white paper presented by Thermo Fisher Scientific. Click here to access the white paper. For More Information about Thermo Scientific informatics solutions for the food and beverage industry, visit:

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