FSMA and Labs

FSMA’s effect on food production facilities and testing laboratories bears considerable analysis. The key technologies that can facilitate compliance with the new legislation, along with the subsequent need for the development of new analytical methods, are, in a sense, under the microscope.

A primary goal of the FSMA is to provide the FDA with more power and control over safety procedures implemented in food production facilities. The increased frequency of inspection of food production facilities by the FDA is probably the most pronounced and remarkable mandate of the FSMA. Until recently, the FDA had been severely understaffed; however, in order to enable enforcement of the new regulation, a significant part of the funding appropriated to the act will be invested in staffing inspections.

To enforce safety procedures, the legislation also empowers the FDA with expanded record access, meaning that the agency is now legally entitled to review the safety records of food production facilities. These records may contain important data regarding facility cleanliness, hazard control procedures, and food safety testing. In general, FDA inspectors can request access to any records that they deem necessary, especially in cases when the food supply is considered to be at risk.

Under FSMA, the FDA’s import certification authority has increased considerably. As a result, imported food products must carry safety certification, which should be issued by authorized and certified bodies recognized by the U.S. government. Certification can be issued by a foreign government itself or by a third party such as an auditing and/or certification body.

An additional, important part of the new legislation is that the FDA now has the authority for mandatory product recalls. In the past, the agency was only able to recommend that a food producer recall a particular product.

The Need for LIMS

The unrestricted access to records granted to the FDA under FSMA is effective immediately, with all food producers legally obliged to register for mandatory inspections. Registration will identify every person involved in the production process so that a food tracing system can be established.

As a result, food producers must work quickly to ensure that they have in place automated systems for monitoring their processes and methodologies in order to verify batch content or origin of raw materials. Manual collection of paper-based data is increasingly recognized as a time-consuming, error-prone, and costly method of monitoring operations and processes in a food production facility.

State-of-the-art laboratory information management systems (LIMS) enable efficient data tracking and management, making it easy to map and monitor safety procedures implemented in food production facilities. A LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording all 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.

A common thread throughout the FSMA is traceability. LIMS play a critical role in the traceability of quality in the production process. These systems can store and monitor any type of food safety data, from information about seed quality at the time that a crop is planted to results of contaminant analysis performed on raw material and records of certificates of analysis. Cleaning schedules and their outcomes can be also archived in a LIMS, enabling food production facilities to easily prove that they are free from contamination when validation takes place. In addition, many food production companies perform shelf-life tests on their products and store the resulting data on a LIMS. Overall, competent LIMS solutions enable food production facilities to comprehensively and efficiently record and store all data, ensuring compliance with FSMA regulations.

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