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Food & beverage, Cold chain management, Technology
Food safety preventive controls are not just required by law, they are also a good business practice that can provide financial benefits to a facility, whether or not they fall under the specific requirements for prevention. The Food Safety Modernization Act (FSMA) holds food enterprises accountable not only for properly controlling food temperatures, but also for monitoring and reporting them.
The costs of a food safety issues are substantial. The average direct cost of a food recall amounts to a staggering $10 million. Additional costs include a reduction in sales due to reputational damage and a loss of consumer confidence, communication and other costs to repair brand image, and the costs of operational improvements and corrections to prevent another incident. In severe instances, civil and criminal sanctions may be imposed, and extend to a business’s board of directors.
There are costs of implementing preventive controls program. They must be measured against the regulatory, operational, and reputational risks that a single food safety incident can bring upon a food brand.
The cold chain—a segment of the food supply chain that includes perishable products requiring strict temperature control—meats and poultry, fruits and vegetables, and proteins—poses a number of unique challenges. Temperature greatly impacts food quality and safety. A single break in the cold chain can lead to food quality and safety issues, and without proper controls in place, these risks may remain unknown by the time food products reach the end consumers.
Prevention is about assessing the relevant risks and then proactively managing those risks. Today’s technology is providing food enterprises with farm-to-fork visibility over the entire supply chain as food products move from manufacture to storage, distribution, and last-mile delivery. Data analytics empower food brands to quickly identify and mitigate risk within the supply chain and drive continuous improvement.
FSMA’s preventive controls rule transforms the FDA’s approach to food safety, shifting from a system that responds reactively to outbreaks to one that proactively prevents them.
Preventive controls are risk-based practices that facilities use to address hazards that their products might be exposed to. Once preventive controls are in place, facilities should continue to monitor them and take corrective actions as needed.
Under the FDA guidelines and FSMA regulations, all covered facilities—those that manufacture, process, pack or hold food— need to develop a plan; identify the hazards, identify and implement preventive controls, and then monitor and ensure that the controls are working.
Each plan is intended to be tailored to fit the facility and the risks associated with the food manufactured, processed, or stored there. Current Good Manufacturing Practices (CGMP’s) are not replaced by FSMA’s final rule; rather, they are intended to form the foundation for preventive controls. Regulatory audits and audit reports must be submitted to the FDA.
One of the central provisions of FSMA is HARPC (Hazard Analysis and Risk-Based Preventive Controls). HARPC requires almost every food facility in the U.S. (and, in some cases, abroad) to:
Temperature management is an important method of controlling pathogen growth in food products.
Another critical aspect of FSMA is monitoring and recordkeeping. Temperatures must be monitored and recorded not only in food processing facilities but throughout the transportation and distribution process. FSMA’s Sanitary Transportation of Human and Animal Food rule requires enterprises to monitor temperatures during transportation and communicate temperature data to stakeholders within the supply chain, as well as maintain comprehensive records.
Thanks to today’s technology, it’s no longer necessary to record temperatures manually on clipboards or even to use a decades-old chart recorder. With modern, digital data-logging solutions that provide time, location, and date stamps, temperature data points—along with all other process parameters—can be logged and stored, meeting 21 CFR Part 11 requirements for electronic recordkeeping, which satisfies FDA, USDA, and other regulatory agencies.
More than just meeting FDA or USDA HARPC/HACCP requirements, today’s technology helps senior management get a handle on temperature status—faster than ever before.
Stakeholders can know immediately whether a product has been too hot or too cold in shipment. Alerts are sent immediately to designated recipients if temperatures start to deviate too far so that corrective action can be taken.
Wireless temperature monitoring technology not only applies to manufacturing facilities and distribution centers. It can connect the transportation and distribution segments of the supply chain.
FSMA’s rules requiring preventive controls mean that this area needs to be updated as well, especially given that the global supply chain is expected to grow as demand continues.
While remote telematics are playing a role in transportation—fleets can remotely monitor and control temperature settings—ambient data readings often only tell part of the story. Measuring product conditions on the pallet level can draw a different picture. A pallet may tip over, blocking airflow to a part of the reefer and impacting some, though not all, of the products in transport. Ambient temperature tracking may not catch the issue, leaving the products vulnerable to waste by the time they reach their destination.
Disorganized and incomplete records can lead to noncompliance. A lack of continuous visibility over the environmental conditions in which perishable and temperature-controlled foods are stored and transported poses unnecessary risks that can lead to a food safety incident. Temperature wheels with paper charts are woefully obsolete, yet still used throughout the industry.
Therefore, adopting the right technology is critical for achieving unmitigated food supply chain transparency and preventing a food safety incident from occurring. Reusable, wireless technology is increasingly affordable and can provide total visibility over the supply chain, and not simply for a single shipment.
Controlant’s technology and solutions make it easier to meet FSMA and regulatory compliance while maintaining food integrity and preparedness in the event of an audit or a food product incident. Our wireless and reusable Internet of Things (IoT) data loggers continuously monitor environmental conditions and product location in real-time while goods are in transit or in storage, and automatically transmit data to a secure cloud-enabled software platform. The Controlant dashboard gives you full transparency into your supply chain, and records your partners’ efforts. Data can be shared with suppliers, distribution centers, and other partners to mitigate risk and drive continuous improvement.
Active and historical data is collected in Controlant’s cloud software platform, which can be viewed on-demand. Custom business intelligence dashboards provide critical insights into risks and improvement areas needed. The system gives businesses the data they need to submit reports to regulatory agencies like the FDA and the USDA.
Our optional 24/7 monitoring and response services (MARS) provide around-the-clock protection of your temperature-controlled facilities. If a temperature starts to deviate, our team will reach out to designated stakeholders to facilitate corrective action and prevent product degradation and waste. Our solution is cost-effective and easy to scale across your facilities and in-transit shipments, giving you complete control and ownership over your data.
Supply chain technology is serving a critical role in devising an effective food safety strategy. Level up your preventive controls with critical insights and build a smarter cold chain.