NIST Certification: How Therma Promotes FDA Compliance
How Therma helps food manufacturers avoid fines, shutdowns, and recalls with NIST certification
In 2010, the CDC released a report on foodborne illness. It concluded that 1 in 6 Americans get sick every year from microbes and chemicals in food, caused by a lack of oversight in food production, manufacturing, and transport. These findings spurred the passing of the Food Safety and Manufacturing Act (FSMA) in 2011, which mandated the use of certified electronic temperature monitoring in food manufacturing. In order to become “certified” temperature monitoring systems must be evaluated for quality. Therma simplifies this process and makes it easy to comply with federal regulations by offering NIST Certification for all its products.
Read on to find out more about food manufacturing regulatory standards and how Therma can help your facility comply with the FSMA.
Revised FDA Food Safety Standards
The FSMA gave the FDA broad authority to oversee and enforce regulations on food supply chains for the first time. One mechanism of the FDA to accomplish this goal was requiring the use of electronic temperature monitoring devices. These devices help manufacturers comply with the following requirements:
- Product Safety Assurance: The FDA mandates that food producers take a science-based approach to quality, including analyzing storage conditions for potential contamination sources.
- Increased Inspection Frequency: This rule requires the FDA to inspect facilities at least every three years.
- Preventive Controls: Every food processing facility is responsible for creating a plan to mitigate contamination. Controls include monitoring facility temperature and humidity conditions and keeping certifiable records to prove that temperature abuse didn’t occur.
Violating these standards comes with penalties that range in severity. Some of the lesser consequences include warning letters and court injunctions. Continued violations or refusal to comply with the requested actions will lead to shutdowns, fines, seizures, and even prison time.
Temperature Monitoring and FDA Compliance
The FDA requires the use of electronic temperature monitoring devices as part of its regulations. Additionally, the FDA mandates operators produce six months of temperature logs during an inspection. They require this to prove that temperature abuse has not occurred in the handling of products. Records are essential because temperature abuse is one of the five primary factors in contamination outbreaks.
Current ordinances require twice-daily inspections of cold storage areas. Remote monitoring systems, like Therma, offer a new way to comply with regulations through continuous temperature and humidity recording and temperature change alerts.
Remote Temperature Monitoring Options
When a manufacturer is selecting a remote temperature monitoring system, there are a variety of features to consider, such as software integrations, range, cost, and reliability. Types of solutions are grouped roughly into the following categories:
- Wired Solutions: Wired sensors are embedded into environments and use physical connections to transmit information via Ethernet. Wired solutions are expensive to install, difficult to change or update, and a poor fit for refrigeration equipment that requires a tightly sealed environment.
- Bluetooth and WiFi: These sensors are wireless and rely on Bluetooth and WiFi to transmit data. These devices are often cheaper but are unreliable in steel environments.
- LoRaWAN Sensors: LoRaWAN, or Long Range Radio, transmits data using 4G instead of Bluetooth and WiFi. LoRaWAN sensors, such as Therma, communicate data effectively in steel environments and do not require a good WiFi signal to function.
For more information about how the types of sensors in the market or the importance of software, check out our article on how restaurants evaluate temperature monitoring systems.
While remote temperature monitoring is more reliable than manual temperature checks, the FDA requires scientific proof of its efficacy. In the latest food code, the FDA stipulates that “food temperature measuring devices shall be calibrated per manufacturer’s specifications as necessary to ensure their accuracy.” To accomplish this, the FDA works with the National Institute of Standards and Technology (NIST) to establish criteria for food manufacturers to follow.
NIST is a government agency that regulates measurement and technology standards. They determine the efficacy of Sensors by subjecting them to a variety of tests to measure their effectiveness. Ultimately, to become certified, sensors must be proven effective within a +/- 1.8° F degree margin of error.
Therma Provides NIST Certification
To serve the food manufacturing industry, Therma provides NIST certification of our sensors on request. We utilize an independent, 3rd party vendor verified by the Department of Commerce. Additionally, Therma’s data is backed up digitally with our easy-to-use dashboard app. When inspectors ask to see your records, Therma’s app allows you to provide them instantly.