Environmental monitoring is a strategic practice involving observing, collecting, and recording environmental data, such as humidity, pressure, and temperature. Precise monitoring of environmental factors is vital for organizations that deal with highly regulated, sensitive, or fragile products, ranging from pharmaceuticals and medical devices to perishables and processed food.
Organizations generally use environmental monitoring systems to ensure consistency in temperature, humidity, and other environmental conditions, as even slight lapses can have far-reaching and costly consequences. At the same time, accurate environmental monitoring helps organizations comply with regulatory requirements and pass audits. Ultimately, these efforts are meant to protect valuable assets and ensure safety for consumers, employees, and products.
In this post, we’re going to share some leading-edge environmental monitoring best practices and tips for a variety of industries where safety and security are obligatory.
Examples of Industries Where Environmental Monitoring is Essential
Food and Beverage
Environmental monitoring is of paramount importance for industries involved in all areas of the food supply chain, especially because they must adhere to a raft of food safety and quality control regulations. Critical environmental factors like temperature, humidity, and CO2 levels must be monitored throughout the food production and distribution process to avoid costly spoilage, protect employee safety, and keep foodborne illness at bay.
Current Good Manufacturing Practices (CGMPs) are the core FDA regulations geared towards ensuring the safety and quality of human food. The FDA, through FDA CFR Title 21 Chapter I, makes it an obligation for food manufacturers and handlers to:
● Put in place temperature controls
● Monitor those temperature controls frequently
● Verify that those temperature controls are consistently well-implemented
And it’s easy to see why industries that produce or distribute food must establish and implement stringent temperature controls. Even small excursions in temperatures can result in wastage and put consumer safety at risk. Worst case scenario, this can result in a severe or fatal outbreak of foodborne illness.
For example, in 2009, the Peanut Corporation of America (PCA) saw one of the most significant and most deadly salmonella outbreaks in recent US history. It resulted in the deaths of 9 people, with at least 714 others being taken ill. PCA had to file for Chapter 7 bankruptcy a few weeks later because of the incident.
Two years later, global food conglomerate Cargill experienced a similar outbreak, causing 136 illnesses, one fatality, and the recall of 36 million pounds of their ground turkey products.
Biopharmaceutical, Healthcare, and Medical Device
Medical devices, healthcare, and biopharmaceutical represent other demanding industries where environmental monitoring is mandatory. The FDA has put a series of stringent regulations and best practices in place to ensure healthcare practices, vaccines, medical equipment, and medications are effective and safe. After all, quality environmental controls in these industries can directly impact consumer health and safety.
So, whether you’re producing vaccines to help fight Covid-19, caring for the elderly in an assisted living facility, or manufacturing high blood pressure medication, monitoring vital environmental controls is a critical step towards meeting FDA regulations.
Beyond regulatory compliance, monitoring systems can also serve as alarms that warn healthcare, medical devices, and pharmaceutical organizations when temperatures, CO2 levels, and other critical environmental conditions go out of range. This monitoring enables personnel to take timely action to ensure patient outcomes and protect product potency.
Manufacturing
Temperature, pressure, and humidity controls must also be established and implemented in manufacturing, typically to ensure consistency in these conditions. Environmental monitoring can help enhance operational efficiency, improve product quality, and ensure employee safety at all manufacturing points, from prototyping to final assembly and beyond.
Of course, these are just a few examples of industries where environmental monitoring is mandated by the law and regulatory bodies for safety and quality purposes. Education, cold chain logistics, aerospace, agriculture, and transportation are other industries that rely on adequate environmental monitoring controls to keep tabs on critical conditions, comply with regulations, and protect their sensitive assets.
Tips for Executing an Effective Environmental Monitoring System
Here are top best practices for creating and implementing actionable and strategic environmental monitoring controls:
Ensure internal alignment
Your organization must define and set clear-cut goals regarding your specific environmental monitoring needs right from the get-go. What do you want to achieve by setting up an environmental monitoring system?
Some examples may include:
● Increase operational efficiency
● Reduce preventable product wastage
● Meet regulatory requirements (and pass compliance audits)
● Improve quality controls
When you identify and document these organizational goals, it becomes easier to ensure everyone involved in the environmental control and monitoring is on the same page. According to Dickson, you must designate a project lead — someone who will be in charge of putting together the team that will design, implement, and manage your organization’s quality assurance and environmental monitoring systems.
More than that, you must hold regular team meetings, both to assess progress towards meeting organization goals and to make the necessary decisions in the future. On top of that, you must set aside an entire budget to successfully implement an effective environmental monitoring system. By prioritizing environmental monitoring financially, your organization can optimize organizational efficiency and minimize risk in the short term and over the long haul.
Leverage the correct monitoring tools
The quality and accuracy of environmental monitoring tools you use can be the difference between business as usual and a failed regulatory audit. That’s why we recommend using best-in-class data loggers, sensors, and software systems to build a robust and holistic environmental monitoring system.
Data loggers are specially designed to measure, record, and document changes in environmental factors (including voltage, CO2 levels, temperature, etc.) over a specific period of time. Of course, not all data loggers are created the same.
Here are key factors to keep in mind when choosing suitable data loggers.
● Certifications – Depending on where you are located and which industry you are in, the data loggers you use must be ratified and accredited by various bodies. Be sure to keep an eye out for NIST, ISO, Accredia, and other trusted accreditations.
● Size – Space is often a significant implication in most real-world environmental monitoring applications. For this reason, it’s best to settle for the most compact data loggers available in the configurations that meet your monitoring needs.
● The number of inputs – The best data loggers are designed to input environmental information from multiple sensors. You’ll find devices in both multi-channel and single-channel designs. The right choice will depend on your specific needs.
● Input signals – You’ll find data loggers that accept a single input, while others are programmable for a variety of inputs, ranging from pH and temperature to CO2 and even microbial contamination levels.
● Continuous monitoring capability – With the advancement in data logging and Internet of Things (IoT) technology, it would be best to incorporate wireless data loggers into your monitoring program. This allows for around-the-clock remote access and analysis of environmental data. A cloud-based monitoring solution will also help streamline the data collection and documentation process.
● Customizable – versatile data loggers are usually configurable, able to send personalized alerts to relevant departments. As a result, excursions and other problems can be caught before they cause damage.
Conclusion
Environmental monitoring can make a huge difference in facilities, storage, and transportation, when safety and product quality might be affected by environmental factors. These best practices will help you design and put in place the proper monitoring system.
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