In the past we've provided articles on what to do when a temperature "disaster strikes." We've also talked about the benefits of a robust temperature and humidity alarming system for products that are perishable: specifically those products that lose potency and become unsafe once exposed to extreme temperatures.
This article is a little different.
We’d like to help you out before disaster strikes. When you are installing a temperature, humidity, or another environmental monitoring system, you need to develop SOP’s for when an emergency occurs. Below, we've outlined some basic tenets you should take into consideration when developing your Emergency Plan for when things get too hot or too cold in your facility.
1. Alarm Thresholds
When developing your SOP’s and Emergency Plans, take into consideration when you want to be notified that your product is in trouble. If you’re monitoring a product that needs to be stored between 35-46F, setting a temperature alarm for 47F is short-sighted. It’s already too late at that point,your temperature is already too high, and your product may already be ruined. Instead, set thresholds. Most wireless monitoring systems and data loggers allow you to set multiple alarms, which enables you to take corrective actions before your product begins to perish. For example: when your temperature hits 43F, one set of actions is taken, and when it hits 45F, another set of actions is taken.
2. Notifications
Who gets notified, and how they get notified when temperatures reach a certain threshold is the first step in your Emergency Plan for when temperatures escalate or dive to unsafe levels. When they rise slightly, an email to a QA manager may suffice. But when temperatures begin drawing closer to danger zones, a phone call to someone in the facility may be required.
3. Confirmations
This is a key process in a temperature alarm response that most people forget. Someone in the facility should confirm that the data logger or wireless monitoring system is reading the correct temperature, and the subsequent alarms are functioning correctly. We suggest confirming via a secondary or backup thermometer that temperatures are indeed too high or too low in your environment.
4. Product Retrieval/Adjustment
Once the temperature of your environment has been confirmed, you will need to decide what corrective action to take. Sometimes that action is manually moving product from one location to another, and other times, it’s just plugging your refrigerator back in. Whatever that action is, be sure to document it. Documenting every step of your Emergency Plan is essential, as the people auditing your application will ask for documentation of the event, and want it to be thorough.
5. Data Analysis and Contact
While not that fun, analyzing what went wrong in your facility is crucial to the response process. Downloading the data from your data loggers and analyzing it will help determine if your products were compromised or not. Also, that data can inform and suggest any changes that need to be made to your SOP’s moving forward.
Now the hardest part: contacting your auditor or regulatory body to alert them to the problem. If you are regulated by a government organization or accreditation body, you will need to alert them to the problem that occurred in your facility, including the Plan of Action that you took, products compromised, and all associated data.
We hope this helps you when you develop new SOP’s for your facility, or are revisiting old ones. Temperature alarms can cause a bit of panic. If your response is organized you’ll handle them much better.
