5 Ways To Mitigate Risk In A Cleanroom

5 Ways To Mitigate Risk In A Cleanroom Medium Image

Did you know we start to mitigate risk in our lives as early as 6 months old? That’s right: at 6 months old, an infant can recognize a stranger and knows - in their gut - that the unfamiliar person could pose a risk. The following cries are the baby’s form of risk mitigation.

But that is exactly how important risk mitigation is: we start practicing it and recognizing the importance of it before we even have conscious thoughts. It’s an instinct.

As we grow, risk mitigation becomes much more comprehensive and different. We practice it in almost every area of our lives: we wear a helmet on a bike, wash our hands before we eat, clean the counters when we cook, etc. We gain the ability to determine what we deem as a risk - and how to mitigate it, even if we do so subconsciously.

Then some of us grow up to work in cleanrooms and we learn the true importance of risk mitigation - and the lives that can be at stake if we don’t pay enough attention to it. Other people’s lives rely on our risk mitigation instincts and knowledge.

We’re here to support you in that endeavor. As clean air experts, we know there are two primary risks in a cleanroom: contamination and data integrity. When either of those are impacted in just about any cleanroom, major problems ensue. That is why we want to talk about a few ways to mitigate risks to your data integrity or contamination risks.

 

 

  1.Know The Right Regulations Inside And Out

Depending on your cleanroom’s application, you will need to comply with a variety of regulations. These regulations outline how to trace your data, what cleanliness requirements you need to meet, and how to conduct your cleanroom in general.

To mitigate risks to your data and product, you need to stay up to date on these regulations and their best practices. Different organizations release updates for these regulations every few years with new guidance on how to mitigate these risks.

  2.Use ALCOA To Trace Your Data

ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. It is the FDA’s recommendation for the best possible data integrity. In summary, you need to have someone or something to attribute the data to. You need to know where it came from and who is responsible for its accuracy.

The data also must be legible - you need to be able to understand it. If there are symbols, they must be explained and noted.

Next, the data must be contemporaneous, which essentially means it must be recorded when it is gathered.

On top of this, the data must be original or a certified copy. If the data is not original, it is critical you have a good and recorded reason for not having the original data.

Lastly, according to ALCOA, data needs to be an accurate reflection of what happened.

There are a number of systems to record data that aligns with ALCOA, so you have to determine what works for you. But one thing is for certain: abiding by ALCOA guidelines helps mitigate risks associated with data integrity in your cleanroom.