FSMA Fridays: Environmental Controls (Part Three Of Three)

View the entire webcast or read part one and part two of this series

In part two of FSMA Fridays: Environmental Controls, SafetyChain’s Jill Bender and The Acheson Group’s Dr. Peyman Fatemi and Gurjit Shergill discussed environmental controls under FSMA. Here, in the third, and final portion of the series, the trio continues their conversation.

Jill: I think the concept of the systematic issues, the things that have been recurring over and over, are always challenging in making sure that you've identified that trend and taking action, right?

Peyman: Yes.

Jill: Interesting. I don't know if you've scared folks, but certainly it made me pause as far as what you were discussing.

Peyman: When we have this discussion, there is a caveat there. If the FDA wants to see the facilities diligently take action, not just show it three years of negative results. The facilities are not sterile environments. It's okay to find it. It's what you do about it that is the key here. It is how they manage their results and can show the actions they've taken all the way to redesigning the facilities, the traffic patterns, the sanitary design, and the conditions of the facility to show that you have taken steps and diligently going about solving the problem. Not doing anything about it is what is getting facilities into trouble.

Jill: That seems to make sense. When you think about that, too, and just in general the environmental controls and brings us to our next topic, could you just at a very high level go through the key principles of the environmental controls.