Construction During an Audit

Hello, 

We have our audit coming up in a couple of weeks and while the audit is going on, we will be in the middle of doing a construction project for a new line that we are adding in. Does anyone have any experience in how to handle an audit during construction? Right now some of the things we have done are; putting up a temporary all that sections off a majority of where the construction is happening from the rest of the warehouse. Since we also have a lot of contractors coming in and out, we have given them red hairnets to wear as a way to identify who is a contractor. Is there something else we should be doing though? Paperwork, risk assessments, management of control, increased swabs, etc?

Your guidance is greatly appreciated!

Chris 

Hi Chris,

Make sure your GMP is not compromised, and there are no risks to product safety and quality. Contractors should also be adhering to your company's policies. I don't think increased swabs is required at this time unless you notice something. They should be signing in/out though. 

As long as you are making all the efforts to not have your products affected by this construction project, you are good! Keep good documentation always. 

Good luck! 

Oh what fun. Be certain your "approved service providers" docs are up to speed, that all chemicals, paints. Etc are checked and approved, increase inspections for potential drift and ingress egress areas.

Make sure all contractors have been trained on your GMP'S as they pertain to contractors.

Outside of that have a no stress audit.

hi ;) 

from BRC issue 9 

4.3.9