3 replies to this topic

[TAW]

So, about a month ago our facility failed our annual recertificaiton audit due to a critical non-conformance. Luckily this non-conformance was enough for our owner to get away from the warehouse where the critical non-conformance was found but now we have to have the 6 month unannounced surveillance audit.  This brings about a question from me as FSM. 

 

For those of you that have gone through a 6-month surveillance audit, will the auditor ask for paperwork from the past 6 months or the past year? 

 

We generate a lot of paperwork here and I would like to box up some of the older paperwork (mostly from 2021).  Our surveillance audit has to occur before mid August.  

 

Is it okay for me to go ahead and start boxing up the 2021 paperwork? Or keep everything from August 2021 onward?

[ChristinaK]

I've never experienced a surveillance audit, but I am familiar with storing overwhelming amounts of physical paperwork. We have very limited space in our current facility, so as soon as January hits, we are nearing critical need to box up the previous year's documentation.

 

What I've done, which has helped me tremendously, is scan paperwork onto our network folder. That way it can be found quickly on the computer during our BRC re-certification audit each February/March. If you get in the habit of scanning documents regularly (weekly, monthly, whatever works), you don't have a mad dash before the audit. It also helps save time if there's a complaint or recall. I name the scanned files in a way so I can search through them quickly: MMYYYY[DocumentNumber].

 

Hope this helps. Good luck on your surveillance audit. 

[TAW]

We are so small that there is no need to scan all the paperwork.  I do use iAuditor for some of our pre-op and GMP checks.  So that's helped.

 

Cute doggo btw.

[nicfarmer12]

I have not been through a surveillance audit but I am going to assume they will ask for any records for 2021. When you box them up, can you place them in folders so that they are easily accessible and you could find them easily?