5 replies to this topic

[Miss Frankie]

We have our SQF audit the 20-21 of September.  We are still waiting for our 3rd quarter USDC audit (hasn't been scheduled yet, can't get ahold of our auditor, which is beyond weird) So we could have those 2 super close to each other, then our 4th quarter audit shortly after that.
AND we're still expecting an FDA audit this year. We also haven't seen WSDA in a while either.

 

At my former job WSDA showed up the same day as our SQF audit started.  We told the auditor what was going on and she said she would come back later. Then Covid shut everything down, and the WSDA auditor retired.  When I quit the end of 2021, they still hadn't had that audit.

 

I'm really hoping that doesn't happen again.  I don't think FDA would be quite as forgiving as WSDA. 

What are the odds of all auditors showing up on the same day?  LOL

 

[SQFconsultant]

I doubt that a situation like you detail will in fact ever happen again and I imagine that soon you will understand why auditors for the various us government agencies are not available for contact or it may be some time before they come again.

The basic reason for this is that a number of 3 and 4 letter agencies are in process of re-organization or outright elimination.

An example of this is that the IRS has been shut down, their main buildings in Latham, Maryland and San Juan Puerto Rico are now empty.

I imagine the corrupt FDA as well as the USDA and numerous other divisions that handle food, drug, etc will be consolidated, some merged and others eliminated.

That's it in a nutshell - but it is based on the roll out of NESARA.

So, I would rest easy.

[Brothbro]

For our FDA inspection earlier this year, they actually called ahead the day before to ask to come onsite. Prior to that, they actually gave notice to which month they intended to visit. We ended up cutting it close too, with three different audits in the span of two months! You may have a bit of a marathon on your hands, but I highly doubt that you'd be unlucky enough to have them show up on the same day. 

[Miss Frankie]

For our FDA inspection earlier this year, they actually called ahead the day before to ask to come onsite. Prior to that, they actually gave notice to which month they intended to visit. We ended up cutting it close too, with three different audits in the span of two months! You may have a bit of a marathon on your hands, but I highly doubt that you'd be unlucky enough to have them show up on the same day. 

I'm not worried about the USDC audit.  Other than our auditor hasn't contacted us yet, and that's highly unusual for him.  I've worked with him for several years at my former job and he's always on top of things. I'm hoping he's just having a super busy summer with kid activities (single father of 2 pre-teens)  

I'm prepared for the SQF audit, that should go smoothly.   WSDA is typically pretty laid back as well. 

The facility had some issues with FDA prior to me coming here so that will be the sticky one. My QC Manager got thrown in to deal with that after our last QC manager left abruptly.  It took him several months to get the issues resolved.  

[Kara S.]

I had back to back SQF and Preventive Controls Audits before. Since you have everything ready for 1 - you'll have everything ready for the other! It ran smoothly although it was initially stressful when the state walked in the following week to do an FDA inspection on their behalf.  

 

Just know you have plenty of resources here to help you with prep and the potential nonconformances. And with all the prep you've been doing, I'm sure those write-ups will be minimal. 

[sqflady]

I have experienced a regulatory agency showing up for an audit during our SQF audit.  This is why you have a back-up practitioner.  One of us stayed with SQF, the other went with the regulatory agency.  Shouldn't happen real often but the potential is always there.