19 replies to this topic

[HokeyPokey]

When FDA show up at your door step to do testing.  Do you stop all production or keep on running?  

[Scampi]

Keep running......................looks weird if you abruptly stop don't you think???

 

If everything is above board, there shouldn't be any issues, plus they get a chance to see that if say something gets dropped on the floor, it isn't put back into production....those kinds of things matter a great deal

[lanetobar]

I'd think the auditor would rather see your normal production running as usual. Like some one else said, It may look strange if everyone were to abruptly stop. You shouldn't need to take special precautions for an auditor if everything is up to snuff already. If it's lunch time or something, then fine. Otherwise I'd say business as usual...just make sure your people are on their best behavior, as they already should be  

[SQFconsultant]

You keep running just as you do when a GFSI or 3rd party auditor comes in.

It would send up a red flag to the auditor if you stopped.

[Setanta]

Keep running as normal.
Answer the door.
Ask for ID.
Allow the to enter, notify your appropriate people

[Hank Major]

You should have already written an SOP to describe the process of being inspected.

[Scampi]

You should have already written an SOP to describe the process of being inspected.

 

Really? You have one of these?????  

[Hank Major]

Here is ours

Attached Files

•  Regulatory Inspection SOP.pdf   140.06KB   135 downloads

[chrcia]

You should keep running I agree with the posts above it will send up multiple red flags if the facility was not functioning as normal

Chris

[Setanta]

Really? You have one of these?????

Per a recent SQF Costco Audit, you will need to spell out that you will take samples of whatever the FDA does, too

[Hank Major]

Per a recent SQF Costco Audit, you will need to spell out that you will take samples of whatever the FDA does, too

I will adjust our SOP, thanks!

[MsMars]

Really? You have one of these?????  

 

It's required for Safe Feed, Safe Food certification.  Don't remember seeing the requirement for SQF or FSSC, but not sure about other human food GFSI certifications.

[bmart]

Attached are some documents I came across when writing up our FDA inspection SOP

 

 

Attached Files

•  Rights-and-Obligations-During-FDA-Inspections.pdf   858.14KB   71 downloads
•  PMA Regulatory Inspection Manual.pdf   2.27MB   52 downloads

[Jeffrey Ort]

Good morning,

I think some of the previous responses are correct, but dependent on product being manufactured. In the case of Food manufacturers, it is not uncommon to stop production if the FDA is requesting a swabathon. If they are testing primary contact surfaces, zone 1,  you can take swabs for comparison, but if they have a positive, yours wont matter even when negative, same as field testing of product that turns up positive for a pathogen or lack of control for a pathogen. Sanitation closes the parenthesis after testing, and swabbing same sites then can become a verification of your sanitation practices, should there be an issue identified by their testing.

We feel we are an audit ready facility, at all times, but we also have a protocol for unannounced inspections as well.

[qctran]

We had the FDA show up at our facility for an unannounced inspection. We never had one of these, and I asked what the protocol is for swabbing. They said some facilities choose swab alongside FDA, so we also sampled of whatever the FDA does. Upon consultation with an outside laboratory, they said that swabbing alongside is detrimental for us. I think it's good to have comparison notes on our end. So, should we have collected swabs too? Or no?

[zanorias]

We had the FDA show up at our facility for an unannounced inspection. We never had one of these, and I asked what the protocol is for swabbing. They said some facilities choose swab alongside FDA, so we also sampled of whatever the FDA does. Upon consultation with an outside laboratory, they said that swabbing alongside is detrimental for us. I think it's good to have comparison notes on our end. So, should we have collected swabs too? Or no?

 

I'm curious as to the lab's statement; did they say why it would be detrimental?

[Jpainter]

I have always been told to take the same swabs as FDA, but do not send them out unless a positive returns from FDA swabs. Taking samples that match the FDA shows them that your are serious about food safety. FDA will never accept your result if they swab positive and you swab negative, so I could see why some chose not to swab along with them. 

[Danielle D]

Opening this topic back up as we have had several people tell us not to swab alongside the FDA. Does it look bad if you choose not to swab? What are the pros of swabbing if they are not going to protect you even if the FDA finds something? 

[Charles.C]

Opening this topic back up as we have had several people tell us not to swab alongside the FDA. Does it look bad if you choose not to swab? What are the pros of swabbing if they are not going to protect you even if the FDA finds something? 

 

One answer is in the previous post ?

Another answer could be that you are (arguably) obtaining a free validation of yr own swab Procedure ? Especially if the 2 results are positive !

(there is also a potential downside in case of a +/- pair of results also )

 

I recall an ancient idiom - Silence is Golden.

[TimG]

It's also an AIB requirement. I wrote ours up to take the same pictures, collect the same samples, swab the same areas, copy the same documents. When it comes to samples/swabs, I have it written to keep them as retain unless the regulatory agency gets a positive. In the case of that positive, we'd then send them out to an accredited and have the exact same methods performed as the regulatory agency did to get our own analysis and perhaps save our butts in the case of a false positive or contaminated regulatory sample.

At the very least it would open up discussion as to the validity of the testing the regulatory body performed if an accredited lab had a different result, hopefully then giving us 'options'.

 

Of course if you get another positive in your own sample you know it's problem fixing time 100%.