9 replies to this topic

[Weebus90]

HI Everyone, 

I have a health department inspector requiring hand sanitizer in my manufacturing plant. 
We produce bakery type products that are Ready to eat. 

 

I know GFSI codes require this in the RTE high risk areas but as far as the food code, i am unable to find this requirement. 

 

Is anyone able to assist or point me to the code?

 

Thanks!

Weebus

[pHruit]

Someone on your side of the pond may be able to give another reference that is clearer, but it's certainly mentioned in 21CFR 110.10(b) and 110.37(e), albeit in a "where appropriate" capacity. I'd have thought that the "and sanitizing if necessary to protect against contamination with undesirable microorganisms" part in 110.10(b) would apply for RTE, but again I'm not in the US so not intricately familiar with the interpretation of these requirement. Nonetheless I hope it helps as a start!

[kfromNE]

We recently had a health inspector from the FDA tell us the same thing and almost wrote it up as a 483 - we fought her on it. She let it go. She cited 117.10 (b) (3) - Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work......

 

It's a corporate policy for us not to have hand sanitizers. We did a risk analysis to why we don't use them (employees would skip washing their hands and only use the hand sanitizer even though they were educated multiple times not to do that)

 

We'll have to see what happens at the next inspection.

[The Food Scientist]

It would probably fall under "FDA 8 KEY SANITATION AREAS".

 

CFR-21 

 

https://www.accessda...h.cfm?fr=123.11

 

You would need to develop a form where you need to check sanitizing and washing areas are adequate. I had a health inspector ask for that form and referenced this part to me. 

[QAGB]

It would probably fall under "FDA 8 KEY SANITATION AREAS".

 

CFR-21 

 

https://www.accessda...h.cfm?fr=123.11

 

You would need to develop a form where you need to check sanitizing and washing areas are adequate. I had a health inspector ask for that form and referenced this part to me. 

 

 

Hey Food Scientist,

 

Not trying to nit-pick, but this might be the better link for general sanitation (below). The link you provided is more for fisheries and so forth. As to the sanitizer, I would certainly have to argue the "where necessary" point. We provided hand sanitizers, but didn't consider them to be necessary. Never had an auditor or inspector from the FDA bring it up.

 

To the OP - If you have a risk assessment created to show why sanitizers are not needed, I don't see why that wouldn't satisfy the "where necessary" statement in the FDA regs.

 

https://www.ecfr.gov...10_137&rgn=div8

Edited by QAGB, 11 December 2019 - 07:20 PM.

[The Food Scientist]

Hey Food Scientist,

 

Not trying to nit-pick, but this might be the better link for general sanitation (below). The link you provided is more for fisheries and so forth. As to the sanitizer, I would certainly have to argue the "where necessary" point. We provided hand sanitizers, but didn't consider them to be necessary. Never had an auditor or inspector from the FDA bring it up.

 

To the OP - If you have a risk assessment created to show why sanitizers are not needed, I don't see why that wouldn't satisfy the "where necessary" statement in the FDA regs.

 

https://www.ecfr.gov...10_137&rgn=div8

 

Oops! Thank you! 

 

The thing is every inspector is different which is why we should always ask them why they said this and that and ask them where in the code it shows that? 

 

I worked in a RTE snack manufacturer and we had no hand sanitizers and never was an issue. Now I work in a RTE spice/snack/seasoning and we have them but never had a form to monitor them and the inspector asked for that! Strange.

Edited by The Food Scientist, 11 December 2019 - 07:34 PM.

[QAGB]

Oops! Thank you! 

 

The thing is every inspector is different which is why we should always ask them why they said this and that and ask them where in the code it shows that? 

 

I worked in a RTE snack manufacturer and we had no hand sanitizers and never was an issue. Now I work in a RTE spice/snack/seasoning and we have them but never had a form to monitor them and the inspector asked for that! Strange.

 

 

Yep! I became very adept at asking auditors/inspectors where a standard or code stated what they were questioning. I grew tired of auditors/inspectors trying to throw their own interpretations & suggestions in where they didn't belong. I also learned that risk assessments were my best friends.

[Weebus90]

Thank you everyone for your quick responses, they were all very helpful!

[SQFconsultant]

I was doing an SQF Audit one day at a coffee company and they had a small restaurant, more like a silver New Jersey diner out front and the BOH showed up to do an inspection.

 

The funny thing was the company wanted the restaurant included in the scope.

 

So, there I was inspecting the diner and in walks the BOH - we chatted, he did his inspection first and I sat down and had a cup of coffee while he was doing that.

 

He looks at me and says, under SQF is this a violation?... pointing to the hand-washing sink not having soap, but only having sanitizer and I said, yes --- he said, no it's not in my book, I told them to get sanitizer and pull the soap!

 

to which I had to open my mouth up and say, can you show me the code on that?

 

He could not answer, gave them an A rating and left.

 

Strange world!

[FurFarmandFork]

Weebus90, what state/county are you being inspected in? That way we can look at or point you in the direction of the code they're auditing against.

Edited by FurFarmandFork, 12 December 2019 - 04:58 PM.