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KRu11

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Posted 14 June 2018 - 06:20 PM

Please advise: During a recent PrimusGFS audit for a dry onion packinghouse, a nonconformance was issued because the employees don't wear hair restraints (2.20.04.) The risk is low (no "processing" [cutting] of the onions is occurring and the mesh bags have the potential to let other contaminants into contact with the onions.) I know we're ascribing to PrimusGFS guidelines but the FDA's Produce Safety Rule doesn't require hairnets to be worn. Bottom line is that management would like to decline doing a corrective action for this. How do I approach this on the paperwork that I must submit back to our auditing body? Is it appropriate to state: "Due to the low risk of exposing the product to a biological, chemical, or physical contaminant via employee's hair, there is no hair restraint policy in place at our facility."

 

Thanks for your feedback!



Scampi

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Posted 14 June 2018 - 07:10 PM

Can you quote the actual Primus code please?


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KRu11

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Posted 14 June 2018 - 07:33 PM

"Wearing effective hair restraints is required in all operations where product is exposed, including with products that require cooking prior to consumption, i.e. potatoes and/or outer layer of commodity (rind, peel, skin, etc.) that is not consumed or used as a food item in any way (e.g., storage onions, garlic, etc.). Hair restraints are not required when there is no exposed product. 07/20/2017 v2.1-2c PrimusGFS GMP (Module 2) Guidelines AZ-R005 Page 39 of 98 Note that citrus peel is often used in drinks, used for zesting, etc., and is viewed as edible for the purpose of this audit. Baseball caps or head covering are allowed in operations only if they are clean and worn with a hair net that is clearly visible and restrains all hair. Bobby pins, hairgrips should not be worn outside hair nets. Long hair should be tied back for safety reasons, using a band of some type (not metal clips or pins). Hair restraints should a) stop hair falling onto the product and b) prevent workers from touching their hair and then the product."

 

This is the provided applicability chart on page 98:

http://www.primusgfs..._GMPModule2.pdf



Scampi

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Posted 14 June 2018 - 07:47 PM

So, if I'm reading this correctly, you ARE required to wear hairnets under this code. Which means you can do 1 of 3 things, 1. enforce hairnets, 2. try for an exemption from your CB or 3, transfer to a different GFSI.

 

While i can understand boss man's argument, the code is the code and in order to comply you need hair restraints.

 

So upon rereading your 1st post, you need to include a direct references to the FDA code. I do not agree the 3rd parties can outweigh federal laws.

 

In all likely hood they will reject your appeal because your company signed up and part of that agreement is to adhere to the code 

 

BTW I agree wholeheartedly. Wearing hairnets in your facility seems silly to me


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Rey Sierra

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Posted 14 June 2018 - 07:59 PM

karufener11

 

Hi,

 

Per the applicability chart, your operation does require hairnets. I understand at times it may be confusing when we read FDA's Produce Safety Rule, however, PrimusGFS' code will supersede FDA "if" you want to be certified by them and fully compliant.  We've ran into the same situation at our facility and have adjusted to maintain compliance with Primus.  Although, you can choose to decline to execute a corrective action it is highly recommended that you do everything in your power to fully comply; when you have the capability to do so.  I hope this helps.

 

 

Rey D. Sierra

Manager Safety, Quality & Risk, AGRO Merchants Vineland

AGRO Merchants Group



Charles.C

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Posted 14 June 2018 - 08:43 PM

Hi kru,

 

I think an analogous Primus post was submitted here a few years back. i will link it if I can find it.

 

IIRC the conclusion was similar to previous post.


Kind Regards,

 

Charles.C


mgourley

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Posted 14 June 2018 - 08:50 PM

What is the objection to wearing hairnets?

 

Marshall



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Posted 14 June 2018 - 09:24 PM

Go for an exemption.

 

Absolutely stupid to make people wear hair nets in a facility where you are packaging raw skin on onions in mesh bags - oh the places those bags will be dragged thru and exposed to all sorts of stuff on their way from your place to the market.


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cindyhaz

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Posted 29 June 2018 - 06:19 PM

Unless it's a real safety issue, every corrective action needn't be followed unless it makes sense to do so for the company and for scoring purposes. Each year we receive a down score on a couple of items because the cost of compliance is too high and illogical. Still, we consistently score in the high 90's. The answer we give on the CA is "We will discuss at the next management meeting." 



FSQA

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Posted 29 June 2018 - 07:00 PM

As you shared the code saying: " Wearing effective hair restraints is required in all operations where product is exposed, including with products that require cooking prior to consumption", requires you to follow the code in respect to adapting to PrimusGFS.

 

Going with "We will discuss at the next management meeting" is a decent approach, however, the issue here could be, if your facility decided not to adapt it (wearing hairnets), this could be a major issue with PrimusGFS in the next audits (as most of the GFSI tend to check the corrective action implementation of the non-conformities observed in the past years GFSI reports).

 

What is the objection by your management? I can assume it has nothing to do with cost, as hairnets are not that expensive. Though your risk is low, but you are passing this risk to your customer (which might be processing these onions at their end)? Look into if your company have received any customer complaints in the past for any FM or hair related issues?

 

IMO ( as shared by others in the earlier post, if the management still do not agree), Request an exemption from the CB (which can be tricky).



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nlesperance

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Posted 15 November 2018 - 02:04 PM

So, if I'm reading this correctly, you ARE required to wear hairnets under this code. Which means you can do 1 of 3 things, 1. enforce hairnets, 2. try for an exemption from your CB or 3, transfer to a different GFSI.

 

 

I think your best option is to find another GFSI auditing company that fits best with your establishment. 

 

Nic



LostMyMind

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Posted 30 April 2019 - 05:38 PM

Older thread, but we have the same issue as a Primus client who fresh packs citrus, the logic of hairnets is hard to comprehend. 

 

So, the current GMPs suggest "where appropriate" that "effective" hairnets be worn (21CFR110.10).  Here's the language:

 

"Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints."

 

One of the underlying questions is whether the FDA would consider not wearing hairnets appropriate.  My very limited experience would say that the local AG people you work with would likely agree with you, but the FDA would not (as they just don't have the experience with AG and produce).  Also, sounds like you would fall under the Produce Safety rule, which doesn't specifically state anything about requiring them; just defers you back to the cGMPs. 

 

IMO, there are a couple of ways to handle your Primus requirements:

 

All options: To get the points, you would have to: Make it policy, have stations close to doors and break areas, "make" your visitors wear them and "inspect" to make sure that they are available (check the box if you will), but from there you could 

 

1.) Only ask employees to wear them on your audit day (I know several companies that take this approach).

2.) Ask packers to wear them, but only enforce the broader rule (everyone and their second cousin wearing them) on the day of the audit.  

3.) Ask everyone to wear them, but only enforce "effective" on the audit day.

4.) Be critical and enforce it daily (it's an option).

5.) Blow it off and lose the points.  

 

My issue with the last is that usually there are some items that you will always get busted on, which lowers the effective score that you can obtain.  Losing points for things you can control can start to become costly.  And some customers might get a little testy if you aren't wearing hairnets. We've been dinged for people not having hairnets over their ears and had other auditors ignore the fact that someone was only wearing a cap or wearing it in a manner that wasn't effective, so I think that at least some of the auditors themselves roll their eyes at this rule.

 

IMO, given that your stance on hairnets is that they are stupid, just ask your employees to wear them that day.  You would have to check the box on the inspections, policy, etc., but that's not a big deal.  In my case, our hairnet and hair sanitizers logs are the same form, so that someone can verify availability of both at the same time.

 

We've chosen to have people wear them, but I only really push on the issue right before the audit and that's to help them remember what effective is.  And we elected to wear them, in part because we are close to some regional regulatory offices and so we get those folks coming through routinely.  Without that, I think we would probably regress into a once a year locale as well.  

 

Anyway, good luck...

 

Todd

 



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Timwoodbag

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Posted 13 January 2020 - 07:10 PM

Older thread, but we have the same issue as a Primus client who fresh packs citrus, the logic of hairnets is hard to comprehend. 

 

So, the current GMPs suggest "where appropriate" that "effective" hairnets be worn (21CFR110.10).  Here's the language:

 

"Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints."

 

One of the underlying questions is whether the FDA would consider not wearing hairnets appropriate.  My very limited experience would say that the local AG people you work with would likely agree with you, but the FDA would not (as they just don't have the experience with AG and produce).  Also, sounds like you would fall under the Produce Safety rule, which doesn't specifically state anything about requiring them; just defers you back to the cGMPs. 

 

IMO, there are a couple of ways to handle your Primus requirements:

 

All options: To get the points, you would have to: Make it policy, have stations close to doors and break areas, "make" your visitors wear them and "inspect" to make sure that they are available (check the box if you will), but from there you could 

 

1.) Only ask employees to wear them on your audit day (I know several companies that take this approach).

2.) Ask packers to wear them, but only enforce the broader rule (everyone and their second cousin wearing them) on the day of the audit.  

3.) Ask everyone to wear them, but only enforce "effective" on the audit day.

4.) Be critical and enforce it daily (it's an option).

5.) Blow it off and lose the points.  

 

My issue with the last is that usually there are some items that you will always get busted on, which lowers the effective score that you can obtain.  Losing points for things you can control can start to become costly.  And some customers might get a little testy if you aren't wearing hairnets. We've been dinged for people not having hairnets over their ears and had other auditors ignore the fact that someone was only wearing a cap or wearing it in a manner that wasn't effective, so I think that at least some of the auditors themselves roll their eyes at this rule.

 

IMO, given that your stance on hairnets is that they are stupid, just ask your employees to wear them that day.  You would have to check the box on the inspections, policy, etc., but that's not a big deal.  In my case, our hairnet and hair sanitizers logs are the same form, so that someone can verify availability of both at the same time.

 

We've chosen to have people wear them, but I only really push on the issue right before the audit and that's to help them remember what effective is.  And we elected to wear them, in part because we are close to some regional regulatory offices and so we get those folks coming through routinely.  Without that, I think we would probably regress into a once a year locale as well.  

 

Anyway, good luck...

 

Todd

 

Problem with this of course is employees slacking off on other things that are kind of necessary but I guess only on audit day do they care?  Like washing hands after the bathroom.  Don't lie, we have all seen people leaving public restrooms without washing their hands.  There are millions of people who do that everyday.  There are people that think it is stupid to wash hands after using the bathroom everytime, because they shower in the morning, therefore their junk isn't dirty, I am not joking.  

 

And I can't think of non-cooked onion peels being used, but plenty of uncooked citrus rinds being used, you are not worried about being the cause of contamination on the fruit?  I know transportation is a higher risk than your factory, but you should still eliminate the risk of hair contaminating the rinds.  





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