20 replies to this topic

[YNA QA]

So I need some thoughts on this:

 

Backstory, I've been at my current position for a short time now, we are a dry manufacture dealing with: Wheat, Egg, Soy and Milk allergens 

 

We have a validated cleaning step, that we use post allergen runs, that involves cleaning our equipment with an abrasive and doing a through dry wipe down of equipment between allergen and non allergen products.  

 

Our methods have been validated previously with ELISA testing, so obviously we continue doing them.

 

When I inquired about the verification step, I was told it was solely visual.  So I've suggested, and we have plans to implement Pro-Clean verification swabs for the general protein.  We don't have to use this step often because most of the products contain a good mix of the allergens, so this occurs pretty rarely, and most of the time a full sanitation between items is performed.  

 

I'm not getting push back from owners, they love it, but scheduling and operations aren't as on board.  They seem to think that because it's worked in the past (visual verification), that adding this step is useless and is causing more headache.  I am saying that I'm shocked an auditor would say a visual is okay.  Past auditors were fine with this cleaning step being visually verified.  

Does anyone have any thoughts on the matter that they could share with me to help me get operations more on board with the swabs.  They are so quick, and I think really add some depth to our program, because I don't think you can be too cautious with allergens.

 

Just hoping for some guidance.

 

Thanks group!

[Hank Major]

Validate that the cleaning works if done correctly by swabbing and send out to a third party lab. Then Validate that employees know what 'Visually Clean' looks like by showing them slightly unclean surfaces. Then Verify by having employees initial a cleaning checklist and different employees initial that they found the area to be Visually Clean.

[CheeseGuy]

I'm not an auditor, but in my experience a visual is just too subjective.  And I would feel pretty weary trying to explain our actions to an auditor.  I would say you don't have to do specific allergen testing, but testing for a general protein as you've suggested would be a great route.  Verifies an effective sanitation and no protein allergens remain for cross contact.  

[Charles.C]

So I need some thoughts on this:

 

Backstory, I've been at my current position for a short time now, we are a dry manufacture dealing with: Wheat, Egg, Soy and Milk allergens 

 

We have a validated cleaning step, that we use post allergen runs, that involves cleaning our equipment with an abrasive and doing a through dry wipe down of equipment between allergen and non allergen products.  

 

Our methods have been validated previously with ELISA testing, so obviously we continue doing them.

 

When I inquired about the verification step, I was told it was solely visual.  So I've suggested, and we have plans to implement Pro-Clean verification swabs for the general protein.  We don't have to use this step often because most of the products contain a good mix of the allergens, so this occurs pretty rarely, and most of the time a full sanitation between items is performed.  

 

I'm not getting push back from owners, they love it, but scheduling and operations aren't as on board.  They seem to think that because it's worked in the past (visual verification), that adding this step is useless and is causing more headache.  I am saying that I'm shocked an auditor would say a visual is okay.  Past auditors were fine with this cleaning step being visually verified.  

Does anyone have any thoughts on the matter that they could share with me to help me get operations more on board with the swabs.  They are so quick, and I think really add some depth to our program, because I don't think you can be too cautious with allergens.

 

Just hoping for some guidance.

 

Thanks group!

 

Hi Ashley,

 

This extract from SQF8 Guidance maybe answers yr query.

There are caveats with respect to alternatives to direct allergen testing verification

 

Cleaning Validation and Verification  
One of the areas of possible confusion is the requirements for allergen cleaning validation and verification.

 

Validation

............................

...........................

 

 

Verification

.......................

........................

 

Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must
verify that the validated procedures were used each time.  This verification must be documented by a responsible
person from the site who has been trained in the validated cleaning method.  The most common method used is
direct  observation  of  the  validated  cleaning  procedure  during  the  sanitation  process.    Another  acceptable
verification method is the use of highly sensitive swabs that test for proteins.  These recently developed swabs will
detect  total  protein  at  approximately  20  ppm.    Since  these  devices  only  test  for  total  protein  and  not  specific
allergens,  they  are  not  acceptable  for  [allergen] validation  but  will  serve  to  verify  that  equipment  has  been  thoroughly
cleaned.    There  are  also  sensitive  ATP  test  swabs  available  however  the  presence  of  ATP  does  not  indicate  the
presence  of  protein  which  is  the  allergenic  material.    The  use  of  these  total  protein  swabs  or  the  ATP  sensitive
swabs  must  be  calibrated  with  the  validated  cleaning  procedure  by  using  them  immediately  after  the  validated
method is used and recording the results of both the allergen specific test and the protein or ATP swab test.   It is
also  to  ensure  surface  swabbing  is  occurring  at  corners,  joins,  and  crevices  in  the  equipment  as  well  as  open
surfaces, to check for protein held up in equipment.

 

[Scampi]

Visual only works for clean vs unclean...............this cannot be used for an allergen clean. YOu must (as charles posted) use a VALIDATED process to ensure the protein is removed, then VERIFY the clean by using swabbing to check for protein residue

 

 

Unless of course ops wants a recall because consumers have had a reaction because the equipment was visually clean!

[AC2018]

This is interesting because we just went through our SQF audit with a new auditor and he said that our generic allergen swabs that we perform after each full clean wasn't enough. We will now use a specific allergen test annually to validate our daily sanitation verification procedures and swabs. This may be something you would want to do in addition to the generic swabs you are thinking of doing. Or swab and send to a lab for validation like someone else posted about doing. 

[Charles.C]

This is interesting because we just went through our SQF audit with a new auditor and he said that our generic allergen swabs that we perform after each full clean wasn't enough. We will now use a specific allergen test annually to validate our daily sanitation verification procedures and swabs. This may be something you would want to do in addition to the generic swabs you are thinking of doing. Or swab and send to a lab for validation like someone else posted about doing. 

 

Hi Allison,

 

Thks comment. It's a little unclear (to me).

 

Perhaps you could elaborate the meanings of "generic" and "specific" ?  (eg "generic" = protein method ??)

 

"annually" seems misaligned to SQF Guidance quote (Post4).  However with SQF (et al), auditor variations are always possible.

[AC2018]

Hi Allison,

 

Thks comment. It's a little unclear (to me).

 

Perhaps you could elaborate the meanings of "generic" and "specific" ?  (eg "generic" = protein method ??)

 

"annually" seems misaligned to SQF Guidance quote (Post4).  However with SQF (et al), auditor variations are always possible.

 

Yes, of course. Generic meaning not a specific allergen protein but rather any protein present. Specific meaning the targeted allergen protein. We currently use Neogen Reveal 3-D for our "specific" tests. Before we used the specific allergen protein tests for validation but not for every allergen, just our most prevalent to show that our cleaning procedure was effective and that the generic allergen protein test was accurate. Now we must test every allergen ran and we are taking it a step further by testing different materials as well. (stainless steal, UHMW, etc.) 

[Charles.C]

Yes, of course. Generic meaning not a specific allergen protein but rather any protein present. Specific meaning the targeted allergen protein. We currently use Neogen Reveal 3-D for our "specific" tests. Before we used the specific allergen protein tests for validation but not for every allergen, just our most prevalent to show that our cleaning procedure was effective and that the generic allergen protein test was accurate. Now we must test every allergen ran and we are taking it a step further by testing different materials as well. (stainless steal, UHMW, etc.) 

 

Thks, that helps.

TBH, it's maybe (generally) operationally easier to refer to either "protein testing" or "allergen testing" but I get what you mean.

[YNA QA]

This is interesting because we just went through our SQF audit with a new auditor and he said that our generic allergen swabs that we perform after each full clean wasn't enough. We will now use a specific allergen test annually to validate our daily sanitation verification procedures and swabs. This may be something you would want to do in addition to the generic swabs you are thinking of doing. Or swab and send to a lab for validation like someone else posted about doing. 

 

Are you saying that you actually got a Minor because the auditor decided that your generic swab verification wasn't sufficient?

[AC2018]

Nope it was just a recommendation and that is what he would be looking for next time around. 

[majoy]

This is interesting because we just went through our SQF audit with a new auditor and he said that our generic allergen swabs that we perform after each full clean wasn't enough. We will now use a specific allergen test annually to validate our daily sanitation verification procedures and swabs. This may be something you would want to do in addition to the generic swabs you are thinking of doing. Or swab and send to a lab for validation like someone else posted about doing. 

 

Honestly, this is more interesting that the auditor "recommended" this to you.

 

This is confusing to me - so you have a validated cleaning program to remove the allergen of concern, which was already validated previously and then you verify this cleaning program using a generic protein swab. And the auditor recommended to validate your verification procedure?

 

Unless you changed your "validated" cleaning program, i don't see the point of another validation being carried out. 

[YNA QA]

Honestly, this is more interesting that the auditor "recommended" this to you.

 

This is confusing to me - so you have a validated cleaning program to remove the allergen of concern, which was already validated previously and then you verify this cleaning program using a generic protein swab. And the auditor recommended to validate your verification procedure?

 

Unless you changed your "validated" cleaning program, i don't see the point of another validation being carried out. 

 

That's why I asked.  It would be a huge cost to us to go this far, when it's really a validation of a verification of a validation.  

 

Yikes.

[AC2018]

Honestly, this is more interesting that the auditor "recommended" this to you.

 

This is confusing to me - so you have a validated cleaning program to remove the allergen of concern, which was already validated previously and then you verify this cleaning program using a generic protein swab. And the auditor recommended to validate your verification procedure?

 

Unless you changed your "validated" cleaning program, i don't see the point of another validation being carried out. 

haha this is what I thought too. That's why we didn't have anything in place to validate every year. I find this frequently with auditors though depending on what they think a facility needs to do. Anyways, we will swab our equipment after each allergen ran and document it. If anything, this can serve as a re-validation on our cleaning process and maybe we wont have to conduct it every year. And correct, our cleaning process and/or chemicals have not changed. 

[Scampi]

Ah, that's the problem. Since this is such an essential step, you should be validating yearly...........you cannot simply put a plan into place once and then walk away!  You've changed staff,  your contact time might be all wrong etc etc etc  This is NOT a CCP and as such you cannot simply validate once and be done with it...........at the very least this step should be evaluated yearly to ensure that the process is still keeping the hazard under control or that the allergen protein hasn't built up to the point where current sanitation can no longer remove all traces of protein

 

haha this is what I thought too. That's why we didn't have anything in place to validate every year. I find this frequently with auditors though depending on what they think a facility needs to do. Anyways, we will swab our equipment after each allergen ran and document it. If anything, this can serve as a re-validation on our cleaning process and maybe we wont have to conduct it every year. And correct, our cleaning process and/or chemicals have not changed. 

[Skyhawk]

Interesting topic and I agree that visual inspection is not sufficient verification for the very serious Food Safety risk of Allergens.
The Pro-clean swabs along with some product testing should be sufficient for best practise verification, assuming that the original validation work was robustly applied has some ongoing revalidation checks.

 

FYI - There has been a huge amount of international & scientifically backed work done by The Allergen Bureau (http://allergenbureau.net/vital/) to define how to do thorough Risk Assessment for allergen cross contact.
The Allergen Bureau is an non-profit Australia & New Zealand based Food Industry funded organisation to address Allergen Mgmt issues in the Food Industry.

Lots of free resources available via the new Allergen Risk Review website : http://allergenbureau.net/risk-review/.

Hope these links might be helpful to this forum.

Edited by Skyhawk, 24 July 2019 - 10:38 PM.

[moskito]

Hi,

 

I agree with scampi - "visual clean" is an important first step (visual clean vs unclean). Depending on the surface you can detected very little amounts of foreign material. The next step could be the rapid inexpensive check for protein impuriies. As long as you are positive you should not test for specific allergens. Situation can be different if you can except one allergen (e.g. egg) and another not (nuts), because egg is part of the coming formulation.

 

Rgds

moskito

[Charles.C]

Hi,

 

I agree with scampi - "visual clean" is an important first step (visual clean vs unclean). Depending on the surface you can detected very little amounts of foreign material. The next step could be the rapid inexpensive check for protein impuriies. As long as you are positive you should not test for specific allergens. Situation can be different if you can except   [accept?] one allergen (e.g. egg) and another not (nuts), because egg is part of the coming formulation.

 

Rgds

moskito

 

Negative ?

[Ryan M.]

Don't agree with the auditor.  As long as your allergen cleaning / sanitation method is validated and you can show that, you really only need to verify it.  Of course, methods of verification can be open to interpretation which is what the auditor may have been alluding to.  If you are co-packing or sending product to other food manufacturers also be aware of their specific requirements about allergen cleaning verification and validation.

[moskito]

Negative ?

 

Hi Charles

 

accecpt is of course correct.

 

Cleaning: Removal of protein includes removal of allergens. As long as you will detect in the general, unspecific, low sensitivity rapid test - the protein test - any protein (positive signal), a cost effective test (specific, high sensitivity) for residual allergens  makes IMO no sense. So I think "positive" is correct.

 

Rgds

moskito

[Charles.C]

Hi Charles

 

accept is of course correct.

 

Cleaning: Removal of protein includes removal of allergens. As long as you will detect in the general, unspecific, low sensitivity rapid test - the protein test - any protein (positive signal), a cost effective test (specific, high sensitivity) for residual allergens  makes IMO no sense. So I think "positive" is correct.

 

Rgds

moskito

 

Hi moskito,

 

I suspect we are talking at "cross-purposes".

 

As I understand -

 

negative protein result (by validated cleaning procedure) can be assumed to imply negative (relevant) allergen condition.

 

But -

 

positive protein result  may imply a positive or negative (relevant) allergen condition., ie indeterminate. So only (immediate) way to check for allergen is then to do an allergen test. Or continue cleaning/protein testing until protein result is negative (assuming overall procedure remains validated).