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Crustacean (allergen) cleaning validation for shrimp product

Crustacean allergen

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jrunique

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Posted 21 November 2018 - 10:40 AM

Hello, our factory manufactures dried shrimp only, therefore all final products will contain crustacean allergen. 

 

According to our consultant, allergen crustacean is identified as a risk and therefore we have to validate cleaning to remove all traces of the allergen, even though the actual product is an allergen.

 

Our consultant says we have to demonstrate removal of the allergen through effective cleaning measures, therefore we have swab all food contact surfaces in our factory for validation. She says this is done just in case you start making a non-allergen product. However I explained that we have no plans or intentions to make any other product.

 

My questions are as follows:

 

1. How often do we have to swab to validate allergen removal, 1 month, 4 months, 6 months etc?

2. Do we have to swab all food contact surfaces or select one surface for testing?

3. Is allergen cleaning validation necessary if the allergen identified is part of our product makeup? If we test our final product for crustacean allergen it is almost 100% certain it will contain crustacean allergen no matter how well the factory has been cleaned.

 

Thank you for your help.



pHruit

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Posted 21 November 2018 - 11:05 AM

As per section 5.3 of the BRC standard, you'd need to conduct a risk assessment (clause 5.3.3) to "identify routes of contamination and establish documented policies and procedures for handling raw materials and intermediate and finished products to ensure cross-contamination (cross-contact) is avoided".

This is a bit surreal as if your site allergen controls are such that crustaceans are the only allergen you have in the facility, the only potential cross-contamination of your shrimp is with... more shrimp. 

Personally I think you can therefore very legitimately skip your questions 1/2 above, and move straight on to part three - you should be able to construct a fairly simple risk assessment to demonstrate that their is no cross-contamination (i.e. introduction of another allergen outside of that which is an inherent and intentional part of the product) risk, given that in the "worst" case you'll only be contaminating your shrimp with traces of shrimp...



Charles.C

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Posted 21 November 2018 - 01:10 PM

Seems analogous to a Dairy-only scenario like milk.

 

As per previous Post, from a haccp POV the only allergen-related control would presumably relate to labelling. The latter would legally depend on local/receiver commercialisation/Regulatory requirements.

 

Maybe try another consultant.


Kind Regards,

 

Charles.C


Lesley.Roberts

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Posted 21 November 2018 - 06:52 PM

Hello, our factory manufactures dried shrimp only, therefore all final products will contain crustacean allergen. 

 

According to our consultant, allergen crustacean is identified as a risk and therefore we have to validate cleaning to remove all traces of the allergen, even though the actual product is an allergen.

 

Our consultant says we have to demonstrate removal of the allergen through effective cleaning measures, therefore we have swab all food contact surfaces in our factory for validation. She says this is done just in case you start making a non-allergen product. However I explained that we have no plans or intentions to make any other product.

 

My questions are as follows:

 

1. How often do we have to swab to validate allergen removal, 1 month, 4 months, 6 months etc?

2. Do we have to swab all food contact surfaces or select one surface for testing?

3. Is allergen cleaning validation necessary if the allergen identified is part of our product makeup? If we test our final product for crustacean allergen it is almost 100% certain it will contain crustacean allergen no matter how well the factory has been cleaned.

 

Thank you for your help.

 

 

I think Charles C has nailed it.

 

 

What is the consultant's role at your site?....

How much knowledge does she have of your product type

What standard is she advising you against (customer standard/BRC/personal opinion)

 

 

 

I was a consultant myself for approx. 10 years & turned down roles that I didn't have sufficient experience/expertise to be able to advise on (not worth the risk!).  However not all consultants will do this & therefore may lack the requisite knowledge of a) your product group b) what standards you are trying to meet.

 

I've worked with some woeful consultants during my career - one asked how we control gluten in a bakery - yes seriously!...

 

Whilst I am not stating that your consultant is wrong - it is worth remembering that just because somebody is paid a very high daily rate, this does not constitute proof that they have the knowledge or skills to perform a specific role.



jrunique

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Posted 23 November 2018 - 06:42 AM

Thank you for all the helpful replies, you have confirmed my thinking. Unfortunately the consultant is still adamant that we have to demonstrate removal of an identified allergen through effective cleaning methods, even if the actual product contains the allergen we're trying to eliminate. He says BRC requirement is preventive action before corrective action. We had a pre-audit and they said the same so to be on the safe side I will be buying some allergen test swabs. :(



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Posted 23 November 2018 - 01:53 PM

Can you not get a new consultant??  The fee your paying plus the cost of swabs makes zero sense!

 

http://allergenburea...-manufacturing/

 

The allergen management guidelines are designed to assist in the development of robust allergen management systems and procedures that adequately meet the requirements of the Standard. The document primarily concentrates on five themes:

  • Significance – the significance of any process, activity or ingredient should be evaluated by accurate risk assessments to determine the control or action required
  • Suppliers – understanding the materials that arrive on site is vital to allergen management
  • Separation – the segregation of allergens is a key allergen management control
  • Scheduling – planning activities to reduce the risk of cross-contamination
  • Sanitation – cleaning controls to remove or reduce the risks of cross-contamination

You clearly DO NOT have a cross contamination issue.

 

https://brcglobalsta...st-english.docx

 

I think your auditor forgot that you're a single ingredient manufacturer...............i would still push hard referencing the SPECIFIC language in the code and guidance and point blank ask WHY you should swab in a single ingredient plant........your paying a CONSULTANT this is NOT and auditor


Please stop referring to me as Sir/sirs


pHruit

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Posted 23 November 2018 - 02:58 PM

Unless I'm missing something (hopefully not, having been running with BRC for 10+ years!) it sounds very much like your consultant has misunderstood. Was the pre-audit from the same consultant / consultancy firm?

If you haven't already done so then it's worth reading the BRC Understanding Allergen Management guide - if you're already registered for BRC then you can access it for free via Participate, or it's available to buy from the BRC Bookshop: https://www.brcbooks...ment/c-24/p-279 (not sure you'll get much long-term use out of it, but probably cheaper than setting up a cleaning and validation system that you don't need, since you don't really have any allergen management required in the sense that this is intending ;) )

Section 4.2 of this guide looks at an example of some biscuits containing various allergens, but where the entire range all contain both Wheat and Milk. The guide specifically states: "It should be noted that in this example none of the ingredients or products need to be protected against cross-contamination with wheat or milk because all of the final products deliberately contain both of these allergens", i.e. it could hardly be clearer that BRC's view is that if you are producing only shrimp products then you really don't need to worry about allergen cross-contamination with shrimp!



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Charles.C

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Posted 23 November 2018 - 11:00 PM

Thank you for all the helpful replies, you have confirmed my thinking. Unfortunately the consultant is still adamant that we have to demonstrate removal of an identified allergen through effective cleaning methods, even if the actual product contains the allergen we're trying to eliminate. He says BRC requirement is preventive action before corrective action. We had a pre-audit and they said the same so to be on the safe side I will be buying some allergen test swabs. :(

 

I anticipate pre-auditor = final auditing organisation.

 

Rather disturbing that 2 "experts"  both seem equally uninformed. (BRC take note ??)

 

Basically you are about to take a line of least resistance.

 

Sometimes there is no option in questionable situations  but this will likely involve significant waste of time/costs and irrelevant  resulting data.

 

Yr choice.


Kind Regards,

 

Charles.C


Charles.C

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Posted 23 November 2018 - 11:09 PM

Can you not get a new consultant??  The fee your paying plus the cost of swabs makes zero sense!

 

http://allergenburea...-manufacturing/

 

The allergen management guidelines are designed to assist in the development of robust allergen management systems and procedures that adequately meet the requirements of the Standard. The document primarily concentrates on five themes:

  • Significance – the significance of any process, activity or ingredient should be evaluated by accurate risk assessments to determine the control or action required
  • Suppliers – understanding the materials that arrive on site is vital to allergen management
  • Separation – the segregation of allergens is a key allergen management control
  • Scheduling – planning activities to reduce the risk of cross-contamination
  • Sanitation – cleaning controls to remove or reduce the risks of cross-contamination

You clearly DO NOT have a cross contamination issue.

 

https://brcglobalsta...st-english.docx

 

I think your auditor forgot that you're a single ingredient manufacturer...............i would still push hard referencing the SPECIFIC language in the code and guidance and point blank ask WHY you should swab in a single ingredient plant........your paying a CONSULTANT this is NOT and auditor

 

Hi Scampi,

 

I was unable to open 2nd link.

 

Maybe the browser FFox.


Kind Regards,

 

Charles.C


Scampi

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Posted 27 November 2018 - 02:38 PM

https://brcglobalsta...st-english.docx

 

Perhaps this one will open-----I'm using Chrome


Please stop referring to me as Sir/sirs


SQFconsultant

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Posted 27 November 2018 - 03:20 PM

Get a new consultant.


Kind regards,
Glenn Oster
 
GOC BUSINESS GROUP | SQF System Development, Implementation & Certification Consultants
Internal Auditor Training - eConsultant Retainer Subscriptions - Pre & Post SQF-GAP Audits - Consultant Training
Visit us @ http://www.GlennOster.com  or call us @ 772.646.4115 US-EST 8am-4pm Anyday except Thursday
 
 

Charles.C

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Posted 28 November 2018 - 02:14 PM

https://brcglobalsta...st-english.docx

 

Perhaps this one will open-----I'm using Chrome

 

Hi Scampi,

 

Thks 

 

Seems to be working in (my) Chrome but not in (my) Firefox.

 

Odd, but 1/2 is good enough. :smile:


Kind Regards,

 

Charles.C






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