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SQF clause - Does anyone know of an Rapid Allergen Test that tests for the Big 8?

Allergen Testing

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#1 Tavish101


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Posted 19 June 2020 - 03:41 PM

Does anyone know of an Rapid Allergen Test that tests for the Big 8 ? Our auditor suggested we use this to verify that employees/visitors are not carrying undeclared allergens from the break room etc..

#2 olenazh


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Posted 19 June 2020 - 03:47 PM

Try Neogen, they have great allergen kits. However, don't you think your auditor exaggerate the danger? I've personally never heard of testing people for allergens - how are you going to do that? Swab the whole body? Personnel training and hand washing are the best practices to prevent allergen entry to the facility (from people's end).

#3 SQFconsultant



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Posted 19 June 2020 - 03:49 PM

Before you go and spend money, the question is -- have you ever had an employee carry food from the breakroom to production, etc.?


I sure wish Auditors would jsut stick to their jobs and and skip making suggestions.

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#4 Food Police

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Posted 19 June 2020 - 03:56 PM

If you must have one, I'd recommend this.




In our case, we just enforce a no allergen policy and we've never had a problem with our post-allergen cleaning and pre-op.


As Glenn was suggesting, it may not be necessary though. SQF requires an allergen risk assessment, including the break room and employees. If you show that the risk is very low due to hand washing policies, break room policies, GMPs, proper food handling techniques, employee awareness of allergens, etc., then I don't think you would need any swabs.


The only exception is if it has happened before, then its kind of hard to justify a low risk.

Edited by Food Police, 19 June 2020 - 04:10 PM.

#5 Ryan M.

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Posted 19 June 2020 - 04:19 PM

Stop.  Analyze the actual risk and assess the actual risk.  Put measure in place to control and minimize the risk.  Verify control measures.  Typically with employees bringing allergens into the plant you verify this with employee GMP inspections / audits and facility inspections to ensure there is no food brought in.

#6 SafetyP


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Posted 19 June 2020 - 08:29 PM

I have used https://www.neogen.c...ions/allergens/ in the past for allergen swab verification. 

However if visitors and employees are trained and follow GMP's in your facility you should be covered. I would conduct a risk assessment prior to implementing this program.

#7 Aliali


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Posted 20 June 2020 - 04:43 AM

Suggest you to carry out a risk assessment first. if it is deemed to be a high risk, protein swabs could be an option because allergen essentially is protein. if it is free of protein residues, it means allergen protein has been removed completely. However, you can only verify it unless you take a swab of everywhere.. so it is back to your allergen management process. 

#8 Charles.C


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Posted 20 June 2020 - 06:09 AM  The  responsibility  and  methods  used  to  control  allergens  and  to  prevent  sources  of  allergens  from contaminating product shall be documented and implemented.  The allergen management program shall include:  
i.  A risk analysis of those raw materials, ingredients and processing aids, including food grade lubricants, that contain food allergens;
ii.  An  assessment  of  workplace-related  food  allergens  from  locker  rooms,  vending  machines,  lunch  rooms,visitors;

etc, etc



This element is mandatory for all food manufacturing sites.  Irrespective of the site’s considered allergen exposure,a risk analysis is required of all ingredients, materials, the workplace (canteens, locker rooms, vending machines) to determine the risk of cross-contact allergens so that action can be taken to minimise or eliminate the risk.


All employees must be made aware of the presence and risk of allergen contamination and receive instruction in their role in managing allergens, and in particular, cross-contact allergens.

etc, etc


Document attached contains a tabular, fairly simple but nonetheless quite comprehensive,  process flow, allergen risk assessment example (see Appendix 3).


Should be readily adapted to apply to other  "areas" of the facility perhaps using appropriate GMP controls (eg refs to Main Allergen Management Program ?) as a low/medium//high risk "marker". Verification would presumably include (a) Visual, (b) perhaps a few risk-relevant, areal, swabs (if data absolutely necessary and maybe using a generic-type scan, eg Post 7)


Attached File  allergens-facility-mapping-guide.pdf   694.2KB   26 downloads


PS - more quantitative formats have also been published  but seemed overkill for this particular situation.

Kind Regards,



#9 moskito


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Posted 24 June 2020 - 01:01 PM

Hi Tavish101,


...... to verify that employees/visitors are not carrying undeclared allergens from the break room etc. really??


Never heard that an auditor asked for such?

IMO it makes no sense to do such a multi-test. It will create a lot of question.

I would asked the auditor to provide a proposal of a risk releated sampling plan.

The Big8 requirement would mean PCR -> cross contact - sensitivity? Results after x-days -> action?

Cost/Benefit relation?





#10 Nathan.


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Posted 24 June 2020 - 01:14 PM

Have to agree with others....really? Unless there is something really odd going on that I don't understand, the general recommedation is absurd.

#11 TimG


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Posted 24 June 2020 - 01:24 PM

It's nonsense like this that gives auditors a bad name. Please don't bow to every whim of an auditor, you will end up with unsustainable programs and in some cases instituting more hazards into your system then you are supposedly protecting against. Absolutely tell them you will "take their suggestion seriously and perform a hazard assessment" and then do so. If your food safety team feels there is sufficient risk associated, by all means, go for it.

Sorry if I wasn't helpful concerning your original question, I've run into too many instances where an auditor told me what I had to do to pass their audit, when those things would actually introduce more hazards then they were alleviating.

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