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Help writing validation for reduction in Allergen testing frequency

Started by , Jul 08 2014 06:36 PM
3 Replies

After initially testing for allergens weekly for 3 months, then once a month for the last year, I'd like to change our policy to test for allergens every 2 or 3 months. We are a bakery, so the only allergens we test for are egg and milk and we have never gotten a 'positive' test result.  Am unsure how to write the validation for my changes using the fact we haven't found any allergens on the equipment in the last year.

 

Thanks!

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First: :welcome: to IFSQN!

 

Now to your question:

 

Discuss it at a food safety team meeting or haccp team meeting... or some team meeting that addresses food safety issues.  Bring up the history and suggest changing it.

 

Check your HACCP system to see if it's in there and would need to be changed.

 

Use a management of change system because that could potentially be a big thing.

After initially testing for allergens weekly for 3 months, then once a month for the last year, I'd like to change our policy to test for allergens every 2 or 3 months. We are a bakery, so the only allergens we test for are egg and milk and we have never gotten a 'positive' test result.  Am unsure how to write the validation for my changes using the fact we haven't found any allergens on the equipment in the last year.

 

Thanks!

Every month?

 

I must be misunderstanding....allergen validation study only happens once per equipment/allergen, right?  Hang in there with me on this one because I'm working it out too -

 

So, you run something with milk or eggs,

you sample the product to prove it would be positive if you hadn't cleaned correctly / as a positive control ,

you clean,

you swab FCS for casein or egg protien,

you send to an accredited lab,

the positive comes back positive and the negatives all come back negative. 

 

You've proven that your clean out is effective for that allergen for the equipment you've swabbed and that's the end of it until you get new equipment or new allergens. 

 

I guess I'm not understanding why you're repeating it on a monthly or quarterly basis? Or ever? I didn't realize it was standard practice.  Uh oh -  :eek_yello:  should I be doing that?

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Dear SDQ,

 

Not a baker myself but i find yr query a bit confusing regarding objectives/data presented. There is also maybe some thread confusion over terminologies.? :smile:

 

(a) Bakery products may surely contain a variety of allergenic components other than egg/milk?

(eg -

http://www.inspectio...2/1401812644916

 

(b) TBH I thought allergen testing for "sanitation" purposes is more often a routine daily "exercise" :smile:

 

Regardless, i think you are now talking about revalidation of a "Procedure", SOP, whatever. Or, equivalently,  a revision of a risk assessment/management etc. I can suggest  a basic, generic, approach since I'm unaware of any possible local regulations which might come into play if present.

 

The frequency is often initially "maximised" for conservatism and then relaxed if no problems. The degree of relaxation depends on, for example, the results/process/product but is usually, and especially, also a compromise in respect to the potential consequences in the event of a significant deviation occurring, eg product retest/recall.

 

So IMO the basic answer to yr query is to repeat yr initial validation where you demonstrated the current procedure is "valid" then simply, similarly justify the decreased frequency based on additional results/consequences,etc.

 

Rgds / Charles.C

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