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Skye

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Posted 19 December 2012 - 12:49 PM

Hi, has anyone got an example allergen risk assessment they would like to share with me? One for a bakery would be fantastic!



DocGra

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Posted 04 January 2013 - 10:40 PM

Hello Skye,

I see no one has replied to you. I think I can understand becauseyou ask a huge question.

I won't pretend to understand your bakery and our factoryassessment may not be appropriate - but I hope I can share our approach toperhaps give you a starter.

The essence is summedup by 'know your enemy' and 'divide and conquer' and you will need to establisha tight objective along the lines 'Limit allergen declarations on labels to ….'or 'Prevent cross contamination from line A to Line B' to help justify thecosts involved.

In advance, I'll apologise if I'm way off-beam or listingthings you are already familiar with - but here's how we approached our 'allergencontamination control and minimisation'

1. List all the allergens you have on site:

· that you use intentionally (I'm guessing: gluten,lactose, egg, sulphites (in sugar and fruit preserves) and perhaps nuts ad afew others)

· that enter your site unintentionally (stafffood, via contractors, transport, neighbours (air borne, etc)

2. Organise the list by finished product (which products containwhich allergen intentionally and which allergen unintentionally) and then againby machine / production line (which machines / lines handle which allergens).This helps put your Risk Assessments into perspective so you can identify thebest route for your analysis, it also helps demonstrate allergen awareness toBRC too.

3. List potential contamination routes and crosscontamination vectors (people, machines, in-house transport (bins, trays etc),conveyors, air borne, shared engineering (CIP pipelines etc). Make sure you challengeyour assumptions, especially if you think some allergens are present only onone machine / line - otherwise simply accept that all your intentional andunintentional allergens are potentially present in all your products.

4. Carefully redefine your cleaning protocols from the pointof view of allergen removal and use test kits backed up by ELIZA tests toverify their efficacy at allergen removal - to provide a means of allergen control.Perhaps identify the machine most likely to be contaminated and the allergenmost difficult to remove to simplify this step (I'm guessing egg and utensilsurfaces - particularly if you use plastic utensils (protein seems to have anaffinity to plastics (oil-based??)) and of course plastic utensils are likelyto be less smooth than metal surfaces). If your cleaning is performedstrategically, you can argue and demonstrate that an allergen may not be presentif / when you don't want it to be.

5. Review ingredient storage and handling to identify and segregateallergens from non-allergens, ensure the allergen tagging follows throughintermediates to finished products waiting to be labelled.

6. Ensure you have allergen-specific utensils, food-protectivewear and staff clean-up when handling allergens and during cleaning operationsto remove allergens. We identify allergen specifics by a colour - purpleingredient bags, product scoops, aprons, gloves, scrubbing brushes, squeegeesetc

7. Turn your lists into Risk Assessments, establish likelihoodand severity. We always viewed allergen contamination (intentional andunintentional) as most severe given anaphylaxis kills - so all of our allergenrisk assessments turn out to be significant. However, I know others considersome allergens to be less severe than others (eg nuts are more severe thangluten) but in my view - severity depends on the affected individual and youwill never know

8. Product Labelling.

· You are required to declare every intentionalallergen (eg Cake .. Contains egg,lactose, gluten)

· At the moment, declaring potential crosscontaminating (unintentional) allergens is not mandatory and folks usestatements like 'Prepared in premises that also handle sulphites, nuts …'. Inmy view BRC6 suggests that a statement of this kind is required if you can'tdemonstrate sufficient controls are in place to guarantee the absence ofunintentional allergens although the emphasis and site approach must be toreduce the risks of contamination by allergen controls - so be careful not tolean too heavily on this 'catch-all escape'

9. Establish procedures that ensure the situation you justdescribed is achieved and maintained:

· React, review and reassess if your suppliers changethe allergen status of your ingredients

· Record and verify your strategic cleaning to demonstratecontinued allergen control

· Audit your systems

· Establish a test program to demonstrate yourcontrols are actually in control and use an external (UKAS) lab to demonstrateyour tests are valid (ELIZA testing?)

10. Be aware allergen controls are not cheap so seniorcommitment is really a pre-requisite:

· Ingredient labelling and segregation takes time,space and storage / labelling consumables

· Allergen-specific utensils, handling systems,even machines (eg extra blender so your meringues can be whipped up in adifferent blender from your bread mixtures so separating gluten and lactosefrom your egg & sugar (contains sulphites) meringues)

· Additional cleaning take time

· Test kits and ELIZA testing are definitely notcheap (We spent approaching £2k to validate our cleaning on just 1 line andanticipate an annual spend around £5k for routine testing)

There are several useful papers around on the subject of allergencontrols and on Risk Assessments - but I feel the best solution to your requestfor an allergen risk assessment for your bakery - is, I'm afraid to generateone for yourself. In my experience other folks' risk assessments are often veryspecific to their regime and any auditor worth his salt will spot thedifference between their regime and yours very quickly. So I hope this helpsand perhaps stimulates debate in here.

Kind regards and good luck

Graham



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Evonna

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Posted 10 January 2013 - 11:14 AM

Hello Skye,

I see no one has replied to you. I think I can understand becauseyou ask a huge question.

I won't pretend to understand your bakery and our factoryassessment may not be appropriate - but I hope I can share our approach toperhaps give you a starter.

The essence is summedup by 'know your enemy' and 'divide and conquer' and you will need to establisha tight objective along the lines 'Limit allergen declarations on labels to ….'or 'Prevent cross contamination from line A to Line B' to help justify thecosts involved.

In advance, I'll apologise if I'm way off-beam or listingthings you are already familiar with - but here's how we approached our 'allergencontamination control and minimisation'

1. List all the allergens you have on site:

· that you use intentionally (I'm guessing: gluten,lactose, egg, sulphites (in sugar and fruit preserves) and perhaps nuts ad afew others)

· that enter your site unintentionally (stafffood, via contractors, transport, neighbours (air borne, etc)

2. Organise the list by finished product (which products containwhich allergen intentionally and which allergen unintentionally) and then againby machine / production line (which machines / lines handle which allergens).This helps put your Risk Assessments into perspective so you can identify thebest route for your analysis, it also helps demonstrate allergen awareness toBRC too.

3. List potential contamination routes and crosscontamination vectors (people, machines, in-house transport (bins, trays etc),conveyors, air borne, shared engineering (CIP pipelines etc). Make sure you challengeyour assumptions, especially if you think some allergens are present only onone machine / line - otherwise simply accept that all your intentional andunintentional allergens are potentially present in all your products.

4. Carefully redefine your cleaning protocols from the pointof view of allergen removal and use test kits backed up by ELIZA tests toverify their efficacy at allergen removal - to provide a means of allergen control.Perhaps identify the machine most likely to be contaminated and the allergenmost difficult to remove to simplify this step (I'm guessing egg and utensilsurfaces - particularly if you use plastic utensils (protein seems to have anaffinity to plastics (oil-based??)) and of course plastic utensils are likelyto be less smooth than metal surfaces). If your cleaning is performedstrategically, you can argue and demonstrate that an allergen may not be presentif / when you don't want it to be.

5. Review ingredient storage and handling to identify and segregateallergens from non-allergens, ensure the allergen tagging follows throughintermediates to finished products waiting to be labelled.

6. Ensure you have allergen-specific utensils, food-protectivewear and staff clean-up when handling allergens and during cleaning operationsto remove allergens. We identify allergen specifics by a colour - purpleingredient bags, product scoops, aprons, gloves, scrubbing brushes, squeegeesetc

7. Turn your lists into Risk Assessments, establish likelihoodand severity. We always viewed allergen contamination (intentional andunintentional) as most severe given anaphylaxis kills - so all of our allergenrisk assessments turn out to be significant. However, I know others considersome allergens to be less severe than others (eg nuts are more severe thangluten) but in my view - severity depends on the affected individual and youwill never know

8. Product Labelling.

· You are required to declare every intentionalallergen (eg Cake .. Contains egg,lactose, gluten)

· At the moment, declaring potential crosscontaminating (unintentional) allergens is not mandatory and folks usestatements like 'Prepared in premises that also handle sulphites, nuts …'. Inmy view BRC6 suggests that a statement of this kind is required if you can'tdemonstrate sufficient controls are in place to guarantee the absence ofunintentional allergens although the emphasis and site approach must be toreduce the risks of contamination by allergen controls - so be careful not tolean too heavily on this 'catch-all escape'

9. Establish procedures that ensure the situation you justdescribed is achieved and maintained:

· React, review and reassess if your suppliers changethe allergen status of your ingredients

· Record and verify your strategic cleaning to demonstratecontinued allergen control

· Audit your systems

· Establish a test program to demonstrate yourcontrols are actually in control and use an external (UKAS) lab to demonstrateyour tests are valid (ELIZA testing?)

10. Be aware allergen controls are not cheap so seniorcommitment is really a pre-requisite:

· Ingredient labelling and segregation takes time,space and storage / labelling consumables

· Allergen-specific utensils, handling systems,even machines (eg extra blender so your meringues can be whipped up in adifferent blender from your bread mixtures so separating gluten and lactosefrom your egg & sugar (contains sulphites) meringues)

· Additional cleaning take time

· Test kits and ELIZA testing are definitely notcheap (We spent approaching £2k to validate our cleaning on just 1 line andanticipate an annual spend around £5k for routine testing)

There are several useful papers around on the subject of allergencontrols and on Risk Assessments - but I feel the best solution to your requestfor an allergen risk assessment for your bakery - is, I'm afraid to generateone for yourself. In my experience other folks' risk assessments are often veryspecific to their regime and any auditor worth his salt will spot thedifference between their regime and yours very quickly. So I hope this helpsand perhaps stimulates debate in here.

Kind regards and good luck

Graham




Evonna

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Posted 10 January 2013 - 11:17 AM


Hi Graham,
How do you validate the cleaning?
I am in bakery sector and use Elisa tests for verification but I want to know what options I have for validation?
Thanks
Evonna



Charles.C

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Posted 10 January 2013 - 04:00 PM


How do you validate the cleaning?
I am in bakery sector and use Elisa tests for verification but I want to know what options I have for validation?
Thanks
Evonna



Dear Evonna,

It may depend on yr particular definitions of Va/Ve (or perhaps standard in use) but this post / surrounding thread may be of interest to you -

http://www.ifsqn.com...dpost__p__56607

Rgds / Charles.C

Kind Regards,

 

Charles.C


DocGra

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Posted 10 January 2013 - 08:57 PM

Hello Evonna



Have a look at the link Charles recommends and then define thedifference between validation and verification in your specific context.

If you look upthe two in Wikipedia, you will see:

"Validation.The assurance that a product, service, or system meets the needs of thecustomer and other identified stakeholders. We interpret this to mean theprocess is shown to achieve the required effect (e the prescribed cleaningprocedure removes allergens)

"Verification.The evaluation of whether or not a product, service, or system complies with aregulation, requirement, specification, or imposed condition. We interpret thisto mean that the detection of an allergen by a given system meets therequirement for precision and reliability - and if the tests says there is noegg then no egg is present

In our case, we defined the levels at which we wouldconsider a surface (for instance) free from a given allergen (we chose the mostlikely to remain - which for us was egg) and accepted ELIZA testing as the 'GoldStandard', then we

1. Verified the swab kits worked to the required standard:

· we contaminated a surface with egg

· used a swab kit to show the swab 'found' the egg

· took an ELIZA swab to test the findings of theswab kit

· cleaned the surface several times to be prettysure the egg was all gone (contamination level<detection level)

· used a swab kit to show the egg had gone

· took another ELIZA swab to test the findings of thesecond swab kit

· sent both ELIZA swabs off to an (expensive!) lab

· when both ELIZA results confirmed the (cheaper)swab kits were telling the truth, we declared the swab kits verified

2. Validated the efficacy of the cleaning process

· contaminated a surface with egg

· used our swab kit to show the presence of whatwe knew was there (ie egg)

· cleaned the surface according to our prescribedprocedures using the prescribed chemicals, utensils etc

· used a swab kit to look for egg and when itshowed egg wasn't present - declared the cleaning method validated

Note:

· we repeat the 4 validation points above whenever we need to show cleaning has been effective (eg after allergen runs). Wepresume the cleaning is effective at other times if the prescribed procedures havebeen followed to the letter

· Note, validating cleaning can only be done ifyou first demonstrate the allergen is present and detectable - otherwise youmay confirm that a surface that was free of allergens is still free ofallergens after you clean it

· we also took ELIZA swabs for the first few cleaningvalidations in each of the critical areas we had previously prescribed for the rangeof allergens we needed to detect and when their results confirmed our swab kitresults, we slept easier! We repeat the exercise a couple of times per yearjust so we can enjoy a sleep-in on a cold winter morning!

So by our definitions, validations help you sleep where asverifications mean we can minimise expensive lab tests - and so enjoy our sleepa little more (hope you appreciate a little fun!)

I've found great debate always follows when definingvalidation and verification, it's easy to argue the opposite and I'm sure thereare those that will want to debate our definitions and approach. the point isthat you first define your 'system' and then you test the system and the meansof testing the system - and don't forget to document everything and sign it alloff when you are done!



In my view, the approach is independent of industry sector,process and product so I'm sure what works for us will give you a good start inbakery. I hope it helps ….

Kind regards,

Graham



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DocGra

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Posted 10 January 2013 - 09:03 PM

Dear Mr Moderator / Forum Technical guru.

When I prepare posts in word (to get teh smelling right!) and then copy and paste into the Post box, I notice spaces dissapear and words join together, never usually more than 2 words - but it looks odd and suggests I Kan't type write (!)

How do I avoid the effect - or must I uplaod the spelling thingy and always use this window?

Thanks for a really good forum and a load of new techy friends ...

Regards,

Graham






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