15 replies to this topic

[MDaleDDF]

There's been a few threads on the v6 update, so I thought maybe it would be good to have a dedicated thread where we can ask questions concerning the update.

Anyway, I have a brain buster for you all.   The update for 2.5.6 Management of Allergens states that we need:

Identification and implementation of control measures to reduce eliminate risk of cross contamination, based on the outcome of a risk assessment.

 

Validation and verification of these control measures shall be implemented and maintained as documented information.

 

Etc etc.

So we have four allergens in our building:   Wheat, Milk, Egg, and Soy.    Those four allergens are in every product we make, and no other allergens are allowed in the building.    So I honestly don't even know what to write up, as we have zero risk of cross contamination, other than a vendor making a mistake, which would trigger a recall anyway.   I've done plenty of risk assessments, and I guess I can write something up saying there is no risk, but why do I need to validate and verify that, and how would I even do it?

 

We already do segregate raw allergens, and use colored scoops, colored storage containers, etc, and that stuff seems redundant and silly considering our stacking protocol, but we do it just to please auditors, though every auditor we've ever had readily admits there's no risk inherent in our system....

 

Thoughts yall?

[Tony-C]

Hi MDaleDDF,

 

I’m assuming that all 4 allergens, Wheat, Milk, Egg, and Soy are declared on the label of every product that you manufacture?

 

If these allergens are in every product then the risk of allergen cross-contamination becomes largely irrelevant during operations. My assessment would note that fact.

 

Other risks to be considered could be for example ‘other’ allergens in incoming ingredients and ‘other’ allergens brought on to site by employees. Supplier Assurance and Hygiene rules should be covering off those risks. In this case verification of your controls would be applicable, I doubt an auditor would expect to see validation unless you have a control measure that is controlling a high risk of cross-contamination which doesn’t appear to be the case.

 

Kind regards,

 

Tony

[MOHAMMED ZAMEERUDDIN]

When all four allergens are in all the products then no need of segregation.

[Dee70]

Hi,

 

Your risks will be from your suppliers and what allergens they currently hold on their site that are stored or manufactured alongside the products you buy (may contain etc), and people (staff, visitors, contractors) bringing other allergens onsite. There is also a small risk from the wrong raw material being delivered but this should get picked up at Goods Intake 

[MDaleDDF]

Hi MDaleDDF,

 

I’m assuming that all 4 allergens, Wheat, Milk, Egg, and Soy are declared on the label of every product that you manufacture?

 

If these allergens are in every product then the risk of allergen cross-contamination becomes largely irrelevant during operations. My assessment would note that fact.

 

Other risks to be considered could be for example ‘other’ allergens in incoming ingredients and ‘other’ allergens brought on to site by employees. Supplier Assurance and Hygiene rules should be covering off those risks. In this case verification of your controls would be applicable, I doubt an auditor would expect to see validation unless you have a control measure that is controlling a high risk of cross-contamination which doesn’t appear to be the case.

 

Kind regards,

 

Tony

Yup, all four allergens are declared on every label.

Other risks have indeed been dealt with through employee training, GMP's, supplier assurance, allergen control PRP docs, etc.   (Any new ingredient is reviewed to make sure we're not introducing a new allergen, etc)

For verification it's discussed at the management review with the entire HACCP team at the table, and myself and the procurement guy go through every supplier/ingredient once annually to be sure everything is in line.  I don't know what I'd do for a validation if they WANTED to see one.   It would be some sort of silly sign off of something we already know, but who knows, they could ask for it.   In my experience it depends on the inspector.  I've had inspectors tell me we can stop segregating allergens and using different color scoops, etc, and other inspectors say absolutely not, we still have to do all that, so we do it anyway.

We don't have any risk of cross contamination in our process internally. as you said.  The only thing that could happen is like Dee said, something being delivered wrong, but we inspect all deliveries of course and keep sign offs on all that stuff.

 

I guess I'll just write up a very basic risk assessment and file it.....

Thanks all.

[olenazh]

Write everything you've just said, plus records of evidence (checks, reviews, assessments, training records, prp inspections, etc.), plus scientific references - and that will be your risk-based assessment as per v.6. The more you write - the better: auditors love wordy documents, especially with references to scientific studies and documents.

[MDaleDDF]

When all four allergens are in all the products then no need of segregation.

I agree with you, but I've had auditors that didn't, so we segregate anyway.   I've had one auditor that says it's fine, don't need to segregate it, and another that said I absolutely still need to, so I err on the side of caution....

[olenazh]

I agree with you, but I've had auditors that didn't, so we segregate anyway.   I've had one auditor that says it's fine, don't need to segregate it, and another that said I absolutely still need to, so I err on the side of caution....

I've always been trying to fight when this happens: one auditor approves your measures, but another one makes a comment. That puts auditors' qualification under question. However, the owners of the companies I work for do not like my attitude saying I'd better oblige. 

[MDaleDDF]

I've always been trying to fight when this happens: one auditor approves your measures, but another one makes a comment. That puts auditors' qualification under question. However, the owners of the companies I work for do not like my attitude saying I'd better oblige. 

That's funny O because I'm always lecturing my owner the same way, lol.   "Just be quiet when you disagree and do what they say!   You're making my job harder!"

[jfrey123]

This kind of highlights the flaws in any GFSI system, where they need to write the codes in such a way to reflect the industry as a whole with no room for operations that don't suffer the risk.  The example here is that allergens must be segregated to prevent cross contamination due to businesses that make products containing separate/unique ingredient formulations.  In OP's operation, allergen cross contamination isn't an allergen hazard because all allergens are in all products.  I'd be tempted to include that in my allergen risk assessment, and then referring to basic storage principals that cross contamination is controlled by ensuring all products are sealed when placed into storage.  You've documented the risk is controlled by your formulations.

 

The auditors who stick to the rule and leave no room for the spirit of the rule will balk and write you up; others will see and appreciate you've done your due diligence in your documentation and leave it as a non-issue.  To me, it's easier just to follow the code, even when the code doesn't make sense for your operation.  Don't get me wrong, I'm happy to argue- er, um...politely discuss, when they want to hit me for a non-issue, but in the end a happy auditor makes for a better score and a less stressful experience.

[MDaleDDF]

This kind of highlights the flaws in any GFSI system, where they need to write the codes in such a way to reflect the industry as a whole with no room for operations that don't suffer the risk.  The example here is that allergens must be segregated to prevent cross contamination due to businesses that make products containing separate/unique ingredient formulations.  In OP's operation, allergen cross contamination isn't an allergen hazard because all allergens are in all products.  I'd be tempted to include that in my allergen risk assessment, and then referring to basic storage principals that cross contamination is controlled by ensuring all products are sealed when placed into storage.  You've documented the risk is controlled by your formulations.

 

The auditors who stick to the rule and leave no room for the spirit of the rule will balk and write you up; others will see and appreciate you've done your due diligence in your documentation and leave it as a non-issue.  To me, it's easier just to follow the code, even when the code doesn't make sense for your operation.  Don't get me wrong, I'm happy to argue- er, um...politely discuss, when they want to hit me for a non-issue, but in the end a happy auditor makes for a better score and a less stressful experience.

Absolutely.   It's like complaining at the drive thru speaker to a teenager making your hamburger (as my wife does).   If you do so, you should ask them to 'hold the spit' when they're making your burger.

Don't upset someone who holds sway.   General rule of a happy life, lol.

[farshad2008]

I remember once I was dong a gap analysis visit of a dairy company. They mentioned that they don't have any other products except dairy one but there was a small maintenance room connected to production hall and a frying pan in that room! 

The operator mentioned that sometimes he makes egg for himself as he was so busy for going to staff facility. ( no washing hand station as well )

Asking some question shows that operators considered eggplant, pepper, as allergen material. (lack of training) .

in another case the supplier was sending pistachio from farm to sorting factory in flour sack (gluten?) 

sometimes we send a form and ask the supplier to declare any allergen while they don't know what is considered as allergen . !!!

so apart from a form with details, consider site visit and staff interview.

in a beverage company peanut was found in raw material warehouse ( they had a shared warehouse with another company! )

[MDaleDDF]

I'm wondering if it's possible to get out of the ongoing shelf life experiments with a risk assessment.   I've shelf life tested multiples of our products out to 12 months in the past and still have all the results.   We're a dry blending facility, non RTE, and we're extremely low risk.

 

Thoughts?

[Scampi]

A shelf life validation is generally only done once...................

 

After that, it's just a verification that your shelf life still holds true

 

You don't even need a risk assessment

 

Curious why you think you need to keep doing this?????

[MDaleDDF]

A shelf life validation is generally only done once...................

 

After that, it's just a verification that your shelf life still holds true

 

You don't even need a risk assessment

 

Curious why you think you need to keep doing this?????

I must've gotten my eyes crossed or something, I swore the V6 update had a clause for ongoing shelf life verification, but I'm looking thru it now, and have no idea where I got that.....

[Tony-C]

A shelf life validation is generally only done once...................

 

After that, it's just a verification that your shelf life still holds true

 

You don't even need a risk assessment

 

Curious why you think you need to keep doing this?????

 

 

I must've gotten my eyes crossed or something, I swore the V6 update had a clause for ongoing shelf life verification, but I'm looking thru it now, and have no idea where I got that.....

 

FSSC Additional Requirements - 2.5.13 Product Design and Development

e) Conduct production and shelf life trials to validate .....

A process for on-going shelf life verification shall be in place, at a frequency based on risk.

 

Kind regards,

 

Tony