2.8.2.1 Risk Analysis for Allergens?

I realize there is a lot of documentation regarding this very section of SQF so please forgive yet another thread to add to the masses, however I'm quite confused as to what I am required to do to conduct a Risk Analysis for allergens. SQF simply says that one must be conducted, yet it does not explain how to conduct such an analysis. I have seen several different examples just from searching online for 10 minutes and am unsure which I should use.

Am I supposed to just state the allergen present in each raw ingredient, if any, the likelihood of its presence, and the severity of the allergen if consumed by an allergic individual? Am I suppose to incorporate the possibility of cross-contamination some how?

Anyone have any examples? Why doesn't the Hazard Analysis Summary in HACCP satisfy this?

Any help would be appreciated!

Hi,

Regarding your inquiry, I think a simple tabular form of risk assessment would suffice if the standard did not specify any specific content for your risk assessment. We made by first referring to raw material decision tree wherein we listed all our raw material and assessed:

if there is a significant allergen associated with this raw material? If yes, then,

Are you or the customer going to process the allergen out of the product? If yes, then

Is there an allergen cross contamination risk to the facility or to other product which will not be controlled?

All the questions are answerable by YES or No only. Then, give some justification and control measures out of your decision tree if the raw materials are sensitive or not.

For allergen cross contamination risk assessment,

1. List all your process steps

2. Identify if this process involve a risk of allergen cross contamination  (answerable by YES or NO)

3. Justify your findings

4. Control measure to prevent occurrence of cross contamination.

I hope this help. 

Best regards,

Joan

I realize there is a lot of documentation regarding this very section of SQF so please forgive yet another thread to add to the masses, however I'm quite confused as to what I am required to do to conduct a Risk Analysis for allergens. SQF simply says that one must be conducted, yet it does not explain how to conduct such an analysis. I have seen several different examples just from searching online for 10 minutes and am unsure which I should use.

 

Am I supposed to just state the allergen present in each raw ingredient, if any, the likelihood of its presence, and the severity of the allergen if consumed by an allergic individual? Am I suppose to incorporate the possibility of cross-contamination some how?

 

Anyone have any examples? Why doesn't the Hazard Analysis Summary in HACCP satisfy this?

 

Any help would be appreciated!

Hi idealdreams,

I'm not a SQF user but this response may prompt some SQF user's inputs -

I think you meant sec. 2.8.2.1.i

more info. is required for a relevant reply (see below).

Comment 1 -

Suppliers should not consider the mandatory elements as the only elements to be implemented.  All applicable elements within module 2 must be implemented and will be audited.  For example, allergen management is not considered to be a mandatory element because some low risk food businesses do not have an allergen risk.  However, every facility that does have an allergen risk must have an allergen management program that meets 2.8.2, and will be audited against that element.

Comment 2 -

I suggest you consult the SQF guidance, pgs 55,62

My interpretation is -

(a) an Allergen Management Program as detailed pg 62 et seq is unavoidable if allergen hazards exist.

(b) risk asessment of any allergen-related hazards (eg from ingredients, cross-contamination) will (surely) be required in the hazard analysis for the Food Safety Plan.

The significance / handling of (a,b), if any, will relate to yr product/process/hazard analysis methodology.

Offhand, i interpret the meaning of 2.8.2.1(i) is that a list is required which includes the assessed risk to the finished product [as per yr hazard analysis], ie input/allergen/risk. The allergen risks will presumably be low if controlled by a labelling CCP / PRP.

Unfortunately, based on many threads here, SQF auditor's interpretation of the SQF Code/Guidance can be unpredictable so only an auditee/consultant can probably verify the above, or otherwise.

Thanks for the comments everyone. Prior to reading these comments, what I did was make a table listing each one of our product, as well as the allergens intentionally added and ones that could be present unintentionally due to cross-contamination and then the likelihood of contamination (high, medium, low) and the severity of cross-contamination if it occurs. We use one production line and three separate allergens so the "risk" of cross-contamination is quite high from this stand point, but we also perform allergen testing between product changeovers in accordance to our allergen matrix and ensure sanitation is adequate.

Does this seem like it is adequate or should I follow another approach?

Hi idealdreams,

IMEX, the severity associated with any allergen-derived hazard is uniformly rated as "High".

IMO the likelihood(s) should be uniformly "low" if PRPs are implemented (= Allergen management program).  If not low, then why not ??

Hi idealdreams,

 

IMEX, the severity associated with any allergen-derived hazard is uniformly rated as "High".

 

IMO the likelihood(s) should be uniformly "low" if PRPs are implemented (= Allergen management program).  If not low, then why not ??

I ranked the likelihood of cross-contamination as "medium" in my risk assessment because of the consideration of using one line and using three of eight (according to FDA) allergens. Should I still rank the risk as low? In general, do you feel this is an acceptable method to satisfy the risk assessment?

I ranked the likelihood of cross-contamination as "medium" in my risk assessment because of the consideration of using one line and using three of eight (according to FDA) allergens. Should I still rank the risk as low? In general, do you feel this is an acceptable method to satisfy the risk assessment?

Hi idealdreams,

IMO yr risk assessment methodology should be consistent, ie the risk for allergenic hazards should be evaluated in the same way as other hazards in yr haccp plan.

My approach to haccp is that where PRPs are satisfactorily implemented, the consequence is that the associated hazard  "likelihood"  must be Low. If the risk assessment shown states otherwise, the implication is that the PRP has (for some reason) failed which then has additional consequences.

afaik, SQF expects the Allergen management program to be implemented as a PRP.

But yr haccp methodology may differ to the above and still be acceptable to SQF. Plus I am not SQF user so maybe the SQF intent is different to my assumptions above. 

You need more inputs.

PS - one exception to above could be if an intrinsic allergen hazard is handled by a end CCP of labelling and separated from the allergen management program. This would not alter the risk assesments (RA) at preceding steps to the CCP  but would affect the RA at the CCP itself of course.

Check out our recent webinar it may give you some ideas:  Best Practices in Allergen Management 

Regards,

Simon

Thanks Simon, that was more than helpful!

Hi idealdreams,

As you stated there is a voluminous history of allergen threads relating to the overall section 2.8.2 which contains yr OP. IMO it reflects the degree of confusion in its presentation / interpretation.

After a review, I have concluded that the contents of my previous posts were incorrect due to my misunderstanding SQF's requirements for 2.8.2.1.i. Not entirely to my surprise and sorry for that ( my comments were probably more appropriate to the full SQF, FS Plan).

I suggest yr consideration of  2 short threads (links below) which contain IMO possible responses to yr request regarding para.2.8.2.1.i From Marshenko and Spurs Girl respectively.

The former has less scope but more semi-quantitative detail (although for allergens its matrix would IMO have a choice of 0% / 100% severity* and perhaps (some) arbitrary estimated likelihoods of 0%<X<100% if cross-contact involved.**

The latter loooks to involve more communicative effort due its scope  but perhaps provides more "directly meaningful" rankings. The scope is maybe 'flexible" from a SQF auditorial POV, eg restrictable to the auditee's site only?.

Regardless, I deduce both presentations were equally SQF acceptable as far as 2.8.2.1.i was concerned.

I noted that para 2.8.2.1.iv suggests that an explicit indication as to whether the allergen is present in an intentional (=intrinsic) or cross-contact scenario may be expected. This is self-evident in Spurs Girl's ranking system and perhaps numerically so in Marshenko's.**

http://www.ifsqn.com...isk-assessment/

http://www.ifsqn.com...ade-lubricants/

* the severity could be ranked via data such as VITAL but i doubt that it's SQF-expected. Although 2.8.2.1.ix rather suggests otherwise for certain cases.

** the table shown is ambiguous as to whether a solely Y/N entry is made in the "allergen" column + the justification column

PS - Only another 8 paragraphs to go !

Thanks again for all of the help everyone. What I have done for my risk assessment is list all ingredients and finished products and the allergens intentionally present. Then I used allergen mapping to show where the risk of cross-contamination could occur using our process flow. Because of the shared production line, I added that allergen swabbing in between product changeovers was necessary when required by the allergen matrix.

Now I have another question -- on our packaging, we list "product contains: peanuts" and then under it "made in a facility that also processes tree nuts and wheat." Why do I need to allergen swab if the customer knows there may be another allergen present, even if it's unintentional?

In determining high, medium, low, I think you also need to consider: 

• the education level of your staff; the chances of their errors to allergen cross contaminate
• the likelihood of poor cleaning and sanitation between products
• the type of allergen in question - what is the worst case scenario if a person with such allergies consumes this allergen-contaminated product?
• what support programs / control methods are in place to prevent allergen cross contamination - and in your opinion how effective are they?  

Also, an example of how I tackled the allergen element at each process step in the HACCP tables is attached.  These documents have been used in SQF programs as well as other Australian programs.  

Hi Jakmqa,

Nice to hear from you.

There do appear to be variances of opinion as to the SQF-intended interpretation of paragraph 2.8.2.1.i.  Notably, as per my understanding of the OP, regarding the expected response to the request for a “risk analysis”  in 2.8.2.1.i  This is particularly in view of the same “exercise”  being further duplicated within the hazard analysis for the complete FS Plan, eg 2.4.3.

I was uncertain which parts of the allergen-related content in yr 2 attachments was intended to correlate to  paragraph 2.8.2.1.i. ? 

(I sort of got the impression that yr attachments are more intended to respond to SQF section 2.4.3 for levels 2/3)

I was also uncertain whether you are regarding the “Allergen Management Program”  of sec. 2.8.2 as a PRP ?

Interpretative issues are inevitable for all the FS Standards of course. The bottom line IMO is how, when and where they are intelligibly clarified by the Standard designers. If ever.

PS - @idealdreams, apologies for slightly stealing yr thread.

Re- post 11. Some consumers are very highly sensitive to minute traces of particular allergens. Swabbing is particularly to verify the effectiveness of control measures to eliminate possible cross-contamination. The labelling is (a) a warning that control measures cannot be guaranteed 100% perfect and (b) a commercial liability disclaimer. The practical significance is possibly "b" first.

Hi Jakmqa,

 

Nice to hear from you.

 

There do appear to be variances of opinion as to the SQF-intended interpretation of paragraph 2.8.2.1.i.  Notably, as per my understanding of the OP, regarding the expected response to the request for a “risk analysis”  in 2.8.2.1.i  This is particularly in view of the same “exercise”  being further duplicated within the hazard analysis for the complete FS Plan, eg 2.4.3.

 

I was uncertain which parts of the allergen-related content in yr 2 attachments was intended to correlate to  paragraph 2.8.2.1.i. ? 

(I sort of got the impression that yr attachments are more intended to respond to SQF section 2.4.3 for levels 2/3)

 

I was also uncertain whether you are regarding the “Allergen Management Program”  of sec. 2.8.2 as a PRP ?

 

Hi Charles, 

Nice to chat again.  Hope you've been well.  

My apologies in my very belated response.  Yes, I suppose I was referring to allergen risk analysis in general.  

In regards to idealdreams's query of "I'm quite confused as to what I am required to do to conduct a Risk Analysis for allergens" , I do stand by the information I supplied - adding allergens to the HACCP analysis/audit table.  

A support program (what you call an OP) should also be supplied as support programs also include general information, whereas HACCP plans focus on the criticals and controls.  

Reading 2.8.2.1 again and its little sister 2.8.2.1i, further suggestions could be: 

• Identify each potential allergen or cross contamination of allergen for each finished product.  I've done this by listing all allergens for the country the product is made/sold in (i.e. my country, Australia).  Then cross referenced each finished product against each declarable allergen and potential cross contamination of each allergen
• VITAL tool by the Allergen Bureau http://allergenbureau.net/vital/.  VITAL tool used to be for free - unsure if it is anymore.  I no longer use VITAL tool as I haven't been working with food manufacturers that have complicated systems