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SQF 2.8.2.1 vii (Allergen cleaning validation)


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#1 bacon

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Posted 11 January 2013 - 04:37 AM

Just got this through a SQF audit.....

This a Major NC:


I think this unjust definition and un-stated-in-the-code change is due to SQF anticipating FDA reg changes coming down the pipe line, even when we use an FDA study as validation of our practices/methods: this is what re just got from our auditor via the C.B via SQFI, this hinges on the interpretation of validating "effective" cleaning measures of allergen cleaning.... (not verification).

______________________________________________________


2.8.2.1 vii

SQF Requirement: Cleaning and sanitation of product contact surfaces between line changeovers shall be effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces, including aerosols as appropriate, to prevent cross contact.

Expectation: The SQF Code requires validation and verification of cleaning and sanitizing procedures for the product contact equipment. Therefore, the use of finished product testing for validation of cleaning is not considered adequate. A program of verification needs to be built on an initial validation study that identifies target allergens, threshold levels and the severity of contamination, and shows the cleaning process and testing used are effective to give the desired results consistently. Once the cleaning process has been validated as effective verification/monitoring program shall be established.

The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen(s). This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence. The acceptable validation testing methods involve the use of a test method which uses an antigen and antibody test, such as the ELISA method. The ELISA method can be qualitative or quantitative and can be conducted in a laboratory or with test kits available for plant use. Most test kits have a sensitivity of 10 PPM.

Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must verify that the validated procedures were used each time. The verification must be documented by a responsible person from the facility who has been trained in the validated cleaning method. The most common method is the use of highly sensitive swabs that test for proteins (sensitivity 20 PPM).

When there is a mixture of different allergens in use, the acceptable method for confirming the effectiveness of cleaning is to test for the highest risk allergens, the highest concentration of allergens, or the ones that are most difficult to remove. Examples of difficult to remove allergens include milk proteins, such as in chocolates.

Nearly all of the allergens have specific test kits available. However, there are a few allergens that do not have a test kit. There are currently no test kits available for certain fish species and all tree nuts. In these cases the use of highly sensitive protein swabs may be an acceptable alternative.

Suppliers using whole or partial nuts such as muffin toppings have to verify removal of all the nut fragments from the equipment (based on visual inspection). Ground nuts and nut butters require the use of validated cleaning procedures and a recognized allergen specific cleaning test such as conveyors, augers and other product transfer devices.

Dry product processing facilities may use an inert product flush to remove allergens. In this case three product flushes may be required to assure removal of allergens.

______________________________________________________

........... So it seems if it is not the ELISA method, it is not "validation" (-10 as a Major NC).

I cant "validate" if this comes directly from SQFI but that is what the contract auditor is stating that is coming from the CB he is working with.
It seems NSF sent out a letter addressing this issue to its auditors and the clients BEFORE audits ensued (we did not get that luxury).

Dont know if this will impact other GFSI benchmarks...
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#2 Marshenko

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Posted 11 January 2013 - 01:23 PM

Funny... this document, although dated Oct 25th, just happened to pop up on the SQFI website very recently:

http://www.sqfi.com/...ce-Document.pdf

Under validation:

The purpose of validation is to prove that the cleaning process employed is effective in removing the
allergen of concern. This proof requires evidence that the specific allergen was in fact removed, or
reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will
provide that evidence.
The acceptable validation testing methods involve the use of a test specific to the allergen being
removed. These generally require the use of a test method which uses an antigen (the allergen) and an
antibody specific to the antigen. One example of the antigen and antibody test is the enzyme linked
immuno-assay or ELISA method. The ELISA method can be either quantitative or qualitative and can be
conducted in a laboratory or with test kits available for in plant use; either is acceptable. ELISA test kits
are available from several manufacturers and are commonly used in the food processing industry.
Lateral flow test devices also use an ELISA-based method and are also effective in detecting specific
allergens. While lateral flow devices are qualitative only, most have sensitivities around 10 parts per
million(ppm) and are available for most of the common allergens and are designed for use in a plant
environment.
Both the ELISA tests and lateral flow test kits have been accepted by recognized allergen research
scientists and meet the requirements for sanitation validation of the SQF Code. It must be noted that
there may be other ‘acceptable’ tests for validation methods that can be used but the test must meet
the “allergen specific” criteria or provide some other evidence that the validation is effective. The SQF
Institute does not endorse any particular technology or methodology and relies on the facility to provide
the evidence of a scientifically validated and effective cleaning method. Like any validation of any food
safety control, periodic re-validation is required to account for any changes that may have occurred.
Not all allergens have specific test kits available which includes some fin fish and allergens that have
been modified by fermentation, heating or hydrolysis.


I think its a bunch of crap personally, and I'm going to get into a nice argument with our auditor regarding the fact - the allergens we use in our process are soy and wheat, both of which are contained in soy sauce, which is the ingredient we use in a couple of marinades. Why do I need to go above and beyond the Hygiena Aller-SNAP swabs that we are already doing to narrow down whether or not its "soy" or "wheat" being found on our tumblers, when they are always being used in the process together?

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#3 bacon

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Posted 11 January 2013 - 02:16 PM

Funny... this document, although dated Oct 25th, just happened to pop up on the SQFI website very recently:

http://www.sqfi.com/...ce-Document.pdf

Under validation:


I think its a bunch of crap personally, and I'm going to get into a nice argument with our auditor regarding the fact - the allergens we use in our process are soy and wheat, both of which are contained in soy sauce, which is the ingredient we use in a couple of marinades. Why do I need to go above and beyond the Hygiena Aller-SNAP swabs that we are already doing to narrow down whether or not its "soy" or "wheat" being found on our tumblers, when they are always being used in the process together?


Thank you Marshenko, we we also concur.

Rules, requirements and regulations change all the time pending on new findings and studies... but our 1st gripe is that our C.B. didn't even give us any lead time; we could have implemented it in time for our audit IF we were notified on Oct. 25th, it is not as of this was a governmental notification (at this time anyway). If your CB has not notified you... ask why. The code specifies that we have to notify our CB and SQFI both with product withdrawal and crisis events... how about SQFI and our CB with us on major changes that will impact our audit.

This is a very interesting development...

Edited by baron, 11 January 2013 - 02:18 PM.

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#4 esquef

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Posted 11 January 2013 - 02:48 PM

Wow, I check the SQFI Document page (http://www.sqfi.com/documents/) regularly and this is the first I've seen this Guidcance Document. Anyone know when they put this up? A couple of days ago I watched a live webinar and the SQFI Technical Manager who presented the webinar (titled "Understanding the SQF Code Updates & the Internal Audit Process") was questioned about the lack of Guidance Docs. She responded that they weer supposed to come out not long after Version 7 was implemented (July 1st) but admitted that they still didn't have them ready and now projected that they would be ready by the end of February. If they're changing their fundemental stance on issues like allergen cleaning validation/verification I have to wonder what other areas will be "updated" (sanitation, supplier approval, etc.).



#5 bacon

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Posted 11 January 2013 - 03:03 PM

Wow, I check the SQFI Document page (http://www.sqfi.com/documents/) regularly and this is the first I've seen this Guidcance Document. Anyone know when they put this up? A couple of days ago I watched a live webinar and the SQFI Technical Manager who presented the webinar (titled "Understanding the SQF Code Updates & the Internal Audit Process") was questioned about the lack of Guidance Docs. She responded that they weer supposed to come out not long after Version 7 was implemented (July 1st) but admitted that they still didn't have them ready and now projected that they would be ready by the end of February. If they're changing their fundemental stance on issues like allergen cleaning validation/verification I have to wonder what other areas will be "updated" (sanitation, supplier approval, etc.).


But even so, please note: "The guidance documents are available to assist the supplier, but are not auditable documents. Where there is a divergence between the guidance document and the SQF Code, the SQF Code prevails." (The SQF Code, Edition 7, 1.9, page 22)

Although they are still helpful and useful, (Per SQF) one really should not care (and some auditors also have stated) what the Guidance Doc say.
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#6 esquef

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Posted 11 January 2013 - 03:10 PM

I understand that Baron, but from what I get from your first post is that you got dinged 10 points for not following the Guidance Doc. If that's the case are going to contest the major NC with your CB?


Edited by esquef, 11 January 2013 - 03:18 PM.


#7 Marshenko

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Posted 11 January 2013 - 04:18 PM

Wow, I check the SQFI Document page (http://www.sqfi.com/documents/) regularly and this is the first I've seen this Guidcance Document. Anyone know when they put this up? A couple of days ago I watched a live webinar and the SQFI Technical Manager who presented the webinar (titled "Understanding the SQF Code Updates & the Internal Audit Process") was questioned about the lack of Guidance Docs. She responded that they weer supposed to come out not long after Version 7 was implemented (July 1st) but admitted that they still didn't have them ready and now projected that they would be ready by the end of February. If they're changing their fundemental stance on issues like allergen cleaning validation/verification I have to wonder what other areas will be "updated" (sanitation, supplier approval, etc.).


I check it regularly too, and I just happened to notice it yesterday. It definitely went up this week, even though its dated much earlier.

Now I'm tasked with how often I should use the Neogen swabs to validate - once a month frequency is still going to run us an extra $500+ a year above all of the steps we already have in place.

It is quite funny how SQF just comes out with these random documents, or even misses their deadlines. Has anyone seen this "general guidance document" that was supposed to be released in April 2012?

http://www.sqfi.com/...-sqf-code-ed-7/


SQF Code Ed. 7 Timeline:

August 2011 – SQF Code Ed. 7 received stakeholder input; reviewed by SQF Technical Advisory Council

Sept. 2, 2011 – SQF Code Ed. 7 submitted to GFSI for benchmarking

Feb. 1, 2012 – SQF Code Ed. 7 final version posted to the SQF Institute website

Feb. 8, 2012 – Auditor criteria for SQF Code Ed. 7 posted and implemented

April 2012 – SQF Institute to release general guidance document for SQF Code Ed. 7

July 1, 2012 – Full implementation of the new code to begin for all audits


Edited by Marshenko, 11 January 2013 - 04:19 PM.


#8 Marshenko

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Posted 11 January 2013 - 04:25 PM

So let me run this one by everyone.

We actually handle three allergens in our facility. One very infrequently (Milk in sausage that is brought in and repacked) and then soy+wheat in the soy sauce based marinades.

Can I just use the Reveal 3D total milk test kits on a monthly basis for validation that 's there's no cross-contact occurring with the milk allergen? That would eliminate the milk allergen as a possibility ... ?



#9 Urban Explorer

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Posted 11 January 2013 - 10:49 PM

This came up in our audit, and they gave us a minor for it. Amazing how different auditors can be.

Anyhoo, we test regularly with Aller-snap swabs after each production run of allergens. Currently we have 6. The auditors told us that once a year is sufficient to "validate" the cleanliness of our procedure. Our contract lab guy gave us a quote for $200 for the actual audit that he will do (coming out himself) and then $35 for each test using an allergen specific test and for each finished product test to verify no other allergens are present (depending on the label claim).

I really didn't like our auditor's attitude about us not having an ATP system. Nowhere is it required to have one, and they are disgustingly expensive. Sure, I'd like to have one available, but really.



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#10 bacon

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Posted 11 January 2013 - 11:49 PM

Attached File  AS Almond (COKAL0710AS) - Package Insert_Original_16358.pdf   430.53KB   105 downloads
Attached File  AS Allergen - Product Focus.pdf   350.69KB   128 downloads
Attached File  AS Allergen - General Product Brochure.pdf   1.83MB   137 downloads

We are researching now, this brand says their testing kit is sensitive (10 PPM).
They are getting back to us with the technical specs.
This is a qualitative test (BRC will not accept it seems)

Cheers,
-B
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#11 Charles.C

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Posted 12 January 2013 - 05:04 AM

Attached File  AS Almond (COKAL0710AS) - Package Insert_Original_16358.pdf   430.53KB   105 downloads
Attached File  AS Allergen - Product Focus.pdf   350.69KB   128 downloads
Attached File  AS Allergen - General Product Brochure.pdf   1.83MB   137 downloads

We are researching now, this brand says their testing kit is sensitive (10 PPM).
They are getting back to us with the technical specs.
This is a qualitative test (BRC will not accept it seems)

Cheers,
-B


Dear baron,

Thks for the data. I really liked the validation against "Competition X".

Didn't see any price validation numbers though. :smile:

AOAC validation would seem a more useful possession. I believe some do have it ?.

Rgds / Charles.C

Kind Regards,

 

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#12 bacon

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Posted 12 January 2013 - 09:28 PM

I understand that Baron, but from what I get from your first post is that you got dinged 10 points for not following the Guidance Doc. If that's the case are going to contest the major NC with your CB?


Yes, but this is rather delicate as our other facility is going through an audit with the same CB in a couple days... if we get it moved down to at lease a minor, we will not have a 6 month surveillance audit...
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#13 Marshenko

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Posted 14 January 2013 - 12:56 PM

I'm planning on keeping the Aller-SNAP, and then buying a set of Neogen Reveal 3D tests for validation purposes to start using. Our facility audit is first week of February.

http://www.neogen.co...est_Kit_Cat=203



#14 SQFconsultant

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Posted 16 January 2013 - 10:28 PM

I imagine that you would be quite happy this happened on the stage 1 audit instead of on the stage 2 certification audit. Granted it's a 14 day corrective item, however it would really be rough if it came up on your certification audit.


Just curious, what did the auditor write in for comments as he/she can note the item but not the recommended correction?



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#15 bill1952

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Posted 17 January 2013 - 02:47 PM

Look at my post in January for 'Allergens in confectionary products"
I am a SQF practitioner and I have been an auditor over my career. There is no acedemic or industry threshold for allergens. There is a limit for Gluten, 20 PPM but this is not one of the Big 8.
I use a Reveal 3D or Alert to check for residual allergen protein after we run a peanut product. It will detect down to 10 PPM. There is a paper I read that peanut sensitivity for some can be as great as 7 'mu' g. To send a sample to an outside lab is costly and time consuming with time sensitive products.
I'm in candy manufacturing with enrobers and the challenge is very high to control allergen cross contamination.
I don't have a good validation of my cleaning process according to SQF v 7. I would challenge the audit results because there is no threshold limit set by any audit service or FDA.



#16 Charles.C

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Posted 17 January 2013 - 06:35 PM

Look at my post in January for 'Allergens in confectionary products"
I am a SQF practitioner and I have been an auditor over my career. There is no acedemic or industry threshold for allergens. There is a limit for Gluten, 20 PPM but this is not one of the Big 8.
I use a Reveal 3D or Alert to check for residual allergen protein after we run a peanut product. It will detect down to 10 PPM. There is a paper I read that peanut sensitivity for some can be as great as 7 'mu' g. To send a sample to an outside lab is costly and time consuming with time sensitive products.
I'm in candy manufacturing with enrobers and the challenge is very high to control allergen cross contamination.
I don't have a good validation of my cleaning process according to SQF v 7. I would challenge the audit results because there is no threshold limit set by any audit service or FDA.


Dear bill,

Thks for the (implicit) agreement to my response in yr parallel candy thread -

http://www.ifsqn.com...dpost__p__58189

Actually i was unable to locate any official US ratification of the (some time ago) proposed 20 ppm Gluten limit you mention. Elsewhere, various opinions seemed to exist, eg -

http://www.glutenfre...g-labeling-laws

Perhaps you have more recent US information ?

Rgds / Charles.C

Kind Regards,

 

Charles.C


#17 bacon

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Posted 17 January 2013 - 08:58 PM

I would challenge the audit results because there is no threshold limit set by any audit service or FDA.


Government food inspection programs have always been weak and could not assure food safety, that is why the market created the GFSI benchmarks. SQF seems to be setting threshold limit for validating allergen cleaning programs. As the 3rd party audit is a voluntary audit, using FDA as a backup will not work I am afraid.

My protest is the way we were informed (during the audit) and not being informed of such changes before our audit.
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#18 williamw

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Posted 16 February 2013 - 12:43 AM

For some of us there is a much bigger issue raised by this guidance than the validation testing. There are some types of equipment and processes where assuring a complete absence of cross contact is not practical. We have relied on advisory labeling for this ( in the US this has been something or a grey area but has been a common practice and at least grudgingly allowed by FDA). When we obtained our initial certification 3 years ago the issue of advisory labeling came up and we provided our CB with an expert opinion letter from Steve Taylor that in our industry and process it was not feasible to eliminate cross contact and the use of advisory labeling was appropriate. This was reviewed by the CB -- and supposedly with SQFI -- and we were allowed to use advisory labeling based on that part of the process but were still required to maintain full allergen controls, changeover cleaning, etc. in all downstream operations.

Now SQF is stating that advisory labeling cannot be used and that only option for equipment/processes that cannot be cleaned is dedicated lines. For us that is a no-go economically. We would need to invest $10-15 Million in equipment and probably $5 million in facility expansion to be able to separate our processes and much of this equipment would have a 15 to 30% utilization rate. I have brought this to the attention of our industry trade association as it is an issue not only for us but for the majority of companies in our industry.



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#19 Charles.C

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Posted 16 February 2013 - 06:48 AM

Dear williamw,

I presume yr basic operational problem is non-accessability into equipment for routine cleaning. Must surely happen.

I deduce that in USA the basic "advisory" issue has been "under consideration", ie grey, since 2004 -

http://www.fda.gov/f...n/ucm106187.htm
[Sect.204 - 3(A)]

And presumably with pressure to clarify the situation at sporadic intervals, eg this 2009 status update -
http://www.ext.colos...r/v13n1s04.html

Analogous problems exist elsewhere of course but seemingly have not (yet) caused dramatic action like you are reporting for SQF, eg
http://www.bmj.com/c...t/343/bmj.d6180
http://www.food.gov....rgyintol/label/

I assume something has happened to induce SQF's rocking-the-boat since no related changes at the Requlatory front as far as i can see ?.

"Irresistable force vs Unmovable Object"

Worst case scenario > Change of food standard perhaps. Not exactly a small leverage if an Industry-wide problem.

Rgds / Charles.C


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Charles.C


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#20 bacon

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Posted 20 February 2013 - 08:56 PM

Some colleagues have referenced BRI's Guideline 59: http://www.campdenbr...php?pubsID=2487


Edited by baron, 20 February 2013 - 08:57 PM.

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#21 Charles.C

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Posted 21 February 2013 - 12:37 AM

Some colleagues have referenced BRI's Guideline 59: http://www.campdenbr...php?pubsID=2487


Dear baron,

Looks attractive but needs deep pockets. :smile:

Rgds / Charles.C

Kind Regards,

 

Charles.C





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