7 replies to this topic

[Dr Vu]

1)we conduct Elisa testing for peanut, milk, soy, wheat and egg; however, we also packages tree nuts, including almonds, hazelnuts and walnuts. Rapid testing kits are available on the market for almonds and hazelnuts but are not currently utilized for validation of allergen changeover cleaning. A veratox 1-hour test exists for walnuts and was not currently used.- is this an industry practice? are we supposed to have/ carryout all allergens tests as long as the test kit is available in the market
2) i have big bags pre printed for a different product - but re use the bags to meet my environmental KPI's (validated there was no cross contamination). We use barcoding to identify all the bags can i get away with these bags ? during internal audit, 14/14 people said if barcode is missing they would not move the bag and would call supervisor. Will this be covered on the code or is this industry practice as well

3) does signing the NC report mean you agree with auditor? or it means you received a copy?

4) what audit trail must you keep for internal audit?

[esquef]

1)we conduct Elisa testing for peanut, milk, soy, wheat and egg; however, we also packages tree nuts, including almonds, hazelnuts and walnuts. Rapid testing kits are available on the market for almonds and hazelnuts but are not currently utilized for validation of allergen changeover cleaning. A veratox 1-hour test exists for walnuts and was not currently used.- is this an industry practice? are we supposed to have/ carryout all allergens tests as long as the test kit is available in the market
2) i have big bags pre printed for a different product - but re use the bags to meet my environmental KPI's (validated there was no cross contamination). We use barcoding to identify all the bags can i get away with these bags ? during internal audit, 14/14 people said if barcode is missing they would not move the bag and would call supervisor. Will this be covered on the code or is this industry practice as well

3) does signing the NC report mean you agree with auditor? or it means you received a copy?

4) what audit trail must you keep for internal audit?

What's the product and risk level? If your process is considered low risk you probably just need to validate your allergen changeover is effective on each line. This should probably be done annually at minimum. I would think that Neogen swabbing would be acceptable, but I would back up the results by sending samples to an outside lab.

I don't quite understand your question on bags. SQF is fairly clear on product identity, and in my experience it's taken seriously in both the document and facility audits. 4.6.1 states "The methods and responsibility for identifying product during all stages of production and storage shall be documented and implemented.The product identification system shall be implemented to ensure:
i. Product is clearly identifyable during all stages of receipt, production, storage, and dispatch; and
ii. Finished product is labeled to the customer specification and/or regulatory requirements.

We were told by our auditor that signing off on the NC report did not preclude appeals to the CB to reduce or retract the NC.

As far as audit trail, you'll need documentation that your internal auditors were trained, an internal audit schedule, documentation of any meetings that your internal audit procedure prescribes, audit checklists signed and dated by the auditors and auditee department head, etc. NC's and corrective/preventive actions also need to be documented.

[Dr Vu]

What's the product and risk level? If your process is considered low risk you probably just need to validate your allergen changeover is effective on each line. This should probably be done annually at minimum. I would think that Neogen swabbing would be acceptable, but I would back up the results by sending samples to an outside lab.

I don't quite understand your question on bags. SQF is fairly clear on product identity, and in my experience it's taken seriously in both the document and facility audits. 4.6.1 states "The methods and responsibility for identifying product during all stages of production and storage shall be documented and implemented.The product identification system shall be implemented to ensure:
i. Product is clearly identifyable during all stages of receipt, production, storage, and dispatch; and
ii. Finished product is labeled to the customer specification and/or regulatory requirements.

We were told by our auditor that signing off on the NC report did not preclude appeals to the CB to reduce or retract the NC.

As far as audit trail, you'll need documentation that your internal auditors were trained, an internal audit schedule, documentation of any meetings that your internal audit procedure prescribes, audit checklists signed and dated by the auditors and auditee department head, etc. NC's and corrective/preventive actions also need to be documented.

• audit trail would be between identifying a NC and applying corrective action.. there should be other records in between but i am not sure if you would recommend generating work orders for the audit?
• Signing that means you agree that the audit was factual and you agree with the findings.. during the appeal they kep saying..ohh you signed. the NCs
• on the bags, yes the bags are identifiable.. but have 2 labels... the label on the bag (pre-printed) is not ours, it is the supplier's label and doesn't mean a thing to us.. as we use barcodes.... does that mean i have to throw away those bags and buy some new ones?
• on the products- they are high risk.. and mostly contain all the allergens specified eg peanuts only.. etc..... (the labs also use neogen kits).. maybe having them inhouse is better.. we ship to US so we are expected to have ALL the tests.. or at least test for all the products as long as test kit is available..

Edited by vulindlela, 11 June 2012 - 11:58 PM.

[esquef]

• audit trail would be between identifying a NC and applying corrective action.. there should be other records in between but i am not sure if you would recommend generating work orders for the audit?

I'd recommend that any corrected actions be entered in you CAPA system, and if a maintenance work order is generated it be availaible to show that the corrective action was taken and verified to be effective (also verification that any product contact surface that was compromised during any maintenance work was properly cleaned and sanitized).

• Signing that means you agree that the audit was factual and you agree with the findings.. during the appeal they kep saying..ohh you signed. the NCs

All I can suggest is that you bring this to the attention of the SQFI. We were assured that an appeal to a NC was an option until your corrective actions had been turned in to thew CB.

• on the bags, yes the bags are identifiable.. but have 2 labels... the label on the bag (pre-printed) is not ours, it is the supplier's label and doesn't mean a thing to us.. as we use barcodes.... does that mean i have to throw away those bags and buy some new ones?

If you need a barcode reader to identify a product that is different than the label I'd think that that wouldn't conform to Product Identity requirements.

on the products- they are high risk.. and mostly contain all the allergens specified eg peanuts only.. etc..... (the labs also use neogen kits).. maybe having them inhouse is better.. we ship to US so we are expected to have ALL the tests.. or at least test for all the products as long as test kit is available..

Neogen swabs should be okay as long as you have a good validation and verification of your allergen changeover cleaning, but that's the auditor's call.

[Charles.C]

Dear Vulindlela,

SQF is not my specific area however another recent thread on allergen testing (don't remember if SQF standard related) suggested that the logical (and economic) response / procedure is to perform a validation exercise which demonstrates that the procedure(s) in use reliably achieves an acceptable "absence" of allergenic material at locations considered to be of significant risk. This then avoids continuous swabbing / kit application all over the place/time while enabling "occasional" verification measurements. Use of "cleanliness" type criteria can be a convenient routine support if correlation is possible. This approach is mentioned on some allergen websites.

My only immediate caution to above is that SQF has previously been shown to contain some rather unorthodox interpretations of validation/verification. Needs checking first maybe.

Rgds / Charles.C

[esquef]

Dear Vulindlela,

SQF is not my specific area however another recent thread on allergen testing (don't remember if SQF standard related) suggested that the logical (and economic) response / procedure is to perform a validation exercise which demonstrates that the procedure(s) in use reliably achieves an acceptable "absence" of allergenic material at locations considered to be of significant risk. This then avoids continuous swabbing / kit application all over the place/time while enabling "occasional" verification measurements. Use of "cleanliness" type criteria can be a convenient routine support if correlation is possible. This approach is mentioned on some allergen websites.

My only immediate caution to above is that SQF has previously been shown to contain some rather unorthodox interpretations of validation/verification. Needs checking first maybe.

Rgds / Charles.C

One way to do what you suggest Charles is to run an unexpensive neutral carrier (ex. salt) through your process and then send a sample off to be analyzed for trace amounts of allergen(s). As our auditor stated you "build your case" showing that you have an adequate SSOP to remove traces of any allergen(s) run before the cleaning procedure. Since SQF defines validation as "proving that what you're doing is working and effective" once you've validated all lines and all allergens run on those lines you wouldn't have to do continuous swabbing unless a significant change was made to your process. In that case a revalidation would be necessary. In my experience the verification is to record when allergen changeover cleanings occur (and those records then need to be verified by the SQF Practioner or a delegated person).

Edited by esquef, 12 June 2012 - 07:01 PM.

[Katja]

One way to do what you suggest Charles is to run an unexpensive neutral carrier (ex. salt) through your process and then send a sample off to be analyzed for trace amounts of allergen(s). As our auditor stated you "build your case" showing that you have an adequate SSOP to remove traces of any allergen(s) run before the cleaning procedure. Since SQF defines validation as "proving that what you're doing is working and effective" once you've validated all lines and all allergens run on those lines you wouldn't have to do continuous swabbing unless a significant change was made to your process. In that case a revalidation would be necessary. In my experience the verification is to record when allergen changeover cleanings occur (and those records then need to be verified by the SQF Practioner or a delegated person).

I am surprised an auditor suggested this to you as from what i have been told bu auditors is that something like this which is equivalent to final product testing is not allowed since you must demonstrate you can prevent cross-contamination, not that you can control it, nor is it acceptable to say that it is below process detectable limits. We validated our allergen changeover cleaning procedures through swabbing of equipment and neogen swabs, we verify either with qualitative allergen protein swabs, visual inspection or ATP as these are indicators of cleanliness.

[esquef]

I am surprised an auditor suggested this to you as from what i have been told bu auditors is that something like this which is equivalent to final product testing is not allowed since you must demonstrate you can prevent cross-contamination, not that you can control it, nor is it acceptable to say that it is below process detectable limits. We validated our allergen changeover cleaning procedures through swabbing of equipment and neogen swabs, we verify either with qualitative allergen protein swabs, visual inspection or ATP as these are indicators of cleanliness.

Swabbing, visual, and ATP dont't show whether there's potential carryover (at least in the dry foods blending type industry). There are places you can't see or reach that could be missed during a dry or wet clean. ATP is virtually worthless IMO. We've done studies on equipment where product contact surfaces have been swabbed and sent to multiple independent analytical labs with those results compared to ATP swab results (all taken on cleaned and uncleaned surfaces). While the independent lab results correlated with each other well, they did no correlate well with ATP results at all. When I worked for an over the counter drug manufacturer a few years ago our FDA inspector didn't even want to hear about using ATP as a validation tool. Different strokes for different auditors I guess.

Edited by esquef, 15 June 2012 - 07:57 PM.