What would you do? Allergen cross contamination

Good afternoon all;

I am having quite the conversation with senior management regarding allergen cross contact.  We run two lines every so often one line is allergen and the other is non-allergen.  99.9% of the time there is no issues and nothing happens.  Recently, we have had the finding of a piece of product from the allergen line being found on the non-allergen line.  We now have a cross contamination scenario and what I would like to know is what would you do if this occurred to you. 

Thanks :oops2:

Jim

The simple answer is that you have a hazard that is not being controlled.  You need to find our why (i.e., a root cause analysis) and then implement controls to prevent it.  From your description this is not a theoretical hazard but an actual one that can not be dismissed or ignored. 

Good afternoon all;

 

I am having quite the conversation with senior management regarding allergen cross contact.  We run two lines every so often one line is allergen and the other is non-allergen.  99.9% of the time there is no issues and nothing happens.  Recently, we have had the finding of a piece of product from the allergen line being found on the non-allergen line.  We now have a cross contamination scenario and what I would like to know is what would you do if this occurred to you. 

 

Thanks :oops2:

 

Jim

It sounds like you need better "segregation".

Thank for information :rofl2:

We have a risk assessment for such an issue in place.  What I am looking for are steps to take when discovered. As below this is what I think should be done, am I missing anything?

1. Stop the line.

2. Advise production management of situation

3. Hold product for disposition

4. Take allergen swabs to determine if contamination present.

5. Clean line to point of contact

6. Conduct allergen swabs again

Jim,

If the problem is that "a piece of product" is getting in the wrong line, cleaning of the line may not be the problem.  You really need to do a root cause analysis to figure out what is happening.

I agree that putting the product on hold is a good idea.  If cleaning is the problem, perhaps you need to change the cleaning and monitoring procedure.  Maybe the lines cross or some utensils are used on both lines.  Maybe you use the same bins to hold both kinds of WIP or rework.  Maybe it is an employee handling problem.  

Steve 

We have a risk assessment for such an issue in place.  What I am looking for are steps to take when discovered. As below this is what I think should be done, am I missing anything?

1. Stop the line.

2. Advise production management of situation

3. Hold product for disposition

4. Take allergen swabs to determine if contamination present.

5. Clean line to point of contact

6. Conduct allergen swabs again

@ Jim E. 

Careful, you can't "test your way out" of a positive value. The fact is that if you found a piece of product containing allergenic material, swabbing the line and not finding allergens does not eliminate the evidence you've already collected. You can use the swabs to "release" the line again after you clean, but I think the crux of your question is the disposition of the product, and testing won't help you unless you do a LOT of it. Pretend the allergenic material was rodent scat instead, would you just micro test the line and some of the product and call it good?

With additional information (e.g. we know that a tool went missing from the allergen line and was used on the non-allergen line on second shift) you can potentially segregate the product made in that implicated time period and save the rest. But if you can't identify a reasonable root cause for when/how the cross-contamination occurred, your entire lot is implicated. The type of product you're running weighs in on this as well. So if you're running dry macaroni for example and you found a milk dud. Provided you had evidence that it was a solitary milk dud and there was no potential for others it's reasonable that you could segregate and destroy material produced directly before and after the contamination event (or all material from the time stamp contamination occurred forward to capture cross-contamination on the shared equipment), but you need evidence.

Essentially, if you can identify where, when, how, and how much regarding the contamination you found, you have options to save at least a partial amount of your product on hold. 

Again, I think your release to continue production procedure is fine. But if you found cross-contamination of an allergen, and have no idea when where or how much (root cause), then the safest action is to destroy product produced since your last sanitation event, because it could have been introduced to the line anytime between then and now, and in any quantity.

Enjoy that discussion with management, and if it's a spendy disposal, use it as fuel to reinforce allergen segregation with your plant employees and supervisors. And find the root cause!