CAPA for product quality - wrong flavour

Hey all,

I have run into a minor food quality issue. A customer of ours found a (one single) watermelon flavored lollipop in a box of strawberry flavored lollipops that we sold to. It was supposed to be all strawberry. The customer requests a CAPA. Since it is one single piece, I don't know how to go about that. Can someone help with possible root causes and corrective action plan examples?

Much appreciated. 

I think I'd do a fishbone with the team who pack it.  Lots of examples are out there on the internet.  I'd work through it with the team and work out all of the controls you have in place, whether they were followed, if there are any gaps (e.g. places in your machine things could get caught and how easy it is to inspect), then once you find the root causes, fix them.  

For the "CA" bit, I would probably make the team aware with a briefing, much as I hate it.  It's the "PA" bit where you need to spend your time.  For example, if your line clearance is time pressured and they can't really do it, then it needs to be less so.  Briefing people won't make a difference.  

Have you determined a root cause? Is this a known issue that happens from time to time? Was this a onetime occurrence with this customer? Does that customer purchase watermelon flavored lolis as well and could they have inadvertently mixed one up? (oops, one fell out, it goes right here!)

Fishbone like GMO said would probably be best starting point if you haven't yet, just to get all the possibles out in front of you.

Sheesh this sounds like a lot of work for one dang wrong flavored sucker.. Are they a big customer?

No, this does not happen often. It's the first occurrence. The customer sent me a photo with the box with the wrong one mixed in. I don't think they would have mixed up inadvertently. It's a med to big customer. I don't know why it's a big deal still. 

It's a big deal because you shouldn't have one product mixed with another.  The ingredients will not be the same.

You should have line clearances between products even if they've not got different allergens in them so the right product and right packaging are used.

I agree some formal RCA is needed and you do need to take this seriously.

How are the lollipops packed?  Is it by hand or by machine?  If by hand, I could see the one watermelon getting in with the strawberry ones possibly being human error.  

I agree with everyone above, meet up with the team and go through a fishbone diagram and see what you get from there.

I'm with the above.  This is a contamination issue as your process permitted a foreign piece of candy to get into a case of finished product.  If lollipops are the only thing you make, sure, it could be as simple as a person was careless and mixed one in while stocking some bins in the warehouse.  But if you handle other candies, say some containing allergens, then a customer would be well within their rights to scream all holy hell if they received such a piece in a bag that should be free from allergen materials.  Review your packing and shipping process and put a good effort into finding out how this happened, because they next incident may not present in such a harmless fashion.

Pic attached of my favorite example for mislabeled/mishandled products.  It happens, and sometimes we want to dismiss it as the relative risk associated is perceived as null.  But, in each and every case of a mislabeled item, it could be severe.  Today it was a wrong flavor of lollipop.  Tomorrow it could be an item containing a tree nut and present as a risk to a person with severe allergy.  That's why I take this photo as an example and tell my teams that even something so arbitrary as the wrong shaped bread is worthy of a recall.

Great example Jfrey.

There was another one I saw online recently where they had some fusilli pasta mixed in with some penne.  They thought it was funny.  I didn't.  Yes it's just different shapes this time but one plant I know who packs products like that also packs nuts.

Not saying this is the situation with the OP but one product mispacked is a mispack.  At some point some bright spark will introduce some product you really CAN'T get mixed up, like sugar free and sugar containing sweets, or worse, allergens.

Anyway, like anything else, get a team together, do some RCA, work out what it is that's causing the gap, fix said issue(s) and Bob's your uncle.

Hi konf,

The complaint leads to lots of questions:

Do you have a trace on the watermelon and strawberry in the box, so know when they were produced?

Do you change from strawberry to watermelon in your production schedule?

I assume that you box during production?

What happens when you don't have a full box at the end of the run?

Was the one watermelon tasted and found to be watermelon flavour or was it strawberry?

Kind regards,

Tony

I think it is important to get as much information as you can about the wrong product as the root cause can be completely different. Is it actually watermelon flavoured or strawberry with the wrong wrapper on them (I assume they are wrapped individually)?

Was the one watermelon tasted and found to be watermelon flavour or was it strawberry?

 

This was my first question as well....

It was watermelon. 

We had run watermelon prior to running strawberry. The mix up happened at production. My assumption is one candy was left on the belt, was overlooked by production personnel and got mixed up with strawberry. We typically run flush between change outs, long enough to get it all out.

What's my CAPA now?

It was watermelon. 

 

We had run watermelon prior to running strawberry. The mix up happened at production. My assumption is one candy was left on the belt, was overlooked by production personnel and got mixed up with strawberry. We typically run flush between change outs, long enough to get it all out.

 

What's my CAPA now?

Do you have a written procedure to be sure the line is cleared before starting another run?   I assume so.   I'd just pull the line together, have a training session to reiterate this is being done, have everyone sign a training sheet, and call it good?   If that's not enough, you can add a line item sign off on current paperwork that addresses checking the line is clear before next item is run?   Or a stand alone sheet?    

Personally I try to keep sign offs to a minimum around here.   Too many and the next thing you know people are just checking boxes...

Belt inspection for over run/unused product along with the flush @ change out?