If a customer reports finding metal in a product how should you decide whether to initiate a recall?

Hello, 

We just got a report of a customer finding a few small metal balls in the loosepack tea they got from us. It is a powder that is mixed with water and is a single ingredient item. 

We pack by hand into plastic bags with plastic scoops, no blending or any sort of processing done to this material. We sold over 500 lbs of this material, thousands of boxes of tea, and have been out of stock of this lot for over a year. We have no remianing stock or raw material in our facility. We are 100% sure this metal did not come from our facility, and our supplier is currently investigating. They are completely sold out of this lot as well and have had no complaints. 

We do not metal check at our facility, but the raw material was metal checked by our supplier. We have no clue where this metal could have come from, and have asked the customer to send it back to us for further investigation. 

If we have one uncomfirmed report from a customer of metal in the product is this enough to trigger a recall? Likely the vast majority of this product would have been consumed and we have not had any other complaints. 

How do we proceed with this and how to make the final decision if we should recall or not? If we don't need to iniate a recall, how to document this to justify? Do we do a risk assessment?

Any help is greatly appreciated!

Hi Victoria,

You do need a risk assessment. 

The powder dissolves in water and consumer drinks it, right? Ask your customer how they found the balls. Is your GMP/personnel hygiene solid?

Do you have RA on why you don't do metal detection or any CCP?

Is this a retail consumer or a customer who resells or further processes?  In either case, given that you've investigated and find that it's unlikely widespread nor can prove it came from your facility, I do not believe a recall is warranted.

I'd be curious what your supplier comes back with, whether the small little balls match an equipment they maintain or maybe came all the way from the plantation.  You should confirm with your supplier that they're aware your company sells the tea in loose form, as they may be operating under the premise all their supplied teas are placed into bags that would contain any FM (something that most tea processors I've visited list in their RA's regarding physical hazards).  

I would consider this a general complaint, albeit a more serious one.  Requesting the foreign material back is a good idea to compare with your process and to assess from your suppliers standpoint.  Yes risk assess however also take into consideration the amount of complaints received to date which you've already stated.  This seems to be a one off situation which does not warrant a recall (knock on wood for saying the "R" word) so I wouldn't jump to that right away until the investigation shows some evidence that there is a lack of control toward this hazard and that it is significant enough to initiate pulling product back. 

I once had a compliant about a nail roughly 3" long being discovered in a baked individual cake that was served on an airline which was metal detected twice, once at our facility and then again prior to commissary at the airline terminal.   The cake itself was only 2.5 inches tall and 3 inches wide in cylindrical shape. Some folks just want free stuff, some want to be malicious, and some are generally good folks trying to help out/notify you of the incident.  In this case this individual wanted to sue the airline for the nail, but the cake was not consumed only cut open with a fork.  

Get the FM back if possible, send a prepaid.

With only one reported incident I would not jump to recall, especially when you can't rule out fraud on the part of the consumer.

Hi VictoriaRK,

I wouldn’t consider a recall until I have seen the metal balls. It sounds like they could be from a bearing, get them back and investigate. You could expedite your investigation by asking for a photo whilst waiting for the post.

Your Engineers/Maintenance guys may be able shed a light on a possible source.

Kind regards,

Tony

So I received the foreign material back this morning and more information. The balls are very small, maybe 1-2 mm, irregular (do not look like bearings) and are picked up easily by a magnet. 

Looking at these I don't think there is any way this came from our facilty. The packing of this item consists of opening the bag from the supplier in our packaging room and scooping it by hand with a scoop into plastic pouches. These objects woujld have had to be in the raw material when we got it. 

I'm still waiting to hear back from our supplier with their investigation, but I have their HACCP plan on file and they state that they use magnets before any processing, and then metal detection after packaing. They list their metal detection controls as 2.5 mm Ferrous, 2.5 mm Non-Ferrous, 2.0 mm Stainless Steel. SO give how small these balls are, I would assume they might have not been detected by them?

This is my first experience dealing with something like this. If the metal is too small to be detected, what do you do in that case? 

The metal you are describing vaguely sounds like weld spatter...do you or the supplier have any welded metal around your production areas or have you or the supplier performed any welding around the production areas?

The metal you are describing vaguely sounds like weld spatter...do you or the supplier have any welded metal around your production areas or have you or the supplier performed any welding around the production areas?

We definately haven't, not sure about the supplier. It was commented by someone here that they thought it looked like solder from pictures the customer sent us. The balls are very hard, I cannot scratch or dent them with a knife. I sent additional information to our supplier along with a bunch of questions, so I'm just waiting back to see. 

 

 

I'm still waiting to hear back from our supplier with their investigation, but I have their HACCP plan on file and they state that they use magnets before any processing, and then metal detection after packaing. They list their metal detection controls as 2.5 mm Ferrous, 2.5 mm Non-Ferrous, 2.0 mm Stainless Steel. SO give how small these balls are, I would assume they might have not been detected by them?

 

This is my first experience dealing with something like this. If the metal is too small to be detected, what do you do in that case? 

That is a valid assumption, they would NOT have been detected by their MD (or any of them for that matter) as they are below the detectable threshold

I would request that they switch to using magnets POST processing.........they must EXPECT metal in the raw material or they wouldn't have the plant set up that way

so our supplier has come back with their investigation results and they indicated that metal shavings were found on the magnets prior to milliing and that during milling, there was a report of a loud noise in the mill, they stopped production and inspectied and line was determined to be clean. They feel the issue happened here and I tend to agree. 

I assumme some metal made its way into their mill, and the result was the small metal balls, which I believe were too small to be detected by their metal detector. I will be usggesting they use magnets at the end of the process as well. 

So in this case, since we have a good idea of the source, and only have the one complaint (the supplier also does not have any additional complaints) can I deem this an isolated incident, document a risk assessment and close it off?

I've gone done a rabbit hole even on this forum about limits for metal, and have found FDA references to less than 7mm, and unoffical Canadian limits of less than 2 mm.

Can I document that the risk is low, and no other complaints, and the peices found are well below the detectable limits? or something like that?

Go ahead! 

so our supplier has come back with their investigation results and they indicated that metal shavings were found on the magnets prior to milliing and that during milling, there was a report of a loud noise in the mill, they stopped production and inspectied and line was determined to be clean. They feel the issue happened here and I tend to agree. 

 

I assumme some metal made its way into their mill, and the result was the small metal balls, which I believe were too small to be detected by their metal detector. I will be usggesting they use magnets at the end of the process as well. 

 

So in this case, since we have a good idea of the source, and only have the one complaint (the supplier also does not have any additional complaints) can I deem this an isolated incident, document a risk assessment and close it off?

 

I've gone done a rabbit hole even on this forum about limits for metal, and have found FDA references to less than 7mm, and unoffical Canadian limits of less than 2 mm.

 

Can I document that the risk is low, and no other complaints, and the peices found are well below the detectable limits? or something like that?

Yes all of this seems reasonable and worthy of an official close out.  Best of luck.