17 replies to this topic

[vkul84]

Hello, we are unfortunately in the middle of a recall. We were notifed by our supplier that a product they sold us had a positive salmonella result (apparently they were notified by another customer of theirs). They had tested it when they recevied it and it tested negative and we recevied it based on their test results. It is a bit of a nightmare currently with CFIA and FDA involved, but luckily we only used the product once and made one lot of product with it so the recall has not been too diffcilut. 

 

What I need help with, is some advice on how to fill out the corrective and preventative actions for this. We have never had a recall of this type. Corrective actions would be the recall and disposal of all remaining material and etc I assume. But as for preventative actions I'm a bit stuck. Our supplier has been amazning about this and we want to keep using them (we are still waiting on their investigation results though). We usually do not test the material ourselves and rely on supplier testing (which has never been an issue at audits). 

 

Do we now need to implement some sort of testing for just this supplier? Our products are dried herbs and spices and we currently have a CCP in our HACCP plan that ALL incoming lots need a negative salmonella test. But I'm assuming I would need to implement something else considering this issue?

 

Any help or advice would be greatly appreciated. We are fairly new to SQF and I am learning as I go. Thank you.

[GMO]

I'd do some root cause analysis, if you're not sure how, there are free resources online or if you have recall insurance (which you probably do) sometimes there is money you can spend with external consultants to support around recall organisation and recovery.  They might be able to help here.

 

BUT... This is a tricky one.

 

So while your supplier did the test, and it tested negative, a test (IMO) cannot be a CCP.  I know that some other countries interpret HACCP differently, especially in Canada and the US but micro testing is almost always NOT a CCP because it's hard to prove a negative.  The CCP for Salmonella within your herbs and spices is presumably the heat treatment (or irradiation or whatever else they do) that the supplier's supplier does.  The testing is verification of that process, not a CCP in itself because that test is inherently fallible.  You can never test a sufficiently large amount to be 100% sure the batch is not contaminated.

 

So for me, it's the supplier to your supplier which is the really interesting part.  How do they control this and what failed here?

Then it's your supplier, what supplier assurance do they have?  How did that fail here?

 

When it gets to you, well, eek... I'm not sure there's much more that you can do apart from make sure that your direct supplier has good controls on their SQA and perhaps as a result of this you go through it together?

 

Thoughts from others?

[GMO]

Also - big virtual hugs.  No recall is ever a good place to be but nice to hear the good in all this that communication has been positive and everyone is doing the right thing.

[TimG]

I would first get very familiar with what my own Recall policy and Supplier Approval policy (and perhaps supplier scorecard/review policy) say. Make sure if you have guidelines on this already documented, you follow those. At the very least, I concur with the root cause analysis review (if your supplier is SQF they are probably doing this) and then a risk analysis that you (your company) would do based on that, discussed with key members of your team. 

[jfrey123]

Always rough to be subjected to a recall due to a supplier (or in this case a supplier's supplier).  As this recall wasn't due to your company's processing of the goods, a preventative action should be focused on supplier controls you have in place.  Do you have any such instructions in your SOP's for what to do with poor supplier performance?  I would request the supplier's investigation and CAPAs (they may want to do this over a meeting vs sharing physical copies), and likely increase verifications of the supplier's product for a period of time: place their material on hold and pull a composite sample from multiple cases to send in for verification testing for the next 3-6 months, charging them accordingly.

 

So many of us rely on COA's showing finished testing, and in this case it sounds like the supplier had their own testing that showed negative.  Just goes to show, to GMO's point, you cannot test your way into food safety because there's no guarantee your sample is reflective of the entire lot.

 

We did something similar to what I suggested when one of the major cheese makers had a national recall a couple of years ago.  Their executive QA team sat on a call with our executive QA team and went open book on their investigation and how it led to the issue.  Same thing with a major peanut butter supplier's recall a couple of years ago.  We still use both as suppliers, though even as big as my company is we aren't big enough to force those national brands to pay us for the increased testing...

[kconf]

If you are a processor and used the ingredient (with salm), did you get your final product tested before releasing? I don't know what your process is like or if there are controls.

 

If not a food processor - it depends on what your supplier sends you as their CAPA. You can tighten your supplier approval and ingredients risk assessment too if needed.

 

Good to know the whole recall is under control though. 

[Tony-C]

Hi vkul84,

 

My corrective action would also include a review verification procedures and move to positive release based on a negative Salmonella test.

 

As GMO has stated you need to carry out a Root Cause Analysis once you have the Investigation Results/Report from the Supplier.

 

I would also be looking at your Supplier Assurance Procedures (Approval and Monitoring) and Review the Food Safety Controls Implemented by the Approved Supplier including Process Controls and Sampling Methods and Frequencies for Salmonella.

 

I am also wondering what products you are making and if the herbs/spices can be put in at a step where they would undergo a treatment that would kill any Salmonella present?

 

Kind regards,

 

Tony

[SHQuality]

 Our products are dried herbs and spices and we currently have a CCP in our HACCP plan that ALL incoming lots need a negative salmonella test. But I'm assuming I would need to implement something else considering this issue?

If all your incoming products require a negative salmonella test, then how did this batch get approved for use? Did the supplier fail to perform a suitable sampling and testing for salmonella? Did your company itself fail to properly judge the COA?

 

If the supplier has done correct testing and their other customer found salmonella, you'd have to wonder if the contamination happened at their location rather than the supplier's. I agree that some root cause analysis is necessary here.

[GMO]

If all your incoming products require a negative salmonella test, then how did this batch get approved for use? Did the supplier fail to perform a suitable sampling and testing for salmonella? Did your company itself fail to properly judge the COA?

 

If the supplier has done correct testing and their other customer found salmonella, you'd have to wonder if the contamination happened at their location rather than the supplier's. I agree that some root cause analysis is necessary here.

 

it's entirely possible that the same batch could be tested multiple times and one test can pass, one can fail.  A micro test is not necessarily representative of the batch.  The amount of testing you'd need to do to establish it's negative is prohibitive.  It's one of the reason we transitioned as an industry to HACCP.

[ShaunD]

I'm reading the original post slightly different to others, "apparently they were notified by another customer of theirs".

Another customer is mentioned rather than a supplier so if I'm correct, it means the other customer does not rely on the COA provided by the supplier, they carry out their own testing.

I may be way off base here.

[jcieslowski]

Call me crazy, but I would, as part of a preventative action, move this supplier to some sort of a 'elevated risk'' supplier.  (In reality, my supplier approval program marks all suppliers by 1. supplied product risk level and 2. supplier past performance risk level.)   Moving the supplier to an 'elevated risk level' for 2 years or something would then trigger a more stringent review of all criteria you currently use as well as potential supplier audit / visit.     I think it's fair to say 'You missed this, I want to personally observe your practices and make sure you're being vigilant on all things'.  (It's also good to use a site visit to build a relationship with the QA folks at the supplier plant).   

 

The reality of the situation is, as long as you did your part by ensuring that you received the recalled product properly, there's not a whole lot you can do.  We rely on the supply chain for all of our foods.  But one broken link and the chain falls apart.  At least you can show that you're being proactive to ensure that the chain is as solid as it can be, at least at the points you attach to it (metaphorically). 

[GMO]

I'm reading the original post slightly different to others, "apparently they were notified by another customer of theirs".

Another customer is mentioned rather than a supplier so if I'm correct, it means the other customer does not rely on the COA provided by the supplier, they carry out their own testing.

I may be way off base here.

 

That was my interpretation as well or at least a customer tested an ingredient, the reasons why they tested it might have been for incoming QA or it might have been verification.  

 

One thing I wouldn't rule out would be a lab error.  But I'd also say a false negative is probably more likely than a false positive unless there had been a sampling issue.  Worth ruling out but without spending a lifetime on it and also it should really be your supplier asking those questions.

[vkul84]

If you are a processor and used the ingredient (with salm), did you get your final product tested before releasing? I don't know what your process is like or if there are controls.

 

If not a food processor - it depends on what your supplier sends you as their CAPA. You can tighten your supplier approval and ingredients risk assessment too if needed.

 

Good to know the whole recall is under control though. 

 

We just repacke the product, and do not do final product testing. We require tests on incoming materials and rely on our sanitiation and enivronmental monitoring program to control and risk of contamination during packaging. This has always been sufficient with auditors and we have scored quite high on our SQF audits.

[vkul84]

Hi vkul84,

 

My corrective action would also include a review verification procedures and move to positive release based on a negative Salmonella test.

 

As GMO has stated you need to carry out a Root Cause Analysis once you have the Investigation Results/Report from the Supplier.

 

I would also be looking at your Supplier Assurance Procedures (Approval and Monitoring) and Review the Food Safety Controls Implemented by the Approved Supplier including Process Controls and Sampling Methods and Frequencies for Salmonella.

 

I am also wondering what products you are making and if the herbs/spices can be put in at a step where they would undergo a treatment that would kill any Salmonella present?

 

Kind regards,

 

Tony

 

The material was stream treated accroding to our supplier's COA and tested by them, results were negative for salmonella. Still waiting on their investigation as to why this happened

[vkul84]

I'm reading the original post slightly different to others, "apparently they were notified by another customer of theirs".

Another customer is mentioned rather than a supplier so if I'm correct, it means the other customer does not rely on the COA provided by the supplier, they carry out their own testing.

I may be way off base here.

I think this was the case. The initial positive result was reported to our supplier from another customer of theirs that had tested the material. Our supplier retested the product but told me they are still waiting for results and have not updated me yet. I can only asssume they receive a positive as well

[Scampi]

1)  are they using an accredited lab?  Do you have the documentation to state as much

 

2) which method are they (or their supplier) using

 

 

Your preventative may have to be hold and test until or unless you can agree upon a test method

 

You should also be receiving copies of the original CoA for the product used

 

As others have stated, you need to revisit the risk level of this supplier/ingredient 

[GMO]

I suspect they've at least had a presumptive through.  It would be good to get on a call with your supplier as they may be more prepared to be detailed on the RCA with the supplier on a call than on an email.  At least once the dust has settled.

[vkul84]

Thank you everyone for all your help, I feel like I would be lost without this forum!

 

I was trying to respond to everyone but will just put some additional details here as well. 

 

Our supplier has not yet responded with their investigation results, or have not yet confirmed if the material of the same lot they have in stock tested positive for salmonella. As per their COA, the material was steam treated and tested neg for salmonella. This whole situation was trigged by a customer of theirs testing the material and reporting back to them that it was pos for salmonella. 

 

After we were notified and started our recall, we tested the raw material we had in stock as well as the finished good we had in stock. The raw material tested negative but the finished good tested positive. We can only assume that there are hot spots or inconsistencies in the material that are causing these results.

 

The material that tested positive had run through one of our packaging machines. I checked the production and sanitation records and as a precaution put on hold the two lots that had run after the affected material. The other two that ran after the affected material tested negative for salmonella, so cleaning was effective.

 

I like some of the suggestions about doing additional checks for this supplier, I will have to determine what level to do that at. I guess a lot of my decisions will be based on what they end up telling me in their investigation.