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Co-Manufacturer Recall Procedure with Non-Retail Customers


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sarahqa

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Posted 28 March 2018 - 06:29 PM

We are a small co-manufacturer that makes a variety of products under different brands. Once we've made the product, we sell & ship them to the brand owner, who then further distributes to retail, consumers, etc. 

 

I am working on our recall program (we are not yet SQF certified but am hoping to meet SQF and FSMA requirements), and am struggling to know how downstream our procedures should go for a recall or mock recall. We will always ship 100% of a given brand owner's product to that brand owner. So, when performing a recall or mock recall, do we only have to notify the brand owner of the recall and expect them to trace the rest of the downstream customers? If so, how do we verify effectiveness and ensure that it is pulled off of shelves, etc? Also, if it is up to the brand owner to notify customers/retailers/consumers of the recall, is my company involved in that process? 

 

Very confused here, and really appreciate the support and help of this online network! Thanks in advance!



Scampi

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Posted 28 March 2018 - 06:58 PM

who would the ingredient/packaging suppliers notify if they had to recall their products?  You or your customer?  

 

This will help understand your position


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sarahqa

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Posted 28 March 2018 - 07:12 PM

Good question. It likely depends on the product. For some products, the ingredients & packaging are ordered by our customer and shipped to us, so it would likely be our customer who was notified. For others, we handle all of the ordering & billing so it would be us. 



Scampi

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Posted 28 March 2018 - 07:43 PM

Ok, well that adds some complexity you could do without.

 

Maybe look at it this way........you just overhead some maintenance guys talking about a leak in a hydraulic line that goes very close to open product (hypothetical here) of a non food chemical. Now, product has already left your premise and you packed in 5 different packages (same product).....how do you know who got what from what day?

 

OR, you supplier of packaging calls....a toxic chemical had been added to the dye and was probably going to migrate through to your finished good. When did you use that packaging and to whom did it ship?

 

 

SO even though you don't OWN the product, it is still your responsibility to be able to recall it 

 

I will however suggest you get upper management involved because this should have been hammered out at the contract stage


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SQFconsultant

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Posted 28 March 2018 - 08:39 PM

From first hand experience operating as a contract manufacturing company consultant on a recall that was and was not caused by the contract manufacturing company.

 

1. On the one that was caused by the contract company - The contract mfg made cookies for customer X, the contractor sourced all ingredients and packaging and in error used non-food grade plastic guides for the dough mix that shredded when heated, little pieces of plastic ended up in 100,000 cookie packs of 3 cookies each. Customer X distributed the packs to 100 small food stores with three of them reporting issues from customers back to customer X who in turn reported immediately to the contract MFG company.

 

In this case the contractor had already identified the issue and recified it and while Customer X instituted a full recall on all cookies from the 100 food stores it was done in conjunction with the contract company and it was the contract company that had to cover all expenses related to the recall - fortunately no injuries.

 

The contractor actually should have been more forthcoming - they knew the issue already but waited until Customer X had gotten feedback from the stores, had they been more proactive, it would have been the contracting company that started the alert system.

 

2. Same contract company again, this time Customer A supplied the packaging material to the contract company who in turn packaged 1,000,000 individually wrapped cookies back to Customer A who in turn was about to distribute them to a number of hotels.  The discovery of the issue with the packaging was interesting...

 

An Auditor had come into the company and in the middle of the conference room table sat a bowl that had wrapped cookies in it - this packaging was damaged in processing, so they took these cookies off the line and would let visitors eat the cookies.

 

The Auditor was having a cup of coffee and grabbed a wrapped cookie and bit into one and said "this tastes funny - it tastes like chemical!"

 

So, QA runs a test on the cookies and the package and finds that a chemical was leaching into the cookies from the packaging.

 

The contract company immediately contacted Customer A who had not as of yet distributed any of the cookies, they stopped the pending shipment Customer A contacted the supplier of the packaging who issued a recall back to the the contract company as well as all of the packaging that was effected with other companies.

 

In this case, the supplier of the packaging actually paid (via insurance) for loss to the contract company.


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Chef_K

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Posted 28 March 2018 - 08:49 PM

To meet the SQF requirements, you must be able to trace all products 1-forward (which mean specifically who you sold the product too), and 1-back (which means specifically who you purchased the product from).

 

Yes, you are only responsible for tacking to the (1-step forward) Brand Owner.

 

To verify the effectiveness of your traceability, Select any item batch/lot that has recently been produced and gather all documentation that can show/confirm that all of the product made in that batch/lot is fully accounted for through sale to owner of the brand company. Provide contact (company) name and contact information. The industry standard is that you be able to obtain this documented information in 2-hours or less.

 

However, you must also be able to go the 1-back (to the supplier of ingredients). You must be able to show what lot of each ingredient was used in the manufactured product, and should be able to follow documentation back to the 'Bill of Lading' or 'Invoice' for the ingredients.

 

Hope this helps

 

 



sarahqa

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Posted 28 March 2018 - 09:26 PM

Thanks for the very helpful feedback, everyone (especially the stories, Simon)! 

Maybe I am over-complicating this. When I do a mock recall (or real recall for that matter), say we identify that one lot code of one product for company ABC has been affected and needs to be recalled. Is our only roll to determine how much we have on hand vs how much we shipped company ABC? We will never ship to anyone else but company ABC. It would only be at our warehouse, company ABC's warehouse, or sold to one of company B's downstream customers. So, in that case, we just notify FDA and company ABC and company ABC takes care of the rest? 



SteveHather

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Posted 28 March 2018 - 09:48 PM

Your responsibility is to your customer - in this case the brand owner that you pack for. You need to be able to track finished batch numbers you supplied to them and be able to identify all ingredients, packaging you used in production (one up, one down principle).

In the event of an incident, your responsibility is to firstly notify and work with the brand owner. Unfortunately too many companies wait for too long to notify their customers often waiting for every test result to come back - often trying to prove it is not their fault, before notifying the customer or worse - waiting until a consumer finds the problem. Meanwhile, more affected product is in the market, the scale of the recall is larger, costs are greater, more consumers at risk, more brand damage. No one wins and potentially damages your relationship with your customer which can lead to you losing your contract. There is little to gain from waiting - you are better off using the precautionary principle and telling your customer that you have found a potential problem and to put product on hold until you have investigated.

Secondly, and depending on your supply arrangement, you need to be able to at least start the investigation. If you have selected the ingredient suppliers, you need to work closely with those suppliers to identify the root cause. You have a responsibility to identify other product sent to other brand owners that may also be affected and notify them.

Just on that subject, I often get into a debate about whether to notify those customers/brand owners that are NOT affected. My view is that if other brand owners know you are the supplier of a product that is recalled, giving them a heads up that the product you supply them is NOT affected is always a good idea. Saves them second guessing and calling you when they find out. I am also aware of situations where good product has been put on hold because the supplier couldn’t confidently rule out the product they supplied was NOT affected. It also helps your relationship with your customers - shows you have actually thought about them and you have your act together!

In the case that the brand owner selects the ingredient supplier and packaging supplier (and assuming you didn’t use those same ingredients in other products) you still need to identify the batch numbers the affected ingredients were used in.

Usually it is the brand owner that is responsible for the actual conduct of the recall and conducting effectiveness checks however you can always run an effectiveness check either through your own staff or using a recall service company like RQA Inc to conduct one for you. That said, I am aware of a couple of retailers that make their suppliers conduct the recall so it will depend on your supply agreement.



Chef_K

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Posted 28 March 2018 - 09:52 PM

Trying not to over complicate this answer.

 

If you are performing a Mock-Recall (Traceability Exercise) *In a large company, I hate the word Mock-Recall because there will be one person in the company that doesn't hear it correctly and states that we have a recall. Therefore, I use the wording "Traceability Exercise".

 

In your case, you must identify the amount of product in-house and the product delivered to company ABC. The total of these two must equal the total from the batch that was manufactured.

 

Now the part that might be confusing you.

If you manufacture a product that is somehow adulterated, or not fit for human consumption, then you must follow the FDA requirements for performing a Voluntary Recall. In those requirements you are required to recall from company ABC, but if company ABC does not have all of the product you are recalling in-house, you must then notify the possible consumers (Public). An example of this would be that you sold to company ABC in City D, You would perform your recall as practiced in the mock-recall, but then you would also have to inform the public of city D. At this point you would be in contact with the FDA and they would be giving you options. An example would be to have a statement placed in the newspaper, or on the news. If the company ABC that you make the product for is in 4-different cities, then you would have to notify the consumer (public) in those 4 cities.



FurFarmandFork

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Posted 28 March 2018 - 10:11 PM

The above answers seem needlessly complicated.

 

Trace one down, where the product ships to from your facility. If someone further distributes it that's not your problem, they will have to coduct their own recalls subsequently. No different than if you were selling peanut butter to a national chain, you have to tell the chain which DC's you sent it to that that it is being recalled, if they have distributed it further that now becomes their own recall. You have no legal obligation to the location of the product once you have sold and shipped it to the customer. You may have contractual obligations to those customers that have nothing to do with your interactions with FDA or a CB.


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Ryan M.

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Posted 05 April 2018 - 08:19 PM

Simple...traceability is one up and one down.  

 

With materials received, must be able to trace one up (who you bought them from and where they came from before receiving).  From here...it is the supplier's or broker's responsibility to trace one up.

 

Finished goods shipped, must be able to trace one down (who you shipped to and where, even if it is a customer's DC).  From there...it is the customer's responsibility to trace further downstream.






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