8 replies to this topic

[nonconformist]

Hi All, 

 

I'm building the FDP for our Dietary Supplement production facility as part of things needed for a future NSF 455-2 Dietary Supplement GMP Audit , and have a query about where responsibility starts and ends when the facility is a contract manufacturer rather than a brand owner who manufactures and distributes their own product ?

 

We blend and pack  products for our customers. The finished goods are not stored in our facility and are moved from our facility into a 3PL warehouse under quarantine. Goods are not released to customer for sale until testing comes through, per requirements. 

 

Does our Food Defence plan need to extend past the point where 'ownership' of goods is transferred to Customer who stores and sells them in a commercial arrangement with the 3PL? ( ie storage and in market tampering etc?) 

 

Similarly, with Raw Materials - these are sourced and supplied by customer. I don't believe the customer has procedures in place , so must we ?

Edited by nonconformist, 01 September 2026 - 11:18 PM.

[jfrey123]

I'm a little out of the 3rd party game but this is where I started my QA life.  As a contract manufacturer, your responsibility for food defense pertains to within the facility because you have no say/no authority over goods once the truck pulls away.  You're also limited to what measures the customer will permit when it comes to packaging and receiving of goods.

 

When it comes to shipping, you can include tamper seals on the boxes and palletized items to help ensure no tampering occurs within your custody and at least help spot potential tampering until the next 3PL is instructed to open or distribute.  When including things like trailer seals on the outbound trucks, you're effectively transferring the defense responsibility to the shipper and the next 3PL as soon as that truck is closed and sealed.

 

Raw materials always caused drama with my SQF auditors when I was in 3PL.  I strongly maintain that we don't have authority over whom our client chooses as a supplier, nor do we have the right to subject incoming goods to randomized testing or even opening it for inspection without the express consent of the product owner.  So we would insist the client share their supplier approval procedures and register, and contact them if deliveries showed up without appointment or from non-approved entities.  We would inspect the loads to ensure they matched BOL and report discrepancies, and hold the unloading process if problems were found.  We often couldn't flat reject certain trucks because it's not up to us to determine who is responsible for the disposition of non-conforming goods, so we'd have to receive under quarantine in some cases while the client and their supplier figured out who was responsible for the issue.  But it absolutely would be your job to ensure materials are received in safe condition (undamaged, no evidence of tampering, etc) and to report potential hazards to the client.

[TimG]

I agree with what jfrey says with this caveat:

have no say/no authority over goods once the truck pulls away.

 

I've always been under the impression that if your company arranges/pays for the shipping, you are now responsible for food defense until the customer receives it as you are still technically in ownership of it. This would mean involving your logistics companies in the food defense plan (review of their food defense or safe transport plan, signed statement or other means you deem appropriate to tack onto your FDP).

 

If your customers arrange/pay for shipping, it is their responsibility.

[LostInTheWoods]

I think there are finer legal points than that. The contracts should specify at which point title (legal ownership) transfers. Ownership usually (but not always) transfers based on who pays for the freight. There can be exceptions negotiated, especially if buyer and seller are in different countries..

 

 

I agree with what jfrey says with this caveat:

have no say/no authority over goods once the truck pulls away.

 

I've always been under the impression that if your company arranges/pays for the shipping, you are now responsible for food defense until the customer receives it as you are still technically in ownership of it. This would mean involving your logistics companies in the food defense plan (review of their food defense or safe transport plan, signed statement or other means you deem appropriate to tack onto your FDP).

 

If your customers arrange/pay for shipping, it is their responsibility.

Edited by LostInTheWoods, 02 September 2026 - 05:39 PM.

[nonconformist]

In our scenario, the 3PL so happens to be adjoining our building so the supply chain is very short  - pallets by fork hoist with outgoing paperwork - very straightforward.

Regarding incoming raw materials, we have an existing Inwards goods receival process and I largely agree with your thoughts. We will make a decision as to whether the goods are suitable for use or not, and if not we hold them pending customer decision ( material supplier is usually overseas, so turning the local truck around isn't a feasible option usually) .NSF455-2 mandates we test dietary ingredients for identity prior to use in manufacturing and our clients are OK with that. We propose reviewing the CoA of qualified suppliers ( qualified by historical performance vs spec)  to release materials along with external lab identity testing. 

On the subject of materials - the way I read it, there's no requirement to consider VACCP ?  21 CFR part 121 just addresses TACCP ? 

 

I'm a little out of the 3rd party game but this is where I started my QA life.  As a contract manufacturer, your responsibility for food defense pertains to within the facility because you have no say/no authority over goods once the truck pulls away.  You're also limited to what measures the customer will permit when it comes to packaging and receiving of goods.

 

When it comes to shipping, you can include tamper seals on the boxes and palletized items to help ensure no tampering occurs within your custody and at least help spot potential tampering until the next 3PL is instructed to open or distribute.  When including things like trailer seals on the outbound trucks, you're effectively transferring the defense responsibility to the shipper and the next 3PL as soon as that truck is closed and sealed.

 

Raw materials always caused drama with my SQF auditors when I was in 3PL.  I strongly maintain that we don't have authority over whom our client chooses as a supplier, nor do we have the right to subject incoming goods to randomized testing or even opening it for inspection without the express consent of the product owner.  So we would insist the client share their supplier approval procedures and register, and contact them if deliveries showed up without appointment or from non-approved entities.  We would inspect the loads to ensure they matched BOL and report discrepancies, and hold the unloading process if problems were found.  We often couldn't flat reject certain trucks because it's not up to us to determine who is responsible for the disposition of non-conforming goods, so we'd have to receive under quarantine in some cases while the client and their supplier figured out who was responsible for the issue.  But it absolutely would be your job to ensure materials are received in safe condition (undamaged, no evidence of tampering, etc) and to report potential hazards to the client.

[Tony-C]

Hi nonconformist,

 

 

Welcome to the IFSQN forums.

 

I believe that the answer is a combination of the previous posts.

 

Most importantly your contract should make it clear what reposbibilities you have and when the customer takes ownership of the product and this should dictate your FDP.

 

Having said that, it would be somewhat irresponsible if you packed a product that was not tamper evident and is open to malicious contamination such as being sold openly on a supermarket shelf. If this was the case then I would be making clear to the customer that there was a risk in that situation in writing.

 

Kind regards,

 

Tony

 

[GMO]

Just to throw a spanner into the works. 

 

There are some contracts where factory gate pricing applies, vendor managed inventory or that the financial transfer only occurs weeks after the goods are supplied. Or might be at the point of arrival. I recall one case where even though the customer contracted the transfer by boat from South America to the US, they only took ownership on arrival which had big implications when there were some sharp market price flucutations en route.

 

It might be different in the US but from a food safety perspective, I've always treated it on who contracts the service where your responsibility starts and ends but that might not be the point where legal ownership transfers. So for example, if you are collecting the ingredients and you contract the haulier for that, your responsibility starts at collection. Even if you don't pay for those goods immediately and they're not strictly "owned" by you at that point. You are still responsible for their food safety. Same at the other end of the logistics. If you contract the haulier and the 3PL, they're your responsibility, if your customer does it's theirs. 

 

Either way, making it really clear with your suppliers and customers what your scope is, is a good idea in my mind. That way you can be more confident nothing can get missed. Also it's good practice, even if you don't contract either, to know that both are, for example, assured to a GFSI storage and distribution scheme as finding that out is pretty low effort and at least gives you some due diligence.

Edited by GMO, 03 September 2026 - 05:50 AM.

[LostInTheWoods]

Hi nonconformist,

 

 

Welcome to the IFSQN forums.

 

I believe that the answer is a combination of the previous posts.

 

Most importantly your contract should make it clear what reposbibilities you have and when the customer takes ownership of the product and this should dictate your FDP.

 

Having said that, it would be somewhat irresponsible if you packed a product that was not tamper evident and is open to malicious contamination such as being sold openly on a supermarket shelf. If this was the case then I would be making clear to the customer that there was a risk in that situation in writing.

 

Kind regards,

 

Tony

 

Yes, at some point common sense and culture (everyone's favorite buzzword) have to be involved.

 

To give a rather bizzare true story here, our only food product is a dissolved protein. We were performing pre-launch activities on our new production line. Customer wanted a small sample sent to them for some kind of testing via refrigerated truck. Our customer was in Boston, and everyone on our end assumed that's where it was going.

 

When the truck showed up, the paperwork showed delivery to a place in Ohio. Our Materials supervisor immediately threw up a red flag. The driver spoke mostly Russian (or maybe some Eastern European). He showed a text from his dispatch that said "Represent yourself as Rainer transportation, no other companies should be mentioned. Ask broker/shipper/receiver to call Rainier Transportation in case of any questions. Do not share dispatch info. No other signs on the truck." Then gave delivery destinations at a lab in Ohio."

 

So everyone in FSQ, Engineering, and the business team frantically called all of our contacts at the customer. We did not load the truck.

 

But, had we gone "by the book," we would have loaded him and apparently our stuff would have ended up in Ohio. Maybe going to the KGB or NSA, or some other acronym that's much scarier than the FDA!

 

   

[jfrey123]

@LostInTheWoods, that is absolutely f-ing wild!  What a freakin' day that must've been.  I think you actually did go "by the book," and when things didn't smell right you contacted the customer to verify your assumptions about where it was supposed to be going and upon what carrier.

 

Stuff like this, the non-routine things that come up in a QA/QC capacity, this is what I thrive upon to help break the monotony of a well regulated system lol.