Customer Supplied Product & Certifications - Drop Ship - FDA and ISO 13485

[abrnidgrl]

We have a customer that is purchasing product from another supplier and then they (the other supplier) drop ship directly to us. However all of the certificates and other documentation are going directly to the customer. From an FDA and ISO13485 standpoint, can we treat this as customer supplied product and use it as is?

 

[Coury Ferguson]

Fellow Cove members-do you have any suggestions or recommendations for this Cover?

 

[Big Jim]

I'm not familiar enough with ISO 13485 to respond specifically to that standard, however I think it would be a poor practice. I'll admit that my response is colored by the "anti wank" clauses of AS9100B which hold an organization responsible even if the customer specified a supplier.

No matter where it comes from, you really should screen everything that you use to build product. Just like anything else you consume in the build, the level of scrutiny needed varies with its impact on the final product.

At the very least ask your customer what they would like checked or what they would check before acceptance if they were receiving it.

What you want to avoid is building product that isn't suitable for your customer for any reason, even if it could be considered the "customer's fault".

 

[MIREGMGR]

From an FDA perspective:

I assume that you'll be doing further manufacturing on the product/material that your customer is having their supplier ship directly to you.

If your relationship with your customer is as a Contract Manufacturer, your contract with them should clearly state that status, and that they are either the Specifications Developer, or the Manufacturer if they do further operations on the product before it's marketable.

The Specifications Developer or Manufacturer has primary regulatory responsibility for the final product. A Contract Manufacturer nonetheless has co-responsibility for all aspects of the final product that are related to those elements of its production over which they have substantial control.

I would think that an FDA inspector under QSIT procedures readily would conclude that, if the supplier ships directly to you, you have full responsibility for Incoming Inspection and for verification of purchasing conformance, because you have substantial control over received goods and your customer is not physically present...unless they have personnel at your facility, or your contractural relationship calls for you to notify them to send such personnel, to perform those responsibilities whenever something arrives that they purchased.

As a Contract Manufacturer, it's your responsibility under Contract Review to ensure that your contract with your customer adequately defines all regulatory aspects of your relationship. Your customer is responsible for offering you a contract that adequately defines regulatory responsibilities, and for controlling your actions. They're really dropping the ball if their regulatory people aren't discussing with you what you have to do to make it possible for them to meet FDA requirements.

 

[achorste]

We are doing a similar thing with one of our sub-contractors - the raw material supplier is drop shipping to them, they do their processing & it's shipped on to us.

However as we do not see the product until it gets to us & it is not in it's original form I would expect our supplier to inspect to the required standard (in fact we are including that in the contractual agreements). We are supplying them with full inspection specifications.

In any case, as mentioned before) as the end customer is not seeing the product before you process it it would be risky not to perform your own inspection of the product. Although this situation is not called out directly in the applicable standards, it could be seen as an un-necessary risk for the business & as such merits some kind of control. Does the end customer have specifications / standards for the drop shipped product? Is it possible to get copies of the documentation delivered with the product?

Of course I do not know the products being supplied, and I may be completely off track but it's my tuppence worth

 

[abrnidgrl]

Thanks everyone.
We do inspection of the product prior to assembling it and sending it on to the customer, but we do not get copies of the vendor's CofC, etc. I'm not sure if this changes the requirements or not, but we do verify that the assembly works prior to shipment. We have requested that the information be sent along with the product, however the vendor does not want to send us copies as well as our customer.

 

[brandomenon]

It would probably be easiest for your company to develop a receiving inspection process with the help of the customer. Two options would be:

1) Have them notify you that they have reviewed the CoC and they accept the product for assembly.

2) Have the customer create the list of criteria to add to a receiving inspection form for inspecting incoming drop shipments (and maybe include it in a quality agreement you might already have)

 

[Al Rosen]

FYI, look at this thread regarding C of Cs.