Do Contract Manufacturers need a complaint procedure?

[katastic2908]

Good Morning,

in regards to the FDA would a contract manufacturer need a complaint procedure? We wouldn't get end user complaints because we don't distribute or sell to the end user, we manufacture for the company that designed and developed the device and they would get any complaints. If we did get a complaint from our customer (the company that designed and developed the device), it would come in the form of a SCAR. So do we need a complaint procedure? Would this justification work as an exception for that clause in 13485 too? Thank you

 

[indubioush]

At the least, you need to have a feedback process to comply with section 8.2.1. Regarding whether to have a complaint handling procedure/process, I suggest you have a conversation with your customer regarding expectations for performing any activities associated with the complaints section of the standard. It could be that only some requirements apply to you. For example, you may be handling complaint related product at some point, and you will need a process for that. But you won't be expected to report to regulatory authorities. If you are expected to comply with some items in this section, you can alter your existing procedures for compliance. You are not required to have a separate "complaint handling" procedure to comply.

 

[Ed Panek]

Does this CM have their name listed in any way a user could/might contact them?

 

[TorstenKn]

I don't know how exactly SCAR works from a process perspective, and it seems to be a proprietary concept. However, we don't you call the procedure you are using to process the SCAR "customer complaint management" and describe in addition a short possibility to process other feedback in a similar manner. Then you would have a complaint procedure. From my perspective as part of the quality management system you need some kind of procedure to process complaints of your customers, however this is. So you would be done with this.

 

[indubioush]

I don't know how exactly SCAR works from a process perspective, and it seems to be a proprietary concept.

SCAR stands for supplier corrective action request. It is not a proprietary concept.

 

[katastic2908]

Does this CM have their name listed in any way a user could/might contact them?

nope. We place all labeling on the product but it only contains their (our customer) information.

 

[katastic2908]

SCAR stands for supplier corrective action request. It is not a proprietary concept.

I meant, if there was a complaint regarding the product from our customer, that would be sent via a Supplier Correction Action Request, since we are their supplier.

 

[pziemlewicz]

The listed manufacturer should be responsible for complaint handling and agency notifications. I would expect you to have a Corrective Action process in place. Unsure if you are 13485 certified or not, but might be worth having a conversation with your customer surrounding expectations of "undue delay" as cited in the standard.

 

[Cthames]

I meant, if there was a complaint regarding the product from our customer, that would be sent via a Supplier Correction Action Request, since we are their supplier.

I would document this. Make a complaint or feedback procedure and explain how you are a contract manufacturer and don't interact with end-users, but you still process and evaluate feedback and complaints from your customers.

I would still create a complaint handling document. What if you end up with a complaint from a customer, but they don't provide you with a formal SCAR? You would still be required to process the complaint. In your procedure, you can note that you are often provided with complaint handling documentation by the customer, but that you will use your internal document if this is not provided to you by the customer.

You don't have to make a traditional complaint handling procedure, as you are a contract manufacturer and not a manufacturer. But you are still required to evaluate feedback and complaints from your customers. It appears you are already doing this, so you should document it and take credit for it. Don't burden yourself with the new procedure, just use it as an opportunity to document what you are already doing.

 

[ParisTommy]

Hello

I would have a complaint procedure because your customer might have a complaint that doesn't come from an end user.

Imagine the customer complains that the pallets are dirty, or the pallets are mixed / the order is wrong.

Just from a customer satisfaction point of view, it is good to have a procedure in place to investigate why did the error occour... the root cause and corrections / CAPAs.

Maybe in your case the complaints won't end up in a vigilance case, but you can put a quick tick box to say « non-vigilance ».

Remember the ISO 13458 was an evolution of the ISO 9001, so the auditor will still be looking to see how you get feedback from your customer, and how you treat that information and incorporate it into your SMQ.

I'd be interested to hear how it went with your auditor

Tom