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Customer Approval (Medical Devices)

#1
Hi all,

The company I work for switched from being a captive manufacturer to a contract manufacturer a few years ago. We had to redo most of our QMS system and tbh it's kind of been one of those "update as your learn" kind of situations. I am looking from some outside opinions on this, as this is all still kind of new to everyone in my company and none of us has really seen how others handle it. Most of our business is manufacturing medical devices or PCBAs that go into medical devices, though we do have a few non-medical device/PCBA contracts.

We do not own the designs. For the majority of our product, we create our own documentation as opposed to using documentation provided by the customer. Such as, releasing it under our own assembly# and creating our own drawings, work instructions, etc.

I know customer approval requirements should be generated from contractual agreements/customer requirements.

We tried to 'make it easy' and create a matrix (attached) and defined customer approval requirements universally depending on the type of document that is being updated. There are some mixed feelings about this, with the various departments involved arguing about what is 'required of us' and that some of the requirements are excessive. Some customers are extremely critical and want to give approval on everything, some customers (per the quality agreement) say they want to give approval for everything but then do not respond to approval requests, and some customers just don't seem to care either way. On some changes, the customers have requested to see the associated work instructions, which brings up a lot of proprietary concerns.

How do you manage this at your company?
 

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DannyK

Trusted Information Resource
#2
Since each customer may have different requirements, you can extend the columns on the spreadsheet to add the customers and indicate in each cell if it is applicable or not.
 

indubioush

Quite Involved in Discussions
#3
customers have requested to see the associated work instructions, which brings up a lot of proprietary concerns.
Per ISO 13485, the medical device manufacturer (your customer) needs to have "specifications or procedures for manufacturing, packaging, storage, handling and distribution" as part of their medical device file, so I'm not surprised that some want copies of your procedures.

Having a one-size-fits-all matrix might not be such a good idea. May be better to just keep the approval requirements in the quality agreement. Or you can do what Danny suggests.
 

yodon

Staff member
Super Moderator
#4
I've worked with CMs before that have proprietary processes. It's ok for your customers not to get to see those but it needs to be understood that a regulatory body can see them, if requested. I put this in the Quality Agreement.
 
#5
Since each customer may have different requirements, you can extend the columns on the spreadsheet to add the customers and indicate in each cell if it is applicable or not.
This is the approach I am leaning more towards. We had attempted to do this early on but ran into difficulties with the matrix not being updated (we did not yet have a fully realized design transfer/new product introduction/customer onboarding process at the time) and the process was putting the heavy burden of determining whether customer approval was required on the Documentation Clerk instead of a joint effort with Documentation + the ECO originator.

Per ISO 13485, the medical device manufacturer (your customer) needs to have "specifications or procedures for manufacturing, packaging, storage, handling and distribution" as part of their medical device file, so I'm not surprised that some want copies of your procedures.
I've worked with CMs before that have proprietary processes. It's ok for your customers not to get to see those but it needs to be understood that a regulatory body can see them, if requested. I put this in the Quality Agreement.
I've really never questioned it when the customer has asked us for supporting documentation (I am in the QMS/QA department and am generally directly involved with audits, including ones performed by our customers). I guess the thought process was we are required to have the documentation per the various standards and regulations so they must also, that and they are their products/designs.

There is a clause in our quality agreement that states "if the request involves a product manufactured to Supplier's proprietary specifications, Supplier may redact the proprietary specifications from the document". I have brought up that some other portions of the quality agreement need to be updated, perhaps I will see if we can flesh that clause out a bit more also.

Our Business Development/Lead Engineer actually raised the concern regarding the proprietary documents - he's gotten so many 'confidential' documents from our customers from their other supplies, asking us to quote the process. If they are freely sending their other suppliers' documents to us, they are probably doing the same to ours.
 
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