Medical device manufacturer and component supplier miscommunication

indubioush

Quite Involved in Discussions
#1
Have any of you come across this, and how do we prevent it? I work for a medical device manufacturer that buys custom components that are manufactured by an ISO 13485 certified component manufacturer. I just audited this supplier. The components they make for us are considered to be in the R&D phase of development. Meanwhile, we as a medical device manufacturer are starting to do design verification and "froze" our medical device design many months ago. The supplier on the other hand has not put our specifications into their quality system. They have no work instructions for manufacturing our component. They can't show training records showing their people were trained to our specific process. They can't show that the specifications we provided to them have been reviewed. They don't have controls for the drawings we have provided to them.

This miscommunication seems to be pretty common. Are there some things that I can suggest to this component manufacturer so they prevent this from happening in the future? Also, are there any suggestions for the medical device manufacturer to prevent this from happening? Audit of course, but anything else? Thanks for reading my rant.
 
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John Predmore

Trusted Information Resource
#2
One idea is to have the supplier submit his shop print, run record, inspection plan or traveler for the parts you consider design-frozen. (The document name will vary depending on the type of fabrication process done by the supplier). This is an quick, inexpensive way to verify they have formal, in-house process documents and that the supplier’s revision level is updated when you make design changes to the customer prints.

If your component supplier makes parts for other industries, they may already employ Production Part Approval Program (PPAP), which is a layer of advanced quality planning provided to automotive and aerospace customers, but increasingly adopted by other industries. Even if you call it First Article Inspection Report (FAIR), you could require the FAIR package contain a Quality Control Plan - how key characteristics are to be measured, tracked, and how deviations are handled.

Of course, if you ask for supplier documents, don’t simply put them in a file. You need to commit qualified people who take the time to review documents, to keep the process honest, improve the state of technical communication and reduce risk.
 
S

skhan5

#3
I just joined this forum and wondering if anyone have experience or expertise developing of medical device component qualification procedure/plan for suppliers.
 

indubioush

Quite Involved in Discussions
#4
Hi Skhan. Welcome to the forum. I suggest you start a new thread as you will get many more replies that way. Hope that helps.
 

somashekar

Staff member
Super Moderator
#6
Have any of you come across this, and how do we prevent it? I work for a medical device manufacturer that buys custom components that are manufactured by an ISO 13485 certified component manufacturer. I just audited this supplier. The components they make for us are considered to be in the R&D phase of development. Meanwhile, we as a medical device manufacturer are starting to do design verification and "froze" our medical device design many months ago. The supplier on the other hand has not put our specifications into their quality system. They have no work instructions for manufacturing our component. They can't show training records showing their people were trained to our specific process. They can't show that the specifications we provided to them have been reviewed. They don't have controls for the drawings we have provided to them.

This miscommunication seems to be pretty common. Are there some things that I can suggest to this component manufacturer so they prevent this from happening in the future? Also, are there any suggestions for the medical device manufacturer to prevent this from happening? Audit of course, but anything else? Thanks for reading my rant.
I think the whole situation is pointing towards your process of evaluation and selection of supplier.....
 
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