Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Please share a medical device company NCMR procedure

alonFAI

Involved In Discussions
#1
Hi Guys, can anyone share an NCMR (nonconforming material report) procedure of a medical device company?
I want to see how it is managed.

1. lets say I use contract manufacturer to manufacture my medical device.
2. during incoming inspection inc case there is a problem with the device, then I will issue an NCMR to the contract manufacturer

I want to understand/see how the procedure is built, what are the defined triggers/criteria/KPIs that will trigger opening a SCAR to the supplier based on NCMRs output/performance (negative trend? safety?other?)
and in general how this whole process is managed (procedure wise, information system?manually?paper based?)

Thanks a lot
Alon
 

XRAY_3121

Starting to get Involved
#3
Hi Alon,
NCMR we use as internal document only. Anytime nonconforming material is identified, from internal production OR from incoming shipments, an NCMR should be completed. Then based on risk, repeated findings, severity, you may choose to issue a SCAR to the manufacturer (their aren't predefined criteria, you simply need to document and justify why you DONT issue a scar... i.e., "first incidence and only 1 item out of 100, will continue to monitor to see if SCAR warranted"). My process just withstood MDSAP audit so I'm pretty confident in my advice. The SCAR does not even have to be responded to, you just have to send 3 times trying believe it or not.
Our system is just with Word documents and we keep in a secure share drive. Then email SCAR to the vendor.

I'm a QA Manager, and doing this now and same process at my last job as QA Manager, but that is my simplistic overview.
 

alonFAI

Involved In Discussions
#4
Hi Alon,
NCMR we use as internal document only. Anytime nonconforming material is identified, from internal production OR from incoming shipments, an NCMR should be completed. Then based on risk, repeated findings, severity, you may choose to issue a SCAR to the manufacturer (their aren't predefined criteria, you simply need to document and justify why you DONT issue a scar... i.e., "first incidence and only 1 item out of 100, will continue to monitor to see if SCAR warranted"). My process just withstood MDSAP audit so I'm pretty confident in my advice. The SCAR does not even have to be responded to, you just have to send 3 times trying believe it or not.
Our system is just with Word documents and we keep in a secure share drive. Then email SCAR to the vendor.

I'm a QA Manager, and doing this now and same process at my last job as QA Manager, but that is my simplistic overview.

Thank a lot Marc! any chance you can share the actual procedure?
 
Top Bottom