Risk Management for Complaints

rmurp

Starting to get Involved
#1
Hi All,
I am looking at implementing a risk based complaint system. Any guidance and information on this whould be of great help. We are an ISO 13485 certified company and have manufacture medical devices, drugs and cosmetics. I really want to be able to stop wasting so much time on, say clogging tips, chemical too thick, to thin... etc. :( Can i just assign a risk number and close? What information do i need to include in the response? If i have a risk based system does every complaint need to have a risk number assigned? :frust:

thanks!
 
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B

Boingo-boingo

#2
Be careful because the ISO 13485 definition of complaint is very broad. We've had several discussions about that in the past, and the regulatory expectation is that you treat any concern as a complaint, to be recorded, tracked and processed.
 

Ronen E

Problem Solver
Moderator
#3
Hi All,
I am looking at implementing a risk based complaint system. Any guidance and information on this whould be of great help. We are an ISO 13485 certified company and have manufacture medical devices, drugs and cosmetics. I really want to be able to stop wasting so much time on, say clogging tips, chemical too thick, to thin... etc. :( Can i just assign a risk number and close? What information do i need to include in the response? If i have a risk based system does every complaint need to have a risk number assigned? :frust:

thanks!
Hi,

I'm not sure what exactly you refer to by "risk based complaint system". Sounds like you're looking for a mechanism to quickly sort complaints into drawers, then address them collectively under some other scheme (which?...). To me, it's not the way to go. Every complaint should be carefully investigated -- as much as it sounds strange, complaints (customer feedback) are a precious resource, not to be wasted. It's your ticket to avoiding trouble and making improvement. I understand that recurring complaints are a pain, especially when they are smallish and easy to solve (in theory), however, the way to handle a recurring complaint is to start a CA(PA).

When I hear "risk based complaint system", my first thought is of a system for collecting reasonably-available information; analysing and assigning a risk level to the problem (how big a trouble can this turn into if we don't act upon it?), according to a pre-defined set of rules; and acting according to a pre-defined set of processing routes, corresponding with the assigned risk-level. Possibly the lowest risk rank would map into "close-out the form and file away" (form close-out involving whatever you deem necessary for adequate conduct, e.g. assigning an-already-open CAPA number). In most cases (if not all), a courteous response to the complaining party would make good business sense.

Cheers,
Ronen.
 
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