Complaint review as part of the complaint handling process?

A

adkats

Registered
#1
#1
Hi all - would like to get some industry feedback on best practices on the following question:

Does every complaint (medical device, regulated industry, 820.198) needs to be reviewed by Quality or another team prior to marking it as "closed"? I have seen in few places where this practice is deployed and this is an additional control in place on top of ensuring customer is made whole through customer resolution/case handling.

Appreciate any feedback/thoughts.

Thanks,
 
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A

adkats

Registered
#3
#3
Some thoughts: Perhaps review based on risk level & put some rules in place to auto-close (low risk) at the Call center level. Utilize track & trend as the mechanism to trigger investigations
 
mihzago

mihzago

Trusted Information Resource
#4
#4
if you consider 820.198 then all complaints must be evaluated to determine if they are reportable and if an investigation must be performed.
At minimum you should review if a customer inquiry meets the definition of a complaint. Whether you make customer happy/whole is irrelevant.
 
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