Complaint review as part of the complaint handling process?

adkats

Registered
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,
 

adkats

Registered
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

Trusted Information Resource
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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