Difference Between Complaints and Feedbacks in terms of Follow-Up Actions Needed

[Alexlefei]

I want to know how you distinguish a complaint and a feedback. What is the difference between complaints and feedbacks in terms of follow-up actions needed.

 

[planB]

Re: Difference Between Complaints and Feedbacks

Alexlefei,

feedback is the more general term. A complaint is feedback fulfilling this definition:

Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

as taken from 21CFR 820.3 (b). In terms of follow-up action for complaints, you need to have an established complaint handling system - take a look at 21CFR820.198.

HTH,

Gerhard

 

[somashekar]

Re: Difference Between Complaints and Feedbacks

I want to know how you distinguish a complaint and a feedback. What is the difference between complaints and feedbacks in terms of follow-up actions needed.

Is this in connection with medical device ....

 

[Mark Meer]

Hi Alexlefei,

We have a single "customer feedback" system procedure, and the first step is to assess if the feedback is a complaint (using the definition supplied by planB in the previous post).

If it's a complaint, then it is subject to reportability determination, and is closed only in 2 cases:
1. If the issue is resolved to the satisfaction of the customer (this may involve return, replacement, repair, refund, etc.); or
2. After at least 3 documented attempts to contact the customer, the customer is unresponsive.

The complaints also often feed into the product non-conformance handling process.

If it's NOT a complaint, it's likely things like general inquiries, feature requests, or suggestions for improvement. These feed into the post-market surveillance process, and are reviewed annually (or semi-annually, depending on volume) to make decisions for future product improvements.

MM.