CFR 21 Section 820.198-(2) specifies that:

"Oral complaints are documented upon receipt"

During a recent FDA inspection, one observation was that it was not documented the process to record oral complaints upon receipt. We have implemented that all complaints are captured into the complaint handling software within 48 hours, but this was not good enough to meet the requirements.

Could anyone please share how you comply with this requirement, specially for field staff? In case you use a paper based system, as they become Quality Records, how do you control them? We have many ideas: voice recording, PDAs, log books, paper forms, etc, so we want to identify bast practices out there before deciding.

Any advice for benchmarking will be useful.

Thanks

CFR 21 Section 820.198-(2) specifies that:

"Oral complaints are documented upon receipt"

During a recent FDA inspection, one observation was that it was not documented the process to record oral complaints upon receipt. We have implemented that all complaints are captured into the complaint handling software within 48 hours, but this was not good enough to meet the requirements.

Could anyone please share how you comply with this requirement, specially for field staff? In case you use a paper based system, as they become Quality Records, how do you control them? We have many ideas: voice recording, PDAs, log books, paper forms, etc, so we want to identify bast practices out there before deciding.

Any advice for benchmarking will be useful.

Thanks

In one of my past organizations that I worked, we used to record the caller details into the Complaint Form and proceed with the investigation. This would be also captured in the Complaint Log where there was a column to indicate the route of receipt like oral / written etc.

Upon completion or resolution of the complaint, the caller would be notified.

Hope this helps.

When a product issue is reported by field staff as an oral complaint, customer care assigns a unique identification number and officially opens a complaint.

If the customer will be returning product or a sample is required for investigation, customer care should assigns a return Material Authorization (RMA) number and instruct the customer or through field staff to send the product or sample back for evaluation.

Customer care documents all customer contact including such as date, unique identification number, customer name and contact details, product description and complaint description, site/department responsible for further action and method of communication.

These above documented objective evidences will useful during the FDA audit.

Regards
Subbu
India