Complaint Handling

Any communication that points to some deficiencies in the product identity, quality, durability, consistency, security, efficiency, or performance of a product or device after it is released for distribution, is considered as a complaint. As seen under MDR, complaints concerning device-related deaths, serious injuries, or malfunctions must be reported to the FDA.

Manufacturers are to maintain a detailed record of all complaints and solve them in a timely and efficient manner. The complaint handling system of a company can define the efficiency of its Quality System. Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially designated unit. A good complaint handling system can
* Provide a suitable solution to the problem;
* Improve customer relations and customer satisfaction;
* Evaluate weaknesses in the product and help resolve it;
* Increase company's accountability and transparency;
* Reduce medical device reporting;
* Reduce costs and improve production schedules;
* Reduce employee confusion.

The GMP regulations state certain requirements that are to be included in any complaint handling system. All manufacturers should:

1. document, review, evaluate, and file all complaints;
2. formally designate a unit or individual to perform these activities;
3. determine if an investigation is necessary;
4. record the reason if no investigation is made;
5. assign responsibility for deciding when not to investigate; and,
6. determine if the complaint requires an MDR report.

A sample complaint handling system is depicted in the image below:
(Source: http://www.assurx.com/software-solutions/complaint-handling-management.htm)

All complaint records should have some basic details like
* sequential number of the complaint;
* origin of the complaint;
* customer information;
* product information;
* any corrective actions already taken;
* details of the complaint;
* and dates, signatures, assignments, etc.
These records should be maintained by the company for review during FDA audits.