Complaints – Regulations, Definitions, and Distinctions
Posted on Wed, Sep 07, 2011
What is a complaint? The reporting process starts with a complaint. All FDA regulated manufacturers are responsible for documenting complaints against the product and evaluating them for reports.
Technically, a communication would be considered as “complaint” only if alleged some “deficiencies in the product identity, quality, durability, consistency, security, efficiency, or performance of a product or device after it is released for distribution” (21 CFR Part 820).
Regulatory Complaint-handling Requirements
All complaints must be consistently handled in a regulatory compliant manner, according to a written complaint procedure of FDA. Failures to handle complaints in a uniform and timely manner can be cited as a nonconformance. In fact, the FDA often begins inspections this way because these records allow the agency to quickly assess whether a company’s quality system and CAPA are adequate.
Each manufacturer must establish and maintain procedures for receiving, reviewing, and assessing complaints by an officially in-house or an off-site designated unit.
Complaints concerning deaths, serious injuries, or malfunctions must be reported to the FDA pursuant to the Medical Device Records regulations. Companies must have documented or validated processes established for each of these situations.
What is or what is not a complaint?
The complaint procedure must identify what is and what is not a compliant. Customer calls that are not complaints should be documented as “NOT A COMPLAINT”, with the individual making that determination and date. This means that returned products, failed devices are complaints.
Some, but not all, service requests are complaints. A salesperson talking to a customer at the customer’s facility can be a complaint. A discussion with a customer at a trade show can be a complaint. An academic journal describing a problem with device can be a complaint.
Distinctions
FDA does not make a distinction between repairs and complaints. Some, perhaps many or most, repair requests are considered as complaints.
Monitoring and trending complaints during clinical trials, early commercialization, and as long as the product is marketed are FDA requirements; however, in order for complaint-handling to serve as a forward quality system it must go beyond the regulatory requirements and provide a means for continuous improvements.
Complying with MEDICAL DEVICE QUALITY SYSTEMS MANUAL
Complaint Handling - It is a good idea for most of the company personnel to receive basic training in complaint handling techniques. Appropriate employees such as receptionists, salespersons, representatives, secretaries, service personnel, and other employees who talk with users should receive training on their responsibilities in regard to complaint handling requirements in section 820.198.
If these employees receive a device complaint, they need to know they have a responsibility to report it to the company person(s) assigned to handle complaints. Likewise, importers and distributors should be made aware of the complaint requirements, and they should be requested to forward complaints to the manufacturer.
