1. Definition of Complaint
According to the FDA regulations any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, or performance of a product that has been placed on the market is a complaint.
2. Welcome Complaints
Treat complaint as a gift. Effective handling of complaints is an opportunity to show what your company can do for customers. It can also improve your product and/or processes and shift service style or market focus to meet customer needs.
3. Processing Complaints
An organization must contain a written well defined process to consistently receive complaints, to respond quickly, to analyze the complaint, to investigate the root cause and to take corrective action.
4. Make complaints part of company culture
The best methods are to adopt customer satisfaction measures, statistical data reporting (metrics), training, strategic planning, employee communication, customer communication.
5. Essential elements of complaint records
Complaint records must have the following evidence of a review for adverse event reporting, name of device, identification of device (lot, catalog, serial), date complaint was received, complainant, investigation or justification, corrective action, reply to the complainant (if applicable).
6. Investigating a Complaint
When you receive a complaint regarding a product or process of your organization, the first step is to form a team to investigate. Talk to experts and process owners regarding all aspects like pros and cons and gather facts. Once you have collected all the facts regarding the complaint review the evidence, brainstorm or use device reasoning and arrive at a conclusion.