Complaint Handling As An Integral Part Of FDA And ISO ComplianceSource: MasterControl
Organizations, especially businesses, exist because of their customers. There are two types of customers — external (i.e., paying clients, general public) and internal (people within the organization). Both are important.
In the broadest sense, customer complaints are a form of communication, and companies can benefit from communicating with their customers. In the FDA and ISO environments, where quality is foremost, complaints have a deeper implication. They may indicate serious safety and quality issues. In this context, effective complaint handling is not just a matter of good business practice but compliance.
To illustrate the critical role of complaints, consider the global recall of ReNu MoistureLoc, a Bausch & Lomb contact lens solution, suspected to have caused serious corneal infection in 109 people. Called fungal keratitis, the infection could potentially lead to blindness. Consumer complaints, first in Asia, and then in the United States, alerted the FDA and Bausch & Lomb to the problem. As a result, the company recalled the product in April 2006 and the FDA launched an investigation.