Xybion provides a complete Complaint Management module as part of our eQCM® XD Quality Management suite. Customer complaints present unique challenges to manufacturers across multiple industry sectors. By nature, customer complaints represent dissatisfaction with either product quality or performance in a post-distribution environment. Valid complaints may lead to required changes in manufacturing product specifications or the costlier action of product recall.
The International Organization for Standardization (ISO) and the FDA’s Quality System Regulation (QSR) require well-established processes to effectively monitor and control customer complaints. To ensure effective governance and compliance, your complaint handling system should not only collect feedback from unsatisfied customers, it should also have the capability to effectively document the failure investigation process and link to the appropriate Corrective and Preventive Actions (CAPA).