Regulatory bodies such as ISO view complaints regarding the safety or performance of a product as a strong indicator of whether a company is in full control of its manufacturing process. Customer feedback has become an integral part of compliance requirements, and failure to manage it is the leading factor named in non-compliance citations.
Simply declaring that a broken device has been reworked doesn’t bode well during an inspection. Many firms have complaints evolve into nonconformances because they fail to analyze, follow through and get to the root cause. They also get into trouble because there is no tie-in to a corrective and preventive action or management review – there is no integration.
ASI DATAMYTE’s Complaint Management Solution keeps complaints under control with automated workflows and integrated data from other relevant areas. It pulls in ISO standards and FDA mandates, ties in CIP and CAPAs and rolls the consolidated and analyzed findings into intuitive focused report and decisive actions.
> Creating opportunities to improve
> Flexible complaint workflow integration
> Enhanced communication and escalation