Future Complaint Management Process for the Medical Device/Diagnostic Industry

Abstract

Complaint handling process is an important process in medical device industry/diagnostic industry. Medical device manufacturers can lose their reputation, face device recall and undergo other business critical impact can happen if devices malfunctions are not handled with all regulated procedures. Therefore, it is important to have an effective and efficient complaint handling process which provide the high-quality resolution in timely manner to the customer. To have an effective complaint handling process, it is needed to optimize the process to support humans in doing more high quality and relevant investigation on malfunctions of devices than searching for information or providing known repetitive answers. In current complaint handling process, there are four steps, evaluation, investigation, peer review and case closure. There are many steps within these four steps which are prone to automation such as repetitive complaints in evaluation phase and peer review. Therefore, this master thesis has analyzed the issues existing in the current complaint management system and proposes a TO-BE model which will integrate intelligent automations within the current complaint management systems to support humans to increase efficiency and effectiveness of the process.