Enhancement of CAPA’s and Audits Responses in a Medical Devices Industry

Abstract

In the regulated industry of medical devices, different issues can compromise regulatory certifications. The CAPA and Audit system were presenting a situation regarding the submission of responses; Timeliness. One of the objectives was to reduce the quantity of extensions requested. During the collection and presentation of data using DMAIC, 24 CAPA’s and 7 audits were analyzed. Identifying the quantity of extension and its justifications. The majority of justifications were about complete a criticality assessment in CAPA’s and incomplete trainings in audits. After a difficulty impact analysis, workload and decision making could be two of the principal contributors for timeliness. 25% of CAPA’s exceed the general rule of requesting only two extensions. The audits does not have a rule. One of the suggested improvement was the implementation of a tracking system, which could facilitate the process. Continuous monitoring should be performed to ensure the effectiveness and the reduction of extensions requests. Key Terms - Audit, CAPA, Medical Device, Timeliness.