There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality Management System based on ISO 13485:2016 ; having a fully compliant CAPA Procedure in place is essential. During FDA inspections, deviations related to CAPA process is one of the most frequent non conformities raised by auditors.
The CAPA is basically a tool for the correction of deviations or the prevention of potential deviations. The process follows a specific well defined flow, that starts from the identification of the problem through root-cause identification and implementation of the action to resolve the issue. In fact, the root-cause analysis is the key part of the CAPA process and found the origin of the issue is essential to implement the concept of continuos improvement within a Quality System.
Moreover, an impact assessment on the deviation shall always be performed, taking in consideration the risk management process, to ensure that the corrective actions are commensurate with the nature of the non-conformity.
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