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 and FDA regulation; having a fully compliant CAPA Procedure and CAPA Report template or CAPA form is essential. During FDA inspections, deviations related to CAPA process is one of the most frequent non conformities raised by auditors. This is the reason why a CAPA template built to be compliant with FDA Requirements is extremely important in your QMS.
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.
Here at QualityMedDev we show a CAPA Report template that can be used to document your CAPA, fully compliant with ISO 13485 and FDA regulations 21 CFR 820. This template can be used in combination with the related CAPA Procedure
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