P-08 : Non-Conforming Products Procedure

P-08 : Non-Conforming Products Procedure


SKU: P-08 Category: Tag:


Having a well established non-conforming products procedure helps to properly manage product related deviations, which need to be fully investigated. This process is highly linked to the  CAPA process, which is a 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 Non-conformities and CAPA processes 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 an example of Non-Conforming Products procedure, fully compliant with ISO 13485 and FDA regulations.

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