Understanding investigations, root causes and implementing an effective CAPA system

Rephine's white paper is available to download now

For any manufacturer, identifying, classifying and managing deviations are of vital importance to increase the effectiveness of the quality system.

In particular, the implementation of an effective CAPA (Corrective/Preventive Action) system is the direct consequence of having identified the "true" causes of the deviation, commonly known as "root causes" which, in turn, can be found only if a thorough and well-structured investigation has been carried out.

From the other side, we can say that a poor investigation will likely lead to an incorrect interpretation of the reasons why the deviation has occurred, thus focusing on merely causal factors (or even worse on casual factors). Consequently, any formulated CAPA will likely be unsuccessful in preventing the reoccurrence of the deviation itself.

To read the full white paper, visit Rephine's website.

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