This paper examines and makes the case for going beyond traditional Quality Management systems (CAPA, Complaint Handling, Audit etc) to the essence of quality; fundamental understanding and control of manufacturing processes.

Excerpt: Developing Corrective Actions to address non-conformances is the reactive approach to quality. The goal for manufacturers should be to eliminate the need for CAPA systems by preventing opportunities for defects and exercising tight controls over manufacturing processes.  

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