Last month I talked about common problems seen with how companies handle the Corrective and Preventive Action (CAPA)
part of their systems. This month I will talk about some ways on how to solve them.
Before I get into the problems stated last month, let me first set the stage by stating the requirements for CAPA
in section 8.5.2 and 8.5.3.
A "30,000 foot" view of the standard
shows a document that provides a model to help organizations to consistently produce conforming products. It also recognizes that nonconformities
can occur. When they do, those must be handled according to section 8.3 to ensure that nonconformities are corrected, and the nonconforming product is not used as if it is conforming product.