Abstract
If actions taken to address root causes are not verified to confirm that the corrective actions taken were effective, the entire investigation and root cause analysis will be a waste of time and resources. In today's competitive environment, a company cannot afford to waste time, resources, and therefore money out the door. More important, completing the verification of effectiveness will help a company to document that the proper investigation was completed. In this chapter, we will review how to determine what constitutes a proper verification of effectiveness: the what, when, where, who, and how to verify that all corrective and preventive actions were, in fact, effective. We will also review what constitutes a successful execution of a CAPA plan to demonstrate that the corrective actions effectively addressed or mitigated the root causes identified in the CAPA record. This chapter will provide a step-by-step outline of what is needed to complete a verification of effectiveness (VOE) plan for both corrective actions and preventive actions.
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