12 - Step 9: verification of effectiveness

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.