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Corrective and Preventive Action Background & Examples Presented by: Kimberly Lewandowski-Walker Food and Drug Administration Division of Domestic Field Investigations Office of Regulatory Affairs
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What is corrective and preventive action?
Corrective and preventive action is a set of actions taken to eliminate the causes of non-conformities, defects, or other undesirable situations in order to prevent their recurrence.
Who is required to file corrective and preventive action?
Any organization that wants to ensure the quality and safety of its products or services may be required to file corrective and preventive action.
How to fill out corrective and preventive action?
Corrective and preventive action forms are typically filled out by documenting the non-conformity, root cause analysis, actions taken, and effectiveness verification.
What is the purpose of corrective and preventive action?
The purpose of corrective and preventive action is to identify and eliminate the causes of non-conformities to prevent their recurrence, and to continually improve the effectiveness of the quality management system.
What information must be reported on corrective and preventive action?
Information such as the description of the non-conformity, root cause analysis, corrective actions taken, preventive actions implemented, and effectiveness verification results must be reported on corrective and preventive action forms.
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