This procedure package includes three documents
1. Corrective and Preventive Action (CAPA) Procedure
Purpose – The purpose of this (5)-page procedure is to provide a process for identifying, preventing and eliminating the causes of actual or potential nonconformity, using risk management principles.
Scope – This procedure applies to all activities, products and processes within the quality management system. This is the primary document meeting the applicable regulatory requirements for Corrective and Preventive Action as defined in your company’s Quality System Manual (POL-001).
2. CAPA Report form
3. CAPA Register form
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