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CAPA YYYYMMDD-N
Section 1: Problem The originator completes this section and submits the form to QA/RA
Originator: Date:
Section 2: Investigation & Identified Cause Investigate and identify the root cause of the problem
Assigned Process Owner(s):
Section 4: Preventive Action Plan What is required to prevent the problem or to make improvements?
Section 5: Verification of Effectiveness Assigned person verifies the effectiveness by sampling evidence
The Quality Assurance/Regulatory Affairs Manager verifies that the Corrective & Preventive Action has been adequately
completed and does not have an adverse effect on product quality, the Quality Management System, or regulatory compliance.