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 3: Corrective Action
What is required to correct the problem?
Section 4: Preventive Action Plan
Section 5: Verification of Effectiveness
Can CAPA be closed?
Yes
No
Verifier:
What is required to prevent the problem or to make improvements?
Assigned person verifies verifies the effectiveness effectiveness by sampling sampling evidence
Date:
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. Quality Assurance/Regulatory Affairs Manager : SOP-XXX-Y R# M/D/Y
