<COMPANY LOGO> CORRECTIVE & PREVENTIVE ACTION REQUEST

CAPA YYYYMMDD-N

CAPA Type Reference Documents

Corrective Action (CA)
Preventive Action (PA)

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 3: Corrective Action What is required to correct the problem?

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

Can CAPA be closed? Yes No Verifier: 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: Date:

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