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CAPA Form Example

This document is a corrective and preventive action request form used by a company to document problems, investigations, corrective actions, and preventive action plans. The form has sections for describing the problem, investigating its cause, outlining corrective and preventive actions, verifying the effectiveness of those actions, and getting final sign-off from quality and regulatory managers. It provides a structured process for continuously improving processes and addressing nonconformities.

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Bharath
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12K views

CAPA Form Example

This document is a corrective and preventive action request form used by a company to document problems, investigations, corrective actions, and preventive action plans. The form has sections for describing the problem, investigating its cause, outlining corrective and preventive actions, verifying the effectiveness of those actions, and getting final sign-off from quality and regulatory managers. It provides a structured process for continuously improving processes and addressing nonconformities.

Uploaded by

Bharath
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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<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:

SOP-XXX-Y R# M/D/Y Page 1 of 1

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