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CAPA Form Template and Example

The document is a CAPA (Corrective/Preventive Action) form designed to address issues related to product or quality systems. It includes sections for describing the issue, root cause investigation, risk assessment, immediate corrections, and action plans. The form requires completion by various responsible parties and is effective from August 20, 2025.

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Carlos ON
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73 views1 page

CAPA Form Template and Example

The document is a CAPA (Corrective/Preventive Action) form designed to address issues related to product or quality systems. It includes sections for describing the issue, root cause investigation, risk assessment, immediate corrections, and action plans. The form requires completion by various responsible parties and is effective from August 20, 2025.

Uploaded by

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

Document no.

: CAPA-REG-001
CAPA form
Version: 0

Owner: Approved by: Effective date: 2025-08-20


Date: Date:

Input for Corrective/Preventive action


Notified Body: Complaints: Other: ________ Ref.: Date:
Description of issue triggering the CAPA:

Scope
CAPA to relate to product or quality system?

Date: Completed by:

Root Cause / Investigation

Date: Completed by:

Risk Assessment
Risk and Impact assessment:

Date: Completed by:

Immediate Correction
Describe the immediate actions taken:

Date: Completed by:

Corrective Action/Preventive Action


Responsible: Q responsible:
Description of corrective and preventive action / Action Plan:

Date: Completed by:

Verification of Corrective/Preventive action


Responsible for verification:
Describe what to verify / verification method:

Date: Completed by:

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