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CAPA Plan

Use this CAPA Plan template to systematically document, assess, and manage corrective and preventive actions for quality issues in your medical device processes. This form guides you through scoring and qualifying incidents, defining action plans, and evaluating their impact on product safety, performance, and regulatory compliance. Complete this template whenever a significant quality event occurs that may require formal CAPA initiation, ensuring traceability and compliance with your internal SOPs and regulatory expectations.
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CAPA Plan

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1. Scope

This plan is used to document the execution of a corrective and preventive action (CAPA) according to SOP Corrective and Preventive Action Consectetur adipiscing elit. The report shall be filled out sequentially by section with the signature pages being signed when all required sections are filled out. When the CAPA is closed, add the CAPA to the List of CAPAs document Sed do eiusmod tempor.

2. CAPA Planning

2.1 CAPA Title and Number

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2.2 CAPA Qualification Score

The quality team should perform CAPA qualification. Using the metric below, a member of the quality team can score the event to determine if a CAPA should be initiated. Go through each row sequentially. For each row that presents a numerical score, summarize the appropriate score from each row. For each row with an agree/disagree question, answer each question to be best of your knowledge. Follow the CAPA Initiation Criteria instructions below the table to determine if a CAPA should be initiated.

CAPA Initiating Criteria

  • Initiate CAPA if the summed score calculated above is >3 and all answers to the agree/disagree questions are "Disagree".
  • Do NOT initiate CAPA if any answer to the agree/disagree questions are "Agree" regardless of the score or if the summed score calculated above is under 3.

2.3 CAPA Information

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2.4 CAPA Plan

Planned Actions to be Implemented

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Impact on Performance and Safety

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Impact on Regulatory Requirements

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Medical Device Certification Made Easy.