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Free Corrective & Preventive Action (CAPA) Form

A complete CAPA form covering all required phases: problem description, immediate containment action, root cause analysis, corrective action plan with owners and target dates, preventive action to address systemic issues, effectiveness verification, and QA closure sign-off. Designed for FDA 21 CFR 820 and ISO 9001:2015 compliance. Generated instantly, no login required.

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How to use this template

  1. Open the CAPA and assign a number — every CAPA needs a unique tracking number and an owner. Assign it immediately when a problem source (complaint, audit NC, trend, or regulatory finding) is identified.
  2. Describe the problem clearly — write the problem in observable, measurable terms using the 5W1H framework: What, When, Where, Who, How many, and Severity.
  3. Implement containment — apply an immediate action to protect the customer and prevent further escapes while root cause is being investigated. Record what was done and by whom.
  4. Identify the root cause — use a structured method (5-Why, Ishikawa, FTA). Document the method used and the confirmed root cause. Link to supporting evidence.
  5. Define and implement the corrective action — the corrective action must address the root cause, not just the symptom. Assign an owner and a realistic target date for each action step.
  6. Define the preventive action — identify other similar processes, products, or locations where the same root cause could exist. Implement controls proactively and update affected documents.
  7. Verify effectiveness and close — after the corrective action has had time to demonstrate results, verify the problem has not recurred. Obtain QA sign-off before closing the CAPA.

FDA 21 CFR 820 Note: CAPA records are a primary focus during FDA inspections (21 CFR 820.100). Ensure your CAPA system captures sources, investigations, corrective actions, and effectiveness checks — and that results are reported to management review.

What's inside the template

1

CAPA Header

CAPA number, date opened, source/trigger, process/product affected, CAPA owner, QA initiator, and target closure date

2

Problem Description

5W1H problem statement: What, When, Where, Who, How Many, and Severity/Impact assessment

3

Immediate / Containment Action

ICA description, date implemented, implementer, quantity contained, and effectiveness verification

4

Root Cause Analysis

Analysis method, root cause statement, contributing factors, supporting evidence, and verification

5

Corrective Action Plan

5-row action table with Action Description, Owner, Target Date, and Completion Date columns

6

Preventive Action

Similar areas reviewed, preventive actions defined, systemic changes made (FMEA/Control Plan/Procedure/Training)

7

Effectiveness Verification

Verification criteria, monitoring period, actual results, effectiveness determination, and verified by

8

Closure Sign-Off

QA Manager signature, closure date, CAPA status, and lessons learned notes

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