PLANREFERENCE OUTLINE

CAPA Plan & Effectiveness Review

Corrective and preventive action plan with owners, due dates, and a pre-defined effectiveness check — so the fix is verified, not assumed. Maps to ISO 13485 clauses 8.5.2–8.5.3 under FDA’s QMSR (formerly 21 CFR 820.100) and ICH Q10.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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HOW TO FILL THIS IN
How to Write a CAPA, step by step →
REGULATIONS MAPPED
21 CFR Part 820ICH Q10
DOCUMENT TYPE
Plan
LAST UPDATED
January 2025
PURPOSE

The plan that turns a confirmed root cause into defined, owned, verifiable actions, with an effectiveness check designed before the actions are taken. The common failure is not a missing CAPA but a closed one: actions completed, boxes ticked, and no evidence the problem stopped. This template makes the effectiveness check a planned step with criteria, not a retrospective opinion recorded at closure.

What's Inside

✓Problem statement and source event, stated in terms of what actually happened rather than what was concluded
✓Root cause summary carried from the investigation, with the evidence that confirmed it
✓Corrective actions addressing the occurrence that happened, each with an owner and due date
✓Preventive actions addressing the same cause wherever else it could occur, including other lines, products, or sites
✓Dependencies between actions, so a check scheduled before its prerequisite is visible
✓Effectiveness check design — what will be measured, over what period, against what criterion, decided now
✓Verification of effectiveness and the closure approval, separated so closure cannot precede evidence

How to Use It

1Restate the confirmed root cause from the investigation; a CAPA written against a symptom will close and the event will recur
2Distinguish corrective from preventive deliberately — retraining the operator who erred is corrective, not preventive
3Extend preventive actions to every place the cause could act, and record the scan you performed to find them
4Design the effectiveness check before the actions start, with a measure, a period, and a pass criterion
5Track dependencies, so an effectiveness check is not scheduled before the action it is meant to evaluate
6Hold closure until effectiveness evidence exists, and record what would reopen the CAPA if the measure moves
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Problem Statement and Source
› Problem statement
2Root Cause Summary
3Corrective Action Plan
4Preventive Action Plan
5Owners, Due Dates, and Dependencies
6Effectiveness Check and Acceptance Criteria
7Verification of Effectiveness
8Closure and Approval
REGULATORY CONTEXT

For devices, the QMSR (ISO 13485:2016 clauses 8.5.2 and 8.5.3, incorporated by 21 CFR 820.7; formerly 21 CFR 820.100) requires procedures for corrective and preventive action including verification or validation that the action does not adversely affect the finished device, and ICH Q10 places CAPA among the pharmaceutical quality system's enablers with the expectation that effectiveness is evaluated. EU GMP Chapter 1 expects corrective and preventive actions to be identified and their effectiveness monitored. What counts as effective for your event is your criterion; this template exists to make you state it in advance.

MAPPED STANDARDS
21 CFR Part 820ICH Q10
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