# CAPA Plan

> Use this template to corrective and preventive action plan for [quality_issue].

## Template Metadata

| Field | Details |
|-------|---------|
| Category | Pharma & Biotech |
| Owner | [Team or owner] |
| Version | [Version number] |
| Effective Date | [Date] |
| Review Cycle | [Monthly / Quarterly / Annual / Event-based] |
| Status | [Draft / In Review / Approved] |

## CAPA Scope

Define the quality issue, affected products, sites, processes, and boundaries of the CAPA.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Source Event

Reference deviations, audits, complaints, OOS events, or inspection observations that initiated the CAPA.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Root Cause

Summarize confirmed root cause and evidence supporting it.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Actions

Separate corrections, corrective actions, and preventive actions with owner, due date, and required records.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Effectiveness Checks

Define measurable criteria, sampling period, responsible reviewer, and failure response.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Risk Controls

Explain interim controls and any quality risk management updates.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]

## Approvals

List required Quality, Manufacturing, Validation, or Regulatory approvals. Use Markdown tables and keep action descriptions auditable.

| Item | Details | Owner | Status |
|------|---------|-------|--------|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |

### Notes

[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]