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SOP-002-CAPA.md

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sop_id SOP-002
title Corrective and Preventive Action (CAPA)
revision R06
revision_date 2026-05-04
status Published
owner_role qa_lead
approver_role management_representative
related_issue #1

1. Purpose

Define a risk-based CAPA process to eliminate causes of nonconformities, prevent recurrence, and prevent occurrence of potential nonconformities.

2. Scope

Applies to quality system and product lifecycle nonconformities originating from audits, complaints, incidents, trend analysis, supplier issues, or management review outputs.

3. Inputs

  • Audit findings
  • Complaint/PMS trend signals
  • Incident investigations
  • Supplier nonconformities
  • Management review actions
  • Process metrics and recurring adverse trends

4. Outputs

  • Approved CAPA record with root cause, action plan, and effectiveness evidence
  • Updates to SOPs, training, risk controls, or product artifacts as needed

5. Roles and Responsibilities

Role Responsibilities
QA Lead Owns CAPA system, assures method quality and timeliness.
CAPA Owner Executes investigation and actions.
Process Owner Implements process/product changes.
Management Representative Reviews escalated/high-risk CAPAs and approves closure.

6. Procedure

6.1 CAPA Initiation

  1. Create CAPA record when systemic issue, significant risk, or adverse trend is identified through complaints, incidents, audits, supplier issues, management review, or process metrics.
  2. Classify severity: critical, major, minor.
  3. Define immediate containment to protect patient/user and compliance state.
  4. Evaluate severity and frequency to determine whether CAPA is required and whether escalation is needed.

6.2 Investigation and Root Cause

  1. Assign investigator independent from the initiating activity when practical.
  2. Use a structured method (5 Why, fishbone, fault-tree, or equivalent).
  3. Identify root cause category: process, design, supplier, training, infrastructure, or oversight.

6.3 Action Plan

  1. Define corrective actions to remove identified root cause.
  2. Define preventive actions where similar failures could occur.
  3. Assign accountable owners and due dates for each action.
  4. For software impacts, include verification evidence requirements.
  5. Assess impact on released or distributed products, including the need for field action, customer communication, or regulatory reporting.

6.4 Implementation and Verification

  1. Implement approved actions through controlled changes.
  2. Verify each action was completed as designed.
  3. Update impacted SOPs, hazard analyses, risk controls, residual risk evaluations, and training where required.

6.5 Effectiveness Check

  1. Define measurable effectiveness criteria before closure.
  2. Observe post-implementation period appropriate to risk.
  3. Reopen/escalate CAPA if effectiveness criteria are not met.

6.6 Closure

  1. QA Lead confirms completeness of objective evidence.
  2. Management Representative approves closure for critical and major CAPAs.
  3. Closed CAPA records are retained as immutable quality records.

7. Required Records

  • CAPA execution record in the designated product/study record repository
  • Investigation evidence and root cause rationale
  • Action completion and effectiveness evidence

8. Traceability

Standard Clause Control in this SOP
ISO 13485:2016 8.5.2 Corrective action trigger, investigation, implementation, and verification.
ISO 13485:2016 8.5.3 Preventive action trigger, risk-based planning, and effectiveness monitoring.

9. Related Controlled Documents

  • SOP-009 Change Management
  • SOP-015 Nonconforming Product Control
  • SOP-016 Quality Metrics and Data Analysis

10. Revision History

Revision Revision Date Change Summary
R00 2026-03-01 Initial placeholder release.
R01 2026-03-02 Full CAPA lifecycle procedure implemented.
R02 2026-03-05 Updated record-location control to designated product/study repositories instead of qms-lite local record paths.
R03 2026-03-18 Removed top-table standards clause metadata; normative references remain in the Traceability section.
R04 2026-03-25 Added trend-based CAPA initiation criteria, severity/frequency evaluation, released-product impact assessment, and explicit risk-file update expectations.
R05 2026-04-27 Renamed YAML metadata field effective_date to revision_date to align controlled-document metadata with the tag-based publication model. The effective date is derived from the published QMS release tag rather than from the document front matter.
R06 2026-05-04 Standardize standards citations to specific versions.