CAPA Definition

CAPA (Corrective and Preventive Action) is a structured, step-by-step process used to investigate issues, eliminate the root cause, and prevent similar problems in the future. It is a core requirement of most quality standards, including ISO 9001, ISO 13485, GMP, HACCP, and FDA regulations.

Corrective Action

Actions taken to identify and eliminate the cause of an existing non-conformance or defect.
It answers:
“Why did this happen, and how do we fix it?”

Preventive Action

Actions taken to prevent potential issues from occurring.
It answers:
“How do we ensure this never happens again?”

Together, CAPA protects product quality, reduces risk, improves customer satisfaction, and strengthens internal processes.

What Is CAPA? A Clear, Simple Explanation for Modern Quality Teams

Every organization—whether manufacturing, food processing, healthcare, logistics, or consumer goods—faces quality issues from time to time. The most successful companies aren’t the ones with zero problems, but the ones that resolve issues quickly, learn from them, and prevent them from happening again.

This is where CAPA becomes essential.

Why Corrective and Preventive Action Matters

A strong Corrective and Preventive Action program helps organizations:

• Reduce repeat defects

• Improve supplier accountability

• Strengthen process control

• Enhance regulatory compliance

• Lower costs from rework, scrap, and returns

• Improve customer trust

• Build a culture of continuous improvement

CAPA turns every issue into an opportunity to strengthen your operations.

---

The Corrective and Preventive Action Process (Simple Overview)

1. Problem Identification

Document the issue clearly: what happened, where, when, how often, and how it was discovered.

2. Containment / Immediate Actions

Take temporary steps to stop the problem from spreading or getting worse.

3. Root Cause Analysis

Use tools such as 5 Whys, Fishbone Diagram, or process mapping to identify the true cause—not just symptoms.

4. Corrective Action Plan

Create a plan to eliminate the root cause. Assign owners, timelines, and required evidence.

5. Preventive Action Plan

Define long-term actions to avoid recurrence, such as training, SOP updates, inspections, or process changes.

6. Implementation

Execute assigned tasks, document progress, and upload supporting evidence.

7. Verification of Effectiveness (VoE)

Ensure the actions actually worked and the issue is not recurring.

8. Closure & Documentation

Approve and store the CAPA record for audits, traceability, and analytics.

---

How the Lyons Quality Audit Tracking System (LQATS) Handles Corrective and Preventive Action

The Lyons Quality Audit Tracking System brings the entire CAPA process into one digital workflow—fast, traceable, and audit-ready.

LQATS makes CAPA automatic, structured, and easy to manage across teams, suppliers, and facilities.

Below is how LQATS handles each step of CAPA:

---

1. CAPA Creation Directly From Audits, NCs, or OQL Results

CAPA can be triggered instantly from:

• Audit findings

• Supplier non-conformances

• High OQL results

• Incident reports

• Customer complaints

• Internal deviations

No more manual forms or separate Excel trackers.

---

2. Root Cause Analysis Tools Built In

LQATS provides guided templates for:

• 5 Whys

• Fishbone (Ishikawa) analysis

• Human error analysis

• Process/flow breakdown

Suppliers and internal teams document their root cause directly in the system.

---

3. Corrective & Preventive Action Assignment

Each action includes:

• Action owner

• Due date

• Priority

• Required evidence

• Automatic reminders

Teams always know exactly what they need to complete.

---

4. Evidence Upload & Document Control

Photos, reports, test results, SOP updates, and training proofs can be uploaded directly into the CAPA record, ensuring complete traceability for audits.

---

5. Automated Workflow Tracking

LQATS tracks CAPA progress from open → investigation → actions → verification → closure.
Status flags show exactly where each CAPA stands:

• Open

• In Progress

• Waiting for Supplier

• Waiting for Verification

• Delayed

• Completed

This gives quality managers a real-time view of compliance.

---

6. Verification of Effectiveness (VoE)

LQATS includes a dedicated VoE stage where:

• Inspectors confirm actions were effective

• Reliability is documented

• Recurrence is checked

• Final verification notes are added

CAPA cannot close without VoE approval.

---

7. Corrective and Preventive Action Closure and Digital Record Retention

Once approved:

• CAPA is locked

• Full history is stored

• Evidence is archived

• The record becomes audit-ready

This satisfies ISO, FDA, and customer audit requirements.

---

8. Corrective and Preventive Action Trend Analysis & Supplier Scorecards

LQATS automatically analyses Corrective and Preventive Action data to highlight:

• Repeat offenders

• Frequent defect types

• Supplier risk trends

• Process gaps

• Cross-location patterns

CAPA is no longer just a report—it becomes a real improvement engine.

---

Why Corrective and Preventive Action in LQATS Is Better

 Fully digital
 Real-time visibility
 Automatic notifications and deadlines
 Supplier collaboration built-in
 Complete audit trail
 OQL-based CAPA triggering
 Analytics for smarter decision-making
 Proven for manufacturing, distribution, food, pharma, and service industries

LQATS transforms Corrective and Preventive Action from a reactive paperwork burden into a proactive quality improvement system.

---

Conclusion

Corrective and Preventive Action is one of the most powerful tools in modern quality management. It helps teams eliminate root causes, prevent recurrence, and protect customers. The Lyons Quality Audit Tracking System takes Corrective and Preventive Action to the next level by providing automated workflows, clear accountability, full traceability, and predictive insights.