Corrective actions & Preventive Actions

You have a CAPA process. But is it connected to your risk management & design controls? Let’s start with the fundamentals.

• Correction is a one-time action to fix a detected nonconformity. It provides an immediate solution (e.g. repair, rework). No impact on recurrence.

• Corrective Action targets the cause of an existing issue. It prevents recurrence by addressing the root cause.

• Preventive Action goes one step further. It eliminates the potential causes of future issues, before they happen.

A solid CA/PA process follows these key steps:

1. Trigger / Identification : Based on events, trends, or quality indicators

2. Investigation : Analysis of historical data and identification of the real root cause (not symptoms)

3. Action Plan Clear responsibilities, timelines, and expected outcomes

4. Adverse effect check: Assess regulatory and product impact

5. Implementation: Execution of corrective or preventive measures

6. Effectiveness check : Review whether the action resolved the root cause

That’s the ideal structure. But the real differentiator? Integrating CA/PA with risk management and design control.

• A proactive FMEA or FTA should trigger preventive actions

• Failures must be captured and analyzed within the risk system

• Actions need to close the loop between medical device design, QMS and safety

Too often, these processes remain disconnected. Risk analysis is managed by engineering. CAPA is handled separately by quality teams. Without a shared system, alignment and traceability become difficult. And the opportunity to prevent future issues is lost.

With Matrix Requirements, those silos are removed.

• Risk control measures, CAPA and design control are connected

• You work with a true closed-loop system

That’s how you move from “reactive” to “preventive”.

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