Design changes are not corrective actions.

Design changes are not corrective actions.

Correction and corrective action are different.

In the course of implementing CAPA (corrective and preventive actions), we see many cases of confusion between corrective and corrective actions.
Correction is different from Corrective Action.
ISO 9000:2015 (JIS Q 9000:2015) defines modifications as follows

3.12.3 Correction
  Actions to remove detected nonconformities.

On the other hand, corrective actions are defined as follows

3.12.2 Corrective Action
  Actions taken to eliminate the cause of nonconformity and prevent recurrence.

In other words, corrective action is to destroy the immediate cause. Corrective action is to destroy the root cause.
Correction is not the removal of the root cause of a nonconformity, but only the nonconformity itself (the direct cause).
In general, corrections are referred to as emergency measures, interim measures, or immediate measures.
The purpose of corrective action is to eliminate the root cause of the nonconformity and to prevent recurrence (to prevent the same thing from happening again at the same location).
However, corrections are part of the corrective action.
Corrections are completed and corrective actions are initiated.
Corrective action is the prevention of recurrence and addresses the cause of the nonconformity.
Pursue the cause of the problem thoroughly and eliminate the source (root cause).

Preventive action is risk management.

It further defines preventive measures as follows

3.12.1 Preventive Action
Treatment to eliminate possible nonconformities or other possible causes of undesirable situations.

What is preventive action? It is risk management. Because a “possible nonconformity” is a problem that has not yet occurred and is a “risk”.
Preventive action is prevention and proactive management (anticipating and preventing where it has not yet happened).
Note that horizontal development is not a preventive measure.

CAPA for accidents caused by drunk drivers

Let’s assume an accident caused by a drunk driver and explain the flow of corrective (including first aid) => corrective action => preventive action.

First aid: Treat injuries of drivers, etc. Put up safety signs.
Correction : Move the car involved in the accident to the shoulder of the road.
Corrective action: Deprivation of driver’s license (to prevent recurrence of drunk driving).
Preventive action: Establish a new crime of dangerous driving manslaughter (eliminating potential causes that have different root causes but similar consequences).

Design changes are not corrective actions.

Often we see examples of CAPAs being implemented and design changes made in response to market complaints, etc.
However, design changes are “corrections” and not “corrective actions.
If only design changes are made, the problem may occur (recur) in another area.
Why did we design it wrong?” and the root causes must be investigated.
What is important in corrective action is to always improve the mechanism (system) rather than human error or product-specific events as the root cause. The important thing in corrective action is to always improve the mechanism (system), not the root cause.

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