Design Changes Are Not Corrective Actions

Corrections and Corrective Actions Are Different

In the implementation of CAPA (Corrective and Preventive Actions), we frequently encounter cases where corrections and corrective actions are confused with one another. Correction and Corrective Action are fundamentally different concepts.

ISO 9000:2015 (JIS Q 9000:2015) defines correction as follows:

“3.12.3 Correction An action to eliminate a detected nonconformity.”

Meanwhile, corrective action is defined as follows:

“3.12.2 Corrective Action Action to eliminate the cause of a nonconformity and to prevent its recurrence.”

In essence, a correction eliminates the direct cause, while a corrective action eliminates the root cause. A correction is a measure that addresses only the nonconformity itself (the direct cause) and is commonly referred to as an emergency measure, temporary measure, or interim measure. In contrast, a corrective action eliminates the root cause of the nonconformity with the objective of preventing recurrence (ensuring the same issue does not occur again in the same location).

Importantly, a correction is part of the corrective action process. After a correction is completed, the corrective action begins. Corrective action is focused on preventing recurrence and addresses the causes that led to the nonconformity. This involves thoroughly investigating the causes, identifying the source (root cause), and eliminating it.

Preventive Actions Constitute Risk Management

Preventive action is further defined as follows:

“3.12.1 Preventive Action Action to eliminate the cause of a potential nonconformity or other potential undesirable situation.”

Preventive action constitutes risk management. The term “potential nonconformity” refers to problems that have not yet occurred—in other words, risks themselves. Preventive action is proactive prevention or forward-looking management (preventing potential issues before they occur). It is important to note that horizontal deployment is not a preventive action. Horizontal deployment is a measure to prevent problems that have already occurred from spreading to other areas, and is essentially a form of corrective action.

CAPA in the Context of a Drunk Driving Accident

To illustrate the flow of correction, corrective action, and preventive action, consider the example of a drunk driving accident:

• Emergency measure: Provide medical care to injured persons and post safety signs to warn of the hazard.
• Correction: Move the damaged vehicle to the roadside.
• Corrective action: Revoke the driver’s license (to prevent recurrence of drunk driving).
• Preventive action: Enact or enhance laws against dangerous driving (or implement stricter alcohol testing protocols) to eliminate potential causes that could lead to similar outcomes, even if the root causes differ.

Design Changes Are Not Corrective Actions

In the medical device industry, we frequently observe cases where companies receive complaints from the market, implement CAPA, and make design changes. However, design changes constitute a “correction,” not a “corrective action.” If the organization relies solely on design changes, there is a risk that problems will recur in other areas of the product. The organization must investigate the root cause of why the design was flawed in the first place.

What is crucial in corrective action is not treating human error or product-specific issues as the root cause, but rather ensuring that the underlying system or process is improved. ISO 14971, the risk management standard for medical devices, emphasizes process improvement through root cause analysis in the risk management process. It is essential not merely to implement design changes but to identify systemic issues throughout the entire design process that led to the change and to implement process improvements accordingly.