Corrective Action (CA)

Corrective Action is the fix that prevents the same mistake from happening twice. It is the "Corrective" part of the comprehensive Corrective and Preventive Action (CAPA) process.

The term Corrective Action (CA) refers specifically to the actions taken within a formal quality system to eliminate the cause of a nonconformity, defect, or quality problem that has already occurred, with the goal of preventing its recurrence.

Relationship to CAPA

Corrective Action (CA) is intrinsically linked to Preventive Action (PA), and together they form the CAPA system.

• Corrective Action (CA): Addresses existing issues to prevent recurrence.
• Preventive Action (PA): Focuses on mitigating risks to prevent potential or future issues from occurring.

The CAPA system itself is a mandatory requirement for medical device manufacturers under regulations like FDA 21 CFR Part 820.100 and ISO 13485:2016, as well as EU MDR and EU IVDR.

Requirements for Corrective Action

In regulated industries, especially the medical device sector, the procedures for implementing Corrective Action are rigorous and mandated by regulatory bodies and standards.

1. Investigation and Root Cause Analysis

Before a Corrective Action can be implemented, the manufacturer must conduct a thorough investigation to determine the underlying factors contributing to the issue, a process known as Root Cause Analysis (RCA).

The Corrective Action procedure must include requirements for investigating the cause of nonconformities relating to the product, processes, and the quality system. The underlying principles of CAPA management include problem identification, root cause analysis, and implementation of corrective actions.

2. Implementation and Verification

Once the root cause is identified, actions are formulated and implemented. These actions must resolve the existing issue and prevent recurrence.

Regulatory requirements specify that Corrective Actions must be validated or verified to ensure that the action is effective and does not adversely affect the finished device. ISO 13485 requires organizations to investigate nonconformities, implement actions to prevent recurrence, and evaluate corrective action effectiveness.

3. Documentation and Records

All activities related to Corrective Action, including the investigation, the actions taken, and the results, must be thoroughly documented.

• FDA QSR (21 CFR 820.100): Requires documentation of changes in methods and procedures needed to correct and prevent quality problems.
• ISO 9001:2015: Requires retaining documented information as evidence of the nature of the nonconformities and any subsequent actions taken, as well as the results of the corrective action.
• HCT/P (21 CFR 1271): Documentation of corrective actions must include, where appropriate, a description of the action taken and its date(s).

4. Remedial Actions vs. Corrections (FDA Definitions)

The sources also address related actions outside the formal CAPA process:

• Correction: This is an action taken on a nonconforming output to make it conform to requirements. The FDA defines Correction (in the context of device removals) as the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use.
• Remedial Action: This refers to actions necessary to prevent recurrence of a reportable event (MDR event). Manufacturers must submit a 5-day report to the FDA if an event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.

Examples of Corrective Action

Corrective Action is triggered by various inputs to the Quality Management System, such as complaints, audits, and nonconforming product reports.

Examples of Corrective Actions include:

• Manufacturing Failure: If defective plungers are produced due to misaligned machinery, the Corrective Action would be to recalibrate the equipment.
• Audit Findings: If an inspection finds missing documentation for sterilization validation, the Corrective Action would involve reviewing sterilization validation, updating SOPs, and conducting staff training on documentation.
• Customer Complaints: If insulin pumps malfunction (e.g., affecting dosage accuracy), the Corrective Action would involve software debugging and strengthening pre-market software validation.
• Product Recalls: A recall due to battery defects in an implantable device leads to Corrective Action involving stricter quality controls and enhanced supplier audits.

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