Corrective and Preventive Action (CAPA) processes are essential for addressing issues, preventing recurrence, and improving our quality management system. Here are examples of our CAPA processes and how they have been implemented:
Example 1: Corrective Action
- Issue Identified: During an internal audit, it was found that a critical equipment calibration was overdue.
- Root Cause Analysis: The root cause was determined to be a breakdown in the equipment maintenance scheduling process.
- Corrective Action: A maintenance procedure review and update were initiated to prevent future delays in calibration. The overdue calibration was promptly performed.
- Verification: After implementing the corrective action, a follow-up audit was conducted to ensure
the equipment calibration process was now on track.
Example 2: Preventive Action
- Issue Identified: A quality trend analysis revealed a recurring pattern of minor deviations in a specific manufacturing process.
- Root Cause Analysis: Investigation revealed that the deviations were caused by variations in raw material quality.
- Preventive Action: A raw material quality monitoring program was established, including tighter specifications and increased supplier communication.
- Implementation: The new raw material quality monitoring process was integrated into the manufacturing workflow, and suppliers were informed of the updated requirements.
- Effectiveness Evaluation: Over the next several months, deviations related to the specific raw material decreased significantly, indicating the effectiveness of the preventive action.
Example 3: CAPA Review
- Regular Review: Our CAPA process involves periodic review of past corrective and preventive actions to assess their ongoing effectiveness.
- Continuous Improvement: During a review, it was noted that a previous corrective action implemented to address equipment downtime could be further optimized.
- Enhancement: The procedure was updated to include additional preventive maintenance steps to reduce the risk of unexpected downtime.
- Communication: The enhanced procedure was communicated to the maintenance team, and training was provided on the new steps.
These examples illustrate how our CAPA processes are applied to address issues, prevent recurrence, and drive continuous improvement. By diligently implementing CAPA processes, we ensure the quality, compliance, and efficiency of our operations in alignment with FDA regulations.