What is a Corrective and Preventive Action (CAPA)?

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Corrective and Preventive Action Definition

Corrective and preventive action (CAPA) is a good manufacturing practice (GMP) concept in which product failures are investigated to determine their root cause in an effort to eliminate occurrences of nonconformity (corrective action) and prevent similar occurrences from happening in the future (preventive action). Whereas a corrective action can be thought of as a reaction to a nonconformance, preventive action is a proactive approach aimed at preventing future occurrences of nonconformance before they happen.

CAPA software helps address these processes and should include the following capabilities:

  1. Organize all documents and processes around the product’s bill of materials
  2. Manage the CAPA process, including tasks, assignments, deadlines, all connected to affected products and documents
  3. Connect quality processes with the engineering change process and product record
  4. Provide analytics for measure and improve related processes

Cloud-native QMS for CAPA Management

Corrective and preventive actions (CAPAs) as part of the quality management system (QMS) are essential for upholding superior standards in new product development (NPD) and new product introduction (NPI). A CAPA guarantees the prompt rectification of detected issues, including design faults or manufacturing errors, during the development phase, thereby averting expensive delays or product recalls. Utilizing a cloud-native QMS for CAPA management enhances efficiency, providing real time data access and facilitating prompt issue monitoring and resolution by teams. This is especially crucial during the NPI phase, where time-to-market is essential.

The cloud-based technology facilitates interdepartmental collaboration, guaranteeing the prompt and uniform execution of corrective measures. Managing corrective and preventive actions (CAPAs) within a cloud-native quality management system (QMS) improves quality, lowers risks, and speeds up problem-solving, making it essential for successful product development and launch.

What is a Corrective and Preventive Action

The Importance of Streamlining CAPA Processes in QMS

Streamlining CAPA processes in QMS is essential for compliance, linking product quality actions from design to manufacturing and addressing FDA requirements. CAPA is one of the most common problems found during FDA inspections. Automation and traceable workflows assist in identifying the underlying causes, implementing preventative measures, and ensuring uniform application of standards across all product lines. This makes it easier to track down problems, stops them from happening again, and encourages constant improvement. In the end, this lowers risk and encourages safer, higher-quality goods within a strong regulatory framework.

FAQs

What does Capa involve?

CAPA involves:

  • Analyzing quality data to identify existing and potential causes of nonconforming products or other quality issues
  • Investigating the root cause of the nonconformity
  • Identifying actions needed to correct and prevent reoccurrence of the nonconformity
  • Verifying and validating the corrective and preventive action to ensure effectiveness
  • Implementing and recording changes in procedures to correct the problem and prevent it from reoccurring
  • Disseminating information related to the identified problem and CAPAs to all key stakeholders

*Source: pharmaceuticalonline.com

What is an example of corrective action?

Capa Example

*Source: techiequality.com

What is the purpose of CAPA?

The purpose of CAPA is to identify the root cause of product nonconformities or quality issues and implement the appropriate corrective and/or preventive measures to prevent their reoccurrence.

*Source: fda.gov

Best
Practice

Medical device companies must have a compliant Corrective Action Preventive Action (CAPA) process in place to comply with FDA 21 CFR 820.100. Learn the essential elements of a CAPA system.

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