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CAPA System (Corrective and Preventive Action)

A CAPA system performs corrective and preventive action by analyzing a manufacturing problem, finding the root cause, correcting it, and documenting the correction. CAPA software captures various forms of complaints, defects, and non-conformances. The CAPA system provides a formal process to systematically investigate, analyze, and resolve identified issues. Streamlining the definition of measures to prevent reoccurrences of the problem, an effective CAPA system also reports results in a simple, intuitive user experience.

An advanced CAPA system provides closed-loop issue resolution and enables a manufacturer to identify, analyze, and share critical product quality data across the enterprise. With an effective CAPA system, design, manufacturing and quality improvement teams can share the same views of the information they need to directly impact Six Sigma and Lean initiatives. CAPA software provides visibility into critical product quality characteristics, failures/non-conformances, and resolutions to these issues for smarter decisions across a global, extended enterprise.

CAPA system streamlines corrective and preventive actions, reducing the cost of quality

CAPA system streamlines corrective and preventive actions, reducing the cost of quality.

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CAPA system functionality

CAPA software can interrogate the full spectrum of control points in a manufacturing operation, including design, production, and process, documents, materials, facilities, and equipment. This broad information domain means that a CAPA system is able to perform corrective and preventive action without the delays and potential inaccuracies created when critical data must be located on other systems and manually entered for analysis.

With a CAPA system, corrective and preventive actions can be managed and communicated through automated workflows. This functionality closes the loop between issue capture and final resolution, generating a positive impact on the cost of quality.

A CAPA system can also add value for engineering and manufacturing teams working on new product programs by making all deliverables, analysis, documentation and validation results retrievable for internal or external audits.

CAPA system benefits

An effective CAPA system streamlines corrective and preventive actions by automating the process through configurable workflows. It also improves problem resolution times and increases visibility of CAPA efforts to all stakeholders.

Additional benefits:

  • Demonstrated compliance to standards
  • Improved closure results to mitigate the risk of rework on repeat issues
  • Ease and timeliness in finding critical data for analysis and trend identification
  • Captured knowledge of how to resolve each issue