Corrective and Preventive Actions (CAPA)

Certification Experts can help provide new insights into a process.

CAPA is an integral part of your standard processes. The challenge lies in completing them correctly, comprehensively, and on time. At Certification Experts, we can assist you in achieving compliance.

Summary

A quick overview of this page

Corrective and Preventive Actions (CAPA)

CAPA (Corrective Action / Preventive Action) is a process used to identify issues (non-conformities), determine their root causes, and implement corrective measures to prevent recurrence.

Challenges with CAPA

The challenges in the CAPA process lie in identifying the various causes. There is very likely never just one reason, but often a combination of events that lead to the non-conformity. Additionally, meeting the deadline, for various reasons, is also a challenge.

Guidance from start to finish

The consultants at Certification Experts leverage their extensive experience and expertise in quality management and regulatory standards, enabling them to play an essential role in overseeing and guiding the CAPA process.

Who We Serve

CAPA

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CAPA Assessment by Certification Experts

The CAPA process can be complex, but following a structured format can help effectively tackle it.

Our methodology is as follows:

  • Identify and document the problem
  • Analyse the root cause
  • Determine immediate corrective action
  • Propose corrective measures
  • Assist in implementing the corrective action
  • Aid in monitoring and measuring effectiveness through performance indicators and measurable objectives
  • Report evaluation results to relevant stakeholders

Difference between corrective action and preventive action

A corrective measure is aimed at correcting or resolving an existing problem or non-conformity that has occurred. The main objective is to address the root cause of an issue and ensure it does not recur.

A preventive measure is aimed at preventing future problems or non-conformities before they occur. The main objective is to identify potential causes of problems and take proactive action to eliminate or reduce them.

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CAPA format

Timely completion of Corrective and Preventive Actions (CAPA’s) requires a structured approach and clear responsibilities.

Benefits of outsourcing CAPA Process

Outsourcing the CAPA process can offer several benefits:

How can Certification Experts help?

In the pursuit of enhancing quality and compliance with regulations, implementing an effective Corrective and Preventive Actions (CAPA) process is essential. The consultants at Certification Experts bring valuable experience and expertise in quality management and regulatory requirements, enabling them to play a crucial role in taking over the CAPA process. Their profound knowledge allows organizations to precisely align CAPA processes with sectoral and regulatory standards, such as ISO 13485. By engaging our experts in the design, implementation, and evaluation of CAPA procedures, organizations can ensure a robust and compliant process that not only addresses problems reactively but also takes proactive measures to prevent future non-conformities. Their insights aid in identifying best practices and optimizing CAPA workflows, resulting in improved operational efficiency, risk management, and customer satisfaction.

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Portfolio

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Frequently asked questions

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Testimonials

What our clients are saying about us

New Compliance

Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

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