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.
Trust our team of experts to handle your CAPA’s
What is 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.
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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CAPA Assessment by Certification Experts
The CAPA process can be complex, but following a structured approach 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.
CAPA format
Timely completion of Corrective and Preventive Actions (CAPA’s) requires a structured approach and clear responsibilities.
Set clear deadlines: When initiating a CAPA, establish clear deadlines for each phase of the process, including identifying the root cause, developing corrective actions, implementing measures, and evaluating effectiveness. Ensure these deadlines are realistic and account for the complexity of the issue.
Assign responsibilities: Designate specific individuals or teams responsible for each phase of the CAPA. Ensure these individuals have the necessary authority and resources to carry out the tasks and meet the deadlines.
Monitor progress closely: Regularly monitor the progress of each CAPA to ensure it stays on track. Establish periodic status updates and keep communication lines open to identify and address any obstacles in a timely manner.
Communicate effectively: Maintain clear communication about expectations, deadlines, and responsibilities with all involved parties. Encourage open communication and provide support and resources as needed.
Prioritize CAPA’s: If multiple CAPA’s are being conducted simultaneously, prioritize them based on risk and impact on the organization. Allocate more resources to CAPA’s with higher priority to ensure they are completed on time.
Benefits of outsourcing CAPA Process
Outsourcing the CAPA process can offer several benefits:
Access to expertise: Our experts specializing in quality management and CAPA processes bring a high level of expertise and experience. They can leverage in-depth knowledge of industry standards, regulatory requirements, and best practices, leading to more effective CAPA implementations.
Efficiency and time savings: Outsourcing CAPA processes to our experts can result in improved efficiency and time savings within your organization. Our experts can handle the implementation of CAPA’s more quickly, freeing up internal resources for other important tasks.
Independent assessment: Our experts can provide an objective and independent assessment of CAPA’s, helping to avoid any bias or conflicts of interest within your organization. This can lead to more accurate problem analysis and more effective solutions.
Flexibility and scalability: Outsourcing CAPA processes provides your organization with flexibility and scalability, as you can leverage the resources and expertise of our experts on an as-needed basis.
Focus on core activities: By outsourcing CAPA processes, you can focus on core activities and strategic objectives while leaving the execution of CAPAs to our experts. This can lead to improved overall business performance and competitive advantage.
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All the answers you might need!
It is part of the QMS. There should be a procedure in place for the CAPA process, described in chapter 8.5 of the ISO13485
During an external audit, this can be seen as a non-conformity. Especially, if this is a repeated issue.
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. Corrective measures are taken after a problem or non-conformity has occurred and been identified.
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. Preventive measures are taken before a problem or non-conformity occurs, based on risk analysis, trend analysis, or other predictive methods.
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