How do you measure and improve your CAPA performance and maturity?

2 Review your CAPA documentation

One of the main objectives of a CAPA inspection is to verify that your CAPA documentation is complete, accurate, and consistent. Your CAPA documentation should include your CAPA policy, procedures, forms, records, and reports. You should also have evidence of your CAPA activities, such as root cause analysis, corrective and preventive actions, verification and validation, effectiveness checks, and closure. You should review your CAPA documentation regularly, and ensure that it is updated, controlled, and accessible to relevant stakeholders.

3 Train your CAPA staff

Another key aspect of a CAPA inspection is to evaluate the competence and awareness of your CAPA staff. Your CAPA staff should include anyone who is involved in initiating, investigating, implementing, monitoring, or reviewing CAPA actions. You should provide adequate training to your CAPA staff, and ensure that they understand their roles and responsibilities, as well as the regulatory requirements and expectations. You should also maintain records of your training activities, such as agendas, attendance sheets, and evaluation forms.

4 Conduct internal audits

An effective way to prepare for a CAPA inspection is to conduct internal audits of your CAPA system. Internal audits are self-assessments that allow you to check the compliance and performance of your CAPA processes and practices. You should follow a risk-based approach, and focus on the areas that are most critical or vulnerable to nonconformities. You should also use the same criteria and standards that the external inspectors will use, such as the FDA's Quality System Regulation (QSR) or ISO 13485. You should document your audit findings, and implement corrective actions as needed.

5 Communicate with the inspectors

The final tip to prepare for a CAPA inspection is to communicate effectively with the inspectors. Communication is essential for establishing trust and rapport, and for demonstrating your commitment to quality and continuous improvement. You should assign a dedicated contact person or a team to liaise with the inspectors, and provide them with the necessary information and support. You should also be prepared to answer their questions, explain your CAPA rationale, and show them your CAPA evidence. You should avoid being defensive, argumentative, or evasive, and instead be respectful, cooperative, and transparent.