CAPA Audit Checklist

Use this CAPA Audit Checklist to evaluate corrective and preventive actions, ensuring effective resolution of quality issues and compliance with standards.

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Manufacturing
CAPA Audit Checklist

CAPA Process Understanding

Issue Identification And Analysis

CAPA Plan Development

Implementation Process

Effectiveness Evaluation

Documentation And Records

Continuous Improvement

Regulatory Compliance

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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CAPA Audit Checklist

Use this CAPA Audit Checklist to evaluate corrective and preventive actions, ensuring effective resolution of quality issues and compliance with standards.

1. Is there clarity on the Corrective and Preventive Action (CAPA) process within the organization?

2. Are documented policies and procedures available for CAPA implementation?

3. Are responsibilities clearly defined for initiating, managing, and closing CAPA?

1. Is there a structured process for identifying issues or non-conformities?

2. Are robust methods employed for root cause analysis of identified issues?

3. Is there proper documentation of identified issues and their root causes?

1. Are specific action plans developed for addressing identified root causes?

2. Are realistic timelines established for implementing CAPA actions?

3. Is there adequate resource allocation for implementing CAPA actions?

1. Have CAPA actions been executed according to the defined plan?

2. Was there effective communication about CAPA actions to relevant stakeholders?

3. Is there a system in place to monitor the progress of CAPA actions?

1. Are metrics defined to measure the effectiveness of CAPA actions?

2. Has the effectiveness of CAPA actions been verified through testing or assessment?

3. Are established criteria met before closing a CAPA?

1. Are records of CAPA activities, changes made, and outcomes maintained?

2. Is there a reporting mechanism to inform stakeholders about CAPA progress and results?

3. Have lessons learned from CAPA implementations been documented?

1. Is there a system to gather feedback on implemented CAPA changes?

2. Are periodic reviews conducted to assess and adjust CAPA processes?

3. Are employees adequately trained to implement CAPA actions?

1. Are CAPA processes aligned with regulatory requirements and standards?

2. Is there proper documentation showing compliance with regulations?