Using the CAPA SOP and Template

Simplifya now provides resources for GMP-certified operators and other licensed operators wishing to implement a CAPA (Corrective and Preventive Action) plan. CAPA is a systematic process used to identify, analyze, and correct root causes of non-conformance or problems in a quality management system. To implement a CAPA plan, follow these steps:

• Identify the problem or non-conformance. This includes defining the problem, determining its impact, and identifying all of the affected areas. 
• Investigate the root cause. This involves collecting data, analyzing it, and determining the root cause of the problem.
• Develop and implement corrective actions. This includes identifying and implementing short-term and long-term solutions to prevent or eliminate recurrence of the cause of the problem.
• Monitor and evaluate the effectiveness of the corrective actions. This includes verifying that the implemented corrective actions have effectively addressed the root cause and prevented recurrence of the problem.

If you haven’t used CAPA before and you're wondering how to incorporate it into your compliance program, start with a small example and walk yourself through the process. Once you have an idea of how it works, determine your threshold for what should qualify as a CAPA-required evaluation and which members of your team will take the lead. Consider evaluating both the quality impacts and risks associated if you do or do not effectively solve your problem.

Determining the root cause of a problem can take considerable effort and may require company-wide discussions. Perform a root cause analysis and continue asking “Why?” until you uncover the root cause and a viable solution becomes apparent. Once you identify the root cause, determine if any immediate actions need to be taken (e.g. issuing a recall).

Once corrective actions have been implemented and determined to be sufficient, the information gathered should be fully documented and shared with your organization. This information can then be discussed to determine the corrective action’s effectiveness and help identify other systems, products, or processes that may benefit from the learnings.

After each use of CAPA, conduct a review and evaluate whether your CAPA processes were effective and how they might be improved, and document your findings.

Some examples of when CAPA should be used include when:

• A product or service does not meet customer or regulatory requirements.
• A product does not meet testing or regulatory standards.
• A deviation or non-compliance is identified.
• An unexpected event occurs, such as a product recall, contamination, or adverse event.
• Customer complaints are received.
• An audit reveals non-conformance.

Simplifya’s Corrective and Preventive Actions (CAPA) Template can be found as an attachment to the “Implementing a Corrective and Preventive Action Plan” SOP, located in available state SOP packages. The SOP can be used as a guide to walk you through how to properly fill out the template. CAPA is a requirement for GMP (Good Manufacturing Practices) operators and considered a best business practice for all other operators. Please reach out to [e-mail] if you are having trouble finding these documents.

All CAPA processes and templates should be fully documented and saved in your business records. In the Simplifya platform, completed CAPA templates can be saved in the Correspondence, Discipline, and Remediation folder of Smart Cabinet, under the “Corrective and Preventive Action (CAPA) Plans” document type.