CAPA - Corrective and Preventive Action

Process of Corrective and Preventive Action

Corrective and Preventive Action (CAPA) process helps an organization to analyze and collect relevant product-related information, investigate and identify product and quality problems, and trigger appropriate and effective corrective or preventive actions to eliminate a problem and prevent its recurrence. CAPA has two different components, corrective action and preventive action. Corrective action is used to address systemic non-conformities when they occur while preventive actions address the risk of non-conformities that are likely to happen. An efficient and compliant CAPA system needs a set of data in order to identify the problems, implement solutions, and document the outcome and further changes. It is important for employees at all levels, from top management to the floor personnel, to understand the process of CAPA and its importance for an effective system.

• The initial phase is called identification that collects the information from the event including the following elements:

• What is the event?
• What is involved in that event?
• Where is the event seen?
• When did the event happen?

• The second phase of the CAPA system is the evaluation phase, a very important phase as it also classifies what is, and is not, affected by the event such as:

• Is it affecting customer safety?
• Is it having an impact on regulatory documents?
• Is this affecting documentation or product design and materials or product performance?
• Has this event appeared before?

Answers to all these questions provide the basis for the impact assessment of the event to assign a risk level to the event (high, medium, low).

• Once the event has been identified and evaluated, this can be investigated. So, the investigation is the third process in the CAPA system used to determine the root cause as well as identify corrective actions.

• The fourth step in the Corrective and Preventive Action system is Appropriate Resolution Plans, having three main categories:

• Correction: A resolution to an existing problem usually occurs right after the event is identified in order to fix the immediate problem.
• Corrective Action: A resolution to prevent the reoccurrence of a problem that will address the root cause identified in the investigation.
• Preventive Action: A resolution to prevent the occurrence of a problem.

Once the Resolution Plans are determined, they should be completed on time.

• Implementation is the fifth step of the CAPA system where teamwork is needed depending on the scope of the resolutions. All resolution plans must be documented and these results must also be reviewed and approved by appropriate quality management to ensure compliance.

• The final step of the CAPA system is the effectiveness check to make sure the action is appropriate for the root cause and prevents events in the future. Effectiveness checks involve the review of event data, conducting audits of affected products, materials, or equipment, etc.