CAPA - Corrective and Preventive Action

Dealing with customer complaints and non-conformances is the backbone for rectifying problems but organizations can now reinforce the process throughout the digitally connected enterprise by managing CAPAs in real-time and ensuring stakeholders take impactful, proper actions.

A general Corrective and Preventive Action (CAPA) process follows the Plan-Do-Check-Act (PDCA) cycle to resolve unexpected events. The first process will be the identification phase where you will identify non-conformities in your processes and determine what kind of problem you are looking at. Non-conformities may be determined during an internal or external audit, through customer complaints, or if reported internally.

In case of systemic issues, Corrective Action is needed to eliminate a problem and prevent its recurrence while for non systemic issues, Preventive Action is required to reduce the risks of this adverse event occurring.

You can use numerous techniques to improve your Corrective Action, Preventive Action approach. Root Cause Analysis (RCA) is an analytical method that helps identify and rectify the sources of potential problems. Failure Mode and Effects Analysis (FMEA) is another effective element of a proactive approach, that provides input for your CAPA activities. APQP (Advanced Product Quality Planning) is generally used in the automotive industry to drive quality improvement in mobility end products. The 5 Whys-technique is also useful in detecting the cause-and-effect relationships inducing a particular problem.

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:

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:

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:

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.

CAPA requirements are not only a regulatory requirement, they also make great business sense for life science industries. Companies must ensure that the corrective actions involve both short-term actions to address the immediate problem and long-term actions to prevent the recurrence of a problem. To successfully manage the CAPA system, companies need to streamline their procedures, filter and prioritize the corrective and preventive actions. Top management must allocate proper resources to find out and eliminate the root causes of recurring problems. There are many complex CAPA issues found in non-routine channels like customer surveys. Companies have to identify and fix the problems before they trigger an FDA warning letter. By avoiding the root causes of recurring problems, companies will benefit in two ways: meeting the regulatory expectations as well as business requirements.