A Corrective Action / Preventive Action (CAPA) system is for developing, approving, tracking, implementing, and determining the effectiveness of corrective actions and preventive actions resulting from deviations (non-conformances), complaints, product recalls, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. CAPA philosophies and practices should result in product and process improvements and enhance product and process understanding.
When developing your CAPA system it is important to ask what would work best for the organization, a one system or multiple systems approach. A one system approach is just what it implies, it is one CAPA system developed to manage, from initiation through conclusion and closure, all of the quality issues to be resolved. While the multiple CAPA systems approach has specific CAPAs within respective quality systems, a deviation’s CAPA, a product complaint’s CAPA, a regulatory inspection / finding’s CAPA, etc. . .
There are many pros and cons for either developing one CAPA system or multiple systems. Most professionals would support a simple CAPA model, as well as a single CAPA system. A con to the multiple CAPA systems approach is the ‘Silo’ effect. An information silo, as it applies to electronic quality systems, is a management system incapable of sharing common operations, data and communications with other, related management systems. This leads to the inability to recognize similar problems across the various quality systems early and additionally leads to a lack of consistency of how CAPAs are prioritized based on risk. Considerations to the organization’s financial position, in the form of time, money and resources needed to develop multiple CAPA systems is immense compared to developing one CAPA system that accommodates all of the quality issues that need corrective actions and preventive actions.
Another vital component to the CAPA system, which companies in the past have overlooked, is instilling a closed loop methodology and the subsequent workflow(s) to support it. It is imperative that there is a mechanism in place to determine that your CAPAs are effective or not. An effectiveness check is the measure and determination, with supportive documentation, as to whether or not the corrective actions and preventive actions that have been implemented were effective in eliminating or reducing the issue to be resolved. The effectiveness check is the last component to the CAPA system and is the conclusion to your closed loop system.
You should always strive to have every CAPA include an effectiveness check, but sometimes it’s just not possible depending on the issue’s specific circumstances. In instances such as these it is key to provide justification as to why an effectiveness check is not required / possible. As with quality decisions, it is always better to have the justification / rationale and not need it later, than to need the justification / rationale and not have it.
Implementing an effective corrective and preventive action system allows an organization to improve their product and process, while meeting regulatory regulations. An important component of an effective CAPA system is the tool used to control the process. Having the electronic system to manage the action items assigned to the appropriate department representatives not only improves the CAPA process, but also promotes greater ownership on the part of individual. To gain the full advantages of an electronic system, an organization should look for a solution that can connect all of their quality data and is a web-based, off-the-shelf, fully-configurable solution to match a company’s forms and processes.