Closing the Loop on CAPAs with Quality Management Software
Corrective and preventive action management is vital to an organization’s quality management initiatives. It ensures that issues that appear unexpectedly in the manufacturing process can be addressed quickly and efficiently, with procedures implemented that can make certain these issues do not repeat themselves.
Many companies fail to realize the advantages of a proactive, closed-loop CAPA process, integrated with enterprisewide quality management software to drive organizational efficiencies. With an effective CAPA procedure, aided by the right software, organizations can alleviate recurring issues that may arise in the manufacturing process, save time and resources, and help generate revenue.
Here are five steps to implementing a closed-loop CAPA system:
1. Deploy an effective electronic quality management system (QMS) for tracking incidents and events that occur, utilizing centralized software. Implement the system to log and manage all issues and incidents that have occurred. This will guarantee that the desired conclusion is reached when it comes time to correct issues, determine the causes, and take the necessary steps to prevent future occurrences.
2. Use your electronic QMS to apply escalation procedures to ensure that the correct people are notified of high-priority incidents, ensuring that these occurrences receive the necessary level of awareness and visibility.
3. An electronic QMS can help you correct problems expediently, and ensure that the proper incident approvals and routings have been executed prior to closure. Such software allows you to define the appropriate routings for different types or areas of problems.
4. Initiate preventive actions using investigation and root cause analysis. QMS software will help you maintain accountability by allowing you to assign responsible parties to investigate the catalyst for the issue and assign an identified timeline for resolution and a structured escalation process of overdue actions.
5. Employ routine effectiveness checks to measure how well the preventive solution is working at set points in time post-implementation. If appropriate, take additional action based on results of the check to ensure a true resolution of identified root causes.
By following these steps, organizations can effectively reduce the cost of quality operations and reporting, while increasing the level of regulatory compliance.
About the author
Mike Jovanis is vice president of product management for Sparta Systems, an enterprise quality management solutions provider.
About Sparta Systems
Sparta Systems’ global quality management solutions enable high-value organizations to safely and efficiently deliver products and services to market. Its TrackWise® Enterprise Quality Management Software, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in Holmdel, N.J. and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer packaged goods markets. Read more about Sparta Systems and TrackWise software on the corporate website and blog: blog.spartasystems.com.