A CAPA isn’t over after you execute the steps to resolve its root cause and associated issues. Before considering a CAPA resolved, you must complete the review and verification procedure. In this blog, we will cover the final stages of CAPA and how to end the experience smoothly. An Enterprise Resource Planning (ERP) system can make this process easier by giving you the tools you need to ensure the issue will never resurface.
Phase V: Review and Verification
After completing the CAPA action plan, your predesignated CAPA team must review the entire CAPA process to see if the issue is actually fixed. If this team determines that the issue is not fully resolved, then you will need to redo previous steps in the CAPA like evaluating the root cause or making a comprehensive action plan. As the CAPA review team goes through what happened, they can look through your ERP to make sure that any new steps added to your business processes are now required in the software, see who is completing these steps and when, and look at current data to check that the issue is resolved. If your software can’t offer this complete data transparency, then it is holding you back. At Datix, we take a business-first approach with our clients to understand their needs and offer them an ERP solution that overcomes their greatest challenges. Learn more about working with Datix.
If the CAPA is considered completed, prechosen staff or leadership can sign off that the CAPA has been reviewed.
You would think that the sign off would be the final step of the CAPA, but it’s not. Medical manufacturers frequently cause trouble for themselves down the line by missing the last stage of CAPA: verification.
To create absolute certainty that the issue is resolved, you need to verify that the CAPA is working. First, identify specific methods for demonstrating success. You may want to look at steps you took during your action plan (like changing your inspection procedure, for instance) and see if you can confirm that these have prevented the issue from taking place since they were initiated. After you come up with a list of verification activities, you can add them to your ERP and your CAPA documentation.
Finally, you must verify that the changes you made to resolve the CAPA worked successfully. An ERP makes it easy to verify and document CAPA results. You can assess outcomes right from your system, and if everything looks good, close out the CAPA confidently knowing that the issue won’t occur again in the future. To update your ERP and strengthen your CAPA process, look to an ERP partner like Datix. We support our customers every step of the way through a software change, and offer guidance during the planning, implementation and beyond.
Completing a CAPA can be a difficult journey that requires meticulous data analysis. An ERP can illuminate the root cause of a CAPA, offer complete data visibility, and give you the other tools you need to make the process as fast and effective as possible. If software is holding you back during CAPA, discover what the right ERP can do to streamline your systems.
For medical manufacturers, Datix is the software consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.