In the ISO 13485 video series, Victor Wong from Vivaldi Software and Verlene Law from The Reg Consultants discuss the most important changes in the latest version of the ISO 13485 standard for the Medical Device Industry.
In this video Verlene and Victor discuss the CAPA Process.

One change in the new release of the ISO13485 is the requirement that an issued CAPA should not adversely affect the ability to meet the regulatory requirements. So it does not impact the safety or performance of the medical devices.

2 common seen mistakes in CAPA management

1. A lot of people mix up Corrections and Corrective actions:

  • A Correction is a solution to eliminate the non-conformity within a short period of time (so immediately). 
  • A Corrective Action is an action to eliminate the Root Cause of the non-conformity to prevent it from happening again

2. You see many companies handling CAPA's without measuring the effectiveness of the CAPA afterwards. 

Brief demo of the Vivaldi CAPA Solution

  • In this demo the follow-up process for CAPA is defined as follows:
    After registration of the CAPA, it is assigned to the function who has to take action on it. If necessary the QA Manager needs to verify the correct completion of this CAPA . After a certain test period, the effectiveness of the CAPA is then checked, and If the result is not satisfying, a follow-up action is triggered.
  • The CAPA process is a process that can be initiated on its own, for instance for a preventive action. However in most cases a CAPA is started from within another process like a customer complaint, a supplier complaint, an internal non-conformance or an audit.
  • The dashboards of Vivaldi are easy and smooth to navigate throughout the information, and can be customized to present the most valuable and useful CAPA data. This allows each group of users to see the overview lists, Pareto graphs and Trend analyses they need in order to get their job done and meet their goals.
  • In Vivaldi every single aspect of a CAPA process is covered: from registration, follow-up to insights through statistics and actions to be taken.
  • Vivaldi 6 works on all devices: mobile phone, tablet, laptop or desktop computer.
  • The CAPA process can be deployed on your own server, in the cloud or even in a private cloud.

Free Personal Demo!

If you want to learn more on how Vivaldi can help you with the CAPA process or other processes in your Management System for Quality & EHS contact us to schedule your Free Personal Discovery Session

Contact us now!