Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Drop the checkbox mentality and embrace accountability and understanding.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
Having a grasp on which actions are necessary at various stages of the CAPA process is critical to a quality program.
Many product development teams use root cause analysis and root cause corrective action to identify the origin of defects in their development processes and prevent them from recurring. Though these can be complicated and time-consuming, automated product development solutions can help reduce the time spent on RCA, RCCA, code reviews, and other quality improvement efforts.
This is the first of a series of articles on conducting a root cause investigation. The model applies to a Corrective Action/ Preventive Action or CAPA investigation, as well as any other type of investigation. In this premier article, we describe a model for conducting a science-based, systematic investigation leaving future articles to delve into more detail as the individual steps are explored, specific tools are highlighted, and example investigations are reviewed.