Corrective Actions are one of the top areas of FDA 483 citations from audits they perform at medical device manufacturers. The FDA once shut down almost all the diagnostic manufacturing of a company that consistently failed to implement an effective corrective action system. To have an effective corrective action system, you must do a good job of understanding the root cause of the problem you are dealing with. This seminar will give you tips on some of the best and most effective ways to do root-cause analysis.
Why Should you Attend:
Is your Corrective action system effective or do the same or similar problems keep occurring? If so, you may not be doing root cause analysis in sufficient depth. Corrective and Preventive actions (CAPA) are key to an effective quality management system. The key to an effective CAPA system is knowing how to do an in-depth root cause analysis. Learn various techniques that are available, so you can choose the one or ones that fit your situation. Learn how Root cause analysis can be used in process control.
Objectives of the Presentation:
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. We will cover where else in your quality management system it can be used, and describe some of the techniques for effective root cause analysis.
We will cover:
Who can Benefit:
- What is Root Cause
- The difference between Correction, Corrective Action and Preventive Action
- Why Root Cause Analysis is important
- Where Root cause Analysis is valuable
- Corrective and Preventive Action
- Risk Management
- Process Control
- Techniques for Root Cause Analysis
This presentation will benefit all those involved with internal or supplier corrective actions. If you issue corrective actions, you need to know what an effective root-cause analysis looks like. If you are assigned to complete a corrective action, you need to know what is expected for a root-cause analysis. If you manage the corrective action system or those doing corrective actions, it is also important that you understand root-cause analysis. So that means almost anyone working within a medical device quality system could benefit from understanding the how and why of root-cause analysis.
This webinar will provide valuable assistance to all personnel in:
- Quality Management
- Quality Engineers
- Manufacturing Engineers
- Internal auditors
- Quality specialists
- Quality Associates
- Operations and Manufacturing Managers
- Process Engineers