Deviations and Non-conformances are enviable. The key is utilizing those events as an avenue to improve the overall quality system. Thorough Root Cause Analysis is essential to correcting and preventing issues. RCA is a systematic approach that utilizes quality tools to objectively identify factors that have resulted in or could contribute to a deviation.
Once the RCA identifies the factors that caused the event, proper generation of CAPA actions is critical to maintaining a healthy quality system. The regulatory agencies fully expect to see documented root cause analysis that resulted in both corrective and preventative actions.
Areas Covered in the Session :
Part 1 – How to Perform a Thorough Root Cause Analysis (RCA)
Understand Regulatory and Industry Guidance
What is Root Cause Analysis?
When Should Root Cause Analysis be performed?
Discuss several Root Cause Analysis Methodologies
Discuss common errors that occur during RCA
Part 2 – Developing Appropriate Corrective and Prevention Actions (CAPA)
Understand Regulatory and Industry Guidance
Discuss the difference between Correction, Corrective Action, and Preventive Actions
Understand How to Develop robust CAPA records; including effectiveness checks
Part 3 – Review Real Life Case Studies
Discuss recent Regulatory observations in regards to insufficient investigations and CAPAs records
Who Should Attend:
- Research and Development Departments
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Facilities Teams