Root Cause Analysis (RCA) & Corrective and Preventive Action (CAPA)
|Event Date/Time: Nov 19, 2009||End Date/Time: Nov 20, 2009|
Identifying RCA by using a Flow-Chart
Investigational Tools â€“ FMEA (Failure Mode and Effects Analysis), Fault Tree Analysis
Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
Essential SOPs and Other Documentation
Root cause investigations
Tracking and Trending Application and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
Identifying and tracking deviations and non-conformances
Connecting Issue Review, Cause Analysis and Problem Prevention
Outlining the requirements of the CAPA process and procedure including building a CAPA file.
Definition of the essential elements of the CAPA file and their intended purpose
Preparing CAPA SOPs & Reports
Establishing a CAPA plan: project definition, individual responsibilities and expected completion dates.
Documentation for root cause analysis in the CAPA file.
QSR and ISO 13485 requirements for CAPA
Elements of a successful CAPA system
Practical Problem Solving Process
CAPA Process Summary