CAPA Investigations
Need help in organizing and conducting your CAPA investigations? Use PES as your CAPA investigator. The methodology we use is as follows:
CAPA Methodolgy | Description |
| Assessment | WHO reported it? WHAT happened? WHERE did it happen? WHEN did it happen? |
Fact gathering: | Collect objective evidence and reliable information |
Root Cause Analysis: | WHY did it happen |
Implement Corrective Actions (CA): | Fix the immediate problem |
Evaluation of effectiveness of Corrective Actions | How can we tell if the problem was fixed or resolved? |
Implement Preventive Actions (PA) | How can we prevent recurrence of the problem at this site and at all of the other sites? |
| Evaluation of effectiveness of Preventive Actions | How can we tell if the problem has been effectively prevented from recurring? |