FMT - Qa.014 Capa Format
FMT - Qa.014 Capa Format
2. Analyze the problem (Plan) Preventive action By Who Target date Closed on Status Status
3. Determine the root cause (Plan) 7. RCA Closure & Sign-off (Act)
5 whys - Cause 1 5 whys - Cause 2 RCA Team: Sign-off RCA Communication
Production √
Why . . .
Why . . . ? Maintenance
?
QA √
Why . . .
Why . . . ? Warehouse √
?
Why . . .
Why . . . ?
Why . . .
Why . . . ?
?
CAPA#_____ Complaint No.
CAPA Format
Doc nr. EA/QA/FMT/014 Rev.00
Team Members:
Problem Definition:
Root Cause:
Responsible
Corrective Action: Target Date
Person
Responsible
Preventive Action: Target Date
Person