CAPA is very important for continuous improvement in pharma plant. We often give up when find a complicated situation. Please do not only find the probable cause. Challange our probable cause to become evidence-based root cause.
2. Introduction
• Problem (may) impact on financial
• Lack of documentation menghambat continuous
quality improvement
• Dokumen harus menunjukkan:
1. Why something went wrong
2. What has been done to solve
Butuh
formal CAPA program
3. Corrective VS Preventive
Root cause
Quality
Improvement
Problem
Corrective Action
Potential
Problem
Potential
Cause
Preventive Action
Quality
Improvement
6. Root Cause Analysis
• Critical element for CAPA
• The good investigation should find evidencebased root cause not only assignable cause
or probable cause to prevent reoccurance
7. Root cause analysis
• Element:
1. Team
team leader should have specialty in root cause analysis
Should include Subject Matter Expert (SME) and technical person
(TP)
SME understand the theory & concept
TP understand the situation and actual
8. Root cause analysis
• Element:
2. Technique Ishikawa/fish bone diagram with
5M perspectives
Factor X
Factor X
Method
Factor X
Factor X
Milieu (environment)
Root
cause
Man
Factor X
Factor X
Machine
Factor X
Material
Factor X
Factor X
9. Root cause analysis
• Element:
3. Investigation Design Design of Experiment
Fractional Factorial Design is powerful design
Parameter VS Desain
A
C (C+A.B)
B
1
-
-
+
2
+
-
-
3
-
+
-
4
+
+
+
10. Root cause analysis
• Element:
4. Attitude Never accuse something, just follow
the data.
Assumption is source of mistake!