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.

1. CAPA
Corrective and Preventive Actions
In Pharma Plant
Muhammad Agung Sumantri

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

4. 7 Cyclic Steps
CLOSED
good
poor
1. IDENTIFIKASI
7. EVALUASI AKSI
6. IMPLEMENTASI
5. RENCANA AKSI
Note:
INISIATOR
EXECUTOR
INVESTIGATOR
REVIEWER
2. EVALUASI MASALAH
3. INVESTIGASI
4. ANALISIS

5. Identifikasi
Kondisi ideal
Kondisi/masalah sekarang
Investigasi + Analisis
• Hasil identifikasi : Definisi masalah
• Hasil Investigasi + Analisis : Akar masalah

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!