Identifying the root cause of the problem is very important. In pharmaceuticals Root cause analysis is an invaluable tool to dig deep and identify the origin of the problem. To perform Root cause analysis, different techniques are used. that I’m going to mention later.

Why Root Cause Technique

• To Identify the origin of the problem

• Involves step-by-step analysis to reach the origin of the problem

• To solve the Problem

• Focus on why the problem occurred, rather than who made it

• More than one root cause for a problem

The root cause analysis technique mainly focuses on why the problem has occurred, in this process we can get answers like the primary cause of the problem and mainly focuses on eliminating the problem at the ground level.

Techniques like Brainstorm technique, Fishbone/Ishikawa diagram,5 Why Technique, Corrective Action, and Preventive action (CAPA), are some of the techniques of Root cause analysis

Steps in Root Cause Analysis

1.  Problem identified

2. Collect data that relates to the problem

3. Go through the data

4. Figure out the root cause(s)

5. Make an action plan

6. Implement the action plan

7. Check and verify the effectiveness measures.