Root cause & risk analysis in pharmaceuticals - using Fish Borne Diagram

Root Cause Analysis using Fish Borne Diagram

 

A fishbone diagram is a visualization tool for categorizing the potential causes of a problem in order to identify its root causes.

Did you know?   ·         It is referred as "fish bone" diagrams because a completed diagram can look like the skeleton of a fish, with the "ribs" representing the causes of an event and the final outcome appearing at the head of the skeleton.   ·       "Fish bone" diagrams also known as Cause–and–Effect Diagram, Ishikawa Diagram   ·       The Ishikawa diagram was developed by Kaoru Ishikawa during the 1960s as a way of measuring quality control processes in the ship building industry.   ·       It is used as risk assessment tool as well.   ·       The Fishbone diagram cannot solve anything. It is simply an information gathering and managing tool that can be used to help identify potential causes of a certain problems or event.

 

The purpose of the Ishikawa diagram is to allow management to determine which issues have to be addressed in order to gain or avoid a particular event.

How to create a fish diagram:

·Create a head, which lists the problem or issue to be studied.

·Create a backbone for the fish (straight line which leads to the head).

·Identify at least four “causes” that contribute to the problem. Connect these four causes with arrows to the spine. These will create the first bones of the fish.

·Brainstorm around each “cause” to document those things that contributed to the cause.

·Continue breaking down each cause until the root causes have been identified.