Root Cause Analysis and Tools Used for RCA- Pharmaceuticals

Root cause analysis is a methodology to find the primary cause of problem, by tracking back the actions which lead to the nonconformance(problem) and helps to solve the problem.

Root cause analysis is used to identify the problem. What happened? why it happened? and then to determine, what improvements or changes are required to overcome the problem. How it can be prevented in the future.

Steps involved in Root Cause Analysis(RCA):

Tools used for Root Cause Analysis:

There are different tools that can be used to find the exact cause of the problem. A single tool or combination of tools can be used to find the root cause of the problem. Some of the tools used for root cause analysis are listed below:

Brain Storming: In this technique all the people involved in process like experts, frontline worker and people who are familiar with the problem can be brought together to discuss upon the problem and its probable solution.

5 Whys: 5 why is a simple and powerful tool to find the root cause of the problem. In this technique question “why” is asked repeatedly from the statement of the problem till the time the primary root cause is analyzed.

In most of the cases by the fifth “? why” is asked the root cause to a problem is found. Some time it may take fewer or more than five “whys” to find the issue related to the problem.

Cause and Effect Analysis: Is also called as fishbone diagram as it resembles to the skeleton of fish. In this technique all the possible and probable causes of problems are listed and grouped under 5M & E category. (5 M are: Material, Machine, Measurement, Man & Method and E is Environment). Then by studying the graph the factors which do not contribute to the problem are eliminated.

The list of all possible and probable causes to the problem identified in brain-storming and using 5 whys technique can be used in cause and effect diagram to reach to root cause and solution to problem.

Summary

Root cause analysis is used in many industries including pharmaceuticals to find the primary cause of the non conformity or problem and its solution, so that the problem is solved from the root and its occurrence in future is prevented or at least minimised.

While an RCA provides necessary feedback on an organization’s operational performance, it also costs it both in resources and time. Therefore organizations may choose to investigate only those events which have a critical impact on products or system