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Root Cause Analysis (RCA) and Tools in Pharmaceutical

Root cause analysis is a methodology to find the primary cause of the 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 processes like experts, frontline workers 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. Sometimes it may take fewer or more than five “whys” to find the issue related to the problem.

Cause and Effect Analysis
  • Is also called a fishbone diagram as it resembles the skeleton of fish. In this technique, all the possible and probable causes of problems are listed and grouped under the 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.

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 the future is prevented or at least minimized.

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.


What are the types of root cause analysis (RCA)?
There are different types of root cause analysis (RCA) on the basis of what kind of problem root cause you want to find.


Types of root cause analysis (RCA)
This is a list of types of different types of root cause analysis as per their purpose.
  1. Safety based RCA
  2. Production-based RCA
  3. System based RCA
  4. Process-based RCA
  5. Failure based RCA
Safety Based RCA:
  • Safety-based RCA arises as a result of occupational safety and health, as well as accident analysis. This type of analysis is performed in order to determine the reason for why an accident occurred on the job (such as why a worker dropped apart from a height accidentally).
Production Based RCA:
  • Quality control is ensured in manufacturing through production-based RCA. If the plastic injection-molded parts are coming off the line warped, you might use this to figure out why.
System Based RCA:
  • In this method, two or more RCA techniques are combined. The systems-based RCA technique originated when some of the here-discussed root cause analysis techniques were combined. It can be applied to a wide range of different fields or situations.
Process Based RCA:
  • Businesses and manufacturing industries use process-based RCA to find faults in processes or systems.
Failure Based RCA:
  • The analysis of equipment failure based on failure-based root cause analysis is used in engineering and maintenance.

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