What is 5 Why Tool for Root Cause Analysis in Pharmaceutical Industry?

The 5 Whys method is a root cause analysis tool that helps determine the root cause of a problem by asking the question “Why?” five times in a row.

The answer to each question forms the basis for the next question. The goal is to dig deeper to ensure corrective action goes beyond addressing just the symptoms.

5 Whys method can be used in the following steps
▪️Create a team
▪️Define the problem
▪️Ask why at least five times, possibly more

The 5 Whys method is often used during the Analyze phase of the DMAIC (Define, Measure, Analyze, Improve, and Control.) process and the Plan phase of PDCA activities.

It can be used as a standalone tool or in coordination with other analysis tools such as the Cause and Effect Diagram.

The Benefits of Five Whys
▪️Helps identify the root cause of a problem.
▪️Understand how one process can cause a chain of problems.
▪️Determine the relationship between different root causes.
▪️Highly effective without complicated evaluation techniques.

When Should You Use This Method?
▪️For simple to moderately difficult problems
▪️More complex problems may require this method in combination with some others
▪️When problems involve human factors or interactions. So any time human error is involved in the process.

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