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Root cause analysis is performed to determine the root cause of errors or problems during the process. Root causes of out-of-specifications, production time deviations, and market complaints must be determined. Various methods are used for root cause analysis in pharmaceuticals.
5 Why is a useful and effective tool for identifying root causes during drug product development or analysis. Just ask the question and try to find the right answer for it.
When the root cause of the error or problem is identified, it is corrected for good. Many FDA warning letters are issued because the root cause of the deviation is not analyzed.
The 5 Why tool is a set of five questions to get to the root of the problem but sometimes more than five questions may be needed. Ask and answer a question for the problem created. Ask the question using ‘why’ repeatedly to navigate to the root cause until you find the exact root cause.
More than half of the problems in the process are caused by human error, but human error is not the root cause in all cases but is a symptom of other problems. When these human errors are investigated further, other problems have root causes.
For example – if an operator of a compression machine suddenly stops the machine during the compression process. The root cause of the problem must be identified. When we apply the 5 whys, we get the following answers.
1. Why did the compression machine stop suddenly?
A human error occurred.
2. Why did this human error occur?
Operator hit the emergency stop button.
3. Why did the operator hit this button?
The label on the button was not clear.
4. Why was the label not clear?
Labels were covered with the dirt.
5. Why the labels were covered with dirt?
The machine was not cleaned properly.
Using the 5 Why tool we found the root cause of the sudden stop of the compression machine was because the compression machine was not properly cleaned and the operator was unable to recognize the stop button. Root cause analysis also helps in implementing corrective and preventive measures effectively.
Fill out a deviation or incident report for this incident and prepare a system to cross-check the cleaning of the machine daily to prevent the same incident from happening again in the future.
