5 Why tools for Root cause analysis in pharmaceuticals

Originating in the manufacturing industry, the “5 Whys” analysis technique has found effective adaptation and application in various fields, including pharmaceuticals. It involves asking “why” multiple times (typically five) to dig deeper into the root causes of a problem. In the context of pharmaceuticals, the 5Whys tool can help identify the underlying causes of quality issues, compliance violations, safety concerns, and other problems.

How to use 5 why analysis in finding root cause:

1.Define the Problem: Start by clearly defining the problem you want to investigate. This could be a product defect, a deviation from regulatory standards, or any other issue.

2. Ask “Why?” for the Problem: Ask why the problem occurred. This is your initial question, and you should answer it based on available information. For example, if the problem is a batch of contaminated medication, the first “why” might be: “Why did contamination occur in the batch??”

3. Repeat the Question: Once you have an answer to the first “why,” ask “why” again based on the answer to the previous question. Continue this process for at least five iterations or until you reach a point where the root cause becomes evident. Each “why” should probe deeper into the causes behind the previous answer.

4. Document the Responses: Record the answers to each “why” question. This documentation is crucial for analysis and future reference.

5. Identify the Root Cause: By the time you reach the fifth “why,” you should ideally have identified the root cause of the problem. The root cause is the fundamental issue that, when addressed, will prevent the problem from recurring.

Example of 5 why technique in pharmaceutical industry:

Problem: Batch of Medication Failed Quality Control

5 why Analysis example
  1. Why did contamination occur in the batch? (Answer: Due to a problem with the manufacturing process)
  2. Why did the manufacturing process have a problem? (Answer: Lack of maintenance led to equipment malfunction)
  3. Why did the team neglect equipment maintenance? (Answer: Maintenance schedule not clearly defined)
  4. Why was the maintenance schedule not defined? (Answer: Lack of proper documentation and oversight)
  5. Why was there a lack of documentation and oversight? (Answer: Insufficient training and resources allocated)

In this example, the root cause of the contaminated batch is the lack of training and resources allocated for equipment maintenance and oversight. By addressing this root cause, the pharmaceutical company can prevent similar issues in the future.

The 5 Whys tool is valuable in pharmaceuticals because, firstly, it promotes a systematic approach to problem-solving, helps identify underlying causes, and ultimately supports the improvement of product quality and compliance with regulatory standards.

Root cause Analysis


Leave a Reply

%d bloggers like this: