Fault Tree Analysis for Investigation : Pharmaceutical Guidelines

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Fault Tree Analysis for Investigation

You will find many articles on fault tree analysis but this is actual method with example by which you can actually prepare a fault tree diagram for the events or problems you found in pharmaceutical manufacturing industry.
The fault tree is an investigation tool to identify and resolve the defects in any system or process. It is also helpful to find the root cause of any event. An organization or company may have more than one fault trees based on their defects, errors or problems.

As fishbone tool has a fish bones like structure, a fault tree also has tree roots like structure. Branches of roots represent possible causes of defects or problems.

In some defects or problems “5 Why” tool doesn’t work and you cannot find the root cause of the problem. This tool works with “5 Why” tool, every time during preparation of fault tree when you want to find the cause behind the problem you need to ask a “Why”. Actually, “5 Why” tool alone will not work if there are more than one possible causes of a complex event and it will confuse you in finding out the root cause of the problem. You can map the root cause of these problems more efficiently using a fault tree diagram.

In such cases, all probable causes are written step by step in a systematic manner by asking “How” or “Why” as a question. It forms a tree root like structure. A fault tree for cross-contamination between two products is created here to understand it better.


Write the event or problem at the top of the diagram followed by the second row that contains the elements directly related to the problem. Then do the same thing for these elements and write the probable causes related to these elements in the next row. You have to follow this process as long as you keep finding out the reasons as shown in the diagram above.

In the diagram given above, we are trying to find out the root cause of the cross-contamination of two products, where some traces of other Product A are found during quality control analysis of a Product B. There could be three possible causes of this cross-contamination i.e. equipment, area and AHU.

Each of these three possible causes is further questioned to get the probable cause. If the equipment was not cleaned properly then it may have two causes, first, if the cleaning of manufacturing equipment was not done and other if the cleaning procedure is not adequate.

Now in the next step, we try to find the cause of these causes. Like if cleaning of equipment was not done then it may occur because cleaning person followed a wrong cleaning procedure or cleaning person was untrained.

Other two primary causes are also analyzed in a similar way to find their probable causes. You can check those in the diagram. In this way, you can find the root cause of the problem easily and efficiently.

Generally “5 Why” tool is considered to find the root cause of any problem or event in pharmaceuticals but now you can make it more effective and accurate by using it in conjugation with fault tree diagram according to the complexity of the problem.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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