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 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.
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.
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 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.
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.
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