Fishbone Tool of Investigation in Pharmaceuticals

Fishbone diagrams, also known as Ishikawa fishbone diagrams, is a visual form of cause and effect diagram which can help analyze the root causes of a problem. It allows the audience to brainstorm the reasons which might otherwise be directly ignored. These causal diagrams have been in use since 1968 to find root-cause analysis of a specific event. 

The fishbone diagrams are a part of root cause analysis techniques which are used by pharmaceutical firms to analyze deviations and avoid series of near-misses. In addition to fishbone diagrams, the root cause analysis tools also include brainstorming and “5 whys” which helps the firm or industry to dig deeper into a problem and then, find a practical solution.

The regulatory authorities around the globe perform an audit of a drug manufacturer, and a very common aspect associated with their finding is lack of investigation of deviations found in intervention. Hence, the necessity to fill the hole arises by solving the problems via fishbone diagrams. It is a useful tool to investigate any deviations, non-compliances and then, evaluate the efficacy of an intervention. 

A number of pharmaceutical organizations waste millions of dollars every year on an ineffective intervention. Hence, in order to minimize such loss, firms may use the resulting analysis to identify areas for change and aim to minimize the possibility of occurrence of such event again.

The problem is represented at the head or mouth of the fish and the putative causes are listed on the smaller bones of the fish. The diagram can also include various sub-branches for root-causes. Hence, a fishbone diagram tool can give a bird's eye of the problem and cause, allowing the audience to think of the practical cause in a brainstorming session and its alternative.

Related: Top 5 Tips for a FDA Inspection

In a brainstorming session, it is very important not to dismiss anyone’s idea. So, considering the technicality all the possible potential causes of the incident are stated on the smaller bones of the fish. The common potential major categories in the pharmaceutical company include people, method, machine and material. This system is very useful as it can help the audience focused on a specific subtopic and the discussion can be done systematically. With each potential cause, the investigator can begin the discussion by asking “why does this happen” and hence, the subsequent discussion can help find further sub-causes which is the ultimate desire of the session.

Unfortunately, Incident reports often cite human error as the cause of an incident and tends to overlook other important factors which might lead to the human error. For instance, employees may have received insufficient training or perhaps a batch record was not clear. In addition to this, the employee’s suggestion to get a productive result might have been overlooked by the supervisor which might have led to errors in the end.

Finding a solution to an event via fishbone diagram ensure that the team focusses on the causes of the problems rather than the symptoms. While drawing a fishbone diagram tool, make sure there is an adequate amount of spacing between the major categories so as to fill later with detailed causes. Encourage each team member to contribute to the discussion. Do not forget to use the “5 whys” techniques in conjunction with fishbone diagram, it will be great to keep asking “why” until one gets a root cause.

To help find the ultimate root cause from all the ideas gathered, a voting technique would solve the problem by having the team members to identify top three major root causes. One can use sticky notes or colored to flags to mark the three major causes. It is very important to understand that not all methods of root cause analysis can be effective, however, using them in conjunction can help obtain a root cause of an event.

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