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FishboneToolofInvestigationinPharmaceuticals

Fishbone tool is widely used in pharmaceutical to find out the root cause of any problem and it is used in conjugation with "5 why" tool.
Fishbone diagrams, also known as Ishikawa 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 nearmisses. In addition to fishbone diagrams, the root cause analysis techniques 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, noncompliances 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.

Fishbone tool for Investigation

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 subbranches for rootcauses. Hence, a fishbone diagram can give a bird's eye of the problem and cause, allowing 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 anyones 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 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 discussion by asking why does this happen and hence, subsequent discussion can help find further subcauses
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 employees
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, make sure there is 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 to 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.

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