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Root Cause Analysis is the most important factor in determining the quality of every organization, including the pharmaceutical industry, it is a method of knowing the first action that leads to the sequence that leads to the resulting problem and finding ways to solve this problem.
Company auditors must observe the deviation and its relationship to past events or interventions, to understand how these interventions may have caused the deviation. So, root cause analysis tool is used to find the cause of every deviation or poor result.
What are the types of root cause analysis techniques?
1. Group Thinking (also known as brain storming): A group of experts come together to find out the exact cause of the deviation and find a solution for it.
2. Fishbone diagram (also known as cause and effect diagram): Fishbone diagram includes the possible causes of a problem and is used to find the actual cause.
3. 5 Whys: As the name of the 5 whys tool suggests, you should ask yourself “Why?” 5 times in order to get the order that is the problem.
These 3 strategies will get you closer to the root cause, and it will help you know what you need to change, where your weak points are, and how to prevent this problem from happening again.
Root cause analysis consumes a lot of time and resources, so it is only indicated when you are sure that an event has adversely affected the organization and action needs to be taken.
