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Highlights from ExL Pharma's Proactive GCP Compliance
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Highlights from ExL Pharma's Proactive GCP Compliance


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  • As described in slide 14, the 3 basic steps of Cause mapping can further be broken up in identifiable steps and can be serve as a easy to follow Root Cause Analysis Process.*DEFINE*Step One: Define the Problem (DEFINE)What do you see happening?What are the specific symptoms?*ANALYZE*Step Two: Collect Data What proof do you have that the problem exists?How long has the problem existed?What is the impact of the problem?You need to analyze a situation fully before you can move on to look at factors that contributed to the problem. To maximize the effectiveness of your Root Cause Analysis, get together everyone who understands the situation.Step Three: Identify Possible Causal FactorsWhat sequence of events leads to the problem?What conditions allow the problem to occur?What other problems surround the occurrence of the central problem?During this stage, identify as many causal factors as possible. You don’t want to simply treat the most obvious causes – you want to dig deeper. Use the following suggested tools to identify causal factors:5xWhys and Fishbone Diagram (Cause and Effect Diagrams)Step Four: Identify the Root Cause(s)Why does the causal factor exists?What is the real reason the problem occurred? Use the same tools you used to identify the causal factors in step 3 to look at the roots of each factor. *PREVENT*Step Five: Recommend and Implement SolutionsWhat can you do to prevent the problem from happening again?How will the solution be implemented?Who will be responsible for it?What are the risks of implementing the solution?Identify the changes needed for various systems. It is also important to plan ahead to predict the effects of your solution. This way, you can spot potential failures before they happen.
  • This slide indicates some of the tools available to be utilized during Root Cause analysis. Only four will be explained in this presentation nl. Brainstorming, Fishbone Diagram/ Cause and Effect diagram, Why-Why Analysis and the Force Field Analysis.
  • When you use the fishbone diagram, you just list the causes under the Major cause categories Major categories is more a system level, for example, process, procedure, human, instrument, facility, training etc.The category with most causes is the root cause. So in this case, human error is the root cause that led to the issue.Just a side note that, when you develop the CAPA plans, u will have to consider the root cause, and also other causes that led to the issue.