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TMF Defect Analysis

Addressing TMF Defects Using Pareto Charts

A Pareto chart is a graphical tool that is used to analyze and identify the most significant factors or causes that contribute to a particular problem or issue. It is a type of bar chart that is ordered by frequency or impact, with the highest bars displayed on the left and the lowest on the right. The Pareto chart is named after Vilfredo Pareto, an Italian economist who is credited with the principle that states that 80% of the effects come from 20% of the causes. The Pareto chart is often used in quality control and business analysis to prioritize improvement efforts and to determine where to focus limited resources.

New Views of TMF Defect Data

Pareto charts can be used for defect analysis in a trial master file (TMF) by organizing and presenting data on the various defects that are found in the file. The Pareto chart shows the frequency or number of occurrences of each type of defect. This view of the trial master file defects can be used to identify and prioritize trial master file issues, help to identify the root causes of the issues, and it can also be helpful in preparing the trial master file for inspection.

Understanding the Root Cause of TMF Defects

TMF defects can take a long time to identify, analyze, and address. It’s important to understand root causes because, as Deming suggested, you can’t inspect quality into a process. You must build it in. In doing so, you can spend less time and resources preparing for inspection readiness and still avoid regulatory findings.

For example, let's say that you are reviewing a trial master file, and you have identified a list of issues that need to be addressed. You may create a Pareto chart that displays the issues in order of importance or impact by TMF Reference Model Zone. This view allows you to quickly see which areas of the TMF are most concerning. Typically, the most common issues are found in the site management documentation zone. The Pareto chart provides insight into these issues and their frequency. 

Pareto charts can lead you to ask important questions about systems and processes. Does the issue stem from a training gap, a process concern, a policy question, or some other cause? Should new or different training be implemented? Do you need to rethink your current process for managing a certain type of document and data? Sometimes the answer can be found in a simple form redesign that may help to reduce or shorten cycle times.  Pareto charts can help you understand the extent and impact of the issues and begin to prioritize improvement efforts based on the most significant factors. This knowledge also helps in allocating your resources accordingly.

Risk-based Trial Master File Management

Most organizations are moving toward a risk-based approach to TMF management. The Pareto charts offer a good foundation for your risk mitigation and TMF action plan to prevent the issues from occurring in the future, thus building quality into your TMF process.  Looking at your data in this manner may lead you to train resources differently or add resources to QC specific trial supply or site management documentation. Additional process changes may also be required to ensure that the data and documents are compliant.

Regardless of the action plan, it is important to assess the impact of the change on your organization. Change management is essential in compliance-driven processes, and understanding, documenting, and implementing changes that improve the overall quality of the process should not be taken lightly. 

Pareto charts are a useful tool for analyzing TMF defect data. As we continue to build on our experience applying them in the context of the TMF business challenge, we are also building on our learnings and creating better practices around their use.