Batch Failure Analysis Fault Tree Analysis(FTA)

Hi readers, a long time after my last post, received many mails in these two days asking me to post about pharma documentation relating to engineering, i donno whats the reason behind these requests, anyway i'm happy of receiving and i'll share my little knowledge regarding batch failure analysis.

 The Fault Tree Analysis tool is an approach that assumes failure of the functionality of a product or process. This tool evaluates system (or sub-system) failures one at a time but can combine multiple causes of failure by identifying causal chains. The results are represented pictorially in the form of a tree of fault modes. At each level in the tree, combinations of fault modes are described with logical operators (AND, OR, etc.). FTA relies on the experts’ process understanding to identify causal factors.

Potential Areas of Use(s)

FTA can be used to establish the pathway to the root cause of the failure. FTA can be used to investigate complaints or deviations in order to fully understand their root cause and to ensure that intended improvements will fully resolve the issue and not lead to other issues (i.e. solve one problem yet cause a different problem). Fault Tree Analysis is an effective tool for evaluating how multiple factors affect a given issue. The output of an FTA includes a visual representation of failure modes. It is useful both for risk assessment and in developing monitoring programs.

About The Author

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Hi! I am Ajay Kumar Kalva, Currently serving as the CEO of this site, a tech geek by passion, and a chemical process engineer by profession, i'm interested in writing articles regarding technology, hacking and pharma technology.
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