FMEA (Failure Mode Effects Analysis) is one of the best ways of analyzing potential reliability problems early in the development cycle, making it easier for manufacturers to take quick action and mitigate failure. Itis a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures.


As per ICH guidelines, 

FMEA provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance. Once failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures. 


FMEA relies on product and process understanding. FMEA methodically breaks down the analysis of complex processes into manageable steps. It is a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures.


Potential Area of Uses

FMEA can be applied to equipment and facilities and might be used to analyze a manufacturing operation and its effect on product or process. It identifies elements/operations within the system that render it vulnerable. The output/ results of FMEA can be used as a basis for design or further analysis or to guide resource deployment.


A Typical Risk Analysis Format

 


A Typical Risk Reduction Format

 


Risk Priority Number (RPN)

RPN is a numeric assessment of a risk to be analyzed and reduced in a process or steps in a process as a part of FMEA. Where the numeric values quantify the likelihood of occurrence (P), likelihood of detection (D) and severity of impact (S).

Let, maximum value for each point (S/P/D) = 5
Then, maximum value of RPN will be = 5*5*5 = 125

Now you have to identify the risk type - low, medium or high based on your SOP indicates value.

For example, if can define the RPN number for low, medium and high risk accordingly, 1-11, 12-27 and 28-125.

During risk reduction, severity (S) value will be same but you have to reduce the probability (P) value and detectability (D) value. Where detectability value will be decrease with the chance of detectability.



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