FMEA Commonly Asked Questions

An FMEA (Failure Modes and Effects Analysis) is a quality improvement tool that helps focus on and understand potential process or product risks. During the course of an FMEA study, potential risks are identified and prioritized, and used to develop action plans to reduce the risks associated with the product or process under study.

An FMEA should be performed by a team, NOT one individual. The interdisciplinary team should include representatives of all of the functions impacting the product or the process under study. See our advisory services to learn more!

Conducting an FMEA involves a systematic step-by-step approach using a standardized FMEA Worksheet (form) to collect information on product or process components, their corresponding functions and potential failure modes. The risk level of those potential failures is then prioritized using a relative ranking scale. Action plans for unacceptable risks are developed. After action plans have been completed, risk levels are reevaluated to ensure the action taken was successful in reducing the risk to an acceptable level.

The time it takes to conduct an FMEA study depends on the scope of the study and the level of preparation done. With a well-defined and “reasonable” scope coupled with a comprehensive set of (organization specific) customized ranking scales, a team can conduct an FMEA study in hours. This will allow further discussion for lowering probability (process controls) or increasing detectability (implementing means of sampling or in-process monitoring).

They can be considered together but both process risks and product risks must be considered. One advantage to separating them is that a process risk could be high (personnel transit) while the product risk is low (because the product is not exposed), so these situations must be taken into account.

In our example, and when you perform your own FMEA, not only should you rank each value for probability, severity and detection, you should provide a rationale for choosing each value. Regulatory authorities need to understand your scientific rationale for the value chosen.

Great question! The answer is yes. In our example, we are ranking the values (Probability, Severity, Detection) with the understanding that we have all controls in place, such as gowning, engineering controls (validated cleanroom air flows, velocities, differential pressure controls, etc.).

With respect to risk analysis tools, ICH Q9 does list a number of tools that can be used, but FMEA is a commonly used and accepted tool for pharmaceutical risk analysis. The section on FMEA says the following:

“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 Areas of Use(s):

FMEA can be used to prioritize risks and monitor the effectiveness of risk control activities. 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.”