My company also uses the FMEA (Failure Modes Effects Analysis) technique to evaluate the risk associated with the medical device or production process for risk assessment. It is a process to identify all possible failures during all stages of design controls. Failure is any defect of the device or any error that may potentially harm the patient and analyzing the severity and preventing of the failure in the future is the analysis process part of the FMEA. Failures are categorized by its severity, frequency and mode of detection. There is an input from the entire design team, quality team, and manufacturing in identifying the possible modes of failures. The main goal of the FMEA process is to put controls in place to eliminate and/or reduce failures. The controls are part of the design, and are also used in the production process to manufacture the products. Overall, FMEA technique is used most widely to mitigate and take action items to reduce or eliminate the risk throughout the lifetime of the device.