Overview
Failure Mode and Effects Analysis (FMEA) is a risk management tool that identifies and quantifies the influence of failures or potential failures in processes or activities. The application automates FMEA by evaluating the level of risk associated with an area of concern or non-conformance in forensic laboratory processes. The application calculates a Risk Priority Number (RPN) that shows the level of risk associated with a failure or potential failure and the action required to mitigate that risk. The RPN is derived from a severity, occurrence, and detection matrix, which has been customized for forensic science service providers (FSSPs). The application provides an option to export to excel to save the data or export to PDF to retain a record of the risk assessment.
When a failure has been identified, such as in a non-conformance, a root cause analysis (RCA) is commonly performed to identify the reason for the failure. Although RCA is an effective tool, it does not provide an assessment of the magnitude of risk associated with the failure. When used with RCA, FMEA provides a clearer understanding of the impact of the failure, which informs FSSPs of the actions needed to mitigate risk to an acceptable level. Ideally, FMEA is used before a failure (area of concern) to assess and mitigate risk to avoid a non-conformance. This application has been designed for use either before or after identification of a failure, providing FSSPs with a proven method to demonstrate compliance with ISO 17025:2017, Clause 8.5.
FTCOE anticipates continually refining and improving the FMEA application. Please email ForensicCOE@rti.org with any suggestions or comments.
NOTE: This application does not store any data entered by users. Data are processed in the browser and are not saved to any server or database. If you exit the page without saving the PDF or Excel export to your local computer drive(s), you will not be able to return to retrieve a copy and will have to restart the entire process.
Funding for this Forensic Technology Center of Excellence tool was provided by the National Institute of Justice, Office of Justice Programs, U.S. Department of Justice.
The opinions, findings, and conclusions or recommendations expressed in this tool are those of the author(s) and do not necessarily reflect those of the U.S. Department of Justice.
Contact us at ForensicCOE@rti.org with any questions and subscribe to our newsletter for notifications.
