This tool made available by the Forensic Technology Center of Excellence assists with the identification and quantification of failures in processes or activities.
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. 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.