This webpage provides an overview of the Failure Mode and Effects Analysis (FMEA) risk management tool.
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. RCA 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.