E&L risk assessments for ENDS & e-liquid products
Working with client subject matter experts, ExtLe Solutions Limited designs, manages, and executes Extractables and Leachables Risk Assessments, using Failure Mode and Effect Analysis (FMEA).
Failure modes associated with leaching are identified for the client’s product. Each failure mode is assessed for the likelihood (probability) of leaching occurring, against the severity if leaching does occur, allowing each failure mode to be classed as low, medium or high risk.
The FMEA process results in a tailored assessment of what risk leachables pose to consumers of the clients ENDS or e-liquid product, by defining the materials most at risk of generating leachables during use.
As such, the risk assessment informs on which materials require E&L studies, and which do not. As such, time and resource are directed towards those materials that pose most risk.
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