Frequently Asked Questions
Failure mode and effect analysis (FMEA) is a commonly used industrial tool used for performing risk assessments, whereby the probability of an event occurring is evaluated against the severity of it occurring.
In an extractables and leachables FMEA, each product contact material is scrutinized. Through discussions with subject matter experts (SMEs) on the product, potential failure modes with respect to leaching, and their causes and effects, are identified.
Each failure mode and the resulting effect (i.e. leaching) is recorded in a product specific FMEA worksheet. As well as these failure modes, as much information as possible is pooled on each material (e.g. supplier test data, compliance statements, previous in-house experience with the material, etc), and again recorded on the FMEA worksheet.
A second discussion with the SMEs is then undertaken, where the specific failure modes are considered, and the probability and severity factors each given a score. The product of these scores yields a risk priority number (RPN), which is a numerical representation of the risk of a patient/consumer being exposed to leachables from each of the identified failure modes. All possible RPN scores are categorized based on their values, into low, medium and high risk.
All failure modes that generate a medium or high risk RPN are considered for mitigation activities, which may involve extractables and/or leachables studies, or other forms of mitigation activity, in order to reduce the risk of patients/consumers being exposed to leachables.
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