Failure Mode and Effect Techniques Analysis (FMEA)
Specific processes are analysed using Failure Mode and Effect techniques Analysis (FMEA) which systematically reviews the process and provides a feedback loop which is used to identify, reduce and control risks. This system, in use since the 1940s, is the backbone of our medical device risk management service and focuses on two key areas;
Failure Modes: Studies into the ways in which something might fail. This includes all errors and defects in the production process.
Effects Analysis: This phase is a continuation of Failure Modes whereby specialist teams study the potential consequences of failures.
This information is then categorised by its severity, frequency and detection methods to ensure the continued improvement of production and use.
FMEA Medical device risk management is best undertaken with a full understanding of the device and the processes used to manufacture the device.
To achieve this Europlaz converse with your medical device risk management team to provide specialist technical knowledge on the activities we undertake and to gain your insight into your product when carrying out our internal risk management for your product. This provides a fresh perspective and can be the difference in critical medical situations.