FMEA medical device (Failure Modes & Effects Analysis)
An important quality assurance function is assessing risk for the critical characteristics of a disposable medical device, throughout its lifecycle. This is true for any disposable medical device product where compliance is required with either the US FDA, the EU (requiring CE mark), ISO-14791 quality standard, or even to demonstrate cGMP compliance.
In order to establish a process for conducting and documenting risk analysis, all manufacturing risks associated with production processes must be documented, detailed and when possible solved proactively. This is the purpose of Failure Modes & Effects Analysis (FMEA medical device), a method that helps medical device manufacturers identify, break down, control and review the risks associated with product development and manufacturing.
As in every analysis process, it is critical to have good quality inputs in an FMEA, in order to expect actionable results that will actually help safeguard the disposable medical device. That is why an important first step to conducting an effective FMEA is gathering the correct information that will go into the FMEA process.
Firstly a timeline with all the exact phases of new product development must be established. Secondly every phase should have its own tasks, with responsibilities assigned for every task involved. Finally for every task or process function there need to be an analysis of the risks regarding failure modes and effects, as well as causes and corrective or preventive actions that need to be taken, in order to minimize risk.
Any FMEA process begins with a risk assessment of the general medical device manufacturing process. Although every medical device developer has their own exact way of documenting and conducting FMEA, following are the most critical steps and information that every FMEA for medical device should include.
To initiate the FMEA requires a detailed description of the process. The items mentioned below need to be documented for every process step, providing a basis for the whole FMEA.
In every process step mentioned above, the process controls currently in place need to be clearly stated since it is those that serve to detect, prevent, and ultimately limit or even eliminate the effects of a failure mode. These include both IPCs (in process controls) during an activity, as well as post process controls such as batch release scheme sampling controls.
The recommended actions can be defined according to each failure mode’s risk priority number and process controls. These can be both preventive or corrective actions, with the goal to reduce the overall risk of each failure mode, which ultimately means one or more of either: decrease risk severity; decrease the probability of occurrence, and lastly increase the probability of detection.
Quasar has over 30 years experience in the development and mass production of disposable and reusable medical devices. Working with us grants you access to an established Quality Assurance system that is tied in with our world class medical device development infrastructure and mass production facilities.
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