Module 14: Design Development and Certification of Medical Devices

17/11/2023

FMEA..

 Failure Modes and Effects Analysis

 Originates from 1940S…

 One of the tools that can be used to help assess risk management  But… it cannot be used solely for assessing risk in accordance with ISO 14971

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

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What is FMEA?

Example assessment ◦ BUT! FMEA only focuses on FAILURES of systems

Ref No.

Function Process Step What are we analysing

Failure mode

Potential cause

Potential Impact (effects) Impact on key output variables e.g., local or system effects

Severity

Probability estimate

Detection mode

Ease of detection

Risk level

Further investigs

Mitigation actions

Unique number!

What has gone wrong? What could go wrong?

What might cause this?

How severe is this effect to customers stakeholders

e.g.,frequency

The existing controls that will prevent or detect the failure

RPN – risk priority no. S x P x D

Further actions

Actions needed to mitigate the risk(s)

needed to define the failure

RISK MANAGEMENT AND RISK ASSESSMENT

November 2023

34

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