Quality in Design - Medical Device Design: Innovation from Concept to Market - page 136

Initiate FMEA or FMECA of an item

Select a component of the item to analyze

Identify failure modes of the selected component

Select the failure mode to analyze

Identify immediate effect and the final effect of the failure mode

Determine severity of the final effect

Identity potential causes of that failure mode

Estimate frequency or probability of occurrence for the failure
mode during the predetermined time period

Do severity and/or
probability of
occurrence warrant the
need for action?

No

Ye s
Propose mitigation method, corrective actions or compensating
provisions. Identify actions and responsible personnel

Document notes, recommendations, actions, and
remarks

Are there
more of the component
failure modes to
analyze?

Are there
other components for
analysis?

No No

Ye s Ye s

Complete FMEA. Determine the next
revision date as appropriate

lEC 2641/05

Figure 7.9
Typical FMEA process (taken from BS EN 60812:2006).