Quality in Design - Medical Device Design: Innovation from Concept to Market - page 134

FMEA was invented to accommodate this type of analysis. It is a simple table. It is not an
assessment of risk, it is a tool to help you identify potential design faults and to help you
concentrate on areas where your design could be deemed to be weak.

Table 7.11 illustrates an example of an FMEA chart. It has 11 columns, with the last four
being repeats, but all will become clear.

Table 7.11 suggests a typical layout for an FMEA analysis. The first column is simply the
number of the row (this helps later if you need to refer to it). The second column is the failure

Table 7.11: Example FMEA Template adapted from BS EN 60812 (BSI,2006)

Rat ing Remedi al

# Text Text Text S O D RPN = S.O.D Text S* O* D* RPN = S*.O*.D*

(b)

S O D

1 = Inconvenience 1 - 1/1000,000 1 = Detectable by anyone

2 = Temporary injury not requiring attention 2 - 1/100,000 3 = Detectable by skilled person

3 = Injury requiring minor attention 3 - 1/10,000 5 = Undetectable except by a rare

highly skilled person

4 = Permanent impairment or life-threatening injury 4 - 1/1000 (you can 1,2,3,4 5; these have

been omitted for clarity of
presentation)

5 = Death 5 - 1/1000

(c)
S
1 = Inconvenience
2 = Temporary injury not requiring attention; can lead to a complaint
3 = Injury requiring minor attention; delay to procedure of < 30mins; could lead to a series of complaints
4 = Permanent impairment: life-threatening injury; potential for a product recall
5 = Death; cancellation of procedure; definite product recall

(d)
O
1 = One occurrence in 3 to 5 years or ½ in 1,000,000,000 uses
2 = One occurrence per year, or six in 100,000 uses
3 = One occurrence every 3 months or 5 in 1000 uses
4 = One occurrence per week or 5 or more in 100 uses
5 = More than one occurrence per day or more than 3 in 10 uses