Biomedical Engineering Reference
In-Depth Information
TABLE 8.12 Simplified of FMEA for Noncleaned Equipment Hold Time
Potential
Potential
S
Potential
O
D
Process
Failure
Effect on
E
Cause for
C
Current
E
Step
Risk Factor
Mode
Patient
V
Failure
C
Controls
T
RPN
Dry product
mfg.
Drying of
product
and
adhesion
to surface
Product will
dry on
surface
Chemical
contamina-
tion (major
adverse
reaction)
10
Powder
hidden
3
Vacuum,
visual
inspection
5
150
Solubility in
cleaning
agent
Product
partially
soluble
Chemical
contamina-
tion
(moderate
adverse
reaction)
5
Cleaning
agent
only
partially
effective
3
Cleaning
validation
performed
success-
fully
3
45
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