Biomedical Engineering Reference
In-Depth Information
Appendix I: (
Continued
)
Major Area
Subarea(s)
Potential Hazard
Potential Harm
Raw
Material
Materials
Use of Wrong Material or
Materials
Management
on Receipt:
Inadequate Identification Wrong Grade of Material
Operating parameters Wrong rate of spin, drum
rotation, wrong air
drying temperature
Inadequate coating;
product degradation or
instability
Branding
Ink solution,
preparation
Wrong ink material (e.g.,
ink too thick or thin)
Inadequate or smeared
imprint, product not
properly identified
Equipment setup
Incorrect pressure
parameters
Inadequate imprint,
product not properly
identified
Equipment
Clogged ink applicator
Inadequate imprint,
product not properly
identified
Packaging
Filling
Product mix-up. Incorrect
product in package
Adulterated product
Incorrect number or
amount in package
Mislabeled product,
patient treatment
impacted
Patient information
Incorrect information
Patient safety
Seal integrity
Inadequate seal (e.g.,
incorrect sealant or
sealant amount,
application misaligned,
incorrect sealing
temperature or
pressure)
Product contamination,
product stability may
be compromised
Facility
Material
flow
Material and
personnel flow
patterns (e.g.,
undedicated/
multi-product
facility)
Shared production and
non-production areas
Product
cross-contamination
Cleaning
Cleaning agents
Inadequate to dissolve
dried, residual product
Product-to-product
contamination
Sanitizing agents
Inadequate to reduce
environmental
microbial bioburden,
as needed
High microbial bioburden
levels, microbial
contamination
Cleaning technique
Practice, as designed,
may re-introduce
contamination
High levels of residual
product and microbial
bioburden; microbial
contamination
Cleaning equipment
Inadequate design to
support
technique/practices
Inadequate cleaning, e.g.,
mop handle too short
to reach upper wall
Not readily cleanable
May re-introduce
contamination or
cross-contaminate
another area
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