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
Calibration
Frequency
Inadequate to ensure
proper performance
(e.g., temperature
recorder)
Incorrect results; failure
to accurately measure
or perform
Methods
Insufficient points used
in calibration to cover
entire use range
Inaccurate measurements
outside of calibrated
range, compromise of
product quality
Validation
Extent of
validation
activities
Inadequate to ensure
equipment is operating
consistently as
intended
Inconsistent product
quality
People
Hygiene
Health habits
Inadequate personal
hygiene
Contribute to
environmental
contamination
Illness or injury
Sneezing, coughing, open
wounds
Microbial contamination
of environment or
product
Protective
clothing or
gear
Type
Inappropriate type or
insufficient protective
garb
Inadequate environmental
or personnel protection
Material of
construction
Improper material of
construction (e.g.,
loose weave bodysuit
or materials shed
particulate)
Unable to provide
adequate barrier;
particulate
contamination of
environment and
product
Size
Improper size (e.g., too
large or too small)
May not completely
cover and expose skin:
may cause rubbing of
skin leading to
excessive shedding;
product contamination
Incoming
packaging
Inappropriate and
inadequate packaging
to protect garb during
transit
Use of garb contaminated
from outside sources,
introduce
contamination to
manufacturing areas
Internal handling
practices and
storage
conditions
Inappropriate practices
and conditions to
maintain integrity of
packaging
Environmental
contamination
Disposal or
replacement
practices
Inadequate protection
leading to
contamination
Donning practices Inappropriate practices May introduce
environmental
contamination
(
continued
)
No replacement schedule
or standards for
nondisposable garb
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