Learning Objectives
At the end of this module, you will be able to:
Scenario
The reader fails while performing ELISA /
EIA tests. There isnt a documented
procedure for troubleshooting, the
maintenance log has not been updated for 2
years, and the manufacturers instructions
are missing.
What should you do? Why?
What should you have done earlier ?
What you would do if this happened in
your laboratory?
Equipment-Module 3
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
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Facilities
&
Safety
Performance
high level
Lowers
repair costs
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Lengthens
lifespan
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Program Considerations
Installation
Installation
Retiring
Retiring
equipment/
equipment/
disposition
disposition
Service
Service
and
and
repair
repair
Selection
Selection
and
and
acquisition
acquisition
Calibration/
Calibration/
performance
performance
evaluation
evaluation
Maintenance
Maintenance
TroubleTroubleshooting
shooting
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review
update
procedures as needed
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Equipment
needs
Facility
requirements
performance characteristics
cost
reagents
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to use
language
warranty
safety
will it fit?
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Acquiring Equipment
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Equipment Installation
when
possible, have
manufacturer install and set up
do not attempt to
use prior to
proper installation
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Equipment Installation
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Inventory Record
Calibration
Verification
Operating
Procedures
Maintenance Program
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Equipment Calibration
perform initial
calibration
use calibrators or
standards
follow manufacturers
instructions
determine frequency
of routine calibrations
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Performance
Evaluation
Establish stability
for temperaturecontrolled equipment
Validate
performance with
parallel samples
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Function Checks
Monitor instrument parameters:
periodically,
temperatures
wavelength calibration
autoclave temperature chart
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Preventive Maintenance
routine cleaning
adjustment,
replacement of
equipment parts
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Implementing a Maintenance
Program
assign responsibility
develop written
policies and
procedures
maintain records
train staff
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Electricity?
Equipment?
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call manufacturer or
other technical expert
stores or manufacturer
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WARNING
OUT OF ORDER
DO NOT
USE
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manufacturers
laboratory
in-house biomedical
service technicians
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Documents
Develop written procedures for:
routine
maintenance
function checks
calibration
troubleshooting
manufacturers
service
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Routine maintenance:
calibration
service repair
by manufacturer
all problems
Function
checks
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Recording Problems
date problem occurred, equipment removed
from service
reason for breakdown or failure
corrective actions taken
date returned to use
change in maintenance or in function checks
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Example of logbook 1
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Example of logbook 2
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Example of logbook 3
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Summary
An
Documents
inventory
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Key Messages
A well-organized equipment maintenance
program provides:
High
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Organization
Personnel
Equipment
Questions?
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Comments?
Facilities
&
Safety
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