Performing the Performance
Qualification.
Test the
performance of the Data Logger as per the Check List and record these in the
Performance Qualification Report. The frequency of recording results has been
decided based on the results of the Operation Qualification. The test
methodology is defined in the check list.
The Data Logger shall
be handed over to Quality Control only after successful completion of
Performance Qualification.
Record all
observations and deviations in the report. In case of deviation prepare a
deviation report with justification and get it approved by Head Quality assurance,
Head Quality Control.
Check list for
Performance Qualification
EQUIPMENT / SYSTEM:
DATA LOGGER
|
Test ( S)
Required
|
Test Description
|
Acceptance Criteria
|
Results
|
Checked
by
|
|
To check the data scanner is functioning or not.
|
Plug the cord of
instrument into the main electrical supply and observe for blinking the scanner
|
It should blink the scanner when it is in ON
condition
|
|
|
|
To check the
all key’s (8 no.)on the data scanner are functioning or not.
|
When it is in ON
condition check all key’s by entering any data into the instrument.
|
All key’s on the data scanner should work properly.
|
|
|
|
To check the RTD probes supplied by manufacturer for showing
temperature on the data scanner.
|
Connect the RTD probes to
the data logger unit as per method
Given in the Manual.
Observe the readings on display by putting these probes into the water.
|
RTD probes should show
temperature on the display.
|
|
|
|
To check & compare the temperature of both
temperature indicator and probe are near about similar.
|
Fix the required number of probes to the data
logger and place in autoclave at different locations and run the autoclave as
per procedure and observe the temperature of both temperature indicator of
autoclave and probes.
|
Both the probe and indicator should show similar
Temperature.
|
|
|
