Operation (Oq) & Performance Qualification (Pq) - Elitech FreezePoint 6000 Series User Manual

Installation, Operation, and Performance Qualification
Operation (OQ) & Performance Qualification (PQ)
The IQ has to be completed before starting the Operation Qualification. In this phase the process
parameters should be challenged to assure that they will result in a product that meets all defined
requirements under all anticipated conditions of manufacturing, i.e., worst case testing. During
routine production and process control, it is desirable to measure process parameters and/or product
characteristics to allow the adjustment of the manufacturing process at various action level(s) and maintain
a state of control. These action levels should be evaluated, established and documented during process
validation to determine the robustness of the process and to proof the ability to avoid approaching "worst
case conditions."
Operation Qualification
Power ON Functional Tests
Is the Display showing the Start Menu?
Initialization phase
After pressing the button measurement
did the screen show a progress
bar for producing ice crystals?
Progress bar needs less than
3 min to be ready?
Upper Cooling System
Raise the cover of the upper cooling system.
Is there some frost visible
on the cooling pin?
Lower the cover of the upper cooling system. .....................................................
Elevator
Raise the elevator up and down.
Can the elevator be moved smoothly?
Moved parts
Does the fan run free of disturbance?
Motor-control (with initiation needle)
Raise the cover of the upper cooling system.
Go to Start Menu
Options Maintenance
Needle and follow instructions
Did the initiation needle rotate in
the cooling pin correctly?
COMMENTS
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Settings Lab
Adjust
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Comment
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Date Verified
120