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Continuous Particle Monitoring System Project - Coggle Diagram
Continuous Particle Monitoring System Project
SOP
Introduction
What is the system? :check:
Why do we need it?
Regulatory expectation :check:
Locations
Appendix/Text
Where are they all located
Site Map
Daily Use in Production
Cleaning
When is it operating?
When does do turn valve on and off?
How do you turn the valve?
Where are the valves located in each location?
Picture
Daily basis - Office interface
How to login and out
Write that it can never be switched off - connected to UPS
How to stop/start recipes
Alarm acknowldgement
How to acknowldge alarm?
Who can acknowledge alarm?
Check what has happened during the night
How do you do that?
When do you proceed? How do you handle an issue?
System set-up
Setting up new users :check:
Security levels and permissings :check:
Reporting
Periodic report generation
Review of Reports
What to do in the event that a particle count thing stops working?
Contingency
Perform manual particle counting
Frequency
Deviation?
When to escalate?
Who to contact?
Troubleshooting
Calibration
As per REG-30
Frequency
Reference training
Responsibilities
QA
PM
Operators
PQ
Gather data
Training Form