Process Monitoring
Verify that routine manufacturing processes are consistently within a state of control
Type
Domain
Competency Area
Quality Management
Levels
Monitor manufacturing processes and identify deviations
Set up process monitoring systems and equipment according to instructions
Interpret manufacturing processes data
Detect deviations of process variables from the steady state condition of process plants
Identify potential causes of deviations
Record details of readings on deviations, actions and activities in accordance to standard procedures
Perform Corrective and Preventive Actions (CAPA) under guidance
Restore processes to within specifications using the correct procedures
Oversee process monitoring procedures and systems and determine follow-up actions to rectify deviations
Oversee monitoring of manufacturing processes
Evaluate patterns and trends in manufacturing processes performance data
Perform analyses to determine causes of process deviations
Determine appropriate actions to correct, anticipate or prevent undesired process variability
Identify CAPA to restore processes to desired state
Implement CAPA to ensure routine manufacturing processes are within a state of control
Document CAPA performed
Lead process monitoring to provide ongoing assurance that the process remains in a state of control
Develop data collection plans and statistical procedures used in measuring process stability and capability
Identify technical systems and technologies that facilitate process monitoring
Plan procedures and schedules to monitor manufacturing processes
Establish processes and mechanisms to trigger appropriate alerts upon detection of process deviations
Facilitate integration of technologies and systems into process monitoring procedures
Determine product and process performance parameters and metrics to be monitored
Review key findings from analyses of manufacturing processes performance data
Review viability and effectiveness of CAPA