Process Monitoring

Verify that routine manufacturing processes are consistently within a state of control



Competency Area

Quality Management


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