Elements and Performance Criteria
- Receipt materials and components
- Confirm incoming goods correspond to workplace documentation
- Clean and label containers with prescribed data, according to workplace procedures
- Quarantine incoming goods including release and reject status according to Good Manufacturing Practice (GMP) requirements and workplace procedures
- Identify and report deviations, unusual events and non-conformances according to GMP and workplace procedures
- Set up the production process for operation
- Confirm equipment and materials meet production requirements
- Confirm cleaning requirements and equipment status
- Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
- Enter processing and operating parameters according to safety and production requirements
- Check and adjust equipment performance
- Conduct pre-start checks according to workplace procedures
- Dispense materials
- Operate and monitor the production process
- Start up, monitor and control production process to maintain process within required limits
- Identify and report out of limit products or processes according to workplace procedures
- Maintain work area according to workplace cleaning standards
- Conduct production process according to safety and environmental requirements
- Complete documentation according to workplace procedures
- Hand over the production process
- Shut down the process