Elements and Performance Criteria
- Determine critical operating requirements
- Establish and maintain relationships between key processes
- Key processing data, such as yield and throughput, is gathered, analysed and applied to ensure the process is optimised.
- Corrective actions for deviations outside allowable parameters are determined and communicated to relevant personnel.
- Circumstances in which emergency procedures should be initiated are determined and communicated to relevant personnel.
- Process data is gathered and analysed to ensure conformance with specifications.
- Monitor processing operations to achieve set requirements or product specifications
- Methods to monitor the process are established to ensure compliance with product specifications.
- Control points for processing operations are monitored to confirm product specifications or to identify variations.
- Causes of operational variations are identified and remedial action implemented, as required.
- Emergency procedures are implemented in a timely manner in response to evidence of contamination or risk to physical safety.