Self Inspection / Quality Audits
Introduction
Under the Quality Management System all transfusion laboratories should have a system for self-inspection. Self inspection allows for the regular review of all activities and a process for correcting deficiencies and should be performed to verify compliance with the principles of GMP and regulatory requirements.
Self-inspection should comprise all parts of the operations, be performed regularly and be documented. Corrective actions should be documented and completed in a timely and effective manner.
The following list of self inspection audits have been compiled to cover the different aspects undertaken by hospital transfusion laboratories. The list is not exhaustive and does not claim to cover all the necessary areas where self inspection audits should be undertaken. Each document contains the following:
- Process
- Area
- Auditees
- Initial preparation
- Additional evidence required
- Interviews/process
- Additional requirements
Before use each hospital should identify the requirements for their hospital and make specific for their organisation.
- Telephone Logs
- Cold chain − laboratory storage
- Cold chain − issues fridge/satellite fridges
- Cold chain − transport
- Cold chain − Alarm testing
- Incident reporting − SABRE
- Quality incident reporting
- Traceability
- Group and Antibody screening − Manual
- Group and Antibody screening − Automated
- Emergency group and issue
- Crossmatching /Electronic Issue
- Collection of blood from Fridge − Manual
- Collection of blood from issue fridges − automated
- Document control
- Training
- Sample acceptance
- Data entry
- Report validation to include Blood Bank IT system
- Recall procedures − internal and external
- Change control
- Equipment maintenance
- Calibration of Pipettes
