Quality Audit Preparation
Recall procedure- internal and external
Blood bank, and areas with issue or satellite fridges
Any person involved in the process, this may include:
- Blood bank staff (BMS or MLA)
- On-Call staff
SOP for the process, is it:
- In date
- Appropriately signed / authorised by an authorised signatory
- Official copy
- Cross-referenced with COSHH register and risk assessments
- Regularly reviewed
Additional Evidence required:
- Documentation of product recall from an external supplier
- Documentation of reason for internal product recall
- Evidence of product quarantine and return to external supplier
- Training records and competency assessment / competency of trainers
- Document control
- Knowledge assessment
- Objective evidence
- General housekeeping of area.
- Designated “quarantine area” for blood or blood products.
- Record of transfusion if product transfused prior to recall.
- Reporting to MHRA via SABRE website of transfusion of recalled products