JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

Equipment maintenance

Quality Audit Preparation

Process:

Equipment maintenance

Area:

Blood bank – all areas

Auditees:

Any person working in this area, this may include:-

  • Blood bank staff BMS or BSW
  • On call staff

Initial preparation:

Is the SOP for the process:-

  • Specific
  • In date
  • Appropriately signed & authorised by an authorised signatory
  • Complete list of all equipment
  • Official copy
  • Links to COSHH / Risk Assessments / SOP
  • Regularly reviewed

Additional Evidence required:

  1. Document control
  2. Calibration records / certificates
  3. Calibration records of external contractors
  4. In house daily / weekly maintenance records
  5. External service records
  6. Service contracts
  7. Instrument fault logs
  8. Evidence of decontamination certificates prior to service.

Interviews/process:

  1. Observation
  2. Knowledge assessment
  3. Objective evidence

Additional requirements:

If applicable for certain equipment:

  1. QC records
  2. Validation of equipment
  3. Temperature charts

(See Additional Evidence Required)