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

Change control

Quality Audit Preparation

Process:

Change Control

Area:

Blood Transfusion

Auditees:

Any person involved in this procedure. This may include:

  • Haematology Lab Manager
  • Blood Bank Manager
  • Quality Manager
  • Other BMS personnel

Initial preparation:

SOP on change control

  • Is the SOP specific, in date, authorised, official copy, document controlled.
  • Evidence of change that may affect quality is communicated to relevant personnel

Additional Evidence required:

  1. Plan of change
  2. Request for change
  3. Evidence of consultation phase
  4. Feedback form consultation phase
  5. QA report
  6. Completed validation reports
  7. Completed risk analysis
  8. Completed commissioning reports
  9. Summarised lab test data
  10. New revised SOP
  11. Evidence of training
  12. Implementation date
  13. Audit of implementation of change

Interviews/process:

  1. Review evidence
  2. Dependent upon what the change was. May include observation, questions, knowledge assessment if the change is procedural.

Additional requirements:

Dependent upon what the change was.