SOP:07:QA:070:08:NIBT PAGE 1 of 26
Document Details
Document Number: SOP:07:QA:070:08 :NIBT No. of Appendices: 1
Supersedes Number: SOP:07:QA:070:07:NIBT
Document Title: PROCEDURE FOR REPORTING AND MANAGEMENT OF
QUALITY INCIDENTS
Prepared By: S Jamison Job Title: R A & C Lead
Department: REGULATORY AFFAIRS & COMPLIANCE
Document Authorisation/ Issue & Implementation
Prepared By: S Jamison ____________________ Date: __________________
Approved By: A Macauley____________________ Date: __________________
RA&C Manager
ISSUE DATE: 03 March 2014 EFFECTIVE DATE: 12 April 2014
CROSS REFERENCES
This SOP refers to the following documents:
Problem Identification and Remedial Action
Investigation and Corrective Action
Follow Up and Effectiveness
Final QA Review and Closure
Checklist For Treatment of Blood Components Giving a Positive
BacT/ALERT result
Application for Extension to Timeline for Completion of Incident
Procedure For Processing Complaints And Other Donor Contacts
Procedure For Reporting And Managing Health and Safety Incidents
Procedure For Handling Apheresis Machine And Harness Defects’
Incorporating Apheresis Related Incident Reporting.
Blood Component/Product Recall Procedure
Procedure For Reporting Blood Pack Faults
Reporting Serious Adverse Events Or Reactions To SABRE
Northern Ireland Blood Transfusion Service
STANDARD OPERATING PROCEDURE
(Operational Copy)