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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:
Doc.
Type
Doc.
No.
Title
FORM
DD:949
Problem Identification and Remedial Action
FORM
DD:950
Initial Quality Review
FORM
DD:951
Investigation and Corrective Action
FORM
DD:952
Follow Up and Effectiveness
FORM
DD:953
Final QA Review and Closure
FORM
DD:649
Checklist For Treatment of Blood Components Giving a Positive
BacT/ALERT result
FORM
DD:1486
Application for Extension to Timeline for Completion of Incident
SOP
BD:017
Procedure For Processing Complaints And Other Donor Contacts
SOP
HS:012
Procedure For Reporting And Managing Health and Safety Incidents
SOP
PH:047
Procedure For Handling Apheresis Machine And Harness Defects’
Incorporating Apheresis Related Incident Reporting.
SOP
QA:002
Blood Component/Product Recall Procedure
SOP
QA:016
Procedure For Reporting Blood Pack Faults
SOP
QA:079
Reporting Serious Adverse Events Or Reactions To SABRE
Northern Ireland Blood Transfusion Service
STANDARD OPERATING PROCEDURE
(Operational Copy)