Quality Incident Report Format
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Blood Component/Product Recall Procedure Procedure For Reporting Blood Pack Faults Reporting Serious Adverse Events Or Reactions To SABRE SOP:07:QA:070:08:NIBT SOP SOP SOP SOP SOP SOP SOP SOP SOP POL POL STG APP QA:092 PAGE 2 of 26 Reporting of Serious Adverse Events Or Reactions To The Human Tissue Authority QA:102 Procedure for Recall of Pharmaceutical Products QS:017 Use of the Q-Pulse Quality Incident Template QS:018 Raising an Incident using Q-Pulse Quality Incident Wizard RM:001 Risk Register Process QB:005 Procedure for Culture Positive Pooled Blood Components QB:012 Bacteriological Investigation of Adverse Reactions Associated with Transfusion QB:013 Procedure for Treatment of Culture Positive Single Donor Platelets or Red Cells QA:110 Techniques to be Employed During Quality Investigation MP:011 Policy For Receipt of Samples Which Do Not Conform With NIBTS Sample Labelling Or Request Form Requirements QP:003 Incident Management Policy RMS:001 Risk Management Strategy 1 Matrices used to Determine Risk Related to a Quality Incident SOP:07:QA:070:08:NIBT PAGE 3 of 26 Key Change from Previous Revision: Major re-write of SOP in response to MHRA inspection Expansion of 1.1 re all staff and addition of responsibilities of root cause analysis experts and investigators Time lines for incident closure reduced from 60 days to 30 calendar days.. This SOP provides a standardised procedure for reporting quality related incidents which is intended to meet the following requirements: The requirements of the Blood Directive and of the MHRA Guidance on SABRE reporting The requirements of the European Tissue and Cells Directive (EUTCD) 2004/23/EC, the Human Tissue Act (2007) and of the current HTA Directives and Guidance The requirements of the CPA/UKAS The requirements of the DHSSPS/HSCB and relevant Controls Assurance Standards including Risk Management NIBTS strategy regarding risk management (STG:RMS:001 Risk Management Strategy) 2.1.2 A Quality Incident is an event wh
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