Risk Management- ISO 15189 NC- some help please
During a recent UKAS inspection the following NC was raised :
[I]The QMS has not documented its approach to Risk Management with regards evaluation of the impact of work processes and potential failures on test results.[/I]
[B]Proposed improvement action[/B]: [I]Document approach and process and evidence that assessments have been carried out.
[/I]
The Blood bank processes already include consideration of risks/ impact on the patient eg: CAPA SOP , IQA/EQA failure SOP, Change control documents.
[B][I]Questions:[/I][/B]
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1. Is Risk Management/ Quality Risk Management the same thing?[/I]
[I][FONT=Calibri][/FONT][/I][I]2. Does this mean the lab needs a separate SOP for QRM based on EU Annex 20, or can a statement be added in the Quality Manual?[/I]
[I][FONT=Calibri][/FONT][/I][I]3. Should we be process mapping/ writing an RAs for every process to identify potential failure points/ mitigation?[/I]
[I][FONT=Calibri][/FONT][/I][I][U][U]4. [/U]Is there a simple way to do this?!!
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[I]All comments would be [U]very, very much appreciated[/U].- many thanks.[/I]