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11th Feb 2018, 10:39 PM
#1
Risk Management- ISO 15189 NC- some help please
During a recent UKAS inspection the following NC was raised :
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.
Proposed improvement action: Document approach and process and evidence that assessments have been carried out.
The Blood bank processes already include consideration of risks/ impact on the patient eg: CAPA SOP , IQA/EQA failure SOP, Change control documents.
Questions:
1. Is Risk Management/ Quality Risk Management the same thing?
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?
3. Should we be process mapping/ writing an RAs for every process to identify potential failure points/ mitigation?
4. Is there a simple way to do this?!!
All comments would be very, very much appreciated.- many thanks.
Last edited by Orr; 11th Feb 2018 at 10:42 PM.
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