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Thread: Risk Management- ISO 15189 NC- some help please

  1. #1
    Forum Member
    Join Date
    Nov 2016

    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.


    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 09:42 PM. Reason: format

  2. #2
    Forum Member
    Join Date
    Nov 2016
    Ok, further to some advice, the Pathology needs a specific SOP on QRM, though BB has covered much of this in local procedures.
    Also, recently I have been advised via two different sources to keep all this stuff very simple (KISS) but relevant, so I am NOT process mapping everything to address this NC....... phew!!

  3. #3
    1. I think risk management is the broader term, quality risk management is part of "risk management"
    4. Our approach to risk assessment for ISO 15189 is to use FMEA. The steps of the analytical process including the pre-analytical, analytical, and post analytical phases can be analysed in turn. The risk mitigated at each step. The output of an FMEA can be a Quality Control Plan if desired. The CLSI have produced guidance and there is also guidance in ISO/TS 22367

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