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

  1. #1
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    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. Reason: format

  2. #2
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    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!!

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