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Thread: Things to consider when reporting SAEs on SABRE

  1. #1

    Things to consider when reporting SAEs on SABRE

    Dear Colleagues

    Following a recent NBTC TLM meeting I have been asked to share again my infographic first published in the 2015 SHOT report. The purpose of this is for me to try and differentiate between those errors that are genuinely slips or lapses by an individual with no influence from other contributory factors, and those which can be linked to deficiencies in the QMS. See attachment below

    qms process.pdf

    Effective CAPA that addresses weaknesses and flaws in the QMS can prevent errors occurring in other areas of the lab, and not just with the actual task that failed. The focus should not necessarily be on re-training, re-competency assessment or adding extra steps in a process, unless it is absolutely necessary to do so. There are certain key principles to consider when improving your QMS and when investigating incidents. This list is not exhaustive and is meant for guidance only.

    QMS
    Is staffing appropriate?
    Is workload manageable?
    Is the environment (premises and plant) fit for purpose?
    Are tasks and processes designed to be robust?

    Procedures
    Are there SOPs to describe the tasks and processes?
    Are they document controlled?
    Do they contain unambiguous instructions as opposed to a set of requirements or expectations that need to be achieved?

    Training
    Is there a training plan?
    Is the training material adequate and fit for purpose?
    Has training been delivered?
    Has training been understood and understanding assessed?
    Does GMP education cover the relevant aspects of GMP?

    Personnel
    Is there effective supervision and leadership?
    Do supervisors watch out for and challenge bad practice?
    Are staff aware of their responsibilities?
    Do staff carry out their duties in accordance to GMP?
    Are staff actively engaged in improving the QMS?

  2. #2
    Forum Member
    Join Date
    Nov 2016
    Posts
    26
    Thanks for this info Chris.

    I have attached a checklist that a colleague forwarded to me - that may also help. This has similar but specifically lab based questions for incident investigations.
    Attached Files Attached Files

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