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Quality Assurance

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  • Anon
    06/11/2015 10:00
    Hi Everyone, can any one explain the Procedure preparation and Evaluation for trend analysis of Audit observations and Identifying risk with respect to the trend analysis. Addition to that, Is Quality matrix is same as trend analysis. Any guideline references please.
  • GCP Committee
    02/12/2015 13:54
    Some informal thought from one of the members of the GCP Com:- • One of the most important aspects of trending audit observations is to be able to compare apples with apples and to do this you have to ensure that audit observations are appropriately categorized for trending. • Often when organisations start trending data they spend a lot of time looking at the proposed taxonomy determining which categories and sub-categories to use for trending to ensure that they have a robust system that doesn’t need to be constantly updated. Introducing new categories and sub-categories can cause a lot of work in terms of re-mapping findings manually to the new categories. • Embedding, standardizing categories and sub categories of standard audit finding statements into an Audit Management System can help promote consistency of use of the categories and make trending easier if the systems is set up to produce trending reports. • When introducing a new system organisations often go back and look historical audit data and map this to the proposed framework and see how that looks and then make adjustments to make sure that it reflects the needs of their organisation. • Need to be careful level of granularity in trending and reporting within the organisation - this will be dependent on the organisation and what level of information gives useful and meaningful information to the audience >>>>The QUASAR 129 that has articles on Quality Issues - Tracking and Management, What should we measure? Metrics and Trend Analysis Reports. There is a whole load of information in there
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