Records are temporal and non-compliance occurs at a specific time. These can be compared to get clues of the root cause of the non-compliance.
An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to that caused the non-compliance?
Tracking down the cause of non-compliance can be a time-consuming and difficult task. But in a compliant laboratory there are numerous records covering everything done within the laboratory.
Fear, uncertainty and doubt (FUD) liner for the marketing purpose (Between 250 - 500 words): Data quality and compliance to a required level of performance are measured by statistical tools. Usually in compliance there is a very heavy weighing towards only 3-sigma deviations. But statistics gives much more than that. There are other signs that being “out of control” is a building situation. These other statistical patterns can be used to trigger preventive actions without the dire consequence of non-compliance.
These records are a coordinated and interlocking system that can be a key tool in finding certain root causes. This webinar will describe the approach and some examples of how to do this.
John C. Fetzer has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers onl iquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
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