Using Records to Identify Root Causes of Non-Compliance
OVERVIEW Records are temporal and non-compliance occursat 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. Root Cause Analysis WHY SHOULD YOU ATTEND 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...