The records in a lab – the logbooks for chemicals, reagents, and calibration solutions, sample preparation, instrument maintenance and calibration, and quality checks – all are time-oriented. This gives a window of cause-and-effect or coincidence that can provide clues. The sum of these, plus the symptoms of the non-compliance, can point out the likely root cause.

Learning Objectives

Tracking down the cause of non-compliance can be a time-consuming and challenging task. However, in a compliant laboratory, there are numerous records covering everything done within the laboratory. These records are a coordinated and interlocking system that can be a key tool in finding specific root causes. This webinar will describe the approach and provide some examples of how to do it.

When non-compliance occurs with the method, the possible root causes are numerous. Finding the actual cause can be time-consuming and stressful. Using both scientific and operational clues can help pinpoint the root causes in a faster and valis way.

Proper laboratory information is rich in facts that help identify the root causes of a problem (non-compliance event). Date and times can be matched to the event/ Changes in operation, such as a repair or maintenance of an instrument or using a different lot number of a solvent, which can give an idea of what symptoms match those seen. Some examples will be provided, as well as how to use other expected symptoms to corroborate the root cause.

Who Should Attend

Research associates, lab chemists, lab supervisors, and quality officers.

Topic Background

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 what caused the non-compliance?