Role of Logbooks and Recordkeeping in Identifying Root Causes in Labs
Duration: 60 Minutes
The records in a lab - the logbooks for chemicals, reagent and calibration solutions, for sample preparation, for instrument maintenance and calibration, for quality checks - all are time oriented. This gives window of cause-and-effect or coincidence that can give clues. The sum of these, plus the symptoms of the non-compliance can point out the likely root cause.
Objectives of the Presentation
Why Should you Attend
- What records are in a compliant laboratory?
- Symptoms - What is normal?
- How is this abnormal?
- What are possible causes?
- How are these tracked by the records?
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. 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.
Who will Benefit
- Research Associates
- Lab Chemists
- Lab Supervisors
- Quality Officers
- Supervisors and Managers
- Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
- GMP auditors
- Analysts and other laboratory staff
- Regulatory Affairs
- Product Development analytical testing Managers and Directors
- Product Development Analysts
- Quality Assurance Directors, Managers and record reviewers
A well-maintained and properly documented laboratory notebook establishes a permanent record of research protocols and results which can be referred to in the future, most commonly in the preparation of scientific papers and reports. Additionally, it can be an invaluable source of information for a variety of purposes, including determination of claims of discovery where new inventions are concerned; demonstration of adherence to standards of good practice, and of academic and ethical integrity; and compliance with contractual provisions permitting sponsors to audit work carried out in pursuit of sponsored research.