Speaker: John C. Fetzer
Speaker Designation: Founder and Principal, Consultant Fetzpahs Consulting
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?
The records in a lab – the logbooks for chemicals, reagent and calibration solutions, sample preparation, instrument maintenance and calibration, for quality checks – all are time-oriented. This gives a 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.
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 the determination of claims of discovery where new inventions are concerned; demonstration of adherence to standards of good practice, and academic and ethical integrity; and compliance with contractual provisions permitting sponsors to audit work carried out in pursuit of sponsored research.
Tracking down the cause of non-compliance can be a time-consuming and difficult 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 certain root causes. Using both scientific and operational clues can help pinpoint the root causes in a faster and more valid way. This webinar will describe the approach and some examples of how to do this.
Proper laboratory information is rich in facts that aid in identifying 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 can give an idea of what symptoms match those seen. Some examples will be given, as well as how to use other expected symptoms to corroborate the root cause.
Major topics covered:
In industries where safety, compliance, and operational efficiency are paramount, the ability to identify and address the root causes of incidents or issues is a cornerstone of continuous improvement. Logbooks and meticulous recordkeeping emerge as indispensable tools in this process, providing a detailed chronicle of events, activities, and conditions. By acknowledging and maximizing the potential of logbooks and recordkeeping, organizations can establish a robust foundation for root cause analysis.
Dr. Fetzer has had many roles in compliance under Good Laboratory Practices and ISO 17025. He developed liquid chromatography and physical-property assays for a variety of compounds. He supervised a compliant laboratory for over a decade. He has performed outside audits for "mock" compliance audits. He has been training in this topical area for many years.
Dr. Fetzer's expertise extends beyond academia, having published over 100 peer-reviewed scientific articles, 2 books, and 8 book chapters. He was key in overseeing the Good Laboratory Practices accreditation for a prominent research chromatography laboratory. Additionally, Dr. Fetzer has shared his knowledge by conducting numerous short courses on GLP and ISO 17025 compliance.
Beyond his contributions to the scientific community, Dr. Fetzer offers Analytical Chemistry Consulting Services and Scientific Career Development Consulting services. As an American Chemical Society tour speaker, he has delivered over twenty invited lectures at conferences, universities, and government laboratories, further solidifying his impact in the field.
