Monitoring a Quality Laboratory to Prevent Non-Compliance
John C. Fetzer, has had over 30 year experience in laboratory compliance, including developing methods, writing SOPs, training, and auditing. He has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation to ensure that it is under control and to see when a problem is arising, but before it is outside of 3-sigma.
Data quality and compliance with 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 a non-compliance.
Many problems that arise in an analysis result from causes that start small and grow over time. Others result from an unplanned change in a procedure or the performance of an instrument. These manifest themselves into changed patterns in certain measurable variables. The use of statistical methods to assess and monitor certain variables will be covered, highlighting the predictable patterns.
Who Should Attend
Research associates, lab chemists, lab supervisors, quality officers.