Using Records to Identify Root Causes of Non-Compliance
November 8, 2017 - Aurora CO USTraining Doyens
support@trainingdoyens.com
Phone:7209961616
Fax:7209961616
OVERVIEW Records are temporal and non-compliance occurs at 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. 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 building situation. These other statistical patterns can be used to trigger preventive actions without the dire consequence of non-compliance. AREAS COVERED • Laboratory records • The non-compliance – Symptoms • Assessing possibilities • Comparing the incident time to the recordkeeping • Investigation and cycling back WHO WILL BENEFIT • Research Associates • Technicians • Chemists • Quality Officers • Laboratory Supervisors • QA Managers and Personnel • QC Managers and Personnel • Quality System Auditors • Regulatory Compliance Associates • Documentation Specialists LEARNING OBJECTIVES 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. For more detail please click on this below link: https://goo.gl/XCVQxV Email: support@trainingdoyens.com Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882