Using Records to Identify Root Causes of Non-Compliance

OVERVIEW
Records are temporal and non-compliance occursat 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.
Root Cause Analysis

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

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