Failure investigation and root cause analysis are expected under cGMPs and the medical device QMS standards. Two of the most challenging issues facing the life sciences industry in a regulated environment are how to conduct effective failure investigations, and how to permanently implement corrective and preventive action.
Six Sigma is a measurement-based strategy that focuses on process improvement and variation reduction. An important part of Six Sigma is the DMAIC (Define, Measure, Analyze, Improve, and Control) model.
This one-day course introduces participants to systematic root cause analysis. Students learn how to apply Six Sigma tools and techniques to facilitate and conduct investigations, identify root causes, analyze for best prevention options, and verify successful implementation of changes.
Learning outcomes and benefits
On successful completion of this course, participants should be able to:
- Apply a systematic approach to problem solving and root cause analysis
- Utilize 6 Sigma tools such as cause and effect diagrams, ranking, matrix analysis, brainstorming, pareto analysis and some SPC tools.
- Apply risk analysis to quality and compliance problems
The participants will be able to practice 6 Sigma tools using industry case studies.
Who Should Attend
The course is applicable at all levels within the life sciences industry. In particular, personnel from these areas would benefit most:
- Operations and manufacturing supervisors and managers
- Compliance, QA/QC personnel, supervisors and managers
- Quality and process improvement engineers
- Continuous improvement personnel
Participant's notes, case studies and certificates of participation will be provided.