11:00 AM - 12:30 PM
Lecture 1: It’s a System! Elements of Quality Management

• Deming 14 points for total quality management
• Dr. Ishikawa, seven quality control tools (7-QC) and supplementals (7-SUPP)
• Pareto principle (80/20 rule)
• Shewhart (Plan, Do, Study, Act)

12:30 PM - 02:00 PM
Lecture 2: Regulatory Requirements in Quality Management

• FDA Quality System Regulation (QSR)
• ISO 13485:2016
• IS 9001:2015
• Harmonization of regulations with FDA guidance/regulations

02:00 PM - 03:30 PM
Lecture 3: Statistical Basics

• Descriptive and Graphical Techniques
• Histograms
• Scatterplots
• Pareto charts
• Cause and effect (fishbone) diagrams
• Defect concentration diagrams

03:30 PM - 05:00 PM
Lecture 4: Statistical Process Control: The ABC’s of Control Charts

• Elements of a control chart
• Control Charts for Discrete Data
o c chart
o u chart
o p chart
o np chart
• Control Charts for Continuous Data
o X-bar chart
o R chart
o I chart
o MR chart
o Combined charts (Xbar-R, I-MR)
• More Control Chart
o Classical Shewhart control charts
o Cumulative Sum (CUSUM) charts
o Exponentially Weighted Moving Average (EWMA) charts
o Hotelling (multivariate) control charts