4462 Statistical Quality Control

Statistical methods for quality analysis and improvement; control charts for variables and attributes, industrial sampling; defect prevention using the Poka-Yoke System; reliability; acceptance sampling; Quality standards, continuous improvement; use of computer software for data analysis and presentation.

TEXT: Besterfield, Dale H. Quality Improvement. Upper Saddle River, NJ: Prentice Hall, 2013. Print. ISBN-10: 0132624419

Course Outline

Course Introduction

  1. Introduction to Quality Improvement
  2. Lean Manufacturing
  3. Six Sigma
  4. Statistical Process Control
  5. Fundamentals of Statistics
    • TEST 1
  6. Control Charts for Variables
  7. Additional SPC Techniques
  8. Fundamentals of Probability
    • TEST 2
  9. Control Charts for Attributes
  10. Acceptance Sampling
  11. Reliability
  12. Management and Planning Tools
  13. Design of Experiments
  14. Taguchi Methods

Lab Assignments

Course Documents (private)

ASQ Quality Glossary

Sources of variation lab (video)

NIST/SEMATECH Engineering Statistics Handbook (online book)

Mintab Getting Started (videos)

UC Berkeley SticiGui (Online book, apps)

Nelson Rules

Western Electric Rules



ASTM E2281 – Standard Practice for Process and Measurement Capability Indices

ASTM E2587 Standard Practice for Use of Control Charts in Statistical Process Control

ASTM F1469 Standard Guide for Conducting a Repeatability and Reproducibility Study on Test Equipment for Nondestructive Testing

FDA, (CBER), Validation of Procedures for Processing of Human Tissues Intended for Transplantation, guidance for industry, May 2002.
FDA, (CDER), Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, guidance for industry, October 2006.
FDA, (CDER, CVM, and ORA), PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, guidance for industry, September 2004.
FDA, (CDER, CBER, CVM, and ORA), Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, guidance for industry, September 2006.
FDA/Global Harmonization Task Force (GHTF; medical devices), Quality Management Systems – Process Validation, edition 2, guidance, January 2004.
FDA/ICH, (CDER and CBER), Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, guidance for industry, August 2001.
FDA/ICH, (CDER and CBER), Q8(R2) Pharmaceutical Development, guidance for industry, November 2009.
FDA/ICH, (CDER and CBER), Q9 Quality Risk Management, guidance for industry, June 2006.
FDA/ICH (CDER and CBER) Q10 Pharmaceutical Quality System, guidance for industry, April 2009.
ASTM E2474-06 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology.
ASTM E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture.
ASTM E2281-03 Standard Practice for Process and Measurement Capability Indices.
ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
ASTM E2709-10 Standard Practice for Demonstrating Capability to Comply with a Lot Acceptance Procedure.