Quality Systems and Risk Management

BMB 350 is an upper-division undergraduate course designed to equip students with a comprehensive understanding of quality system development and risk management within regulated environments. The curriculum delves into the structure and implementation of quality management system standards, emphasizing process control, documentation, and continuous improvement. Students will learn to identify and evaluate risks associated with technical systems, apply structured methodologies for root cause analysis, and design effective corrective and preventive action plans. Through a combination of theoretical knowledge and practical exercises, this course prepares future professionals to uphold the highest standards of quality and safety in their respective fields, ensuring compliance and enhancing organizational performance.

Course outline

Lectures, virtual labs, and graded assignments — completed in your browser.

01Lesson 1: Introduction to Quality Systems and Risk Managementlecture

02Lesson 2: Quality Management System Principles and Documentation Structurelecture

03Lesson 3: Introduction to Quality Management System Standard Requirementslecture

04Hands-on Lab: Quality Management System Documentation Reviewlab

05Lesson 5: Management Responsibility and Resource Managementlecture

06Lesson 6: Product/Service Realization Processes and Controlslecture

07Lesson 7: Measurement, Analysis, and Improvement Processeslecture

08Hands-on Lab: Process Mapping and Control Identificationlab

09Lesson 9: Risk Management Principles and Planninglecture

10Lesson 10: Risk Analysis, Evaluation, and Controllecture

11Hands-on Lab: Risk Assessment and Mitigation Strategieslab

12Lesson 12: Root Cause Analysis Methodologieslecture

13Lesson 13: Corrective and Preventive Actions (CAPA) Systemslecture

14Capstone Service Project: Quality System and Risk Management Implementation Planassignment

Syllabus

["Week 1: Lesson 1: Introduction to Quality Systems and Risk Management","Week 2: Lesson 2: Quality Management System Principles and Documentation Structure","Week 3: Lesson 3: Introduction to Quality Management System Standard Requirements","Week 4: Hands-on Lab: Quality Management System Documentation Review","Week 5: Lesson 5: Management Responsibility and Resource Management","Week 6: Lesson 6: Product/Service Realization Processes and Controls","Week 7: Lesson 7: Measurement, Analysis, and Improvement Processes","Week 8: Hands-on Lab: Process Mapping and Control Identification","Week 9: Lesson 9: Risk Management Principles and Planning","Week 10: Lesson 10: Risk Analysis, Evaluation, and Control","Week 11: Hands-on Lab: Risk Assessment and Mitigation Strategies","Week 12: Lesson 12: Root Cause Analysis Methodologies","Week 13: Lesson 13: Corrective and Preventive Actions (CAPA) Systems","Week 14: Capstone Service Project: Quality System and Risk Management Implementation Plan"]