BIOT 104 - Quality Practices

or Program Chair Approval.
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
DATE OF LAST REVISION: Fall 2022

Covers basic quality principles including quality audits and the statistics involved in analyzing and maintaining quality. Includes continuous and process improvement practices, as well as an understanding of customers and suppliers. Students will learn about the importance of teams and validation processes in quality. Corrective and preventative actions will be covered. Prepares students for ASQ Certified Quality Improvement Associate and Certified Quality Process Analyst exams, which can be taken upon obtaining the associate's degree.

MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to know or have an understanding of the following:

1. Understand basic quality terms and philosophies, including the construction and interpretation of basic quality tools.
2. Understand the benefits of quality as well as quality audits.
3. Describe the importance of workplace teams, and understand and apply the various roles and responsibilities of team members.
4. Apply the basic principles of team formation and group dynamics.
5. Understand and apply continuous and process improvement tools and techniques, including six sigma, lean, benchmarking and incremental and breakthrough improvement.
6. Apply quality management and quality improvement tools, as well as analyze and monitor project management tools.
7. Apply basic statistics such as measures of central tendency and dispersion, frequency distributions, and probability and reliability concepts and use them in statistical process control.
8. Comprehend data types and collection methods, as well as sampling characteristics and methods.
9. Understand customers and suppliers, both internal and external, including tools used to gather their feedback.
10. Describe the process of validation of products and process and the importance of identification of materials for traceability purposes.
11. Apply the basic principles of corrective and preventative actions.
12. Develop an understanding of training within a medical device or pharmaceutical company through a field trip.

• Basic quality terms
• Quality tools
• Benefits of quality
• Quality audits
• Team formation and dynamics
• Process improvement techniques
• Project and quality management tools
• Data collection and analysis
• Statistical process control
• Statistical analysis
• Customer supply relations
• CAPA