Introduction to Quality Management Systems (BIOT6005)

Introduction to Quality Management Systems (BIOT6005)

• Module Code: BIOT6005
• Module Title: Introduction to Quality Management Systems
• Lectures:
  • Tuesday: 4-5 pm, D242
  • Wednesday: 10 am - 12 pm, B248
• Assessments:
  • MCQ assessment (Week 6/7, TBC): 50%
  • Terminal exam: 50%
  • No lab component

Learning Outcomes

• LO1: Describe the principles of quality and quality assurance
• LO2: Outline the elements and implementation of a total quality system
• LO3: Describe the methods and application of quality improvement techniques
• LO4: Explain the principles and use of statistical process control tools and introduce lean sigma systems
• LO5: Describe and explain the basis of quality cost analysis

Module Content & Assessment

• Introduction to Quality Systems: Quality control, quality assurance, total quality management, quality standards, specifications, process control
• Elements of a Total Quality System: Quality audits, documentation, quality manual, training, quality of design
• Quality Improvement Techniques: Quality improvement, teamwork, problem-solving techniques, introduction to lean-sigma systems
• Manufacturing Quality Control: Statistical process control, quality control charts
• Quality Costs: Prevention and failure costs, cost reporting and measurement, economic models, quality cost reduction programs

Module Descriptor Summary

• Recommended Book Resources: Summers D.C. (2009), Quality, 3rd Ed; Dipak K Sarker (2008), Quality Systems and Control for Pharmaceuticals; Goetsch D.L. (2009), Introduction to Total Quality, 3rd Ed.
• Workload: 7 hours total weekly (3 hours in-class instruction and 4 hours independent/directed learning).
• Further Resources: Available from the institution's website, including specific links for the FDA and ISO.
• Module assessment overview: 50% multiple choice mid-term assessment in week 7; 50% end-of-semester formal examination

Quality Meaning

• Quality is the standard of a product or service as compared with others of similar kind, and is also described as a degree of excellence.
• Defining quality isn't straightforward. Advertising often implies that all products and services are high-quality.
• Standardised regulations in manufacturing and products/services are necessary.

Fitness for Purpose

• Quality is ensuring the product meets a defined purpose; user satisfaction.
• It is also economical and delivered on time.

Quality Products: Variability

• Whether or not a product is deemed high-quality depends on the customer's perceptions and requirements. A watch simple enough to tell time may not be of high enough quality to satisfy all users who have more complex needs.

This quiz assesses your understanding of the principles and implementation of quality management systems. You will explore topics such as quality assurance, total quality management, and statistical process control tools. Prepare to demonstrate your knowledge of quality improvement techniques and cost analysis.