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Questions and Answers
What is the implication of a product being labeled as 'quality'?
What is the implication of a product being labeled as 'quality'?
Which of the following is NOT a characteristic of a quality product?
Which of the following is NOT a characteristic of a quality product?
Why is quality particularly vital for life-saving devices and drugs?
Why is quality particularly vital for life-saving devices and drugs?
How is quality typically assessed in products or services?
How is quality typically assessed in products or services?
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In the context of quality, what does 'fitness for purpose' mean?
In the context of quality, what does 'fitness for purpose' mean?
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What can be inferred about the relationship between quality and customer expectations?
What can be inferred about the relationship between quality and customer expectations?
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Which factor can significantly influence the perceived value of a product's quality?
Which factor can significantly influence the perceived value of a product's quality?
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What main challenge arises in defining and determining quality?
What main challenge arises in defining and determining quality?
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Study Notes
Introduction to Quality Management Systems (BIOT6005)
- Module Code: BIOT6005
- Module Title: Introduction to Quality Management Systems
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Lectures:
- Tuesday: 4-5 pm, D242
- Wednesday: 10 am - 12 pm, B248
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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.
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Description
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.
