Lecture 16

Question 1

Definition of Quality Assurance

Answer 1

• Refers to the systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled
• Important aspect of design and production
• As a designer you are responsible for the QA of your work

Question 2

Design Considerations

Answer 2

• Need a QA plan for design
• A way of checking design quality
• Technological requirements for design
• Define the sustainability of the design

Question 3

Design Considerations (For Prototypes)

Answer 3

• What kind of prototype is used
• Sustainability of prototype
• Can the prototype meet the design requirements
• Prototype is used by design analysts for QA

Question 4

Design Considerations (For Production)

Answer 4

• What are the important features in your design
• Design translates into a final product that fulfills QA
• By this process the design quality can be tracked

Question 5

Isola Set Screw

Answer 5

• Used for deformaties and trauma pathologies
• Impossible to fix during surgeries
• Most screws are implanted so no examples to test
• Very upset clinicians
• Screws had no lot number (Hard to track)
• Cause of problem was consistence of materials and lack of traceability
• Solution was improved QA procedures