L6 Quality of Design Flashcards
Quality of design definition
- is defined as the quality of the product/service specified by the designer.
- It specifies the conditions that the product/service must minimally to meet customer needs
What can quality by design be used for?
- Active pharmaceutical ingredients
- Material including exicipients
- Analytics
- Simple dosage forms
- Advanced drug delivery
- Devices
-Combination products
Design quality is the value of a design to customers.
Design is the root of all quality including the quality of products, services, experiences, systems and process. E.g Product with low design will be low quality, even if quality control and quality assurance is succeeding.
What are the common types of design quality?
- Predictability: Designs that work as expected. If it requires training to work it may be poorly designed.
- Consistency: e.g the same controls on every page.
- Stability: Error free
- Fault tolerance: Ability to continue in a reasonable way even when errors occur.
- Safety and Security: Designing things for the safety and security e.g transportation systems designed to reduce human error
- Reusability: Design that is reusable and extensible eg. phones that allows memory upgrade.
- Functionality and Features: Functionality that serves customer needs and meets.
- Performance:The operational characteristics of a design such as the conversion efficiency of solar panels.
- Usability: A design that is pleasing to use.
- Accessibility: A design that is equally useful for everyone.
- Aesthetics: Pleasing look and feel
- Reliability: Designs that endure real world conditions overtime.
Define the quality of conformance
The extent to which the manufactured p/s meets the specification or standard selected in the design stage
Define the quality of performance
The operation of the product when actually put to use, or on the service performed must satisfy customer needs
Advantages of Quality - Benefits for the industry
- Better understanding of the process
- Less batch failure
- More efficient and effective control of change
- Return on investment / cost of savings
________________________ - More efficient technology transfer to manufacturing
- Risk based approach and identification
- Innovative process validation approaches
Aims of quality of design
- Ensures quality of product and process characteristics important for the desired performance must be from prior knowledge
–> ensures combination of product + process knowledge is gained during development.
Role of the design department
- Details quality of design
- Prepares specifications and drawings which-> satisfy customers, are within the manufacturing capability of organisation, can be made within time promised and price allowed.
Steps in design process
- Concept (product idea)
- Feasability + preliminary market testing (market research, assessment of cost)
- Detailed design (alternative designs evaluated -> - purchasing specification, -dabality of equipment, - determine new components if necessary, - design new components)
- Prototype (complete/incomplete units manufactured and tested, prototype units should be manufactured for full scale production, revision of prototype)
- Pre production testing (released full scale or for re-assesment)
- Design changes (for improvement)
- Production and launch (full scale production for sale and delivery)
Design Reviews
A technique to evaluate if the proposed design will:
1. Perform successfully
2. Manufactured at a suitable cost
3. Be suitable for prompt + and low cost maintenance.
Internal review of design
- Held within the designing department
- In an inter-department team will attend
- feasability/market test stage - could involve design, marketing & purchasing personnel
- prototype stage (production and design department
External Review of design
- Carried by contracting company or by customer
- Purpose is to review design based on customer requirements
Product design is the result of..
series of compromises between conflicting demands of customers, manufacturers, cost and law
Quality design model consists of …
- Establish the project design goals
- Define market and customers that will be targeted
- Find out market, customers and societal needs
- Develop features of new design that will meet needs
- Develop/redevelop processes to produce features
- Develop process controls to transfer the new designs to operations.
