3. Opportunities to accomplish
Quality
1. Correcting at the Point of Use- Repairs/
Replacements
2. Quality Control- Testing/ Inspection
3. Quality Assurance- Reviews, Proto typing,
simulation, modeling, etc
4. Design
Costofdefectfix
Low
High
1:10:100:1000 rule
CostofDefectfix
Quality by Plan
&
not a chance !!!!
Quality by Design (QbD), FICCI, 19th Jan 2012 3
4. Quality by Design (QbD)
Quality by Design (QbD) is a concept first outlined by well-
known quality expert Joseph M. Juran who believed that
quality could be planned, and that most quality crises and
problems relate to the way in which quality was planned in
the first place.
• Based on FTR Philosophy
• Proactive & risk based approach for predictable & predefined
quality
• Planning quality into the process
• A leading indicator for better controls & to handle quality
crises and problems early in the cycle
Quality by Design (QbD), FICCI, 19th Jan 2012 4
5. Interpretations of Quality
QUALITY
Standards compliance
Time
Cost
Regulations
Perception
Satisfaction
Meeting Specifications
Aesthetics
Fitness for use
Performance
Experience
Safety
Features
Easy Maintenance
Look & Feel
Quality by Design (QbD), FICCI, 19th Jan 2012 5
6. Target Quality Profiling-
A Perspective
Customer
Market
Regulations
Research
Engineering
Business insights
Manufacturability
Installation &
Service
Purchasing
Suppliers
Competitor(s)
Corporate
Social
Responsibility
HRM)
Quality by Design (QbD), FICCI, 19th Jan 2012 6
7. Critical Decision Factors
• Clarity on Product Roadmap
• Intended Use
• Hardware v/s software budgeting in System Design
• Target Markets(s)
• Phase In-Phase Out Plan
• Product EOL, EOP, EOS
• Make-Buy, Inhouse- Outsource decision
• Standardisation activities
• Budgeting between Hardware & Software
• Change Mgt
• Process automation v/s resource intensive processes
Quality by Design (QbD), FICCI, 19th Jan 2012 7
9. Critical to Quality (CTQ)
Implicit Requirements
Explicit Requirements
Getting all the Product
Requirements is the first step to
plan for Quality Quality by Design (QbD), FICCI, 19th Jan 2012 9
10. Quality Attributes
• Tradeoff between Q-C-T
• Innovations or New Technologies available
• Involving all relevant stake holders for inputs/
requirements & clear acceptance criteria
• Quick design realisation timelines (Design
throughput time)- Early entry to capture market,
staying in market
• IP protection and market sustainance
• Predictability/ forecasting of failure &
Obsolescence of Electronics and SW components
• Ergonomics & Usability
• Hardware to Software transition
Time
Quality
Cost
Customer/
Market
Quality by Design (QbD), FICCI, 19th Jan 2012 10
11. Quality Attributes
• Joint Development and design modularity
• Globalisation & localisation requirements- Design
anywhere and Build anywhere
• Miniaturisation of components- size, weight,
interfaces, interop,
• Packaging, storaging & handling
• Designing for Abuse/ misuse
• Interoperability
• Multifeatured
• Look and Feel
• Intelligence & decision making protocols
• Redundancy Planning
Quality by Design (QbD), FICCI, 19th Jan 2012 11
17. Process Approach
There is no GOOD or BAD process
ISO 9001 Process Model
Quality by Design (QbD), FICCI, 19th Jan 2012 17
18. Process Quality Assurance
• Process definitions to be aligned with Skills & competency of
staff to achieve defined criteria
• Unambiguous design inputs including analysis of Field
experiences/ performances including similar products in
markets
• Detailed Risk evaluation and mitigation
• Alternative design evaluations
• Design reviews at each product development stages by early
involvement of all stakeholders
• Prototyping & feasibility tests, Simulation, DEMOs, BETA
models, DFSS, Design of Experiments (DOE), Brainstorming,
Design calculations, FMEA, Fault Tree Analysis, Inhouse tests
Quality by Design (QbD), FICCI, 19th Jan 2012 18
19. Process Quality Assurance
• Early tests- Burn-in Tests, Accelerated tests- Stress, reliability,
endurance, Environmental tests (corrosion,
• Design qualification for safety & efficacy including Product
type tests and product certifications
• User Experience/ Field tests followed by Field performance
analysis and design improvements
• Closed loop process controls & performance improvements
• Process & domain trainings to staff
• Strong Change Management process
Quality by Design (QbD), FICCI, 19th Jan 2012 19
