1. Quality by Design (QbD)
N. Vidyashankar
Quality by Design (QbD), FICCI, 19th Jan 2012

2. Product Development Lifecycle
System Requirements
Design
Development
Integration
V&V
Quality by Design (QbD), FICCI, 19th Jan 2012

3. Opportunities to accomplish Quality
Quality by Plan
not a chance !!!!
&
1:10:100:1000 rule
Cost of Defect fix
Low
Customer Satisfaction
Brand Image
Market Value
Cost of defect fix
Reliability
Gross Margin
Desired objective
Correcting at the Point of Use- Repairs/ Replacements
Quality Control- Testing/ Inspection
Quality Assurance- Reviews, Proto typing, simulation, modeling, etc
Design
High
Quality by Design (QbD), FICCI, 19th Jan 2012

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.
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

5. Interpretations of Quality
Meeting Specifications
Features
Perception
Easy Maintenance
Fitness for use
Cost
Time
Satisfaction
QUALITY
Safety
Standards compliance
Regulations
Experience
Look & Feel
Aesthetics
Performance
Quality by Design (QbD), FICCI, 19th Jan 2012

6. Target Quality Profiling- A Perspective
Market
Regulations
Corporate Social Responsibility
Customer
Research
HRM)
Installation &
Service
Business insights
Engineering
Manufacturability
Suppliers
Purchasing
Competitor(s)
Quality by Design (QbD), FICCI, 19th Jan 2012

7. Critical Decision Factors
Clarity on Product Roadmap
Intended Use
Hardware v/s software budgeting in System Design
Target Markets(s)
Make-Buy, Inhouse- Outsource decision
Standardization activities
Budgeting between Hardware & Software
Change Mgt
Process automation v/s resource intensive processes
Quality by Design (QbD), FICCI, 19th Jan 2012

8. Attributes contributing to Product Quality
Quality by Design (QbD), FICCI, 19th Jan 2012

9. Critical to Quality (CTQ)
Explicit Requirements
Implicit Requirements
Getting all the Product Requirements is the first step to plan for Quality
Quality by Design (QbD), FICCI, 19th Jan 2012

10. Quality by Design (QbD), FICCI, 19th Jan 2012
Quality Attributes
Time
Quality
Cost
Customer/
Market
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
Predictability/ forecasting of failure & Obsolescence of Electronics and SW components
Ergonomics & Usability
Hardware to Software transition
Quality by Design (QbD), FICCI, 19th Jan 2012

11. Quality by Design (QbD), FICCI, 19th Jan 2012
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
Multifeatured
Look and Feel
Intelligence & decision making protocols
Redundancy Planning
Quality by Design (QbD), FICCI, 19th Jan 2012

12. Quality by Design (QbD), FICCI, 19th Jan 2012
Quality Attributes
Customers & User community
Quality by Design (QbD), FICCI, 19th Jan 2012

13. Quality by Design (QbD), FICCI, 19th Jan 2012
Quality Attributes
Environmental Conditions
salt content
Emi/ emc
temperature
humidity
vibrations
Antistatic
packaging
Current/ voltage
variations
moisture
shock
Altitudes
& pressure
contamination
Quality by Design (QbD), FICCI, 19th Jan 2012
more……

14. Social Responsibility & Sustainability reporting
Quality Attributes
Social Responsibility &
Sustainability reporting
(RoHS, ECO, REACH, WEEE, Battery disposal )
Regulations
Safety
Security & Privacy
Radiation
Sterlisation
Quality by Design (QbD), FICCI, 19th Jan 2012

15. Process Approach to Product Quality
Quality by Design (QbD), FICCI, 19th Jan 2012

16. Quality by Design (QbD), FICCI, 19th Jan 2012
Process Approach
ISO 9001 Process Model
There is no GOOD or BAD process
Quality by Design (QbD), FICCI, 19th Jan 2012

17. 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. 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. Quality by Design (QbD), FICCI, 19th Jan 2012
Q&A
Quality by Design (QbD), FICCI, 19th Jan 2012