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

2. Product Development Lifecycle System Requirements DesignDevelopmentIntegrationV&V Quality by Design (QbD), FICCI, 19th Jan 20122

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 Customer Satisfaction Brand Image Market Value Cost of defect fix Low High Reliability Gross Margin 1:10:100:1000 rule Cost of Defect fix Quality by Plan & not a chance !!!! Desired objective Quality by Design (QbD), FICCI, 19th Jan 20123

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.Joseph M. Juran 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 20124

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 20125

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 20126

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 20127

8. Attributes contributing to Product Quality Quality by Design (QbD), FICCI, 19th Jan 20128

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 20129

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 201210

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 201211

12. Quality Attributes Technology Enthusiasts VisionariesPragmatistsConservativesSkeptics Customers want Technology & Performance Customers want Solutions & Convenience Customers & User community Quality by Design (QbD), FICCI, 19th Jan 201212

13. Quality Attributes Product Reliability & Obsolescence Bathtub Curve Obsolescence Proactive Obsolescence planning Reactive Obsolescence planning Quality by Design (QbD), FICCI, 19th Jan 201213

14. Quality Attributes Environmental Conditions more…… temperature humidity Altitudes & pressure Antistatic packaging vibrations shock Current/ voltage variations moisture Emi/ emc contamination salt content Quality by Design (QbD), FICCI, 19th Jan 201214

15. Quality Attributes Safety Social Responsibility & Sustainability reporting (RoHS, ECO, REACH, WEEE, Battery disposal ) Security & Privacy Radiation Regulations Sterlisation Quality by Design (QbD), FICCI, 19th Jan 201215

16. Process Approach to Product Quality Quality by Design (QbD), FICCI, 19th Jan 201216

17. Process Approach There is no GOOD or BAD process ISO 9001 Process Model Quality by Design (QbD), FICCI, 19th Jan 201217

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 201218

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 201219

20. Quality by Design (QbD), FICCI, 19th Jan 201220