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

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

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

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

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

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

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

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

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

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

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

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

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……

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

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

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

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

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

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