Quality by Design (Qb. D) N. Vidyashankar Quality by Design (Qb. D), FICCI, 19 th Jan 2012 1
Product Development Lifecycle System Requirements Design Development Integration Quality by Design (Qb. D), FICCI, 19 th Jan 2012 V&V 2
Opportunities to accomplish lan Quality y. P b ity al Desired objective Gross Margin Reliability Low Cost of defect fix 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 ot n & c an ch a Market Value Qu !!!! e Brand Image Cost of Defect fix 1: 100: 1000 rule High Quality by Design (Qb. D), FICCI, 19 th Jan 2012 3
Quality by Design (Qb. D) • • Quality by Design (Qb. D) is a concept first outlined by wellknown 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 (Qb. D), FICCI, 19 th Jan 2012 4
Interpretations of Quality Meeting Specifications Perception Easy Maintenance Features Fitness for use Cost Satisfaction QUALITY Safety Aesthetics Regulations Experience Time Standards compliance Look & Feel Performance Quality by Design (Qb. D), FICCI, 19 th Jan 2012 5
Target Quality Profiling. A Perspective Market Regulations Customer Corporate Social Responsibility Research HRM) Business insights Installation & Service Engineering Suppliers Manufacturability Purchasing Competitor(s) Quality by Design (Qb. D), FICCI, 19 th Jan 2012 6
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 (Qb. D), FICCI, 19 th Jan 2012 7
Attributes contributing to Product Quality by Design (Qb. D), FICCI, 19 th Jan 2012 8
Critical to Quality (CTQ) Explicit Requirements Implicit Requirements Getting all the Product Requirements is the first step to plan for Quality by Design (Qb. D), FICCI, 19 th Jan 2012 9
Customer/ Market Cost Time 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 Quality by Design (Qb. D), FICCI, 19 th Jan 2012 10
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 (Qb. D), FICCI, 19 th Jan 2012 11
Quality Attributes Customers & User community Technology Enthusiasts Visionaries Customers want Technology & Performance Pragmatists Conservatives Skeptics Customers want Solutions & Convenience Quality by Design (Qb. D), FICCI, 19 th Jan 2012 12
Quality Attributes Product Reliability & Obsolescence Bathtub Curve Proactive Obsolescence planning Reactive Obsolescence planning Quality by Design (Qb. D), FICCI, 19 th Jan 2012 13
Quality Attributes Environmental Conditions Emi/ emc salt content temperature humidity vibrations Antistatic packaging Current/ voltage variations moisture shock Altitudes & pressure contamination Quality by Design (Qb. D), FICCI, 19 th Jan 2012 more…… 14
Quality Attributes Social Responsibility & Sustainability reporting Regulations (Ro. HS, ECO, REACH, WEEE, Battery disposal ) Safety Security & Privacy Radiation Quality by Design (Qb. D), FICCI, 19 th Jan 2012 Sterlisation 15
Process Approach to Product Quality by Design (Qb. D), FICCI, 19 th Jan 2012 16
Process Approach ISO 9001 Process Model There is no GOOD or BAD process Quality by Design (Qb. D), FICCI, 19 th 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 (Qb. D), FICCI, 19 th 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 (Qb. D), FICCI, 19 th Jan 2012 19
Q&A Quality by Design (Qb. D), FICCI, 19 th Jan 2012 20
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