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Quality by Design (QbD)

Quality by Design (QbD). N. Vidyashankar. Product Development Lifecycle. System Requirements. Design. Development. Integration. V&V. Opportunities to accomplish Quality. Quality by Plan & not a chance !!!!. 1:10:100:1000 rule. Cost of Defect fix. Low. Reliability. Gross Margin.

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Quality by Design (QbD)

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  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 Reliability Gross Margin Customer Satisfaction Brand Image Market Value Cost of defect fix 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. • 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

  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 Customer Corporate Social Responsibility 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) • 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

  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 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 Customer/ Market Cost Time Quality Quality by Design (QbD), FICCI, 19th Jan 2012

  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

  12. Quality Attributes Customers & User community Technology Enthusiasts Visionaries Pragmatists Conservatives Skeptics Customers want Technology & Performance Customers want Solutions & Convenience Quality by Design (QbD), FICCI, 19th Jan 2012

  13. Quality Attributes Product Reliability & Obsolescence Bathtub Curve Obsolescence Proactive Obsolescence planning Reactive Obsolescence planning Quality by Design (QbD), FICCI, 19th Jan 2012

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

  15. 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

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

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

  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

  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

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

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