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- 1. Quality by Design (QbD) 1Quality by Design (QbD), FICCI, 19th Jan 2012 • Presented by: • DEEPAK KUMAR UPADHYAY, • M.PHARMA ( P’CEUTICS ), • ISFCP, MOGA , PUNJAB
- 2. Product Development Lifecycle System Requirements Design Development Integration V&V Quality by Design (QbD), FICCI, 19th Jan 2012 2
- 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 Costofdefectfix Low High 1:10:100:1000 rule CostofDefectfix Quality by Plan & not a chance !!!! Quality by Design (QbD), FICCI, 19th Jan 2012 3
- 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 4
- 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 2012 5
- 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 2012 6
- 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 7
- 8. Attributes contributing to Product Quality Quality by Design (QbD), FICCI, 19th Jan 2012 8
- 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 2012 9
- 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 2012 10
- 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 11
- 12. Quality Attributes Technology Enthusiasts Visionaries Pragmatists Conservatives Skeptics Customers want Technology & Performance Customers want Solutions & Convenience Customers & User community Quality by Design (QbD), FICCI, 19th Jan 2012 12
- 13. Quality Attributes Product Reliability & ObsolescenceBathtub Curve Obsolescence Proactive Obsolescence planning Reactive Obsolescence planning Quality by Design (QbD), FICCI, 19th Jan 2012 13
- 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 2012 14
- 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 2012 15
- 16. Process Approach to Product Quality Quality by Design (QbD), FICCI, 19th Jan 2012 16
- 17. Process Approach There is no GOOD or BAD process ISO 9001 Process Model Quality by Design (QbD), FICCI, 19th Jan 2012 17
- 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 18
- 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 19
- 20. Quality by Design (QbD), FICCI, 19th Jan 2012 20