Transcript Quality by Design (QbD)

Quality by Design
(QbD)
N. Vidyashankar
Quality by Design (QbD), FICCI, 19th Jan 2012
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Product Development Lifecycle
System
Requirements
Design
Development
Integration
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V&V
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Opportunities to accomplish
Quality
Cost of Defect fix
1:10:100:1000 rule
Desired objective
Gross Margin
Reliability
Cost of defect fix
Market Value
Brand Image
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
Low
High
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Quality by Design (QbD)
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Quality by Design (QbD) 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
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Interpretations of Quality
Meeting Specifications
Perception
Easy Maintenance
Features
Fitness for use
Cost
Satisfaction
QUALITY
Safety
Aesthetics
Time
Standards compliance
Regulations
Experience
Look & Feel
Performance
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Target Quality ProfilingA Perspective
Market
Regulations
Customer
Corporate
Social
Responsibility
Research
HRM)
Business insights
Installation &
Service
Engineering
Manufacturability
Suppliers
Purchasing
Competitor(s)
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Critical Decision Factors
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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
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Attributes contributing to
Product Quality
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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
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Customer/
Market
Cost
Time
Quality
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
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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
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Quality Attributes
Customers & User community
Technology
Enthusiasts
Visionaries
Customers want
Technology
& Performance
Pragmatists
Conservatives
Skeptics
Customers want
Solutions &
Convenience
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Quality Attributes
Product Reliability
& Obsolescence
Obsolescence
Bathtub Curve
Proactive Obsolescence
planning
Reactive Obsolescence
planning
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Quality Attributes
Environmental Conditions
Emi/ emc
salt content
temperature
humidity
vibrations
Antistatic
packaging
Current/ voltage
variations
moisture
shock
Altitudes
& pressure
contamination
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Quality Attributes
Social Responsibility &
Sustainability reporting
Regulations
(RoHS, ECO, REACH, WEEE, Battery
disposal )
Safety
Security & Privacy
Radiation
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Sterlisation
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Process Approach to
Product Quality
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Process Approach
ISO 9001 Process Model
There is no GOOD or BAD process
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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
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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
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