Quality by Design(QbD)

N. Vidyashankar

1Quality by Design (QbD), FICCI, 19th Jan 2012

Product Development Lifecycle

System Requirements Design Development Integration V&V

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Opportunities to accomplish Quality

1. Correcting at the Point of Use- Repairs/ Replacements

2. Quality Control- Testing/ Inspection3. Quality Assurance- Reviews, Proto typing,

simulation, modeling, etc4. Design

Cost

of d

efec

t fix

Low

High

1:10:100:1000 rule

Co

st

of

De

fec

t fi

x Quality by Plan

&

not a chance !!!!

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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

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Interpretations of Quality

QUALITY

Standards compliance

TimeCost

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

Target Quality Profiling-A Perspective

Customer

Market Regulations

Research

Engineering

Business insights

Manufacturability

Installation & Service

PurchasingSuppliers

Competitor(s)

Corporate Social

Responsibility

HRM)

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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

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Attributes contributing to Product Quality

Quality by Design (QbD), FICCI, 19th Jan 2012 8

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

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

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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

Technology Enthusiasts

Visionaries Pragmatists Conservatives Skeptics

Customers want Technology& Performance

Customers want Solutions & Convenience

Customers & User community

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Quality AttributesProduct Reliability

& ObsolescenceBathtub Curve

Obs

oles

cenc

e

Proactive Obsolescence planning

Reactive Obsolescence planning

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Quality AttributesEnvironmental Conditions

more……

temperaturehumidity

Altitudes & pressure

Antistatic packaging

vibrations

shock

Current/ voltage variations

moisture

Emi/ emc

contamination

salt content

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Quality Attributes

Safety

Social Responsibility & Sustainability reporting

(RoHS, ECO, REACH, WEEE, Battery disposal )

Security & Privacy

Radiation

Regulations

Sterlisation

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Process Approach to Product Quality

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Process Approach

There is no GOOD or BAD process

ISO 9001 Process Model

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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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