Quality by Design at Procter & Gamble:

Fueling Innovation and Business

ResultsKent Lynde – Director, Corporate Quality Assurance, Procter & Gamble

PCPC Conference, October 2017, Alexandria, VA

P&G Confidential Material – Please no further sharing without prior authorization

Introduction to P&G

Our Heritage

P&G was founded in Cincinnati in 1837 by William

Procter and James Gamble, a candle maker and a soap

maker.

Their small business has grown into one of the world’s

most admired companies, and includes brands that have

become household names, used and TRUSTED by

consumers every day in nearly every part of the world.

“If you cannot make pure

goods and full weight, go to

something else that is honest

even if it is breaking stone.”

– James Gamble

We will provide branded products of superior quality and value that improve the lives of the world’s consumers.

Consumers will reward us

with leadership sales,

profit and value creation.

Statement of Purpose

Improving the

lives of the

world’s

consumers.

Category

Leadership and

Business

Success

Virtuous

Circle

as a result…

P&G Today

Sales $65.1 Billion

Earnings $15.3 Billion

Countries of Operations ~70

Countries Where Our 180+

Brands are Sold

Baby

Care

Feminine

Care

Family

Care

Fabric

Care

Home

Care

Hair

Care

Skin & Personal

CareGrooming

Oral

Care

Personal

Health Care

*Not representative of all brands

P&G: Creating value via consumer-preferred brands and products

10 product categories, 65 brands

Innovation at P&G

Consumer is boss!

The PROMISE = Brand Equity

Define DELIGHT Design DELIGHT Deliver DELIGHT

Driving Growth: Fueling Brand Equity via Irresistible Delight

What’s Possible

Deep Technical

Mastery

What’s

Needed

Depth of Consumer

Understanding

Successful Innovation…Magical Connections

Quality Journey Map

Remediate:

Compliance

Stabilize:

Loss Elimination

Leverage:

Grow the Business

Quality by Design

QbD Virtuous Cycle

Consumer-Centric QbD

Quality by Design

• Culture/Mindset Paradigm Shift

• Design in vs. inspect out

• Rooted in Brand Strategy

• Consumer-focused

• End-to-end, Built-In Quality

• Real-Time, Dynamic

• Continuous Improvement

• Total Employee Engagement

QbD Example: Tide® Pods™

QbD – Define the Promise

• Understand Compliance requirements

• Understand Consumer / Customer needs

• Define Product Proposition that meets all needs

• Integrate all End-to-End elements

• Validate & Document!

Holistic Quality Promise

QbD: Define the Promise

- Key unmet consumer needs – Voice of Consumer

- Brand Equity/Promise/Messaging

- What is Delightful Experience?

- Performance

- Aesthetics

- Packaging

Tide® Pods™

QbD – Design the Promise

• Material & Supplier Qualification

• Validation of Product, Equipment & Process Design

• Parametric Control Strategy Definition

• Quality Testing Design & Validation

• Technical Readiness & Risk Assessment

• Document in clear, easy-to-follow standard

QbD: Design the Promise

- Performance design/technologies

- Dosage/Delivery technology

- Aesthetics design

- Package design

- Process/Supply Chain Design/Control Strategy

- Compatibility (Machines, Materials)

- Safety/Regulatory/Legal Fit for Use

- Intellectual Property

Tide® Pods™

QbD – Deliver the Promise

• Robust process control strategy

• Real-time parametric control & testing

• Ongoing Verification

• Change Management Controls

• Quality Program Health Assessments

• Feedback to Design / Voice of Consumer

QbD: Deliver the Promise

- End-to-End Synchronized Supply Chain

- Product/Package/Process Validation & Verification

- Statistical Process/Parametric Control

- Dynamic, Real-time Quality Assurance

- Rigorous Daily Operational rigor

- Holistic E2E risk assessment/robust change control

- Sharply tuned Voice of Consumer sensing

- Continuous improvement/feedback to design

Tide® Pods™

Quality Evolution Chart

DEFINE: Requirements to Win with the

Consumer/Customer

DESIGN: Quality in Product &

Package

DELIVER: Delivering Quality via Materials, Process &

Operations

CONSUMER & OTHER

NEEDSMeasures/Methods Measures/Methods Operational Controls Measures/Methods

Con

su

me

r/C

usto

me

r L

an

gu

ag

e

Rela

tive

Im

po

rta

nce

Cri

tica

l D

esig

n C

om

po

ne

nts

QbD – Real-Time Quality

• Automation/Engineered Design Solutions

• Process Analytical Tools – Real-Time Quality

• Digital Technical Standards – Integrated Quality

• Parametric Control – Touchless Quality

QbD: Touchless Confidence

Labeler and carton feeder

Filler

Product FeedLiquid or Powder

Code date Packer PalletizerPallet Labeler

7652 48

1

3

RIGHT Product

RIGHT Pack

RIGHT Labels

RIGHT Codes

• Parametric Process Control

– End-to-End Mechanistic Understanding, Systemic approach

• Continuous Quality control Real-Time product disposition

– Parametric Controls, Design Solutions, PAT’s

• Standardized Criteria, Methodology & Landscape Assessment

• Culture Follow the STANDARD

QbD for Continuous Manufacturing: Controlled State

From: Low confidence, non synchronized Quality

Make Hold Check

MakeShip & Hope

Check

ShipOr

scrap

Positive Release

Continuous Release

Controlled State & Release

To: Real-Time synchronized Quality

Quality by Design Results

Promise Defined ✔

Promise Designed ✔

Promise Delivered ✔

• Virtual Zero defects

• Process Reliability Targets

• Lowest complaints ever in new country launch

• Record shares

• Energized organization.

• Focus R&D for innovation

Tide® Pods™

QBD drives delight, grows share

QbD - Benefits

• Delivering compliance AND consumer delight

• Maintain focus on Innovation

• Building & protecting our brands, our company

• Creating value to the business

• Reducing losses in operations, increased productivity

• Advancing sustainability

• Shifting paradigm:

Transform Quality Assurance from barrier to a…

VECTOR OF GROWTH.

• Tangible benefits for the business & consumers

• Seamless Partnership

• Holistic Design

• Standard Methodology & criteria

• Digital Innovation

• FDA guidance

• MOST CRITICAL: Leadership / Declaration / Commitment / Culture

QBD Enablers

Acknowledgments

Special thanks for their collaboration in

preparing this presentation:

Dr. Angelina Pena, Principal Engineer, P&G

Fabric & Home Care Quality Assurance

Steve Greer, Global External Engagement

Leader, P&G Quality Assurance

Thank You!