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MINIMIZE RISK AND OPTIMIZE

QUALITY THROUGHOUT THE PRODUCT
LIFECYCLE
OR
“DO YOU KNOW YOU KNOW OR THINK
YOU KNOW”
February 2019
MINIMIZE RISK AND OPTIMIZE
QUALITY THROUGHOUT THE PRODUCT
LIFECYCLE
OR
“DO YOU KNOW YOU KNOW OR THINK
YOU KNOW”
February 2019
DRIVEN BY OVER A CENTURY OF INNOVATION

“I find out what the world

“I FIND OUT WHAT THE
needs,
WORLDthen I proceed
NEEDS, THEN Ito
PROCEED
invent it” TO INVENT IT.”
Thomas Edison
Thomas Edison

3
EVOLUTION OF REGULATORY RISK DRIVERS

TIC ATIC
Test Assurance
Add the A
Inspection Test
Certification Inspection
Certification
ASSURANCE

On-Demand Resources and Expertise

• Support when a project requires

specialized skills or knowledge
• Provide additional bandwidth in your
core competencies
• Allow you the flexibility to expand your
operation without adding fixed cost.

Assurance TIC
Support for the other 95% of the PDP 3-5% project
RISK

DO YOU KNOW YOU KNOW OR

THINK YOU KNOW?
RISK MANAGEMENT IS A BUSINESS PROCESS!

COST = HIGH
RISK = HIGH
COST = LOW

RISK = LOW
Beginning of Project to First Months of Production
WHAT IS BEING DONE?

Three Basic Methods of Managing Risk in NPD

• Rely on Experienced Engineer

• Leave it to the Suppliers
• Use Tools

When you Launch…..

Do you Know you Know you have a Robust Product?

Or
Do you Think you Know you have a Robust Product?
TRICK QUESTION: HOW DO YOU CREATE YOUR PRODUCT TEST PLAN AND
WHY?

What is a test plan?

• Simply put – it is the method used to determine if your product is “GOOD” as
defined by your brand.

Who creates, owns and manages the test plan?

• The people who make and sell the product.

So… If the product complies with all the requirements of the test plan – Is it good?
CHANGES IN THE REGULATORY WORLD Traditional Prescriptive Standards

Provides a set of rules to follow to

• Most standards are being developed demonstrate compliance

and evolved using this method going
forward
• All industries are impacted
• Accountability for compliance is pushed
very much forward in the design
process
• Accentuates grey and eliminates
black/white Risk / Hazard Based Standards
• Can cause confusion at the regulator •Identifying safety hazards in the early product
• “I know more about my product than you development phase and designing the product
ever will!” to eliminate them
•Providing more performance options to
demonstrate compliance

10
SOME TOOLS FOR MANAGING RISK
Concept Conversion Execution
Idea Phase
Phase Phase Phase

• Project Charter / •Thought Mapping •Design Validation (FMEA • Regulatory Compliance

Specification •Design FMEA Driven) •Product Literature
•Why are we •Test Plan •Design Test Results •Hazard Communication
doing this? •Engineering Field Tests •Consumer Field Tests •Quality Plan
•Collateral Customer •Supplier Selections •Manufacturing FMEA •Final BoM
mapping? •Design Review •Field Test Results analysis •Final Design
•Secondary •6 Sigma •Poka Yoke Documentation
Markets? •MSE, CoV, DOE •6 Sigma •Schematics
•Tollgate Passage •Tollgate Passage •MSE, CoV, DOE •Prints
Document Document •Tollerancing •Specs
•Financial Sensitivity •Kan Ban
•Identify Possible Global •Tollgate Passage Document •Kaizen
Markets •Identify Model Family •Production Release
•Current Markets Groupings Document
•Customer •Involve Compliance Experts •EMC
Locations •Source IEC compliance •Glow Wire
components •RoHS, REACH, WEEE, •Technical Construction
•Understand NON – NA test PAH… File
needs •Food Contact •CB Scheme
•Design Specs •Sound •Country Flavorization
•Model Mix •Capital Expenditure Planning
•SKU Management •Add 50 Hz??
•Articulate costs of testing to •Country Outlets?
Global Standards
•ROI Market Access
•Schedule compliance and
unit needs
EXAMPLE OF THINK YOU KNOW

A typical Risk Assessment might go something like this:

Complete FMEA
• Exposed Electrical Terminals are a shock hazard
Solution
• Insulate terminals where possible and warn where
not possible
INSULATE TERMINALS AND WARN

Did you stop here and move on to the next risk topic???
THINK YOU KNOW VS. KNOW YOU KNOW
EXAMPLE - GLOBALIZATION

Many North American standards DO NOT allow for certification

outside of North America.

Products need to comply with the regulations, codes and laws of the
end country. Most of the time, these are different than North
America.
FACT

A Company’s choice to enter the global marketplace is a business decision.

Following this decision, the company’s business processes shall be

executed to reduce risk to the company.

These process are cross functional and impact all areas of the organization.
WHERE IS GLOBAL?

Total number of European Union

Independent States Members
195 27-28
US State Dept. Europa.eu

CB Scheme Members Basic Plug Configurations = 14

56 Mains Voltages (1Φ)= 100-127 &
IECEE 200-240
Mains Frequency = 50 or 60 Hz
Input Phases = Variable??
WORLD ORDER OF COMPLEXITY
A GENERALIST VIEW

Traditional Markets,
Core US, Canada, Mexico,
EU, Nordic

B.R.I.C. Brazil, Russia,

India, China

ASEAN,
Emerging Middle East,
Eastern Europe,
S. America
Rest of the World Africa, Minor
Markets,
Embargo
STANDARDS STACK UP

International Standard??
IEC

CB, EAC Regulatory Schemes

EN, G-Mark …. Regional Standards

UL, CSA, GB, Energy Star, BR, SNAP ……. Country

Specific
 KEYS TO SUCCESS

Design Risk
• Engage Engineering and Suppliers early in
the process to Perform Product Risk
assessments – In your format and the
regulators format
• Create a Regulatory ROI with executives
Capital Risk Cost Risk
• Marketing says I want to go everywhere in
the world – show the ROI!
• Going Global adds model numbers – Model
Numbers have costs associated with them:
Product planning complexity, inventory
complexity, WIP complexity
WIP And
Product
• Have you included the cost of unique
Material
Planning Risk
global capital demands into the product
Handiling Risk cost and ROI – 50hz Generators, Plug
Panels, Voltage Variations

20
“CODES” MODEL OF COMPLIANCE

Concept Conversion Execution

Idea Phase
Phase Phase Phase

• Project Charter •Intellectual Property • Design Test Results • Regulatory

•Invention vs. Extension •Product Claims •Manufacturing Compliance
analysis assessment Specifications •Product Literature
•Tollgate Passage •Product Specifications •Manufacturing FMEA •Hazard Communication
Document •Design FMEA •Field Test Results •Quality Plan
•Test Plan •BoMs •Final BoM
•Engineering Field Tests •Design Drawings / •Final Design
•Supplier Selections Schematics Documentation
•Project Timeline •Tooling Designs / •Schematics
•Tollgate Passage Release •Prints
Document •Tollgate Passage •Specs
Document •Production Release
Document

-Do “Codes” at the end of the project

-Most of the key development team has been reassigned
-Costs and timelines are unplanned
-Sales becomes involved because the project is in their lap now!

**** THIS PROCESS DOES NOT MANAGE RISK EFFECTIVELY ****

SOME TOOLS FOR MANAGING RISK

Concept Conversion Execution

Idea Phase
Phase Phase Phase

• Project Charter / •Thought Mapping •Design Validation • Regulatory

Specification •Design FMEA (FMEA Driven) Compliance
•Why are we •Test Plan •Design Test Results •Product Literature
doing this? •Engineering Field •Consumer Field Tests •Hazard
•Collateral Customer Tests •Manufacturing FMEA Communication
mapping? •Supplier Selections •Field Test Results •Quality Plan
•Secondary •Design Review analysis •Final BoM
Markets? •6 Sigma •Poka Yoke •Final Design
•Tollgate Passage •MSE •6 Sigma Documentation
Document •CoV •MSE •Schematics
•DOE •CoV •Prints
•Tollgate Passage •DOE •Specs
Document •Tollerancing •Kan Ban
•Financial Sensitivity •Kaizen
•Tollgate Passage •Production Release
Document Document
 DESIGN FOR COMPLIANCE TOOLS

• Build a Strong and Widely Accepted Design Foundation

CB Scheme Source IEC End of Line Define “possible

Manufacturing
Technology

Procurement

Marketing / Sales
IEC Level Standards Components differentiation markets”
IEC Level Components Supply Base needs Production Use Compliance in ROI
global outlook infrastructure expense Be Specific – ASIA is a
Learn the differences!
Component cost 50Hz big place!
differences Outlets
Supplier expense Assy. Line Change over
amortization

EXECUTIVE TEAM:
• Implement this methodology and learn why
• Compliance can be:
• Predictable
• Reduced churn = speed to market = competitive advantage
“DESIGN FOR COMPLIANCE” MODEL

Concept Conversion Execution

Idea Phase
Phase Phase Phase

• Project Charter / •Thought Mapping

•Design Validation (FMEA
Specification •Design FMEA • Regulatory Compliance
•Test Plan Driven)
•Why are we •Product Literature
•Engineering Field Tests •Design Test Results
doing this? •Hazard Communication
•Supplier Selections •Consumer Field Tests
•Collateral Customer •Quality Plan
•Design Review •Manufacturing FMEA
mapping? •Final BoM
•6 Sigma •Field Test Results analysis
•Secondary •Final Design
•MSE, CoV, DOE •Poka Yoke
Documentation
Markets? •Tollgate Passage Document •6 Sigma
•Schematics
•Tollgate Passage •MSE, CoV, DOE
•Prints
Document •Tollerancing
•Specs
•Identify Model Family •Financial Sensitivity
•Kan Ban
•Identify Possible Global Groupings •Tollgate Passage Document
•Involve Compliance Experts •Kaizen
Markets •Production Release
•Current Markets •Source IEC compliance
components Document
•Customer •EMC
•Understand NON – NA test •Glow Wire
Locations needs •RoHS, REACH, WEEE,
•Design Specs •Technical Construction File
PAH…
•Model Mix •CB Scheme
•Food Contact
•SKU Management •Country Flavorization
•Sound
•Articulate costs of testing to
•Capital Expenditure Planning
Global Standards
•ROI Market Access •Add 50 Hz??
•Schedule compliance and unit •Country Outlets?
needs
 Due Diligence vs. TCF

Concept Conversion Execution

Idea Phase
Phase Phase Phase

• Project Charter •Intellectual Property • Design Test Results • Regulatory

•Invention vs. •Product Claims •Manufacturing Compliance
Extension analysis assessment Specifications •Product Literature
•Tollgate Passage •Product Specifications •Manufacturing FMEA •Hazard
Document •Design FMEA •Field Test Results Communication
•Test Plan •BoMs •Quality Plan
•Engineering Field •Design Drawings / •Final BoM
Tests Schematics •Final Design
•Supplier Selections •Tooling Designs / Documentation
•Project Timeline Release •Schematics
•Tollgate Passage •Tollgate Passage •Prints
Document Document •Specs
•Production Release
Document

Only the “Snap-Shot” Items in RED make it to the TCF.

Any Questions?

Thank You!