Design for Six Sigma - An Overview by RAISE Ramanan Delivered at HAL Management Academy - Soft Copy...

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Design for Six Sigma An Inevitable Risk Prediction & Mitigation Approach for Robust Product Design

An Overview to DFSS and an Example as Case Study

L Ramanan. BE, MS (IITM), MS (BITS), PhD

6 Sigma Quality Champion, Management Consultant, Predictive & Robust Design Expert, Founder –

Visiting Faculty – HAL Management Academy

Membership & Title

Delivered

by

1st September 2015

Venue: HAL Management Academy

Report No DOI: 10.13140/RG.2.1.1302.4485

http://www.lramanan.com/RAISE

http://asq.org/index.aspx

http://www.asme.org/

http://www.pdma.org/

http://www.qcin.org/

https://www.ieindia.info/

http://lramanan.com/behind_my_success/most_significant_awards

http://www.bmesi.org.in/

2 /

LRamanan, September 2, 2015

Hearty Welcome:

• On Behalf of RAISE and myself

as Faculty of the program, hearty welcome

to all of you.

Sincere Thanks:

• Our Sincere thanks are due to

your respectable Management, executives

and in particular to Prof Shivaprasad and

Ms Jugunu Srivatsa for this opportunity.

• Our Sincere thanks are due to all

of you for your time & participation

RAISE is Humbled:

• RAISE is humbled to deliver its

L&D programs to the Nation Builders like

DRDL, DRDO Hyderabad,, BEL&, HAL

About RAISE:

• RAISE, an IIT Alumni

enterprise founded in 2011, with a

network of SMEs Multi Domain,

Product & Cross functional Experts.

• RAISE is honored by

serving 100+ customers & 15000+

man hours of skill development in

Pan-India

• RAISE delivered design for

‘Coronary Artery Stent’ to one of our

customer – A humble contribution to

‘Make in India’.

Welcome & Acknowledgements



3 /


What We Will Cover in this Over View

• Customer • Quality • Variation • Effect of Variation • Gurus of Quality • Six Sigma Evolution • Six Sigma as a Metric • Quality Tree & Harvest • Opportunities, Not Defects

as Benefit from Six Sigma • Various Phases of DFSS • An Example as Case Study



4 /


• Cost & Quality

• Technology & Competitiveness

• Product Variety & Options

• Brand Image

• Availability Service

Bar Keeps Raising… Need Continual Improvement

Customer Need & Expectations – Many!!!



5 /


Quality - Make or Brake Towards Loyalty

• Ability to Satisfy Need

• Free of Deficiency

• Free of Defects

• Accounts Variations

• Commitment

• Consistency

• Satisfaction

• Objective

• Subjective

• ….. Ref:

“Quality in Design”, L Ramanan, ASQ Members Conference, ASQ India, Bangalore 2010

Measure of Customer Satisfaction



6 /


• Meet Expectations –

Results in Satisfaction

• Exceed Expectations -

Results in Delight

• Failed to meet Expectations –

Results in Dissatisfaction

Key for Survival, Excellence & Sustenance !!!

Satisfy or Exceed Customer Expectations?

Quality Expectations are, Across Industry

Segments – Aero, Auto, Loco, Defence…

covers Service Industries like Hospitals,

Railway etc.



http://www.brainbasedbusiness.com/2006/11/paying_your_bills_during_unexp.html

Goal on Quality… Many Models over a Period of Time

Quality Initiatives & Gurus

8 /

LRamanan, September 2, 2015 Six Sigma A Popular Quality Model for Business

Origin & Evolution of Six Sigma as Business Model • Till 15 Jan 1987, 6σ was a Statistical Term

• Crusade Began at Motorola 1985

• Became Popular / well known when Jack Welch made 6σ as

GE’s Business Strategy in ’95

• Mikel Harry is ‘God father’ of Six Sigma

• In Mikel’s words ‘Father of 6 Sigma’ is Bill Smith

• Mikel & Bill developed MAIC as 4 Stage Problem Solving

Technique. Number of publications in Arizona University

• 1989 Unisys Corp – Harry named 6σ skilled as Black Belts

• 1993 ABB – Harry Teamed with Richard Schroeder

• 1996 GE’s Organization vide Initiative – Jack is the Crusader

• GE’s Jack Popularized & Proved - Six Sigma as a Business

Model

Mikel Harry

John F Welch



9 /

LRamanan, September 2, 2015 Common Across Process & Products

Six Sigma… As A Quality Metric

Ref:

“Role of Six Sigma in Building Robust Products”, L Ramanan, PDMA India IV Annual International Conference on NPD, 2009 – IITM

“Lean Six Sigma – A Techno Managerial Business Model”, L Ramanan, Seminar for Sr. Executives of IMTMA, 2011



10 /


Classical Quality vs Six Sigma Quality Classical Q – 99% is Good

20000 lost articles of mail / week

Unsafe Drinking water 15 min/day

5000 incorrect Surgery / week

200000 wrong drug prescription / year

No Electricity for ~ 7 hr / Month

6σQ- 99.999668% is Good

7 lost articles of mail / week

Unsafe drinking Water 1 min / 7 M

1.7 incorrect Surgery / Week

68 wrong drug prescription / year

No Electricity for 1 hr / 34 Years

Paradigm Shift in Thinking… Reduce Variations

Wrong Surgery

Ref:



http://en.wikipedia.org/wiki/Retained_surgical_instruments

http://en.wikipedia.org/wiki/Retained_surgical_instruments

http://operatingroom.blog.com/?p=73

http://www.businessweek.com/lifestyle/content/healthday/644585.html

http://www.turkewitzlaw.com/surgical-mistakes.htm

11 /


Variation Results in Defects… Defects Results Risks

Variation Could Come from Components or Sub-Systems

Defect from Process Quality

Defect from Product Quality



12 /


Defects Results in Loss & Delivers Huge Risks • Cause may arise from Component… But, Effect shall be felt at System

Not Fault of Vehicle or Vehicle Manufacturers as

OEM – But, Sub-system / component failures

which could be from off-the-shelf products, could

lead to system level issues

Products of Today are Complex… With Many Sub-System & Components



http://ibnlive.in.com/news/forbes-india-nano-tata-motors-burning-issue/115047-7.html

13 /


Variation - An Example From Manufactured Shaft

• Measured data on the Length of the Shaft Machined in a

Manufacturing Shop for Gear Box Assembly

• All the Measured Data are within the Specification Limits (490 to

510mm)

• Can we Infer about the Process from these Samples of measured

Data?

Data Provides Wealth of Information on RISK



14 /


ISO 9001 – 2015 Focusses on Risk Based Approach

Key is Predict & Mitigate the Risk



15 /


Risk Based Thinking – An OPPORTUNITY for SAVINGS?

Variation is a Risk – Is it an Opportunity !!??

• Measured Lengths from one of RAISE’s Workshop

• Is there an Issue and an Opportunity?

Values, Ethics and Integrity:

• I want to be sure, I never produce even single pencil less than 174mm, which I am committed

Existing Process Mean 187.5mm Std. Dev: 0.579mm

187

187.5

188

186

188

188

188

187.5

188.5

187

187

188

188

188

187

187.5

187.5

187.5

187.5

188.5

187

187.5

187

187.5

188

187

188

188

187.5

187.6

189

187

187.5



16 /


More Production from Same Resource

Opportunity of More Savings… Avoid Loss

Existing Process Mean 187.5mm Std. Dev: 0.579mm

Revised Process Thro’ Robust Process Design Mean 177.5mm Std. Dev: 0.579mm

With Values, Ethics and Integrity:

• We are sure, to produce not even single pencil shall be less than 174mm

• But Savings of 10mm per length of Pencil… A company producing 1Mn pencil / day, can produce 54471 pencils from Same Resource, with out any additional investments

• Revenue of 4.02Lakhs/day, with no additional expenses / investments



17 /




18 /


Cost of Poorly Performing Process – CP3 *

Cost of quality is an expense to the organization due to repair / rework / warranty / Inspection / product re-calls / complaints etc. CP3 range between 25 to 40% for 3σ, 15 to 25% for 4σ, 5 to 15% for 5σ and <1% for 6σ process Each sigma shift provide 10% net income improvement

* Ref: Client, Enterprise & Competitive Intelligence for

Product, Process & Systems Innovation & Design by Dr. Rick L. Edgeman, University of Idaho

Quality Focus – • Reactive to Proactive… • Appraisal to Continuous

Improvement… • Risk Predictions to Mitigation

Six Sigma and Cost of Quality

Key is Understanding Variation (Risk) & Control (Mitigate)



19 /


Six Sigma… Not a Magic or Mantra… Data Driven

Process - Off the Target Process – with wide Variation

v v

Opportunity!! – For Improvement? (Defects? – Target for Reduction!!)

Goal of Six Sigma: Success for Industry Delightment for Customer

Hitting the Goal Post?

Six Sigma Focus - Target the Mean & Reduce Variation



20 /

LRamanan, September 2, 2015 Process Capability vs Design Capability

Quick Look… Std Deviation is Measure of Variability

• Probability Distribution

• 3σ to the right and 3σ to the Left

• Area under the Curve is 1

Pro

babili

ty



21 /

LRamanan, September 2, 2015 Design Products for 6σ… Design for Six Sigma

Six Sigma Focus is on Design…

Design Spec

• There shall be Shift due to random variation

• Even accounting for a shift of 1.5σ, we could deliver a Robust Product, if it is good design

Class Discussion on

Process Shift



22 /


Build a Robust Product… DFSS Holds the Key

Control Output Variations Thro’ Inputs… QUALITY

Current Day Products are Complex with

Many Sub-Systems: Example

• Electrical & Electronics

• Mechanical

• Communication

• ….

Each Sub-System, has many

components,: Example

• Capacitor

• Condenser

• Analog / Digital

• Timer

• ….

Each one of them brings with them their

inherent variation



23 /


Quality Fruits and Harvest

Strategies and Approaches

Ripped Fallen Fruits,,

without Much Efforts -

Logic and Intuitions

Low Hanging Fruits

5 S

Kaizen

7 QC Tools

Mid Range Bulk of Fruits

Process Improvements

Lean

Six Sigma – DMAIC Methods

Statistical Tools - SPC

Top Range – Great Fruits

DFSS – Design for Six Sigma

Robust Engineering

Ref: L Ramanan (2011), Lean Six Sigma – A Techno-Managerial Business

Model, Seminar on Innovation through Six Sigma for CEOs & Sr. Executives

of Indian Machine Tool Industry, IMTMA, BIEC Bangalore

Ref: L Ramanan (2015), “Practical Statistics for

Practising Engineers, Statistics the Back Bone of all

Data Driven Quality Approaches and Analytics - In-

house Corporate Program at Covidien India

Engineering Centre



DFSS an Approach To Predict & Mitigate Risk

Proactive Approach By Controlling Variations



Benefit of Proactive vs Reactive Approaches

DFSS is a Proactive Design Approach

Fixing Issues at a Later Stage of Product is Time consuming



Benefit of Design for Six Sigma… Pre-Fix vs Post-Fix

Impact of Quality vs Cost - in Product Development

Lower Cost in Addressing issues at Design Stage



Concept

Concept

Analysis

Finalization

of Concept

System

Integration,

Proto-Type &

Correlation of

Prediction &

Measurement

Verification,

Validation &

Reliability

Tests

Regulatory

Approvals

Clinical

Trails

Product

Launch

DFSS an Approach - End to End

Ref: L Ramanan (2010) Six Sigma and Simulation –

Cutting Edge Technology for Innovative, Safety Critical

Medical Product – CPDM, IISC Bangalore

Voice of

Customer

Concept Development to Customer Delight



DFSS Applicable to All Products & Across Segments

Ref: Kevin Craig, Marquette University, US

Mechatronics System Design

Products - Complex System with Sub-System & Components



DFSS Methodology

- A Six Step Structured Approach

Define

1.Design Improvements – (Inputs from Mfg, Field Failures

etc.)

2. New Product Introduction

(Inputs from Marketing, Bench Mark, Competitors, R&D

Ideas, Open Innovation, Customer Preference/Need) Measure

1. Revisit of Existing DFMEA, . MSA, Gauge R & R Design

Improvement Projects

2. QFD – In identifying the important factors that impacts

Customer CTQ, Edge in the Market, New Ideas

Analyse

Conceptual Designs / Design Improvements –

Brain Storm, Affinity, Competitor Bench Mark,

Trade-Off, TRIZ, Clue Generation, Kano Model Analysis, Risk Prediction,

Design

Design Concepts, Predictive Modelling,

DFM, Design for X, Simulation Models –

CAD CAE Lab View, Multiple concepts Evaluation, conflict resolution, IP Land

Scape / Patent

Optimise

Design Variation DoE, Taguchi, Montecarlo Simulation Regression,

Optimise

Link this with Simulation

Verify (Design Improvements)

1. Proto Type Test / Ensure Change / Document Release

Validate (New Designs)

Validation for CTQ. 2. Proto & DFR 3. Design Documentation,

4. Design Transfer to Mfg., 5. Identify Cost Reduction

Opportunities and DMAIC projects

DFSS Phases & Tools




30 /


DFSS & Robust Design - Approach Design for Six Sigma – Approach to Robust

Products

Zone of Applied Research to Products

Product Design

Change

Process Design

Change

• Quality Needs

• Process

Entitlement

• Manufacturability

• Material Change

• ….

• Productivity

• Process Change

• Best Practices

• Quality Needs

• Vendor Change

• ….

• New Variant

• New Product in

Adjacent Space

(Ex: Screws for

Machines to Bio

Medical Needs,.

)

• New Idea

• …

Research

Efforts of lower

Magnitude

Research

Efforts

Robustness of

Magnitude Research

Efforts of lower

Magnitude

New Product Existing Product



31 /


Based on Severity of Issue, Choose the Approach Opinion:

1. Process Design approach: by

defining current defect levels, goals,

measure for defects, identification

of all controllable variations and un-

controllable noise parameters,

deliver robust process design

through DoE, Taguchi methods

2. Product Design Approach: By

identifying and quantifying

parameters by involving R&D efforts

like CAE simulations for quantifying

current, thickness of L-Connector

3. New Design Approach: If the issue

can not be addressed by process or

design changes – Adopt New

Design Approach through DFSS

Business Impact vs Time, Money & Effort



32 /


Understanding DFSS with an Example as a Case Study



33 /


Background of the Example as Case Study

• Water cans are inversed on Water

Dispenser by the customer, to comfort

him with hot or cold water to tap as he

needs

• Water Manufacturer and Dispenser

Manufacturers are different

• Issues of water dispenser damages

during loading water cans

• Low hanging Fruits and Process

Improvement Strategies have not

completely resolved the issue and

calling for New Design Development

D M D A O V



34 /


D M D A O V

Need Assessment & Goal Setting • The disc of the cap shall be meeting different

designs of the dispenser and loading conditions.

• All of the stems of the dispenser in the field are not

of same dia, hence force that is transferred on the

disc during piercing

• The type of loading the can (inclination to abuse)

and resultant sliding on the cap results in varying

force

• Force max is not weight of water

• Water can max vol results in Max Force

• Current issue from the cap at the present level of

xxxx DPMO after all process improvements &

changes that has been exhausted

• To be brought down to 3.4 issues / Millions through

DFSS approach of new design for the cap

dia

LSL USL

Force Variations



35 /


D M D A O V

Phase Objective Tool/Process Deliverable

Define

Need Assessment, Goal Setting, Objectives, Team, Resources, Project Communication and CTQ

Team input, Brainstorm, Bench Mark, ARMI, SIPOC, Structure Tree , QFD

CTQ Identification

Measure Optimum Force of the Can with water can that breaks the disc on the cap

Measuring the Force for Breakage - GRR

Force Variations from Field & Cans

Analyze Development of Various Design Concepts and their impact

Fishbone, Includes & Excludes, Hypothesis Test, Risk Assessment & Mitigation, Engineering Reviews, Safety FMEA and PUGH matrix

Discuss various options, Competitor Bench Mark Studies. Choose at least 1 or 2 Design concepts

Design Analyze Various Design Concepts

Design FMEA, Finite Element Simulation, Factorial or Taguchi DoE and Engineering Review

Design of the Cap that is best for the needs

Optimize Robust and Parameter Design & Optimisation

Engineering Input, FEA, DoE, Regression, Transfer Function, Crystal Ball Simulation, Pareto, Perturbation Plot, Quality Loss Function & Taguchi Parameter Design. Business benefit on ROI

Robust Product Design

Verify & Validate

Design Release, Documentation and Transition

Testing & Release Learning on New Ideas

Project Roadmap – Objectives, Tools & Deliverables



36 /


D M D A O V

Flowing Down & Identifying CTQ

Shown QFD is Example and Actual Covering all Whys and Hows



37 /


D M D A O V

CTQ Measurement – Force to Break Disc in Cap

• Gauge R & R Studies of the

Instrument to be Quantified

for ensuring variation in

measurement of forces for

breaking the disc, has a very

little or no contribution from

Gauge Variation



38 /


D M D A O V

Best Practices & Brain Storm Influential Factors



39 /


D M D A O V

• Build Multiple Concepts in CAD Model

• Varying Thickness of Disc, Designs

• Helps in Brain Storm & Discussions

• Analyse various concepts for the worst

case of the force through CAE Simulations

for evolution of Concepts

Build Various Concepts in CAD & Brain Storm



40 /


Selection of Best Two or Three Concepts

Concepts Finalized - Ranking Order

The entire needs of the design is not

shown

Three concepts are chosen for further

Design analysis to finalize final Design

D M D A O V



41 /


D M D A O V

Design FMEA & Concepts Analysis

• From the Concepts analysis,

DFMEA, DFM analysis, Concept

5 found to be satisfying all the

needs of the CTQ.

• Design concept finalized taken

for further optimization,

parameter & Tolerance Studies



42 /


DoE with CAE Predictive Design Simulation

Problem Simplified for Practice and Hands-On

Ref:

1. L Ramanan, (2014), “Robust Design – Application of DoE, Non-linear Material Model & Simulation”,

MTech (Design), Course Lecture Material

2. L Ramanan (2008), “Simulation of Non-Linear Analysis in ANSYS”, BISO-MISO , ANSYS India User’s

Conference

3. L Ramanan (2014), “Introduction of DoE and Robust Design for Practising Engineers of ANSYS”-

Workshop

Simplified 2 D Axi Symmetric Model –

Hence we do not Consider Spokes in

Inner Cap

To Facilitate Faster turn around time

Three Factors at Two Level

• This real Life example is related

to cap of the water can and the

Dispensing Machine.

• As the Can is inversed on

dispensing machine, the disc has

to break and allow the Stem of

Dispensing Machine to

Penetrate.

• But, there are instances where

the Stem of the Dispensing

Machine is Broken

• Solemnise marriage between

Technology & Statistical

Approach

Important Tools

CAE, Design of Experiments,

Transfer Functions

Approach

Predictive Design

Insenstise variations into design

D M D A O V



43 /


DoE, Regression, Parameter & Tolerance Studies D M D A O V

Disc Force, Thickness, Dia, side wall thickness, fillet with side wall Noise: Shrinkage, Material

• Factor & Noise Interaction

studies through Taguchi Method

• Full Factorial Design on

Significant Factor to Factor

Interaction

• Setting Levels for Significant

Parameter

• Statistical Tolerance

• Quantified benefits through

Taguchi Quality Loss Function



44 /


Verification, Validation & Design Transfer D M D A O V

• The Last Step in DFSS /

Robust Design Process is

Verification, Validation Trials

• Measurement of Force by

validated Instrument

• Documentation

• Design Transfer to

Manufacturing



45 /


‘s Humble

Contribution to

D M D A O V Through By Marrying Technology & Quality




46 /

LRamanan, September 2, 2015 Stent is a Marvel & Invention… Variation to Address in Design is Huge

Coronary & Vascular Products - Stents

Vascular Picture from www.Covidien.com

Discussions on Stent Physics & Relating to Variation

Picture to Explain Flexibility

Hyper Linked with Cardiac Stenting from Femoral Artery with the Home Page of American Heart association

1. L Ramanan (2013) – “Train to Vein

CAE is the Way of Life – My

Experiences in Building Robust

Products” – ANSYS Users

Conference Keynote Address

D M D A O V


http://watchlearnlive.heart.org/CVML_Player.php?moduleSelect=cstent

../../../../../../YouTube Movies/Coronary Stents/What is ANGIOPLASTY and STENTING_.avi

47 /

LRamanan, September 2, 2015 RAISE’s Humble Contributions to ‘ MAKE in INDIA ’

1. L Ramanan (2013) – “Innovation Trends & Research Opportunities in Safety Critical

Coronary artery Stents”- International Conf on Sustainable Innovation and Successful

Product Development, PDMA, IIT Madras

2. L Ramanan (2014) – “To Make in India Bake Hard Skills”, Indo-Japan National Seminar

3. L Ramanan (2014) – Work-Shop on “Robust Design Through Predictions” for Practicing

Engineers of ANSYS

4. L Ramanan (2015) – “Practical Statistics for Practicing Engineers - Benefits of data driven

decision making”

Product that Lives in the Human Heart

Complexity in the Product Design is Huge… Requires • Mechanical Physics - Geometry, Design, System, Material

• Clinical Knowledge - Impact on Artery & Restenosis • Bio-Material - Material Mechanics

• ……

Coronary Stent – Crimped on Balloon and Recoiled

RAISE’s AC – AC Program Delivery

Coronary Stent – Expanded and Recoiled at Target Site of Coronary Artery

RAISE Delivered First Pass Stent Design to its

Indian Customer D M D A O V



Thank You

1st September 2015

Venue: HAL Management Academy




• Target Mean • Control Variation • Build Product

Excellence • Achieve Growth of

• Self • Business • Country

• Celebrate Success

Be a Soldier in Driving Quality…

For On-Site SME support and L&D Programs on Robust Quality, write to [email protected]




mailto:[email protected]

Let Us Salute Our Nation….

Build Brand as ‘Made in India’




../../../../YouTube Movies/India - My Country - Sare Jahan Se Acha - National Anthem/NATIONAL ANTHEM.mp4

Design for Six Sigma - An Overview by RAISE Ramanan Delivered at HAL Management Academy - Soft Copy...

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