lean transformation

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Lean Transformation for Medical Device Development and

Manufacturing

Lean Leadership: Anchoring Organizational Values To Lean Principles

Darren DolcemascoloKen Flaherty


Agenda and Objectives

2

Introduction – Lean and Why Lean Efforts Often Fail to Yield Long Term Results

Lean Transformation – Bridging the Gap

Anchoring Values to Lean Principles, Aligning Principles to Systems, and Using Tools to Create Great Systems

Lean Leadership

Role of A Lean Leader

Managing for Daily Improvement

Q&A

ObjectivesToday’s Agenda

Understand why most lean programs fail to produce lasting results.

Understand Why a Lean Transformation Model Should be Based on Key Process Indicators (KPI) and Key Behavioral Indicators (KBI)

Understand How Strategy Deployment and A-3 Thinking Can be Used to Cascade Metrics and Goals Down to the front lines

Understand How to Operationalize Lean Daily Management and Daily Kaizen using A-3 and the Improvement Kata


Introduction: What Lean Means

Taichi Ohno once said, “All we are doing is looking at the time line from the moment the customer gives us an order to the point when we collect the cash, and we are reducing the time line by reducing the non-value adding wastes.”

But, he also said: “The Toyota style is not to create results by working hard. It is a system that says there is no limit to people’s creativity. People don’t go to Toyota to ‘work’ they go there to ‘think’.”


Goal:

Highest Quality, Lowest Cost, Shortest Lead Time

Best Safety, High Morale

Just In TimeRight part-Right amount-Right

Time

JidokaQuality at the

Source

•Line Stop

•Visual Controls

•Error Proofing

•Andon

•5 Whys

Operational StabilityStandardized Work

PM/ TPM 5S

Leveled Production

•Flow

•Takt Time

•Pull

•Quick Changeover

Lean: Toyota Production System

Flexible, Capable,Highly Motivated

People


Observations About Lean “Programs”

Executive Management often expresses a desire to “implement” lean practices for cost reduction, inventory reduction, faster time to market, etc.

Initial Rapid Improvement Events (Kaizen Events) yield promising results.

After a short period of time, level of engagement decreases.

There is a return to the status quo before “Lean Implementation.”


Why Does Lean Fail to Yield Long Term Results

No Strategy and/or No method for cascading strategy from the boardroom to the front lines

No Way to Tie Company Guiding Principles to Actual Day to Day Activities.

No System for Daily Kaizen (Continuous Improvement)

No System for Daily Management

Little or No Leadership Engagement

“Expert” Driven / No Front-Line Engagement

Focus on “Implementing Tools” Rather than Solving Problems


Closing the Gap

VALUES govern BEHAVIOR

PRINCIPLES govern CONSEQUENCES

thinking

behaviorCore values

Anchored to Guiding Principles

Desired

CULTURE“If principles govern consequences, value principles.”- Steven R. Covey

What we

value

Thinking

beliefs/attitude

GUIDING PRINCIPLES SUPPORTING PRINCIPLES

Measure what MattersAlign Behaviors with PerformanceCreate Value for the CustomerIdentify Cause & Effect Relationships

See RealityFocus on Long TermCreate Constancy of Purpose Enterprise Align Systems

Think SystemicallyAlignment Align Strategy

RE

SU

LT

SStabilize ProcessRely on Data

Focus on ProcessStandardize Processes

Embrace Scientific ThinkingInsist on Direct ObservationContinuous

Flow & Pull Value Focus on Value StreamImprovementAssure Quality at the Source Keep it Simple & VisualSeek Perfection Identify & Eliminate Waste

Integrate Improvement with Work

Empower & Involve EveryoneLead with Humility

Cultural Enablers Develop PeopleRespect Every Individual

Assure a Safe Environment

Aligning the Organization

EXERCISE – Anchoring Principles

1. Select an example of ONE of the Following:(Place on the left side of the grid)

1. Values (identify 3-4)

2. Strategic Objectives/Priorities (identify 3-4)

2. Select 3-4 Principles from ANY dimension(Place a check mark under the principle)

3. Identify key ROLE (L) Leader, (M) Manager, (A)

Associate.

EXERCISE – Anchoring Principles PART 1

3. Describe ideal behaviors for

each combination of principle and

selected (value or objective) (One for each Role – L, M, A)

L M A

Focus

Leaders define the strategic

direction of the organization that

captivates the voice of the

customer using strategy

deployment at all levels. Leaders

routinely communicate the

direction and transparently shares

organizational performance to

ALL levels on a regular basis.

Managers communicate the

strategic direction of the

organization in a simple, visual

manner with regular follow-up at

the worksite. Managers engage

in two-way communication to

ensure associates understand

how they affect the strategic

direction in their area.

Associates identify how

improvements in their area link

to the strategic direction and

objectives of the organization.

They also translate how the

work they do impacts their

area's goals and measures.

L M Aleaders managers associates

EXERCISE – Anchoring Principles PART 2

FOCUS HERE

behavior behavior “Ideal behavior”behavior behavior

TOOLS

SYSTEMS

PRINCIPLES

Behavior can be…Frequency

• Observed Duration• Described Intensity

Scope• RecordedRole

Levels of Observing Behavior

SPStrong

Positive

WWeak

XNot

Existent

SNStrong

Negative

Assessment Scale

(Objectives)

V.1

V.2

V.3

V.4

V.5

Key Behavior Indicators (KBI)

Mission

Vision

Strategic

Philosophy

C.1

C.2

C.3

C.4

C.5

W.1

W.2

W.3

W.4

W.5

W.1

W.2

W.3

W.4

W.5

S.1a S.1b S.1c

• Tool. 1• Tool. 2• Tool. 3• Tool. 4

• Tool. 1• Tool. 2• Tool. 3• Tool. 4• Tool. 5

• SubSystem.1.1c• Tool. 1• Tool. 2• Tool. 3

• SubSystem.1.2c• Tool. 1• Tool. 2

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

CE CPI EA R

G G G G G G

G

G G G G G G G G G G G G G

❺ ASSESS

Mapping Performance and Behavior for Alignment

Key Performance Indicators (KPI)

• Identify existing

culture

• Describe the desired

(ideal) culture

• Translate the desired

culture into specific

behaviors

• Align the

organizational

objectives, goals, &

measures

• Examine, adjust &

monitor

organizational

structures and work

processes (systems)

Mapping for Alignment Continued


Where is Your Time Spent

Top

Management

Middle

Management

Supervisor

Front Line

Associate

Strategic Implementation

(Breakthrough)

Daily

Management

Kaizen

0% 25% 50% 75% 100%

Percent of Time


What Lean Leaders Need to Learn

Managing from where the work takes place (gemba)

Developing themselves and others

Live the core values and principles (example; respect for people and continuous improvement)

Manage effectively from the gemba

Become a role model for discipline problem solving

Become a teacher and coach for disciplined problem solving


Daily Management System

What is your dailysystem for: Understanding

performance? Modeling principle

based behavior Seeing waste and

eliminating waste? Discovering problems

and resolving problems? Continuously improving? Coaching and developing

staff?


Visual Controls

Leader Standard Work

Managing Daily Performance

Managing Standard Work

Daily Problem Solving and Continuous Improvement

Employee Suggestion System

Start Up Huddles and Escalation Systems

Gemba Walks

Developing People / Coaching

Elements of a Daily Management System:


Problem Solving Story

Theme (subject)

Background (Why I/We Chose Theme)

Current Situation

(Analysis of Problem(s) and Cause(s))

Countermeasures

(to address causes(s))

Implementation

Follow-Up

(Review/Evaluation Results – Unresolved Problems)

Future Actions

(New Countermeasures and/or Standardization)

Grasp

The

Situation

Plan

Do

Check

Act


A3 Problem Solving Report Story

Theme:

Answers the question, “What are we trying to do?”

I. Problem Situation

•The Standard

•Current Situation

• Discrepancy/Extent of the ProblemRationale for picking up problem (importance to business

activity, goals and values of the organization)

II. Target/Goal

• Measurable description of what you

want to change;quantity, time

III. Cause Analysis

Problem:

Potential Causes

Most likely direct cause

Why?

Why?

Why?

Why?

Why?

Root Cause:

IV. Countermeasures

(Resulting from Cause Analysis)

• Temporary Measure

• Long Term Countermeasure

V. Implementation

What Where Who When

Action to Place Respons- Times,

be taken ible person Dates

Cost

VI. Follow-up

•Unresolved issues & actions to address them?

•How will you check effects?

• When will you check the effects?

• How will you report your findings?

•When will you report your findings?


Daily Kaizen Using the Improvement Kata

kata - a routine you practice deliberately; a pattern that becomes a habit.


The 5 Questions

1. What is the Target Condition?

2. What is the Actual Condition now?

3. What Obstacles do you think are preventing you from reaching the target condition? Which *one* are you addressing now?

4. What is your Next Step? (next PDCA / experiment) What do you expect?

5. When can we go and see what we have Learned from taking that step?


Why the Improvement Kata Works

People consciously

practice new behaviors

each day.

In the long term, this

affects the

organization’s culture.

Over time, this

influences people’s

thinking and attitudes.

Adapted from Toyota Kata, p. 237


Lean Programs fail to create a lasting culture change because the focus is often on the application of tools alone.

In order to effect culture change, we must adopt a principle-based architecture.

We must align our organization’s activities to its values/principles/strategy, and then measure KPI’s and KBI’s.

We must adopt a system for Daily Management and Daily Kaizen.

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Summary


Questions?

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