This presentation was done at the MD&M West Conference in Anaheim, CA on 2/11/15. In it, we explain why most lean programs fail to produce lasting results, why a lean transformation model should be based on Key Process Indicators (KPI) and Key Behavioral Indicators (KBI), how strategy deployment and A-3 thinking can be used to cascade metrics and goals down to the front lines, and how to operationalize lean daily management and daily Kaizen using A-3 and the Improvement Kata

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Lean Transformation for Medical
Device Development and
Manufacturing
Lean Leadership: Anchoring
Organizational Values To Lean Principles
Darren Dolcemascolo
Ken Flaherty

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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

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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’.”

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Goal:
Highest Quality, Lowest Cost, Shortest Lead Time
Best Safety, High Morale
Just In Time
Right part-Right
amount-Right
Time
Jidoka
Quality at the
Source
•Line Stop
•Visual Controls
•Error Proofing
•Andon
•5 Whys
Operational Stability
Standardized Work
PM/ TPM
5S
Leveled Production
•Flow
•Takt Time
•Pull
•Quick
Changeover
Lean: Toyota Production System
Flexible, Capable,
Highly Motivated
People

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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.”

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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

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Closing the Gap

8. 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

9. GUIDING PRINCIPLES SUPPORTING PRINCIPLES
Measure what Matters
Align Behaviors with PerformanceCreate Value for the Customer
Identify Cause & Effect Relationships
See Reality
Focus on Long TermCreate Constancy of Purpose Enterprise Align Systems
Think Systemically Alignment Align Strategy
RESULTS
Stabilize Process
Rely on DataFocus on Process
Standardize Processes
Embrace Scientific Thinking
Insist on Direct ObservationContinuous
Flow & Pull Value Focus on Value StreamImprovement
Assure Quality at the Source Keep it Simple & Visual
Seek Perfection Identify & Eliminate Waste
Integrate Improvement with Work
Empower & Involve EveryoneLead with Humility
Cultural Enablers Develop People
Respect Every Individual
Assure a Safe Environment

10. Aligning the Organization

11. EXERCISE – Anchoring Principles

12. 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

13. 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

14. FOCUS HERE
behavior behavior “Ideal behavior”behavior behavior
TOOLS
SYSTEMS
PRINCIPLES
Behavior can be… Frequency
• Observed Duration
• Described Intensity
Scope• Recorded
Role
Levels of Observing Behavior

15. SPStrong
Positive
W
Weak
XNot
Existent
SNStrong
Negative
Assessment Scale

16. (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)

17. • 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

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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

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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

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Daily Management System
 What is your daily
system for:
 Understanding
performance?
 Modeling principle
based behavior
 Seeing waste and
eliminating waste?
 Discovering problems
and resolving problems?
 Continuously improving?
 Coaching and developing
staff?

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 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:

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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

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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 Problem
Rationale 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?

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Daily Kaizen Using the Improvement Kata
 kata - a routine you practice deliberately; a pattern that
becomes a habit.

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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?

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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

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 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.
27
Summary

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Questions?