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www.emsstrategies.com
Lean Transformation for Medical
Device Development and
Manufacturing
Lean Leadership: Anchoring
Organizational Values To Lean Principles
Darren Dolcemascolo
Ken Flaherty
www.emsstrategies.com
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
www.emsstrategies.com
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’.”
www.emsstrategies.com
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
www.emsstrategies.com
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.”
www.emsstrategies.com
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
www.emsstrategies.com
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 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
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• Recorded
Role
Levels of Observing Behavior
SPStrong
Positive
W
Weak
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
www.emsstrategies.com
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
www.emsstrategies.com
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
www.emsstrategies.com
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?
www.emsstrategies.com
 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:
www.emsstrategies.com
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
www.emsstrategies.com
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?
www.emsstrategies.com
Daily Kaizen Using the Improvement Kata
 kata - a routine you practice deliberately; a pattern that
becomes a habit.
www.emsstrategies.com
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?
www.emsstrategies.com
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
www.emsstrategies.com
 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
www.emsstrategies.com
Questions?

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Lean Transformation

  • 1. www.emsstrategies.com Lean Transformation for Medical Device Development and Manufacturing Lean Leadership: Anchoring Organizational Values To Lean Principles Darren Dolcemascolo Ken Flaherty
  • 2. www.emsstrategies.com 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
  • 3. www.emsstrategies.com 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’.”
  • 4. www.emsstrategies.com 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
  • 5. www.emsstrategies.com 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.”
  • 6. www.emsstrategies.com 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
  • 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
  • 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
  • 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
  • 18. www.emsstrategies.com 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
  • 19. www.emsstrategies.com 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
  • 20. www.emsstrategies.com 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?
  • 21. www.emsstrategies.com  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:
  • 22. www.emsstrategies.com 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
  • 23. www.emsstrategies.com 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?
  • 24. www.emsstrategies.com Daily Kaizen Using the Improvement Kata  kata - a routine you practice deliberately; a pattern that becomes a habit.
  • 25. www.emsstrategies.com 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?
  • 26. www.emsstrategies.com 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
  • 27. www.emsstrategies.com  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