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2013 International ISO/LSS
               Conference

    Highlights




                        1
Sunday February 17, 2013
4 hours
Seize the Moment- Strategic Planning
Jack West and Charles Cianfrani

• The most important thing we can do as Leaders is plan
• Follow the PDCA model
• Unclear business purpose (Mission) or and unclear picture of the future state
  of the business (Vision) will limit growth
• Make staffing decisions based upon competence
• A process to obtain and respond to customer perceptions is critical. Teach
  Sales and Customer Service how to ask the right questions. Manage Voice
  of Customer tables- what was said, what was meant, how to address it, who
  owns it, when is it due, and verify effectiveness
• Consider the potential global effects on the business
• Create a shared, common day-to-day focus throughout the organization



                                                                            2
• Communicate objectives in ―their‖ language. Corporate leadership- money,
  turnover, risk, etc. Process Owners- what’s in it for them, simplified work,
  more enjoyment, etc.
• Teach to reach a point where each employee can communicate their
  individual role in Quality and achieving Business Objectives
• Create five position candidate qualification questions for key roles that all
  must be met for consideration
• Effective presentation formats follow the 5-5-5 rule. No more than 5 words
  per bullet, no more than five bullets per slide, no more than 5 bullet slides
  before a visual slide is used
• Leaders should focus on getting cost out!
• Effective Policy Deployment processes tie Executive and Management
  bonuses to objectives
• Partner with key customer and suppliers in a mutual continuous
  improvement process
• Drive continuous improvement from the bottom up, not top down



                                                                              3
Regularly identify and execute preventative actions that can be taken in each of
the following areas to minimize/eliminate impact of achieving growth and profit
objectives (Apply FMECA process tool);

•   Planning
•   People
•   Process Controls
•   Financial
•   Customers



Definition, development, deployment, control, and improvement of a relatively
small set of processes can ensure performance to requirements, promote
customer satisfaction, and provide a foundation for a sustainable organization.




                                                                                  4
Sunday February 17, 2013
4 hours
Certified Manager of Quality and Organizational Excellent Exam Prep
Chris Hayes

• Each multiple choice question on the exam has two correct answers; the
  candidate must rationalize the best option of the of the two based upon
  information provided
• Create a glossary and page number reference sheet for test resources
• All questions demand a Bloom level response of 2 or greater
  (Remember, Understand, Apply, Analyze, Evaluate, Create)
• Create a Body of Knowledge 5-point card to ensure acceptable essay
  responses
• Apply the 7 Basic Quality Tools; flow charts, Ishikawa
  diagrams, checklists, Pareto charts, histograms, scatter diagrams, and
  control charts
• Apply the basic management and planning tools; affinity diagrams, tree
  diagrams, process decision program charts, matrix
  diagrams, interrelationship diagrams, prioritization matrices, activity network
  diagram                                                                       5
• Apply Process improvement tools; root cause
  analysis, PDCA, DMAIC, FMEA, SPC
• Apply Innovation and creativity tools; brain-storming, mind mapping, lateral
  thinking, critical thinking, Design for Six
  Sigma, Triz, Scamper, Storyboard, Nominal group technique, multi-voting
• Apply Cost of Quality; prevention, appraisal, internal failure, external failure
• Apply Process management; process goals, process analysis, lean
  tools, theory of constraints
• Apply Measurement; assessment and metrics, statistical
  use, sampling, statistical analysis, trend and pattern analysis, theory of
  variation, process capability, reliability and validity, qualitative
  assessment, survey analysis and use
• I have a 192-slide presentation from Chris I can share with anyone else that
  may be preparing for this professional certification exam




                                                                                 6
Monday February 18, 2013
Next Generation QSM
Joe DeFeo
Juran Institute

• Quality and CI professionals must provide management with information
  they will ―get‖, in their language, i.e. risk, money, market share, sustainment
• Move the ―Quality Management System‖ to a ―Mission Assurance System‖
  that leaves no doubt Customers and Stakeholders needs will be met fast
  and efficiently
• Understand Societal needs and Stakeholder needs to meet the Enterprise
  mission
• Drive continual process optimization though multi-functional improvements
• Leaders must ask ―What part of the QMS can we focus on to help the
  company?‖
• Consider an ―a la carte‖ approach to build into the QMS elements of
  standards that will ensure the Enterprise mission


                                                                               7
• Shift ―Management Review‖ toward ―Management Renewal‖
• Perform an annual ―stop-doing‖ exercise to free and redirect limited
  resources
• Build the QMS to mitigate and manage risk
• Quality and CI professional must work to develop a broader business
  acumen to understand and support the overall goals of the organization




                                                                           8
Sustainment?
 UBS reports $2.8 billion loss

 Bank fines top $10 billion this year

 JPMorgan's trading loss: $5.8 billion

 Compounding pharmacies have been linked
  to deaths, illnesses and safety failures for
  years



                                                 9
What Do These Companies & Industries
         Have in Common?

           Most had:
      Quality Management
            Systems
     Compliance Systems
    Third Party Assessments

                                       10
Evolution & Benefits of Standards
Performance                                Continuous
                        Better Social     Improvement
                        Responsible
                        Companies


              Greener
              Society

                         Mitigated          More
                          Risks         Transparency

          Higher
          Quality


                          Time
                                                        11
ISO & QMS Principles
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision-making
8. Mutually beneficial supplier relationships
                                            12
Future of QMS
                        Quality



  Process
Improvement                            Environment
                      Integrated
                     Management
                        System


              Risk                  Social



                                                     13
Will It Be Different From Today?
1. Greater understanding of Societal Needs & Stakeholder Needs to
   meet the Enterprise Mission
2. Continual process optimization through multi-functional
   improvements
3. Enterprise-wide integrated management standards to maintain
   daily compliance and control of mission critical processes
4. Creating an Integrated Quality Function to assure the Enterprise
   System if working
5. Multi-lingual staff = they know Voice of the Business and Voice of
   the Standards to enable the Enterprise to meet needs
6. Engaged employees trained in business and quality acumen
7. Annual renewal of performance improvement programs to avoid
   quality failures and maintain effective internal controls

                                                                   14
Enterprise Assurance: A Model
            Integrated Quality Management Standards

            Monitor    Deploy Policies and Standardize Work
Identify
            Current
Strategic                                                      Replicate
            State &
& Risk                                                         Results,
            Risk                       Design
Drivers                 Identify &                             Meet
                                       and         Sustain
                        Establish                              Needs
                                       Implement   Gains
                        Projects
                                       Solutions


                 Daily                                   Daily
                                     Projects
              Improvement                              Compliance


                                                                    15
Will Quality Lead The Charge?

 The professionals that truly
understand that the purpose of
Quality Management Systems
is to help assure the enterprise
       meets its Mission.


                                   16
Monday February 18, 2013
General Motors Drive for Customer Satisfaction
Michael Hardy
Director of Global Quality Strategy
General Motors
• Center quality objectives around the customer experience, imagine the
  perceptions, senses, and overall experience from purchasing, receipt, and
  use




                                                                          17
Monday February 18, 2013
Future of ISO9001 QMS in a Global Economy
Alka Jarvis
Process and Excellence Leader
Cisco Systems
• Over 10 years without any significant changes in the ISO standard
• It is a Golden Age of technology and innovation transforming the way we do
  business, work, communicate, live, and learn
• ISO must change to be relevant
• ISO must address Resource Management, the Voice of the
  Customer, Measures, Knowledge Management, Risk
  Management, Systematic Problem Solving and Learning




                                                                          18
2012 Top 5 CEO Challenges;

Innovation- Technology is the #1 enabler to innovation in products, process
design, and business models

• Human Capital- grow talent internally, improve leadership development
  program, provide employee training and development

• Global Political and Economic Risk- debt concern, mushrooming regulations
  on a global scale, increasing trade tension, Political divergence with respect
  to market access and governance of key sectors

• Government Regulations- Continued uncertainty of the overall regulatory
  environment, which forces many companies to put growth plans on hold until
  the playing field is clearly defined

• Global Expansion- Large, medium and small companies are all realizing that
  in order to stay competitive, they must expand globally


                                                                              19
Monday February 18, 2013
Best Kept Secrets of Great Quality Leaders
Connie Conboy
VP of Corporate Quality -Retired
Bayer Corporation
• Secure your foundation- build a rigorous system, constantly strengthen,
  maintain certification
• Identify the real value proposition for quality- is quality a primary brand
  attribute? Communicate real business impact and value
• Bayer aspirin is priced 400% higher than generic aspirin. How can they
  compete? Quality
• Wake up the C-Suite- speak their language, engage them, help them see
  what’s in it for them
• Think like a consultant- foster internal consulting skills, create bold plans,
  deliver, measure, and communicate results
• Build knowledge base- benchmark, master broad quality tools and skills,
  actively participate in key industry conferences, explore best practices

                                                                                   20
• Expand you footprint- create a larger role inside and outside your
  organization
• Innovate- leverage technology, embrace innovation to deliver maximum
  value




                                                                         21
Monday February 18, 2013
Implementing ISO 9000 in a Mature Company
Ben Overwyk
Technical Services Engineer
Olin Brass
• Keep what you can of what they already have as it will reduce the amount of
  change for the organization
• Communicate through pre-implementation meetings to salary and hourly for
  less confusion during implementation
• Communicate business and employee job benefits. What’s in it for them?
• Identify roadblocks, people and systems
• Use key employees that understand the standard as front-line coordinators
• Focus on areas of concern first; calibration? document control?
• Determine data/information available, build management review with
  consideration, content, publish dates
• Build responsibility through internal audits
• Involve everyone; especially executives

                                                                          22
•   Take time to help employees that are struggling with understanding
•   Understand old habits are hard to break
•   Follow-up, track changes, communicate
•   Ask for feedback
•   Communicate accomplishments
•   Show how ISO has helped




                                                                         23
Monday February 18, 2013
ISO 9001 & ISO 14001; The Revisions as a Partnership
Lorri Hunt, Jack West, Jose Dominguez



   • The ISO 9001 standard is in a revision process
   • The revision will be in alignment with Annex SL
   • Annex SL is a standard for standards, basically working toward common
     formats, structure, and language
   • Revision will likely publish in 2015
   • Too early to take any action on your QMS




                                                                             24
Tuesday February 19, 2013
QMS Quick Self-Assessment- What a Good QMS Looks Like
Colin Gray
President
Cavendish Scott, Inc.

 • Customer Focus
 • Leadership
 • Involvement of people
 • Process Approach
 • System Approach
 • Continual Improvement
 • Factual approach to decision making
 • Mutually beneficial supplier relationships




                                                        25
Customer Focus

• Organizations depend on their customers and therefore should understand
  current and future customer needs, should meet customer requirements and
  strive to exceed customer expectations.
• Malcolm Baldrige – Customer Focus
• Where are top management involved in customer orders? Satisfaction
  assessment?
• How in touch are (all) top management with customers?
• How do they promote this throughout?




                                                                             26
Leadership

• Leaders establish unity of purpose and direction of the organization. They
  should create and maintain the internal environment in which people can
  become fully involved in achieving the organization's objectives.
• Malcolm Baldrige – Leadership, Strategic Planning
• Strategy, Direction, Planning – Published?. Change Management? Is QA
  involved in organizational change?
• Communication. To all? Planned? Consistent?
• Is Management ―Leading‖ quality? Do employees know,
• understand and believe the same message?




                                                                               27
Involvement of People

• People at all levels are the essence of an organization and their full
  involvement enables their abilities to be used for the organization's benefit.
• Malcolm Baldrige - Workforce Focus
• Communication, Responsibility? Authority?
• Fair and ―mutually beneficial‖ relationships?
• You can only effect change with information!




                                                                                   28
Process Approach

• A desired result is achieved more efficiently when activities and related
  resources are managed as a process.
• Malcolm Baldrige - Operations Focus
• Non-bureaucratic - Were they established for ISO or for ―our‖ organization?
  Best practice? As appropriate?
• Documented? Communicated? Trained? Valuable controls?
• Average processes but good people = Average performance
• Good processes with average people = Good Performance
• Normal activities managed by processes most of the time? Time for projects,
  exceptions, improvements?




                                                                                29
System Approach

• Identifying, understanding and managing interrelated processes as a system
  contributes to the organization's effectiveness and efficiency in achieving its
  objectives.
• Malcolm Baldrige - Operations Focus, Results
• Organizational success with objectives/measures?
• How well are process interactions achieved?
• Visibility of organization objectives at individual levels?
• Process handover problems? Politics and interdepartmental issues?




                                                                                    30
Continual Improvement

• Continual improvement of the organization's overall performance should be
  a permanent objective of the organization.
• Malcolm Baldrige – Results
• Systemic Improvement systems throughout
• Pervasive attitude looking for opportunities




                                                                              31
Factual approach to decision making

• Effective decisions are based on the analysis of data and information.
• Malcolm Baldrige - Measurement, Analysis and Knowledge Management
• Do Objectives exist? Flowed down to all levels? What metrics exist? Are
  they communicated? Are they available to all functions and levels of
  personnel?
• Decisions based on data – not ―good‖ management




                                                                            32
Mutually beneficial supplier relationships

• An organization and its suppliers are interdependent and a mutually
  beneficial relationship enhances the ability of both to create value.
• Malcolm Baldrige - Operations Focus
• How do we treat suppliers (short term, long term)?
• Could we lose (have we lost) important vendors?
• What is vendor performance? How responsive are they?




                                                                          33
Tuesday February 19, 2013
Keys to Creating Accountability in a Quality Management System
Cynthia Juncosa
Director-Lean Compliance Partners




                           Is this Accountability?




                                                                 34
35
A personal choice to rise above one's circumstances and demonstrate
      the ownership necessary for achieving desired results—to
    See It, Own It, Solve It, and Do It




                                                                      36
Culture of Accountability

•   Understand WHY – Positive, Engaging, Sense of Purpose
•   Results‐Oriented Culture, open to improvements
•   Compliance – Support from Leadership to do the right thing!
•   Clear Definition of Responsibilities + Authority
•   Effective Training
•   Empowerment to identify and correct mistakes
•   Poke Yoke, Simple Principles and Methods




                                                                  37
Understand WHY

Desire to partake in meaningful work is a motivator
– How does my work fit in the ―Big Picture‖?
– What’s in it for me?

Make the WHY compelling
– Why we need to do it and
– Why we need to do it now
– What if we do NOT do it

Create dialogue for ―Buy In‖

Engage heart and mind




                                                      38
Results‐Oriented Culture

“Is my performance meeting expectations?”

“What exactly is expected from me?”




                                            39
Leadership Support

• "Walk the Talk"
• Change must be fully supported from the top
• down
• Hold YOURSELF accountable ‐ lead by example!
• Create culture where it's ok to make a mistake and admit to it so it can be
  fixed ASAP
• Mechanism to fix problem
• Non‐punitive system for reporting and correcting the mistake BUT If don't
  follow system, then result is punitive




                                                                                40
Responsibility + Authority

• Authority is "the power to enforce rules or give orders, a privilege
given to an individual in a management or supervisory position.”

• Responsibility is "a duty or obligation where someone is held
accountable.“

Delegate Responsibility with Authority to take action, make
decisions, really own the task at hand!


  See It, Own It, Solve It, and Do It



                                                                         41
Effective Training

•   What tasks? What target? The ―correct‖ way? Which tools and where can I find
    them?

•   People not having access to the knowledge they need to do their jobs effectively and
    efficiently.

•   Audit observations – training records

•   Training metrics trending

•   WHY incorporated

•   Verify individual training effectiveness

•   Individual ―certification‖

•   CAPAs, NCMRs

•   Defect Trending by station/shift

                                                                                      42
Empowerment

• Empower employees to identify and correct their mistakes by providing
  mechanisms with standard methods and solutions.
• Put the systems in place so people know what to do!
• Standardize your solutions or standardize methodology to deal with the
  mistakes. e.g., NCRs, defects
• Individuals have authority to course correct or initiate investigations ‐> take
  ownership of their areas




                                                                                43
Poke Yoke

• Poka Yoke (Error and Mistake Proofing of processes)

        Easy to do correctly, hard or impossible to do wrong

• Show your commitment by implementing simple error‐proofing solutions ‐>
  prevent common mistakes from occurring

        Engage, solicit solutions
        Respect for people and value they provide to solve problems
        Excellent methodology to obtain and assure on‐going quality

• ROI = Priceless




                                                                        44
Simple Principles and Methods

Standardized Work

• The best way to accomplish a task
• Apply to repeatable processes first
• Reduces training time, more consistent output allows for better
  improvements

Visual Management

• Allows all employees to understand how they affect the company’s overall
  performance –WHY
• Real‐time information and feedback
• Access to performance data to react accordingly
• Prescribe actions to return performance to specified limits




                                                                             45
Summary

Culture of Accountability is attainable by engaging hearts and minds of your
teams

•   Help teams Understand WHY behind what they do
•   Responsibilities + Authority clearly defined
•   Results‐Oriented – Measure Metrics
•   Lead by Example
•   Effective Training
•   Empowerment Poke Yoke, Simple Principles and Methods




                                                                               46
Tuesday February 19, 2013
Six Sigma: The Breakthrough Management Strategy
Dr. Mikel Harry
President and CEO
Six Sigma Management Institute

• Dr. Harry is widely considered the principle architect of the Six Sigma
  methodology
• He is currently launching a program to train returning military veterans to
  be Six Sigma Black Belts
• Additionally he is promoting a new system, book, and software ―The Great
  Discovery‖
• The core of the concept is that any problem or opportunity can be
  effectively addressed with the six sigma methodology whether process-
  related or within one personal life
• Taking Six Sigma from ―Toolbox‖ to ―Way of Thinking‖
• Do the Dreaming- Dream the Doing- Plan the Doing- Do the Plan


                                                                                47
The Great Discovery

•   Clarify Your Core Values
•   Determine the Dream
•   Establish Leading Milestones
•   Select Problematic Milestone (Apply 80% of efforts to 20% (vital few)
    factors
•   Identify Vital Forces
•   Define Enabling Actions
•   Complete Action Plan
•   Check Progress Results




                                                                            48
When you can measure what you are speaking about, and express it in
numbers, you know something about it; but when you cannot measure
it, when you cannot express it in numbers, your knowledge of it is of a
meager and unsatisfactory kind; it may be the beginning of knowledge,
but you have scarcely, in your thoughts, advanced it to the stage of
science.

--Sir William Thompson, Lord Kelvin (1824-1907)




   Jack Welch- GE supported an approach to fire the bottom 10% within
   the organization each year




                                                                        49
Wednesday February 20, 2013
Cisco’s Corporate Quality and Six Sigma+ Journey
Alka Jarvis
Process & Excellence Leader
Cisco Systems




                                                   50
Common Reasons for Project Failure          How to Mitigate

1. Lack of management support               1. Project selection process that focuses
                                               on ROI, resource commitment, timeline
                                               prior to launch

2. Failure to manage expectations           2. Tollgate process to ensure leaders and
                                               stakeholders sign off on progress,
                                               changes

3. Failure to adequately identify & track   3. Methodology that begins with gathering
   requirements                                VOC and focuses on collecting
                                               evidence to support decisions

4. Inadequate project management            4. Standardized, and proven,
   methodology                                 methodology & tools (DMAIC/DMADV)

5. Inadequately trained project managers    5. Rigorous training and mentorship to
                                               increase success and knowledge
                                               transfer


                                                                                        51
VSEM

• Vision – A vision is a vivid, idealized and memorable description of a desired
  outcome

• Strategy – An overarching statement that summarizes how, over the next 2-4
  years, the team will achieve its vision. Priorities/Focus Areas – Priorities, which
  may also be called Focus Areas, are a subset of the team’s strategy

• Execution Commitments – Funded annual initiatives, programs or actions
  intended to drive the success in the team’s Priorities/Focus Areas

• Measurement – Metrics show how the team is measuring progress towards
  achieving the Annual Plan




                                                                                   52
53
54
55
Wednesday February 20, 2013
Statistical Engineering for Project Selection
Forrest Breyfogle
CEO
Smarter Solutions, Inc.




                                                56
A Key Performance Metric can follow the SMART criteria.

This means;

•   the measure has a Specific purpose for the business
•   it is Measurable
•   It should create Action
•   the improvement of a KPM has to be Relevant to the success of the organization
•   and finally it must be Timely




                                                                              57
Thursday February 21, 2013
Creating Process Improvement Through Conversation
Melissa Falvo
VP Process Improvement Support Manager
PNC Bank




                                                    58
59
60
61
62
63
64
Thursday February 21, 2013
Globalizing Your Lean and Six Sigma- Tips, Tricks, and Traps
Joeseph Cirafesi
President
Cirafesi Consulting

 Strategic Considerations

 •   Where can the LSS program best gain traction?
 •   What gaps in performance are most strategic?
 •   Has this been tried before at this location?
 •   Can the right resources be made available?
 •   Will other initiatives hurt or help us?
 •   What support will management provide?




                                                               65
Cultural Elements

•   Organizational hierarchy – can somebody make a decision!
•   Social versus work orientation – let eat and drink!
•   Team versus individual / public versus private recognition
•   Language challenges / translating concepts
•   Work / Life Balance – long lunches and late dinners


Tips, Tricks, and Traps

•   Tip – Get cultural training before beginning
•   Trap – don’t settle for part-time resources
•   Trick – hide some gains and reinvest
•   Tip – Allow 30% to 50% more time for training in initial roll out
•   Tip – produce initial materials in English and in each trainee’s mother tongue
•   Trap – assuming translations are correct
•   Tip – deliver ―mini‖ training to translators


                                                                                 66
Tips, Tricks, and Traps

• Trap – concurrently implementing major changes
• Tip – look for translation provider well in advance of need – lengthy process
• Trick – ask for a variety of management levels to become trained – build
  influencers
• Trap – develop your own training materials while implementing your LSS
• Trap – Translation costs are an iceberg and can be a huge barrier to effective
  communication




                                                                               67
Thursday February 21, 2013
Keeping Lean Alive
Jim Joyner
VP of Corporate Excellence
Card-Monroe Corporation




                             68
69
70
71
72
73
Thursday February 21, 2013
Sustain Project Results without Staying in the Process Until the End of Time
David Haim
Process Improvement Black Belt
PNC Bank




                                                                               74
75
76
Thursday February 21, 2013
Building and Maintaining a Culture to Support Quality
Dr. Judith Ann Pauley
CEO
Process Communications, Inc.


Truly an outstanding presentation on people, what makes
them different, what makes them the same, what motivates
them, how to communication with them, how to engage
them, how to lead them. Very entertaining, informative and
dynamic!



―Leadership is the art of getting someone else to do what you
want done because they want to do it.‖

President Dwight D. Eisenhower

                                                                77
Two Legs of Process Communication

1. Everyone is One of Six Basic Personality Types

2. How We Say Something is More Important Than What We Say




                                                             78
79
80
81
82
Leading Cultural Change

•   Build Trust
•   Keep everyone informed
•   Allow people to express their views
•   Listen to their views
•   Quality cannot be imposed from above
•   Don’t be condescending or arrogant
•   Allow Reactors to express feelings
•   Make certain Reactors feel they belong
•   Give Workaholics data
•   Provide timelines for the Workaholic
•   Show Persisters how a Quality Program improves quality, standards and values
•   Ask Persisters their opinions
•   Allow Rebels to say what they like and don’t like
•   Periodically inject humor into meetings
•   Tell Promoters how they will benefit personally
•   Give Promoters action assignments
•   Give Dreamers time to think about changes
•   Actively solicit Dreamer’s ideas
                                                                              83
Distress Behaviors

•   Reactors – Make Mistakes
•   Workaholics – Over Control
•   Persisters – Push Beliefs
•   Dreamers – Shut Down
•   Rebels – Blame
•   Promoters - Manipulate




    http://kahlercom.com/




                                 84
Thursday February 21, 2013
Questions and Theories: Two Essential Elements of Change
Dr. Cheryl Hild
Director of Quality
Aegis Sciences Corporation




                                                           85
86
If I overreact
without
knowledge of
cause I will put
the wrong
solutions in
motion…


                   87
88
Thursday February 21, 2013
Use Modular Kaizen to Reduce Disruption
Grace Duffy
President
Management and Performance Systems




                                          89
90
Friday February 22, 2013
Hoshin Planning
Anthony Manos
Catalyst
Profero, Inc




                           91
Types of Planning       Advantages           Disadvantages

   No Planning          Saves Time        Probably Won’t Stay in
                                                Business
                     Failure Comes as a
                     Complete Surprise      No clear direction




Whatever Boss Says   Pleases the Boss     Boss May not Know All
                                            the Right Things

                                            Little to No Buy-In




                                                              92
Types of Planning       Advantages               Disadvantages

    Budgeting       At least you are trying   You may not know that
                                              you are spending your
                                               resources on what is
                                                  really important




 Management by       When/If we ―hit the       We can make things
   Objective        numbers‖ we get our       worse trying to ―hit the
                        bonuses                    numbers‖




                                                                   93
Types of Planning         Advantages             Disadvantages

Strategic Planning   Sets longer-term vision      Can be biased
                          of where the
                     organization should be    May have issues with
                                               follow-up and follow-
                                                      through


  Hoshin Kanri       Aligns long-term vision     Requires Time to
Policy Deployment    with short-term action    Implement Correctly
                              items
                                               Shortcuts will cause
                        Shows linkages          less than optimal
                                                      results
                          All levels in
                      organization help set
                           objectives
                                                                  94
95
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99
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101
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103
104
105
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107
108
109
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111
112
113
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115
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120
121
122
It is five years in the
  future, we are wildly
        successful.

What do we look like and
 how did we get here?

                            123
124
125
126
127
128
129
130
131
132
133
134
135
136
Kaplan and Norton Strategy Map




                                 137
Real benefits come when managers begin to
understand the profound difference between "cost
  cutting" and "eliminating the causes of costs‖

                                              -Brian Joiner


If You are not the lead-dog, the view (and smell) is always
                        the same…..




                                                              138

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2013 ISO LSS International Conference

  • 1. 2013 International ISO/LSS Conference Highlights 1
  • 2. Sunday February 17, 2013 4 hours Seize the Moment- Strategic Planning Jack West and Charles Cianfrani • The most important thing we can do as Leaders is plan • Follow the PDCA model • Unclear business purpose (Mission) or and unclear picture of the future state of the business (Vision) will limit growth • Make staffing decisions based upon competence • A process to obtain and respond to customer perceptions is critical. Teach Sales and Customer Service how to ask the right questions. Manage Voice of Customer tables- what was said, what was meant, how to address it, who owns it, when is it due, and verify effectiveness • Consider the potential global effects on the business • Create a shared, common day-to-day focus throughout the organization 2
  • 3. • Communicate objectives in ―their‖ language. Corporate leadership- money, turnover, risk, etc. Process Owners- what’s in it for them, simplified work, more enjoyment, etc. • Teach to reach a point where each employee can communicate their individual role in Quality and achieving Business Objectives • Create five position candidate qualification questions for key roles that all must be met for consideration • Effective presentation formats follow the 5-5-5 rule. No more than 5 words per bullet, no more than five bullets per slide, no more than 5 bullet slides before a visual slide is used • Leaders should focus on getting cost out! • Effective Policy Deployment processes tie Executive and Management bonuses to objectives • Partner with key customer and suppliers in a mutual continuous improvement process • Drive continuous improvement from the bottom up, not top down 3
  • 4. Regularly identify and execute preventative actions that can be taken in each of the following areas to minimize/eliminate impact of achieving growth and profit objectives (Apply FMECA process tool); • Planning • People • Process Controls • Financial • Customers Definition, development, deployment, control, and improvement of a relatively small set of processes can ensure performance to requirements, promote customer satisfaction, and provide a foundation for a sustainable organization. 4
  • 5. Sunday February 17, 2013 4 hours Certified Manager of Quality and Organizational Excellent Exam Prep Chris Hayes • Each multiple choice question on the exam has two correct answers; the candidate must rationalize the best option of the of the two based upon information provided • Create a glossary and page number reference sheet for test resources • All questions demand a Bloom level response of 2 or greater (Remember, Understand, Apply, Analyze, Evaluate, Create) • Create a Body of Knowledge 5-point card to ensure acceptable essay responses • Apply the 7 Basic Quality Tools; flow charts, Ishikawa diagrams, checklists, Pareto charts, histograms, scatter diagrams, and control charts • Apply the basic management and planning tools; affinity diagrams, tree diagrams, process decision program charts, matrix diagrams, interrelationship diagrams, prioritization matrices, activity network diagram 5
  • 6. • Apply Process improvement tools; root cause analysis, PDCA, DMAIC, FMEA, SPC • Apply Innovation and creativity tools; brain-storming, mind mapping, lateral thinking, critical thinking, Design for Six Sigma, Triz, Scamper, Storyboard, Nominal group technique, multi-voting • Apply Cost of Quality; prevention, appraisal, internal failure, external failure • Apply Process management; process goals, process analysis, lean tools, theory of constraints • Apply Measurement; assessment and metrics, statistical use, sampling, statistical analysis, trend and pattern analysis, theory of variation, process capability, reliability and validity, qualitative assessment, survey analysis and use • I have a 192-slide presentation from Chris I can share with anyone else that may be preparing for this professional certification exam 6
  • 7. Monday February 18, 2013 Next Generation QSM Joe DeFeo Juran Institute • Quality and CI professionals must provide management with information they will ―get‖, in their language, i.e. risk, money, market share, sustainment • Move the ―Quality Management System‖ to a ―Mission Assurance System‖ that leaves no doubt Customers and Stakeholders needs will be met fast and efficiently • Understand Societal needs and Stakeholder needs to meet the Enterprise mission • Drive continual process optimization though multi-functional improvements • Leaders must ask ―What part of the QMS can we focus on to help the company?‖ • Consider an ―a la carte‖ approach to build into the QMS elements of standards that will ensure the Enterprise mission 7
  • 8. • Shift ―Management Review‖ toward ―Management Renewal‖ • Perform an annual ―stop-doing‖ exercise to free and redirect limited resources • Build the QMS to mitigate and manage risk • Quality and CI professional must work to develop a broader business acumen to understand and support the overall goals of the organization 8
  • 9. Sustainment?  UBS reports $2.8 billion loss  Bank fines top $10 billion this year  JPMorgan's trading loss: $5.8 billion  Compounding pharmacies have been linked to deaths, illnesses and safety failures for years 9
  • 10. What Do These Companies & Industries Have in Common? Most had: Quality Management Systems Compliance Systems Third Party Assessments 10
  • 11. Evolution & Benefits of Standards Performance Continuous Better Social Improvement Responsible Companies Greener Society Mitigated More Risks Transparency Higher Quality Time 11
  • 12. ISO & QMS Principles 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision-making 8. Mutually beneficial supplier relationships 12
  • 13. Future of QMS Quality Process Improvement Environment Integrated Management System Risk Social 13
  • 14. Will It Be Different From Today? 1. Greater understanding of Societal Needs & Stakeholder Needs to meet the Enterprise Mission 2. Continual process optimization through multi-functional improvements 3. Enterprise-wide integrated management standards to maintain daily compliance and control of mission critical processes 4. Creating an Integrated Quality Function to assure the Enterprise System if working 5. Multi-lingual staff = they know Voice of the Business and Voice of the Standards to enable the Enterprise to meet needs 6. Engaged employees trained in business and quality acumen 7. Annual renewal of performance improvement programs to avoid quality failures and maintain effective internal controls 14
  • 15. Enterprise Assurance: A Model Integrated Quality Management Standards Monitor Deploy Policies and Standardize Work Identify Current Strategic Replicate State & & Risk Results, Risk Design Drivers Identify & Meet and Sustain Establish Needs Implement Gains Projects Solutions Daily Daily Projects Improvement Compliance 15
  • 16. Will Quality Lead The Charge? The professionals that truly understand that the purpose of Quality Management Systems is to help assure the enterprise meets its Mission. 16
  • 17. Monday February 18, 2013 General Motors Drive for Customer Satisfaction Michael Hardy Director of Global Quality Strategy General Motors • Center quality objectives around the customer experience, imagine the perceptions, senses, and overall experience from purchasing, receipt, and use 17
  • 18. Monday February 18, 2013 Future of ISO9001 QMS in a Global Economy Alka Jarvis Process and Excellence Leader Cisco Systems • Over 10 years without any significant changes in the ISO standard • It is a Golden Age of technology and innovation transforming the way we do business, work, communicate, live, and learn • ISO must change to be relevant • ISO must address Resource Management, the Voice of the Customer, Measures, Knowledge Management, Risk Management, Systematic Problem Solving and Learning 18
  • 19. 2012 Top 5 CEO Challenges; Innovation- Technology is the #1 enabler to innovation in products, process design, and business models • Human Capital- grow talent internally, improve leadership development program, provide employee training and development • Global Political and Economic Risk- debt concern, mushrooming regulations on a global scale, increasing trade tension, Political divergence with respect to market access and governance of key sectors • Government Regulations- Continued uncertainty of the overall regulatory environment, which forces many companies to put growth plans on hold until the playing field is clearly defined • Global Expansion- Large, medium and small companies are all realizing that in order to stay competitive, they must expand globally 19
  • 20. Monday February 18, 2013 Best Kept Secrets of Great Quality Leaders Connie Conboy VP of Corporate Quality -Retired Bayer Corporation • Secure your foundation- build a rigorous system, constantly strengthen, maintain certification • Identify the real value proposition for quality- is quality a primary brand attribute? Communicate real business impact and value • Bayer aspirin is priced 400% higher than generic aspirin. How can they compete? Quality • Wake up the C-Suite- speak their language, engage them, help them see what’s in it for them • Think like a consultant- foster internal consulting skills, create bold plans, deliver, measure, and communicate results • Build knowledge base- benchmark, master broad quality tools and skills, actively participate in key industry conferences, explore best practices 20
  • 21. • Expand you footprint- create a larger role inside and outside your organization • Innovate- leverage technology, embrace innovation to deliver maximum value 21
  • 22. Monday February 18, 2013 Implementing ISO 9000 in a Mature Company Ben Overwyk Technical Services Engineer Olin Brass • Keep what you can of what they already have as it will reduce the amount of change for the organization • Communicate through pre-implementation meetings to salary and hourly for less confusion during implementation • Communicate business and employee job benefits. What’s in it for them? • Identify roadblocks, people and systems • Use key employees that understand the standard as front-line coordinators • Focus on areas of concern first; calibration? document control? • Determine data/information available, build management review with consideration, content, publish dates • Build responsibility through internal audits • Involve everyone; especially executives 22
  • 23. Take time to help employees that are struggling with understanding • Understand old habits are hard to break • Follow-up, track changes, communicate • Ask for feedback • Communicate accomplishments • Show how ISO has helped 23
  • 24. Monday February 18, 2013 ISO 9001 & ISO 14001; The Revisions as a Partnership Lorri Hunt, Jack West, Jose Dominguez • The ISO 9001 standard is in a revision process • The revision will be in alignment with Annex SL • Annex SL is a standard for standards, basically working toward common formats, structure, and language • Revision will likely publish in 2015 • Too early to take any action on your QMS 24
  • 25. Tuesday February 19, 2013 QMS Quick Self-Assessment- What a Good QMS Looks Like Colin Gray President Cavendish Scott, Inc. • Customer Focus • Leadership • Involvement of people • Process Approach • System Approach • Continual Improvement • Factual approach to decision making • Mutually beneficial supplier relationships 25
  • 26. Customer Focus • Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. • Malcolm Baldrige – Customer Focus • Where are top management involved in customer orders? Satisfaction assessment? • How in touch are (all) top management with customers? • How do they promote this throughout? 26
  • 27. Leadership • Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. • Malcolm Baldrige – Leadership, Strategic Planning • Strategy, Direction, Planning – Published?. Change Management? Is QA involved in organizational change? • Communication. To all? Planned? Consistent? • Is Management ―Leading‖ quality? Do employees know, • understand and believe the same message? 27
  • 28. Involvement of People • People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. • Malcolm Baldrige - Workforce Focus • Communication, Responsibility? Authority? • Fair and ―mutually beneficial‖ relationships? • You can only effect change with information! 28
  • 29. Process Approach • A desired result is achieved more efficiently when activities and related resources are managed as a process. • Malcolm Baldrige - Operations Focus • Non-bureaucratic - Were they established for ISO or for ―our‖ organization? Best practice? As appropriate? • Documented? Communicated? Trained? Valuable controls? • Average processes but good people = Average performance • Good processes with average people = Good Performance • Normal activities managed by processes most of the time? Time for projects, exceptions, improvements? 29
  • 30. System Approach • Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. • Malcolm Baldrige - Operations Focus, Results • Organizational success with objectives/measures? • How well are process interactions achieved? • Visibility of organization objectives at individual levels? • Process handover problems? Politics and interdepartmental issues? 30
  • 31. Continual Improvement • Continual improvement of the organization's overall performance should be a permanent objective of the organization. • Malcolm Baldrige – Results • Systemic Improvement systems throughout • Pervasive attitude looking for opportunities 31
  • 32. Factual approach to decision making • Effective decisions are based on the analysis of data and information. • Malcolm Baldrige - Measurement, Analysis and Knowledge Management • Do Objectives exist? Flowed down to all levels? What metrics exist? Are they communicated? Are they available to all functions and levels of personnel? • Decisions based on data – not ―good‖ management 32
  • 33. Mutually beneficial supplier relationships • An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. • Malcolm Baldrige - Operations Focus • How do we treat suppliers (short term, long term)? • Could we lose (have we lost) important vendors? • What is vendor performance? How responsive are they? 33
  • 34. Tuesday February 19, 2013 Keys to Creating Accountability in a Quality Management System Cynthia Juncosa Director-Lean Compliance Partners Is this Accountability? 34
  • 35. 35
  • 36. A personal choice to rise above one's circumstances and demonstrate the ownership necessary for achieving desired results—to See It, Own It, Solve It, and Do It 36
  • 37. Culture of Accountability • Understand WHY – Positive, Engaging, Sense of Purpose • Results‐Oriented Culture, open to improvements • Compliance – Support from Leadership to do the right thing! • Clear Definition of Responsibilities + Authority • Effective Training • Empowerment to identify and correct mistakes • Poke Yoke, Simple Principles and Methods 37
  • 38. Understand WHY Desire to partake in meaningful work is a motivator – How does my work fit in the ―Big Picture‖? – What’s in it for me? Make the WHY compelling – Why we need to do it and – Why we need to do it now – What if we do NOT do it Create dialogue for ―Buy In‖ Engage heart and mind 38
  • 39. Results‐Oriented Culture “Is my performance meeting expectations?” “What exactly is expected from me?” 39
  • 40. Leadership Support • "Walk the Talk" • Change must be fully supported from the top • down • Hold YOURSELF accountable ‐ lead by example! • Create culture where it's ok to make a mistake and admit to it so it can be fixed ASAP • Mechanism to fix problem • Non‐punitive system for reporting and correcting the mistake BUT If don't follow system, then result is punitive 40
  • 41. Responsibility + Authority • Authority is "the power to enforce rules or give orders, a privilege given to an individual in a management or supervisory position.” • Responsibility is "a duty or obligation where someone is held accountable.“ Delegate Responsibility with Authority to take action, make decisions, really own the task at hand! See It, Own It, Solve It, and Do It 41
  • 42. Effective Training • What tasks? What target? The ―correct‖ way? Which tools and where can I find them? • People not having access to the knowledge they need to do their jobs effectively and efficiently. • Audit observations – training records • Training metrics trending • WHY incorporated • Verify individual training effectiveness • Individual ―certification‖ • CAPAs, NCMRs • Defect Trending by station/shift 42
  • 43. Empowerment • Empower employees to identify and correct their mistakes by providing mechanisms with standard methods and solutions. • Put the systems in place so people know what to do! • Standardize your solutions or standardize methodology to deal with the mistakes. e.g., NCRs, defects • Individuals have authority to course correct or initiate investigations ‐> take ownership of their areas 43
  • 44. Poke Yoke • Poka Yoke (Error and Mistake Proofing of processes) Easy to do correctly, hard or impossible to do wrong • Show your commitment by implementing simple error‐proofing solutions ‐> prevent common mistakes from occurring Engage, solicit solutions Respect for people and value they provide to solve problems Excellent methodology to obtain and assure on‐going quality • ROI = Priceless 44
  • 45. Simple Principles and Methods Standardized Work • The best way to accomplish a task • Apply to repeatable processes first • Reduces training time, more consistent output allows for better improvements Visual Management • Allows all employees to understand how they affect the company’s overall performance –WHY • Real‐time information and feedback • Access to performance data to react accordingly • Prescribe actions to return performance to specified limits 45
  • 46. Summary Culture of Accountability is attainable by engaging hearts and minds of your teams • Help teams Understand WHY behind what they do • Responsibilities + Authority clearly defined • Results‐Oriented – Measure Metrics • Lead by Example • Effective Training • Empowerment Poke Yoke, Simple Principles and Methods 46
  • 47. Tuesday February 19, 2013 Six Sigma: The Breakthrough Management Strategy Dr. Mikel Harry President and CEO Six Sigma Management Institute • Dr. Harry is widely considered the principle architect of the Six Sigma methodology • He is currently launching a program to train returning military veterans to be Six Sigma Black Belts • Additionally he is promoting a new system, book, and software ―The Great Discovery‖ • The core of the concept is that any problem or opportunity can be effectively addressed with the six sigma methodology whether process- related or within one personal life • Taking Six Sigma from ―Toolbox‖ to ―Way of Thinking‖ • Do the Dreaming- Dream the Doing- Plan the Doing- Do the Plan 47
  • 48. The Great Discovery • Clarify Your Core Values • Determine the Dream • Establish Leading Milestones • Select Problematic Milestone (Apply 80% of efforts to 20% (vital few) factors • Identify Vital Forces • Define Enabling Actions • Complete Action Plan • Check Progress Results 48
  • 49. When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge of it is of a meager and unsatisfactory kind; it may be the beginning of knowledge, but you have scarcely, in your thoughts, advanced it to the stage of science. --Sir William Thompson, Lord Kelvin (1824-1907) Jack Welch- GE supported an approach to fire the bottom 10% within the organization each year 49
  • 50. Wednesday February 20, 2013 Cisco’s Corporate Quality and Six Sigma+ Journey Alka Jarvis Process & Excellence Leader Cisco Systems 50
  • 51. Common Reasons for Project Failure How to Mitigate 1. Lack of management support 1. Project selection process that focuses on ROI, resource commitment, timeline prior to launch 2. Failure to manage expectations 2. Tollgate process to ensure leaders and stakeholders sign off on progress, changes 3. Failure to adequately identify & track 3. Methodology that begins with gathering requirements VOC and focuses on collecting evidence to support decisions 4. Inadequate project management 4. Standardized, and proven, methodology methodology & tools (DMAIC/DMADV) 5. Inadequately trained project managers 5. Rigorous training and mentorship to increase success and knowledge transfer 51
  • 52. VSEM • Vision – A vision is a vivid, idealized and memorable description of a desired outcome • Strategy – An overarching statement that summarizes how, over the next 2-4 years, the team will achieve its vision. Priorities/Focus Areas – Priorities, which may also be called Focus Areas, are a subset of the team’s strategy • Execution Commitments – Funded annual initiatives, programs or actions intended to drive the success in the team’s Priorities/Focus Areas • Measurement – Metrics show how the team is measuring progress towards achieving the Annual Plan 52
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  • 56. Wednesday February 20, 2013 Statistical Engineering for Project Selection Forrest Breyfogle CEO Smarter Solutions, Inc. 56
  • 57. A Key Performance Metric can follow the SMART criteria. This means; • the measure has a Specific purpose for the business • it is Measurable • It should create Action • the improvement of a KPM has to be Relevant to the success of the organization • and finally it must be Timely 57
  • 58. Thursday February 21, 2013 Creating Process Improvement Through Conversation Melissa Falvo VP Process Improvement Support Manager PNC Bank 58
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  • 65. Thursday February 21, 2013 Globalizing Your Lean and Six Sigma- Tips, Tricks, and Traps Joeseph Cirafesi President Cirafesi Consulting Strategic Considerations • Where can the LSS program best gain traction? • What gaps in performance are most strategic? • Has this been tried before at this location? • Can the right resources be made available? • Will other initiatives hurt or help us? • What support will management provide? 65
  • 66. Cultural Elements • Organizational hierarchy – can somebody make a decision! • Social versus work orientation – let eat and drink! • Team versus individual / public versus private recognition • Language challenges / translating concepts • Work / Life Balance – long lunches and late dinners Tips, Tricks, and Traps • Tip – Get cultural training before beginning • Trap – don’t settle for part-time resources • Trick – hide some gains and reinvest • Tip – Allow 30% to 50% more time for training in initial roll out • Tip – produce initial materials in English and in each trainee’s mother tongue • Trap – assuming translations are correct • Tip – deliver ―mini‖ training to translators 66
  • 67. Tips, Tricks, and Traps • Trap – concurrently implementing major changes • Tip – look for translation provider well in advance of need – lengthy process • Trick – ask for a variety of management levels to become trained – build influencers • Trap – develop your own training materials while implementing your LSS • Trap – Translation costs are an iceberg and can be a huge barrier to effective communication 67
  • 68. Thursday February 21, 2013 Keeping Lean Alive Jim Joyner VP of Corporate Excellence Card-Monroe Corporation 68
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  • 74. Thursday February 21, 2013 Sustain Project Results without Staying in the Process Until the End of Time David Haim Process Improvement Black Belt PNC Bank 74
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  • 77. Thursday February 21, 2013 Building and Maintaining a Culture to Support Quality Dr. Judith Ann Pauley CEO Process Communications, Inc. Truly an outstanding presentation on people, what makes them different, what makes them the same, what motivates them, how to communication with them, how to engage them, how to lead them. Very entertaining, informative and dynamic! ―Leadership is the art of getting someone else to do what you want done because they want to do it.‖ President Dwight D. Eisenhower 77
  • 78. Two Legs of Process Communication 1. Everyone is One of Six Basic Personality Types 2. How We Say Something is More Important Than What We Say 78
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  • 83. Leading Cultural Change • Build Trust • Keep everyone informed • Allow people to express their views • Listen to their views • Quality cannot be imposed from above • Don’t be condescending or arrogant • Allow Reactors to express feelings • Make certain Reactors feel they belong • Give Workaholics data • Provide timelines for the Workaholic • Show Persisters how a Quality Program improves quality, standards and values • Ask Persisters their opinions • Allow Rebels to say what they like and don’t like • Periodically inject humor into meetings • Tell Promoters how they will benefit personally • Give Promoters action assignments • Give Dreamers time to think about changes • Actively solicit Dreamer’s ideas 83
  • 84. Distress Behaviors • Reactors – Make Mistakes • Workaholics – Over Control • Persisters – Push Beliefs • Dreamers – Shut Down • Rebels – Blame • Promoters - Manipulate http://kahlercom.com/ 84
  • 85. Thursday February 21, 2013 Questions and Theories: Two Essential Elements of Change Dr. Cheryl Hild Director of Quality Aegis Sciences Corporation 85
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  • 87. If I overreact without knowledge of cause I will put the wrong solutions in motion… 87
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  • 89. Thursday February 21, 2013 Use Modular Kaizen to Reduce Disruption Grace Duffy President Management and Performance Systems 89
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  • 91. Friday February 22, 2013 Hoshin Planning Anthony Manos Catalyst Profero, Inc 91
  • 92. Types of Planning Advantages Disadvantages No Planning Saves Time Probably Won’t Stay in Business Failure Comes as a Complete Surprise No clear direction Whatever Boss Says Pleases the Boss Boss May not Know All the Right Things Little to No Buy-In 92
  • 93. Types of Planning Advantages Disadvantages Budgeting At least you are trying You may not know that you are spending your resources on what is really important Management by When/If we ―hit the We can make things Objective numbers‖ we get our worse trying to ―hit the bonuses numbers‖ 93
  • 94. Types of Planning Advantages Disadvantages Strategic Planning Sets longer-term vision Can be biased of where the organization should be May have issues with follow-up and follow- through Hoshin Kanri Aligns long-term vision Requires Time to Policy Deployment with short-term action Implement Correctly items Shortcuts will cause Shows linkages less than optimal results All levels in organization help set objectives 94
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  • 123. It is five years in the future, we are wildly successful. What do we look like and how did we get here? 123
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  • 137. Kaplan and Norton Strategy Map 137
  • 138. Real benefits come when managers begin to understand the profound difference between "cost cutting" and "eliminating the causes of costs‖ -Brian Joiner If You are not the lead-dog, the view (and smell) is always the same….. 138