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Managing a successful team



       Paul Hancock Ph.D.
      Paul.Hancock@Genoceutics.com
McGregor's X-Y theory of management

              Theory X                                                                   Theory Y




           management
                                                                                           staff



Authoritarian, oppressive, coercive.                            Liberating, developmental. Control,
  Tight control, no development.                              achievement, continuous improvement,
Produces limited, depressed culture                           achieved by enabling and empowering,
                                                                      and giving responsibility




               staff                                                                management

                    Ref: Douglas McGregor , X-Y theory , 1960 , The Human Side Of Enterprise'.
X-Y theory of management



   The Culture

      Quality

     The Team

   The System
X theory of management : The Culture

Blame culture
   • Seeks culprits for failures or shortfalls
   • Holds on to responsibility but shifts accountability to subordinates
   • Communicates one-way, shouts, demands, never asks
   • Issues deadlines, ultimatums
   • Thinks giving orders is delegating


Results : Atomized workforce
   • Demoralised workers fearful of castigation
   • High Staff Attrition
   • More time spent training new staff
   • Process speed decreases, defects increase
   • Reactive environment – firefighting multiplier
Y theory of management : The Culture

Engagement : Nurture an Inclusive Environment
   • Encourage contribution & open discussion where ideas are valued .
   • Drive out any fear of retribution that may be implied from expressing a point of view so
                                                        {ref 2,3: Deming}
   that everyone may work effectively for the company
                                                                                      {ref 7: Shidle}
   • Encourage people – tell them they‟re going to do good before they’ve done it
   • Focused on learning from experience and preventing recurrence
   • Focused on performance, urgency and commitment to make the system perform better
   • Anticipate opportunities to continually improve and to develop long term goals


Results : Cohesive workforce
   • Positive Proactive culture
   • Multiplier effect on solutions to both challenges as well as problems
   • Valued engaged colleagues. Low Staff Attrition. Less time spent training new staff
   • Quality built into the system, improved processes & productivity
   • Customer oriented to meet expectations of quality {VOC} = Customer delight
X theory of management : Quality


Behaviour
                                                                         {ref 5: Adam Smith}
     • Focuses on productivity – reductionism - division of labour
                                                                                                    {ref
     • Relying on quality inspection to achieve quality rather than improve product quality
     2,3: Deming}


     • Results-driven and deadline-driven, to the exclusion of everything else.


Results
     • Low quality, continual firefighting = low productivity [non-sequitur]
     • When you are reactive, you blame other people and circumstances for obstacles or
                    {ref 4: Covey}
     problems.




"A manager of people needs to understand that all people are different. This is not ranking people. He/she
needs to understand that the performance of anyone is governed largely by the system that he/she works in.
Placing blames on workforces who only responsible for 15% {4%} of mistakes where the system desired by
management is responsible for 85% {96%} of the unintended consequences. “ {ref 2 & 3: Deming}
Y theory of management : Quality


Behaviour
   • Focuses on quality above all else
   • You cant inspect quality into a product
   • Eliminate the need for massive inspection by building quality into the product in the first
            {ref 2,3: Deming}
   place‟
   • Continual improvement and ever better understanding of customers needs
   • Improve constantly and forever the system of production and service, to improve quality
                                                           {ref 2,3: Deming}
   and productivity, and thus constantly decrease costs


Results
   • Improved quality, higher productivity & lower costs
   • Removes barriers that rob the worker of his/her right to pride of workmanship. The
                                                                                    {ref 2,3: Deming}
   responsibility of supervisors must be changed from sheer numbers to quality.
Y theory of management : Quality model 1
Improvement in quality begets improvement in productivity




   Ref 9: Walter A. Shewhart, 1931, ‘Economic Control of Quality of Manufactured Product '.
Y theory of management : Quality model 2
                                                  High quality makes it possible to attain fast speed*



                                                                    Lean Six Sigma
 Up to 96% problems built into work system




                                                        Delight                                            Improve
                                                       Customers         4% Individual                    Processes




                                                                                              Variation & Defects



                                                                                                                    Process Flow**
                                                    Quality



                                                                 Speed




                                                                         Team - work

                                                                   Data and Facts
                                             * Overall process speed – not how quickly an individual person works
** The physical path, get rid of unnecessary complexity i.e. division of labour, poor logistics
Only customers can define quality {VOC}: Ref 8 : Mike George, What is Lean Six Sigma’, 2004
Y theory of management : Quality model 3
                                      Quality by Design {ICH Q8, 9 & 10}
Aspects                  Traditional                               QbD
Quality                  Quality assured by testing and inspection Quality built into product & process by design, based on scientific
                                                                   understanding. Develop effective CAPA –eliminate “special cause
                                                                   ”variability. An ability to effect continuous improvement and
                                                                   continuous "real time" assurance of quality
Pharmaceutical           Empirical, Random, Focus on optimization, Systematic, Multivariate experiments, Focus on control strategy and
Development              typically univariate experiments          robustness
Manufacturing Process    Fixed; validation on 3 initial full-scale   Adjustable within design space, managed by company’s quality
                         batches; focus on reproducibility           systems; continuous verification within design space; focus on
                                                                     control strategy and robustness. Understanding and controlling
                                                                     CQA’s
Process Control          Some in-process testing for go/no-go;       PAT utilized for feedback and feed forward at real time. Process
                         offline analysis w/ slow response           operations tracked and trended
Product Specification    Specifications based on batch history.     Part of the overall quality control strategy, specifications based on
                         Primary means of quality control, based on desired product performance. Establish CQA target values and
                         batch data                                 acceptable variability around the target value
Control Strategy         Mainly by intermediate inspection and end Risk-based control strategy , real-time release possible, controls
                         product testing                           shifted upstream; Utilize a monitoring system that demonstrates
                                                                   “state of control” preferably based on critical material attributes
Submission               Data intensive submission – disjointed      Knowledge rich submission – showing product knowledge &
                         information without ‘big picture’           process understanding
Lifecycle management     ‘Frozen process’ discouraging changes.      Flexible process within design space, allowing continuous
                         Reactive to problems & OOS; post-           improvement
                         approval changes needed

          QbD leads to identification of critical quality attributes, process steps, and process parameters, which
                     provides focus to specifications, validation protocol, batch record and controls
X theory of management : Quality

                        Productivity by Design




               Operating Expenses increase due to
               rework, more mistakes, more             • Quality suffers
Focus on                                               • Operating Profit decreases
               delays, poor logistical planning, use
Productivity                                           • Operating Margin lowers
               of machine-time, {people, methods}
               and materials                           • Company’s Net Profit Suffers
X theory of management : The ‘X’ Team

Behaviour
                                    {ref 2,3: Deming}
   • Lack of constancy of purpose
   • Myopic vision {focusing on the shadows}
   • Power used to achieve surface compliance
   • Does not participate or team-build, unconcerned about staff welfare, or morale
   • Does not thank or praise. distant, detached, arrogant, elitist, poor listener


Results
   • Atomisation of mission
   • [Cassandra complex]
Y theory of management : The ‘A’ Team

Behaviour
                                                                   {ref 4: Covey}
    • Visualisation character ethic : Begin with the End In Mind
                                                                                        {ref 2,3: Deming}
    • Create constancy of purpose toward improvement of product and service
                                                                                      {ref 2,3: Deming}
    • Put everybody in the company to work to accomplish the transformation
                                                                                    {ref 4: Covey}
    • Synergize : The way a team plays as a whole determines its success
    • Apply collaborative decision making. effective problem solving. DMAIC Six Sigma Tools
    • Value differences
    • Embrace and leverage innovation, creative collaboration
                                       {ref 6: Templar}
    • Make your team better than you


Results - Together Everyone Achieves More
    • When synergy is pursued as a habit, the result of the teamwork will exceed the sum of
    what each of the members could have achieved on their own. “The whole is greater than
    the sum of its parts.”
    • Shared purpose - Internalised cognitive change through leadership – Cohesion
X theory of management : The System

Behaviour
                                                                                 {ref 2,3: Deming}
    • Thinks short term - Transactional - Emphasis on short-term profits
    • Manages by visible figures alone
    • Treats system as fixed, individual parts
    • Scrutinises expenditure to the point of false economy [mission creep]
    • Unconcerned with investing in anything to gain future improvements
    • Concentration of knowledge – {epistemical mercantilism}
Results - the little picture
                                                             {ref 2,3: Deming}
    • Measuring productivity does not improve productivity
    • Inspection doesn‟t improve quality or guarantee it [its too late – good or bad, quality is
    already in the product]
    • A fixed system cannot buffer the influence of incoming variability
    • Narrow spectrum of operational definition
    • Low skilled workforce, systemic apathy, low appreciation / knowledge of variation
    • High division of labour leading to increased opportunity for defects
Y theory of management : The System

Behaviour – the big picture
    • Thinks long term – Transformational – Emphasis on Continual Development
    • Continuously sharpen knowledge/mind & skills to anticipate/meet ever-changing
                                 {ref 4: Covey}
    requirements for success
                                                                      {ref 2,3: Deming}
    • Institute training on the job, education and self-improvement
    • Develop in others exceptional management & teamwork abilities
    • Provide operational definition and share knowledge
    • Helpful feedback to reinforce behavior {+ve} & motivate players to learn from mistakes {-ve}
    • Skillfully listen {empathetically} - the other person feels as though he/she has been
    listened to in a way that encourages further contribution
                                                                                          {ref 4: Covey}
    • Think Win/Win {reciprocity} where mutually beneficial solutions are sought
    • Communicate & collaborate - Integrate helpful efforts of other departments to help the
    whole system become more effective
    • Break down barriers between departments so the whole company works
                       {ref 2,3: Deming}
    interdependently
The Bottom Line
• Businesses need to make money

• Employee engagement is a significant lead indicator to success

• „We were successful because our employees were motivated to meet the customer need.‟

     Companies with low levels of Engagement                                         Companies with high levels of Engagement
     Above Avg. Financials            Below Avg. Financials                          Above Avg. Financials             Below Avg. Financials




                                                                                                     29%
                      38%

                                         62%
                                                                                                                          71%




„When we see financials as the indicator of our success, we are too late. Financials are like
the rear view mirror in our car, we are looking at a picture of the past. The moment we react to
                                                                            {ref 10: Federman}
financials, we make short term decisions to achieve fiscal responsibility‟
     Source: Adapted from Corporate Leadership Council, a division of The Conference Executive Board Company, 2004 Employee Engagement Study
In Summary

Management Theory ‘X’ {Sisyphus}
• The average person dislikes work and will avoid it he/she can.
• Therefore most people must be forced with the threat of punishment to work towards
                               {ref 1: McGregor}
organisational objectives.



Management Theory ‘Y’ {Prometheus}
• Pride and effort in work are natural
• Self actualisation : People will apply self-control and self-direction in the pursuit of
organisational objectives, without external control or the threat of punishment
• Commitment to objectives is a function of „rewards‟ associated with their achievement
• People usually accept and often seek responsibility
• The capacity to use a high degree of imagination, ingenuity and creativity in solving
organisational problems is widely, not narrowly, distributed in the population



              Ref: Douglas McGregor , X-Y theory , 1960 , The Human Side Of Enterprise'.
Thank You

      Insanity : ‘Doing the same thing over and over again and expecting different results.’

                                                                                                       Albert Einstein


References
[1] Douglas McGregor , X-Y theory , ‘The Human Side Of Enterprise‘, 1960
[2] Dr. William E. Deming, Points for Management for transforming business effectiveness, ‘Out of the Crisis’, 1982
[3] Dr. William E. Deming, Deadly Diseases of Management, ‘Out of the Crisis’, 1982
[4] Stephen R. Covey, ‘The 7 Habits of Highly Effective People’, 1989
[5] Adam Smith, ‘An Inquiry into the Nature and Causes of the Wealth of Nations’, 1776
[6] Richard Templar ‘The rules of management’, 2005
[7] Norman Glass Shidle, ‘The art of successful communication’, 1965
[8] Mike George, ‘What is Lean Six Sigma?’, 2004
[9] Walter A. Shewhart, ‘Economic Control of Quality of Manufactured Product ‘, 1931
[10] Brad Federman, ‘Employee Engagement : A Roadmap for Creating Profits, Optimizing Performance, and Increasing Loyalty’, 2009
Spaghetti diagram showing excessive travel during work activity




Define Measure Analyse Implementation Control
Baseline data were collated and assessed by the Lean Lab team. Specific improvement
activities were identified from this analysis. These activities were then combined into an
implementation plan that was approved and resourced by the sponsoring Vice President.
Improvement activities included redesign of equipment layouts, re-assigning
responsibilities and the removal of unused or underused equipment. Ref: Kevin D. Altria, Ann M.
Dufton, Stephen W. Carleysmith, ‘Learning from Lean Sigma’, PHARMACEUTICAL TECHNOLOGY EUROPE, Volume 21, Issue 2, Feb 1, 2009
A system of profound knowledge
Understand how interactions (i.e. feedback) between the elements of a system can result
in internal restrictions that force the system to behave as a single organism that
automatically seeks a steady state. It is this steady state that determines the output of the
system rather than the individual elements. Thus it is the structure of the organization {e.g.
process flow} rather than the employees, alone, which holds the key to improving the
quality of output.
The Knowledge of variation involves understanding that everything measured consists of
both "normal" variation due to the flexibility of the system and of "special causes" that
create defects. Quality involves recognizing the difference to eliminate "special causes"
while controlling normal variation. Deming taught that making changes in response to
"normal" variation would only make the system perform worse. Understanding variation
includes the mathematical certainty that variation will normally occur within six standard
                           {ref 2,3: Deming}
deviations of the mean.
Medical Devices Mind Map
Device Patents Mind Map
Product Taxonomy Mind Map
Cascade Impaction Variability Ishikawa Diagram

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Managing A Successful Team Offline Version

  • 1. Managing a successful team Paul Hancock Ph.D. Paul.Hancock@Genoceutics.com
  • 2.
  • 3. McGregor's X-Y theory of management Theory X Theory Y management staff Authoritarian, oppressive, coercive. Liberating, developmental. Control, Tight control, no development. achievement, continuous improvement, Produces limited, depressed culture achieved by enabling and empowering, and giving responsibility staff management Ref: Douglas McGregor , X-Y theory , 1960 , The Human Side Of Enterprise'.
  • 4. X-Y theory of management The Culture Quality The Team The System
  • 5. X theory of management : The Culture Blame culture • Seeks culprits for failures or shortfalls • Holds on to responsibility but shifts accountability to subordinates • Communicates one-way, shouts, demands, never asks • Issues deadlines, ultimatums • Thinks giving orders is delegating Results : Atomized workforce • Demoralised workers fearful of castigation • High Staff Attrition • More time spent training new staff • Process speed decreases, defects increase • Reactive environment – firefighting multiplier
  • 6. Y theory of management : The Culture Engagement : Nurture an Inclusive Environment • Encourage contribution & open discussion where ideas are valued . • Drive out any fear of retribution that may be implied from expressing a point of view so {ref 2,3: Deming} that everyone may work effectively for the company {ref 7: Shidle} • Encourage people – tell them they‟re going to do good before they’ve done it • Focused on learning from experience and preventing recurrence • Focused on performance, urgency and commitment to make the system perform better • Anticipate opportunities to continually improve and to develop long term goals Results : Cohesive workforce • Positive Proactive culture • Multiplier effect on solutions to both challenges as well as problems • Valued engaged colleagues. Low Staff Attrition. Less time spent training new staff • Quality built into the system, improved processes & productivity • Customer oriented to meet expectations of quality {VOC} = Customer delight
  • 7. X theory of management : Quality Behaviour {ref 5: Adam Smith} • Focuses on productivity – reductionism - division of labour {ref • Relying on quality inspection to achieve quality rather than improve product quality 2,3: Deming} • Results-driven and deadline-driven, to the exclusion of everything else. Results • Low quality, continual firefighting = low productivity [non-sequitur] • When you are reactive, you blame other people and circumstances for obstacles or {ref 4: Covey} problems. "A manager of people needs to understand that all people are different. This is not ranking people. He/she needs to understand that the performance of anyone is governed largely by the system that he/she works in. Placing blames on workforces who only responsible for 15% {4%} of mistakes where the system desired by management is responsible for 85% {96%} of the unintended consequences. “ {ref 2 & 3: Deming}
  • 8. Y theory of management : Quality Behaviour • Focuses on quality above all else • You cant inspect quality into a product • Eliminate the need for massive inspection by building quality into the product in the first {ref 2,3: Deming} place‟ • Continual improvement and ever better understanding of customers needs • Improve constantly and forever the system of production and service, to improve quality {ref 2,3: Deming} and productivity, and thus constantly decrease costs Results • Improved quality, higher productivity & lower costs • Removes barriers that rob the worker of his/her right to pride of workmanship. The {ref 2,3: Deming} responsibility of supervisors must be changed from sheer numbers to quality.
  • 9. Y theory of management : Quality model 1 Improvement in quality begets improvement in productivity Ref 9: Walter A. Shewhart, 1931, ‘Economic Control of Quality of Manufactured Product '.
  • 10. Y theory of management : Quality model 2 High quality makes it possible to attain fast speed* Lean Six Sigma Up to 96% problems built into work system Delight Improve Customers 4% Individual Processes Variation & Defects Process Flow** Quality Speed Team - work Data and Facts * Overall process speed – not how quickly an individual person works ** The physical path, get rid of unnecessary complexity i.e. division of labour, poor logistics Only customers can define quality {VOC}: Ref 8 : Mike George, What is Lean Six Sigma’, 2004
  • 11. Y theory of management : Quality model 3 Quality by Design {ICH Q8, 9 & 10} Aspects Traditional QbD Quality Quality assured by testing and inspection Quality built into product & process by design, based on scientific understanding. Develop effective CAPA –eliminate “special cause ”variability. An ability to effect continuous improvement and continuous "real time" assurance of quality Pharmaceutical Empirical, Random, Focus on optimization, Systematic, Multivariate experiments, Focus on control strategy and Development typically univariate experiments robustness Manufacturing Process Fixed; validation on 3 initial full-scale Adjustable within design space, managed by company’s quality batches; focus on reproducibility systems; continuous verification within design space; focus on control strategy and robustness. Understanding and controlling CQA’s Process Control Some in-process testing for go/no-go; PAT utilized for feedback and feed forward at real time. Process offline analysis w/ slow response operations tracked and trended Product Specification Specifications based on batch history. Part of the overall quality control strategy, specifications based on Primary means of quality control, based on desired product performance. Establish CQA target values and batch data acceptable variability around the target value Control Strategy Mainly by intermediate inspection and end Risk-based control strategy , real-time release possible, controls product testing shifted upstream; Utilize a monitoring system that demonstrates “state of control” preferably based on critical material attributes Submission Data intensive submission – disjointed Knowledge rich submission – showing product knowledge & information without ‘big picture’ process understanding Lifecycle management ‘Frozen process’ discouraging changes. Flexible process within design space, allowing continuous Reactive to problems & OOS; post- improvement approval changes needed QbD leads to identification of critical quality attributes, process steps, and process parameters, which provides focus to specifications, validation protocol, batch record and controls
  • 12. X theory of management : Quality Productivity by Design Operating Expenses increase due to rework, more mistakes, more • Quality suffers Focus on • Operating Profit decreases delays, poor logistical planning, use Productivity • Operating Margin lowers of machine-time, {people, methods} and materials • Company’s Net Profit Suffers
  • 13. X theory of management : The ‘X’ Team Behaviour {ref 2,3: Deming} • Lack of constancy of purpose • Myopic vision {focusing on the shadows} • Power used to achieve surface compliance • Does not participate or team-build, unconcerned about staff welfare, or morale • Does not thank or praise. distant, detached, arrogant, elitist, poor listener Results • Atomisation of mission • [Cassandra complex]
  • 14. Y theory of management : The ‘A’ Team Behaviour {ref 4: Covey} • Visualisation character ethic : Begin with the End In Mind {ref 2,3: Deming} • Create constancy of purpose toward improvement of product and service {ref 2,3: Deming} • Put everybody in the company to work to accomplish the transformation {ref 4: Covey} • Synergize : The way a team plays as a whole determines its success • Apply collaborative decision making. effective problem solving. DMAIC Six Sigma Tools • Value differences • Embrace and leverage innovation, creative collaboration {ref 6: Templar} • Make your team better than you Results - Together Everyone Achieves More • When synergy is pursued as a habit, the result of the teamwork will exceed the sum of what each of the members could have achieved on their own. “The whole is greater than the sum of its parts.” • Shared purpose - Internalised cognitive change through leadership – Cohesion
  • 15. X theory of management : The System Behaviour {ref 2,3: Deming} • Thinks short term - Transactional - Emphasis on short-term profits • Manages by visible figures alone • Treats system as fixed, individual parts • Scrutinises expenditure to the point of false economy [mission creep] • Unconcerned with investing in anything to gain future improvements • Concentration of knowledge – {epistemical mercantilism} Results - the little picture {ref 2,3: Deming} • Measuring productivity does not improve productivity • Inspection doesn‟t improve quality or guarantee it [its too late – good or bad, quality is already in the product] • A fixed system cannot buffer the influence of incoming variability • Narrow spectrum of operational definition • Low skilled workforce, systemic apathy, low appreciation / knowledge of variation • High division of labour leading to increased opportunity for defects
  • 16. Y theory of management : The System Behaviour – the big picture • Thinks long term – Transformational – Emphasis on Continual Development • Continuously sharpen knowledge/mind & skills to anticipate/meet ever-changing {ref 4: Covey} requirements for success {ref 2,3: Deming} • Institute training on the job, education and self-improvement • Develop in others exceptional management & teamwork abilities • Provide operational definition and share knowledge • Helpful feedback to reinforce behavior {+ve} & motivate players to learn from mistakes {-ve} • Skillfully listen {empathetically} - the other person feels as though he/she has been listened to in a way that encourages further contribution {ref 4: Covey} • Think Win/Win {reciprocity} where mutually beneficial solutions are sought • Communicate & collaborate - Integrate helpful efforts of other departments to help the whole system become more effective • Break down barriers between departments so the whole company works {ref 2,3: Deming} interdependently
  • 17. The Bottom Line • Businesses need to make money • Employee engagement is a significant lead indicator to success • „We were successful because our employees were motivated to meet the customer need.‟ Companies with low levels of Engagement Companies with high levels of Engagement Above Avg. Financials Below Avg. Financials Above Avg. Financials Below Avg. Financials 29% 38% 62% 71% „When we see financials as the indicator of our success, we are too late. Financials are like the rear view mirror in our car, we are looking at a picture of the past. The moment we react to {ref 10: Federman} financials, we make short term decisions to achieve fiscal responsibility‟ Source: Adapted from Corporate Leadership Council, a division of The Conference Executive Board Company, 2004 Employee Engagement Study
  • 18. In Summary Management Theory ‘X’ {Sisyphus} • The average person dislikes work and will avoid it he/she can. • Therefore most people must be forced with the threat of punishment to work towards {ref 1: McGregor} organisational objectives. Management Theory ‘Y’ {Prometheus} • Pride and effort in work are natural • Self actualisation : People will apply self-control and self-direction in the pursuit of organisational objectives, without external control or the threat of punishment • Commitment to objectives is a function of „rewards‟ associated with their achievement • People usually accept and often seek responsibility • The capacity to use a high degree of imagination, ingenuity and creativity in solving organisational problems is widely, not narrowly, distributed in the population Ref: Douglas McGregor , X-Y theory , 1960 , The Human Side Of Enterprise'.
  • 19. Thank You Insanity : ‘Doing the same thing over and over again and expecting different results.’ Albert Einstein References [1] Douglas McGregor , X-Y theory , ‘The Human Side Of Enterprise‘, 1960 [2] Dr. William E. Deming, Points for Management for transforming business effectiveness, ‘Out of the Crisis’, 1982 [3] Dr. William E. Deming, Deadly Diseases of Management, ‘Out of the Crisis’, 1982 [4] Stephen R. Covey, ‘The 7 Habits of Highly Effective People’, 1989 [5] Adam Smith, ‘An Inquiry into the Nature and Causes of the Wealth of Nations’, 1776 [6] Richard Templar ‘The rules of management’, 2005 [7] Norman Glass Shidle, ‘The art of successful communication’, 1965 [8] Mike George, ‘What is Lean Six Sigma?’, 2004 [9] Walter A. Shewhart, ‘Economic Control of Quality of Manufactured Product ‘, 1931 [10] Brad Federman, ‘Employee Engagement : A Roadmap for Creating Profits, Optimizing Performance, and Increasing Loyalty’, 2009
  • 20. Spaghetti diagram showing excessive travel during work activity Define Measure Analyse Implementation Control Baseline data were collated and assessed by the Lean Lab team. Specific improvement activities were identified from this analysis. These activities were then combined into an implementation plan that was approved and resourced by the sponsoring Vice President. Improvement activities included redesign of equipment layouts, re-assigning responsibilities and the removal of unused or underused equipment. Ref: Kevin D. Altria, Ann M. Dufton, Stephen W. Carleysmith, ‘Learning from Lean Sigma’, PHARMACEUTICAL TECHNOLOGY EUROPE, Volume 21, Issue 2, Feb 1, 2009
  • 21. A system of profound knowledge Understand how interactions (i.e. feedback) between the elements of a system can result in internal restrictions that force the system to behave as a single organism that automatically seeks a steady state. It is this steady state that determines the output of the system rather than the individual elements. Thus it is the structure of the organization {e.g. process flow} rather than the employees, alone, which holds the key to improving the quality of output. The Knowledge of variation involves understanding that everything measured consists of both "normal" variation due to the flexibility of the system and of "special causes" that create defects. Quality involves recognizing the difference to eliminate "special causes" while controlling normal variation. Deming taught that making changes in response to "normal" variation would only make the system perform worse. Understanding variation includes the mathematical certainty that variation will normally occur within six standard {ref 2,3: Deming} deviations of the mean.
  • 25. Cascade Impaction Variability Ishikawa Diagram