Quality Tools and Methodologies

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Quality Tools and Methodologies

• Compiled by Larry Nyman

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Index

• List of Key Quality Standards
• Six Sigma Methodologies
• KAIZEN
• Lean Production
• TQM
• Hoshin
• SWOT
• Balanced Scorecard
• 8 disciplines (8D)
• 5S (Housekeeping)
• Good to Great
• Demings 14 points
• PDCA cycle
• Sampling
• Seven Classical Quality Improvement Tools
• Checksheet (tally sheet)
• Control Chart (SPC)
• Process Flow Chart
• Histogram (frequency distribution)

• Brainstorming
• Root Cause Analysis
• Malcolm Baldrige
• TRIZ
• Kepner-Tregoe's Five-Phase Strategy Model
• Zero Defects Approach
• Cost of Quality
• FMEA
• PFMEA
• TOC (Theory of Contraints)
• Process Capability
• QFD
• APQP
• CMM
• HACCP

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List of Key Quality Standards
ISO 9001 Quality Management Standard
ISO 14001 Environmental Management Standard
OHSAS 18001 Occupational Health and Safety Management Standard
ISO 17025 Laboratory Management Standard
HACCP-9000 encompasses all of ISO 9001 plus food and beverage (inc. water) specific requirements.
ISO/TS 16949 encompasses all of ISO 9001 plus Automotive specific requirements. Replaces QS 9000.
ISO 13485/13488 encompasses all of ISO 9001 plus Medical Device specific requirements.
AS 9100 encompasses all of ISO 9001 plus Aerospace specific requirements.
TL 9000 encompasses all of ISO 9001 plus Telecommunication specific requirements
ISO 9000 Fundamentals and Vocabulary for using ISO 9001 and ISO 9004
ISO 9004 Guidelines on implementing ISO 9001 and continuous improvement
ISO 10005 Guidelines for Quality Plans
ISO 19011 Guidelines for Auditing
ISO 10012 Guidelines for Calibration
Malcolm Baldrige Business Excellence Standard
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Six Sigma Methodologies

• Six Sigma methodology is a proven tool set for
  driving and achieving transformational change
  within an organization. It is a business
  improvement process that focuses an organization
  on customer requirements, process alignment,
  analytical rigor, and timely execution.
• Six Sigma is a measure of quality that strives
  for near perfection. The Six Sigma process uses
  data and rigorous statistical analysis to
  identify "defects" in a process or product by
  reducing variability and achieve as close to zero
  defects as possible.

• The DMAIC methodology breaks down as follows
• Define the project goals and customer (internal
  and external) requirements.
• Measure the process to determine current
  performance.
• Analyze and determine the root cause(s) of the
  defects.
• Improve the process by eliminating defect root
  causes.
• Control future process performance.
• DFSS is the acronym for Design For Six Sigma

• The five phases of DMADV are defined as
• Define the project goals and customer (internal
  and external) requirements.
• Measure and determine customer needs and
  specifications benchmark competitors and
  industry.
• Analyze the process options to meet the customer
  needs.
• Design (detailed) the process to meet the
  customer needs.
• Verify the design performance and ability to meet
  customer needs.

• DCCDI methodology breaks down as follows
• Define the project goals.
• Customer analysis is completed.
• Concept ideas are developed, reviewed and
  selected.
• Design is performed to meet the customer and
  business specifications.
• Implementation is completed to develop and
  commercialize the product/service.
• DMEDI is being taught by PricewaterhouseCoopers
  and stands for Define, Measure, Explore, Develop
  and Implement.

• IDOV is a well known design methodology,
  especially in the manufacturing world.
• Identify the customer and specifications
  (Critical To Quality CTQs ).
• Design translates the customer CTQs into
  functional requirements and into solution
  alternatives. A selection process whittles down
  the list of solutions to the "best" solution.
• Optimize uses advanced statistical tools and
  modeling to predict and optimize the design and
  performance.
• Validate makes sure that the design you've
  developed will meet the customer CTQs.

5
Quality Level v defects per million
3 s 3.5 4 s 4.5 5 s 5.5 6 s
66,803 22,800 6,200 1,350 233 32 3.4
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(No Transcript)
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KAIZEN

• The Japanese word "KAIZEN" means improvement,
  improvements without spending much money,
  involving everyone from managers to workers, and
  using much common sense. The Japanese way
  encourages small improvements day after day,
  continuously. The key aspect of KAIZEN is that it
  is an on-going, never-ending improvement process.
  It's a soft and gradual method opposed to more
  usual western habits to scrap everything and
  start with new.
• Kaizen activities can be conducted in several
  ways. First and most common is to change worker's
  operations to make his/her job more productive,
  less tiring, more efficient or safer. To get
  worker buy-in as well as significant improvement,
  worker is invited to cooperate, to reengineer by
  himself and with help of team mates. The second
  way is to improve equipment, like installing
  foolproof devices (poke yoke) and/or changing the
  machine layout. Third way is to improve
  procedures. All these alternatives can be
  combined in a broad improvement plan.
• The first stage is reviewing the current work
  standards to check the current performance and
  than estimate how and how much performance can
  still be improved. When new leap is done, upgrade
  the standards.
• Kaizen is controlled It is not acceptable to let
  anybody change designs, layouts or standards for
  some pretended "improvement". Most often Kaizen
  is controlled by improvement groups and
  everybody, regardless to rank or position, is
  encouraged to suggest through suggestion
  submitting system (TEIAN in Japanese).
  Suggestions will be discussed by authoritative
  committee. Suggestions likely to be turned into
  application are usually rewarded according to the
  global gain. Improvement idea can be a response
  to a problem exposed by KAIZEN committee or come
  out spontaneously.

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Lean Production

• Lean production is aimed at the elimination of
  waste in every area of production including
  customer relations, product design, supplier
  networks and factory management. Its goal is to
  incorporate less human effort, less inventory,
  less time to develop products, and less space to
  become highly responsive to customer demand while
  producing top quality products in the most
  efficient and economical manner possible.
• Seven types of waste
• Overproduction to produce more than demanded or
  produce it before it is needed (JIT). It is
  visible as storage of material. It is the result
  of producing to speculative demand
• Inventory or Work In Process (WIP) is material
  between operations due to large lot production or
  processes with long cycle times (kanban)
• Transportation does not add any value to the
  product. Instead of improving the transportation,
  it should be minimized or eliminated (e.g.
  forming cells)
• Processing waste should be minimized by asking
  why a specific processing step is needed and why
  a specific product is produced. All unnecessary
  processing steps should be eliminated
• Motion of the workers, machines, and transport
  (e.g. due to the inappropriate location of tools
  and parts) is waste. Instead of automating wasted
  motion, the operation itself should be improved
• Waiting for a machine to process should be
  eliminated. The principle is to maximize the
  utilization/efficiency of the worker instead of
  maximizing the utilization of the machines
• Making defective products is pure waste. Prevent
  the occurrence of defects instead of finding and
  repairing defects (poke yoke).
• Muda Any wasteful activity or any obstruction
  to smooth flow of an activity. Activity Work
  Muda
• Mura Inconsistencies in the system
• Muri Physical Strain

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TQM

• Understand customer needs. Develop processes that
  continuously collect, analyze, and act on
  customer information. Activities are often
  extended to understanding competitor's customers.
  Developing an intimate understanding of customer
  needs allows TQM organizations to predict future
  customer behavior.
• Integrate customer knowledge with other
  information and use the planning process to
  orchestrate action throughout the organization to
  manage day to day activities and achieve future
  goals. Plans are reviewed at periodic intervals
  and adjusted as necessary. The planning process
  is the glue that holds together all TQM activity.
  
• Understand that customers will only be satisfied
  if they consistently receive products and
  services that meet their needs, are delivered
  when expected, and are priced for value. Use the
  techniques of process management to develop
  cost-controlled processes that are stable and
  capable of meeting customer expectations.
• Understand that exceptional performance today may
  be unacceptable performance in the future so use
  the concepts of process improvement to achieve
  both breakthrough gains and incremental
  continuous improvement. Process improvement is
  even applied to the TQM system itself!
• The final element of the TQM model is total
  participation. Understand that all work is
  performed through people. This begins with
  leadership. Top management must take personal
  responsibility for implementing, nurturing, and
  refining all TQM activities. They make sure
  people are properly trained, capable, and
  actively participate in achieving organizational
  success. Management and employees work together
  to create an empowered environment where people
  are valued.

All of the TQM model's elements work together to
achieve results.
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When all of its elements are implemented
properly, TQM is like a well-built house.  It's
solid, strong, and cohesive.  If TQM is not
planned for and implemented correctly, it will be
structurally weak and will probably fail.
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Hoshin

• The hoshin process is, first of all, a systematic
  planning methodology for defining long-range key
  entity objectives. These are breakthrough
  objectives that typically extend two to five
  years with little change. Second, the hoshin
  process does not lose sight of the day-to-day
  "business fundamental" measures required to run
  the business successfully. This two-pronged
  approach provides an extended period of time for
  the organization to focus its breakthrough effort
  while continuously improving key business
  processes day to day.
• The hoshin methodology provides
•  Breakthrough objective focus
•  Development of plans that adequately support
  the objective
•  Review of progress of these plans
•  Changes to plans as required
•  Continuous improvement of key business
  processes and
•  A vehicle for organizational learning.
•  
• Hoshin ensures that everyone in the organization
  is working toward the same end. The plan is
  hierarchical, cascading down through the
  organization and to key business-process owners.
  Ownership of the supporting strategies is clearly
  identified with measures at the appropriate level
  or process owner within the organization.
• The hoshin process fits under the umbrella
  management philosophy of total quality management
  (TQM).

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SWOT Analysis

• SWOT is an acronym for Strengths, Weaknesses,
  Opportunities, Threats.
• Assists in decision making.
• Here are some examples of what a SWOT analysis
  can be used to assess
• a company (its position in the market, commercial
  viability, etc)
• a method of sales distribution
• a product or brand
• a business idea
• a strategic option, such as entering a new market
  or launching a new product
• a opportunity to make an acquisition
• a potential partnership
• changing a supplier
• outsourcing a service, activity or resource
• an investment opportunity

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Balanced Scorecard

• The balanced scorecard forces managers to look at
  the business from four important interconnected
  perspectives.
• Reference The Balanced Scorecard by Kaplan
  Norton. IBSN0-87584-651-3
• The balanced scorecard method seems to be more of
  a one-way street -- the executive team creates
  the strategy, and it cascades down from there.
• The balanced scorecard has strong similarities to
  Hoshin Planning. Hoshin Planning or hoshin kanri
  is widely used by Japanese companies.
• One thing that the Japanese emphasize is
  "catchball", the process of give and take between
  levels/functions/divisions that helps to define
  strategy.

Satisfied Employees need effective efficient
Processes to delight the Customers so Financials
will increase thus, increasing Employee
satisfaction Start the flywheel spinning and
people will jump on
-Jim Collins
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8 D (8 disciplines)A Process Improvement approach

• 1. Use Team Approach
• Establish a small group of people with the
  knowledge, time, authority and skill to solve the
  problem and implement corrective actions. The
  group must select a team leader.
• 2. Describe the Problem
• Describe the problem in measurable terms. Specify
  the internal or external customer problem by
  describing it in specific terms.
• 3. Implement and Verify Short-Term Corrective
  Actions
• Define and implement those intermediate actions
  that will protect the customer from the problem
  until permanent corrective action is implemented.
  Verify with data the effectiveness of these
  actions.
• 4. Define end Verify Root Causes
• Identify all potential causes which could explain
  why the problem occurred. Test each potential
  cause against the problem description and data.
  Identify alternative corrective actions to
  eliminate root cause.
• 5. Verify Corrective Actions
• Confirm that the selected corrective actions will
  resolve the problem for the customer and will not
  cause undesirable side effects. Define other
  actions, if necessary, based on potential
  severity of problem.
• 6. Implement Permanent Corrective Actions
• Define and implement the permanent corrective
  actions needed. Choose on-going controls to
  insure the root cause is eliminated. Once in
  production, monitor the long-term effects and
  implement additional controls as necessary.
• 7. Prevent Recurrence

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5Ss

• 5S is the Japanese concept for House Keeping.
  1.) Sort (Seiri) 2.) Straighten (Seiton) 3.)
  Shine (Seiso) 4.) Standardize (Seiketsu) 5.)
  Sustain (Shitsuke)
• The following are the real meaning of each
  element in English Japanese - English
  Translations Seiri - Put things in order
  (remove what is not needed and keep what is
  needed) Seiton - Proper Arrangement (Place
  things in such a way that they can be easily
  reached whenever they are needed) Seiso - Clean
  (Keep things clean and polished no trash or
  dirt in the workplace) Seiketsu - Purity
  (Maintain cleanliness after cleaning -
  perpetual cleaning) Shitsuke Commitment
• (Conduct a Gemba Walk where management walks
  around the workplace to inspect and ask
  non-judgemental productivity questions)

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Good to Greatby Jim Collins (IBSN 0-06-662099-6)

• Level 5 LeadershipLevel 5 leaders channel their
  ego needs away from themselves and into a larger
  goal of building a great company. Put these
  people in leadership roles.
• First Who, Then WhatBefore strategizing, get the
  right people on the bus. They will be
  self-motivated.
• Confront the Brutal FactsAcknowledge the
  realistic facts of the current status. Confront
  reality with open and honest communication.
• Hedgehog ConceptDefine what you can be best in
  the world at define what you can make money
  doing define what your passion is. This is the
  Companys long-term Vision. Dont let go of it
  Persevere!
• Develop a Disciplined CultureAfter the right
  people are in place, take planned actions within
  the framework of the Hedgehog Concept. Create a
  Stop Doing list.
• Once people see how improvements and positive
  results fit into the Vision (Hedgehog Concept),
  they will be motivated to jump on board. This is
  called the Flywheel Effect. As momentum of the
  flywheel increases, a breakthrough will occur
  resulting in Greatness.

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Demings 14 points(reference Out of the
Crisis by W.Edwards Deming IBSN 0-911379-01-0)

• Create constancy of purpose toward improvement of
  product and service, with the aim to become
  competitive and to stay in business, and to
  provide jobs.
• Adopt the new philosophy. We are in a new
  economic age. Western management must awaken to
  the challenge, must learn their responsibilities,
  and take on leadership for change.
• Cease dependence on inspection to achieve
  quality. Eliminate the need for inspection on a
  mass basis by building quality into the product
  in the first place.
• End the practice of awarding business on the
  basis of price tag. Instead, minimize total cost.
  Move toward a single supplier for any one item,
  on a long-term relationship of loyalty and trust.
  
• Improve constantly and forever the system of
  production and service, to improve quality and
  productivity, and thus constantly decrease costs.
  
• Institute training on the job.
• Institute leadership (see Point 12 and Ch. 8).
  The aim of supervision should be to help people
  and machines and gadgets to do a better job.
  Supervision of management is in need of overhaul,
  as well as supervision of production workers.
• Drive out fear, so that everyone may work
  effectively for the company (see Ch. 3).
• Break down barriers between departments. People
  in research, design, sales, and production must
  work as a team, to foresee problems of production
  and in use that may be encountered with the
  product or service.
• Eliminate slogans, exhortations, and targets for
  the work force asking for zero defects and new
  levels of productivity. Such exhortations only
  create adversarial relationships, as the bulk of
  the causes of low quality and low productivity
  belong to the system and thus lie beyond the
  power of the work force.
• Eliminate work standards (quotas) on the factory
  floor. Substitute leadership.
• Eliminate management by objective. Eliminate
  management by numbers, numerical goals.
  Substitute leadership.
• Remove barriers that rob the hourly worker of his
  right to pride of workmanship. The responsibility
  of supervisors must be changed from sheer numbers
  to quality.
• Remove barriers that rob people in management and
  in engineering of their right to pride of
  workmanship. This means, inter alia, abolishment
  of the annual or merit rating and of management
  by objective (see Ch. 3).
• Institute a vigorous program of education and
  self-improvement.
• Put everybody in the company to work to
  accomplish the transformation. The transformation
  is everybody's job.

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PDCA cycle

• Plan - a change or a test, aimed at improvement.
• In this phase, analyze what you inted to improve,
  looking for areas that hold opportunities for
  change. The first step is to choose areas that
  offer the most return for the effort you put
  in-the biggest bang for your buck. To identify
  these areas for change consider using a Flow
  chart or Pareto chart .
• Do - Carry out the change or test (preferably on
  a small scale).
• Implement the change you decided on in the plan
  phase.
• Check or Study - the results. What was learned?
  What went wrong?
• This is a crucial step in the PDCA cycle. After
  you have implemented the change for a short time,
  you must determine how well it is working. Is it
  really leading to improvement in the way you had
  hoped? You must decide on several measures with
  which you can monitor the level of improvement.
  Run Charts can be helpful with this measurement.
• Act - Adopt the change, abandon it, or run
  through the cycle again.
• After planning a change, implementing and then
  monitoring it, you must decide whether it is
  worth continuing that particular change. If it
  consumed too much of your time, was difficult to
  adhere to, or even led to no improvement, you may
  consider aborting the change and planning a new
  one. However, if the change led to a desirable
  improvement or outcome, you may consider
  expanding the trial to a different area, or
  slightly increasing your complexity. This sends
  you back into the Plan phase and can be the
  beginning of the ramp of improvement.
• The Ramp of Improvement
• This is a schematic representation of the use of
  the PDCA cycle in the improvement process. As
  each full PDCA cycle comes to completion, a new
  and slightly more complex project can be
  undertaken. This rolling over feature is integral
  to the continual improvement process.

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Sampling

• Sampling Plans originate from MIL-STD-105E and
  are now within spec ASQ Z1.4. get a free copy
  here old MIL STDs
• Heres how to use 105E (simplistically)
• On Page 13 find the lot size range (the number
  of units in the lot). Go to General Inspection
  Level II (normal) column and find the
  corresponding Letter code.
• On Page 14 find the Letter code and find the
  sample size (this is the number of units that
  will be randomly chosen from the lot). Go to the
  corresponding AQL (Acceptable Quality Level)
  column and determine the Ac and Re numbers.
• If Ac are not acceptable, the entire lot is
  accepted.
• If Re are not acceptable, the entire lot is
  rejected.
• All rejected units are repaired or replaced.
• Switching rules
• If 2 of 5 consecutive lots are rejected, use the
  General Inspection Level III (tightened) column
  (page 13).
• If 5 consecutive lots are accepted at Level III,
  return back to Level II.
• If 10 consecutive lots are rejected at Level III,
  perform 100 inspection.
• If 10 consecutive lots are accepted at Level II,
  go to Level I (Reduced).
• If 1 lot is rejected at Level I, return back to
  Level II.
• Also see http//iew3.technion.ac.il/sqconline/mils
  td105.html

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When to Sample? General Rule of Thumb Let p
nonconforming product (NCP) per lot. Let C1
cost of inspection and removal of NCP. Let C2
cost of rework if NCP went to the next step. Use
100 inspection if p gt C1 / C2 Use NO
inspection if p lt C1 / C2 Use Sampling if p
C1 / C2 Also based on supplier quality history
and criticality of the material. One needs to
ask what would be the result of allowing a
nonconforming item to continue through production
and/or on to the consumer?
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Seven Classical Quality Improvement Tools

1. Checksheet (tally sheet)
2. Control Chart (SPC)
3. Process Flow Chart
4. Histogram (frequency distribution)
5. Pareto Analysis (80-20 rule)
6. Scatter Diagram (variable relationship)
7. Cause and Effect Analysis (fishbone)

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1. Checksheet

• Also known as a tally sheet
• Used for simple data collection.
• Used to measure the frequency of events or
  defects over short time intervals.
• It illustrates, at a glance, what the most
  occurring problems are.

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2. Statistical Process Control (SPC)

• Every process varies.
• unusual variations are due to "special causes
  Process is Out-of-Control
• consistent variations are called common causes
  Process is In Control
• All control charts have three basic components
• a centerline, usually the mathematical average of
  all the samples plotted.
• upper and lower statistical control limits that
  define the constraints of common cause
  variations. (3s)
• performance data plotted over time

• Things to look for
• The point of making control charts is to look at
  variation, seeking special causes and tracking
  common causes. Special causes can be spotted
  using several tests
• 1 data point falling outside the control limits
• 6 or more points in a row steadily increasing or
  decreasing
• 8 or more points in a row on one side of the
  centerline
• 14 or more points alternating up and down
• Reducing common cause variation saves money and
  time.

• Types of control charts
• X bar R charts
• XmR charts
• C charts
• p charts
• np charts
• u charts

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3. Process Flow Chart

• A pictorial representation describing a process
  being studied.
• Used to plan stages of a project or steps in a
  process.
• Provides people with a common language or
  reference point when dealing with a project or
  process.
• The shapes

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4. Histogram

• Sometimes called the Bell Curve.
• Lets you see the shape of a set of data - where
  its center it, how far it spreads out on either
  side, and location of outliers.
• As the shape gets thinner, the variation is less.
• Used to determine process capability.

Normal Distribution
Bimodal Distribution
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5. Pareto Analysis

• Used to graphically summarize and display the
  relative importance of the differences between
  groups of data.
• Used to focus on critical issues by ranking them
  in terms of importance and frequency.
• 80/20 Rule About 80 of the problems are from
  20 of the causes.

Focus on these three items (80)
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6. Scatter Diagram

• Used to interpret data by graphically displaying
  the relationship between two variables.

• Rules
• If the points cluster in a band running from
  lower left to upper right, there is a positive
  correlation (if x increases, y increases).
• If the points cluster in a band from upper left
  to lower right, there is a negative correlation
  (if x increases, y decreases).
• Imagine drawing a straight line or curve through
  the data so that it "fits" as well as possible.
  The more the points cluster closely around the
  imaginary line of best fit, the stronger the
  relationship that exists between the two
  variables.
• If it is hard to see where you would draw a line,
  and if the points show no significant clustering,
  there is probably no correlation.

• Validating "hunches" about a cause-and-effect
  relationship between types of variables (ex is
  there a relationship between the production speed
  of an operator and the number of defective parts
  made?)
• Displaying the direction of the relationship
  (positive, negative, etc.) (ex will increasing
  assembly line speed increase or decrease the
  number of defective parts made?)
• Displaying the strength of the relationship (ex
  how strong is the relationship between assembly
  line speed and the number of defective parts
  produced?)

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7. Cause and Effect Analysis

• Brainstorm and write down all the potential
  reasons why.
• Continue asking why at least 5 times or until
  there are no other (practical) reasons.
• To visualize the discussion, construct a
  Fishbone (aka Ishikawa or Cause-and-Effect)
  diagram.

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Brainstorming

• Brainstorming is simply listing all ideas put
  forth by a group in response to a given problem
  or question.
• To conduct a successful brainstorming session
• Make sure everyone understands and is satisfied
  with the central question before you open up for
  ideas.
• You may want to give everyone a few seconds to
  jot down a few ideas before getting started.
• Begin by going around the table or room, giving
  everyone a chance to voice their ideas or pass.
  After a few rounds, open the floor.
• More ideas are better. Encourage radical ideas
  and piggybacking.
• Suspend judgment of all ideas.
• Record exactly what is said. Clarify only after
  everyone is out of ideas.
• Don't stop until ideas become sparse. Allow for
  late-coming ideas.
• Eliminate duplicates and ideas that aren't
  relevant to the topic.
• Rapidly group ideas that seem to belong together
  (called an Affinity Diagram). These groups can
  be used as the Fishbones categories.

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Root Cause Analysis

• Will determine why the root cause occurred in
  the first place.
• Asks difficult and sometimes embarrassing
  questions about how the organization is managed.
  It may even be ignored for internal political
  reasons.
• Stops when youve exhausted all practical
  causes.
• The best candidates for root cause analysis are
  those situations which are recurring the most and
  use up the greatest amount of resource to
  correct.
• Extremely important because if done correctly, it
  will prevent the problem from happening again.
• 10 Steps
• Develop a problem statement
• Understand how the affected process works
• In a team setting (preferably) or individually,
  ask why the problem occurred (5x)
• Determine the Solution (Corrective Action) to
  each Root Cause
• Score and prioritize the causes by their
  frequency, likelihood and ease to correct
• Select the Root Cause(s) and attempt to validate
  them
• Develop a Plan to Implement the Solution
• Execute the Corrective Action Plan
• Verify that the Corrective Action was effective
• Monitor Process

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Team Dynamics

• Charter What is the purpose of the team?
• Set a clear Objective and Target.
• Leader Facilitates the teams actions.
• Champion/Angel motivates and provides
  management support to remove obstacles and
  provide funding/resources.
• The Team maturity progression is
• Creating Cross functional include suppliers,
  process, customers.
• Forming High dependence on leader for guidance
  and direction.
• Storming Conflict occurs in interpersonal
  relationships.
• Norming Agreement and consensus is reached among
  team, who respond well to facilitation by the
  leader.
• Performing The team has a shared vision and is
  able to stand on its own feet with no
  interference or participation from the leader.
• Adjourning the break-up of the team, hopefully
  when the task is completed successfully, its
  purpose fulfilled.

Adjourn Create
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Malcolm Baldrigesee http//baldrige.nist.gov/

• Applying for the Baldrige Award is an opportunity
  to examine your organization critically and
  identify strengths and opportunities to improve.
• An organization will accelerate improvement
  efforts energize their employees gain an
  outside perspective learn from feedback and
  focus on results.
• The Core Values and Concepts are embodied in
  seven Categories, as follows
• Leadership
• Strategic Planning
• Customer and Market Focus
• Measurement, Analysis, and Knowledge Management
• Human Resource Focus
• Process Management
• Business Results

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Malcolm Baldrige

• Core Values and Concepts
• The Criteria are built upon the following set of
  interrelated Core Values and Concepts
• visionary leadership
• customer-driven excellence
• organizational and personal learning
• valuing employees and partners
• agility
• focus on the future
• managing for innovation
• management by fact
• social responsibility
• focus on results and creating value
• systems perspective
• These values and concepts are embedded beliefs
  and behaviors found in high-performing
  organizations. They are the foundation for
  integrating key business requirements within a
  results-oriented framework that creates a basis
  for action and feedback.

34
TRIZ(see http//www.triz-journal.com)

• A problem solving tool based on logic and data
  rather than intuition.
• Eliminates contradictions (e.g., Training should
  be thorough but not take any time)
• Uses 40 Principals (see website)
• TRIZ doctrine
• Somebody, someplace, has already solved any
  problem or one similar to it
• Creativity means finding that solution and
  adapting it to a current problem.

35
Kepner-Tregoe'sFive-Phase Strategy Model

• Phase I Strategic Intelligence Gathering and
  AnalysisA rigorous process is undertaken to
  gather, organize, and analyze data on markets,
  competitors, technology, and past performance to
  ensure that the right information is used to
  facilitate good strategic decision making. Phase
  One provides an information base for strategic
  decision making and an agreed-upon set of
  assumptions about the internal and external
  environments in which an organization will
  operate during its strategic time frame.
• Phase II Formulating StrategyA strategic
  profile of the organization is developed for
  guiding day-to-day decision making. This profile
  defines key strategic elements including
• The basis for competitive advantage
• The scope of the products and services that will
  and will not be offered, and the markets that
  will and will not be served
• The relative emphasis and financial mix of the
  future product/market scope
• The source of new business and growth
• The capabilities needed to implement the strategy
  
• The business results to be achieved
• The critical issues (barriers to implementation)
  to be resolved
• Phase III Implementation PlanningAs a result of
  formulating a clear strategy, many projects
  emerge, the execution of which leads to
  successful implementation of the strategy. The
  creation of a strategic Master Project Plan is
  the key output of this phase, providing a
  detailed definition of each project, sequencing
  projects, developing a schedule, and indicating
  the required resource levels for each project.
  The training of key staff in Project Management
  techniques ensures successful implementation.

• Phase IV Implementing StrategyEven the most
  elegant and robust strategic visions are
  worthless without effective implementation. It is
  the implementation phase of the process that
  yields the tangible results sought by all
  organizations. During this phase, planned actions
  are taken, implementation is monitored, and the
  plan is modified as circumstances change and the
  strategy is revised. Also during this phase,
  employees are given the necessary skills to play
  their role effectively in implementation, with a
  particular emphasis on project management and
  decision making. Effective communication is at
  the heart of flawless strategy implementation.
  Every employee and external stakeholder is
  briefed on the strategy with the intent of
  creating understanding, commitment, and answers
  to the question, "What's in it for me?"
• Phase V Strategy Monitoring and UpdatingOngoing
  review of the strategy is essential for keeping
  the strategy vibrant and relevant as a key tool
  in the continuous quest for success. Typically,
  executive leaders are adept at reviewing the
  operations and financial dimensions of the
  business. The strategic review process is equally
  important. Activities include determining if the
  assumptions upon which the strategy rests remain
  valid assessing if the strategic direction
  continues to make business sense and keeping
  abreast of progress toward implementation.

36
Philip CrosbysZero Defects Approach
Why would a target be anything other than ZERO
Defects?

1. Obtain Management Commitment Make it clear where
   management stands on quality.
2. Form a Quality Improvement Team Manages the
   quality improvement program.
3. Measure Performance Bring problems into the
   light.
4. Determine Cost of Quality Compare with overall
   sales .
5. Provide Quality Awareness Let employees know
   what you intent to do and what you expect from
   them.
6. Corrective Action Identify/prioritize
   improvement opportunities and fix them so they
   dont recur.
7. Zero Defects Planning Develop plan to launch
   Zero Defects Program.

1. Supervisor Training Get buy-in and prepare them
   to train their workers.
2. Zero Defects Day Let employees know that Mgmt is
   serious about the Zero Defects program.
3. Goal Setting Every division will set stretch
   goals.
4. Error Cause Removal employees will identify
   problems throughout the business.
5. Recognition Reward those who exceed goals or
   perform outstanding acts.
6. Quality Councils Form teams to discuss
   improvements and lessons learned.
7. Do it over again After 12-18 months, form a new
   QI Team.

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Cost of (poor) Quality

• The costs associated with quality are divided
  into two categories
• costs due to poor quality and
• costs associated with improving quality.
• Prevention costs and appraisal costs are costs
  associated with improving quality, while failure
  costs result from poor quality.
• Cost of quality comprises of four parts
• External Failure Costs associated with product
  failure after the completion of the production
  process. (e.g., customer complaints, returns,
  recalls, penalties)
• Internal Failure Costs expenses incurred before
  the product or service is provided to the
  customer. (e.g., repair, rework, scrap, data
  corrections)
• Appraisal Costs direct costs of measuring
  quality. (e.g., inspection, test, calibration and
  maintenance)
• Prevention Costs associated with preventing
  defects and imperfections from occurring. (e.g.,
  process monitoring, SPC, audits, planning)
• Phillip Crosby states that quality is free.
  The costs related to achieving quality are traded
  off between the prevention/appraisal costs and
  the failure costs. Therefore, the
  prevention/appraisal costs resulting from
  improved quality, allow an organization to
  minimize or be free of the failure costs
  resulting from poor quality. Do it right the
  first time. The total Cost of Quality should not
  be gt 2.5 of your total Sales dollar. (reference
  Quality is Free IBSN 0-451-62585-4)

38
FMEA(see steps at http//www.npd-solutions.com/fm
ea.html)

• Failure Modes and Effects Analysis (FMEA)
• a methodology for analyzing potential
• reliability problems early in the development
• cycle where it is easier to take actions to
  overcome these issues,
• thereby enhancing reliability through design.
• FMEA is used to identify potential failure modes,
  determine their effect on the operation of the
  product, and identify actions to mitigate the
  failures. A crucial step is anticipating what
  might go wrong with a product. While anticipating
  every failure mode is not possible, the
  development team should formulate as extensive a
  list of potential failure modes as possible.
• The early and consistent use of FMEAs in the
  design process allows the engineer to design out
  failures and produce reliable, safe, and customer
  pleasing products. FMEAs also capture historical
  information for use in future product improvement.

39
PFMEA

• Process Failure Modes Effects Analysis.
• Is a systemized group of activities intended to
• recognize and evaluate the potential failure of a
  product/process and its effect,
• identify actions which could eliminate or reduce
  the occurrence,
• document the process, and
• track changes to process- incorporated to avoid
  potential failures.
• Is a living document. Is better to take actions
  addressed to eliminate or reduce the potential
  causes than implement controls in process. Is a
  process which before hand tells you the potential
  failure modes and their effects.

40
TOC (Theory of Contraints)Ref The Goal by
Goldratt IBSN 0-88427-061-0

• The Five focusing steps
• 1. Identify the System's constraints.
• A process is analyzed so that a task or activity
  that limits the productivity of an entire system
  can be identified. A system constraint may be
  identified by a long queue of work or long
  processing times.
• 2. Decide how to exploit the system's
  constraints.
• Decisions must be made on how to modify or
  redesign the task or activity so that work can be
  performed more effectively and efficiently.
• 3. Subordinate everything else to the above
  decision. (step 2)
• Management directs all its efforts to improving
  the performance of the constraining task or
  activity and any other task or activity and any
  other task or activity that directly affects the
  constraining task or activity.
• 4. Elevate the system's constraint.
• Additional capacity is obtained that will
  increase (elevate) the overall output of the
  constraining task or activity. This differs from
  step 2 in that the added output comes from
  additional purchased capacity, such as buying a
  second machine tool or implementing a new
  information technology.
• 5. If, in the previous step, a constraint has
  been broken, go back to step 1 but do not allow
  inertia to cause a new constraint
• Sets up a process of ongoing improvement. As a
  result of the focusing process, the improvement
  of the original constraining task or activity may
  cause a different task to become a constraining
  task or activity. Inertia could blind management
  from taking steps to improve the system's output
  now limited by a new constraint.(1)

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Process Capability

• Measures the ability of a process to produce a
  product that will consistently meet design
  specifications.

s CPk Defects/million opportunities Yield
1.5 0.50 500,000 50
3.0 1.00 66,800 93.32
3.5 1.17 22,800 97.73
4.0 1.33 6,200 99.379
4.5 1.50 1,350 99.865
5.0 1.67 233 99.977
6.0 2.00 3.4 99.9997

• Process Capability (Cpk)
• Relationship between the natural variation of
• the process and the design specifications.
• A Cpk of greater than one indicates that the
  process spread is less than the width of the
  specification. Potentially, this means that the
  process can fit inside the specification limits.
• Cpk gt 1.33 (capable)
• 1.00 gt Cpk lt 1.33 (capable with tight control)
• Cpk lt 1.00 (not capable)

UTL Upper spec limit LTL Lower spec limit s
std deviation of process µ process mean min
which ever is smaller
Process Capability Index
Process Capability Ratio
42
QFD(also see http//sern.ucalgary.ca/courses/sen
g/613/F97/grp2/report.htm)

• Quality Function Deployment (QFD) is a method of
  listening to customers to learn exactly what they
  want, and then using a logical system to
  determine how best to fulfill those needs with
  available resources. It is a product-development
  tool that can systematically deploy customer
  requirements into production requirements. QFD is
  a team builder approach it ensures that everyone
  works together to give customers what they want.
  It gives everyone in the organization a road map
  showing how every step, from design through
  delivery, interacts to fulfill customer
  requirements.
• QFDs primary goal is to overcome three major
  problems in traditional methods
• disregard for the voice of the customer
• loss of information, and
• different individuals and functions working to
  different requirements.
• In QFD, these issues are addressed by effectively
  answering the following questions
• What are the qualities the customer desires?
• What functions must the product serve and what
  functions must we use to provide the product or
  service?
• Based upon the resources we have available, how
  can we best provide what our customer wants?

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APQP

• Advanced Product Quality Planning (used mostly
  in automotive industry)
• Phase 1 - Plan Define Program - determining
  customer needs, requirements expectations using
  tools such as QFD review the entire quality
  planning process to enable the implementation of
  a quality program how to define set the inputs
  the outputs.
• Phase 2 - Product Design Development - review
  the inputs execute the outputs, which include
  FMEA, DFMA, design verification, design reviews,
  material engineering specifications.
• Phase 3 - Process Design Development -
  addressing features for developing manufacturing
  systems related control plans, these tasks are
  dependent on the successful completion of phases
  1 2 execute the outputs.
• Phase 4 - Product Process Validation -
  validation of the selected manufacturing process
  its control mechanisms through production run
  evaluation outlining mandatory production
  conditions requirements identifying the
  required outputs.
• Phase 5 - Launch, Feedback, Assessment
  Corrective Action - focuses on reduced variation
  continuous improvement identifying outputs
  links to customer expectations future product
  programs.
• Control Plan Methodology - Discusses use of
  control plan relevant data required to
  construct determine control plan parameters
  stresses the importance of the control plan in
  the continuous improvement cycle.

44
CMM

• The Capability Maturity Model for Software (also
  known as the CMM and SW-CMM) has been a model for
  judging the maturity of the software processes of
  an organization. This model helps organizations
  identify the key practices required to help them
  increase the maturity of these processes.
• Predictability, effectiveness, and control of an
  organization's software processes are believed to
  improve as the organization moves up these five
  levels. While not rigorous, the empirical
  evidence to date supports this belief.

1) Initial. The software process is characterized
as ad hoc, and occasionally even chaotic. Few
processes are defined, and success depends on
individual effort and heroics. 2) Repeatable.
Basic project management processes are
established to track cost, schedule, and
functionality. The necessary process discipline
is in place to repeat earlier successes on
projects with similar applications. 3) Defined.
The software process for both management and
engineering activities is documented,
standardized, and integrated into a standard
software process for the organization. All
projects use an approved, tailored version of the
organization's standard software process for
developing and maintaining software. 4) Managed.
Detailed measures of the software process and
product quality are collected. Both the software
process and products are quantitatively
understood and controlled. 5) Optimizing.
Continuous process improvement is enabled by
quantitative feedback from the process and from
piloting innovative ideas and technologies.
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HACCPHazard Analysis and Critical Control Point

• HACCP is a scientific system for process control
  that has long been used in food/beverage
  production to prevent problems by applying
  controls at points in a production process where
  hazards could be controlled, reduced, or
  eliminated.
• The program reduces risks to the customers. A
  plant must have an effective HACCP system to
  comply with regulatory requirements and prevent
  adulteration of product.
• See 9 CFR Part 417.
• Steps to meet HACCP are defined on the right.