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PDCA
Cycle that provides the basis for continuous improvement, persistence is key in continuous improvement
Core method of Lean: Plan-Do-Check-Act
Plan: Devise or revise process components to improve results
Do: Implement the plan and measure it’s performance
Check: Assess the measurements and report the results
Act: Decide and implement the changes needed to improve the processes
focus on the customer
attack waste, expose problems, streamline production
Engage employees at all levels
DMAIC
Core method of Six Sigma Define, Measure, Analyze, Improve, Control
Define: identify customers and their priorities
Measure: determine how to measure the process and how it is performing
Analyze: determine the most likely cause of defects
Improve: identify means to remove the causes of defects
Control: determine how to maintain the improvements
Focus on the customer
Improve processes, reduce variation
Engage Employees at all Levels
Similarities of Lean and Six Sigma
Both emphasize systems thinking and process management
focus on the customer
Engage Employees at all Levels
continuous improvement
high-level leadership
Six Sigma
philosophy and set of methods companies use to eliminate defects in their products and processes
seeks to reduce variation in processes that lead to product defects
NO MORE THAN 3.4 DPMO
Types of Waste
Overproduction (production that is more than needed or before it is needed)
Waiting (wasted time waiting for the next step in a process)
Transportation (unnecessary movement of products & materials)
Inefficient Processing (more work or higher quality than is required by the customer)
Inventory (excess products and materials not being processed)
Motion (unnecessary movements by people or poor ergonomics)
Quality Failures/Defects (efforts caused by rework, scrap, and incorrect information
*Non Utilized Talent (under utilizing people’s talents, skills & knowledge) \
8th waste
Push Versus Pull
Push System: materials is pushed into downstream workstations regardless of whether resources are avalible
Pull System: material is pulled to a workstation as needed
SIPOC
Suppliers, Inputs, Processes, Outputs, Customers
diagram that outlines processes and gets a sense of process boundaries
focus on aspects of the process that are critical to quality
DEFINE tool
DMAIC Tools
Define: Project Charter, SMART objectives, SIPOC, CTQ
Measure: VSM (current state map), SPC (Control Charts)
Analyze: Hypothesis Testing, Root Cause Analysis, Experimentation, SPC (Control Charts), Ishikawa Diagram
Improve: Pilots & Experimentation, SPC (Control Charts), Set Performance Metics & Target performance levels
Control: Standardization, Visual Management Systems, Error Proofing
Best Practices for charts, figures, and tables
Labeled Axes, Cumulative Percents only go to 100, Chart Title,
figured should be stand alone (no accompanying text needed to interpret the chart
Appraisal vs. Prevention Costs
Appraisal: after the fact quality management expense
final product testing
limited by sampling
does not improve process capability
reduce the chances of having an internal failure
ex. Inspections
ex. Audits
Prevention: investments before the fact for quality management
ex. employee training
ex. Standardization & SOPs
ex. Preventive maintenance
ex. FMEA
ex. Quality planning
Affinity Diagrams
useful for processing brainstorm output
allows team organization of ideas
can reduce output of brainstorm into manageable categories
may uncover previously unrecognized connections
works by organizing ideas into multiple categories which are then labeled with a common theme
Pareto Analysis & Charts
Based on the “Pareto principle” - separate the vital few from the trivial many
Analysis that uncovers relative frequency or impact of various issues
Chart is organized in descending order, most frequent to least frequent, to identify the critical few areas to address first for highest impact
Descriptive Analysis
What data is available
create a table aka data dictionary
Describe Data
Central Tendency (Mean & Median)
Dispersion (minimum, maximum, standard deviations)
Correlations (for pairs of continuous variables)
Missing Data
Unusual Observations
Visualize Data
create line charts for time series, histograms for distribution, scatter plots for associations
Interpret & Report Descriptive Analysis
Measure in DMAIC
Value Add vs. Non Value Add
Value Add: work the customer is willing to pay for
Non Value Add: work that the customer is not willing to pay for and which does not otherwise add value, this is considered waste
Visual Management
process conditions are easy to observe and interpret
color coding
labels
outlines
shadow boards
5 S
Sort - determining what is necessary and what should be moved or discarded
Set in order - orginaze logically to suit task
Shine - clean
Standardize - use visual management tools to indicate where each item should be stored
Sustain - set routines to make sure new order is maintained (weekly scorecard, routine shine activity)
Value Stream Mapping
a special type of flowcharting tool used to analyze where value is or is not being added as materials flow through a process
start by defining value stream boundaries (where map will start/stop)
VSM includes
Physical materials flows (activities, waiting/storage)
Information Flows (planning, scheduling, quality approvals, shipping approvals)
Major suppliers & customers
Existing process data (information on cycle times, available operating time, first pass yield rates, scrap/defect rates, changeovers, “pain points” etc.)
Decision points (where flow spits)
Dirty Dozen
12 Common Causes of Human Factor Error
Lack of Communication
Complacency
Lack of Knowledge
Distractions
Lack of Teamwork
Fatigue
Lack of Resources
Pressure
Lack of Assertiveness
Stress
Lack of Awareness
Norms
Ishikawa Diagram
Fishbone Diagram
Identify key performance measure or event of interest
Use Categories
Manufacturing: (People, machines, materials, methods, measurement, environment)
Transactions: (People, processes, procedures, policies, measurement, environment)
Brainstorm under each category
get as close to variable levels
Label each fact/variable as C, N, or X
C = variables that are already controlled
N = variables that are not controlled or held constant
X = variables we believe are key to process performance and which we can influence (x variables may turn into c)
Principles of Cause & Effect
Time order Precedence
X occurs before Y
Covariance
when X moves Y moves
Rule out Alternative Causes
mitigated with experiments
can’t be statistically calculated
FMEA
Failure Mode Effect Analysis
Failures are prioritized for mitigation based on FREQUENCY of occurrence
and SEVERITY of effects.
When to apply:
New process/products
Process/product changes
Periodically for existing processes/products
To analyze failures
How to conduct:
Process Function (What is being done)
Failure Mode (How could the function go wrong)
Failure Effects (What is the result of the failure)
Severity
Potential Causes or Mechanisms
Occurrence
Existing Control
Detection
Risk Priority Number
IMPROVE - DMAIC
Improve Best Practices
Regardless of Root Cause Analysis (RCA) method applied, improve should focus on root cause
Validate underlying causes through investigation, observation, and experimentation
Investigation: Underlying cause validated by consulting with process experts, operators, data collection
Observation: RCA involves some level of speculation regarding underlying factors. When relevant/adequate data is not available, it should be collected to verify causes.
Experimentation: Where possible, manipulate factors (X Variables) through controlled experiments to verify cause and improvement
Based on Validated Root Cause:
Brainstorm potential improvements (use cross-functional expertise and process experts)
Consider performance objectives (How do we get from X to Z)
Benchmark improvements and performance
Internal benchmarks: What is best practice or performance in your firm for smaller processes
External benchmarks: What is best practice or performance in your industry for similar processes
Evaluate & Mitigate risks
Failure Modes & Effect Analysis
Questions to ask to develop evaluation criteria
What should the ideal situation look like
What are the barriers to implementing a solution
How will cost impacts be measured
How quickly can an improvement be implemented
What are risks of implementation
What other processes could be impacted
Define criteria for evaluating improvements:
Critical to Quality
Customer requirements & Customer satisfaction
Business needs
Alignment with strategy
Contribution to performance objectives including time, cost, revenue, market share regulatory compliance
cost, risk to implement
Organize & define potential improvements:
Synthesize/group ideas using affinity diagrams or similar processes
Define Improvement ideas
What is it exactly?
How should it be measured?
What additional data, investigation, experimentation is needed to define the improvement
Start Small
Focus improvements on one area or process or one location
Carefully consider scope of improvements - quality v quantity
Pilot solutions, evaluate performance, seek feedback
Evaluate readiness for change
Develop change management/implementation plans
Make case for broader implementation
consider motivations and incentives of all stakeholders
Articulate benefits (individual, team, business unit, organization)
Build support among stakeholders
Communicate implementation plan, including performance measurement
Make performance measures visible
Control Best Practices
Control practices are intended to:
Sustain improvements
Evaluate continued effectiveness of improvements
Identify need for additional problem solving/change
Developing control - questions to ask
Measurement - how should performance be measured
Standards - what standard should be set for adequate performance
Change management - what is the review process for the procedure/standard/process/improvement
Checklist Manifesto
2 Major Challenges to preventing mistakes
Lack of Knowledge - either the knowledge doesn’t exist, or we don’t have that knowledge
Memory or inattention (distraction) issues - we have the knowledge, but we forget or are distracted/inattentive etc. so we don’t apply the knowledge
What kind of tasks are amenable to checklists
Routine (we perform it multiple times are there are multiple steps, useful when multiple persons need to execute task repeatedly)
What kind of tasks are not amenable to checklists
Tasks where there is no realistic/consequential problem if performed incorrectly
Tasks that have never been performed before
VOC - Voice of Customer
Describes what customers want or expect (their needs, preferences, and quality requirements)
Costs of Control
Prevention & Appraisal Costs
Quality Costs
the total costs associated with ensuring and maintaining product quality, including prevention, appraisal and failure costs (internal + external)
Cost of Failure
External
Defect gets to the customer
Costs are higher than internal failures and are hard to measure
affect liability & reputation/brand
ex. returns/warranty claims
Internal
defect found before getting to customer
ex. scrap
Dimensions of Quality
key aspects customers use to judge a product or service’s excellence
help firms understand what drives customer satisfaction and guide product design and improvement.
Performance
Features
Reliability
Conformance
Durability
Serviceability
Aesthetics
Perceived Quality
Variable Types
Categorical (Qualitative)
Nominal (e.g., gender)
Shirt Size (e.g. S, M, L).
Numerical (Quantitative):
Discrete (counts)
Continuous (measurements).
Conformance Quality
Those that must be present for a product to be considered “good enough” to enter the next process or to be sold. Will meet all specifications.
Conformance Quality Is:
Determined by the producer to meet customer requirements are
the degree to which process outputs meet specifications
typically includes attributes that ensure the product meets regulatory requirements
Specifications
documented target values or standards that define how a product or process should perform → set acceptable limits or tolerances for CTQs to ensure consistency and customer satisfaction.
Process control vs process capability
Process control
focuses on monitoring and maintaining process stability over time using control charts to detect unusual variation.
Process capability
measures how well a stable process can produce output within customer or design specifications.
CTQ Attributes
key measurable characteristics of a product or process that directly affect customer satisfaction → translate customer needs (VOC) into specific, actionable performance requirements.
Statistical Process Control (SPC)
uses statistical methods, mainly control charts, to monitor and maintain process stability over time
helps detect unusual variation early, prevent defects, and ensure consistent, predictable quality in products and processes.
provides a leading indicator of process performance
testing and inspection in quality management
examining products or processes to verify they meet specifications and quality standards
detect defects or deviations before products reach customers, ensuring reliability and compliance.
Operational Definition
clearly describes how a variable or process will be measured or identified so it can be observed and repeated consistently
remove ambiguity so everyone measures & interprets data the same way.
X-bar chart
Centerline: mean of means
LCL & UCL: calculated based on sample
Signal: mean of sample observations
Optional: specification limits (LSL & USL – determined by producer for conformance quality)
R Bar Chart
Centerline: mean of ranges
LCL & UCL: calculated based on sample
Signal: sample ranges
Optional: specification limits rely on the assumption of normality
Rules for interpreting X & R Bar Chart
Does the process violate an LCL or UCL?
if yes then process is statistically OOC and there is likely a specific reason (non random error)
Rule 1: 10 or more consecutive samples above or below the centerline indicate OOC,
Rule 2: non-random patterns in chart suggest special cause variation & should be investigated
if any of these criteria are met the process is NOT STABLE aka OOC
Current vs Future VSM Maps
Current - how process operates in current moment
Future - how process should ideally operate after improvements are implemented
Control Chart Assumptions
Control charts assume a stable, consistent process in which data are independent, normally distributed (for variable charts), measured reliably, and collected in rational subgroups so that only common-cause variation is present when establishing control limits.
Corrective Action
Actions taken after root cause analysis to address the underlying cause(s) of issues, intended to prevent future, similar occurrences
Verifying Root Cause
Pilot Testing and Experimentation
•Control as many contributing factors as possible
•Vary X variables, measure changes in Y (outcome)
•Ideally, hypothesis tests to demonstrate the statistical effect of change
•Small scale pilot allows adjustment of improvement, employee feedback prior to broad implementation
Standardization
Objectives:
Sustain improvements
Evaluate continued effectiveness of improvements
Identify need for additional problem solving/change
Key Principles:
Standards define what standard should be set for adequate performance
Procedures outline how a task must be done:
Include standards for acceptable quality (completion, accuracy, etc.)
Incorporate change management - regularly updated for consistency, changes in practice & requirements
Checklists:
Not for training, but for use by those who already have competency
Selective use depending on situation
Job aids:
Memory aids for those who have been trained
More detailed than a checklist
Often implemented when tasks are completed infrequently
Tools include: SOPs, job aids, training, and visual management systems
Error Proofing (Poke Yoke)
Objectives:
Verify root cause (evidence, logic, hypothesis testing)
Prevent errors from occurring or detect them before they cause problems
Part of the Control phase tools
General Principles & Examples:
Physical design constraints: Dedicated material hoses have unique fittings that cannot be used for other materials because connectors do not match (prevents wrong material use)
Checklist verification systems:
2-person checklist verification on the floor
1-person checklist verification in control room by radio
End of checklist review
End of shift review with incoming shift
Root Cause Analysis
Objectives:
Solutions should NOT be generated or evaluated until Root Cause Analysis is complete (exception: low risk, quick improvements)
Identify key performance measure or event of interest
Use Ishikawa Diagram (Cause & Effect) with categories appropriate for your context
Label factors as C (controlled), N (not controlled), or X (key variables we can influence)
Work from factors "close" to performance or event outward to get to variable level if possible
General Principles:
Root Cause Analysis occurs in the "Analyze" phase of DMAIC
Generate as many meaningful ideas for each category
Facilitator must clarify meaning of terms and supporting evidence
Facilitator must keep group from jumping to solutions
Validate underlying causes through investigation, observation, and experimentation
Once underlying causes are identified, verify with data/evidence, test through experiments, and investigate cost impact before implementing solutions