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CMQ-OE Certification Preparation

Module IV
Quality Management Tools
BoK OBJECTIVE

IV.A.1 The Seven


Classic Quality Tools

Select, interpret, and evaluate output


from these tools: Pareto charts, cause
and effect diagrams, flowcharts, control
charts, check sheets, scatter diagrams,
and histograms. (Evaluate)

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The Seven Classic Quality Tools
The seven classic tools for quality control, also
referred to as the seven basic quality tools, include:
• Flowcharts/process maps
• Check sheets
• Pareto charts
• Cause-and-effect diagrams
• Scatter diagrams
• Control charts
• Histograms

Each tool provides a means for organizing and


analyzing data.

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Flowchart
Helps understand the steps and sequence of steps to any
process

Load files

Audit files Credit

Send memo

Distribute

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Check Sheet

Warehouse 43

Damaged Defective Missing

Station 1

Station 2

Station 3

Station 4

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Pareto Charts
Pareto principle states that 80 percent of process
variation is caused by 20 percent of the variables.

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Cause-and-Effect Diagram
Helps you brainstorm potential causes of a major problem and
then organize and categorize those causes for further analysis.

Management
Environment
Process

Effect

People
Machine Materials
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Scatter Diagram
Used to analyze and depict the relationship between two
different variables to determine whether a correlation exists
between them.

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Control Charts
Control charts help users distinguish between variation that is
inherent in a process and variation that arises from sources
that come and go unpredictably.
60

50

40
Time

30

20

10

0
0 1 2 3 4 5 6
Day
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Histogram
A bar graph that takes measurement data, separates them
into ranges, and displays their distribution to reveal the
amount of variation in the data set.

70
60
50
Frequency

40
30
20
10
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
Steps
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BoK OBJECTIVE

IV.A.2. Basic Management


and Planning Tools
Select, interpret, and evaluate output
from these tools: affinity diagrams, tree
diagrams, process decision program
charts (PDPCs), matrix diagrams,
prioritization matrices, interrelationship
digraphs, and activity network
diagrams. (Evaluate)

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Affinity and Tree diagrams

Affinity Diagram Tree Diagram

Lean Safety Design


Order

Volume Injuries Machines Pickup

Accurate
Machine Noise Costs Tracking Info
Shipment

Product Setup
Delivery

useful when facts or


useful for moving broad
thoughts seem too large
goals to specifics
and too complex to grasp

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PDPC and Matrix Diagram

Process Decision used to improve the


Program Chart implementation of new or revised
tasks that are complex

shows the presence and strength


Matrix Diagram
of relationships between data sets.
Task 1 Task 2 Task 3 Several formats to use depending
on number of groups of items
Role 1

Role 2

(L-shaped)

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Interrelationship Digraph
Question: What factors increase defects?

Instructions not
clear

Training is Equipment is
inconsistent damaged

Operators are Quality of


not held incoming
accountable material is
for defects inconsistent

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Activity Network Diagram
used to show the optimum
Activity Network Diagram schedule for fulfilling a plan and
tracking its progress

Identify Identify info


Assign roles Document
key tasks gaps
3 days key tasks
5 days 90 days 10 days

Gain Consensus Coordinate with


10 days managers
Coordinate with 10 days
operators
10 days

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Prioritization Matrix
1. Identify criteria
Used as a rough 2-axis correlation 2. Determine weights
3. Identify variables
picture between two variables. 4. Apply scores
5. Calculate weight x scores
6. Sum across
Criteria Detectability Occurrence
Severity 7. Sort by sums
5 2 3
Variables

3 2 2
Wrong
15
25
color 4 6

3 5

sum
4
Folding
wrong 20 6
41
15

4 1 3
Missing
paper clip 20 2 9 31

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BoK OBJECTIVE

IV.A.3 Process
Improvement Tools

Select, interpret and evaluate tools


such as root cause analysis, Kepner-
Tregoe, PDCA, six sigma DMAIC
(define, measure, analyze, improve,
control), and failure mode and effects
analysis (FMEA). (Evaluate)

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Root Cause Analysis
If an organization eliminates the cause, it eliminates the
problem. If it fails to identify the cause, the problem will
probably recur.

Cause
Tools include:
Affinity diagrams
Cause-and-effect diagrams
Root
Flowcharts/process maps Cause

Interrelationship diagraphs
Tree diagrams
Five whys Cause

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Root Cause Analysis
7 Step Problem-Solving Model
Problem solving is about identifying root causes that have
caused the problem to occur and taking actions to alleviate
those causes.

Identify the Search out the Identify


List possible
problem and most likely potential
root causes
the process root cause solutions

Follow up to Select and


Standardize
evaluate the implement a
the process
effect solution

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Kepner-Tregoe Method
• Decision-making model to understand root cause
• When a problem occurs, K-T answers four basic questions
via the application of four rational processes

Problem Analysis (Why did it happen?

Situation Analysis
Decision Analysis (What should we do?)
(What happened?)

Potential Problem Analysis


(What does the future hold?)

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PDCA
Four-step process improvement methodology

Continuously rotates
Provides a single root cause focus
Teaches process discipline

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Six Sigma DMAIC

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Six Sigma DMAIC
Define project objectives from the customer’s perspective
Measure the current process and set interim metrics to
measure progress.
Analyze current process-related problems and causes
Improve the process through pilot solutions
Control the improved process through monitoring and
standardization

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Failure Modes and Effects
Analysis (FMEA)
Identify ...
critical process characteristics and
variables
Key
Prioritize ...
Activities process deficiencies in support of
downstream improvement actions

Focus ...
on prevention of process problems

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FMEA Types and Uses
Process Control
• Improvement of an existing • Before developing control plans
process, product, or service for a new or modified process

Design
• Design or redesign of a • New application of an
process, product, or service existing process, product, or
service

Defect
• Failure analysis of an existing
process, product, or service with
focus on the cost of defects

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BoK OBJECTIVE

IV.A.4 Innovation and


Creativity Tools

Use various techniques and exercises


for creative decision-making and
problem-solving, including
brainstorming, mind mapping, lateral
thinking, critical thinking, the 5 whys,
and design for six sigma (DFSS).
(Apply)

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Innovation and Creativity Tools
Brainstorming
– Knowledge pooling to create idea waves
Mind Mapping
– information intake, processing, remembering,
and connecting new ideas to an existing idea
Lateral Thinking
– Specific methods to change concepts and
perceptions for idea generation
Critical Thinking
– Identify question, form hypothesis, gather data,
evaluate hypothesis, draw conclusion

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Innovation and Creativity Tools
5 Whys
– Ask ‘why’ 5 times to get to the root cause
– most useful when problems involve human
factors or interactions.
– shows the relationship between different root causes of
the same problem.

Design for Six Sigma (DFSS)


– prevent defects by transforming customer wants
and perceptions
– Customer focus

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 28
5 Whys Exercise
Think of a problem or mishap or error that
has happened in the past 7 days:

At work
At home
While travelling via airlines
On a project
Getting a task done
In communication with
yourself and others

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 29
Reflection

Which quality tools do you currently use in


your line of work?

How do you use the tools?

Which tools would you


like to learn more about?

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BoK OBJECTIVE

IV.A.5 Cost of Quality (COQ)


Define and distinguish between
prevention, appraisal, internal, and
external failure cost categories and
evaluate the impact that changes in one
category will have on the others.
(Evaluate)

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Cost of Quality
Quality costs refer to:
incurred by an organization to attain
Those expenditures
and ensure specified quality levels
The losses incurred when satisfactory quality is not achieved

Quality costs are the total of the costs incurred by:


Investing in the prevention of non-conformances to
requirements.
Appraising a product or service for conformance to
requirements and failure (internal or external) to
meet requirements.

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Cost of Quality

Appraisal Prevention Internal External


costs costs failure costs failure costs

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BoK OBJECTIVE

IV.B.1 Process Goals

Describe how process goals are


established, monitored, and measured
and evaluate their impact on product or
service quality. (Evaluate)

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Process Goals

1 Define the process.

2 Develop process goals and objectives.

3 Measure the process against established objectives.

4 Make improvements.

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BoK OBJECTIVE

IV.B.2. Process Analysis

Use various tools to analyze a process


and evaluate its effectiveness on the
basis of procedures, work instructions,
and other documents. Evaluate the
process to identify and relieve
bottlenecks, increase capacity, improve
throughput, reduce cycle time, and
eliminate waste. (Evaluate)

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Process Analysis
Identifying an organization’s business processes
✓Brainstorm
✓Map elements
✓Rank and prioritize processes

Analyzing the processes


✓Identify process elements (SIPOC)

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SIPOC

Clients files Memos Clients


Mfr’s Reports

Audit client sales Generate credit Distribute credit


against price files memos and reports memos and report

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Process Documentation

Commonly achieved through the use of


flowcharts

Written procedures define responsibilities.

Work instructions results in an output.

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BoK OBJECTIVE

IV.B.3 Lean Tools

Identify and use lean tools such as 5S,


just-in-time (JIT), kanban, value stream
mapping (VSM), quick-changeover
(single-minute exchange of die),
poke-yoke, kaizen, standard work
(training within industry), and productivity
(OEE). (Apply)

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 40
Lean Tools
Lean is a collection of tools, techniques, and
processes to reduce waste through continuous
improvement.
In general, by reducing waste, lean reduces
• costs
• cycle times
• customer dissatisfaction

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Lean Tools
Cycle-time reduction
Cycle time = total amount of time required to complete a process,
from first step to the last (define process, list activities, flowchart
process, list elapsed time for each activity, identify non-value-
added tasks, eliminate all possible non-value-added tasks)
5S (workplace organization)
• Seiri (Sort): Eliminate the unnecessary
• Seiton (Set in order): Organize what remains
• Seiso (Shine): Clean work area
• Seiketsu (Standardize): Set regular cleaning and maintenance
schedules
• Shitsuke (Self-discipline): Make 5S a way of life
(sustain)

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Kanban
Just-in-time (JIT)
JIT is a material requirement planning system that
provides for the delivery of material or product at the exact
time and place where the material or product will be used
(demand pull, manufacturing processes, reduced setup
and lead times)
Kanban
• Works in concert with JIT
• Visual signal to restock

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Value Stream Mapping
Visually maps the material and information flow. Includes the physical
mapping of the “current state” with focus on getting to “future state.”

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SMED
Single minute exchange of dies is a key strategy to
decrease overproduction and excess inventory.

The time between the last good piece from


one run and the first good piece from the next
run is considered to be the changeover time.

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Lean Tools
• Poke-Yoke
– Eliminate opportunity for error, detect error potential, prevent error
• Kaizen
– Continual, incremental improvement
– Kaizen blitz – rapid change
• Standard work (training within industry)
– Rapidly teach people to do their jobs in industry, by industry; three
programs
• Job Instruction (teach supervisors how to train)
• Job Methods (teach supervisors how to break jobs into operations)
• Job Relations (teach supervisors how to work with others)
• Overall equipment effectiveness (OEE) metric
– Multiplying availability, performance, and quality
– Allows an organization to assess how well a machine or operation is
performing
Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 46
BoK OBJECTIVE

IV.B.4 Theory of Constraints (TOC)


Define key concepts of TOC: systems
as chains, local vs. system
optimization, physical vs. policy
constraints, undesirable effects vs.
core problems, and solution
deterioration. Classify constraints in
terms of resources and expectations as
defined by measures of inventory, and
operating expense. (Understand)

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Theory of Constraints
Systems as chains
Weakest link

Local vs. system optimization


System optimum is not the sum of the local optima

Physical vs. Policy constraints


Policy constraints elimination means higher system improvement

Undesirable effects vs. core problems


UDEs are manifestations of core problems

Solution deterioration
Solutions that eliminate individual UDEs ignores core problem; to
solve, eliminate all UDEs

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TOC - Goldratt’s Principles*:

01 02
Identify Decide

05
Go Back G.P 03
Subordinate

04
Evaluate

*Goldratt’s Theory of Constraints, Eliyahu M. Goldratt, Author

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 49
Theory of Constraints
TOC tools:
• Current reality tree
• Future reality tree
• Prerequisite tree
• Transition tree
• Conflict resolution diagram
Flow of money:
System
$ $ $

Throughput Inventory Operating


Money Money tied up inside Expense
coming in Money going out
Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 50
BoK OBJECTIVE

IV.C.1 Basic Statistical Use

Use statistical techniques to identify


when, what, and how to measure
projects and processes. Describe how
metrics and data gathering methods
affect resources and vice-versa. (Apply)

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Basic Statistical Use
Techniques/tools for measuring processes:
– Goal – Question – Metric (GQM)
• Conceptual level (goal)
• Operational level (question)
• Quantitative level (metric)
Measuring independent process variables; Critical-
to-quality (CTQ): Inputs (x), Outputs (y)

Measuring projects:
• Planning and management measures
• Project deliverables measures

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 52
Basic Statistical Use
• Establishing process measures
• Techniques/tools for measuring projects
• Effect of metrics and measuring on people:
– What data you need
– Who will supply data
– How data is transformed
– How information is used
– How information is communicated

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BoK OBJECTIVE

IV.C.2 Sampling
Define and describe basic sampling
techniques such as random and
stratified. Identify when and why
sampling is an appropriate technique to
use. (Understand)

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Sampling Techniques
The sampling process will depend on the purpose, desired
statistical confidence, and economics.
• Random sampling: Equal opportunity for each sample to
be selected
• Stratified sampling: Sample from particular portion of the
population
• Systematic sampling: Where every nth item is selected
• Cluster sampling: Random sample is taken from within a
selected subgroup
• Best judgment sampling: Opinion determines the best
location and characteristics of the sample group

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 55
Sampling Techniques
• Acceptance sampling
– Sampling a batch of material to evaluate the level of
nonconformance relative to a specified quality level
• Risks in sampling
– (1) Alpha/producer’s risk
– (2) Beta/consumer’s risk
Actual Lot Quality
Good Bad
Decision Made

Lot 1- 
Accepted Producer’s Type 2 Error
confidence Consumer’s Risk
 1-
Lot Type 1 Error Consumer’s
Rejected Producer’s Risk confidence

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 56
BoK OBJECTIVE

IV.C.3 Statistical Analysis


Calculate basic statistics: measures of
central tendency (mean, median,
mode), and measures of dispersion
(range, standard deviation, and
variance). Identify basic distribution
types (normal, bimodal, skewed) and
evaluate run charts, statistical process
control (SPC) reports, and other control
charts to make data-based decisions.
(Evaluate)
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Central Tendency
Measures of central tendency:
• Mean: mathematical average of the numbers in a data
set.
• Median: middle number of the data set.
• Mode: most frequently occurring value in a data set.

When analyzing data, different measures of central tendency


provide differing answers, and knowing which measure is
most appropriate in a given scenario will allow you to provide
an accurate interpretation of the data set.

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Measures of Dispersion
The term "Measure of Dispersion" refers to the amount of
variation or spread of a set of data within a population.

Common terms include:


Range - the difference between the maximum and minimum
values in a data sample
Range (R) = Xmax - Xmin
Standard deviation - standard measure of deviation from
the population or sample mean.

Variance - the square of the standard deviation (limited


application).
Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 59
Distribution Types
Probability Distribution: mathematical formula that
relates the values of characteristics with their probability of
occurrence in a population.
• Discrete distribution
• Continuous distribution

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Data-Based Decision Making
Run Charts
• Trend analysis
• Data shifts
• Frequency and magnitude of data variation
Regression
• Allows people to predict one variable from one or more other
variables.
Correlation
• measure of the relationship between two sets of numbers or
variables.
Statistical Process Control (SPC)
• measuring and analyzing the variation in processes

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 61
Statistical Process Control - SPC
The application of statistical techniques for measuring and
analyzing process variation for both variables and attributes
Variables-type control charts:
• x-bar and R chart
• x-bar and s chart
• CUSUM chart

Attributes-type control charts:


• np-chart (defective units)
• p-chart (fraction of units
defective)
• c-chart (number of defects)
• u-chart (number of defects
per unit)
Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 62
BoK OBJECTIVE

IV.C.4 Measurement
System Analysis

Understand basic measurement terms


such as accuracy, precision, bias,
linearity. Understand the difference
between repeatability and
reproducibility in gauge R&R studies.
(Understand)

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Measurement System Analysis
Accuracy: The degree to which a device ‘agrees’ with the
‘true’ value according to a standard

Calibration: Maintaining measurement system performance


usually by comparison to a standard

Bias: A difference between the output of the measurement


method and the true value

Linearity: Equal bias (hopefully small) across the operating


range

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Measurement System Analysis
Precision is the aspect of
measurement that addresses
repeatability or consistency when an
identical item is measured multiple
times.

Repeatability is the amount of


variation in a single gage and is
determined by having the same operator
measure the same thing with the same
gage multiple times.

Reproducibility is the amount of


variation between operators. This is
determined by having different
operators measure the same thing
multiple times.

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 65
Accuracy and Precision
Accurate and precise Not accurate, but precise

Not accurate and not precise Accurate, but not precise

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BoK OBJECTIVE

IV.C.5 Trend
and Pattern Analysis

Interpret graphs and charts to identify


cyclical, seasonal, and environmental
data trends. Evaluate control chart
patterns to determine shifts and other
trend indicators in a process.
(Evaluate)

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Trend and Pattern Analysis
Trend analysis: look at data over time to find patterns.
Long-range trend analysis
• Can occur regularly over weeks, months, or years.

Short-range trend analysis


• Detail oriented. Changes quickly.

Patterns:
• Cyclical: output to gradually increase (or decrease), then
gradually return to approximately the original level.
• Shifts: an abrupt change in an important variable that
may cause an output measure to suddenly increase or
decrease.
Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 68
Trend and Pattern Analysis
Control Charts - used to evaluate trends and patterns
Run Charts - allow the observer to understand, over time,
the cycles, trends, and shifts that have occurred in a
process.

Certified Manager of Quality/Organizational Excellence Certification Preparation v02.01 © 2019 ASQ. All Rights Reserved. 69
BoK OBJECTIVE

IV.C.6 Process Variation

Analyze data to distinguish between


common and special cause variation.
(Analyze)

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Theory of Variation
Factors affecting variation:
– People
– Machinery
– Environment
– Material
– Measurement
– Methods
Common causes (inherent)
Special causes (chance or assignable causes)

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BoK OBJECTIVE

IV.C.7 Process Capability

Recognize process capability (Cp and


Cpk) and performance indices (Pp and
Ppk). (Understand)

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Process Capability
Definition: Range within which a process is normally able to
operate given the inherent variation due to design and
selection of materials, equipment, people, and process steps
Stability or statistical control is an essential requirement
to assess process capability.
Capability indices can be used to determine whether to:
• Do nothing
• Change the specs
• Center the process
• Reduce variability
• Accept the losses
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Process Capability Indices
• Cp measures the spread of the specifications relative to
the six sigma spread in the process.
– Cp does not take into account where the process
mean is located relative to the specifications.
𝑈𝑝𝑝𝑒𝑟 𝑠𝑝𝑒𝑐 − 𝐿𝑜𝑤𝑒𝑟 𝑠𝑝𝑒𝑐
𝐶𝑝 =
6𝜎

• Cpk takes process centering into consideration and it


represents shortest distance for the specification limit
nearest to the process average.
|𝑈𝑝𝑝𝑒𝑟 𝑠𝑝𝑒𝑐 − 𝐴𝑣𝑒𝑟𝑎𝑔𝑒| |𝐴𝑣𝑒𝑟𝑎𝑔𝑒 − 𝐿𝑜𝑤𝑒𝑟 𝑆𝑝𝑒𝑐|
𝐶𝑝𝑘 = 𝑜𝑟
3𝜎 3𝜎

(Whichever is smaller)
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Performance Capability Indices
• Pp – Indicator of past process performance
• Ppk – Potential process capability

Where s is the usual sample standard deviation…


𝑈𝑝𝑝𝑒𝑟 𝑠𝑝𝑒𝑐 −𝐿𝑜𝑤𝑒𝑟 𝑠𝑝𝑒𝑐
P𝑝 =
6𝑠

|𝑈𝑝𝑝𝑒𝑟 𝑠𝑝𝑒𝑐 −𝐴𝑣𝑒𝑟𝑎𝑔𝑒| |𝐴𝑣𝑒𝑟𝑎𝑔𝑒 −𝐿𝑜𝑤𝑒𝑟 𝑆𝑝𝑒𝑐|


P𝑝𝑘 = 𝑜𝑟
3𝑠 3𝑠
(Whichever is smaller)

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BoK OBJECTIVE

IV.C.8 Reliability Terminology


Define and describe basic reliability
measures such as infant mortality, end
of life (e.g. bathtub curve), mean time
between failures (MTBF) and mean
time to repair (MTTR). Understand the
value of estimating reliability to meet
requirements or specifications.
NOTE: Reliability calculations will not
be tested. (Understand)

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Reliability and Validity

Reliability:
(precision, repeatability)

Validity: (accuracy)
• Face
• Criterion-related
• Construct-related
• Content-related

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Infant Mortality and End-of-Life
Infant Mortality
Premature, early product failures that occur prior to the
product entering service
End-of-Life (Bathtub Curve)
Maps product infant mortality failures, rate of product failure
during normal use, and rate of failures as the product wears
Reliability

Failure
Rate

Infant Mortality Normal Life Wear Out


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MTBF and MTTR
Mean Time Between Failures
(MTBF) is the expected time a process or machine can
expect to be operating between failures.

Mean Time to Repair


(MTTR) is the mean or average
time required to repair a failure.

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Quality Management Tools

Problem solving tools

Process management

Measurement: Assessments and Metrics

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Reflection

What are two ways you can use or apply


something we’ve covered in Module IV?

What questions do you have


from Module IV?

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