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Statistical Quality Control
by ENG/Alaa Abdrabou
Saturday, 17
February 2024
The Right Statistical Tools
Saturday, 17
February 2024
DATA
Saturday, 17
February 2024
Basic Statistics
 Descriptive Statistics
 A straightforward presentation of facts. A
survey or summary of a population in
which all data are known.
 Inferential Statistics
 Drawing conclusions about a population
from a random sample
Saturday, 17
February 2024
Inferential Statistics
 Inferential statistics is a valuable tool because it allows us to look at a
small sample size and make statements on the whole population.
 Samples must be pulled RANDOMLY from a population so that the
sample truly represents the population. Every unit in a population
must have a equal chance of being selected for the sample to be truly
random.
 The distribution or shape of the data is important to know for analytical
purposes.
 The most common distribution is the bell shaped or normal distribution.
 Parameters can be estimated from sample statistics. Two of the most
common parameters are the mean and standard deviation.
 The mean (or average, denoted by μ) measures central tendency
This is estimated by the sample mean or xbar.
 The standard deviation (σ ) measures the spread of the data and is
estimated by the sample standard deviation
Saturday, 17
February 2024
SYMPOLS OF STATISTICS
Saturday, 17
February 2024
Three SQC Categories
 Statistical quality control (SQC) is the term used to describe
the set of statistical tools used by quality professionals
 SQC encompasses three broad categories of;
 Descriptive statistics
 e.g. the mean, standard deviation, and range
 Statistical process control (SPC)
 Involves inspecting the output from a process
 Quality characteristics are measured and charted
 Helpful in identifying in-process variation
 Acceptance sampling used to randomly inspect a batch of goods to
determine acceptance/rejection
 Does not help to catch in-process problems
Saturday, 17
February 2024
Sources of Variation
 Variation exists in all processes.
 Variation can be categorized as either;
 Common or Random causes of variation, or
 Random causes that we cannot identify
 Unavoidable
 e.g. slight differences in process variables like diameter, weight, service
time, temperature
 Assignable causes of variation
 Causes can be identified and eliminated
 e.g. poor employee training, worn tool, machine needing repair
Saturday, 17
February 2024
Traditional Statistical Tools
 Descriptive Statistics
include
 The Mean- measure of central
tendency
 The Range- difference
between largest/smallest
observations in a set of data
 Standard Deviation
measures the amount of data
dispersion around mean
 Distribution of Data shape
 Normal or bell shaped or
 Skewed
n
x
x
n
1
i
i



 
1
n
X
x
σ
n
1
i
2
i





Saturday, 17
February 2024
Distribution of Data
 Normal distributions  Skewed distribution
Saturday, 17
February 2024
Seven Quality Tools
Saturday, 17
February 2024
Objective
 Present an overview of Seven Quality Tools
 Address purpose and applications
 Highlight benefits
Saturday, 17
February 2024
The Deming Chain
Improve Quality
Decrease Costs
Improve Productivity
Decrease Price
Increase Market
Stay in Business
Provide More Jobs
Return on Investment
Why Do This?
Saturday, 17
February 2024
Six Problem Solving Steps
 Identify
 recognize the symptoms
 Define
 Agree on the problem and set boundaries
 Investigate
 Collect data
 Analyze
 Use quality tools to aid
 Solve
 Develop the solution and implement
 Confirm
 Follow up to ensure that the solution is effective
Saturday, 17
February 2024
Seven Quality Tools
 Checksheets
 Cause and Effect Diagrams
 Flow Charts
 Histograms
 Pareto Charts
 Scatter Diagrams
 Control Charts
Saturday, 17
February 2024
Quality Tool
Brainstorming
Rules
• Diverse group
• Go around room and get input from all – one idea
per turn
• Continue until ideas are exhausted
• No criticism
• Group ideas that go together
• Look for answers
Saturday, 17
February 2024
Quality Tool
Checksheets
Saturday, 17
February 2024
Checksheets
Purpose:
 Tool for collecting and
organizing measured or
counted data
 Data collected can be used
as input data for other
quality tools
Benefits:
 Collect data in a systematic
and organized manner
 To determine source of
problem
 To facilitate classification of
data (stratification)
Saturday, 17
February 2024
Quality Tool
Cause and Effect Diagrams
Saturday, 17
February 2024
Fishbone Diagram
Purpose: Graphical representation
of the trail leading to the root cause of
a problem
How is it done?
• Decide which quality characteristic,
outcome or effect you want to
examine (may use Pareto chart)
• Backbone –draw straight line
• Ribs – categories
• Medium size bones –secondary
causes
• Small bones – root causes
Saturday, 17
February 2024
Cause & Effect Diagrams
Benefits:
 Breaks problems down into bite-size pieces to find root
cause
 Fosters team work
 Common understanding of factors causing the problem
 Road map to verify picture of the process
 Follows brainstorming relationship
Saturday, 17
February 2024
Cause & Effect Diagrams
Sample
Incorrect
shipping
documents
Manpowe
r
Materials
Methods Machine
Environmen
t Keyboard sticks
Wrong source info
Wrong purchase order
Typos
Source info incorrect
Dyslexic
Transposition
Didn’t follow proc.
Glare on
display
Temp.
No procedure
No communications
No training
Software problem
Corrupt
data
Saturday, 17
February 2024
Quality Tool
Flow Charts
Saturday, 17
February 2024
Flow Charts
Purpose:
Visual illustration of the sequence of operations required to
complete a task
 Schematic drawing of the process to measure or improve.
 Starting point for process improvement
 Potential weakness in the process are made visual.
 Picture of process as it should be.
Benefits:
 Identify process improvements
 Understand the process
 Shows duplicated effort and other non-value-added steps
 Clarify working relationships between people and
organizations
 Target specific steps in the process for improvement.
Saturday, 17
February 2024
Flow Charts
Top Down
Benefits
• Simplest of all
flowcharts
• Used for planning new
processes or examining
existing one
• Keep people focused on
the whole process
How is it done?
• List major steps
• Write them across top of
the chart
• List sub-steps under each
in order they occur
Problem report
Hardware return
Failure analysis
Measure
Customer input
Stress analysis
Heat transfer
analysis
Life analysis
Substantiation
Analyze
Hardware
procurement
Customer
coordination
Compliance
verification
Documentation
FAA approval
Improve
Fleet leader
reports
Service reports
Operational
statistics
Control
Saturday, 17
February 2024
Flow charts
Linear
Benefits
 Show what actually happens
at each step in the process
 Show what happens when
non-standard events occur
 Graphically display processes
to identify redundancies and
other wasted effort
How is it done?
 Write the process step inside
each symbol
 Connect the Symbols with
arrows showing the direction
of flow
Toolbox
Saturday, 17
February 2024
Quality Tool
Sample Linear Flow
1- Fleet Analysis
utilizes data
warehouse reports to
create and distribute
a selection matrix.
2 - Other Groups
compile data as
determined by FRB.
3 - FRB meets to
analyze data.
4 - FRB selects
candidate problems
for additional
investigation.
5 - Action Assignee
performs detail
analysis of failure.
Requests failure
analysis as needed.
6 - Action Assignee
documents
investigation
findings.
7 - Action Assignee
reports investigation
results to FRB.
8 - Fleet Analysis
monitors failed item
to ensure failure has
been corrected.
Still
failing?
9 - FRB Categorize
Failure: Workmanship,
component, material,
maintenance, or
design. Also fleet
wide or RSU.
10 - FRB determines
required corrective
action - i.e. QAM or
supplier corrective
action.
11 - Fleet Analysis
monitors failure to
ensure corrective
action is effective.
Still
failing?
No
Yes
Yes
END
No
Start
Saturday, 17
February 2024
Quality Control Tool
Histograms
Saturday, 17
February 2024
Histograms
Purpose:
To determine the spread or variation
of a set of data points in a
graphical form
How is it done?:
 Collect data, 50-100 data point
 Determine the range of the data
 Calculate the size of the class
interval
 Divide data points into classes
Determine the class boundary
 Count # of data points in each
class
 Draw the histogram
Stable process, exhibiting bell shape
Saturday, 17
February 2024
Histograms
Benefits:
• Allows you to understand at a glance the variation that exists in a
process
• The shape of the histogram will show process behavior
• Often, it will tell you to dig deeper for otherwise unseen causes of
variation.
• The shape and size of the dispersion will help identify otherwise hidden
sources of variation
• Used to determine the capability of a process
• Starting point for the improvement process
Saturday, 17
February 2024
Quality Control Tool
Pareto Charts
Saturday, 17
February 2024
Pareto Charts
Purpose:
Prioritize problems.
How is it done?
 Create a preliminary list of
problem classifications.
 Tally the occurrences in each
problem classification.
 Arrange each classification in
order from highest to lowest
 Construct the bar chart
Saturday, 17
February 2024
Pareto Charts
Benefits:
 Pareto analysis helps
graphically display
results so the
significant few
problems emerge
from the general
background
 It tells you what to
work on first
0
20
40
60
80
100
120
Quantity
Defects 104 42 20 14 10 6 4
Dent Scratch Hole Others Crack Stain Gap
Saturday, 17
February 2024
Pareto Charts
Weighted Pareto
 Weighted Pareto charts use
the quantity of defects
multiplied by their cost to
determine the order.
0
100
200
300
400
500
600
700
800
900
Weighted
Cost
Weighted cost 800 208 100 80 42 14 6
Gap Dent Hole Crack Scratch Others Stain
Defect Total Cost
Weighted
cost
Gap 4 200 800
Dent 104 2 208
Hole 20 5 100
Crack 10 8 80
Scratch 42 1 42
Others 14 1 14
Stain 6 1 6
Pareto Charts
Saturday, 17
February 2024
Quality Control Tool
Scatter Diagrams
Saturday, 17
February 2024
Scatter Diagrams
Purpose:
To identify the correlations that might
exist between a quality characteristic
and a factor that might be driving it
 A scatter diagram shows the
correlation between two variables in
a process.
 These variables could be a
Critical To Quality (CTQ)
characteristic and a factor
affecting it two factors affecting a
CTQ or two related quality
characteristics.
 Dots representing data points are
scattered on the diagram.
 The extent to which the dots
cluster together in a line across
the diagram shows the strength
with which the two factors are
Saturday, 17
February 2024
Scatter Diagrams
How is it done?:
• Decide which paired factors you want to examine. Both
factors must be measurable on some incremental linear
scale.
• Collect 30 to 100 paired data points.
• Find the highest and lowest value for both variables.
• Draw the vertical (y) and horizontal (x) axes of a graph.
• Plot the data
• Title the diagram
The shape that the cluster of dots takes will tell you something
about the relationship between the two variables that you tested.
Saturday, 17
February 2024
Scatter Diagrams
• If the variables are correlated,
when one changes the other
probably also changes.
• Dots that look like they are
trying to form a line are strongly
correlated.
• Sometimes the scatter plot may
show little correlation when all
the data are considered at once.
 Stratifying the data, that is,
breaking it into two or
more groups based on
some difference such as
the equipment used, the
time of day, some
variation in materials or
differences in the people
involved, may show
surprising results
Saturday, 17
February 2024
Scatter Diagrams
• You may occasionally get scatter
diagrams that look boomerang- or
banana-shaped.
To analyze the strength of the
correlation, divide the scatter plot into
two sections.
Treat each half separately in your
analysis
Benefits:
• Helps identify and test probable causes.
• By knowing which elements of your
process are related and how they are
related, you will know what to control or
what to vary to affect a quality
characteristic.
Saturday, 17
February 2024
Quality Control Tool
Control Charts
Saturday, 17
February 2024
Control Charts
Purpose:
The primary purpose of a control chart is to
predict expected product outcome.
Benefits:
 Predict process out of control and out of
specification limits
 Distinguish between specific, identifiable
causes of variation
 Can be used for statistical process control
Saturday, 17
February 2024
Control Charts
 Strategy for eliminating assignable-cause
variation:
 Get timely data so that you see the effect of the
assignable cause soon after it occurs.
 As soon as you see something that indicates that an
assignable cause of variation has happened, search
for the cause.
 Change tools to compensate for the assignable cause.
 Strategy for reducing common-cause variation:
 Do not attempt to explain the difference between any
of the values or data points produced by a stable
system in control.
 Reducing common-cause variation usually requires
making fundamental changes in your process
Saturday, 17
February 2024
Control Charts
 Control Chart Decision Tree
 Determine Sample size (n)
 Variable or Attribute Data
 Variable is measured on a continuous scale
 Attribute is occurrences in n observations
 Determine if sample size is constant or changing
Saturday, 17
February 2024
Control Charts
Start
X bar , R
X bar, S
IX, Moving Range
p (fraction defective) or
np (number def. Per
sample
p
c (defects per sample
or
u defects per unit
u
Control Chart Decision Tree
Saturday, 17
February 2024
Control Charts
What does it look like?
o Adding the element of time
will help clarify your
understanding of the causes
of variation in the processes.
o A run chart is a line graph of
data points organized in time
sequence and centered on the
median data value.
Saturday, 17
February 2024
Control Charts
Individual X charts
How is it done?
 The data must have a normal distribution (bell curve).
 Have 20 or more data points. Fifteen is the absolute
minimum.
 List the data points in time order. Determine the range
between each of the consecutive data points.
 Find the mean or average of the data point values.
 Calculate the control limits (three standard deviations)
 Set up the scales for your control chart.
 Draw a solid line representing the data mean.
 Draw the upper and lower control limits.
 Plot the data points in time sequence.
Saturday, 17
February 2024
Control Charts
 Next, look at the upper and
lower control limits. If your
process is in control, 99.73%
of all the data points will be
inside those lines.
 The upper and lower control
limits represent three standard
deviations on either side of the
mean.
 Divide the distance between
the centerline and the upper
control limit into three equal
zones representing three
standard deviations.
Saturday, 17
February 2024
Control Charts
 Search for trends:
 Two out of three
consecutive points are in
zone “C”
 Four out of five
consecutive points on the
same side of the center
line are on zone “B” or “C”
 Only one of 10
consecutive points is in
zone “A”
Saturday, 17
February 2024
Control Charts
 Basic Control Charts
interpretation rules:
 Specials are any points above
the UCL or below the LCL
 A Run violation is seven or
more consecutive points above
or below the center (20-25 plot
points)
 A trend violation is any upward
or downward movement of
five or more consecutive points
or drifts of seven or more
points (10-20 plot points)
 A 1-in-20 violation is more than
one point in twenty consecutive
points close to the center line
Saturday, 17
February 2024
SPC Methods-Control Charts
 Control Charts show sample data plotted on a graph with CL,
UCL, and LCL
 Control chart for variables are used to monitor characteristics
that can be measured, e.g. length, weight, diameter, time
 Control charts for attributes are used to monitor characteristics
that have discrete values and can be counted, e.g. % defective,
number of flaws in a shirt, number of broken eggs in a box
Saturday, 17
February 2024
Analysis of Patterns on Control Charts
 When do you have a problem with your process?
 One or more points outside of the control limits
 A run of at least seven points (up, down or above or
below center line)
 Two or three consecutive points outside the 2-sigma
warning limits, but still inside the control limits
 Four or five consecutive points beyond the 1-sigma
limits
 An unusual or nonrandom pattern in the data
From Douglas C. Montgomery “Introduction to Statistical Quality Control”
Saturday, 17
February 2024
Setting Control Limits
 Percentage of values
under normal curve
 Control limits balance
risks like Type I error
Saturday, 17
February 2024
Hypothesis Tests
 Results of hypothesis tests fall into one of
four scenarios:
Type I Error OK
OK Type II Error
Saturday, 17
February 2024
Type I and Type II Error
ART and BAF
 Type I - ART (Alpha, Reject Ho
when true)
 Type II - BAF (Beta, Accept Ho
when false)
Saturday, 17
February 2024
Jury Trial vs. Hypothesis Test
Defendant is
Innocent
Jury Trial Hypothesis
Test
Assumption
Standard of Proof
Evidence
Decision
Beyond a
reasonable doubt
Null hypothesis
is true
Facts presented
at trial
Fail to reject
assumption
(not guilty)
or
reject (guilty)
Determined by

Summary
statistics
Fail to reject H0
or
Reject H0 in favor
of Ha
Saturday, 17
February 2024
Context?
 What does it mean to make a type I error here?
 Convict an innocent person of a crime.
 What does it mean to make a type II error?
 Fail to convict a guilty person.
 What do we usually say about type I and type II
error rates in this context?
Saturday, 17
February 2024
Control Charts for Variables
 Use x-bar and R-bar
charts together
 Used to monitor
different variables
 X-bar & R-bar Charts
reveal different
problems
 In statistical control on
one chart, out of control
on the other chart? OK?
Saturday, 17
February 2024
Control Charts for Variables
 Use x-bar charts to monitor the
changes in the mean of a process
(central tendencies)
 Use R-bar charts to monitor the
dispersion or variability of the process
 System can show acceptable central
tendencies but unacceptable variability or
 System can show acceptable variability
but unacceptable central tendencies
Saturday, 17
February 2024
Graphical Analysis
“A picture is worth a thousand words.”
 Graphical analysis is the first step in
analyzing your data. Examples:
 Distribution (histogram, dotplot,
boxplot)
 Time Series plot for trending
 I-chart (for Individual data points)
 Normality
 Cpk (when applicable) graph (Minitab)
Saturday, 17
February 2024
Dotplot of Tensile Test Data
80
75
70
65
60
55
50
CONTROL
Dotplot of CONTROL
Saturday, 17
February 2024
Time Series Plot
70
63
56
49
42
35
28
21
14
7
1
80
75
70
65
60
55
50
Index
CONTROL
Time Series Plot of CONTROL
Saturday, 17
February 2024
Individuals (I) Chart
71
64
57
50
43
36
29
22
15
8
1
85
80
75
70
65
60
55
50
Observation
Individual
Value
_
X=71.72
UCL=82.74
LCL=60.69
1
1
1
1
1
1
1
I Chart of CONTROL
Saturday, 17
February 2024
Normal Probability Plot
90
80
70
60
50
99.9
99
95
90
80
70
60
50
40
30
20
10
5
1
0.1
CONTROL
Percent
Mean 71.72
StDev 6.485
N 73
AD 7.366
P-Value <0.005
Probability Plot of CONTROL
Normal
Saturday, 17
February 2024
Cpk Graph (Minitab)
84
78
72
66
60
54
LSL USL
LSL 65
Target *
USL 85
Sample Mean 71.7151
Sample N 73
StDev(Within) 3.67538
StDev(Overall) 6.4853
Process Data
Cp 0.91
CPL 0.61
CPU 1.20
Cpk 0.61
Pp 0.51
PPL 0.35
PPU 0.68
Ppk 0.35
Cpm *
Overall Capability
Potential (Within) Capability
PPM < LSL 123287.67
PPM > USL 0.00
PPM Total 123287.67
Observed Performance
PPM < LSL 33846.99
PPM > USL 150.42
PPM Total 33997.41
Exp. Within Performance
PPM < LSL 150234.16
PPM > USL 20257.02
PPM Total 170491.18
Exp. Overall Performance
Within
Overall
Process Capability of CONTROL
Saturday, 17
February 2024
65
Process control
( Standardization )
Evaluation of result
Implementation
Develop
Improvement
method
( Solution )
Detecting causes of
problem
Record of facts
Defining the
problem
Identification of
problem
Control
Chart
Scatter
Diagram
Histogra
m
Cause &
Effect
Diagram
Pareto
Diagra
m
Stratifi
cation
Check
sheet
Graphs
Application of QC tools in Problem Solving
Relation :-
Strong Normal
Confidence Statements
 A confidence statement is used to state the level of
quality of manufactured product. Whether it is
dimensional or pass/fail data, confidence statements
can help to state the quality level achieved by a
process in relation to the specification.
 When the true means and standard deviations are
not known, estimates of these parameters such as
sample standard deviations and sample means are
used to make confidence statements based on
tolerance limits using either binomial probabilities or
k-factors.
 There are three types of confidence statements that
are primarily used.
Saturday, 17
February 2024
Confidence Statements
 1. Attribute data confidence statements are used to
state the quality level when data is of a pass/fail
type. A binomial probability is used to calculate a
95% confidence statement that at least x% of the
population will pass the required specification.
 2. Two sided confidence statements are used to
describe the quality level of data that has an upper
and lower specification limit. The data is assumed to
come from a normally distributed population. A two
sided tolerance limit table is used for determining
probability levels for percent of population. This
probability is stated as a 95% confidence that at
least x% of the population will be within the
specification.
Saturday, 17
February 2024
Confidence Statements
 3. One sided confidence statements are used to
describe the quality level of data that has either a
maximum or minimum specification limit. As with the
two sided confidence statement the data is assumed
to be from a normally distributed population. A one
sided tolerance limit table is used for the probability
levels for percent of population in this case. This
probability is stated as a 95% confidence that at
least x% of the population will be either above the
minimum specification or below the maximum
specification.
Saturday, 17
February 2024
Confidence Statements
For confidence that data is greater than min spec
Sample mean – K*(sample sd) = min spec
xbar- Ks = min
- Ks = min - xbar
K = (xbar - min)/s
For confidence that data is less than max spec
Sample mean + K*(sample sd) = max spec
xbar + Ks = max
Ks = max - xbar
K = (max - xbar)/s
For two sided tolerance limit both calculations should be made and lowest k-factor
compared with table value.
Saturday, 17
February 2024
Confidence Statements
Saturday, 17
February 2024
Confidence Statements
 In the case of attribute data sample size will determine the level that is
reached with a confidence statement. The higher the sample size used
(with zero or minimal failures), the higher the percent of population is
when stating the confidence.
 Below is a chart showing how sample sizes can effect the 95%
confidence statements:
Percent of Population Defects Sample Size
90 0 30
95 0 60
99 0 300
99.9 0 3,000
99.99 0 30,000
99.999 0 300,000
Saturday, 17
February 2024
Sample Size
 The following simple formula may be used to estimate sample
size (for any distribution) to determine a sample mean, or
average, when estimates of the standard deviation are known.
2
2
2
B
s
z
n 
n represents the sample size to be calculated
z represents the table value for the specified confidence desired
(i.e., z %)
90
( = 1.65, z %)
95
( = 1.96, z %)
99
( = 2.58)
s represents the estimated standard deviation
B represents the bound of the error of estimation, or ½ of the
desired range of accuracy, e.g., if you desire accuracy of x ± 3 psi,
then B = 3 psi.
Saturday, 17
February 2024
Sample Size
 The following simple formula may be used to estimate sample
size to determine a proportion (fraction) defective.
n= p (1-p) (z / B)
Where:
n represents the sample size to be calculated.
p represents the estimate of the population fraction defective. If no
estimate of p is available, assume worst case of p = 0.5.
z represents the table value for the specified confidence desired
(i.e., z %)
90
( ) = 1.65, z %)
95
( = 1.96, z %)
99
( - 2.58).
B represents the bound of the error of estimation, or ½ of the
desired range of accuracy, e.g., if you desire accuracy of p ± 0.002.
Saturday, 17
February 2024
Sample Size
 Example: An engineer wants to estimate a sample size to determine the
proportion of unacceptable attributes that may be present in a
manufacturing process, e.g., the number of molded components with
flash present on the parting line.
 If a known history of scrap is already present in a similar product, then
that proportion can be used.
 If the expected proportion is unknown, then you should use the worst
case, or 0.5 as your estimated proportion.
 Let’s say the engineer does not know the proportion and uses 0.5 as the
estimate.
 He/she wants to know at 95% confidence what the sample size should
be and is willing to be accurate within ± 0.1.
n = 0.5 (0.5) (1.96/0.1) = 96.04 or rounded up, 97
Saturday, 17
February 2024
Process Capability
Process Capability Study is an approach to determine the
inherent variability of each process, sub-process, and piece of
equipment.
 This study provides a method to compare the relationship
between the variability of the process and the tolerance range
to assure that the process is capable of achieving the
tolerance window.
 Typically process capability studies occur in five stages;
 (1) process characterization,
 (2) metrology characterization,
 (3) capability determination,
 (4) optimization or reduction of variability, and
 (5) preventive control.
The two standard methods for measuring process capability are Cp
and CpK.
Saturday, 17
February 2024
Process Capability
 Cp: Process Cp is a numeric index that represents the inherent
capability of a process to meet the requirements of the
tolerance range without respect to centeredness. It represents
precision, and is calculated as follows:

6
LSL
USL
Cp


Where:
USL= The Upper Specification Limit
LSL = The Lower Specification Limit
σ = The population standard deviation
Saturday, 17
February 2024
Process Capability
 Cp represents the precision, but not the
accuracy of the process in respect to the
tolerance window.
High Accuracy but low
precision
High Precision but low
Accuracy
Saturday, 17
February 2024
Process Capability
 The 6  is estimated from the process, and is
more accurate as the sample size gets larger.
 Decisions about process capability may not be
valid with data from a single run, and when
possible, should be based on data from 2 or
more runs.
 Cp is only valid when the distribution of the
data is statistically normal.
 Outliers, bimodal tendencies and skewness may
lower the Cp value.
Saturday, 17
February 2024
Process Capability
 CpK: Process Cpk is a numeric index that represents the ability
of the process to manufacture parts that are within
specification. It represents accuracy. Cpk provides a numeric
index that focuses on the centeredness of the process on the
tolerance window. Cpk is the smallest resulting ratio of the
following two (2) equations:
S
LSL
x
Cpk
3


S
x
USL
Cpk
3


USL = The upper specification limit
LSL = The lower specification limit
= The product related process mean.
s = The product related standard deviation
x
x
x
x
Saturday, 17
February 2024
Process Capability
 A machine or process is sometimes referred to as being
capable when its Cpk has a minimum value of one (1.00) and
when process stability has been proven.
 A Cpk equal to one (1.00) implies that 99.73% of the product
is within specification limits, provided that the process is
stable. However, it should be noted that if the machine
capability is only 1.0, it will be impossible to maintain a Cpk of
1.0 or higher.
 The goal should be a Cp as high as possible.
 It is possible for a process to have a high Cp, but a low Cpk, if
the process is not centered in the tolerance window. A Cpk of
1.33 or higher should be targeted.
Saturday, 17
February 2024
CpK
 A CpK of 1.33 means that the difference between the
mean and specification limit is 4σ (since 1.33 is 4/3).
 With a CpK of 1.33, 99.994% of the product is
within the within specification.
 Similarly a CpK of 2.0 is 6σ between the mean and
specification limit (since 2.0 is 6/3).
 With a CpK of 2.0 99.9999998% of the product is
within specification.
Saturday, 17
February 2024
Acceptance Sampling
 Definition: the third branch of SQC refers to the
process of randomly inspecting a certain number of
items from a lot or batch in order to decide whether to
accept or reject the entire batch
 Different from SPC because acceptance sampling is
performed either before or after the process rather
than during
 Sampling before typically is done to supplier material
 Sampling after involves sampling finished items before shipment
or finished components prior to assembly
 Used where inspection is expensive, volume is high, or
inspection is destructive
Saturday, 17
February 2024
Acceptance Sampling Plans
 Goal of Acceptance Sampling plans is to determine the criteria
for acceptance or rejection based on:
 Size of the lot (N)
 Size of the sample (n)
 Number of defects above which a lot will be rejected (c)
 Level of confidence we wish to attain
 There are single, double, and multiple sampling plans
 Which one to use is based on cost involved, time consumed, and cost of
passing on a defective item
 Can be used on either variable or attribute measures, but more
commonly used for attributes
Saturday, 17
February 2024
Acceptance Sampling Plans
 ANSI/ASQC Z1.4 (Attribute or P/F Data)
 ANSI/ASQC Z1.9 (Variable Data)
 C=0 (Attribute, reject on 1)
 MIL STD 1235C (Continuous
Production)
Saturday, 17
February 2024
Sample Size Calculation –Z 1.4
Saturday, 17
February 2024
Sampling Plan for Normal Inspection
Saturday, 17
February 2024
AQL Inspector’s Rule
Saturday, 17
February 2024
AQL Inspector’s Rule
Accept/Reject
Sample Size
Saturday, 17
February 2024
Acceptance Sampling Plans
• As mentioned acceptance sampling can reject “good” lots and accept “bad”
lots. More formally:
Producers risk refers to the probability of rejecting a good lot. In order to
calculate this probability there must be a numerical definition as to what
constitutes “good”
– AQL (Acceptable Quality Limit) - the numerical definition of a good lot. The
ANSI/ASQC standard describes AQL as “the maximum percentage or proportion
of nonconforming items or number of nonconformities in a batch that can be
considered satisfactory as a process average”
• Consumers Risk refers to the probability of accepting a bad lot where:
– LTPD (Lot Tolerance Percent Defective) - the numerical definition of a bad lot
described by the ANSI/ASQC standard as “the percentage or proportion of
nonconforming items or noncomformities in a batch for which the customer
wishes the probability of acceptance to be a specified low value.
Saturday, 17
February 2024
Acceptance Sampling
0
0.2
0.4
0.6
0.8
1
1.2
Probability
of
Acceptance
Percent Defective
OC Curve
LTPD
AQL
Producers Risk
Consumers Risk
Saturday, 17
February 2024
Implications for Managers
 How much and how often to inspect?
 Consider product cost and product volume
 Consider process stability
 Consider lot size
 Where to inspect?
 Inbound materials
 Finished products
 Prior to costly processing
 Which tools to use?
 Control charts are best used for in-process production
 Acceptance sampling is best used for inbound/outbound
Saturday, 17
February 2024
SQC Across the Organization
 SQC requires input from other organizational
functions, influences their success, and are actually
used in designing and evaluating their tasks
 Marketing – provides information on current and future
quality standards
 Finance – responsible for placing financial values on SQC
efforts
 Human resources – the role of workers change with SQC
implementation. Requires workers with right skills
 Information systems – makes SQC information accessible for
all.
Saturday, 17
February 2024
Quality Control
Saturday, 17
February 2024

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SQC ESQE_Statistical Quality Control .pptx

  • 1. Statistical Quality Control by ENG/Alaa Abdrabou Saturday, 17 February 2024
  • 2. The Right Statistical Tools Saturday, 17 February 2024
  • 4. Basic Statistics  Descriptive Statistics  A straightforward presentation of facts. A survey or summary of a population in which all data are known.  Inferential Statistics  Drawing conclusions about a population from a random sample Saturday, 17 February 2024
  • 5. Inferential Statistics  Inferential statistics is a valuable tool because it allows us to look at a small sample size and make statements on the whole population.  Samples must be pulled RANDOMLY from a population so that the sample truly represents the population. Every unit in a population must have a equal chance of being selected for the sample to be truly random.  The distribution or shape of the data is important to know for analytical purposes.  The most common distribution is the bell shaped or normal distribution.  Parameters can be estimated from sample statistics. Two of the most common parameters are the mean and standard deviation.  The mean (or average, denoted by μ) measures central tendency This is estimated by the sample mean or xbar.  The standard deviation (σ ) measures the spread of the data and is estimated by the sample standard deviation Saturday, 17 February 2024
  • 7. Three SQC Categories  Statistical quality control (SQC) is the term used to describe the set of statistical tools used by quality professionals  SQC encompasses three broad categories of;  Descriptive statistics  e.g. the mean, standard deviation, and range  Statistical process control (SPC)  Involves inspecting the output from a process  Quality characteristics are measured and charted  Helpful in identifying in-process variation  Acceptance sampling used to randomly inspect a batch of goods to determine acceptance/rejection  Does not help to catch in-process problems Saturday, 17 February 2024
  • 8. Sources of Variation  Variation exists in all processes.  Variation can be categorized as either;  Common or Random causes of variation, or  Random causes that we cannot identify  Unavoidable  e.g. slight differences in process variables like diameter, weight, service time, temperature  Assignable causes of variation  Causes can be identified and eliminated  e.g. poor employee training, worn tool, machine needing repair Saturday, 17 February 2024
  • 9. Traditional Statistical Tools  Descriptive Statistics include  The Mean- measure of central tendency  The Range- difference between largest/smallest observations in a set of data  Standard Deviation measures the amount of data dispersion around mean  Distribution of Data shape  Normal or bell shaped or  Skewed n x x n 1 i i      1 n X x σ n 1 i 2 i      Saturday, 17 February 2024
  • 10. Distribution of Data  Normal distributions  Skewed distribution Saturday, 17 February 2024
  • 11. Seven Quality Tools Saturday, 17 February 2024
  • 12. Objective  Present an overview of Seven Quality Tools  Address purpose and applications  Highlight benefits Saturday, 17 February 2024
  • 13. The Deming Chain Improve Quality Decrease Costs Improve Productivity Decrease Price Increase Market Stay in Business Provide More Jobs Return on Investment Why Do This? Saturday, 17 February 2024
  • 14. Six Problem Solving Steps  Identify  recognize the symptoms  Define  Agree on the problem and set boundaries  Investigate  Collect data  Analyze  Use quality tools to aid  Solve  Develop the solution and implement  Confirm  Follow up to ensure that the solution is effective Saturday, 17 February 2024
  • 15. Seven Quality Tools  Checksheets  Cause and Effect Diagrams  Flow Charts  Histograms  Pareto Charts  Scatter Diagrams  Control Charts Saturday, 17 February 2024
  • 16. Quality Tool Brainstorming Rules • Diverse group • Go around room and get input from all – one idea per turn • Continue until ideas are exhausted • No criticism • Group ideas that go together • Look for answers Saturday, 17 February 2024
  • 18. Checksheets Purpose:  Tool for collecting and organizing measured or counted data  Data collected can be used as input data for other quality tools Benefits:  Collect data in a systematic and organized manner  To determine source of problem  To facilitate classification of data (stratification) Saturday, 17 February 2024
  • 19. Quality Tool Cause and Effect Diagrams Saturday, 17 February 2024
  • 20. Fishbone Diagram Purpose: Graphical representation of the trail leading to the root cause of a problem How is it done? • Decide which quality characteristic, outcome or effect you want to examine (may use Pareto chart) • Backbone –draw straight line • Ribs – categories • Medium size bones –secondary causes • Small bones – root causes Saturday, 17 February 2024
  • 21. Cause & Effect Diagrams Benefits:  Breaks problems down into bite-size pieces to find root cause  Fosters team work  Common understanding of factors causing the problem  Road map to verify picture of the process  Follows brainstorming relationship Saturday, 17 February 2024
  • 22. Cause & Effect Diagrams Sample Incorrect shipping documents Manpowe r Materials Methods Machine Environmen t Keyboard sticks Wrong source info Wrong purchase order Typos Source info incorrect Dyslexic Transposition Didn’t follow proc. Glare on display Temp. No procedure No communications No training Software problem Corrupt data Saturday, 17 February 2024
  • 24. Flow Charts Purpose: Visual illustration of the sequence of operations required to complete a task  Schematic drawing of the process to measure or improve.  Starting point for process improvement  Potential weakness in the process are made visual.  Picture of process as it should be. Benefits:  Identify process improvements  Understand the process  Shows duplicated effort and other non-value-added steps  Clarify working relationships between people and organizations  Target specific steps in the process for improvement. Saturday, 17 February 2024
  • 25. Flow Charts Top Down Benefits • Simplest of all flowcharts • Used for planning new processes or examining existing one • Keep people focused on the whole process How is it done? • List major steps • Write them across top of the chart • List sub-steps under each in order they occur Problem report Hardware return Failure analysis Measure Customer input Stress analysis Heat transfer analysis Life analysis Substantiation Analyze Hardware procurement Customer coordination Compliance verification Documentation FAA approval Improve Fleet leader reports Service reports Operational statistics Control Saturday, 17 February 2024
  • 26. Flow charts Linear Benefits  Show what actually happens at each step in the process  Show what happens when non-standard events occur  Graphically display processes to identify redundancies and other wasted effort How is it done?  Write the process step inside each symbol  Connect the Symbols with arrows showing the direction of flow Toolbox Saturday, 17 February 2024
  • 27. Quality Tool Sample Linear Flow 1- Fleet Analysis utilizes data warehouse reports to create and distribute a selection matrix. 2 - Other Groups compile data as determined by FRB. 3 - FRB meets to analyze data. 4 - FRB selects candidate problems for additional investigation. 5 - Action Assignee performs detail analysis of failure. Requests failure analysis as needed. 6 - Action Assignee documents investigation findings. 7 - Action Assignee reports investigation results to FRB. 8 - Fleet Analysis monitors failed item to ensure failure has been corrected. Still failing? 9 - FRB Categorize Failure: Workmanship, component, material, maintenance, or design. Also fleet wide or RSU. 10 - FRB determines required corrective action - i.e. QAM or supplier corrective action. 11 - Fleet Analysis monitors failure to ensure corrective action is effective. Still failing? No Yes Yes END No Start Saturday, 17 February 2024
  • 29. Histograms Purpose: To determine the spread or variation of a set of data points in a graphical form How is it done?:  Collect data, 50-100 data point  Determine the range of the data  Calculate the size of the class interval  Divide data points into classes Determine the class boundary  Count # of data points in each class  Draw the histogram Stable process, exhibiting bell shape Saturday, 17 February 2024
  • 30. Histograms Benefits: • Allows you to understand at a glance the variation that exists in a process • The shape of the histogram will show process behavior • Often, it will tell you to dig deeper for otherwise unseen causes of variation. • The shape and size of the dispersion will help identify otherwise hidden sources of variation • Used to determine the capability of a process • Starting point for the improvement process Saturday, 17 February 2024
  • 31. Quality Control Tool Pareto Charts Saturday, 17 February 2024
  • 32. Pareto Charts Purpose: Prioritize problems. How is it done?  Create a preliminary list of problem classifications.  Tally the occurrences in each problem classification.  Arrange each classification in order from highest to lowest  Construct the bar chart Saturday, 17 February 2024
  • 33. Pareto Charts Benefits:  Pareto analysis helps graphically display results so the significant few problems emerge from the general background  It tells you what to work on first 0 20 40 60 80 100 120 Quantity Defects 104 42 20 14 10 6 4 Dent Scratch Hole Others Crack Stain Gap Saturday, 17 February 2024
  • 34. Pareto Charts Weighted Pareto  Weighted Pareto charts use the quantity of defects multiplied by their cost to determine the order. 0 100 200 300 400 500 600 700 800 900 Weighted Cost Weighted cost 800 208 100 80 42 14 6 Gap Dent Hole Crack Scratch Others Stain Defect Total Cost Weighted cost Gap 4 200 800 Dent 104 2 208 Hole 20 5 100 Crack 10 8 80 Scratch 42 1 42 Others 14 1 14 Stain 6 1 6 Pareto Charts Saturday, 17 February 2024
  • 35. Quality Control Tool Scatter Diagrams Saturday, 17 February 2024
  • 36. Scatter Diagrams Purpose: To identify the correlations that might exist between a quality characteristic and a factor that might be driving it  A scatter diagram shows the correlation between two variables in a process.  These variables could be a Critical To Quality (CTQ) characteristic and a factor affecting it two factors affecting a CTQ or two related quality characteristics.  Dots representing data points are scattered on the diagram.  The extent to which the dots cluster together in a line across the diagram shows the strength with which the two factors are Saturday, 17 February 2024
  • 37. Scatter Diagrams How is it done?: • Decide which paired factors you want to examine. Both factors must be measurable on some incremental linear scale. • Collect 30 to 100 paired data points. • Find the highest and lowest value for both variables. • Draw the vertical (y) and horizontal (x) axes of a graph. • Plot the data • Title the diagram The shape that the cluster of dots takes will tell you something about the relationship between the two variables that you tested. Saturday, 17 February 2024
  • 38. Scatter Diagrams • If the variables are correlated, when one changes the other probably also changes. • Dots that look like they are trying to form a line are strongly correlated. • Sometimes the scatter plot may show little correlation when all the data are considered at once.  Stratifying the data, that is, breaking it into two or more groups based on some difference such as the equipment used, the time of day, some variation in materials or differences in the people involved, may show surprising results Saturday, 17 February 2024
  • 39. Scatter Diagrams • You may occasionally get scatter diagrams that look boomerang- or banana-shaped. To analyze the strength of the correlation, divide the scatter plot into two sections. Treat each half separately in your analysis Benefits: • Helps identify and test probable causes. • By knowing which elements of your process are related and how they are related, you will know what to control or what to vary to affect a quality characteristic. Saturday, 17 February 2024
  • 40. Quality Control Tool Control Charts Saturday, 17 February 2024
  • 41. Control Charts Purpose: The primary purpose of a control chart is to predict expected product outcome. Benefits:  Predict process out of control and out of specification limits  Distinguish between specific, identifiable causes of variation  Can be used for statistical process control Saturday, 17 February 2024
  • 42. Control Charts  Strategy for eliminating assignable-cause variation:  Get timely data so that you see the effect of the assignable cause soon after it occurs.  As soon as you see something that indicates that an assignable cause of variation has happened, search for the cause.  Change tools to compensate for the assignable cause.  Strategy for reducing common-cause variation:  Do not attempt to explain the difference between any of the values or data points produced by a stable system in control.  Reducing common-cause variation usually requires making fundamental changes in your process Saturday, 17 February 2024
  • 43. Control Charts  Control Chart Decision Tree  Determine Sample size (n)  Variable or Attribute Data  Variable is measured on a continuous scale  Attribute is occurrences in n observations  Determine if sample size is constant or changing Saturday, 17 February 2024
  • 44. Control Charts Start X bar , R X bar, S IX, Moving Range p (fraction defective) or np (number def. Per sample p c (defects per sample or u defects per unit u Control Chart Decision Tree Saturday, 17 February 2024
  • 45. Control Charts What does it look like? o Adding the element of time will help clarify your understanding of the causes of variation in the processes. o A run chart is a line graph of data points organized in time sequence and centered on the median data value. Saturday, 17 February 2024
  • 46. Control Charts Individual X charts How is it done?  The data must have a normal distribution (bell curve).  Have 20 or more data points. Fifteen is the absolute minimum.  List the data points in time order. Determine the range between each of the consecutive data points.  Find the mean or average of the data point values.  Calculate the control limits (three standard deviations)  Set up the scales for your control chart.  Draw a solid line representing the data mean.  Draw the upper and lower control limits.  Plot the data points in time sequence. Saturday, 17 February 2024
  • 47. Control Charts  Next, look at the upper and lower control limits. If your process is in control, 99.73% of all the data points will be inside those lines.  The upper and lower control limits represent three standard deviations on either side of the mean.  Divide the distance between the centerline and the upper control limit into three equal zones representing three standard deviations. Saturday, 17 February 2024
  • 48. Control Charts  Search for trends:  Two out of three consecutive points are in zone “C”  Four out of five consecutive points on the same side of the center line are on zone “B” or “C”  Only one of 10 consecutive points is in zone “A” Saturday, 17 February 2024
  • 49. Control Charts  Basic Control Charts interpretation rules:  Specials are any points above the UCL or below the LCL  A Run violation is seven or more consecutive points above or below the center (20-25 plot points)  A trend violation is any upward or downward movement of five or more consecutive points or drifts of seven or more points (10-20 plot points)  A 1-in-20 violation is more than one point in twenty consecutive points close to the center line Saturday, 17 February 2024
  • 50. SPC Methods-Control Charts  Control Charts show sample data plotted on a graph with CL, UCL, and LCL  Control chart for variables are used to monitor characteristics that can be measured, e.g. length, weight, diameter, time  Control charts for attributes are used to monitor characteristics that have discrete values and can be counted, e.g. % defective, number of flaws in a shirt, number of broken eggs in a box Saturday, 17 February 2024
  • 51. Analysis of Patterns on Control Charts  When do you have a problem with your process?  One or more points outside of the control limits  A run of at least seven points (up, down or above or below center line)  Two or three consecutive points outside the 2-sigma warning limits, but still inside the control limits  Four or five consecutive points beyond the 1-sigma limits  An unusual or nonrandom pattern in the data From Douglas C. Montgomery “Introduction to Statistical Quality Control” Saturday, 17 February 2024
  • 52. Setting Control Limits  Percentage of values under normal curve  Control limits balance risks like Type I error Saturday, 17 February 2024
  • 53. Hypothesis Tests  Results of hypothesis tests fall into one of four scenarios: Type I Error OK OK Type II Error Saturday, 17 February 2024
  • 54. Type I and Type II Error ART and BAF  Type I - ART (Alpha, Reject Ho when true)  Type II - BAF (Beta, Accept Ho when false) Saturday, 17 February 2024
  • 55. Jury Trial vs. Hypothesis Test Defendant is Innocent Jury Trial Hypothesis Test Assumption Standard of Proof Evidence Decision Beyond a reasonable doubt Null hypothesis is true Facts presented at trial Fail to reject assumption (not guilty) or reject (guilty) Determined by  Summary statistics Fail to reject H0 or Reject H0 in favor of Ha Saturday, 17 February 2024
  • 56. Context?  What does it mean to make a type I error here?  Convict an innocent person of a crime.  What does it mean to make a type II error?  Fail to convict a guilty person.  What do we usually say about type I and type II error rates in this context? Saturday, 17 February 2024
  • 57. Control Charts for Variables  Use x-bar and R-bar charts together  Used to monitor different variables  X-bar & R-bar Charts reveal different problems  In statistical control on one chart, out of control on the other chart? OK? Saturday, 17 February 2024
  • 58. Control Charts for Variables  Use x-bar charts to monitor the changes in the mean of a process (central tendencies)  Use R-bar charts to monitor the dispersion or variability of the process  System can show acceptable central tendencies but unacceptable variability or  System can show acceptable variability but unacceptable central tendencies Saturday, 17 February 2024
  • 59. Graphical Analysis “A picture is worth a thousand words.”  Graphical analysis is the first step in analyzing your data. Examples:  Distribution (histogram, dotplot, boxplot)  Time Series plot for trending  I-chart (for Individual data points)  Normality  Cpk (when applicable) graph (Minitab) Saturday, 17 February 2024
  • 60. Dotplot of Tensile Test Data 80 75 70 65 60 55 50 CONTROL Dotplot of CONTROL Saturday, 17 February 2024
  • 63. Normal Probability Plot 90 80 70 60 50 99.9 99 95 90 80 70 60 50 40 30 20 10 5 1 0.1 CONTROL Percent Mean 71.72 StDev 6.485 N 73 AD 7.366 P-Value <0.005 Probability Plot of CONTROL Normal Saturday, 17 February 2024
  • 64. Cpk Graph (Minitab) 84 78 72 66 60 54 LSL USL LSL 65 Target * USL 85 Sample Mean 71.7151 Sample N 73 StDev(Within) 3.67538 StDev(Overall) 6.4853 Process Data Cp 0.91 CPL 0.61 CPU 1.20 Cpk 0.61 Pp 0.51 PPL 0.35 PPU 0.68 Ppk 0.35 Cpm * Overall Capability Potential (Within) Capability PPM < LSL 123287.67 PPM > USL 0.00 PPM Total 123287.67 Observed Performance PPM < LSL 33846.99 PPM > USL 150.42 PPM Total 33997.41 Exp. Within Performance PPM < LSL 150234.16 PPM > USL 20257.02 PPM Total 170491.18 Exp. Overall Performance Within Overall Process Capability of CONTROL Saturday, 17 February 2024
  • 65. 65 Process control ( Standardization ) Evaluation of result Implementation Develop Improvement method ( Solution ) Detecting causes of problem Record of facts Defining the problem Identification of problem Control Chart Scatter Diagram Histogra m Cause & Effect Diagram Pareto Diagra m Stratifi cation Check sheet Graphs Application of QC tools in Problem Solving Relation :- Strong Normal
  • 66. Confidence Statements  A confidence statement is used to state the level of quality of manufactured product. Whether it is dimensional or pass/fail data, confidence statements can help to state the quality level achieved by a process in relation to the specification.  When the true means and standard deviations are not known, estimates of these parameters such as sample standard deviations and sample means are used to make confidence statements based on tolerance limits using either binomial probabilities or k-factors.  There are three types of confidence statements that are primarily used. Saturday, 17 February 2024
  • 67. Confidence Statements  1. Attribute data confidence statements are used to state the quality level when data is of a pass/fail type. A binomial probability is used to calculate a 95% confidence statement that at least x% of the population will pass the required specification.  2. Two sided confidence statements are used to describe the quality level of data that has an upper and lower specification limit. The data is assumed to come from a normally distributed population. A two sided tolerance limit table is used for determining probability levels for percent of population. This probability is stated as a 95% confidence that at least x% of the population will be within the specification. Saturday, 17 February 2024
  • 68. Confidence Statements  3. One sided confidence statements are used to describe the quality level of data that has either a maximum or minimum specification limit. As with the two sided confidence statement the data is assumed to be from a normally distributed population. A one sided tolerance limit table is used for the probability levels for percent of population in this case. This probability is stated as a 95% confidence that at least x% of the population will be either above the minimum specification or below the maximum specification. Saturday, 17 February 2024
  • 69. Confidence Statements For confidence that data is greater than min spec Sample mean – K*(sample sd) = min spec xbar- Ks = min - Ks = min - xbar K = (xbar - min)/s For confidence that data is less than max spec Sample mean + K*(sample sd) = max spec xbar + Ks = max Ks = max - xbar K = (max - xbar)/s For two sided tolerance limit both calculations should be made and lowest k-factor compared with table value. Saturday, 17 February 2024
  • 71. Confidence Statements  In the case of attribute data sample size will determine the level that is reached with a confidence statement. The higher the sample size used (with zero or minimal failures), the higher the percent of population is when stating the confidence.  Below is a chart showing how sample sizes can effect the 95% confidence statements: Percent of Population Defects Sample Size 90 0 30 95 0 60 99 0 300 99.9 0 3,000 99.99 0 30,000 99.999 0 300,000 Saturday, 17 February 2024
  • 72. Sample Size  The following simple formula may be used to estimate sample size (for any distribution) to determine a sample mean, or average, when estimates of the standard deviation are known. 2 2 2 B s z n  n represents the sample size to be calculated z represents the table value for the specified confidence desired (i.e., z %) 90 ( = 1.65, z %) 95 ( = 1.96, z %) 99 ( = 2.58) s represents the estimated standard deviation B represents the bound of the error of estimation, or ½ of the desired range of accuracy, e.g., if you desire accuracy of x ± 3 psi, then B = 3 psi. Saturday, 17 February 2024
  • 73. Sample Size  The following simple formula may be used to estimate sample size to determine a proportion (fraction) defective. n= p (1-p) (z / B) Where: n represents the sample size to be calculated. p represents the estimate of the population fraction defective. If no estimate of p is available, assume worst case of p = 0.5. z represents the table value for the specified confidence desired (i.e., z %) 90 ( ) = 1.65, z %) 95 ( = 1.96, z %) 99 ( - 2.58). B represents the bound of the error of estimation, or ½ of the desired range of accuracy, e.g., if you desire accuracy of p ± 0.002. Saturday, 17 February 2024
  • 74. Sample Size  Example: An engineer wants to estimate a sample size to determine the proportion of unacceptable attributes that may be present in a manufacturing process, e.g., the number of molded components with flash present on the parting line.  If a known history of scrap is already present in a similar product, then that proportion can be used.  If the expected proportion is unknown, then you should use the worst case, or 0.5 as your estimated proportion.  Let’s say the engineer does not know the proportion and uses 0.5 as the estimate.  He/she wants to know at 95% confidence what the sample size should be and is willing to be accurate within ± 0.1. n = 0.5 (0.5) (1.96/0.1) = 96.04 or rounded up, 97 Saturday, 17 February 2024
  • 75. Process Capability Process Capability Study is an approach to determine the inherent variability of each process, sub-process, and piece of equipment.  This study provides a method to compare the relationship between the variability of the process and the tolerance range to assure that the process is capable of achieving the tolerance window.  Typically process capability studies occur in five stages;  (1) process characterization,  (2) metrology characterization,  (3) capability determination,  (4) optimization or reduction of variability, and  (5) preventive control. The two standard methods for measuring process capability are Cp and CpK. Saturday, 17 February 2024
  • 76. Process Capability  Cp: Process Cp is a numeric index that represents the inherent capability of a process to meet the requirements of the tolerance range without respect to centeredness. It represents precision, and is calculated as follows:  6 LSL USL Cp   Where: USL= The Upper Specification Limit LSL = The Lower Specification Limit σ = The population standard deviation Saturday, 17 February 2024
  • 77. Process Capability  Cp represents the precision, but not the accuracy of the process in respect to the tolerance window. High Accuracy but low precision High Precision but low Accuracy Saturday, 17 February 2024
  • 78. Process Capability  The 6  is estimated from the process, and is more accurate as the sample size gets larger.  Decisions about process capability may not be valid with data from a single run, and when possible, should be based on data from 2 or more runs.  Cp is only valid when the distribution of the data is statistically normal.  Outliers, bimodal tendencies and skewness may lower the Cp value. Saturday, 17 February 2024
  • 79. Process Capability  CpK: Process Cpk is a numeric index that represents the ability of the process to manufacture parts that are within specification. It represents accuracy. Cpk provides a numeric index that focuses on the centeredness of the process on the tolerance window. Cpk is the smallest resulting ratio of the following two (2) equations: S LSL x Cpk 3   S x USL Cpk 3   USL = The upper specification limit LSL = The lower specification limit = The product related process mean. s = The product related standard deviation x x x x Saturday, 17 February 2024
  • 80. Process Capability  A machine or process is sometimes referred to as being capable when its Cpk has a minimum value of one (1.00) and when process stability has been proven.  A Cpk equal to one (1.00) implies that 99.73% of the product is within specification limits, provided that the process is stable. However, it should be noted that if the machine capability is only 1.0, it will be impossible to maintain a Cpk of 1.0 or higher.  The goal should be a Cp as high as possible.  It is possible for a process to have a high Cp, but a low Cpk, if the process is not centered in the tolerance window. A Cpk of 1.33 or higher should be targeted. Saturday, 17 February 2024
  • 81. CpK  A CpK of 1.33 means that the difference between the mean and specification limit is 4σ (since 1.33 is 4/3).  With a CpK of 1.33, 99.994% of the product is within the within specification.  Similarly a CpK of 2.0 is 6σ between the mean and specification limit (since 2.0 is 6/3).  With a CpK of 2.0 99.9999998% of the product is within specification. Saturday, 17 February 2024
  • 82. Acceptance Sampling  Definition: the third branch of SQC refers to the process of randomly inspecting a certain number of items from a lot or batch in order to decide whether to accept or reject the entire batch  Different from SPC because acceptance sampling is performed either before or after the process rather than during  Sampling before typically is done to supplier material  Sampling after involves sampling finished items before shipment or finished components prior to assembly  Used where inspection is expensive, volume is high, or inspection is destructive Saturday, 17 February 2024
  • 83. Acceptance Sampling Plans  Goal of Acceptance Sampling plans is to determine the criteria for acceptance or rejection based on:  Size of the lot (N)  Size of the sample (n)  Number of defects above which a lot will be rejected (c)  Level of confidence we wish to attain  There are single, double, and multiple sampling plans  Which one to use is based on cost involved, time consumed, and cost of passing on a defective item  Can be used on either variable or attribute measures, but more commonly used for attributes Saturday, 17 February 2024
  • 84. Acceptance Sampling Plans  ANSI/ASQC Z1.4 (Attribute or P/F Data)  ANSI/ASQC Z1.9 (Variable Data)  C=0 (Attribute, reject on 1)  MIL STD 1235C (Continuous Production) Saturday, 17 February 2024
  • 85. Sample Size Calculation –Z 1.4 Saturday, 17 February 2024
  • 86. Sampling Plan for Normal Inspection Saturday, 17 February 2024
  • 88. AQL Inspector’s Rule Accept/Reject Sample Size Saturday, 17 February 2024
  • 89. Acceptance Sampling Plans • As mentioned acceptance sampling can reject “good” lots and accept “bad” lots. More formally: Producers risk refers to the probability of rejecting a good lot. In order to calculate this probability there must be a numerical definition as to what constitutes “good” – AQL (Acceptable Quality Limit) - the numerical definition of a good lot. The ANSI/ASQC standard describes AQL as “the maximum percentage or proportion of nonconforming items or number of nonconformities in a batch that can be considered satisfactory as a process average” • Consumers Risk refers to the probability of accepting a bad lot where: – LTPD (Lot Tolerance Percent Defective) - the numerical definition of a bad lot described by the ANSI/ASQC standard as “the percentage or proportion of nonconforming items or noncomformities in a batch for which the customer wishes the probability of acceptance to be a specified low value. Saturday, 17 February 2024
  • 90. Acceptance Sampling 0 0.2 0.4 0.6 0.8 1 1.2 Probability of Acceptance Percent Defective OC Curve LTPD AQL Producers Risk Consumers Risk Saturday, 17 February 2024
  • 91. Implications for Managers  How much and how often to inspect?  Consider product cost and product volume  Consider process stability  Consider lot size  Where to inspect?  Inbound materials  Finished products  Prior to costly processing  Which tools to use?  Control charts are best used for in-process production  Acceptance sampling is best used for inbound/outbound Saturday, 17 February 2024
  • 92. SQC Across the Organization  SQC requires input from other organizational functions, influences their success, and are actually used in designing and evaluating their tasks  Marketing – provides information on current and future quality standards  Finance – responsible for placing financial values on SQC efforts  Human resources – the role of workers change with SQC implementation. Requires workers with right skills  Information systems – makes SQC information accessible for all. Saturday, 17 February 2024