SPC Training 2016

Six Sigma Statistical Process Control
by Asia Supply Line. LLC
1 March 11, 2020 – v4.0

Statistical Process Control (SPC) – Table of Contents
Section 1: Introduction
Section 2: The Histogram
Section 3: Measure of Location and Variability
Section 4: Process Control Charts
Section 5: Process Control Limits
Section 6: Out-of-Control Criteria
Section 7: Sample Size and Frequency
Section 8: Out-of-Control Action Plan
Section 9: Process Control Plan
2 March 11, 2020 – v4.0

Statistical Process Control – Table of Contents
3 March 11, 2020 – v4.0

The History of Statistical and Process Thinking
The process and quality control methods and techniques used today
got their start in the American Civil War at around 1789, when Eli
Whitney took a contract from the U.S. Army for the manufacture of
10,000 rifles at the unbelievably low price of $13.40 each.
At that time most of the products were handmade by small owner-
managed shops and product parts were thus not interchangeable.
The result of Whitney’s first mass production trail was that the rifles did
not work as well as the handmade rifles. In addition, the copied parts
did not fit as expected.
4 March 11, 2020 – v4.0

The History of Statistical and Process Thinking
GO - Test
NO-GO - Test
The first time that one presented machine produced parts was 1851 at the
industry exhibition in the Crystal Palace in London. An American gun smith took
10 working guns, took them apart, mixed all the parts in a box and re-assembled
them again. This was found a quite surprising “experiment”.
5 March 11, 2020 – v4.0

The Traditional Process Control Concept
The Detection Control Scheme
Scrap
Monitor/Adjust
Repair
Bad
Process Inspection
Good
+
6 March 11, 2020 – v4.0

The Traditional Process Control Concept
• The traditional process control concept does not help us

to produce only good products or services.
• Every process outcome, product or service, has to be
inspected 100%.
• Products have to be repaired or even scraped.
• Rendered services result in customer dissatisfaction.
• With respect to productivity and efficiency every activity
after the actual process is a non-value added activity.
7 March 11, 2020 – v4.0

An Advanced Process Control Concept
Prevention Control Scheme
Scrap
Monitor/Adjust
Learn/Improve
Repair
Bad
Process Inspection
Good
+
Selective measurement
• Product / Service
• Process
8 March 11, 2020 – v4.0

Statistical Thinking - A Definition
All work is a series of

interconnected processes
All processes vary
Understanding and
reducing variation are keys
to success
ASQ
9 March 11, 2020 – v4.0

The Variation Management Approach
Machines Methods
Ishikawa Diagram
Environment
Process/
System
Customer Satisfaction
or
Customer Dissatisfaction
Men Material
10 March 11, 2020 – v4.0
Variation Management – Defect Definition
A defect is any variation of a required characteristic of the product or

service, which is far enough removed from the MEAN (Nominal)
value to prevent the product or service from fulfilling the physical and
functional requirements of the customer.
11 March 11, 2020 – v4.0

SPC Tool Box
There are four basic tools we use

• Cpk – Tells you the process capability vs. the Product Specs
• X-Bar-R Chart – Tells you change over time
• P Chart – Percent defect over time
• NP Chart – Measures number of defects over time
DEFINITIONS
• PROCESS
– UCL – Upper Process Control Limit
– LCL – Lower Process Control Limit
• CUSTOMER SPECIFICATION
– USL = Upper Spec Limit
– LSL = Lower Spec Limit
• Sigma is variation and is the Standard Deviation of a process
12 March 11, 2020 – v4.0

SPC Tool Box
DEFINITIONS
• Cpk Chart
– DESIGN
• LSL – Lower Specification Limit
• USL – Uppser Specification Limit
• Mean – Middle of the LSL/USL
– Cpk
• Cp – Sometimes this is written as ET
(engineering tolerance)
– Traditionally engineering will use 6
times standard deviation for
USL/LSL
– Ensures that actual measurements
will meet 6 σ
– But to set the USL/LSL at 6σ requires
us to do a process capability study
first?
• Cpk then means the process
capability to be centered between
the USL/LSL
– Accounts for variation Within the
subgroup – i.e. One Heat Lot
– Does not measure shift between
different subgroups
– Theoretical process capability
13 March 11, 2020 – v4.0

SPC Tool Box
DEFINITIONS
– Ppk
• Accounts for variation considering
Overall data points– i.e. All Heat
Lot
• Measures shift between different
subgroups
• Actual process capability
14 March 11, 2020 – v4.0

SPC Tool Box
DEFINITIONS
– Ppk
• PPU – Process Overall Upper
Control Limit
• PPL – Process Overall Lower
Control Limit
• 𝛍 – Pronounced “Mew” is the
Mean
• Different Calculations
15 March 11, 2020 – v4.0

SPC Tool Box
DEFINITIONS
– Expected Overall
Performance
•ppm – Parts Per
Million
– Rejected
divided by
received
multiplied by 1
million
16 March 11, 2020 – v4.0

Difference Between Process and Specs
17 March 11, 2020 – v4.0

Customer Specs vs Process
18 March 11, 2020 – v4.0

What is 6-σ
• A statistical term that refers to the standard deviation of a process

about its mean
• If normally distributed the measurements will be distributed as follows
• ± 3 Sigma 99.73%
• ± 4.5 Sigma 99.99966%
Sigma Level ppm

6 sigma 3.4 ppm .000003% Reject
5 sigma 233 ppm
4 sigma 6,210 ppm
3 sigma 66,810 ppm 2% Reject
2 sigma 308,770 10% Reject
ppm
1 sigma 697,672
19 March 11, 2020 – v4.0 ppm
Sigma Ranges
Flight Delays
Process capability in ppm
IRS Tax Advice
Burglary Closure
Bogie Golf
Baggage
Handling
Order
Processing
Tech Center Wait Time
Airline Fatality
Process capability in σ
20 March 11, 2020 – v4.0
Six Sigma
Attempts to improve an organization's:

• Effectiveness (reducing stress)
• Efficiency (improving costs)
21 March 11, 2020 – v4.0

Standard Deviations
22 March 11, 2020 – v4.0

Six Sigma Demystified
Remember Cp = Design Specs at 6σ
23 March 11, 2020 – v4.0

Cost of Quality
Converting PPM into cost of quality
24 March 11, 2020 – v4.0

Variation Management – Continuous Improvement
The key to process control and continuous process

improvement is to understand the meaning and causes of
variation in the outcome of the process.
25 March 11, 2020 – v4.0

Remarks or Questions ?!?
26 March 11, 2020 – v4.0

27 March 11, 2020 – v4.0

The Histogram
0 10 20 30 40 50
A histogram provides graphical presentation and a first estimation about

the location, spread and shape of the distribution of the process.
28 March 11, 2020 – v4.0

The Histogram – Typical Patterns of Variation
1. The bell-shaped distribution:

Symmetrical shape with a peak in the
middle of the range of the data.
While deviation from a bell shape should
be investigated, such deviation is not
necessarily bad.
29 March 11, 2020 – v4.0

2. The double-peaked distribution:

A distinct valley in the middle of the range
of the data with peaks on either side.
This pattern is usually a combination of
two bell-shaped distributions and suggests
that two distinct processes are at work.
30 March 11, 2020 – v4.0

3. The plateau distribution:

A flat top with no distinct peak and slight
tails on either sides.
This pattern is likely to be the result of
many different bell-shaped distribution
with centers spread evenly throughout the
range of data.
31 March 11, 2020 – v4.0

4. The skewed distribution:

An asymmetrical shape in which the peak
is off-center in the range of the data and
the distribution tails off sharply on one
side and gently on the other.
This pattern typically occurs when a
practical limit, or a specification limit,
exists on one side and is relatively close to
the nominal value.
32 March 11, 2020 – v4.0

5. The truncated distribution:

An asymmetrical shape in which the peak is
at or near the edge of the range of the
data, and the distribution ends very
abruptly on one side and tails off gently on
the other.
This pattern often occurs if the process
includes a screening, 100 % inspection, or a
review process. Note that these truncation
efforts are an added cost and are,
therefore, good candidates for removal.
33 March 11, 2020 – v4.0

The Histogram – The Bell-Shaped or Normal Distribution
We will come back to

this one later.
34 March 11, 2020 – v4.0

The Histogram – Exercise 1
Distribution of Heights of U.S. Population: 59 66 63 70

Use the plot area below to construct a histogram from the 60 66 69 70
random sample of heights on the right: 65 62 71 72
68 65 67 69
65 66 70 68
64 64 73 73
63 67 71 68
63 68 70 68
65 67 64 71
61 64 70 72
70 63 68 68
68 63 66 66
64 63 67 74
63 62 66 68
62 62 67 70
35 March 11, 2020 – v4.0

36 March 11, 2020 – v4.0

37 March 11, 2020 – v4.0

Measure of Location – The Sample Average
Definition:
x1 + x2 + ... + x N
x=
N
Example: x1 = 5 x2 = 7 x3 = 4 x4 = 2 x5 = 6
5+7+ 4+ 2+6 24
x= = = 4.8
5 5
38 March 11, 2020 – v4.0

Measure of Location – The Sample Median
Construction: Order all data points from the smallest to largest. Then choose the
middle data point if the number of data points is odd, or the mean value of the
two middle data points if the number of data points is even.
Example 1: x1 = 2 x2 = 5 x3 = 4 median = 4
Example 2: x1 = 5 x2 = 7 x3 = 4 x4 = 2 median = 4.5
Example 3: x1 = 5 x2 = 7 x3 = 4 x4 = 2 x5 = 6 ?
39 March 11, 2020 – v4.0

Measure of Variability – The Sample Range
Definition:
R = max(x1 , x2 ,..., xN ) - min( x1 , x2 ,..., xN )
Example: x1 = 5 x2 = 7 x3 = 4 x4 = 2 x5 = 6
R = max(5,7,4,2,6) - min(5,7,4,2,6) = 7 - 2 = 5
Definition: Result is the range of variation.
40 March 11, 2020 – v4.0

Measure of Variability – Sample Variance
𝑥" - 𝑥̅ x3 x6
_
x
average Time
x1 x2 𝑥# - 𝑥̅
x10
(x1 - x ) 2
(
+ x2 - x )2
(
+ ... + x10 - x )
2
(10 - 1) or 9
N=Number of samples
41 March 11, 2020 – v4.0
Measure of Variability – Sample Variance
Definition:
s 2
=
(x
1 -x )
2
( ) 2
+ x2 - x + ... + x N - x ( ) 2
( N - 1)
N=Number of samples
Example: x1 = 5 x2 = 7 x3 = 4 x4 = 2 x5 = 6
s2 =
(5 - 4.8 )2
+ (7 - 4.8 )2
+ (4 - 4.8 )2
+ (2 - 4.8 )2
+ (6 - 4.8 )2
= 3.7
(5 - 1)
4.8=Range
42 March 11, 2020 – v4.0
Measure of Variability – Sample Standard Deviation
Definition:
s LT =
(x1 -x )
2
( )
2
(
+ x2 - x + ... + x N - x )2
( N - 1)
Example: x1 = 5 x2 = 7 x3 = 4 x4 = 2 x5 = 6
2
sLT =
(5 - 4.8) + (7 - 4.8) + (4 - 4.8) + (2 - 4.8) + (6 - 4.8)
2 2 2 2 2
= 3.7
(5 - 1)
sLT = 3.7 = 1.92 Sigma Level
43 March 11, 2020 – v4.0

Measure of Variability – The Principle of Subgrouping
Process
Characteristic
e.g. Hole Size Number of subgroups N = 7
Subgroup size n = 5
Process not in control

•
•
• • •• •
• •• • • •
• •
average • •
• • • • •• • •• •
• • • • •
•• •
Time t
44 March 11, 2020 – v4.0

Measure of Variability – Standard Deviation sST
sST , often notated as s or sigma, is another measure of

dispersion or variability and stands for “short-term
standard deviation”,
R1 + R2 + ... + RN
s ST = d2 = R d2
N
n d2
which measures the short-term variability of a process or 2 1.128

system using “rational” subgrouping. 3 1.693
4 2.059
Where 5 2.326
R j = X max - X min 6 2.534
7 2.704
is the range of subgroup j, N the number of subgroups, 8 2.847
and d2 depends on the size n of a subgroup (see 9 2.970
10 3.078
handout).
45 March 11, 2020 – v4.0

Measure of Variability – The Principle of Subgrouping
Process Number of subgroups N = 7

Characteristic Subgroup size n = 5
e.g. Hole Size
Process not in control
•
•
• • •• •
• •• • • •
• •
average • •
• • • •• • •• •
• • • • • •
•• •
Ø sST stays the same, even if the process is not in control

Ø sLT increases over time because the process is not in control
Ø sST and sLT are identical if the process was in control
Time t
46 March 11, 2020 – v4.0

Measure of Variability – Difference between sLT and sST
Long-term standard deviation:
s LT =
(x
1 -x )
2
( )2
(
+ x2 - x + ... + x N - x )
2
( N - 1)
Short-term standard deviation:
R1 + R2 + ... + RN
sST = d2 = R d2
N
The difference between the standard deviations sLT and sST gives an
indication of how much better one can do with respect to process
variation when using appropriate process control, like Statistical Process
Control (SPC).
47 March 11, 2020 – v4.0

Measure of Variability – The Normal Distribution
34.13 % 34.13 %
13.60 % 13.60 %
2.14 % 2.14 %
0.13 % 0.13 %
average average average average average average average

-3*s(igma) -2*s(igma) -1*s(igma) +1*s(igma) +2*s(igma) +3*s(igma)
If your process is under control, over 99.74% of your data points will fall between the
average ± 3s(sigma) limits.
48 March 11, 2020 – v4.0

49 March 11, 2020 – v4.0

Process Control Charts – Types of Control Charts
Type of Data
Attribute Data Variable Data

(Count or Yes/No Data) (Measurements)
Count Yes/No Data
Incidences or Defectives or
nonconformities nonconforming units
Fixed Variable Fixed Variable Subgroup Fixed Variable

oppor- oppor- subgroup subgroup size subgroup subgroup
tunity tunity size size of 1 size size
I x-bar x-bar
c - chart u - chart np - chart p - chart
MR chart R chart s chart
50 March 11, 2020 – v4.0

Process Control Charts – The I - MR Chart
Ø The I-MR (or Individual – Moving Range) chart is a method of

looking at variation in a variable data or measurement.
Ø One source is the variation in the individual data points over time
(Individual chart). This represents “long term” variation in the
process.
Ø The second source of variation is the variation between successive
data points (Moving Range chart). This represents “short term”
variation.
Ø I-MR charts should be used when there is only one data point to
represent a situation at a given time.
Ø To use the I-MR chart, the individual sample results should be
“sufficient” normally distributed. If not, the I-MR chart will give
more false signals.
51 March 11, 2020 – v4.0

Process Control Charts – Test for Normality
The Normality Test from Anderson & Darling provides a method to determine if
our data comes from a process that creates normally distributed data.
If the all the individual data

points fall on the red line, the
sample data itself is perfectly
normally distributed.
The red line represents

the normal distribution. As long as the p-value stays
above 0.05, we can assume
that the process creates
normally distributed data.
52 March 11, 2020 – v4.0

Process Control Charts – I-MR Chart Example
Individual chart showing the

individual data points we
collected from our process.
Moving Range chart showing

the difference between two
consecutive individual data
points.
53 March 11, 2020 – v4.0

Process Control Charts – The Central Limit Theorem
Regardless of the shape of the distribution of a population, the

distribution of average values, x-bar’s, of subgroups of size n drawn
from that population will tend toward a normal distribution as the
subgroup size n becomes large.
Laplace and Gauss
Pierre Laplace Carl Friedrich Gauss
54 March 11, 2020 – v4.0

Process Control Charts – The (x-bar/R) - Chart
Ø The (x-bar / R) - chart should be used if

Ø the individual measurements are not normally distributed,
Ø one can rationally subgroup the data and is interested in
detecting differences between the subgroups over time.
Ø the large amount of data collected makes it difficult to analyze
the data using the I-MR chart
Ø The (x-bar / R) - chart is a method of looking at two different
sources of variation. One source is the variation in subgroup
averages. The other source is the variation within a subgroup.
Ø The x-bar - chart shows variation over time or long-term variation
and the R - chart is a measure of the short-term variation in the
process.
55 March 11, 2020 – v4.0

Process Control Charts – (x-bar/R) - Chart Example
Average of the individual data

points in each subgroup. In
this case we had 3 data
points in each subgroup.
Range of the individual data

56 March 11, 2020 – v4.0

Process Control Charts – The (x-bar/s) - Chart
Ø The (x-bar / s) - chart should be used instead the (x-bar / R) -

chart if the subgroup is larger than 10. In this case, the standard
deviation is a better measurement than the range for the
variation between individual measurements in a subgroup.
Ø The (x-bar / s) - chart can be used whenever one can use the (x-
bar / R) - chart.
Ø The (x-bar / s) - chart is a method of looking at sources of
variation. One chart looks at variation in the subgroup averages
x-bar. The other chart examines variation in the subgroups
standard deviation s.
57 March 11, 2020 – v4.0

Process Control Charts – (x-bar/R) - Chart Example
Average of the individual data

points in each subgroup. In
this case we had 15 data
Standard Deviation (long-term

formula) of the individual data
58 March 11, 2020 – v4.0

Process Control Charts – Attribute “Yes/No” Data
The number of defect phones produced per hour were

1. hour: 100 phones and 10 defect phones.
11. hour: 75 phones and 5 defective phones. Something wrong ???
59 March 11, 2020 – v4.0

Process Control Charts – The Binomial Distribution
Average
0 1 2 3 4 5 6 7 8 9
Number of defective Items
60 March 11, 2020 – v4.0

Process Control Charts – The p - Chart
Ø The p - chart is used to look at variation in the yes/no attribute

data. It can for example be used to determine the percentage p of
defective items in a group of items.
Ø The number n of items in each group has not to be constant, but
should not vary more than 25 %.
Ø Operational definitions must be used to determine what constitutes
a defective item.
The percentage of defective items is given by
nro. of defective items np

p= =
nro. of items n
61 March 11, 2020 – v4.0

Process Control Charts – The p – Chart Example
Proportion of defects in each

subgroup. In this case we had
always 100 “items” coming out of
our process (subgroup size = 100)
and in average 14.44% were
defective.
62 March 11, 2020 – v4.0

Process Control Charts – The np - Chart
Ø The np - chart, like the p - chart, is used to look at variation in

yes/no type attributes data.
Ø np - charts are used to determine the number np of defective
items in a group of items, while p - chart looked at the
percentage of defective items in a group of items. Because the np
- chart uses the number of defects, it is easier to use.
Ø However, the major difference between the np - chart and the p
- chart is that the subgroup size has to be constant for the np -
chart. This is not necessary for the p - chart.
63 March 11, 2020 – v4.0

Process Control Charts – The p – Chart Example
Number of defects in each

subgroup. In this case we had
always 100 “items” coming out of
our process (subgroup size = 100)
and in average we had 14.44
defects per subgroup.
64 March 11, 2020 – v4.0

Process Control Charts – The Attribute “Count” Data
The number of wrong assembled components in SMD made on 20 PCBs were
1- 20: 10 wrong assembled components

21 - 40: 8 wrong assembled components
161 - 180: 2 wrong assembled components. Something wrong ???
65 March 11, 2020 – v4.0

Process Control Charts – The Poisson Distribution
Average
0 1 2 3 4 5 6 7 8 9
Number of Incidences
66 March 11, 2020 – v4.0
67 March 11, 2020 – v4.0

68 March 11, 2020 – v4.0

Process Control Limit – The Basic Idea
Lower Upper
Control Limit Control Limit
34.13 % 34.13 %
13.60 % 13.60 %
2.14 % 2.14 %
0.13 % 0.13 %
average average average average average average average

-3*(sigma) -2*(sigma) -1*(sigma) +1*(sigma) +2*(sigma) +3*(sigma)
If your process is under control, over 99.74% of your data points will fall between the
average ± 3s(sigma) limits.
69 March 11, 2020 – v4.0

Process Control Limit – Upper & Lower Control Limit
average + 3*sigma
average + 2*sigma
average + 1*sigma • •
average • • •
average - 1*sigma •
average - 2*sigma • •
average - 3*sigma
Upper Control Limit (UCL) = average + 3*(sigma)
Lower Control Limit (LCL) = average - 3*(sigma)
70 March 11, 2020 – v4.0

Process Control Limit – Upper & Lower Control Limit
Because the variation of a process is not known beforehand, one

cannot calculate or define the control limits in advance.
The calculation of the control limits should be based on at least 20 to

25 data points from a process that was in statistical control (stable).
Control limits are characteristics of a stable process. They bound the

variation of the process that is due to common causes.
The limits should not be recalculated and modified unless there is a

reason to do so (e.g. a process change or improvements).
71 March 11, 2020 – v4.0

72 March 11, 2020 – v4.0

Out-of-Control & Process Improvement
Defect
Upper Specification Limit (USL)
large variation Þ problem exist

nominal value Þ root cause analysis
Þ process improvement
Lower Specification Limit (LSL)
Defect
Upper Specification Limit (USL)
trend Þ problem occurs

nominal value Þ root cause analysis
Þ corrective action
Lower Specification Limit (LSL)
73 March 11, 2020 – v4.0

Process Tempering & Overcontrol
LSL USL LSL USL

Sample
Sample
LSL= 45 50 55 = USL 45 50 55
LSL USL LSL USL

45 50 55 45 50 55
74 March 11, 2020 – v4.0

Process Tempering & Overcontrol
LSL USL
Original Process
Tempered Process
45 50 55
Process tampering may substantially increase the product variability since
the process average is shifted each time an adjustment to the process is
made as a reaction to a product or service defect.
75 March 11, 2020 – v4.0

Out-of-Control Criteria – Two Causes of Variation
Common Causes: Causes that are implemented in the process due to

the design of the process and the random variation in the process
inputs, and affect all outcomes of the process. Identifying these types
of causes often requires Six Sigma methods and tools, including Multi-
vari Study and Design of Experiment (DOE).
Special Causes: Causes that are not present in the

process all the time and do not affect all outcomes,
but arise because of specific circumstances. These
causes could be the result of a new process input
entering the process, or an existing process input
behaving very differently than normal. Special causes
can be identified using SPC.
Walter A. Shewhart (1931)
76 March 11, 2020 – v4.0

Out-of-Control Criteria – Two Types of Processes
Unstable Process: A process in which variation is a result of both

common and special causes.
Stable Process: A process in which variation in outcomes arises only

from common causes.
77 March 11, 2020 – v4.0

SPC Out-of-Control Criteria – The Types of Signals
An out-of-control criteria is a signal of a special causes of

variation:
• Is a systematic pattern of the product or process
characteristic monitored and charted
• Has a low probability of occurring when the process is
stable and in control
78 March 11, 2020 – v4.0

Everything is possible, but is it likely?
What is the “chance” to

loose the coin flip 11 times
in a row?
1 = 50% or 0.50
2 = 25% or 0.50*0.50
…
…
…
11 = 0.049% or 0.5011
79 March 11, 2020 – v4.0

Process Out-of-Control Criteria
Below is a list of the most commonly used out-of-control criteria included

in Minitab 17 and as defined by Walter Shewhart in the 1920s.
Criteria 1: Outlier
Criteria 3: Process Trend
Criteria 2 & 5 & 6: Process Shift
80 March 11, 2020 – v4.0

SPC Criteria #1 – 1 Point above or below 3 Sigma
All SPC Out-of-Control Criteria have

about a 1 in 1,000 chance to occur in
a process without a special cause.
Therefore, they are strong evidence
for the presence of a special cause.
81 March 11, 2020 – v4.0

SPC Criteria #2 – 9 Points on the same Side of the Average
9 consecutive points above or below

the process performance average line
often indicates a shift in process
performance.
82 March 11, 2020 – v4.0

SPC Criteria #3 – 6 Consecutive Points Increasing or Decreasing
6 consecutive points increasing or

decreasing often indicates a trend in
process performance due to a special
cause.
83 March 11, 2020 – v4.0

SPC Criteria #5 – 2 of 3 Points above or below 2 Sigma
2 of 3 consecutive points above or

below 2 Sigma line often indicates
a shift in process performance.
84 March 11, 2020 – v4.0

SPC Criteria #6 – 4 of 5 Points above or below 1 Sigma
4 of 5 consecutive points above

or below the 2 Sigma line often
indicates a shift in process
performance.
85 March 11, 2020 – v4.0

Special Causes showing in the MR, R, or s Chart
1 data point above or below the

3 Sigma line is often the only
criteria used to identify special
causes in process performance.
86 March 11, 2020 – v4.0

Note: Special causes in the process performance that (also) show up in

the MR, R or s chart, i.e. special causes resulting in a “more than usual”
increase or decrease in process performance from one data point to the
next, will increase the short-term standard deviation of the process.
As a result, that will increase the upper and decrease the lower control
limit of the I or x-bar chart. That will then result in a reduced ability to
actually identify special causes in the I or x-bar chart.
Solution: Special causes that (also) show up in the MR, R or s chart, need
to be eliminated from the data set and the control chart needs to be re-
calculated to make sure that all special causes in the I or x-bar chart are
identified.
However, that does not mean that these special causes do not need to be
investigated and eliminated.
87 March 11, 2020 – v4.0

The process performance data indicates two special causes in process.

Both special causes show only in the MR chart, increasing the average MR and
therefore the short-term standard deviation used to calculate the control limits
for the I chart.
88 March 11, 2020 – v4.0

After we exclude the individual data points

causing the two special causes shown in the
MR chart, we can now see an additional
special cause in the I chart (2 out of 3 points
below the 2 Sigma line).
89 March 11, 2020 – v4.0

SPC Out-of-Control Criteria – Summary
- -
Chart x x/R x/s np p u c
Criteria 1 • •• •• • • • •
Criteria 2 • • •
Criteria 4 • •• •• • • • •
Criteria 7 • •• •• • • • •
90 March 11, 2020 – v4.0
SPC Out-of-Control Criteria – Exercise 6
Efficiency Out-of-Control Conditions:
Determine why the process control chart below indicates that the efficiency of production line H300 is out-
of-control.
o N
F
o
r a
k i a
n k fNotes:
5 - 2
A
A
*
. 0
U
. 0
2
INDVUALS
1
R9955..001122334678 ANGES AVERGS
7
6
. 0
. 0
. 0
. 0
6
0 .60. 0
0
G
A
0
C
r o
u
L
u
t o
UO
1
2
A
L C
5 0
C u r v
K - S :
4 0
A V E
P R O
3 0
U C L
L C LR
2 0
1 0
0 L C
9955..0022146783
r e
1
C
91
0
H
. 0
A
4
March 11, 2020 – v4.0

e n
92 March 11, 2020 – v4.0

93 March 11, 2020 – v4.0

Sample Size and Frequency – Rational Subgrouping
Ø Applying the Central Limit Theorem to make the average of the

subgroups normally distributed.
Ø Dividing the sources of variation in the process outcomes into

two different subgroups (short-term and long-term variation).
Ø Optimizing the probability of identifying a shift in the process

average with the next observation.
94 March 11, 2020 – v4.0

Sample Size and Frequency – Subgroup Size and Sensitivity
LCL USL
UCL
Defects
avg - 3 × sST avg avg + 3 × sST avg + E
95 March 11, 2020 – v4.0

Sample Size and Frequency – Sample Frequency
Ø The frequency of sampling of two consecutive subgroups can be

determined by dividing the average time period between two out-
of-control situations by at least 3 but not more than 6.
Example: If experience shows that your process produces defects or
goes out-of-control once every 12-hour shift, the you should collect
measurements from your process every 2 to 4 hours.
Ø However, no general rule can be defined about which time interval
works best. You have to start with a good (conservative) guess and
refine the time interval if necessary.
96 March 11, 2020 – v4.0

97 March 11, 2020 – v4.0

98 March 11, 2020 – v4.0

Out-of-Control-Action-Plans (OCAP)
An OCAP is a flowchart that guides the operator through a defined

and repeatable response to “any” out-of-control situation.
Activators (out-of-control decision rules)
Checkpoints (list of possible assignable causes)
Terminators (corrective actions)
99 March 11, 2020 – v4.0

Out-of-Control-Action-Plans (OCAP)
Start
Yes Yes
No No
Activators Yes Yes
No No
Yes Yes
No Checkpoints Corrective Actions
End
100 March 11, 2020 – v4.0

Out-of-Control-Action-Plans – Activators
1. One point outside the 3-sigma control limits.

2. A run of at least seven or eight consecutive points, where the type of
run could be either a run up or down, a run above or below the
center line.
3. Two out of three consecutive points plot beyond from the 2-sigma
warning level.
4. Four out of five consecutive points at a distance of 1-sigma or
beyond.
5. One or more consecutive points near a 2-sigma warning or 3-sigma
control level.
6. …
101 March 11, 2020 – v4.0

Out-of-Control-Action-Plans – Checkpoints
The checkpoints instruct the operator to investigate specific items as

possible assignable causes for the out-of-control situation.
Once a checkpoint has identified a probable assignable cause for the

out-of-control situation, the OCAP will flow into a terminator or
corrective action.
102 March 11, 2020 – v4.0

Out-of-Control-Action-Plans – Terminators
The terminator contains a detailed description of the corrective action

that the operator has to take to resolve the out-of-control situation.
103 March 11, 2020 – v4.0

An Analysis of Out-of-Control-Action-Plans ...
... typically generate one or more of the following actions:
ü Eliminate the most common assignable causes
ü Analyze the activators
ü Revise the order of the checkpoints and terminators
ü Train the operators to perform more of the corrective actions included

into the OCAP to resolve out-of-control situations quickly
104 March 11, 2020 – v4.0

Some Benefits of Out-of-Control-Action-Plans
ü The OCAP is a systematic and ideal problem-solving tool for

process problems because it reacts to out-of-control situations in
real time.
ü OCAPs standardize the best problem-solving approaches from the

most skilled and successful problem solvers (experts/operators).
ü The OCAP also allows (and requires) off-line analysis of the

terminators to continually improve OCAP efficiency.
105 March 11, 2020 – v4.0

106 March 11, 2020 – v4.0

Process Control Plan → Objective
A Control Plan is a written statement of an organization’s quality planning

actions for a specific process, product, or service.
The Objective of an effective Process Control Plan is to
Ø operate processes consistently on target with minimum variation, which
results in minimum waste and rework
Ø assure that product and process improvements that have been
identified and implemented become institutionalized
Ø provide for adequate training in all standard operating procedures,
work instructions and tools
Process Process
Customer Product & Part Process
Input & Output Control
Requirements Characteristics Controls
Characteristics Plan
107 March 11, 2020 – v4.0

Process Control Plan → Template
Operational Excellence
Process Control Plan
Supplier: Product:
Date (Orig):
Key Contact: Process:
E-Mail / Phone:
Date (Rev):
Characteristic
Specification Control Limits Measurement
Process Step Product Process Sample Size Sample Frequency Control Method Reaction Plan
(LSL, USL &Target) (LCL & UCL) System
Characteristic Characteristic
108 March 11, 2020 – v4.0

Ø Process: Name of the process to be controlled

Ø Process Step: The process steps of the process to be controlled
Ø Characteristic (Product/Process): Name of the characteristic of a process step
or a product, which will actually be controlled.
Ø Specification: Actual specification, which has been set for the characteristic to
be controlled. This may be verified e.g. in standards, drawings, requirements
or product requirement documents.
Ø Control Limits: Control limits are specified for characteristics that are
quantifiable and selected for trend analysis (x-bar/R, x/mR, p charts). When
the process exceeds these limits, corrective actions are required.
Ø Measurement System: Method used to evaluate or measure the characteristic.
This may include e.g. gages, tools, jigs and test equipment or work methods.
An analysis of the repeatability and the reproducibility of the measurement
system must first be carried out (e.g. Gage R&R Study).
109 March 11, 2020 – v4.0

Ø Sample Size: Sample size specifies how many parts are evaluated at any
given time. The sample size will be “100 %” and the frequency
“continuous” in case of 100% inspection.
Ø Sample Frequency: Sample frequency specifies the how often a sample will
be taken, e.g. once per shift or every hour.
Ø Control Method: Brief description of how the information/data will be
collected, analysed/controlled and reported. More detailed information
may be included in a named work instruction.
Ø Reaction Plan: Necessary corrective actions to avoid producing non-
conforming products or operating out-of-control. Corrective actions should
normally be in the responsibility of the person closest to the process, e.g.
the machine operator. This is to secure, that immediate corrective actions
will take place and the risk of non-conforming products will be minimized.
More detailed information may be included in a named work instruction.
110 March 11, 2020 – v4.0

Process Control Plan → Check List
ü Process maps detail manufacturing ü Reaction plan in place for out-of-spec

steps, material flow and important conditions and material
variables ü Operating procedures identify actions,
ü Key product variables identified with responsibilities, maintenance schedule
importance to customer, desired target and product segregation requirements
value and specification range defined ü Training materials describe all aspects
ü Key and critical process input variables of process operation and
identified with targets, statistically responsibilities
determined control limits & control ü Process improvement efforts fully
strategies defined documented and available for
ü Measurement systems are capable with reference
calibration requirements specified ü Control plan is reviewed and updated
ü Sampling, inspection and testing plans quarterly and resides in the operating
include how often, where and to area
whom results are reported
111 March 11, 2020 – v4.0

112 March 11, 2020 – v4.0

113 March 11, 2020 – v4.0

When SPC fails, look in the mirror ...
Ø People are trained without regard for the need to know or

implementation timing.
Ø Once the necessary charts are created, they are rarely reviewed.
Ø Charts have characteristics or parameters that do not really
represent the process.
Ø Control limits are not reviewed or adjusted, or conversely, they
are adjusted too often.
Ø Someone other than the process operator maintains the chart.
(This is not always bad, however)
Ø The process is not capable or set up well off target.
Ø Corrective actions and significant events are not recorded on the
chart.
114 March 11, 2020 – v4.0

The End …
“Perfection is not attainable, but if we chase perfection we can catch

excellence.” - Vince Lombardi
115 March 11, 2020 – v4.0

Terms & Conditions
After you have downloaded the training material to your own

computer, you can change any part of the course material and
remove all logos and references to Operational Excellence
Consulting. You can share the material with your colleagues and
re-use it as you need. The main restriction is that you cannot
distribute, sell, rent or license the material as though it is your
own. These training course materials are for your — and
your organization's — usage only. Thank you.
116 March 11, 2020 – v4.0

SPC Training 2016

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

SPC Training 2016

Uploaded by

Copyright:

Available Formats

Six Sigma Statistical Process Control

by Asia Supply Line. LLC

1 March 11, 2020 – v4.0

2 March 11, 2020 – v4.0

3 March 11, 2020 – v4.0

4 March 11, 2020 – v4.0

5 March 11, 2020 – v4.0

The Detection Control Scheme

6 March 11, 2020 – v4.0

• The traditional process control concept does not help us

7 March 11, 2020 – v4.0

Prevention Control Scheme

8 March 11, 2020 – v4.0

All work is a series of

All processes vary

9 March 11, 2020 – v4.0

A defect is any variation of a required characteristic of the product or

11 March 11, 2020 – v4.0

There are four basic tools we use

12 March 11, 2020 – v4.0

13 March 11, 2020 – v4.0

14 March 11, 2020 – v4.0

15 March 11, 2020 – v4.0

16 March 11, 2020 – v4.0

17 March 11, 2020 – v4.0

18 March 11, 2020 – v4.0

• A statistical term that refers to the standard deviation of a process

Sigma Level ppm

IRS Tax Advice

Tech Center Wait Time

Attempts to improve an organization's:

21 March 11, 2020 – v4.0

22 March 11, 2020 – v4.0

Remember Cp = Design Specs at 6σ

23 March 11, 2020 – v4.0

Converting PPM into cost of quality

24 March 11, 2020 – v4.0

The key to process control and continuous process

25 March 11, 2020 – v4.0

26 March 11, 2020 – v4.0

27 March 11, 2020 – v4.0

A histogram provides graphical presentation and a first estimation about

28 March 11, 2020 – v4.0

1. The bell-shaped distribution:

29 March 11, 2020 – v4.0

2. The double-peaked distribution:

30 March 11, 2020 – v4.0

3. The plateau distribution:

31 March 11, 2020 – v4.0

4. The skewed distribution:

32 March 11, 2020 – v4.0

5. The truncated distribution:

33 March 11, 2020 – v4.0

We will come back to

34 March 11, 2020 – v4.0

Distribution of Heights of U.S. Population: 59 66 63 70

35 March 11, 2020 – v4.0

36 March 11, 2020 – v4.0

37 March 11, 2020 – v4.0

38 March 11, 2020 – v4.0

Example 2: x1 = 5 x2 = 7 x3 = 4 x4 = 2 median = 4.5

39 March 11, 2020 – v4.0

R = max(x1 , x2 ,..., xN ) - min( x1 , x2 ,..., xN )

Definition: Result is the range of variation.