STATISTICAL

PROCESS
CONTROL
 TRAINING TOPICS

 Introduction.
 Types of Variation.
 “Process In Control” and “Process Out of Control”.
 Advantages of Statistical Process Control.
 SPC Charts.
 Process Capability Analysis.
 Methods of finding out process capability.
 Use Process Capability to ensure Process Quality.
 STATISTICAL
DEFINATION

“Branch of mathematics dealing with the

collection, analysis, interpretation, and
inference of conclusions from
quantitative data”.
 STATISTICAL PROCESS CONTROL (SPC)

•Is the application of Statistical Methods to monitor

and control a process to ensure that it operates at
its full potential to produce conforming product.

•Is an analytical decision making tool which allows

you to see when a process is working correctly and
when it is not.

•Variation is present in any process, deciding when

the variation is natural and when it needs correction
is the key to quality control.
 PROCESS VARIATION

•Concluded That While Every Process Displays Variation,

Some Processes Display Controlled Variation That Is
Natural To The Process (Common Causes Of Variation),
While Others Display Uncontrolled Variation That Is Not
Present In The Process Causal System At All Times
(Special Causes Of Variation).
TRADITIONAL METHODS VS STATISTICAL PROCESS CONTROL

The quality of the finished article was traditionally

achieved through post-manufacturing inspection of
the product; accepting or rejecting each article (or
samples from a production lot) based on how well it
met its
design specifications

SPC uses Statistical tools to observe the

performance of the production process in order to
predict significant deviations that may later result in
rejected product.
 Variation in Quality

▶ No two items are exactly alike.

▶ Some sort of variations in the two items is bound to be there.

In fact it is an integral part of any manufacturing process.

▶ This difference in characteristics known as variation.

▶ This variation may be due to substandard quality of

raw material, carelessness on the part of operator,
fault in machinery system etc..
 TYPES OF VARIATION

Two kinds of variation occur in all manufacturing

processes
1. Natural or Common Cause Variation
consists of the variation inherent in the
process as it is designed.

2. Special Cause Variation or Assignable-cause

Variation With sufficient investigation, a
specific cause, such
as abnormal raw material or incorrect set-up
parameters,
can be found for special cause variations.
 COMMON CAUSE VARIATION
Variation due to
chance
causes/common causes
▶ Variation occurred due to chance.

▶ This variation is NOT due to defect in machine,

Raw material or any other factors.
▶ Behave in “random manner”.
▶ Negligible but Inevitable
▶ The process is said to be under the state of
statistical control.
Variation due to assignable causes

Non – random causes

like:

▶Difference in quality of raw

material
▶ Difference in machines
▶ Difference in operators
 ‘In Control’ and ‘Out Of Control’

Process is said to be ‘in control’ and stable

If common cause is the only type of variation

that exists in the process
It is also predictable within set limits i.e. the
probability of any future outcome falling within the
limits can be stated approximately.

Process is said to be ‘out of control’ and unstable

Special cause variation exists within the process

Specification and control limits

▶ No item in the world can be a true copy of another item.

▶ It is not expressed in absolute values but in terms of a

range.

▶ For Eg:
The diameter of a pen is expected by
its manufacturer not as 7mm but as 7mm ± 0.05.

Thus, the diameter of a pen produced by

the manufacturer can vary from 6.95 mm to 7.05 mm.
Setting
Control Limits
HOW CONTROL LIMITS ARE
USEFUL…..?
 SPC Methods- C ontrol C harts

▶ 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
C ontrol C harts for V ariables

▶x-bar charts
It is used to monitor the changes in the mean of
a process (central tendencies).

▶R-bar charts
It is used to monitor the dispersion or variability of
the process
C ontrol C harts for A ttributes

▶ Attributes are discrete events; yes/no,

pass/fail
Use P-Charts for quality characteristics
discrete
that are and involve yes/no or good/bad
decisions
▶ Number of leaking caulking tubes in a box of 48
▶ Number of broken eggs in a carton

Use C-Charts for discrete defects when

there can be more than one defect per unit
▶ Number of flaws or stains in a carpet sample cut from
a production run
▶ Number of complaints per customer at a
hotel
Statistical process control -broadly broken
down into 3 sets of activities

1. Understanding the process

2. Understanding the causes of

variation

3. Elimination of the sources of special

cause variation.
 Understanding the process

• Process is typically mapped out and the process is

monitored using control charts.

Understanding the causes of variation

• Control charts are used to identify variation that may

be due to special causes, and to free the user from
concern over variation due to common causes.

• It is a continuous, ongoing activity.

• When a process is stable and does not trigger any of

the detection rules for a control chart, a process
capability analysis may also be performed to predict
the ability of the current process to produce
conforming product in the future.
•When excessive variation is identified by the control
chart detection rules, or the process capability is found
lacking, additional effort is exerted to determine
causes of that variance.

• The tools used include

•Ishikawa diagrams
•Designed experiments
•Pareto charts

•Designed experiments are critical -only means of

objectively quantifying the relative importance of the
many potential causes of variation.
Elimination of the sources of special cause variation

•Once the causes of variation have been quantified,

effort is spent in eliminating those causes that are
both statistically and practically significant.

•includes development of standard work, error-

proofing and training.

•Additional process changes may be required to

reduce variation or align the process with the
desired target, especially if there is a problem
with process capability.
 ADVANTAGES OF SPC

• Reduces waste

•Lead to a reduction in the time required to produce

the product
or service from end to end
due to a diminished likelihood that the final
product will have to be reworked, identify bottlenecks,
wait times, and other sources of delays within the
process.

•A distinct advantage over other quality

methods, such as inspection - its emphasis on
early detection and prevention of problems

•Cost reduction

•Customer satisfaction
 SPC CHARTS

•One method of identifying the type of variation present.

•Statistical Process Control (SPC) Charts are essentially:

Simple graphical tools that enable process
performance monitoring.
Designed to identify which type of variation exists
within the process.
Designed to highlight areas that may require
further investigation.
 Easy to construct and interpret.

• most popular SPC tools

 X-bar Chart
 R-bar Chart
 Control charts

Show the variation in a measurement during the time

period that the process is observed.

Monitor processes to show how the process is

performing and how the process and capabilities are
affected by changes to the process. This information is
then used to make quality improvements.

 A time ordered sequence of data, with a centre line

calculated by
the mean.

 Used to determine the capability of the process.

 Help to identify special or assignable causes for

factors that
impede peak performance.
Control charts have four key features:

1) Data Points:
Either averages of subgroup measurements or
individual measurements plotted on the x/y axis and
joined by a line. Time is always on the x-axis.

2) The Average or Center Line

The average or mean of the data points and is drawn
across the middle section of the graph, usually as a
heavy or solid line.

3) The Upper Control Limit (UCL)

Drawn above the centerline and annotated as
"UCL". This is often called the “+ 3 sigma” line.

4) The Lower Control Limit (LCL)

Drawn below the centerline and annotated as
"LCL". This is called the “- 3 sigma” line.
X-bar chart and R-bar chart formula:
Control limits define the zone where the observed
data for a stable and consistent process occurs
virtually all of the time (99.7%).

Any fluctuations within these limits come from

common causes inherent to the system, such as choice
of equipment, scheduled maintenance or the precision
of the operation that results from the design.

An outcome beyond the control limits results from a

special cause.

 The automatic control limits have been set at 3-

sigma limits.
•The area between each control limit and the
centerline is divided into thirds.

1) Zone A - "1-sigma zone“

2) Zone B - "2-sigma zone"
3) Zone C - " 3-sigma zone “
 PROCESS CAPABILITY
ANALYSIS
⚫ Examines
◦ whether the process is capable of producing products which
conforms to specifications
◦ range of natural variability in a process what we measure with
control charts

⚫ Process capability studies distinguish between conformance to

control limits and conformance to specification limits (also called
tolerance limits)
◦ if the process mean is in control, then virtually all points will
remain within control limits
◦ staying within control limits does not necessarily mean that
specification limits are satisfied
◦ specification limits are usually dictated by customers
21
 4
Process Capability 6

▶ Evaluating the ability of a production process to meet

or exceed preset specifications. This is called process
capability.

▶ Product specifications, often called tolerances, are

preset ranges of a c c eptable quality characteristics,
such as product dimensions.
Two parts of pro c e ss capab ility 4
7

▶ 1) Measure the variability of the output of a process,

and

▶ 2) Compare that variability with a proposed specification

or product tolerance.
 4
M easuring P rocess C a p a bility
8

▶ To produce an acceptable product,

the process must be capable and in
control before production begins.

U SL LSL
C p
6
 4

E xample
9

▶ Let’ssay that the specification for

the acceptable volume of liquid
is preset at 16 ounces ±.2
ounces,
which is 15.8 and 16.2 ounces.
 5

F igure (a)
0

▶ The process produces 99.74 percent (three sigma) of

the product with volumes between 15.8 and 16.2
ounces.

Cp 1
 5

F igure (b)
1

▶ The process produces 99.74 percent (three sigma)

of the product with volumes between 15.7 and
16.3 ounces.

Cp 1
 5

F igure (c)
2

▶ the production process produces 99.74 percent

(three sigma) of the product with volumes between
15.9 and
16.1 ounces.

Cp 1
5
3
 Process capability 5
ratio 5
(off centering
▶ There is a possibility that the process
mean may shift over a period of time, in
process)
either direction, i.e., towards the USL or
the LSL. This may result in more
defective items then the expected. This
shift of the process mean is called the
off-centering of the process.

USL LS L
C m in ,
p k 3 3
 5

E xample
6

▶ Process 1 5 .9
mean:

▶ Process standard 0.067

deviation:
▶ LSL = 15.8
▶ USL = 16.2

0 .4
C p 1
6 ( 0 .0 6 7 )
 5
7

US LSL
C ,
pk L 3 3
min

C 16.2 15.9 15.9

pk min ,
15.8
C pk
3(.1) 3(.1)

min 1.00, 0.33

C pk
Process Capability analysis cont.

Design
Specificatio
ns

(a) Natural variation

exceeds design
specifications;
process is not
capable of meeting
specifications all the
time.
Process
Design
Specificatio
ns

(b) Design
specifications and
natural variation the
same; process is
capable of meeting
specifications most of
the time.
Process
22
Process Capability (cont.)

Design
Specificatio
ns

(c) Design
specifications
greater than natural
variation; process is
capable of always
conforming to
specifications.
Process
Design
Specificatio
ns

(d) Specifications
greater than natural
variation, but
process off center;
capable but some
output will not meet
upper
specification. Process
23
 Nomenclature

 Four indices:
– Cp: process capability index
– Cpk: minimum process capability index
– Pp: process performance index
– Ppk: minimum process performance index

ASTM E2281: Standard Practice for Process and

Measurement Capability Indices
47
 Calculation Formula

(USL  LSL)
C 
p

6SD

Mean  LSL
Cpkl 

3SD

USL  Mean
Cpku 

3SD

Cpk= min (Cpkl, Cpku)

USL: upper specification limit; LSL: lower specification limit;
Mean: grand average of all the data
SD: overall variability

48
 A Perfectly Centered Process…

USL
LSL

For this case:

LSL
USL USL= +4σ
LSL = -4σ
USL-LSL= 8σ
Cp= 1.333
Cpku=1.333
Cpkl=1.333
Cpk=1.333
-5 -4 -3 -2 -1 0 1 3 4 5
2

Mean (μ ), Sigma (σ)

49
 Process Mean is not
Centered…
For this case:
USL= +4σ
LSL = -4σ
USL-LSL= 8σ
Cp= 1.333
Cpkl = 1.667
Cpku = 1.0
Cpk= 1.0

 When the process is not centered, or deliberately run off-center for economic
reasons, or only a single specification limit is involved, Cpk should be used.

50
Cpk, Sigma Value, and PPM
Area under Non conforming parts per million (ppm)
Sigma normal Capability
Cpk distribution
Valu curve (%)* Unilateral specification Bilateral specification* Rating**
e Value

0.333 1 68.27 158650 317300 Terrible

0.667 2 95.45 22750 45500 Poor

1.0 3 99.73 1350 2700 Marginally

capable
1.333 4 99.993636 32 64 Capable
1.667 5 99.999942 0.29 0.58 Good
2.0 6 99.9999998 0.001 0.002 Excellent
*Process mean is centered at middle of the specification limits and has normal distribution
**Bothe, D. R., Measuring Process Capability, Cedarburg, W.I., Landmark Publishing Inc., 2001
51
 Process Capability Index Cpk
 Cpk represents the potential process capability (i.e.
how well a given process could perform when all
special causes have been eliminated).
 Forecast future batch failure rate
– Cpk (Yes) ; Ppk (No)

52
 QUESTION

In tablet manufacturing process,

standard deviation of a tablet weight
variation result is 1.42, mean is 145.4
with upper specification limit and
lower specification limit is 152.25 mg
and 137.75 respectively. Calculate the
Cpk value and predict about the
process and sigma level.
 ANSWER 5
7

US LSL
C ,
pk L 3 3
min

C min
152.25 145.4 , 145.4
pk
137.75
3(1.42)
C pk 3(1.42)

C pk min 1.607, 2.43

 ANSWER

CpK = 1.607
Sigma Level = 4
 QUESTION
Product X is compressed on three different
compression machines with following data.

Tablet Press A Tablet Press B Tablet Press C

Mean = 5.01 g Mean = 5.40 g Mean = 5.32 g
St.dev. = 0.082 St.dev. = 0.115 St.dev. = 0.047

The Upper Specification limit and lower specification limit

of Product X is 5.51 g and 4.99 g respectively. Which
machine is capable of producing the tablets within
specifications
 TABLET PRESS A 5
7

US LSL
C ,
pk L 3 3
min

C 5.51 5.01 5.01

pk min ,
4.99
C pk
3(0.082)
3(0.082)
C pk min 2.03, 0.08
 TABLET PRESS B 5
7

US LSL
C ,
pk L 3 3
min

C 5.51 5.40 5.40

pk min ,
4.99
C pk
3(0.115)
3(0.115)
C pk min 0.31, 0.14
 TABLET PRESS C 5
7

US LSL
C ,
pk L 3 3
min

C 5.51 5.32 5.32

pk min ,
4.99
C pk
3(0.047)
3(0.047)
C pk min 1.34, 2.34
 ANSWER

TABLET PRESS C IS CAPABLE OF

PRODUCING TABLET X WITHIN
SPECIFICATIONS LIMIT
5
4
 Summary: Process Capability Indices

 Consider not only process mean & variability but also in relation
to the specification
 No additional testing is required since batch release data is
available per current regulation
 A simple and powerful indicator to ensure product quality and
process robustness.

62