Statistical Quality

Control

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Quality is the determining factor the success of any product or service.
Large resource are committed in every organization to ensure quality.

Definition: It is defined as customer satisfaction in general and fitness for

use in particular. Both the external consumer who buy the product and
services and the internal consumers that is, all divisions or departments of
the business organization are equally interested in the quality.

Statistical quality control: The process of applying statistical principles to

solve the problem of controlling the quality control of a product or service is
called statistical quality control.

Quality elements: a) Quality design b) Quality conformance

a)Quality design: Quality of design refers to product feature such as

performance, reliability durability, ease of use, serviceability

b)Quality conformance: Quality conformance means whether the product

meets the given quality specification or not .QC is considered for SQC. 2
Inspection: The process of measuring the out put and comparing it to check
whether it meets the given specified requirements or not, is called inspection.

The nature and process of inspection varies in relation to its purpose

Inspection Methods: The following are the methods of inspection based on

merits

1)Incoming inspection: In this method, the quality of the goods and services
arriving into the organization is inspected. This ensures that the material
supplies adhere to the given specifications. With this, defective material
cannot enter into the production process. This focuses on the vendor quality
and ability to supply acceptable raw materials.

2)Critical point inspection: Inspecting at the critical points of a product

manufacture gives valuable insight into the completely functional process. At
the points of manufacture that involve high costs or which offer no possibility
for repair or rework, inspection is crucial further operation depend on these
results critical point inspection helps to drop the defective production, and
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thereby, facilitate avoiding unnecessary further expenditure on them.
3)Process inspection: This is also called patrolling inspection or
floor inspection or roving inspection. Here the inspector goes around
the manufacturing points in the shop floor to inspect the goods
produced on random sample basis from time to time.

4)Fixed inspection: It provides for a centralized and independent

where work is brought for inspection from time to time. This method
is followed where the inspection equipment cannot be moved to the
points of productions.

5)Final inspection: This is centralized inspection making use of

special equipment. This certifies the quality of the goods before they
are shipped.

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 Three SQC Categories
Statistical quality control (SQC): the term used to describe the set of
statistical tools used by quality professionals; SQC encompasses
three broad categories of:
1. Statistical process control (SPC)
2. Descriptive statistics include the mean, standard deviation, and
range
Involve inspecting the output from a process
Quality characteristics are measured and charted
Helps identify in-process variations
3. Acceptance sampling used to randomly inspect a batch of
goods to determine acceptance/rejection
Does not help to catch in-process problems
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Descriptive Statistics
Descriptive Statistics include:
n

The Mean- measure of central

tendency
x i

The Range- difference between x i 1

largest/smallest observations in a
set of data
n

x
Standard Deviation measures the n
2
amount of data dispersion around i X
mean
Distribution of Data shape i 1

Normal or bell shaped or

n 1
Skewed

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Distribution of Data
Normal distributions Skewed distribution

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Elements of statistical Quality Control: The technique under SQC can
be divided in to two parts
a) Process control (It is carried out through control chats )
b) Acceptance sampling (It is carried out through sampling plan)

a) Process control: Process control is a technique of ensuring the

quality of the products during the manufacturing process itself. If a
process consistently produces items with acceptable or tolerable
range of specification. It is said to be statically under control.
Process control is achieved through control charts. Process control
aims to control and maintain the quality of the products in the
manufacturing process.
Statistical control charts: A control chart compares graphically the
process performance data to computed statistical control limits. These
control limits act as limit lines on the chart control chats are the tools
to determine whether the process is under control or not.
The quality of the production process may be affected by chance
cause or assignable cause. 8
Chance cause: such causes, which may or may not affect the
manufacturing process are called chance cause, chance cause cannot
even be identified. It is not possible to always maintain the given
specification.
Assignable Cause: Assignable causes affect the quality of the
production process. These causes can be identified and specified.
Causes such as change in the labour shift, power fluctuations, or
excessive tool wear are said to be assignable causes as they affect the
quality of manufacturing process in different ways.

The control chart helps to identify the different ways in which the
assignable causes can affect the manufacturing process. But it cannot
find out what it is in specific terms. A subsequent investigation of the
process alone can reveal what the specific cause it.

Process capability: Process capability refers to the ability to achieve

measurable results from a combination of machines, tools, methods,
materials and people engaged in production.
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Process Capability
A measure of the ability of a process to meet preset
design specifications:
Determines whether the process can do what we are
asking it to do
Design specifications (tolerances):
Determined by design engineers to define the acceptable
range of individual product characteristics (e.g.: physical
dimensions, elapsed time, etc.)
Based upon customer expectations & how the product
works (not statistics!)
Example of Bulk drug manufacture old scenario and
new scenario
Confidence limits and control limit:
Confidence limit: It indicate the range of confidence level. A confidence
level refers to the probability that the value of measurement or parameter,
such as length of screw, is correct.

Ex: If a component is required with measurement of 50 mm. across, then

the buy accept all components measuring between 48 mm and 52 mm
across, considering a five percent confidence level.

Control limit: Control limits are found in the control charts. There are two
control limits
1) Upper control limit (UCL) and
2) Lower control limit (LCL).
These are determined based on the principles of normal distribution. The
control limits are used to decide whether the variation found in the
production process is desirable or undesirable.
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 Area of Normal Confidence Limits
distribution curve ( % of observations
covered)
1 68.27
1.96 95.0
2 95.45
3 99.73

As the above table reveals, 1 occupy 68.27 percent of the area of the
normal curve and indicate that one can be used 68.27 percent confident
that a random observation will fall in this area. Similarly, 2, 3
limits 95.45, and 99.73 percent area of the normal curve, respectively and
process a confidence level of 95.45, and 99.73 respectively.

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Three Sigma Capability
Mean output +/- 3 standard deviations falls within
the design specification
It means that 0.26% of output falls outside the
design specification and is unacceptable.
The result: a 3-sigma capable process produces
2600 defects for every million units produced
Six Sigma Capability
Six sigma capability assumes the process is capable
of producing output where the mean +/- 6
standard deviations fall within the design
specifications
The result: only 3.4 defects for every million
produced
Six sigma capability means smaller variation and
therefore higher quality
 SPC Methods-Developing Control Charts
Control Charts (aka process or QC 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, # of flaws in a shirt,
etc.
Ex: In a pilot investigation of the length of the nails produced in the shop
floor, it is found that the mean length x (simple mean) is 4 cm, the S.D 3,
the measure of variability of the nails produced 0.2 cm. How do you
construct the centre chart for this data?
Solution: A control chart can be set up with a mean of 4 cm and control
limits of plus and minus 3 standard deviations. Such a chart can be used to
test the quality of the nails then produced.

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Importance of control charts or Reasons
for popularity of control charts
1. Control charts are a proven technique for improving
productivity
2. Control charts are effective in defect prevention
3. Control charts are prevent unnecessary process
adjustment
4. Control charts provide diagnostic information
5. Control chats provide information about process
capability.
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Control Charts for Variables
A variable is one whose quality measurement changes from unit to
unit. The quality of these variables is measured in terms of hardness,
thickness, length, and so on. The control charts for variables are
drawn using the principles of normal distribution.
These are usually designed to test the means of the samples more
effectively rather than the measurement of the individual variables.
Therefore, while constructing a control chart, only the mean or the
average value of the dimensions in the sample is plotted on it. The
distribution of means is aptly represented by the standard deviation,
which is calculated as bellow

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 Control Charts for Variables
Use x-bar charts to monitor the changes in the mean of a process
(central tendencies)Tracks the central tendency (the average value
observed) over time
Use R-bar charts to monitor the dispersion or variability of the
process . Tracks the spread of the distribution over time (estimates
the observed variation)
System can show acceptable central tendencies but unacceptable
variability or
System can show acceptable variability but unacceptable central
tendencies
The X-bar chart shows how the mean or average changes over time and
the R chart shows how the range of the subgroups changes over time. It
is also used to monitor the effects of process improvement theories.
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Constructing a X-bar Chart:
A quality control inspector at the Cocoa Fizz soft drink company has taken
three samples with four observations each of the volume of bottles filled. If
the standard deviation of the bottling operation is .2 ounces, use the data
below to develop control charts with limits of 3 standard deviations for the
16 oz. bottling operation.

Time 1 Time 2 Time 3

Observation 1 15.8 16.1 16.0

Observation 2 16.0 16.0 15.9

Observation 3 15.8 15.8 15.9

Observation 4 15.9 15.9 15.8

Step 1:
Calculate the Mean of Each Sample

Time 1 Time 2 Time 3

Observation 1 15.8 16.1 16.0

Observation 2 16.0 16.0 15.9

Observation 3 15.8 15.8 15.9

Observation 4 15.9 15.9 15.8

Sample means 15.875 15.975 15.9

(X-bar)
Step 2: Calculate the Standard Deviation
of the Sample Mean

.2
x .1
n 4
 Step 3: Calculate CL, UCL, LCL

Center line (x-double bar):

15.875 15.975 15.9
x 15.92
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Control limits for 3 limits (z = 3):

UCLx x z x 15.92 3 .1 16.22

LCLx x z x 15.92 3 .1 15.62
x-bar and R charts
monitor different parameters!
X-Bar Control Chart

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R chart is a type of control chart used to monitor variables
data when samples are collected at regular intervals from a
business or industrial process.

The chart is advantageous in the following

situations:
1.The sample size is relatively small (say, n 10

2.The sample size is constant

3.Humans must perform the calculations for the

chart

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 Control Chart for Range (R)

Center Line and Control Limit Factors for three sigma control limits
formulas: Sample Size
Factor for x-Chart Factors for R-Chart

(n) A2 D3 D4
2 1.88 0.00 3.27
0.2 0.3 0.2 3 1.02 0.00 2.57
R .233 4 0.73 0.00 2.28
3
5 0.58 0.00 2.11
6 0.48 0.00 2.00
UCL R D4 R 2.28(.233) .53 7 0.42 0.08 1.92
8 0.37 0.14 1.86
LCL R D3 R 0.0(.233) 0.0 9 0.34 0.18 1.82
10 0.31 0.22 1.78
11 0.29 0.26 1.74
12 0.27 0.28 1.72
13 0.25 0.31 1.69
14 0.24 0.33 1.67
15 0.22 0.35 271.65
R-Bar Control Chart

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WHEN TO USE X-R CHARTS
X-R charts should be used when you have taken data frequently.
How often you plot points on the charts depends on your subgroup
size

X-R charts should be used if you can rationally subgroup the data
and are interested in detecting differences between subgroups over
time. This means there should be some logical basis for the way the
subgroups are formed. They should be formed to examine the
variation of interest to you.

The X chart would examine the variation from day to day, while the
R chart would examine the variation within a day.

The R chart is a measure of the short-term variation in the process.

Subgroups should be formed to minimize the amount of variation
within a subgroup. This causes the X chart to do the work in
detecting process changes. 29
 Control Charts for Attributes
Definition
The term Attribute refers to those quality characteristics that conform to
specifications or do not conform to specifications.
Attribute are used:
Where measurements are not possible.
Where measurements can be made but are not made because of time, cost,
or need.
Defect
Defect is appropriate for use when evaluation is in terms of usage.
Nonconformity is appropriate for conformance to specifications.
The term Nonconforming Unit is used to describe a unit of product or service
containing at least one nonconformity.
Types of Attribute Charts:

1. Nonconforming Units (based on the Binomial

distribution): p chart, np chart.
2. Nonconformities (based on the Poisson
distribution): c chart, u chart.
 P chart

The P Chart is used for data that consist of the

proportion of the number of occurrences of an
event to the total number of occurrences.
It is used in quality to report the fraction or
percent nonconforming in a product, quality
characteristic, or group of quality characteristics.
Control Charts for Attributes P-
Charts & C-Charts
Attributes are discrete events: yes/no or pass/fail
Use P-Charts for quality characteristics that are discrete 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

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 P-Chart Example: A production manager for a tire company has inspected
the number of defective tires in five random samples with 20 tires in each
sample. The table below shows the number of defective tires in each
sample of 20 tires. Calculate the control limits.

Sample Number Number of Proportion Solution:

of Tires in Defective
Defective each
Tires Sample
1 3 20 .15 # Defectives 9
CL p .09
2 2 20 .10 Total Inspected 100
3 1 20 .05 p(1 p ) (.09)(.91)
p 0.64
4 2 20 .10 n 20
5 2 20 .05 UCL p p z .09 3(.064) .282
Total 9 100 .09 LCL p p z .09 3(.064) .102 0

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P- Control Chart

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C-Chart Example: The number of weekly customer complaints are
monitored in a large hotel using a c-chart. Develop three sigma
control limits using the data table below.

Week Number of Solution:

Complaints
1 3
2 2 # complaints 22
3 3 CL 2.2
# of samples 10
4 1
5 3 UCL c c z c 2.2 3 2.2 6.65
6 3
LCL c c z c 2.2 3 2.2 2.25 0
7 2
8 1
9 3
10 1
Total 22 36
C- Control Chart

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 Acceptance Sampling
Defined: 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

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 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 39
 Operating Characteristics (OC)
Curves
OC curves are graphs which show
the probability of accepting a lot
given various proportions of defects
in the lot
X-axis shows % of items that are
defective in a lot- lot quality
Y-axis shows the probability or
chance of accepting a lot
As proportion of defects increases,
the chance of accepting lot decreases
Example: 90% chance of accepting a
lot with 5% defectives; 10% chance
of accepting a lot with 24%
defectives

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 AQL, LTPD, Consumers Risk () &
Producers Risk ()
AQL is the small % of defects that
consumers are willing to accept; order of
1-2%
LTPD is the upper limit of the percentage
of defective items consumers are willing
to tolerate
Consumers Risk () is the chance of
accepting a lot that contains a greater
number of defects than the LTPD limit;
Type II error
Producers risk () is the chance a lot
containing an acceptable quality level will
be rejected; Type I error

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 Developing OC Curves

OC curves graphically depict the discriminating power of a sampling plan

Cumulative binomial tables like partial table below are used to obtain probabilities of
accepting a lot given varying levels of lot defectives
Top of the table shows value of p (proportion of defective items in lot), Left hand column
shows values of n (sample size) and x represents the cumulative number of defects found

Table 6-2 Partial Cumulative Binomial Probability Table (see Appendix C for complete table)
Proportion of Items Defective (p)
.05 .10 .15 .20 .25 .30 .35 .40 .45 .50
n x
5 0 .7738 .5905 .4437 .3277 .2373 .1681 .1160 .0778 .0503 .0313
Pac 1 .9974 .9185 .8352 .7373 .6328 .5282 .4284 .3370 .2562 .1875
AOQ .0499 .0919 .1253 .1475 .1582 .1585 .1499 .1348 .1153 .0938
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 Example: Constructing an OC Curve

Lets develop an OC curve for a sampling

plan in which a sample of 5 items is drawn
from lots of N=1000 items
The accept /reject criteria are set up in
such a way that we accept a lot if no more
that one defect (c=1) is found
Using Table 6-2 and the row corresponding
to n=5 and x=1
Note that we have a 99.74% chance of
accepting a lot with 5% defects and a
73.73% chance with 20% defects

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 Average Outgoing Quality (AOQ)

With OC curves, the higher the quality of the lot,

the higher is the chance that it will be accepted
Conversely, the lower the quality of the lot, the
greater is the chance that it will be rejected
The average outgoing quality level of the
product (AOQ) can be computed as follows:
AOQ=(Pac)p
Returning to the bottom line in Table 6-2, AOQ
can be calculated for each proportion of defects
in a lot by using the above equation
This graph is for n=5 and x=1 (same as c=1)
AOQ is highest for lots close to 30% defects

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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

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SQC in Services
Service Organizations have lagged behind manufacturers in the use of
statistical quality control
Statistical measurements are required and it is more difficult to measure
the quality of a service
Services produce more intangible products
Perceptions of quality are highly subjective
A way to deal with service quality is to devise quantifiable measurements
of the service element
Check-in time at a hotel
Number of complaints received per month at a restaurant
Number of telephone rings before a call is answered
Acceptable control limits can be developed and charted

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