By

V.Bhanu Chander

Basic Definitions

1. Statistics : It is a process of collection, grouping
and analysis of a group of data, making it useful for
some future applications.
2. Control : Process by means of which we observe the
actual performance and compare it with some
standard. If there is any deviation, then it is necessary
to make corrective action.


3. Quality : Quality can be defined in a number of
ways. Major definitions are based on the following
concepts
Fitness for purpose
Conformance to requirements
Grade
Degree of performance
Degree of excellence
Measure of fulfillment of promises
Meeting customer needs


About Quality :
Quality is generally used with
reference to the end use of the product. The quality
depends on the perception of a person in a given
situation.
A product can be said to possess good
quality if the following requirements are properly
balanced while designing and manufacturing it
1. Suitability
2. Reliability
3. Durability
4. Safe and foolproof workability


5. Affordability
6. Maintainability
7. Aesthetic look
8. Satisfaction to customers
9. Economical
10. Versatility
Factors affecting quality :
Quality can be asserted if we answer to the
five questions: what, why, when, where and whom,
combining with how. This are termed as 5W-H factors.

Whom factors
(W5)
1. Responsibility
2. Management
Why factors (W1)
1. Market compellations
2. Product complexities
How factors (H)
1.Information
system
Where factors
(W4)
1.Shop floor
2. Point of
delivery
What factors
(W2)
1. Money
2. Men
3. machines
When factors (W3)
1. All the time
5W-H factor
description
Product Quality cycle is shown below
Customer
Marketing
Product Engg.
Purchasing
Manufacturing
Engg.
Manufacture
Inspection and
Testing
Package and
shipping
Product service
Quality
Product

Quality Control (QC):
Quality control is the process through which we measure the
actual quality performance, compare it with the standards and take
corrective action if there is a deviations.
It is a system, plan or method of approach to the solution of
quality problems.
It is also the tools, devices or skills through which quality
functions
A QC system performs inspection, testing and analysis to
ensure that the quality of the products produced is as per the laid
down quality standards

I nspection should not be confused with quality
control. Inspection means checking of material, product or
components of product at various stages, with reference to
certain pre-determined factors and detecting and sorting out
the faulty or defective items.

Quality control involves inspection at particular
stage. In QC activity, the emphasis is placed on the quality of
the past production.
Objectives of Quality Control : To
1. Improve the companys income
2. Reduce companys cost
3. Achieve interchangeability of manufacturing
4. Produce optimum quality at minimum time
5. Ensure satisfaction of customers
6. Make inspection prompt to ensure quality control at proper
stages to ensure production of non-defective products.
7. Judging the conformity of the process to the established
standards and taking suitable action when there are deviations



8. To improve quality and productivity by process control,
experimentation and customers feedback
9. Develop procedure for good vendor-vendee relations
10. Develop quality consciousness in the organization
Statistical Quality Control (SQC) :
A QC system is said to be SQC when statistical
techniques are employed to control, improve and maintain quality
or to solve quality problems. SQC is Systematic as compared to
guess-work of haphazard process inspection.



SQC consists of three general activities :
1. Systematic collection and graphic recording of accurate
data
2. Analyzing the data
3. Practical Engg. or management action, if the information
obtained indicates significant deviations from the specified
limits.
The following are the tools of SQC
1. Frequency distribution
2. Control chart
3. Acceptance sampling
4. Analysis of the data
Benefits of SQC :
Efficiency- SQC ensures rapid and efficient inspection at a
minimum cost
Reduction of scrap, Easy detection of faults
Adherence to specifications
Increases output, reduces wasted machine and man hour
Efficient utilization of personnel, machines and materials
resulting in higher productivity
Better customer relations
Elimination of bottlenecks in the process of manufacturing
Creating quality awareness in employees


Sources of quality variation
Raw materials
In-process
Packaging material
labeling
Finished product variables

Steps of QC :
Material qc
In process qc
Product qc
Specifications and tests for
active ingredients
Excipients
Product itself
Stability procedures
Freedom from microbial contamination
Storage and labeling
Containers
Provision for cross referencing

Control of quality variation
Can be done by
Raw material control
In-process items control
Packaging materials control
Label control
Finished product control
Quality Costs :
1. Cost of prevention
2. Cost of appraisal
3. Cost of material failure
4. Cost of external failures
Control Charts
Definition :
A control chart is a graphical representation of the
collected information. The information may pertain to measured
quality characteristics or judged quality characteristics of samples.
Thus it is an important aid or statistical device used for the study
and control of the repetitive processes.
It detects the variations in processing and warns if
there is any departure from the specified tolerance limits. With the
help of CC it is possible to find out the natural capability of a
production process, which permits better decisions on engg.
Tolerances and other fields.
In other words CC is a device which specifies
the state of statistical control, second a device for attaining
statistical control, and third, a device to judge whether statistical
control has been attained.
The CC which are most commonly used are:
1. CC for measurable quality characteristics (CC for Variables).
This includes X bar and R charts and charts for X bar and
2. CC for fraction defective (P-chart)
3. CC for number of defects per units (C-chart)
SQC Charts
1. Variables
2. Attributes
--Variables
1. X bar chart
2. R bar chart
3. X bar and S chart
4. X bar and chart
--Attributes
1. P chart
a. Fraction rejected as non conforming units
2. np chart
a. No. of non conforming units
3. C chart
a. No. of nonconformities
4. V chart
a. No. of non conformities per unit
X bar shows the centering of the process, i.e. it shows the
variations in the averages of samples. It is most commonly
used variable chart.
R-chart shows the uniformity or consistency of the
process, i.e. it shows the variations in the ranges of the
samples. It is a chart for measure of spread.
chart shows the variation of the process.
P- chart is an attribute control chart.





Need for Control of Both Mean and Variability
The number of nonconforming product is dependent on both mean shift
and larger variation
Normal mean and
variance
Larger mean and normal variance
normal mean and larger variance
Mean is monitored by X bar chart
Variability is monitored by either S chart (standard
deviation) or R chart (range)
Review of the Basic Model of Control Charts
Let w be a sample statistic that measures some quality
characteristic of interest, and suppose that the mean of w is w
and the standard deviation of w is w. Then the center line, the
upper control limit, and the lower control limit become
UCL = w + k w
Center line = w
LCL = w - k w
where k is the "distance" of the control limits from the center line,
expressed in standard deviation units
Control Chart for X bar and R Known ,




- Statistical Basis of the Charts
1. suppose {xij, i=1,,m, j=1,,n} are normally distributed with
xij,~N(,2), thus,
2. X bar chart monitors between-sample variability (variability over
time) and R chart measures within-sample variability
(instantaneous variability at a given time)
3. If and are known, X bar chart is
+3x => +3/sqrt(n) => +A
X ~ N(,( / n )2 )
UCL = + A
Center line =
LCL = - A
A = 3/sqrt(n)
Control Chart for X bar and R Known , ( Conts)
Range Ri=max(xij)-min(xij) for j=1,..n
If and are known, the statistical basis of R charts is as
follows:
Define the relative range W=R/. The parameters of the
distribution of W are a function of the sample size
Denote W =E(W)=d2, W =d3,
a. (d2 and d3, are given in Tables)
R =d2, R=d3 , which are obtained based on R=W
R chart control limits
Contd
3 d2 3d3 (d2 3d3 )
UCL = D1
Center line = d2
LCL = D2
D1 = d2 3d3
D2 = d2 + 3d3
Interpretation of X bar and R Chart
First check the R chart and eliminate the assignable causes
from R chart, and then check the X bar chart
Check non-random pattern
1. Cyclic pattern due to temperature, regular rotation of
operators or machines, maintenance schedules, tool wear
2. Mixture pattern when the plotted points tend to fall near or
slightly outside the control limits. Two overlapping
distributions are resulted from too often process adjustment.
.
3. Shift in process level due to introduction of new workers,
methods, materials, or inspection standard.
4. Trend pattern due to gradual tool wear.
5. Stratification pattern for the points to cluster around the
center line due to incorrect calculation of Control limits or
inappropriate reasonable sampling group
Application Conditions of X bar and R chart
1. Underlying distribution of the quality characteristics is normal
a. X bar chart is more robust to non normality than R chart
b. samples of 4 or 5 are sufficient to ensure reasonable
robustness to the normality assumption for X bar chart
2. Calculation accuracy of Type I error is dependent on the
distribution
3. X bar chart (n=4, 5, 6) is not effective to detect a small mean shift
(less than 1.5 ) on the first sample following the shift
4. R chart is insensitive to small or moderate shifts (1/0 <2.5) for
the sample size of n=4, 5, or 6. If n>10, a s chart should be used
instead of a R chart
Revisit Example: Sample Thread Pitch Diameter Data
Aircraft Fittings (Thread Pitch Diameter)
5 items sampled each hour
Values in .0001 inches excess of 0.4000 in.
Sample Avg. R
1 36 35 34 33 32 34.0 4
2 31 31 34 32 30 31.6 4
3 30 30 32 30 32 30.8 2
4 32 33 33 32 35 33.0 3
5 32 34 37 37 35 35.0 5
6 32 32 31 33 33 32.2 2
7 33 33 36 32 31 33.0 5
8 23 33 36 35 36 32.6 13
9 43 36 35 24 31 33.8 19
10 36 35 36 41 41 37.8 6
11 34 38 35 34 38 35.8 4
12 36 38 39 39 40 38.4 4
13 36 40 35 26 33 34.0 14
14 36 35 37 34 33 35.0 4
15 30 37 33 34 35 33.8 7
16 28 31 33 33 33 31.6 5
17 33 30 34 33 35 33.0 5
18 27 28 29 27 30 28.2 3
19 35 36 29 27 32 31.8 9
20 33 35 35 39 36 35.6 6
33.6 6.2
Out of control
Out of control
CL
UCL
LCL
X bar chart
Out of control
CL
UCL
LCL
R BAR CHART
CL
UCL
LCL
Revised X bar chart
CL
UCL
LCL
Revised R BAR CHART
References :

1. Quality control- A practical approach- Basterfield H.Dale
2. Statistical Quality Control- M.Mahajan
3. SQC Grant E.L
4. SQC R.C.Gupta
5. Fundamentals of QC and improvement- Amitava Mitra