Statistical Quality Control for

Process Development

Gülhatun TELLİOĞLU
Tezer ŞAHAN
 LEARNING OBJECTIVES
 Identifying and describing the approach
 Using SQC to improve a process
 Clarifying Cause-and-Effect Analysis
 Designing and Conducting Experiments
 Statistical Quality Control for
Process Development
 "Statistical Quality Control" (SQC) is a term for an approach to solving problems in
production processes. It has recently been discussed in the popular press because of
its effective use by various Japanese manufacturing companies.

 The term "statistical quality control" is misleading. First, quality is not the only
focus of these techniques. Identical methods are useful for improving production
rates, yields, and activities in sales and other non-manufacturing areas.
 Statistical Quality Control for
Process Development
Second, the only universal technique for SQC is careful logical reasoning;
complex statistical methods are generally helpful but not essential.

Finally, SQC is more a method of management than of control in any

narrow sense.

It is a way of learning systematically, rather than haphazardly. Nonetheless

this note will continue to use the term "statistical quality control."
 Statistical Quality Control for
Process Development
• One approach to improving a process is the hit-or-miss approach:
guess at a cause of problems, assume it is really the cause, implement
something that fixes that cause, and see whether the problem goes
away.

This ad hoc approach is simple and common, but it is usually a slow and
costly way to improve a process.
 Statistical Quality Control for
Process Development
 All too often it does not lead to deeper knowledge about the
process and what affects it, and the improvements are not sustained
when conditions change. The approach described here is a more
systematic way to learn about and improve a process.
 Basic Approach
Using SQC to improve a process can be divided into five major steps

1- Awareness that a problem exists.

2- Determine the specific problem to be solved.
3- Diagnose the causes of the problem.
A- Formulate hypotheses about possible causes
B- Test the hypotheses, using either existing information or new experiments
C- Continue until one or more causes are proven.
 Basic Approach
4- Determine remedies.
5- Implement remedies.
6- Implements controls to hold the gains.

This approach is designed to find underlying problems which cause defects or

other undesirable results, and fix them permanently.
Seven Useful Diagrams
• There are at least seven diagrams that aid in statistical quality control.

• 1) The Pareto chart. Shows the magnitude of each of many effects.

Used to distinguish critical problems. (Step 2)
• 2) The cause and effect diagram (sometimes called a "fishbone"). A
method of showing possible causes of a problem. An aid to
brainstorming and hypothesis generation. (Step 3a)
Seven Useful Diagrams
• 3) Process flow chart. Useful for showing linkages among parts of a
process. (Steps 3 and 4)
• 4) Run chart. A sample graph, over time, of some variable which is
thought to be important.
• Can be examined to see whether the process is subject to changes or
behaves consistently over time.
Seven Useful Diagrams
• Noting when changes occur may suggests hypotheses about their
cause. For example, if they occur at meal times or shift change times
one then looks for events that happen at those times but not at
other times.
Seven Useful Diagrams

• 5) Frequency histogram. Shows the distribution of some variable that

is thought to be important. Useful for hypothesis testing—how does
the distribution compare with what you would expect?

• 6) Scatter diagram. Shows correlation between two variables, typically

a problem and a potential cause. (Step 3) To examine interactions
among several variables, use multiple regression.
Seven Useful Diagrams

• 7) Control chart. Similar to a run chart, but used for operational

control. Shows upper and lower allowable limits for a process
variable.
• When the process exceeds those limits or shows other recognizable
patterns, action should be taken to adjust the process controls. Once
set up, an effective tool for day-to-day monitoring and management of
a process.
Cause-and-Effect Analysis

• The cause-and-effect analysis (also called "fish-bone" analysis) is a

technique to stimulate ideas about the causes of problems.
• This technique may appear at first glance to be mechanistic and
simplistic, but the results from it are usually well worthwhile because
it stimulates creative responses from employees and managers.
Cause-and-Effect Analysis

• The cause-and-effect analysis starts by naming the undesired effect. In

the case illustrated in Exhibit 2 it is excessive delayed flight
departures.
• Then major categories of causes are listed on the spine, hence the
reference to a "fish bone.«
• It is normal practice to use very broad categories such as:(1) material,
(2) people, (3) procedure, (4) equipment, and (5) other.
Cause-and-Effect Analysis

• Additional information is gained by stratification or dividing the data

into useful subcategories or segments.
• For example, different patterns may show up in the Pareto analysis
when the data are separated into different services, times, or locations.
Designing and Conducting Experiments

• Sometimes you will be lucky enough to find the causes of a problem

without doing any formal experiment.
• Occasionally, the cause will be obvious once the problem is examined,
such as a broken machine which had not been noticed.
• Or, careful analysis of old control charts and other process data may
contain explanations buried within the data.
Designing and Conducting Experiments

• More likely, however, you will have to do a series of experiments, if

only to test your hypothesis.
• Careful design of the experiments can help you get lots of information,
quickly and cheaply.
• But poorly designed experiments may just confuse the situation, while
costing time and disrupting the production process.
Designing and Conducting Experiments

• The basic principle of controlled experiments is:

• Make batches of the product under identical conditions, except that the
batches are treated differently for the one variable being studied.
• Any differences among the batches must then be due to the one
variable which was changed.
Designing and Conducting Experiments

• For example, if you want to see the effect of processing time at one
process step on product quality, run a large number of products
through the process as a singel batch.
• Then, when the batch reaches the critical step, randomly select half of
the products to be treated for a long time, and half for a short time.
Designing and Conducting Experiments

• After the critical step, re-join the two groups into a single batch, and
continue processing.
• Then when you reach the inspection or testing point, add up the test
results separately for products which were treated in the two different
ways.
• Careful design of the experiments will remove the effects of as many
confounding variables as possible and will check for the presence of
others.
Designing and Conducting Experiments

• Different batches should be processed as close together as physically

possible and the treatments should alternate back and forth to reduce
the impact of variables which change over time.
• For example run 10 products high, then 10 low, then 20 high, then 30
low, then 10 high.
• Also you may deliberately vary two or more variables at once as part
of the same experiment.
Designing and Conducting Experiments

• In conclusion, managerial judgement is required to decide what to

investigate and how to examine it. The "right" answer will depend on
many factors, both tactical and strategic, including:
• The importance of the product.
• The maturity of the product and the manufacturing process.
• The current level of understanding about the process and what affects
it.
Designing and Conducting Experiments

• The availability of resources to devote to experimentation, including

engineers and surplus production capacity.
• Whether knowledge gained about this one product and process will
have value and possible strategic leverage for other products and
processes.
• How much effort to put into each problem and each hypothesis.
 Managerial Implications
We will use Statistical Quality Control to improve a process

We will consider an experiment to determine the effect of one variable.

THANKS FOR LISTENING