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KOMBOLCHA POLYTECHNIC COLLEGE

Department Of Metal Manufacturing

 TVET PROGRAM TITLE :- METM LEVEL V

 MODULE TITLE: - Apply Quality Systems And Perform


Advanced Statistical Quality Control.

 Unit Code: MNF MNF MTM5 03 11

 NOMINAL DURATION = 100 hours.

By Muluneh Negussie
January 2016E.C
Metal Engineering Technology Management Level V
Table of Contents
Unit One: Work Within a Quality System 3
1.1 Performing Instructions and procedures 4
1.2 Ensuring conformance to specifications. 7
1.3 Detecting and reporting defects 8
1.4 Monitoring performance of operation or quality of product or service 8
Self Check -1 10
Unit Two :- Engage in quality improvement 11
2.1 Introduction 12
2.2 Assessing and Identifying current performance Measures . 12
2.3 Identifying specifications and standard operating procedures. 13
2.4 Detecting and reporting defects according to standard operating procedures. 14
2.5 Participating process improvement procedures 15
2.6 The improvement of internal/external customer/supplier relationships. 16
Self- CHECK POINT 2 17
Unit Three :- Take samples 18
3.1 Difference between population and sample 18
3.2 Taking sample according to the procedure. 20
CHECK POINT 3 26
Unit Four :- Apply statistical process to monitor production 28
4.1 Variation in terms of average and spread. 28
4.2 Using data to produce relevant statistical information. 31
4.3 Interpreting data accurately and information is presented 32
CHECK POINT 4 38
Reference Materials 39

Page 1 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
Introduction to the Module

Module Descriptor: This module covers the knowledge, skills and attitudes in applying
Quality Systems and Perform Advanced Statistical Quality Control

This module covers the units :

1. Work within a quality system.

2. Engage in quality improvement.

3. Take samples.

4. Apply statistical process to monitor production.

Learning Outcomes (Objectives):- At the end of this module the trainees will be able to:

1. Work within a quality system.

2. Engage in quality improvement.

3. Take samples.

4. Apply statistical process to monitor production.

1. Module Instruction
For effective use this modules trainees are expected to follow the following module instruction:
1. Read the information written in each unit
2. Accomplish the self-checks at the end of each unit
3. Perform operation sheets which were provided at the end of units
4. Do the “LAP test” given at the end of each unit and
5. Read the identified reference book to get more knowledge as well as to do examples and
exercise

Page 2 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V

Unit One: Work Within a Quality System

This unit to provide you the necessary information regarding the following content coverage
and topics:

1. Performing Instructions and procedures for quality improvement system.

2. Ensuring conformance to specifications.

3. Detecting and reporting defects

4. Monitoring performance of operation or quality of product or service for customer satisfaction

This unit will also assist you to attain the learning outcomes stated in the cover page.
Specifically, upon completion of this learning guide, you will be able to:

1. Perform Instructions and procedures are followed

2. Ensure conformance to specifications.

3. Detect and reporting defects

4. Monitor performance of operation or quality of product or service

Page 3 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
1.1 Performing Instructions and procedures

Definition:- WHAT IS QUALITY?


 It is degree of excellence of a thing or it is More than average; more than “good enough”
 According to the American Society for Quality: totality of features and characteristics that
satisfy needs.
 The International Organization for Standardization (ISO) defines quality as “the degree (of
excellence of a thing) to which a set of inherent characteristics fulfils requirements”
(ISO9000:2000).

 QUALITY SYSTEM

A quality system refers to activities a business uses to promote quality within the organization. It
is often called a quality management system (QMS). This system includes the organization
structure, responsibilities, resources, business's activities, plans, policies and procedures used in
producing quality goods and services.

 Purpose

 The purpose of a quality system is to meet customer's expectations/hope and increase


profitability. With a quality system, a company focuses on the quality of goods and services
produced.

 A quality system consists of planning, documenting and controlling all business processes. It
requires constant review to implement changes and improvements to increase customer
satisfaction and demand. A quality system focuses on continuously measuring the company's
performance to make improvements to the system leading to increased profitability.

 Principles

1) Quality systems focus on eight principles: customer focus, leadership, involvement of people,
process approach, system approach to management, continual improvement, factual/accurate
approach to decision making and mutual beneficial supplier relationships. These eight
components work together and allow companies to increase the quality in their products.

2) The first step in building a Quality System is a Quality Manual.

3) A quality manual is written to describe a company’s International Standards Organization


(ISO) quality management program. It has several sections describing the scope, procedures,

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BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
processes and reporting procedures of the program. The manual is a guidebook and reference
for employees and managers involved in the program.
•A Quality Manual is the main, top-level document which establishes the quality policies and
objectives of an organization.

 Key Elements of a Quality System:


There are five key elements in a quality system:
1) Organizational management,
2) Standards for quality systems,
3) Documentation ,
4) Training Assessment,
5) Quality systems are designed to control processes

TERMINOLOGY AND CONCEPTS

1) Quality Assurance (QA) is a way of preventing mistakes or defects in manufactured


products and avoiding problems when delivering solutions or services to customers.
 QA is applied to physical products in pre-production to verify what will be made meets
specifications and requirements, and during manufacturing production runs by validating
lot samples meet specified quality controls.

Two principles included in Quality Assurance are:

 "Fit for purpose", the product should be suitable for the intended purpose; and

 "Right first time", mistakes should be eliminated.

 This is also known as a ‘zero defects’ approach.

In quality assurance, there is more emphasis on ‘self-checking’, rather than checking by


inspectors. Advantages include:

 Costs are reduced because there is less wastage and re-working of faulty products as the
product is checked at every stage.

 It can help improve worker motivation as workers have more ownership and recognition
for their work.

 It can help break down ‘us and them’ barriers between workers and managers as it
eliminates the feeling of being checked up on.
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BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
 With all staff responsible for quality, this can help the firm gain marketing advantages
arising from its consistent level of quality.
 An overall management plan to guarantee the integrity of data (The “system”)

2) Quality Control (QC)

 Controlling mechanism that ensures the release of only good quality products.

 Quality Control testing is done to detect the quality of a product or services by checking
their degree of conformity with the required standards.

 This method checks the quality of completed products for faults.

 Quality control can be defined simply as 'maintenance of quality at a level that satisfies
the customer and that is economical to the producer or seller'.

 The observation techniques and activities used to fulfill requirements for quality.

 A series of analytical measurements used to assess the quality of the analytical data

(The “tools”)

 Quality Control = Inspection + Corrective action

3) Quality inspection

The act of monitoring or observing (usually involving sampling and related sampling plans), a
process, procedures or services to ensure compliance with operational definition and to ensure
that all customers’ requirements or internal pre-requisites are meet. Visual inspection, physical
inspection, ongoing inspection and finishing product inspection

 Advantages - inspection is intended to prevent faulty products reaching the customer. This
approach means having specially trained inspectors, rather than every individual being
responsible for his or her own work.

 Disadvantages – individuals are not necessarily encouraged to take responsibility for the
quality of their own work. Giving workers responsibility for their own work helps to improve
motivation by increasing the interest and variety in the job, so quality assurance tends to be
preferred for this reason as well.

4) Total quality control

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BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
• Defined as an effective system for integrating the quality development, quality
maintenance and quality improvement efforts of the various groups in an organization so
as to enable production and service at the most economical level which allow for full
customer satisfaction.
• It may be classified as a ‘‘Management Tool’’ for many industries outstanding
improvement in product quality design and reduction in operating costs and losses

‘‘Control’’ represents a tool with four steps:


 Setting up of quality standards.
 Appraising conformance to these standards
 Acting when these standards are exceeded.
 Planning for improvements in these standards.

1.2 Ensuring conformance to specifications.

Quality characteristics are often evaluated relative to specifications. For a manufactured product,
the specifications are the desired measurements for the quality characteristics of the components
and subassemblies that make up the product, as well as the desired values for the quality
characteristics in the final product.

A value of a measurement that corresponds to the desired value for that quality characteristic is
called the nominal or target value for that characteristic. These target values are
usually bounded by a range of values that, most typically, we believe will be sufficiently close
to the target so as to not impact the function or performance of the product if the quality
characteristic is in that range. The largest allowable value for a quality characteristic is called the
upper specification limit (USL), and the smallest allowable value for a quality characteristic is
called the lower specification limit (LSL). Some quality characteristics have specification limits
on only one side of the target

Specifications are usually the result of the engineering design process for the product. Product
quality may be conforming or non-conforming for the customer satisfaction A nonconforming
product is considered defective if it has one or more defects, which are nonconformities that are
serious enough to significantly affect the safe or effective use of the product. Obviously, failure
on the part of a company to improve its manufacturing processes can also cause nonconformities
and defects.

Page 7 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
Therefore, there are two kinds of quality are sought out here

1) Quality of design

 The characteristic that designers specify for an item


 This encompasses requirements, specifications, and the design of the system

2) Quality of conformance (i.e., implementation)

 The degree to which the design specifications are followed during manufacturing.
This focuses on how well the implementation follows the design and how well the
resulting system meets its requirements
• Quality also can be looked at in terms of user satisfaction
User satisfaction = compliant product
+ good quality
+ delivery within budget and schedule

1.3 Detecting and reporting defects

Problems in product quality usually are greater when the over-the-wall approach to
design is used. In this approach, specifications are often set without regard to the inherent
variability that exists in materials, processes, and other parts of the system, which results in
components or products that are nonconforming; that is, nonconforming products are those
that fail to meet one or more of its specifications.

A specific type of failure is called a nonconformity. A nonconforming product is not necessarily


unfit for use; for example, a detergent may have a concentration of active ingredients that is
below the lower specification limit, but it may still perform acceptably if the customer uses a
greater amount of the product.

A nonconforming product is considered defective if it has one or more defects, which are
nonconformities that are serious enough to significantly affect the safe or effective use of the
product.
Obviously, failure on the part of a company to improve its manufacturing processes can also
cause nonconformities and defects.

Page 8 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
1.4 Monitoring performance of operation or quality of product or service

 It is important to Monitor performance of operation or quality of product or service for


customer satisfaction because of so many factors which are affect quality.

The Fundamental Factors Affecting Quality

 The nine fundamental factors (9 M’s), which are affecting the quality of products and
services, are: markets, money, management, men, motivation, materials, machines and
mechanization. Modern information methods and mounting product requirements.
1) Market: Because of technology advancement, we could see many new products to satisfy
customer wants. At the same time, the customer wants are also changing dynamically.
So, it is the role of companies to identify needs and then meet it with existing
technologies or by developing new technologies.
2) Money: The increased global competition necessitates huge outlays for new equipments
and process. This should be rewarded by improved productivity. This is possible by
minimizing quality costs associated with the maintenance and improvements of quality
level.
3) Management: Because of the increased complex structure of business organization, the
quality related responsibilities lie with persons at different levels in the organization.
4) Men: The rapid growth in technical knowledge leads to development of human resource
with different specialization. This necessitates some groups like, system engineering
group to integrate the idea of full specialization.
5) Motivation: If we fix the responsibility of achieving quality with each individual in the
organization with proper motivation techniques, there will not be any problem in
producing the designed quality products.
6) Materials: Selection of proper materials to meet the desired tolerance limit is also an
important consideration. Quality attributes like, surface finish, strength, diameter etc., can
be obtained by proper selection of material.
7) Machines and mechanization: In order to have quality products which will lead to higher
productivity of any organization, we need to use advanced machines and mechanize
various operations.
8) Modern information methods: The modern information methods help in storing and
retrieving needed data for manufacturing, marketing and servicing.

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BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
9) Mounting product requirements: Product diversification to meet customers taste leads to
intricacy in design, manufacturing and quality standards. Hence, companies should plan
adequate system to tackle all these requirements.

Self Check -1

I. Part one: fill in the blank

1. ………………….. Is a way of preventing mistakes or defects in manufactured products or


services to customers

II. Part two short answer

2. What are the two principles of quality assurance?


3. What is quality control?
4. What is quality?
5. What is the difference between Quality Control and Quality inspection?
6. There are five key elements in a quality system. What are they?
7. List at least four Quality systems principles

Unit Two :- Engage in quality improvement


Page 10 of 42 KPC Apply Quality Systems And Perform Advanced Version -1
BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V

This unit is developed to provide you the necessary information regarding the following content
coverage and topics:

1. Assessing and establishing current performance measures.


2. Identifying specifications and standard operating procedures.
3. Detecting and reporting defects according to standard operating procedures.
4. Participating process improvement procedures
5. The improvement of internal/external customer/supplier relationships.

This unit will also assist you to attain the learning outcomes stated in the cover page.
Specifically, upon completion of this learning guide, you will be able to define :

 What is Quality improvement?

 Quality improvement procedures

 Common Quality defects


 Process improvement / the quality cycle /PDSA cycle
 Process improvement steps

2.1 Introduction

Quality improvement is about giving the people closest to issues affecting care quality the time,
permission, skills and resources they need to solve them. It involves a systematic and
coordinated approach to solving a problem using specific methods and tools with the aim of
bringing about a measurable improvement.
Page 11 of 42 KPC Apply Quality Systems And Perform Advanced Version -1
BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
2.2 Assessing and Identifying current performance Measures .

What is Quality improvement?


a) Quality improvement is the reduction of variability in processes and products . Excessive
variability in process performance often results in waste. For example, consider the wasted
money, time, and effort that is associated with the repairs represented
b) Quality Improvement for Manufacturing and Production
There are many avenues/ways manufacturers take to become more attractive to their
customers. They lower their prices even though it hurts their margins. They increase costly
inventory to ensure they have product on hand when their customers order. They may even
try to leverage their relationships to ensure business keeps coming. There are many paths to
short-term customer satisfaction success, but only one can sustainably make manufacturers a
go-to supplier: high quality products at a reasonable cost.
Typical benefits of Quality Improvement include:
 Less warranty cost
 Less scrap and rework
 Fewer Internal Defects
 Proactive Quality Organizational Culture
 Lower Cost of Quality & focus on proactive quality efforts
 Higher Customer Satisfaction based on Quality & Proactive
 More effective Quality Management System and Certification Support
What is the purpose of quality improvement?
 Quality improvement (QI) is a systematic, formal approach to the analysis of practice
performance and efforts to improve performance. A variety of approaches—or QI
models—exist to help you collect and analyze data and test change.
What are examples of quality improvement? Examples include:
 Reducing adverse events.
 Preventing unnecessary hospitalizations.
 Developing safer health products and devices.
 Achieving financial efficiencies and savings.
 Improving patient quality of life.

Page 12 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
2.3 Identifying specifications and standard operating procedures.

 Quality specifications are detailed requirements that define the quality of a product,
service or process. Quality includes tangible elements such as measurements and
intangible elements such as smell and taste. The following are illustrative examples of
quality specifications.
 A specification or spec is a precise statement of a set of requirements to be satisfied by a
material, product, system, or service that indicates the procedures for determining
whether each of the requirements is satisfied.
 There are three primary types of specifications: proprietary, performance and
prescriptive.
 A standard operating procedure (SOP) provides clear-cut directions and detailed
instructions needed to perform a specific task or operation consistently and
efficiently. Often seen in a myriad of industries, SOPs aim to achieve uniformity
in execution, reduce miscommunication, and adhere to regulatory standards.
 To write an actionable, easy-to-follow standard operating procedure, you need to follow
these eight simple steps:
 Step 1: Identify the procedure and collect data. ...
 Step 2: Identify the target audience. ...
 Step 3: Define SOP scope. ...
 Step 4: Choose a format. ...
 Step 5: Write your SOP. ...
 Step 7: Review, test and edit.

The term used below is “Specification,” but you can substitute “Document” if that is your
terminology. A requirement is a thing a product must do or a quality it must have. A
requirement specification is a collection of all requirements that are to be imposed on the
design and verification of the product.

2.4 Detecting and reporting defects according to standard operating procedures.

 What is defective quality?

Page 13 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
A quality defect is a problem with a product or service that does not meet the specified quality
standards. Defects can occur at any stage of the production process and can be caused by a
variety of factors, including faulty materials, equipment problems, or human error.

Industrial are occurred from

 Defects in appearance, such as dents, scratches, rust, stains, etc.


 Defects concerning missing parts or components.
 Defects with measurements and/or dimensions that are out of tolerance.
 Defects regarding labeling, such as non-compliance with regulatory requirements.
 Classification of defects for quality

Most buyers separate defects into three types based on the standard definition commonly used by
third party inspection companies as follows (here are more examples):

 A critical defect is likely to result in hazardous or unsafe conditions for individuals using
or maintaining the product.

 A major defect is one, other than critical, that is likely to result in failure, or to reduce
the usability of the unit of product for its intended purpose.

 A minor defect is not likely to reduce the usability of the product for its intended
purpose.

Buyers can change the definition of critical, major and minor defects based on its own
requirement and quality expectations. In this case, it is necessary to inform the supplier and the
inspection company at the order confirmation.

To supporting product to drive forward quality and implementing best practice in


manufacturing / services there are three systems:
 Engaging with Quality plan;
 Engaging with Quality in Primary product; and
 Closing the Gap through experimental (PDSA)

2.5 Participating process improvement procedures

 What is PDSA cycle

The P-D-C-A cycle, promoted by Deming, is the basis for continuous improvement. It differs
from traditional problem solving in that problems are prioritized and addressed one at a time, and
Page 14 of 42 KPC Apply Quality Systems And Perform Advanced Version -1
BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
Metal Engineering Technology Management Level V
a solution is implemented on a small scale first and verified that it works before implementing on
a large scale. After the most important problem has been solved, the group moves on to the
problem, cause or solution with the next highest priority and follows the same cycle. This
repetitive enactment of the cycle creates a spiral of improvement that can continue indefinitely.

 Steps in Process Improvement

 Plan
1) Recognize problem 4) Develop performance measures
2) Form quality improvement teams 5) Analyze problem
3) Define problem 6) Determine possible causes

 Do  Study
7) Implement solution 8) Evaluate solution

 Act
9) Ensure performance 10) Continuous improvement

Page 15 of 42 KPC Apply Quality Systems And Perform Advanced Version -1


BY Muluneh N. Statistical Quality Control. Janu,, 2023
Level V
2.6 The improvement of internal/external customer/supplier relationships.

• What is a customer? Anyone who is impacted by the product or process delivered by an


organization.

 External customer: The end user as well as intermediate processors. Other external customers
may not be purchasers but may have some connection with the product.
 Internal customer: Other divisions of the company that receive the processed product.
 The major difference between internal and external customers is that internal customers
operate from within the company structure, while external customers are not part of the
company.
 Both internal customers (employees) and external customers (paying customers)
are crucial for the success of a business, and it's challenging to prioritize one over the
other definitively. The two groups are interconnected and impact each other in various
ways.
 In other words, an internal customer is anyone who works within the company or
stakeholders that interact with people inside the business as part of their job or
responsibility. Examples may include business owners, employees, subcontractors, and
in some cases, suppliers.
 What is internal customer and internal supplier?
 The terms internal customer and internal supplier can be used to describe the micro operations
that take outputs from, and give inputs to, other micro operations. The internal customer-supplier
concept is regarded by some as one of the most powerful aspects to emerge from total quality
management
 While external suppliers are companies that provide goods or services so that their clients can
conduct their business successfully, internal suppliers form part of the enterprise's own
workforce.
1) What are the internal customers of a business?
2) Why are they important from a quality perspective?
Self- CHECK POINT 2

PART I TRUE/FALSE
1) Excessive variability in process performance often results in waste
2) Quality improvement is the reduction of variability in processes and products

PART II SHORT ANSWER


3) List benefits of Quality Improvement:
4) What does PDSA cycle mean? Explain
5) Elaborate the following term/ defects for quality/
a) Critical defect
b) Major defect
c) Minor defect
Unit Three :- Take samples

This learning guide is developed to provide you the necessary information regarding the
following content coverage and topics –

1. The difference between population and sample


2. Taking sample according to the procedure.

This guide will also assist you to attain the learning outcome Specifically, upon completion of
this Learning Guide, you will be able to –

1. Appling difference between population and sample


2. Taking sample according to the procedure.
3.1 Difference between population and sample

What is Population ?
 A population is the entire group that you want to draw conclusions about.
 Generally, population refers to the people who live in a particular area at a specific time. But in
statistics, population refers to data on your study of interest. It can be a group of individuals,
objects, events, organizations, etc. You use populations to draw conclusions.

What is Sample ?
 A sample is defined as a smaller and more manageable representation of a larger group.
 Or A sample is the specific group of people from which you will be collecting data
 The sample is an unbiased subset of the population that best represents the whole data which
contains characteristics of that population.
 A sample is used in statistical testing when the population size is too large for all members or
observations to be included in the test..
 The size of the sample is always less than the total size of the population
Samples are used when :

 The population is too large to collect data.

 The data collected is not reliable.


 The population is hypothetical and is unlimited in size.
A sample should generally :
 Satisfy all different variations present in the population as well as a well-defined selection
criterion.
 Be utterly unbiased on the properties of the objects being selected.
 Be random to choose the objects of study fairly.

Population and Sample Formulas

Population Parameter:

 Mean: μ = , where ΣX is the sum of all values in the population and N is the size of the

population.

 Standard Deviation: σ = √[(Σ(X-μ)²) / N], where X is a value in the population, μ is the


population mean, and N is the size of the population

Sample Statistic:
 Mean: x̄ = (Σx) / n, where Σx is the sum of all values in the sample and n is the size of the sample
 Standard Deviation: s = √[(Σ(x-x̄ )²) / (n-1)], where x is a value in the sample and x̄ is the sample
mean
Note that the formulas for the population parameter and sample statistic are similar, but they use
different notation and have slightly different calculations. The population parameter uses the entire
population, while the sample statistic uses a subset (i.e., sample) of the population.

Population Parameter vs. Sample Statistic

Population parameter and sample statistic are two important concepts in statistics that are used to
describe a population or a sample.

A population parameter is a numerical value that describes a characteristic of a population, such as the
mean or standard deviation. It is usually unknown and is estimated from sample data. For example, the
population mean height of all students in a school is a population parameter.

A sample statistic, on the other hand, is a numerical value that describes a characteristic of a sample,
such as the sample mean or sample standard deviation. It is calculated from sample data and used to
make inferences about the population. For example, the sample mean height of a group of randomly
selected students is a sample statistic.

The key difference between a population parameter and a sample statistic is that the former
describes the entire population, while the latter describes only a sample from the population. In
general, population parameters are more precise and accurate, as they are calculated using all
available data. However, they are usually unknown and can only be estimated from sample data,
which is where sample statistics come into play.

3.2 Taking sample according to the procedure.

What is Sampling ?

 A process used in statistical analysis in which a predetermined number of observations will be


taken from a larger lot. Or Sampling means a process of selecting the group that you will actually
collect data from in your research.
 The methodology used to sample from a larger lot will depend on the type of analysis being
performed, but it will include simple random sampling, systematic sampling and observational
sampling.
 For example, if you are researching the opinions of students in your university, you could survey
a sample of 100 students.
 In statistics, data plays an essential role in deciding the validity of the outcome. The data being
used must be relevant, correct, and representative of all classes. While more data is good to get
impartial results, it is crucial to make sure that the data collected is suitable for the problem at
hand.

Methods of sampling from a population

1) Probability Sampling
a) Simple random sampling./probability
b) Systematic sampling. ...
c) Stratified sampling. e.g mixing male and female to balance them from given data
d) Clustered sampling. ...
2) Nonprobability Sampling
a) Convenience sampling. .by selecting specific person esp. leader
b) Quota sampling. ..
c) Judgement (or Purposive) Sampling. ..by asking responsive person
d) Snowball sampling…

In sampling process there are the following concepts

a) Acceptable sampling
b) Acceptable Quality Level (AQL)
c) Average Outgoing Quality Level (AOQL) plans
d) Operating Characteristic Curve (OC Curve) of a sample plan etc.

Where a sample is taken from a lot and upon the results of the sample taken the lot will either be
rejected or accepted.
 Accept Lot Ready for customers
 Reject Lot Not suitable for customers

a) What is 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

Acceptance sampling is an important field of statistical quality control that was popularized by Dodge
and Rooming and originally applied by the U.S. military for the testing of bullets during World War
II. If every bullet was tested in advance, no bullets would be left to ship. If, on the other hand, none
were tested, failure might occur in the field of battle, with potentially disastrous results.
Acceptance Sampling Plans

It helps in distinguishing between the acceptable and the unacceptable lots. Acceptance Sampling is
the middle of the road approach between 100% inspection and no inspection.

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


• Problems with 100% inspection
– Very expensive
– When product must be destroyed to test
– Inspection must be very boring so defective items do not slip through inspection
• Acceptance sampling advantages
 Less handling damages
 Fewer inspectors to put on payroll
 100% inspection costs are to high
 100% testing would take to long
• Acceptance sampling disadvantages
– Risk included in chance of bad lot “acceptance” and good lot “rejection”
– Sample taken provides less information than 100% inspection
b) WHAT IS ACCEPTABLE QUALITY LEVEL?

A statistical measurement of the maximum number of defective goods considered acceptable in a


particular sample size. If the acceptable quality level (AQL) is not reached for a particular sampling of
goods, manufacturers will review the various parameters in the production process to determine the
areas causing the defects

They help determine two key elements:


 How many samples should be picked and inspected, among a batch of product or parts?
 Where is the limit between acceptability and refusal, when it comes to defective products?

It is often true even after the manufacturer has checked each individual product and has repaired the
defective ones, since visual inspection is not 100% reliable.

For example: “I want no more than 1.5% defective items in the whole order quantity, on average
over several production runs with that supplier” means the AQL is 1.5%.

In practice, three types of defects are distinguished. For most consumer goods, the limits are:

 0% for critical defects (totally unacceptable: a user might get harmed, or regulations are not
respected).

 2.5% for major defects (these products would usually not be considered acceptable by the
end user).

 4.0% for minor defects (there is some departure from specifications, but most users would
not mind it).

These proportions vary in function of the product and its market. The acceptance decisions based on
AQL based inspections contain two kinds of risks as detailed below:

1) Producer's risk :( Type I Error, The symbol α) the chance of rejecting a good lot that contains
equal or less percent defective than AQL. And typical values for α range from 0.2 to 0.01
2) The Customer's risk(Type II error symbol β ) The chance of accepting a bad lot that contains
more defective than the largest proportion of defects that a consumer is willing to accept a very
small percentage of the time. It is also known as Lot Tolerance Percent Defective (LTPD) or
represented as RQL (Rejecting Quality level). LTPD is the upper limit of the percentage of
defective items consumers are willing to tolerate and typical values for β range from 0.2 to 0.01.

c) 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

 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
 Consumer’s Risk (α) is the chance of accepting a lot that contains a greater number of defects
than the LTPD limit; Type II error
 Producer’s risk (β) is the chance a lot containing an acceptable quality level will be rejected;
Type I error
d) Average Outgoing Quality Level (AOQL):
 The average of rejected lots (100% inspection) and accepted lots (a sample of items inspected)
 A common procedure when sampling and testing is non-destructive, is to 100 % inspect rejected
lots and replace all defectives with good units. If all lots come in with a defect level of exactly p ,
and the OC curve for the chosen (n,c ) indicates a probability p a of accepting such a lot, over the
long run the AOQ can easily be shown to be:
 AOQ = Pac*p(N-n)/N where
 Pac= Probability of accepting a lot
 p = Fraction defective
 n = sample size N = Lot size

For example, let N=10000 , n=52 , c=3 , and p , the quality of incoming lots, equals 0.03. Now at
p=0.03 , we pick up from the OC curve table that p a =0.930 and

AOQ=(0.930)(0.03)(10000−52) 10000 =0.02775.

Setting p=0.01, 0.02… 0.12, we can generate the following table.

AO 0.001 0.019 0.027 0.033 0.036 0.037 0.035 0.031 0.027 0.022 0.017 0.013
Q 0 6 8 8 9 2 1 5 0 3 8 8

p 0.01 0.02 0.03 0.04 0.05 0.06 0.07 0.08 0.09 0.10 0.11 0.12
A plot of the AOQ versus p is given below

CHECK POINT 3

PART I TRUE/FALSE
1. Sampling is a process used in statistical analysis in which a predetermined number of
observations will be taken from a larger lot
2. Type II Error is the chance of rejecting a good lot that contains equal or less percent defective
than AQL.

PART II SHORT ANSWER


3. What are Problems with 100% inspection?
4. List some advantages for Acceptance sampling
5. What arte the two kinds of risks on AQL based inspections
6. Writ the equation of Average Outgoing Quality Level (AOQL):

Introduction Learning Guide 4


THIS learning guide is developed to provide you the necessary information regarding the following
content coverage and topics -

LO4. Apply statistical process to monitor production

 Understanding concept of variation in terms of average and spread.

 Using data to produce relevant statistical information.

 Interpreting data accurately according to standard operating procedures.

This guide will also assist you to attain the learning outcome stated in the cover page. Specifically, upon
completion of this Learning Guide, you will be able to –

 define statistical quality control(SQC) and statistical process(SPC )


 Describe Categories of SQC
 Identify and describe causes of variation
 Describe the use of control charts
 Explain the Statistical process control procedures, which may include six-sigma etc
 Plotting of control charts such as variable (X,R)charts, attribute(P,C) charts, random and
assignable causes etc

Unit Four :- Apply statistical process to monitor production


4.1 Variation in terms of average and spread.

A quality control tools are measure the value of a quality characteristic, and identify a change or
variation in the product or process.
e) TYPES OF VARIATION:
 Variation exists in all processes.
 Variation can be categorized as either;
A. Common or Random causes of variation

Common causes of variation are based on random causes that we cannot identify. These types of
variation are unavoidable and are due to slight differences in processing.

If you look at bottles of a soft drink in a grocery store, you will notice that no two bottles are filled to
exactly the same level. Some are filled slightly higher and some slightly lower.

These types of differences are completely normal. No two products are exactly alike because of slight
differences in materials, workers, machines, tools, and other factors. These are called common, or
random, causes of variation.

For example, if the average bottle of a soft drink called Cocoa Fizz contains 16 ounces of liquid, we may
determine that the amount of natural variation is between 15.8 and 16.2 ounces. If this were the case, we
would monitor the production process to make sure that the amount stays within this range. If
production goes out of this range—bottles are found to contain on average 15.6 ounces— this would
lead us to believe that there is a problem with the process because the variation is greater than the
natural random variation.
B. Assignable causes of variation

The second type of variation that can be observed involves variations where the causes can be exactly
identified and eliminated. These are called assignable causes of variation. Examples of this type of
variation are poor quality in raw materials, an employee who needs more training, or a machine in need
of repair. In each of these examples the problem can be identified and corrected. Also, if the problem is
allowed to continue, it will continue to create a problem in the quality of the product. In the example of
the soft drink bottling operation, bottles filled with 15.6 ounces of liquid would signal a problem. The
machine may need to be readjusted. This would be an assignable cause of variation. We can assign the
variation to a particular cause (machine needs to be readjusted) and we can correct the problem (readjust
the machine).

These chance and assignable causes of variation are illustrated in Fig. 1. Until time t1 the process shown
in this figure is in control; that is, only chance causes of variation are present.

As a result, both the mean and standard deviation of the process are at their in-control values (say, mue 0
and σ 0). At time t1 an assignable cause occurs. As shown in Fig. 1, the effect of this assignable cause is
to shift the process mean to a new value mue 1 > mue 0. At time t2 another assignable cause occurs,
resulting in mue = mue 0, but now the process standard deviation has shifted to a larger value σ 1 > σ 0.
At time t3 there is another assignable cause present, resulting in both the process mean and standard
deviation taking on out-of-control values. From time t1 forward, the presence of assignable causes has
resulted in an out-of-control process.

Process quality characteristic, x

Fig.1 change and assignable cause of variation


Several different variations of acceptance sampling are shown in Fig. 2. In a, the inspection operation is
performed immediately following production, before the product is shipped to the customer. This is
usually called outgoing inspection. In b illustrates incoming inspection; that is, a situation in which lots
of batches of product is sampled as they are received from the supplier. Various lot-dis positioning
decisions are illustrated in c.

Fig 2 Variation of acceptance sampling


4.2 Using data to produce relevant statistical information.

f) What is Statistical Quality Control (SQC)?

Statistical Process Control (SPC) Vs Statistical Quality Control (SQC)


 SPC is synonym of SQC
 SPC is widely used for discrete parts manufacturing (e.g., automobiles, microelectronics) and
product quality control.
 Basic Model for SPC monitoring activity:

x = m + e, where x is the measure value, m is its (constant) mean, and e is a random error.
 SQC is more of a monitor technique, than a control technique like feedback control.

It is based on the principle that some degree of variability in manufacturing processes is expected

Statistical quality control can be divided into three broad categories:

1. Descriptive statistics/traditional statistical tools are used to describe quality characteristics and
relationships, Such as the mean, standard deviation, the range, and a measure of the distribution of data.
They are not enough to help us evaluate whether there is a problem with quality.

2. Statistical process control (SPC) involves inspecting a random sample of the output from a process
and deciding whether the process is producing products with characteristics that fall within a
predetermined range. SPC answers the question of whether the process is functioning properly or not.

3. Acceptance sampling is the process of randomly inspecting a sample of goods and deciding whether
to accept the entire lot based on the results. Acceptance sampling determines whether a batch of goods
should be accepted or rejected.

IT is helpful in making the quality acceptance decision after the product has been produced, it does not
help us identify and catch a quality problem during the production process. For this we need tools in the
statistical process control (SPC) category.

All three of these statistical quality control categories are helpful in measuring and evaluating the quality
of products or services. However, statistical process control (SPC) tools are used most frequently
because they identify quality problems during the production process.
4.3 Interpreting data accurately and information is presented

 Process control system model with feedback

Generally Statistical process control (SPC) is a powerful collection of problem-solving tools useful in
achieving process stability and improving capability through the reduction of variability.
SPC is one of the greatest technological developments of the twentieth century because it is based on
sound underlying principles, is easy to use, has significant impact, and can be applied to any process. Its
seven major tools are
1. Histogram or stem-and-leaf plot 5. Defect concentration diagram
2. Check sheet 6. Scatter diagram
3. Pareto chart 7. Control chart
4. Cause-and-effect diagram

Basic Principles of Control Chart


A typical control chart has control limits set at values such that if the process is in control, nearly
all points will lie between the upper control limit (UCL) and the lower control limit (LCL).
Types the control chart
Variables Control (Weight, length, voltage, volume )
•R-Chart x bar – chart
Attributes Control Charts (good/bad; yes/no; correct/incorrect )
• p-chart c-chart

Mean chart (x bar – chart)

• UCL = =x + z sx LCL = =x - z sx

• Where

• s = process standard deviation

• sx = standard deviation of sample means =s/

• k = number of samples (subgroups)

• n = sample size (number of observations)

Example Constructing an 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 below
data 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

Sample means (X-bar) 15.875 15.975 15.9

Sample ranges (R) 0.2 0.3 0.2

Center line and control limit formulas


 Factors for three sigma control limits
Factor for x-Chart Factors for R-Chart
Sample Size
(n)
A2 D3 D4
2 1.88 0.00 3.27
3 1.02 0.00 2.57
4 0.73 0.00 2.28
5 0.58 0.00 2.11
6 0.48 0.00 2.00
7 0.42 0.08 1.92
8 0.37 0.14 1.86
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 1.65
Second Method for the X-bar Chart Using R-bar and the A2 Factor

Control Charts for Attributes –P-Charts & C-Charts


 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

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 No of No of Tires Proportion


Defective Tires in each Defective
Sample

1 3 20 .15

2 2 20 .10

3 1 20 .05

4 2 20 .10

5 2 20 .05

Total 9 100 .09


C-Chart Example: The numbers 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 1 2 3 4 5 6 7 8 9 10 Total

No. Of Complaints 3 2 3 1 3 3 2 1 3 1 22

Process Monitoring

Process monitoring also plays a key role in ensuring that the plant performance satisfies the
operating objectives.
The general objectives of process monitoring are:

1. Routine Monitoring. Ensure that process variables are within specified limits.

2. Detection and Diagnosis. Detect abnormal process operation and diagnose the root
cause.

3. Preventive Monitoring. Detect abnormal situations early enough so that corrective


action can be taken before the process is seriously upset.

Traditional Monitoring Techniques

Limit Checking

Process measurements should be checked to ensure that they are between specified limits, a
procedure referred to as limit checking. The most common types of measurement limits are:

1. High and low limits

2. High limit for the absolute value of the rate of change

3. Low limit for the sample variance

CHECK POINT 4

PART I TRUE/FALSE
1) SQC is more of a monitor technique, than a control technique like feedback control.
2) SPC is widely used for discrete parts manufacturing (e.g., automobiles, microelectronics)
and product quality control.

PART II SHORT ANSWER


3) What are the general objectives of process monitoring?
4) List and elaborate Types the control chart
5) Statistical quality control can be divided into three broad categories. What are they?
Reference Materials
1. Dipak Kumar Bhattacharyya, Production and Operations Management, Universities Press.
2. Operations Management R. Dan Reid & Nada R. Sanders 3rd Edition © Wiley 2007
3. Journal of the American Statistical Association, 101, 368-386.Nelson, Loyd S. (1985),
"Interpreting Shewhart X Control Charts", Journal of Quality Steel, R. G. D. and J. H.
4. Torrie (1980), Principles and Procedures of Statistics. New York: McGraw-Hill.Western
5. Electric Company (1956), Statistical Quality Control Handbook, available from ATT
Technologies, Commercial Sales Cle

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