Professional Documents
Culture Documents
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
Module Descriptor: This module covers the knowledge, skills and attitudes in applying
Quality Systems and Perform Advanced Statistical Quality Control
3. Take samples.
Learning Outcomes (Objectives):- At the end of this module the trainees will be able to:
3. Take samples.
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
This unit to provide you the necessary information regarding the following content coverage
and topics:
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:
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
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.
"Fit for purpose", the product should be suitable for the intended purpose; and
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.
Page 5 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
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”)
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.
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”)
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.
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.
1) Quality of design
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
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 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.
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.
Self Check -1
This unit is developed to provide you the necessary information regarding the following content
coverage and topics:
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 :
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 .
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.
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.
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.
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
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
This learning guide is developed to provide you the necessary information regarding the
following content coverage and topics –
This guide will also assist you to attain the learning outcome Specifically, upon completion of
this Learning Guide, you will be able to –
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 :
Population Parameter:
Mean: μ = , where ΣX is the sum of all values in the population 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 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.
What is Sampling ?
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…
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
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.
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:
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.
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
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
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.
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 –
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.
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
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
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
• UCL = =x + z sx LCL = =x - z sx
• Where
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
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.
1 3 20 .15
2 2 20 .10
3 1 20 .05
4 2 20 .10
5 2 20 .05
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.
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:
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.