NATIONAL TECHNICAL UNIVERSITY COLLEGE OF

MALAYSIA

Quality Management System (QMS)

Implementation in Manufacturing
Industries
Thesis submitted in accordance with the requirements of the
National Technical University College of Malaysia for the Degree of
Bachelor of Engineering (Honours) Manufacturing (Process)

Wan Haslinda Wan Hussin

Faculty of Manufacturing Engineering

December 2005

ABSTRACT

The road to a quality organization is paved with the commitment of management. The
quality management practices will enable a company to achieve its goals. The main thrust of
a Quality Management System (QMS) is in defrning the processes, which will result in the
production of quality products and services, rather than in detecting defective products or
services after they have been produced. Quality Management means what the organization
does to ensure that its products conform to the customer's requirements. Hence, the
establishment of this research is an attempt to observe the implementation of Quality
Management System (QMS) tools and techniques in the manufacturing industry. The tools
and techniques observed are; Statistical Process control (SPC), Acceptance Sampling,
Reliability, Design of Experiment (DOE), Failure Mode and Effect Analysis (FMEA), and
Quality Function Deployment (QFD). Furthermore, this study significantly important to
studied the effectiveness of Quality Management Systems tools and techniques that have
been implemented in the industry. This research methodology focuses on examining the
literature review. The literature reviews were obtained by reviewing the relevant topics from
Internet, textbooks, journals, documents and other resources. According to the field research
approaches, the survey data for this study has been conducted by questionnaires distribution.
The data has been gathered within three states which are Perak, Selangor, and Wilayah
Persekutuan Kuala Lumpur. This study concludes that, all of the companies have
implemented the Quality Management System (QMS) awareness. However not all of the
listed tools and techniques were use by the companied. The companies have rated the
Statistical Process Control (SPC) which used by most companies as an excellent technique.
Furthermore, this study probably requires to cany out in the extended of one techniques
which focused in only five companies. This will result more information in this techniques
which differentiation can be made among these five companies.

ABSTRAK

Pejalanan bagi sesuatu organisasi berkualiti adalah bergantung kepada komitmen

pengurusan organisasi itu sendiri. Pengurusan berkualiti membolehkan syarikat mencapai
sasaran yang diinginkan. Sistem pegurusan berkualiti adalah bagi mengenal pasti proses
yang mana akan memberi impak pada kualiti produk dan proses. h i baik berbanding
mengesan kepincangan pada produk atau semis yang telah siap. Pengurusan berkualiti
bermaksud usaha yang dilakukan bagi memastikan produk yang dihasilkan memenuhi
kehendak pengguna. Oleh yang demikian, penyelidikan ini bertujuan memantau
perlaksanaan teknik dan kaedah sistem pengurusan berkualiti di industri pembuatan. Ia juga
bertujuan bagi melihat sejauh mana keberkesanan sistem ini. Bagi memperolehi maklumat
yang berkaitan, kajian ilmiah yang memfokus kepada kaedah dan teknik sistem pengurusan
berkualiti dijalankan. Kajian yang dijalankan adalah berkenaan kaedah dan teknik
"Statistical Process control" (SPC), "Acceptance Sampling", "Reliability", "Design of
Experiment" (DOE), "Failure Mode and Effect Analysis" (FMEA), and "Quality Function
Deployment" (QFD). Maklumat bagi kajian ilmiah ini diperolehi dari rujukan menerusi
internet, buku, jurnal, dokumen dan sebagainya. Bagi memperolehi maklumat yang
berkaitan, borang soal selidik berkaitan pengaplikasian teknik dan kaedah sistem pengurusan
berkualiti diedarkan kepada industri pempuatan. Borang soal selidik ini diedarkan pada tiga
negeri iaitu Perak, Selangor, dan Wilayah Persekutuan Kuala Lumpur. Bedasarkan kepada
soal selidik, kesemua industri yang memberikan maklumbalas telah mengaplikasikan sistem
pegurusan berkualiti di syarikat masing-masing. Walaubagimanapun, tidak semua teknik dan
kaedah yang disenaraikan digunakan dalam sesebuah syarikat. "Statistical Process Control"
(SPC) telah diaplikasikan oleh hampir kesemua syarikat yang memberikan maklum balas.
Pengaplikasian SPC dalam syarikat telah dikategorikan sebagai teknik yang sangat baik.
Walaubagairnanapun, adalah disyorkan agar pada masa hadapan penyelidikan dilakukan
berdasarkan pada satu teknik sahaja yang memfokuskan kepada lima syarikat. h i bagi
memperolehi lebih infomasi berkaitan teknik yang digunakan dan perbandingan
pengaplikasian boleh dilakukan berdasarkan kelima-lima syarikat ini.

Quality Management System (QMS) Implementation in Manufacturing

CHAPTER 1
INTRODUCTION

1.

INTRODUCTION
The road to a quality organization is paved with the commitment of

management. If the management is not totally behind this effort, the road will be
filled with potholes, and the effort will drag to halt. A keen sense of involvement is a
prerequisite for this journey because, like any journey of import, the company will
sometimes find itself in uncharted temtory. Company policies must be carefully
formulated according to principle of a quality program.
The quality management practices will enable a company to achieve its goals.
These practice start at the top, where top management creates the road map, they
continue with middle and line management, who help the employees follow the map.
With an ever -watchful eye on the satisfaction of the customer, the entire workforce
embarks on an intensive study of product design and process design.
The International Organization for Standardization's IS0 9000 series
describes standards for a QMS addressing the processes surrounding the design,
development and delivery of a general product or service. Organizations can
participate in a continuing certification process to demonstrate their compliance with
the standard. A QMS can be defined as:
"A set of co-ordinate activities to direct and control an organization in order

to continually improve the effectiveness and efficiency of its performance."

Quality Management System (Qm)Implementation in Manufacturing

These activities interact and are affected by being in the system, so the
isolation and study of each one in detail will not necessarily lead to an understanding
of the system as a whole. The main thrust of a QMS is in defining the processes,
which will result in the production of quality products and services, rather than in
detecting defective products or services after they have been produced. Quality
Management means what the organization does to ensure that its products conform to
the customer's requirements.

1.2

RESEARCH OBJECTIVES
The study is aimed to achieve the following objectives:
a)

The project was to find out the implementation of Quality

Management System tools and techniques in the manufacturing industries.

This project also studied the effectiveness of Quality Management
b)
Systems implementation in the industries.

1.3

RESEARCH SCOPES
The scopes are focusing on certain quantitative QMS tools and techniques

that been used by manufacturing industries. Types of tools discussed are:

a)

Statistical Process Control (SPC)

b)

Acceptance Sampling

c)

Reliability

d)

Experimental Design

e)

Failure Mode and Effect Analysis (FMEA)

f)

Quality Function Deployment (QFD)

Quality Management System (QMS) Implementation in Manufacturing

Industries

1.4

PROBLEM STATEMENTS
The problem statement is to study the Quality Management System (QMS)

tools and techniques that been used by manufacturing industries. In order to achieve
quality management, certain tools and techniques have been used. In this study, tools
and techniques that been used were defined. Certain management didn't use the tools
and techniques even though there are many types of it. These tools and techniques
will give helps management to achieve targets, improve customer satisfaction,
increase productivity and etc. However, there are companies which are using the
tools but still didn't achieve any improvements.
The aim of this study is to observe the implementation of quality
management system in the manufacturing industry and its performance in the
industry. However, the study will be based on the tools and techniques which might
be used by management to ensure that its products conform to the customer's
requirements. The tools and techniques discussed are the Statistical Process Control
(SPC), Acceptance Sampling, Reliability, Experimental Design, Failure Mode and
Effect Analysis (FMEA) and Quality Function Deployment (QFD).

1.5

LIMITATION OF STUDY
This are several problems will be faced during conducted the project

research. The problems that needed to be considered are:

1.5.1. Time Constraint

In preparing and conducting the report, the researcher needed long
duration to collect the data and make analysis about the research. So, in order
to produce a better research, it needs to have a longer time than currently.

Quality Management System (QMS) Implementation in Manufacturing

1.5.2. Lack of Experience and Knowledge

The researcher still lack of knowledge and experience in doing
research comprehensively but researcher try to work hard and committed to
complete the research properly.

1.5.3. Lack of Cooperation from Respondents

Not all the respondents are willing to answer the questionnaires. Lack
of cooperation from the respondents are also happen because maybe they are
busy in perfbrming jobs and sometimes refuse to answer some of questions.
In addition, some respondents also not return back the questionnaire given to
them. This had caused delay in getting the data needed.

1.5.4. Accessibility of Data

The researcher needs to ask the permission from the management
before take out any information regarding to the operation of the company.
Generally, there are some data that are important to the organization, which is
secret and confidential. The organization cannot distribute to the data to
outside parties. This is to avoid any misuse of information of the company.
Therefore, it is difficult to obtain some of the information related to the study,
which considered as confidential.

1.5.5. Concentration and Commitment

This project paper is one of the subjects that should be taken during
final semester in order to accomplish the program. Thus, a full concentration
and commitment on this research is not possible.

Quality Management System (QMS) Implementation in Manufacturing

Industries

CHAPTER 2
LITERATURE REVIEW

QUALITY MANAGEMENT SYSTEM

2.1.1 Definition of Quality

The word "quality" shows a concern for customer satisfaction. Quality
is the totality of features and characteristics of a product or service that bear
on its ability to satisfjr stated or implied needs. Some goals of quality
programs include:

a)

Fitness for use. (Is the product or service capable of being used?)

b)

Fitness for purpose. (Does the product or service meet its intended
purpose?)

c)

Customer satisfaction. (Does the product or service meet the

customer's expectations?)

d)

Conformance to the requirements. (Does the product or service

conform to the requirements?)

Quality Management System (QMS) Implementation in Manufacturing

2.1.4 Definition of Quality Management System

A Quality System (QMS) is a system that outlines the policies and

procedures necessary to improve and control the various processes that will
ultimately lead to improved business performance. One of their purposes is
quality control in manufacturing.
Traditional quality systems in manufacturing focus primarily on
technical issues such as equipment reliability, inspection, defects
measurement and process control. (Evans J.R and Lindsay W.M., 2005)

2.2

QUALITY

MANAGEMENT

SYSTEM

(QMS)

IMPLEMENTATION IN MANUFACTURING INDUSTRIES

Burgess (1999) state, any good quality management system should have as its
foundation comprehensive reviews of new products and processes. Design reviews
must begin early, when the design is still flexible, and extend to qualification of the
initial product produced and the process producing it. A quality system that permits
either skipping review steps or making them superficial can lead to serious quality
problems.
Bhuiyan and Alam (2005) explain, understanding the quality system, the
implementation requirements and the benefit was crucial to make the system
effective at the grass-roots level. From the start, many employees misunderstood the
perception of the quality effort. A number of key people considered the effort to be
useless, believing that the status quo was good enough as the quality of their products
was considered best on the market. Furthermore, the Quality system implementation
assembly supervisor believed that tracking defects at the inspection stage meant that
the company had good internal quality. As a result, not everyone seriously
committed to making the changes needed to successfully implement a quality
system.

Quality Management System (QMS) Implementation in Manufacturing

Van Der Wiele and Brown (2002) said that the quality management
philosophy has gone through a process of change itself. It started in the 1980s in the
Western world as a motivational drive to change work environments in order to
become more customer oriented and develop a competitive advantage. It has
stimulated the development and use of many tools and techniques which can be used
to improve processes and to prevent problems. Now, quality management is being
linked to and intergrated with company management systems, e.g. the IS0 9000
series and the management systems, related to the quality awards models.
Organization with high level of quality maturity have been able to integrate the
quality management systems into their normal day-to-day fabric of managing the
business and by doing so, the glamour and enthusiasm around the philosophy has
gone, although many of the core principles have been installed. Quality is now seen
strongly as means to an end rather than end in itself.
Lee S.F. et al. (1999) state, being the major part of management
responsibility within the quality management system, management should establish
and maintain a proper documented quality system as the means of ensuring product
conformance to the specified requirements. Besides, management should also be
concerned with the initiation, development, implementation, and maintenance of the
quality system.

Quality Management System (QM) Implementation in Manufacturing

2.3

IMPLEMENTATION OF QMS TOOLS AND TECHNIQUES IN

MANUFACTURING INDUSTRIES
Tools and techniques are practical methods, skills, means or mechanisms that

can be applied to particular tasks. Among other things they are used to facilitate
positive change and improvements, (McQuater et al., 1995).
The management focus and commitment phase required the use of data
analysis tools (e.g. cause and effect analysis, flow charts and Pareto analysis) to
identify problem areas, quantifj their effects and prioritize the need for solution.
During the intensive improvement phase the introduction of more complex tools (e.g.
statistical process control (SPC) and failure mode and effects analysis (FMEA)
helped to facilitate company-wide improvement but was dependent on the
understanding and deployment of the other more basic tools introduced earlier.
The quality management tools and techniques were applied in the
organization at different times during the period from 1987to the end of 1994 (see
Figure 2.1). In the early stages, the tools and techniques were applied in a haphazard
manner, without serious thought to the implications on the long-term development of
the improvement strategy and process. The choice of tools and techniques was also
affected by the resources available within the company to facilitate their successful
introduction. By the end of 1994 a wide range of tools and techniques was being
applied in different parts of the organization for different reasons but the major
utilization was by the quality improvement facilitators and by quality improvement
teams, (Bunney and Dale, 1997).
The most successfbl application of tools and techniques was during the
quality improvement team meetings. While focusing on a particular problem, the
application of Pareto charts, control charts and flowcharting became a positive help
rather than just another new tool or technique, as previously perceived.

Qualiy Management System (QMS) Implementation in Manufacturing

Industries
bar
1987 1988 1989 1990 1991 1992 1993 1994
Tools
Cause and effect
J
Paretoanalysis
J
SPC
J
Quality costing
J
Wpartmntal
purpose analysis
J
Qmappingl
flowchartitlg
J
FMEA
J
(KD
J
Check sheet
J
Histogram
J
Scatter plot
J
Graphs
J
Mistake
proofing
J

Figure 2.1: Introduction of Tools and Techniques. Source: Bunney H.S., and
Dale B.G. (1997). The Implementation of Quality Management Tools and
Techniques: A Study. The TQM Magazine. 9 (3): 183-1 89.
Initially a number of the quality management tools and techniques were
introduced as a means of increasing awareness of the total quality management
concepts and the importance of continuous and company-wide improvement (see
Figure 2.2). For example, the introduction of SPC to senior management in 1987 was
envisaged as being a means of them finding ways to involve their people in process
improvement. Unfortunately this never came to fruition due to the inadequate
training carried out by the management consultants engaged for this task and
subsequent application in the operational aspects of the business. Around the same
time other tools and techniques were introduced to facilitate the data collection
process including cause and effect diagrams and quality costing, (Bunney and Dale,
1997).

Quality Management System (QMS) Implementation in Manufacturing

Tools
Cause andeffect
Pareto analysis
SPC
Quality axsting
Departmental
purpose analysis
Qmappingl
flowcharting
FMEA
QFD
checksheet
Histogram
Scatter plot
Graphs
Mistake proofing

Data
collectim
J

bpplication
Pmbkm Custrnnerkupplier Newproduct
Qwli
solving
relatiomhip
introduction awareness

J
J

J
J

J
J
J

4
J
J

Figure 2.2: Analysis of Application of Tools and Techniques. Source:

Bunney H.S., and Dale B.G. (1997). The Implementation of Quality Management
Tools and Techniques: A Study. The TQM Magazine. 9 (3): 183-1 89.
As the quality improvement process developed the use of FMEA and QFD
was piloted in areas such as new product andlor service development. These pilots
have proved invaluable to all involved but the effectiveness of the use of these
techniques is very much dependent on the prior understanding of the basic quality
control tools such as check sheets, cause and effect analysis, Pareto diagrams, etc.
The organizations have got to start employing some basic problem-solving
methodology using the more simple tools and techniques to identify what is wrong
with their business processes and providing the means to make improvements. They
need to pick up the information on problems to allow them to improve customer
service. The inspiration to do this can come from an internal change agent andlor
suppliers who are more advanced in their quality management thinking, (Dale et al,
2001).

Quality Management System (QMS) Implementation in Manufacturing

Industries

2.4

TOOLS AND TECHNIQUES FOR QUALITY MANAGEMENT

SYSTEM (QMS)
2.4.1 Introduction
A single tool may be described as a device which has a clear role. It is

often narrow in focus and is usually used on its own. These include cause and
effect diagrams, pareto analysis, check sheet, scatter diagram, control charts,
histograms, and flow charts, (McQuater et al., 1995).
A technique, on the other hand, has a wider application than a tool.

This often results in a need for more thought, skill and training to use
techniques effectively. Viewed simplistically, techniques can be thought of as
a collection of tools. For example, statistical process control (SPC) employs a
variety of tools such as charts, graphs and histograms, as well as other
statistical methods, all of which are necessary for the effective use of the
technique. These techniques include SPC, quality function deployment and
design of experiments, (McQuater et al., 1995).

2.4.2 Statistical Process Control (SPC)

SPC is certainly a list of techniques and prominent in the list is the
control chart, or process control chart, or statistical process control chart or
SPC chart. However, SPC is not simply a collection of tools and techniques.
Anyone who has successfully used these tools will have learned by
experience that SPC is also a way of thinking about variability. This
underlying philosophy of variation has profound implications for managers.
Any manager who does not understand what could be described as the most
fundamental concept of SPC will very likely cause waste of resources, both
financial and human. Furthermore, this waste could be caused by any
manager of any process, in any business, not simply manufacturing.

Quality Management System (QMS) Implementation in Manufacturing

Graphical methods are easy to understand and provide comprehensive

information; they are viable tools for the analysis of product and process data.
The information they provide on existing product or process characteristic
helps to determine whether these characteristic are close to desire form. The
graphical techniques help to identifl where to focus quality improvement
efforts. The tools are Control Chart, Scatter Diagram, Cause and Effect
Diagram, Histogram, Flow Chart, Pareto Chart and Check Sheet.
A typical control chart is a graphical display of a quality characteristic
that has been measured or computed ffom a sample versus the sample number
or time. A point that plots outside of the control limits is interpreted as
evidence that the process is out of control, and investigation and corrective
action is required to find and eliminate the assignable causes responsible for
this behavior. Even if all the points plot inside the control limits, if they
behave in a systematic or nonrandom manner, then this is an indication that
the process is out of control. Control chart is a device for describing in a
precise manner what is meant by statistical control.
Scatter diagrams are used to study possible relationships between two
variables. Although these diagrams cannot prove that one variable causes the
other, they do indicate the existence of a relationship, as well as the strength
of that relationship. The purpose of the scatter diagram is to display what
happens to one variable when another variable is changed. The diagram is
used to test a theory that the two variables are related. The type of
relationship that exits is indicated by the slope of the diagram
Cause and Effect Diagrams are typically constructed through
brainstorming techniques. As a result, they are often drafted by hand on
paper. To provide a pictorial display of a list in which to identifl and
organize possible causes of problems, or factors needed to ensure success of
some effort. It is an effective tool that allows people to easily see the
relationship between factors to study processes, situations, and for planning.

Quality Management System (QMS) Implementation in Manufacturing

Histograms are effective Q.C. tools which are used in the analysis of
data. It used as a check on specific process parameters to determine where the
greatest amount of variation occurs in the process, or to determine if process
specifications are exceeded. This statistical method does not prove that a
process is in a state of control. Nonetheless, histograms alone have been used
to solve many problems in quality control. When combined with the concept
of the normal curve and the knowledge of a particular process, the histogram
becomes an effective, practical working tool in the early stages of data
analysis.
A flow chart is defined as a pictorial representation describing a

process being studied or even used to plan stages of a project. Flow charts
tend to provide people with a common language or reference point when
dealing with a project or process. Four particular types of flow charts have
proven useful when dealing with a process analysis: top-down flow chart,
detailed flow chart, work flow diagrams, and a deployment chart. Each of the
different types of flow charts tends to provide a different aspect to a process
or a task. It provides an excellent form of documentation for a process, and
often u s e l l when examining how various steps in a process work together.
Pareto analysis is a technique to assist in determining where to begin
an attack on a problem or to display the relative importance of problems or
conditions. The resulting chart is used to choose a starting point for problem
solving, monitor success, or identifj. basic causes of problems. It is the result
data collections in which possible anomalies have been identifj. and count
(attributes) data have been collected using check sheets, computer process
control results, or some other data collection and analysis method. "Before"
and "after" improvement Pareto Diagrams form a good basis for determining
the success of an improvement effort. If shown superimposed or side by side,
the number of units inspected in each case should be the same and the lefthand scale of counts of defects, nonconformance, and the like, should be the
same. In this way the overall improvement is clearly illustrated.

Quality Management System (QMS) Implementation in Manufacturing

A check sheet is a manual graphical counting mechanism for

enumerating the result of sampling. Often it is the beginning of the process of

translating opinions into facts, or it is used as a beginning step in the manual
preparation of a histogram. It used to illustrate the distribution of
nonconformities in complex assemblies or rejected units in lots of product.
Any manager, who truly understands the fundamental concept of SPC,
is likely to question process performance rather more usefully than would a
less enlightened colleague. As a result of his understanding he will ask the
right questions. Perhaps even more importantly, he will resist the temptation
to ask the wrong questions. These wrong questions are the ones which would
send his people off on a wild goose chase, seeking the causes of random
variation, (Caulcutt R., 1996).
This reduction in wasted effort is one of the benefits of using control
charts. A second benefit is process improvement. By seeking the assignable
causes, we increase our understanding of the process. Thus we are better able
to hold the mean on target or change the mean to a more profitable level (e-g.
increased sales), (Caulcutt R., 1996).
A third benefit is greater consistency of the process output. By finding
and eliminating the assignable causes, we reduce the variability in the
process. This will, in many cases, make our product or service more
acceptable to the customer, (Caulcutt R., 1996).

Quality Management System (QMS) Implementation in Manufacturing

2.4.3 Acceptance Sampling

Acceptance sampling is "the middle of the road" approach between no
inspection and 100% inspection. There are two major classifications of
acceptance plans: by attributes ("go, no-go") and by variables. The attribute
case is the most common for acceptance sampling, and will be assumed for
the rest of this section. A point to remember is that the main purpose of
acceptance sampling is to decide whether or not the lot is likely to be
acceptable, not to estimate the quality of the lot.
Acceptance sampling is often used to determine the disposition of
incoming raw material or parts when 100 percent inspection is destructive,
time consuming, or expensive. An effective acceptance sampling plan will
allow a company to set and maintain an acceptable quality assurance standard
while procuring parts or raw material fiom outside vendors. Sampling can be
described as the activity of taking a snap-shot of a population in order to
obtain an understanding of the observed population. In acceptance sampling,
inspection is performed on a sample taken fiom a lot of incoming materials.
A decision is made concerning the disposition of the lot based on the
information obtained fiom this sample. In general, three approached could be
considered when receiving a lot: (1) no inspection, (2) 100% inspection, and
(3) sampling inspection. The fmt approach can be taken when the quality of

the vendor's process is stable and has met certain quality assurance
requirements. A 100% inspection procedure may be needed when the
received part or material is so critical that warrants a full inspection. In most
other cases, sampling inspection could be considered.
A single sampling plan is where one sample of items is selected at
random fiom a lot and the disposition of the lot is determined fiom the
resulting information. These plans are usually denoted as (n, c) plans for a
sample size n, where the lot is rejected if there are more than c defectives.

'Q

Quality Management System (QMS) Implementation in Manufacturing

Industries

These are the most common (and easiest) plans to use although not the most
efficient in terms of average number of samples needed.
Double sampling plans means after the first sample is tested, there are
three possibilities:
a)

Accept the lot

b)

Reject the lot

c)

No decision

If the outcome is (c), and a second sample is taken, the procedure is to

combine the results of both samples and make a final decision based on that
information.
Multiple sampling plans are an extension of the double sampling
plans where more than two samples are needed to reach a conclusion. The
advantage of multiple sampling is smaller sample sizes.
Sequential sampling plans is the ultimate extension of multiple
sampling where items are selected from a lot one at a time and after
inspection of each item a decision is made to accept or reject the lot or select
another unit. Nevertheless, skip lot sampling plans means that only a fraction
of the submitted lots are inspected
The quality tools in the on-line quality controls level is acceptance
sampling. It is used as a screen to stop any defective products from escaping.
Using statistical methods, a random sample of products is selected and
checked to ensure the quality level is acceptable. The acceptance sampling
can be carried out not only by the quality assurance specialists but also by the
production personnel. When products pass the acceptance sampling test, they
are delivered to customers, or progress to the next process. ?'his tool can
indicate that the supplier or personnel carrying out the next process should be
responsible for the quality of products before they enter the next set of on-line
quality control tools, (Kwok and Tummala, 1998).

Quality Management System (QMS) Implementation in Manufacturing

2.4.4

Reliability
Reliability is the probability of a product performing its intended

function for a stated period of time under certain specified conditions. To

ensure customer satisfaction in the performance phase, the address measures
to improve reliability in design phase. The complex nature of product
requires many components in their construction. With the customer and
warranty cost in mind, the chances of successful operation of the product
should known for at least at certain stipulated period of time. Such
information helps the manufacturer to select the parameter of a warranty
policy.
There are several tools that can be used for analysis the life data of
product. There are Weibull Distribution, Exponential Distribution,
Lognormal Distribution, Mixed Weibull Distribution, and Generalized
Gamma Distribution.
The Weibull distribution gives the distribution of lifetimes of objects.
It is also used in analysis of systems involving a weakest link. The Weibull
distribution is often used in place of the Normal distribution due to the fact
that a Weibull variant can be generated through inversion, while Normal
variants are typically generated using the more complicated Box-Muller
Method, which requires two uniform random varieties. Weibull distributions
may also be used to represent manufacturing and delivery times in industrial
engineering problems.
The exponential distribution is primarily used in reliability
applications. The exponential distribution is used to model data with a
constant failure rate (indicated by the hazard plot which is simply equal to a
constant). Because of the memory less property of this distribution, it is wellsuited to model the constant hazard rate portion of the bathtub curve used in
reliability theory. It is also very convenient because it is so easy to add failure

Quality Management System (QM) Implementation in Manufacturing

Industries

rates in a reliability model. The exponential distribution is however not

appropriate to model the overall lifetime of organisms or technical devices,
because the "failure rates" here are not constant: more failures occur for very
young and for very old systems.
The lognormal and Weibull distributions are probably the most
commonly used distributions in reliability applications. The lognormal
distribution is commonly used to model the lives of units whose failure
modes are of a fatigue-stress nature. Since this includes most, if not all,
mechanical systems, the lognormal distribution can have widespread
application. Consequently, the lognormal distribution is a good companion to
the Weibull distribution when attempting to model these types of units. As
may be surmised by the name, the lognormal distribution has certain
similarities to the normal distribution. A random variable is Lognormal
distributed if the logarithm of the random variable is normally distributed.
Because of this, there are many mathematical similarities between the two
distributions. For example, the mathematical reasoning for the construction of
the probability plotting scales and the bias of parameter estimators is very
similar for these two distributions.
The mixed Weibull distribution (also known as a multimodal Weibull)
is used to model data that do not fall on a straight line on a Weibull
probability plot. Data of this type, particularly if the data points follow an Sshape on the probability plot, may be indicative of more than one failure
mode at work in the population of failure times. Field data from a given
mixed population may frequently represent multiple failure modes. The
necessity of determining the life regions where these failure modes occur is
apparent when it is realized that the times-to-failure for each mode may
follow a distinct Weibull distribution, thus requiring individual mathematical
treatment. Another reason is that each failure mode may require a different
design change to improve the component's reliability.

Quality Management System (QMS) Implementation in Manufacturing

The generalized gamma distribution does have the ability to mimic

the attributes of other distributions such as the Weibull or lognormal, based
on the values of the distribution's parameters. While the generalized gamma
distribution is not often used to model life data by itself, its ability to behave
like other more commonly-used life distributions is sometimes used to
determine which of those life distributions should be used to model a
particular set of data.
Reliability is needed in the performance phase of quality, but plans for
its achievement are actually addressed in the design phase. Procedures for
improving the reliability of a system by means of adding components in
parallel (redundant systems) or through standby systems should be observed.
The life-cycle curve of products was studied to identify the period of useful
life of the product.
The reliability requirements for products are changing rapidly and
alternative methods of demonstrating reliability will have to be found in the
near future to avoid the necessity of doing exhaustive end-of-line life testing
to show product reliability. Building-in reliability methodology is the next
logical step for the reliability community to make to demonstrate product and
process reliability. The building-in reliability philosophy will involve forming
strategic partnerships with customers and sharing hitherto confidential data
with them which demonstrate control for reliability, rather than the customary
life test data which will in future be very difficult to generate. The customer
will have to become an extension of the manufacturers' plant and will have to
understand the reasoning behind the manufacturers' decisions, Prendergast et
al., 1996).

Quality Management System (QMS) Implementation in Manufacturing

Industries

2.4.5 Design of Experiment (DOE)

An experimental is a planned method of inquiry conducted to support

a hypothesized belief or to discover new information about a product,

processes, r service. It is an active method of obtaining information, as
opposed to passive observation. It involves inducing a response to determine
the effect of certain controlled parameters. Experimental design is used to
determine the impact of factors on the response variable. With quantitative
factors, which vary on a continuous scale, the information about the
variable's behavior can be obtain even for factors level that have not been
experimental determined.
Experimental design should be used at all stages during product
development where experiments are performed. It is one of several
techniques important for rapid and goal-oriented product development.
Experimental design is an effective tool to identifjr the most important design
variables (raw materials and processing), and to select the conditions that
result in lowest cost, highest quality and most reliable product.
Experimental design can greatly increase the efficiency of
experimentation and troubleshooting that takes place during the development
of any product. The use of screening designs can reduce the number of runs
and thereby decrease the experimental cost, but it also ensures rapid data
collection, reveal interaction effects and a wider inductive basis for decision
making, (Ellekjaer and Bisgaard, 1998).
The application of experimental design has significantly reduced the
time and expense needed to develop the extrusion press, has greatly improved
the performance of the extrusion press, and has led to the overall success of
the new product development. This clearly demonstrates that experimental
design is an efficient technique for new product development. To ensure
success when undertaking experimental design in new product development,
there are some prerequisites which have to be taken into account. These

Quality Management System (QMS) Implementation in Manufacturing

include, for example, the need for a better understanding of customer

requirements and expectations, a carefully planned design for experiments,
and sound knowledge in the subject matter. In addition, the economy and
simplicity of experimental design should also be taken into account, (Zhang,
1998).

2.4.6 Failure Mode and Effect Analysis (FMEA)

The technique of failure, mode, effect and critical analysis provides a
methodical way of examining a given design for possible ways in which
failures of components or assemblies can occur. A product is examined for all
the ways in which a failure may occur. For each potential failure, an estimate
of its effect on the total system and of its seriousness is prepared. A review of
the actions being taken to minimize the probability of failures or to minimize
the effect of failure is also done. This analysis can-be elaborated according to
requirements of the product and it may include topics such as safety,
availability, accessibility, reparability and repair planning, down time
required, spare parts availability, loss of orders etc.
FMEA is a technique that identifies, first, the potential failure modes

of a product during its life cycle; second, the effects of these failures; and,
third, the criticality of these failure effects in product functionality. FMEA
provides basic information to reliability prediction, and product and process
design. FMEA helps engineers find potential problems in the product earlier
and thus avoids costly changes or reworks at later stages, such as at the
manufacturing stage and at the product warranty stage. In the FMEA process,
product functions must be carefully evaluated, and the potential failures must
be listed. This analysis process provides a thorough analysis at each detailed
functional design element. It allows FMEA to be a very useful tool in quality
planning and reliability prediction, (Teng and Ho, 1996).

Quality Management System (QMS) Implementation in Manufacturing

Industries

FMEA include the activities at both design and manufacturing stages.

It is common and critical to conduct reliability analysis at the earliest stage of
the product life cycle. Hence, the problems can be eliminated as early as
possible to avoid complicated and costly correction processes, (Teng and Ho,
1996).
Most of the automotive part designs are required to be evaluated by
the use of FMEA in the design process. A FMEA report accompanied with
the componentlpart design is a common practice in automotive industry. A
good use of the FMEA technique can provide a manufacturing company
benefits such as high product reliability, less design modification, better
quality planning, continuous improvement in product and process design, and
lower manufacturing cost. A company must fully utilize FMEA to improve
the reliability of the products and the processes to obtain the benefits
mentioned above. If a company's main purpose of developing the FMEA
report is to fulfil customers' demand, then the benefits of performing FMEA
will be reduced, and the cost for the FMEA process may not be compensated
by the benefits of performing the analysis except that it satisfies customers'
demand to have the report, (Teng and Ho, 1996).

Quality Management System (QMS) Implementation in Manufacturing

2.4.7 Quality Function Deployment (QFD)

Quality function deployment or "QFD" is a flexible technique used in
brand marketing and product management to help a company decide what
product(s) to add to its product portfolio and what characteristics to include in
a new product. It has been applied in a wide variety of industries from
services to consumer products, all the way to militaryhigh tech products.
The quality function deployment (QFD) is a marketing approach to
create customer satisfaction and improve customer relations by designing the
products just according to what the customers want. The customer's voice in
this approach is the main driving force behind the planning and design,
whereas in the traditional approach, the design executives and the
management policy determine the design requirements. Even if the
customer's requirements are considered their own choice from various view
points carry more weight. The twin objectives of meeting the requirements of
function as well as quality are achieved keeping the customer's needs directly
in mind. Thus, QFD is used as a design and planning tool to ensure that the
voice of customer's advice and opinion is deployed through out the product
planning and designing stages
QFD is the most complete and convincing methodology for planning
the goals of a stream of processes to align them to meet the customer's
requirements. QFD methodology consists of the identification of goals from
an end user's viewpoint and of the diffusion upstream of these goals. The
basic design tool of QFD is the house of quality, a kind of conceptual map
giving the means for inter functional planning and communications,
(Kathawala and Motwani, 1994).
The implementation and success of QFD depends on many
prerequisites or critical factors, the first of which is support for QFD from top
management. In order to be competitive in this global market, top