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SECTION A
INTRODUCTION
Chapter 1:
Introduction to Project
Title
Chapter 3:
Introduction to Quality
Management System
Chapter 4:
Introduction to the
Company
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Design and development of a Quality Management System for a production plant
CHAPTER 01
Quality Management System (QMS) can be defined as a set of policies, processes and
procedures required for planning and development of an organization. QMS integrates
the various internal processes within the organization and intends to provide a process
approach for project execution. QMS enables the organizations to identify, measure,
control and improve the various processes that will ultimately lead to improved
business performance.
The concept of a Quality Management System has been introduced for a long period
of time. The management needs specific practices to install a quality program. Terms
like Total Quality Management (TQM), Continuous Quality Improvement (CQI),
Total Quality Control (TQC), and Total Quality Excellence (TQE) (Quality Manual
Ford Motor Company: 1997) derive and come under the umbrella of QMS.
The scope of the project required that a Quality Management System was to be
provided to a production plant. For which, the Group was supposed to:
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To identify the Gaps present between the current system and the Quality
Management System that is desired by the Owner, their Suppliers, and their
Customers.
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CHAPTER 02
INTRODUCTION TO QUALITY
2.1 QUALITY
The notion of Quality has been defined in different ways by various authors. Garvin
(1984) divides the definition of quality into five categories, namely:
i. Transcendent
ii. Product-based
iii. User-based
iv. Manufacturing-based
v. Value-based
Furthermore, Garvin identified a framework of the following eight attributes that may
be used to define Quality:
i. Performance
ii. Features
iii. Reliability
iv. Conformance
v. Disability
vi. Serviceability
vii. Aesthetics
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2.1.1 Definition
The Quality of a product or service is the fitness of that product or service for
meeting or exceeding its intended use as required by the customer.
The elements which define the intended quality level of a product or service are
known as quality characteristics, which can be categorized in these groupings:
Structural characteristics include such elements as the length of a part, the weight
of a can, the strength of a beam, the viscosity of a fluid, and so on…
Sensory characteristics include the taste of good food, the smell of a sweet
fragrance, and the beauty of a model, among others.
2.1.2.1 Variables And Attributes: Quality characteristics fall into two broad classes,
namely:
Variables
Attributes
Variables: characteristics that are measurable and are expressed on a numerical scale
are called variables.
For e.g. the diameter of a bearing expressed in millimeters is a variable, as are the
density of a liquid in grams per cubic centimeter and the resistance of a coil in ohms.
For e.g. the smell of a cologne is characterized as either acceptable or not; the color
of a fabric is either acceptable or not.
However, there are some variables that are treated as attributes because it is simpler to
measure them this way or because it is difficult to obtain data on them.
For e.g. the diameter of a bearing is, in theory, a variable. However, if we measure the
diameter using a go/no-go gage and classify it as either conforming or nonconforming
(with respect to some established specifications), then the characteristic is expressed
as an attribute.
2.1.2.2 Defect: A defect is associated with a quality characteristic that does not meet
certain standard. Furthermore, the severity of one or more defects in a product may
cause it to be unacceptable (or defective). The modern term for a defect is non-
conformity and the term for a defective is a non-conforming item.
Definition:
The American National Standards Institute (ANSI) and The American Society for
Quality Control (ASQC) provide the following definition of a defect as stated in
ANSI/ASQC Standard A3 (1987):
Since the definition of quality involves meeting the requirements of the customer,
these requirements need to be documented. A standard, or specification, refers to a
precise statement that formalizes the requirements of-the customer; it may relate to a
product, a process, or a service. For example, the specifications for an axle might be
2 ± 0.1 centimeters (cm) for the inside diameter, 4 ± 0.2 cm for the outside diameter,
and 10 ±0.5 cm for the Length. This means that for an axle to be acceptable to the
customer, each of these dimensions must be within the specified values.
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2.1.3.2 Standard: The U.S. National Bureau Of Standards (1983) Defines A Standard
As Follows:
This task may be achieved through different measures such as planning, design, use of
proper equipment and procedures, inspection, and taking corrective action in case a
deviation is observed between the product, service, or process output and a specified
standard (ASQC 1983; Walsh et al. 1986).
This general area may be divided into three main sub areas, namely:
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Off-line quality control procedures deal with measures to select and choose control-
lable product and process parameters in such a way that the deviation between the
product or process output and the standard will be minimized.
Much of this task is accomplished through product and process design. The goal is to
come up with a design within the constraints of resources and environmental
parameters such that when production takes place, the output meets the standard.
Thus, to the extent possible, the product and process parameters are set before
production begins.
On-line quality control involves comparing the output of a process or a service with a
standard and taking remedial actions in case of a discrepancy between the two. It also
involves determining whether a process can produce a product that meets desired
specifications or requirements.
It deals with inspection of the product or service. When 100 percent inspection of all
items is not feasible, a decision has to be made on how many items should be sampled
or whether the batch should be sampled at all. The information obtained from the
sample is used to decide whether to accept or reject the entire batch or lot.
In the case of attributes, one parameter is the acceptable number of nonconforming
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items in the sample, if the observed number of nonconforming items is less than or
equal to this number, the batch is accepted. This is known as the acceptance number.
In the case of variables, one parameter may be the proportion of items in the sample
that are outside the specifications. This proportion would have to be less than or equal
to a standard for the lot to be accepted.
2.2.3.1 Definition: A plan that determines the number of items to sample and the
acceptance criteria of lot. Based on meeting certain stipulated conditions (such as the
risk of rejecting a good lot or accepting a bad lot), is known as an acceptance
sampling plan
The objective of the quality assurance function is to have in place a formal system
that continually surveys the effectiveness of the quality philosophy of the company.
The quality assurance team thus audits the various departments and assists them in
meeting their responsibilities for producing a quality product.
2.3.1 Definition
Quality Assurance: all those planned or systematic actions necessary to provide confi-
dence that a product or service will satisfy given needs.
Quality assurance may be conducted, for example, at the product design level by
surveying the procedures used in design. An audit may be carried out to determine the
type of information that should be generated in the marketing department for use in
designing the product.
If any discrepancies are found, the quality assurance team will then advise the
department in question of the changes that should be adopted. This function acts as a
watchdog over the whole system.
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2.4.1 Employees
2.4.2 The Organization
2.4.3 Suppliers
2.4.4 Community
2.4.1 Employees
High quality products and services sometimes demand higher prices, which can result
in higher wages. Well-documented quality systems and processes make the em-
ployee's job easier and less frustrating, reduce errors, and allow employees to grow
because they are given ready access to the information they need to acquire the skills
and knowledge to succeed
Employees benefit from the positive organizational culture that exists in a high-
quality organization. The reputation, prestige, and image of a high-quality
organization make it easier to recruit new employees and play an important part in
employee job satisfaction. Satisfied employees are less likely to want to move onto
other organization.
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Quality benefits the organization because it represents the productive and profitable
use of the organization's resources. Processes that generate high-quality products and
services result in lower cost from repair, re-work and warranty actions. High quality
can lead to repeat orders from current customer and it often enables and organizations
to win an enhanced reputation and additional orders in the market.
When there is a lack of quality it can not only result in losing the current order but
also damage the supplier's reputation and result in loss of future orders. It's widely
believed that one unsatisfied customer will tell at least 20 other people how poor your
organization's product or service is, and the loss of future orders could be substantial.
The lack of a quality system can create the need for extensive re-reduce the
productivity of the system. When components are scrapped or services have to be
repeated, it is not only the time and material cost that is lost but about the cost of all
the work done on the product or service (the added value) up to the point at which it is
scrapped. Poor quality costs money. Good quality may cost money, too, but in most
cases the costs of poor quality exceed those of good quality.
2.4.3 Customers
Customer satisfaction has been defined as meeting or exceeding the customers' re-
quirements for product and service features, price, timeliness, and performance.
Quality benefits the customer by increasing customer satisfaction. Fewer defects
mean that the customer will be more satisfied. Higher service quality will also make
the customer experience much more pleasant.
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Customers dealing with an organization that has a strong quality program will have
fewer complaints because they are being supplied a product or service from better-
trained staff following clearer processes and thus making fewer errors. As the
organization progressively reduces the time it is forced to devote to correcting
mistakes, it can turn to streamlining its processes to make them more cost-effective
and more customer-friendly. Customers will trust the organization more because they
know that it takes quality seriously and gives a better level of service.
2.4.4 Suppliers
Quality organizations work closely with their suppliers and share information to
ensure that the suppliers fully understand the organization's requirements and that the
organization knows the capabilities of their suppliers.
Suppliers' sales, marketing, and service personnel know what the organization needs
and can communicate with the appropriate personnel at their customers' facilities to
resolve potential problems before they become serious concerns.
Suppliers benefit from working with quality organizations because of the close
partnerships that the organizations and the suppliers establish to accomplish their
Mutual goals and Good supplier-organization partnership tends to have a common set
of characteristics, including:
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The individual communities in which high quality organizations operate share in the
benefits just mentioned. Successful employees, organizations, and suppliers are
taxpayers. They contribute to the community by stabilizing the economy. The quality,
productivity, and competitiveness of high-quality organizations directly affect the
viability of the communities they occupy.
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Design and development of a Quality Management System for a production plant
CHAPTER 03
Several methods have evolved to achieve, sustain and improve Quality; they are:
Quality Control
Quality Assurance
Quality Improvement
One view management as the management of success and other the elimination of
failure. They are both valid; each approaches the subject from a different angle.
We need Principles to help us determine the right things to do and understand why we
do what we do.
3.2.1 Definition
Customer Focus
Leadership
Involvement Of People
Process Approach
System Approach
Continual Improvement
Factual Approach
Mutually Beneficial Supply Relationship
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customers are not simply purchasers but any person or organization that receives a
product or service. Not-for-profit organizations therefore have customers. Customer
focus means putting your energy into satisfying customers and understanding that
profitability or avoidance of loss comes from satisfying customers. Profit is not the
reason for an organization's existence.
Management commitment
3.4 LEADERSHIP
“Leaders establish unity of purpose and direction for the organization. They should
create and maintain the internal environment in which people can become free
involve in achieving the organization’s object”.
Leaders exist at all levels in an organization; they are not simply the ones at the top.
Within every team there needs to be a leader - one who provides a role-model
consistent with the values of the organization. It is therefore vital that leaders measure
the right things. Without a good leader an organization will go where the tide takes it,
and as is so predictable with tides.
Leaders are responsible for the internal environment .If the workforce is unhappy, de-
motivated, dissatisfied, it is the fault of the leaders.
Planning
Internal communication
“The people at all levels are the essence of the organization and their full
involvement enable their abilities to be used for the organization’s benefit”.
Every person has knowledge and experience beyond the job he or she has been
assigned to perform. No one is limited in knowledge and experience to the current job
they do. This principle means that management should tap this source of knowledge,
encourage personnel to make a contribution and utilize their personal experience. It
also means that management should be open - not hide its discussions unless national
or business security could be threatened. Closed-door management leads to distrust
among the workforce. Managers should be seen to operate with integrity and this
means involving the people.
“A desired result is achieved more efficiently when related resources and activities
are managed as a process”.
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All work is a process because it takes inputs and converts these into outputs. In the
organizational sense, such processes add value to the input. Processes are therefore
dynamic-they cause things to happen.
That has a clearly defined purpose and objective that is based on the needs of
the interested parties
That are designed to achieve these objectives through tasks that use capable
human, physical and financial resources and information
That produces outputs that satisfy the interested parties
That measure review and continually improves process efficiency and
effectiveness
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Design and development of a Quality Management System for a production plant
The organization should be continually questioning its performance and seeking ways
to reduce variation, continually questioning their methods and seeking better ways of
doing things, continually questioning their targets and seeking new targets that
enhance the organization's capability.
Performance - methods - targets; three key areas where improvement is necessary for
organizations to achieve and sustain success.
Improvement processes.
Identifying improvements.
Facts are obtained from observations performed by qualified personnel using devices,
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the integrity of which is known. The factual approach to decision making leads us to
take certain actions. To make decisions on the basis of facts, we need reliable
mechanisms for collecting facts such measurement systems. We need valid methods
for interpreting the facts and producing information in a form that enables sound
decisions to be made.
The factual approach leads us to control activities based on fact rather than opinion or
emotion. It means using statistical techniques to reveal information about a process,
rather than reacting to variation that is an inherent characteristic of the system.
The factual approach principle can be achieved through the following requirements
are addressed:
“An organization and its suppliers are inter-dependent and a mutually beneficial
relationship enhances the ability of both to create value”.
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Control of Suppliers
Evaluation of Suppliers
In validating decisions
Where in the process are the facts collected and transmitted to the
decision makers??
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CHAPTER 04
The company assigned to us is SuperTech Auto Parts (Pvt.) Ltd (STAPL) located in
North Karachi industrial Area.
The production facilities are semi- automatic, with manual material handling methods.
The workforce present is about 200+ workers. The working hours are usually two- 8
hrs shifts, but unexpected increase in demand causes three shifts to be worked.
4.2 PRODUCTS
Motorcycle Rims
Motorcycle Handlebars
Motorcycle Mufflers
4.3 CUSTOMERS
Along with these they also have customers in the locally based motorcycle
manufacturers which include:
Pak Hero, Memon Motorcycles, Sohrab Motorcycles, Star Motorcycles & etc.
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SECTION B
DESIGN OF QMS
Chapter 5:
USING ISO 9000 QMS Requirements at
STAPL
ISO 9000 quality system standards should not be confused with the
product standards. Most organizations, new to the concepts of quality
systems and in particular the ISO 9000 series of standards, confuse Chapter 6:
product quality with the concept of quality management What is ISO 9000?
Chapter 7:
ISO 9001:2000
Standard
Chapter 8:
Gap Analysis
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CHAPTER 05
However, the current ISO Standard revision (i.e. 2002) has specialized the standard
for their type of product or function, therefore the ISO 9000:2000 Standard will be
certified as ISO / TS 16949:2002 that is the ISO Quality Management Systems
Standard for Automobile Manufacturers and Vendors.
The core requirements of ISO / TS 16949:2002 are the same as the original ISO 9000
requirements along with some special mandatory requirements such as the FMEA
(Failure Mode and Effect Analysis) tool, Process Capability analysis and more.
Since, we could not obtain the ISO / TS 16949:2002 Standard or it’s Manual
therefore; our project scope was confined to ISO 9001:2000 Standard which was
available in our Reference Library [David Hoyle, 2001]
The STAPL Management is itself willing to obtain a certification from ISO for their
QMS, therefore, our group aligned with their team towards an ISO QMS.
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FUTURE PLAN
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CHAPTER 06
6.1 INTRODUCTION
ISO 9000 is a family of Standards which lay down the requirements of a quality
system for organizations. They deal with the quality management systems used by
organizations for the design, production, delivery, and support of their products. A
quality system, on its own, will not automatically lead to improvement of work
processes or product quality. It is a systematic approach to control the quality of a
business.
ISO 9000 quality system standards should not be confused with the product
standards. Most organizations, new to the concepts of quality systems and in
particular the ISO 9000 series of standards, confuse product quality with the concept
of quality management. In fact, these are complementary to the technical
specifications, standards, or regulations applicable to the organization's product.
After their release by the International Organization for Standardization for the first
time in 1987, these standards have rapidly gained importance in the world trade.
These standards serve the three market segments:
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The ISO 9000, generally denoted, is in fact a series of Standards. These are basically
of two types:
ISO 9001
ISO 9002
ISO 9003
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It includes:
ISO 9000-3: Guidelines for Software development and Supply, interpret a quality
system for the software industry
ISO 9004-3: Guidelines for processed material such as Steel Mill, Canned Milk
etc
ISO 10011: Guidelines for Auditing Quality System. It is further classified into:
ISO 10011-1
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ISO 10011-2
ISO 10011-3
ISO 9000 requirements can lead to achievement of the primary quality goals. It is a
short term quality improvement tool with clear classifications of actions and
definitions of requirements. These standards are useful, especially to organizations in
the developing countries, including Pakistan, where insufficient or lack of quality
system is the problem of majority of organizations. With the certification of this
system, there are now better opportunities for companies to compete internationally. It
has become a world-wide quality movement which, had it not had a good impact on
companies policies and strategies, would have faded away a long time ago. The key
benefits are:
1. The Quality Control extends from the room of the QC Departments to company-
wide quality management. Involvement of every department and every level, from top
management to workshop level is necessary.
2. A strong foundation of quality is laid down in the organization for up-grading the
businesses to world-class level.
3. World-wide recognition is achieved. Presently about 80 countries have officially
adopted these standards into their national standards. Due to increased customer
confidence, many buyers and customers give more values to the ISO certified firms.
Increase in exports and sales have been indicated by many certified firms.
4. Improvement in company-wide performance.
5. Achievement and maintenance of product and service quality.
6. Better consistency in production and work.
7. Opportunity to compete on the same basis with larger Organizations.
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With all the benefits, there are a number of Vulnerabilities and Difficulties with ISO
9000 Certification. It is important to recognize and deal with them while
implementing. They are:
1. Non-Prescriptive Characteristics:
The standards do not provide solutions on how to work. They only lay down the
requirements to be met and achieved. This means that they only suggest the end
results to achieve through various activities. The Company implementing the
Standards will have to develop procedures themselves, which suits to their particular
situations. For certification, the quality auditors verify whether the requirements
are met. Thus, the effectiveness may differ from company to company. For the new
comers, this always poses a problem. They remain confused until they themselves
learn and evolve the subsystems. For example, the use of statistical techniques is one
of its requirements. However, what statistical tool to use and how to use them, is not
given in the standard. Similarly, there are a number of requirements which
require certain know-how and capability, to be learned while implementing the
system.
2. Manufacturing Bias:
The QA models are written in the Manufacturing environment. Although ISO 9004-2
provides guideline for services, its transformation into service environment and
terminology is still quiet difficult and confusing for many organizations. Its
acceptance in the service sector is therefore slow.
3. General Approach:
The approach of the standards is very general. People demand modularized approach,
where the modules are tailored and sequenced to meet the objectives of a particular
organization or business sector. No interpretation in different business sectors is
available.
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4. SMEs:
1. Lack of availability of management staff who are literate to carry out the
documentation.
2. Minimal available resources.
3. Costs involved in setting up and maintaining the system.
4. Difficulty in understanding and applying the standards.
5. Documentation:
6. Training:
Various technical and system training are the requirements of these standards. Again,
managers may not be good as trainers. Therefore, the trainer’s capabilities are to be
developed during the system implementation.
7. Vendors:
Companies with large numbers of vendors, especially at distant places, often find it
difficult to carry out a complete control of vendors. With particular reference to
Pakistan, common shortages of materials from the market have a lot of associated
difficulties to maintain the requirements of the standards.
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1. Management Awareness: The starting point is knowing the standards and its
requirements. The management should facilitate its learning through formal training
programs.
2. Top Management Commitment: If decided to implement, then a strong
commitment, push and involvement of top management is desired. Otherwise the
program generally fails or is prolonged considerably.
3. Project Team: Appoint a project team for ISO 9000, composed of senior
management from every function or department. This should be headed by the chief
executive.
4. Prepare Documentation: Assign writing and compiling of documents to
management. Identify the present documentation and the ISO 9000 requirements.
Write the quality manual, departmental and quality procedures and work instructions
mentioned in the standards. Departmental heads should review, approve and finalize
these quality procedures.
5. Company-wide Training: The project team should develop a training program for
all the levels and departments. Before installing the quality procedures, relevant
people need to know them. Each departmental head should execute this training
program using his managers and engineers.
6. Implementation: Release each procedure to concerned persons and demand its
implementation.
7. Internal Audits: Initiate internal quality audits, which is one of the requirements
of the standard. The internal auditors should be formally trained on quality audits.
References should be obtained from formal training programs and ISO 10011.
Corrective actions should be taken based on the audit reports.
8. Pre-audit: After satisfactory performance is observed, a company may go for a
pre-audit, if required.
9. Actual Audit: On satisfactory completion and corrections of any non-compliance,
the company should make arrangements with the certification agency for an audit.
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The International Organization for Standardization does not itself certify companies.
There are nationally accredited certification agencies in different countries who offer
certification schemes. There are about more than 220 such bodies presently operating
world-wide. An organization is free to choose any certification agency they want to,
depending upon cost consideration, reputation, and markets.
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CHAPTER 07
The organization shall determine what it needs to do to satisfy its customer, establish
a system to accomplish its objectives and measures, review and continually improve
its performance.
Determine the needs and expectations of customer and other interested parties;
The ISO 9001 standard specifies quality system requirements for use when a contract
between two parties requires the demonstration of a vendor's capability to design and
supply the product or service. The standard is aimed at preventing nonconformity at
all stages from design to servicing (reinforcing the notion that quality assurance
efforts should be directed toward defect prevention rather than defect detection).
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The Standard requires that the vendor describe its management responsibilities in all
aspects of the vendor's quality system. The vendor's management should define a
policy that documents goals and objectives for attaining quality. In creating an
organizational structure for a quality system, the responsibilities, distribution of
authority, and interrelationship of all employees who manage, perform, and verify
work affecting quality must be defined. The vendor should provide adequate
resources for such verification activities as inspection, testing, monitoring of the
design, production, installation, and servicing of the process and/or product. The
employees responsible for design reviews and audits of the quality system must be
distinct from those having direct responsibility for the work performed. The vendor's
management should conduct reviews at appropriate intervals to ensure the
effectiveness of the quality system.
Acceptability
Measurement Procedures
Design compatibility
Production processes
Installation
Inspection
Test Procedures
Quality Manual
Record keeping
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An important section of the standard deals with design control. Here the vendor is
expected to establish and maintain procedures to control and verify the design to en-
sure that the requirements are met. To achieve this control, the vendor should draw up
plans that identify responsibilities for each design activity. Design input requirements
should be reviewed, as should design output. The output is expected to meet the de-
sign input requirements, conform to appropriate regulatory requirements, and identify
those characteristics of the design that are crucial to the safe and proper functioning of
the product.
The Standard requires the vendor to ensure that the products the vendor purchases
conform to the requirements. Selection of subcontractors should be based on their
ability to meet contractual requirements, as demonstrated through past performance.
Purchasing documents should contain data describing the product ordered, the type
(or other form of identification), the requirements for approval or qualification of
product, the procedures, the process equipment, and the personnel. The purchaser or
purchaser's representative should be given the right to verify the purchased product at
the source or upon receipt of the product. Such verification, however, cannot be used
by the vendor as evidence of effective quality control for the subcontractors.
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The Vendor is expected to establish and maintain procedures for identifying the
product from applicable drawings or other documents during all stages of production,
delivery, and installation. If traceability is a requirement, an individual product or
batch should have a unique identification.
Guidelines for process control are laid out in the Standard. They require the vendor to
identify and plan production, and installation processes and to operate them under
controlled conditions. The control section requires documenting work instructions that
define the process and its installation in addition to monitoring suitable product and
process characteristics. Product and process control should be monitored continuously
to ensure that specified requirements are met.
Product verification through inspection and testing may involve in-process as well as
final inspection. The vendor should ensure that the incoming product conforms to
requirements. The amount and nature of receiving inspection will be influenced by the
control exercised at the source and by documented evidence of quality conformance.
In-process product conformance can be verified by process monitoring and control
methods. Nonconforming products should be identified. Final inspection and testing
should be conducted according to the quality plan, and documented procedures and
appropriate records should be maintained.
Measuring and test Equipment should be appropriate to the task and should be
carefully calibrated: this is the responsibility of the vendor. Inspection, measuring,
and test equipment should be capable of achieving the required accuracy and
precision. The environmental conditions under which calibrations, inspections, and
measurements are carried out should be adequate. Furthermore, handling,
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preservation, and storage of such test equipment should be such that the accuracy and
fitness for use are maintained.
The Standard requires that products should be inspected and tested to indicate
conformance or non-conformance. These procedures must be maintained throughout
production and installation to ensure the delivery of conforming products only. Con-
trol of nonconforming products should be established by the vendor through identifi-
cation, documentation, evaluation, segregation (or disposal), and notification of the
relevant departments. Nonconforming products should be examined to determine
whether they should be reworked, regarded for alternative applications, or rejected.
An important feature of the standard makes the vendor responsible for establishing
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The Vendor is responsible for establishing and maintaining procedures that identify
the training needs and for providing training to all personnel who perform activities
that affect quality. Task assignments should be based on such qualifications as
appropriate education, training, and experience, as required. Appropriate records of
training activities should be maintained.
7.3.17 Servicing
In the event that servicing is specified in the contract, the vendor should establish and
maintain procedures tor performing and verifying that servicing meets the specified
requirements.
The vendor should establish procedures for identifying adequate statistical techniques
to verify the acceptability and product characteristics.
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CHAPTER#08
GAP ANALYSIS
8.1 INTRODUCTION
Gap Analysis is one of the most important techniques develop for the ISO 9000
Implementation Project Monitoring & Control. It must be modified according to the
company’s specific requirements and needs. It should be updated every month to
monitor the implementation of ISO 9000. This is one of the most powerful tools to
assign activities and then monitor their product.
Initially it serves as a Gap Analysis of the Company’s present situation to the ISO
9000’s requirements. Later on, it should be used as the Project Monitoring Tool.
provision
4.1f Implement
5.6 Management System needs to be
actions to review developed.
achieve planned
7.3.7 Control of design
results and development
changes
8.1 General
8.2.3 Monitoring and
measurement of
processes
8.5.1 Continual
improvement
8.5.2 Corrective
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action
8.5.3 Preventive
action
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SECTION C
DOCUMENTATION
Chapter 9:
AT STAPL Scope
Chapter 12:
The Level Three
Documentation
Chapter 13:
The Level Four
Documentation
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CHAPTER 09
SCOPE
The Gap Analysis revealed an initial line of action. Our Group with consulting our
Project Internal Advisors prepared an outline of this huge task. Thus, a large Project
was segmented into sub-sections.
The initial concern was regarding documentation and refinement of the procedures
practice at STAPL. Some of the requirements were also identified missing.
The detail of the prepared documentation by the Project Group is explained in the
following Chapters. The figure below shows the level-wise requirements of
documentation.
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CHAPTER 10
Clause 4.2.3
Clause 4.2.4
The purpose of this manual is to provide the General Policy Guidelines on all the
activities that have been taken place in SuperTech Autoparts (Pvt) Ltd. relating to ISO
Quality Management System development and implementation.
This is a First Level document and this manual describes and refers to other
supporting documents that describe procedures and formats.
The standard requires a manual to be established and maintained that includes the
scope of the QMS, the documented procedures or reference to them and a description
of their sequence and interaction of processes included in the quality management
system.
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When formulating the Policies, objectives and identifying the processes to achieve
them, the manual provides a convenient vehicle for containing such information. If
left as separate pieces of information, it may be more difficult to see the linkages.
The requirement provides the framework for the manual. Its content may therefore
include the following:
1. Introduction:
2. Business Overview:
3. Organization:
a. Function descriptions
b. Organization chart
c. Locations with scope of activity
4. Business Processes:
a. The system model showing the key business processes and how they are
interconnected
b. System performance indicators and method of measurement
c. Business planning process description
d. Resource management process description
e. Marketing process description
f. Product/service generation processes description
g. Sales process description
h. Order fulfillment process description
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A template of the Quality Manual prepared by the Group is included in the Appendix.
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CHAPTER 11
The Level Two documentation hierarchy defined, requires the system procedures to
be defined and documented. The Quality System Procedures are the second level
Quality System documents, which contain a detailed description of how Quality
system requirements have been addressed and implemented in various departments of
the SuperTech Autoparts (Pvt.) Ltd. The Quality System Procedures serves as an
operational guide for all the concerned staff to ensure that operations are carried out in
a controlled and systematic manner as per Quality System requirements. Controlled
copies of Quality System Procedures are distributed to all the concerned persons in
the controlled distribution list, given on the first pages of the each procedure.
The QSPs prepared at STAPL cover all the necessary functions of STAPL.
Management Review
Control of Documents & Records
Internal Audit
Control of Nonconforming Product
Improvement
Internal Communication
Infrastructure & Work Environment
Human Resource Management
Purchasing
Maintenance
Production & Service Provision
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The Group members were advised by the team at STAPL to focus on only a few of
the procedures, due to the immense shortage of time and expertise regarding the
management practices at STAPL. Our group tried to focus on the procedures as in
their possible capacity;
Management Review
Improvement
Internal Communication
Analysis of Data
The proposed draft of the prepared procedure describes the procedure of reviewing
the management of STAPL. The proposal suggest building a Quality Management
Review Committee. This committee is responsible for monitoring and control of
QMS at STAPL. The committee organizes meetings on a defined frequency and
schedule to coordinate and communicate the status of the QMS.
The proposed draft of the prepared procedure describes the procedure for
controlling documents and records. The proposal suggests that Quality
Management Representative (QMR) monitoring the control of documents and
records activities. Moreover QMR maintains a master list of documents and
records and conducts the reviewing procedure as defined in the procedure.
Also the procedure addresses the departmental heads for preparing documents
and controlling documents and the amendment procedure in documents and
records.
The proposed draft of the prepared procedure describes the procedure for controlling
nonconforming products. The procedure suggests the use of Defect Analysis &
Counter Measure Form (DCAR). The Non-conforming product is identified,
segregated reworked or repaired and then re-inspected. The product unable to repair is
scrapped. The DCAR documentation helps the traceability and analysis and
minimization of non-conforming product.
The proposed draft of the prepared procedure describes the procedure improvement in
the system. The procedure suggests the use the Corrective Preventive Action Request
(CPAR) Form to identify and minimize any Non-conforming condition. The
procedure encourages suggestions by the personnel at STAPL through a proper
channel to allow continual improvements.
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The proposed draft of the prepared procedure describes the procedure for internal
communication in the system. The procedure suggests a general method to
communicate among various departments and sections in STAPL
The proposed draft suggests the procedure for producing the product. It also includes
allocation of the resources needed for the smooth production and meeting the sales
targets, preparing Training Manuals for training of workforce, implementation of WIs
on shop floor, utilization of all machines and equipments, conducting continuous
monitoring for ensuring that product is continuously meeting the specified criteria.
The proposed draft suggests the procedure for monitoring & measurement of product
& processes being done & its proper documentation. The procedure suggests
inspection plans and calibration records to be maintained and practiced.
The proposed draft suggests the procedure for collecting data, performing analysis to
that data, and addressing the possible necessary steps in the light of the results of the
those analysis. The procedure defines a few of the tools that can be used at the
STAPL. The procedure refers to the Manual for Measurement and Statistical Analysis
(MSA).
The proposed draft suggests the procedure for Quality Control / Assurance
departments of STAPL whose function is covered in all the inspection and
testing activities related to monitoring and measurement of products and
processes.
All of these Quality System Procedures were submitted as proposals to the STAPL
management. These procedures were prepared under the supervision of the STAPL
team.
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A copy of the prepare proposal is submitted along with the final year project report.
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CHAPTER 12
Clause 7.5.1b
The standard requires the organization to control production and service provision
through the availability of work instructions where necessary.
Clause 7.5.1c
The standard requires the organization to control production and service provision
through the use of suitable equipment.
The Standard Operating Procedure, Work Instructions are third level Quality System
Documents, which contain instructions for individuals to perform routine tasks or
specific functions. The Standard Operating Procedures / Work Instructions are then
distributed and, where required, displayed at the related workplace to ensure that the
activities are performed as per instructions. QMR maintains the distribution status of
Standard Operating Procedure and Work Instructions on the Document Distribution
Sheets.
The Group members conducted on-floor study along with the Management Level
personnel to prepare these Work Instructions and Training Manuals.
These documents were prepared by the members as possible in the time availability.
The areas covered were as much possible.
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A template of the Work Instructions, Job Descriptions and Training Manual is given
in the Appendix.
The prepared documents are submitted along with the project report.
As mentioned in the Clause of 7.5.1a and 7.5.1d and 7.5.1e of ISO 9001:2000
The standard requires the organization to control production and service provision
through the availability and use of measuring and monitoring devices.
The standard requires the organization to control production and service provision
through the implementation of monitoring and measurement.
Control Plan and FMEA is also a Third Level Product-specific Quality System
Document that describes all the control parameters of various operations or processes
to be carried out during the production or realization of product and specifies what
Quality requirements to be met to ensure compliance with customer requirements.
Although the ISO 9000 requirements do not mention FMEA, but recent developments
in the ISO in a refined manner for TS 16949:2002 standard does mention the
requirement of FMEA ( or comparable tool) as mandatory.
The Group members conducted on-floor study along with the Management Level
personnel to prepare these Control Plans and FMEA charts.
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Process Plan. These two documents were combined to prepare a single document to
serve the same purpose.
The Control Plans prepared by the group have the following features and contents;
1. The formatting scheme and template as defined in the Procedure for Control of
Documents
2. Document Title
3. Document / Control Plan no.
4. Revision No. and Date
5. Page No.
6. Process Flow Chart
7. Process Number
8. Process Name
9. Machine / Device / Tool for Manufacturing
10. Product
11. Process Parameter
12. Parameter Specifications
13. Evaluation / Measurement Technique
14. Sample Frequency and Size
15. Control Method (Document Ref.)
16. Rejection Plan (Document Ref.)
12.2.2 FMEA Framework
A FMEA along with control charts fills the requirement of a documented procedure
for control and preventive action for producing a product.
The FMEA charts prepared by the group have the following features and contents;
1. The formatting scheme and template as defined in the Procedure for Control of
Documents
2. Document Title
3. Document / Control Plan no.
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A template of the proposed Control Chart format and FMEA sheet is given in the
Appendix.
The prepared documents are submitted along with the project report.
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CHAPTER 13
These are fourth level Quality System Documents, which include reports, forms, log
sheets and other reports generated while performing routine activities.
A number of related forms, and their templates were suggested. Some of them are
supporting documents for the procedures. However other common forms are also
attached in the appendix as templates.
A few of complete forms prepared by the group are also submitted along with the
project report which include;
The control charts were prepared as initial samples for future reference. The data was
collected by the group members under the supervision of QC officers at the
manufacturing area. The control chart calculations are based on the template for
Control Chart for Variable Data. The template made by ASQ is available on the
official web site of American Society of Quality (www.asq.org/about%20control%20
chart%20.htm).
The control charts sheet prepared, contains the readings column along with the
heading format as described in the QSP for Control of Documents. The related
calculations and details about control charts are described in the Manual for
Measurement and Statistical Analysis (MSA).
The capability analysis of processes was done on the same readings for which the
control charts were prepared. They also served the same purpose as the control charts
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Chapter 16:
Zero Defect
RECOMMENDATIONS
Chapter 17:
Deming’s 14-Points for
Management
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CHAPTER 14
LEAN PRODUCTION
Lean Production is a term that embraces many of the topics, such as flexible
manufacturing, minimizing work-in-process, "pull" systems of production control,
and setup time reduction. The term itself was coined by MIT researchers to describe
the collection of efficiency improvements that Toyota Motors undertook to survive in
the Japanese automobile business after World War II. Because of its origins at Toyota
Motors, the same collection of improvements has also been called the "Toyota
production system"
14.1 DEFINITION
"More and more with less and less-less human effort, less equipment, less time, and
less space-while coming closer and closer to providing customers with exactly what
they want"
1. Minimize waste
2. Perfect first-time quality
3. Flexible production lines
4. Continuous Improvement
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All four principles of lean production are derived from the first principle: minimize
waste.
The various procedures used in the Toyota plants were developed to minimize these
forms of waste. lean principle 2 (perfect first-time quality), discussed next, is directed
at eliminating production of defective parts (waste form l).The just-in-time production
system was intended to produce no more than the minimum number of parts needed at
the next workstation (waste form 2). This reduced unnecessary inventories (waste
form 3). And so on…
In the area of Quality, the comparison between mass production and lean production
provides a sharp contrast. In mass production, quality control is defined in terms of an
acceptable quality level or AQL. This means that a certain level of fraction defects is
sufficient, even satisfactory. In lean production, by contrast, perfect quality is
required. The just-in-time delivery discipline used in lean production necessitates a
zero defects level in parts quality, because if the part delivered to the downstream
workstation is defective, production stops.
inventory buffers are used just in case these quality problems occur. The defective
work units are simply taken off the line and replaced with acceptable units. However,
the problem is that such a policy tends to perpetuate the cause of the poor quality.
Therefore, defective parts continue to be produced. In lean production, a single defect
draws attention to the quality problem, forcing corrective action and a permanent
solution. Workers inspect their own production, minimizing the delivery of defects to
the downstream production station.
Minimum waste
Inventory buffers
Minimum inventory
Just-in-case deliveries
Perfect first-time quality
Acceptable quality level (AQL)
Worker teams
Taylorism
Worker involvement
Maximum efficiency
Flexible production systems
Continuous improvement
If it ain't broke, don't fix it
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production' plants received many more hours of training than their U.S. counterparts
(380 hours of training vs. 46 hours). Another finding was the lower number of job
classifications in Japanese lean plants. The study showed an average of 11.9 job
classifications in Japanese plants versus an average of 67.1 in U.S. plants. Fewer job
classifications mean more cross-training among workers and greater flexibility in the
work force.
In Mass Production, the goal is to maximize efficiency. This is achieved using long
production runs of identical parts. Long production runs tolerate long setup
changeovers. In lean production, procedures are designed to speed the changeover.
Reduced setup times allow for smaller batch sizes, thus providing the production
system with greater flexibility. Flexible production systems were needed in Toyota's
comeback period because of the much smaller car market in Japan and the need to be
as efficient as possible.
Cost Reduction
Quality Improvement
Productivity Improvement
Setup-time Reduction
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CHAPTER 15
SIX-SIGMA QUALITY
15.1 INTRODUCTION
While a company may be striving toward an ultimate goal of zero defects, numerical
standards for performance measurement should be avoided. Setting numerical values
that may or may not be achievable can have an unintended negative emotional impact.
Not meeting the standard, even though the company is making significant progress,
can be demoralizing for everyone. Numerical goals also shift the emphasis to the short
term; as long-term benefits are sacrificed for short-term gains.
By making Continuous Improvement the goal and then measuring the trend (not the
numbers) in improvement. This is also motivational. Another effective method is
benchmarking; this involves identifying high-performance companies or intra
company departments and using their performance as the improvement goal. The idea
is that, although the goals may be difficult to achieve, others have shown it can be
done.
Quantitative goals do have their place, however, as Motorola, Inc. has shown with its
concept of Six-Sigma Quality.
Sigma (σ) stands for the standard deviation, which is a measure of variation in the
process Assuming that the process output is represented by a normal distribution,
about 99.73% of the output is contained within bounds that are 3 standard deviations
(3σ) from the mean. These are represented as the Lower and Upper Tolerance Limits
(LTL and UTL). The normal distribution is characterized by two parameters: the mean
and the standard deviation. The mean is a measure of the location of the process.
Now, if the product specification limits are 3 standard deviations from the mean, the
proportion of non-conforming product is about 0.27% which is approximately 2700
parts per million (ppm); that is, the two tails, each 1350 ppm, add to 2700 ppm.
On the surface, this appears to be a good process, but appearances can be deceiving.
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When we realize that most products and services consist of numerous processes or
operations, reality begins to dawn. Even though a single operation may yield 97.73%
good parts, the compounding effect of out-of-tolerance parts will have marked
influence oil the quality level of the finished product. For instance, for a product that
contains 1000 parts or has 1000 operations, an average of 2.7 defects per product unit
is expected. The probability that a product contains no defective parts is only 6.72%
This means that only about 7 units in 100 will go through the entire manufacturing
process without a defect—not a desirable situation.
In real-world situations, the process distribution will not always be centered between
the specification limits; process shifts to the right or left are not uncommon. It can be
shown that even if the process means shifts by as much as 1.5 standard deviations
from the center, the proportion nonconforming will be about 3.4 ppm. Comparing this
to a three-sigma capability of 2700 ppm demonstrates the improvement in the
expected level of quality from the process.
If we consider the previous example for a product containing 1000 parts and we
design it for six-sigma capability, then an average of 0.0034 defect per product unit
(3.4 ppm) is expected, instead of the 2.7 defects expected with three-sigma capability.
The cumulative yield from the process will thus be about 99.66%—a vast
improvement over the 6.72% yield in the three-sigma case.
15.4 CONCLUSION
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CHAPTER 16
ZERO DEFECT
16.1 INTRODUCTION
Quality defects have significant costs associated with them - some of the most
obvious being money, time, resources, and lost reputation. Programs to eliminate
quality defects can be expensive and time consuming.
One of the most influential ideas about this was the notion of "Zero Defects". This
phrase was coined by Philip Crosby in his 1979 book titled, "Quality is Free."
His position was that where there are zero defects, there are no costs associated with
issues of poor quality; and hence, quality becomes free.
Zero defects is a way of thinking and doing that reinforces the notion that defects are
not acceptable, and that everyone should "do things right the first time". The idea here
is that with a philosophy of zero defects, you can increase profits both by eliminating
the cost of failure and increasing revenues through increased customer satisfaction.
The question that often comes up when zero defects is discussed, is whether or not
zero defects is ever attainable. Essentially, does adopting a zero defect environment
only set users up for failure??
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Zero defects is NOT about being perfect. Zero defects is about changing your
perspective. It does this by demanding that you:
Work proactively to address the flaws in your systems and processes, which
allow defects to occur
Zero defects is a standard. It is a measure against which any system, process, action,
or outcome can be analyzed. When zero defects is the goal, every aspect of the
business is subject to scrutiny in terms of whether it measures up.
"The quality manager must be clear, right from the start, that zero defects is not a
motivation program. Its purpose is to communicate to all employees the literal
meaning of the words 'zero defects' and the thought that everyone should do things
right the first time."
There are no step-by-step instructions for achieving zero defects, and there is no
magic combination of elements that will result in them. There are, however, some
guidelines and techniques to use:
Management must commit to zero defects. Zero defects requires a top down
approach: The best-intentioned employees cannot provide zero defects if they
are not given the tools to do so.
When you decide that zero defects is the approach you want to take, recognize
that it likely represents a significant change to the way people do things.
Manage the introduction using the principles of change management.
Zero defects require a proactive approach. If you wait for flaws to emerge you
are too late.
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Create quality improvement teams. Zero defects must be integrated with the
corporate culture. Zero defects needs to be accepted as "the ways things are
done around here".
Monitor your progress. Build mechanisms into your systems and methods of
operating that provide continuous feedback. This allows you act quickly when
flaws do occur.
[http://www.mindtools.com/zero_defect/htm]
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CHAPTER 17
17.1 INTRODUCTION
17.2 14-POINTS
1. Create and publish to all employees a statement of the aims and purposes
of the company or other organization. The management must demonstrate
constantly their commitment to this statement
4. End the practice of awarding business on the basis of price tag alone
6. Institute training
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COMPENDIUM
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CHAPTER 18
SUMMARY
18.1 INTRODUCTION
The project assigned to the group is titled as: “to design and develop a Quality
Management System for a production plant”.
The scope of the project requires that a Quality Management System is to be provided
to a production plant.
The Quality of a product or services is the fitness of that product or service for
meeting or exceeding its intended use as required by the customer. The elements
which define the intended quality level of a product or service are known as quality
characteristics, which can be categorized in these groupings: Structural
characteristics, Sensory characteristics, Time-oriented characteristics, Ethical
characteristics .Quality characteristics fall into two broad classes, namely: Variables,
Attributes. A defect is associated with a quality characteristic that does not meet
certain standard. A standard, or specification, refers to a precise statement that
formalizes the requirements of-the customer; it may relate to a product, a process, or
n service Three aspects are usually associated with the definition of quality: Quality
of Design, Quality of Conformance, and Quality of Performance. Quality Control may
generally be defined as a system that is used to maintain a desired level of quality in a
product or service. This general area may be divided into three main sub areas,
namely Off-line quality control, Statistical process control, Acceptance sampling
plans. The objective of the quality assurance function is to have in place a formal sys-
tem that continually surveys the effectiveness of the quality philosophy of the com-
pany. Quality affects all of the organization stakeholders.
Several methods have evolved to achieve, sustain and improve Quality; they are:
Quality Control Quality Assurance Quality Improvement. These methods collectively
are known as Quality Management. There are two schools of thought on Quality
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Design and development of a Quality Management System for a production plant
Management .One view management as the management of success and other the
elimination of failure. They are both valid; each approaches the subject from a
different angle. We need Principles to help us determine the right things to do and
understand why we do what we do. Eight principles have emerged as the fundamental
to the management of Quality. Customer Focus, Leadership, Involvement of
People, Process Approach, System Approach, Continual Improvement, Factual
Approach, Mutually Beneficial Supply Relationship. The customer focus principle
needs the following requirements to be addressed: Communication with the customer,
Care for customer property, the determination of customer needs and expectations,
Appointment of a management representative, Management commitment. The
leadership principle requires the following principle to be addressed. The setting of
objectives & policies, Planning, Internal communication, Creating an effective work
environment The involvement of people principle requires the following points to be
addressed: Participation in design reviews, Defining, objectives , responsibilities and
authority, Creating an environment in which people are motivated, Identifying
competence needs. The process approach principle requires the addressing of: The
identity of processes, Defining process inputs and outputs, Providing the
infrastructure & resources for processes to function. The system approach principle
requires: Establishing, implementing and maintaining the management system,
Interconnection, interrelation and sequence of processes, the links between processes,
establishing measurement processes. The Continual Improvement principle requires
an addressing of: Improvement processes, Identifying improvements, reviewing
documents and processes for opportunities for improvement. The factual approach
principle can be achieved through the following requirements are addressed: Reviews,
measurements and monitoring to obtain fact, Control of measuring devices, Analysis
to obtain facts from information, Records for documenting the facts, Approvals based
on facts. The mutually beneficial supplier relationships principle requires: Control of
Suppliers, Evaluation of Suppliers, and Analysis and Review of Supplier data. The
Principle can be used: In validating the design of processes, in validating decisions, in
auditing system and processes.
The company assigned to us is SuperTech Auto parts (Pvt.) Ltd (STAPL) located in
North Karachi industrial Area. Their biggest customers’ name includes: Honda
Motorcycles (Atlas Honda Pakistan), Yamaha Motorcycles (DYL Motorcycles
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ISO 9000 is a family of Standards which lay down the requirements of a quality
system for organizations. They deal with the quality management systems used by
organizations for the design, production, delivery, and support of their products.
These standards serve the three market segments: Implementing organization for
internal improvement, Government and regulatory activities for enhancing the overall
qualitative level of the country and for consumer, protection and, Customers and
registration bodies for external Quality Assurance purposes. The ISO 9000, generally
denoted, is in fact a series of Standards. These are basically of two types: Quality
Assurance Model, It includes following models: ISO 9001, ISO 9002, and ISO
9003.Quality Management Guidelines. It includes: ISO 9000-1, ISO 9000-2, ISO
9000-3, ISO 9000-4, ISO 9004-1, ISO 9004-2, ISO 9004-3, and ISO 9004-4. ISO
9000 requirements can lead to achievement of the primary quality goals. It is a short
term quality improvement tool with clear classifications of actions and definitions of
requirements. The International Organization for Standardization does not itself
certify companies. There are nationally accredited certification agencies in different
countries who offer certification schemes.
The basic requirement of ISO 9000:2001 is the organization shall determine what it
needs to do to satisfy its customer, establish a system to accomplish its objectives and
measures, review and continually improve its performance. The ISO 9001 standard
specifies quality system requirements for use when a contract between two parties
requires the demonstration of a vendor's capability to design and supply the product or
service. the feature include: Management Responsibilities, Documentation of a
Quality System, Contract Review, Design Control, Document Control, Purchasing
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Design and development of a Quality Management System for a production plant
Section, Identifying the Product, Process Control, Product verification ,Measuring and
Test Equipment, Control of Nonconforming Products, Corrective Action, Maintaining
Procedures for Postproduction Handling Functions ,Quality Records, Internal Quality
Audits, Training Needs, Servicing, Statistical Techniques.
Gap Analysis is one of the most important techniques develop for the ISO 9000
Implementation Project Monitoring & Control. It must be modified according to the
company’s specific requirements and needs. It should be updated every month to
monitor the implementation of ISO 9000. This is one of the most powerful tools to
assign activities and then monitor their product.
The Level one documentation includes the quality manual. The purpose of this
manual is to provide the General Policy Guidelines on all the activities that have been
taken place in SuperTech Autoparts (Pvt) Ltd. relating to ISO Quality Management
System development and implementation. This manual describes and refers to other
supporting documents that describe procedures and formats.
The level two documentation hierarchy defined, requires the system procedures to be
defined and documented. The Quality System Procedures are the second level Quality
System documents, which contain a detailed description of how Quality system
requirements have been addressed and implemented in various departments of the
SuperTech Autoparts (Pvt.) Ltd. The Quality System Procedures serves as an
operational guide for all the concerned staff to ensure that operations are carried out in
a controlled and systematic manner as per Quality System requirements. Controlled
copies of Quality System Procedures are distributed to all the concerned persons in
the controlled distribution list, given on the first pages of the each procedure.
The Level three documentation: Sop, Work Instructions, Control Plan & FMEA. The
Standard Operating Procedure, Work Instructions are third level Quality System
Documents, which contain instructions for individuals to perform routine tasks or
specific functions. The Standard Operating Procedures / Work Instructions are then
distributed and, where required, displayed at the related workplace to ensure that the
activities are performed as per instructions. QMR maintains the distribution status of
Standard Operating Procedure and Work Instructions on the Document Distribution
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The fourth level Quality System Documents include reports, forms, log sheets and
other reports generated while performing routine activities.
18.3 RECOMMENDATIONS
Lean Production is a term that embraces many of the topics, such as flexible
manufacturing, minimizing work-in-process, "pull" systems of production control,
and setup time reduction. Lean production is based on four principles: Continuous
Improvement, Minimize waste, Perfect first-time quality, Flexible production lines.
While a company may be striving toward an ultimate goal of zero defects, numerical
standards for performance measurement should be avoided. The performance can be
measured by making Continuous Improvement the goal and then measuring the trend
(not the numbers) in improvement. Sigma (σ) stands for the standard deviation, which
is a measure of variation in the process assuming that the process output is rep-
resented by a normal distribution; about 99.73% of the output is contained within
bounds that are 3 standard deviations (3σ) from the mean. For a product to be built
virtually defect-free, it must be designed to tolerance limits that are significantly more
than ±3σ from the mean. Motorola's answer to this problem is Six-Sigma Quality.
Quality defects have significant costs associated with them - some of the most
obvious being money, time, resources, and lost reputation. One of the most influential
ideas about this was the notion of "Zero Defects". This phrase was coined by Philip
Crosby in his 1979 book titled, "Quality is Free."His position was that where there are
zero defects, there are no costs associated with issues of poor quality; and hence,
quality becomes free. Zero defects is a way of thinking and doing that reinforces the
notion that defects are not acceptable, and that everyone should "do things right the
first time".
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so in Deming’s view, what must change is the fundamental style of management and
the corporate culture.
CHAPTER 19
CONSTRAINTS
As all Projects have hurdles in their path, therefore, so did this one. But mentioning
them is for the reason of helping those who sought to do the same in the future while
consulting this Project Report.
The Project Title had itself some puzzlement as designing a QMS requires many years
and expertise in its development. Moreover, it is much harder to get a self-designed
QMS much recognition and appreciation, when there is already an immense
competition in your design by an internationally recognized organization.
The Group initially took the Project task to design its own QMS based on a limited
amount of knowledge and expertise on the subject.
The Quality Management System initially strikes as, the application of Quality
Control and Decision tools but it is a much vast term as each and every function of an
Organization plays some part in the Quality of its product. Therefore, the quality
Management System cannot be limited to production or servicing environment of the
product.
The biggest constraint for the Project was time. Even though, the Group members
tried to put much more efforts and energy to this Project but time remained un-
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sufficient.
Another problem was that the Management of STAPL could not allow the Group
members to focus on a few areas of the Project.
Even with the shortage of time and co-operation by STAPL Management, the group
tried to cover as much levels of the Project. Thus, the Group members prepared
document on every level.
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REFERENCES
2. Richard E. DeVor, Statistical Quality Design & Control, ASTM Hand Book
3.Kamran Moosa and Imranullah Shariff, Practical Guide to ISO 9000 Quality
Management System, First Edition, Ibrahim Publishers & PIQC Pakistan, 1996, p 41-
4.John E. Bauer, Grace L. Duffy, and Russell T. Westcott, The Quality Improvement
Hand Book, Second Edition, American Society for Quality Publication, 2006, p 16-
25.
5.David Hoyle, ISO 9000 Quality Systems Hand Book, Second Edition
7. Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, Third
8.
WEBSITES:
1.
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APPENDIX
Clause Statement
S No
No.
4.1 Establishing a quality management system
4.1c Criteria and methods for the effective operation and control
15. 4.1 and Continual improvement in the quality management system and
4.1f its processes
The standard requires the quality manual to include the scope of the
17.
quality management system including details of justification for any
exclusion. (Pg.177)
22. The standard requires the documents be approved for adequacy prior
to issue. (Pg.184)
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37. The standard requires that top management ensure that quality
objectives are established. (Pg.232)
39. The standard requires that top management ensure the availability of
necessary resources. (Pg.235)
41. The standard requires customer requirements to be met with the aim
of enhancing customer satisfaction. (Pg.241)
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44. The standard requires the quality policy to provide a framework for
establishing reviewing quality objectives. (Pg.246)
46. The standard requires the quality policy to be reviewed for continuing
suitability. (Pg.250)
49. The standard requires top management to ensure that the planning of
the quality management system is performed to meet the quality
objectives and the requirement in clause 4.1.
(Pg.261)
5.4.2b Planning for change
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purpose of review
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6.3 Infrastructure
74. The standard requires the organization to identify and manage the
work environment needed to achieve conformity product.(Pg-336)
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This heading implies there are other requirements that do not relate to
the product that may form part of the customer requirements.
85. However, ISO 9000 defines a product as the result of a process and
includes services among these. It is therefore difficult to imagine any
aspect of customer requirements that would not relate to the product
or service that is being provided. Requirements related to the product
or service could include.
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7.2.2c Ensuring that the organization has the ability to meet defined
requirements
94.
The standard requires that the review ensure that the organization
has the ability to meet defined requirements.(Pg-389)
95. The standard requires the results of the review and actions as a
consequence of the review to be recorded (see 4.2.24).(Pg-390)
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115 The standard requires design inputs to be reviewed for adequacy and
. for the requirements to be complete, unambiguous and not in conflict
with other requirements.(Pg-419)
117 7.3.31 Ensuring that design output meets design input requirements
.
The standard requires that design and development output meets the
design and development input requirements.(Pg-423)
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120 The standard requires design and development output to define the
. characteristics of the product that are essential to its safe and proper
use.(Pg-425)
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The standard requires the type and extent of control applied to the
135
supplier and the purchased product to be dependent upon the effect
.
of the purchased product on subsequent product realization or the
final product.(Pg-451)
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Identifying product
151
The standard requires the organization to identify the product by
.
suitable means throughout product realization where appropriate.
(Pg-494)
152 The standard requires the organization to identify the status of the
. product with respect to measurement and monitoring requirements.
(Pg-496)
7.5.3 Traceability
153 The standard requires the organization to control and record the
. unique identification of the product, where traceability is a
requirement (see 5.5.7).(Pg-498)
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162 The standard requires the organization to identify the measuring and
. monitoring devices needed to provide evidence of conformity of
product determined requirements.(Pg-513)
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178 The standard requires the audit criteria, scope, frequency and method
. to be defined.(Pg.565)
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191
The standard requires the organization to ensure that product which
.
does not conform to product requirement is identified and controlled
to prevent unintended use or delivery and goes on to require the
control and related responsibilities for dealing with nonconforming
product to be defined in a documented procedure.(Pg.584)
198
The standard requires the organization to determine collect and
.
analyze appropriate data to demonstrate the suitability and
effectiveness of the quality management system including data
generated as a result of monitoring and measurement and from other
relevant sources. (Pg.595)
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Continual improvement:
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