Final Report

Design and development of a Quality Management System for a production plant
SECTION A
INTRODUCTION
Chapter 1:
Introduction to Project
Title
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 Chapter 2:
Introduction to Quality
Chapter 3:
Introduction to Quality
Management System
Chapter 4:
Introduction to the
Company
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CHAPTER 01
INTRODUCTION TO PROJECT TITLE
1.1 PROJECT TITLE
The project assigned to the group is titled as:
“Design and development of a Quality Management System for a production plant”.
1.2 ABOUT THE PROJECT TITLE
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.
1.3 SCOPE OF THE PROJECT
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 study and analyze the current Quality Management System of the

Company
 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.
 To focus on these identified Gaps in order to achieve an acceptable Quality

Management System.
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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
viii. Perceived Quality
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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.
2.1.2 Quality Characteristics
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.
Time-oriented characteristics include such measures as a warranty, reliability, and

maintainability.
Ethical characteristics include honesty, courtesy, friendliness.
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.
Attributes: a quality characteristic is said to be an attribute if it is classified as either

conforming or nonconforming to a stipulated specification. A quality characteristic
that cannot be measured on a numerical scale is expressed as an attribute.
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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):
“A defect is a departure of a quality characteristic from its intended level or

state that occurs with a severity sufficient to cause an associated product or
service not to satisfy intended normal or reasonably foreseeable usage
requirements”
2.1.3 Standard or Specification
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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2.1.3.1 Specification: A Definition Given By The U.S. National Bureau Of Standards

(1983) Is As Follows:
“ A set of conditions and requirements, of specific and limited application, that

provide a detailed description of the procedure, process, material, product, or
service for use primarily in procurement and manufacturing. Standards may be
referenced or included in a specification.”
2.1.3.2 Standard: The U.S. National Bureau Of Standards (1983) Defines A Standard
As Follows:
“ A prescribed set of conditions and requirements, of general or broad appli-

cation, established by authority or agreement, to be satisfied by a material,
product, process, procedure, convention, test method; and/or the physical,
functional, performance, or conformance characteristic thereof. A physical
embodiment of a unit of measurement (for example, an object such as the
standard kilogram or an apparatus such as the cesium beam clock)”
Acceptable bounds on individual quality characteristics are usually known as

specification limits, whereas the document that addresses the requirements of all the
quality characteristics is labeled the standard.
2.2 QUALITY CONTROL
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 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:
2.2.1 Off-line quality control
2.2.2 On-line quality control
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2.2.3 Acceptance sampling plans
2.2.1 Off-line Quality Control
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.
2.2.2 On-line Quality Control
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.
For e.g. to control paperwork errors in an administrative department, information

might lie gathered daily on the number of errors. If the observed number exceeds
some specified standard, then on identification of possible causes, action should be
taken to reduce the number of errors. This may involve training the administrative
staff, simplifying operations if the error is of an arithmetic nature, redesigning the
form, or other appropriate measures.
2.2.3 Acceptance Sampling Plans
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
2.3 QUALITY ASSURANCE
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
The ANSI/ASQC Standard A3 (1987) defines Quality Assurance as follows:
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.
[Amitava Mitra, 2004]
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2.4 BENEFITS OF QUALITY
Quality affects all of the organization stakeholders.
2.4.1 Employees
2.4.2 The Organization
2.4.3 Suppliers
2.4.4 Community
2.4.1 Employees
Quality benefits the employees involved in producing high-quality products and

services' by enhancing their feeling of accomplishment in knowing they have done
their jobs to the best of their abilities. It also strengthens the security of their position
by ensuring continued work to meet the demands of satisfied customer.
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
By participating in the development of the organization's processes, employees can

see their experience, skills, and ideas being put to use for the benefit of everyone in
the organization. Accurate, complete documentation reduces errors. And with instant
access, documentation allows unplanned problems to be dealt with quickly and safely.
Well-informed employees have less risk of on-the-job injuries.
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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2.4.2 The Organization
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.
A high-quality organization can focus on continuous improvement—assessing what's

happening in the organization and preventing bad product and service quality—rather
than just reacting to problems and cases of customer dissatisfaction. This proactive
style of management will result in a much more profitable organization. Then a style
that only reacts to problem. It greatly increases the probability of organization
survival.
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:
 Reduced cost of inspections
 Less-frequent customer audits
 Open sharing of organization and supplier quality information
 Frequent visits to both the organization's and the suppliers’ facilities to

ensure mutual understanding of each party's relative responsibilities
 Supplier shipments of materials directly to the organizations

production line for immediate use
 Decreased expenses from cost sharing
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 Reduced risk to the organization because of its ability to use the

suppliers knowledge and skills to improve its product or service
2.4.5 The Community
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.
Communities are very aware of the benefits of having high-quality organizations.

Many states and local government jurisdictions provide incentives, training and
consulting, for organizations to fully develop their potential and to assist employees.
[John E.Bauer, Grace L. Duffy, and Russell T. Westcott, 2006]
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CHAPTER 03
INTRODUCTION TO QUALITY MANAGEMENT SYSTEM
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.
3.1 QUALITY MANAGEMENT
There are two schools of thought on Quality 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.
3.1.1 The Success School
The success school is categorized by five questions:
1. What are you trying to do??

2. How do you make it happen??
3. How do you know its right??
4. How do you know it's the best way of doing it??
5. How do you know it's the right thing to do??
3.1.2 The Failure Elimination School
The failure elimination school is characterized by five different questions:
1. How do you know what is needed??

2. What could affect your ability to do it right??
3. What checks are made to verify achievement??
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4. How do you ensure the integrity of these checks??

5. What action is taken to prevent a recurrence of failure?
3.2 QUALITY MANAGEMENT PRINCIPLES
We need Principles to help us determine the right things to do and understand why we
do what we do.
3.2.1 Definition
ISO/TC 176 defined principle as:
“A comprehensive and fundamental rule or belief, for leading and operating an

organization aimed at continually improving performance over the long term by
focusing on customer’s while addressing the need of all other interested parties”.
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
3.3 CUSTOMER FOCUS
This Principle is expressed as follows:
“Organizations depend on their customers and, therefore, should understand current

and future customer needs, meet customer requirement and strive to exceed customer
expectations”.
Customers are the lifeblood of every organization. All organizations provide

something to others they do not exist in isolation. We should remember that
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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.
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
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.
The leadership principle requires the following principle to be addressed.
 The setting of objectives & policies

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 Planning
 Internal communication
 Creating an effective work environment
3.5 INVOLVEMENT OF PEOPLE
“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.
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
3.5 PROCESS APPROACH
“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.
A process is as capable of producing rubbish as a procedure is capable of wasting

resources - therefore processes need to be managed effectively for the required results
to be produced. The process approach to management is therefore not simply
converting inputs into outputs that meet requirements but about managing processes:
 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
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
3.6 SYSTEM APPROACH
“Identifying, understanding, and managing inter-related processes as a system

contributes to the organization effectiveness and efficiency in achieving its
objective”.
A system is an ordered set of ideas, principles and theories or a chain of operations

that produce specific results. To be a chain of operations, the operations need to work
together in a regular relationship. Taking a systems approach to management means
managing the organization as a system of processes so that all the processes fit
together, the inputs and outputs are connected, resources feed the processes,
performance is monitored and sensors transmit information which cause changes in
perform together to achieve the organization's objectives.
The system approach principle requires
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 Establishing, implementing and maintaining the management system
 Interconnection, interrelation and sequence of processes
 The links between processes
 Establishing measurement processes
3.7 CONTINUAL IMPROVEMENT
“Continual improvement of the organization overall performance should be a

permanent objective of the organization”.
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.
The Continual Improvement principle requires an addressing of:
 Improvement processes.
 Identifying improvements.
 Reviewing documents and processes for opportunities for improvement.
3.8 FACTUAL APPROACH TO DECISION MAKING
This Principle states that:
“Effective decisions are based on the analysis of data and information”.
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:
 Reviews, measurements and monitoring to obtain facts.
 Control of measuring devices.
 Analysis to obtain facts from information.
 Records for documenting the facts.
 Approvals based on facts.
3.9 MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS
“An organization and its suppliers are inter-dependent and a mutually beneficial
relationship enhances the ability of both to create value”.
Organizations depend on their suppliers. Suppliers provide the materials, resources

and often many services that were once provided by internal functions. The
organizations of the 21st century arc more dependent upon their suppliers than ever
before. The quest for lower and lower costs with higher and higher performance has
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cause many organizations to consider the economics of continuing to operate their

own support services.
The mutually beneficial supplier relationships principle requires:
 Control of Suppliers
 Evaluation of Suppliers
 Analysis and Review of Supplier data
3.10 USING THE PRINCIPLES
The Principle can be used:
 In validating the design of processes
 In validating decisions
 In auditing system and processes
We look at a process and ask:
 Where is the customer focus in this process??
 Where in this process is there leadership, guiding policies, measurable

objectives and the environment that motivates the workforce to achieve
these objectives??
 Where in this process is the involvement of people in the design of the

process, the making of decisions, the monitoring and measurement of
performance and the improvement of performance??
 Where is the process approach to the accomplishment of these

objectives??
 Where is the systems approach to the management of these processes??
 Where in the process are the facts collected and transmitted to the
decision makers??
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 Where is there continual improvement in performance, efficiency and

effectiveness of this process??
 Where is there a mutually beneficial relationship with suppliers in this

process??
[David Hoyle, 2001]
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CHAPTER 04
INTRODUCTION TO THE COMPANY
4.1 ABOUT THE COMPANY
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
The manufacturing resources in the plant produce the following parts:
 Motorcycle Rims
 Motorcycle rim Spokes
 Motorcycle spoke Nipples
 Motorcycle Handlebars
 Motorcycle Mufflers
4.3 CUSTOMERS
STAPL is an automotive parts vendor, producing parts for motorcycle manufacturers.
Their biggest customers’ name includes OEMs like:
 Honda Motorcycles ( Atlas Honda Pakistan)

 Yamaha Motorcycles ( DYL Motorcycles Pakistan)
 Suzuki Motorcycles (Pak Suzuki Motorcycles Pakistan)
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
QMS REQUIREMENTS AT STAPL
STAPL is a Medium Scale Enterprise, so it is not feasible technically as well as

economically, to develop and implement their own QMS. Therefore, they opted for
that system which is acceptable to their customer and as well as is efficient enough to
manage the quality of their all processes. That’s why they went for ISO 9000/2000
Certification.
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 summary of ISO/TS 16949 may be written as:
ISO/TS 16949=ISO 9001:2000 + Automotive Requirements +

Customer Specific Requirement
[Online TS 16949 tutorial www.16949store.com]
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
Since STAPL management is deeply committed to develop a QMS which is

internationally recognized therefore, they are moving forward for an ISO / TS
16949:2002 Certification and they are considering a consultant for their certification.
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CHAPTER 06
WHAT IS ISO 9000?
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.
6.1.1 MARKET SERVED
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:
1. Implementing organization for internal improvement.

2. Customers and registration bodies for external Quality Assurance purposes.
3. Government and regulatory activities for enhancing the overall qualitative level
of the country and for consumer protection.
6.2 THE ISO 9000 SERIES
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The ISO 9000, generally denoted, is in fact a series of Standards. These are basically
of two types:
1. Quality Assurance Model.

2. Quality Management Guidelines.
6.2.1 QUALITY ASSURANCE MODELS
It includes following models:
 ISO 9001
 ISO 9002
 ISO 9003
6.2.1.1 ISO 9001:

Quality System- Model for quality assurance in design/development, production,
installation and servicing; in the most comprehensive standard. It includes all
elements listed in ISO 9002 & ISO 9003. It is used when the organization must ensure
product/service conformance to a specified needs throughout an entire product cycle
including the design stage.
6.2.1.2 ISO 9002:

Quality System-Model for quality assurance in production, installation and servicing.
It includes all the elements covered in ISO 9001 except design control. It is used when
an organization produces according to the established standards or specifications
provided by their customers. It is relevant for organizations that do not involve any
design aspect.
6.2.1.3 ISO 9003:

Quality System-Model for quality assurance in final inspection and test . It is used
when only detection and control of problems are required during final inspection and
testing. Generally this refers to less complex products or services.
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6.2.2 Quality Management Guidelines
It includes:
 ISO 9000-1: Introduces the 9000 series
 ISO 9000-2: Guidelines for the Application, describes explanations for

implementations
 ISO 9000-3: Guidelines for Software development and Supply, interpret a quality
system for the software industry
 ISO 9000-4: Guide to dependability program management, such as transportation,

electricity, telecommunications and Information Services
 ISO 9004-1: General guideline (for manufacturing)
 ISO 9004-2: Guideline for services, such as hospitals, banks, education,

consultancies
 ISO 9004-3: Guidelines for processed material such as Steel Mill, Canned Milk
etc
 ISO 9004-4: Guidelines for Quality Improvement, describes fundamental tools

and concepts for continuous quality improvements
6.2.3 Other Related ISO Standards
ISO 8402: Quality Management and Quality Assurance Vocabulary
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 10012: Quality Assurance requirements for measuring equipment
ISO 10005: Guidelines for developing Quality Plans
6.3 KEY BENEFITS OF ISO 9000
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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6.4 KEY VULNERABILITIES & DIFFICULTIES
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:
Small and Medium Enterprises have unique problems, especially in developing

countries, with putting ISO 9000 Quality System in place. They feel that the system is
tailored to large size companies. Their common difficulties in applying these
standards are:
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:
The standard demands a lot of documentation in a structured form. Managers may be

good in their work but with this system a lot of procedures are to be written. Not all
managers are good in writing thus extra writing capabilities are required when
documenting the system requirements.
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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6.5 PREPARING FOR ISO 9000
Each organization is different in culture and availability of resources. Therefore no set

model can fully work for every company. However, the following points are given for
guidelines
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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6.6 THE CERTIFICATION
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.
[Kamran Moossa and Imranullah Shariff, 1996]
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CHAPTER 07
ISO 9001:2000 STANDARD
7.1 BASIC REQUIREMENT
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.
7.2 GENERIC REQUIREMENTS
The Organization shall:
 Determine the needs and expectations of customer and other interested parties;
 Establish policies, objectives and a work environment necessary to motivate

the organization to satisfy these needs;
 Design, resource and mange a system of interconnected processes necessary to

implement the policy and attain the objectives;
 Measure and analyze the adequacy, efficiency and effectiveness of each

process in fulfilling its purpose and objectives and;
 Pursue the continual improvement of the system from an objective evaluation

of its performance
7.3 FEATURES OF ISO 9001:2000
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).
7.3.1 Management Responsibilities
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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.
7.3.2 Documentation of a Quality System
The documentation of a quality system must ensure product conformance to specified

requirements. In the creation of a quality system, standards should be developed for
the following:
 Acceptability
 Measurement Procedures
 Design compatibility
 Production processes
 Installation
 Inspection
 Test Procedures
 Preparation of Quality Plans
 Quality Manual
 Record keeping
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7.3.3 Contract Review
Quality in marketing is maintained through contract reviews. The vendor is expected

to review each contract to ensure that the requirements are adequately defined and
documented. Also, the vendor should make sure that the contractual requirements can
be met.
7.3.4 Design Control
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.
7.3.5 Document Control
The Standard ensures the availability of pertinent information from appropriate

documents at all locations where such documents are essential for conducting
operations. Obsolete documents should promptly be removed.
7.3.6 Purchasing Section
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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7.3.7 Identifying the Product
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.
7.3.8 Process Control
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.
7.3.9 Product verification
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.
7.3.10 Measuring and Test Equipment
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.
7.3.11 Control of Nonconforming Products
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.
7.3.12 Corrective Action
Maintaining procedures for corrective action is critical. The Vendor's procedures

should investigate the cause of nonconforming products and should stipulate correc-
tive actions to prevent recurrence. Analysis of processes, work operations, quality
records, service reports, and customer complaints is crucial to detecting and eliminat-
ing potential causes of nonconforming products. The vendor should implement and
record changes in procedures that result from corrective action.
7.3.13 Maintaining Procedures for Postproduction Handling Functions
The Vendor is responsible for establishing, documenting, and maintaining procedures

for postproduction handling functions such as storage, packaging, and delivery. The
vendor should provide means of handling that prevent damage or deterioration. Areas
for storage should be secure, with appropriate methods stipulated for authorizing
receipt and dispatch. Packing and preservation processes should conform to
requirements. The protection of quality, where contractually specified, should be ex-
tended to include delivery to destination.
7.3.14 Quality Records
An important feature of the standard makes the vendor responsible for establishing
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and maintaining procedures for identification, collection, indexing, filing, storage,

maintenance, and disposition of quality records. These records should be maintained
to demonstrate achievement of the required quality and the effective operation of the
quality system. Pertinent subcontractor quality records should be included in this data.
Retention times for quality records should be established and recorded. Where agreed
upon contractually, quality records should be made available for a specified-period for
evaluation by the purchaser or purchaser's representative.
7.3.15 Internal Quality Audits
To verify whether quality activities comply with planned arrangements and to

determine the effectiveness of the quality system, the vendor must carry out a compre-
hensive system of planned and documented internal quality audits. Scheduling for
these audits should be based on the status and importance of the activity. The results
of the audits should be documented and brought to the attention of the personnel re-
sponsible for the area audited. Appropriate management personnel should then lake
timely corrective action on the deficiencies found by the audit.
7.3.16 Training Needs
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.
7.3.18 Statistical Techniques

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The vendor should establish procedures for identifying adequate statistical techniques
to verify the acceptability and product characteristics.
[David Hoyle, 2001]
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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.
[Kamaran Moosa and Imranullah Shariff, 1996]
8.2 LINKAGES BETWEEN PROCESS STAGES, CLAUSES & GAPS AT STAPL
Process Base Clause Related Clauses Gaps

Stag
e
Determine 5.3 Establish 5.1 Management Company’s Quality

the goal organization's responsibility Policy statement has
purpose to be developed.
5.1 Establish 5.3 Quality policy Company’s Quality

Quality policy Policy statement has
to develop.
5.4.1 Establish 5.1 Management

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Quality objectives responsibility Quality Objectives

5.2 Customer focus (Key Performance
7.1 Planning of Indicators) at
product realization Corporate, Functions
7.2.1 Determination of (departments) and
requirement related to Project level have
the product not been formally
7.3.2 Design and established.
development The business plan
needs to develop as
well.
Develop 4.la Identify 5.4.2 QMS planning System is not
processes to processes 7.1 Planning of properly
achieve the product realization documented.
goal 7.3.1 Design and
development planning
4.1b Determine 7.1 Planning of

sequence and product realization System is not
interaction of 7.3.1 Design and properly
processes development planning documented.
7.4.1 Purchasing
process
7.5.1 Control of
production and service
provision
8.1 General
4.1c Develop5.5.1 Responsibility

criteria and and authority
methods 5.5.2 Management System is needed to
representative be developed.
7.1 Planning of
product realization
7.4.1 Purchasing
process
7.5.1 Control of
provision
7.5.3 Identification
and traceability
7.5.4 Customer
property
7.5.5 Preservation of
product
8.1 General
8.3 Control of
nonconforming product
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4.Id Provide 4.2.1 General System is not

information documentation properly
requirements documented.
4.2.2 Quality manual
4.2.3 Control of
documents
4.2.4 Control of
records
5.1 Management
commitment
5.5.3 Internal
communication
7.1 Planning of
product realization
7.2.3 Customer
communication
7.3.3 Design and
development outputs
7.4.2 Purchasing
information
4.1d Provide 6.1 Provision of System is present but

resources resources requires
6.2 Human improvement.
resources
6.3 Infrastructure
6.4 Work
environment
7.1 Planning of
product realization
Operate and 4.1 Implement 4.2.2 Quality manual System has to be

maintain and maintain QMS 4.2.3 Control of developed.
processes documents
5.1 Management
commitment
5.4.2 Quality
management system
planning
5.5.2 Management
representative 6.3
Infrastructure
7.2.3 Customer
communication
7.5.1 Control of
product and service
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provision
Establish 8.2.4 Monitor 7.2.2 Review of System is present but

that goal is and measure requirements related to requires proper
being product the product documentation and
achieved 7.3.4 Design and maintenance.
development review
7.3.5 Design and
development verification
7.3.6 Design and
development validation
7.4.3 Verification of
purchased product
7.5.1 Control of
provision
7.6 Control of
monitoring and
measuring devices
8.1 General
8.2.1 Customer
satisfaction
8.2.2 Internal audit Audit Procedures
needs to be
developed.
Establish 8.4 Analyze 8.1 General System is not
that goal is product 8.5.2 Corrective properly maintained.
being action
achieved 8.5.3 Preventive
(continued) action
8.3 Control of
nonconforming product
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
Establish 4.1e Monitor 5.6 Management System needs

goal is and measure review improvement.
achieved in processes 7.5.2 Validation of
the best processes for production
way and service provision
7.6 Control of
monitoring and
measuring devices
8.1 General
8.2.2 Internal audit
8.2.3 Monitoring and
measurement of
processes
4.1e Analyze 8.1 General System needs to be

processes 8.4 Analysis of data developed.
4.1f Continually 8.1 General System needs to be

improve processes 8.5.1 Continual developed.
improvement
Establish if 8.4 Analyze 5.6.2 Review input System is present but

it's the right suitability, 7.6 Control of needs improvement.
goal adequacy and monitoring and
effectiveness measuring devices
5.6.1 Review 5.6 Management System is present but

system resview needs improvement.
effectiveness
4.1f Continually 8.5.1 Continual System needs to be

improve processes improvement developed.
Table 8.1: Gap Analysis
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SECTION C
DOCUMENTATION
Chapter 9:
AT STAPL Scope
This section includes the level of documentation done at STAPL. The

Level one documentation includes the quality manual.The level two Chapter 10:
documentation hierarchy defined, requires the system procedures to beThe Level One
defined and documented The Level three documentation: Sop, Work Documentation
Instructions, Control Plan & FMEA.The fourth level Quality System
Documents include reports, forms, log sheets and other reports generated
while performing routine activities.
Chapter 11:
The Level Two
Documentation
Chapter 12:
The Level Three
Documentation
Chapter 13:
The Level Four
Documentation
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CHAPTER 09
SCOPE
As discussed in the earlier sections the Management of STAPL desired a Quality

Management System Certification by ISO. Our group was aligned with the team
nominated for this task by STAPL Management.
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.
Our Project presents a Documentation of the QMS under development at STAPL.
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
THE LEVEL ONE DOCUMENTATION:
THE QUALITY MANUAL
As mentioned in the Clause 4.2.3 & 4.2.4 of ISO 9001:2000, that:
Clause 4.2.3
The standard required that a documented procedure be established to define the

controls needed.
Clause 4.2.4
The standard required that records to be established and maintained to provide

evidence of conformity to requirement and effective operation of quality management
system.
Under the guidance of these Clauses a primary need of a manual is mentioned.
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.
10.1 GENERAL REQUIREMENTS OF A QUALITY MANUAL
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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This requirement is response to the systems approach principle. A description of a

management system is necessary a mean of showing how al l processes are inter-
connected and how they collectively deliver the business outputs. It has several uses
like:
 A means to communicate the vision, values, mission, policies and

objective of the Organization. A means of showing how the system has
been designed
 A means of showing linkage between processes
 Means of showing who does what
 A aid to training new people
 Tool in the analysis of potential improvements
 A means of demonstrating compliance with external standards and

regulations
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.
10.2 THE QUALITY MANUAL FRAMEWORK
The requirement provides the framework for the manual. Its content may therefore
include the following:
1. Introduction:
a. Purpose (of the manual)

b. Scope (of the manual)
c. Applicability (of the manual)
d. Definitions (of terms used in the manual)
2. Business Overview:
a. Nature of the Business/Organization - its scope of activity, its products and

services
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b. The Organization's interested parties (customers, employees, regulators,

shareholders, suppliers, owners etc.)
c. The context diagram showing the organization relative to its external
environment
d. Vision, values
e. Mission
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
5. Function matrix (Relationship of functions to processes)
6. Location matrix (Relationship of locations to processes)
7. Requirement deployment matrices
a. ISO 9001 compliance matrix

b. ISO 14001 compliance matrix
c. Regulation compliance matrices (FDA, Environment, Health, Safety, CAA
etc.)
8. Approvals (List of current product, process and system approvals)
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A template of the Quality Manual prepared by the Group is included in the Appendix.
[David Hoyle, 2001]
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CHAPTER 11
THE LEVEL TWO DOCUMENTATION:
QUALITY SYSTEM PROCEDURES
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.
11.1 QSPS PREPARED AT STAPL
The QSPs prepared at STAPL cover all the necessary functions of STAPL.
QSPs prepared at STAPL are for the following;
 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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 Customer Related Process
 Control of Monitoring & Measuring Devices

 Tooling Management
 Storage & Inventory Control Management

 Production Part Approval Process
 Advance Product Quality Planning
 Monitoring and Measurement of Processes & Product

 Analysis of Data
11.2 CONTRIBUTION OF THE PROJECT GROUP IN THE QSP’S

PREPARATION AT STAPL
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;
The list of QSPs in which the group was involved is as follows;
 Management Review
 Control of Documents & Records
 Control of Nonconforming Product
 Improvement
 Internal Communication
 Production & Service Provision
 Control of Monitoring & Measuring Devices
 Analysis of Data
 Monitoring and Measurement of Processes & Product

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A brief Summary of these Procedures is as follows;
11.2.1 Procedure For Management Review
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.
11.2.2 Procedure for Control of Documents and Records
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.
11.2.3 Procedure for Control of Non-Conforming Product
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.
11.2.4 Procedure for Improvement
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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11.2.5 Procedure for Internal Communication
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
11.2.6 Procedure for Production and Service Provision
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.
11.2.7 Procedure for Control of Monitoring and Measuring Devices
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.
11.2.8 Procedure for Analysis of Data
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).
11.2.9 Procedure for Monitoring and Measurement of Processes & Product
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.
A template of the procedure format is included in the Appendix.
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CHAPTER 12
LEVEL THREE DOCUMENTATION:
SOP, WORK INSTRUCTION, CONTROL PLAN & FMEA
12.1 SOP’s AND WORK INSTRUCTIONS, TRAINING MANUALS & JOB

DESCRIPTIONS
As mentioned in the Clause of 7.5.1b and 7.5.1c of ISO 9001:2000
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
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.
12.2 CONTROL PLANS AND FMEA
As mentioned in the Clause of 7.5.1a and 7.5.1d and 7.5.1e of ISO 9001:2000
12.2.1.1 Clause 7.5.1a:

through the availability of information that describes the characteristics of the
product.
Clause 7.5.1d and e
through the availability and use of measuring and monitoring devices.
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.
12.2.1 Control Plan Framework
A control charts fills the requirement of a documented procedure for producing a

product. This document is also prepared by some organizations as Quality Plan and
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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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4. Revision No. and Date

5. Page No.
6. Process / Function Requirements
7. Potential Failure Mode
8. Potential Effects of Failure
9. Severity Index of the Effect
10. Potential Causes of Failure
11. Occurrence Probability Index
12. Current Controls for Prevention
13. Current Process Detection Control
14. Detection by Control Index
15. Risk Priority Number (RPN)
16. Recommended Actions
17. Responsibility of the Action
18. Action Taken
19. and the New RPN
More details of CPA calculations are defined in the Manual for Measurement and
Statistical Analysis (MSA).
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
LEVEL FOUR DOCUMENTATION:
SUPPORTING DOCUMENTS, FORMS, ETC
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;
13.1 CONTROL CHARTS (FOR PROCESSES SUGGESTED BY STAPL

MANAGEMENT)
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).
13.2 CAPABILITY ANALYSIS (FOR PROCESSES SUGGESTED BY STAPL

MANAGEMENT)
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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did. The CPA was calculated by software named

MiniTab by BCIS Labs, St. Cloud University.
However to fulfill the documentation requirements SECTION C
defined by the STAPL QMS, the CPA was presented
as a sheet in the formatting scheme defined at
STAPL.
Chapter 14:
The details of CPA calculations are defined in the Lean Production
Manual for Measurement and Statistical Analysis
(MSA).
In Deming’s ideal organization, workers, management, vendors, and
Chapter 15:
investors are a team. However, without management commitment, the
Six-Sigma Quality
adoption and the implementation, a total quality system will not succeed
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
Womack and Jones define lean as doing:
"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"
14.2 PRINCIPLES OF LEAN MANUFACTURING
Lean Production can be defined as an adaptation of mass production in which

workers and work cells are made more flexible and efficient by adopting methods that
reduce waste in all forms.
Lean production is based on four principles:
1. Minimize waste
2. Perfect first-time quality
3. Flexible production lines
4. Continuous Improvement
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14.2.1 Minimize Waste
All four principles of lean production are derived from the first principle: minimize
waste.
Taiichi Ohno's list of waste forms can be listed as follows:
1. Production of defective parts

2. Production of more than the number of items needed
3. Unnecessary Inventories
4. Unnecessary processing steps
5. Unnecessary movement of people
6. Unnecessary transport of materials
7. Workers waiting.
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…
14.2.2 Perfect First-Time Quality
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.
There is minimum inventory in a lean system to act as a buffer. In Mass Production,

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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.
Comparison of Mass Production and Lean Production
Mass Production Lean Production
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
14.2.3 Flexible Production System
Mass production is predicated largely on the principles of Frederick W. Taylor, one

of the leaders of the scientific management movement in the early 1900s. According
to Taylor, workers had to be told every detail of their work methods and were
incapable of planning their own tasks. By comparison, Lean Production makes use of
worker teams to organize the tasks to be accomplished and worker involvement to
solve technical problems. One of the findings was that workers in Japanese "lean
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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.
14.2.4 Continuous Improvement
In Mass Production, there is a tendency to set up the operation, and if it is working,

leave it alone. Mass production lives by the motto: "If it ain't broke, don't fix it." By
contrast, lean production supports the policy of continuous improvement. Called
kaizen by the Japanese, Continuous Improvement means constantly searching for and
implementing ways to reduce cost, improve quality, and increase productivity. The
scope of Continuous Improvement goes beyond factory operations and involves
design improvements as well. Continuous Improvement is carried out one project at a
time. The projects may be concerned with any of the following problem areas:
 Cost Reduction
 Quality Improvement
 Productivity Improvement
 Setup-time Reduction
 Cycle time Reduction
 Manufacturing lead time and Work-in-process inventory reduction
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 Improvement of product design to increase performance and customer appeal
[Mikell P. Groover, 2001]
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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.
So, the question is, how do we measure performance??
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.
15.2 THREE-SIGMA QUALITY CONCEPT
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.
15.3 SIX-SIGMA QUALITY CONCEPT
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. In other words, the process spread
as measured by ±3σ has to be significantly less than the spread between the Upper
and Lower specification limits (USL and LSL). Motorola's answer to this problem is
Six-Sigma Quality; that is, process variability must be so small that the specification
limits arc 6 standard deviations from the mean.
If the process distribution is stable—that is, it remains centered between the

specification limits—the proportion of nonconforming product should be only about
0.001 ppm on each tail.
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
Establishing a goal of Three-Sigma Capability is acceptable as a starting point,

however, because it allows the Organization to set a baseline for Improvement. As
management becomes more process oriented, higher goals such as "Six-Sigma
Capability" become possible. Such goals may require fundamental changes in
management philosophy and the Organizational Culture.
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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.
16.2 EXPLAINING THE IDEA
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.
"Zero defects" is referred to as a philosophy, a mentality or a movement. It's not a

program, nor does it have distinct steps to follow or rules to abide by. This is perhaps
why zero defects can be so effective, because it means it's adaptable to any situation,
business, profession or industry.
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:
 Recognize the high cost of quality issues
 Continuously think of the places where flaws may be introduced
 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."
16.3 ADOPTING ZERO DEFECTS
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.
 Understand what your customers expect in terms of quality. Design systems

that support zero defects where it matters, but don't over-design if the end-user
just doesn't care.
 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".
 Learn poka - yoke (POH-kay YOH-kay.) Invented in the 1960s by Shigeo

Shingo of Japan, it translates to "prevent inadvertent mistakes". It's an
approach that emphasizes designing systems that make defects almost
impossible or, if they can't be avoided, easy to detect and address. To
implement zero defects, you have to have strong systems in place.
 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.
 Measure your quality efforts. It is important to express your progress in terms

of the bottom line. Take baseline measurements so you understand the cost of
defects in your organization, and can measure the benefits your achieving in
eliminating them.
 Build quality into your performance expectations. Encourage members of your

team to think about how they can achieve zero defects, and reward them when
they're successful.
 Recognize that although zero defects is a destination, circumstances keep

changing. Monitor, evaluate, and adapt in a continuous, never-ending cycle.
[http://www.mindtools.com/zero_defect/htm]
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CHAPTER 17
DEMING’S 14 POINTS FOR MANAGEMENT
17.1 INTRODUCTION
The focus of Deming’s philosophy is management. Since, a major proportion of

problems can be solved by management, Deming noted that management cannot
“pass the buck”, only a minority of problems can be attributed to suppliers or workers,
so in Deming’s view, what must change is the fundamental style of management and
the corporate culture.
In Deming’s ideal organization, workers, management, vendors, and investors are a

team. However, without management commitment, the adoption and the
implementation, a total quality system will not succeed.
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
2. Learn the new philosophy, top management and everybody
3. Understand the purpose of inspection, for improvement of processes and

reduction of cost
4. End the practice of awarding business on the basis of price tag alone
5. improve constantly and forever the system of production & service
6. Institute training
7. Teach an Institute leadership
8. Drive out fear. Create trust. Create a climate of Innovation

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9. Optimize toward the aims and purposes of

the Company. The efforts of teams,
groups, staff, areas SECTION D
10. Eliminate exhortations for the workforce
11. (a). Eliminate numerical quotas for

Chapter 18:
production. Instead, learn and institute
Summary
methods for improvement
(b). Eliminate M.B.O [management by
objectives]. Instead learn the capabilities
of processes and how to improve them
12. Remove barriers that rob people of pride Chapter 19:

of workmanship Constraints
13. encourage education and self-
improvement for everyone
14. take action to accomplish the

transformation
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COMPENDIUM
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.
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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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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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Pakistan), and Suzuki Motorcycles (Pak Suzuki Motorcycles Pakistan).STAPL is an

automotive parts vendor, producing parts for motorcycle manufacturers.
18.2 DESIGN OF QMS USING ISO 9000
STAPL is a Medium Scale Enterprise, so it is not feasible technically as well as

economically, to develop and implement their own QMS. That’s why they went for
ISO 9000/2000 certification. 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.
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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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.
18.4 DOCUMENTATION AT STAPL
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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Sheets. A control charts fills the requirement of a documented procedure for

producing a product. A FMEA along with control charts fills the requirement of a
documented procedure for control and preventive action for producing a product.
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".
The focus of Deming’s philosophy is management. Since, a major proportion of

problems can be solved by management, Deming noted that management cannot
“pass the buck”, only a minority of problems can be attributed to suppliers or workers,
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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.
Availability of international standards is also an expensive constraint. Although, the

standard has been simplified into simplified templates and manuals but they are quiet
expensive to obtain.
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.
The Project remains. The tasks remaining are as follows:
1. Review and approval of the proposed documents

2. Validation of these documents
3. Preparation of departmental operating procedures (SOP’s)
4. Log sheets, In-process control sheets, etc for various departments to be prepared
5. Deployment of these procedures and documents to all concerned personnel
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REFERENCES
1. Amitava Mitra, Fundamentals Of Quality Control & Improvement, Second Edition,
Pearson Education Publication, 1998, p 1-84, 138-204, 235-375.
2. Richard E. DeVor, Statistical Quality Design & Control, ASTM Hand Book
Publications, 2000, p 719-753.
3.Kamran Moosa and Imranullah Shariff, Practical Guide to ISO 9000 Quality
Management System, First Edition, Ibrahim Publishers & PIQC Pakistan, 1996, p 41-
55, 95-96 and Appendix.
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
6.Mikell P. Groover, Automation, Production System & Computer-integrated
Manufacturing, Second Edition, Pearson Education Publication, 2001, p 848-859.
7. Potential Failure Mode and Effects Analysis (FMEA), Reference Manual, Third
Edition, Ford Motor Company, General Motors Corporation, 2001, p 41-57
8.
WEBSITES:
1.
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APPENDIX
Appendix B1: List of ISO 9001:2000 Standard Clauses.
Clause Statement
S No
No.
4.1 Establishing a quality management system
The standard requires the organization to establish a quality

1.
management system in accordance with the requirements of ISO
9001. (Pg.117)
4.1a Identifying processes
The standard requires the organization to identify the processes need

2.
for the quality management system and their application throughout
the organization. (Pg.121)
4.1b Sequence and interaction of processes
3. The standard requires the organization to determine the sequence

and interaction of the identified processes. (Pg.127)
4.1c Criteria and methods for the effective operation and control
The standard requires the organization to determine the criteria and

4.
methods require to ensure the effective operation and control of the
identified processes. (Pg.128)
4.1,4.2. Documenting a quality management system

1
The standard requires the organization to document a quality
5.
9001. (Pg.130)
4.2.1c Documented procedures
6. The standard requires the management system documentation to

include documented procedures required by ISO 9001. (Pg.137)
7. 4.2.1d Documents that ensure effective planning, operation and control

of processes
The standard requires management system documentation documents

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include documents required by the organization to ensure the

effective planning, operation and control of its processes. (Pg.140)
4.2 What should be documented?
The standard requires the extent of quality management system

8. documentation to be dependent on the size and type of organization,
complexity of the processes, and the competency of personnel.
(Pg.155)
4.1 Implementing a quality management system
The standard requires the organization to implement a quality

9.
9001. (Pg.158)
4.1 Managing processes
The standard requires the organization to manage the identified

10.
processes in accordance with the requirements of ISO 9001. (Pg.
159)
4.1d Ensuring information availability
The standard requires the organization to ensure the availability of

11.
information necessary to support the operation and monitoring of the
identified processes. (Pg.164)
4.1d Ensuring the availability of resources
The standard requires the organization to ensure the availability of

12.
resources necessary to support the operation and monitoring of the
identified processes. (Pg. 166)
4.1e Measuring, monitoring and analyzing processes

The standard requires the organization to measure, monitor and
13. analyze the identified processes. (Pg.167)
4.1 Maintaining a quality management system
The standard requires the organization to maintain a quality

14.
9001. (Pg.170)
15. 4.1 and Continual improvement in the quality management system and
4.1f its processes
The standard requires the organization to continually improve the

effectiveness of the quality management system in accordance with
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the requirements of ISO 9001 and to implement action necessary to

achieve planned results and continual improvement of the identified
processes. (Pg.172)
4.2.2 Preparing the quality manual
The standard requires a quality manual to be established and

maintained that includes the scope of the quality management
16.
system, the documented procedures or reference to them and a
description of the sequence and interaction of processes included in
the quality management system. (Pg.174)
4.2.2 Scope of the quality management system
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)
4.2.2 Referencing procedures in the quality manual
The standard requires the quality manual to include the documented

18.
procedures established for the quality management system reference
to them. (Pg.178)
4.2.2 Describing the processes and their interaction
The standard requires the quality manual to include a description of

19.
the interaction between the processes of the quality management
system. (Pg.179)
4.2.3 Documents required for the management system
20. The standard requires documents required by the quality

management system to be controlled. (Pg. 180)
4.2.3 Document control procedures
21. The standard requires that a documented procedure be established to

define the controls needed. (Pg.182)
4.2.3a Document approval
22. The standard requires the documents be approved for adequacy prior
to issue. (Pg.184)
4.2.3b Document review

23.
The standard requires that documents be reviewed. (Pg.188)
24. 4.2.3b Revision of documents
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The standard requires that documents be updated as necessary and

re-approved following their review. (Pg.189)
4.2.3c Identifying the change
25. The standard requires that changes to documents be identified.

(Pg.194)
4.2.3c Identifying the current revision of documents
26. The standard requires the current revision status of documents to be

identified. (Pg.195)
4.2.3b Re-approving documents after change
27. The standard requires that documents be re approved after revision.

(Pg. 197)
4.2.3d Ensuring the availability of controlled documents
28. The standard requires that relevant versions of applicable documents

are available at points of use. (Pg.198)
4.2.3e Ensuring documents are legible and identifiable

The standard requires documents to remain legible and readily
29.
identifiable. (Pg.202)
4.2.3f Control of external documents
30. The standard requires documents of external origin to be identified

and their distribution controlled. (Pg.203)
4.2.3g Preventing unintended use of obsolete documents
The standard requires the intended use of obsolete documents to be

31.
prevented and a suitable identification to be applied to obsolete
documents retained for any purpose. (Pg.204)
4.2.4 Establishing and maintaining records
The standard requires records to be established and maintained to

32.
provide evidence of conformity to requirements and the effective
operation of quality management system. (Pg.207)
33. 4.2.4 Establishing a record procedure
The standard requires records to remain legible, readily identifiable

and retrievable and that a procedure defines the controls needed for
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the identification, storage, protection, retrieval, retention time and

disposition of records. (Pg. 211)
5.1 Management commitment
The standard requires that top management provide evidence of its

34. commitment to be development and implementation of quality
management system and continually improving its effectiveness.
(Pg.223)
5.1a Communicating the importance of requirements
The standard requires that top management communicate to the

35.
organization the importance of meeting customer as well as statutory
and regulatory requirements. (Pg.228)
5.1b Establishing quality policy

The standard requires that top management establish a quality policy.
36.
(Pg.230)
5.1c Establishing quality objectives
37. The standard requires that top management ensure that quality
objectives are established. (Pg.232)
5.1d Conducting management reviews

The standard requires that top management conduct management
38.
reviews. (Pg.233)
5.1e Ensuring availability of resources
39. The standard requires that top management ensure the availability of
necessary resources. (Pg.235)
5.2 Customer focus(5.2)

Determining customer requirements
40.
The standard requires top management to ensure that customer
requirements are determined. (Pg.236)
5.2 Meeting requirements
41. The standard requires customer requirements to be met with the aim
of enhancing customer satisfaction. (Pg.241)
42. 5.3a Quality policy(5.3)

ensuring policy is appropriate
The standard requires the quality policy to be appropriate to the
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purpose of the organization. (Pg.242)
5.3b Expressing a commitment
The standard requires that quality policy include a commitment to

43.
comply with requirements and continually improve the effectiveness
of the quality management system. (Pg.244)
5.3c providing a teamwork for quality objectives
44. The standard requires the quality policy to provide a framework for
establishing reviewing quality objectives. (Pg.246)
5.3d Ensuring policy is communicated and understood

45.
The standard requires that the quality policy is communicated and
understood within the organization. (Pg. 247)
5.3e Ensuring that the policy is reviewed
46. The standard requires the quality policy to be reviewed for continuing
suitability. (Pg.250)
5.4.1 Quality objectives(5.4.1)

Establishing objectives
The standard requires that top management ensure that quality

47.
objectives, including those needed to meet requirements for product,
are established at relevant functions and levels within the
organization. (Pg.251)
5.4.1 Expressing quality objectives
48. The standard requires quality objectives to be measurable and

consistent with the quality policy. (Pg.256)
5.4.2a Quality management system planning (5.4.2)

Planning to meet quality objectives
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
The standard requires the integity of the quality management system

50.
to be maintained when changes to the quality management system
are planned and implemented. (Pg.265)
51. 5.5.1 Responsibility and authority (5.5.1)
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Defining responsibilities and authority
The standard requires that the responsibilities and authority be

defined. (Pg.267)
5.5.1 Communicating responsibilities and authority
52. The standard requires that the responsibilities and authority be

communicated within the organization. (Pg.269)
5.5.2 Management representative (5.5.2)

Appointing management representatives
The standard requires the top management to appoint a member of

53.
management who has certain defined responsibilities and authority
for ensuring the quality management system is established, (Pg.273)
implemented and maintained.
5.5.2 Responsibilities for establishing and maintaining processes
The standard requires the management representative to ensure that

54.
processes needed for the quality management system are established,
implemented and maintained. (Pg.276)
5.5.2 Responsibilities for reporting on QMS performance
The standard requires the management representative to report top

55.
management on the performance of the quality management system
and the need for improvement. (Pg.278)
5.5.2 responsibilities for promoting awareness of customer

requirements
56. The standard requires the management representative to ensure the

awareness of customer requirements throughout the organization.
(Pg.279)
5.5.3 Internal communication (5.5.3)
Establishing communication processes

57.
The standard requires appropriate communication processes to be
established within the organization. (Pg.280)
5.5.3 Communicating the effectiveness of QMS
58. The standard requires communication take place regarding the

effectiveness of the quality management system. (Pg.283)
59. 5.6 Management review (5.6)
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purpose of review
The standard requires top management to review the quality

management system to ensure its continuing suitability, adequacy
and effectiveness. (Pg.284)
5.6.1 Planning the review
60. The standard requires management reviews at planned intervals.

(Pg.287)
5.6.1 Scope of review
The standard requires the review to include assessing opportunities

61. for improvement and the need for the changes to the quality
management system including quality policy and quality objectives.
(Pg.288)
5.6.1 Records of management reviews
62. The standard requires the results of management reviews to be

maintained. (Pg.289)
5.6.2 Review inputs
63. The standard requires inputs to management review to include

information about various aspects of the system. (Pg.291)
5.6.3 Review outputs
The standard requires the outputs form the management review to

64. include decisions related to the improvement of the effectiveness of
the quality management system and its processes, improvement of
product and actions related to source needs. (Pg.295)
6.2.1 Determining Resources:
The standard requires the organization to determine the resources

65. needed to implement and maintain the quality management system,
continually improve its effectiveness and enhance customer
satisfaction by meeting customer requirements.(Pg-304)
6.1 Providing Resources
The standard requires the organization to provide the resources

66. needed to implement and maintain the quality management system,
and continually improve its effectiveness and enhance customer
satisfaction by meeting requirements.(Pg-307)
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6.2.1 Competence Personnel
The standard requires personnel performing work affecting product

67.
quality to be competent on the basis of appropriate education,
training, skills and experience.(Pg-310)
6.2.2a Training, awareness and competence (6.2.2)

Determining competence necessary
68. The standard requires the organization to determine the necessary

competence for personnel performing work affecting product quality.
(Pg-314)
6.2.2b Providing for training
69. The standard requires the organization to provide training or take

other actions to satisfy these needs.(Pg-318)
6.2.2c Evaluating the effectiveness of personnel development activities
70. The standard requires the organization to evaluate the effectiveness

of the actions taken.(Pg-321)
6.2.2d Increasing sensitivity to the impact of activities
The standard requires the organization to ensure that its personnel

71. are aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives.(Pg-
324)
6.2.2e Maintaining training records
72. The standard requires the organization to maintain records of

education, training, skills and experience.(Pg-327)
6.3 Infrastructure
The standard requires the organization to determine, provide and

73.
maintain the infrastructure needed to achieve conformity to product
requirements.(Pg-329)
6.4 Work environment
74. The standard requires the organization to identify and manage the
work environment needed to achieve conformity product.(Pg-336)
75. 7.1 Planning product realization processes (7.1)

Planning and developing product realization processes
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The standard requires the organization to plan and develop the

processes required for product realization.(Pg-356)
7.1 Creating consistency in process planning
The standard requires planning of the realization processes to be

76.
consistent with the other requirements of the organizations’ quality
management system.(Pg-362)
7.1a Quality objectives and requirement for product
77. The standard requires the organization to determine the quality

objectives and requirements for the product.(Pg-363)
7.1b Determining the need for specific processes
78. The standard requires the organization to determine the need to

establish processes specific to the product.(Pg-364)
7.1b Determining the need for documentation
79. The standard requires the organization to determine the need to

establish documents specific to the product.(Pg-367)
7.1b Determining the need for resources
80. The standard requires the organization to provide resources specific

to the product.(Pg-368)
7.1c Determining verification, validation and monitoring activities
The standard requires the organization to determine the required

81.
verification, validation, monitoring, inspection and test activities
specific to the product.(Pg-369)
7.1c Determining the criteria for product acceptance
The standard requires the organization to determine the criteria for

82.
product acceptance.(Pg-372)
7.1d Determining the need for records
The standard requires the organization to determine the records

83.
needed to provide evidence that the realization processes and
resulting product meeting requirements.(Pg-374)
84. 7.1 Documenting product realization planning
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The standard requires the product realization planning to be in a form

suitable for the organizations’ method of operations.(Pg-375)
7.2 Customer-related processes

Determination of requirements related to the product:
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.
7.2.1a Products requirements specified by the customer
The standard requires the organization to determine requirements

86.
specified by the customer including requirements for delivery and
post delivery activities.(Pg-377)
7.2.1b Product requirements not specified by the customer
The standard requires the organization to determine product

87.
requirements not specified by the customer but necessary for known
intended use.(Pg-380)
7.2.1c Statutory and regulatory requirements
88. The standard requires the organization to determine statutory and

regulatory requirements related to the product.(Pg-381)
7.2.1d Organization’s product requirement
89. The standard requires any additional requirements determined by the

organization for the product to be determined.(Pg-383)
7.2.2 Review of requirements related to the product (7.2.2)

Conducting the review
90.
The standard requires the organization to review the requirements
related to the product.(Pg-383)
7.2.2 Timing of review
The standard requires the review to be conducted prior to the

91.
decision or commitment to supply a product to the customer (e.g.
submission of a tender, acceptance of a contact or order).(Pg-385)
92. 7.2.2a Ensuring that product requirements are defined
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The standard requires that the review of requirements ensure product

requirements are defined.(Pg-387)
7.2.2b Resolving differences
The standard requires the review to ensure that contract or order

93.
requirements differing form those previously expressed are resolved.
(Pg-388)
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)
7.2.2 Maintaining records of product requirements reviews
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)
7.2.2 Handling undocumented statements of requirements
The standard requires that where the customer provides no

96.
documented statement of requirement, the customer requirements are
to be confirmed by the organization before acceptance.(Pg-391)
7.2.2 Changes to product requirements
The standard requires that where product requirements are changed,

97. the organization ensure that relevant documents are amended and
that relevant personnel are made aware of the changed requirements.
(Pg-392)
7.2.3a Customer communication (7.2.3)

Providing product information
98. The standard requires the organization to determine and implement

effective arrangements for communicating with customers relating to
product information.(Pg-393)
7.2.3a Handling enquiries
The standard requires the organization to determine and implement

99.
enquiries. (Pg-394)
100 7.2.3b Handling contracts and orders

.
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The standard requires the organization to determine and implement

contracts or order handling.(Pg-395)
7.2.3b Handling contract amendments
101 The standard requires the organization to determine and implement

. effective arrangements for communicating with customers relating to
amendments.(Pg-398)
7.2.3c Customer feedback
102 The standard requires the organization to determine and implement

. effective arrangements for communicating with customers relating to
customer feedback including customer complaints.(Pg-399)
7.3.1 Design and implement (7.3)

Design and development control
103
. The standard requires the organization to control design and
development of the product.(Pg-401)
7.3.1 Design and development planning (7.3.1)

Preparing the plans
104
. The standard requires the organization to plan design and
development of the product.(Pg404)
7.3.1a Stages of design and development process

105
The standard requires the stages of design and development to be
.
determined. (Pg-407)
7.3.1b Planning review, verification and validation activities
106 The standard requires the review, verification and validation

. activities appropriate to each design and development stage to be
determined.(Pg-408)
7.3.1c Determining responsibilities and authority for design and

development activities
107
. The standard requires the responsibilities and authorities for design
and development activities to be determined.(Pg-410)
108 7.3.1 Managing organizational interfaces

.
The standard requires the interfaces between different groups
involved in design and development proves to be managed to ensure
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effective communication and clarity of responsibilities.(Pg-411)
7.3.1 Ensuring that plans are updated as the design progresses

109
The standard requires planning output to be updated, as appropriate,
.
as the design and development progresses.(Pg-413)
7.3.2 Design and development input

Determining and recording design inputs (7.3.2):
110
The standard requires inputs relating to product requirements to be
.
determined and records maintained (see 4.2.4).(Pg-414)
7.3.2a Defining functional and performance requirements

111
The standard requires design inputs to include functional and
.
performance requirements.(Pg-416)
7.3.2b Defining statutory and regulatory requirements

112
The standard requires design inputs to include applicable statutory
.
and regulatory requirements.(Pg-417)
7.3.2c Defining information from previous designs

113
The standard requires the design inputs to include applicable
.
information derived from previous similar designs.(Pg-417)
7.3.2d Identifying other essential requirements

114
The standard requires design inputs to include any other
.
requirements essential for design and development.(Pg-419)
7.3.2 Reviewing design input requirements
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)
7.3.3 Design and development output (7.3.3)

Documenting the design and development output
116
The standard requires that the outputs of design and development be
.
provided in a form that enables verification against the design and
development inputs.(Pg-420)
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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7.3.3b Providing information for purchasing, production and service

provision
118
The standard requires that design and development output provide
.
appropriate information for purchasing, production and service
provision.(Pg-424)
7.3.3c Defining acceptance criteria

119
The standard requires design and development output to contain or
.
reference product acceptance criteria.(Pg-424)
7.3.3d Specifying essential characteristics
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)
7.3.3 Approval of design outputs

121
The standard requires design and development outputs to be
.
approved prior to release.(Pg-426)
7.3.4 Design reviews (7.3.4)

Planning design reviews
122
The standard requires that at suitable stages, systematic reviews of
.
design and development be performed in accordance with planned
arrangements.(Pg-428)
7.3.4a Conducting design reviews

and b
The standard requires design reviews to be conducted to evaluate the
123
ability of the results of the design and development to fulfill
.
requirements, identify problems and propose required actions.(Pg-
430)
7.3.4 Participants at design reviews
124 The standard requires participants in design reviews to include

. representatives of functions concerned with the design and
development stage(s) being reviewed.(Pg-431)
7.3.4 Design review records

125
The standard requires the results of the reviews and actions arising
.
from the review to be recorded.(Pg-432)
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7.3.5 Design verification (7.3.5)

Performing design verification
126
The standard requires design and development verification to be
.
performed in accordance with planned arrangements to ensure the
output meets the design and development inputs.(Pg-433)
7.3.5 Recording design verification results

127
The standard requires the results of the verification and any required
.
actions to be recorded.(Pg-437)
7.3.6 Design validation (7.3.6)

Performing validation
128 The standard requires design and development validation to be

. performed in accordance with planned arrangements to confirm that
resulting product is capable of fulfilling the requirements for the
specified application or intended use where known.(Pg-438)
7.3.6 Timing of validation
129 The standard requires validation to be completed wherever

. applicable prior to the delivery or implementation of the product.
(Pg-441)
7.3.6 Recording the results

130
The standard requires the results of the validation and subsequent
.
follow-up actions to be recorded.(Pg-442)
7.3.7 Control of design and development changes (7.3.7)

Identification and recording of design changes
131
. The standard requires design and development changes to be
identified and records maintained.(Pg-442)
7.3.7 Review and evaluation of changes

132
The standard requires the changes to be reviewed and approved
.
before implementation, including the evaluation of the effect of
changes on constituent parts and delivered product.(Pg-446)
7.3.7 Verification and validation of design changes
133
The standard requires design changes to be verified and validated as
.
appropriate before implementation.(Pg-448)
134 7.4.1 Purchasing (7.4)

. Purchasing process (7.4.1)
_____________________________________________________________________
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Ensuring purchased product and conforms to specified

requirements
The standard requires the organization to ensure that purchased

product conforms to specified purchase requirements.(Pg-449)
7.4.1 Control of suppliers
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)
7.4.1 Evaluation and selection of suppliers
The standard requires the organization to evaluate and select

136
suppliers based on their ability to supply product in accordance with
.
the organization’s requirements and to establish criteria for
selection, evaluation and re-evaluation.(Pg-454)
7.4.1 Results of supplier evaluation

137
The standard requires the records of evaluations and any necessary
.
follow-up actions to be maintained.(Pg-464)
7.4.2 Purchasing information (7.4.2)

Describing products to be purchased
138
. The standard requires purchasing information to describe the product
to be purchased.(Pg-466)
7.4.2 Adequacy of purchasing requirements
139 The standard requires the organization to ensure the adequacy of

. specified purchase requirements prior to their communication to the
supplier.(Pg-467)
7.4.3 Verification of purchased product (7.4.3)
Ensuring purchased product meets requirements

140
The standard requires the organization to establish and implement the
.
inspection or other activities necessary for ensuring that purchased
product meets specified purchase requirements.(Pg-469)
141 7.4.3 Verification on supplier promises

.
The standard requires that where the organization or its customer
intends to perform verification activities at the supplier’s premises,
the organization is to state the intended verification arrangements
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and method of product release in the purchasing information.(Pg-

472)
7.5.1 Product and service provision (7.5)

Control of production and service provision (7.5.1)
142 Planning production and service provision

. The standard requires the organization to plan and carry out
production and service provision under controlled conditions.(Pg-
473)
7.5.1a Availability of information that describes the product
143 The standard requires the organization to control production and

. service provision through the availability of information that
describes the characteristics of the product.(Pg479)
7.5.1b Availability of work instructions

. service provision through the availability of work instructions where
necessary.(Pg-480)
7.5.1c Use of suitable equipment

145
The standard requires the organization to control production and
.
service provision through the use of suitable equipment.(Pg-482)
7.5.1d Use of monitoring and measuring devices

. service provision through the availability and use of measuring and
monitoring devices.(Pg-483)
7.5.1e): Implementation of monitoring and measurement activities

. service provision through the implementation of monitoring and
measurement.(Pg-484)
7.5.1f Release processes (7.5.1f):
The standard requires the implementation of release activities.(Pg-

485)
148
Delivery processes
.
The standard requires the implementation of delivery activities.(Pg-
487)
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7.5.1f Post delivery processes

149
The standard requires the implementation of post-delivery activities.
.
(Pg-491)
7.5.2 Validation of processes
150 The standard requires the organization to validate any production

. and service provision where the resulting output cannot be verified
by subsequent measurement or monitoring.(Pg-492)
7.5.3 Identification and traceability (7.5.3)
Identifying product
151
The standard requires the organization to identify the product by
.
suitable means throughout product realization where appropriate.
(Pg-494)
7.5.3 Verification status
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)
7.5.4 Customer property (7.5.4)

Care of customer property
154
The standard requires the organization to exercise care with customer
.
property while it is under the organization’s control or being used by
the organization.(Pg-500)
7.5.4 Identification of customer supplied property

155
The standard requires the organization to identify customer property
.
provided for use or incorporation into the product.(Pg-501)
7.5.4 Verification of customer supplied property

156
The standard requires the organization to verify customer property
.
157 7.5.4 Protection of customer supplied property

.
_____________________________________________________________________
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The standard requires the organization to protect customer property

7.5.4) Maintenance of customer supplied property

158
The standard requires the organization to maintain customer property
.
7.5.4 Reporting problems to the customer
159 The standard requires occurrence of any customer property that is

. lost, damaged or otherwise found to be unsuitable for use to be
recorded and reported to the customer.(Pg-504)
7.5.5 Preservation of product
The standard requires the organization to preserve conformity of

160
product during internal processing and delivery to the intended
.
destination and goes on to require these measures to include
identification, handling, packaging, storage and protection.(Pg-505)
7.6 Control of measuring and monitoring devices (7.6)

Determining monitoring and measurements to be undertaken
161 The standard requires the organization to identify the monitoring and
. measurement to be undertaken to provide evidence of conformity of
product to be determined requirements.(Pg-510)
7.6 Determining measuring and monitoring devices needed
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)
7.6 Defining the measuring and monitoring processes
The standard requires processes to be established to ensure that

163
monitoring and measuring can be carried out and are carried out in
.
a manner consistent with the measuring and monitoring
requirements.(Pg-515)
7.6a Calibrating and verifying measurements
164 The standard requires measuring and monitoring devices to be

. calibrated at specified intervals or prior to use, against measurement
standards traceable to international or national standards.(Pg-521)
165 7.6a) Recording the basis for calibration

.
The standard requires that where no international or national
_____________________________________________________________________
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standards exist, the basis used for calibration or verification be

recorded.(Pg-525)
7.6b Adjustment of devices

166
The standard requires measuring equipment to be adjusted or re-
.
adjusted as necessary.(Pg-526)
7.6c Indicating calibration status

167
The standard requires measuring devices to be identified to enable
.
the calibration status to be determined.(Pg-527)
7.6d Safeguarding measuring and monitoring devices

. safeguarded from adjustments that would invalidate the
measurement result.(Pg-528)
7.6e Protection of measuring and monitoring devices

. protected from damage and deterioration during handling,
maintenance and storage.(Pg-529)
7.6 Action on equipment found out of calibration
The standard requires the validity of previous measuring results to be

170
assessed and recorded when equipment is found not to conform to
.
requirements and for appropriate action to be taken on the
equipment in any product affected.(Pg-530)
7.6 Calibration and verification records

171
The standard requires records of the results of calibration and
.
verification to be maintained.(Pg-531)
7.6 Software validation
The standard requires confirmation of the ability of software used for

172
measuring and monitoring of specified requirements to satisfy
.
intended application to be undertaken prior to initial use and
reconfirmed as necessary.(Pg-533)
173 8.1 Monitoring ,measurement, analysis and improvement processes:

.
Processes to demonstrate conformity:
The standard requires the organization to plan and implement the

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Page 107
monitoring measurement, analysis and improvement processes need

to demonstrate conformity of the product including determination of
conformity of the product including determination of applicable
methods such as statistical techniques and the extent of their use.
(Pg.544)
8.1 Processes to ensure conformity of management system:

monitoring measurement, analysis and improvement processes need
to ensure conformity of the quality management system including
determination of applicable methods such as statistical techniques
174 and their use. (Pg.549)

.
Processes to continually improve the effectiveness of the
management system

monitoring, measurement, analysis and improvement processes
needed to continually improve the effectiveness of quality
management system including determination of applicable methods
such as statistical techniques and their use. (Pg.551)
8.2.1 Customer satisfaction:
The standard requires the organization to monitor information
175 relating to customer perception as to whether the organization has

. met customer requirements and requires the method of obtaining and
using this information to determine.(Pg.553)
176 8.2.2 Internal audit

.
Auditing for conformance with planned arrangements:
The standard requires the organization to conduct internal audits at

planned intervals to determine whether the quality management
system conforms to the planned arrangements.(Pg.556)
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8.2.2 Planning audits:
The standard requires the audit programme to planned taking into

177
consideration the status and importance of the processes and areas
.
to be audited as well as the result of previous audits.(Pg.563)
8.2.2 Defining audit criteria , scope, frequency, methods:
178 The standard requires the audit criteria, scope, frequency and method
. to be defined.(Pg.565)
8.2.2 Selection of auditors:
The standard requires the selection of auditors and the conduct of

179
audits to ensure objectivity and impartiality of the audit process and
.
for auditors not to audit their own work.(Pg.566)
8.2.2 Audit procedure:
The standard requires the responsibilities and requirements for

180
planning and conducting audits for reporting results and maintaining
.
records to be defined in a documented procedure.(Pg.567)
8.2.2 Taking actions:
The standard requires management responsible for the area audited

181
to ensure that the actions are taken without undue delay to eliminate
.
the detected nonconformities and their causes.(Pg.569)
8.2.2 Follow-up audits:

182
. The standard requires follow-up activities to include the verification
of the actions taken and the reporting of verification results.(Pg.571)
183 8.2.2(a) Auditing for compliance:
.
The standard requires the organization to conduct internal audits at
_____________________________________________________________________
Page 109

system conforms to the requirements of this International Standard.
(Pg.559)
8.2.2(b) Auditing for effective implementation and maintenance:
184
. The standard requires the organization to conduct internal audits at
system is effectively implemented and maintained.(Pg.561)
8.2.3 Monitoring and measurement of processes
Monitoring and measuring methods:

185
. The standard requires the organization to apply suitable methods for
monitoring and where applicable measurement of the quality
management processes.(Pg.572)
8.2.3 Process capability:

186
. The standard requires the monitoring and measurement methods to
demonstrate the ability of the processes to achieve planned results.
(Pg.573)
8.2.4 Monitoring and measurement of product:
Verifying conformity with product requirements:
The standard requires the organization to monitor and measure the

187
. characteristics of the product to verify that the product requirements
have been met and that these activities be conducted at appropriate
stages of the product realization process in accordance with the
planned arrangements.(Pg.576)
8.2.4 Evidence of conformity:

188
The standard requires the evidence of conformity with the acceptance
.
criteria to be maintained.(Pg.579)
8.2.4 Identifying the person(s) authorizing release:

189
The standard requires records to indicate the person(s) authorizing
.
release of product.(Pg.581)
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8.2.4 Product release approval:
190 The standard requires that unless otherwise approved by a relevant

. authority and where applicable, by the customer ,product release
and service delivery is not to proceed until the planned arrangements
have been satisfactory completed.(Pg.582)
8.3 Control of nonconforming product:
Preventing unintended use
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)
8.3 Records of nonconformity:
192 The standard requires records of the nature of non-conformities and

. any subsequent actions taken, including concessions to be
maintained.(Pg.592)
8.3 Re-verification of corrected product:
193 The standard requires non-conformity product to be subject to re-

. verification after correction to demonstrate conformity to the
requirements.(Pg.593)
8.3 Consequence of nonconformity:
194 The standard requires the organization to take action appropriate to

. the effects or potential effects of the nonconformity when
nonconforming product is detected after delivery or use has started.
(Pg.594)
8.3(a) Correction of nonconforming product:
195
. The standard requires the organization when appropriate to deal with
nonconforming product by taking action to eliminate the detected
nonconformity.(Pg.588)
196 8.3(b) Authorizing use of nonconforming product:
.
The standard requires the organization when appropriate to deal with
_____________________________________________________________________
Page 111
nonconforming product by authorizing its use, release or acceptance

under concession by a relevant authority and where applicable by
the customer.(Pg.589)
8.3 (c) Action to preclude use or application:
197
. The standard requires the organization when appropriate to deal with
nonconforming product by taking action to preclude its original
intended use or application.(Pg.591)
8.4 Analysis of data:
Collecting and analyzing appropriate data:
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)
8.4 Evaluating where improvements in effectiveness can be made:

199
. The standard requires the organization to evaluate where continual
improvement of the effectiveness of the quality management system
can be made.(Pg.599)
8.4 (a) Analysis of customer satisfaction data:
200
. The standard requires analysis of data to provide information
relating to customer satisfaction.(Pg.600)
8.4(b) Analysis of conformance to customer requirements:
201
relating to conformity to product requirements.(Pg.603)
8.4(c) Analysis of product and process characteristics:
202
relating to characteristics and trends of processes and product
including opportunities for preventive action.(Pg.604)
8.4(d) Analysis of supplier data:
203
relating to supplier.(Pg.607)
204 8.5.1 Improvement:
.
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Continual improvement:
The standard requires the organization to continually improve the

effectiveness of the quality management system through use of the
quality policy, quality objectives, audit results, analysis of data,
preventive and corrective actions and management review.(Pg.609)
8.5.2 Corrective action:
Eliminating the cause of actual nonconformities

205
.
The standard requires the organization to take actions to eliminate
the cause of nonconformities in order to prevent recurrence and
requires the actions to be appropriated to the effects of the
nonconformities encountered.(Pg.612)
8.5.2(a) Reviewing nonconformities:
206
. The standard requires the documented procedure for corrective
action to define requirements for reviewing
nonconformities(including customer complaints).(Pg.615)
8.5.2(b) Determining the cause of non-conformities:
207
action to define requirements for determining the causes of
nonconformities.(Pg.618)
8.5.2(c) Evaluating the need for action:
208
action to define requirements for evaluating the need for action to
ensure that nonconformities do not recur.(Pg622)
8.5.2(d) Determining and implementing actions:
209
action to define requirements for determining and implementing the
corrective action needed.(Pg.623)
8.5.2(e) Recording results of action taken:
210
action to define requirements for recording results of action taken.
(Pg.625)
8.5.2(f) Reviewing corrective action taken:
211
. The standard requires the documented procedure for corrective action
to define requirements for reviewing corrective action taken.(Pg.626)
212 8.5.3 Preventive action:
.
_____________________________________________________________________
Page 113
Eliminating the cause of potential non conformities:
The standard requires the organization to determine action to

eliminate the causes of potential nonconformities in order to prevent
their occurrence and for such actions to be appropriate to the effects
of the potential problems.(Pg.628)
8.5.3(a) Determining potential nonconformities:
213
. The standard requires a documented procedure that defines
requirements for determining potential nonconformities and their
causes.(Pg.631)
8.5.3(b) Evaluating need for action:
214
requirements for evaluating the need for action to prevent
occurrence of nonconformities.(Pg.634)
8.5.3(c) Determining and implementing preventive action:
215
requirements for determining and implementing action needed to
prevent occurrence of nonconformities.(P.636)
8.5.3(d) Recording the results of preventive action:
216
requirements for recording of results of action taken to prevent
occurrence of nonconformities.(Pg.638)
8.5.3(e) Reviewing preventive action:
217
The standard requires a documented procedure that defines
.
requirements for reviewing action taken to prevent occurrence of
nonconformities.(Pg.639)
[David Hoyle, 2001]
_____________________________________________________________________
Page 114
Appendix B2: Template for Quality Manual (Pg 1 of 2)
_____________________________________________________________________
Page 115
Appendix B2: Template for Quality Manual (Pg 2 of 2)
_____________________________________________________________________
Page 116
Appendix B3: Template for Quality System Procedure (Pg 1 of 2)
_____________________________________________________________________
Page 117
_____________________________________________________________________
Page 118
Appendix B3: Template for Quality System Procedure (Pg 2 of 2)
_____________________________________________________________________
Page 119
Appendix B4: Template for Work Instructions
_____________________________________________________________________
Page 120
Appendix B5: Template for Training Manuals
_____________________________________________________________________
Page 121
Appendix B6: Template for Job Descriptions
_____________________________________________________________________
Page 122
_____________________________________________________________________
Page 123
Appendix B7: Template for Control Plan
_____________________________________________________________________
Page 124
Appendix B8: Template for FMEA
_____________________________________________________________________
Page 125
Appendix B9: Template for Control Chart (Pg 1 of 2)
_____________________________________________________________________
Page 126
Appendix B9: Template for Control Chart Sheet (Pg 2 of 2)
_____________________________________________________________________
Page 127
Appendix B10: Template for Process Capability Analysis Sheet
_____________________________________________________________________
Page 128
APPENDIX B11: TEMPLATE FOR PROCESS FLOW CHART SHEET
_____________________________________________________________________
Page 129

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Design and development of a Quality Management System for a production plant

The concept of a Quality Management System has been introduced for a

INTRODUCTION TO PROJECT TITLE

1.1 PROJECT TITLE

The project assigned to the group is titled as:

“Design and development of a Quality Management System for a production plant”.

1.2 ABOUT THE PROJECT TITLE

1.3 SCOPE OF THE PROJECT

 To study and analyze the current Quality Management System of the

 To focus on these identified Gaps in order to achieve an acceptable Quality

viii. Perceived Quality

2.1.2 Quality Characteristics

Time-oriented characteristics include such measures as a warranty, reliability, and

Ethical characteristics include honesty, courtesy, friendliness.

Attributes: a quality characteristic is said to be an attribute if it is classified as either

“A defect is a departure of a quality characteristic from its intended level or

2.1.3 Standard or Specification

2.1.3.1 Specification: A Definition Given By The U.S. National Bureau Of Standards

“ A set of conditions and requirements, of specific and limited application, that

“ A prescribed set of conditions and requirements, of general or broad appli-

Acceptable bounds on individual quality characteristics are usually known as

2.2 QUALITY CONTROL

Quality Control may generally be defined as a system that is used to maintain a

2.2.1 Off-line quality control

2.2.2 On-line quality control

2.2.3 Acceptance sampling plans

2.2.1 Off-line Quality Control

2.2.2 On-line Quality Control

For e.g. to control paperwork errors in an administrative department, information

2.2.3 Acceptance Sampling Plans

2.3 QUALITY ASSURANCE

The ANSI/ASQC Standard A3 (1987) defines Quality Assurance as follows:

[Amitava Mitra, 2004]

2.4 BENEFITS OF QUALITY

Quality affects all of the organization stakeholders.

Quality benefits the employees involved in producing high-quality products and

By participating in the development of the organization's processes, employees can

2.4.2 The Organization

A high-quality organization can focus on continuous improvement—assessing what's

 Reduced cost of inspections

 Less-frequent customer audits

 Open sharing of organization and supplier quality information

 Frequent visits to both the organization's and the suppliers’ facilities to

 Supplier shipments of materials directly to the organizations

 Decreased expenses from cost sharing

 Reduced risk to the organization because of its ability to use the

2.4.5 The Community

Communities are very aware of the benefits of having high-quality organizations.

[John E.Bauer, Grace L. Duffy, and Russell T. Westcott, 2006]

INTRODUCTION TO QUALITY MANAGEMENT SYSTEM

These methods collectively are known as Quality Management.

3.1 QUALITY MANAGEMENT

There are two schools of thought on Quality Management.

3.1.1 The Success School

The success school is categorized by five questions:

1. What are you trying to do??

3.1.2 The Failure Elimination School

The failure elimination school is characterized by five different questions:

1. How do you know what is needed??

4. How do you ensure the integrity of these checks??

3.2 QUALITY MANAGEMENT PRINCIPLES

ISO/TC 176 defined principle as:

“A comprehensive and fundamental rule or belief, for leading and operating an