CP 320

QUALITY CONTROL IN CHEMICAL

AND FOOD INDUSTRIES

Course Instructor:
Divina D. Kaombe, PhD
Tel. 0788 999689; Email: divinakaombe@yahoo.co.uk
 Objectives
• The course objective is to impart knowledge
to student on application of quality control
principles in chemical and food processing
industries.
 Learning Outcomes
At the end of the course students will be able to:
• Define the term quality, food quality and food
safety
• Explain why quality is important and the
consequences of poor quality
• Identify the determinants of quality
• Describe the costs associated with quality
 Learning Outcomes …
• Describe TQM, GMPs, SOPs, SSOPs, HACCP,
and ISO 9000 and 21000 series.
• Give an overview of problem solving
• Give an overview of process improvement
• Describe and use various quality control tools
• Explain how to implement statistical tools to
improve quality.
• Use sampling procedures to make decisions
and solve problems
 Pre-requisite
• Engineering Mathematics (MT 271)
 Mode of Delivery
• Lecture: 2 hours per week
• Tutorial: 2 hour per week
• Total hours: 60
• Credits: 8
 Course Assessment
The course will be assessed as shown below:
• Continuous Assessment (Tests, Quizzes and/or
Homework): 40%
• University Examination: 60%
 Course Contents
• Chapter 1: Introduction to concepts of quality,
food safety, quality assurance and quality
management; objectives, importance and
functions of quality control. Current
challenges to food safety.
 Course Contents . . .
• Chapter 2: Principles of quality assurance,
total quality management (TQM) – good
manufacturing/management practices, good
hygienic practices, good lab practices, general
awareness and role of management practices
in quality control.
• Chapter 3: Quality programs
• Chapter 4: Food safety management,
applications of HACCP in food safety.
 Course Contents . . .
• Chapter 5: Statistical quality control in
chemical and food industry.
– Statistical tools used in quality control
(histograms, Pareto charts, cumulative probability
functions, Six-sigma).
– Process capability.
– Application of control charts in process industries.
– The role of sampling in quality control: Sampling
and sample management techniques; Acceptance
sampling.
 Recommended Textbooks /
References
1. Merton R. Hubbard, Statistical Quality
Control for the Food Industry
2. Mark Clute, Food industry quality control
systems
3. George B., Gwilym M. J. and Gregory R.
(2006) Time Series Analysis: Forecasting &
Control (3rd Edition),
4. Hans-J. L, Peter T W, and Wolfgang S. (2008)
Frontiers in Statistical Quality Control.
 Chapter 1
Basic Quality Control Concepts as
applied to Chemical and Food
Industries

Introduction to concepts of quality,

quality assurance and quality
management; objectives, importance
and functions of quality control
 Definition of Quality
• Consider a food product.
– If foreign matter is found in a food,
– If the product is discolored or crushed or
– If causes illness or discomfort when eaten.
• The consumer reacts with anger, fear, and sometimes
mass hysteria (i.e. panic, madness, emotion).
• The offending product is often returned to the seller, or a
disgruntled letter is written to the manufacturer, or at
worst, an expensive law suit may be filed against the
company.
• The reaction is almost as severe if the failure is a difficult-
to-open package or a leaking container. There is no
tolerance for failure of food products.
 Your conclusion about this
product?

Good product!!!
Buy this product again!

Recommend to friends!

??? Quality of the Product!!!

 Definition of Quality
▪ Quality in its broadest sense
– Merriam Webster’s Collegiate Dictionary,
10th Edition(1994) defines quality as
“an inherent feature; degree of excellence;
and superiority in kind

Quality is a result
Quality is the result of a comparison between what was
required and what was provided. It is judged not by the
producer but by the receiver.
 Definition of Quality
▪ Some definitions that have gained wide acceptance
in the business world
▪ “Meeting or exceeding customer expectations”
▪ Juran, one of the quality qurus, defined quality
as;
▪ Fitness for Use
▪ That is, Quality is the extent to which
something is fit for its purpose.
 Definition of Quality
▪ Based on Juran‘s definiton, Quality therefore
does not only have to be perceived by the
customer, but the customer experience of
quality of a product or service is more
important.
▪ It places emphasis on the consumer aspect
of quality.
▪ It emphasizes that requirements and
specifications translate fitness for use into
measurable quantities.
▪ Quality does not mean an expensive product
 Definition of Quality
• Quality is conformance to requirements
or specifications.
– This is the definition used by Crosby who suggests
that in order to manage quality adequately, we
must be able to quantify and measure it.
 Definition of Quality
• Quality is inversely proportional to variability
– Customers value consistency and predictability

• Thus, quality improvement is the reduction of

variability in processes and products
 Definition of Quality
• Quality is the totality of features and
characteristics of a product or service that bear
on its ability to satisfy given needs.
– In this definition if you replace the word given with
stated or implied you have the ISO definition.
– This definition implies that quality is an attribute of
a product.
– A product is a quality product if it meets all the
requirements established for it; that is, it is a defect-
free product.
 Definition of Quality
▪ In quality management, quality is defined as;
▪ The totality of features and characteristics of a
product or service that bears on its ability to
satisfy customer’s stated and implied
needs.

▪ Quality is those features of a product or

service that allows it to satisfy (or
delight) customers
 Definition of Quality . . .
▪ Freedom from deficiencies – refers to
quality of conformance
▪ Conformance to standards- ability of the
product or service to conform to the stated
and implied requirements of customers.
▪ Higher conformance means fewer
complaint and increased customer
satisfaction
Customer-Driven Definitions of Quality

▪ What is a customer?
▪ Anyone who is impacted by the product
or services delivered by an organization

▪ External customer- the end user

▪ Internal customer- other divisions of

the company that receive the processed
product.
Eight Critical Dimensions of Quality
▪ Quality framework for strategic analysis:
▪ Performance – measures to what extent a
product or service meets the expectations of
the customer (primary operating characteristics
of a product).
▪ Features – secodary aspects of performance;
supplemental to basic functioning/operating
characteristics.
Eight Critical Dimensions of Quality
• Reliability - degree of dependability and
trustworthiness of the benefit of the product for a
long period of time ( consistency in perfomance
within specifications)
• Conformance – measures if processes are carried out
the way they were intended to be carried out (meet
established standards).
• Durability – length of time that a product performs
before it deteriorates
Eight Critical Dimensions of Quality
• Serviceability - promptness , courtesy,
proficiency/competence and ease of repair.

• Aesthetics – subjective in nature(deals with

art, beauty and taste); a product’s impacts on
the human senses eg. How it looks, feels,
sounds, tastes, smells and so on ( personal
judgement and a reflection of individual
preference).
Eight Critical Dimensions of Quality
• Perceived Quality – perception of the quality
of the product in the mind of the consumer. It
is related to personal experience.
 Importance of Quality
Reasons why quality is a cardinal priority for most
organizations.
• The need for safety and reliability - as systems have
become more complex the reliability requirements for
suppliers of components have become more stringent as
well as safety.
• Desire to excel – quality at its best
• Competition - Higher level of customer satisfaction-
higher customer expectations are getting spawned by
increasing competition.
 Importance of Quality
• Liberalization and globalization – multiple
choice for customers.
• Meaningful Choice –customers want to
make best decisions in money spending.
Benefits of Quality Control in Industry
• Improving the quality of products.
• Increasing the productivity of manufacturing
processes.
• Reducing manufacturing and corporate costs.
• Determining and improving the marketability of
products.
• Reducing consumer prices of products.
• Improving and/or assuring on-time deliveries and
availability.
 What does quality apply to?
• Every product, service, process, task, action,
decision can either be acceptable or
unacceptable.
• Hence, there is an intrinsic quality in everything
that an organization does.
• Everyone must pay attention to quality, from the
chief executive to the shop-floor across all
functions in an enterprise.
• It is as important for support staff to pay
attention to quality as well as production staff.
 Who is responsible for quality?
• One can only be responsible for doing something
relative to quality.
• Hence a person can be responsible for:
– specifying quality requirements
– achieving quality requirements
– determining the quality of something
• A role of Quality Manager is to enable others to
achieve quality by providing encouragement,
leadership, training, tools, techniques and
performance data.
 How can quality be achieved?
• Several methods have evolved to achieve, sustain and
improve quality.
• They are known as quality control, quality
improvement and quality assurance
• They are collectively known as quality management.
• Quality management is not the task of one manager
but of all managers and members in the production
chain.
• Quality is achieved through a chain of processes, each
of which has to be under control and subject to
continual improvement.
 How can quality be achieved?

The chain starts with top management expressing a

firm commitment to quality, then:
1. establishing customer needs and expectations
2. developing and maintaining a management
system that will enable achievement of
customer needs and expectations - reliably,
repeatedly and economically
3. designing products and services with features
which reflect customer needs
 How can quality be achieved?

4. building products and services so as to

reproduce faithfully the design
5. verifying before delivery that products and
services possess the features required
6. preventing the supply of products and services
which possess features which dissatisfy
customers
7. discovering and eliminating undesirable features
in products and services
 How can quality be achieved?
8. finding less expensive solutions to customer
needs
9. making operations more efficient and
effective
10.discovering what will delight customers and
providing it
11.most importantly, honouring commitments
 How can Quality be achieved?
There are standards, philosophies, methodologies,
tools, techniques and measures used to meet
quality goals:
• Management systems / Standards
– ISO 9001, ISO 14001, ISO 21000, ISO/IEC 27001
• Philosophies
– Total quality management
• Methodologies
– Business process management, continual
improvement
 How can Quality be achieved?
• Tools and techniques
– Process charts, failure mode and effects analysis,
statistical process control, quality function
deployment
• Measures
– Quality awards, best value, ISO 9000 and Investing
in People
Major Quality Concepts
 Major Quality Concepts
1. Balanced Scorecard (BSC) – introduced by Robert
Kaplan and David Norton (Measures that drives
performance).
➢ It is a strategic planning and management system that
organizations use to:
• Communicate what they are trying to accomplish
• Align the day – to – day work that everyone is
doing with strategy
• Prioritize projects, products, and services
• Measure and monitor progress towards strategic
targets
 Major Quality Concepts
➢ BSC examines company’s initiatives from four different
perspectives:
• Financial (how do the company looks to
shareholders)
• Customer/stakeholders (how do the customers see
the company)
• Internal business process (what must the company
excel at; strategic goals) and
• Learning/growth/innovation (can the company
continue to improve and create value)
Using the knowledge to focus the entire organization and its
various programs on “balancing” the scorecard
Major Quality Concepts
 Major Quality Concepts
2. ISO Standards - The International Standardization
Organization/international organization for
standardization (ISO).
- headquartered in Switzerland
- more than 100 nations are “members”, that define and
agree on, and abide by a wide range of product and
process safety and quality standards
- the idea behind ISO certification is that products made
in different nations be compatible for use in others.
- this allows manufacturers to buy parts from suppliers
in other countries.
 Major Quality Concepts
- Use of the standards aids in the creation of products
and services that are safe, reliable, and of good quality.
- The standards help businesses increase productivity
while minimizing errors and waste.
- By enabling products from different markets to be
directly compared, they facilitate companies in entering
new markets and assist in the development of global
trade on a fair basis.
- The standards also serve to safeguard consumers
and the end-users of products and services, ensuring
that certified products conform to the minimum
standards set internationally.
 Major Quality Concepts
- The Quality Management Systems (QMS) standards
are known as “ISO 9000” family of standards; (ISO
9000-2000, ISO 9001-2000, ISO 9004-2000); the
environmental management system are ISO 14000 and
so on.

3. Just-in-Time – a manufacturing theory of producing just

enough product to fill current orders as they are due.
“just –in time for them to be used”
 Major Quality Concepts
4. Kaizen – a Japanese term for “unending improvement”
-Kaizen represents a system in which management
encourages and implements small, incremental
improvements, involving employees as team members and
creating a culture of workers who all striving to do better
- it focuses on simplifying complex process and training
employees to measurable improve them.
 Major Quality Concepts
5. Quality Circles – based on a Japanese method of grouping
people together in “Quality Control” (QC) meetings where
they share their expertise and work to solve problems and
improve production.

6. Six Sigma – created by Motorola in 1980s. The name refers to

a scientific way of improving the quality of the output of a
process by identifying and removing the causes of defects
and minimizing variability in processes.

-the “sigma level” quantifies defects per million opportunities (DPMO)

 Major Quality Concepts

7. TOTAL QUALITY MANAGEMENT

– a management philosophy, a paradigm, a continuous
improvement approach to doing business through a new
management model
– a comprehensive, organization-wide effort to improve the
quality of products and services, applicable to all
organizations.

- TQM quality is managed by the total effort of an

organization, and that each department or phase of
production is responsible for making its part of the product or
services as flawless as possible before passing it on the next
user or phase.
Design Quality vs Manufactured
Quality
 Design Quality vs Manufactured
Quality
• Design quality refers to the quality of those
product characteristics that will appeal to
potential customers.
– It takes into account what it will cost to produce
the product and what the customers are willing to
pay for the product.
– It can be considered as the potential for achieving
manufactured quality.
 Design Quality vs Manufactured
Quality . . .
• After the manufacturing process has begun, the
process does not always produce a unit in
conformity with the design.
• When these defects are not related to the design,
but are related to an inadequate, poorly planned,
poorly controlled manufacturing process, we are
concerned with manufactured quality (which is
also known as the `quality of conformance to
design').
 Design Quality vs Manufactured
Quality . . .
• Any defective or nonconforming materials, parts,
assemblies, and finished products that are
discarded or reworked during the manufacturing
process result in increased cost and customer
dissatisfaction.
• Consequences of manufactured quality:
– The lost time and effort in producing the defective or
non-conforming product,
– The loss of business resulting from delays in delivery,
– Other associated costs attributable to a poorly
manufactured product.
 Design Quality vs Manufactured
Quality . . .
• Higher design quality usually means higher
cost, but higher manufactured quality usually
means lower cost.
• Because the goal should be to provide good
quality at low cost, both aspects of quality
need to be considered simultaneously.
 Design Quality vs Manufactured
Quality . . .
• At the corporate level, insufficient
preproduction testing or design qualification
may result in the necessity to recall (e.g.
automobiles, food products) and repair or
replace the product.
• Thus, quality is also part of corporate attitude.
 Design Quality vs Manufactured
Quality . . .
• Understanding of quality concepts contributes
to correct implementation and management
of product quality, and the entire production
enterprise benefits.
• A manufacturer must be aware of the
physical, cultural, and operational
environment in which the product will be used.
• If quality is understood, great reductions in
cost may be possible.
Dimensions of Quality
 The Dimensions of Quality
• One way to think about quality is the
degree to which performance of a product
or service meets or exceeds customer
expectations
• Expectations and Perceptions
– Customers’ prior expectations (generalized and
specific service experiences) and their perception
of service performance affect their satisfaction
with a service.

• Satisfaction = (Perception of Performance) –

(Expectation)
 Customers’
expectations for
the product or
service

is poor
Customers’

perceptions
perceptions of
Gap

Expectations >
the product or
service

Perceived quality
Customers’
expectations of
the product or
service

perceptions Customers’
perceptions of
Expectations =

the product or
service
product or service

Customers’
expectations
for the product
Gap

or service
perceptions

Customers’
Expectations <

perceptions of the
Perceived quality is governed by the gap between

product or service
Perceived quality is
good
customers’ expectations and their perceptions of the
 Additional views of Quality in Services
• Technical Quality versus Functional Quality
– Technical quality — the core element of the good
or service (what is delivered).
– Functional quality — customer perception of how
good functions or the service is delivered (how is it
delivered).
 The Dimensions of Quality
• Customer expectations can be broken
down into a number of categories, or
dimensions, that customers use to judge
the quality of a product or service.

• Understanding these dimensions helps

organizations in their efforts to meet or
exceed customer expectations.
The Dimensions of Product Quality
• Product quality is often judged on eight
dimensions of quality:
1) Performance: the main characteristics of the
product or service (Will the product do the
intended job?)
2) Reliability: consistency of performance (How
often does the product fail?)
3) Durability: The useful life of the product or
service. (How long does the product last?)
4) Serviceability: Handling of complaints and
repairs. (How easy is it to repair the product?)
The Dimensions of Product Quality
• . . . eight dimensions of quality (cont’d):
5) Aesthetics: Appearance, feel, smell, taste. (What
does the product look like?)
6) Features: Extra characteristics. (What does the
product do?)
7) Perceived quality: Indirect evaluation of quality
(e.g. reputation). (What is the reputation of the
company or its product?)
8) Conformance to standards: Is the product made
exactly as the designer intended? (How well a
product or service corresponds to design
specifications?)
 The Dimensions of Service Quality
• Since dimensions of product quality don’t adequately
describe service quality, service quality is often
described using the following dimensions:
1) Tangibles: The physical appearance of facilities, equipment,
personnel, and communication materials
2) Convenience: The availability and accessibility of the service
3) Reliability: The ability to perform a service dependably,
consistently, and accurately.
4) Responsiveness: the willingness of service providers to help
customers in unusual situations and to deal with problems
5) Time: the speed with which service is delivered
6) Assurance: the knowledge exhibited by personnel who come
into contact with a customer and their ability to convey trust
and confidence
7) Courtesy: the way customers are treated by employees who
come in contact with them.
Quality Factors in Food Products
 Quality Factors in Food Products
• Every food product has characteristics and
indices measurable by sensory, physical-
chemical, or microbiological methods.
• Some characteristics are easily perceived,
whereas others are not seen.
• Understanding these quality characteristics
and being familiar with appropriate measuring
tools are vital to quality control and the
quality assurance of food products.
 Factors Determining Food Quality
1.Sensory properties
• Appearance and colour, texture, taste and flavour
2.Physical properties
• Viscosity, consistency, etc.
3.Chemical composition
• Moisture content, fat content, food protein,
carbohydrates, vitamins, minerals
 Factors Determining Food Quality
4. Food additives
5.Microbiological characteristics
6.Other natural or synthetic components
influencing quality and safety
7.Packaging and labelling
Management Aspects of Quality
Control
Quality Planning
Quality Assurance
Quality Control
 Quality Planning
• Quality planning is the development of strategic
activities designed to improve the quality of a
product.
• It includes both statistical and management
activities.
• Benefits of a strategic quality plan
– Saves amount of time, money, and effort that would
otherwise be wasted by the organisation to deal with
faulty designs, manufacturing defects, field failures,
and customer complaints.
 Quality Planning
• Quality planning involves identifying customers
and their needs. Then develop products or
services that meet or exceed customer
expectations.
• The eight dimensions of quality are an important
part of this effort.
• The organisation must then determine how these
products and services will be realised.
• Planning for quality improvement on a specific,
systematic basis is also a vital part of this process.
Quality Assurance and Quality Control
• Quality Assurance is process oriented and
focuses on defect prevention

• Quality control is product oriented and

focuses on defect identification
 Quality Control - QC
• This is the most basic level of quality.
• It started with activities whose purpose is
to control the quality of products or services by finding
problems and defects.
• QC is inspecting, testing or checking something
(service or product) to make sure it's OK.
• The intent is to identify anything that isn't OK, and
either fix it or eliminate it, to make sure it conforms to
the specifications, and has/does/functions as required.
• QC is typically done at the end of the line, before it
'goes out the door'.
• If the something isn't OK, this is called 'nonconformity'
or a nonconforming service/product.
 Quality Control – QC . . .
• Quality Control does not ensure quality, it only
finds instances where quality is missing.
 Quality Assurance (QA)
• Quality Assurance developed from the realisation
that quality could be improved by looking 'further
up the line'.
• It is aimed at preventing nonconformities/
defects.
• QA still has QC at its core to control the quality of
service/product.
• But, it goes beyond mere testing or inspection to
also consider related activities or processes that
may be resulting in defects further down the line.
 Comparison of QA and QC
Quality Assurance Quality Control
QA is a set of activities for QC is a set of activities for ensuring
ensuring quality in the processes quality in products. The activities
Definition:
by which products are focus on identifying defects in the
developed. actual products produced.
QA aims to prevent defects with QC aims to identify (and correct)
a focus on the process used to defects in the finished product.
Focus on:
make the product. It is a Quality control, therefore, is a
proactive quality process. reactive process.
The goal of QA is to improve The goal of QC is to identify defects
development and test processes after a product is developed and
Goal: so that defects do not arise before it's released.
when the product is being
developed.
 Quality Assurance Quality Control
When Statistical Tools & Techniques are When statistical tools &
applied are applied to processes (process techniques are applied to
Statistical inputs & operational parameters), they are finished products (i.e. process
Techniques: called Statistical Process Control (SPC); & it
outputs), they are called as
becomes the part of QA. Statistical Quality Control (SQC) &
comes under QC.
Prevention of quality problems through The activities or techniques used
planned and systematic activities including to achieve and maintain the
What:
documentation. product quality, process and
service.
Establish a good quality management Finding & eliminating sources of
system and the assessment of its adequacy quality problems through tools &
How: & conformance audit of the operation equipment so that customer's
system & the review of the system itself. requirements are continually
met.
Everyone on the team involved in Quality control is usually the
Responsibility: developing the product is responsible for responsibility of a specific team
quality assurance. that tests the product for defects.
As a Tool: QA is a managerial tool QC is a corrective tool
Total Quality Management
(TQM)
 Quality Management
• Quality management is a much broader field.
• While it includes quality planning, as well as
quality control and quality assurance, it also
includes quality improvement and extends
beyond just QA and QC to a systems approach
and looking at the quality management
system as a whole.
QC, QA & Management

Quality Management

Quality Assurance

Quality
Control
 Total Quality Management (TQM)
• It is the most widely recognized quality
assurance system
• It is a culture of quality that involve all
employees of a firm
• It is based on the philosophy of “Right first
time”
• Emphasis on widespread training, quality
awareness
TQM Model
 Three Key Philosophies of TQM
1. Never-ending push to improve (Continuous
improvement)
2. Involvement of everyone in the organization
3. Customer satisfaction (meeting or exceeding
customer expectations)
Traditional view of Looking only at the quality of the
quality final product or service

Looking at the quality of every

TQM view of aspect of the process that
quality produce the product or service
 TQM Approach
1. Find out what customers want.
2. Design a product or service that will meet (or
exceed) what customers want.
3. Design processes that facilitate doing the job
right the first time.
4. Keep track of results, and use them to guide
improvement in the system.
5. Extend these concepts to suppliers and
distributors.
 Elements of TQM
1. Continuous improvement
2. Competitive benchmarking
3. Employee empowerment
4. Team approach
5. Decisions based on facts rather than opinions
6. Knowledge of tools
7. Supplier quality
8. Champion
9. Quality at the source
10. Suppliers are partners in the process, and long-term
relationships are encouraged.
 Continual improvement of the quality management system

Customers Customers
(and other Management (and other
interested responsibility interested
parties) parties)

Measurement,
Resource
analysis and
management improvement
Satisfaction

Requirements

Input
Product Output
Key: Product
Value adding activity realisation
information flow
 Comparing the cultures of TQM and
traditional organizations
Aspect Traditional TQM
Overall mission Maximize return on investment Meet or exceed customer
expectations
Objectives Emphasis on short term Balance of long term and short term
Management Not always open; sometimes Open; encourage employee input;
inconsistent objectives consistent objectives
Role of manager Issue orders; enforce Coach; remove barriers; build trust
Customer Not highest priority; may be Highest priority; important to
requirements unclear identify and understand
Problems Assign blame; punish Identify and resolve
Problem solving Not systematic; individuals Systematic; teams
Improvement Erratic Continuous
Suppliers Adversarial Partners
Jobs Narrow; much individual effort Broad; much team effort
Focus Product oriented Process oriented
QC, QA & TQM
 Kaizen
• Kaizen is a policy of implementing SMALL, incremental
CHANGES in order to achieve better quality and/or
greater efficiency
• It is focused on making “CONTINUAL IMPROVEMENT”

KAI = CHANGE
"CHANGE FOR THE BETTER"
ZEN = GOOD

Kaizen = Continuous Improvement

 Kaizen Guiding Principles
• Good processes bring good results
• Go see for yourself to grasp the current situation
• Speak with data, manage by facts
• Take action to contain and correct root causes of
problems
• Work as a team
• Kaizen is everybody’s business
• And much more!
 Six Sigma
• This is a business process for:
a) reducing defects
b) reducing product and/or process variability
c) reducing delivery time
d) reducing costs
e) Increasing productivity
f) Improving customer satisfaction
Management components of Six-sigma
• Providing strong leadership
• Defining performance metrics
• Selecting projects likely to achieve business
results
• Selecting and training appropriate people
 Six Sigma
• Statistically, six sigma means having no more
than 3.4 defects per million opportunities in
any process, product, or service.
• Six sigma programs can be employed in
design, production, service, inventory
management, and delivery.
• There are management and technical
components of six-sigma programs.
Technical components of Six-sigma
• Improving process performance
• Reducing variation
• Utilizing statistical methods
• Designing a structured improvement strategy
– i.e. Definition, measurement, analysis,
improvement, and control (DMAIC)
Quality Systems and Standards
 Quality System?
• Aggregate of the organizational activities,
incentives, plans, policies, procedures,
processes, resources, responsibilities, and the
infrastructure required in formulating and
implementing a total quality management
(TQM) approach.

• It's the system that an organization uses to

manage the quality of their services or
products.
 Quality Standards
• A set of criteria for quality established by an
organization.
• The standard also requires an organization to
have systems for implementing and monitoring
its standards.
• ISO 9000: The international standard for quality
assurance
• It is a standards award granted to organizations
that posses quality assurance systems that meet
the standards set
The Benefits of ISO Standards Awards
• Marketing advantages from the
acknowledgement of higher quality standards
• Assurance to customers that products meet
certain quality
• Greater employee motivation from the sense
of responsibility and recognition
• Financial benefits in the long term (due to
elimination of waste and improved reputation
of the company)
 Quality Management
• All the activities of the overall management
function that determine the quality policy,
objectives and responsibilities, and
implementation is by means of the quality
management system (QMS).
• Quality management practices include the
ongoing search for opportunities to improve.
 Quality Management
Quality
management
Quality
=
Control
Quality
+
Planning
Quality
+
Assurance
Quality
+
Improvement
 Quality Management System (QMS)?
• A system by which an organization aims to
reduce and eventually eliminate
nonconformance to specifications, standards,
and customer expectations in the most cost
effective and efficient manner.
 Quality Management System (QMS)?
• A quality management system (QMS) is a set
of policies, processes and procedures required
for planning and execution (production/
development/service) in the core business
area of an organisation.
– (i.e. areas that can impact the organization's
ability to meet customer requirements.)
Quality Management System (QMS) . . .
• Quality management systems are only one
type of management system;
• Other examples of management systems
include:
– financial management systems,
– environmental management systems
– food safety management systems.
 Quality Management System . . .
• Think of it as the system that your company
uses to plan, create, develop, make and/or
deliver your services or products.

• For a service business, it's the system you use

to provide those services. If you sell or
distribute products that other people
build/make/create, then it's the system you
use to get, store, sell and deliver or install
them.
 Elements of QMS
ISO 9001 groups them into 4 categories:
1. Management - planning, goals & objectives,
(reviewing progress)
2. Resources - people, tools, equipment, etc.
3. Services or Products 'realization' - whatever
is involved in creating or delivering them, and
4. Monitor, Measurement & Checking - the all-
important feedback loop.
 Scope of QMS
The scope of a QMS includes how you:
i. manage your organisation: planning, setting goals,
reviewing progress and results
ii. make sure people are competent for their work and
the right resources are available: plant, equipment,
IT, tools, etc
iii. check and analyse results, to see what happened and
why
iv. identify failures or problems systematically and fix
them
v. improve.
 Scope of QMS . . .
All these elements work together in the system
with two main overall aims:
• Producing services or goods of consistent
quality which meet all applicable requirements
• Increasing customer satisfaction.
The eight principles of
quality management
• Stated in ISO 9000:2000 and ISO 9004:2000
• They provide the basis for the performance
improvement outlined in ISO 9004:2000
 What is ISO?
• ISO is the International Organisation for
Standardisation
• It is a worldwide federation of national
standards bodies from some 130 countries, one
from each country. TBS is one of them.
• ISO’s work results in international agreements
which are published as international standards.
• Standards for QMSs have been developed by
ISO and are published as the ISO 9000 family.
 ISO 9000 Family of Standards
• The technical committee responsible for the
ISO 9000 family of standards is TC 176.
• The 3 main standards in the ISO 9000 family
are:
– ISO 9000: QMS – Fundamentals and Vocabulary
– ISO 9001: QMS – Requirements
– ISO 9004: QMS – Guidelines
 ISO 9000 Family of Standards
• The greatest value is obtained when you use
the entire family of standards in an integrated
manner.
– E.g. ISO 9000:2000, ISO 9001:2000, and ISO
9004:2000
• ISO 9001:2000 and ISO 9004:2000 have been
formatted as a consistent pair of standards to
facilitate their use.
 ISO 9001:2000
• This standard is used if an organisation is
seeking to establish a management system
that provides confidence in the conformance
of its product to established or specific
requirements.
• It is now the only standard in the ISO 9000
family against whose requirements the quality
system can be certified by an external agency.
 8 Quality Management Principles
• Principle 1 – Customer focus
• Principle 2 – Leadership
• Principle 3 – Involvement of people
• Principle 4 – Process approach
• Principle 5 – System approach to management
• Principle 6 – Continual improvement
• Principle 7 – Factual approach to decision making
• Principle 8 – Mutually beneficial supplier
relationships
 1. Customer Focus
• Your customers‘ needs are understood
throughout the company.
• Your internal company are directly linked to
customer expectations.
• You improve your company‘s ability to fulfill
customer needs in day-to-day activities.
• You ensure that your employees have the
necessary knowledge and skills to satisfy your
customers.
 2. Leadership
• You develop and communicate a clear vision
of your organization’s future.
• You translate your vision into measurable
goals for the organization.
• You involve your employees in the realization
of your company goals.
• You have a motivated, competent and stable
staff.
 3. Involvement of people
• Your employees contribute actively to the
improvement of your business strategy.
• Your employees adopt the organization‘s goals
as their own goals.
• Your employees are involved in decision-
making and the improvement of processes.
• Your employees are more satisfied with their
work and devote their individual development
potential to the service of your organization.
 4. Process Approach
• Your processes ensure achievement of
planned results and efficient use of resources.
• You take advantage of improvement potentials
because you are aware of the essential
success factors.
• Consistent emphasis on process orientation
helps you to reduce costs and prevent errors.
 5. System Approach to Management
• You develop extensive and ambitious business
plans, which combine functional and process
aspects.
• Sub-goals of individual processes become aligned
with the main goals of your organization.
• Monitoring the effectiveness of individual
processes allows you to better identify error
causes and improvement potential.
• You coordinate competencies and responsibilities
for superordinate goals, avoid any overlapping of
competencies and stimulate teamwork.
 6. Continual Improvement
• You combine continuous improvement and
strategic planning for more competitive business
plans.
• You set, realistic, measurable and ambitious goals
for improvement and provide any necessary
resources
• Your employees become involved in the process
of continual improvement.
• All employees of your organization are capable of
improving products, processes and systems.
 7. Factual Approach to Decision
Making
• You develop your company strategies based on
facts and information.
• Taking into account relevant comparative data,
you pursue more realistic and more ambitious
goals.
• You make use of recognized methods for data
analysis, making results available where
appropriate.
• You optimize your company’s processes and
systems performance, taking into account data
and information, manage improvement of
processes and prevent future problems
 8. Mutually beneficial supplier
relationships
• You increase your competitive advantage through
the development of strategic partnerships with
suppliers.
• You develop more ambitious goals by including
your suppliers in your planning at an early stage.
• Through improved relationships with suppliers,
you ensure reliability, punctuality and error free
compliance of incoming goods.
• You develop and strengthen the performance
capability of your suppliers through training
activities and joint efforts towards continuous
improvement.
Determinants of Quality
 Determinants of Quality
The degree to which a product or a service
successfully satisfies its intended purpose has
four primary determinants:
1. Design
2. How well it conforms to the design
3. Ease of use
4. Service after delivery
 1. Quality of Design
(Design Quality)
• Design involves decisions about the specific
characteristics of a product or service such as
size, shape, and location.
• Quality of design refers to the intention of
designers to include or exclude certain features in
a product or service, e.g. size, appearance, fuel
economy, materials used, etc.
• Design decisions must take into account customer
wants, production or service capabilities, safety
and liability, costs, and other similar
considerations.
 Quality of Design . . .
• Designers may determine customer wants from
information provided by marketing through the use of
consumer surveys or other market research.
• Designers must work closely with representatives of
operations to ascertain that designs can be produced;
that is, that production or service has the equipment,
capacity, and skills necessary to produce or provide a
particular design.
• A poor design can result in difficulties to attain. E.g.
materials might be difficult to obtain, specifications
difficult to meet, or procedures difficult to follow.
 2. Quality of Conformance
• This is the degree to which goods and services
conform to (i.e. achieve) the intent of the
designers.
• This is affected by factors such as:
– capability of equipment used;
– the skills, training and motivation of workers;
– the extent to which the design lends itself to
production;
– the monitoring process to assess conformance; and
– the taking of corrective action (e.g. through problem
solving) when necessary.
 3. Ease of use
• The determination of quality does not stop once the
product or service has been sold or delivered.
• Ease of use and user instructions are important.
• This increase the chances, but do not guarantee, that a
product will be used for its intended purposes and in
such a way that it will continue to function properly
and safely.
• Much consumer education takes the form of printed
instructions and labeling.
• Thus manufacturers must ensure that directions for
unpacking, assembling, using, maintaining, and
adjusting the product, and what to do if something
goes wrong, - are clearly visible and easily understood.
 4. Service after delivery
• For a variety of reasons, products do not always
perform as expected, and services do not always
yield the desired results.
• Whatever the reasons, it is important from a
quality standpoint to remedy the situation, and to
do whatever is necessary to bring the product or
service up to standard.
– Remedy the situation through recall and repair of the
product, adjustment, replacement or buyback, or re-
evaluation of a service.
The Consequences of
Poor Quality
The Consequences of Poor Quality
Some of the major ways that quality affects an
organisation are:
• Loss of business
• Liability
• Productivity
• Costs
 Loss of business
• Poor designs or defective products or services
can result in loss of business.
• Failure to devote adequate attention to
quality can damage a profit-oriented
organisation’s image and lead to a decreased
share of the market, or it can lead to increased
criticism.
 Liability
• Organisations must pay special attention to
their potential liability due to damages or
injuries resulting from faulty design or poor
workmanship.
• Liability for poor quality has been well
established in the courts.
• An organisation’s liability costs can often be
substantial, especially if injury or damage is
involved.
 Productivity
• Productivity and quality are often related.
• Poor quality can adversely affect productivity
during the manufacturing process if parts are
defective and have to be reworked or if an
assembler has to try a number of parts before
finding one that fits properly.
• Poor quality in tools and equipment can lead to
injuries and defective output , which must be
reworked.
• Poor service can mean having to redo the service
and reduce service productivity.
 Cost
• Cost to remedy a problem is a major
consideration in quality management.
• The earlier the problem is identified in the
process, the cheaper the cost to fix it.
• It has been estimated that the cost to fix a
problem at the customer end is about five
times the cost to fix a problem at the design
or production stages.
 The Costs of Quality
Costs associated with quality can be classified
into three categories:
1. Appraisal costs
2. Prevention costs
3. Failure costs
 Appraisal costs
• These costs relate to inspection, testing, and
other activities intended to uncover defective
products or services, or to assure that there
are none.
• They include the cost of inspectors, testing,
test equipment, labs, quality audits, and field
testing.
 Prevention costs
• These costs relate to attempts to prevent
defects from occurring.
• They include costs such as planning and
administrative systems, working with vendors,
training, quality control procedures, and extra
attention in both the design and production
phases to decrease the probability of
defective workmanship.
 Failure costs
• These are costs incurred by defective parts or
products or by faulty services.
• Internal failures are those discovered during
the production process
• External failures are those discovered after
delivery to the customer.
 Internal failures
Internal failures occur for a variety of reasons,
including:
• Defective material from vendors/suppliers;
• Incorrect machine settings;
• Faulty equipment;
• Incorrect methods;
• Incorrect processing;
• Carelessness; and
• Faulty or improper material handling procedures.
 Costs of internal failures
The costs of internal failures include:
• Lost of production time
• Scrap and rework
– salary of workers and the additional resources
needed to perform the rework, e.g. equipment,
energy and raw materials
• Investigation costs
• Possible equipment damage
• Possible employee injury
 Costs of external failures
External failures are defective products or poor service
that go undetected by the producer. Resulting costs
include:
• Warranty work;
• Handling of complaints;
• Replacements;
• Liability;
• Payments to customers or discounts used to offset the
inferior quality;
• Loss of customer goodwill; and
• Opportunity costs related to lost sales.
Quality costs increase over time
Liability costs
Failure Costs

Failure found by customer

Field repair costs

Failure found at installation

Failure found at final inspection

Failure found at onset of manufacture
Failure found during design phase
Prevention Costs

Time when failure found