QUALITY CONTROL AND ASSURANCE

The reputation enjoyed by any organization is it built by:

 Quality,
 Services ,
 Price ,
 Facilities, etc

QUALITY
 The Production
& Operations Process
Inputs Conversion Process Output

Manufacturing

UB’s Dry
Cleaners

Service
 What is Quality?
Quality of a product or services is its ability to satisfy
the needs and expectations of the customer.
“The quality of a product or service is a
customer’s perception of the degree to which the
product or service meets customer’s expectations.”

“degree of excellence of a thing”

“totality of features and characteristics that satisfy needs”

“ Quality is never by an accident , it is always the result of

an intelligent effort”
“fitness for use” “conformance to
requirements”

Quality

Product Freedom from

Features Deficiencies

That Customers Want At Six Sigma Levels

Design for Six Sigma Improve to Six Sigma
 Meaning of Quality:
Meaning of Quality

Producer’s Perspective Consumer’s Perspective

Quality of Conformance Quality of Design

Production • Conformance to • Quality characteristics Marketing
specifications • Price
• Cost and profit

Fitness for
Consumer Use

Consumer’s and producer’s / Provider’s perspectives depend on each other

Consumer’s perspective: A rightful level of expectations to buy high quality products
at the lower possible cost
Provider’s perspective: A rightful level of expectations to produce high quality
products at the highest possible profits
Consumer’s view must dominate
 Who defines Quality - the Q Lens

people
Lens of the
products organisation
processes

results
outcomes
benefits
Lens of the
customer
 Right Lower
Features Deficiencies
Loyal
Customers

Fast Low Low

Good Mkt.
Cycle Warranty Scrap/
Price Share
Time Costs Rework

Lower
Higher
Total Cost
Revenue

How do we achieve these desired results?

 Introduction
• Quality control (QC) includes the activities
from the suppliers, through production, and to
the customers.
• Incoming materials are examined to make
sure they meet the appropriate specifications.
• The quality of partially completed products are
analyzed to determine if production processes
are functioning properly.
• Finished goods and services are studied to
determine if they meet customer expectations.
QC Throughout Production Systems
Inputs Conversion Outputs
Raw Materials,
Production Products and
Parts, and
Processes Services
Supplies

Control Charts Control Charts

and Control Charts and
Acceptance Tests Acceptance Tests

Quality of Quality of Quality of

Inputs Partially Completed Outputs
Products
 QA and QC systems

Quality Control:
planned activities designed to provide a quality
product.

Quality Assurance:
planned activities designed to ensure that the
quality control activities are being properly
implemented.
 Dimensions of Quality - Product

1. Performance
 Basic operating characteristics
2. Features
 “Extra” items added to basic features
3. Reliability
 Probability product will operate over time
4. Conformance
 Meeting pre-established standards
5. Durability
 Life span before replacement
Dimensions of Quality - Product

6. Serviceability
 Ease of getting repairs, speed & competence of repairs
7. Aesthetics
 Look, feel, sound, smell or taste
8. Safety
 Freedom from injury or harm
9. Other perceptions
 Subjective perceptions based on brand name, advertising, etc
 Dimensions of Quality Service
1. Time & Timeliness
 Customer waiting time, completed on time
2. Completeness
 Customer gets all they asked for
3. Courtesy
 Treatment by employees
4. Consistency
 Same level of service for all customers
5. Accessibility & Convenience
 Ease of obtaining service
6. Accuracy
 Performed right every time
7. Responsiveness
 Reactions to unusual situations
 Quality and Value
• Value is not a price tag but measure of
perceived benefits (meet requirements but…)
• Training outcome(50cents less)
• Quality of the complete transaction
counts…service quality as well…
human relationship – Banks (attempt to
reduce costs)
 Importance of Quality
Market Gains
Reputation
Volume
Price
Improved Increased
Quality Profits
Lower Costs
Productivity
Rework/Scrap
Warranty
 Cost of Quality

Cost of good Quality Cost of poor Quality

• Prevention • Internal failure
• Planning • Scrap
• Design • Rework
• Process • Process failure
• Training •Downtime
• Information
• Appraisal (=control)
? •Price reduction
• External failure
•Inspection • Complaints
•Testing • Returns
•Equipment •Warranty Claims
•Operator •Liability
•Lost sales
Quality: the performance objective

Quality

Speed

Dependability

Flexibility

Cost
Quality Process (Manufacturing)

Customer Marketing Engineering Operations

Specifies Interprets Designs Produces

Need Need Product Product

Defines Plans
Quality Quality
is e n !
li ty d ri v
Qua omer Monitors
us t
c Quality
 Quality Defects
A Defect
• Non conformance of a unit of a product with specified
requirements
Minor- Unnoticeable
Major- Cause stoppage of operations, may affect performance
Critical- Must be attended to Promptly
Causes of Defects
• lack of Know How
• carelessness
• Improper Designs
• Lack of or insufficient instructions
• Inherent errors in Raw Materials , MACHINES
 INSPECTION
Definition : “The process of

- measuring,

- examining,

- testing,

- Gauging, or

- otherwise comparing one or more characteristics

of a product, or

- service with the specified requirements”

 INSPECTION
Definition : Critical appraisal involving examination, measurement, testing, gauging,
and comparison of materials or items.

An inspection determines, if the material or item is in proper quantity and condition,

and if it conforms to the applicable or specified requirements.

Inspection is generally divided into three categories:

(1) Receiving inspection,

(2) In-process inspection, and

(3) Final inspection.

In quality control (which is guided by the principle that "Quality cannot be inspected

into a product") the role of inspection is to verify and validate the variance data; it
does not involve separating the good from the bad.
 Inspection
• How Much / How Often
• Where / When Y
Process

• Centralized vs. On-site

Measurements

Inputs Transformation Outputs Y

Finished Product
or Service

Process Acceptance
Acceptance control sampling Y
sampling
Statistical Methods for Quality
Control and Improvement

Three major areas:

• Statistical process control (SPC)

• Design of experiments (DOX)
• Acceptance sampling
 SQC-SPC

• SQC- Techniques designed to evaluate

quality from a conformance view. That is
how well we are doing at meeting the
specifications that have been set during the
design of the parts or services that we are
providing.

• SPC- Techniques for testing a random

sample of output from a process to determine
whether a process is producing items within a
prescribed range.
 Statistical Methods for Quality
Control and Improvement

Statistical Process
Control (SPC)
• Control charts are
used for process
monitoring and
variability reduction.
• SPC is an on-line
quality control tool.
Statistical Process Control:
Statistical evaluation of the output of a process during production
 Statistical process control (SPC)
• Statistical process control (SPC)
– The costs are low, if the problems are detected early
– If a large number of defective products are produced,
the scrap or rework costs can be high.
– Prevention of defects by applying statistical methods
to control the process is known as SPC
– Prevention refers to those activities designed to
prevent defects, defectives, and nonconformance in
Cost of detection (Rupees)

products and services

Process Final testing Customer

When defect is detected
 Control Chart
• Control Chart
– Purpose: to monitor process output to see if it is
random
– A time ordered plot representative sample
statistics obtained from an on going process
(e.g. sample means)
– Upper and lower control limits define the range
of acceptable variation
 Control Chart

Abnormal variation Out of

due to assignable sources control Limit
UCL

Mean
Normal variation
due to chance
LCL
Abnormal variation
due to assignable sources

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Sample number
 Statistical Process Control
• The essence of statistical process
control is to assure that the output of a
process is random so that future output
will be random.
 Statistical Process Control
• The Control Process
– Define
– Measure
– Compare
– Evaluate
– Correct
– Monitor results
 Statistical Methods for Quality
Control and Improvement

Design of Experiments (off-line quality tools)

• Experimental design is an approach to
systematically varying the controllable input
Parameters / factors in the process and determine
the effect these factors have on the output
responses.
• Experimental designs are off-line quality tools.
• Crucial for variability reduction.
 Statistical Methods for Quality
Control and Improvement
Acceptance Sampling
• Acceptance sampling is the inspection and
classification of a sample of the product selected at
random from a larger batch or lot and the ultimate
decision about disposition of the lot.
• Two types:
1. Outgoing inspection - follows production
2. Incoming inspection - before use in production
• Acceptance sampling eliminates the need for 100%
inspection
 Steps in Quality Control
i) Formulate quality control
ii) Set the standards or specifications on the basis of customer’s
preference , cost and profit .
iii) Select inspection plan and set up procedure for checking
iv) Detect deviations from set standards of specifications.
v) Take corrective actions or necessary changes to achieve
standards.
vi) Decide on salvage method i.e., to decide how the defective
parts are disposed of, entire scrap or network.
vii) Co-ordination of quality problems.
viii) Developing quality consciousness both within and outside the
organization.
ix) Developing procedure for good vendor-vendee relations.
 Quality management
• Quality management is concerned with
controlling activities with the aim of ensuring
that products and services are fit for their
purpose and meet the specifications.
 Evolution of Quality Management System

Inspection Salvage, sorting, grading, blending, corrective

actions, identify sources of non-conformance
Develop quality manual, process performance
Quality data, self-inspection, product testing, basic
Control quality planning, use of basic statistics,
paperwork control.
Quality systems development, advanced quality
Quality
planning, comprehensive quality manuals, use of
Assurance quality costs, involvement of non-production
operations, failure mode and effects analysis, SPC.
Quality Policy deployment, involve supplier & customers,
Management involve all operations, process management,
System performance measurement, teamwork, employee
[Link] and QC are parts of QMS
 Quality assurance
• Quality assurance is about how a business
can design the way a product of service is
produced or delivered to minimize the
chances that output will be sub-standard. The
focus of quality assurance is, therefore on the
product design/development stage.
ISO 9000 is a series  of standards ,
development and published by the ISO
that define,establish and maintain an
effective quality assurance system for
manufacturing and service industries.
 WHAT IS ISO
ISO is a name used for the 
International Organization for Standardization 

It was formed in 1947 in Geneva, Switzerland.

It is a federation of national standard bodies of 162

countries.
 NEED
1)By implementing an organization can benefit many
industries such as banking, health care, manufacturing etc

2)The goal of this implementation is to achieve customer

satisfaction at its highest value

3)To compete in domestic/ international markets

4)To improve quality system

 OBJECTIVE
1. To promote development of
standardization to facilitate international
exchange of goods and services.
2. To promote cooperation in intellectual,
scientific, technological, and economic
activity
 ADVANTAGES
For the customer:-

-Increase satisfaction and growth in confidence.

-for the company:

1)Well defined organization and responsibilities,

i.e., minimize grey areas and possible resources wastage

2)Establishment of proper communication channel

 ADVANTAGES

 A greater degree of internal control.

Greater productivity and cost reduction

Evidence of compliance

Recognition of standard achieved

STANDARD CONTENT APPLICATION

ISO 9000 Provides definition and concepts. All industries including software
Explains how to select other development
standards for a given business

ISO 9001 Quality assurance in design, Engineering and construction

development, production, firms, manufacturers that design,
installation and servicing develop, install and service
products
ISO 9002 Quality assurance in production Companies in the chemical
and installation process industries that are not
involved in product design or after
sales service
ISO 9003 Quality assurance in test and Small shops, divisions within a
inspection firm, equipment distributors that
inspect and test supplied products
ISO 9004 Quality management and quality All industries
system elements
 The ISO 9000 Concept…

• Represents an international consensus on good

management practices for a systematic and generic
application of principles and practices based on quality

• ISO 9000 is a written standard that defines the basic

elements of a QMS that organizations should use to
ensure that their products and/or services meet or
exceed customer expectations

• Is a set of standardized requirements for QMS and is

applicable to any organization regardless of it’s size or
whether public or private sectors
 The ISO 9000 Concept…
• ISO 9000 is seen as a vehicle towards TQM
• The principal goal of the ISO 9000 Standards is to
demonstrate quality assurance
• “Quality culture” refers to the
degree of awareness,

commitment,

collective attitude

and

behaviour of the
organization with
regard to quality.
 QUALITY MANAGEMENT PRINCIPLES
The eight quality management principles are:-

1. Customer focus

2. The role of Leadership

3. Involvement of People

4. Process Approach

5. System Approach to Management

6. Continual Improvement

7. Factual Approach to Decision Making

8. Mutual Beneficial Supplier relationship

 The Principles
1. Customer focus

Organizations depend on their customers and

therefore should understand current and future
customer needs, should meet customer requirements
and strive to exceed customer expectations

Implication
Customer focused means putting your energy into
satisfying customers and understanding that profitability
comes from satisfying customers.
 2. Leadership
Leaders establish unity of purpose and direction of
the organization. They should create and maintain the
internal environment in which people can become
fully involved in achieving the organization’s
objectives.
Implication
Leadership is providing role model behaviours consistent
with the values of the organization.
Behaviour that will deliver the organizations objectives.
Internal environment includes the culture and climate,
management style, shared, trust, motivation and support.
 3. Involvement of People

People at all levels are the essence of an

organization and their involvement enables their
abilities to be used for the organization’s benefit

implication
involving people means sharing knowledge, encouraging
and recognizing their contribution, utilizing their
experience and operating with integrity.
 4. Process Approach
A desired result is achieved more efficiently when
activities and their related resources are
managed as a process

Implication
Processes are dynamic-they cause things to happen.
processes within an organization should be structured in
order to achieve a certain objective in the most efficient
and effective manner.
 5. System Approach to Management

Identifying, understanding and managing

interrelated processes as a system contributes to
the organization’s effectiveness and efficiency in
achieving it’s objectives

Implication
Systems are constructed by connecting interrelated
processes together to deliver the system objectives which
in the case of the QMS is the satisfaction of the interested
parties.
 6. Continual Improvement

Continual improvement of the organization’s

overall performance should be a permanent
objective of the organization

Implication
Continual improvement is the progressive improvement in
organizational efficiency and effectiveness.
 [Link] Approach to Decision Making

Effective decisions are based on the analysis of

data and information

Implication:
Facts are obtained from observations performed by
qualified people using qualified means of measurements
i.e. the integrity of the the information is known.
8. Mutual Beneficial Supplier relationships

An organization and it’s suppliers are

interdependent and a mutually beneficial
relationship enhances the ability for both to create
value

implication
beneficial relationships are those in which both parties are
knowledge,vision,values,and [Link] are
not treated as adversaries.
 Quality Management System( QMS)
Quality Policy: Quality policy means the overall intentions and direction of an
organization with respect to quality, as established by management with executive
responsibility.
Quality System: Quality system means the organizational structure,
responsibilities, procedures, processes, and resources for implementing
quality management.
 ISO 9001 : 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 organization.
(i.e. areas that can impact the organization's ability to meet customer
requirements.) ISO 9001:2008 is an example of a Quality Management System.

QMS integrates the various internal processes within the organization and intends
to provide a process approach for project execution.

A Process based QMS enables the organizations to identify, measure, control

and improve the various core business processes that will ultimately lead to
improved business performance.

A complete ISO 9001 Quality Management System must address all

the requirements of ISO 9001, and more specifically must meet the ISO 9001
Documentation Requirements.
 ISO 9001:2008 Requirements
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realisation
8. Measurement, analysis and improvement
 PDCA Cycle

4. ACT 1. PLAN
Permanently Identify im-
implement provements and
improvements develop plan

3. CHECK 2. DO
Evaluate plan Try plan on
to see if it a test basis
works
ISO Clause ISO Clause
Number ISO Clause Name Number ISO Clause Name
0 INTRODUCTION 7 PRODUCT REALIZATION
0.1 General 7.1 Planning of Product Realization
0.2 Process Approach 7.2 Customer-related Processes
0.3 Relationship with ISO 9004 7.2.1 Determination of Requirements Related to the Product
0.4 Compatibility with Other Management Systems 7.2.2 Review of Requirements Related to the Product
1 SCOPE 7.2.3 Customer Communication
1.1 General 7.3 Design and Development
1.2 Application 7.3.1 Design and Development Planning
2 NORMATIVE REFERENCES 7.3.2 Design and Development Inputs
3 TERMS AND DEFINITIONS 7.3.3 Design and Development Outputs
4 QUALITY MANAGEMENT SYSTEM 7.3.4 Design and Development Review
4.1 General Requirements 7.3.5 Design and Development Verification
4.2 Documentation Requirements 7.3.6 Design and Development Validation
4.2.1 General 7.3.7 Design and Development Changes
4.2.2 Quality Manual 7.4 Purchasing
4.2.3 Control of Documents 7.4.1 Purchasing Process
4.2.4 Control of Records 7.4.2 Purchasing Information
5 MANAGEMENT RESPONSIBILITY 7.4.3 Verification of Purchased Product
5.1 Management Commitment 7.5 Production and Service Provision
5.2 Customer Focus 7.5.1 Control of Production and Service Provision
5.3 Quality Policy
5.4 Planning 7.5.2 Validation of Processes for Production and Service Provision
5.4.1 Quality Objectives 7.5.3 Product Identification and Traceability
5.4.2 Quality Management System Planning 7.5.4 Customer Property
5.5 Responsibility, Authority, and Communication 7.5.5 Preservation of Product
5.5.1 Responsibility and Authority 7.6 Control of Monitoring and Measuring Equipment
5.5.2 Management Representative 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
5.5.3 Internal Communications 8.1 General
5.6 Management Review 8.2 Monitoring and Measurement
5.6.1 General 8.2.1 Customer Satisfaction
5.6.2 Review Input 8.2.2 Internal Audits
5.6.3 Review Output 8.2.3 Monitor and Measurement of Processes
6 RESOURCE MANAGEMENT 8.2.4 Monitoring and Measurement of Product
6.1 Provision of Resources 8.3 Control of Nonconforming Product
6.2 Human Resources 8.4 Analysis of Data
6.2.1 General 8.5 Improvement
6.2.2 Competence, Training, and Awareness 8.5.1 Continual Improvement
6.3 Infrastructure 8.5.2 Corrective Actions
6.4 Work Environment 8.5.3 Preventive Actions
 Quality Management System
CUSTOMERS
Feedback
8.2 Monitoring Customer
Satisfaction

Covering the entire QMS is:

8.2 Internal Audits
4.2.3 DOCUMENT CONTROL
Shipping &
AND
Delivery 8.3 Control of
4.2.4 RECORDS CONTROL
Nonconforming Product

8.4 Analysis of Data

(Suppliers, Process,
Product, Customer)

7.6 Monitoring & 8.5 Corrective & 8.5 CONTINUAL

Measuring Devices Preventive Action IMPROVEMENT

8.0 MEASUREMENT,

RESPONSIBILITY
5.0 MANAGEMENT
7.5 Production Control ANALYSIS AND 5.6 Management Review
REALIZATION
7.0 PRODUCT

IMPROVEMENT 5.4 Quality Objectives

7.4 Purchasing &
Receiving
5.3 Quality Policy

7.3 Design 5.1 Management

Commitment
6.0 RESOURCE
7.1 Planning MANAGEMENT

6.2 Human Resources

(Training)

6.3 Infrastructure

6.4 Work Environment

Bids, Quotations,
Orders, and Contracts CUSTOMERS
CUSTOMER REQUIREMENTS
 The Concept of Quality Management

Quality Management System in its basic concept is

quite simple. It seeks to:

 Recognize the external quality related

requirements specified in Licenses to Trade,
guidelines, specified customer requirements, and the
chosen management system standard(s).

 Ensure that all requirements have been

documented within the management system in the
appropriate location in terms of defined specific
system requirements
 The Concept of Quality Management

 Confirm that employees receive applicable

training in the quality system requirements.

 Outline performance processes, where applicable,

to the quality system requirements.

 Produce records or evidence that system

requirements have been met Measure, monitor and
report the extent of compliance with these
performance procedures
 The Concept of Quality Management

Continually monitor and analyze changes to the

requirements and confirm that all changes are
reflected in changes to the specific requirements
when necessary.

Execute the audit and analyze the system

processes and correct them when necessary.

Includes processes that will help continually

improve the quality system.
 Salient Features- ISO 9001:2008

 Establishes and streamlines processes through complete documentation

 Improves and establishes training processes

 Defines roles and responsibilities

 Greatly increases operational efficiency

 Increases ability to troubleshoot

 Develops and builds relationships that help to retain existing customers

 Provides advantages over competitors that aren't certified ISO 9001:2008

 Builds opportunities for global commerce with international recognition

 Improves customer relations

 Salient Features- ISO 9001:2008

 Improves relationships with suppliers due to clear, concise production

standards·

 Provides basis for consistent and fact-based decision making

 Carefully planned improvements, based on documentation and analysis

 Provides for regular audits/reviews of performance

 Key Benefits of ISO 9001:2008

 Increases productivity· Maximizes quality

 Increases revenue· Improves employee morale and satisfaction

 Saves time and money

 Enhances ability to attract new customers that have adopted requirements for
certification

 Improves accountability of management

 Increases employees' understanding of their roles in success of their work and

the company

 Creates greater motivation and dedication

 The Quality Improvement Model
Define
Process

A Roadmap to Improvement Select

Measures

Collect &
Interpret
Data
Purpose: To provide a sequence of steps
to improve any process so that
the customers will realize the Is
Process
No Investigate &
highest quality and value. Stable Fix Special
Causes
?

Yes

No Is
Improve
Process
Process
Capable
Capability ?

Yes
Use SPC to
Maintain
Current
Process
 QUALITY CONTROL

“THOSE QUALITY ASSURANCE ACTIONS

WHICH PROVIDE A MEAN TO CONTROL

AND MEASURE THE CHARACTERISTICS

OF AN ITEM, PROCESS OR FACILITY

TO ESTABLISHED REQUIREMENTS.”
 QUALITY ASSURANCE
“ALL THOSE PLANNED & SYSTEMATIC

ACTIONS NECESSARY TO PROVIDE

ADEQUATE CONFIDENCE THAT AN

ITEM OR A FACILITY WILL PERFORM

SATISFACTORILY IN SERVICE.”
 Phases of Quality Assurance

Inspection and
Inspection corrective Quality built
before/after action during into the
production production process

Acceptance Process Continuous

sampling control improvement

The least The most

progressive progressive
 ISO 9001 and ISO 14001 in brief

• ISO 9001 and ISO 14001 are among ISO's most well
known standards ever.

• They are implemented by more than a million organizations

in some 175 countries.

• ISO 9001 helps organizations to implement quality

management.

• ISO 14001 helps organizations to implement environmental

management.
 Quality management
• ISO 9001 is for quality management.
• Quality refers to all those features of a product (or
service) which are required by the customer.
• Quality management means what the organization
does to
• ensure that its products or services satisfy the
customer's quality requirements and
• comply with any regulations applicable to those
products or services.
 Quality management (cont.)
• Quality management also means what the
organization does to
 enhance customer satisfaction, and
 achieve continual improvement of its
performance.
 Environnemental management
• ISO 14001 is for environmental
management. This means what the
organization does to:
 minimize harmful effects on the
environment caused by its activities,
 to conform to applicable regulatory
requirements, and to
 achieve continual improvement of its
environmental performance.
 Management systems
• Management system means what the organization does
to manage its processes, or activities in order that
 its products or services meet the organization’s
objectives, such as
 satisfying the customer's quality
requirements,
 complying to regulations, or
 meeting environmental objectives
 Management systems
• To be really efficient and effective, the organization can
manage its way of doing things by systemizing it.
• Nothing important is left out.
• Everyone is clear about who is responsible for doing
what, when, how, why and where.
• Management system standards provide the organization
with an international, state-of-the-art model to follow.
 Management systems (cont.)
• Large organizations, or ones with
complicated processes, could not function
well without management systems.
• Companies in such fields as aerospace,
automobiles, defence, or health care
devices have been operating management
systems for years.
• The ISO 9001 and ISO 14001 management
system standards now make these
successful practices available for all
organizations.
 Processes, not Products
• Both ISO 9001 and ISO 14001 concern
the way an organization goes about its
work.
• They are not product standards.
• They are not service standards.
• They are process standards.
• They can be used by product
manufacturers and service providers.
 Accreditation
• Accreditation is like certification of the certification
body.
• It means the formal approval by a specialized body - an
accreditation body - that a certification body is competent
to carry out ISO 9001:2008 or ISO 14001:2004
certification in specified business sectors.
• Certificates issued by accredited certification bodies -
and known as accredited certificates - may be
perceived on the market as having increased credibility.
• ISO does not carry out or approve accreditations.
 Benefits of ISO 9001 and ISO 14001

• International, expert consensus on state-

of-the-art practices for quality and
environmental management.
• Common language for dealing with
customers and suppliers worldwide in
B2B.
• Increase efficiency and effectiveness.
• Model for continual improvement.
 Benefits of ISO 9001 and ISO 14001 (cont.)

• Model for satisfying customers and other

stakeholders.
• Build quality into products and services
from design onwards.
• Address environmental concerns of
customers and public, and comply with
government regulations.
• Integrate with global economy.
 Benefits of ISO 9001 and ISO 14001 (cont.)

• Sustainable business
• Unifying base for industry sectors
• Qualify suppliers for global supply
chains
• Technical support for regulations
 Benefits of ISO 9001 and ISO 14001 (cont.)

• Transfer of good practice to developing

countries
• Tools for new economic players
• Regional integration
• Facilitate rise of services
 Certification not a requirement
• Certification is not a requirement of ISO
9001 or ISO 14001.
• The organization can implement and
benefit from an ISO 9001 or ISO 14001
system without having it certified.
• The organization can implement them for
the internal benefits without spending
money on a certification programme.
 Certification is a business decision

• Certification is a decision to be taken for

business reasons:
• if it is a contractual, regulatory, or market
requirement,
• If it meets customer preferences
• it is part of a risk management programme,
or
• if it will motivate staff by setting a clear goal.
 ISO does not certify
• ISO does not carry out ISO 9001 or ISO
14001 certification.

• ISO does not issue certificates.

• ISO does not accredit, approve or control the

certification bodies.

• ISO develops standards and guides to

encourage good practice in accreditation
and certification.
 The ISO 9000 family

• ISO 9001 is the standard that gives the

requirements for a quality management
system.
• ISO 9001:2008 is the latest, improved version.
• It is the only standard in the ISO 9000 family
that can be used for certification.
• There are 16 other standards in the family
that can help an organization on specific
aspects such as performance improvement,
auditing, training…
 Seven Tools for Quality Control
Pareto Charts

Check Sheets

Cause & Effect Diagrams

Scatter Diagram

Histograms

Graphs or Flowcharts

Control Charts
 Pareto Charts
Purpose:
Prioritize problems.

How is it done?
• Create a preliminary list of
problem classifications.
• Tally the occurrences in each
problem classification.
• Arrange each classification
in order from highest to
lowest
• Construct the bar chart
 Pareto Charts
Benefits: 120

 Pareto analysis 100

helps graphically
display results so 80

the significant few

Quantity
problems emerge 60

from the general

40
background
 It tells you what to 20

work on first
0
Dent Scratch Hole Others Crack Stain Gap
Defects 104 42 20 14 10 6 4
 Pareto Charts
PARETO CHART
A graphical representation ranking
discontinuities from the most to least
 Weighted Pareto charts significant. Used to help brainstorm what
use the quantity of discontinuities, if worked upon first, would be
defects multiplied by the most likely to produce the greatest
their cost to determine improvement in quality.
the order. 900

800

Weighted 700
Defect Total Cost cost
Gap 4 200 800 600

Dent 104 2 208

Weighted Cost

500
Hole 20 5 100
Crack 10 8 80 400
Scratch 42 1 42
Others 14 1 14 300

Stain 6 1 6
200

100

0
Gap Dent Hole Crack Scratch Others Stain
Weighted cost 800 208 100 80 42 14 6
 Checksheets
Purpose:
– Tool for collecting and
organizing measured or
counted data
– Data collected can be used as
input data for other quality tools

Benefits:
– Collect data in a systematic
and organized manner
– To determine source of problem
– To facilitate classification of
data (stratification)
 Fishbone Diagram
Purpose: Graphical
representation of the trail leading to
the root cause of a problem

How is it done?
• Decide which quality
characteristic, outcome or effect
you want to examine (may use
Pareto chart)
• Backbone –draw straight line
• Ribs – categories
• Medium size bones –secondary
causes
• Small bones – root causes
 CAUSE AND EFFECT DIAGRAMS (Fishbone Diagram)

Used in brainstorming session to help identify the causes of quality losses. This
diagram is particularly useful after the flow chart and the Pareto diagrams have
been developed.

QUALITY
Cause (Effect)

Step 1: Decide on the quality characteristic

Step 2: Set up the fish bone backbone
Step 3: Identify main factors causing effect {e.g. Personnel (Workers),
Materials, Procedures, Equipment, Inspection, Tools , and others}
Step 4: Add Cause to each branch
 Cause & Effect Diagrams
Benefits:
• Breaks problems down into bite-size pieces to find root

cause

• Fosters team work

• Common understanding of factors causing the problem

• Road map to verify picture of the process

• Follows brainstorming relationship

 Cause & Effect Diagrams
Sample

Manpower Materials

Typos
Source info incorrect
Wrong source info
Didn’t follow proc.

Po
Dyslexic
Wrong purchase order
or
Transposition
t
ra
in
ing
Incorrect
shipping
Glare on documents
Temp. display Corrupt
data
No training
Environmen
No procedure
t Keyboard sticks
No communications

Software problem

Methods Machine
 Scatter Diagrams
Purpose:
To identify the correlations that might
exist between a quality characteristic
and a factor that might be driving it
• A scatter diagram shows the
correlation between two variables in
a process.
– These variables could be a
Critical To Quality (CTQ)
characteristic and a factor
affecting it two factors affecting a
CTQ or two related quality
characteristics.

• Dots representing data points are scattered on the diagram.

- The extent to which the dots cluster together in a line across the
diagram shows the strength with which the two factors are related.
 Scatter Diagrams
How is it done?:
• Decide which paired factors you want to examine. Both
factors must be measurable on some incremental linear
scale.
• Collect 30 to 100 paired data points.
• Find the highest and lowest value for both variables.
• Draw the vertical (y) and horizontal (x) axes of a graph.
• Plot the data
• Title the diagram
The shape that the cluster of dots takes will tell you something
about the relationship between the two variables that you tested.
 Scatter Diagrams
• If the variables are
correlated, when one
changes the other probably
Scatter Diagrams
also changes.
• Dots that look like they are
trying to form a line are
strongly correlated.
• Sometimes the scatter plot
may show little correlation
when all the data are
considered at once.
 Stratifying the data, that
is, breaking it into two or
more groups based on
some difference such as
the equipment used, the
time of day, some
variation in materials or
differences in the people
involved, may show
surprising results
 Scatter Diagrams
• You may occasionally get scatter
diagrams that look boomerang- or
banana-shaped.
To analyze the strength of the
correlation, divide the scatter plot
into two sections.
Treat each half separately in your
analysis
Benefits:
• Helps identify and test probable
causes.
• By knowing which elements of your
process are related and how they are
related, you will know what to control
or what to vary to affect a quality
characteristic.
 Histograms or Bar Charts
Purpose:
To determine the spread or variation
of a set of data points in a graphical
form

How is it done?:
• Collect data, 50-100 data point
• Determine the range of the data
• Calculate the size of the class
interval
• Divide data points into classes Stable process, exhibiting bell shape
Determine the class boundary
• Count # of data points in each class
• Draw the histogram
 Histograms or Bar Charts
Benefits:
• Allows you to understand at a glance the variation that exists in a
process
• The shape of the histogram will show process behavior
• Often, it will tell you to dig deeper for otherwise unseen causes
of variation.
• The shape and size of the dispersion will help identify otherwise
hidden sources of variation
• Used to determine the capability of a process
• Starting point for the improvement process
 Flow Charts
Purpose:
Visual illustration of the sequence of operations required to
complete a task
 Schematic drawing of the process to measure or improve.
 Starting point for process improvement
 Potential weakness in the process are made visual.
 Picture of process as it should be.
Benefits:
 Identify process improvements
 Understand the process
 Shows duplicated effort and other non-value-added steps
 Clarify working relationships between people and organizations
 Target specific steps in the process for improvement.
Benefits
• Simplest of all
Flow Charts
Top Down
flowcharts
• Used for planning new
processes or
examining existing one Measure Analyze Improve Control

• Keep people focused Hardware Fleet leader

Problem report Customer input
on the whole process procurement reports
Customer
Hardware return Stress analysis coordination Service reports
How is it done? Failure analysis
Heat transfer Compliance Operational
• List major steps analysis verification statistics

• Write them across top Life analysis Documentation

of the chart Substantiation FAA approval

• List sub-steps under

each in order they
occur
 Flow charts
Benefits Linear
• Show what actually happens
at each step in the process
• Show what happens when
non-standard events occur Toolbox
• Graphically display
processes to identify
redundancies and other
wasted effort
How is it done?
• Write the process step inside
each symbol
• Connect the Symbols with
arrows showing the direction
of flow
 FLOW CHARTS

Flow charts are graphical representations of the steps involved in a process.

Constructing a flow chart helps give a better understanding of the systems
involved.

Process

Data Decision No
Process

Yes Control
transfer

Process

Terminator
 Control Charts
Purpose:
The primary purpose of a control chart is to predict
expected product outcome.

Benefits:
• Predict process out of control and out of specification
limits
• Distinguish between specific, identifiable causes of
variation
• Can be used for statistical process control
 Control Charts
• Strategy for eliminating assignable-cause variation:
– Get timely data so that you see the effect of the assignable
cause soon after it occurs.
– As soon as you see something that indicates that an
assignable cause of variation has happened, search for the
cause.
– Change tools to compensate for the assignable cause.
• Strategy for reducing common-cause variation:
– Do not attempt to explain the difference between any of the
values or data points produced by a stable system in control.
– Reducing common-cause variation usually requires making
fundamental changes in your process
 Control Charts

• Control Chart Decision Tree

– Determine Sample size (n)

– Variable or Attribute Data

• Variable is measured on a continuous scale

• Attribute is occurrences in n observations

– Determine if sample size is constant or changing

 Control Charts
What does it look
like?
o Adding the element of
time will help clarify your
understanding of the
causes of variation in the
processes.
o A run chart is a line graph
of data points organized in
time sequence and
centered on the median
data value.
 Services
Quality
Processes

Human Resources

Price
Technology

Facilities Delivery
Reliability
 QUALITY ASSURANCE & INSPECTION

CQA ROLE IN SPECIFICATION FINALISATION

AND PRE-AWARD AGREEMENT

QA REQUIREMENTS IN VALIDATION FOR PACKAGE

MODULAR SPECIFICATION CONTRACT SPECIFICATION

BID EVALUATION
C BID EVALUATION REPORT
E
N
G
G
PRE-AWARD AGREEMENT (I) LIST OF ITEMS
WITH IDENTIFIED VENDORS/ REQUIRING QP AND
MAIN CONTRACTORS SUB-VENDOR APPROVAL

FEEDBACK OF SUB-
Q (II) QA&I CO-ORDINATION
PROCEDURE
VENDOR PERFORMANCE (III) SUB-VENDOR
BY RIO / SITE ASSESSMENT PROCEDURE TO
(IV) QUALITY AUDIT CS
REQUIREMENTS &
ANALYSIS OF PREVIOUS

A
NON-CONFORMITIES (NCRs) FORM
PART
OF
LOA
 QUALITY ASSURANCE & INSPECTION

1975-1980 1980-1990

THE INFANCY : ESTABLISHING MATURE

DEVELOPMENT OF SYSTEM.
STRONG BASICS IMPLEMENTATION OF
SAME IN POWER PLANTS

1995-2004
1990-1995
AMBITIOUS GENERATION
ENTRY INTO BULK O&M AND CAPACITY ADDITION
PHASE OF PLANTS. PLAN.
STRONG BASE OF FQA STRONG BASE OF FQA,
RIOs & CQA