Total Qualiy Management ESEC Students 1

Total Quality
Management
Dr Anirban Basu
abasu@pqrsoftware.com
080 41311505
PQR Software copyright reserved Slide 1

Introduction to Total Quality
Management

Introduction
Total Quality Management (TQM) is an enhancement to the traditional way of

doing business. It is a proven technique to guarantee survival in world-class
competition.
TQM is for the most part common sense. Analyzing the three words, we have
Total Made up of the whole.

Quality Degree of excellence a product or service provides.
Management Act, art, or manner of handling, controlling, directing, etc.
Therefore, TQM is the art of managing the whole to achieve excellence.

Definition
TQM is defined as both a philosophy and a set of guiding principles

that represent the foundation of a continuously improving
organization. It is the application of quantitative methods and human
resources to improve all the processes within an organization and
exceed customer needs now and in the future.
TQM integrates fundamental management techniques, existing

improvement efforts, and technical tools under a disciplined
approach.

Basic Approach
TQM requires six basic concepts:
1. A committed and involved management to provide long-term top-to-

bottom or organizational support.
2. An unwavering focus on the customer, both internally and externally.
3. Effective involvement and utilization of the entire work force.
4. Continuous improvement of the business and production process.
5. Treating suppliers as partners.
6. Establish performance measures for the process.

New and Old Cultures
Quality Element Previous State TQM
Definition Product-oriented Customer-oriented

Priorities Second to service and cost First among equals of service
and cost
Decisions Short-term Long-term
Emphasis Detection Prevention
Errors Operations System
Responsibility Quality control Everyone
Problem Solving Managers Teams
Procurement Price Life-cycle costs, partnership
Managers Role Plan, assign, control, Delegate, coach, facilitate,
and enforce and mentor

What is a Process?

How do you define a Process?
A process is a set of practices performed to achieve

a given purpose; it may include tools, methods, materials, and/or
people.
While process is often described as a leg of the process-people-

technology triad, it may also be considered the glue that unifies
the other aspects.

What is a Process?
Hardware and Software

Resources
PP
User Specifications RR
Procedures OO
Skills
CC
EE
Nature SS
SS
People

What is a Process?
A Process is just not a sequence of steps performed to achieve a task but

is the organization of people, tools, methods, practices we use to
achieve a specified end result.

Quality Leverage Points
Everyone realizes the importance of

having a motivated, quality work force
but...
PEOPLE
...even our finest people

cant perform at their best
when the process is not
TECHNOLOGY
PROCESS
understood or operating
at its best.

Why Focus on Process?
Process provides a constructive, high-leverage focus...

as opposed to focus on people
Your work force, on the average, is as good as it is trained to
be.
Working harder is not the answer.
Working smarter, through process, is the answer.
as opposed to focus on technology
Technology applied without a suitable roadmap will not result
in significant payoff.
Technology provides the most benefit in the context of an
appropriate process roadmap.

Process Improvement
The quality of a product is largely determined by the quality of the

process that is used to develop and maintain it.
It is based on TQM principles as taught by Shewhart, Juran, Deming

and Humphrey.

Major Processes in Software
Development
Requirements Definition
Project Planning
Project Management
Design
Coding
Testing
Maintenance and Support

Improving Quality
Formulating Quality Standards and Process Frameworks such as

ISO 9000, CMM, CMMI and Six Sigma
Developing techniques implemented as practices within the process

framework

Continuous Process Improvement

Jurans Quality Trilogy
Quality Planning
Quality Control
Quality Improvement

Quality Planning
Preparing to meet Quality Goals
End Results : A process capable of meeting Quality Goals under

operating conditions

Quality Planning
Identify the customers, both external and internal.

Determine customer needs.
Develop product features that respond to customer needs
( Product includes both goods and services)
Establish quality goals that meet the needs of customers and
suppliers alike, and do so at a minimum combined cost.
Develop a process that can produce the needed product features
Prove process capability prove that the process can meet the
quality goals under operating conditions

Quality Control
Measuring actual performance
End Result: Difference of actual performance to Goals

Quality Control
Choose control subjects- what to control

Choose units of measurements
Establish measurements
Establish standards of performance
Measure actual performance
Interpret the difference (actual versus standard)
Take action on the difference

Quality Improvement
The Process of breaking through unprecedented levels of

performance,
End Result: Conduct of operations at levels distinctly superior to

planned performance

Quality Improvement
Prove the need for improvement

Identify specific projects for improvement
Organize to guide the projects
Organize for diagnosis- for discovery of causes
Diagnose to find causes
Provide remedies
Prove that the remedies are effective under operative conditions
Provide for control to hold the gains

The PDSA Cycle
Plan
Do
Study
Act

Quality Improvement Steps: PDSA
Plan Do Study Act

Six Sigma Philosophy
SIGMA Level Defects Per Million Percentage Accuracy

Opportunities (DPMO)
1 sigma 691462 30.85
2 sigma 308537 69.15
3 sigma 66807 93.32
4 sigma 6210 99.38
5 sigma 230 99.98
6 sigma 3.4 99.9997

What is a defect?
A defect is any variation of a required characteristic of the

product (or its parts) or services which is far enough from its
target value to prevent the product from fulfilling the physical
and functional requirements of the customer, as viewed
through the eyes of the customer.
Remember you can not specify a defect without

a specification or target value

Process Frameworks

ISO 9000:2000
QMS
Ho
What
w
ISO 9000 - 2000

So Many Models, so Little Time
Different structures,
EIA 731 Software formats, terms, ways
CMM of measuring maturity
Causes confusion,
especially when using
Systems more than one model
Engr People
CMM CMM Hard to integrate them
in a combined
improvement program
IPD Software Hard to use multiple
CMM Acq
models in supplier
CMM Systems selection
Security
Engr CMM
FAA
iCMM

CMMI to the Rescue! Bridging the Divide
Systems engineering and

software engineering
processes are integrated.
Integrates systems and
software disciplines into one
process improvement
framework.
Provides a framework for
introducing new disciplines
as needs arise.

Capability Maturity Model- Integrated
DoD sponsored collaboration between industry, Government, SEI
Over 100 people involved
U.S. Army, Navy, Air Force KPMG

Federal Aviation Administration Lockheed Martin
National Security Agency Motorola
Software Engineering Institute Northrop Grumman
ADP, Inc. Pacific Bell
AT&T Labs Q-Labs
BAE Raytheon
Boeing Reuters
Computer Sciences Corporation Rockwell Collins
EER Systems SAIC
Ericsson Canada Software Productivity Consortium
Ernst and Young Sverdrup Corporation
General Dynamics TeraQuest
Harris Corporation Thomson CSF
Honeywell TRW

A Proliferation of Models
Model Description
SW- CMM The original CMM developed at the Software Engineering
Institute in 1986. The SEI with assistance from Mitre
Corporation, began developing a process maturity
framework intended to assist organizations in improving
their software processes.The fully developed model
(Version 1.1) was released in 1993
SE-CMM The Systems Engineering Capability Maturity Model

describes the elements of an organizations systems
engineering process.
SECM, EIA /731 Systems Engineering Capability Model which is a merger

of SE-CMM and SE-CAM (Capability Assessment Model)
IPD-CMM The Integrated Product Development CMM published only

in draft form (not released)

A Proliferation of Models
Model Description
CMM- Integration (CMMI) This model addresses the ability of software organizations to
attract, develop, motivate, organize and retain talent. It
combines SW-CMM, IPD-CMM, and EIA/731.
V 1.02 was released in 2000. The current version is V1.1
ISO 15504 /SPICE Information Technology Process Assessment report issued

by ISO in 1998-99
People CMM SEI facilitated work to integrate SW-CMM,SE CM and IPD-

CMM
SSE-CMM Security Systems Engineering CMM by the US National

Security Agency and concerns security of information
systems.

CMMI The Maturity Levels
Optimizing
5 Focus on process
improvement
Quantitatively
4 Process measured Managed
and controlled
Defined
3 Process characterized for the
organization and is proactive
Managed
2 Process characterized for
projects and is often reactive
Performed
1 Process
unpredictable, poorly
controlled and
reactive

CMMI- Staged Representation
Level Focus Process Areas

Continuous Organizational Innovation and Deployment
5 Optimizing process Causal Analysis and Resolution
improvement
Organizational Process Performance
4 Quantitatively Quantitative Quantitative Project Management
Managed management
Requirements Development
Technical Solution
Product Integration
Verification
Process Validation
3 Defined standardization Organizational Process Focus
Organizational Process Definition
Organizational Training
Integrated Project Management
(SS) Integrated Supplier Management
Risk Management
Decision Analysis and Resolution
(IPPD) Organizational Environment for Integration (IPPD)
(IPPD) Integrated Teaming (IPPD)
Basic Requirements Management
2 Managed project Project Planning
management Project Monitoring and Control
Supplier Agreement Management
Measurement and Analysis
Process and Product Quality Assurance
Configuration Management
1 Performed

ISO 9001:2000

About ISO
Started operation in February 1947

A non-governmental organization
Located at Geneva, Switzerland
A network of national standards institutions from 146 countries
Objective of the organization facilitating international co-
ordination and unification of industrial standards.
Have released more than 13,000 standards as on date

About ISO
The task of designing and releasing standards are carried out by

various technical committees.
Technical committee TC-176-SC2 was responsible for releasing
ISO 9000 series of standards.
History of ISO 9000 series:
1st release 1987

2nd release 1994
3rd release 2000

ISO 9001:2000 Principles
ISO 9001: 2000 is based on the 8 quality management principles

that reflect best management practices. They are
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach decision making
Mutually beneficial supplier relationship

Principle#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.
Key benefits
Increased revenue and market share obtained thorough flexible

and fast responses to market opportunities.
Increased effectiveness in the use of the organization's resources
to enhance customer satisfaction.
Improved customer loyalty leading leading to repeat business

Principle#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 organizations
objectives.
Key benefits
People will understand and be motivated towards the
organizations goals and objectives.
Activities are evaluated, aligned and implemented in a unified
way.
Miscommunication between levels of an organization will be
minimized.

Principle#3: Involvement of People
People at all levels are the essence of an organization

and their full involvement enables their abilities to be
used for the organizations benefit
Key benefits
Motivated, committed and involved people within the
organization.
Innovation and creativity in furthering the organizations
objectives.
People being accountable for their own performance.
People eager to participate in and contribute to continual
improvement.

Principle#4:Process Approach
A desired result is achieved more efficiently when activities

and related resources are managed as a process
Key benefits
Lower costs and shorter cycle times through effective use of
resources.
Improved, consistent and predictable results.
Focused and prioritized improvement opportunities.

Principle#5:System Approach to Management
Identifying, understanding and managing interrelated processes as a

system contributes to the organizations effectiveness and efficiency in
achieving its objectives.
Key benefits
Integration and alignment of the processes that will best achieve the
desired results.
Ability to focus effort on the key processes.
Providing confidence to interested parties as to the consistency,
effectiveness and efficiency of the organization.

Principle#6:Continual Improvement
Continual improvement of the organizations overall performance

should be a permanent objective of the organization.
Key benefits
Performance advantage through improved organizational
capabilities.
Alignment of improvement activities at all levels to an
organizations strategic intent.
Flexibility to react quickly to opportunities.

Principle#7:Factual Approach to Decision
Making
Effective decisions are based on the analysis of data and

information
Key benefits
Informed decisions.
An increased ability to demonstrate the effectiveness of past
decisions through reference to factual records.
Increased ability to review, challenge and change opinions and
decisions.

Principle#8:Mutual Beneficial Supplier
Relationship
An organization and its suppliers are interdependent and a

mutually beneficial relationship enhances the ability of both to
create value
Key benefits
Increased ability to create value for both parties.
Flexibility and speed of joint responses to changing market or
customer needs and expectations.
Optimization of costs and resources.

ISO 9000:2000
Eight clauses as follows:
1) Scope
2) Normative reference
3) Terms and definitions
4) Quality management system
5) Management responsibility
6) Resource management
7) Product realization
8) Measurement, analysis and improvement

Five Clauses Related to Requirements
4. Quality management system

5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement

ISO 9000:2000
QMS
Ho
What
w
ISO 9000 - 2000

Key Elements of
ISO 9001:2000 based
Quality Management
System

Role of Management
Demonstration of Commitment
Establishment of Quality Policy and Objectives
Focus on Customer
Motivation and environment
Provision of resources
Monitoring and review
Decisions and improvement actions

Quality Policy
Appropriate to the organizations purpose

Commitment to customer requirements and to continual
improvement
Provides framework for setting objectives
Communicated to and understood by all concerned
Reviewed for continuing stability
Controlled

Quality Objectives
Derived from Quality Policy
Top Management shall ensure that objectives are established at
relevant function and levels
Shall be measurable and consistent with the Quality Policy
Commitment to continual improvement
Shall include those needed to meet requirements for
product/service

Documentation
Requirements in ISO 9001:200 allow more flexibility

Only 6 procedures required by the standard
Requires a Quality Manual
Requires that processes are identified, their sequence and
interactions described and responsibilities and ad authorities
assigned
Cannot write Non Conformance Report if no procedure for a
process

Documents and Records
A Document is something that gives you information or instruction to

do something. It comes before the event.
Documents can be amended
A record is evidence that the event took place. It comes after the
event.
Records cannot be amended.

Types of Documents
Quality Manuals
Flow Charts and Process Maps
Procedures, plans and instructions
Drawings
Computer programs or instructions
Actual samples
Forms
Standards or specifications, contracts
Reference material, charts, tables etc.

Values of Documentation
Ensuring planning and communication

Achieving the required quality
Evaluating the quality system
Improving and maintaining improvements
Demonstrating the quality system to customers and potential customers
Retaining knowledge and for training

Documentation Pyramid
Define WHAT
WHY
will be done
Stated once
Policy
Procedures WHO
WHEN
WHERE
HOW Work Instructions
or
Practices
Evidence
Records or Proof

Continual Improvement
To increase the effectiveness of the QMS in

meeting the policy and objectives of the
organization
Objectives have to be set and the
organization must plan to achieve these
objectives
Continual improvement is planned and
documented
Reviewed by top management

Quiz
To what extent processes need to be documented?

Is it acceptable, if an organization only has a policy, objectives,
flowchart of processes, organization chart and 6 procedures
required by the standard?
What records are needed to provide evidence that processes
and products meet requirements?
What if objectives have not been met?

Section 1: Scope
1.1 General
States requirements for an organization to
Demonstrate its ability to provide consistently product that meets

customer and applicable regulatory requirements, and
Enhance customer satisfaction by effective application of the

system, including processes for continual improvement and the
assurance of conformity to customer and applicable regulatory
requirements.

1.2 Application
All requirements of the International Standard are generic and

intended to be applicable to all organizations regardless of type, size
and product or service provided.
Where any requirements cannot be applied, it can be considered for

exclusion.

Possible Exclusions
Planning for product realization

Customer communications
Design and development
Purchasing
Control of product and service provision
Validation of processes
Identification and traceability
Customer property
Preservation of product
Control of monitoring and measuring devices

Sections 2 and 3
2. Normative References - ISO 9000 : 2000, Quality

Management Systems - Fundamentals and Vocabulary.
3 Terms and definitions.

Supplier > Organization > Customer The term organization
replaces supplier
Supplier now replaces subcontractor.
Product also means service.

Clause 4: Quality Management
System

Quality Management System
4.1 General Requirements
4.2 Documentation Requirements

4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents*
4.2.4 Control of Records*

4.1 General Requirements
Shall establish, document, implement, maintain and continually

improve QMS
Shall identify the processes needed.
Determine the sequence and interaction
Determine criteria and methods
Ensure resources & information available
Measure, monitor and analyse processes
Implement actions to achieve plans and continual
improvement.
Controls over outsourced processes

4.2 Documentation Requirements
4.2.1 General
Documented Policy and Objectives.

Quality Manual.
Documented procedures required by standard
Documents to ensure effective planning, operation and control
of processes.
Records required by the standard.
Documented = established, documented, implemented,
maintained.

4.2.2 Quality Manual
Shall establish and maintain a quality manual that includes -

Scope and justification for exclusions
Documented procedures or reference
Description of interaction between processes of the QMS.
Note Can be in any form or medium.

4.2.3 Control of Documents
Procedure to define controls

Approval prior to issue.
Review and re-approval.
Changes and status identified.
Documents available at point of use.
Legible and identifiable.
External documents identified, and controlled.
Prevent unintended use of obsolete docs.

4.2.4 Control of Records
To provide evidence of conformity and effective operation of

QMS.
Legible, readily identifiable, retrievable.
Procedure to define controls for storage, identification,
protection, retrieval, retention and disposition.

Clause 5:Management
Responsibility

5. Management Responsibility
5.1 Management commitment

5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and authority
5.5.2 Management Representative
5.5.3 Internal Communication

Management Responsibility
5.1 Management Commitment
Top management shall demonstrate commitment to

development, implementation and improvement of the QMS by
Communicating the importance of meeting customer and legal

requirements.
Establishing Quality Policy and objectives.
Conducting Management Reviews.
Ensuring availability of resources.
5.2 Customer Focus
Top management shall ensure customer requirements are

determined and met with the aim of enhancing customer
satisfaction.

5.3 Quality Policy
Top management shall ensure that the Quality Policy -

Is appropriate.
Includes a commitment to meet requirements and to
continually improve effectiveness.
Provides a framework for objectives.
Is communicated and understood.
Reviewed for continued suitability.

5.4 Planning
5.4.1 Quality Objectives

Top Management shall ensure that objectives are at relevant
levels and functions. Objectives shall be measurable and
consistent with Policy.
5.4.2 Quality Planning

Top management shall ensure that the
Planning is carried out to meet requirements and quality
objectives.
Integrity of the system is maintained and changes are planned and
implemented.
5.5 Responsibility Authority and Communication

5.5.1 Responsibility & Authority

5.6 Management Review
5.6.1 General
Management shall review the QMS at planned intervals to
ensure continuing suitability, adequacy and effectiveness. Shall
review need for changes to the system, policy or objectives.
Records needed.
5.6.2 Review Input

Audit results and Customer feedback.
Process reports + conformity analysis
Status of preventive & corrective actions
Actions from prior reviews . Changes.
Recommendations for improvement.

5.6.3 Review output
Outputs from the review shall include actions related to -

Improvement of the effectiveness of the QMS and processes.
Improvement of product related to customer requirements.
Resource needs.

Clause 6:Resource
Management

6. Resource Management
6.1 Provision of resources

6.2 Human Resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work Environment

Resource Management
6.1 Provision of Resources
Shall provide resources needed to
implement and maintain the QMS and continually improve its

effectiveness
enhance customer satisfaction by meeting customer
requirements.

Resource Management
6.2 Human Resources
6.2.1 General
Personnel performing work affecting quality shall be competent
on the basis of appropriate education, training, skills and
experience.

Resource Management
6.2.2 Training awareness and competency
Determine competency needs

Provide training or take other actions to satisfy these needs.
Evaluate effectiveness of actions taken.
Ensure that employees are aware of the relevance and
importance of activities and contribution to meeting objectives.
Maintain records.

Resource Management
6.3 Infrastructure
Determine and maintain infrastructure to achieve conformity to

requirements -
Buildings, Workspace and Utilities.
Equipment, hardware and software.
Supporting services.
6.4 Work Environment

Determine and manage the work environment to achieve
conformity.

Clause 7:Product Realization

7.Product Realization
7.1 Planning of product realization

7.2 Customer related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes

7.4 Purchasing
7.4.1 Purchasing process

7.4.2 Purchasing information
7.4.3 Verification of purchased product

7.5 Production and service provision
7.5.1 Control of production an service provision

7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product

7.6 Control of monitoring and measuring
devices
Shall ensure use of calibrated measurement and monitoring

devices for product.
In case of software organizations, it can be interpreted as use

of proper testing tools and methods.

Product Realization
7.1 Planning for product realisation
Plan and develop processes & determine

Quality objectives & requirements for product.
Need for processes, documents, and provide resources.
Verification, validation, monitoring and test activities, and
criteria for acceptance.
Records to provide evidence of conformity.
Outputs shall be in a suitable form.

Product Realization
7.2 Customer-related processes
7.2.1 Determine Product requirements.

Specified by the customer including delivery and post delivery.
Not specified by the customer but necessary for intended use.
Statutory and regulatory requirements.
Any others.

Product Realization
7.2.2 Review of Requirements Related to the Product
Review the identified customer needs before commitment to

supply - ensure
Product requirements are defined.
Requirements differing from those previously expressed are
resolved.
Requirements can be met.
Records of reviews and actions kept.
If requirements change, documents change & personnel shall
be made aware of changes

Product Realization
7.2.3 Customer Communication
Determine and implement plans for customer communications

relating to -
Product information.
Enquiries, contracts or order handling including amendments.
Customer feedback and complaints.

Product Realization
7.3 Design and Development
7.3.1 Design & Development Planning

Plan control design and development- include
Stages of design and development,
Review, verification and validation activities.
Responsibilities and authorities for activities.
Interfaces managed to ensure clarity of communication and
responsibilities.
Planning output updated as appropriate.

Product Realization
7.3.2 Design and Development Inputs
Requirements recorded and include

function and performance requirement
Applicable statutory and regulatory requirements.
Information derived from other similar designs and any others
needed.
Review for adequacy. Any incomplete, ambiguous or conflicting
requirements resolved.

Product Realization
7.3.3 Design and Development Outputs
The outputs shall be recorded in a format that allows

verification v inputs. Output documents reviewed & approved
Design output shall -
Meet input requirements,
Provide information for purchasing, production and service
provision,
Contain or reference acceptance criteria
Specify characteristics essential to safe and proper use.

Product Realization
7.3.4 Design Review
Formal reviews conducted to plans to -

Evaluate capability to meet requirements,
Identify problems and propose necessary actions
Participants to include representatives of functions concerned
with stages for review.
Results of design reviews and follow up actions shall be
recorded.

Product Realization
7.3.5 Design and Development Verification
Verification shall be planned and carried out to ensure outputs

meet inputs.
Record results of verification and actions.

Product Realization
7.3.6 Design and Development Validation
Validation shall be performed to confirm product / service is

capable of meeting the needs of specific customer use.
If possible performed before delivery.
Record results of validation and actions taken

Product Realization
7.3.7 Design Changes
Changes shall be identified and recorded, and shall be

reviewed, verified, validated and approved by authorized
personnel before implementation.
Consider effects between elements and interaction between
constituent parts and product already delivered.
Record review of changes and actions.

Product Realization
7.4 Purchasing
7.4.1 Purchasing Process

Shall control purchasing processes to ensure conformance to
requirements.
Type and extent of control depends on the effects on
processes & final product.
Shall evaluate and select suppliers based on ability to meet
requirements.
Criteria to be established.
Results and actions recorded.

Product Realization
7.4.2 Purchasing Information
Purchasing information shall describe the product to be

purchased.
May include -
Requirements for approval of personnel, product, procedures,
processes, and equipment.
Any system requirements.
Shall ensure adequacy prior to release.

Product Realization
7.4.3 Verification of Purchased Product
Shall establish and implement plans for verification of product /

services.
Where verification is performed at the suppliers premises shall
specify the verification requirements and method of release in
purchasing documentation.

Product Realization
7.5 Production and Service Provision
7.5.1 Control of production & service provision

Shall control operations through -
Availability of product information.
Availability of work instructions.
Use of suitable equipment.
Suitable working environments.
Availability and use of inspection, measuring and test devices.
Monitoring and measurement activities.
Release, delivery, post-delivery activities.

Product Realization
7.5.2 Validation of Processes
Shall validate processes where output not verified by

monitoring and measurement. Includes faults appearing after
delivery.
Validation shall be planned and include -
Defined criteria for review and approval of processes.
Approval of equipment & personnel.
Use of specific methods and procedures.
Requirements for records & re-validation.

Product Realization
7.5.3 Identification & Traceability
Where appropriate
Identify status of product with respect to monitoring and
measurement requirements.
Where traceability is required shall control and record the
unique identification of the product.

Product Realization
7.5.4 Customer Property
Exercise care with customer property.

Identify, verify, protect and safeguard customer property for use
or inclusion.
Any product or property lost, damaged or unsuitable for use
shall be recorded and reported to the customer.
Note - May include information.

Product Realization
7.5.5 Preservation of Product
Shall preserve conformity of product during internal processing

and delivery to intended destination.
Shall include identification, packaging, storage, handling and
protection.
Applies to constituent parts of a product.

Product Realization
7.6 Control of Measuring and Monitoring Devices
Shall determine monitoring measurements and devices to be

used to provide evidence of product conformity.
Establish and implement measurement processes to enable
needs can be met.
Assess validity of previous inspections.
Initiate actions if found out of calibration
Software shall be confirmed

Product Realization
To ensure valid results

Calibrate at specified intervals or prior to use.
Traceability to national standards.
Adjusted as necessary
Identify to show calibration status.
Safeguard against adjustment.
Be protected from damage or deterioration.

Clause 8: Measurement, Analysis
and
Improvement

8. Measurement, Analysis and
Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer satisfaction
8.2.2 Internal Audit*
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product*
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action*
8.5.3 Preventive Action*

Measurement, Analysis and
Improvement
8.1 General
Plan & implement measurement monitoring, analysis and

improvement.
To demonstrate conformity of product.
Ensure conformity of QMS.
Continually improve effectiveness of QMS.
Includes determination of methods and extent of use also
Statistical Methods, Quality Tools to analyse data to bring
about improvement.

Improvement
8.2 Measurement and Monitoring
8.2.1 Customer Satisfaction

Shall monitor information relating to customer perception as to
whether their expectations have been met.
Methods for obtaining and using this information and data
determined.

Improvement
8.2.2 Internal Audit
Audits to determine if system conforms is effectively

implemented and current.
Planned based on status and importance and previous results.
Define audit criteria, scope, methods, frequency.
Auditors to be independent.

Improvement
8.2.2 Internal Audit Contd
Responsibilities for planning and conducting audits and

records defined in a procedure.
Management shall ensure corrective actions taken without
undue delay.
Follow up actions including verification and reporting of results.
See ISO 19011

Improvement
8.2.3 Monitoring and Measurement of Processes
Shall apply suitable methods for measurement of processes to

meet customer requirements.
Results shall be used to determine opportunities for
improvement.
If planned results not achieved must take corrective action.

Improvement
8.2.4 Monitoring & Measurement of Product
Monitor and Measure product at appropriate stages to verify

product requirements met.
Evidence of conformity with criteria maintained.
Records of authority for release.

Improvement
8.3 Control of Nonconforming Product
Shall ensure nonconforming product is identified and controlled

to prevent inadvertent use or delivery. Controls, responsibilities
and authorities shall be defined in procedures.
Shall take actions to eliminate problem or authorize release by
relevant authority, or take action to preclude its use.
Records of the nature of nonconformities and actions taken
including concessions kept.
If product is corrected must be re-validated.
If problem after delivery must take actions.

Improvement
8.4 Analysis of Data
Analysis of data for improvements -

Suitability and effectiveness of QMS.
Process operation trends.
Customer satisfaction.
Conformity to requirements.
Characteristics of process, product and opportunities for
preventive actions.
Suppliers

Improvement
8.5 Improvement
8.5.1 Continual Improvement

Shall continually improve effectiveness of QMS.

Improvement
8.5.2 Corrective Action
Process for eliminating potential causes to prevent recurrence

Procedure to define requirements for -
Reviewing nonconformities.
Determining causes and need for actions.
Determine, implement and record actions.
Review actions taken

Improvement
8.5.3 Preventive Action
Process for eliminating potential causes to prevent occurrence.
Documented procedure to define -

Determination of potential problems and causes.
Evaluation of need for action.
Determine and implement actions.
Record results of actions taken.
Review actions taken.

Quality Function Deployment

Kano ModelKANO MODEL OF QUALITY
Satisfied
eds
Ne
ent
it em
x c s
E e d
Ne e
n c
U nkno w rm a n
e rfo
P
Didnt do it at all Basic Did it Very Well
Needs
o k en
S p
te d
la
vio
le ss
- u n
k e n
sp o
Un Dissatisfied

Quality Function Deployment (QFD)
QFD is a scientific technique for translating the voice of the

customer into development of products and services. It is a
complete product planning process as opposed to problem solving
and analysis. The technique was invented by Akashi Fukuhara of
Japan and first applied with very good results at Toyota.

Translating For Action

House of Quality
Correlation
matrix of
Hows
Technical descriptors of Hows
Objective Statement Target Goals of Hows
Customer
Requirements
of Whats Importance
Relationship Matrix Customer
ratings of
Whats
between the assessment of
competitors
Hows and the Whats
Technical competitive assessment of Hows

A Typical 4 House QFD
Software
Requirements
(HOWs)
Design
House Decisions
Customer
(WHATs)
(HOWs)
of
CTQs
Implementation
Quality House Requirements
Requirements
#1 (HOWs)
(WHATs)
Software
of Verification
Requirements
Requirements Quality House Requirements
House (HOWs)
(WHATs)
House #2
decisions
of
Design
Quality House
Requirements
Implementation
#3
(WHATs)
Design
Design of
House
House Quality
Coding
Coding
House
House #4
Verification
Verification
House
House

Structure of a QFD

Step 1: List customer requirements and rank
Importance
Customer Requirements on 5 point
scale
Very Important
Moderately Important
Slightly important

Step 2: List technical requirements to meet
Technical Requirements

Step 3:Comparing with nearest competitor
Complaints
Customer competitive
evaluation on 5 point scale( 5 high , 1 low )
Rank
1 2 3 4 5 Action
Customer Requirements
Competitor product Our product

Step 4:Establish relationship
Strong relation
Moderate relation
Weak relation
Rank

QFD Matrix after Step 4
Competitive evaluation
Rank
Competitor
We
Step 5: Competitive Technical Assessment
Customer Requirements Rank
5
Competitive 4
Technical 3
Assessment 2 Competitor
1 We

Step 6:Find Action Points
Customer Requirements Rank
Competitive
Technical
Assessment
Operational
Targets New Product
Correlation Matrix of Hows
Legend: ++ Strong positive relationship

+ Positive relationship
- Negative relationship
-- Strong negative relationship
+
+ + +
++ +
+
++ + + +
How#1 How#2 How#3 How#4 How#5 How#6 How#7

Relationship between Whats and Hows
Relation between what and how:
1: Low relationship
3 : Medium relationship
9: High relationship

Risk Management using FMEA

FMEA
Notice that only the causes and effects are rated - failure modes
themselves are not directly rated in the FMEA analysis.
FMEA is cause-and-effect analysis by another name avoid being
hung up on the failure mode.
The failure mode simply provides a convenient model, which allows
us to link together multiple causes with multiple effects.
It is easy to confuse failures, causes, and effects, especially since
causes and effects at one level can be failures at a lower level.
Effects are generally observable, and are the result of some cause.
Effects can be thought of as outputs.

FMEA
Effects are usually events that occur downstream that affect internal or
external customers.
Root causes are the most basic causes within the process owners
control. Causes, and root causes, are in the background; they are an
input resulting in an effect.
Failures are what transform a cause to an effect; they are often
unobservable.
One can think of failures, effects, and causes in terms of the following
schematic:
Root Cause Failure Effect

x f(x) y

FMEA
Note that a failure mode can have numerous distinct effects, and that
each effect has its own system of root causes.
With this in mind, another way to think of failures, effects, and causes is:
Causes - x's
Failure - f(x) Effect - y

Risk Priority Numbers
The failures identified by the team in an FMEA project are prioritized by

what are called Risk Priority Numbers, or RPN values.
The RPN values are calculated by multiplying together the Severity,
Occurrence, and Detection (SOD) values associated with each cause-
and-effect item identified for each failure mode.
Note: The failure mode itself is not rated and only plays a conceptual
role in linking causes with their effects on the product, process, or
system.
For a given cause-and-effect pair the team assigns SOD values to the
effects and causes. Then an RPN is calculated for that pair: RPN =
Severity x Occurrence x Detection.

FMEA
Severity rates the seriousness of the effect for the potential failure
mode - how serious is the effect if the failure did occur?
The more critical the effect, the higher the severity rating.

FMEA
Severity ratings for the online systems availability FMEA.
Severity Rank Criterion

None 1 No effect
Very Minor 2 No noticeable effect
Minor 3 Minor effect
Very Low 4 Very low effect
Low 5 Low effect
Moderate 6 Moderate effect
Significant 7 Noticeable effect
High 8 Work nearly halted
Very High 9 Work halted
Disaster 10 Implement Hotsite recovery

FMEA
Occurrence, or frequency of occurrence, is a rating that describes the

chances that a given cause of failure will occur over the life of
product, design, or system.
Actual data from the process or design is the best method for
determining the rate of occurrence. If actual data is not available, the
team must estimate rates for the failure mode.
Examples:
The number of data entry errors per 1000 entries, or
The number of errors per 1000 calculations.
An occurrence value must be determined for every potential cause of
the failure listed in the FMEA form.

FMEA
The higher the likelihood of occurrence, the higher the occurrence

value.
Once again, occurrence guidelines can be developed and should

reflect the situation of interest.

FMEA
Occurrence guidelines for the system availability FMEA:
Occurrence Rank Criterion Possible failure rate
Remote 1 Unlikely that cause occurs 1 in 15,00,000
Very low 2 Very low chance that cause occurs 1 in 1,50,000
Low 3 Few occurrences of cause likely 1 in 15,000
4 1 in 2000
Moderate 5 Medium number of occurences of cause 1 in 400
6 1 in 80
7 1 in 20
High High number of occurrences of cause
8 1 in 8
9 1 in 3
Very High Very high number of occurrences of cause
10 1 in 2

FMEA
The detection rating describes the likelihood that we will detect a cause
for a specific failure mode.
An assessment of process controls gives an indication of the likelihood
of detection.
Process controls are methods for ensuring that potential causes are
detected before failures take place.
For example, process controls can include:
Required fields or limited fields in electronic forms,
Process and/or system audits, and
Are you sure dialog boxes in computer programs.
If there are no current controls, the detection rating will be high. If there
are controls, the detection rating will be low.
FMEA
The higher a detection rating, the lower the likelihood we will

detect a specific cause if it were to occur.
Detection guidelines developed for the system availability FMEA:
Detection Rank Criterion
Almost certain 1 Cause obvious and easy to detect
Very High 2 Very high chance of detecting the cause
High 3 High chance of detecting the cause
Moderately High 4 Cause easily detected by inspection
Moderate 5 Moderate likelihood of detection
Low 6
Low likelihood of detection
Very Low 7
Very low likelihood of detection
Remote 8 Cause is hard to identif y
Very Remote 9 Cause is very hard to identif y
Almost impossible 10 Cause usually not detectable

Types of Data

Data Characteristic
Q u a lit y C h a r a c t e i s t ic
Q u a l it a t i v e V a r ia b le ( Q u a n t i t a t i v e )
A ttrib u te C o n tin u o u s D is c r e te
(E g .T y p e o f c a r o w n e d ) ( E g . H e ig h t o f a p e r s o n ) ( E g . n u m b e r o f c h i ld r e n )

Quality Characteristics
Quality Characteristics fall into two broad classes
Variables : Characteristics that are measurable and are expressed

on a numerical scale are called Variables. Examples are height of a
person, resistance of a wire etc..
Attributes: It is a Quality Characteristic that is classified as either

conforming or non conforming to a stipulated specification.It is a
characteristic that cannot be measured on a numerical scale. For
example, color of skin, smell of a fragrance, etc

Variable Quality Characteristics
Data on variable quality characteristic can be categorized as
Continuous: A characteristic that can take any value within a

definite range, e.g., the body weight, length of a pencil, service
response time, temperature in a room, etc. This is recorded with the
help of a measuring equipment of defined accuracy.
Discrete: A characteristic may take only some isolated or discrete

values, e.g., the number of defects in an item, the number of
breakdown of machines in a shop, etc. This is often obtained by
counting.

Scales of Measurement for Attribute
Data
Nominal: It is used when the data variables are simply labels used
to identify an attribute of the sample element and numerical values
are not involved.
Labels can be conforming and nonconforming or critical, major,
minor.
Ordinal: It is used when the data has the properties of attribute

quality characteristic i.e., labels and data ranks or orders the
observations.
For example data on customer satisfaction: Excellent, Very good,

Good, :Poor, Severity of Customer complaints etc..

Continuous Data-Examples
Elapsed Time
Effort Expended
Length of Experience
Manpower Utilization
CPU Utilization
Cost of Rework

Discrete Data-Examples
Number of Defects Found

Number of Defective Items
Number of LOC
Number of employees with expertise in a specific area

Attribute Data
Defective PO
Job delivered on time / not on time
An accountant with expertise in Foreign Exchange

Continuous Data Characteristics
Location / Central Tendency
Measure of the center point of any data set
Spread / Dispersion
Measure of the spread of any data set around its center
Shape
Measure of symmetry of any data set around its center

Summary statistics (of sample)
Measures of location
Mean
Median
Mode
Quartiles

Location Measures
Mean
Mean is the arithmetic average of all data points in a data set
X1 + X2 + X3 + . + Xn
X= Where n = number of data points
n
Mode
Mode is the most frequently occurring data point in a data set
Median
Median is the middle data point of a data set arranged in an ascending /
descending order
Odd number of data points Even number of data points
Average

Spread Measures
Range is the difference between the maximum & minimum data value
Variance / Standard Deviation
Variance and Standard Deviation tell us how individual data points are
spread around mean
( X1 - X )2 + ( X2 X )2 + . + ( Xn X )2
Variance = s2 =
(n1)
Standard Deviation = s = s2

Population and Sample

Population and Sample
The entire set of items is called the Population.
The small number of items taken from the population to make a

judgment of the population is called a Sample.
The numbers of samples taken to make this judgment is called
Sample size.
SAMPLE OF
POPULATION SIZE THREE

Population,Sample and Data
NO ACTION
Measurement /
Random Sampling Observation
POPULATION Sample Data
ACTION

What is Sampling and why do it?
Sampling is
Collecting a portion of all the data.
Using that portion to draw conclusions (make inferences).
Why sample? Because looking at all the data may be
Too expensive.
Too time-consuming.
Destructive (e.g., taste tests).
Sound conclusions can often be drawn from a relatively small amount

of data.

Sampling from a process
Generally, collect small samples more frequently to ensure that

the process behavior is represented fairly over time.
Make a control chart or time plot to determine if the process is

stable or unstable (look for outliers, shifts, trends, or other
patterns).

Total Qualiy Management ESEC Students 1

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Total Quality

PQR Software copyright reserved Slide 1

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Total Quality Management (TQM) is an enhancement to the traditional way of

Total Made up of the whole.

Therefore, TQM is the art of managing the whole to achieve excellence.

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TQM is defined as both a philosophy and a set of guiding principles

TQM integrates fundamental management techniques, existing

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TQM requires six basic concepts:

1. A committed and involved management to provide long-term top-to-

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Quality Element Previous State TQM

Definition Product-oriented Customer-oriented

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A process is a set of practices performed to achieve

While process is often described as a leg of the process-people-

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Hardware and Software

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A Process is just not a sequence of steps performed to achieve a task but

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Everyone realizes the importance of

...even our finest people

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Process provides a constructive, high-leverage focus...

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The quality of a product is largely determined by the quality of the

It is based on TQM principles as taught by Shewhart, Juran, Deming

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Formulating Quality Standards and Process Frameworks such as

Developing techniques implemented as practices within the process

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Preparing to meet Quality Goals

End Results : A process capable of meeting Quality Goals under

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Identify the customers, both external and internal.

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Measuring actual performance

End Result: Difference of actual performance to Goals

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Choose control subjects- what to control

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The Process of breaking through unprecedented levels of

End Result: Conduct of operations at levels distinctly superior to

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Prove the need for improvement

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Plan Do Study Act

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SIGMA Level Defects Per Million Percentage Accuracy

1 sigma 691462 30.85

2 sigma 308537 69.15

3 sigma 66807 93.32

4 sigma 6210 99.38

5 sigma 230 99.98

6 sigma 3.4 99.9997

PQR Software copyright reserved Slide 26