Quality Assurance

and Reliability
 QUALITY - DEFINITION
- Fitness for Use >product follows the specs
>can be use as expectation

- Meeting an Expectation
- Degree of Excellence
- Conformance to Standards
>follow the international standard
as per: -standard label ( sirim)

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PRINCIPAL ASPECTS

Functional
Appearance
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>less failure,more rely
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Quality Assurance
 Refers to planned and systematic production processes that
provide confidence in a product's suitability for its intended
purpose.
 It is a set of activities intended to ensure that products (goods
and/or services) satisfy customer requirements.
 For fulfillment, organizations must ensure means of
preventing, detecting and correcting errors or any tendency
towards errors.
 It determines the effectiveness of the system, appraises the
current quality, determines quality problem areas or
potential areas, and assists in the correction or
minimization of these problem areas.
 The overall objective is the improvement of quality in
cooperation with the responsible departments.

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Quality Control

Quality control is the use of techniques and activities to

achieve, sustain and improve the quality of product/service –
involves integrating of specifications, design, production,
inspection and review of usage.
Quality control emphasizes testing of products to uncover
defects, and reporting to management who make the
decision to allow or deny the release.
QC activities are treated as an integral part of the overall QA
processes

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Testing and Inspection

• The activities to assure materials, products, processes,

inspections and services comply with the specifications.

• Specifications –design data / drawing, airworthiness

regulations, customer requirements, and international
standards

• Test results can be used as reference for issuance of

Certificate of Conformance of parts.

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Scope of Quality Assurance Functions

• Contracts & Sales

• Product Development
• Design
• Procurement
• Manufacturing
• Assembly
• Packaging
• Maintenance
• Delivery etc.

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Quality Management System (QMS)
What is QMS?
1. A quality management system (QMS) is a system that
outlines the policies and procedures necessary to
improve and control the various processes that will
ultimately lead to improve business performance.
2. The comprehensive and coordinated efforts (policies,
processes and procedures) are designed to meet
quality objectives, to direct and control an
organization with regard to quality.
3. The concept of a quality management system is based
on principles described in ISO 9001:2015, Quality
Management Systems.
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Quality Management System (QMS) – cont.

• What are Standards?

–standards are no regulations.
–they were meant to simplify life in industry and trade by a
clear definition of technical or other facts.

• Question:
• 1. Does quality defined by Standards?

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Quality Management System (QMS) – cont.
• Quality is defined by the expectations of the customer
– not by the standard!

• What is Quality?
Quality = degree to which a set of inherent
characteristics to fulfill requirements.

• What is Requirements?
Requirement = need or expectation, which is
stated, or generally implied, or obligatory

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 Quality Management System (QMS) – cont.

• Quality requirements on the • Requirements related to quality

product management system
– Describe the characteristics of – Describe the efficiency of the
the product system that guarantees the
permanent compliance of the
requirement characteristics.
– Defined by
– Defined by the
• Design Requirement
ISO 9000 - family
Document
• Drawings, Specification
• etc.

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Quality Management System (QMS) – cont..

• If a company wants to assure the quality of their

products,
–the company itself needs a quality management system,
–and it has to make sure that all suppliers also have a
maintained quality management system!

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 Benefits of QMS
A. Customer/Marketing Benefits
• Achieve greater focus & consistency on customer requirements
and customer service which will improve customer satisfaction
• Conveys commitment to quality and partnering
• Promotional credibility to an international standard - Exploit
new market sectors and territories
• Provides access to markets and bids.
• Employees become more responsive to customer needs and
requirements.

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Benefits of QMS – cont.
B. Internal Benefits

• Continuous Improvement Cycle of a management system results in

savings.
• Encourages active and effective leadership by top management
• Guarantees that new and existing products and services satisfy customers
• Encourages self-assessment and maintains internal consistency
• Makes internal operations more efficient and effective - Involves and
empowers staff
• Corporate walls come down; people communicate better
• Ensures product development and design changes are controlled
• Creates awareness of the need for training and encourages operational
problem solving
• Provides insights on organizational interrelationships, encourages internal
focus, facilitates internal operational control, and assists employees in
understanding and improving operations
• Reduces errors by doing things right the first time
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Benefits of QMS – cont.
C. Customer-Supplier Partnering Benefits
• Forms the basis for a common language of quality
• Ensures a minimum level of quality problem
• Facilitates just-in-time delivery
• Assists in monitoring suppliers

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ISO Family
• ISO 9000 is a family of ISO (the International Organization for
Standardization) standards for quality management systems.
• The ISO 9000 standards are maintained by ISO and administered by
accreditation and certification bodies.
• Standards in the ISO 9000 family include:
- ISO 9001:2015 - sets out the requirements of a quality management
system
- ISO 9000:2015 – fundamentals and concepts
- ISO 9004:2009 - focuses on how to make a quality management system
more efficient and effective
- ISO 19011:2011 - sets out guidance on internal and external audits of
quality management systems
• 3 more quality system derived from ISO9001 for specific industry is
AS9100 – Aerospace Industry
ISO/TS 16949 – Automotive Industry
TL 9000 – Telecommunications Industry
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ISO Versions
1. The initial 1987 version, ISO 9000:1987
– Had the same structure as the UK Standard BS 5750
– Prevention oriented quality assurance requirements were present in the 1987
document
– the Standard did not focus on quality control via retroactive checking and
corrective actions
2. The 1994 version, ISO 9000:1994
– Emphasized quality assurance via preventive actions
3. The 2000 version, ISO 9001:2000
– Radical change in thinking by actually placing the concept of process
management front and centre in the Standard
– Expectations of continual process improvement and tracking customer
satisfaction were made explicit at this revision 2. Emphasized quality assurance
via preventive actions
4. The 2008 version, ISO 9001:2008
- process approach
4. The 2015 version, ISO 9001:2015
- emphasized on the organizational contact, risk management and leadership– from
8 to 10 clauses

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ISO Versions (cont..)
• ISO 9001:2015 sets out the criteria for a quality management
system and is the only standard in the family that can be
certified to (although this is not a requirement). It can be
used by any organization, large or small, regardless of its field
of activity. There are over one million companies and
organizations in over 170 countries certified to ISO 9001.

• ISO 9001 is underpinned by the 8 Principles of Quality

Management – Customer Focus, Leadership, People
Involvement, Process Approach, Systematic Approach to
Management, Continual Improvement. Factual Approach to
Decision Making and Mutually Beneficial Supplier Relations.

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Quality Policy, Vision & Mission
 QUALITY POLICY - An overall, high level statement that gives a general
idea of the quality goals of the organisation. It is not too specific.

 VISION - Defines the desired or intended future state of an organization

in terms of its fundamental objective and/or strategic direction. Vision is
a long term objective.

 MISSION - Defines the fundamental purpose of an organization, basically

describing why it exists. A corporate Mission can last for many years, or
for the life of the organization. It is not an objective with a timeline, but
rather something that is accomplished over the years as the company
achieves objectives that are aligned with the corporate mission.

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Quality Policy
ISO 9000 Series outlines:
Quality policy must:
be appropriate to the organisation
Include a commitment to requirements and continual improvements
Provide basis for re-establishing and reviewing quality objectives
Be communicated and understood
Be periodically reviewed for suitability
Top management is responsible to ensure the above
Auditors will wish to test staff's understanding on the quality policy.

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 Quality Vision
The vision statement includes vivid description of the organization as it
effectively carries out its operations.

 Developing a vision statement can be quick culture-specific, i.e.,

organization may use methods ranging from highly analytical and rational
to highly creative and divergent, e.g., focused discussions, divergent
experiences around daydreams, sharing stories, etc.
Originally, the vision was a compelling description of the state and function
of the organization once it had implemented the strategic plan, i.e., a very
attractive image toward which the organization was attracted and guided
by the strategic plan.

 Recently, the vision has become more of a motivational tool, too often
including highly idealistic phrasing and activities which the organization
cannot realistically aspire.
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Quality Mission
The mission statement describes the overall purpose of the organization.
The vision’s purpose is often the same as the mission.
A mission statement can be quick culture-specific, may use methods
ranging from highly analytical and rational to highly creative and divergent,
e.g., focused discussions, divergent experiences around daydreams,
sharing stories, etc.
When wording the mission statement, consider the organization's
products, services, markets, values, and concern for public image, and
maybe priorities of activities for survival.
 Ensure that wording of the mission is to the extent that management and
employees can infer some order of priorities in how products and services
are delivered.

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 Process Approach
• The process approach involves the systematic
definition and management of processes, and their
interactions, so as to achieve the intended results in
accordance with the quality policy and strategic
direction of the organization.

• Management of the processes and the system as a

whole can be achieved using PDCA (Plan-Do-Check-
Action) Cycle with overall focus on risk based thinking
aimed at taking advantage of opportunities and
preventing undesirable results.

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 Process Approach

Schematic representation of the elements of a single process

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Process Approach – PDCA Cycle

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Total Quality Management
“TQM is a management approach for an
organization, centered on quality, based on the
participation of all its members and aiming at long-
term success through customer satisfaction, and
benefits to all members of the organization and to
society."
ISO 8402:1994

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Total Quality Management

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Total Quality Management (cont..)
 TQM places strong focus on process measurement
and controls as means of continuous improvement.

 Total quality is called total because it consists of two

qualities: quality of return to satisfy the needs of the
shareholders, or quality of products.

 One major aim is to reduce variation from every

process so that greater consistency of effort is
obtained.

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Total Quality Management (cont..)
TQM requires six basic concepts / principles :-

1. Leadership - A commitment and involved management

to provide long-term top-to-bottom organizational
support.
2. Customer Satisfaction- An unwavering focus on the
customer, both internally and externally.
3. Employee Involvement - Effective involvement and
utilization of the entire work force.
4. Continuous improvement – Continually improve the
business and production processes.
5. Supplier Partnership - Treating suppliers as partners.
6. Performance measures – established for all the
processes. 31
 Total Quality Management (cont..)
New and Old Cultures
Quality Element Previous State TQM
Definition Product-oriented Customer-oriented
Priorities Second to service & cost 1st among equals of service& 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
Manager’s Role Plan, assign, Delegate, coach, facilitate and
control,enforce mentor

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Total Quality Management (cont..)
The road to business growth :
Continuos Business
Supplier Improvement Growth
Partnering

Employee
Involvement
Focus on
Quality Process
Orientation
Leadership
Customer
Satisfaction Clear Vision

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Total Quality Management (cont..)
Tools & Techniques

1. Quantitative :
- Statistical Analysis (SPC), Acceptance Sampling,
Reliability, Experimental Design, Taguchi’s Quality
Engineering, FMEA and QFD etc.

2. Non-quantitative
- ISO 9000, ISO 14000, Benchmarking, Total Productive
Maintenance, Management and Planning Tools, Lean etc.

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Q&A

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