QA All - Jan2018
QA All - Jan2018
QA All - Jan2018
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
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Testing and Inspection
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Scope of Quality Assurance Functions
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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.
• 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.
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Quality Management System (QMS) – cont..
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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
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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.
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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.
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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.
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.
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Process Approach
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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.
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Total Quality Management (cont..)
TQM requires six basic concepts / principles :-
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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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