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Total
Quality Management
MGT510
VU
Lesson
# 25
ISO
9001(2000) (CLAUSE # 7) PRODUCT
REALIZATION AND CUSTOMER
RELATED
PROCESSES
7
Product
Realization
ISO
9001:2000 Quality Management
Systems - Requirements
7.1
Planning
of Product Realization
The
organization shall plan and
develop the processes needed
for product realization.
Planning of
product
realization shall be consistent
with the requirements of the other
processes of the quality
management
system
In
planning product realization, the
organization shall determine the
following, as appropriate:
a)
Quality
objectives and requirements for the
product;
b)
The
need to establish processes, documents,
and provide resources
specific to the product;
c)
Required
verification, validation, monitoring,
inspection and test
activities specific to the
product
and the criteria for product
acceptance;
d)
Records
needed to provide evidence that the
realization processes and resulting
product meet
requirements
The
output of this planning
shall be in a form suitable
for the organization's method of
operations.
NOTE
1
A
document specifying the processes of the
quality management system
(including the
product
realization processes) and the resource
to be applied to a specific product,
project or contract,
can
be referred to as a quality
plan.
NOTE
2
The
organization may also apply
the requirements given in 7.3 to the
development of
product
realization processes.
General
Guidance
The
definition of quality requirements
relates to how an activity is to be
performed, while
quality
objectives
are measured by process
output or achievement. This lends itself
to the recognition of any
organization
as a collection of processes and
activities. The interdependence of
processes can be
complex,
resulting in a network. To ensure
all processes operate as an efficient
system, the organization
should
undertake an analysis of how processes
interrelate. The analysis should
recognize that the output
of
one process is often the input to
another.
The
principles of process management
should be applied to all
activities. The basic
concept for a
process
consists of three elements: inputs,
activities and outputs.
Realization
processes result in the products of the
organization that add value to the
organization.
Support
processes, including management
processes, are necessary to the
organization, but do
not
directly
add value. Realization and
support processes can include
networks of sub-processes.
Issues
to be Considered
A
process can be represented as a
flow of activities. This
concept can help to define
inputs, specify
resources
and actions and achieve desired outputs. Results from
validation of processes and
verification
of
outputs should also be considered as
inputs for a process, to achieve
continual improvement and
promotion
of excellence throughout the organization.
Improvement of the processes will
improve the
quality
management system and the organization.
Annex B describes a process
improvement
methodology
to assist in recognizing activities as a
process flow, and achieve continual
improvement of
processes.
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Documentation
related to processes should
support
·
identification
and communication of significant features
of the processes.
·
training
in the operation of processes,
·
sharing
knowledge and experience in teams and
work groups, .measurement and audit
of
processes,
and
·
analysis,
review and improvement of
processes.
The
role of people within
processes should be evaluated in
order
·
to
ensure the health and safety of
people,
·
to
ensure that the necessary
skills exist,
·
to
support. networks of processes,
·
to
provide for input of people
in process analysis, and
·
to
promote innovation from
people.
The
drive for continual
improvement should focus on process
improvement as the means by
which
beneficial
results are achieved. Increased
benefits, improved customer
satisfaction and reduction of
waste
are examples of measurable
results achieved by greater effectiveness and
efficiency of processes.
7.1
Managing
Processes
General
The
organization should identify
processes needed to realize products to
satisfy the requirements of
customers
and other interested parties. To ensure
product realization, consideration
should be given to
desired
outputs, process steps,
activities, flows, control
measures, training needs,
equipment,
methodologies,
information, materials and other
resources.
A
plan should be defined to
manage the processes
including
·
input
and output requirements such as
specifications and resources,
·
activities
within the processes,
·
validation
of the processes,
·
verification
of products,
·
analysis
of the process including operability
and maintainability,
·
risk
assessment and mitigation, .corrective
action,
·
opportunities
for improvement, and .control of
change.
Internal
production and service operations also
exist as support processes and
sub-processes and should
be
considered in order to achieve improved
interested-party satisfaction.
Examples
of internal operations include
·
managing
information, .training of
people,
·
machining
of components for assembly,
·
availability
of spare and replacement parts,
·
realization
of product for service.
7.1
Planning
for Process Inputs, Outputs
and Review
Process
inputs should be defined and recorded in
order to provide a basis for
the fom1ulation of
requirements
to be used for verification and
validation of outputs. Inputs can be
internal or external to
the
organization.
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Input
requirements critical to the product or
process should be identified in
order to assign
appropriate
responsibilities
and resources.
Resolution
of ambiguous or conflicting input requirements
can involve consultation
with affected
internal
and external parties. Input derived
from activities not yet
fully evaluated should be subject
to
evaluation
through subsequent review,
verification and validation.
The
organization should identify
significant or critical features of
products and processes in order to
develop
a plan for control and
monitoring of the activities within the
process.
Examples
of issues to consider include:
·
competence
of people, .documentation,
·
equipment
capability and monitoring,
·
health,
safety and work environment.
Process
outputs should be verified against input
requirements and compliance with
acceptance criteria
in
order to satisfy customer
and other interested party requirements.
For verification purposes,
the
outputs
should be documented and evaluated against
input requirements and acceptance
criteria. This
evaluation
should identify necessary
corrective actions, preventive actions or
potential improvements in
the
efficiency of the process. Verification
of the product can be carried
out during operations in order
to
identify
process variation.
The
organization should undertake a
periodic review of process performance to
ensure the process is
consistent
with the operating
plan.
Examples
of issues for consideration
include:
·
reliability
and repetitiveness of the process,
·
identification
of and prevention against potential
nonconformance,
·
adequacy
of design and/or development
inputs,
·
adequacy
of design and/or development
outputs,
·
consistency
of inputs and outputs with planned
objectives,
·
potential
for improvements, and
·
unresolved
issues.
7.1
Planning
for Process Validation and
Changes
Validation
of products should ensure they
meet the needs and expectations of
customers and satisfy
other
interested parties. Validation activities
can include modeling,
simulation and trials, and
reviews
involving
customers or other interested
parties.
Issues
to be considered should include
·
quality
policy and objectives,
·
qualification
of equipment.
·
operating
conditions for the
product,
·
use
or application of the product.
·
disposal
of the product,
·
product
life-cycle,
·
environmental
impact of the product,
and
·
impact
of the use of natural resources
including materials and energy.
Validation
should be carried out at
appropriate intervals to ensure
timely reaction to changes
impacting
the
process.
Particular
attention should given to
validation of processes
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·
for
high-value products,
·
where
deficiency in product will
only be apparent in use, and
·
which
cannot be repeated,
·
where
verification of product is not
possible.
The
organization should implement a
process for the control of
changes to ensure that
changes benefit
the
organization and satisfy the
needs and expectations of interested parties.
Changes should be
identified,
recorded, evaluated, reviewed and
controlled, depending on the effect on
other processes and
the
needs and expectations of customers and
other interested parties.
Any
changes in the process affecting
product characteristics should be
recorded and communicated in
order
to maintain the integrity of the product
and provide information for
improvement. Authority
for
initiating
change should be defined in
order to maintain
control.
A
product or process should be
verified after any related
change to ensure that the
instituted change had
the
r' desired effect.
Use
of simulation techniques can be considered in
order to plan for the
prevention of failures in
processes.
Risk
assessment should be undertaken to
assess the potential for,
and the effect of, possible
failures in
processes.
The results should be used
to define and implement
preventive actions to mitigate
identified
risks.
Examples
of tools for risk assessment
include:
·
process
failure mode and effects
analysis,
·
fault
tree analysis.
·
reliability
assessment.
ISO
9001:2000 - Quality Management
Systems - Requirements
7.2
Customer-Related
Processes
7.2.1
Determination of Requirements Related to
the Product
The
organization shall
determine
a)
Requirements
specified by the customer, including the requirements
for delivery and post-
delivery
activities,
b)
Requirements
not stated by the customer
but necessary for specified
or intended use, where
known,
c)
Statutory
and regulatory requirements related to the
product, and
d)
Additional
requirements determined by the
organization,
7.2.2
Review of Product
Requirements
The
organization shall review the
requirements related to the product. This
review shall be conducted
prior
to the organization's commitment to
supply a product to the customer
(e.g. submission of tenders,
acceptance
of contracts or orders, acceptance of
changes to contracts or orders) and shall
ensure that:
a)
Product
requirements are defined;
b)
Contract
or order requirements differing from
those previously expressed
are resolved, and
d)
The
organization has the ability to
meet defined requirements.
Records
of the results review and actions
arising from the review
shall be maintained
Where
the customer provides no documented
statement of requirement, the customer
requirements, shall
be
confirmed by the organization before
acceptance.
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Where
the customer provides no documented
statement of requirement, the customer
requirements shall
be
confirmed by the organization before
acceptance. Where product requirements
are changed, the
organization
shall ensure that relevant
documents are amended and
that relevant personnel are
made
aware
of the changed requirements.
NOTE:
In some situations, such as
internet sales, a formal
review is impractical for
each order. Instead
the
review can cover relevant
product information such as
catalogues or advertising
material.
7.2.3
Customer
Communication
The
organization shall determine
and implement effective
arrangements for communicating
with
customers
in relation to
a)
Product
information;
b)
Enquiries,
contracts or order handling,
including amendments, and
c)
Customer
feedback, including customer
complaints.
7.2
Processes
Related to Interested Parties
The
organization should define,
implement and maintain processes to
ensure adequate understanding
of
the
needs and expectations of interested parties. These
processes should include
identification and
review
of relevant information and could
actively involve customers
and other interested parties.
Examples
of information sources include
results from
·
Processes
or activities specified by the customer
or other interested parties.
·
Market
research,
·
Contract
requirements.
·
Competitor
analysis, .benchmarking, and
·
Processes
due to statutory or regulatory
requirements.
The
organization should have a full
understanding of the process requirements of the
customer, or other
interested
party, before initiating
action to comply. This
understanding and its impact
should be
mutually
acceptable to the participants.
ISO
9001:2000 - Quality Management
Systems Requirements
7.3.1
Design and Development
Planning
The
organization shall plan and
control design and development of
product. During the design
and
development
planning, the organization shall
determine
a)
The
design and development stages;
b)
The
review, verification and validation
that are appropriate to each
design and development
stage,
and
c)
The
responsibilities and authorities for
design and development.
The
organization shall manage the interfaces
between different groups involved in design
and
development
to ensure effective communication and
clear assignment of
responsibility.
Planning
output shall be updated, as appropriate,
as the design and development
progresses
7.3
Design
and/or Development
General
Guidance
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When
designing and/or developing products or
processes, the organization should
consider life cycle,
safety,
dependability, durability,
maintainability, ergonomics, the environment,
disposal, and other risks.
The
organization should ensure
that the needs of all interested parties
can be satisfied.
Risk
assessment should be undertaken to
assess the potential for,
and the effect of, possible
failures in
products
or processes. The results
should be used to define and
implement preventive actions to
mitigate
identified
risks. Examples of tools for risk
assessment of design and/or development
include
·
design
failure mode and effects analysis-
·
fault
tree analysis
·
reliability
assessment,
·
relationship
diagrams,
·
ranking
techniques, and
·
simulation
techniques.
ISO
9001:2000-Quality Management Systems
-Requirements
7.3.2
Design and Development
Inputs
Inputs
relating to product requirements shall be
determined and records maintained
.These inputs shall
include
a)
Functional
and performance requirements;
b)
Applicable
statutory and regulatory
requirements;
c)
Where
applicable, information derived
from previous similar
designs, and
d)
Other
requirements essential for design and
development.
These
inputs shall be reviewed for
adequacy. Requirements shall be complete, unambiguous and
not in
conflict
with each other.
7.3.2
Design
and/or Development Guidance
The
organization should identify
process inputs that impact
product design and/or development
to
satisfy
the needs and expectations of interested
parties.
Examples
include;
a)
Internal
inputs such as
-
Policies,
standards and specifications,
-
Skill
requirements,
-
Dependability
requirements,
-
Documentation
and data on existing products, and
-
Outputs
from other processes;
b)
External
inputs such as
-
Customer
or marketplace needs and
expectations,
-
Contractual
requirements and interested party
specifications,
-
Relevant
statutory and regulatory
requirements,
-
International
or national standards, and
-
Industry
codes of practice;
c)
Other
inputs that identify those
characteristics of the product or process
that are crucial to
its
safe
and proper functioning, such
as
-
Operation,
installation and application,
-
Storage,
handling, maintenance and
delivery,
-
Physical
parameters and environment, and
-
Disposal
requirements.
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It
should be noted that in the design
and development of software and service
products, inputs on end-
user
requirements, as well as direct customer
requirements, could be particularly
important. Such
inputs
should
be formulated in such a way
that the product can be
tested effectively through
subsequent
verification
and validation.
Design
and/or development output
should lead to realization of the
product and also include
information
necessary
to satisfy the needs and expectations of
customers and other interested
parties.
Examples
of the output of design and/or
development activities
include
·
product
specifications,
·
training
requirements,
·
methodologies,
·
purchase
requirements, and
·
acceptance
criteria.
ISO
9001:2000 - Quality Management
Systems - Requirements
7.3.3
Design and/or Development
Outputs
The
outputs of the design and development shall be
provided in a form that
enables verification against
the
design and development input and
shall be approved prior to
release
Design
and development outputs shall:
a)
Meet
the input requirements for design and
development;
b)
Provide
appropriate information for purchasing,
production and for service
provision,
d)
Contain
or reference product acceptance criteria,
and
e)
Specify
the characteristics of the product that
are essential for its
safe and proper
use.
7.3.3
Design
and Development
Outputs
The
organization should conduct periodic
reviews to consider design and/or
development objectives,
including
·
meeting
verification and validation goals,
·
evaluation
of potential hazards or modes of
failure in product
use,
·
life-cycle
data on performance of the product,
and
·
potential
impact of the product on the
environment.
The
organization should undertake
reviews of design and/or development
outputs, as well as the
process,
in order to satisfy the needs and
expectations of interested parties. It should be
verified that the
outputs
meet the design specifications and
validated that they meet the
needs of the customer. Sufficient
data
should be generated through
verification and validation activities to
enable design and/or
development
methodologies and decisions to be reviewed.
The review of methodologies
should include
process
and product improvement, failure
investigation, activities, and future
design and/or development
process
needs. Partial validation of the design
and/or development outputs may be
necessary to provide
confidence
in their future application. by
means such as:
·
Validation
of engineering designs prior to
construction.
·
Installation
or application, .validation of software
outputs prior to installation or
use.
·
Validation
of direct customer services
prior to widespread introduction.
Examples
of verification activities
include:
·
comparative
methodologies, such as alternative design
and/or development
calculations,
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·
evaluation
against similar products,
·
testing,
simulations or trials to check
compliance with specific
input requirements.
1S0
9001:2000 - Quality Management
Systems Requirements
7.3.4
Design and Development
Review
At
suitable stages, systematic
reviews of design and development
shall be performed in accordance
with
planned
arrangement
a)
To
evaluate the ability of the results of
design and development to meet requirements,
and
b)
To
identify any problems and
propose necessary actions.
Participants
in such reviews shall
include representatives of functions
concerned with the design and
development
stage(s) being reviewed.
Records of the results of the reviews
and any necessary
actions
shall
be maintained
7.3.5
Design
and development verification
Verification
shall be performed in accordance
with planned arrangements to
ensure that the design and
development
outputs have met the design and
development input requirements. Records
of the results of
the
verification and any
necessary actions shall be
maintained
ISO
9001:2000-Quality Management Systems
-Requirements
7.3.6
Design
and Development
Validation
Design
and development validation shall be
performed in accordance with
planned arrangements
sure
that
the resulting product is capable of
meeting the requirements for the
specified application or
intended
use, where known. Wherever
practicable, validation shall be
completed prior to the delivery or
implementation
of the product. Records of the results of
validation and any necessary
actions shall be
maintained
7.3.7
Control
of design and development
changes
Design
and development changes shall be
identified and records
maintained. The changes
shall be
reviewed,
verified and validated, as appropriate,
and approved before
implementation. The review
of
design
and development changes shall
include evaluation of the effect of the
changes on constituent
parts
and product already delivered.
Records of the results of the review of
changes and any
necessary
actions
shall be maintained.
7.4
Purchasing
1S0
9001:2000 - Quality Management
Systems - Requirements
7.4
Purchasing
7.4.1
Purchasing Process
The
organization shall ensure
that purchased product conforms to
specified purchase requirements.
The
type
and extend of control applied to the
supplier and the purchased product
shall be dependent upon the
effect
of the purchased product on subsequent
product realization or the final
product.
The
organization shall evaluate and
select suppliers based on their
ability to supply product
in
accordance
with the organization's requirements.
Criteria for selection evaluation and
re-evaluation shall
be
established. Records of the results of
evaluations and any
necessary actions arising from
the
evaluation
shall be maintained
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7.4.1
Purchasing
Process
The
organization should identify
and implement purchasing process
for selection, evaluation,
and
control
of purchased products to ensure they
satisfy its needs, total
cost of purchased product to
ensure
they
satisfy its needs and
requirements, as well as those of interested
parties.
Purchasing
processes should
include
·
identification
of needs,
·
total
cost of purchased product,
taking account of performance, price and
delivery,
·
inquiries,
quotations and tendering,
·
verification
of purchased products,
·
selection
of suppliers, including those with
unique processes,
·
purchase
documentation,
·
contract
administration.
·
nonconforming
purchased products.
·
supplier
control and supplier development,
and
·
assessment
of risks associated with the purchased
product.
Process
requirements and specifications should be
developed with suppliers in order to
benefit from
available
specialist knowledge. Suppliers could
also be involved in the specification of
quality
management
system requirements in relation to their
products
ISO
9001:2000 - Quality management systems
-Requirements
7.4.2
Purchasing Information
Purchasing
information shall describe the
product to be purchased, including where
appropriate
a)
Requirements
for approval of product,
procedures, processes and
equipment,
b)
Requirements
for qualification of personnel,
and
c)
Quality
management system requirements.
The
organization shall ensure the
adequacy of specified purchase
requirements prior to their
communication
to the supplier.
7.4.2
Suppliers
The
organization should establish processes
to identify potential suppliers or to
develop existing
suppliers
and evaluate their ability to
supply the required products. These
processes may include
·
evaluation
of relevant experience.
·
review
of product quality.
·
price,
delivery performance and response to
problems.
·
audits
of supplier management systems and
evaluation of their potential
capability to provide
the
required products efficiently and within
schedule
·
checking
references for customer
satisfaction,
·
financial
assessment to assure the viability of the
supplier throughout the intended
period of
supply,
·
service and support
capability.
·
logistic
capability including locations
and resources.
The
organization should ensure
that orders for purchased
product are adequate to
satisfy the input
requirements
of the organization's processes.
Examples
of issues to be considered include
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·
purchasing
from qualified suppliers,
·
logistic
requirements,
·
product
identification,
·
preservation
of product,
·
traceability
of product,
·
documentation
and records,
·
communication,
·
acceptance
criteria, and
·
right
of access to supplier's premises.
The
organization should establish a process
for verification of purchased products to
ensure compliance
with
specification. The level of
verification activity can
vary according to the nature or the type
of
product
and historical performance of the
supplier.
The
organization should define the
need for records of
purchased product verification,
supplier
communication
and response to nonconformities in order
to demonstrate its conformance to
specification.
ISO
9001:2000 - Quality Management
Systems -Requirements
7.4.3
Verification of Purchased
Product
The
organization shall establish and
implement the inspection or other
activities necessary for
ensuring
that
purchased product meets
specified purchase requirements.
Where
the organization or its customer
intends to perform verification at the
supplier's premises,
the
organization
shall state the intended
verification arrangements and method of
product release in the
purchasing
information.
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Table of Contents:
- OVERVIEW OF QUALITY MANAGEMENT:PROFESSIONAL MANAGERIAL ERA (1950)
- TOTAL QUALITY MANAGEMENT AND TOTAL ORGANIZATION EXCELLENCE:Measurement
- INTEGRATING PEOPLE AND PERFORMANCE THROUGH QUALITY MANAGEMENT
- FUNDAMENTALS OF TOTAL QUALITY AND RATERS VIEW:The Concept of Quality
- TOTAL QUALITY MANAGEMENT AND GLOBAL COMPETITIVE ADVANTAGE:Customer Focus
- TOTAL QUALITY MANAGEMENT AND PLANNING FOR QUALITY AT OFFICE
- LEADERS IN QUALITY REVOLUTION AND DEFINING FOR QUALITY:User-Based
- TAGUCHI LOSS FUNCTION AND QUALITY MANAGEMENT
- WTO, SHIFTING FOCUS OF CORPORATE CULTURE AND ORGANIZATIONAL MODEL OF MANAGEMENT
- HISTORY OF QUALITY MANAGEMENT PARADIGMS
- DEFINING QUALITY, QUALITY MANAGEMENT AND LINKS WITH PROFITABILITY
- LEARNING ABOUT QUALITY AND APPROACHES FROM QUALITY PHILOSOPHIES
- TOTAL QUALITY MANAGEMENT THEORIES EDWARD DEMING’S SYSTEM OF PROFOUND KNOWLEDGE
- DEMING’S PHILOSOPHY AND 14 POINTS FOR MANAGEMENT:The cost of quality
- DEMING CYCLE AND QUALITY TRILOGY:Juran’s Three Basic Steps to Progress
- JURAN AND CROSBY ON QUALITY AND QUALITY IS FREE:Quality Planning
- CROSBY’S CONCEPT OF COST OF QUALITY:Cost of Quality Attitude
- COSTS OF QUALITY AND RETURN ON QUALITY:Total Quality Costs
- OVERVIEW OF TOTAL QUALITY APPROACHES:The Future of Quality Management
- BUSINESS EXCELLENCE MODELS:Excellence in all functions
- DESIGNING ORGANIZATIONS FOR QUALITY:Customer focus, Leadership
- DEVELOPING ISO QMS FOR CERTIFICATION:Process approach
- ISO 9001(2000) QMS MANAGEMENT RESPONSIBILITY:Issues to be Considered
- ISO 9001(2000) QMS (CLAUSE # 6) RESOURCES MANAGEMENT:Training and Awareness
- ISO 9001(2000) (CLAUSE # 7) PRODUCT REALIZATION AND CUSTOMER RELATED PROCESSES
- ISO 9001(2000) QMS (CLAUSE # 7) CONTROL OF PRODUCTION AND SERVICES
- ISO 9001(2000) QMS (CLAUSE # 8) MEASUREMENT, ANALYSIS, AND IMPROVEMENT
- QUALITY IN SOFTWARE SECTOR AND MATURITY LEVELS:Structure of CMM
- INSTALLING AN ISO -9001 QM SYSTEM:Implementation, Audit and Registration
- CREATING BUSINESS EXCELLENCE:Elements of a Total Quality Culture
- CREATING QUALITY AT STRATEGIC, TACTICAL AND OPERATIONAL LEVEL
- BIG Q AND SMALL q LEADERSHIP FOR QUALITY:The roles of a Quality Leader
- STRATEGIC PLANNING FOR QUALITY AND ADVANCED QUALITY MANAGEMENT TOOLS
- HOSHIN KANRI AND STRATEGIC POLICY DEPLOYMENT:Senior Management
- QUALITY FUNCTION DEPLOYMENT (QFD) AND OTHER TOOLS FOR IMPLEMENTATION
- BASIC SQC IMPROVEMENT TOOLS:TOTAL QUALITY TOOLS DEFINED
- HOW QUALITY IS IMPLEMENTED? A DIALOGUE WITH A QUALITY MANAGER!
- CAUSE AND EFFECT DIAGRAM AND OTHER TOOLS OF QUALITY:Control Charts
- STATISTICAL PROCESS CONTROL (SPC) FOR CONTINUAL QUALITY IMPROVEMENT
- STATISTICAL PROCESS CONTROL….CONTD:Control Charts
- BUILDING QUALITY THROUGH SPC:Types of Data, Defining Process Capability
- AN INTERVIEW SESSION WITH OFFICERS OF A CMMI LEVEL 5 QUALITY IT PAKISTANI COMPANY
- TEAMWORK CULTURE FOR TQM:Steering Committees, Natural Work Teams
- UNDERSTANDING EMPOWERMENT FOR TQ AND CUSTOMER-SUPPLIER RELATIONSHIP
- CSR, INNOVATION, KNOWLEDGE MANAGEMENT AND INTRODUCING LEARNING ORGANIZATION