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Total
Quality Management
MGT510
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Lesson
# 27
ISO
9001(2000) QMS (CLAUSE # 8)
MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
8.
Measurement,
Analysis and
Improvement
ISO
9001:2000 - Quality Management
Systems - Requirements
8.
Measurement,
Analysis and
Improvement
8.1
General
The
organization shall plan and
implement the monitoring, measurement,
analysis and improvement
processes
needed
a)
To
demonstrate conformity of the
product,
b)
To
ensure conformity of the quality
management system, and
c)
To
continually improve the effectiveness of the
quality management
system.
This
shall include determination of
applicable methods, including
statistical techniques, and the
extent
of
their use.
8.1
General
Guidance
Introduction
An
organization should provide
for the measurement and evaluation of
its product, the capability
of
processes,
customer satisfaction and items
required by other interested parties at
appropriate intervals.
This
includes the recording, collecting,
analyzing, summarizing and communication
of relevant data
needed
to monitor and improve the organization's
performance.
Measurements
should be evaluated in terms of the
added value provided to the
organization, and should
be
deployed only where the benefit
can be identified. The
measurement criteria and objectives
should be
identified.
These measurements should
lead to consideration of appropriate
action. They should not
be
purely
for the accumulation of
information.
The
results of measurement can show a
level of achievement, but consideration
should also be given
to
trends
and variation. The causes of
trends and variation should be
identified in order to ensure
they are
understood.
The organization should
determine the need for the
use of statistical techniques
for
analyzing
data, including verifying
process operations and product
characteristics. Statistical techniques
selected
for use should be suitable
for the application. The
organization should control and
monitor the
use
of the statistical techniques
selected.
The
results of analysis of data from
improvement activities should be
one of the inputs to the
management
review process. The
information and data collected
should be used throughout
the
organization
to support effective and efficient
management.
The
organization should promote the
use of creative and innovative
approaches for
improvement
processes.
Also, the organization should
plan the implementation of the
improvement action and
provide
adequate resources. The
organization should continually
monitor and record the
implementation
of
improvement actions, which will
also provide data for
future improvements. Relevant
comparative
data
and information should be used to
set realistic and challenging
goals.
Continual
improvement requires change within the
organization. Evaluation of change
requires
measurement.
Measurement itself does not
initiate change. Measurements should be
taken for a clearly
defined
purpose.
Issues
to be Considered
Measurement,
analysis and improvement include
issues such as the
following:
a)
Measurement,
analysis and improvement should be used
to establish appropriate priorities
for
the
organization;
b)
The
measurements employed by the organization
should be reviewed periodically,
and data
should
be verified on a continuum (basis
for accuracy and
completeness;
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c)
The
benchmarking of individual processes as
well as customer satisfaction
should be employed
as
.an improvement tool;
d)
The
use of measurements and the
generation of information are
essential for good
communication
and they should be the basis
for improvement and involvement of
all interested
parties;
such information should be
current, and be clearly defined as to
its purpose;
e)
Appropriate
tools for the communication of
information resulting from the
analyses of the
measurements
should be implemented;
f)
The
effectiveness of communication to interested par1ies
should be measured to
determine
whether
the information is clearly
understood;
g)
Self-assessment
should be considered on a periodic basis
to assess organizational
performance
and
to define improvement Opportunities
(see annex A).
ISO
9001:2000 - Quality Management
Systems - Requirements
8.2
Monitoring
and Measurement
8.2.1
Customer Satisfaction
As
one of the measurements of the performance of the
quality management system, the
organization
shall
monitor information relating to
customer perception as to whether the
organization has met
customer
requirements. The methods for
obtaining and using this
information shall be
determined.
8.2
Measurement
and Monitoring
8.2.1
Measurement and Monitoring of
System Performance
General
The
organization should identify the
methodologies needed for
identification of areas for
improvement
in
the overall efficiency and effectiveness
of the quality management system.
Examples of
measurement
and monitoring methodologies include
customer satisfaction
measurement,
·
Internals
audits,
·
Financial
measurements, and
·
Self-assessment
methodologies.
8.2.1
Measurement
and Monitoring of Customer
Satisfaction
The
organization should recognize that there
are many sources of customer-related
information, arid
should
establish processes to gather analyze and deploy
this information. The
organization should
identify
sources of customer and end-user
information available in written and
verbal forms, from
internal
and external sources. Examples of
customer- related information
include
·
Feedback
on all aspects of
product.
·
Customer
requirements and contract information, .marl<et
needs.
·
Service
delivery data, and
·
Information
relating to competition.
The
organization's process for requesting,
measuring and monitoring feedback of customer
satisfaction
and
dissatisfaction should provide
information on a continual basis. It
should address conformance to
requirements,
meeting needs and expectations of
customers, as well as price and
delivery of product.
The
organization should establish and use
sources of customer information
and should cooperate
with
its
customers in order to anticipate
future needs. The
organization should plan and establish
processes
for
implementing appropriate marketing
activities to efficiently obtain the
"voice of the customer".
The
organization should specify the
methodology and the measures to be
used and the frequency of
gathering
and analyzing data for
review.
The
organization should plan
data collection methodologies. Examples
of sources of information on
customer
satisfaction include
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·
Customer
complaints,
·
Direct
communication with
customers.
·
questionnaires
and surveys, .focus groups,
·
Reports
from consumer
organizations,
·
Reports
in various media, and .sector
studies.
ISO
9001:2000 - Quality Management
Systems - Requirements
8.2.2
Internal Audit
The
organization shall conduct internal
audits at planned intervals to determine
whether the quality
management
system:
a)
Conforms
to the planned arrangements (see
7.1) to the requirements of this Internal
Standards
and
to the quality management system
requirements established by the organization,
and
b)
Is
effectively implemented and
maintained
An
audit program shall be
planned, taking into
consideration the status and importance
of the processes
and
areas to be audited, as well as the
results of previous audits. The
audit criteria, scope,
frequency and
methods
shall be defined. Selection of
auditors and conduct of audits shall
ensure objectivity and
impartiality
of the audit process. Auditors
shall not audit their
own work.
The
responsibilities and requirements for
planning and conducting audits,
and for reporting results
and
maintaining
records shall be defined in a documented
procedure.
The
management responsible for the area
being audited shall ensure
that actions are taken
without under
delay
to eliminate detected nonconformities and
their causes. Follow-up
activities shall include
the
verification
of the actions taken and the reporting of
verification results (see
8.5.2)
8.2.2
Internal
Audit
An
organization should establish an internal
audit process to assess the
strengths and weaknesses of the
Quality
Management system. The
internal audit process may
also review the efficiency
and
effectiveness
of other activities and support processes
in the organization. The internal
audit process
should
include the planning, implementation,
reporting and follow-up activities
related to internal
audits.
Planning for internal audits
should be flexible in order to
permit changes in emphasis
based on
findings
and observations obtained during the
audit Input from the area to
be audited, as well as
from
other
interested parties, should be considered in the
development of internal audit
plans.
Examples
for consideration by internal
auditing include
·
existence
of adequate documentation,
·
effective
implementation of processes,
·
identification
of nonconformance,
·
documentation
of results, .competence of
people,
·
opportunities
for improvement,
·
capability
of processes,
·
use
of statistical techniques,
·
use
of information technology,
·
analysis
of quality cost data,
·
assigned
responsibilities and authorities,
·
performance
results and expectations,
·
adequacy
and accuracy of performance
measurement,
·
improvement
activities, and
·
relationships
with interested parties, including
internal customers.
In
addition to documenting non-conformances,
internal audit reporting
could also indicate areas
for
improvement
(with recommendations), as well as areas
of outstanding performance.
Examples
of follow-up activities
include
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·
Verification
of implementation.
·
timeliness
and effectiveness of corrective action,
and
·
Effectiveness
of the internal audit
process.
8.2.2
Self
Assessment
Organizations
should consider establishing and
implementing a self-assessment process.
The range and
depth
d the assessment should be planned in
relation to the organization's objectives
and priorities. The
self-assessment
methodology described in annex A, as well as
existing quality awards
criteria or other
appropriate
methodologies may be used
for self-assessment of the organization.
Some of the
advantages
of
using the self-assessment methodology
given in annex A are that
.it is simple to understand,
·
it
is easy to use,
·
it
has minimal impact on the
use of management resources,
and
·
it
provides input to enhance the performance
of the organization's Quality management
system.
The
self-assessment methodology described in annex A
focuses on determining the degree of
efficiency
and
effectiveness of implementation of the Quality
management system defined in
this International
Standard.
Annex A is not intended to
provide a self-assessment methodology to
compete with existing
models.
Self-assessment methodology should
not be considered as an alternative to
internal or external
quality
auditing. Use of the methodology
described in annex A can provide an
overall view of the
performance
of the organization and the degree of
maturity of the quality management
system. It can
also
provide input for
identifying areas in the organization
requiring improvement and can
help to
determine
priorities.
8.2.3
Measurement
and Monitoring of
Processes
The
organization should identify
measurement methodologies and
perform measurements to
evaluate
process
performance. The organization should
consider how these measurements
can be incorporated
into
the product realization process and the
role of measurement in process
management.
Examples
of measures of process performance
include .accuracy,
·
timeliness,
·
dependability
,
·
reaction
time of processes and people to special
internal and external
requests.
·
cycle
time or throughput,
·
effectiveness
and efficiency of
people,
·
utilization
of technologies, and
·
cost
reduction.
ISO
9001:2000 - Quality Management
Systems - Requirements
8.2.3
Monitoring and Measurement of
Processes
The
organization shall apply
suitable methods for
measurement and, where applicable,
measurement of
the
quality management system
processes. These methods
shall demonstrate the ability of the
processes
to
achieve planned results. When
planned results are not
achieved, correction and corrective
action shall
be
taken, as appropriate, to ensure
conformity of the product
8.2.4
Monitoring
and Measurement of Products
The
organization should establish and specify
the measurement requirements (including
acceptance
criteria)
for its products. The
measurement of product should be
planned and performed to
verify
conformance
to specified requirements.
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The
organization should consider the
following when choosing a methodology to
measure products:
a)
The
conformance to specified requirements of its products,
and those provided by
suppliers;
b)
The
location of each measurement
point in its process
sequence;
c)
Characteristics
to be measured at each point, the
documentation and acceptance
criteria to be
used;
d)
Equipment
and tools required;
e)
Customer
established points for witness or
verification of selected characteristics
of a product;
f)
Inspections
or testing that are required
to be witnessed or performed by statutory
and regulatory
authorities;
g)
Where,
when and how the organization
intends, or is required by the customer
or statutory and
regulatory
authorities, to engage qualified
third parties to perform
-
type
testing.
-
In-process
inspections or testing,
-
Product
verification,
-
Product
validation;
h)
Qualification
of material, product, process,
people or the quality management
system;
i)
Final
inspections to confirm that all
specified inspections and testing are
completed and
accepted;
j)
Outputs
of the measurement process of the
product.
The
measurement of product should be
performed prior to delivery to
verify that the product is
in
conformance
with requirements. The organization
should review the approach used
for measuring
products
and the records of verification and make
appropriate improvement.
Typical
examples of product measurement
records include
·
inspection
and test reports,
·
material
release notices,
·
certificates
as required, and
·
electronic
data.
ISO
9001:2000 -Quality Management
Systems - Requirements
8.2.4
Monitoring and Measurement of
Product
The
organization shall monitor and
measure the characteristics of the
product to verify that
requirements
have
been met. This shall be
carried out at appropriate
stages of the product realization
process in
accordance
with the planned arrangement (see
7.1).
Evidence
of conformity with the acceptance
criteria shall be maintained.
Records shall indicate
the
person(s)
authorizing release of
product.
Product
release and service delivery shall
not proceed until the
planned arrangements (see
7.1) have
been
satisfactorily completed, unless
otherwise approved by a relevant
authority and, where applicable,
by
the customer.
8.2.4
Measurement
and Monitoring of Satisfaction of
Interested Parties
The
organization should identify the
measurement information required to
meet the needs of
other
interested
parties at appropriate stages of product
realization. Such information
should include
measurements
relating to people, owners, suppliers and
society.
8.2.4
People
in the Organization
The
organization should
·
gather
the opinion of its people
regarding the manner in which the
organization satisfies
their
needs
and expectations, and
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·
assess
individual and collective
performances and their
contribution to organizational
results.
8.2.4
Owners
The
organization should
·
assess
its capacity to attain the
defined goals,
·
measure
financial performance,
·
measure
the impact of external factors on
results, and
·
identify
the value contributed by the actions
taken.
8.2.4
Suppliers
The
organization should
·
monitor
the performance of suppliers and their compliance
with the purchasing policy,
·
measure
or monitor the quality of the product
purchased, and
·
measure
the performance of the purchasing processes of the
organization.
8.2.4
Society
The
organization should
·
define
appropriate measurements relative to
its objectives, for
interaction with society,
and
·
periodically
assess the efficiency of its actions and
the perceptions of the results by
relevant
parts
of society.
8.3
Control
of Nonconformance
General
All
people within the organization
should have the authority to report
non-conformances at any stage of
a
process. This is particularly
true for those people
engaged in monitoring processes and
process output
verification.
Prompt attention to non-conformances permits the
initiation of prompt corrective
action.
Authority
for reaction to non-conformances should
be defined to maintain achievement of
product
requirements.
The organization should
control product identification,
segregation and disposition in
order
to prevent misuse. The
organization may also need
to consider recording information on
those
non-conformances
which are corrected in the normal
course of work. Such data
can provide valuable
information
for process improvement It is
essential that all non-conformances be
recorded, together with
their
disposition, to assist learning and
provide data for analysis
and improvement
activities.
8.3
Nonconformance
Review and
Disposition
The
organization should have a process to
provide for review and
disposition of all
non-conformances.
Review
of non conformances should be conducted
by designated persons to determine if any
trends or
patterns
of occurrence exist. These
trends should be considered for
improvement and as input to
management
review. People carrying out the
review should be competent to evaluate
the effects of the
non-conformance
and should have the authority and
resource to define corrective
action. Customer
acceptance
of the disposition may be a contractual
requirement.
ISO
9001:2000-Quality Management Systems
Requirements
8.3
Control
of Nonconforming Product
The
organization shall ensure
that product which does
not conform to product requirements is
identified
and
controlled to prevent unintended
use or delivery. The
controls and related responsibilities
and
authorities
for neither dealing with
nor conforming product shall
be defined in a documented procedure.
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The
organization shall deal with
nonconforming product by one or more of the
following ways:
a)
By
taking action to eliminate the
detected nonconformity;
b)
By
authorizing its use, release
or acceptance under concession by a
relevant authority and,
where
applicable, by the customer;
c)
By
taking action to preclude
its original intended use or
application.
Records
of the nature of nonconformities and any
subsequent actions taken, including
concessions
obtained,
shall be maintained (see
4.2.4)
When
nonconforming product is corrected it
shall be subject to re-verification to
demonstrate
conformity
to the requirements. When nonconforming
product is detected after
delivery or use has
started,
the organization shall take
action appropriate to the effects, or
potential effects, of the
nonconformity.
operational
performance
customer
satisfaction and dissatisfaction,
satisfaction
level of other interested parties,
effectiveness
and efficiency of -
organization,
supplier
contribution,
economics
of quality and financial and
market-related performance and,
bend1marrking
of performance.
8.4
Analysis
of Data for
Improvement
The
organization should analyze data
from various sources to
assess performance against plans
and
goals
and to identify areas for
improvement. The organization
should plan to use
statistical
methodologies
for data analysis, which can
help in assessing, controlling, and
improving performance of
processes.
The
analysis of data can help
deten11ine the cause of problems, and
therefore guide effective
corrective
and
preventive action. This may
require analysis of the product
specifications, as well as analysis
of
relevant
processes, operations and quality
records.
Information
and data from all parts of
the organization should be
integrated and analyzed to evaluate
the
overall
performance of the organization. The
overall performance should be presented
in a forma that is
suitable
to different levels of
management.
The
results of analysis can be used to
deten11ine
trends,
operational
performance
customer
satisfaction and dissatisfaction,
satisfaction
level of other interested parties,
effectiveness
and efficiency of -
organization,
supplier
contribution,
economics
of quality and financial and
market-related performance and,
bend
marking of performance.
ISO
9001; 2000 - Quality Managements
-Requirements
8.4
Analysis
of Data
The
organization shall determine collect and
analyze appropriate data to demonstrate
the suitability and
effectiveness
of the quality management system and to
evaluate where continual improvement of
the
effectiveness
of the quality management system
can be made. This shall
include data generated as a
result
of monitoring and measurement and from
other relevant
sources.
The
organization shall analyze this
data to provide information
on:
a)
Customer
satisfaction (see
8.2.1)
b)
Conformity
to product requirements (see
7.2.1)
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c}
characteristics
and trends of processes and products
including opportunities for
preventive
action,
d)
Suppliers
ISO
9001:2000- Quality Management
Systems - Requirements
8.5
Improvement
8.5.1
Continual Improvement
The
organization shall continually
improve the effectiveness of the quality
management system
through
the
use of the quality policy,
quality objectives, audit
results, analysis of data, corrective and
preventive
actions
and management review.
8.5
Improvement
8.5.1
General
The
organization should continually
seek to improve its
processes, rather than wait
for a problem to
reveal
opportunities for improvement.
Potential improvements can range
from continual activities
to
long-term
improvement projects. The organization
should have a process in place to
identify and
manage
improvement projects.
The
efficiency and effectiveness of processes
should be emphasized when actions
are taken. These
actions
should be monitored to ensure
that desired goals are met.
Identification of causes of
deviations
may
result in changes to, the
product, processes and even
revision of the quality management
system.
8.5.2
Corrective
Action
The
organization should plan and establish a
process for corrective
action. Corrective action
planning
should
include evaluation of the significance of
problems affecting quality. The
evaluation should be in
terms
of the potential impact on such
aspects as operating costs,
costs of nonconformance, performance,
dependability,
safety and customer satisfaction.
Appropriate functions should be
represented in the
corrective
action process.
The
organization should identify
sources of information, collect
information and define the
necessary
corrective
- actions. The defined corrective
action should be focused on
eliminating causes of
non-
conformances
and defects in order to avoid
recurrence.
Examples
of sources of information
include
·
customer
complaints,
·
non-conformance
reports,
·
outputs
from management
review,
·
internal
audit reports,
·
outputs
from data analysis,
·
relevant
quality management system
records,
·
outputs
from satisfaction
measurements,
·
process
measurements, and .results of
self-assessment
The
corrective action process
should include
·
a
definition of the causes of non-conformances and
defects,
·
elimination
of causes of non-conformances and
defects,
·
appropriate
actions to avoid recurrence of problems,
and
·
a
record of the activity and
results.
Efficiency
and effectiveness of processes should be
emphasized when actions are
taken and the actions
should
be monitored to ensure that desired goals
are met.
Corrective
actions should be considered for
inclusion in the management review
process. For example,
corrective
actions with high financial
impact or those that have
significant potential impact on
customer
satisfaction
should be considered.
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Root
because analysis results should be
verified by testing, where appropriate,
in order to define
effective
corrective action.
ISO
9001:2000 -Quality Management
Systems -Requirements
8.5.2
Corrective Action
The
organization shall take
corrective action to eliminate the
cause of nonconformities in order
to
prevent
recurrence. Corrective action
shall be appropriate to the effects of the
nonconformities
encountered.
The
documented procedure shall be established to define
requirement for
a)
Reviewing
nonconformities (including customer
complaints);
b)
Determining
the causes of nonconformities;
c)
Evaluating
the need for actions to ensure
that nonconformities do not
recur;
d)
Determining
and implementing the corrective action
needed;
e)
Recording
results of action
taken;
f)
Reviewing
of corrective action
taken.
8.5.3
Preventive
Action
The
organization should use
preventive methodologies to identify the
causes of potential
non-
conformances.
Examples of such methodologies include
risk analyses, .trend
analyses, statistical
process
control, fault tree analysis, failure
modes and effects and
criticality analyses.
Appropriate
organizational representatives should
participate in the preventive
actions.
The
organization should identify
sources of information for
planning and prioritizing preventive
actions.
Examples
of sources are
·
customer
needs and expectations,
·
market
analysis,
·
management
review output,
·
outputs
from data analysis,
·
satisfaction
measurements,
·
process
measurements,
·
systems
that consolidate many
sources of customer
information,
·
relevant
quality management system
records,
·
results
of self-assessment, and
·
processes
that provide early warning
of approaching out-of-control operating
conditions.
Preventive
actions should be considered for
inclusion in the management review
process. This is
especially
true for preventive actions
with high financial impact
or those that have significant
potential
impact
on satisfaction of customers and other
interested parties.
ISO
9001:2000-Quality Management Systems
-Requirements
8.5.3
Preventive Action
The
organization shall determine
preventive action to eliminate the
causes of potential
nonconformities
in
order to prevent occurrence.
Preventive actions shall be appropriate
to the effects of the potential
problems.
A documented procedure shall be established to define
requirements for:
a)
Determining
potential nonconformities and their
causes;
b)
Evaluating
the need for action to
prevent occurrence of
nonconformities
c)
Determining
and implementing action
needed,
d)
Records
of results of action taken
and
e)
Reviewing
preventive action
taken.
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8.5.4
Process
for Improvement
In
addition to the improvement actions described in the
previous sub-clauses, the organization
should
define
and implement a methodology for
process improvement that can
be applied to all processes
and
activities.
Such a standard methodology
for process improvement can
become a tool for
improving
internal
effectiveness and efficiency, as well as
improving the satisfaction of customers
and other
interested
parties.
Examples
of inputs to the improvement process
include
·
validation
data,
·
test
data,
·
requirements and
feedback from interested parties,
·
financial
data,
·
product
performance data, and
·
service
delivery data.
The
organization should undertake
small step improvement
activities integral to routine operations
in
order
to maintain continual improvement
through involvement of people.
Improvement should also
be
planned
for breakthrough projects to achieve
specific objectives.
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