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Benchmarking
is a methodology that is used to search for best
practices. Benchmarking can be applied to
strategies, policies,
operations, processes, products, and organizational
structures.
By finding and adopting best practices you can improve
your
organization’s overall performance.
Best practices can be found either
within your own organization or
within other organizations. It usually means identifying
organizations
that are doing something in the best possible way and then
trying to
emulate how they do it.
There are at least two types of external
benchmarking: competitive
benchmarking and generic benchmarking. Competitive
benchmarking
involves comparing how you do things with how your
competitors do
things while generic benchmarking involves comparing
yourself with
organizations in unrelated sectors.
In order to carry out benchmarking
projects, you need to develop
a benchmarking methodology. Your benchmarking methodology
should define rules that control:
- How the scope of each project is
defined.
- How benchmarking partners are
selected.
- How confidentiality is respected
and ensured.
- How benchmarking characteristics
are specified.
- How benchmarking indicators or
metrics are chosen.
- How benchmarking data is collected
and analyzed.
- How potential improvements
are identified.
- How
improvement
plans are developed.
- How your benchmarking
experience is added
to your organization’s knowledge base.
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A characteristic is a
distinctive feature or property of something.
Characteristics
can be inherent or assigned. An inherent
characteristic exists in something or is a permanent
feature
of something, while an assigned characteristic is a
feature
that is attributed or attached to something.
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A concession is a special
approval that is granted to release
a nonconforming product for use or delivery. Concessions
are
usually limited by time and quantity
and tend to specify that
nonconforming characteristics may not violate specified
limits.
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To conform
means to meet or comply with requirements.
There are many types of requirements.
There are quality
requirements, customer requirements, product requirements,
management requirements, legal requirements, and so on.
Requirements can be explicitly specified
(like the ISO 9001
requirements) or implied. A specified
requirement is one that
has been stated (in a document, for example). When your
organization meets a requirement, you can say that it
conforms to that requirement.
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Continual improvement is a set of recurring activities that an
organization carries out in order to enhance its ability
to meet
requirements. Continual improvements
can be achieved by
carrying out audits,
self-assessments, management reviews,
and benchmarking projects. Continual improvements
can also
be realized by collecting data, analyzing
information, setting
objectives, and implementing corrective and preventive
actions.
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A correction is any action that
is taken to eliminate a
nonconformity. However, corrections do not address
causes. When applied to products, corrections can
include reworking products, reprocessing them,
regrading them, assigning them to a different
use, or simply destroying them.
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Corrective
actions are steps
that are taken to eliminate
the causes of existing
nonconformities in order to prevent
recurrence. The corrective action
process tries to make
sure that existing
nonconformities and potentially
undesirable situations don’t happen again.
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A customer is anyone who
receives products or services from a
supplier organization. Customers can be people or
organizations
and can be either external or internal to the supplier
organization.
For example, a factory may supply products or services to
another
factory (customer) within
the same
organization. According to
ISO 9000, examples of customers include
clients, consumers,
end-users, purchasers, retailers, and beneficiaries.
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Customer satisfaction is a perception. It is also a question of
degree. It can vary from high satisfaction to low
satisfaction.
If customers believe that you've met their requirements,
they
experience high satisfaction. If they believe that you've
not
met their requirements, they experience low satisfaction.
Since satisfaction is a perception,
customers may not be
satisfied even though you’ve met all contractual
requirements.
Just because you haven’t received any complaints doesn’t
mean that customers are satisfied.
There are many ways to monitor and
measure customer
satisfaction. You can use customer satisfaction and
opinion
surveys; you can collect product quality data (post
delivery),
track warranty claims, examine dealer reports, study
customer
compliments and criticisms, and analyze lost business
opportunities.
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Design and development is a process (or a set of processes).
This process uses resources to transform requirements
(inputs)
into characteristics or specifications (outputs) for
products,
processes, and systems.
You may treat design and development
as different stages
of a single integrated design and development process or
you may treat design and development as two (or more)
separate processes. You may also use the terms design
and development interchangeably if they mean the
same thing in your organization.
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Design and development review is a set of activities whose purpose
is to evaluate the suitability, adequacy, effectiveness,
and sometimes
the efficiency of a set of characteristics or
specifications. Design and
development review can be used to evaluate product,
process, and
system characteristics or specifications. In this context,
an effective
set of characteristics or specifications is one that has
the potential
to achieve planned results or realize planned activities.
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Design and development validation is a process. This process uses
objective evidence to confirm that products meet the
requirements
which define their intended use or application. Whenever
specified
requirements have been met, a validated status is
achieved. The
process of validation can be carried out under
realistic use
conditions or within a simulated use environment.
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Design and development verification
is a process. It uses objective
evidence to confirm
that design and development outputs meet
design and development input requirements. Whenever
specified
input requirements have been met, a verified status
is achieved.
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Effectiveness
refers to the degree to which a planned effect is
achieved. Planned activities are effective if
these activities are
realized. Similarly, planned results are effective
if these results
are actually achieved.
For example, an effective process
is one that realizes planned
activities and achieves planned results. Similarly, an effective
set
of characteristics or specifications is one that has
the potential to
realize planned activities and achieve planned results.
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Efficiency
is a relationship between results achieved (outputs) and
resources used (inputs). Efficiency can be
enhanced by achieving
more with the same or fewer resources. The efficiency
of a process
or system can be enhanced by achieving more or getting
better
results (outputs) with the same or fewer resources
(inputs).
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The term infrastructure refers
to the entire system of facilities,
equipment, and services that an organization needs in order
to
function. According to ISO 9001, Part 6.3, the term infrastructure
includes buildings and workspaces (including related
utilities),
process equipment (both hardware and software), support
services (such as transportation and communications),
and information systems.
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Inspections
use observation, measurement, testing and
judgment to evaluate conformity.
Inspection
results are
compared with specified requirements in order to establish
whether conformity has been achieved. Product
inspections
compare product characteristics with product
requirements
in order to evaluate conformity.
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An interested party is a
person or group that has a stake in the
success or performance of an organization. Interested
parties
may be directly affected by the organization or actively
concerned
about its performance. Interested parties can come
from inside or
outside of the organization. Examples of interested
parties include
customers, suppliers,
owners, partners,
employees, unions,
bankers, or members of the general public. Interested
parties are also referred to as stakeholders.
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A key performance indicator (KPI)
is a metric or measure. KPIs are
used to quantify and evaluate organizational success. They
measure
how much success you’ve had and how much progress you’ve
made
relative to the objectives
you wish to achieve. KPIs are also used to
set measurable objectives, evaluate progress, monitor
trends, make
improvements, and
support decision making. KPIs
should be
quantifiable and
appropriate and should collect information
that is useful to your organization and relevant to the
needs and expectations of interested parties.
Examples of KPIs include the
following: average revenue per
customer, customer attrition rate, student failure rate,
average
response time, average delivery time, employee retention
rate,
return on equity, lost time due to accidents, and energy
costs
per unit of production.
The following analogy might help make
the point: when you go
to your doctor he or she might measure blood pressure,
cholesterol
levels, heart rate, and your body mass index as key
indicators of
health. KPIs try to do the same thing for
organizations.
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The term management refers to
all the activities that are used
to coordinate, direct, and control an organization. In this
context,
the term management does not refer to
people. It refers to activities.
ISO 9000 uses the term top management to refer to
people.
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The overall purpose of a management
review is to evaluate the
suitability, adequacy, and effectiveness of an
organization's quality
management system, and to look for improvement
opportunities.
Management reviews
are also used to identify and assess
opportunities to change an organization’s quality policy
and
quality objectives, to address resource needs, and to look
for
opportunities to improve its products.
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In the context of this standard, measuring
equipment includes all
the things that are needed to carry out a measurement
process.
Accordingly, measuring equipment includes measuring
instruments
and apparatuses as well as all the associated software,
standards,
and reference materials.
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According to ISO 9004, a mission
statement explains why an
organization exists. It defines its reason for being (its raison
d'être).
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When one or more
characteristics of a
product fail to meet
specified requirements, it is referred to as a nonconforming
product.
When a product deviates from specified product requirements,
it
fails to conform. Nonconforming products must be
identified and
controlled to prevent unintended use or delivery.
A product is the output of a
process. Products can be tangible
or intangible. ISO 9000 lists four generic product
categories:
services, software, hardware, and processed materials.
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Nonconformity
refers to a failure to comply with requirements.
A requirement is a need, expectation, or obligation. It
can be
stated or implied by an organization, its customers, or
other
interested parties.
There are many types of requirements.
Some of these
include quality requirements, customer requirements,
management requirements, product requirements, and
legal requirements. Whenever your organization fails to
meet one of these requirements, a nonconformity
occurs.
ISO 9001 lists quality management system requirements.
When your organization deviates from these requirements,
a nonconformity occurs.
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Objective evidence is information that
shows or proves
that something exists or is true. Objective evidence can
be collected by performing observations, measurements,
tests, or by using any other suitable method.
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Your organization’s environment
includes all the internal and
external factors and conditions that can affect how well you
achieve your objectives and how you treat interested
parties.
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An outsourced process is any
process that is part of your
organization’s quality
management system
(QMS) but is
performed by a party that is external to your organization.
According to ISO 9001, you must identify
and control your
outsourced processes,
and you must ensure that each
outsourced process is effective. You also need to figure
out how to control the interaction between internal and
outsourced processes.
A process is a set of activities
that are interrelated or that
interact with one another. Processes use resources to
transform inputs into outputs.
According to ISO/TC 176/SC
2/N526R, “the terms subcontract and
outsource are interchangeable and have the same meaning”.
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Preventive actions
are steps that are taken to remove the
causes of potential nonconformities or potential
situations
that are undesirable.
The preventive action process is
designed to prevent the
occurrence of nonconformities or situations that do not yet
exist. It tries to prevent occurrence by eliminating causes.
While corrective actions prevent
recurrence, preventive
actions prevent occurrence. Both types of
actions are
intended to prevent nonconformities.
Preventive actions
address potential problems, ones that
haven't yet occurred. In general, the preventive
action
process can be thought of as a risk analysis
process.
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A procedure is a way of carrying
out a process or activity.
According to ISO 9000,
procedures may
or may not be
documented. However, in most cases, ISO 9001 expects
you to document your procedures.
Documented procedures
can be very general or very detailed,
or anywhere in between. While a general procedure
could take
the form of a simple flow diagram, a detailed
procedure could
be a one page form or it could be several pages of text.
A detailed procedure defines and
controls the work that should
be done and explains
how it should be done, who should do
it, and under what circumstances. In addition, it explains
what
authority and what responsibility
has been allocated, which
inputs should be used, and what outputs should be generated.
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A process is a set of activities
that are interrelated or that
interact with one
another. Processes use
resources to
transform inputs into outputs. Processes are
interconnected
because the output from one process becomes the input for
another process. In effect, processes are “glued”
together
by means of such input output relationships.
Organizational processes should be planned and carried out
under controlled conditions. An effective process
is one that
realizes planned activities and achieves planned results.
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The process approach is a
management strategy. When
managers use a process approach, it means that they
manage
the processes that make up their organization, the
interaction
between these processes, and the inputs and outputs that
tie these processes together.
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A process-based quality management
system uses a
process approach to manage and control how its quality
policy is implemented and how its quality objectives are
achieved. A process-based QMS is a network of
interrelated and interconnected processes.
Each process uses resources to transform
inputs into outputs.
Since the output of one process becomes the input of another
process, processes interact and are interrelated by means of
such input-output relationships. These process interactions
create a single integrated process-based QMS.
The concept of a “process-based
quality management system”
is briefly mentioned in the introduction to ISO 9001
(section 0.2).
However, ISO 9000 does not formally define this important
term
so we've given it a try.
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A product is the output of a
process. Products can be tangible
or intangible. ISO 9000 lists four generic product
categories:
services, software, hardware, and processed materials. Many
products combine several of these categories. For
example,
an automobile (a product) combines hardware (e.g. tires),
software (e.g. engine control algorithms), and processed
materials (e.g. lubricants).
Service
is always the result of an interaction between a
service supplier and a customer and can take many forms.
Service can be provided to support an organization’s
own
products (e.g.
warranty service
or the serving of
meals).
Conversely, service can be provided for a product
supplied
by a customer (e.g. a repair service or a delivery
service).
Service can
also involve the provision of an intangible
thing to a customer (e.g. entertainment, transportation,
or advice). While software is intangible, and
includes
things like approaches and procedures, hardware
and processed materials are tangible and are often
referred to as goods.
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Product inspection
is an activity that compares product
characteristics with product requirements in order to
evaluate
conformity. More precisely, a product inspection
compares one
or more characteristics of a product with specified
requirements
in order to determine if the product meets these
requirements.
Product inspections use observation, measurement,
testing
and judgment to evaluate conformity.
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A product starts out as an idea. The
idea is realized or actualized
by following a set of product
realization processes.
Product
realization refers to all the processes that
are used to bring
products into being.
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The quality of something can be
determined by comparing
a set of inherent characteristics with a set of
requirements.
If those inherent characteristics meet all requirements,
high
or excellent quality is achieved. If those characteristics
do
not meet all requirements, a low or poor level of quality
is achieved.
Quality is, therefore, a question of degree.
As a result,
the central quality
question is: How well does this set of
inherent characteristics comply with this set of
requirements?
In short, the quality of something depends on a
set of inherent
characteristics and
a set of requirements
and how
well the former complies with the latter.
According to this definition, quality
is a relative concept.
By linking quality to requirements, ISO 9000 argues that the
quality of something cannot be established in a
vacuum.
Quality is always relative to a set of
requirements.
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Quality
assurance (QA)
Quality assurance is a set of activities intended to
establish
confidence that quality requirements will be met. QA is
one
part of quality management.
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A quality characteristic is
tied to a requirement and is an inherent
feature or property of a product, process, or system.
A requirement is a need,
expectation, or obligation. It can be stated
or implied by an organization, its
customers, or other interested
parties. An inherent feature or property exists in
something
or is a permanent characteristic of something.
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Quality control is
a set of activities intended to ensure that
quality requirements are actually being met. Quality
control
is one part of quality management.
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Quality improvement
refers to anything that enhances an
organization's ability to meet quality requirements. Quality
improvement is one part of quality management.
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Quality management includes
all the activities that organizations
use to direct, control,
and coordinate quality. These activities
include formulating a quality policy and setting quality
objectives.
They also include quality planning, quality control,
quality
assurance, and quality improvement.
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A quality management system is a
set of interrelated or interacting
elements that organizations use to direct and control how
quality
policies are implemented and quality objectives are
achieved.
A process-based QMS uses a
process approach to manage
and control how its quality policy is implemented and
quality
objectives are achieved. A process-based QMS is a
network
of many interrelated and interconnected processes
(elements).
Each process uses resources to transform
inputs into outputs.
Since the output of one process becomes the input of another
process, processes interact and are interrelated by means of
such input-output relationships. These process interactions
create a single process-based QMS.
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A quality manual documents an
organization's quality
management system (QMS). It can be a paper manual
or an electronic manual. According to ISO 9001 section
4.2.2, your quality manual should:
- Define the scope of your QMS.
- Explain reductions in the scope of your
QMS.
- Justify all exclusions (reductions in
scope).
- Describe how your QMS processes interact.
- Document your quality procedures or refer
to them.
Notice that an ISO 9001 quality manual
does not regurgitate the
ISO 9001 standard. While this is a common practice, it
not only fails
to comply with the standard it also fails to serve any
useful function.
NOTE: ISO 9004
2009 does not require a quality manual.
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Quality planning involves
setting quality objectives and then
specifying the operational processes and resources that
will
be needed to achieve those objectives. Quality
planning is
one part of quality management.
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A quality plan is a document
that is used to specify the procedures
and resources that will be needed to carry out a project,
perform a
process, realize a product, or manage a contract. Quality
plans
also specify who will do what and when.
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An organization’s quality policy
defines top management’s
commitment to quality. A quality policy statement
should
describe an organization’s general quality orientation
and clarify its basic intentions.
Quality policies should
be used to generate quality objectives
and should serve as a general framework for action. Quality
policies can
be based on the ISO 9000 Quality
Management
Principles and should be
consistent with the organization’s
other policies.
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A quality objective is a
quality oriented goal. A quality
objective is something you aim for or try to achieve.
Quality objectives are
generally based on or derived from
an organization’s quality policy and must be consistent
with it. They are usually formulated at all relevant
levels
within the organization and for all relevant functions.
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A record is a type of
document. Records provide evidence that
activities have been performed or results have been
achieved.
They always document the past. Records can, for
example, be
used to show that traceability requirements are being met,
that
verification is being performed, and that preventive and
corrective actions are being carried out.
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A requirement is a need,
expectation, or obligation. It can be
stated or implied by an organization, its customers, or
other
interested parties. A specified
requirement is one that has
been stated (in a document for example), whereas an implied
requirement is a need, expectation, or obligation that
is
common practice or customary.
There are many types of requirements.
Some of these include
quality requirements, customer requirements, management
requirements, product requirements, and legal requirements.
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A review is an activity. Its
purpose is to figure out how well
the thing being reviewed is capable of achieving established
objectives. Reviews ask the following question: is
the subject
of the review a suitable, adequate, effective, and efficient
way
of achieving your organization’s objectives?
There are many kinds of reviews.
Some of these include
management reviews,
design and development reviews,
customer requirement reviews, and nonconformity reviews.
Relative to the previous types of reviews, the focus
of each
review is as follows: quality management systems, design
characteristics and specifications, customer requirements,
and nonconformities, respectively.
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According to ISO 9004, a self-assessment
is a comprehensive
and systematic review of an organization’s overall maturity
and
is used to help achieve and sustain organizational success.
Maturity self-assessments evaluate an organization’s practices and
performance and identify improvement and innovation
opportunities.
Self-assessment results are used to identify and recognize
best
practices and to encourage innovation and improvement.
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According to ISO 9000, a service
is a type of product. Service is
always the result of an activity or interaction between a
service
supplier and a customer and can take many forms.
Service
can be provided to support an organization’s own
products (e.g.
warranty service
or the serving of meals).
Conversely, service can be provided for a product
supplied
by a customer (e.g. a repair service
or a delivery service).
Service can also involve the provision of an
intangible thing
to a customer (e.g. entertainment, transportation, or
advice).
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A special process is any
production or service delivery process
that generates outputs that cannot be measured, monitored,
or
verified until it's too late. It's often too late because
deficiencies
may not be obvious until after the resulting products have
been
used or services have been delivered. In order to prevent
output
deficiencies, these special processes must be
validated in order
to prove that they can generate planned results.
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A standard is a document. It is
a set of rules that control how
people develop and manage materials, products, services,
technologies, processes, and systems.
ISO's
standards are agreements. ISO refers to them as
agreements because its members must agree on
content and
give formal approval before they are published. ISO
standards
are developed by technical committees. Members of these
committees come from many countries. Therefore, ISO
standards tend to have very broad support.
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A strategy is a logically
structured plan or method for achieving long
term goals. According to ISO 9004, you need to develop a strategy
and
policies to ensure that your organization’s mission, vision,
and values
are accepted and supported by interested parties.
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A supplier is a person or an
organization that provides products.
Suppliers can
be either internal or external to the organization.
Internal suppliers
provide products to people within their own
organization while external
suppliers provide products to other
organizations. Examples of suppliers include
organizations and
people who produce, distribute, or sell products, provide
services, or publish information.
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According to ISO 9004 2009, an
organization achieves sustained
success when it meets its objectives and continues to
do so over the
long term. It further says that objectives can only be
achieved if the
organization consistently meets the needs and expectations
of
interested parties (stakeholders).
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When managers use a systems
approach, it means that they
treat the interrelated processes that make up an
organization
as an integrated system and then they use this system to
achieve
its objectives. A system is a set of elements that
are interrelated
or interact with one another.
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When ISO 9001 (and ISO 9004) uses the
term top
management
it is referring to a person or a group of people at the
highest level
within an organization. It refers to the people who
coordinate,
direct, and control organizations.
The term management refers to
all the activities that are used
to coordinate, direct, and control an
organization. The term
management does not refer to people. It refers to
activities.
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Traceability
is the ability to identify and trace the history,
distribution, location, and application of products,
parts, and
materials. A traceability system records and
follows the trail as
products, parts, and materials come from suppliers and are
processed and ultimately distributed as end products.
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Validation
is a process. It uses objective evidence to confirm that
the requirements which define an intended use or
application have
been met. Whenever all requirements have been met, a validated
status is achieved. The process of validation
can be carried out
under realistic use conditions or within a simulated use
environment.
In the context of this standard, the
term validation is used in
at least two different situations: design and development
and
production and service provision. Design and development
validations use objective evidence to confirm that
products
meet the requirements which define their intended use
or application.
Production and service provision
processes must be validated
whenever process outputs cannot be measured,
monitored, or
verified until after
the product is in use or the service has been
delivered (by then it’s
too late to do anything about
output
deficiencies and defects). In this case, validations
use objective
evidence to confirm that production and service provision
processes are capable of producing planned results.
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According to ISO 9004, your values
are the general principles
and beliefs that are important to your organization.
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Verification
is a process. It uses objective evidence to confirm
that specified requirements have been met. Whenever
specified
requirements have been met, a verified status is
achieved.
In the context of this standard, the
term verification is used in
at least two different situations: design and development
and
purchasing. Design and development verifications use
objective
evidence to confirm that design and development outputs meet
specified input requirements. Similarly, objective evidence
must
be used to verify or confirm that purchased
products meet
specified purchasing requirements.
There are many ways to verify
that requirements have been met.
For example, you could do tests, perform demonstrations,
carry
out alternative calculations, compare a new design
specification
with a proven design specification, or you could inspect
documents before you issue them.
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According to ISO 9004, an
organization's vision describes what
it wants to be and how it wants to be seen by interested
parties.
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The term work environment
refers to working conditions. It
refers to all of the conditions and factors that influence
work.
In general, these include physical, social, psychological,
and
environmental conditions and factors. Work
environment
includes lighting, temperature, and noise factors, as well
as
the whole range of ergonomic
influences. It also includes
things like supervisory
practices as well as reward and
recognition programs. All of these things influence work.
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