In the context of ISO 22000, the term
continual improvement refers
to an ongoing need to improve the effectiveness of a
food safety
management system (FSMS). The effectiveness of any
FSMS can
be continually improved
through the use of
communications,
management reviews, internal audits, corrective actions,
system
updates, verification research, and validation studies.
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Control measures
are actions or activities that are used to manage
and control food safety hazards. Control measures must be
capable
of preventing or eliminating food safety hazards or
reducing them
to an acceptable level.
See Codex at
http://www.codexalimentarius.net
for examples of specific control measures.
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A correction is any action
that is taken to eliminate a nonconformity.
In the context of the ISO 22000 standard, a correction is
any action
that is taken to deal specifically with potentially
unsafe products
(nonconforming products).
Corrections may include the following types of actions:
reprocessing or further processing of potentially unsafe
products,
assigning them to a different use, or simply destroying
them.
In the context of this standard, a correction
is not the same as a
corrective action (see below). Corrections
are carried out in order to
deal immediately with unsafe products, while corrective
actions are
designed to prevent recurrence by addressing causes.
Corrective
actions often take a longer term perspective and tend to
take a
more systemic approach.
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Corrective actions
are steps that are taken to eliminate the causes
of an existing nonconformity. The corrective action
process includes
causal analysis and is designed to prevent recurrence.
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A critical control point (CCP)
is the point (or step) at which a
control measure must be applied. It is a point that is
critical or
essential to safety. It is the point where a control measure
can
be used to prevent or eliminate a food safety hazard or
to
reduce it to an acceptable level.
Critical limits (see
below) are set at critical control points.
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A critical limit is a
criterion or boundary that is used to distinguish
between what is acceptable
(safe) and what is unacceptable
(unsafe). A critical limit is a value of a parameter
or variable.
Critical limits
(values) are used to ensure that a process produces
safe food products. When critical limits are violated or
exceeded,
products are deemed to be potentially unsafe.
Critical limits
are established at critical control points (CCPs).
They are used to determine whether or not a CCP is
still under
control. Whenever critical limits are violated or
exceeded, CCPs
are out of control and the associated products are
considered
to be potentially unsafe.
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An end product is a finished
product. It requires no further
processing or transformation. However, an end product for
one organization could be an ingredient or raw material
for
another (customer) organization.
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The food
chain consists of the entire sequence of
stages and
operations involved
in the creation and consumption of food
products. This includes every step from initial
production to final
consumption. It includes the production, processing,
distribution,
storage, and handling of all food and food ingredients.
The food chain also includes
organizations that do not directly
handle food. These include organizations that produce feed
for
animals that produce food and organizations that produce
feed
for animals that will be used as food. It also
includes organizations
that produce materials that will eventually come into
contact with
food or food ingredients.
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The basic food
safety concept is this: food will not
harm the
consumer so long as intended use guidelines are followed
when
it is prepared or eaten. Conversely, food is
potentially harmful
whenever it has been exposed to hazardous agents and
intended use guidelines have not been followed.
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A
food safety hazard is an agent or
condition that could
potentially cause an adverse
human health effect. Agents
are either in or on food
and can be either biological, chemical,
or physical. Furthermore, the condition of the food
itself can
also be hazardous.
Food safety hazards
can also be found in or on animal feed and
feed ingredients. Since these may be transferred to
food through
the consumption of animal products, they can also
cause adverse
human health effects.
Organizations that do not directly
handle food and feed may also
compromise food safety. These include producers of packaging
materials, cleaning agents, and other products that
eventually come
into contact with food or feed. If such products have been
exposed
to hazardous agents and they come into contact with food or
feed,
adverse human health effects can occur.
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A food safety hazard analysis
is done in order to determine which
hazards need to be controlled, how much control is needed,
and
which combination of control measures should be used in
order to
make sure that food is safe. In the context of ISO 22000
(section 7.4),
a food safety hazard analysis is carried out in the
following way:
1. Identify your organization’s
food safety hazards.
2. Pinpoint where each hazard may be
introduced.
3. Specify acceptable hazard levels for
each hazard.
4. Assess each hazard and decide how to
control it.
5. Select control measures
to control your hazards.
6. Use OPRPs and HACCP plans to manage
hazards.
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A food
safety management system (FSMS) is a network
of
interrelated elements that combine to ensure that food does
not
cause adverse human health
effects. These elements include
programs, plans, policies, procedures, practices, processes,
goals,
objectives, methods, controls, roles, responsibilities,
relationships,
documents, records, and resources. A FSMS is often one part
of a
larger management system.
In spite of the fact that it is all
about establishing a food safety
management system, ISO 22000 does not formally define this
concept. As a result, we’ve given it a try.
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A food safety policy statement
formally defines an organization's
commitment to food safety. It expresses, in general terms,
what
top management intends to do about food safety and describes
the direction the organization wishes to take.
More precisely, a food safety
policy statement should express an
organization’s commitment to the implementation and ongoing
maintenance of its food safety management system (FSMS).
The food safety policy should drive the establishment
of the
FSMS and should also encourage people to update
and
improve its overall effectiveness.
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A food safety record is a
document that contains objective evidence
which shows how well food safety activities are being
performed or
what kind of results are being achieved. It always documents
what
has happened in the past.
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HACCP
stands for Hazard Analysis and Critical Control Point.
HACCP is a methodology and a management system. It is
used
to identify, prevent, and control food safety
hazards. HACCP
management systems use the following methodology:
1. Conduct a hazard
analysis.
2. Identify critical control points
(CCPs).
3. Establish critical limits
for each critical control point.
4. Develop procedures to monitor
critical control points.
5. Design corrective actions
to handle critical limit violations.
6. Create a food safety record keeping
system.
7. Validate and verify
your safety system.
HACCP
was developed by the Codex Alimentarius
Commission. See:
http://www.codexalimentarius.net/.
While we characterize the seven steps
as a methodology,
they are traditionally referred to as HACCP principles.
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An HACCP plan is a written
document that describes how you plan
to manage and control your organization’s food safety
hazards.
An HACCP plan contains at least the following
information:
1. Critical
control points (CCPs).
2. Hazards that will be controlled at each CCP.
3. Control
measures that
will be used at each CCP.
4. Critical
limits that
will be applied at each CCP.
5. Procedures that will be used to
monitor CCPs.
6. Actions that will be taken when
limits are violated.
Consider using your HACCP plan
to manage a control measure:
- If strict control must be applied.
- If your control measure is likely to fail
in the future.
- If a control failure would have severe
consequences.
- If monitoring and rapid corrective
action is feasible.
- If your control measure must be able
to cope
with significant processing
variability.
- If your control measure is designed
to eliminate
or reduce the level of a specific food
safety hazard.
- If your control measure's place in
the system makes
it convenient to make it part of your HACCP plan.
- If a control measure helps to boost
the effectiveness
of another control measure that is also part of your
particular HACCP plan.
If the above conditions do not
seem to apply to your specific
control measure, consider using an operational
prerequisite
program (OPRP) to manage it.
NOTE: HACCP plans use critical control
points (CCPs) and
critical limits to control food safety hazards,
while operational
prerequisite programs (OPRPs) do not.
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An
internal audit is a systematic evidence
gathering process
that is carried out in order to determine how well
a food safety
management system (FSMS) meets a set of
expectations.
According to section 8.4.1 of this standard, your
internal audits
should determine how well your FSMS complies with both the
ISO 22000 requirements as well as your organization’s
own
requirements and arrangements. In addition, section 8.4.1
expects internal auditors to evaluate how well the FSMS
has been implemented and how well it is being
updated
and improved.
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The purpose of a management
review is to evaluate the overall
performance of an organization's food safety management
system
and to identify improvement opportunities. These
reviews are
carried out by the organization's top managers and are
done
on a regular basis.
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In the context of ISO 22000,
nonconforming products are products
that are potentially unsafe. They are potentially unsafe
because they
were produced or manufactured during a period when critical
limits
were violated or exceeded or when an organization has lost
control
of a prerequisite program (PRP) or an operational
prerequisite
program (OPRP).
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Operational prerequisite programs
(OPRPs) are prerequisite
programs (PRPs) that are essential. They are essential
because
a hazard analysis has shown that they are necessary
in order
to control specific food safety hazards.
OPRPs are used to reduce the likelihood that
products will be
exposed to hazards, that they will be contaminated, and
that hazards
will proliferate. OPRPs are also used to reduce the
likelihood that the
processing environment
will be exposed to hazards, that it will be
contaminated, and that hazards will proliferate in that
environment.
Consider using an operational
prerequisite program
(OPRP) to manage a control measure:
- If strict control is
not needed.
- If your control measure is unlikely
to fail in the future.
- If a control failure would not
have severe consequences.
- If monitoring and
rapid corrective action is
not
feasible.
- If your control measure does not
need to be able
to cope with significant processing
variability.
- If your control measure is not
designed to eliminate
or reduce the level of a specific food safety
hazard.
- If your control
measure's place in the system
makes it convenient to make it part of your
OPRP.
- If a control measure helps to boost
the effectiveness of
another control measure that is also part of your
OPRP.
If the above conditions do not
apply to your specific control
measure, consider using your HACCP plan to manage it.
NOTE:
HACCP plans use critical control points (CCPs) and
critical limits to control food safety hazards, while
OPRPs do not.
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Prerequisite programs (PRPs) are the conditions that must be
established throughout
the food chain and
the activities and
practices that must be performed in order to establish and
maintain
a hygienic environment. PRPs must be suitable and be
capable of
producing safe end products and providing food that is
safe for
human consumption. PRPs support HACCP plans.
In order to select the most suitable PRPs,
organizations
must consider their type of organization and their own
unique
circumstances, as well as the capabilities of their
suppliers and
service providers. In order to select the most suitable
PRPs, they
must also consider customer needs and expectations; they
must
consider statutory and regulatory requirements; they must
consider
good practices in their segment of the food chain; and they
must
consider all relevant standards and guidelines.
PRPs
are also referred to as good hygienic practices,
good agricultural practices, good production
practices,
good manufacturing practices, good distribution
practices,
and good trading practices.
See the Codex website at http://www.codexalimentarius.net
for
examples of PRPs and access to all food safety publications.
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Procedures
control processes or activities. A well defined
procedure controls a logically distinct process or
activity, including
the associated inputs and outputs. Such a procedure
defines 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
supplies and materials should be used, and which documents
and
records must be used to carry out the work. While
procedures may
be documented or undocumented, ISO usually expects them to
be
documented.
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Traceability
is the ability to identify and trace the history,
location,
and application of products and materials. A traceability
system
records and follows the trail as products
and materials come from
suppliers and are processed and distributed as end
products.
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An update is an immediate or
planned activity. Its purpose is
to ensure that the most recent information is being
applied.
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Validation
is a process that is used to ensure that food safety
control measures are capable of being effective. The
validation
process uses evidence to determine whether control
measures
are capable of controlling food safety hazards and
ensuring
that end products are safe.
Control measures
must be validated before they are implemented.
Control measures are implemented and managed using
operational
prerequisite programs (OPRPs) and HACCP plans.
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Verification
is a process that uses objective evidence to confirm
that specified requirements have been met. In the
context of this
ISO 22000 standard, you are expected to verify that
your food
safety management
system (FSMS) has been implemented.
More precisely, you are expected to do at least
the following:
1. Verify that your PRPs
have been implemented.
2. Verify that hazard analysis
inputs are updated.
3. Verify that your hazard levels are
acceptable.
4. Verify that OPRPs
are implemented and effective.
5. Verify that HACCP plan
is implemented and effective.
6. Verify that procedures are
implemented and effective.
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