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