ISO 22000 2005

PLAIN ENGLISH DEFINITIONS

ISO 22000 is a Food Safety Management Standard

OTHER PLAIN ENGLISH DEFINITIONS

ISO 9001 Quality Management Definitions

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ISO 27001 Information Security Management Definitions

OHSAS 18001 Occupational Health and Safety Definitions

Continual improvement

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.

Control measure

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.

Corrections

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.

Corrective actions

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.

Critical control point (CCP)

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.

Critical limit

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.

End product

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.

Food chain

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 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.

Food safety

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.

Food safety hazard

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.

Food safety hazard analysis

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.

OPRPs are operational prerequisite programs.

HACCP is hazard analysis critical control point.

Food safety management system (FSMS)

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.

Food safety policy

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.

Food safety record

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.

HACCP

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.

HACCP plan

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.

Internal audit

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.

Management review

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.

Nonconforming products

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).

Operational prerequisite programs (programmes)

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.

Prerequisite programs (programmes)

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.

Procedure

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.

Traceability system

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.

Update

An update is an immediate or planned activity. Its purpose is to ensure that the most recent information is being applied.

Validation

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.

Verification

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.

Introduction to ISO 22000 2005 Food Safety Management

Overview of ISO 22000 2005 Food Safety Management Standard

ISO 22000 2005 Food Safety Standard Translated into Plain English

ISO 22000 2005 Food Safety Management Gap Analysis Tool

ISO 22000 2005 Food Safety Management Audit Program

Our Plain English Approach to ISO 22000 2005