This introduction to the ISO 22000 Procedures Manual provides an introduction to ISO 22000, a brief history of ISO, and an explanation of the process involved in certifying to ISO 22000, as well as definitions of ISO terms. This section also provides a brief introduction to the basic concept of food safety – its structure, standards, security requirements, and definitions. The food supply chain is constantly changing, so that no document can claim to capture every possible issue, policy, or procedure and still be current. The concepts discussed in this manual cover the common, basic elements of a Food Safety Management System (FSMS).
The Food Safety Introduction covers the following:
FOOD SAFETY BACKGROUND
- International Organization for Standardization (ISO)
- Why Register for ISO 22000?
ISO 9001 and ISO 22000
- ISO 9001:2000 Series Overview
- Making the Transition from ISO 9001:2000 to ISO 22000:2005
- ISO 22000 – ISO 9001 Cross Reference
- Why Is There A Need For ISO 22000?
- ISO 22000:2005 Food Safety Management Systems
- What is Safe Food?
- Hazard Analysis and Critical Control Points
- The Food Supply Chain
- Safety Guidelines and Enforcement
- The ISO 22000 Standard
ISO 22000:2005 STANDARD
- The Design of ISO 22000
- Hazard Analysis and Critical Control Points (HACCP)
- An Auditable Standard
- Copies of the ISO Standard
- Certifying to the ISO 22000 Standard
FOOD SAFETY SYSTEMS
- Food Safety Objectives
- ISO 22000 Implementation
- ISO 22000 Documentation
- Level I – Quality Policies and Objectives
- Level II – Departmental Procedures and Responsibilities
- Level III – Work Instructions
- Level IV – Forms and other Documents
- Confidentiality Statements
CERTIFICATION, REGISTRATION, AND ACCREDITATION
- Accreditation Bodies
- Finding A Registrar
- Selecting A Registrar
- Considerations Before Registration
- The Registration Process
- Application or Contract
- Document Review
- Assessment or Audit
- Publicizing Your ISO Certification
ISO 22000 Food Safety Definitions
The level of a safety hazard considered to present a risk the consumer would accept. The acceptable level of the hazard in the end product, sometimes referred to as the “target level”, should be stated in the product description and set at or below statutory/regulatory limits. An acceptable level for a hazard at an intermediate step in the commodity (product) flow diagram may be set higher than that of the final product, provided that the acceptable level in the final product is achieved.
One of the food safety terms that refers to the record currently in use or used in the context of ongoing business. May also be referred to as a “production” record.
Comparison of a measurement standard or instrument of known accuracy with another standard or instrument to detect, correlate, report, or eliminate by adjustment any variation in the accuracy of the item being compared.
Period during which a certified calibration is valid.
See “critical control point”.
CCP decision tree
A sequence of questions to assist in determining whether a control point is a CCP.
State of having a combination of adequate training and experience to perform a task or set of tasks.
An action or activity that can be used to prevent or eliminate a food safety hazard (3.3) or reduce it to an acceptable level.
Any step at which biological, chemical, or physical factors can be controlled.
Document that provides information or direction for performance of work within the scope of a given procedure. Control characteristics of this one of the food safety terms may include, but are not limited to, revision number/letter, revision date, signatures indicating review and approval, and controlled distribution.
Action taken to eliminate a detected nonconformity.
- For the purposes of ISO 22000, a correction relates to the handling of potentially unsafe products and can, therefore, be made in conjunction with a corrective action.
- A correction may be, for example, reprocessing, further processing, and/or elimination of the adverse consequences of the nonconformity (such as disposal for other use or specific labeling).
Action taken to eliminate the reoccurence (root cause) of a detected nonconformity or other undesirable situation
- A nonconformity may have more than one cause.
- Corrective action includes [root] cause analysis and is taken to prevent recurrence.
- Often confused with “preventive action”.
Critical control point (CCP)
A step at which control can be applied that is essential to prevention or elimination of a food safety hazard or reduction of the hazard to an acceptable level.
Criterion that separates the acceptable from the unacceptable. Critical limits are established to determine whether a CCP remains in control. If a critical limit is exceeded or violated, the affected products are deemed potentially unsafe.
This food safety term refers to the transfer of harmful bacteria from one food to another by way of a nonfood surface, such as a cutting board, countertop, utensils, or a person’s hands.
Failure to meet a critical limit.
Information and its supporting medium. The medium may be paper, magnetic, electronic, optical computer disc, photograph, or sample.
A product that will undergo no additional processing or transformation within the organization. This one of the food safety terms refers to the product that undergoes further processing or transformation by another organization is an end product within the context of the first organization and a raw material or ingredient in the context of the second organization.
A document of external origin that provides information or direction for the performance of activities within the scope of the Food Safety Management System. Examples include, but are not limited to, customer drawings, industry standards, international standards, and equipment manuals.
A multi-step journey that food travels before it is consumed. The steps in the continuum are Farm, Processing, Transportation, Retail, and Table. Each sector along the farm-to-table continuum plays a role in ensuring that the food supply is fresh, of high quality, and safe from hazards. If a link in the continuum is broken, the safety and integrity of the food supply can be threatened.
A schematic, systematic presentation of the sequence and interactions of steps in a process. A flow diagram usually takes the form of a flowchart, where all steps in a process and their inputs and outputs (including byproducts and waste) are shown as boxes connected by unidirectional arrows. Flow diagrams may be referred to as “process maps“.
Food Code ( USA)
A 400-page reference guide published by the U.S. Food and Drug Administration (FDA). The Food Code instructs retail outlets (such as restaurants and grocery stores) and institutions (such as nursing homes and schools) on how to prevent food borne illness. It consists of model requirements for safeguarding public health and ensuring that food is unadulterated (free from impurities) and honestly presented to the consumer. The FDA first published the Food Code in 1993 and revised it every two years through 2001; at that time, it was agreed that the Food Code would be revised every four years. The last revision was in 2009.
The concept that food will not cause harm to the consumer when prepared and/or eaten according to its intended use.
Food safety hazard
Biological, chemical, or physical agent in food or condition of food with the potential to cause an adverse health effect.
- The term “hazard” is not to be confused with the term “risk” which, in the context of food safety, means a function of the probability of an adverse health effect (e.g. becoming diseased) and the severity of that effect (death, hospitalization, absence from work, etc.) when exposed to a specified hazard. Risk is defined in ISO/IEC Guide 51 as the combination of the probability of occurrence of harm and the severity of that harm.
- Food safety hazards include allergens.
- In the context of feed and feed ingredients, relevant food safety hazards are those that may be present in and/or on feed and feed ingredients and that may subsequently be transferred to food through animal consumption of feed and may thus have the potential to cause an adverse human health effect. In the context of operations other than those directly handling feed and food (e.g. producers of packaging materials, cleaning agents, etc.), relevant food safety hazards are those hazards that can be directly or indirectly transferred to food because of the intended use of the provided products and/or services and thus can have the potential to cause an adverse human health effect.
Examine free sample ISO 22000 food safety systems policies and procedures.
Food Safety Management System (FSMS)
An ordered, well-documented system that results in safe food. The FSMS is designed to ensure consistency and improvement of work procedures and practices, including produced goods. These procedures are based on standards or principles, such as ISO 22000 or HACCP, that specify procedures for achieving effective management in the safety of food production.
Food safety policy
Overall intentions and direction of an organization related to food safety, as formally expressed by top management
Food safety team
This one of the food safety terms means personnel responsible for testing, inspecting, and reporting on FSMS procedures to ensure their conformance to applicable requirements.
Food safety team leader
Someone who has acquired the necessary competencies, training, certifications, and managerial skills to lead a Food Safety Team.
Food supply chain (or food chain)
A sequence of stages and operations involved in the production, processing, distribution, storage, and handling of food and/or its ingredients, from primary production to consumption.
- This includes production of feed for food-producing animals and for animals intended for food production.
- The food (supply) chain also includes the production of materials intended to come into contact with food or raw materials.)
Good practice or GMP
A Good Manufacturing Practice (GMP is a practice or set of practices designed to ensure that manufactured food products, services, etc., are executed according to prescribed food safety standards. Good Practices ensure that finished products have the correct identity, strength, quality and purity characteristics they are represented to have, and have not been altered during processing, packaging, or handling. Most “good practices” have been around for so long and are commonly followed by good producers, etc., that standards and regulations have grown up around them. Examples of “good practices” include Good Manufacturing Practice, Good Veterinary Practice, and Good Hygienic Practice.
Hazard Analysis & Critical Control Points (HACCP) is an acronym for the systematic approach to the identification, evaluation, and control of food safety hazards. Identify the hazards, analyze the hazards and implement controls at critical points within the system.
The HACCP Plan is a written document, based upon the principles of HACCP, which delineates the food safety procedures to be followed by the Company.
The result of implementing the HACCP Plan.
People responsible for developing, implementing, and maintaining the HACCP system.
The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan. Hazard analysis is one of the food safety terms and consists of two steps, identification and evaluation.
Food that supports the growth of bacteria and/or microbes, such as meat, dairy, or eggs.
Time period used for investigation after a food has been identified as potentially unsafe. The “hold” process is unique to USDA commodity foods.
Document of internal origin (developed entirely by or completed by the Company) that provides information or direction for the performance of activities within the scope of the Food Safety Management System. Examples include, but are not limited to, the procedures contained in the Company’s FSMS manual.
Consists of the Food Safety Team Leader, Department Managers, and the Company President, at a minimum.
Material Safety Data Sheet (MSDS)
A Material Safety Data Sheet is designed to provide workers and emergency personnel with the proper procedure(s) for handling or working with a particular substance. MSDSs include information such as physical data (melting point, boiling point, flash point, etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill/leak procedures that are of particular use if a spill or other accident occurs.
An MSDS is designed for employees who may be occupationally exposed to hazards at work, employers who need to know the proper methods for storage, etc., and emergency responders (such as fire fighters, hazardous material (HazMat) crews, emergency medical technicians, and hospital emergency room personnel).
MSDSs are not designed for consumers – they reflect the hazards of working with materials occupationally. For example, an MSDS for paint does not apply to someone who uses a can of paint once a year but does apply to someone who uses paint, especially in confined spaces, 40 hours a week.
Modified atmosphere packaging (MAP)
Food packaging in which a mixture of gases replaces ordinary air in the food package. Carbon dioxide and nitrogen are commonly used in MAP to replace oxygen. Many food borne pathogens cannot thrive in low-oxygen environments. A low-oxygen environment also inhibits spoilage by preventing growth of molds and yeasts.
Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended; also, the regular measurement or observation of a critical control point to make sure the product does not go outside of its critical limits.
Operational prerequisite program
A prerequisite program or PRP identified during a hazard analysis as essential to controlling: (a) the likelihood of introducing food safety hazards to; (b) contamination of; and/or (c) proliferation of food safety hazards in the product(s) or processing environment(s). Also known as an “operational PRP.”
PreRequisite Program (PRP)
Basic conditions and activities necessary to maintain a hygienic environment throughout the food supply chain which is suitable for production, handling, and provision of safe end products and safe food for human consumption. Prerequisite programs of PRPs depend on the segment of the food chain in which the organization operates and the type of organization (see ISO 22000:2005, Annex C). Examples of equivalent terms are Good Agricultural Practice (GAP), Good Veterinarian Practice (GVP), Good Manufacturing Practice (GMP), Good Hygienic Practice (GHP), Good Production Practice (GPP), Good Distribution Practice (GDP), and Good Trading Practice (GTP).
Long term cost / risk weighted action taken to prevent or reduce the likelihood of a problem from occurring, based on an understanding of the product or process. See “corrective action”.
The act of bring a product (goods or services) into existence; making a product.
Remove a food product from the market because it may cause health problems or possible death; withdraw.
A standard of the highest order of accuracy in a calibration system, establishing the basic accuracy values for that system. See “working standard”.
A function of the probability of an adverse health effect (e.g., disease, illness) and the severity of that effect (e.g., work absence, hospitalization, death) when exposed to a specified hazard.
Food that is not harmful or injurious when consumed; food that does not cause medical illness or pose a health hazard to the consumer. Recently, food scientists, nutritionists, and various organizations have pushed for a narrower definition of safe food, to include only foods that provide a long-term nutritional benefit or promote health. It is unlikely the narrower definition will ever have full force of law, considering the economic impact it would have on producers, not to mention the success of similar legislation (e.g., Prohibition, 1919-1933, USA). Regardless, one must be mindful of the context in which the term “safe food” is used.
Removal of product to an area of storage that spatially (physically) isolates it from other foods.
Company/organization that directly supplies Our Company with food; food ingredients; food processing, handling, and/or packaging equipment; and/or other items directly or indirectly related to food safety (e.g., cleaning/sanitation chemicals, labels, containers, equipment maintenance services).
Standard which must be met to control a hazard.
The ability to relate individual measurement results to national standards or nationally accepted measurement systems through an unbroken chain of comparisons.
Document that was removed from – or never was a part of – the Company’s controlled document system. Uncontrolled documents may not be used to provide work direction or information necessary for the performance of work. Uncontrolled copies of documents may be used as training aids.
Immediate and/or planned activity to ensure application of the most recent information on a given topic.
Obtaining evidence that the control measures managed by the HACCP plan and by the operational PRPs are capable of being effective
Confirmation, by obtaining objective evidence, that specified requirements have been fulfilled. (See the difference between verification and validation).
Designated measuring equipment used in a calibration system as a medium for transferring the basic value of reference standards to lower echelon transfer standards or other measuring and test equipment. See “reference standard”.
Examine free sample ISO 22000 food safety systems policies and procedures.