Food safety management standards and certification schemes (Part 2)

As mentioned in the first part of this topic, the basis of food safety schemes is the Hazard Analysis and Critical Control Points (HACCP). However, when the Codex Alimentarius Commission (CAC) recognized the importance of HACCP for food control, during the twentieth session of the CAC, held in Geneva, Switzerland, from June 28 to July 7, 1993, it adopted the Guidelines for the application of the Hazard Analysis and Critical Control Points (HACCP) system. The revised version of the Recommended International Code of Practice: “General Principles of Food Hygiene [CAC / RCP 1-1969, Rev. 3 (1997)]”, adopted during the 22nd Session of the CAC, held in Geneva in June 1997, it incorporated as an Annex the Hazard Analysis and Critical Control Points (HACCP) system, as well as the guidelines for its application.

If we consider that this Codex Alimentarius Commission is a government-type organization so that its standards and codes are applied by the health authorities of the different countries through their own regulations, and that HACCP was neither a norm nor a code, but a document annexed to a code, and despite the fact that the CAC itself established an intense training program for trainers on this subject, it was difficult and took many years for most countries to use this scheme in their regulations.

Now, if we look at it from the point of view as a voluntary standard, the ISO was very slow to take up the issue of food safety, and when it did, it was not integrating a specific technical committee on the issue of food safety management, as in the previous cases of management system standards, like the TC 176 or the TC207, but creating a subcommittee, the number 17 "Food safety management systems", within its Technical Committee No. 34 "Food products", which took a long time to establish its work structure and to develop the ISO 22000 family standards, for which, in the absence of a solid scheme of standards of this organization, the needs of the food sector led to the development of other standardization and certification schemes for management food safety.

This caused various schemes to be developed, each with its own regulatory and conformity assessment particularities. In order to organize these markets, the role played by the GFSI has been very important, through its program for the recognition of standards and certification schemes.

There is an element in all the schemes in which Hazard Analysis and Critical Control Points (HACCP) are used, including the ISO 22000: 2018 standard, which from my point of view generates some confusion when applying these normative documents and that It is worth analyzing, and I comment on it to get other opinions about it, and I mean the concept of Prerequisite Programs or Prerequisites (PRPs).

I have had the opportunity to talk with many people in Mexico about the elements of application of the ISO 22000 standard in particular, or of HACCP in general, and it has become clear to me that for most people the concept of prerequisite programs is not well understood. It may be a cultural matter, but when a standard indicates that there are prerequisites, it is implied that they must be implemented before thinking in comply with that standard, or it is assumed that they must already be met in some way. This leads to the fact that sometimes these prerequisites are not adequately met.

However, in the case of these normative documents supported in the HACCP, it turns out that they are not prerequisites for compliance with the normative document, but rather are requirements that clearly the standard itself establishes, but that are identified that way because they must be applied completely before the hazard analysis is performed, so that said process can add value. It may be a very subtle thing, but a proper application of these analysis schemes largely depends on their correct understanding.

We will first present what has been worked within the ISO 22000 Family of standards; and later, in the following article, the main standardization and certification schemes approved by the GFSI.

 

- ISO 22000 Family.- The ISO 22000 standard, as the basis of this family of standards, was published by the International Organization for Standardization (ISO), originally in 2005 and revised in 2018. Currently the ISO 22000 family of standards it is made up of the following:

1) ISO 22000: 2018 - Food safety management systems — Requirements for any organization in the food chain.

This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain:

a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use;

b) to demonstrate compliance with applicable statutory and regulatory food safety requirements;

c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them;

d) to effectively communicate food safety issues to interested parties within the food chain;

e) to ensure that the organization conforms to its stated food safety policy;

f) to demonstrate conformity to relevant interested parties;

g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document.

All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials.

This document allows any organization to implement externally-developed elements in their FSMS.

Internal and/or external resources can be used to meet the requirements of this document.

This document employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. This process approach enables an organization to plan its processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.

If you want to know what is this PDCA cycle, I invite you to watch a short video which explaines it.

Risk-based thinking enables an organization to determine the factors that could cause its processes and its FSMS to deviate from the planned results, and to put in place controls to prevent or minimize adverse effects.

Food safety is related to the presence of food safety hazards at the time of consumption (intake by the consumer). Food safety hazards can occur at any stage of the food chain. Therefore, adequate control throughout the food chain is essential. Food safety is ensured through the combined efforts of all the parties in the food chain. This document specifies the requirements for a FSMS that combines the following generally recognized key elements:

• interactive communication;

• system management;

• prerequisite programmes;

• hazard analysis and critical control point (HACCP) principles.

In addition, this document is based on the principles that are common to ISO management system standards. This management principles are:

• customer focus;

• leadership;

• engagement of people;

• process approach;

• improvement;

• evidence-based decision making;

• relationship management.

This document has been developed within the ISO high level structure (HLS). The objective of the HLS is to improve alignment between ISO management system standards. This document enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its FSMS approach with the requirements of other management systems and supporting standards.

This document is the core principle and framework for FSMSs and sets out the specific FSMS requirements for organizations throughout the food chain. Other guidance related to food safety, specifications and/or requirements specific to food sectors can be used together with this framework.

In addition, ISO has developed a family of associated documents. These include documents for:

• prerequisite programmes (ISO/TS 22002 series) for specific sectors of the food chain;

• requirements for auditing and certification bodies;

• traceability.

2) ISO/TS 22002-1:2009 - Prerequisite programmes on food safety — Part 1: Food manufacturing.

ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.

This Technical Specification is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.

Food manufacturing operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-1:2009 apply to an individual establishment or process.

Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.

ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene.

In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.

As you can see, although ISO indicates that this standard remains current, it no longer corresponds to the requirements of the new version, since it would be applying this correspondence to the requirements of clause 8 of ISO 22000: 2018.

 

3) ISO/TS 22002-2:2013 - Prerequisite programmes on food safety — Part 2: Catering.

ISO/TS 22002-2:2013 specifies the requirements for the design, implementation, and maintenance of prerequisite programmes (PRPs) to assist in controlling food safety hazards in catering.

This Technical Specification is applicable to all organizations which are involved in the processing, preparation, distribution, transport, and serving of food and meals and wish to implement PRPs in accordance with the requirements specified in ISO 22000:2005, 7.2.

The scope of ISO/TS 22002-2:2013 includes catering, air catering, railway catering, banquets, among others, in central and satellite units, school and industry dining rooms, hospitals and healthcare facilities, hotels, restaurants, coffee shops, food services, and food stores.

Users of catering can belong to vulnerable groups, such as children, elderly and/or ill people.

In some countries, the term "food services" is used synonymously with catering.

The application of ISO/TS 22002-2:2013 does not exempt the user from compliance with current and applicable legislation. Where local legal requirements are in specified for parameters (temperatures, among others) given in ISO/TS 22002-2:2013, the local requirements shall be used by the food business.

As you also can see, although the ISO indicates that this standard remains current, it no longer corresponds to the requirements of the new version, since it would be applying this correspondence to the requirements of clause 8 of ISO 22000: 2018.

 

ISO/TS 22002-3:2011 - Prerequisite programmes on food safety — Part 3: Farming

ISO/TS 22002-3:2011 specifies requirements and guidelines for the design, implementation, and documentation of prerequisite programmes (PRPs) that maintain a hygienic environment and assist in controlling food safety hazards in the food chain.

This Technical Specification is applicable to all organizations (including individual farms or groups of farms), regardless of size or complexity, which are involved in farming steps of the food chain and wish to implement PRPs in accordance with ISO 22000:2005, 7.2. If an organization is using ISO/TS 22002-3:2011 as a reference for the purpose of making a self-declaration of conformity with or seeking certification to ISO 22000:2005, deviations therefrom (i.e. where exclusions are made or alternative measures are implemented) need to be justified and documented. It is expected that such deviations will not affect the ability of the organization to comply with the requirements of ISO 22000.

ISO/TS 22002-3:2011 is applicable to the farming of crops (e.g. cereals, fruits, vegetables), living farm animals (e.g. cattle, poultry, pigs, fish) and the handling of their products (e.g. milk, eggs). It is not applicable to activities such as picking of wild fruits, vegetables and mushrooms, fishing, hunting, which are not considered as organized farming activities.

All operations related to farming are included in the scope (e.g. sorting, cleaning, packing of unprocessed products, on-farm feed manufacturing, transport within the farm). However, ISO/TS 22002-3:2011 is not applicable to processing activities carried out on farm premises (e.g. heating, smoking, curing, maturing, fermenting, drying, marinating, extraction, extrusion or a combination of those processes). Neither is ISO/TS 22002-3:2011 applicable to products or animals that are being transported to or from the farm.

As you also can see, as before, although the ISO indicates that this standard remains current, it no longer corresponds to the requirements of the new version, since it would be applying this correspondence to the requirements of clause 8 of ISO 22000: 2018.

 

ISO/TS 22002-4:2013 - Prerequisite programmes on food safety — Part 4: Food packaging manufacturing

ISO/TS 22002‑4:2013 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) to assist in controlling food safety hazards in the manufacture of food packaging.

This Technical Specification is applicable to all organizations, regardless of size or complexities that manufacture food packaging and/or intermediate products.

 

ISO/TS 22002-5:2019 - Prerequisite programmes on food safety — Part 5: Transport and storage

This document specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) for transport and storage in the food chain to assist in controlling food safety hazards.

This Technical Specification is applicable to all organizations, regardless of size or complexity, that are involved in transport and storage activities across the food supply chain and that wish to implement PRPs in such a way as to address the requirements specified in ISO 22000.

Live animals are excluded from the scope of this document except when intended for direct consumption, e.g. molluscs, crustaceans and live fish.

 

ISO/TS 22002-6:2016 - Prerequisite programmes on food safety — Part 6: Feed and animal food production

ISO/TS 22002-6:2016 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) to assist in controlling feed safety hazards in feed and animal food and in materials intended for use in the production of feed and animal food. Feed safety hazards in this context relate to attributes that have a potential to affect adversely animal and/or human health.

Prerequisite programmes are intended to ensure feed safety and to prevent, control and detect potential contamination including cross-contamination that could occur under the responsibility of the organization.

ISO/TS 22002-6:2016 is applicable to all organizations regardless of size, location or complexity that are involved in the manufacturing and/or supply of feed and animal food and wish to implement a PRP. Feed and animal food operations are diverse in nature and not all of the requirements specified in this Technical Specification necessarily apply to an individual organization or process. Where exclusions are made or alternative measures are implemented, these need to be justified by a hazard assessment and verified to be effective. Any exclusions or alternative measures adopted should not affect the ability of an organization to comply with other requirements contained in this Technical Specification.

 

ISO/TS 22003:2013 - Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems.

ISO/TS 22003:2013 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements). It also provides the necessary information and confidence to customers about the way certification of their suppliers has been granted. This specification was revised and confirmed in 2016, so it is current.

 

ISO 22005:2007 - Traceability in the feed and food chain — General principles and basic requirements for system design and implementation

ISO 22005:2007 gives the principles and specifies the basic requirements for the design and implementation of a feed and food traceability system. It can be applied by an organization operating at any step in the feed and food chain.

It is intended to be flexible enough to allow feed organizations and food organizations to achieve identified objectives.

The traceability system is a technical tool to assist an organization to conform with its defined objectives, and is applicable when necessary to determine the history or location of a product or its relevant components.

This standard was last reviewed and confirmed in 2016. Therefore this version remains current.

These are the standards that are part of the ISO 22000 Family of standards.

There are various standardization and certification schemes for food safety management systems recognized by the GFSI, and in the next post I will introduce you to the most important globally.

 

Author:

Ernesto Palomares Hilton