ISO 22000

ISO 22000:2018 Food Safety Management System -Requirements for any organization in the food chain

ISO 22000:2018 

ISO 22000 is an Auditable standard published by International Organization for Standardization(ISO). This standard provides the requirements for the organization in order to implement and maintain a food safety management system. The topic of food safety management is gaining more and more attention in recent years as worldwide consumers’ demand for safe and healthy food is increasing day by day.

The standard has been developed under ISO Technical Committee (TC) 31, Food products to establish and implement a food safety management system. The standard specifies requirements for the implementation of six modules:

• -Food Safety Objective; 
• -Management Responsibility; 
• -Hazard Analysis and Risk Assessment; 
• -Preventive Controls: 
• -Monitoring & Measurement; and, 
• -Verification – Corrective actions and Verification.

ISO 22000:2018 is effective from September 1st 2018. The previous version, ISO 22000:2005 was published in 2005 and it has been implemented by many organizations as a good standard to achieve Food Safety Management System requirements. Therefore, the main change can be seen in its revision based on lessons learned from implementation of the previous version.

Two revisions to ISO 22000:2005 were made in 2013 and 2017; however, the main improvements in the current revision are around the requirements for food safety management system itself such as:

• -more specific guidance for each requirement; 
• -organization’s own choice of words (e.g. “must” or “should”) to express the requirements; 
• -definitions and many others.

ISO 22000:2018’s Scope is aimed at any organization in the food chain that wants to achieve management system requirements for food safety, regardless of whether or not they handle food. Organizations such as farms, packaging companies, transportation companies, and other organizations which do not hold, receive, or transport food products should look at other standards for their management system needs.

ISO 22000:2018 is very similar to ISO 9001:2015 standard in the sense that it provides a generic approach for any organization in the food chain that needs a management system. A food safety management system has been a requirement for a food business operator since 2005 and ISO 22000:2018 is an excellent choice to fulfill this requirement.

ISO 22000 Revision History [Source] 

• – 2005: First edition of ISO 22000
• – 2008: Technical Corrigendum 1 published covering clarification of additional requirements on shelf life stability testing
• – 2011: Technical Corrigendum 2 published covering clarification of additional requirements on allergen control
• – 2013: Technical Corrigendum 3 published covering clarification of additional requirements on environmental conditions including temperature, pressure, humidity and other
• – 2017: Revision based on lessons learned from implementation of the previous version
• – 2018: August 1st first edition of ISO 22000:2018

Requirements of ISO 22000

The standard provides requirements for general management on food safety. This includes items such as: 

• – A Food Safety Objectives; 
• – Management responsibility; 
• – Hazard analysis and risk assessment of food safety hazards of each type of product.

ISO 22000 is an auditable standard based on ISO 19011, which means that it can be implemented in any organization regardless of the type (e.g. farm, factory) or size (large or small). Since different types of food safety risks will result in different preventive measures; therefore, organizations need to look at ISO 22000 for complete guidance on this area.

ISO 22000 is not intended to be used alone and it should be used together with other food-related standards such as ISO 9001:2015 for quality management and HACCP plan.

ISO 22000:2018 – Assigning Requirements

Requirements of the standard are organized in six modules each focusing on a different area of the Food Safety Management System (FSSMS). It is recommended to follow an approach to assigning the requirements of ISO 22000:2018 as described below.

• – The first step is to look at all the modules and order them from the basic requirements to more specific. 
• – Then, it is recommended reading through each module and assigning a risk priority number (RPN) for every requirement depending on the severity of a hazard that the requirement addresses. For example, the most severe hazard would have an RPN of 1 and the least critical would have an RPN of 10.
• – Finally, based on their assigned RPNs requirements are grouped in modules with consecutive RPNs so that higher risk requirements are listed first. 

ISO 22000:2018 – Management Responsibility

ISO 22000:2018 is aimed to provide a common language for the food industry and this includes clear roles and responsibilities of all members of an organization. The management system standards such as ISO 9001:2015 and ISO 14001:2015 do not include requirements on management responsibility and these should be assigned from other standards or from prior experience in implementing FSSMS.

ISO 22000:2018 – Food Safety Objectives

After management responsibility, the standard provides requirements for food safety objectives as a reflection of an organization’s commitment to delivering safe products. This covers three major areas including product safety, food hygiene, and quality. In addition, ISO 22000:2018 is an auditable standard based on ISO 19011 and it can be implemented in any organization regardless of the type (e.g. farm, factory) or size (large or small).

ISO 22000:2018 – Hazard Analysis and Risk Assessment

Hazard analysis and risk assessment is a very important step in FSSMS design and implementation. In this stage, an organization identifies food safety hazards that could impact each type of product, then analyzes their probability of occurrence, the severity of its consequences, and finally lays out appropriate preventive measures.

There are three steps in this process including: 

• The first step is to look at all the modules and order them from the basic requirements to more specific. 
• Then, it is recommended to read through each module and assigning a risk priority number (RPN) for every requirement depending on the severity of a hazard that the requirement addresses. For example, the most severe hazard would have an RPN of 1 and the least critical would have an RPN of 10. 
• Finally, based on their assigned RPNs requirements are grouped in modules with consecutive RPNs so that higher risk requirements are listed first.
• The third step, after hazards is identified and preventive measures are defined, is to review them for consistency within the management system standards such as ISO 9001:2015 and ISO 14001:2015. 

ISO 22000:2018 – Preventive Measures

After hazard analysis and risk assessment, the standard provides requirements for preventive measures. Preferably, these should be defined during the hazard analysis and risk assessment phase however if this was not possible they can still be mentioned in this section.

ISO 22000:2018 – Verification

ISO 22000 specifies that verification can be done through process control, calibration of equipment, document control, or personal observation by an authorized observer. This is important to ensure consistency within the organization. 

ISO 22000:2018 – Documentation

The establishment of documentation requirements should have been already done in an organization that has implemented process management systems such as ISO 9001:2015 and ISO 14001:2015. However, the standards for documentation should be separated from their procedural steps and kept in a separate standard such as ISO 22000:2018. 

FSMS documentation can vary significantly depending on an organization’s type, size and culture; however, ISO 22000:2018 specifies that documented procedures and records should be at the core of the system.

FSMS documentation requirements include: 

• Documenting procedures and records as part of a defined standard such as ISO 9001:2015 and ISO 14001:2015; 
• Keeping them up to date; 
• Ensuring cross-references between standards (for example, linking a procedure in the HACCP plan to a prerequisite program in ISO 9001:2015); and 
• Reinforcing their use by employees through training.

ISO 22000:2018 – Record Keeping

Record-keeping requirements can vary depending on the product and all records should be kept for a minimum of two years.

ISO 22000:2018 – Training Requirements

Training is one of the most important aspects within FSSMS and it must include training on food safety objectives, hazards that could impact each type of product (i.e. allergens), preventive measures that are implemented to address those hazards (i.e. allergen controls), and finally the responsibilities of each employee to ensure food safety across the organization.

Conclusion

Food Safety Management System is crucial for food safety within an organization because it allows the establishment of procedures that prevent hazards from reaching consumers. In this sense, FSMS can’t ensure that products are free of harmful hazards but it does reduce the probability of occurrence, the severity of its consequences, and finally lays out appropriate preventive measures.

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