Sunday, September 30, 2018

ISO 22000:2018 Structural Changes


What Really Changed in ISO 22000:2018
Considering these food safety problems and trade issues generated over the time, the International Standard Organization developed the ISO 22000 Food Safety Management System to harmonize the requirements of various food safety standards into integrated food safety management system while eliminating lots of trade issues faced on exports. Thus ISO 22000 is an international, auditable standard which specifies the requirements for food safety management system by incorporating all the elements of Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Points (HACCP) together with a comprehensive management system. The standard ensures the complete food safety of entire food supply chain while satisfying global food safety statutory and regulatory requirements. It promotes the conformity to the international standard of the product or services offered by providing the assurance of quality, safety and reliability. 

According to the Food safety experts in the field, set of well-functioning prerequisite programs (PRPs) initially simplify and strengthen the HACCP plan, where ISO 22000:2005 was a HACCP-type standard which fits very well with ISO 9001:2000 because, it was especially developed to assure food safety. ISO 22000 has dynamically combine the HACCP principles and application steps with prerequisite programs, using the hazard analysis to determine the strategy to be used to ensure hazard control by combining the prerequisite programs and the HACCP plan. Nevertheless, ISO 22000:2005 was the first in a family of standards which was entirely focused on food safety that introduced focusing entire food chain.

Strong Bondage of Sister Standards
However, the several food safety standards evolve overtime, but most of them are based on the guidelines of ISO 22000 and HACCP, hence adhering to ISO 22000 usually covers minimum compliances which are required internationally. Hence, rest of the additions are basically applied in private standards such as FSSC 22000, etc. Nonetheless, standard directly refers its sister standards for application of traceability, prerequisite programs and certification and auditing. However, the ISO 22000 released its first revision in 2018, where the current applicable standard is ISO 22000:2018 and it has strongly emphasized the use of its sister standards which are usually applied together based on the specific requirements in the supply chain that includes the following documents:

[  ISO/TS 22003:2013, Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems.
[  ISO/TS 22004:2014, Food safety management systems – Guidance on the application of ISO 22000.
[  ISO 22005:2007, Traceability in the feed and food chain – General principles and basic requirement for system design and implementation.
[  ISO 22002-I:2009, Prerequisite programs on food safety – Part I: Food manufacturing.

The ISO/TS 22002 series further specifies requirements and guidance for establishing, implementing and maintaining prerequisite programs (PRPs) to assist in controlling food safety hazards. These Technical Specifications are:
ISO/TS 220021 Prerequisite programs on food safety Part 1: Food manufacturing
ISO/TS 220022 Prerequisite programs on food safety Part 2: Catering
ISO/TS 220023 Prerequisite programs on food safety Part 3: Farming
ISO/TS 220024 Prerequisite programs on food safety Part 4: Food packaging manufacturing
ISO/TS 220026 Prerequisite programs on food safety Part 6: Feed and animal food production.

Hence, FSCC 22000 was initially claiming that ISO 22000 is not a comprehensive standard due to use of PRP, supplier evaluation and selection, traceability, food security and food allergen, tec., has not been clearly adapted where new version has emphasized these requirements when and where necessary. However, more than that the ISO 22000:2018 has open-up the opportunities to organization to decide product specific and industry specific, statutory regulatory, customer or any interested party’s requirements to cater instead of working on a completely fixed format. Thus, standard provides certain flexibility to move away from bare minimum requirements to go beyond the private standards.  

The standard specifies the requirements for a food safety management system (FSMS) that combines the following generally recognized key elements to ensure food safety along the food chain, up to the point of final consumption, that are,
  1. Interactive communication
  2. System management
  3. HACCP principles
  4. Prerequisite programs

In addition to the previous version of above elements, standard is further extend on the principles that are common to ISO management system standards, particularly the Annex SL format or high level structure which are;
  1. Customer focus
  2. Leadership
  3. Engagement of people
  4. Process approach
  5. Improvement
  6. Evidence-based decision making
  7. Relationship management

Adaptation of Annex SL
Since ISO has hundreds of different standards, there was a requirement for common platform to reduce merging issues as well as updating them in a regular manner where ISO developed a common platform in few years back. The objective was to provide identical structure, text and common terms and definitions for management systems standards of the modern tech savvy global economy. The platform, known as Annex SL, or the high level structure was designed to ensure consistency among future and revised management systems standards, while making the standards easier to read and be understood by users, and greatly aid with the integration of multiple standards within one organization.

Annex SL is promised to be a new approach to management system format that helps streamlining the creation of new standards, and implementation of multiple standards within one organization easier. The Annex SL replaces ISO’s Guide 83, which previously provided a base structure and standardized texts for management system standards (MSS). Initially, guide 83 was started to address complaints that many have received when integrating MSS like ISO 9001, ISO 14001, ISO 22000, and ISO 2700, etc.  In addition, Annex SL also addresses much of criticism expressed by organizations integrating multiple management systems, because these standards have common elements, which are described and organized differently, making it difficult for organizations to implement multiple standards.

Thus, major clause numbers and titles of all ISO management system standards will be identical, such as the introduction, terms and definitions and operation, where introduction, scope and normative references will have content which is specific to each discipline and each standard can have its own bibliography. Overall, there is a reorganizing of management system requirements into this structure that may be unfamiliar, but some of the management system standards have already successfully migrated to this new structure such as ISO 9001, ISO 22000, etc.

Thus, Annex SL addresses these issues by creating a template upon which ISO MSS are to be built, where it was primarily developed as a guide to those who draft the standards. Hence, core of Annex SL consists of 8 clauses and 4 appendices that encompass a “high level structure” (essentially shared high level concepts among standards), shared terms/definitions and actual shared clause titles and text. The appendix three is in three parts which are high-level structure, identical core text and common terms and core definitions. Despite the fact that, these standards have common elements, they are described and organized differently, making effective integration difficult. Hence, development of Annex SL has improved the use of the same structure, as well as commonly used terms and definitions, will make it far easier, less time-consuming, and consequently cheaper to implement, integrate, and maintain standards. Nonetheless, Annex SL has enabled organizations to enhance alignment among ISO’s management system standards, while facilitating their implementation for organizations that may need to simultaneously meet the requirement of two or more such standards. As a result of application of Annex SL in the development of new standards, approximately 30% or so of each new and revised standard will contain identical text.

The intent of adaptation of Annex SL to create ISO 22000:2018 food safety management system to have the same overall look and feel, where all other ISO standards will progressively migrate during their next phase, thus creating opportunities to use in multiple platform initiatives.  In addition, Annex SL provided the framework for a generic management system, with options for the addition of discipline-specific requirements such as HACCP to make fully functional standard while integrating with other standards such as quality, environmental, service management, business continuity, information security and energy management.

Considering the MSSs writers, Annex SL provides the template for their work, which promote concentration of their development efforts on the discipline-specific requirements of the given MSS that focused on clause 8 – Operation while eliminating additional works for rest of the works that can be synchronized easily between multiple systems. For management system implementers, Annex SL provides an overall management system framework within which they can pick and choose what discipline-specific standards they need to include, which will minimize the conflicts and duplication, confusion and misunderstanding from different MSSs. For management system auditors, there will be a core set of generic requirements that need to be addressed for all audits, no matter what discipline to be audited. Nonetheless, it could drive the development of auditor training, by addressing the common core set of requirements with additional training for discipline-specific requirements.


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