Thursday, October 18, 2018

ISO 22000:2018 Structural Changes – II


Why Structural Changes of ISO 22000:2018 are Important?
As of 2005, International Organization for Standardization launched ISO 22000 and by 2016 the famous food safety management system (FSMS) standard has been adopted more than 32,000 organizations worldwide according to the annual ISO Survey last published in 2016. Nonetheless, more than 16,000 organizations have been certified under the Food Safety System Certification 22000 (FSSC) private certification scheme, where core of the FSSC 22000 is ISO 22000 while adaptation of several other additional compliances but keeping the core requirements exactly align to ISO 22000. Hence, improvements in the revision will also effect these companies to upgrade all systems, because ISO 22000 is anyway revised where FSSC 22000 is majorly depend on its progress, thus there is no alternative for organizations practicing GFSL standard since it is not independent. Thus, standard has created vacuums in existing systems where organizations required to adjust their system with considering the core changes and improvements to comply with new requirements. considering the broadness of ISO 22000's core changes, the standard has given a reasonable time period to convert the existing systems. The auditing model of the FSSC 22000 is much better and superior to ISO 22000, because they also conduct once a year unannounced audit to keep organizations continuously following their compliance rather than audit day fireworks.       

The Process Approach
As ISO 22000:2018 explains, the process approach of the standard involves systematic definition and management of processes, and their interactions, to achieve the intended results in accordance with the food safety policy and strategic direction of the organization. Hence, management of the processes and the system can be achieved using the PDCA cycle as a whole with an overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing undesirable results, because understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. Thus, communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain. This implies the importance of communication between organizations between both upstream and downstream in the food chain. Nonetheless, recognition of the organization’s role and the position within the food chain is essential to ensure effective interactive communication throughout chain in order to deliver safe food product to the end user.

Further, ISO 22000:2018 has expanded the use of PDCA (plan-do-check-act) cycle while integrating HACCP into the common cycle used in the ISO 9001 which has been segregated to two levels as organizational planning and control and operational planning and control. Hence, first covers the overall frame of the FSMS (Clause 4 to Clause 7 and Clause 9 to Clause 10), while operational planning and control covers the operational processes within the food safety system as described in Clause 8, where communication between two levels is essential. Here is the brief explanation given by the standard regards to its new expansion. 
Plan:
Establish the objectives of the system and its processes, provide the resources needed to deliver the results, and identify and address risks and opportunities;
Do:
Implement what was planned;
Check:
Monitor and (where relevant) measure processes and the resulting products and services, analyze and evaluate information and data from monitoring, measuring and verification activities, and report the results;
Act:
Take actions to improve performance, as necessary.

The new version integrates PDCA in a more comprehensive manner where planning has absorbed the HACCP system and application steps developed by Codex Alimentarius Commission; by means of auditable requirements, it combines the HACCP plan with (PRPs) perquisite programs, traceability system and emergency preparedness and response through operational planning and control. On the other hand, standard offers an alternative to food manufacturers who do not implement ISO 9001, while they want to have an effective food safety management system as it combines a series of advantages, involving quality management, external and in-house communications, designating responsibility, implementing crisis management, continual improvement, good health practices and differentiating between PRP, OPRP and CCP.

As we already discussed, PDCA cycle has been applied to the operational planning and controls for food safety in the organization, which is more clearly established based on HACCP principles and the latest versions of the Codex Alimentarius standards, the requirements clarify the role of PRPs, OPRPs and CCPs in the system. The applicable Technical Specification ISO/TS 22002-X must be considered in the determination of PRPs for the relevant sector in the food chain. A new entity – ‘action criteria’ – is introduced for the control of OPRPs and which will be determined from the hazard analysis. A ‘hazard control plan’ must include relevant OPRPs and CCPs which are now dealt with in similar ways within the system, albeit recognizing the different food safety risk levels involved. A number of other requirements such as those relating to traceability and emergency response are tightened up, including a range of new verification activities.

The Foundation 
The ISO 22000 FSMS has been developed based on risk based management model focusing the entire food supply chain through harmonization. The risk based management model has eight steps. Through RBMM, each and every processing step is evaluated for its suitability, if any step is not complying with validation requirements, will start from the beginning until it can be validated.

The 3 major pillars/layers of ISO 22000 FSMS has not changed from its initial debut in the new version; they can be shown below figure 5.3, where ISO 22000 has been developed basically merging GMP, HACCP and ISO 9001 as to the initial development of the standard. Hence, core of the standard is still the same, even though there are several new changes has been proposed. As to the figure 5.3, the foundation layer is consist of GMP/GHP/GAP, Codex General Principles of Food Hygiene and Prerequisite programs which altogether creates very sound infrastructure and physical requirements to implement food safety requirements inside the plant focusing on basic food hygiene standards.

The total food safety is achieved through HACCP system of Codex Alimentarius while using its seven principles indirectly in different terminologies to identify hazards and to control them under strict management plan (figure 5.1). This includes the hazard analysis, identification of critical control points, establishment of critical control limits, monitoring procedures, corrective actions, record keeping, validation and verification activities. However, the use of HACCP word has been minimized to the bare minimum while promoting the hazard analysis.

Context and Scope
As to the modern context in the food industry as well as Annex SL format, ISO 22000:2018 has requested organizations to consider upstream and downstream issues affecting customers and consumers as well as suppliers of products and services. Thus, standard requesting organizations to consider their context in supply chain as well as scope which was already a part of the food safety system. The context required to consider events or incidents such as food fraud, food terrorism and related legal issues, which is likely to have a bearing on the management of food safety risk both for the management system and the product/process operations.

Management Involvement
The role of top management and their engagement in the food safety management system is emphasized through the responsibility to demonstrate leadership and commitment to food safety, which further requested to develop an appropriate food safety policy with relevant business objectives. Hence, overall responsibility is vested on top management for oversight of system planning, communication, resource provision and ongoing improvement by reviewing the system’s suitability, adequacy and effectiveness.

System Support
The new edition has concentrated relevant topics in appropriate headings while eliminating the most of the repetitions where basic system elements requirements are clarified and strengthened, including communication systems and needs. Nonetheless, resource planning has been improved with tighter controls over external contributors to system development, while further strengthening the previous requirements such as   competence of employees, both internal and external, are more fully explained. In addition, supplier control mechanism are requested under prerequisite programs for greater control of suppliers of goods and services.

Evaluation and Improvement
The requirements for evaluation of the performance of the FSMS by monitoring, measurement, auditing and review are retained, with a greater emphasis on the use of a more integrated, systematic approach to performing these activities across the whole system. Evaluation outcomes should be directed towards the prevention of failure in the food safety management system in order to improve the effectiveness of the system.

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