, nye = Free Resource ISO 22000:2018 Food Safety Management System Course Section 2: Publication of ISO 22000:2018 Publication Milestone Aim: The world’s most important International Standard for Food safety management systems (FSMS) is envisioned to provide a framework of food safety paving ways out for food chains to operate. Objective: ISO 22000:2018 (Food safety management systems) offers a vigorous and effective management system for improving food safety performance in global supply chains. Designed for whom? The ISO 22000 standard is designed to help food chains of different sizes and different industries Expectation: The new International Standard ISO 22000:2018 is expected to effectively control food safety hazards around the world., nye = Free Resource High Level Structure (HLS) ISO 9001:2015 i.e. Quality Management System, ISO 14001:2018 i.e. Environment Management System, ISO 45001:2018 i.e. Occupational Health and Safety Management Systems are all based on HLS Structure. After this publication food safety management system standard i.e. ISO 22000:2018 is also based on HLS Structure. It means ISO 22000:2018 can be easily integrated with other business systems based on HLS structures. The HLS Structure is shown below: Clause — 1 SCOPE Clause - 2 NORMATIVE REFERENCES Clause - 3 TERMS AND DEFINITIONS Clause - 4 CONTEXT OF THE ORGANIZATION: Clause — 5 LEADERSHIP Clause - 6 PLANNING Clause —- 7 SUPPORT Clause — 8 OPERATION Clause - 9 PERFORMANCE EVALUATION Clause - 10 IMPROVEMENT, nye = Free Resource Is ISO 22000 the answer to the food safety issues around the world? ISO 22000 is expected to change the unsafe food situation by empowering companies to perform better in the area of food safety. It offers legislative and regulatory bodies, ministry, industry and other interested participants with operative, practical management for ensuring a check on industries in food chain all over the world. With the help of a friendly and known ISO standardization framework, good food safety conditions are practical for food producers, suppliers, and vendor houses. The management system will help all in achieving food safety irrespective of their country and regional dynamics. What makes ISO 22000 internationally important? World standards experts and writers have worked together to produce this standard. This standard is the result of collaboration of many contributing countries. The standard aims to offer a framework for food chains that focuses on food safety. People from any sector, any job and any industry can avail the benefits of this standard in the world. Itis produced by ISO committee ISO/TC 34/SC 17 responsible for standardizing Food safety management system. The Danish Standards Institution (DS) served as the committee’s secretariat for the development of standard., nye = Free Resource Which is more effective FSMS; ISO 22000 or FSSC 22000? As with many queries on management systems, there is no definite answer. Every company is unique, and the effectiveness of the Food safety Management System actually relies on how the company applies the requirements, instead of which requirements are implemented. One can choose either ISO 22000:2018 or FSSC 22000 as the requirements for organization’s management system. How operational system is, really comes down to one’s company’s commitment to improving food safety performance. FSSC 22000 is a robust system, which uses current standards ISO 22000, ISO 22003 together with the technical industrial specifications “Programs of preliminary conditions” (PPU), which were made on the grounds of public sessions in cooperation with several interested food organizations. Are ISO 22000 certified food organizations eligible for FSSC22000? Food chains that are certified on the standard ISO 22000 can attain the certificate FSSC 22000 accepted by the Global Food Safety Initiative (GFSI) on compliance of the technical industrial specifications PPU and additional scheme requirements. What are the needs of concerning interested parties? If a company has a legal or other requirement to use FSSC 22000, then the decision may not be there for the company to select. Company has to go for it.Free Resourcey myles = Free Resource What is the difference between ISO 22000 and FSSC 22000 FSSC 22000 is a certification scheme that contains ISO 22000 and has a more extensive list of standards to be compliant by the food organization. ISO 22000 offers less detailed and specific requirements for the certification authority and the requirements for the food organization itself, to its infrastructure and documentation maintenance compared with FSSC 22000. For certification scheme FSSC 22000 it is mandatory to make and implement the same procedures and documents as for ISO 22000. Moreover additional requirements will also be taken care of. Does a company need to follow the stricter auditing practices of FSSC 22000? The procedure of certification is not much different. However, the needs of FSSC 22000 scheme are more widespread and rigid, so the certification under this scheme is a very extensive and extensive work- oriented process. ISO 22000 versus FSSC 22000 Auditing When it comes to checking and evaluating the FSMS, there are minor differences. ISO 22000:2018 audit is being carried out by certification bodies that are recognized by national accreditation bodies that follow ISO auditing standards and IAF (International Accreditation Forum) rules. On the other hand, FSSC 22000 involves the same auditing practice as of ISO 22000 however there are less number of FSSC 22000 auditors available compared with ISO 22000., nye = Free Resource Transition Plans to ISO 22000:2005 compliant and certified food organizations Ifyou are presently implementing ISO 22000:2005, then it is a good way out since multiple requirements of ISO 22000:2018 are the equivalent or analogous. But the clauses may be offered in a changed order and may utilize different terminology. Four steps guidance to existing ISO 22000:2005 users: + Get a copy of the standard from ISO Store (https://www.iso.org/standard/65464.html) or your national ISO representative store + Examine the changes in the standard or use comparative matrix as a free resource. + Conduct a gap analysis against ISO 22000:2018 versus your current FSMS system + Plan and apply actions to fulfill highlighted gaps in your study.y nye = Free Resource Important Areas of Publication Organization’s Context External and Internal Issues External and internal issues of food organization needs to be addressed as per Clause - 4.1, it is actually a business context analysis with food safety in perspective. It mandates that the company to recognize systematically and study the numerous issues related to food safety which effects their business operations as well as the management system. Interested parties Clause - 4.2 presents a prerequisite for a greater emphasis on the needs and expectations of other interested parties in the area of food safety. The company is required to recognize and comprehend the issues related with these parties that should be pondered and controlled through the Food safety management systems. Scope Clause - 4.3 is related to scope and unlike FSMS ISO 22000:2008, scope should only be defined when earlier 4.1 & 4.2 have been analyzed properly. It should incorporate both issues & influential factors. Food safety management system To achieve the intended outcomes, including enhancing its food safety performance, the food organization must establish, implement, maintain and continually improve a food safety management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.y nye = Free Resource Leadership & Commitment Similar to ISO 900] and ISO 14001, there is a higher stress on the responsibility of top management in the area of improvement of food safety performance and ensuring the effectiveness of the FSMS. FSMS Policy Top management i.e. Leadership will be accountable for developing organizational food safety policy. As per Clause - 5.2, there is an increased requirement for effective communication and participation so as to ensure compliant food safety conditions. The policy should be in accordance with company’s processes and its context. Organizational Roles, Responsibilities & Authorities As per Clause - 5.3, all roles, responsibilities and authorities must be properly defined, communicated and understood. However accountability of top management for the overall system can never be delegated. Unlike ISO 9001 and ISO 14001, ISO 22000:2018 mandates the role of food safety team leader, who is assigned specific responsibilities by the standard.y myles Free Resource Actions to address risks and opportunities As per Clauses 6.1.1, 6.1.2 & 6.1.3 food organizations are to identify, ponder and make action to optimize risk and opportunities with the factors of organization's context referenced in clauses 4.1 and 4.2. These issues, needs and expectations may influence in the favor of organization or against it. Therefore risk should not only be managed for negative impact but also for internal and external issues, the needs and expectations of interested parties related to food safety management stream. All these factors together influence the capability of the management system to yield its envisioned results i.e. improved food safety performance. When planning for the food safety management system, the food organization must consider: a) the issues referred to in internal and external issues b) the requirements referred to in needs and expectations of interested parties c) the scope of its food safety management system; Risk and opportunities related to FSMS can address following key areas: a) give reassurance that the FSMS can yield planned results b) improve desirable effects ©) avoid, or minimize, undesired effects 4) attain continual improvement, WS: Free Resource Objectives and Performance Clause - 6.2 enforces emphasis on objectives as incentive for improvements (Example Clauses 6.2.1 & 6.2.2) and performance evaluation (Example Clause - 9.1.1). The objectives should support the food safety policy and reflect the strategic direction. Moreover context of the organization will also help in identifying relevant objectives to perform. Support From Clause - 7.1 to 7.5, there are various support functions which include availability of sufficient resources, competency among the workers to ensure food safety, necessary awareness of workers and suppliers, sufficient communication for food safety, and requirements for documented information. Some important points in these support requirements are: + Actions related with communication must be appraised for their effectiveness. + Awareness must include the policy, critical food safety hazards as well as employees’, contractors’ role for food safety performance together with awareness and competence to control critical points from what is considered as ‘critical food safety risk’. + The words ‘documented information’ has been presented similar to ISO 9001. It encompasses how an organization opts to create, maintain & retain information believed as compulsory for the food safety management system. + The organization is required to decide what documented information (both internal & external) should be controlled. This also involves the need of documented procedures.y myles = Free Resource Operations & Emergency Preparedness From Clause - 8.1 to 8.9 it is the operation planning and control, prerequisite programs PRPs, traceability systems, hazard control, verification related to hazard control plan and PRPs, control of product and process nonconformities, control of measurement and monitoring and emergency preparedness response. Each section has detailed requirements to maintain the effective food safety management systems. Planning has been incorporated, explicating plans to control the identified risk and hazards. Hazards should be addressed with critical controls that are to be implemented. Procurement and outsourcing, in the new standard, is required to scrutinize purchased goods and services fit in to the requirements of food safety management system. One more improvement in the standard is to clarify the end users, the differences of Pre-requisite Programs (PRPs), Operational Prerequisite Programs (OPRPs) and Critical Control Points (CCPs)y nye = Free Resource Performance Evaluation The Clause - 9 i.e. Performance Evaluation is brought forth in order to have the same structure as of ISO 9001, ISO 14001 and other international standards. + General requirements on measurement and monitoring for food safety management system + Analysis and evaluation from information coming from measurement and monitoring, results of verification activities for prerequisite programs PRPs and the hazard control plan. Moreover analysis and evaluation should also include results of intemal and external audits. + Internal audits should be carried out in planned manner; the results should be communicated food safety team, and the management. The audit activity must be completed. + Management review Clause has improved earlier requirements and inputs of FSMS ISO 22000:2008. It now adds context of food organization, improvement, risks and opportunities, complete management system effectiveness, issues of interested parties etc., myles = Free Resource Improvement As per Clause - 10 of ISO 22000:2018, ‘preventive’ action of ISO 22000:2008 has been linguistically removed, as it is already considered in the risk management phase. The food organization has to deal with the incident, correct the problem, investigate the root cause and take corrective action. Corrective action is then evaluated to check its effectiveness for food safety performance. The food organization is required to show that it has implemented the values of risk management and continual improvement. With the help of root cause investigation, in depth analysis, modified risk analysis and operations where needed. The food organization must be capable to prove that they are using the outputs from developments of performance analysis and evaluation (such as analysis on verification results, validation controls etc.) to recognize and resolve regions of gaps and opportunities.