DNV-GL be edit: bce OR ES CU I) The clause structure Oe ene RF Re Ae ye MUS Cun ce Seri) Ome ey Cocca CWGround Rules for the Webinar * 45 minutes presentation by the facilitator * 15 minutes Question & Answer session at the end * Participants can text the questions through the question tab * Request to restrict the question to the content of the webinar " understanding the Key changes” * Polls will be conducted in between the presentation to gauge the understanding of the participants * All participants mike kept in mute condition during the session to avoid background noise * Facilitator mode of Language will be English “Thanks for your co-operation” > wae DNVGL,DONV-GL mao ‘SAFER, SMARTER, GREENERDNV GL Group: Who we are Long history, Global presence ne EY TS i 1864 Pcl Suan 0d) (OUR PURPOSE ‘To safeguard if, property ‘andthe environment OUR VISION ‘Gobal impact for a safe ‘and sustainable future ‘OUR VALUES We build trast and confidence We never compromise on qualty or integrity We are commited to teamwork and innovation We care for our customers and each other We embrace change and deliver resutsThe annual ISO Survey shows the number of valid certificates to ISO management system standards worldwide. Total number of active ISO certificates is more than 1.5 million (end of 2017). parry PO eared on DNV-GLbiacel tet acm UT ep rli ree LL DNV-GLThe standard - ISO 22000:2018 * ISO 22000:2018 was published 19 June 2018. * The aim of ISO 22000 is to harmonize the requirements for food safety management ona ) global level. * The standard contributes to ensure food safety throughout the whole food chain from farm- to-table. © wae DNV-GLTransition to ISO 22000 : 2018 June Publication of YEAR PERIOD ‘18 130 22000-2018, Perform an ISO 22000-2018 aud to ensure your crticaeis renewed belore 29 Juno 2021, a 42% -paysmowreRo0 e108 150 22000:2005 certificates vase tobe validFrom ISO 22000:2005 to ISO 22000:2018 - DNV GLs contribution * ISO 22000 was developed by the ISO committee ISO TC 34 SC 17, including several working groups for both the main standard ISO 22000 and the related family, that is the ISO TS 22002-X series (prerequisite programs for each food chain segment), as well as the relevant guidelines. * Since the starting of the revision process in 2014 DNV was an active member of the working group and a co-author and contributor to the content of the standards. * DNV GL is currently participating to the working groups for ISO TS 22003 revision and for the new ISO TS 22002-5 PRP for storage and distribution. DNV-GLISO 22000 adapts the High Level Structure 1SO decided in 2012 that all management system standards shall use a Iso common framework containing: Pelt is ty " Unified High Level Structure (HLS) oR had te ey laclty * Common Text and Terminology * Individual management systems standard will add additional “discipline-specific® requirements as required. Main advantages = Enhanced compatibility of standards * Easier to implement new standards * Easier to integrate standards into a management system = Increase value for users « Increased effectiveness in standard development for the technical committees 1 DwaLe DNVGL,10 clause structure - Main clauses of High Level Structure (HLS) SOE UC Ly Scope Planning See ence) eee uu terms and definitions to Pare Normative references 14 ‘Support. SS For Clauses 4-10 there eet a ue Rea g (requirements) to be Pees Terms and definitions Operation Context of the organization Performance evaluation Lie Ry 2 owae DNV-GLISO 22000:2018 - Scope Ch. 1 ‘Scope’ states that an organization directly or indirectly involved in the food chain shall: a) Plan, implement, operate, maintain and update a food safety management system providing products and services that are safe, b) Demonstrate compliance with applicable statutory and regulatory food safety requirements. ©) Evaluate and assess mutually agreed customer food safety requirements and demonstrate conformity. d) Effectively communicate food safety issues to interested parties. ) Ensure that the organization conforms to its stated food safety policy. f) Demonstrate conformity to relevant interested patties. 1 owae ONVGL= There is no normative reference in this standard. 1s wae DNV-GLTerms and Definitions * ISO 22000 : 2005 has 17 Terms and definitions * ISO 22000 : 2018 has 45 Terms and definitions * 28 number of Terms and Definitions are added in the 2018 version. 1% oWae ONVGLNew Terms and Definitions are added in the 2018 version * Acceptable level * Management system, * action criterion + Measurement * Audit * Nonconformity * Competence * Objective * Conformity * Organization * Contamination * Outsource * Continual improvement + Performance + Documented information * Process * Effectiveness * Product * Feed * Requirement * Food * Risk * Animal food * Significant food safety hazard * Interested party * Top management + Lot + TraceabilityAnimal food added in the Scope ‘SCOPE ‘Now specifically includes animal food: food for animals not producing food for human consumption. Feed is intended to be fed to food producing animals.Key changes - Term & Definitions ACCEPTABLE LEVEL level ofa food safety hazard not to be exceeded in the end product provided by the ry F\_ organization ACTION CRITERION measurable or observable specification for the monitoring of an OPRP DOCUMENTED INFORMATION information required to be controlled and maintained by an organization and the medium Sen o" which it is contained eS » owae DNCKey changes - Term & Definitions FEED single or multiple product(s), whether processed, semi-processed or raw, which is (are) EET] intended to be fed to food-producing animals ANIMAL FOOD single or multiple product(s), whether processed, semi-processed or raw, which is (are) i intended to be fed to non-food-producing animals FOOD SAFETY (NOT NEW REWORDING DONE) assurance that food will not cause an adverse health effect for the consumer when it is —-, _ Prepared and/or consumed in accordance with its intended use a Eyay tars replaced by adverse health effect because consistency with definition of food safety hazard (where "advélse health effect” is used). The use of assurance (“concept is replaced) highlights the relationship between the consumer and the food product, based on the assurance of safety.Key changes - Term & Definitions INTERESTED PARTY | _ person or organization be affected by, or perceive itself to be affected by a decision or — activity LoT Defined quantity of a product produced and/or processed and/or packaged essentially under OUTSOUREE Make an afrangement where an external organization performs part of an organization's function or process Note : An external organization is outside the scope of the management system, although the outsourced function or process is within the scope. m owale DNVGLKey changes - Term & Definitions RISK Effect of uncertainty “(Note : an effect is a deviation from the expected (Positive or Negative) <<" Note : uncertainty is the state of deficiency of information related to, understanding or knowledge of, an event, its consequence, or likelihood. (Risk at the operational level and the strategic level of a management system) FOOD SAFETY HAZARD (NOT NEW REWORDING DONE) biological, chemical or physical agent in food with the potential to cause an adverse health STEP effect EPr) Note : Food safety hazards include allergens and radiological substances. SIGNIFICANT FOOD SAFETY HAZARD —..__ food safety hazard, identified through tge hazard assessment, which needs to be controlled -_,__ by control measures 2 wae DNV-GL.ISO 22000:2018 requirements Eos * SECTIONS 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the organization 4.1-Understanding the organization and its context 4,2-Understanding the needs and expectations of interested parties 4.3-Determining the scope of the food safety management system 4.4-Food safety management system 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 2 omae DNV-GLISO 22000:2018 requirements Een * SECTIONS 6 Planning 6.1 Actions to address risks and opportunities 6.2 Objectives of the food safety management system and planning to achieve them 6.3 Planning of changes 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information % owa.e DNV-GLISO 22000:2018 requirements Eee esi! * SECTIONS 8 Operation 8.1 Operational planning and control 8.2 Prerequisite programmes (PRPS) 8.3 Traceability system 8.4 Emergency preparedness and response 8.5 Hazard control 8.6 Updating the information specifying the PRPs and the hazard control plan 8.7 Control of monitoring and measuring 8.8 Verification related to PRPs and the hazard control plan 8.9 Control of product and process nonconformities 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 6 WE ‘Aw vein cf oii e525 exhaeaupenenISO 22000:2018 requirements eect + SECTIONS 10 Improvement 10.1 Nonconformity and corrective action 10.2 Continual improvement 10.3 Update of the food safety management system + Annexure A-Cross reference between the Codex HACCP and ISO 22000:2018 1 Annexure B-Cross reference between ISO 22000:2018 to ISO 22000:2005 7 wae DNV-GLISO 22000:2018 requirements yeni 4 Context of the organization 4.1-Understanding the organization and its context. organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result 4.2-Understanding the needs and expectations of interested parties 4) the interested parties that are relevant to the FSMS; b) the relevant requirements of the interested parties of the FSMS, ‘The organization shall identiy, review and update information related to the interested parties and their requirements. 4.3-Determining the scope ofthe food safety management system 4.4-Food safety management system y EE eee eee) 8 owe DNV-GL“CRYSTAL CLEAR” - Packaged drinking water company + Company "CRYSTAL CLEAR” involved in “bottled water processing” using ground water as source water and located in the middle of farm lands. This is a green zone declared by the local government and only limited industries which are identifi classified as “non-polluting” are allowed to operate in this zone. Current year due to heavy pest infestation among the paddy ‘crop farmers used pesticides in uncontrolled manner leading to residues of pesticide detected in the raw water taken from bore holes of the water company , this isthe fist time company is facing ths issu til it was established from 1996. + The company water treatment system is not a multi barrier system as it was validated way back since there was no significant hazards in the raw water parameter identified in their annual verification before this current pesticide residue incident. ‘The company has a ready customer order to be signed for bottling 6000 KL of water for @ multinational brand planning aggressive growth starting from June 2019 The major business objective of the organization identified is within the next 1 year ~ Ensure food safety and grow by 30% compared last year. Eee » mae DNV-GL,External & Internal Issues * External issue ~ Raw water having pesticide residues = Internal Issues ~The WTP not having facilities to remove pesticide residues * Risk ( Strategic / Operational level ) - May not meet Customer & Statutory & Regulatory requirements * Opportunities — Awaiting customer order to improve business a 0 DWaLE DNV-GLKey changes induced by the HLS * As a result of the HLS the structure and clauses of the standard are largely changed compared to the previous version. = New clauses for systematic determination and monitoring of the business context (external and internal issues) (Ref. 4.1) and needs and expectations of interested parties (Ref. 4.2). This to identify and understand factors that can (potentially) affect the ability of Management System to reach the intended results. ° = Strengthened emphasis on leadership and management commitment (Ref. 5.1), including to actively engage and take accountability for the effectiveness of the management system. 3 owe DNV-GLKey changes induced by the HLS «5.1 Top Management shall demonstrate leadership and commitment by: a) Ensuring that the food safety policy and the objectives of the food safety management system (FSMS) are established. b) Ensuring the implementation of the FSMS. C) Ensuring that the resources for the FSMS are available. d) Communicating the importance of effective food safety management. e) Ensuring that the FSMS is evaluated and maintained. f) Directing and supporting persons to contribute to the FSMS' effectiveness, g) Promoting continual improvement; h) supporting other relevant management roles i) demonstrate their food safety leadership. 2 OWE DNV-GLISO 22000:2018 requirements nena) * SECTIONS 6 Planning 6.1 Actions to address risks and opportunities, 6.2 Objectives of the food safety management system and planning to achieve them 6.3 Planning of changes 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information DNV-GLKey changes induced by the HLS * Risks management (Ref. 6.1.1 to 6.1.3) to determine, consider and, where necessary, take action to address any risks that may impact (either positively or negatively) the ability of Management System to deliver its intended results. « Strengthened focus on objectives as drivers for improvements (6,2.1/6.2.2) (Consistent, measurable ,account regulatory and customer requirements, monitored and verified, communicated, maintained and updated) & performance evaluation (9.1.1/9.1.2). * Extended requirements related to Communications (7,4): More prescriptive in respect of the mechanics of communication, including determination of what, when and how to communicate. * Less strict requirements for a Food Safety Manual (7.5.1). It is still required to have documented information. a Ty wae ONVGLKey changes induced by the HLS * Documented information shall be controlled to ensure it is adequately protected (ref. 7.5.3). The explicit requirement to have a documented procedure has been removed, * The HLS does not refer to Preventive action as a term or clause. However the concept of preventive action is considered to be covered through the risk based thinking throughout the standard and implicitly embedded in relevant clauses (e.g. through chapter 4, 6, 8 and 9). * Documented information is now the term used as replacement of Documents and Records. SOT) CEC las Core Doe] ee 38 owaLe DNV-GLISO 22000 - two stage PDCA implementation + nang na oneray ped pa, pate mos Organiatona planing and cont The PDCA cycle * The standard clarifigs the Plan-Do-Check-Act cycle, by having two separate Operational paoing aed conto! cyeles in the standard ms =] PS working together: one aby m+ “oe. ae + oe covering the Emergency prepares & response si) management system PUN (ed se) and the other, covering the principles of aay eae ~ = ct ot sty) ee oad sty) 0 (hed sey) erry DNV-GLOther specific key changes COMMUNICATING THE FOOD SAFETY POLICY Explicitly requires the management to facilitate understanding of the Food Safety Policies by employees. BEd 5.2.2 FOOD SAFETY MANAGEMENT SYSTEM OBJECTIVES Establishing objectives for the FSMS is further specified. now includes tems as ¢.9. consistent with customer requirements, monitored and verified. Note that FSMS objectives are not food safety objectives; a food safety objective (FSO) 8.5.2.2 isa tool to meet a public health goal such as an appropriate level of protection (ALOP). An FSMS objective is related to the management system itself. CONTROL OF EXTERNALLY-PROVIDED PRI ES, PRODUCTS OR SERVIC Pepa TPs clause introduces the need to control the externally provided Processes, Products and services. (including outsourced processes) and to ensure adequate communication of relevant requirements, in EEE order to ensure to meet the FSMS requirements, relevant documented information shall be retained. u owae DNV-GLOther specific key changes COMPETENCE The scope ofthis clause does not solely cover own employees, but also includes subcontractors and other people performing work on behalf of the organization. GENERAL ‘There has to be a clear decision on whether, what and rm to communicate. GENERAL The term documented information relates both to how to operate a process (former procedure) and evidence of the results achieved (former records). The extent of documentation will vary depending on its risk exposure, size of the organization, nature of its activities, complexity of the process and competency ofits employees. A key aspect of documenting processes is knowledge preservation and management. 5 mae DNVGL,Other specific key changes PRPS ES Tea tien selecting and/or establishing prp(s), the organization shall ensure that applicable statutory, regulatory PERE and mutually agreed customer requirements are identified, the organization should consider: sama 2) the applicable part of the ISO /TS 22002 series; TRACEABILITY SYSTEM Fema he clause Is mre pecs inthe specication of unique identification, taking into account rework and BAM ‘ctention time of records related to the shelf life ofthe products. EZR Shall verity and test the Traceability system , to include the reconciliation of quantities of end products with the quantity of ingredients as evidence of effectiveness EMERGENCY PREPAREDNESS AND RESPONSE Top management shall ensure procedures are in place to respond to potential emergency situations or incidents that can have an impact on food safety ° Periodically test procedures where practical 6 wae ONV-GLOther specific key changes DESCRIPTION OF PROCESSES AND PROCESS ENVIRONMENT The responsibilty ofthe food safety team within the organization is now explicitly stated forthe relevant activities. The need to describe the process environment, food contact materials existing PRPs and any ‘occurring change (e.g. seasonal and shift pattern) is now explicit VERIFICATION PRP verification shall confirm not only that the PRP is implemented, but also that it's effective. The verification activities shall be carried out by person not involved in the monitoring. DNV-GL 7 waeOther specific key changes EVALUATION FOR RELEASE When the nonconformity ofa product is related to critical imits and CPs, the product is unsafe and cannot be released. only nonconformities related to action criteria and oPRP may result in product release, provided the condition given in the clause are met. a) other control measures have been effective; b) combined effect of the control measures c) the results of sampling analysis DISPOSITION OF NONCONFORMING PRODUCTS When a nonconformity is related to critical limits and CPs, the product is unsafe and cannot be ESM released. a) reprocessed or further processed ,food safety hazard is reduced to acceptable levels; EXSEM b) redirected for other use as long as food safety in the food chain is not affected; ¢) destroyed and/or disposed as waste. MANAGEMENT REVIEW INPUT ‘The lst ofthe inputs to be considered has been better detailed, including e.g. the performance of external providers, the review of risks and opportunities and the need of resources, ° # OW aO ONChanges affecting systematics on hazard analysis, CCP’s and oPRP’s OPERATIONAL PREREQUISITE PROGRAMME == The oPRP concepts changed and dried, oPRP is now applied to Prevent or reduce a significant fod - safety hazard. It makes explicit reference to contro! measure instead of PRP and the need for action <"<\ criteria and measurement or observation enable effective control of the process and/or the product. OPERATIONAL PLANNING AND CONTROL This is the inner POCA cycle. It includes the codex Alimentarius’ 7 principles / 12 steps (except assemble HACCP team which is covered in 5.3.1 and 7.2 c). It develops the risk-based thinking embedded in the food safety field through the HACCP methodology. I's important to remind, that the operational control is dealing with hazards. This clause includes a reminder to consider the control of changes (ref 6.3) and the control of outsourced processes (ref 7.1.6). SELECTION AND @ntEGORIZATION OF CONTROL MEASURE(S) - REWORDED AND CLARIFIED The control measures categorization is an assessment based on likelihood, severity and feasibility and aspects affecting the severity of consequences are specified. the concept of synergistic effect (removed) Now mentioned single or combination of control measures. DNVGL st owaeSelection and categorization of control measure(s) - Reworded and clarifiedSelection and categorization of control measure(s) - Reworded and clarified > mae ONVGLSelection and categorization of control measure(s) - Reworded and clarifiedChanges affecting systematics on hazard analysis, CCP’s and oPRP’s HACCP PLAN vs HAZARD CONTROL PLAN The new wording hazard control plan is important to highlight that the oPRPs and the HACCP plans are actually part of the same hazard control plan, based on the same hazard assessment, with the shared ‘objective to control significant food safety hazards. DETERMINATION OF CRITICAL LIMITS AND ACTION CRITERIA This isa key change in the standard, now better clarifying the diference between CCP and oPRP as well as their common structure and shared objective. The monitoring of both CCPs and oPRPs needs the definition of itera to determine the status ofthe relevant control measure and take action if needed, These criteria are the critical limit for the CCP (measurable) and the action criteria for the oPRP (measurable or observable). It should be recognized that in some cases the action criteria could be having the oPRP itself in place; for example if the oPRP is the hand washing with hourly frequency, the action criterion will be the observation of the hand washing itself (wile the relevant hand swabbing should be considered verification) ° STEP 85.4.2 ow aLeChanges affecting systematics on hazard analysis, CCP’s and oPRP’s MONITORING SYSTEMS AT CCPs AND FOR oPRPs + The monitoring system shall be established for control measures, both at CCPs and for oPRPs, + The need to evidence of document information the monitoring results is now explicit, + Note that despite the different wording used for CCPs and oPRP, the technical approach forthe selection of the monitoring methods and frequency is substantially the same. While frequency and monitoring methods at CCPs shall be capable to detect any failure before the product leaves the organization's control because the product is unsafe (same as previous version), the selection of ‘methods and frequency for oPRP monitoring shall be based on the likelihood of failure (of the control measure) and the severity of consequences (ofthe failure), which in turn means that monitoring shal be stricter and stricter according to the actual risk for consumer + The requirement related to the monitoring based on observation such as the visual inspection is now referred specifically to the oPRPs, as tis type of criteria is accepted for action criteria only (not for critical control points). Owae DNV-GLTimeline rie ya crate renewed Dobro « Accredited ‘2005’ certificates can be migrated to ‘2018’ during a scheduled periodic or recertification audit within in the 3 year period. = Normally depending on the FSMS complexity 0.5-1 auditor man day will be added when transition audit is done in conjunction with a scheduled periodic or recertification audit. Additional time is to cover existing and new requirements implied by ISO 22000:2018. Eee OOOO] DNV-GLHow to prepare for implementation of the new standard? By Our recommendation is to start preparing for the migration as early as possible and plan properly to incorporate needed changes into your management system. Recommended steps for the migration * Get to know the content and requirements of ISO 22000:2018. The standard is available for purchase from ISO and possibly from your normal national standards provider. If you are @ current user of ISO 22000:2005 you should focus on the changes in requirements. + Ensure that relevant personnel in your organization are trained and understand the requirements and key changes. « Identify gaps which need to be addressed to meet the new requirements and establish an implementation plan. « Implement actions and update your management system to meet the new requirements. Evaluate the effectiveness of implementation via intergal audits and define further actions were needed.How can DNV GL support your implementation? DNV GL can support through + Seminars, webinars, e-learning etc. where you typically learn about the standard and where you get a basic overview of the content and key changes compared with ISO 22000:2005, the migration process etc. * Tutored training courses, in-company or public. The objective of these courses is to provide detailed insight to the content and changes and about the required steps for migration. These are modular courses where the level of detail can be tailored to your needs. (ey Pomc cL * Gap assessment (workshops) where we assess your management system against the requirements of the new standard and identify the = gaps that need to be addressed. This will provide useful input to your / Ce process to comply with the new standard, The level of detail offsuch com assessment can be tailored to your needs. @ owe DNV-GL