ISO 22000:2018 – Food Safety Management System.
Standard overview – ISO 22000 is a Food Safety Management System, The implementation of ISO 22000 can be adopted by any type of organization involved in Food Supply Chain Business – i.e food processing/ Manufacturing/ Storage/ Distribution and not limited to size, nature of the organization, by establishing this standard it helps the business and the organization to be efficiently handled and improve the performances at every stage and in every department, by implementing this standard the enhancement of customer satisfaction is seen, ensures safe, healthy and hygienic food to end-users, by this the organization identifies several goal and objectives and the organization strives to achieve the goals and full fill the achievements which is seen from the Business development, enhanced customer satisfaction and it involves the stakeholder in the processes.
ISO 22000 – Requirements
This standard is broadly defined in 07 Main Clause/ Sections and further in Sub-Clause/ Sub-Sections (Clause 4 Context of the organization, Clause – Leadership, Clause 6 – Planning, Clause 7 – Support, Clause 8 – Operations, Clause 9 – performance evaluation, Clause 10 – improvements).
The requirement of Clause 4: Context of the organization, Here the organization needs to identify potential internal-external issues related to the food safety management system, which can impact the organization, its management system, and the product/ service, the organization needs to identify the needs and expectation of interested parties such as employee, contractor, supplier, regulatory body, parent organization, shareholders etc… related to food safety management system, The organization needs to identify the scope of certification based on the nature of the work/ activities done in the organization considering the requirements in clause 4.1/4.2 of the standard, Finally the QMS processes needs to identified and the sequence needs to be defined for the compliance to the scope of certification, the input and out needs to identified based on the process and activities, the organization needs to update, improve their FSMS including their process time to time,
Documents required for Clause 4 of ISO 22000:2018 :
- internal external issues,
- Needs and expectation of interested parties,
- Scope of certification
Requirements of Clause 5. Leadership.
- Here in the clause, the organization needs to define the Food Safety Management System policy appropriate to the organization based on its activities and nature of the work, addressing the context of the organization and shall provide a framework to develop the FSMS objectives, the top management should integrate the FSMS requirements into its business practices, provide essential resources to comply to achieve the FSMS outcome, the organization should evaluate and maintain the intending results of the FSMS, and shall promote continual improvements within the organization,
- the Top management shall be responsible for the implementation of the management system within the organization,), it shall identify the mode of communication of the policy at relevant stages and levels, the organization shall identify and communicate the applicable statutory and regulatory requirements to the organization and ensure the compliances are met, the top management shall focus on the customer requirements, define the role, responsibilities and authority at relevant stages and functions considering their work activities, experience, skill & knowledge, the organization shall appoint a Food Safety Team Leader (FSTL), he / she shall be responsible to update the FSMS at planned intervals and report the update to the top management.
Requirements of Documents for Clause 5 of ISO 22000:2018 :
- Food Safety Management System Policy.
- Visitors Policy
- Wooden Policy
- Jewelry Policy
- Tobacco Policy
- Glass policy etc…
- Legal Register,
- Role and Responsibility (Job Description).
- Organizational chart
Requirements of Clause 6 – Planning – in this clause the organization needs to define the criteria to identify the significant and non-significant risk arise from the context of the organization (internal/ External), needs and expectation of interested parties, the risk can be identified and opportunities can provide the option to adopt new technologies, ideas etc.. And action can be initiated to reduce the impact of the risk or even eliminate the risk,
In this clause the organization should define the FSMS objectives for the relevant function (Every Function), the objectives shall be consistent to the FSMS policy, measurable, consider the applicable regulatory requirements, objectives to be communicated to all functions, all the objectives shall be updated from time to time and monitor the same, finally the planning to the objectives needs to be done by the organization.
Documents required for Clause 6 of ISO 22000:2018 :
- Risk Register with Mitigation plan and opportunity for improvements.
- FSMS objective planning and monitoring sheet.
Requirements of Clause: 7 – Support.
- In this clause, all the requirements to the support services are described. Support services to comply to the scope of certification, standard requirements, support such as competent manpower, in fracture to achieve the product & Service conformity, develop of the environmental friendly work environment to achieve the product / Service conformity, ensuring the availability of the proper monitoring and measuring resource, Calibration of the equipment and ensuring the traceability of the master equipment and lab, The organization shall ensure all the relevant organization knowledge is available at the organization so the employees enhance their competence and awareness,
- The organization shall define criteria for a section of the contractors, outsourcing processes, the organization has to identify the Hazards and risk involved in the outsourcing processes, and the contracting processes such as involvement of contracted workers and the activities which may impact the interested parties and verify the compliances involved in the legal requirements.
- The organization shall define the competence criteria for each process and function, provide awareness training to relevant functional level employees and maybe to all employees, Dealing the media of communication internal and external, and communicate all the relevant information at relevant stages/ function and each employee.
- All the document information (SOP) relevant standard requirements need to be developed so the system runs smoothly and should be communicated to all.
Documents required for Clause 7:
- Competency Matrix
- Training Plan,
- Training effectiveness
- List of machinery & equipment
- Calibration records.
- Documented information (SOP).
- Suppliers selection criteria,
- List of approved suppliers and Contractors.
- Suppliers selection criteria,
- Supplier assessment order
- Suppliers evaluation record,
- Purchase order.
Requirements of Clause 8. Operations,
- In this clause, the operational planning and control/realization of the product is required to be done by the organization, while planning the acceptance criteria shall be established. All the controls at the relevant stages shall be done as per the criteria set, the organization has monitor, control all the changes and review the consequences and take action to mitigate any adverse effects,
- The organization shall develop the relevant PRP’s at relevant stages, which shall be appropriate with the context of the organization, which should be appropriate to the size and type of operations, should be appropriate to the products being manufactured and same should be approved by the FSTL, while selecting/ establishing the organization shall ensure the applicable statutory and regulatory requirements and customer requirements are considered. When finalizing the PRP’s construction, the layout of the building, layout of premises, supply of air, water, energy, pest control, waste and sewage disposal and supporting services, cleaning, disinfection, personal hygiene, product information, suppliers approval all theses points shall be considered.
- The organization shall establish a process for identify the and monitoring the traceability of the product within the FSMS details such as Lot No/ ingredients and intermediate products to the end products, the status of material accepted / Rejected, distribution of end products,
- The organization needs to develop the emergency plan considering the potential Food safety emergency situations, the organization should conduct mock drill considering the same and the records shall be maintained and the effectiveness should be changed, and the organization shall define the frequency for conducting the mock drill,
- The organization shall identify the hazard control by complying to the applicable statutory, regulatory and customer requirements, product, process, and process equipment and food hazards relevant to the Food safety management System,
- The organization shall monitor Characteristics of raw materials, ingredients, and product contact materials through internal inspection and testing or from external independent labs, test shall include parameters such as biological, chemical and physical characteristics, its composition, source of material, place of origin, method of packaging and delivery, storage conditions and shelf life, acceptance criteria against the specification of purchased materials and ingredients appropriate to their intended use.
- The organization shall maintain the records for the inspection and testing the characteristics of end products which shall ensure the compliance to the legal and regulatory requirements, parameters such as biological, chemical and physical characteristics, its composition, source of material, place of origin, method of packaging and delivery, storage conditions and shelf life, acceptance criteria against the specification of purchased materials and ingredients appropriate to their intended use the time period within the use and application of the products.
- The organization shall develop the Process flow chart for each product and the HACCP/ CCP and the same is to be verified on the site,
- The organization needs to identify the Hazard identification elated to FSMS and determine the acceptable levels, , its Risk involved considering the organization context/ activities, information of food chain, statutory and regulatory requirements, Hazard assessment shall be done and selection of suitable control measures shall be done, it shall ensure the applicable legal and regulatory requirements are complied, considering the other relevant information relevant to the FSMS,
- The organization shall conduct a hazard assessment considering the Detection, Severity, likelihood identify the ccp and maintain the records for CCP,
- Considering the product and service the selection and categorization of control measures is been selected.
- The organization shall validate the monitoring and measuring equipment at planning intervals.
- The organization shall develop and HACCP Plan where the ccp, oprp shall be identified, the criteria for identifying g the OPROP shall be developed, roles and responsibilities shall be identified the organization shall implement the Hazard control plan,
- Updating the CCP and OPRO at the time to time,
- The organization shall verify the PRP and the Hazard control plan from time to verify all the PRP’s are found in the limit.
- The clause requirements call for the Non-conformity and corrective action related to the environmental management system, The organization needs to develop a documented information for controlling the non-conformity and corrective action, at first the organization needs to identify the route cause imitate the correction and take the corrective action to eliminate the route cause.
- The organization shall develop a documented procedure to handle the potentially unsafe products and same shall be circulated within the organization, the information shall include the Food safety hazards, defined acceptable levels, product acceptable limits etc… and after evaluation, the evaluation for release of the product shall be done,
- One the segregation is done then the Disposition of Non-conformity of the product is been done,
- The organization will conduct the mock recall/ withdrawal from the market to verify the effectiveness of its management system considering any unsafe material is dispatch to the market and at the same time, the material in the stock shall also be verified to verify the for the unsafe products.
Documents required for Clause 8.
- Documented information required for Operational control.
- Acceptance criteria.
- HACCP Plan.
- Work and/or test instructions
- Quality Plans,
- Control Plans.
- Receiving inspection Report.
- Inspecting and test plans.
- Quality plans
- Identification and traceability tags
- Emergency Plan,
- Documented procedure for Emergency Preparedness and response,
- Mock Drill Report.
- Legal Register
- Inward register and incoming inspection and testing reports.
- Final inspection and testing reports,
- Process Flow Charts.
- Calibration certificates,
- List of CCP,
- List of OPR
- CCP monitoring records
- OPRP records
- Documented information for Control of Non Conformity
- CAPA Reports.
- Evaluation record,
- Product release records
- Product disposition record
- Withdrawal/ Recall record
- List of unsafe products.
Requirements of Clause 9 – Performance Evaluation.
- The clause requires the organization to collect and analyze the necessary data and measure the effectiveness of the management system and to identify the opportunities, these data can be considered whole the organizational objectives are been finalized,
- The monitoring and measuring criteria, the organization needs to review the performance of the functional objectives data may from customer satisfaction/ supplier performance ratings/ on-time delivery/ rejection data, etc…
- Customer satisfaction needs to be monitored and maintained as per objectives.
- The internal audit shall be done as per planned intervals minimum once in a year, the organization can outsource a consultant for conducting the Internal audit in case the organization is small in size, or it can train its own employees for the same, it shall prepare an annual plan, schedule, conduct the audit and verify the effectiveness of the management system implemented in their organization, and close the audit findings as per procedure if any,
- Management review shall be done as per planned intervals minimum once in a year, the organization needs to circulate the agenda for MRM, then the MRM shall be done as per plan and the output of the MRM shall be recorded and maintained and monitored,
Documents required for Clause 9
- Objective monitoring sheet/ Performance evaluation record.
- Internal audit plan.
- Internal audit schedule
- Internal audit report
- Corrective action report.
- Document information for internal audit and management review.
- Agenda for MRM,
- Minutes of Meeting (MRM) along with the outputs.
Requirements of Clause – 10.0.- Improvements.
- The clause requirements call for the Non-conformity and corrective action, The organization needs to develop a documented information for controlling the non-conformity and corrective action, at first the organization needs to identify the route cause imitate the correction and take the corrective action to eliminate the route cause.
- Identify the improvement projects, imitate them, and get the projects completed as per plan, the organization can develop the kaizen team or form a quality circle team to execute the same.
Documents Required for Clause 10.
- Documented information for controlling the non-conformity and corrective action.
- Corrective action report,
- Continual improvement project records.
Benefits of ISO 22000 Certification.
- Reduction in the unsafe product,
- Reduced process rejection,
- No customer complaints or fewer complaints,
- Improvement in food safety with the organization,
- Context of the organization is not identified, need and expectations, the risk involved is monitored,
- The shelf life of product is monitored,
- Mock drill id done to demonstrate the compliance to the emergency plan,
- Proper identification and traceability is provided,
- ISI/Agmark / FASSI Lic No are evident on the product,
- FASSI requirements are followed,
- reduction the Food wastages,
- minimize the disposal of waste material,
- Open the way to market at national & international level.
- increased customer satisfaction,
- Good and hygienic food for consumers,
- Reduced hazards at the workplace,