Iso 22000 awareness training

FOOD SAFETY MANAGEMENT SYSTEM INTERNAL AUDITOR PROGRAM

FOOD SAFETY MANAGEMENT SYSTEM INTERNAL AUDITOR PROGRAM

Ramasubramanian.sRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

WELCOMESafety-Be aware of emergency exitsRest rooms and Telephones-Nearest locationsContact number-For Emergency situationsMobile Phones -Please avoid interruptionsRecording devices-Not allowed in classLunch and Breaks-Please return on timeSmoking-Not permitted in the class roomSpecial needs-Please inform the instructor

Ramasubramanian.s +919952229598 Management consultant/Trainer/Auditor

INTRODUCTIONSNameQualification, Job role and ExperienceKnowledge of ISO 22000(Scale 1-10)Knowledge of Auditing (Scale 1-10)Your Aim and Expectations of this courseSomething interesting about Yourself


Learning objectives: KnowledgeFundamental purpose of a food safety management system,Principles,processes and techniques used for the assessment and management of food safety hazards including the significance of these for FSMS auditors.Purpose, content and interrelationship of the ISO 22000:2005,ISO 9001:2000 Series, guidance documents, industry practice, Standard operating procedure and legal framework relevant to a FSMSRole of an auditor to plan,conduct,report and follow up and FSMS audit in accordance with ISO 19011 and ISO 17021Ramasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Learning objectives: SkillsInterpret the requirements of ISO 22000:2005 in the context of an organizations FSMS with particular reference to: -The effectiveness of the organizations management of risk through its food safety risk assessment and control planning.-The capability of an organization to maintain and exceed compliance with legislative requirements-The adequacy of the organizations emergency preparedness and response-The implementation of operational risk control, monitoring and measurement-The continuous improvement of FSMSPlan,conduct,report and follow up a FSMS audit in accordance with ISO 19011 and ISO 17021 Ramasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Food SafetyAssurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.

Source: Codex Alimentarius (WHO)


The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.

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Food SafetyProtecting People

Keeping the Employees and Customers

Preventing Food Safety Errors


Protecting People: People may get sick if the food products are not handled carefullyKeeping the Employees and Customers: Keeping Customers and Co-workers safe helps make the industry better place to work and a place where customer returnsPreventing Food Safety Errors: Due to food handling errors during industrial operations any food product can become dangerous

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Food Safety Historical BackgroundFirst food law written in 2500 B.C.Indian food laws are dated back 1876.First HACCP system was developed between NASA and Pillsbury in 1971.Become a regulatory requirements in EU since 1998.US FDA also adopted the HACCP approach as part of control mechanism for food safety.FSSAI has been established under the Food Safety and Standards Act, 2006


Food Safety Management SystemWhy it is required?Intense farming and processing of foodIncrease in meals consumed outside homeIncrease in ready to eat foodsMore traveling across the worldIncreased amount of exotic imported foodsIncrease in number of susceptible people


INTENSE FARMING, INTENSE PRODUCTION-INCREASE RISK OF PATHOGENS AND HAZARDEOUS CHEMICALS ON RAW FOODINCREASE IN NUMBERS OF SUSCEPTIBLE PEOPLE-ELDERLY.

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Food Safety Management System

FAMI-QSGMOISO 9001GMP standard for Corrugated & Solid BoardEFSISIFSGFSI GuideSQFAG 9000McDonalds systemKraft food systemNestl NQSEurepgapFriesland Coberco FSSDS 3027BRC-IoPBRC-FoodDucth HACCPIrish HACCPM&S systemAldi systemGMPGTPRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

ISO 22000:2005A management system designed to enable organizations to control food safety hazards along the food chain in order to ensure that food is safe at the time of consumption

ISO 22000:2005, clause 1


ISO 22000:2005Features;First global food safety standard.Harmonizes the voluntary international standards.Employs proven management system principles. Enables a common understanding of what a food safety management system is.


ISO 22000:2005FeaturesRequires legal compliance checkingIntegrates existing good practiceInternal and external monitoring


ISO 22000:2005Benefits;Overcomes many of the limitations of traditional approaches to food safety control.Potential to identify all conceivable, reasonably expected hazards.Capable of accommodating the changes.


collecting and examining sufficient number of samples, -high cost, -time,-identification of problems without understanding the causes,-limitations of snap-shot inspection

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ISO 22000:2005Benefits;Help to target or manage resources to the most critical part of the food operation.Can promote international trade by equalizing food safety control and by increasing confidence in food safety.Applicable to whole food chain.


FOOD CHAIN


Entry of Hazards in Food Chain


EXERCISE 1

Understanding the Food chainRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Food chain and process approachConsideration to effect of the food chain on organizations operation

Identification, application and management of a system of processes within the organization

Ongoing control over linkage, combination and interaction of individual processes within the system of processes


Consideration: effect of the food chain prior to and subsequent to organizations operation while developing and implementing FSMS.ISO22000 promotes the adoption of a food chain approach when developing, implementing and improving the effectiveness and efficiency of a food safety management system. In this regard, in ISO22000 the organization is required to consider the effects of the food chain prior to and subsequent to its operations when developing and implementing the food safety management system.For an organization to function effectively and efficiently, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs,is considered as a process. Often the output from one process directly forms the input to the next.The application of a system of processes within an organization, together with the identification of interactions and the management of these processes can be referred to as the process approach.An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as their combination and interaction.When used within a food safety management system, such an approach emphasizes the importance of a)understanding and fulfilling the requirements,b)the need to consider processes in terms of food safety and traceability,c)obtaining results of process performance and effectiveness, andd)continual improvement of processes based on objective measurement. Interested parties play a significant role in defining requirements as inputs. Monitoring the satisfaction of interested parties requires evaluation of information relating to their perception of whether the organization has met their requirements or not.

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WHY HACCP ?

HACCP based food safety system has become a necessity in the present situation due to the following reasons : Cultural Changes Change of Habits Fast Food Addiction Deterioration of quality and scarcity of waterEnvironmental changes & impacts Poor monitoring of Animal health Inadequate disposition of waste Use of synthetic manure, insecticides and pesticides Implementation of WTO agreement Consumer Safety


EXERCISE 2 Key Terms


Process Approach

PlanWhat to do?How to do it?

DoDo what wasplanned

CheckDid things happenaccording to plan?

ActHow to improvenext time?

A desired result is achieved more efficiently when related resources and activities are managed as a processRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

PlanEstablish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies;DoImplement the processes;CheckMonitor and measure processes and product against policies, objectives and requirements for the product and report the results;ActTake actions to continually improve process performance;

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Process Approach

Resource Processes

Product Design

Process Design

Project Planning

Production

Management Processes

Measurement, Analysis, and Improvement

OII

OI

OI

OI

OI

OI

OI

O

Resource Processes

Product Design

Process Design

Project Planning

Production

Management Processes

Measurement, Analysis, and Improvement

OII

OI

OI

OI

OI

OI

OI

OI

OI

OI

OI

OI

OI

OI

ORamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Process ApproachBenefits;Lower costs and shorter cycle times through effective use of resourcesImproved, consistent and predictable resultsFocused and prioritised improvement opportunities


FSMS Process model


EXERCISE 3

Understanding the Process and PDCA approachRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Key elements

InteractiveCommunication

Systems Approach to FSM

Pre-requisite Programs

HACCP Principles

ISO 22000:2005 Control Food Safety Hazards


ISO 22000 standardScope

Normative references

Terms and definitions

Requirements

Annex(s)


ApplicationAll requirements of this International Standard are generic and are intended to be applicable to all organisations in the food chain, regardless of type, size and complexity.

This includes organizations directly or indirectly involved in one or more steps of the food chain

The standard allows small and/or less developed organization to implement an externally developed combination of control measures


Examples of indirectly involved organizations; suppliers of equipment, cleaning and sanitizing agents, packaging material and other food contact materials.Example of small or less developed organization: small farm, small packer-distributor, small retail or food service outlet.ISO22000 allows any organization, in particular a small and/or less developed organization, to implement an externally developed and established combination of prerequisite programme(s) [PRP(s)], operational PRP(s) and Hazard Analysis and Critical Control Point (HACCP) plans provided that it can be demonstrated that a)this combination has been developed in compliance with the requirements of ISO22000 specified for the hazard analysis, PRP(s) and HACCP plan,b)specific measures have been undertaken to adapt the externally developed combination to the organization, and c)this combination has been implemented and is operated in accordance with the other requirements of ISO22000.

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ISO 22000 standard - RequirementsSection 4: Food Safety Management System (FSMS) General Requirements Section 5: Management ResponsibilitySection 6: Resource ManagementSection 7: Planning and Realization of Safe ProductsSection 8: Validation, Verification and Improvement of the Food Safety Management System


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Section 4 General RequirementsScope of the Food Safety Management System

Documentation requirements

More than twenty six types of documents required by ISO 22000:2005

Twenty eight mandatory records required by ISO 22000:2005

Documents needed by the organization to ensure effective development, implementation and updating of the FSMS


Scope: Shall specify the products, or product categories, processes and production sites that are addressed by the FSMS.Food safety policy, Business objectives (food safety related), Business plan (food safety related),Supplier/Vendor agreement or contracts,Specifications/Drawings,Organization chart,Job description/Specification,Legislation, codes of practice, guidelines, food safety requirements from statutory and regulatory authorities including correspondence,Food safety requirements from customers including correspondence,Emergency preparedness and response plan,Technical Expert agreements or contracts, if applicable,Training plan,Site map showing utilities, water etc.,Employee surveys, if applicable,Hazard study,Risk Assessment study,Product descriptions (raw material and end product),Flow diagrams,Operational PRPs,HACCP Plan,Maintenance /Calibration/ Sanitization -Cleaning programmes,Process equipment documents,Licenses,HACCP Plan,Audit programmeMandatory documents required by ISO 22000:2005,Other documents deemed necessary by the organization31

Section 4 Documentation requirementMandatory documented procedures specified by ISO 22000:2005

Control of documentsControl of recordsCorrectionsCorrective actionsHandling potentially unsafe productWithdrawalsInternal audits Ramasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Section 5 Management ResponsibilityManagement commitmentFood Safety PolicyFood safety management system planningResponsibility and authorityRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

33Evidence of top management commitment includes the setting of awareness and leadership initiatives linked to the development and implementation of the system. By showing that food safety is supported by business objectives. By communicating the to the organization the importance of meeting the requirements i.e. of standard, statutory and regulatory & customer requirements related to food safety.

Section 5 Management ResponsibilityFood safety team leader

External communicationSuppliers and contractorsCustomers/consumersStatutory and regulatory authoritiesOther organizations

Internal communicationRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

34The purpose of any communication is to ensure that the necessary interactions occur.ISO 22000 requires that both external and internal communication takes place as part of the food safetymanagement system.External communication aims to exchange information in order to ensure that any relevant hazard is controlledat one step through the food chain by interaction, for example,a) up and down the food chain, for food safety hazard(s) that may not or cannot be controlled by theorganization and which consequently need(s) to be controlled at other steps in the food chain,b) with customers as the basis for mutual acceptance of the level of food safety required (by the customer),andc) with statutory and regulatory authorities and other organizations.External communication is the method whereby the organization and the external organization agree bycontract or other means upon the level of food safety required and on the capability of delivering to the agreedrequirements. Channels of communication with statutory and regulatory authorities and other organizationsshould be established as a basis for providing public acceptance of the level of food safety and for ensuring thereliability of the organization.Training of designated personnel in communication skills may be an important aspect as well.The internal communication system of the organization should ensure that sufficient and relevant informationand data are available to all personnel involved in the various operations and procedures. The food safety teamleader has a major role in the area of the internal communication of food safety issues within the organization.Communication to personnel within in the organization should be carried out in a clear and timely manner on thedevelopment and launch of new products, as well as intended changes in raw materials and ingredients,production systems and processes and/or customers and customer requirements. In particular, attention shouldbe given to the communication of changes in statutory and regulatory requirements, new or emerging foodsafety hazards, and the method of control of these new hazards.Any member of the organization seeing something which may have an impact on food safety should know howto report this event.

Section 6 Resource ManagementThe organization shall provide adequate resources for;

EstablishmentImplementationMaintenanceUpdating


Section 6 Resource ManagementHuman ResourceFood safety team and personnel impacting food safety External expertsCompetence, Awareness and TrainingInfrastructureBuildingsProcess equipmentUtilitiesSurrounding areasSupporting servicesRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

36The organization shall identify necessary competencies.Ensure that the requirement for effective communication is understood by all.Training should be maintained at a level that ensures that all employees know their responsibilities to maintainthe food safety management system. Details of training sessions should include, for example, programmecontent, name and qualifications of the trainer, final assessment of trainees, and establishment of therequirement for retraining.

Section 6 Resource ManagementWork Environment

Measures to prevent cross contaminationWork space requirementsProtective work wear requirementsAvailability and location of employee facilitiesRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Section 7 Planning and Realization of Safe ProductsThe organization shall plan and develop the processes needed for the realization of safe products

The organization shall implement, operate and ensure the effectiveness of the planned activities and any change to those activities including;

Pre-requisite programmes ( PRPs)Operational PRPs HACCP plan


Section 7 Planning and Realization of Safe ProductsPrerequisite programmes (PRPs)Preliminary steps to enable hazard analysisHazard analysisEstablishing the operational prerequisite programmes (PRPs)Establishing the HACCP planRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

HACCPConduct hazard analysis1.2. Determine critical control points (CCP)3. Establish4. Establish5. Establish6. Establish7. Establishcritical limitssystem to monitor control of CCPcorrective action verification procedures documentationRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

HACCP principle 1Conduct hazard analysisHazardA biological, chemical or physical agent in, or condition the potential to cause an adverse health effectof, food withHazard analysisThe process of collecting and evaluating information onhazards andconditions leading to their presence to decide which are significant tofood safety and therefore should be addressed in the HACCP planRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Tasksrequiredtoapply HACCP principle1 Ensure availability of allrequired expertise - multidisciplinary teamScope of HACCP plan decidedAssemble HACCP teamDescribe productIdentify intended useConstruct flow diagramOn-site confirmation of flow diagramList all potential hazards, conduct hazard analysisRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Tasksrequiredtoapply HACCP principle 1A full description of theproduct should be preparedAll relevant safety information should be reported including: composition, physical/ chemical characteristics, packaging, storage conditions, etc.Assemble HACCP teamDescribe productIdentify intended useConstruct flow diagramOn-site confirmation of flow diagramList all potential hazards, conduct hazard analysisRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

TasksrequiredtoapplyHACCP principle 1Specify expected use of the productWhere appropriate consider vulnerable groups of the populationAssemble HACCP teamDescribe productIdentify intended useConstruct flow diagramOn-site confirmation of flow diagramList all potential hazards, conduct hazard analysisRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Tasksrequiredtoapply HACCP principle1Flow diagram for processshould be constructed byHACCP teamThe flow diagram should cover all steps in the operationHACCP team should confirm the processing operation against the flow chartAssemble HACCP teamDescribe productIdentify intended useConstruct flow diagramOn-site confirmation of flow diagramList all potential hazards, conduct hazard analysisRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Conducting hazard analysisControl measureAny action or activity that can be used to preventoreliminateafoodsafetyhazardorreduceittoanacceptablelevelMoreathan one control measure maybe requiredto controlspecific hazard and more than one hazard may becontrolled by a specified control measure


HACCP principle 2Determine critical controlCritical control pointpoints (CCP)A step at which control can be applied andis essential to prevent oreliminate a food safety hazard or reduce it to an acceptable levelStepA point, procedure, operation or stage in the food chain, including raw materials, from primary production to final consumptionRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

ApplyingHACCPprinciple 2Determination of CCPs can be facilitated by application of decision treeThere may be more than one CCP at which control is applied to address the same hazardEstablish critical limitsDetermine critical controlpointsList all potential hazards,conduct hazard analysisRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

HACCP principle 3Establish critical limitsCritical limitAcriterionthatseparates acceptability fromunacceptabilityMaximum load:Maximum speed:1 tonne15 km/hIf you exceed thecritical limit ...The bridge will breakRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Critical limitsEstablishcritical limitsCritical limitA criterion that separates acceptability from unacceptabilityRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

ApplyingHACCPprinciple 3Critical limits must bespecified and validated for each CCPMore than one CL may be elaborated at aparticular stepCriteria commonly used include Aw, time, pH, temperature, etc.Critical limits are notnecessarily numericalEstablish a monitoring systemEstablish critical limits foreach CCPDetermine critical controlpointsRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

HACCP principle 4Establish system to monitor control of the CCPControlThe state wherein correct procedures are being followed and criteria are being metMonitorThe act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under controlRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

ApplyingHACCPprinciple 4Monitoring data should be evaluated by designated person with knowledge and authority to take actionFrequency of monitoring must be sufficient to ensure effective controlEstablish corrective actionsEstablish a monitoringsystemEstablish critical limits foreach CCPRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

HACCP principle 5Establish the corrective action to be taken when monitoringindicates that a particular CCP is not under controlCorrective actionAny action to be taken when the results of monitoring at the CCP indicate a loss ofcontrolRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

ApplyingHACCPprinciple 5Specific corrective actionsmust be developed for each CCP in the HACCP system in order to deal with deviations when they occurActions must ensure that the CCP has been brought under controlDeviation and product disposition procedures must be documentedEstablish verification proceduresEstablish correctiveactionsEstablish a monitoringsystemRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

HACCP principle 6Establish procedures for verification to confirm that theHACCP system is working effectivelyVerificationThe application of methods, procedures tests and other evaluations, in addition to monitoring, to determine compliance with the HACCP planRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

ApplyingHACCPprinciple 6Establish procedures, including random sampling and analysis to determine if the HACCP system isworkingcorrectly Validation should includeactions to confirm the efficacy of all elements in the HACCP planEstablish documentation systemsEstablish verificationproceduresEstablish correctiveactionsRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

HACCPprinciple7Establish documentation concerningall proceduresand records appropriate to these principles and their applicationRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

ApplyingHACCPprinciple 7Documentation and record keeping should be appropriate to the size and nature of the operation Documentation includes Hazard analysis; CCP and CLdetermination Records of CCP monitoring; Deviationsand corrective actionsEstablish documentation and record keeping systemsEstablish verificationproceduresRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

Planning of safe food


60The core element of the planning is the conduct of the hazard analysis to determine those hazards that need to be controlled (see 7.4.3 of ISO 22000:2005), the degree of control required to meet acceptable levels and the combination of control measures that can deliver this (see 7.4.4 of ISO 22000:2005). To enable this, preliminary steps are needed (see 7.3 of ISO 22000:2005) to furnish and organize relevant informationThe hazard analysis determines the appropriate control measures and permits their categorization into those that are to be managed by the HACCP plan and/or operational PRPs, respectively, and will assist in thesubsequent design of the details on how the measures are to be implemented, monitored, verified and kept updated (see 7.5 to 7.8 of ISO 22000:2005). ISO 22000 reorganizes the traditional concept of dividing control measures into two groups [prerequisites and measures applied at critical control points (CCPs)] in a logical order for the development, implementation and control of the food safety management system. Control measures are grouped into three groups. a) prerequisite programmes (PRPs) that manage the basic conditions and activities; the PRPs are notselected for the purpose of controlling specific identified hazards but for the purpose of maintaining ahygienic production, processing and/or handling environment (see 7.2 of ISO 22000:2005);b) operational prerequisite programmes (operational PRPs) that manage those control measures that thehazard analysis identifies as necessary to control identified hazards to acceptable levels, and which are not otherwise managed by the HACCP plan;c) a HACCP plan to manage those control measures that the hazard analysis identifies as necessary tocontrol identified hazards to acceptable levels, and which are applied at critical control points (CCPs).Purchased material; RM,PM, ingredients, chemicals.Supplies; water, air, steam and iceDisposals; waste and sewage.Handling of products; storage and transportationCategorization of control measures facilitates the application of different management strategies to each group with respect to validation, monitoring, and verification of measures to control nonconformities, includinghandling of resulting products

Traceability system: In developing the traceability system, consideration should be given to the activities of the organization thatmight impact on system complexity, such as the types of ingredient and their number, re-use of product, productcontact material, batch versus continuous production, aggregation. The organization should also giveconsideration to the extent of its traceability system to identify better any potentially unsafe products that mayneed to be withdrawn.The organization shall establish and apply a traceability system that enables the identification of product lots and their batches of RM, processing and delivery records

Decision treeRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

61Critical limits should be designed to ensure control of the food safety hazard(s) for which they have beendesignated. For CCPs intended to control more than one food safety hazard, the critical limit(s) should beestablished relative to each food safety hazard.

7.7 Updating PRPs and HACCP planThe organization shall update the following information;

Product characteristicsIntended useProcess stepsControl measuresHACCP planProcedures instructions specifying PRPsRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

7.8 Verification planningShall define the purpose, methods, frequencies and responsibilities for the verification activities

Output of planning suites to organizations method of operation

Verification results enables analysis of the result of verification activitiesRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

63Verification activities shall confirm that;PRPs are implemented.Input to the hazard analysis is continually updated.Operational PRPs and the elements within HACCP plan are implemented and effective.Hazard levels are within identified acceptable levels.Other procedures required by the organization are implemented and effective. The concepts of validation, verification and monitoring are often confused. Validation is an assessment prior to operation, the role of which is to demonstrate that individual (or a combination of) control measures are capable of achieving the intended level of control. Verification is an assessment carried out during and after the operation, the role of which is to demonstratethat the intended level of control has actually been achieved. Monitoring is a procedure to detect any failures in the control measure.The frequency of verification depends on the degree of uncertainty in the effect(s) of the control measure(s) applied relative to the determined acceptable level(s) of food safety hazard(s) or predetermined performance(s),as well as on the ability of the monitoring procedures to detect loss of control. Hence, the frequency required will depend on the uncertainties associated with the result of validation and the functioning of the control measure (e.g. process variability). For instance, where validation demonstrates that the control measure delivers a hazard control significantly higher than the minimum required to meet acceptable levels, verification of the effectiveness of that control measure may be reduced or might not be required at all.

7.9 Traceability systemThe system shall enables the identification of product lots and their relation to batches of raw material, processing and delivery records.

The system shall be able to identify incoming material from the suppliers and the initial distribution route of the product.Ramasubramanian.s +919952229598 Management consultant/Trainer/Auditor

64In developing the traceability system, consideration should be given to the activities of the organization that might impact on system complexity, such as the types of ingredient and their number, re-use of product, product contact material, batch versus continuous production, aggregation. The organization should also give consideration to the extent of its traceability system to identify better any potentially unsafe products that may need to be withdrawn. Further guidance will be given in ISO 22005.

7.10 Control of non conformityCorrectionsCorrective actionsHandling potentially unsafe productsEvaluation of releaseDisposition of Nonconforming productsWithdrawalsRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

65Corrections: the organization shall ensure that when critical limits for CCPs are exceeded, or there is a loss of control of operational PRPs, the products affected are identified and controlled with regard to their use and release.Documented procedure shall be established definingIdentification and assessment of affected products to determine their proper handling.A review of corrections carried out.Products manufactured under conditions where critical limits have been exceeded are potentially unsafe products and shall be handled in accordance with 7.10.3. products manufactured under conditions where operational PRPs have not been conformed with shall be evaluated with respect to cause(s) of the NCs and to the consequences thereof in terms of food safety and shall, where necessary be handled in accordance with 7.10.3. Records.All corrections shall be approved by the responsible person(s) and shall be records together with information on the nature of the NC, its cause, consequence(s), including information needed for traceability purposes related to the NC lots.Data derived from the monitoring of PRPs and CCPs shall be evaluated by the designated person with sufficient knowledge and authority to initiate CAs.CAs shall be initiated when critical limits are exceeded or when there is lack of conformity with operational PRPs.Documented procedure that specify appropriate actions to identify and eliminate the cause of detected NCs, to prevent recurrence and to bring the process or system back into control after NC is encountered. these include;Reviewing NCs, reviewing trends in monitoring results that may indicate development towards loss of control, determining the cause of NCs, evaluating the need for action to ensure that NC do not recur, determining and implementing the actions needed, recording the results of actions taken, and reviewing CAs to ensure that they are effective.NC product shall handled such to prevent entering it into food chain unless;Food safety hazard of concern have been reduced to defined acceptable levels, or will be reduced to the defined acceptable level prior to entering into food chain, or the product still meets the limits of food safety hazard despite NC.The organization shall notify the interested parties and initiate withdrawal if a unsafe product left the control of the organization. NC product may only be released if the evidences; demonstrate that control measures have been effective, that the combined effect of the control measures for that particular product complies with the performance intended use or identified acceptable levels, through results of sampling, analysis and other verification activities that the affected lot of product complies with the identified acceptable levels. Disposition: reprocess to ensure that food safety hazard is eliminated or reduced, destruction and/or disposal as waste.Authorize personnel only to initiate the withdrawal and execution, documented procedure for notification, handling of withdrawn products and sequence of actions to be taken.The cause extent and results of withdrawal and effectiveness of the withdrawal programme shall be recorded

Validation, Verification and ImprovementThe food safety team shall plan and implement the processes needed to validate control measures, its combination, and to verify and improve the FSMS.

Validation of control measure combination

Control of monitoring and measuringRamasubramanian.s +919952229598 Management consultant/Trainer/Auditor

66The requirements in Clause 8 of ISO 22000:2005 address those activities that are needed to demonstrate that the food safety management system, as designed, is reliable, is able to deliver and actually delivers the level of control that is expected of it. It is the responsibility of the organization's management to make certain that the food safety management system is designed to produce the desired controls, is operated as designed, and is updated as new information is provided. The food safety management system should be developed using sound scientific principles. The means tocollect the necessary information for the system design can usually be obtained from academic institutions, regulatory agencies, trade associations, consultants, or any party that has educated expertise in the food process and product. Once the control measure combination is designed on paper, it must be validated.The validation process provides assurance that the combination will deliver products that meet identified acceptable levels. The validation usually includes such activities asa) reference to validations carried out by others, to scientific literature, or to historical knowledge,b) experimental trials to simulate process conditions,c) biological, chemical and physical hazard data collected during normal operating conditions,d) statistically designed surveys,e) mathematical modelling, andf) use of a guide approved by competent authorities.If relying upon validations carried out by others, care should be taken to ensure that the conditions of the intended application are consistent with those identified in the referenced validations. Generally accepted industrial practices may be used. Scaling up of laboratory-based experimental trials in a pilot plant may be required to ensure that the trials properly reflect actual processing parameters and conditions. Intermediate and/or finished product sampling and testing based on the use of statistical sampling plans and validated testing methodology may be used. Validations may be conducted by external parties, and microbiological or analytical testing can effectively be used to verify that a process is in control and that acceptable product is being produced. If additional control measures, new technology or equipment, changes in the control measures, product (recipe) changes, identification of new or emerging hazards or changes in their frequency of occurrence, or unexplained failures of the system occur, revalidation of the system might be necessary.Validation: Prior to implementation of control measures to be included in PRPs and HACCP plan and any change therein; the capability of achieving the intended control of the designated hazards, and that the control measures are effective and capable of ensuring the control of identified food safety hazards to obtain end products that meet acceptable levels.Control measures and/or its combinations shall be modified and reassessed if previously mentioned elements are not conformed through validation results.The concept of calibration is complex and can depend on the type of process, type of equipment and how prone they are to loose calibration. Thermometers and metal detection units are commonly used in the food industry and can be used as examples. Calibration of thermometers may differ depending ona) the type of thermometer,b) the degree of accuracy needed, or c) the thermometer range over which the thermometer will operate.Thermometers should be checked against a traceable reference thermometer. Electronic thermometers can be adjusted, whilst mercury thermometers should be labelled with the deviation from the reference. It may be sufficient to calibrate annually or biannually. Metal detection units can be verified or calibrated by the use of metal dummies with a known topography/mass/iron content and adjusted on site. The frequency of verification/calibration can be substantially higher than for thermometers due to unit stability and changes in the monitored product (e.g. moisture content).Optimal calibration frequency depends on the type, condition and past performance of the monitoring instrument. ISO/IEC 17025 gives further guidance on inter calibration surveys and other laboratory quality assurance techniques.Verification of the food safety management system assures that it is functioning as designed and is updatedbased upon currently available information. A food safety system that is functioning properly minimizes the need for extensive product sampling and testing. Verification occurs in two stages that may be loosely classified asongoing and periodic.Ongoing activities use methods, procedures or tests separate from, and in addition to, those used in monitoringof the system. Verification reports should include information about the system, the persons administering and updating it, the status of records associated with monitoring activities, certification that monitoring equipment is properly calibrated and in working order, and results of records review and any samples analysed.Training records of the personnel should be reviewed and the results should be documented as well.A schedule of verification activities is developed as part of the food safety management system (plannedaccording to 7.8 and evaluated according to 8.4.2 of ISO 22000:2005). This schedule should include theprocedures or methods to be utilized, the frequency and the person(s) responsible for performing the activity.Examples of verification activities that should be considered as part of the system include reviewing monitoring records, reviewing deviations and their resolution or corrective action, including the handling of affected product, calibrating thermometers or other critical measuring equipment, visually inspecting operations to observe if control measures are under control, analytically testing or auditing monitoring procedures, randomly collecting and analysing samples of in-process or end product, sampling for environmental and other concerns, and reviewing consumer or customer complaints to determine whether they relate to the performance of the control measures or reveal the existence of unidentified and/or need for additional control measures. When conducting internal audits (see 8.4.1 of ISO 22000:2005) for these verification activities, sound audit principles should be observed. Auditors should be competent to perform the audit. They should be independent of the work or processes being audited, although they may be from the same work area or department. For example, in a small business where there might be only one or two people in the management structure, this requirement may not be achievable. It is suggested that, in such cases, in carrying out the duties of an auditor, the manager tries to step back from direct involvement in the business operations and to be very objective about the audit. Another approach might be to seek the cooperation of another small business and each provide the internal audit for the other. This can prove attractive if there are good relations between the two businesses. Alternatively, external parties (e.g. chamber of commerce, consultant, inspection agencies) might be able to provide independent auditors. The periodic verification activities involve the overall assessment of the system (see 8.4.3 of ISO 22000:2005). This is usually performed during a management or verification team meeting, and all the above evidence over a period of time is reviewed to ascertain if the system is functioning as planned and if updating or improvement is necessary. Notes of the meeting should be kept and should include any decisions made regarding the system. At a minimum, verification of the entire system in this manner should take place on an annual basis.Organization ensures continual improvement through the use of communication, management review, internal audits, evaluation of individual verification results, analysis of results of verification activities, validation of control measure combinations, corrective actions and FSMS updating, use of ISO 9004 as guide.Updating the FSMS: shall evaluate the FSMS at planned intervals, activitied shall be based on; Input from external and internal communication, input from other information concerning the suitability, adequacy and effectiveness of the FSMS, output from the analysis of results of verification activities, output from management review. System updating activities shall use as input to the management review.

Validation, Verification and ImprovementFSMS verificationInternal auditsEvaluation of individual verification resultsAnalysis of results of verification activities

Improvement

Updating the Food safety management system


FSMS Overview


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Industrial emissionsand effluents

Landfills

Vehicleemission

Agriculturalpractices

Processing

Storage

CookingLivestock

Crops

Seafood

Distribution

Retail

Continuous ImprovementContinuous Improvement

DefineDefine

HACCP &PRPPlans

ApproveApproveProcedures

ImplementImplement

Safe products,Records

ReviewReview

Improvements

StudyList pot. hazardsHazard AnalysisList significant haz. CCP (& CPs)MonitoringCritical LimitsCorrective actionsValidationList verification act.

Approval:(NOT VALIDATION)Monitoring(Prerequisites)Contr. meas.ModificationsCorr. actionsVerificationVerif. mation

ImplementationTrainingAwarenessInformationPrerequisitesControl MeasuresMonitoringCorrective actionsRecording

VerificationConfirm compliance (HACCP & Prerequis.)Review the studyReview resultsReview recordsReview changesReview of validation dataGather Int. & Ext. Inf.

ChangeChange