ISO 22000 & HACCP

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ISO 22000 & HACCP Hazard Analysis Critical Control Point HACCP PRINCIPLES Conduct a hazard Analysis Identify Critical Control Points (CCP) Establish critical limits for CCP Establish Monitoring procedures Establish Corrective Actions Establish Recordkeepi ng Establish Verificatio n Procedures Key element s of ISO Interacti ve communica tion System managem ent Prerequ isite program HACCP Princip les 1

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Transcript of ISO 22000 & HACCP


ISO 22000 & HACCPHazard Analysis Critical Control Point


Contents:Introduction to ISO 22000ScopeTerms and definitionFood safety management systemsManagement responsibilityResource managementPrerequisite programsHACCP2

ISO 22000

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies.The international standard specifies the requirements for a Food Safety Management System (FSMS).Aim of ISO 22000: To harmonize the requirement for FSMS for businesses within the food chain on a global scale ISO Combines key elements Ensure safety along the food chain, up to the point of final consumption.


ISO 22000 Has been aligned with ISO 9001 in order to enhance the compatibility of the two standards.Can be applied independently of other management system standards.Integrates the principles of the Hazard Analysis and Critical Control Point (HACCP). It combines the HACCP plan with Prerequisite Programs (PRPs) by means of auditable requirements.Has been developed as an auditable standards Facilitate the application of this International Standard.

1) Scope: Regardless of size.It is applicable to all organizations Involved in any aspect of food chain. Implement systems that provide safe products.

ISO 22000


International Standard specifies requirements to enable an organization to:

ISO 220005

TermsDefinitionFood safetyConcept that food will not cause harm to the consumer.Food ChainSequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients.Food Safety HazardBiological, Chemical or physical agent in food, or condition of food with the potential to cause an adverse health effect.Food safety PolicyOverall intentions and direction of an organization related to food safety.End productProduct that will undergo no further processing or transformation by the organization.Glow DiagramSchematic and systematic presentation of the sequence and interactions of steps.Control MeasureAction or activity that can be used to prevent or eliminate a food safety hazard.PRP prerequisite programBasic conditions and activities that are necessary to maintain a hygienic environment.MonitoringConducting a planned sequence of observations or measurements to assess whether control measures are operation as intended.CorrectionAction to eliminate a detected nonconformity.Corrective actionAction to eliminate the cause of a detected nonconformity or other undesirable situation.ValidationObtaining evidence that the control measures managed by the HACCP plan and by the Operational PRPs are capable of being effective.VerificationConfirmation through the provision of objective evidence that specified requirements have been fulfilled.UpdatingImmediate or planned activity to ensure application of the most recent information.

2) Terms and Definitions6

3) Food Safety Management SystemGeneral RequirementsEnsure that food safety hazards are identified, evaluated and controlled.Communicate appropriate information throughout the food chain regarding safety issues.Communicate information concerning development, implementation and updating of food safety management.Evaluate FSM periodically and update when necessary.Documentation RequirementsDocumented statements of a food safety policy and related objectives.Documented procedures and record required by this international standard.Document needed by organization to ensure the effective development, implementation and updating of FSMS.Control of DocumentsApprove documents for adequacy prior to issue.Review and update documents as necessary and re-approve documents.Ensure that changes and revision status of documents are identified.Ensure that relevant versions of applicable documents are available at points of use.Ensure that documents remains legible and readily identifiable.Prevent unintended use of obsolete documents. Control of RecordsEstablished and maintained to provide evidence of conformity to requirements and evidence of the effective operation of FSM.


4) Management responsibility



5) Resource Management10Human Resources:

The Organization shall implement, operate and ensure the effectiveness of the planned activities and any changes to those activities. This Include PRP and HACCP.

6) Planning and Realization of Safe Product1) Premises (Out side property, Building, Sanitary facilities)

2) Transportation, Purchasing, Receiving, Shipping and Storage

3) Equipment (Design, Maintenance)

4) Personnel (Training, General food hygiene program )

5) Sanitation and Pest Control

6) Recall

7) Operational Prerequisite Programs (Allergens, Nutrients, Food Additives and Processing Aids)


HACCP This is a preventative food safety system in which every step in the manufacture, storage and distribution of a food product is scientifically analyzed for microbiological, physical and chemical hazards.Most important aspect Is a preventive system rather than inspection system

Major components of HACCP 1. HA The Logic in Hazard analysis Identifies where and how of hazard Make product 2. CCP The Critical Control Points as safe as Provide the control of the process Possible and the proof of the control7) HACCP Plan


Types of Food Safety Hazards Controlled by HACCP System:

Biological HazardsCaused by micro-organisms Bacteria: Salmonella in chicken and eggs, E. coli in beef, VP in seafood. Viruses : Hepatitis in water, Norovirus in Shellfish. Parasites: Cryptosporidium and Cyclospora in water.

Often associated with the failure of process step (Pathogen survival due to improper time/temperature applications during pasteurization).


B) Chemical HazardsInclude those caused by substances/ molecules that : 1) Naturally derived from Plants or animals. 2) Intentionally added to the food during food processing (Sodium Nitrite, Pesticides). 3) Contaminate the food accidentally (Cleaning chemicals). 4) Cause some individuals experience an immune system response (Allergens).

C) Physical HazardsInclude substances not Normally found in food which can cause physical injury to consumer.HACCP


History of HACCPDeveloped by the Pillsbury Company.While working on producing foods for NASA.First represented to public in 1971 National Conference of Food Protection.

Benefits of HACCPFormally incorporates food safety principles as integral steps of production.Increased employees ownership of the production of safe food.Increased buyer and consumer confidence.Maintaining or increasing market access.Reduced waste.HACCP


Frist step of HACCP system is writing a plan

A team of individuals from within the company+Some assistance from outside expert

Conduct five preliminary steps and applies the seven HACCP principlesHACCP


Preliminary steps of HACCP1) Bring together the HACCP ResourcesAssemble Team

HACCP coordinator should have overall responsibility for the HACCP program.17

Preliminary steps of HACCP2) Describe Product and identify its intended use


3) Develop a Complete List of Ingredients and Raw MaterialsComposition of formulated ingredients.Additives Processing aids and incoming materials that come in contact with the product or are used in preparing the product.4) Develop a Process Flow and Plant Schematic Diagram and Confirm its AccuracyFlow diagrams shall be clear, accurate and sufficiently detailed.Should Contain:The sequence and interaction of all steps in the operation from receiving to final shipping.The introduction of ingredients and intermediate products into the process flow. The introduction of product for reworking.

5) Meet the Regulatory Requirements for SanitationGood Sanitation is the basic way to ensure that a safe product is Produced.Shows the plant has the commitment and the source to implement the HACCP plan. Preliminary steps of HACCP

Pasteurization process flow19

1) Identify and Analyze HazardsPreparing list of HazardsDescribe control measures

HACCP PrinciplesProcess Step Hazards introduced or enhanced at this stepShould the hazard be addressed in the HACCP plan?Control measures to prevent the hazardReceptionB:Contamination with vegetative pathogensC: Cleaning and sanitizing residuesP: Gasket materials B: Yes C: YesP: YesTruck unloading should be constructed to protect the milk.

PasteurizationB: Survival of vegetative pathogens C:Cleaning & Sanitizing Solution Residues B: YesC: YesP: NoConstruction, operation and testing of pasteurization equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance.


Purpose of Hazard Analysis:Identify significant hazards and control measures.Use to modify a process or products to further assure or improve safety.Basis for determining Critical Control Points (CCP).

Hazard Analysis Series of questions to determine factors that affect the safety of the product. Questions vary depending on product and process.

HACCP PrinciplesFor each hazard identified, an analysis shall be conducted to determine: The likely occurrence of the hazard; The severity of possible adverse health effect associated with the hazard; If the identified hazard is controlled by prerequisite programs; If the identified hazard is partially controlled by a process control; If the identified hazard is controlled at a CCP; If the identified hazard is out of the establishments control21

2) Identifying the Critical Control Points (CCP)Critical Control Point:A point, step, or procedure at which control can be applied and hazard can be prevented, eliminated, or reduced to acceptable levels . Metal detection after packaging. pH drop during fermentation.HACCP PrinciplesThe HACCP team should utilize the decision tree to evaluate each point where hazards can be prevented or eliminated. 22

3) Establishing Critical LimitsCritical Limits: The maximum or minimum value to which a physical, biological, or chemical food hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.For each CCP, a critical limit is established to see whether a CCP is in or out of control.Parameters of CCP: Time, Temperature, Water activity (Aw), pH, Salt concentration, Weight and Visual evaluationAre already established for many Critical Control Points in the USDA regulations.For each Critical Control Point :Determine if there is a regulatory critical limit (or find one based on scientific evidence.) If theres no regulatory critical, you may have to obtain assistance from outside HACCP experts.File letters or other documentation for critical limits you had to determine (for validation).HACCP Principles23

4) Monitoring critical LimitsMeasurements or observations for each CCP assess whether: The control measure is functioning as intended; The critical limits are met.HACCP PrinciplesWho will conduct monitoring?Each CCP must be Monitored by a Specific Individual (Line supervisors, QC personnel, selected line workers, Maintenance)Must be trained, understand the purpose of monitoring, unbiased in monitoring and reportingReport unusual occurrence immediately and take corrective actionWhat will be monitored?Determine if the process is operating within the established critical limits.When will it be monitored?Continuous (Ideal):Time/Temp, pH of Batch, equipment calibration Discontinuous:Establish monitoring intervalsStatistically designed data collectionSelect the worst caseSelect the best (when variation is low)Random Checks (useful for supplementing monitoring)


5) Deviation and Corrective actionsDeviations in a CCP will result in actual or potential hazard to the customer.Actions must be taken to eliminate the hazard.HACCP requires that immediate corrective actions is already assigned and the CCP will be brought back into control before production continues.

HACCP PrinciplesCorrective actionsThe cause of the deviation is identified and eliminated.The CCP will be under control after the corrective action is taken.Measures to prevent recurrence are established.(Time, flow rate, humidity, pressure)No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.Records of corrective actions must be maintained.


An individual knowledgeable in CCP control must have the authority to make quick decisions on the production floor. The individual responsible for the action must record on the CCP data sheet what action was taken and by whom.

HACCP PrinciplesCCP Data SheetCCP#Pasteurization filter inspectionHACCP Plan NoMonitoring procedureVisually inspect the filter to ensure it is intactFrequency of monitoring2x daily at startup and shutdownCorrective actionReplace the filter and contact the operations manager regarding holding of productDate and time1/3/2016ResultFilter was not intactAction takenFilter was replaced and operation manager was informed.Signature


6) Validation, Verification and reassessmentEvery establishment shall validate the HACCP Plans adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.

A) Validation:The element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.

Validation objective: 1) Provide an evaluation of the HACCP plan to determine if the plan will control food safety hazards. 2) Initial evaluations are needed before implementation of the HACCP plan. 3) On a periodic basis after implementation of the HACCP plan Reassessment (Once per year or after changes in process)

HACCP Principles27

B) Verification:Purpose of Verification:1) Determine if the HACCP plan is implemented. 2) Determine if Operations are in Compliance with HACCP Plan.

C) Reassessment Is a thorough review of hazard analysis to address specific hazards to determine if they are controlled.Purpose of Reassessment:1) Is the HACCP Plan Still Controlling Hazards?Reasons to Conduct Re-validation or Reassessment:

HACCP PrinciplesNew safety information becomes AvailableThe food Item you produce is linked to an Outbreak. New scientific or technical literature

Regulatory agency alerts related to the product or processRecalls or product withdrawals


7) Establish effective record keeping procedures that document the HACCP system Records shall be kept to demonstrate the effective application of the critical control points and to facilitate official verifications by competent authority.Types of recordA)The HACCP Plan:

B) Records obtained during operation of plan:

C) Supportive Documentation HACCP PrinciplesList of HACCP team Establishing Critical Limits Product limit Description Flow Diagram Monitoring system Corrective actions Flow Diagram plans Identification of Hazards plans Record keeping procedures Establishing CCPs Procedures for verification

Daily CCP Records Calibration records Calibration records Employee Training Records Validation of HACCP Plan

GMPSOPData to support Critical LimitsTesting Methods for measuring CL