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ISO 22000 & HACCP
Hazard Analysis Critical Control Point
HACCP
PRINCIPLES
Conduct a
hazard
Analysis
Identify
Critical
Cont...
Contents:
 Introduction to ISO 22000
 Scope
 Terms and definition
 Food safety management systems
 Management respons...
ISO 22000
• The International Organization for Standardization (ISO) is a worldwide federation of national standards
bodie...
ISO 22000
• Has been aligned with ISO 9001 in order to enhance the compatibility of the two standards.
• Can be applied in...
International Standard specifies requirements to enable an organization to:
ISO 22000
Plan, implement, operate, maintain a...
Terms Definition
Food safety Concept that food will not cause harm to the consumer.
Food Chain Sequence of the stages and ...
3) Food Safety Management System
General
Requirements
Ensure that food safety hazards are identified, evaluated and contro...
4) Management responsibility
Management
commitment
• Food safety is supported by the business objectives.
• Communicating ...
Food safety
team leader
• Manage a food safety team and organize work.
• Ensure relevant training and education of the foo...
5) Resource Management
General
• Competent and educated personnel.
• Available records and agreement in case of external a...
• The Organization shall implement, operate and ensure the effectiveness of the planned activities and any
changes to thos...
HACCP
• This is a preventative food safety system in which every step in the manufacture, storage and distribution
of a fo...
Types of Food Safety Hazards Controlled by HACCP System:
A) Biological Hazards
• Caused by micro-organisms Bacteria: Salmo...
B) Chemical Hazards
• Include those caused by substances/ molecules that :
1) Naturally derived from Plants or animals.
2)...
History of HACCP
• Developed by the Pillsbury Company.
• While working on producing foods for NASA.
• First represented to...
Frist step of HACCP system is writing a
plan
A team of individuals from within the company
+
Some assistance from outside ...
Preliminary steps of HACCP
Bring together the HACCP
resources/assemble the HACCP team.
Company should bring together as
mu...
Preliminary steps of HACCP
Process/Product Common
Name:
Generic or common name
of the product family or
process covered
Pr...
3) Develop a Complete List of Ingredients and Raw Materials
• Composition of formulated ingredients.
• Additives
• Process...
1) Identify and Analyze Hazards
• Preparing list of Hazards
• Describe control measures
HACCP Principles
Process Step Haza...
Purpose of Hazard Analysis:
1. Identify significant hazards and control measures.
2. Use to modify a process or products t...
2) Identifying the Critical Control Points (CCP)
Critical Control Point:
A point, step, or procedure at which control can ...
• 3) Establishing Critical Limits
• Critical Limits: The maximum or minimum value to which a physical, biological, or chem...
4) Monitoring critical Limits
Measurements or observations for each CCP assess whether:
• The control measure is functioni...
5) Deviation and Corrective actions
• Deviations in a CCP will result in actual or potential hazard to the customer.
• Act...
• An individual knowledgeable in CCP control must have the authority to make quick decisions on the production
floor.
• Th...
6) Validation, Verification and reassessment
• Every establishment shall validate the HACCP Plan’s adequacy in controlling...
B) Verification:
Purpose of Verification:
1) Determine if the HACCP plan is implemented.
2) Determine if Operations are in...
• 7) Establish effective record keeping procedures that document the HACCP system
• Records shall be kept to demonstrate t...
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ISO 22000 & HACCP

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Introduction to ISO 22000 & HACCP

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ISO 22000 & HACCP

  1. 1. 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 Recordkeeping Establish Verification Procedures Key elements of ISO Interactive communicat ion System managem ent Prerequis ite program HACCP Principle s 1
  2. 2. Contents:  Introduction to ISO 22000  Scope  Terms and definition  Food safety management systems  Management responsibility  Resource management  Prerequisite programs  HACCP 2
  3. 3. 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. Key elements of ISO Interactive communicatio n System managemen t Prerequisit e program HACCP Principles Based on Codex Allimentarus 3
  4. 4. 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 4
  5. 5. International Standard specifies requirements to enable an organization to: ISO 22000 Plan, implement, operate, maintain and update FSMS in order to provide safe food to consumers. Demonstrate compliance with applicable statutory and regulatory food safety requirements. Ensure that the organization conforms to its stated food safety policy. Evaluate and assess costumer requirements and demonstrate conformity with those mutually agreed  costumer satisfaction. Effectively communicate food safety issues. Ensure that the organization conforms to its stated food safety policy and demonstrate it to relevant interested parties. Seek certification and registration of its food safety management system (external organization or self assessment). 5
  6. 6. Terms Definition Food safety Concept that food will not cause harm to the consumer. Food Chain Sequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients. Food Safety Hazard Biological, Chemical or physical agent in food, or condition of food with the potential to cause an adverse health effect. Food safety Policy Overall intentions and direction of an organization related to food safety. End product Product that will undergo no further processing or transformation by the organization. Glow Diagram Schematic and systematic presentation of the sequence and interactions of steps. Control Measure Action or activity that can be used to prevent or eliminate a food safety hazard. PRP prerequisite program Basic conditions and activities that are necessary to maintain a hygienic environment. Monitoring Conducting a planned sequence of observations or measurements to assess whether control measures are operation as intended. Correction Action to eliminate a detected nonconformity. Corrective action Action to eliminate the cause of a detected nonconformity or other undesirable situation. Validation Obtaining evidence that the control measures managed by the HACCP plan and by the Operational PRPs are capable of being effective. Verification Confirmation through the provision of objective evidence that specified requirements have been fulfilled. Updating Immediate or planned activity to ensure application of the most recent information. 2) Terms and Definitions 6
  7. 7. 3) Food Safety Management System General Requirements Ensure 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 Requirements Documented 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 Documents Approve 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 Records Established and maintained to provide evidence of conformity to requirements and evidence of the effective operation of FSM. 7
  8. 8. 4) Management responsibility Management commitment • Food safety is supported by the business objectives. • Communicating the importance of meeting the requirements to the organization. • Establishing the food safety policy. • Conducting management reviews. • Ensuring the availability of resources. Food safety policy • Is appropriate to the role of the organization in the food chain. • Conforms with both statutory and regulatory requirements and with mutually agreed food safety requirements of customers. • Is communicated, implemented and maintained at all levels of organization. • Is reviewed for continued suitability. • Adequately addresses communication. Food Safety System planning • Planning of the food safety management system is carried out to meet requirements. • Integrity of food safety management system is maintained. 8
  9. 9. Food safety team leader • Manage a food safety team and organize work. • Ensure relevant training and education of the food safety team members. • Ensure that food safety management system is established, implemented and updated. • Report to top management on effectiveness and suitability of the FSMS. Communication • External communication: suppliers and contactors, costumers and consumers, statutory and regulatory authorities and Other organization. • Internal communication: communicating with personnel about changes to each aspect of food plant. Management Review • General Include assessing opportunities for improvement and the need for change to the FSM. • Review input Information on follow-up actions, analysis of results, emergency situations, reviewing results of system-updating, external audits or inspections. • Review output Assurance of food safety, improvement of effectiveness of FSMS, resource need, revision of the organization’s food safety policy. Emergency response • Establish, manage, implement and maintain procedures to manage potential emergency situations. 9
  10. 10. 5) Resource Management General • Competent and educated personnel. • Available records and agreement in case of external assistance. Competence, Awareness and Training • Identify necessary competence. • Provide training. • Ensure personnel are trained. • Ensure personnel are aware of relevance and importance of their activities. • Maintain appropriate records. Infrastructure • Resources for establishment and maintenance of infrastructure should be provided by organization. Work Environment • Resources for establishment and maintenance of work environment should be provided by organization. 10 Human Resources:
  11. 11. • 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 Product PRP • Assist in controlling the likelihood of introducing food safety hazards to the product through the work environment and operational practices. • Reflect the current work environment and operational practices within comply with specific commodity policies, manuals, procedures and associated regulations. • 7 prerequisite programs. 1) 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) 11
  12. 12. 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 control 7) HACCP Plan 12
  13. 13. Types of Food Safety Hazards Controlled by HACCP System: A) Biological Hazards • Caused 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). HACCP SalmonellaHepatitisCryptosporidium 13
  14. 14. B) Chemical Hazards • Include 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 Hazards • Include substances not Normally found in food which can cause physical injury to consumer. HACCP 14
  15. 15. History of HACCP • Developed by the Pillsbury Company. • While working on producing foods for NASA. • First represented to public in 1971 National Conference of Food Protection. Benefits of HACCP • Formally 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 15
  16. 16. 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 principles HACCP HACCP PRINCIPLES Conduct a hazard Analysis Identify Critical Control Points (CCP) Establish critical limits for CCP Establish Monitoring procedures Establish Corrective Actions Establish Recordkeep ing Establish Verification Procedures 16
  17. 17. Preliminary steps of HACCP Bring together the HACCP resources/assemble the HACCP team. Company should bring together as much knowledge as possible. Assemble written materials and company documents that relate to food safety. Assemble a team of individuals that represent different segments. Team should be multi-disciplinary and represent all areas of plant. 1) Bring together the HACCP Resources Assemble Team HACCP coordinator should have overall responsibility for the HACCP program. 17
  18. 18. Preliminary steps of HACCP Process/Product Common Name: Generic or common name of the product family or process covered Product Name: Brand name and/or common name of the individual products Important product characteristics: Physio-chemical characteristics Intended use : Ready-to-Eat food product, ready-to-cook, for further processing Packaging Intended shelf life and storage conditions Where the product will be sold Labelling instructions related Special distribution control 2) Describe Product and identify its intended use 18
  19. 19. 3) Develop a Complete List of Ingredients and Raw Materials • Composition 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 Accuracy • Flow diagrams shall be clear, accurate and sufficiently detailed. • Should Contain: 1. The sequence and interaction of all steps in the operation from receiving to final shipping. 2. The introduction of ingredients and intermediate products into the process flow. 3. The introduction of product for reworking. 5) Meet the Regulatory Requirements for Sanitation • Good 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 flow 19
  20. 20. 1) Identify and Analyze Hazards • Preparing list of Hazards • Describe control measures HACCP Principles Process Step Hazards introduced or enhanced at this step Should the hazard be addressed in the HACCP plan? Control measures to prevent the hazard Reception B:Contamination with vegetative pathogens C: Cleaning and sanitizing residues P: Gasket materials B: Yes C: Yes P: Yes Truck unloading should be constructed to protect the milk. Pasteurization B: Survival of vegetative pathogens C:Cleaning & Sanitizing Solution Residues B: Yes C: Yes P: No Construction, operation and testing of pasteurization equipment must conform to all of the requirements of the Grade A Pasteurized Milk Ordinance. 20
  21. 21. Purpose of Hazard Analysis: 1. Identify significant hazards and control measures. 2. Use to modify a process or products to further assure or improve safety. 3. Basis for determining Critical Control Points (CCP). Hazard Analysis 1. Series of questions to determine factors that affect the safety of the product. 2. Questions vary depending on product and process. HACCP Principles For 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 establishment’s control 21
  22. 22. 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 Principles The HACCP team should utilize the decision tree to evaluate each point where hazards can be prevented or eliminated. 22
  23. 23. • 3) Establishing Critical Limits • Critical 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 evaluation • Are already established for many Critical Control Points in the USDA regulations. • For each Critical Control Point : 1. Determine if there is a regulatory critical limit (or find one based on scientific evidence.) 2. If there’s no regulatory critical, you may have to obtain assistance from outside HACCP experts. 3. File letters or other documentation for critical limits you had to determine (for validation). HACCP Principles 23
  24. 24. 4) Monitoring critical Limits Measurements or observations for each CCP assess whether: • The control measure is functioning as intended; • The critical limits are met. HACCP Principles Who 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 reporting Report unusual occurrence immediately and take corrective action What 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 intervals • Statistically designed data collection • Select the worst case • Select the best (when variation is low) Random Checks (useful for supplementing monitoring) 24
  25. 25. 5) Deviation and Corrective actions • Deviations 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 Principles Corrective actions The 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. 25
  26. 26. • 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 Principles CCP Data Sheet CCP# Pasteurization filter inspection HACCP Plan No Monitoring procedure Visually inspect the filter to ensure it is intact Frequency of monitoring 2x daily at startup and shutdown Corrective action Replace the filter and contact the operations manager regarding holding of product Date and time 1/3/2016 Result Filter was not intact Action taken Filter was replaced and operation manager was informed. Signature 26
  27. 27. 6) Validation, Verification and reassessment • Every establishment shall validate the HACCP Plan’s 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 Principles 27
  28. 28. 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 Principles • New safety information becomes Available • The food Item you produce is linked to an Outbreak. • New scientific or technical literature • Regulatory agency alerts related to the product or process • Recalls or product withdrawals 28
  29. 29. • 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 record A)The HACCP Plan: B) Records obtained during operation of plan: C) Supportive Documentation HACCP Principles • List 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 • GMP • SOP • Data to support Critical Limits • Testing Methods for measuring CL 29

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