ISO 22000 & HACCP
Hazard Analysis Critical Control Point
Introduction to ISO 22000
Terms and definition
Food safety management systems
• The International Organization for Standardization (ISO) is a worldwide federation of national standards
• 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
• ISO Combines key elements Ensure safety along the food chain, up to the point of final consumption.
• 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
• Has been developed as an auditable standards Facilitate the application of this
1) Scope: Regardless of size.
• It is applicable to all organizations Involved in any aspect of food chain.
Implement systems that provide safe products.
International Standard specifies requirements to enable an organization to:
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
Effectively communicate food safety issues.
Ensure that the organization conforms to its stated
food safety policy and demonstrate it to relevant
Seek certification and registration of its food safety
management system (external organization or self
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
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
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
3) Food Safety Management System
Ensure that food safety hazards are identified, evaluated and controlled.
Communicate appropriate information throughout the food chain regarding safety
Communicate information concerning development, implementation and updating of
food safety management.
Evaluate FSM periodically and update when necessary.
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
4) Management responsibility
• 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.
• 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.
• Planning of the food safety management system is carried out to meet requirements.
• Integrity of food safety management system is maintained.
• 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.
• 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.
• 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.
• Establish, manage, implement and maintain procedures to manage potential emergency situations.
5) Resource Management
• Competent and educated personnel.
• Available records and agreement in case of external assistance.
• Identify necessary competence.
• Provide training.
• Ensure personnel are trained.
• Ensure personnel are aware of relevance and importance of their
• Maintain appropriate records.
• Resources for establishment and maintenance of infrastructure should
be provided by organization.
• Resources for establishment and maintenance of work environment
should be provided by organization.
• 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
• Assist in controlling the likelihood of
introducing food safety hazards to
the product through the work
environment and operational
• Reflect the current work environment
and operational practices within
comply with specific commodity
policies, manuals, procedures and
• 7 prerequisite programs.
1) Premises (Out side property, Building,
2) Transportation, Purchasing, Receiving,
Shipping and Storage
3) Equipment (Design, Maintenance)
4) Personnel (Training, General food
hygiene program )
5) Sanitation and Pest Control
7) Operational Prerequisite Programs
(Allergens, Nutrients, Food Additives and
• 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
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
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.
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.
Frist step of HACCP system is writing a
A team of individuals from within the company
Some assistance from outside expert
Conduct five preliminary steps and applies the
seven HACCP principles
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
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
HACCP coordinator should have overall
responsibility for the HACCP program.
Preliminary steps of HACCP
Generic or common name
of the product family or
Brand name and/or
common name of the
Intended use :
for further processing
Intended shelf life and
Where the product will
2) Describe Product and identify its intended use
3) Develop a Complete List of Ingredients and Raw Materials
• Composition of formulated ingredients.
• Processing aids and incoming materials that come in contact with the product or are used in preparing the
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
1) Identify and Analyze Hazards
• Preparing list of Hazards
• Describe control measures
Process Step Hazards introduced or
enhanced at this step
Should the hazard be
addressed in the
Control measures to
prevent the hazard
Reception B:Contamination with
C: Cleaning and sanitizing
P: Gasket materials
protect the milk.
Pasteurization B: Survival of vegetative
C:Cleaning & Sanitizing
conform to all of the
requirements of the
Grade A Pasteurized
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).
1. Series of questions to determine factors that affect the safety of the product.
2. Questions vary depending on product and process.
For each hazard identified, an analysis shall be conducted to
• 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
• If the identified hazard is partially controlled by a process
• If the identified hazard is controlled at a CCP;
• If the identified hazard is out of the establishment’s control 21
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.
The HACCP team should utilize the
decision tree to evaluate each point
where hazards can be prevented or
• 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
• 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).
4) Monitoring critical Limits
Measurements or observations for each CCP assess whether:
• The control measure is functioning as intended;
• The critical limits are met.
Who will conduct monitoring?
Each CCP must be Monitored by a Specific Individual
(Line supervisors, QC personnel, selected line
Must be trained, understand the purpose of
monitoring, unbiased in monitoring and reporting
Report unusual occurrence immediately and take
What will be monitored? Determine if the process is operating within the
established critical limits.
When will it be monitored?
Time/Temp, pH of Batch, equipment calibration
• Establish monitoring intervals
• Statistically designed data collection
• Select the worst case
• Select the best (when variation is low)
Random Checks (useful for supplementing monitoring)
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.
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
Records of corrective actions must be maintained.
• An individual knowledgeable in CCP control must have the authority to make quick decisions on the production
• The individual responsible for the action must record on the CCP data sheet what action was taken and by
CCP Data Sheet
CCP# Pasteurization filter inspection
HACCP Plan No
Visually inspect the filter to ensure it is
2x daily at startup and shutdown
Corrective action Replace the filter and contact the
operations manager regarding holding of
Date and time 1/3/2016
Result Filter was not intact
Action taken Filter was replaced and operation
manager was informed.
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.
• 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.
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)
Purpose of Verification:
1) Determine if the HACCP plan is implemented.
2) Determine if Operations are in Compliance with HACCP Plan.
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:
• New safety information becomes
• The food Item you produce is
linked to an Outbreak.
• New scientific or technical
• Regulatory agency alerts related
to the product or process
• Recalls 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 record
A)The HACCP Plan:
B) Records obtained during operation of plan:
C) Supportive Documentation
• List of HACCP
• Product limit
• Flow Diagram • Monitoring system • Corrective actions
• Flow Diagram plans • Identification of
• Record keeping
• Establishing CCPs • Procedures for
• Daily CCP Records • Calibration records Calibration
• Employee Training Records • Validation of HACCP Plan
• GMP • SOP
• Data to support Critical Limits • Testing Methods for measuring