ISO 22000 & HACCP

Hazard Analysis Critical Control Point

Conduct a Interactive
hazard communicat
Analysis ion

Identify
Establish
Critical
Verification
Control Points
Procedures
(CCP)

HACCP Key System

HACCP Principle elements managem

Establish
PRINCIPLES Establish
critical limits
s
of ISO ent

Recordkeeping for CCP

Establish Establish Prerequis

Corrective Monitoring ite
Actions procedures
program
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Contents:

 Introduction to ISO 22000

 Scope

 Terms and definition

 Food safety management systems

 Management responsibility

 Resource management

 Prerequisite programs

 HACCP

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 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.

Interactive
communicatio
n

HACCP
Principles
Key System
Based on elements managemen
t
Codex
Allimentarus of ISO

Prerequisit
e program
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 ISO 22000

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.

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 ISO 22000
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 
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).

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 2) Terms and Definitions
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.
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 3) Food Safety Management System
Ensure that food safety hazards are identified, evaluated and controlled.
Communicate appropriate information throughout the food chain regarding safety
General
issues.
Requirements
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.
Documentation
Documented procedures and record required by this international standard.
Requirements
Document needed by organization to ensure the effective development,
implementation and updating of FSMS.
Approve documents for adequacy prior to issue.
Review and update documents as necessary and re-approve documents.
Control of 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.
Management • Establishing the food safety policy.
commitment
• 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
Food safety requirements of customers.
policy • 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.
Food Safety • Integrity of food safety management system is maintained.
System
planning

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 • Manage a food safety team and organize work.
• Ensure relevant training and education of the food safety team members.
Food safety
• Ensure that food safety management system is established, implemented and updated.
team leader
• 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.
Communication • 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
Management of system-updating, external audits or inspections.
Review • 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.
Emergency
response

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 5) Resource Management
Human Resources:

• Competent and educated personnel.

General
• Available records and agreement in case of external assistance.

• Identify necessary competence.

• Provide training.
Competence, Awareness • Ensure personnel are trained.
and Training • Ensure personnel are aware of relevance and importance of their
activities.
• Maintain appropriate records.

• Resources for establishment and maintenance of infrastructure should

Infrastructure
be provided by organization.

• Resources for establishment and maintenance of work environment

Work Environment
should be provided by organization.

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 6) Planning and Realization of Safe Product

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

• Assist in controlling the likelihood of

introducing food safety hazards to 1) Premises (Out side property, Building,
the product through the work Sanitary facilities…)
environment and operational
practices. 2) Transportation, Purchasing, Receiving,
PRP • Reflect the current work environment Shipping and Storage
and operational practices within
comply with specific commodity 3) Equipment (Design, Maintenance)
policies, manuals, procedures and
associated regulations. 4) Personnel (Training, General food
• 7 prerequisite programs. hygiene program )

5) Sanitation and Pest Control

6) Recall

7) Operational Prerequisite Programs

(Allergens, Nutrients, Food Additives and
Processing Aids)
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 7) HACCP Plan

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

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 HACCP

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).

Cryptosporidium Hepatitis Salmonella

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 HACCP

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.

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 HACCP

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.

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 HACCP

Conduct a
hazard Frist step of HACCP system is writing a
Analysis plan
Identify
Establish
Critical
Verification
Control
Procedures A team of individuals from within the company
Points (CCP)
+
HACCP Some assistance from outside expert
Establish
Establish PRINCIPLES critical
Recordkeep limits for
ing CCP

Establish Establish
Corrective Monitoring
Conduct five preliminary steps and applies the
Actions procedures
seven HACCP principles

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 Preliminary steps of HACCP

1) Bring together the HACCP Resources

Assemble Team

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

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 Preliminary steps of HACCP

2) Describe Product and identify its intended use

Process/Product Common
Product Name: Important product
Name:
Brand name and/or characteristics:
Generic or common name
common name of the Physio-chemical
of the product family or
individual products characteristics
process covered

Intended use :
Ready-to-Eat food Intended shelf life and
Packaging
product, ready-to-cook, storage conditions
for further processing

Where the product will Labelling instructions Special distribution

be sold related control

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 Preliminary steps of HACCP
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.

Pasteurization process flow 19

 HACCP Principles
1) Identify and Analyze Hazards
• Preparing list of Hazards
• Describe control measures

Process Step Hazards introduced or Should the hazard be Control measures to

enhanced at this step addressed in the prevent the hazard
HACCP plan?
Reception B:Contamination with B: Yes Truck unloading
vegetative pathogens C: Yes should be
C: Cleaning and sanitizing P: Yes constructed to
residues protect the milk.
P: Gasket materials

Pasteurization B: Survival of vegetative B: Yes Construction,

pathogens C: Yes operation and
C:Cleaning & Sanitizing P: No testing of
Solution Residues pasteurization
equipment must
conform to all of the
requirements of the
Grade A Pasteurized
Milk Ordinance.

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 HACCP Principles
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.

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
 HACCP Principles

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
eliminated.

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 HACCP Principles
• 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).

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 HACCP Principles
4) Monitoring critical Limits
Measurements or observations for each CCP assess whether:
• The control measure is functioning as intended;
• The critical limits are met.

Each CCP must be Monitored by a Specific Individual

(Line supervisors, QC personnel, selected line
workers, Maintenance)
Must be trained, understand the purpose of
Who will conduct monitoring? 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.
Continuous (Ideal):
Time/Temp, pH of Batch, equipment calibration
When will it be monitored?
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)

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 HACCP Principles

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.

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.

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 HACCP Principles

• 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.
CCP Data Sheet
CCP# Pasteurization filter inspection
HACCP Plan No
Monitoring Visually inspect the filter to ensure it is
procedure intact
Frequency of 2x daily at startup and shutdown
monitoring
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
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 HACCP Principles

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)

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 HACCP Principles
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:

• New safety information becomes • The food Item you produce is • New scientific or technical
Available linked to an Outbreak. literature

• Regulatory agency alerts related • Recalls or product withdrawals

to the product or process

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 HACCP Principles
• 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:
• List of HACCP • Establishing • Product limit • Flow Diagram • Monitoring system • Corrective actions
team Critical Limits Description
• Flow Diagram plans • Identification of • Record keeping • Establishing CCPs • Procedures for
Hazards plans procedures verification

B) Records obtained during operation of plan:

• Daily CCP Records • Calibration records Calibration

records
• Employee Training Records • Validation of HACCP Plan

C) Supportive Documentation
• GMP • SOP

• Data to support Critical Limits • Testing Methods for measuring

CL

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