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

Transcript of ISO 22000 & HACCP

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ISO 22000 & HACCPHazard 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 Recordkeepin

g

Establish Verification Procedures

Key elements of ISO

Interactive communic

ation

System manage

ment

Prerequisite

program

HACCP Principle

s

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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.

Key elements of ISO

Interactive communicat

ion

System manageme

nt

Prerequisite program

HACCP Principles Based on

Codex Allimentaru

s

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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

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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).

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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

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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.

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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.

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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.

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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.

Human Resources:

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• 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)

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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

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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

SalmonellaHepatitis

Cryptosporidium

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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

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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

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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 Recordkee

ping

Establish Verificatio

n Procedures

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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 ResourcesAssemble Team

HACCP coordinator should have overall responsibility for the HACCP program.

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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

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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

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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

hazardReception B:Contamination with

vegetative pathogensC: Cleaning and sanitizing residuesP: Gasket materials

B: Yes C: YesP: Yes

Truck unloading should be constructed to protect the milk.

Pasteurization

B: Survival of vegetative pathogens C:Cleaning & Sanitizing Solution Residues

B: YesC: YesP: No

Construction, operation and

testing of pasteurization

equipment must conform to all of the requirements

of the Grade A Pasteurized Milk

Ordinance.

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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 4. Series of questions to determine factors that affect the safety of the product. 5. 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

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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.

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• 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

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4) Monitoring critical LimitsMeasurements 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 reportingReport 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)

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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 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.

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• 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 SheetCCP# Pasteurization filter inspection

HACCP Plan NoMonitoring 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 1/3/2016Result Filter was not intact

Action taken Filter was replaced and operation manager was informed.

Signature

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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

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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

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• 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 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