Introduction to FSSC 22000 6/13/2013

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INTRODUCTION

TO FSSC 22000

FOOD SAFETY

MANAGEMENT

SYSTEMBy

Jacqueline Toon

SQC Management Sdn Bhd

SECTION 1: BACKGROUND OF FSSC 22000

SECTION 2: BACKGROUND OF ISO 22000

SECTION 3: TERMS & DEFINITIONS

SECTION 4: ISO 22000 REQUIREMENTS

COURSE CONTENT

SECTION 1:BACKGROUND OF FSSC 22000

FOODBORNE INCIDENTS According to the Centers for Disease Control and Prevention, Atlanta, foodborne illness affects an estimated 48 million people in the United States every year.

Of those, 128,000 are hospitalized and around 3,000 die.

Source: http://www.foodsafetymagazine.com/fsm-edigest/food-safety-focus-on-packaging/ , June 4, 2013

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Key Food Safety Issues Existing Issues Being addressed

Hygiene of eating establishment

Residue of veterinary drugs

Pesticides

Abuse and overuse of food additives

Mycotoxin

inorganic contaminants

Effort already taking place to reduce the contravention and risk to consumers.

Key Food Safety Issues New Issues beginning to be addressed

Migration of chemicals substances from packaging materials and other

materials in contact with food

Persistent Organic Environmental Pollutants(dioxin, PCBs, PAH)

Chemical substances formed during cooking/processing

Hypersensitivity, intolerance and allergic reactions

Antibiotic resistant microorganism

Food Packaging Safety Quotes

If you supply a food company, you are

no longer just the packaging industry, you

are a part of the food industry

We treat food packaging with the same

food safety rigor as food ingredients.

(Ms. Wade-Kudla senior manager of packaging at

General Mills Inc., Minneapolis)

What is FSSC 22000

A set of requirements for a Food Safety

Management System (FSMS)

It was developed to fill the need for a

worldwide Food Safety Standard

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WHY FSSC 22000?There have been an

abundance of food safety standards in use, the problem

was that they were not equivalent.

It was hard to know what each certification really

meant.

If your customers want to see a

GFSI recognized certification

you will need to use FSSC 22000, ISO 22000

is not recognized.

GFSI determine that the prerequisite

programs requirements in ISO 22000 were

not specific enough!!

Global Food Safety Initiative

(GFSI)

A food retail initiative created in May 2000

by the Global Food Business Forum (CIES)

A network of 175 retailers and 175

suppliers in over 150 countries,

representing 65 percent of global food

retail revenue.

How the GFSI requirements are covered in the

key global food safety standards:

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SCOPE OF FSSC 22000

Applies to Food manufacturers or food packaging

manufacturers

Uses ISO 22000 for the food safety management system

requirements

Uses an additional document for prerequisite requirements

Food Manufacturers/Processors - ISO/TS 22002-1 (supersedes PAS

220: 2008)

Food Packaging Manufacturers - PAS 223

THE ORIGINS OF A GLOBAL

STANDARD

WHY FSSC 22000 WORKS? Integrates food safety management easily with other management

systems, such as quality, environmental and safety management systems;

Fully incorporates ISO 22000:2005, PAS 220:2008 Pre-requisite Programmes (PRPs), HACCP, and the application steps of CODEX;

Is fully recognised by the Global Food Safety Initiative (GFSI);

Controls/reduces food safety hazards and promotes continuous improvement on Food Safety Aspects;

Fosters legal compliance;

Increases transparency throughout the food supply chain; and

Allows small and/or less developed organisations to implement an externally developed system.

SECTION 2:BACKGROUND OF ISO 22000

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ISO 22000 throughout the food

chain What is ISO 22000?Food Safety Management Systems -Requirements for any organization in the food chain.

ISO Technical Committee 34

Working Group 8 (ISO TC 34/ WG 8)

Also members:

Global Food Safety Initiative (CIES)

Codex Alimentarius

CIAA

Why ISO 22000?

Problems in food supply chains

Needs for harmonization

Integration Food Safety in management

systems (ISO 9001, ISO 14001 etc)

Characteristics of ISO 22000 Food Safety Management System standard

Apply to all suppliers within the food supply chain

Requirements for internal & external communications Food safety hazards: controlled by CCPs & Operational PRPs

Reference: List of specific code of practices

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SECTION 3:TERMS & DEFINITIONS

TERMS AND DEFINITIONS

Food Safety Concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use

Food Safety Hazard

Biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect

Control Measure

action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level

TERMS AND DEFINITIONS

Operational PRP

PRP identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment

Critical Control Point (CCP)

step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level

TERMS AND DEFINITIONS

Critical Limit Criterion which separates acceptability from unacceptability

Monitoring Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended

Correction Action to eliminate a detected nonconformity

Corrective Action

Action to eliminate the cause of a detected nonconformity or other undesirable situation

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TERMS AND DEFINITIONS

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

Producers of ingredients

Producers of equipment

Producers of cleaning

agents

Producers of packaging

materials

Others

Services providers

Re

gu

lato

ry a

uth

oritie

s

Figure 1 : Communication along the food chain

Feed producers

Primary food producers

Food processors

Transport and storage operators

Distributors

Retailers

Consumer

Components of Food Safety

Management System Outline of ISO 22000?Sections 4 - 8 Contain the requirements ISO 22000 Standard

Section 1: Scope Section 2: Normative Reference Section 3: Terms & Definit ions Section 4: General Requirements Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning & Realizat ion of Safe Products Section 8: Validation, Verificat ion & Improvement

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SECTION 4:ISO 22000 REQUIREMENTS

4.1 General

Establish an effective

Food Safety

Management System

(FSMS)

Keep it current

Identify outsourced

processes

4.2 Documentation

Requirements

Document your system

Control your documents

4.2 Records

Maintain required

records

Control your records

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5.1 Management

Commitment

Management must be involved in and

committed to the FSMS.

Objectives support safety

Everyone knows the importance of meeting the requirements

5.2 Food Safety Policy

Management creates for Food Safety

Policy

Management is responsible for

communicating the policy

Management is responsible for ensuring

that the policy is implemented

5.3 FSMS Planning

As top management, take an active role

in planning the system

Be involved in the design and implementation

Make sure the integrity is maintained as changes are made

5.4 Responsibility and

Authority

Define responsibilities and authority

Communicate them

Everyone is responsible for reporting

problems with the FSMS - make sure they

know that

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5.5 Food Safety Team

Leader

Appointed by top management

Reports to top management on the status

of the FSMS

5.6 Communication

Establish a system for external

communication

Suppliers, contractors, customers, SR&R authorities, external expert

Establish a system for internal

communication

Food safety team meeting

5.7 Emergency

Preparedness

Be prepared to respond to emergency

situations

Prepare an emergency plan to address

potential situations:

Fire

Flood

Accidents

Contamination

Others...

5.8 Management Review

Key step in a Management Systems

Approach

Management meets to evaluate the

performance of the FSMS

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6 Resource Management

Top management is responsible for

providing the resources required

Human resources

Infrastructure

Work Environment

Pre-requisite

Programme

7 Planning & Realization of

Safe Product

Your organization will need to plan all of

the processes that go into making your

product in order to ensure a safe end

product

PRP

OPRP

HACCP

7.2 Prerequisite Program

Basic Conditions and activities that are

necessary to maintain a hygienic

environment throughout the food chain

The Food safety Team establishes PRPs

For FSSC 22000 you will also include prerequisite programs to meet the requirements of PAS 223

7.3 Preliminary Steps

The Food Safety Team

Identifies product characteristics

Describe intended use

Prepare flow diagrams

Describe process steps and control measures

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7 core principle steps of HACCP The HACCP system is implemented as described

above which includes five preparatory steps and

seven principle steps.

Hazard Analysis Critical control point

Critical LimitsMonitoringand sampling

Corrective Action

VerificationDocumentation

7.4 Hazard Analysis

The Food Safety Team

Verifies the accuracy of the flow diagrams

Conducts hazard analysis to identify potential food safety hazards

Selects control measures to prevent or eliminate those hazards

FOOD SAFETY HAZARDS &

CONTROL

Types of Hazards

Biological

Physical

Chemical

BIOLOGICAL HAZARD Bacillus cereus

Campylobacter jejuni Clostridium botulinum Clostridium perfringens

Escherichia coli Listeria Monocytogenes

Salmonella species Shigella dysenteriae

Staphylococcus aureus Vibrio cholerae Yersinia ente

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FACTORS AFFECTING

MICROBIAL GROWTH

Food Acidity)

Temperature

TimeOxygen

Moisture

Preservative

PHYSICAL HAZARDS Hair, feather

Pest & their droppings

metal fragment , glass

Sand, wood, stone

peeled off paint

jewelry, buttons

cigarette butts

band aid, pen caps

rubber band, plastic pieces

CHEMICAL HAZARDS Naturally occurred

mushroom, some fish species, some tapioca

species, allergen

Commercially added

pesticides, herbicides, colouring, additives

Unintentionally added

cleaning agents, sanitizers, lubricants

Risk is to be calculated for each hazard and a risk rating

sheet can be developed as described below:

Food Hazard Assessment

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Food Safety Risk Matrix

Value of 15 25 (red area): High Risk, control measure is essential, determined by Decision Tree

Value of1 12 (green area): Low Risk, Up to the HACCP team to decide whether it makes sense to have the control measures

CCP Decision Tree

Q1 Is there a hazard with this raw material?

Q2 Are you or the customer going to processthis hazard out of the product?

NONot a CCP

Go to next raw material

Q3 Is there a cross contamination risk to thefacility or to other products which will not becontrolled?

YES

YES

NO

NO

Not a CCP

YES

Go to next raw

materialCCP

CCP

RAW MATERIAL CCP DECISION

TREE Q1 Are there preventive measure(s) for theidentified hazard?

Q2 Is the step specifically designed to eliminate orreduce the likely occurrence of a hazard to anacceptable level?

Q3 Could contamination occur atunacceptable level(s) or increase to anunacceptable level?

Is control necessary at thisstep for safety?

Modify step, process or product)

Q4 Will a subsequent process step eliminate orreduce the hazard to an acceptable level?

YES

YES

YES

YES

YES

Not a CCP

(Ctrl by OPRP)

NO

NO

NO

Next process step

NO

NO

CCP

Next process step

Next process step

PROCESS STEP CCP DECISION

TREE

Not a CCP

(Ctrl by OPRP)

Not a CCP

(Ctrl by OPRP)

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7.5 Establish Operational

PRPs

Similar to a Critical Control Point, an Operational Prerequisite Program is a control point where biological, physical, or chemical hazards identified in hazard analysis can be controlled.

Your food safety team will determine if the control point is a CCP or oPRP using the decision criteria in Section 7 of the standard.

The Food Safety Team establishes Operational PRPs

7.6 Establish the HACCP

Plan

Documents the HACCP plan

7.7 Updating

Updates any preliminary information that

may have changed during or as a result

of the hazard analysis

7.8 Verification Planning

Identify what verification activities are

required including verification of PRPs, the

HACCP Plan and other procedures.

Verification will include internal audits, any

food safety or GMP audits, verification of

cleaning records and HACCP records

and other activities that you identify for

your system.

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7.9 Traceability

A traceability system ensures that the

identification of product is maintained

from raw material to delivery.

Establish the traceability of product

From supplier to distribution

7.10 Control of Nonconformity

When a control limit is exceeded or an

OPRP is found to be out of control

affected product must be controlled.

Corrections

Corrective actions

Handling of potentially unsafe product

7.10.4 Withdrawal

To have complete & timely withdrawal of

lots of end products

8.2 Validation, & 8.3 Control of

Measuring & Monitoring

All measuring equipment must be

capable of the required measurements

and show calibration to national or

international standards.

Calibrate and control measuring

equipment to ensure that measurements

are valid

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8.4 Verification

Establish and document an internal audit

process

The Food Safety Team evaluates and

analyzes verification results

The Food Safety Team takes any

necessary action

8.5 Improvement

Continually improve the FSMS through the

use of:

Management review

Internal audits

Corrective actions

Verification results

Validation results

8.5 Updating the FSMS

Top management is responsible for seeing

that the FSMS is continually updated

The Food Safety Management Team

evaluates the FSMS at planned intervals

THANK YOU FOR YOUR

ATTENTION

QUESTIONS

?