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Page 1: Introduction to Fssc 22000

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

<Food safety> 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)

<Food safety> 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 <Food safety> 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 Limits

Monitoringand sampling

Corrective Action

Verification

Documentation

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

?