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ISO 22000:2005 Food SafetyManagement Systems Auditor/Lead

Auditor Training Course

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Session 1 Objectives

Describe the course aims, objectives, structure, logistics

To establish what Students want to gain from the courseand to allow each Student to identify themselves to theirfellow Students

Understand the role of IRCA (IRCA K4.3.1e)

Understand the IRCA Food Safety Management SystemsAuditor/Lead Auditor certification scheme criteria andprocess (IRCA K4.3.1e)

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Learning is an act of creationActive learning beatsPassive learning every time

What are the order

of the planets fromthe sun?

Accelerated Learning Introductio

Unless what is learned is

applied, there is no learnin

RULES OF THIS CLASS

-Make mistakes

-Ask lots of questions-Cheat

-Have fun

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Aims and Objectives

Describe the fundamental purpose of a Food SafetyManagement System (FSMS)

Explain the purpose, content and interrelationship of:management system standard ISO 22000:2005 andguidance document, industry practice; standard operatingprocedures; and relevant food safety legislation

Explain the role of an auditor to plan, conduct, report andfollow up an audit in according with ISO 19011

Plan, undertake and report an audit of a food safetymanagement system in accordance with ISO 19011

Audit the adequacy of an organisations Food SafetyManagement System

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Course Program Day 1

Introduction and WelcomeIRCA and Auditor Registration

Purpose of a Food Safety Management System

HACCP Based Control Systems

ISO 22000:2005 series

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The International Register of

Certificated Auditors (IRCA)

Independent organization within the

Institute of Quality Assurance (IQA)

IRCA has two principle activities:

Certification of Auditors

Certification of Auditor Training

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IRCA Food Safety Management

Systems Auditor CertificationScheme

The objectives of the Food Safety Scheme;

To provide confidence to the regulatoryauthorities, to the accreditation bodies

and certification bodies, to business andindustry, and indirectly to the public atlarge, that auditors certified to thisscheme are competent..

To benefit the auditor by conferringregistration status

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IRCA Food Safety Certification

Categories Three certification grades for auditors:

Food Safety Provisional Auditor

Food Safety Auditor

Food Safety Lead Auditor

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IRCA Auditor Registration Schem

Academic Qualification

Formal

Auditor TrainingWork Experience

Auditing Experience

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IRCA Contact Information

Address: IRCA,

PO Box 25120,

12 Grosvenor Crescent,

London SW1X 7ZL

Telephone / Fax: +44 (0)20 7245 6833/

+44 (0)20 7245 6755

E-Mail: [email protected]

Website: www.irca.org

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Students become familiar with and understand food/Food Safety Management System (FSMS) terminologyincluding key Food Safety concepts

Students understand the ISO 22000 Process Model andits relationship with the PDCA cycle

Students understand food safety risk management andits significance as a strategic business driver (IRCAK4.1.1/K4.1.2a)

Students understand the social and historical aspects of

public health provision (IRCA K4.1.2b)

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Key Elements of ISO 22000:2005

ISO 22000:2005 specifies the requirements for a FoodSafety Management System (FSMS) that combines thefollowing generally recognized key elements:

- Interactive communication

- System management

- prerequisite programmes

- CODEX HACCP principles

It is a specification for any organization in the food

chainISO/TC 34, Food Products

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ISO 22000:2005 System Management

FMEA

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Regulatoryauth

orities

Consumers

Food service

operators/caterers

Service providers

Producers of cleaning and

sanitizing agents

Producers of equipment

Producers of packaging

materials

Producers of pesticides,fertilizers, and veterinary

drugs

Food chain for the

production of ingredients

and additives

Transport and storage operators

Crop producers

Feed producers

Primary food producers

Food producers

2nd food processors

Retailers

Wholesalers

Scope of ISO 22000:2005

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ISO 22000:2005 and the Food

Chain

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InspectionProcess

Old Vision New Vision

Correction

Action

Audit

Do

Check

Improve

Design

Plan

ISO 22000:2005 Philosophy

The primary purpose of a food safety management system isto achieve a balance between a reactive and a preventative

approach with greater emphasis or statistical weighting onprevention

Simply stated, if we can understand what can go

wrong we can prevent it from happening

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Definition of Food Safety

Concept that food will not cause harm to theconsumer when it is prepared and/or eaten accordingto its intended use

ISO 22000:2005 3.1

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ISO 22000:2005 Process Model

Plan

Do

Check

Act

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Terms that are often confused

Hazard = agent causing the illness or adverse health affect.See ISO 22000:2005 3.3Risk= probability of getting ill be ingesting a certain hazard &the severity of that illness

Hazard Analysis = Industry taskRisk Analysis = Governmental task

Monitoring during implementation, verifying that the controlmeasure functions as intended. See ISO 22000:2005 3.12Verification after implementation, verifiable evidence thatthe monitoring works and the degree of intended control hasbeen delivered See ISO 22000:2005 3.16

Validation prior to implementation, verifiable evidence thatthe control measure is capable of delivering the neededobjectives See ISO 22000:2005 3.15

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Purpose of a Food Safety

Management System

Organization provides safe food when it is prepared

and/or eaten according to its intended use Demonstrate conformity and compliance

Evaluate the overall effectiveness/maturity of the

organizations Food Safety Management System Provide a basis for continual improvement

Demonstrate a food safety culture within the

organization

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Food Safety Risk Management

as a Strategic Business Driver Secure in the knowledge that the product is safe when

reaching the marketplace

Legal requirement

Saves money by targeting resources and reducing therequirement for end product testing

Will yield a safer product in less time and at lower costwhich will satisfy customers requirements

Establishes priority for improvement actions

There is a demand from customers for a recognisedfood safety standard

Assists new product development

Concept ofdue diligence

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Historical aspects of public

health and food safety provision Hunter gatherer to communal life

First food laws written in 2500 B.C

Preservation methods a preventative response

HACCP predecessors HACCP and the space program

FDA and HACCP

Regulatory requirement since 1998

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Social aspects of public health

and food safety provision Food safety management is more important now than ever

before due to:

Increased number of pathogens on raw foods due tointensive farming, intensive production and reducednumber of slaughterhouses

Increase in meals consumed outside the home Increase in ready prepared foods

More foreign holidays

Increased amounts of exotic imported foods

Increase in numbers of susceptible people (elderly)

Reduction in the use of preservatives

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Session 3 - Objectives

Students understand and can describe the CODEX HACCPbased control system (IRCA K4.1.2c,f;K4.2.2a)

Students understand what is a pre-requisite program and its

importance within a FSMS (IRCA K4.1.2f)

Students can evaluate the appropriate attribution of risk toidentified hazards and the effectiveness of the organizationsmanagement of risk through its food safety risk assessmentand control planning (IRCA K4.1.2c,d,e,f; S4.4.2)

Students determine appropriate operational controls for specififood safety hazards and evaluate the implementation ofoperational risk control, monitoring and measurement (IRCAS4.4.3)

li i f

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CODEX - Application of a HACCP

based hazard control systemFive Steps Assemble the HACCP team

Describe the product Identify the intended use

Construct a flow diagram

Confirm accuracy of the flowdiagram

Seven Principles

Carry out Hazard Analysisand list the control measures

Determine the Critical ControlPoints (CCPs)

Establish Critical Limits for

each CCP Establish monitoring system

for each CCP

Establish corrective actions Establish verification

procedures

Establish documentation andrecord keeping

D fi iti f C t l

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Definition of a Control

Measure

(Food Safety) action or activity that can be used to prevent

or eliminate a food safety hazard or reduce it to anacceptable level

ISO 22000:2005 3.7

D fi i i f P R i i

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Definition of a Pre-Requisite

Program (PRP)

Basic conditions and activities that arenecessary to maintain a hygienicenvironment throughout the food chainsuitable for the production, handling, storage and

provision of safe end products and safe food forhuman consumption

ISO 22000:2005 3.8

D fi iti f O ti l

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Definition of an Operational

Pre-Requisite Program O-PRPPRP identified by the hazard analysis as essential inorder to control the likelihood of introducing food safetyhazards to and/or the contamination or proliferation offood safety hazards in the product(s) and safe food forconsumption

ISO 22000:2005 3.9

HACCP/FSMS R l i hi

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HACCP/FSMS Relationship

HACCP based control system vs

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HACCP based control system vs

ISO 22000:2005 (FSMS) Starting point Flow

diagram

What can go wrong (events) ?

Focus on determining the CCPs

Limited documentation of

hazard analysis Tends to result in a static

control system

Semi-quantitative approach(zero-tolerance/ALARA)

Starting point Output/Input

Controls needed/not needed

Focus on determining thecontrol measure combinations

Full documentation of hazard

analysis Encourages dynamic control

systems

Enables a quantitativeapproach (FSO/PO approach)

H f S f F d

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House of Safe Food

House of Safe Food

Food Safety Management System

HACCP based control system

Representative Prerequisite Programs

Productsornew

products

Raw

materials,

ingredientsand

services

P

roductionsystemsa

ndequipment

Productionpremises

,locationof

equipment,surroundin

genvironment

Cleaningandsa

nitation

programmes

P

ackaging,storagean

ddistribution

systems

P

ersonnelqualification

levelsand/o

allocationofrespons

ibilitiesand

authorizatio

ns

Statutorsandre

gulatory

requiremen

ts

Knowledgeregarding

foodsafety

hazardsandcontro

lmeasures

Session 4 Objecti es

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Students understand the evolution of Food SafetyManagement System Standards and the ISO 22000:2005series (IRCA K4.2.1; K4.1.1; K4.2.2d)

Students understand the requirements of ISO 22000:2005and can apply the requirements consistently in the foodchain of relevant food category businesses (IRCAK4.2.2b)

Evolution of ISO 22000:2005

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Evolution of ISO 22000:2005

Standard Series CODEX HACCP principles

National and voluntarily to InternationalManagement Standards

ISO 9001:2000 and 15161:2002

ISO 22000:2005 Standard series

ISO 22000:2005 Standard

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ISO 22000:2005 Standard

Series Objectives Complying with CODEX HACCP principles

Harmonizing voluntarily to international managementstandards

Provides a specification for requirements that can be

assessed and achieve certification, either self declarationor for first, second and third party verification

Is aligned with other management systems standards (ISO

9001:2000, ISO 14001:2004)

ISO 22000:2005 Standard Series

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ISO 22000:2005 Standard Series

ISO 22000:2005 is the first in a family of standards that includesthe following documents:

ISO/TS 22004, Food safety management systems

Guidance on the application of ISO 22000:2005, November2005, provides guidance for ISO 22000.

ISO/TS 22003, Food safety management systems

Requirements for bodies providing audit and certificationof food safety management systems, providing harmonizedguidance for the accreditation (approval) of ISO 22000certification bodies and defining the rules for auditing a

food safety management system - first quarter of 2006. ISO 22005, Traceability in the feed and food chain

General principles and guidance for system design anddevelopment.


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Students understand the International Accreditation Forum(IAF) interpretations and guidelines for 3rd party CertificationBodies (Registrars) (IRCA K4.3.1b)

Students understand the system of accredited certificationincluding the functions of the Accreditation Bodies andCertification Bodies (Registrars) (IRCA K4.3.1c; K4.3.5d)

Students understand the existence of private schemes andtheir differences in content and operations, e.g. BRC,Eurepgap (IRCA K4.3.1d)

International Accreditation

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International Accreditation

Forum (IAF) The International Accreditation Forum, Inc. (IAF) is the world

association of Conformity Assessment Accreditation Bodies

Its primary function is to develop a single worldwide programof conformity assessment which reduces risk for business and

its customers by assuring them that accredited certificatesmay be relied upon.

IAF Guidance Documents GD Serie

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IAF Guidance Documents GD Serie

IAF publishes Guidance documents commonly called GDdocuments. IAF Guidance documents are not intended toestablish, interpret, subtract from or add to the requirements

of any ISO/IEC Guide but simply to assure consistentapplication of those Guides.

Copies of all published IAF Guidance to the application of

ISO/IEC Guides are available at www.iaf.nu

Infra-structure for Registration

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Infra-structure for Registration

of Management Systems

National Accreditation

Board(s)

Quality/Environmental

Management

Systems

EN45012

Product Approval

EN45011

Personnel Approval

EN45013

Application For

AccreditationNAB AUDIT

Certification Body

Industry

Application for

Registration

Audit & Surveillance

by Certification Body

Consumers and

Purchasers

Regional Accreditation

International

Accreditation Forum

Roles Of Accreditation &

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Roles Of Accreditation &Certification Bodies

Operate the Accreditation

system for Laboratories,Attestors/Attestation bodiesand Certification Bodies orRegistrars

Provide accreditation in linewith their accreditation field

Provide a service in line with

the requirements of the EN45000 series/ISO Guide 62 andshortly ISO 17021:2006

Provide certification in line withtheir accredited scope

Issue a Certificate ofRegistration to organisationswho meet the requirement ofthe relevant System Standard

Accreditation Body Certification Body

Types of Conformity Assessment

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Types of Conformity Assessment

Preliminary Assessment (Mock/Trial)

Initial Registration assessment (System)

Surveillance assessment (Partial)

Follow-up assessment (Partial)

Re-registration assessment (System)

Private Schemes - BRC

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Private Schemes BRC

In 1998 the British Retail Consortium, responding to industryneeds, developed and introduced the BRC Food TechnicalStandard to be used to evaluate manufacturers of retailersown brand food products.

The Standards are available in Food, Consumer Products,Packaging and Non GM Food Standards

Further details on the BRC can be found on their websitehttp:// www.brc.org.uk

Private Schemes - EurepGap

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Private Schemes EurepGap

EurepGAP started in 1997 as an initiative of retailersbelonging to the Euro-Retailer Produce Working Group(EUREP). It has subsequently evolved into an equalpartnership of agricultural producers and their retailcustomers. Our Mission is to develop widely acceptedstandards and procedures for the global certification of GoodAgricultural Practices (GAP).

EurepGAP has Standards covering fruit and vegetables;flower and ornamentals; integrated farm assurance;integrated aqua culture assurance; green coffee etc. The

standards are based on best practices.

Further details on EurepGAP can be found on this website

http://www.eurep.org


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Students identify and describe the documents and recordsrequired by ISO 22000:2005 including hierarchy andbenefits of a documented FSMS. This includes the

difference between a document and a record (IRCAK4.2.2c)

Students know what the key document types looks like

including their contents (IRCAK4.4.2c)

Students understand the importance of documents ofexternal origin, how they should be controlled and managed

including the difference between auditable standards andguidance documents (IRCA K4.2.2c)

Students understand the different methods of controlling

and managing documents and the implications for Auditors

Objectives of ISO 22000:2005

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Objectives of ISO 22000:2005

Standards ISO requires (and alwaysISO requires (and always hashasrequired) arequired) a

Documented food safety management systemDocumented food safety management system,,

and not aand not a system of documentssystem of documents

ISO 22000:2005 allows an organisation flexibilityISO 22000:2005 allows an organisation flexibilityin the way it chooses to document its FSMS. This enables

each individual organisation to develop the minimumamount of documentation needed in order todemonstrate the effective development, implementationand updating of the FSMS, when necessary

Typical FSMS Documentation

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yp

Hierarchy

POLICIES

OBJECTIVES

Hazard Analysis/Control Measure

Combinations

PROCESSES

SUPPORTING

DOCUMENTATION

Benefits of a documented

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Demonstrate conformity + compliance

Due Diligence Communication

Training & Development

Marketing

Auditing

FSMS


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Students understand the framework of relevant regional,national and local legislation, codes of practice etc., and theinteraction between the food organization and the relevantauthorities (IRCA K4.2.4)

Students have the skills to determine the legislative andregulatory items appropriate to specific food chain activitiesand the appropriate activities for an organization to maintaincompliance with legislative and regulatory requirements(IRCA S4.4.1)

Students have the skills to evaluate the capability of anorganization to maintain compliance with legislativerequirements (IRCA S4.4.4)

Origins of Food Safety Legislation

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Origins of Food Safety Legislation

Global food safety/health issues

Increasing scientific understanding

Increased consumer debate on food safety issues

Drivers for economic change

Consumer pressure groups

Government policies on freedom of information

Food Safety Problems

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ood Sa ety ob e s

Major incidents involving impact on human health

Labeling

Use of Harmful substances

Hygiene Standards

Enforcement controls

Issues for Industry

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Consumer concerns

Consumer information/Rapid Alerts

Prohibition of certain substances

Labelling

Food safety enforcement controls

Food safety legislation

The Response

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p

International

Establishment of the Food Safety Agency (FDA, EFSA)

Closer integration with International Bodies, e.g. United

Nations Codex Alimentarius, World Trade Organisationetc.

National

Establishment of National Food Safety Agencies Sector Quality Schemes

Local

Service contracts Switch from reliance on inspection alone to audit and

inspection

Business Response

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Stronger emphasis on quality

Adoption of HACCP based control systems

Support Quality Schemes

Bord Bia (Ireland)

Types of Legislation

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Regulations

same law throughout Community

Directives

sets out aims to be achieved for countries to enact locallaws

Decisions

as regulations but addressed to specific individuals,

companies or states Recommendations

not binding, but may influence policy

European Union Food Safety Polic

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Objectives

Food must be safe, wholesome and healthy

Protect human health

Promote international action to tackle regional or global

problems

European Union Food Safety PolicP i i l

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Principles

Aim for a high level of protection

Shared responsibility

Precautionary principle, where appropriate

Subsidiary principle

Topics of Legislation

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Food Law, European Food Safety Authority

Hygiene

Residues

BSE GM Food

Hormones

Supplements Contaminants

Additives

Labelling Flavourings

ISO 22000:2005 Requirements

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General Requirements, reference 4.1 Documents Control, reference 4.2.2 Management Commitment, reference 5.1b, 5.2b

External Communication, reference 5.6.1c Internal Communication, reference 5.6.2h Competence, Awareness and training, reference 6.2.2a Prerequisite programmes (PRPs) reference 7.2.2/7.2.3

Product characteristics, reference 7.3.3 Process steps and control measures, reference 7.3.5.2 Hazard analysis, reference 7.4.2.3 Product withdrawals, reference 7.10.4a,b


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Students have a common definition of employeecompetence and are able to distinguish betweentraining and competence (IRCA K4.4.2b)

Students understand the critical elements ofemployee competence including the relationship withorganization capability and performance (IRCAK4.4.2b)

Students have a methodology for assessing theeffectiveness of an organizations employeecompetence system and its contribution to businessperformance (IRCA K4.4.2b)

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ISO 9000:2005 Definition ofCompetency

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Competency

ISO 9000:2005 defines competency as the demonstratedability to apply knowledge and skills what a personneeds to be doing to demonstrate he or she is competent

Competencies needs to be defined for hourly andmanagement staff

Competencies may be established for a specific position,

family of positions or cluster of jobs There are essentially two types of competencies, namely

soft (visible leadership, good listening skills) and hard(planning, scheduling, controlling work or processes)

Minimum competencies for managers and supervisors,whereas for hourly personnel the focus is typically on thehard skills


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Students understand the scope, principles, terms andrequirements of ISO 19011:2002

Students will understand the key auditing terms and

principles of auditing Students will understand what is expected of an audit

management program and show to assess theeffectiveness of an organizations internal audit

program

Students will understand the life cycle of an audit andkey activities (IRCA K4.3.2a)

Students will understand the competencies required byAuditors including the relevance of ISO 17024:2003

Introduction and Scope ofISO 19011:2002

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ISO 19011:2002

Both the ISO 9000 and ISO 14000 series of standards emphasisethe importance of audits as a management tool for monitoringa management tool for monitoring

and verifying the effective implementation of anand verifying the effective implementation of an

organization's policy for quality and/or environmentalorganization's policy for quality and/or environmentalmanagementmanagement

This International Standard provides guidance on conducting

internal or external QMS and/or EMS auditsinternal or external QMS and/or EMS audits, as well as onthe management of audit programmes

It is discretionarydiscretionary whether or not QMS and/or EMS audits areconducted separately or together

This International Standard can be applied to othercan be applied to other

management system standardsmanagement system standards

Key Terms

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AuditAudit, a systematic,independent and documentedprocess for obtaining auditevidence and evaluating it

objectively to determine theextent to which audit criteriaare fulfilled.

Audit criteriaAudit criteria, set of policies,

procedures or requirements Audit evidenceAudit evidence, records,

statements of fact or otherinformation, relevant to the

audit criteria and verifiable.

Audit findingsAudit findings, results of theevaluation of the collected auditevidence against audit criteria.

Audit conclusionAudit conclusion, outcome of

an audit, provided by the auditteam after consideration of theaudit objectives and all auditfindings

AuditorAuditor, person with thecompetence to conduct an audit

Audit ProgrammeAudit Programme, set of oneor more audits planned for a

specific time frame and directedtowards a specific purpose

AuditAudit PlanPlan, description of theactivities and arrangements for

an audit

Principles of Auditing

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Ethical conductEthical conduct the foundation of professionalism

Fair presentationFair presentation the obligation to report truthfullyand accurately

Due professional careDue professional care application of diligence andjudgment in auditing

IndependenceIndependence the basis for the impartiality and

objectivity of the audit conclusions

EvidencEvidencee--based approachbased approach the rational method forreaching reliable and reproducible audit conclusions in a

systematic audit process

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Students understand the process approach including itssignificance when auditing management systems (IRCAK4.2.2a)

Students know how to assess the capability of a processand its relationship with a Food Business Organization(FBO) objectives (IRCA K4.2.2a)

Students understand the process methodology forassessing top management in a (FBO) (IRCA K4.3.4c andS4.5.3b)

Students can identify potential emergency situations andcan evaluate the planning and capability of an organizationto respond to emergency situations (IRCA S4.4.4)

Understanding the ProcessApproach

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Approach

ISO 9000:2005 defines a ProcessProcess as:

set of interrelated or interacting activities which transforms

inputs into outputs Processes in an organisation are generally planned and carried

out under controlled conditions to add valueadd value

Data should be gathered to establish process capability andanalyse process performance including input and outputcharacteristics

The P-D-C-A Cycle

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PLANWhat to do ?How to do it?

DODo what was

planned

CHECKDid things happen

according to plan?

ACTHow to improvenext time

Approach to Audit Planning

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Verify the organizations role in the food chain includingscope of registration sought

Understand the organisations food safety goals and

objectives including alignment with the food safety policy

Understand and verify the Food Safety ManagementSystem framework

Develop the Audit Plan based on the process steps withinthe organizations food chain/scope of registration sought

Develop process based Checklist(s)

Understanding the systemapproach to management

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approach to management

Individual processes rarely occur in isolation, namelyoutputs from one process typically form part of inputs intosubsequent processes

Simply stated, a food safety management system comprisesa number of interrelated processes

Inputs and outputs of these processes can often be relatedto both internal and external customers

Customer feedback of a process output is an importantinput to the continual improvement of an organizations

FSMS

High-Level Process Map

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S

UPPLIERS

C

USTOMERS

OutputsInputs Process

S I P OS I P O CC

Model

SIPOC Example

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Suppliers Inputs Process Outputs Customers

Hazard

Analysis

Preliminary DataHazard

Identification

Hazard

Evaluation

Validation of

Control Measure

Combinations

Process Steps

Statutory &

Regulatory

Customer Product

Requirements

Various

Codex GuidelinesCodex

Customer

FSMS team

Scientific DataScientific Source

O-PRP Plan

HACCP Plan

Auditors

Emergency Preparedness andResponse

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p

Identifying potential emergency and accidents

Emergency and accident response procedure Emergency and accident response command and

control structure

Competence, awareness, and training

Emergency preparedness and response plan

Periodic review and testing, where practical


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Students understand basic audit terminology

Student understand the audit terms, pre-registration,initial registration, surveillance and re-registration andthe difference between them from an audit perspective

(IRCA K3.3.6e)

Students understand the purpose of 1st, 2nd, and 3rdparty audits (IRCA K3.3.2a)

Students understand the qualities and responsibilities ofauditors and the management responsibilities of theLead Auditor in managing the audit and the audit team(IRCA K3.3.3)

Students understand the need for effectivecommunication with the Auditee throughout the auditprocess (IRCA K3.3.3c; K3.3.5b)

AuditAudit, a systematic, Audit conclusionAudit conclusion, outcome of

Key Terms

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Auditud t, a syste at c,

independent and documentedprocess for obtaining auditevidence and evaluating itobjectively to determine the

extent to which audit criteriaare fulfilled.

Audit criteriaAudit criteria, set of policies,procedures or requirements

Audit evidenceAudit evidence, records,statements of fact or otherinformation, relevant to theaudit criteria and verifiable.

Audit findingsAudit findings, results of theevaluation of the collectedaudit evidence against auditcriteria.

Audit conclusionud t co c us o , outco e o

an audit, provided by the auditteam after consideration of theaudit objectives and all auditfindings

AuditAudit clientclient, organisation orperson requesting an audit

AuditAuditeeee, organisation beingaudited

AuditorAuditor, person with thecompetence to conduct an audit

AuditAudit teamteam, one or more

auditors conducting an audit,supported if needed by technicalexperts

AuditAudit PlanPlan, description of the

activities and arrangements foran audit

Audit Types & Roles

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1st Party

2nd Party

3rd Party

Internal External

Audit of ones

own

organisation

Audit of aSupplier by a

Customer

Audit by an

independent

Body

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Main Purpose of 1st Party Audits

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To determine if the Food Safety Management Systemconforms to the agreed audit criteria

To ensure the Food Safety Management System hasbeen effectively implemented and maintained

To review the efficiency and effectiveness of its

processes

To identify opportunities for improvement

Main Purpose of 2nd Party Audits

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To evaluate the degree ofconformity to customerproduct criteria

To evaluate the effectiveness of the suppliers FoodSafety Management System


Main purpose of 3rd Party audits

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To provide objective evidence ofconformity with thecriteria/requirements of ISO 22000:2005

To provide objective evidence of the degree ofeffectiveness of the Food Safety ManagementSystem


Personal Qualities of an Auditor

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Precise

Reasonable

Objective Fair

Energetic

Sensitive

Supportive

Integrity

Organised

Not afraid of reporting thefacts

Astute and analytical

Listener

Sensitive to local customs

PROFESSIONALS

IRCA Code of Conduct

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To act in a trustworthy and unbiased manner

To disclose any potential conflict of interest

Not to accept any inducement, gift, commission, discountor any other profit

To keep the audit findings confidential

Not to act any any way prejudicial to the reputation orinterest of the audit organisation or credibility of IRCA

Co-operate fully in any formal enquiry procedure

Communication during the Audit

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The audit team should confer periodically to

Exchange information

Assess audit progress

Reassign work between audit team members as needed

Discuss concerns about any issues outside the scope ofthe audit

The Lead Auditor should communicate to the auditee/auditclient any

Significant risks identified during the audit process Concerns about any issues outside the audit scope

Evidence which indicates audit objectives are unattainable

Auditor Responsibilities

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Understand the purpose, scope and criteria of the audit

Ensure adequate planning is carried out prior to the audit

Conduct the audit in a professional manner Establish and maintain good relations with employees

Produce a factual and balanced audit report, in a timely

manner Comply with audit organizations audit rules and guidelines

Lead Auditor Duties andResponsibilities

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Form a competent and capable audit team

Be the main focal point of contact with the client organisation(auditee)

Conduct any preliminary visits

Lead and manage the audit team

Report the audit findings

Co-ordinate any follow-up activities

Sub-Team Leader Responsibilitie

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Support the Lead Auditor

Co-ordinate and manage the Sub-team

Communicate to other team(s)

Assemble evidence

Report (verbally or in written form) whenrequested

Be available for follow-up reviews

Trainee Auditor Duties andResponsibilities

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Conduct the audit under the supervision of aCompetent Auditor/Lead Auditor

Provide feedback to audit organization on learningexperience

Establish and maintain good relations with

employees Comply with audit organizations audit rules and

guidelines

Technical Expert Duties andResponsibilities

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Take notes

Establish and maintain good relations with

employees

Comply with audit organizations audit rules andguidelines

Translator Duties andResponsibilities

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Comply with audit organizations audit rules andguidelines


Take notes

Establish and maintain good relations with Auditteam and employees

Observer Duties andResponsibilities

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Not to influence or interfere with the auditactivity - focus on the audit process

Maintain confidentiality

Provide feedback to own organisation on learningexperience

Guide Duties and Responsibilities

Assist the Auditors during the audit process by:

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Assist the Auditors during the audit process by:

Conducting the Auditors from area to area

Introducing area manager(s) + employee(s)

Occasionally providing clarification, when requested

Obtaining additional support documentation, if requested

Ensure rules concerning site safety and securityprocedures are known and respected by audit team

members

Consultant Duties andResponsibilities

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Not to influence or interfere with the audit activity,

findings or audit conclusion

Provide feedback/input to the client on audit findingsand/or audit performance

Due professional care

Auditee Responsibilities

Create the right environment for the audit to take place

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Create the right environment for the audit to take place

Ensure employee(s) are aware of the audit

Support the audit process by providing facilities andsupport services, when requested

Support the agreed audit plan

Provide access to people, processes, products, areas, anddata and records

Ensure the audit team receive open co-operationthroughout the audit


Students know the activities and task to be completed during thel i h f th dit lif l (IRCA K3 3 4 S3 4 1)

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Students know the activities and task to be completed during theplanning phase of the audit life cycle (IRCA K3.3.4a, c; S3.4.1)

Students know how to approach an organization which does nothave a formal documented FSMS based on ISO 9001:2000 (IRCA

K3.3.4f) Students have the skill to conduct a document review, determine its

conformity and whether there is adequate arrangements to justify

proceeding with the on-site audit (IRCA K3.3.4b; S3.4.2a) Students have the skill to develop an audit plan based on the scopeof registration sought and the food chain process steps of theorganization (IRCA K3.3.4 S3.4.2d)

Students have the knowledge and skill to develop and technicallyassess a process based checklist (IRCA K3.3.4e, f; S3.4.2e)

Main activities during thePlanning Phase

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Agreeing the audit

objectives, scope andcriteria

Communicating with

the Auditee/AuditClient

Determining the

feasibility of the audit

Forming a competent

audit team/audit teamassignments

Developing an audit

plan

Creating processbased checklists

Holding an audit teambriefing, if required

Initiating the Audit Preparing for the Audit

Establishing Initial Contact withthe Auditee

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Establish communication channels with AuditeeRepresentative/FSMS Team Leader

Confirm the authority to conduct the audit

Request access to relevant documents, including records

Provide information on proposed timing and audit team

composition

Establish what, if any applicable site safety rules andPPE

Make arrangements for the audit

Agree attendance of Trainee Auditors, Observers andthe need for Guides

Determining the Feasibility ofthe Audit

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Verifying and validating the data provided by theAuditee

Conducting a preliminary document review

Conducting a preliminary audit visit

Audit Team Selection

Audit objectives, scope, criteria and estimated durationof the audit

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Audit objectives, scope, criteria and estimated durationof the audit

Statutory, regulatory, contractual and accreditation/certification requirements

Overall competence of the audit team to needed toachieve the objectives of the audit including audit teamassignments

Independence from the activities to be audited includingconflict of interest

Ability of the audit team to interact with the auditee andwork together

Availability

What is an Audit Plan?

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Description of the activities and arrangements for an

audit

ISO19011:2002

Factors to be considered whendeveloping an Audit Plan

h d b d l d h l

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The audit objectives, scope and criteria including the roleof the organization in the food chain

The product categories, processes and locations/shiftswhere the on-site audit activities are to be carried out

The expected duration and time for the on-site activities

including safety/security requirements

Persons to be interviewed

Competency of auditors

Audit team performance monitoring

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What is a Checklist?

A structured list of points to evaluate

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A structured list of points to evaluate

Identifies and communicates the scope of an audit

An Auditors tool to gather evidence and provide an audittrail

Guides the course and controls the pace of an audit

Benefits of a Checklist

Helps an Auditor understand the food safety hazards,d t l i t d ith th

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p yprocesses and control measures associated with thefood chain process/activity assigned by the LeadAuditor/Audit Plan including its significance for the

auditor

A record agreed audit criteria was checked and auditobjectives fulfilled

Helps an Auditor manage time in line with the auditplan and covers agreed audit criteria

Assists future audit preparation

Key points when developing aProcess-Based Checklist

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Audit objectives and criteria

Audit sample/time available

Format of checklist

Food categories

Associated risks/hazards and controlmeasures associated with the foodcategories

Risk assessment techniques in place

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Reasons for an Opening Meeting

Cover the main points of the audit plan

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Courtesy to talk to the Auditee managers and employees

Create the right atmosphere Audit process can be explained

Confirm communication channels

Expectations can be set

Questions can be answered

A Typical Opening Meeting Agenda

Introductions, if applicable

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Confirmation of the objectives, scope and criteria of theaudit

Confidentiality Statement/Sample

Confirmation of audit plan

Outline the audit process and approach

Explain the reporting method

Confirmation of availability and roles of guides

Provide any clarifications which may be required

How to Manage the OpeningMeeting

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Be prepared

Control the meeting

Keep it short and stick to the point

Be professional

Keep a record of people who attend

What information can be gatheredat an Opening Meeting

Who the Guides are

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Who the Guides are

Confirmation employees are aware of the audit

What the layout of the site/facility is

Confirmation of support services available

Confirmation of relevant work safety, emergency andsecurity procedures for the audit team

What managements commitment is

What the real power structure is


Students know the activities and tasks to be completedinvestigative phase of the audit life cycle

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investigative phase of the audit life cycle

Students understand the term audit evidence, therequirement for audit evidence and the primarymethods for obtaining audit evidence (IRCA K3.3.5e)

Students understand the benefits and limitations ofsampling (IRCA K3.3.5d)

Students understand and demonstrate thecommunication skills required to obtain audit evidence(IRCA S3.4.3)

Students know how to manage difficult situations whileobtaining audit evidence (IRCA S3.4.3)

Main activities during thePerformance Phase

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Opening Meeting

Gathering Evidence

Writing Audit Finding Reports

Collating and generating the Final Audit

Report

Preparing for the Closing Meeting

Closing Meeting

What is Evidence?

Qualitative or quantitative information, records, or

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Q q , ,statements of fact pertaining to:

a. the quality, safety, and environment of the product orservice

b. to the existence and implementation of afood safety management system requirement

which is based on observation, measurement or test andwhich can be independently verified

Procedure for Gathering Evidenc

Question/Analyze

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CheckObserve/Analyze

General Points on QuestioningTechniques

Use appropriate types of question

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Use appropriate types of question

Adopt a logical approach

Follow a natural sequence

Actively listen to what is being said

Use silence appropriately

Seek clarification, where necessary

Verify responses, where necessary

Typical Questions

Information Verification

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How

What

When

Where Who

Why

Verification

Show me

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Observation

People

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Product and service

Processes

Information systems

Taking Notes

Employee names and job titles

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Product identification

Quotes and statements

Rough sketches

Surroundings

Issues which may impact other

functions/Audit team members

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Reaching Audit Conclusions

Sources of information

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Collecting by

appropriate sampling

and verifying

Evaluating against audit

criteria

Reviewing

Audit conclusions

Audit Evidence

Audit Findings

Sampling

S l f /S l

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Sample frame/Sample

Representative

Random

Reduced time and costs

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Importance of Audit TeamPerformance

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Keep to the original audit plan

Auditor/Lead auditor checks progressregularly

Manage delays

Communication Skills

Verbal

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Body language

Style and tone of speech

Facial

Range of literacy

Handling Difficult Situations

Time Wasting Undermining

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Discrimination

Hostility

Avoidance

Finger Pointing

Deception

Obstruction

Usurping Control

Flattery


Students understand what a non-conformity audit findingis and the typical content of a non-conformity and are ableto describe and apply the risk classification system used

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to describe and apply the risk classification system used(IRCA K3.3.6a,b)

Students are able to write both a non-conformity (NCR)and Opportunity for Improvement (OI) audit finding(S3.3.4a,d)

Students understand the contents of an audit report andare able to write one (IRCA S3.4.4b,e)

Students understand who gets a copy of the audit report,

when, and the retention period

What is a Nonconformity?

The absence of, or the failure to implement and maintain, one ormore food safety management system requirements, or asituation which would, on the basis of available objective

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s tuat o c ou d, o t e bas s o a a ab e object eevidence, raise significant doubt as to the safety of theproduct the organization is supplying

A nonconformity exists where there is evidence of a failure tocomply with a requirement of a:

Statutory and regulatory requirementProduct or Service SpecificationCustomer requirement

Process and procedureFood Safety Management System requirement

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NCR Definitions

A Major nonconformity is where there is a total break-down or

absence of objective evidence to satisfy one or more foodsafety management system requirements, or a situation whichwould, on the basis of available objective evidence, raise

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, j ,significant doubt as to the safety of what the organization is

supplying. A Minor nonconformity is where there is a defined and

documented system which generally satisfies one of more foodsafety management system requirements, or a situation which

would, on the basis of available objective evidence, raiseconcern as to the potential safety of what the organization issupplying, e.g. the system and/or one or more processes havenot reached an acceptable maturity level.

An observation/Opportunity for Improvement is a remark byan Auditor which warrants clarification or investigation so as toimprove the overall effectiveness and/or efficiency of theorganization's Food Safety Management System.

An Audit Report is

A summary or record of the outcome of an audit, in line

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y ,with the agreed audit objectives, scope and criteria

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Audit Reporting Principles

Never loose sight of the basic aim of an audit, namelyto get management commitment to act on the findings

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It should be fair and balanced

Never point the finger!

Keep it simple and concise

Keep the audit outcome confidential

Publish in a timely manner

Audit Report Approval

The Auditor/Lead Auditor should sign and date thefi l dit t i if i th dit bj ti h

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final audit report signifying the audit objectives have

been met and the fact the report is accurate andcomplete

The Top Executive and/or Food Safety Team Leader

should sign and date the report to signify agreementwith and commitment to act on the findings

Audit Report Distribution, TimingRetention

Distribution should be limited to the Food Safety Team

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Distribution should be limited to the Food Safety Team

Leader and the audit organisation

Ideally it should be available for the Closing Meeting. Ifnot, it should be available within an agreed timescale

It should be retained in accordance with Audit organizationpolicy and/or regulatory requirements


Students understand the activities to be covered during a

final team meeting including its importance Student can describe the process for collating the findings

of the audit team

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Students know how to manage situations where the

organizations QMS is deemed not to conform and tocorrectly assess the maturity of the organizations QMSand risk to the integrity of the registration and supplierapproval (IRCA S3.4.4e, f)

Students understand the ISO policy on recommendationsand offers of advice Students understand the importance of audit follow-up;

the terms correction, corrective action and CAPA processincluding responsibilities including the objective evidence

required to demonstrate effective implementation ofCAPA(IRCA K3.3.6c, d; S3.4.4g)

Activities to be covered during theFinal Team Meeting

Review the audit findings against the audit objectives

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Agree the audit conclusions (recommendationrecommendation)

Decide your strategy for presenting the findings

Ensure any nonconformity and/or observation reports

are signed in advance of the closing meeting

Anticipate possible areas of disagreement

Decide the follow-up strategy (recommendation)(recommendation)

Process for Collating the AuditFindings

Collate all the information List the strengths

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List the strengths Evaluate and distil List the weaknesses (Nonconformities) Evaluate and distil List any observations

List any obstacles encountered, if any Decide the overall conclusion (recommendationrecommendation) Decide the follow-up strategy (recommendation)(recommendation)

Lead Auditors Facilitation Role

Lead and maintain control

C t iti t li t

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Create a positive team climate

Use the synergy of the audit team

Remain objective

Distil and analyse the audit teams findings

In summary, Keep it simple, add value where practical

If the Auditee does not conform

Be mindful of the level of your authority Maintain control

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Double check the findings are based upon sound

evidence

Do not waiver from the intended message

Ensure the Auditee does not see it as purely anegative message

Check the tone and choice of language used

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Risks associated with Offersof Advice

Ownership

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Possible confusion in roles

Legal and financial

Therefore, never give advice in an external audit.

There is greater scope to give advice in an internalaudit, however the risks albeit small still exist

Contributions during the ClosingMeeting

The Lead Auditor should always lead and manage thepresentation and deliver the audit report executive

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presentation and deliver the audit report executive

summary The Lead Auditor may request individual auditors to

clarify individual nonconformities, if required

The Lead Auditor should assign an audit team memberto take minutes of the meeting and record attendance

Audit Follow-up, why is itimportant ?

Corrective action takes place in a timely manner

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Corrective action is effective and suitable

The real benefits of the audit can be realised

The effectiveness of the audit programme can bemeasured


Students understand the reasons for a Closing Meeting(IRCA K3.3.5b)

Students know the typical agenda for a Closing

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Meeting (IRCA K3.3.5b)

Students have the skill to manage a Closing Meetingand evaluate proposal for corrective action (IRCAK3.3.5b; S3.4.4b,e,f,g)

Students understand the audit records to bemaintained during the life cycle of an audit

Students understand the methods for improving auditperformance including the importance of improvingaudit performance

Purpose of a Closing Meeting

To verbally present the audit teams findings andconclusions in such a manner that they are

d d d k l d d b h di d

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understood and acknowledged by the auditee, and to

agree, if appropriate, on the time period for theauditee to present a corrective action plan

Who attends the ClosingMeeting?

Audit Team Auditee

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Lead Auditor Auditor(s)

Observer(s), if used

Top Executive/Manager Food Safety Team Leader

Functional Representative(s)

Guide(s) (Optional) Employees (Optional)

A Typical Closing Meeting Agend

Re-statement of audit objectives, scope, and criteria

Representative sample statement/confidentiality

A dit l i ti

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Audit conclusion - executive summary

Audit findings detail

Follow-up activities

Obtaining ownership and commitment

Reporting

Questions

Hidden Agenda

Preparation

Objectivity

Control

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Control

Constructive attitude

Professional, businesslike and polite at all

times

Avoid traps

Timing

Evaluating CAPA Proposals?

The Lead Auditor or assigned Auditor technicallyassesses the proposed corrective and preventativeaction and root cause analysis data

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Ideally the Auditor/Lead Auditor who raised the auditfinding should verify and validate closure of anynonconformities raised

CAPA proposals should be received and reviewedwithin 10 calendar days or sooner and verified +validated and closed out within 12 weeks, unless avariation is granted

Methods for Closing Out CorrectivActions

Documentation review

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Re-audit

- Partial

- Full

Audit Objective

To obtain commitment to act on findings so that thereal benefits of an audit can be realised.

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The ultimate Auditor is the consumer!