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Session 1 Objectives
• Describe the course aims, objectives, structure, logistics • To establish what Students want to gain from the course and to allow each Student to identify themselves to their fellow Students • Understand the role of IRCA (IRCA K4.3.1e) • Understand the IRCA Food Safety Management Systems Auditor/Lead Auditor certification scheme criteria and process (IRCA K4.3.1e)
Accelerated Learning Introduction
Unless what is learned is applied, there is no learning
Active learning beats Passive learning every time
Learning is an act of creation
RULES OF THIS CLASS -Make mistakes -Ask lots of questions -Cheat -Have fun
What are the order of the planets from the sun?
Aims and Objectives
• Describe the fundamental purpose of a Food Safety Management System (FSMS) • Explain the purpose, content and interrelationship of: management system standard ISO 22000:2005 and guidance document, industry practice; standard operating procedures; and relevant food safety legislation • Explain the role of an auditor to plan, conduct, report and follow up an audit in according with ISO 19011 • Plan, undertake and report an audit of a food safety management system in accordance with ISO 19011 • Audit the adequacy of an organisation’s Food Safety Management System
Course Program Day 1
Introduction and Welcome IRCA and Auditor Registration Purpose of a Food Safety Management System HACCP Based Control Systems ISO 22000:2005 series
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
– To provide confidence to the regulatory authorities. – To benefit the auditor by conferring registration status . to business and industry.IRCA Food Safety Management Systems Auditor Certification Scheme • The objectives of the Food Safety Scheme.. to the accreditation bodies and certification bodies. that auditors certified to this scheme are competent. and indirectly to the public at large.
IRCA Food Safety Certification Categories • Three certification grades for auditors: – Food Safety Provisional Auditor – Food Safety Auditor – Food Safety Lead Auditor .
IRCA Auditor Registration Scheme Academic Qualification Work Experience Auditing Experience Formal Auditor Training .
London SW1X 7ZL Telephone / Fax: +44 (0)20 7245 6833/ +44 (0)20 7245 6755 E-Mail: fs@irca. 12 Grosvenor Crescent.irca.org Website: www.org .IRCA Contact Information Address: IRCA. PO Box 25120.
2b) .Session 2 Objectives • Students become familiar with and understand food/ Food Safety Management System (FSMS) terminology including key Food Safety concepts • Students understand the ISO 22000 Process Model and its relationship with the PDCA cycle • Students understand food safety risk management and its significance as a strategic business driver (IRCA K22.214.171.124a) • Students understand the social and historical aspects of public health provision (IRCA K4.1/K4.1.
Key Elements of ISO 22000:2005 ISO 22000:2005 specifies the requirements for a Food Safety Management System (FSMS) that combines the following generally recognized key elements: Interactive communication System management prerequisite programmes CODEX HACCP principles It is a specification for any organization in the food chain ISO/TC 34. Food Products .
ISO 22000:2005 System Management FMEA .
and veterinary drugs Food chain for the production of ingredients and additives Transport and storage operators Primary food producers Producers of equipment Producers of cleaning and sanitizing agents Producers of packaging materials Service providers Food service operators/caterers Retailers Feed producers Regulatory authorities Food producers 2nd food processors Wholesalers Consumers .Scope of ISO 22000:2005 Crop producers Producers of pesticides. fertilizers.
ISO 22000:2005 and the Food Chain .
if we can understand what can go wrong we can prevent it from happening .ISO 22000:2005 Philosophy Old Vision New Vision Do Check Improve Process Inspection Design Plan Audit Correction Action • The primary purpose of a food safety management system is to achieve a balance between a reactive and a preventative approach with greater emphasis or statistical weighting on prevention • Simply stated.
1 .Definition of Food Safety • Concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use ISO 22000:2005 3.
ISO 22000:2005 Process Model Check Act Do Plan .
verifiable evidence that the control measure is capable of delivering the needed objectives See ISO 22000:2005 3.12 Verification – after implementation. See ISO 22000:2005 3. verifying that the control measure functions as intended.Terms that are often confused Hazard = agent causing the illness or adverse health affect.3 Risk = probability of getting ill be ingesting a certain hazard & the severity of that illness Hazard Analysis = Industry task Risk Analysis = Governmental task Monitoring – during implementation.15 .16 Validation – prior to implementation. See ISO 22000:2005 3. verifiable evidence that the monitoring works and the degree of intended control has been delivered See ISO 22000:2005 3.
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 organization’s Food Safety Management System • Provide a basis for continual improvement • Demonstrate a food safety culture within the organization .
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 the requirement for end product testing • Will yield a safer product in less time and at lower cost which will satisfy customers’ requirements • Establishes priority for improvement actions • There is a demand from customers for a recognised food safety standard • Assists new product development • Concept of due diligence .
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 .
intensive production and reduced number 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 .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 to intensive farming.
2.4.3) .2a) • Students understand what is a pre-requisite program and its importance within a FSMS (IRCA K4.4.2c.2c.e.1.d. S4.f.2) • Students determine appropriate operational controls for specifi food safety hazards and evaluate the implementation of operational risk control.1.2f) • Students can evaluate the appropriate attribution of risk to identified hazards and the effectiveness of the organization’s management of risk through its food safety risk assessment and control planning (IRCA K4.f. monitoring and measurement (IRCA S4.Session 3 .1.K4.Objectives • Students understand and can describe the CODEX HACCP based control system (IRCA K4.
CODEX .Application of a HACCP based hazard control system Five Steps • Assemble the HACCP team • Describe the product • Identify the intended use • Construct a flow diagram • Confirm accuracy of the flow diagram Seven Principles • Carry out Hazard Analysis and list the control measures • Determine the Critical Control Points (CCPs) • Establish Critical Limits for each CCP • Establish monitoring system for each CCP • Establish corrective actions • Establish verification procedures • Establish documentation and record keeping .
7 .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 an acceptable level ISO 22000:2005 3.
8 . handling.Definition of a Pre-Requisite Program (PRP) Basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for the production. storage and provision of safe end products and safe food for human consumption ISO 22000:2005 3.
Definition of an Operational Pre-Requisite Program O-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) and safe food for consumption ISO 22000:2005 3.9 .
HACCP/FSMS Relationship .
HACCP based control system v’s 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 the control measure combinations • Full documentation of hazard analysis • Encourages dynamic control systems • Enables a quantitative approach (FSO/PO approach) .
storage and distribution systems Personnel qualification levels and/or allocation of responsibilities and authorizations Statutors and regulatory requirements Knowledge regarding food safety hazards and control measures House of Safe Food House of Safe Food HACCP based control system Food Safety Management System Representative Prerequisite Programs . surrounding environment Cleaning and sanitation programmes Packaging. location of equipment.Products or new products Raw materials. ingredients and services Production systems and equipment Production premises.
2.1.1.Session 4 Objectives • Students understand the evolution of Food Safety Management System Standards and the ISO 22000:2005 series (IRCA K4. K4. K126.96.36.199.2d) Students understand the requirements of ISO 22000:2005 and can apply the requirements consistently in the food chain of relevant food category businesses (IRCA K4.2b) • .
Evolution of ISO 22000:2005 Standard Series • • • • CODEX HACCP principles National and voluntarily to International Management Standards ISO 9001:2000 and 15161:2002 ISO 22000:2005 Standard series .
second and third party verification Is aligned with other management systems standards (ISO 9001:2000. ISO 14001:2004) • .ISO 22000:2005 Standard Series Objectives • • • Complying with CODEX HACCP principles Harmonizing voluntarily to international management standards Provides a specification for requirements that can be assessed and achieve certification. either self declaration or for first.
Traceability in the feed and food chain – General principles and guidance for system design and development. ISO 22005.ISO 22000:2005 Standard Series ISO 22000:2005 is the first in a family of standards that includes the following documents: • ISO/TS 22004. • • . November 2005. ISO/TS 22003. Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems. Food safety management systems – Guidance on the application of ISO 22000:2005. providing harmonized guidance for the accreditation (approval) of ISO 22000 certification bodies and defining the rules for auditing a food safety management system .first quarter of 2006. provides guidance for ISO 22000.
e.3.g. Eurepgap (IRCA K4.1d) . K4. BRC.3.5d) • Students understand the existence of private schemes and their differences in content and operations.3.1c.3.1b) • Students understand the system of accredited certification including the functions of the Accreditation Bodies and Certification Bodies (Registrars) (IRCA K4.Session 5 Objectives • Students understand the International Accreditation Forum (IAF) interpretations and guidelines for 3rd party Certification Bodies (Registrars) (IRCA K4.
(IAF) is the world association of Conformity Assessment Accreditation Bodies • Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Inc. .International Accreditation Forum (IAF) • The International Accreditation Forum.
IAF Guidance documents are not intended to establish. subtract from or add to the requirements of any ISO/IEC Guide but simply to assure consistent application of those Guides.nu . interpret.IAF Guidance Documents GD Series • IAF publishes Guidance documents commonly called GD documents.iaf. • Copies of all published IAF Guidance to the application of ISO/IEC Guides are available at www.
Infra-structure for Registration of Management Systems International Accreditation Forum Regional Accreditation National Accreditation Board(s) Application For Accreditation Quality/ Environmental Management Systems EN45012 Product Approval EN45011 Personnel Approval EN45013 NAB AUDIT Certification Body Application for Registration Audit & Surveillance by Certification Body Industry Consumers and Purchasers .
Attestors/Attestation bodies and Certification Bodies or Registrars • Provide accreditation in line with their accreditation field Certification Body • Provide a service in line with the requirements of the EN 45000 series/ISO Guide 62 and shortly ISO 17021:2006 • Provide certification in line with their accredited scope • Issue a Certificate of Registration to organisations who meet the requirement of the relevant System Standard .Roles Of Accreditation & Certification Bodies Accreditation Body • Operate the Accreditation system for Laboratories.
Types of Conformity Assessments • Preliminary Assessment (Mock/Trial) • Initial Registration assessment (System) • Surveillance assessment (Partial) • Follow-up assessment (Partial) • Re-registration assessment (System) .
Private Schemes . developed and introduced the BRC Food Technical Standard to be used to evaluate manufacturers of retailers own brand food products.brc. • The Standards are available in Food. Packaging and Non GM Food Standards • Further details on the BRC can be found on their website http:// www.uk . Consumer Products.BRC • In 1998 the British Retail Consortium.org. responding to industry needs.
It has subsequently evolved into an equal partnership of agricultural producers and their retail customers.EurepGap • EurepGAP started in 1997 as an initiative of retailers belonging to the Euro-Retailer Produce Working Group (EUREP).org . • EurepGAP has Standards covering fruit and vegetables. integrated farm assurance. The standards are based on best practices.eurep.Private Schemes . Our Mission is to develop widely accepted standards and procedures for the global certification of Good Agricultural Practices (GAP). integrated aqua culture assurance. green coffee etc. flower and ornamentals. • Further details on EurepGAP can be found on this website http://www.
2.2c) • Students understand the different methods of controlling and managing documents and the implications for Auditors .2c) • Students understand the importance of documents of external origin.2c) • Students know what the key document types looks like including their contents (IRCAK4.2. how they should be controlled and managed including the difference between auditable standards and guidance documents (IRCA K4.4.Session 6 Objectives • Students identify and describe the documents and records required by ISO 22000:2005 including hierarchy and benefits of a documented FSMS. This includes the difference between a document and a record (IRCA K4.
Objectives of ISO 22000:2005 Standards • ISO requires (and always has required) a “Documented food safety management system”. implementation and updating of the FSMS. and not a “system of documents” • ISO 22000:2005 allows an organisation flexibility in the way it chooses to document its FSMS. when necessary . This enables each individual organisation to develop the minimum amount of documentation needed in order to demonstrate the effective development.
Typical FSMS Documentation Hierarchy POLICIES OBJECTIVES Hazard Analysis/ Control Measure Combinations PROCESSES SUPPORTING DOCUMENTATION .
Benefits of a documented FSMS • • • • • • Demonstrate conformity + compliance Due Diligence Communication Training & Development Marketing Auditing .
4..2.4) . and the interaction between the food organization and the relevant authorities (IRCA K4. codes of practice etc.4.Session 7 Objectives • Students understand the framework of relevant regional.1) • Students have the skills to evaluate the capability of an organization to maintain compliance with legislative requirements (IRCA S4. national and local legislation.4) • Students have the skills to determine the legislative and regulatory items appropriate to specific food chain activities and the appropriate activities for an organization to maintain compliance with legislative and regulatory requirements (IRCA S4.
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 • Major incidents involving impact on human health • Labeling • Use of Harmful substances • Hygiene Standards • Enforcement controls .
Issues for Industry • Consumer concerns • Consumer information/Rapid Alerts • Prohibition of certain substances • Labelling • Food safety enforcement controls • Food safety legislation .
• National – Establishment of National Food Safety Agencies – Sector Quality Schemes • Local – Service contracts – Switch from reliance on inspection alone to audit and inspection . EFSA) – Closer integration with International Bodies.“The Response” • International – Establishment of the Food Safety Agency (FDA.g. e. United Nations’ Codex Alimentarius. World Trade Organisation etc.
Business Response • Stronger emphasis on quality • Adoption of HACCP based control systems • Support Quality Schemes – Bord Bia (Ireland) .
Types of Legislation • Regulations – same law throughout Community • Directives – sets out aims to be achieved for countries to enact local laws • Decisions – as regulations but addressed to specific individuals. companies or states • Recommendations – not binding. but may influence policy .
wholesome and healthy • Protect human health • Promote international action to tackle regional or global problems .European Union Food Safety Policy Objectives • Food must be safe.
European Union Food Safety Policy Principles • Aim for a high level of protection • Shared responsibility • Precautionary principle. where appropriate • Subsidiary principle .
Topics of Legislation • • • • • • • • • • • Food Law. European Food Safety Authority Hygiene Residues BSE GM Food Hormones Supplements Contaminants Additives Labelling Flavourings .
6. reference 7.3. reference 188.8.131.52 Product withdrawals.2 Hazard analysis. reference 7. reference 5.1c Internal Communication.2. reference 7. reference 5.10. 5.3. Awareness and training.1 Documents Control.2a Prerequisite programmes (PRPs) reference 7.ISO 22000:2005 Requirements • • • • • • • • • • • General Requirements.4.4a.3 Process steps and control measures.b . reference 5.5.2b External Communication.2 Management Commitment.1b.2.3 Product characteristics. reference 184.108.40.206/7. reference 7.2h Competence. reference 4.
4.2b) Students have a methodology for assessing the effectiveness of an organization’s employee competence system and it’s contribution to business performance (IRCA K4.Session 8 Objectives • Students have a common definition of employee competence and are able to distinguish between training and competence (IRCA K4.2b) • • .2b) Students understand the critical elements of employee competence including the relationship with organization capability and performance (IRCA K4.4.4.
skills and experience .ISO 22000:2005 Human Resource Requirements • People are competent rather than qualified • Organizations must provide training or other actions to satisfy competency needs and the training or actions must be evaluated for effectiveness • Personnel in the organization must be aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives • Training records need to include education.
controlling work or processes) • Minimum competencies for managers and supervisors. namely soft (visible leadership. family of positions or cluster of jobs • There are essentially two types of competencies. scheduling. whereas for hourly personnel the focus is typically on the hard skills . good listening skills) and hard (planning.ISO 9000:2005 Definition of Competency • ISO 9000:2005 defines competency as “the demonstrated ability to apply knowledge and skills” – what a person needs to be doing to demonstrate he or she is competent • Competencies needs to be defined for hourly and management staff • Competencies may be established for a specific position.
principles.Session 9 Objectives • • • Students understand the scope. terms and requirements 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 the effectiveness of an organization’s internal audit program Students will understand the life cycle of an audit and key activities (IRCA K4.3.2a) Students will understand the competencies required by Auditors including the relevance of ISO 17024:2003 • • .
as well as on audits the management of audit programmes It is discretionary whether or not QMS and/or EMS audits are conducted separately or together This International Standard can be applied to other management system standards • • • .Introduction and Scope of ISO 19011:2002 • Both the ISO 9000 and ISO 14000 series of standards emphasise the importance of audits as a management tool for monitoring and verifying the effective implementation of an organization's policy for quality and/or environmental management This International Standard provides guidance on conducting internal or external QMS and/or EMS audits.
Audit independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. • Audit findings. provided by the audit team after consideration of the audit objectives and all audit findings • Auditor. person with the Auditor competence to conduct an audit • Audit Programme. set of one Programme or more audits planned for a specific time frame and directed towards a specific purpose • Audit Plan. set of policies. outcome of conclusion an audit. • Audit criteria. relevant to the audit criteria and verifiable.Key Terms • Audit. a systematic. criteria procedures or requirements • Audit evidence. evidence statements of fact or other information. description of the Plan activities and arrangements for an audit . results of the findings evaluation of the collected audit evidence against audit criteria. records. • Audit conclusion.
Principles of Auditing • Ethical conduct – the foundation of professionalism • Fair presentation – the obligation to report truthfully and accurately • Due professional care – application of diligence and judgment in auditing • Independence – the basis for the impartiality and objectivity of the audit conclusions • Evidence-based approach– the rational method for approach reaching reliable and reproducible audit conclusions in a systematic audit process .
3.Auditor Competency Auditor Competence Quality Quality Specific knowledge and skills (220.127.116.11) Generic knowledge and skills (7.2) Environmental / Food Safety Environmental /Food safety Specific knowledge and skills (7.3.1 and 7.4) .
2.3b) Students can identify potential emergency situations and can evaluate the planning and capability of an organization to respond to emergency situations (IRCA S4.4c and S4.2a) Students understand the process methodology for assessing top management in a (FBO) (IRCA K18.104.22.168) • • • .Session 10 Objectives • Students understand the process approach including its significance when auditing management systems (IRCA K4.5.2a) Students know how to assess the capability of a process and its relationship with a Food Business Organization (FBO) objectives (IRCA K4.3.
Understanding the Process Approach • ISO 9000:2005 defines a Process 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 value Data should be gathered to establish process capability and analyse process performance including input and output characteristics • • .
The P-D-C-A Cycle ACT How to improve next time PLAN What to do ? How to do it? CHECK Did things happen according to plan? DO Do what was planned .
Approach to Audit Planning • Verify the organization’s role in the food chain including scope of registration sought • Understand the organisation’s food safety goals and objectives including alignment with the food safety policy • Understand and verify the Food Safety Management System framework • Develop the Audit Plan based on the process steps within the organization’s food chain/scope of registration sought • Develop process based Checklist(s) .
namely outputs from one process typically form part of inputs into subsequent processes • Simply stated.Understanding the system approach to management • Individual processes rarely occur in isolation. a food safety management system comprises a number of interrelated processes • Inputs and outputs of these processes can often be related to both internal and external customers • Customer feedback of a process output is an important input to the continual improvement of an organization’s FSMS .
High-Level Process Map S S U P P L I E R S I P Model O C C U S T O M E R S Inputs Process Outputs .
SIPOC Example Suppliers Inputs Process Outputs Customers Various Statutory & Regulatory HACCP Plan FSMS team Codex Guidelines Customer Product Requirements Scientific Data Codex Customer Scientific Source Hazard Analysis O-PRP Plan Auditors Process Steps Preliminary Data Hazard Identification Hazard Evaluation Validation of Control Measure Combinations .
awareness.Emergency Preparedness and Response • Identifying potential emergency and accidents • Emergency and accident response procedure • Emergency and accident response command and control structure • Competence. and training • Emergency preparedness and response plan • Periodic review and testing. where practical .
3c.6e) Students understand the purpose of 1st. pre-registration. initial registration.3) Students understand the need for effective communication with the Auditee throughout the audit process (IRCA K3.2a) Students understand the qualities and responsibilities of auditors and the management responsibilities of the Lead Auditor in managing the audit and the audit team (IRCA K3.5b) • • • .3. K3. and 3rd party audits (IRCA K3.3. 2nd. surveillance and re-registration and the difference between them from an audit perspective (IRCA K3.Session 11 Objectives • • Students understand basic audit terminology Student understand the audit terms.3.3.3.
results of the findings evaluation of the collected audit evidence against audit criteria. • Audit conclusion. Audit independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. evidence statements of fact or other information. outcome of conclusion an audit. provided by the audit team after consideration of the audit objectives and all audit findings • Audit client. organisation or client person requesting an audit • Auditee. set of policies. description of the Plan activities and arrangements for an audit . one or more team auditors conducting an audit. organisation being ee audited • Auditor.Key Terms • Audit. • Audit findings. • Audit criteria. a systematic. relevant to the audit criteria and verifiable. criteria procedures or requirements • Audit evidence. supported if needed by technical experts • Audit Plan. records. person with the Auditor competence to conduct an audit • Audit team.
Audit Types & Roles Internal External 1st Party Audit of one’s own organisation Audit of a Supplier by a Customer Audit by an independent Body 2nd Party 3rd Party .
Conformance / Effectiveness ISO Standard FSMS Documentation Operational Practices .Systems vs.
Main Purpose of 1st Party Audits • To determine if the Food Safety Management System conforms to the agreed audit criteria • To ensure the Food Safety Management System has been effectively implemented and maintained • To review the efficiency and effectiveness of its processes • To identify opportunities for improvement .
Main Purpose of 2nd Party Audits • To evaluate the degree of conformity to customer product criteria • To evaluate the effectiveness of the supplier’s Food Safety Management System • To identify opportunities for improvement .
Main purpose of 3rd Party audits • To provide objective evidence of conformity with the criteria/requirements of ISO 22000:2005 • To provide objective evidence of the degree of effectiveness of the Food Safety Management System • To identify opportunities for improvement .
Personal Qualities of an Auditor • • • • • • • Precise Reasonable Objective Fair Energetic Sensitive Supportive • Integrity • Organised • Not afraid of reporting the facts • Astute and analytical • Listener • Sensitive to local customs PROFESSIONAL’S .
commission. discount or any other profit • To keep the audit findings confidential • Not to act any any way prejudicial to the reputation or interest of the audit organisation or credibility of IRCA • Co-operate fully in any formal enquiry procedure . gift.IRCA Code of Conduct • To act in a trustworthy and unbiased manner • To disclose any potential conflict of interest • Not to accept any inducement.
Communication during the Audit • 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 of the audit • The Lead Auditor should communicate to the auditee/audit client any – Significant risks identified during the audit process – Concerns about any issues outside the audit scope – Evidence which indicates audit objectives are unattainable .
in a timely manner • Comply with audit organization’s audit rules and guidelines .Auditor Responsibilities • 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.
Lead Auditor Duties and Responsibilities • 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 Responsibilities • Support the Lead Auditor • Co-ordinate and manage the Sub-team • Communicate to other team(s) • Assemble evidence • Report (verbally or in written form) when requested • Be available for follow-up reviews .
Trainee Auditor Duties and Responsibilities • Conduct the audit under the supervision of a Competent Auditor/Lead Auditor • Provide feedback to audit organization on learning experience • Establish and maintain good relations with employees • Comply with audit organization’s audit rules and guidelines .
Technical Expert Duties and Responsibilities • Conduct the audit under the supervision of a Competent Auditor/Lead Auditor • Take notes • Establish and maintain good relations with employees • Comply with audit organization’s audit rules and guidelines .
Translator Duties and Responsibilities • Comply with audit organization’s audit rules and guidelines • Conduct the audit under the supervision of a Competent Auditor/Lead Auditor • Take notes • Establish and maintain good relations with Audit team and employees .
focus on the audit process • Maintain confidentiality • Provide feedback to own organisation on learning experience .Observer Duties and Responsibilities • Not to influence or interfere with the audit activity .
when requested • Obtaining additional support documentation.Guide Duties and Responsibilities Assist the Auditors during the audit process by: • Conducting the Auditors from area to area • Introducing area manager(s) + employee(s) • Occasionally providing clarification. if requested • Ensure rules concerning site safety and security procedures are known and respected by audit team members .
findings or audit conclusion • Provide feedback/input to the client on audit findings and/or audit performance • Due professional care .Consultant Duties and Responsibilities • Not to influence or interfere with the audit activity.
processes. and data and records • Ensure the audit team receive open co-operation throughout the audit . when requested • Support the agreed audit plan • Provide access to people. products.Auditee Responsibilities • 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 and support services. areas.
3.2d) Students have the knowledge and skill to develop and technically assess a process based checklist (IRCA K3.4f) Students have the skill to conduct a document review.2a) Students have the skill to develop an audit plan based on the scope of registration sought and the food chain process steps of the organization (IRCA K3.4e. f.3. determine its conformity and whether there is adequate arrangements to justify proceeding with the on-site audit (IRCA K3.4b. S3.3.4. S3.Session 12 Objectives • • Students know the activities and task to be completed during the planning phase of the audit life cycle (IRCA K3.3. c.1) Students know how to approach an organization which does not have a formal documented FSMS based on ISO 9001:2000 (IRCA K3.4. S22.214.171.124 S3.3.2e) • • • .4a.
if required .Main activities during the Planning Phase Initiating the Audit • Agreeing the audit objectives. scope and criteria • Communicating with the Auditee/Audit Client • Determining the feasibility of the audit Preparing for the Audit • Forming a competent audit team/audit team assignments • Developing an audit plan • Creating process based checklists • Holding an audit team briefing.
Observers and the need for Guides . including records • Provide information on proposed timing and audit team composition • Establish what. if any applicable site safety rules and PPE • Make arrangements for the audit • Agree attendance of Trainee Auditors.Establishing Initial Contact with the Auditee • Establish communication channels with Auditee Representative/FSMS Team Leader • Confirm the authority to conduct the audit • Request access to relevant documents.
Determining the Feasibility of the Audit • Verifying and validating the data provided by the Auditee • Conducting a preliminary document review • Conducting a preliminary audit visit .
Audit Team Selection
• Audit objectives, scope, criteria and estimated duration of the audit • Statutory, regulatory, contractual and accreditation/ certification requirements • Overall competence of the audit team to needed to achieve the objectives of the audit including audit team assignments • Independence from the activities to be audited including conflict of interest • Ability of the audit team to interact with the auditee and work together • Availability
What is an Audit Plan?
• Description of the activities and arrangements for an audit ISO19011:2002
Factors to be considered when developing an Audit Plan
• The audit objectives, scope and criteria including the role of the organization in the food chain • The product categories, processes and locations/shifts where 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
Audit Team Briefing • Introduce team members • Present a briefing statement about the auditee • Assign roles and responsibilities • Distribute relevant audit working documentation • Ensure specialist team members / technical expert are clear on the area(s) they need to focus on • Discuss any queries with the audit plan • Reconfirm commitment. availability and independence and impartially of the audit team .
What is a Checklist? • A structured list of points to evaluate • Identifies and communicates the scope of an audit • An Auditor’s tool to gather evidence and provide an audit trail • Guides the course and controls the pace of an audit .
Benefits of a Checklist • Helps an Auditor understand the food safety hazards. processes and control measures associated with the food chain process/activity assigned by the Lead Auditor/Audit Plan including its significance for the auditor • A record agreed audit criteria was checked and audit objectives fulfilled • Helps an Auditor manage time in line with the audit plan and covers agreed audit criteria • Assists future audit preparation .
Key points when developing a Process-Based Checklist • Audit objectives and criteria • Audit sample/time available • Format of checklist • Food categories • Associated risks/hazards and control measures associated with the food categories • Risk assessment techniques in place .
Types of Checklists Standard • Ready formatted • Facilitates consistency across different area(s) • Uniform questions • Can be inflexible • Not suited to all types of audit Customised • Constructed as and when needed • Usually specific to a particular audit • Assists preparation by Auditee • Demonstrates professional approach by Audit team .
5b) Students have the skill to be able to run an Opening Meeting (IRCA K3.5b) .5b.3.3.3a) Students know the typical agenda for an Opening Meeting (IRCA K3.4.3.Session 13 Objectives • • • Students understand the reasons for an Opening Meeting (IRCA K3. S3.
Reasons for an Opening Meeting • Cover the main points of the audit plan • 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 • Confirmation of the objectives. scope and criteria of the audit • 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 Opening Meeting • 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 gathered at an Opening Meeting • 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 and security procedures for the audit team • What management’s commitment is • What the real power structure is .
3) • • • .4.3.3) Students know how to manage difficult situations while obtaining audit evidence (IRCA S3. the requirement for audit evidence and the primary methods for obtaining audit evidence (IRCA K3.4.5d) Students understand and demonstrate the communication skills required to obtain audit evidence (IRCA S3.3.5e) Students understand the benefits and limitations of sampling (IRCA K3.Session 14 Objectives • • Students know the activities and tasks to be completed investigative phase of the audit life cycle Students understand the term audit evidence.
Main activities during the Performance Phase • Opening Meeting • Gathering Evidence • Writing Audit Finding Reports • Collating and generating the Final Audit Report • Preparing for the Closing Meeting • Closing Meeting .
safety. and environment of the product or service b. the quality.What is Evidence? Qualitative or quantitative information. or statements of fact pertaining to: a. measurement or test and which can be independently verified . to the existence and implementation of a food safety management system requirement which is based on observation. records.
Procedure for Gathering Evidence Question/Analyze Observe/Analyze Check .
where necessary . where necessary • Verify responses.General Points on Questioning Techniques • 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.
• Information • • • • • • How What When Where Who Why Verification • Show me
Types of Questions
• Open • Closed • Hypothetical • Obvious • Answered
• People • Product and service • Processes • Information systems
Taking Notes • Employee names and job titles • Product identification • Quotes and statements • Rough sketches • Surroundings • Issues which may impact other functions/Audit team members .
Mental Notes • Workload • Employee behaviour • Management approach • Organisation • Knowledge of business and applicable standards • Reactions .
Reaching Audit Conclusions Sources of information Collecting by appropriate sampling and verifying Audit Evidence Evaluating against audit criteria Audit Findings Reviewing Audit conclusions .
Sampling • Sample frame/Sample • Representative • Random • Reduced time and costs .
Role of the Technical Expert • Listen • Watch • Audit • Provide expertise • Take notes .
Importance of Audit Team Performance • Keep to the original audit plan • Auditor/Lead auditor checks progress regularly • Manage delays .
Communication Skills • Verbal • Body language • Style and tone of speech • Facial • Range of literacy .
Handling Difficult Situations • Time Wasting • Discrimination • Hostility • Avoidance • Finger Pointing • Usurping Control • Flattery • Undermining • Deception • Obstruction .
4b. when.3.b) Students are able to write both a non-conformity (NCR) and Opportunity for Improvement (OI) audit finding (S3.e) Students understand who gets a copy of the audit report.6a.d) Students understand the contents of an audit report and are able to write one (IRCA S3.4.4a. and the retention period • • • .3.Session 15 Objectives • Students understand what a non-conformity audit finding is and the typical content of a non-conformity and are able to describe and apply the risk classification system used (IRCA K3.
or the failure to implement and maintain. one or more food safety management system requirements. on the basis of available objective evidence. raise significant doubt as to the safety of the product the organization is supplying A nonconformity exists where there is evidence of a failure to comply with a requirement of a: • Statutory and regulatory requirement Product or Service Specification Customer requirement Process and procedure Food Safety Management System requirement . or a situation which would.What is a Nonconformity? • The absence of.
Typical Root Causes of Nonconformities • Organisation structure • Management System Standard • Education and training • Resources • Adherence to defined processes and procedures • Management leadership and support • Information • Legal & Regulatory Requirements .
g. on the basis of available objective evidence. • An observation/Opportunity for Improvement is a remark by an Auditor which warrants clarification or investigation so as to improve the overall effectiveness and/or efficiency of the organization's Food Safety Management System. or a situation which would. on the basis of available objective evidence. • A Minor nonconformity is where there is a defined and documented system which generally satisfies one of more food safety management system requirements. the system and/or one or more processes have not reached an acceptable maturity level. . raise concern as to the potential safety of what the organization is supplying. e. raise significant doubt as to the safety of what the organization is supplying. or a situation which would.NCR Definitions • A Major nonconformity is where there is a total break-down or absence of objective evidence to satisfy one or more food safety management system requirements.
An Audit Report is • A summary or record of the outcome of an audit. scope and criteria . in line with the agreed audit objectives.
Contents of an Audit Report • • • • • • • • • • • • • • Audit objectives. scope and criteria Statement of the confidential nature of contents Audit conclusions Strengths and Weaknesses Number of nonconformities (including classification) and observations. if any Nonconformity/Observation Reports Recommendations (risk assessment audit findings). if any Obstacles encountered Follow-up activities Audit Plan Audit Checklists (Appendix) Identification of the Lead Auditor and team members Identification and contact details of Auditee Opening/Closing Meeting Minutes .
namely to get management commitment to act on the findings • 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 Reporting Principles • Never loose sight of the basic aim of an audit.
Audit Report Approval • The Auditor/Lead Auditor should sign and date the final audit report signifying the audit objectives have been met and the fact the report is accurate and complete • The Top Executive and/or Food Safety Team Leader should sign and date the report to signify agreement with and commitment to act on the findings .
it should be available within an agreed timescale • It should be retained in accordance with Audit organization policy and/or regulatory requirements . Timing & Retention • Distribution should be limited to the Food Safety Team Leader and the audit organisation • Ideally it should be available for the Closing Meeting.Audit Report Distribution. If not.
f) Students understand the ISO policy on recommendations and offers of advice Students understand the importance of audit follow-up.4g) • • .4.3. corrective action and CAPA process including responsibilities including the objective evidence required to demonstrate effective implementation of CAPA (IRCA K3.4e. d. the terms correction. S3.6c.Session 16 Objectives • • • 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 Students know how to manage situations where the organization’s QMS is deemed not to conform and to correctly assess the maturity of the organization’s QMS and risk to the integrity of the registration and supplier approval (IRCA S3.4.
Activities to be covered during the Final Team Meeting • Review the audit findings against the audit objectives • Agree the audit conclusions (recommendation) recommendation • 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) .
Process for Collating the Audit Findings
• • • • • • • • • Collate all the information 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 (recommendation) recommendation Decide the follow-up strategy (recommendation)
Lead Auditor’s Facilitation Role
• Lead and maintain control • Create a positive team climate • Use the synergy of the audit team • Remain objective • Distil and analyse the audit team’s finding’s 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 • 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 a negative message • Check the tone and choice of language used
Offers of Advice – Are they a good idea? • Promotes a spirit of “were here to help” • There is no obligation on the part of the Auditee organisation to implement offers of advice • There are risks associated with giving advice .
however the risks albeit small still exist . There is greater scope to give advice in an internal audit.Risks associated with Offers of Advice • Ownership • Possible confusion in roles • Legal and financial Therefore. never give advice in an external audit.
Contributions during the Closing Meeting • The Lead Auditor should always lead and manage the 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 member to take minutes of the meeting and record attendance .
Audit Follow-up. why is it important ? • Corrective action takes place in a timely manner • Corrective action is effective and suitable • The real benefits of the audit can be realised • The effectiveness of the audit programme can be measured .
5b) Students have the skill to manage a Closing Meeting and evaluate proposal for corrective action (IRCA K3.5b.5b) Students know the typical agenda for a Closing Meeting (IRCA K3.3.g) Students understand the audit records to be maintained during the life cycle of an audit Students understand the methods for improving audit performance including the importance of improving audit performance • • .3.Session 17 Objectives • • • Students understand the reasons for a Closing Meeting (IRCA K3.3.4. S3.e.f.4b.
if appropriate. on the time period for the auditee to present a corrective action plan . and to agree.Purpose of a Closing Meeting • To verbally present the audit team’s findings and conclusions in such a manner that they are understood and acknowledged by the auditee.
if used Auditee • • • • • Top Executive/Manager Food Safety Team Leader Functional Representative(s) Guide(s) (Optional) Employees (Optional) .Who attends the Closing Meeting? • Audit Team • Lead Auditor • Auditor(s) • Observer(s).
and criteria • Representative sample statement/confidentiality • Audit conclusion .A Typical Closing Meeting Agenda • Re-statement of audit objectives. scope.executive summary • Audit findings – detail • Follow-up activities • Obtaining ownership and commitment • Reporting • Questions .
businesslike and polite at all times • Avoid traps • Timing .Hidden Agenda • Preparation • Objectivity • Control • Constructive attitude • Professional.
unless a variation is granted .Evaluating CAPA Proposals? • The Lead Auditor or assigned Auditor technically assesses the proposed corrective and preventative action and root cause analysis data • Ideally the Auditor/Lead Auditor who raised the audit finding should verify and validate closure of any nonconformities raised • CAPA proposals should be received and reviewed within 10 calendar days or sooner and verified + validated and closed out within 12 weeks.
Methods for Closing Out Corrective Actions • Documentation review • Re-audit .Partial .Full .
Audit Objective • To obtain commitment to act on findings so that the ‘real’ benefits of an audit can be realised. • The ultimate Auditor is the consumer! .
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