Unit of competency details

Unit descriptor 

This unit of competency covers the skills and knowledge required to verify and confirm validation of food safety programs in the context of food safety legislation and client requirements.

Application of the unit 

At the time of writing the terms and definitions relating to the audit process were consistent with and further described in the international standard ISO/IEC 19011:2002, 'Guidelines on quality and/or environmental management systems auditing'.

Users of this unit should refer to the current ISO standard and current food safety legislation.

This unit applies to conducting on-site audits and is relevant to regulatory and commercial food safety system auditors who may be auditing low, medium or high risk food safety hazards. When this unit is applied to regulatory auditing it should be noted that the National Food Safety Audit Policy for regulatory auditing, requires that this unit must be pre or co-assessed with:

• FDFAU4002A Communicate and negotiate to conduct food safety audits
• FDFAU4004A Identify, evaluate and control food safety hazards.

When applied to conducting regulatory food safety audits of high risk food businesses or processes, additional units relevant to the specified business or process may be required to meet the National Food Safety Audit Policy.

Prerequisite units 

Employability skills 

This unit contains employability skills.

Elements describe the essential outcomes of a unit of competency.

Performance criteria describe the performance needed to demonstrate achievement of the element. Where bold italicised text is used, further information is detailed in the required skills and knowledge section and the range statement. Assessment of performance is to be consistent with the evidence guide.

ELEMENT 

PERFORMANCE CRITERIA 

1. Define the scope of the audit

1.1. Audit scope is identified and defines the extent of the audit to meet legislative and audit client requirements

1.2. Audit criteria meet legislative and client requirements

1.3. The definition and levels of non-conformity and related reporting responsibilities are identified consistent with legislative requirements and client requirements

1.4. Evidence required to address audit scope and criteria is identified and appropriate collection methods are selected

1.5. Food safety management system documents are reviewed to determine adequacy for the purposes of the audit

2. Plan the audit

2.1. An audit plan is developed that includes definitions and levels of non-conformity to meet the audit scope

2.2. Activities and responsibilities for the audit are identified

2.3. Audit timing (as required by legislation and/or client) is identified, including timetable for each stage of the audit

2.4. Resource, personnel and reporting requirements are identified

2.5. Follow up and completion procedures are identified

2.6. Communication protocols are established to facilitate the effective exchange of information and suited to the auditee environment

3. Conduct the audit

3.1. Information on the audit scope and methodology is communicated in an effective and timely manner

3.2. Stages and activities of the audit process are followed

3.3. Methods used by the food business to carry out preliminary work, identify food safety hazards and assess level of risk are reviewed to confirm that they are appropriate and correctly applied

3.4. Evidence used by the food business to support identification of control measures and establish control limits is identified and evaluated to determine adequacy and relevance

3.5. Methods used by the food business to control hazards and determine corrective action where processes are identified as not meeting targets or critical limits are reviewed to confirm they are adequate, effective and appropriate

3.6. Evidence is collected to confirm that the documented food safety policies and procedures are working effectively, reflect actual practice and are consistently applied

4. Manage the audit process

4.1. Audit progress is monitored against the audit plan and any variation to plan is identified and addressed

4.2. Circumstances requiring the audit plan to be adjusted are identified and negotiated in a timely manner

4.3. Audits address audit scope and are conducted within time and resource constraints to meet quality and professional standards

4.4. The audit process is reviewed to identify opportunities for improvement

5. Consolidate audit outcomes

5.1. Evidence is analysed and assessed to identify any areas of non-compliance with legislation and/or client requirements as appropriate to the audit scope

5.2. Non-conformities are identified and classified as agreed by the audit plan

5.3. Non-conformities are reported in accordance with agreed client and/or legislative requirements

5.4. Audit findings are communicated to the auditee

5.5. Audit reports and/or certificates are prepared and submitted or presented as required to meet regulatory and client requirements

5.6. Corrective actions proposed by the auditee in response to non-conformances are reviewed for compliance with the template or food safety program

5.7. Audit findings are reviewed to confirm that evidence is appropriate and sufficient and findings are accurate

5.8. The food safety management system is reviewed to identify areas of potential improvement of the system according to audit scope

6. Confirm and close out corrective actions

6.1. Implementation and effectiveness of corrective actions are monitored and verified and any variation to the food safety plan is identified and addressed

6.2. Audit records are maintained to record corrective actions

REQUIRED SKILLS AND KNOWLEDGE 

This section describes the skills and knowledge required for this unit.

Required skills 

Ability to :

• locate relevant commonwealth, state and/or territory legislation, regulations and related codes of practice and determine the legal responsibilities of food businesses relevant to the industry sector
• plan and manage audit activities
• communicate information in ways appropriate to the purpose and the audience and to facilitate opening and closing meetings
• negotiate and facilitate audit processes, including following meeting procedures and resolving issues
• select and use research skills relevant to audit activities, including researching technical sources to validate food safety programs and collecting evidence to support verification
• consolidate audit findings based on objective evidence
• prepare records and reports appropriate to the purpose of the audit and the needs of the auditee and the client (system owner/regulator)

Required knowledge 

Knowledge of :

Auditor roles and responsibilities 

• audit activities and stages, including guidelines on audit stages and activities as outlined in ISO 19011:2002
• personal attributes required of food safety auditors, including those outlined in ISO 19011:2002, and additional client requirements where required
• role, responsibilities and powers of enforcement agencies, authorised officers and commercial auditors, including reporting responsibilities, legal liability of auditors and delegation of authority to commercial auditors as may apply in some states and territories
• relevant competencies and certification/registration criteria and processes applying to both regulatory and commercial auditors
• audit management to develop and implement an audit against an agreed plan, including the scope/level of authority to revise the resource and allocate time allocations to take account of variation to plan

Food safety management systems 

• purpose and intent of each element of a food safety management system
• the underlying principles of risk-based approaches to controlling food safety hazards, including HACCP as described in the Codex Alimentarius Guidelines
• vocabulary and terms relating to food safety, including terms and jargon to describe technical processes, industry standards and common biological and chemical terms
• food safety management system knowledge relevant to the system being audited., including system requirements, definitions and levels of non-compliance and related reporting responsibilities as defined by legal and management system requirements
• the interaction between different types of management systems, including the impact of food safety decisions on other management systems, such as occupational health and safety (OHS), quality, environmental risk management and animal welfare
• technical knowledge required to assess the adequacy of the food safety management system performance and corrective actions
• role of prerequisite programs in controlling hazards, including the relationship between prerequisite programs and risk-based approaches, such as HACCP to controlling food safety hazards
• information handling and management system protocols, including issues, such as rights of access to information, maintenance of confidentiality of audit information and reports and information dissemination requirements

Food safety legislation 

• the purpose and intent of food safety legislation, including sources of information on importing country requirements and of requirements of countries and retailer driven systems in importing markets
• the content covered by the Food Standards Code and/or other relevant standards
• the structure and responsibilities of commonwealth, state and territory government departments and local government to manage and implement food safety legislation, including where to find information on relevant commonwealth, state/territory legislative requirements, product or industry sector legislation and regulations and import and export market requirements
• the regulatory framework and specific legislation relevant to the audit, including relevant risk profiling or classification systems where they apply
• sources of information on legislation and codes governing primary production and primary processing
• requirements for scheduling and conducting further auditing as determined by food safety legislation and/or client system requirements
• legal liability of auditors and protection against litigation and professional practice issues, including the circumstances under which an auditor could be prosecuted and insurance requirements
• the role of auditors when called on to provide evidence as a witness in court

Food safety audit processes 

• preliminary work required to identify food to be covered by the food safety program, define the food and the method of distribution, identify customers and intended use of food, describe the process (flowchart) and check accuracy and completeness
• methods used identify food safety hazards and assess food safety hazard risk levels taking account of severity and likelihood of occurrence
• methods used to identify critical control points and establish critical limits, suited to the nature of the hazard, the requirements of the audit and the industry sector
• methods used to validate control techniques and critical limits, including industry or sector codes of practice, technical standards and research
• types of evidence, including the difference between objective and hearsay evidence and methods for recording and managing evidence to provide reliable reference information in the event that evidence is challenged
• evidence collection methods, including record sampling and sample analysis, and the evidence collection options relevant to a given audit situation, the reliability of each collection method and the range/extent of evidence collection methods required to ensure that audit outcomes are objective, consistent, fair and reliable
• methods to assess skill requirements and options to confirm that the responsible personnel within the food business have the required skills and knowledge of food safety and food hygiene relevant to the food business
• circumstances, implications and responsibilities in the event that the auditee requests that the audit ceases
• circumstances and authority of an auditor to initiate cessation of an audit
• understanding of the context in which audits are conducted, including workplace culture and preferred communication methods, industry, process and/or product knowledge and related jargon
• information recording requirements and audit reporting requirements

EVIDENCE GUIDE 

The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment 

A person who demonstrates competence in this unit must be able to verify and confirm validation of food safety programs in the context of food safety legislation and client requirements.

Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competency in this unit must be achieved in accordance with food safety standards and regulations.

Critical aspects for assessment and evidence required to demonstrate competency in this unit 

Evidence of the ability to:

• Identify food safety legislation applying to a food business. Legislative requirements may relate to actual or hypothetical food businesses. A minimum of two scenarios must be covered providing that at least one food business operates in a market segment that has to meet compliance requirements in place of or in addition to the Food Standards Code. One such market segment is export meat processors who must comply with the Export Control Act and the Export Meat Orders.
• The assessment activity must:

• identify the relevant legislation applying to the food business taking account of the industry sector, range of food handling activities undertaken and the markets into which products and/or services are sold.
• locate advice on relevant authorities and enforcement agencies in a state or territory and for international markets as appropriate.
• explain the legal responsibilities of a given food business.

• Plan and conduct an audit that complies with legal and client requirements as appropriate. The criteria and evidence requirements may be developed to apply to an actual or hypothetical food business. The assessee must substantiate:

• how audit scope and criteria meet legislative and client requirements.
• the evidence required to assess compliance with the criteria and to support an objective, reliable and consistent audit outcome.
• definitions, levels and related reporting of non-conformance to comply with legislative requirements.

• Submit completed audit records for the selected audit including the final audit report, non-conformity reports, corrective action reports, follow up reports and suggestions for improvements to the food safety management system and to the audit process. These latter items may be documented in personal notes rather than part of the formal audit report according to the audit scope.

Context of and specific resources for assessment 

Competency may be assessed in an actual workplace or simulated environment that provides access to the required resources. At least one of the audit scenarios should be assessed in an actual workplace context.

Assessment is to occur under standard and authorised work practices, safety requirements and environmental constraints.

The following resources must be available:

• food safety plans
• food safety-related documentation typical of commercial manufacturing businesses and used for the purpose of verification
• evidence and documentation relevant to processes that would typically be used by commercial manufacturing businesses to support validation processes
• plant and equipment that would typically be used in a commercial manufacturing business.

Method of assessment 

The following assessment methods should be considered to gather sufficient and valid evidence of competency:

• observation, including the completion of documentation to show the planning and conducting of an audit
• a report on the legal responsibilities of the food business
• questioning to test the level and application of knowledge
• documentation to show validation and verification processes used
• completion of all audit records.

The whole audit process must be witnessed by the assessor.

Assessment methods must satisfy the endorsed Assessment Guidelines of FDF10 Food Processing Industry Training Package.

Guidance information for assessment 

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

RANGE STATEMENT 

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Food safety audits 

Audits may be conducted for either regulatory or commercial food safety systems for low, medium or high risk food safety hazards

Licensing /certification requirements 

Licensing and registration arrangements are determined by system owners

Audit scope 

The audit scope describes the purpose, extent and boundaries of the audit. This may include:

• physical locations
• products
• processes
• time period covered by the audit
• extent of authority of the auditor

Legal requirements 

The scope of the audit determines and may be determined by food safety legislation which may include:

• Food Standards Code
• relevant state legislation and related codes of practice, including industry sector-specific legislation and related codes of practice, such as those relating to meat, seafood, dairy and primary production and processing
• regulatory and commercial requirements relevant to importing countries
• commonwealth legislation (e.g. Export Control Act)
• other legislation which may impact on the conduct of a food safety auditor and may include legislation covering:

• OHS, anti-harassment, anti-discrimination and industrial relations
• trade practices legislation
• environmental risk management
• legal contracts or agreements

Audit client 

Audit client refers to the organisation or person requesting an audit (system owner). This may be the same as the auditee or any other organisation which has the regulatory or contractual right to request an audit.

The system owner may be the regulator

Auditee 

Auditee refers to the organisation being audited

Audit client requirements 

Client requirements are typically defined in audit contracts or agreements and may relate to:

• legal requirements
• food safety management system requirements
• compliance with client site operational policies and procedures
• confidentiality
• business size, activities and processes
• business culture
• professional standards of conduct

Audit criteria 

The audit criteria must comply with relevant food safety legislation and may extend to address additional system owner/client requirements. In addition to meeting the requirements of food safety legislation, reference against which conformity is determined may include:

• management systems policies and procedures
• industry standards or codes
• contractual requirements
• international treaties and conventions

Levels of non-conformity 

Levels of non-conformity are defined and based on food safety risk. They may be determined by:

• the management system
• the audit client
• legislation
• where legislation applies, definitions may be determined by:

• state and territory authorities
• AQIS
• primary industry jurisdiction
• primary food production jurisdiction

Audit evidence 

Evidence required for the purposes of meeting relevant food safety legislation may be defined by:

• the client and/or the regulatory authority

Audit evidence should be based on objective information rather than hearsay and may include:

• system records

• evidence collection records
• statements of fact or other information relevant to the audit criteria and which is verifiable
• observations
• records of audit stage progression

Evidence collection methods and sources 

Evidence collection methods and sources will depend on the purpose and scope of the audit and may include:

• observation
• interviews
• checklists
• auditee documentation review
• reports/data from other sources, such as customer feedback, technical references, computerised databases
• results of analyses

Food safety management system 

A food safety management system is a documented arrangement implemented (and resourced) by a business for control of food safety. A food safety management system includes:

• commitment from management, procedures and practices to identify and control food safety hazards and prevent their recurrence. It may incorporate recognised food safety tools, such as HACCP and its prerequisite programs

Resource requirements 

Resource requirements will depend on the purpose and scope of the audit and may include:

• audit personnel directly involved in undertaking the audit
• access to relevant personnel and information within the business
• access to any additional resources as required

Food businesses 

A food business refers to a business, vehicle, enterprise or activity where food is produced, processed, stored, displayed, transported and/or sold. It may also include primary producers

Preliminary work 

Preliminary work includes but is not limited to:

• identifying food to be covered by the food safety program
• defining the food and the method of distribution
• identifying customers and intended use of food
• describing the process (flowchart)
• checking for accuracy and completeness of the previous steps

Validation 

Validation refers to obtaining evidence to confirm that a HACCP-based food safety program is complete and effective and will deliver the expected food safety outcomes

Verification 

Verification refers to methods and procedures used to carry out monitoring, including sampling and testing to provide evidence that the specifications set by relevant legislation and codes of practice continue to be met

Audit records 

Audit records are maintained to demonstrate the implementation of the audit process. These may include but are not limited to:

• audit plans
• audit reports
• non-conformity reports
• corrective action reports
• follow up reports

Close out 

Auditors have different levels of responsibility and authority to close out audits according to the level of non-conformity and whether they are an authorised officer or a commercial auditor. Closing out may involve notifying the regulator with the power to enforce legislation

Commercial auditor 

Commercial auditor refers to any auditor other than a regulatory auditor, who is external to and independent of the food business being audited

Risk-based approaches 

Risk-based approaches to controlling food safety are typically based on HACCP, described in the Codex Alimentarius guidelines

Prerequisite programs 

Prerequisite programs are also referred to as support programs, such as Good Manufacturing Practice (GMP), Good Agricultural Practice (GAP) and Good Hygiene Practice (GHP)

Prerequisite programs can be divided into two categories.

Infrastructure and maintenance programs . These may include:

• layout, design and construction of buildings and facilities
• supplies of air, water, energy and other utilities
• equipment, including preventative maintenance, sanitary design and accessibility for maintenance and cleaning
• support services, including waste and sewage disposal

Operational prerequisite programs . These may include:

• personal hygiene
• cleaning and sanitation
• pest control
• measures for the prevention of cross-contamination
• packaging and labelling procedures
• supplier assurance
• chemical storage
• employee training
• maintenance
• calibration
• document control
• internal audit programs
• traceability and recall programs
• on-farm food safety schemes
• inspecting and testing regimes, including analytical and microbiological testing

Critical control point 

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

Critical limit 

Critical limit refers to criterion which separates acceptability from unacceptability

Unit sector 

Food safety auditing

Competency field 

Co-requisite units