This unit applies to regulatory, commercial or internal auditors.

When this unit is applied to regulatory auditing it should be noted that the National Food Safety Audit Policy for regulatory auditing requires that the unit FDFAU4002A Communicate and negotiate to conduct food safety audits, must be pre or co-assessed with this unit when applied to assessing compliance against approved food safety programs that have been validated by a technical expert.

ELEMENT

PERFORMANCE CRITERIA

1. Plan the audit

1.1. An audit plan is developed to meet the audit scope

1.2. The plan is capable of delivering the required outcomes within resource and time allocations

1.3. Plan includes audit purpose, scope and relevant templates or approved food safety program

1.4. Activities and responsibilities for the audit are identified

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

1.6. Resource, personnel and reporting requirements are identified

1.7. Follow up and completion procedures are identified

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

2. Confirm that the food business has documented required preliminary work

2.1. The food and the method of distribution are defined

2.2. Customers and intended use of food is identified

2.3. The process is described and documented

2.4. The food business has checked their documentation for accuracy and completeness

3. Confirm the food safety program is supported by a tool or template or has been validated

3.1. The documented food safety program and related procedures and prerequisite programs are assessed to confirm that they have a prescriptive tool or have been validated by a technical expert

3.2. The food business method of identifying and analysing food safety hazards is reviewed

3.3. Templates or the approved food safety program are correctly selected to meet audit scope

3.4. Templates or the approved food safety program are appropriately adapted to suit the needs of the business without adversely affecting food safety

3.5. Documented verification records are reviewed to confirm that the requirements of the food safety program are being met

3.6. Corrective actions required where processes are identified as not meeting targets or critical limits are assessed to confirm they meet the requirements of the template or food safety program

3.7. Food safety prerequisite programs are assessed to confirm they are appropriate for the food business/industry sector to maintain a safe food environment

3.8. Food safety program documents are reviewed to confirm currency, accuracy and adequacy to facilitate maintenance of an adequate food safety program

4. Collect evidence to review and assess implementation of food safety programs

4.1. Evidence is collected to confirm that documented programs and procedures are working effectively, reflect actual practice and are consistently applied

4.2. Evidence is collected to confirm that food safety monitoring and corrective actions are carried out according to procedure

4.3. Evidence is collected to confirm that safety prerequisite programs are effective and consistently followed

4.4. Evidence is collected to confirm that food safety records are completed and provide an accurate record of events

4.5. Evidence is collected to confirm that records are accessed and analysed to confirm effective program maintenance in accordance with the template or food safety program

4.6. Evidence is collected to confirm that food safety skills and knowledge of food business personnel is commensurate with their work role

4.7. Evidence is collected to confirm that the food safety program has been internally monitored and assessed, updated and improved by a technical expert

5. Manage the audit process

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

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

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

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

6. Consolidate audit outcomes

6.1. Audit evidence is analysed and assessed to identify any areas of non-compliance with legislation and/or the food safety program

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

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

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

6.5. A corrective action implementation plan defining proposed actions and timelines developed by the auditee is reviewed by the auditor to confirm that template or food safety program requirements are met

6.6. Audit findings are reviewed to confirm that evidence is sufficient as defined by the template or approved food safety program

7. Confirm and close out corrective actions

7.1. Implementation and effectiveness of corrective action is monitored and verified against the template or the approved food safety program

7.2. Audit records are maintained to record corrective actions

Required skills

Ability to:

plan and organise audit activities

identify work processes and work flow

interpret food safety programs including flow charts, standard operating procedures (SOPs), and other process documentation

describe each process step and identify food safety hazards

conduct research to identify, collect and analyse evidence of compliance with food safety programs

use communication skills to support evidence collection and outcome presentation

identify and classify non-compliances

prepare audit reports and certificates to meet regulatory and client requirements

review corrective action implementation plans

monitor the implementation of corrective actions

maintain audit records

Required knowledge

Knowledge of:

required content and scope of food safety programs as defined in the National Food Safety Standard 3.2.1 or other relevant standards

purpose and minimum requirements of risk-based approaches to managing food safety hazards, including the role of prescriptive templates or approved food safety programs in supporting a risk-based approach and the process used to validate these tools

guidelines on implementing industry templates or approved food safety programs

legal requirements of food businesses

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

audit activities and principles, 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 system owner 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

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

evidence appropriate for use in audit processes, 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

vocabulary and terms relating to food safety programs, includign terms and jargon to describe technical processes, industry standards and common biological and chemical terms

common biological, physical and chemical hazards that may occur in the food business and appropriate methods of control and critical limits as outlined in the approved food safety program or template

the impact of (1) the design and construction of premises and (2) the selection, application and condition of equipment, on food safety as defined in Food Safety Standard 3.2.3

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

circumstances, implications and responsibilities in the event that the auditee requests that the audit ceases

circumstances and authority to initiate cessation of an audit

methods to assess skill requirements and options to confirm that the responsible personnel within the food business have the of food safety and food hygiene relevant to the food business

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 assess compliance against an approved food safety program where the program is supported by a prescriptive template or tool or where compliance is checked against a food safety program that has been validated by a technical expert.

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 ability to:

confirm that the food safety program and/or template is appropriate to the activities of the business

review food safety program records to assess compliance against the approved food safety program and/or template

collect and analyse evidence to confirm that the food safety program is consistently followed and controls all critical risks

identify circumstances where variation or customising of the template or food safety program requires further validation

submit non-compliance reports to clearly identify the aspects of the food safety program that have broken down/need further development in order to prevent recurrence.

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 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 required to implement and record the food safety plan

evidence and documentation relevant to processes that would typically be used to assess compliance with the food safety program

plant and equipment that would typically be used in a commercial manufacturing business.

Method of assessment

Assessment methods must satisfy the endorsed Assessment Guidelines of FDF10 Food Processing Industry Training Package. The following assessment methods should be considered to gather sufficient and valid evidence of competency:

observation and a report covering the critical aspects for assessment identified above

questioning to test the level and application of knowledge

workplace example or scenario to allow a valid decision on the compliance of the food safety program to be made, with evidence of recording and feedback.

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.

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 program

Food safety programs include both prerequisite programs and a risk-based analysis of food safety hazards to determine required control measures to eliminate, prevent or reduce hazards. Minimum legal requirements for food safety programs are specified in National Food Safety Standard 3.2.1 or other relevant legislative requirements.

The food safety program may be based on a template or externally developed program that is adapted to the needs of the business

Licensing/certification requirements

Licensing and certification requirements are determined by system owners

Technical expert

The requirements of a technical expert are determined by the system owner. System owners may include:

government regulators as well as private system owners

Audit scope

The 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

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

Legal requirements

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

Food Standards Code

relevant state and territory legislation and related codes of practice, including industry sector-specific legislation and related codes of practice, such as that 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 may include legislation covering:

occupational health and safety (OHS), anti-harassment, anti-discrimination and industrial relations

trade practices legislation

environmental risk management

legal contracts or agreements

Food businesses

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

Food safety program documents

Food safety program documents may include:

documented statements of food safety policy and objectives

documented procedures and records

documented complaints register

documents and records to ensure the effective development, implementation and updating of the food safety program

Risk-based approaches

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

Unit sector

Food safety auditing

This unit contains employability skills.