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Registered establishment guide to the approved auditor management system


ContentsIntroduction..................................................................................................................................................................3

Purpose and scope.....................................................................................................................................................4

Approval process for a registered establishment to engage an approved auditor........................7

Managing the audit process...................................................................................................................................9

Approval of approved auditors..........................................................................................................................16

Managing the approved auditor........................................................................................................................22

Appendix 1—Legislative basis for the approval of auditors.................................................................25

Appendix 2—Contact list......................................................................................................................................27

Appendix 3—Legislation, Australian standards and the department’s guidelines....................28

Department of Agriculture and Water Resources

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Introduction The Department of Agriculture and Water Resources (the department) is the Commonwealth authority responsible for the regulation of prescribed goods prepared for export as food from Australia. This maintains the integrity of the exported product and Australia’s reputation as a reliable exporter.

The department’s role in providing export inspection, audit and certification services helps retain wide access to overseas export markets.

As a result of the service delivery models agreed with the fish, dairy and meat export industries to support export certification reform in 2011, it has been agreed that the audit of registered establishments that prepare fish, eggs, dairy and some meat products for export may be undertaken by persons approved by the department to carry out this activity – Approved auditors.

To facilitate this, the department has implemented the ‘Approved auditor management system’ to approve, manage and verify the performance of persons other than department employees to conduct audits of registered establishments on the department’s behalf. The system is based on both legislative requirements and the requirements of the National Food Safety Audit Policy and the National Regulatory Food Safety Auditor Guideline (copies of these documents can be found at www.health.gov.au) and aims to reduce duplication of audits for registered establishments.

Audit of export and domestic requirements

Currently, a number of state regulatory authorities (SRAs) have responsibility for the conduct of audits, at registered establishments on the department’s behalf. Conversely, in some jurisdictions the department may conduct audits of export registered establishments for compliance with both export and domestic requirements- these latter audits are conducted on behalf of SRAs.

The department may approve auditors to audit on its behalf in all Commonwealth jurisdictions.

Where the department is responsible for the audit of both domestic and export requirements, the approval of approved auditors only applies to audits of export requirements.

Auditors who also wish to audit domestic requirements must make application to the appropriate food regulator in that jurisdiction for approval.

In order to determine if approval as an auditor is applicable to a specific jurisdiction or a specific commodity (i.e. fish, dairy, eggs and/or meat); reference should be made to the service delivery arrangements information available at: www.agriculture.gov.au/export/from-australia/documentation-registration-licensing/audit-arrangements.

It should also be noted that for some commodities, an importing country may place restrictions on who can undertake audits. For example, establishments that prepare or store meat for export to the United States of America may only be audited by an auditor employed by the department.


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http://www.agriculture.gov.au/export/from-australia/documentation-registration-licensing/audit-arrangements

http://www.agriculture.gov.au/export/from-australia/documentation-registration-licensing/audit-arrangements

http://www.health.gov.au/


Purpose and scope This guide is provided by the department to inform the occupiers of registered establishments of the system that has been implemented to manage the approval process for both the approved auditor and establishments.

Approved auditors under this system, may include independent, third party or commercially employed auditors, but due to potential conflicts of interest may not include persons in the direct employ of the department registered establishment subject to the audit.

Definitions

In this document, terms have the following meaning:

Approved auditor: is an auditor approved by the Secretary (or delegate of) under Schedule 10 of the Export Control (Eggs and Egg Products) Orders 2005, Export Control (Fish and Fish Products) Orders 2005, Export Control (Milk and Milk Products) Orders 2005 and/or Schedule 9 of the Export Control (Meat & Meat Products) Orders 2005, Export Control (Poultry Meat and Poultry Meat Products) Orders 2005 or Export Control (Wild Game Meat and Wild Game Meat Products) Orders 2010.

AMS: Audit Management System—the department’s electronic system that manages all aspects of audits.

Approved arrangement (AA): the food safety management system in place at a registered establishment, which is approved by the department for the identification, control, monitoring, review and reporting of food safety hazards and compliance with legislative and importing country requirements.

Registered establishment: refers to an export registered establishment engaged in the preparation (including storage, handling and loading) of prescribed goods for export.

Introduction to the departments approved auditor management system

The department has developed and implemented the ‘Approved auditor management system’ to:

approve, manage and verify the performance of persons other than the department’s employees – known as approved auditors – who conduct audits of registered establishments on the department’s behalf

manage the approved auditor

approve registered establishments to engage the services of an approved auditor

manage the regulatory audit process.

The responsibility for activity in the regulatory audit process is shared between the department, approved auditors conducting regulatory audits and the registered establishments that require regulatory audits.


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For additional information on the legislative framework and the legislative basis for the approval of auditors, See Appendix 1—Legislative basis for the approval of auditors.


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The role and responsibility of the department

As part of effectively demonstrating compliance with legislative and National Food Safety Auditor policy requirements, the department has systems in place to approve, manage and verify the activities of authorised officers and approved auditors, to approve registered establishments to operate under the approved auditor management system and, where applicable, respond to audit findings and results of verification activities.

Within this system, the department maintains responsibility for any enforcement action that needs to be taken in response to audit outcomes.

The role and responsibilities of the occupier of a registered establishment

The role of the occupier of a registered establishment is to ensure compliance with legislative requirements through the effective implementation and maintenance of their approved arrangement (AA).

The occupier of a registered establishment is responsible for ensuring that:

the department’s approval to engage an approved auditor is sought

their premises and AA is audited at the frequency outlined in the applicable departmental guideline.

The approved auditor engaged under the system has the appropriate scope of approval, including the appropriate commodity risk classification, to conduct the regulatory audit.

As per the requirements of the legislation1, all necessary assistance is provided to the auditor as is reasonably necessary to enable them to perform the audit of their operations, including, but not limited to:

the provision of information, explanation, documents, translations and demonstrations of use of equipment; and

allowing the auditor to interview their employees, agents or contractors and export permit issuers; and

allowing the observation of their procedures; and

use of their equipment for the purposes of accessing, examining, testing, sampling, recording or reproducing any documents or thing at their premises; and

bringing onto the premises any equipment required to perform the audit.

Any corrective action agreed to be taken to address audit findings is implemented and reviewed for effectiveness within the timeframes specified in the audit report.

1 Order 65 of the Export Control (Fish & Fish Products) Orders 2005, Order 60 of the Export Control (Eggs & Egg Products) and (Milk & Milk Products) Orders 2005 and Order 59 of the Export Control (Meat & Meat Products) Orders 2005, (Poultry Meat & Poultry Meat Products) and (Wild Game Meat & Wild Game Meat Products) Orders 2010


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The occupier and the approved auditor are responsible for organising and managing the audit process. The department is not involved in any contract negotiations or agreement between the occupier and an approved auditor.

Failure to comply with these requirements may result in a direction being given to the occupier by the department to comply or the revocation of approval to engage an approved auditor. Where approval has been revoked, audits will be conducted by the department.

The role and responsibilities of approved auditors

The role of the approved auditor is to conduct regulatory audits of a registered establishment’s compliance with:

the applicable requirements of the Act and the commodity Orders, and

the requirements of the establishment’s food safety management system, known as an AA including any conditions that may apply, and

the applicable importing country requirements identified in the establishment’s AA.

For all aspects of the preparation (including storage, handling and loading) of the commodity or commodities for export as food that falls within the scope of the auditor’s conditions of approval and commodity risk classification.

The approved auditor is responsible for ensuring that:

The necessary knowledge, training, skills and experience required to conduct audits are maintained, including the maintenance of any competencies or qualifications specified in the approval criteria.

Audits conducted are objective, independent, fair and accurate and, unless otherwise stated in the audit report are completed.

Audits are conducted as expeditiously as possible and in a way that causes as little interference as possible to the operations which may be the subject of the audit.

Any additional documented procedures provided by the department in relation to the conduct of audits are complied with.

The approved auditor code of conduct is complied with.

The department is informed immediately of any circumstances that may affect the approved auditor’s approval with regards to criminal activity or real or perceived conflicts of interest.

A current approved auditor identity card can be presented on request.

Failure to competently undertake these responsibilities, which will be verified, may result in the department revoking auditor approval or requiring the approved auditor to take agreed corrective action which may include, but is not limited to, the undertaking of additional training.


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Approval process for a registered establishment to engage an approved auditor To be approved by the department to engage the audit services of an approved auditor, a registered establishment must:

be eligible; and

apply to the department.

Eligibility

Registered establishments wishing to engage the services of an approved auditor must meet the following minimum conditions:

have a satisfactory compliance history; and

have an AA that is approved without conditions; and

have no outstanding enforcement action against it.

Where the department utilises an A to E rating system to indicate establishments’ audit performance, an establishment must have achieved at least a C rating at the audit prior to application. Registered establishments on a D or E rating will be audited by the department until a satisfactory performance level is achieved and successful application is made t by the establishment to engage an approved auditor.

Other eligibility conditions may be set by individual food export programs. Registered establishments should contact the department’s food export programs for more information.

Registered establishments are under no obligation to move to this system. The department will continue to perform audits of establishments that choose not to adopt this system.

Apply to the department

Registered establishments seeking approval to engage the services of an approved auditor must apply to the department using the registered establishment application form found on the department’s website.

A contact list for all enquiries relating to establishment approval is provided at Appendix 2—Contacts.

Multiple establishments

Where approval is being sought by an occupier for a number of establishments, a separate application form must be completed for each establishment. Eligibility will be considered on the basis of the individual establishment.

Assessment of application


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http://www.agriculture.gov.au/export/from-australia/approved-auditors/registered-establishment-application-form


Upon receipt of the application form, the department will review the application and determine the suitability of the establishment based on eligibility and any additional conditions that may be a requirement of the food export program. These additional conditions may include the requirements of an importing country with whom the establishment is listed for export and service delivery arrangements applicable in the establishment’s state or territory of operation.

Notice of approval

Establishments will be notified in writing of the approval, which will specify: the establishment commodity risk classification(s) which is determined by the commodities prepared and the food safety risk posed by the operations conducted at the establishment, and the frequency at which audits are to be conducted to comply with departmental requirements.

A copy of this written approval must be retained by the occupier and produced during audits. Failure to produce this letter will result in the approved auditor immediately terminating the audit and notifying the department.

Registered establishments that are not assessed as eligible to engage an approved auditor will continue to be audited by the department or the SRA conducting audits on behalf of the department.

An approval may be revoked by the department providing a notice in writing given to the registered establishment.

Duration of approval

Once approved, the registered establishment shall continue to utilise the services of approved auditors until such time as they choose to return to departmental audits, their performance at audit drops below the program minimum or their approval to engage an approved auditor is revoked by the department due to enforcement action.

Engaging an approved auditor

It is the responsibility of the occupier of a registered establishment to arrange for an approved auditor to conduct the audit at the frequency specified by the department.

The department is not involved in the contractual arrangements between the registered establishment and the approved auditor.

Following are the steps to engaging an approved auditor:

access the approved auditors register on the departments website: www.agriculture.gov.au/export/from-australia/approved-auditors/registerofapprovedauditors

The register includes: auditor name, contact details (phone and e-mail only), commodity risk classification/s, operating regions (see below).

ensure that the approved auditor is approved to conduct audits for your establishment’s commodity risk classification/s.

contact the approved auditor and schedule an audit at the frequency specified by the department.


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http://www.agriculture.gov.au/export/from-australia/approved-auditors/registerofapprovedauditors


Operating regions of approved auditors

Approved auditors are approved to audit within the entire Commonwealth. However, to assist establishments in finding an approved auditor within their local area, the state/s and/or territory/s in which the auditor has elected to deliver services is provided.

Managing the audit processThe department has developed procedures for managing the audit process where auditing of registered establishments is undertaken by approved auditors.

The following section provides details of the duties of approved auditors and the overarching procedures that must be complied with for the conduct of regulatory audits of registered establishments.

Duties of approved auditors

An approved auditor conducting audits of registered establishments on behalf of the department has the following duties:

to carry out audits of the AA approved and in place at the registered establishment

to carry out any necessary follow-up action, including further audits, if necessary, to determine whether action has been taken to remedy any deficiencies of any such AA identified in an audit

to audit and report in accordance with legislation and the departments requirements.

Scheduling the audit

Prior to scheduling the audit, approved auditors must ensure that the occupier of the registered establishment has written approval from the department to engage an approved auditor.

It is the responsibility of the occupier of the establishment to engage an approved auditor with the appropriate commodity risk classification to conduct their regulatory audit. The registered establishment and the approved auditor are then responsible for organising and managing the audit process.

These two parties must ensure that audit frequencies determined by the department as applicable to the establishment being audited are met, taking into consideration that audit frequency may vary dependent on audit findings.

Observation of processes

Audits must be scheduled to coincide with production to enable actual processing operations to be observed. However, where the establishment to be audited is a vessel where processing occurs at sea, audits should be scheduled where possible to coincide with vessel unloads to provide access to product and crew.


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Auditing of multi-sited food businesses

Irrespective of whether an occupier operates from many sites, each site is an individual registered establishment and must maintain their own AA and records and be audited against that establishment’s AA.

The AA used on site must accurately reflect how export requirements and food safety issues are being managed on that site.

Audit teams

There may be instances where teams of approved auditors, rather than individual approved auditors, are required to carry out regulatory audits. Under these circumstances the lead auditor of the audit team will be required to ensure that all auditors undertaking work as part of the audit team are approved auditors and have the appropriate commodity risk classification to conduct such audits.

Planning the audit

Audit criteria

All audits of registered establishments must be conducted against the appropriate audit criteria – that is, the requirements of the Act, the applicable commodity Orders and where applicable the Australian Standards as referenced in the commodity Orders. Audit criteria can include the AA as the system to ensure compliance with the requirements of the legislation. Criteria may also include applicable importing country requirements where identified in the establishment’s AA.

The departments audit report templates include provision for selecting and indicating the applicable criteria.

The approved auditor should ensure that they have access to all relevant legislation applicable to the type of registered establishment that is to be audited. Copies of this legislation and any applicable Australian Standards and department guidelines should be on hand during the audit for easy reference.

See Appendix 3 for a list of legislation, Australian Standards and department guidelines and details of where these documents can be accessed.

Audit scope

The departments audit report templates detail the scope of the audit in the form of a list of elements that are to be audited and include provision for selecting the elements that are actually audited at a given audit.

It is a departmental requirement that, regardless of the frequency of audit, all elements are audited within a 12-month period. It is the responsibility of the approved auditor to ensure that this requirement is met through effective audit planning, consideration of audit frequency and the elements audited at previous audits.

Where an establishment’s hazard analysis identifies critical control points (CCPs), the department requires the audit of the HACCP element at each audit.


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Documentation review

Where an approved auditor requires documents for review prior to the on-site audit, the auditor must make the request directly to the occupier (or their agreed representative) of the establishment to be audited. The department does not provide copies of AAs or HACCP plans directly to approved auditors.

As part of audit preparation or entry meeting, the approved auditor is to obtain and review copies of the previous audit report/s including any corrective action requests.

It is a requirement of the Export Control (Prescribed Goods – General) Order 2005 that an establishment display a current copy of their certificate of registration. This document provides details of the commodities and operations that the establishment is approved by the department to prepare and undertake. The certificate of registration also provides details of the persons listed as being in management and control at the establishment and may include details of importing country listings. This document should be available and reviewed for currency at each audit.

Conduct the audit

All audits must be conducted at the registered establishment to be audited.

The time taken to perform the audit is not predetermined. An audit shall continue until the approved auditor is satisfied that the audit of all elements of scope required to be reported to the department have been completed effectively.

The table below outlines the minimum requirements expected when conducting a regulatory audit of a registered establishment.

Table 2: Minimum requirements for conducting an audit of a registered establishment.

Audit activity Minimum requirements

Entry meeting Approved auditor to present identity card on request. Appropriate management must be present and recorded. Auditor to detail the audit criteria and the scope of the audit. Previous audit report/s reviewed and discussed. Where required, outstanding non-compliances discussed, including evidence

and verification that corrective action taken has been effective. Current department Certificate of Registration to be available and reviewed

for accuracy. AA is available and on site. Monitoring records and any other documents applicable to the audit are

available, current and on site.Any changes to activities, products or processes conducted at the registered establishment that may affect the establishment’s food safety risk and/or compliance with legislative requirements are reviewed.

Conducting the audit

Audit of approved arrangement including:

review of amendments to AA


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review of audit elements as specified on department audit Report template

review of HACCP plan inspection of the registered establishment and observation of processing trace back of export eligible product transferred to another

establishment or exported to source / supplier to determine effective procedures to identify and trace product

review of export documentation (where applicable may include a review of procedures for the completion/validation of export documentation).

Review objective evidence to determine and classify any non-compliances identified.

Document non-compliance/s identified.

Where, in the approved auditor’s opinion, a non-compliance identified is to be classified as critical, the department is to be contacted immediately as direction may be required to be given by an authorised officer to the occupier for the cessation of processing for export.

Exit meeting—conducted at completion of the audit

Appropriate management to be present and recorded. Audit findings to be presented including details of any non-compliances

identified. Agree appropriate corrective action/s, including the evidence to be

presented and the timeframes required for closure of any corrective action requests (CARs) issued as a result of non-compliances identified.

Overall audit outcome to be presented and discussed. If a critical non-compliance has been identified, the occupier must be informed that they will be contacted by the department regarding the action to be taken.

Date of next audit to be confirmed. Copies of completed, acknowledged audit reports and non-compliance

reports / CARs must be provided to both the occupier and the department within 14 days of the date of audit.

The occupier and approved auditor are responsible for ensuring that all non-compliances are actioned and CARs are closed out within the agreed timeframes.

Audit findings

Audit reports must clearly state the audit findings, that is:

Whether in the auditor’s opinion the audit was satisfactorily completed or was terminated prior to completion.

Whether in the auditor’s opinion the following have been complied with and the reasons for those opinions:

The applicable requirements of the Act and the applicable commodity Orders. The requirements of the AA and its conditions. The applicable importing country requirements.


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For all aspects of the operations in relation to the commodity for export as food covered under operations.

Approved auditors must act on non-compliances observed during the audit by classifying and documenting them as CARs or non-compliance reports.

Classification of non-compliances

The department requires the classification of all non-compliances identified at audit and all non-compliances that are critical which are summarised as follows:

Critical non-compliance:

Division II of Part 6 of the fish, egg, milk, meat, poultry and wild game commodity Orders requires that should an approved auditor identify a failure (or a combination of failures) that amounts to a critical non-compliance, the approved auditor must notify the department immediately.

A critical non-compliance when used in relation to the audit of a registered establishment means a failure (or a combination of failures) to comply with any of the following:

A requirement of the Act or the Orders. The requirements of any applicable approval, including an approval of an AA. The applicable importing country requirements.

that results in, or is likely to result in, the preparation or export of food that:

is not fit for human consumption or its integrity is compromised or does not comply with an importing country requirement or results in or is likely to result in the issue or giving of an export permit or government

certificate that is inaccurate or incomplete or prevents an accurate assessment being made as to the above.

Under no circumstances can an approved auditor take enforcement action or act as a department authorised officer. At any time where an approved auditor feels that enforcement action is necessary, they must contact the department immediately.

Major non-compliance:

Where a requirement of the legislation has not been addressed.

An activity that is in direct contravention of the legislation.

An activity that is in direct contravention of a procedure and could have a significant effect on product or legislative compliance.

Minor non-compliance:

An isolated incident of a non-compliance with a system or procedural requirement with no direct consequential effect on product or legislative compliance.

Trends of minor non-compliances could lead to major non-compliance if several incidents of the same deficiency are encountered.

Observations / advisory findings


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Where an observation or advisory finding is made, sufficient detail must be provided to clearly determine that the finding is an observation only and could not be considered as a non-compliance under the definitions provided.

Corrective actions

The corrective action to be taken to address non-compliances identified at audit is to be determined by the occupier of the establishment (or their representative) and detailed on the CAR /non-compliance report. Corrective actions are to be agreed between the occupier and approved auditor that must be taken to prevent the reoccurrence of the non-compliance and must include actions that will effectively address both the immediate and long term (systemic) issues.

CARs should include details of the evidence that the occupier will be required to provide to the approved auditor to demonstrate that effective corrective action has been taken.

Audit outcomes

Audit outcomes are reported as either ‘acceptable’ or if a critical non-compliance is identified as ‘unacceptable’.

Non-compliant

The department may require additional audit/s of the establishment by a department authorised officer.

The purpose of these additional audits by the department is to provide evidence that the establishment has taken steps to comply with their export requirements and has sustained compliance over a period of time.

If the registered establishment continues to not comply, appropriate enforcement action will be taken by an authorised officer of the department.

Copies of enforcement action must be produced by the registered establishment at their next audit.

Audit frequency

Details of the specific commodity audit frequency is detailed in the guideline ‘Department audit regime’ on the department website.

Audit reporting

Approved auditors will be provided with the department audit report templates to be used for the documenting of CARs/non-compliance reports and the audit report.

Templates may be completed either in the department’s AMS system where the approved auditor has been provided with a log-on or in the form of a template to be e-mailed to the department.


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http://www.agriculture.gov.au/export/controlled-goods/dairy/dairy-eggs-fish-export-guidelines/audit-regime

http://www.agriculture.gov.au/export/controlled-goods/dairy/dairy-eggs-fish-export-guidelines/audit-regime


Finalised audit reports, including details of agreed corrective actions and timeframes for action, must be acknowledged by the occupier of the establishment audited and copies provided to both the occupier and the department within 14 days of the date of audit.

It is the approved auditor’s responsibility to confirm agreed corrective actions, receive acknowledgement from the occupier and provide copies to the department within the required 14 day timeframe.

Finalisation/closure of CARs/non-compliance reports

It is the responsibility of the approved auditor to:

Carry out any necessary follow-up action, including further audits if necessary, to determine whether the agreed corrective action has been taken to address the non-compliances identified at audit within the required timeframes.

Provide the department and the occupier with copies of finalised CARs / non-compliance reports within 14 days of completion.

Immediately advise the department when agreed timeframes for the corrective action to be taken have not been met and an additional CAR for failure to take action has been issued.

Escalation policy

Failure by registered establishments to rectify non-compliance within the required timeframe is to be actioned by the approved auditor by:

The issuing of an additional CAR for failure to take corrective action.

Reporting the issuing of the CAR to the department with a maximum timeframe for action of 14 days.

The department will manage the failure to take correction action within agreed timeframes.

Records

Registered establishments

Registered establishments must retain copies of all finalised audit reports and CARs/non-compliance reports. These must be provided to approved auditors for review at entry meetings.

Approved auditors

Approved auditors must use audit report templates as provided by the department.

These documents must be filled in completely and accurately including:

All dates must be recorded as DD/MM/YY.

Establishment numbers must be included where indicated on forms.

References to the name of the company must be the occupier name, not a trading name.


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Names of persons from the establishment who were involved in the audit.

All handwritten notes must be clear and legible.

It is important that approved auditors have a filing and record keeping system for all documents that is consistent and enables accurate identification and timely retrieval of files.

All hand written notes, checklists and computer based documents may be required by the department at short notice. This may be in response to a Freedom of Information request, a Ministerial directive or as part of the department’s verification program.

Approval of approved auditorsAuditors seeking to become an approved auditor must apply to the department and demonstrate that they meet the criteria for approval as described in this section.

Fees

Details of fees are available from the department’s website at:

www.agriculture.gov.au/fees/charging-guidelines

Duration of auditor approvals

The duration of an approved auditor’s approval is 12 months from the date of initial approval, unless revoked. Approved auditors must undergo an annual renewal process to maintain their status.

Approval process and criteria for approved auditors

Auditors seeking to become an approved auditor with the department must apply by completing the Approved auditor application form.

The approved auditor approval process

The approval process consists of the following six steps:

Step 1—Submit application to the department

Applicants will be required to submit a completed application form and supporting documentation that includes:

Personal / contact details.

Consent of the applicant to the publishing by the department of contact details in a public registerer of approved auditors.

Details of approval to work in Australia if not an Australian citizen (certified copies of valid passport/current working/permanent residency visa if applicable).

Photographs (4) and signature sample.

Nomination of the commodity risk classification/s that the applicant is seeking approval for.


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http://www.agriculture.gov.au/export/from-australia/approved-auditors/approved-auditor-application-form

http://www.agriculture.gov.au/fees/charging-guidelines


Details of commodity experience (medium and high risk)

Nomination of region/s of operation.

Details of qualifications—Statements of attainment / technical qualifications (certified copies to be supplied) applicable to the commodity risk classification applied for.

Certified copy of professional indemnity insurance certificate.

Disclosure of any real or perceived conflicts of interest.

Disclosure of any pending criminal charges / denial of approval as a regulatory auditor.

Certified copy of an AFP National Police Check if issued within the last two years.

Certified copies of documents sufficient for a 100 Point Identification Check.

Acknowledgement of having read, understood and agreed to comply with the department’s approved auditor manual and approved auditor code of conduct.

A signed declaration to the accuracy of the information provided.

Commodity risk classification

The department uses the risk classification system defined in Table 1 for commodities and processes to determine: the qualifications and experience required by approved auditors to effectively conduct audits for some commodities.

The frequency of auditing of the AAs implemented by the registered establishments.

Applicants must indicate both the commodity and risk classification for which they are applying and ensure that they have the appropriate qualifications and commodity experience.

Low risk

Low risk classification is not commodity specific—an auditor applying for approval to audit low risk processes may audit any commodity / process classified as ‘low risk’.

Storage includes dry, cool and frozen storage.

Medium risk

Medium risk processes include all processes not specifically noted as low or high and includes processes that result in a product that will be subject to further processing or is intended to be cooked by the consumer prior to consumption. Medium risk classification is not applicable to milk products.

High risk

High risk processes include:

Heat treatment processes where the product is retorted or pasteurised with a nominated refrigerated shelf life and commercially sterile, shelf stable product.

Cook / chill processes where minimally heat processed foods are distributed as chilled products with a defined shelf life.


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Ready to eat fish, egg, dairy and meat processes not included in the definition of heat treatment or cook/chill that result in a ready to eat product.

Processing of bivalve molluscs where in-shore harvesting is included in the process to be audited.

Please note: Where an auditor has been approved for a medium or high risk commodity classification, approval is automatically acknowledged for the lower levels of risk (i.e. medium risk classification includes approval to audit low risk processes, high risk classification includes approval to audit both low and medium), but only for the approved commodities.

Table 1—Commodity risk classification

Risk Fish Eggs Milk Meat Poultry Game

Low Storage, packing live fish

Storage, packing of whole eggs

Storage Storage Storage Storage

Medium Products to be further processed

Products intended to be cooked

Products to be further processed

Products intended to be cooked

N/A Slaughter, boning, processing & packing of raw, chilled or frozen meat

Slaughter, boning, processing & packing of raw, chilled or frozen poultry

Slaughter, boning, processing & packing of raw, chilled or frozen game

High Heat treatment processes

Ready-to-eat

Cook/chill processes

Bivalves

Heat treatment processes

Ready-to-eat



Ready-to-eat



Ready-to-eat meat products








Commodity experience

Applicants applying for medium and/or high commodity risk classifications must be able to demonstrate recent commodity experience, such as relevant qualifications, industry experience and/or audit experience.

Regions of operation

Approved auditors will be approved to conduct audits within all state and territory jurisdictions. However, the approved auditor application form requires applicants to nominate which state/s and/or territory/s they wish to operate in. This will assist registered establishments in locating and engaging an approved auditor within their state or territory.

Applicants may choose to select multiple jurisdictions; however consideration should to be given to SRA requirements (see introduction).

Qualifications

See step 2 for details of the minimum qualification requirements for approved auditors.


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Conflicts of interest

Applicants are required to provide details of any conflicts of interests (real or perceived) that may exist, or may be likely to arise, if the applicant is appointed as an approved auditor. Applicants must provide details of any relationships or positions of management or control that may have been offered, are currently held or have previously been held, in regard to the operations carried out in any registered establishment.

Payment to an auditor for carrying out the functions of an auditor does not constitute a direct or indirect interest in a registered establishment.

Department of Agriculture and Water Resources approved auditor manual

Applicants are required to acknowledge that they have read, understood and agree to comply with the requirements of the approved auditor manual.

The approved auditor manual is available on the department website at www.agriculture.gov.au/export/from-australia/approved-auditors.

Approved auditor code of conduct

Applicants are required to acknowledge that they have read, understood and agree to comply with the requirements of the approved auditor code of conduct.

Where an allegation is made that an approved auditor has breached the code of conduct, the department will investigate the breach and, if confirmed, revocation of the auditor’s approval may occur.

A copy of the approved auditor code of conduct is included in the approved auditor manual.

Step 2—Application assessed by the department in accordance with approval criteria

In addition to meeting the requirements detailed in step 1, applications will be assessed to ensure that the minimum approval criteria are met.

Applicants must demonstrate achievement of the required competencies, qualifications and commodity experience applicable to the scope of their application before the application can be progressed.

It is a requirement of the National Regulatory Food Safety Auditor Guideline that regulatory auditors maintain the following units of competency from the Food Processing Industry Training Package.

FDF10 issued by a registered training organisation (RTO) under the requirements of the Australian Quality Training Framework (AQTF):

Low risk

FDFFSACA / FDFAU4001A—Assess compliance with food safety program (this competency may be superseded by a person who has already obtained competency FDFFSCFSAA/FDFAU4003A)

FDFFSCOMA / FDFAU4002A—Communicate and negotiate to conduct food safety audits


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FDFFSCFSAA / FDFAU4003A—Conduct food safety audits

FDFFSCHZA / FDFAU4004A—Identify, evaluate and control food safety hazards.

Medium risk

In addition to the above listed units of competency, regulatory auditors in the medium classification must hold a Certificate IV or higher in food science or related field (including 40 hours of food microbiology).

High risk

In addition to the above requirements for auditing medium risk classifications, auditors applying for approval to audit high risk processes must, where applicable to the commodity and process being audited, have the following high risk units of competency3:

FDFFSCC4A / FDFAU4006A—Audit a cook chill process

FDFFSHT4A / FDFAU4007A—Audit a heat treatment process (retort and pasteurisation)

FDFFSME4A / FDFAU4008A—Audit manufacturing of ready-to-eat meat products

FDFFSBM4A / FDFAU4005A—Audit bivalve mollusc growing and harvesting operations.

Where application is made for approval to audit processes that result in ready-to-eat fish, egg or dairy products, applicants will be required to provide evidence of experience with both commodity and process.

_______________________

3 Units of Competency FDFFSCOMA / FDFAU4002A, FDFFSCFSSA / FDFAU4003A, FDFFSCHZA / FDFAU4004A are a pre-requisite requirement for any high risk units

Exemplar Global certification (formerly known as RABQSA) equivalence

The following RABQSA issued units of competency NFS 1-4 will be accepted as equivalent to the 4 nationally recognized units of competency for auditing where an auditor has applied for either low or medium risk commodity risk classification:

RABQSA-NFS1: Assess compliance of food safety programs

RABQSA-NFS2: Communicate and negotiate to conduct food safety audits

RABQSA-NFS3: Conduct food safety audits

RABQSA-NFS4: Identify, evaluate and control food safety hazards

Auditors seeking approval for high risk commodity approval must provide evidence of having obtained the applicable AQTF pre-requisite and high risk units of competency as listed above.

Units of competency

Additional information on training packages, units of competency and registered training organisations (RTOs) able to provide Statements of Attainment in the above listed units of competency can be found on the National training Information Services website www.training.gov.au.


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http://training.gov.au/


The department may from time to time alter the required qualifications of approved auditors. Approved auditors will be notified in writing of any changes to the requirements.

Declarations

If investigation reveals that any information provided by the applicant is intentionally false or misleading, it may result in an application being questioned or rejected outright. If investigation following the approval of a person reveals that substantial false and misleading statements have been made, the approved auditor’s approval will be revoked.

Step 3—Access provided to training in the department’s legislative requirements

Once the initial approval criteria has been met the applicant will be contacted in writing and provided with a personal log-on to a web-based learning management system where training in the department’s legislative requirements is provided and is required to be successfully completed.

Applicant is to advise the department of the successful completion of training.

Step 4—Assessment

On successful completion of the self-paced, self-assessed training at step 3:

Applicants will then be required to undergo an on-site assessment or ‘witness audit’. This assessment will assess the applicant’s skills and knowledge, understanding of the Act and applicable commodity Orders and will verify that the prospective approved auditor can appropriately interpret and apply the applicable legislation.

The assessment will be carried out by a department officer who holds appropriate auditing competencies, technical and educational qualifications and specialised endorsements. The assessment(s) will be conducted to the highest commodity risk classification that the auditor has applied for.

Approved auditors wishing to change or upgrade their scope of approval must re-apply to the department and may be subject to additional assessment.

Notice of approval

Successful applicants will receive a notice of approval which specifies their responsibilities to the department while undertaking the duties and responsibilities of an approved auditor. The notice of approval will include:

Name of approved auditor

Date of approval

Conditions of approval including the following:

Commodity risk classification Scope of approval Code of conduct.


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The scope of approval of the approved auditor will be restricted to the requirements of the legislation and commodity risk classification that the approved auditor has been assessed and approved against. Approved auditors must not conduct audits outside of their scope of approval.

Identity card

The approved auditor will be issued with an identity card. The identity card will be dated and is valid for one year.

Step 6—Listing on the approved auditor register

Approved auditor register

The department maintains a register of approved auditors. This register is publically available on the department website at www.agriculture.gov.au/export/from-australia/approved-auditors/registerofapprovedauditors and will be updated as required. It is the responsibility of approved auditors to ensure that the information they supply for the register is accurate and updated as necessary.

The following information, collected from the approved auditor application form, is the minimum information that will be listed on the approved auditor register:

Approved auditor’s name.

Contact details (phone number and e-mail contact only).

Commodity risk classification.

Operating regions.

Managing the approved auditorThe following section provides details of both the department’s requirements and the responsibilities of approved auditors with regard to management of auditor performance.

Verification system

The verification systems used to check for compliance to set standards, systems and legislative requirements enables the department to assess and monitor the competence and performance of approved auditors.

Verification activities may be scheduled or triggered by complaints, system reviews, trends, audit reports or requests by registered establishments.

Scheduled verification activities

The department will conduct scheduled verification activities based upon the approved auditor’s commodity risk classification. Outcomes of verification activities may result in requests for corrective action, re-training or revocation of approval, if poor auditor performance is identified.

Scheduled verification activities may include:


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an examination of reports made by the approved auditor in the course of auditing operations at registered establishments

an audit of at least one operation that was audited under the applicable commodity Order or Orders within the previous six months by the approved auditor; and/or

observing the auditor while he or she is conducting an audit.

Review of audit reports

Audit reports will be reviewed by the department to ensure compliance with reporting requirements. The following may be included in the review:

audit duration

classification of non-compliances issued

compliance with timeliness of report submission

notification of audit failure or non-completion

notification of critical non-compliances

relevance of non-compliances issued

review of the content of the audit report; clarity of findings.

Approved auditors will be notified in writing of any findings of the review of audit reports. This may take the form of advice or information or it may result in the issuing of a corrective action request.

Refresher training

The department will provide refresher training where required by changes to legislative requirements or procedures. Approved auditors may also be required to undertake refresher training as a result of verification findings.

Changes in requirements and procedures

Approved auditors will be advised of any changes in requirements and procedures by the posting of information to the department website at www.agriculture.gov.au/export/from-australia/approved-auditors.

Maintaining the requirements for approval

Approved auditors are responsible for maintaining the currency of the applicable competencies / technical qualification and annual renewal of approval.

Renewal of approval

Approved auditors are responsible for applying for renewal of approval prior to the expiration date detailed in the notice of approval. Approved auditors must not perform audits without a current approval.

Notification


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All approved auditors must, during the term of their approval, immediately notify the department of any event or information which relates to or may affect the department’s satisfaction that the auditor is a suitable person to be appointed as an approved auditor including:

Unintentional or suspected breach of the approved auditor code of conduct.

Conviction of an offence against the Crimes Act 1914, or another law of the Commonwealth or a law of a state or territory.

Threats, intimidation, bribery against the approved auditor.

Complaints against the approved auditor.

Conflict of interests (real or perceived) of the approved auditor.

Conflict of interests

The approved auditor must notify the department of any direct or indirect interest in any registered establishment that the auditor has, as soon as possible after becoming aware of that interest.

Payment to an auditor for carrying out the functions of an auditor does not constitute a direct or indirect interest in a registered establishment.

The code of conduct also states that a failure to declare any conflict of interests (real or perceived) may result in the revocation of approval by the department.

Confidentiality

The approved auditor code of conduct requires that an approved auditor must not disclose certain confidential information.

The approved auditor code of conduct states that approved auditors must keep all commercially sensitive and official information confidential. If an auditor discloses such information without appropriate consent, their approval may be revoked.

Revocation or variation of approval

Should the department find reason to vary the conditions of or revoke an approved auditor’s approval, the department will notify the auditor in writing. On receipt of that notice, the approved auditor will have an opportunity to make submissions to the department for a review of the decision.

Complaints system

The department’s complaints system is accessible by registered establishments, approved auditors, other jurisdictions and the general public. Complaints may be made via the website, email, phone, or by letter. The complainant may remain anonymous if they wish.


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Procedures for making complaints are detailed on the website at: www.agriculture.gov.au/about/commitment/suggestions-compliments-complaints.


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http://www.agriculture.gov.au/about/commitment/suggestions-compliments-complaints


Appendix 1—Legislative basis for the approval of auditors

The legislation framework2

The framework for the Australian government to regulate prescribed goods for export as food consists of:

an Act of Parliament: the Export Control Act 1982

subordinate legislation made by the Governor-General: the Export Control (Orders) Regulations 1982, and

subordinate legislation made by the Minister: the Orders – specifically:

the Export Control (Prescribed Goods – General) Order 2005

and the ‘commodity’ Orders:

the Export Control (Fish and Fish Products) Orders 2005

the Export Control (Eggs and Egg Products) Orders 2005

the Export Control (Milk and Milk Products) Orders 2005

the Export Control (Meat and Meat Products) Orders 2005

the Export Control (Poultry Meat and Poultry Meat Products) Orders 2010

the Export Control (Wild Game Meat and Wild Game Meat Products) Orders 2010

The Export Control Act 1982 (the Act) is the overarching legislation controlling the export of food and other goods from Australia. The introduction of the Act provided a stable but flexible legal framework for controlling the export of food and other goods.

The Act came into force on 1 January 1983. It has not been significantly altered since that date, but Orders prescribed under the Act – subordinate legislation – have been amended and new Orders have been established in line with changes in markets and industries, and in accordance with international trade agreements.

The Act, its subordinate Regulations and Orders provide the legal basis for:

controlling the export of prescribed goods from Australia

setting conditions and restrictions for the export of prescribed goods

conditions for registering premises for the preparation of goods for export

powers for the Secretary and authorised officers to deal with prescribed goods and premises, and

offences and maximum penalties for contraventions of the Act.

The export legislative framework, through subordinate legislation – specifically, the commodity Orders – provides the Secretary with the power to approve auditors to conduct audits in accordance with legislative requirements.

2 Copies of all legislation cited in this document are available at: www.legislation.gov.au/


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http://www.legislation.gov.au/


Approval of auditors

Schedule 10 of the Export Control (Fish and Fish Products), (Eggs and Egg Products), (Milk and Milk Product) Orders 2005 and Schedule 9 of the Export Control (Meat and Meat Products Orders) 2005, (Poultry Meat and Poultry Meat Products) and the (Wild Game Meat and Wild Game Meat Products) Orders 2010 provide the legislative basis for:

the application and approval process of auditors

assessment of auditor competence

decisions to approve (or not approve) auditors

conditions of auditor approval

conditions for the revocation of auditor approval

period of auditor approval Issuing of identity cards

maintenance of a register of approved auditors.

The Secretary (or their delegate) may approve a person as an auditor for the purposes of auditing registered establishments against the requirements of the applicable commodity Orders when the Secretary (or their delegate) is satisfied that:

the applicant has the necessary knowledge, training, skills and experience to competently carry out audits of the kind for which approval is sought; and

the audits conducted by the applicant will be objective, independent, fair and accurate and, unless stated otherwise in the audit report, will be complete; and

the applicant will comply with the requirements of Division II of Part 6 of the applicable commodity Orders; and

the applicant will comply with documented procedures for the conduct of audits; and

the applicant is a fit and proper person having regard to the matters specified in section 4.05 of the Export Control (Prescribed Goods — General) Order 2005.

Additionally, the Secretary (or their delegate) may:

take into account any real or perceived conflict of interest that could arise if the applicant was to be approved

request that the applicant provide further documents or information

request that the applicant submit to assessment by interview, audit or written examination, or any combination of those ways

apply conditions to the approval.

Appendix 2—Contact listDairy, Eggs and Fish Exports

[email protected]


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mailto:[email protected]


Approved auditor verification.

Learning Management System (LMS) access and issues.

Reporting critical non-compliances—Dairy, eggs, fish.

Reporting requirements (templates).

Technical issues / legislative interpretation.

Witness audits.

Meat Export program

[email protected]

Approved auditor verification.

LMS access and issues.

Reporting critical non-compliances—Meat, poultry, wild game.

Reporting requirements (templates).

Technical issues/legislative interpretation.

Witness audits.

Certification Integrity Unit

[email protected]

Service delivery arrangements.


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Appendix 3—Legislation, Australian standards and the department’s guidelines The following is a list of the legislation, Australian standards, guidelines and industry notices applicable to the auditing of registered establishments that approved auditors are required to have access to and knowledge of prior to undertaking an audit.

Web links are provided to ensure currency of information and it remains the responsibility of the approved auditor to maintain their knowledge of current legislation and relevant guidelines.

All commodities

Export Control Act 1982.

Export Control (Prescribed Goods – General) Order 2005

www.agriculture.gov.au/biosecurity/legislation/export .

Food Standards Australia New Zealand (FSANZ) Food Standards Code www.foodstandards.gov.au/code/Pages/default.aspx .

Fish

Export Control (Fish and Fish Products) Orders 2005


Department of Agriculture and Water Resources guidelines www.agriculture.gov.au/export/controlled-goods/dairy/dairy-eggs-fish-export-guidelines?wasRedirectedByModule=true .

Eggs

Export Control (Eggs and Egg Products) Orders 2005



Milk

Export Control (Milk and Milk Products) Orders 2005



Meat

Export Control (Meat and Meat Products) Orders 2005


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http://www.agriculture.gov.au/export/controlled-goods/dairy/dairy-eggs-fish-export-guidelines?wasRedirectedByModule=true


http://www.agriculture.gov.au/biosecurity/legislation/export







http://www.foodstandards.gov.au/code/Pages/default.aspx




Australian Standard for the Hygienic Production and Transportation of Meat and Meat Products for Human Consumption, (AS 4696:2002).

Department of Agriculture and Water Resources Meat Notices.

Department of Agriculture and Water Resources guidelines

www.agriculture.gov.au/export/controlled-goods/meat/elmer-3 .

Poultry

Export Control (Poultry Meat and Poultry Meat Products) Orders 2010.

Australian Standard for Construction of Premises and Hygienic Production of Poultry Meat for Human Consumption, (AS 4465:2005)


Wild Game

Export Control (Wild Game Meat and Wild Game Meat Products) Orders 2010

Version 1.1 –November 2011 Page 41 of 42.

Australian Standard for the Hygienic Production of Wild Game Meat for Human Consumption (AS 4464:2007)



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