Audits for goods intended for animal related purposes

Biosecurity officers from the department may need to conduct an audit of offshore manufacturing facilities and export pathways for biological goods intended for:

• animal consumption; or
• veterinary vaccines

Audit process

A desk audit involves reviewing documentation and records provided by the overseas manufacturer to assess compliance with regulatory standards, without visiting the facility.

A site audit includes an in-person inspection of the manufacturing premises to verify operational practices, infrastructure, and adherence to quality systems firsthand.

Desktop audit

Through the desktop audit process, the department’s auditor will determine whether quality management systems are in place within the manufacturing facility, which align with Australia’s biosecurity requirements.

The scope of the desktop audit includes:

• the quality systems in place within the manufacturing facility; and
• procedures, processes, and resources supporting effective controls, which are aligned with Australia’s biosecurity requirements.

The department requires the desktop audit questionnaire to be completed by the overseas manufacturer and any other facilities involved in the export of the goods to Australia.

Submit the completed desktop audit questionnaire to the Animal and Biological Imports Branch using imports@aff.gov.au.

Biosecurity officers from the department will assess the information provided to ensure that biosecurity risks are managed at every link in the chain of manufacture and supply.

Findings of the desktop audit form part of the overarching biosecurity risk assessment.

Desktop audit questionnaire must be completed by:

• the overseas manufacturer
• any other facilities involved in the export of the goods to Australia.

After completing the questionnaire, you will need to submit it to the Animal and Biological Imports Branch using imports@aff.gov.au.

Site audit

A site audit of the manufacturing facility and other export facilities will need to be undertaken when:

• the department’s biosecurity policies dictate this requirement; or
• the facility has not previously manufactured goods for the Australian market; or
• the animal health status in the country of manufacture (and/or the country of origin of one or more ingredients) increases the underlying biosecurity risk level associated with the manufacture of goods for the Australian market; or
• there is high risk biological material held at the manufacturing premises (e.g., animal derived material); or
• cross contamination risks controls associated with shared production lines need to be assessed; or
• there is a history of non-compliance at the manufacturing premises and a site audit is required to verify the effectiveness of corrective actions.

Site audits typically take 1-2 days. This does not include the time for preparation, travel and reporting. The importer is responsible for all associated costs.

Third party site audits for plant-based stockfeed products

For plant-based stockfeed products, the department may permit independent, third-party audit (TPA) service providers to undertake site audits on behalf of the department.

Eligibility for TPA service providers is dependent on:

• existing trade;
• previously audited history; and
• compliance history

More information about the use of TPA service providers can be found in the Guidelines for Engaging Third-Party Audit Service Providers:

If biosecurity officers from the department determine that the site audit can be conducted by a TPA service provider, an assessment of the suitability of the service provider will need to be completed.

Nomination and assessment of TPA service providers

Importers can nominate their preferred TPA service provider. The TPA service provider will need to complete the third-party auditor application form.

Once the department receives the completed application form, a review will be completed to assess the service provider’s suitability to undertake the audit on behalf of the department, including whether they are:

• Competent
• Impartial
• Operating in accordance with ISO/IEC 17021-1:2015 and/or ISO/TS 22003:2013
• Accredited to audit against recognised standards/systems e.g. FAMI-QS, GMP+ international, APVMA GMP; and
• Experienced auditing the biological goods sector or food safety management systems.

See more about our suitability criteria on Guidelines for Engaging Third-Party Audit Service Providers.

Once our assessment is complete, we will notify the importer and the auditor of our decision regarding the suitability of the nominated TPA service provider.

TPA service providers will need to re-submit application forms to the department with each nomination by an Australian importer.

Third party audit team prepare a site audit plan

The department will provide the auditor(s) with a copy of the outcomes of our desk audit. They will also receive the corresponding documents and records to assist them prepare a site audit plan.

Once the department approves the proposed audit plan, the auditor will work with the overseas facility to schedule the site audit.

Third party audit team conducts the site audit and reports outcomes

The third-party auditor(s) will conduct the site audit according to the audit plan approved by the department.

The auditor(s) must share final outcomes with the department as soon as possible. The department will review the draft report within 20 business days of receiving it and may seek further evidence or clarification before approving the report.

Once the report has been approved, the department will provide the final audit report.

Fees and charges

All costs associated with time spent assessing an import permit application and managing associated audit activities is recovered by the department. The Australian importer is responsible for all costs associated with the provision of biosecurity audit services whether for audits conducted by the department or TPA service provider. For site audits conducted by the department, importer is responsible for all costs associated with the travel including airfares, accommodation, meals and fee for service costs. All costs will be outlined in a service level agreement.

To minimise assessment charges, please ensure that a complete information package is provided to the department and that all information is current and accurate.

See the department’s charging guidelines and biosecurity cost recovery implementation statements for current information.