Audits

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

• Goods for administration to or consumption by animals

Audit process

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 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 (ABIB) 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.

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.

Findings of the desktop audit form part of the overarching biosecurity risk assessment and are provided to the site audit team.

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 1-5 days, not including time for preparation, travel and reporting. The importer is responsible for all associated costs.

Using third party auditors

The department is conducting a trial whereby independent, third-party audit (TPA) service providers can undertake site audits on behalf of the Australian importer. More information about the use of TPA service providers can be found in the following document:

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.

1. Nomination and assessment of TPA service providers

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

Note: It is recommended that Australian importers seeking to engage a TPA service provider liaise with representatives from the offshore manufacturing facility early in the audit process. Offshore facility representatives will need to support the arrival of third-party auditors, as required, and facilitate the audit process. Documentation relating to the manufacturing facility and export pathway will be shared with the audit team as part of their preparation and they will also need unrestricted access to all areas of the site when they undertake the audit.

Once the department receives the completed third-party auditor application form, a review will be undertaken to assess the TPA service provider’s suitability to undertake the audit, 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.

NB. Please refer to the Guidelines for Engaging Third-Party Audit Service Providers above for more information on the department’s suitability criteria.

Once our assessment is complete, we will notify the importer and the auditor of our decision.

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

2. 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 plan, the auditor will work with the overseas facility to schedule the site audit.

3. 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) will share final outcomes with the department. The department will review the draft report within 20 business days 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 to the importer and the overseas facility to take corrective action as necessary.

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 liable for all costs associated with the provision of biosecurity audit services.

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

The importer is responsible for all costs associated with the department’s site audits. This includes airfares, accommodation, meals and fee for service costs. All costs will be outlined in a service level agreement.

Terms of the provision of biosecurity audit services by a TPA service provider, including terms for payment of fees for service, are negotiated between the Australian importer and the service provider. The department will not moderate in any way between the importer and the service provider on contract terms.

The following is a breakdown of estimated charges associated with the department’s engagement with TPA service providers on behalf of the Australian importer:

Activity	Time taken (estimate); associated charge (at $37 per 15 minute in-office fee)
Assessment of TPA suitability to perform a biosecurity audit	1.5 days (11.5 hours); $1,702
Pre-audit briefing of the third-party audit team	1.5 days (11.5 hours); $1,702
Post-audit debrief, including discussion of audit findings	1 day (7.5 hours); $1,110
Review of site audit report	0.5 day (4 hours); $592
Time taken to review corrective action plan and supporting evidence	1.5 days (11.5 hours); $1,702
Total estimated charges	$6,808

Information in the table above is an estimate only. The final invoice issued to the Australian importer by the department will reflect actual time taken to finalise all TPA-related activities.

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