Quarantine Approved Premises - General Policies

Version 3.0 - September 2011

1 Purpose

This document details how the Australian Quarantine and Inspection Service (AQIS) will:

1. Assess compliance with the requirements set out in the AQIS Quarantine Approved Premises ( QAP) Conditions of Approval document and QAP Class 1-8 criteria.
2. Assist the QAP operator after the detection of a non-conformity, to address matters of quarantine concern, monitor performance, and to re-establish compliance.
3. Receive and process appeals submitted by the QAP operator.

2 Scope

This QAP Compliance Policy applies to QAPs that belong to one of the following QAP categories:

• QAP Classes 1-8
• QAP Class 95

This policy does not apply to QAP Class 7.9 facilities as audits are undertaken pre-importation for particular consignments.

3 Types of Audits

The types of audit outlined below are designed to assess the performance of the premises against the requirements stated in the AQIS QAP Conditions of Approval document and the applicable QAP Class Criteria.

3.1 Initial Audits

Initial audits are conducted on-site to assess whether the premises meets the requirements stated in the AQIS QAP Conditions of Approval document and applicable QAP Class Criteria.

A prospective QAP operator will be required to pass an initial audit to become eligible for approval as a QAP.

Initial audits will continue until the QAP operator meets the requirements stated in the QAP Conditions of Approval and QAP Class Criteria. When approval is granted, the QAP operator will commence at review level 1 (entry audit rate) described in Table 2.

Note: Classes 5.2, 5.3, 5.4, 7.2, 7.3 and 7.4 are required to have passed a third party assessment undertaken by an AQIS approved engineer prior to the initial audit being undertaken by AQIS.

3.2 Announced Audits

Announced audits will be scheduled by AQIS. AQIS will make contact with the QAP operator and arrange a convenient time and date for these audits. Announced audits will occur in line with the prescribed audit rate for the QAP operator as described in Table 2.

3.3 Unannounced Audits

AQIS may also undertake audits with no prior notification to the QAP. These are known as unannounced audits.

3.4 Surveillance

Surveillance may be conducted by AQIS at the QAP. Details of any non-conformity detected will be recorded and review levels for the QAP operator adjusted accordingly.

3.5 Audit Charging

Audits will be charged at the prescribed fee for service rate by AQIS at the conclusion of the audit. Information regarding AQIS fees is available from the Fees and Charges for Import Clearance page. Where a quarantine officer is required to visit the QAP to determine if a non-conformity has been rectified, the visit will be charged at the prescribed fee for service rates.

4 Audit Results

At the end of each audit the result will be determined using Table 1 – Audit Results Matrix. The audit result will be determined by the number and type (minor, major, critical) of non-conformities detected during the audit including any non-conformities carried over or re-issued from previous audits (e.g. 3 minor and 1 major non-conformities generate a pass, whereas 4 minor and 1 major generate a fail).

Table 1. Audit Result Matrix

	MAJOR non-conformities
MINOR non-conformities		0	1	2	3
	0	Pass	Pass	Pass	Fail
	1	Pass	Pass	Pass	Fail
	2	Pass	Pass	Pass	Fail
	3	Pass	Pass	Fail	Fail
	4	Pass	Fail	Fail	Fail
	5	Pass	Fail	Fail	Fail
	6	Pass	Fail	Fail	Fail
	7	Fail	Fail	Fail	Fail
	8	Fail	Fail	Fail	Fail
	9	Fail	Fail	Fail	Fail

Note: A critical non-conformity will result in immediate suspension.

5 Compliance Action

There are 5 review levels that apply to QAP operators. Table 2 describes the review level, audit rate and review period applicable to QAP Classes.

Table 2. Review Levels, Audit Rates and Review Periods

Review Level	QAP Class	Audit rate	Review Period
1	4, 5.3, 5.4, (7.1–7.8), 7.12, 8	3 audits	1 year
	1, 2, 3, 5.1, 5.2, 6, 7.10, 7.11	2 audits
2	4, 5.3, 5.4, (7.1–7.8), 7.12, 8	2 audits	90 days
	1, 2, 3, 5.1, 5.2, 6, 7.10, 7.11	1 audit
3	4, 5.3, 5.4, (7.1–7.8), 7.12, 8	3 audits	90 days
	1, 2, 3, 5.1, 5.2, 6, 7.10, 7.11	2 audits
4	4, 5.3, 5.4, (7.1–7.8), 7.12, 8	4 audits	90 days
	1, 2, 3, 5.1, 5.2, 6, 7.10, 7.11	3 audits
5	All classes	Suspension and full AQIS supervision	N/A

5.1 Commencement Level

The QAP operator will commence at review level 1 subject to passing an initial audit.

5.2 Failing an Audit

If the QAP operator is determined to have failed the audit, it will be placed on the next highest audit review level (e.g. from level 1 to level 2) as described in Table 2.

If the QAP operator fails the subsequent audit, the audit review level will again be increased. This will continue until review level 5 (suspension) is reached. The QAP approval will be suspended until the QAP operator can demonstrate adequate corrective action to AQIS.

If the QAP operator is at review level 2, 3 or 4 and passes the required number of audits, the review level will revert to the previous review level (e.g. from level 2 to level 1) described in Table 2.

If the QAP operator is operating at any review level above level 1 the 90 day review period commences from the date of the most recent failed audit. If another failed audit occurs during this 90 day review period, the review level (and associated audit rate) for the QAP operator will be increased immediately and a new 90 day review period starts.

Any increase or decrease in the review level and associated audit rate immediately supersedes the previously applicable review level and audit rate.

5.3 Review Period

The review period is the duration for which a review level is applicable.

5.4 Reinstatement Audit

Reinstatement audits will be scheduled and conducted by AQIS following a period of suspension. AQIS will contact the QAP operator and arrange a convenient time and date for these audits.

If the result of the reinstatement audit is a fail as described in Table 1 Audit Result Matrix, the suspension will continue and the QAP operator will be asked to show cause as to why its QAP approval should not be revoked.

If the result of the reinstatement audit is a pass as described in Table 1 Audit Result Matrix, the QAP operator will revert to review level 4.

5.5 Audit Rate Reductions

Where the QAP operator is determined to have passed the audit but has recorded one or more minor or major non-conformities, there will be no change to the review level and audit rate. However, that audit result will not contribute to the qualifying total for an audit rate reduction.

If, however, the QAP operator is determined to have passed the audit and has recorded no non-conformities, the audit result will contribute to the qualifying total. If the QAP operator has reached the required number of qualifying audits then the audit rate will be reduced as described in Table 3 – Audit rate reduction.

Note: QAP classes not listed in Table 3, are ineligible for audit rate reductions and are subject to the audit rates listed in Table 2 only.

If the QAP operator is on a reduced audit rate as described in Table 3, and it fails an audit, its audit rate will be increased by one level (e.g. if on a medium reduced audit rate, audit rate would increase to the entry audit rate, and if on a low reduced audit rate, the audit rate would increase to the medium reduced audit rate).

Table 3. Audit rate reduction

QAP Class	Entry audit rate (every)	Qualifying criteria for reduction	Medium reduced audit rate (every)	Qualifying criteria for reduction	Low reduced audit rate(every)
4, 5.3, 5.4, (7.1–7.8), 8	4 months	3 audits without non-conformities	6 months	2 audits without non-conformities	9 months
1, 2, 5.1, 5.2, 6, 7.10, 7.11	6 months	2 audits without non-conformities	6 months	2 audits without non-conformities	12 months
3	6 months	2 audits without non-conformities	12 months	1 audit without non-conformities	12 months

6 Non-conformities

6.1 Non-conformity Classification

There are three (3) levels of non-conformities:

Conformities

Type	Description
CRITICAL Non-conformity	A breach of the Quarantine Act 1908 (Cwlth), or a major breach of the responsibilities and/or the requirements stated in the QAP Conditions of Approval and the relevant QAP Class Criteria resulting in immediate suspension of the approval. Examples: 1. Not disposing of quarantine waste in a manner approved by AQIS. 2. Not contacting AQIS when live animal/s or insect/s are detected a container.
MAJOR Non-Conformity	A breach of the responsibilities and/or the requirements stated in the QAP Conditions of Approval and the relevant QAP Class Criteria. Examples: 1. The Quarantine Area is not separate from other operations in the premises 2. There are no insect proof bins (with lids) labelled ‘Quarantine Waste’, for residues, loose items and spillages of quarantine concern. 3. There is no effective pest control program in place to ensure that goods are not contaminated nor infested by pests during storage.
MINOR Non-Conformity	Less serious breach of the responsibilities and/or the requirements stated in the QAP Conditions of Approval and the relevant QAP Class Criteria. Examples: 1. The quarantine area is not clearly defined by either a painted yellow line on the floor, a permanently affixed person-proof security fence, a separate room, or other approved devices. 2. The Quarantine Area where goods subject to quarantine are stored or handled does not display a quarantine sign.

6.2 Notification of a Non-conformity

AQIS will notify the QAP operator in writing, via a Corrective Action Request or formal letter, upon the detection of a non-conformity and will advise the QAP operator of subsequent compliance action to be taken by AQIS.

7 Multiple Class Approvals

Where a QAP has more than one QAP Class approval, the audit rate will be determined by using the QAP Class with the highest audit rate. For example, a QAP approved as both a QAP Class 2 and a QAP Class 4 premises would be subject to an entry audit rate of 3 audits per year (QAP Class 4 entry audit rate).

8 Co-located Premises

Co-location is where a number of premises are located at the physical site, are managed as the same entity, and have the same senior manager responsible for all approvals. For co-located premises if one of the premises fails an audit, all of the co-located premises will be subject to the new audit review level.

9 Suspension and Revocation

If there is a failure to comply with the QAP Conditions of Approval or the applicable QAP class criteria, AQIS may suspend or revoke the premises approval in accordance with sections 6B and 46A of the Quarantine Act 1908 (Cwlth).

Suspension will occur once the QAP operator reaches review level 5 through the accumulation of non-conformities, or the QAP operator incurs a critical non-conformity.

During the suspension period, AQIS will invite the QAP operator to show cause as to why its approval should not be revoked. The QAP operator should provide all information and evidence to support its case, including details of their supervisory and counselling procedures used for accredited persons to prevent the recurrence of non-conformities.

AQIS may seek further information or advice before making a decision to re-instate or revoke an approval.

Failure to comply with all quarantine directions may result in immediate suspension of the approval.

AQIS may, at its discretion, decrease the rate of review applicable to the QAP operator based on information gathered at an audit or following the outcome of an appeal.

The QAP operator’s approval may be revoked if:

• on a reinstatement audit a critical non-conformity is incurred
• there is a breach of the Quarantine Act 1908 (Cwlth).

10 Appeals

Where the QAP operator believes that the result of the formal audit/surveillance visit was incorrect, due to AQIS failing to take into account objective evidence or extenuating circumstances relating to a non-conformity or due to misinterpretation of the compliance policy, the QAP operator may appeal against the decision.

The onus of responsibility to provide either objective evidence or proof of extenuating circumstances is on the QAP operator, as to why it believes the result of the formal audit/surveillance visit to be in error.

The QAP operator must appeal in writing within 10 business days from the date of notification of a non-conformity. The QAP operator should clearly set out its reasons for appeal.

Appeals should be forwarded in writing to the following address:

Co-regulation Administration and Support Program
Australian Quarantine and Inspection Service (AQIS)
GPO Box 858
Canberra ACT 2601

Fax: 02 6272 5888
Email: QAP Canberra

AQIS undertakes to:

• Acknowledge receipt of the appeal within two (2) business days of its receipt
  
• Make a decision on the appeal, in writing, within 10 business days of the receipt of all available facts relating to the matter.

11 Review

AQIS reserves the right to assess and review the ongoing validity of QAP Conditions of Approval and the QAP class criteria at any time to ensure that the requirements continue to align with legislation, government policy and the relevant operating environment.

In addition, the QAP Conditions of Approval and the QAP class criteria are subject to periodic review to ensure the continued effectiveness of the requirements in meeting both AQIS and industry needs.

12 Additional materials to be read in conjunction with this document

• QAP Conditions of Approval
• QAP Class Criteria
• Generic Glossary.

13 Amendments

The latest version of this document can be obtained from the Department of Agriculture, Fisheries and Forestry (DAFF) website.