Co-location of Quarantine Approved Premises A Guide for Operators Version 1.3 December 2015 © Commonwealth of Australia Ownership of intellectual property rights Unless otherwise noted, copyright (and any other intellectual property rights, if any) in this publication is owned by the Commonwealth of Australia (referred to as the Commonwealth). Creative Commons Licence All material in this publication is licensed under a Creative Commons Attribution 3.0 Australia Licence, save for content supplied by third parties, logos and the Commonwealth Coat of Arms. Creative Commons Attribution 3.0 Australia Licence is a standard form licence agreement that allows you to copy, distribute, transmit and adapt this publication provided you attribute the work. A summary of the licence terms is available from creativecommons.org/licenses/by/3.0/au/deed.en. The full licence terms are available from creativecommons.org/licenses/by/3.0/au/legalcode. This publication (and any material sourced from it) should be attributed as: Industry Arrangements Management Program, 2014, Co-location of Quarantine Approved Premises: A Guide for Operators, (Guide prepared for the Department of Agriculture and Water Resources), Canberra. Department of Agriculture and Water Resources Postal address GPO Box 1563 Canberra ACT 2601 Switchboard +61 2 6272 2010| Facsimile +61 2 6272 2001 Web agriculture.gov.au Inquiries regarding the licence and any use of this document should be sent to: copyright@agriculture.gov.au. The Australian Government acting through the Department of Agriculture and Water Resources has exercised due care and skill in the preparation and compilation of the information and data in this publication. Notwithstanding, the Department of Agriculture and Water resources, its employees and advisers disclaim all liability, including liability for negligence, for any loss, damage, injury, expense or cost incurred by any person as a result of accessing, using or relying upon any of the information or data in this publication to the maximum extent permitted by law. Version history Date Version Changes to document December 2007 1.0 First release Industry Partnerships Unit April 2014 1.1 Updated to reflect Department of Agriculture branding and templates Industry Arrangements Management Program July 2014 1.2 Updated to reflect the change to non-conformity management of co-located networks Approved Arrangements Section December 2015 1.3 Updated to include structuring a co-located network, examples of how fees are applied. Approved Arrangements Section Department of Agriculture and Water Resources Co-location of Quarantine Approved Premises: A Guide for Operators Changed by 2 Summary This document outlines the Department of Agriculture and Water Resources (the department) policy for the co-location of Quarantine Approved Premises (QAPs) by explaining the: Eligibility requirements of a facility to be approved as a co-located network. Fees and charges that are applicable QAPs in a co-located network. How the QAP General Polices are applied to QAPs in a co-located network. How the renewals process is applied to collocated networks How to structure co-located networks. Background Co-location is a system of approval under which the department can approve multiple facilities sharing a common Australian Business Number (ABN) and a Senior Manager and operating within a single physical site as a QAP under a single approval fee. Definitions Definitions that are not included within the Approved Arrangements Glossary located on the department’s website can be found in the most recent edition of the Macquarie Dictionary or in the Quarantine Act 1908. Additional reference material The following reference material contains information that relates to the application of this document, they are all available on the departments website: Approved Arrangements Glossary QAP Conditions of Approval QAP Class Criteria QAP- Containment facilities multiple room approval Charging Guidelines 2015-16 Department of Agriculture and Water Resources Co-location of Quarantine Approved Premises: A Guide for Operators 3 Why co-locate QAPs? Since its implementation the co-location policy has provided benefits to institutions operating multiple facilities. Some of the identified benefits include: potential cost savings through the institution incurring one approval fee for multiple facilities a single point of contact and management for quarantine, resulting in: increased quarantine awareness better communication flow with the department a focused responsibility of quarantine issues by the organisation efficiencies in time, organisation and delivery of audits of large premises. Although co-location can be undertaken for all classes of QAPs, it is of particular relevance to class 5 Operators as the implementation of the new containment criteria requires approval of the space (room/laboratory) to a specific level of containment. As a result there are potential financial advantages, where an institution may currently have multiple rooms registered under a single approval. Co-location is not mandatory and you will need to make a commercial decision based on the benefits of co-location versus the risk of a nonconformity potentially affecting quarantine related activities at all co-located premises. I want to co-locate, am I eligible? To be eligible for co-location, three mandatory criteria must be met. 1. Common Senior Manager The Senior Manager nominated by your organisation as the person responsible for the management of quarantine activities and any quarantine issues at the premises must be common between the ‘parent’ and all co-located ‘child’ premises. Example A: One university, one parent site One parent site: University of Quarantine School of Science (parent premises) School of Forestry (child premises) Lab 1 Lab 2 (child) (child) One parent site One Senior Manager Several premises under one co-location arrangemen Both schools are suspended if a critical nonconformity occurs in one of the schools. Senior Manager: The Dean In this example ‘the Dean’ is the nominated Senior Manager and is responsible for the quarantine activities of the School of Science and the School of Forestry. Department of Agriculture and Water Resources Co-location of Quarantine Approved Premises: A Guide for Operators 4 2. All co-located premises are located at the one physical site address All QAPs to be co-located must be located within a single site address. If there are buildings containing facilities you wish to co-locate but they are separated by a public road the co-location policy cannot be applied. The buildings will be considered as two sites and co-location can only be undertaken within each site (see Example B below). Example B: One university, two parent sites Site A: University of Quarantine Site B: University of Quarantine School of Forestry School of Forestry (parent premises) (parent premises) Lab 1 Lab 2 Lab 1 Lab 2 Lab 3 (child) (child) (child) (child) (child) Senior Manager: Senior Manager: Professor Tree Professor Tree Two parent sites – Site A and Site B Site A and B separated by an arterial road One Senior Manager for both sites One approval fee charged to Site A One approval fee charged to Site B. The University of Quarantine may be physically located in the suburbs of Barton (Site A) where it has two laboratories, and Civic (Site B) where it has three laboratories. Between the campuses is a main arterial route for Canberra traffic and is also used by the university as a boundary for the two campuses. The two campuses must therefore be considered as two separate physical sites. The Barton site may choose to co-locate its two laboratories and in turn the Civic site may co-locate its three laboratories, but co-location of all premises cannot be applied. 3. All QAPs belong to one organisation or company All approvals within the site must be registered and operated under a single legal entity. Department of Agriculture and Water Resources Co-location of Quarantine Approved Premises: A Guide for Operators 5 Fees The charges for compliance monitoring activities are still applicable to each QAP within the co-located network as defined in the department’s Charging Guidelines 2015-16. The application for renewal of approval fee will only be applied to the nominated parent QAP and covers all child QAPs in the network. The following case studies explain how fees will be applied in different circumstances. New applicant applying for a co-located network A currently unapproved applicant submits an application for three new QAPs. Once the individual QAPs are approved they are then co-located into a new network. The applicant will be charged: one application levy application assessment time as a fee for service for each QAP. audit fees for each QAP within the network. single renewal fee, applied to the arrangement, when renewal is due. Existing QAP operator applying for a co-located network A QAP operator submits an application for three new QAPs under their current arrangement. Once the individual QAPs are approved they are then co-located into a new network. The QAP operator will be charged: application assessment time as a fee for service for each new QAP. audit fees for each QAP within the network and existing arrangement. single renewal fee, applied to the arrangement, when renewal is due. New QAP added to an existing co-located network A QAP Operator submits an application for a new QAP to be added to an existing co-located network. Once the new QAP is approved it is added to the existing co-located network. The QAP operator will be charged: application assessment time as a fee for service for new QAP. audit fees for each QAP within the network and existing arrangement. single renewal fee, applied to the arrangement, when renewal is due. Existing QAPs consolidated in a new or existing co-located network A QAP Operator submits a request to change their QAP approvals so that two existing QAPs are consolidated to one QAP. This is considered a variation to the original approval. Once a decision has been made on the variation, the QAP operator will be charged: application assessment time as a fee for service for the variation to their original approval. audit fees for each QAP within the arrangement. single renewal fee, applied to the arrangement, when renewal is due. Department of Agriculture and Water Resources Co-location of Quarantine Approved Premises: A Guide for Operators 6 Structuring a co-located network There are situations where it is impracticable to have refrigerators, cabinets, etc. located within the laboratory itself. These external storage devices should not be individually ‘registered’ as part of the co-located site. These areas must be documented for audit purposes. Appropriate security must be agreed to (e.g. padlocks, etc.) in order for goods subject to quarantine to be maintained within these external storage devices. In the case of QAP Class 5.2 - 5.4 Containment Facilities, Third Party Assessors will be required to audit all registered premises against the applicable Australian / NZ standard. This is why items such as refrigerators cannot be considered a QAP. Refer to the Approved Premises Criteria for detailed description of physical requirements for placement of refrigerators/storage etc. Within one building three laboratories/rooms may require approval as QAPs. See Example C below. If the three are co-located, one QAP must be selected as the ‘Parent Premises’. The remaining two QAPs would then be linked as ‘the child’ to this Premises. Quarantine areas (e.g. store rooms and refrigerators) located outside of the QAP but still within the building must be linked to either a Parent and/or a Child Premises. Example C: Co-located network including store room and fridge Uni of Quarantine Child 1 Co-located premises showing relationship between Parent and Child Parent Lab 2 Store Child 2 1 Fridge Location of Store & ‘Fridge noted in QPR comments field In order to be able to apply these principles as they are intended, it must be understood what constitutes the “containment barrier”. The containment barrier is defined as: “the physical structures/barriers, such as the walls, doors, floors, ceilings which comprise a fully enclosable space. The room and its support facilities provides secondary physical containment in the event of the failure of the primary barrier (eg. Biological safety cabinet)”. A quarantine containment barrier provides protection of the environment external to the laboratory through a combination of facility design and quarantine practices. Department of Agriculture and Water Resources Co-location of Quarantine Approved Premises: A Guide for Operators 7 Containment facilities multiple room approval The department may allow multiple spate rooms to be approved as a single QAP provided requirements for quarantine containment are met. For further information refer to the document ‘Quarantine Approved Premises – Containment facilities multiple room approval’ available on the department’s website. Movement of goods subject to quarantine Relevant class criteria, under which the premises operate, outline the requirements for the movement of goods subject to quarantine between co-located premises Application of the QAP General Policies Each QAP that is part of a co-located network is subject to individual compliance measures. This means that any QAP that is part of a co-located network is treated as a separate, ‘stand-alone’ QAP for the purposes of monitoring compliance and addressing non-compliance, including: determining the audit results determining the audit rates, and taking suspension and/or revocation action Renewal of premises approvals A failure to complete the renewal requirements for the parent premises at each renewal period will result in suspension of the parent and all child premises. Should a co-located ‘child’ premises fail to complete the renewal requirements, the approval for that premises would expire, however all other facilities co-located under the same ‘parent’ premises would not be affected. Review This document is subject to regular review to ensure it continues to be relevant, effective and fit for purpose. The department reserves the right to assess and review the ongoing validity of this document, the 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 meeting both departmental and industry needs. Department of Agriculture and Water Resources Co-location of Quarantine Approved Premises: A Guide for Operators 8