7.3c Is a contracted waste disposal company used for waste disposal? Yes No if No, go to Q7.4a) Comments: 7.3d Does the entity have in place mechanisms to ensure that waste taken by an external contractor is: Kept secure until it is picked up? The entity is notified when the is destroyed? Yes No Yes No Comments: 7.4 Record Keeping 7.4a Was risk assessment an integral part of the process to identify records of decontamination/deactivation and validation data that must be kept? Yes No Comments: 7.4b Are records of decontamination/deactivation kept for at least 5 years for Tier 1 SSBAs or 2 years for Tier 2 SSBAs? Yes No Comments: Part 7 Further considerations The questions below are based on the suggestions made under the commentary of the SSBA Standards or are best practice recommendations. These are not mandatory requirements but may be used to enhance the security of the SSBAs in your facility. P7a Do the validation procedures take into account issues such as: Nature of the material being treated? Contact times and material compatibility issues? Potential health hazards? Need to maintain the required level of active compound including deterioration over time? Yes No Yes No Yes No Yes No Comments:
Comments: P8d Is the policy appropriate to the nature and scale of risks associated with the facility and associated activities? Yes No Comments: P8e Does the policy commit to: Complying with legal requirements for handling SSBAs? Reducing the level of biosecurity risk to an acceptable level? Ensuring that the need for effective SSBA management takes precedence over non ‘health and safety’ operational requirements? Continually improving SSBA management performance? Yes No Yes No Yes No Yes No Comments: P8f When communicating information regarding SSBA policies to relevant parties, does the entity consider if the person has a need-to-know the information as part of activities? Yes No Comments: P8g When assigning and responsibilities under the SSBA management system, are potential conflicts of interest taken into account? Yes No Comments: P8h Is determination of staffing levels, equipment and facilities done in consultation with the Responsible Officer? Yes No Comments: P8g Does documentation of SSBA related activities include the nature of the activities authorised to be conducted and their definitions? Yes No Comments: P8h Are all activities routinely associated with the work program specified and supported by formal SOPs? Yes No
Comments: P8i Are any changes to these activities subjected to a formal change management process, including approval by management and communication to and training of staff? Yes No Comments: P8j Are controls monitored by: Regular reviews? Using corrective action reporting processes? Investigation of accidents and incidents? Improving controls and their implementation? Ensuring adequate resources are provided? Yes No Yes No Yes No Yes No Yes No Comments: P8k Do the terms of reference include: A short statement of the purpose of the committee? Defined roles and functions of the committee and how objectives are achieved? Who is part of the committee as a member, observer or other? Details regarding quorums – is there one, what is the number and what happens if this is not reached? Defined deliverables? Defined timeframes such as meeting frequency, reporting, review and set task timeframes? Details on what is to be reported and to whom? Details on the evaluations undertaken by the committee on the role and function or other terms of reference Details on how the effectiveness of the committee will be evaluated? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Comments:
P9Aa Does the entity send confirmed SSBAs to a reference laboratory for further genetic typing? Yes No Comments: PART 10 – NON REGISTERED ENTITY HANDLING AN SSBA ON A TEMPORARY BASIS The objective of Part 10 is to ensure that SSBAs are handled temporarily are handled securely prior to disposal. 10.2 Access and Storage 10.2a Does the entity ensure that access to the SSBA is restricted to persons that have a need to handle? Yes No Comments: 10.2b Does the entity store SSBAs securely to ensure physical access is restricted to those who have a need to handle? Yes No Comments: 10.2c Does the entity maintain a record of who accesses the SSBA, including the identity of the person and time and date of access? Yes No Comments: 10.3 Transport 10.3.1 Transport requirements for a sending facility