Information for operators of a major hazard facility (MHF) on how to prepare a safety case outline within 90 days of being registered by WorkSafe.
What is a safety case outline
A safety case outline is a formal part of the planning process for the initial preparation of a safety case. It documents your plan for developing the safety case and is submitted and reviewed by WorkSafe as part of the registration process for new major hazard facilities.
The safety case is a comprehensive suite of documents that demonstrates how to effectively manage health and safety at your facility.
The objectives of the safety case outline are to ensure that operators:
understand the legal duties that apply to major hazard facilities under the Occupational Health and Safety Regulations 2017 (OHS Regulations)
understand the requirements for a safety case, and
will ensure that the work to produce the safety case is sufficiently planned and resourced so it can be delivered within 24 months of registering with WorkSafe your intention to operate a major hazard facility
WorkSafe must register the facility as an MHF within 90 days of receiving application - unless WorkSafe is satisfied that the applicant does not intend to operate a MHF.
See Notification and Registration guidance note for notification requirements.
Operators must do this within 90 days of being registered as a major hazard facility by WorkSafe.
WorkSafe may request additional materials from you if we believe your safety case outline requires them to give you the best chance of success in creating a robust safety case.
Operators must do this within 24 months of being registered as a major hazard facility by WorkSafe.
WorkSafe may require evidence that you are meeting the milestones for developing your safety case, which were included in your safety case outline. You may also be asked to submit or revise materials until WorkSafe is satisfied your safety case is sufficient.
WorkSafe will notify you within 6 months after we receive your full safety case submission.
How WorkSafe evaluates a safety case outline
When reviewing an operator's safety case outline, WorkSafe expects that:
the operator's safety philosophy is reflected in the outline
the tasks required for preparing the safety case have been systematically identified
tasks have milestones and deliverables
there is a timetable for the sequence of tasks that demonstrates the operator’s understanding of the interactions and links between the tasks
adequate and appropriate resources have been allocated to each task
the balance between internal and external resources is appropriate to the operator’s ownership of the safety case
the outline will result in a safety case that is robust, satisfies legal requirements and will be delivered in a timely manner
methodologies for safety assessments and other tasks are suitable for the specific facility and are compatible with the operator’s safety philosophy
the basis for 'demonstration of adequacy', including risk criteria, is suitable for the specific facility and is compatible with the operator's safety philosophy
requirements and robust processes have been identified and established for consultation with, stakeholders, including health and safety representatives (HSRs), employees, emergency services, municipal councils and other MHFs as necessary
the outline explains how the results of consultation will be used in the safety case
milestones are built into the development phase of the safety case to allow for monitoring of progress against the plan
Additionally, when assessing the application for an MHF licence, WorkSafe has to be satisfied that the operator meets the following requirements:
The safety case has been prepared in accordance with Division 8 of part 5.2 of the OHS Regulations.
The applicant has complied with the safety duties of an operator under Divisions 6 and 9 of Part 5.2 of the OHS Regulations.
WorkSafe will work with the operator if the safety case outline needs to be changed to meet regulatory requirements related to the safety case.
What to include in a safety case outline
For the purposes of the outline, you do not need to develop the content for your full safety case; however you should explain how you will do so, including the human and financial resources that will be allocated to ensure you meet the submission deadline for the full safety case. As per regulation 367, the safety case outline must include specific reference to each of the matters required by regulation 385, details of the scope of consultation that will be undertaken in preparation of the safety case, and a draft of the emergency plan you propose to include in the safety case.
We recommend that you contact WorkSafe before you start work on your safety case outline so we can guide you through the process. Contact the Major Hazards Program through WorkSafe Advisory.
The safety case outline should describe your safety philosophy, which informs the facility's safety aims and objectives, and the systems, policies and procedures to achieve these objectives. In addition it should provide information on how the philosophy will be incorporated in safety case development.
One of the required elements of the safety case outline is a detailed, written program and time frame for the preparation of the safety case. This timetable should:
define the tasks that will be undertaken
indicate key milestones, including start and end dates
present milestones for core tasks including hazard identification, safety assessment, adoption and justification of control measures, implementation of an emergency plan, and enhancements of the Safety Management System (SMS) that prove necessary
describe the amount of work and sequencing for the core tasks that will be undertaken during development of the safety case
specify the resources that will be required for each task and the linkages between tasks
An effective means of presenting this timetable should be used, for example Gantt charts or other graphical representation. Since these may be impractical to present on paper, WorkSafe will accept them electronically, provided sufficient supporting documentation exists and there is no requirement for proprietary software.
Milestones specified in the safety case outline must be met by the operator. If the operator states that certain tasks will have been completed by certain dates, WorkSafe will assume that compliance with the corresponding duties is reasonably practicable by those dates. Non-compliance may be an offence. Where the safety case outline states that no work is required, WorkSafe will assume that the facility is already in compliance.
Some tasks depend on the completion of others, while others have more complex interactions. These interactions may affect the scheduling of tasks and the resources required. This effect may be shown in the timetable using an information flow diagram (see example in Figure 3.2).
The methods chosen for the safety case may have an impact on resource requirements and timelines and should, at least, be broadly established early. The safety case outline should state and explain the operator’s key methods, including those for hazard identification, safety assessment (including risk assessment methods) and adoption and rejection of control measures.
The safety case outline should reflect the nature of the facility, and the operator's basis for major hazard safety management, while at the same time challenging the basis of safety to ensure it is robust. When operating in an industry where there is heavy reliance on procedural controls, an outline detailing extensive use of hazard and operability studies or quantitative risk assessment is unlikely to be appropriate. A more appropriate approach may include audits of the SMS, at both systems and compliance level, focussing on competency assurance and on development and use of procedures. The opposite may apply to highly automated plants with potential off-site impact.
The safety case outline should detail how the various tasks will be resourced, including who is accountable for each task. It is important that those who are accountable have the expertise, authority and other resources necessary. Where these issues are not clearly addressed in the timetable, additional supporting material may be required.
Accountabilities may be demonstrated by:
an organisational chart to show the relationships between the personnel (both internal and external) involved in the development of the safety case and that they have the authority to complete their assigned tasks
brief resumes of the key members of the safety case team and position descriptions of all involved personnel. These may be used to assure WorkSafe that tasks are being performed by those with appropriate expertise
Consultation with stakeholders including an operator's employees and independent contractors ensures the safety case reflects the actual operations at the facility and contributes to improving health and safety. Consultation is required under the general duties of the Occupational Health and Safety Act 2004 (OHS Act) and specific duties under Part 5.2 of the OHS Regulations, under a range of circumstances relevant to the safety case and the operation of the facility.
The safety case outline must describe the scope of the consultation that the operator intends to undertake, to assure WorkSafe that sufficient and appropriate consultation will occur throughout the preparation of the safety case. Consultation means obtaining input from stakeholders, using that input where it is appropriate, and reaching an understanding with stakeholders when the input is not appropriate. It is therefore recommended that the outline details how the results of consultation will be incorporated into the safety case and not just the forum that will be used for consultation.
Key considerations for consultation are:
Groups to be consulted on various aspects of the safety case, and at the right stage, include employees, contractors, HSRs, emergency services, neighbouring MHFs and municipal councils. Consultation should be well prepared and not superficial or at the end of the process.
Who should be consulted depends on the issues to be reviewed. For example, the emergency services must be consulted on the emergency plan (it must be prepared in conjunction with the emergency services), but not necessarily for control measures unrelated to emergency planning, response and fire safety.
In some cases, the main purpose is to keep stakeholders informed, so it may be adequate to simply present information and ensure it is understood. In other situations, operators may need to gather information, opinions or ideas from people at a meeting, consider this data and draw conclusions from the information as a whole before informing all parties about decisions that are made.
Development of safety roles for employees. It is necessary to involve employees in various aspects of the safety case including in defining what their roles in the safety case process should be.
The description of consultation should show how the operator proposes to use the results of the consultation in other areas of the safety case, safety assessment or SMS. For example, involving personnel in the adoption of control measures would require a link to the safety assessment process.
In addition to the legislative requirements to consult, there should be effective communication of the safety case throughout the organisation (including all levels of management).
The OHS Regulations require a draft version of the emergency plan for an MHF to be submitted as part of the safety case outline. The draft emergency plan must comply with the requirements in regulations 375 and 376, and Schedule 16 of the OHS Regulations (Matters to be included in major hazard facility emergency plan). Where the draft emergency plans do not comply fully with the relevant regulations, this should be identified and the safety case outline should make specific provision for consultation and other activities needed to achieve full compliance.
The safety case regime does not remove the need for operators to comply with their other statutory obligations, such as other Parts of the OHS Regulations or the Dangerous Goods (Storage and Handling) Regulations 2012 (DGS&H Regulations). The operator should make it clear in the safety case outline how they intend to continue complying with these requirements during and following development of the safety case.
Other information WorkSafe may need, which should be considered for inclusion in a safety case outline includes:
contact details of the person responsible for developing the safety case
description of the site, including aerial photograph and map, if available
overview of safety case layout, such as a draft table of contents
summary of the existing SMS with reference to the application of performance standards and indicators
description of the local community and how the area surrounding the MHF was defined
how the proposed safety case will interact with other related legislation and other regulators, such as that of Energy Safe Victoria
quality assurance and control processes to be used in safety case development
the process for achieving sign-off at the required level
how assumptions made in the safety case process are to be recorded and authorised
a copy of the operator's health, safety and environment policy and a description of how the safety case will contribute to the achievement of this policy.
Operators should include any information to help convey their safety case philosophy, their current degree of compliance with the OHS Regulations, and to assure WorkSafe that they will produce a successful safety case in a timely manner.
Tips for developing a safety case outline
Getting safety case planning right
It is important that operators get their planning right when preparing the safety case outline. The safety case outline should provide a statement by the operator as to the current degree of compliance with the Part 5.2 (Major hazard facilities) of the OHS Regulations, for example through a gap analysis. It should also provide a statement of intent and a timetable for achieving full compliance.
A registered MHF must comply 'so far as is reasonably practicable' with the safety, consultative and property protection duties under Part 5.2 of the OHS regulations. The initial gap analysis, or equivalent, will show the areas where there is already compliance and where there is partial or non-compliance. Where the gap analysis shows full compliance, an operator cannot claim later that it is impracticable to achieve compliance in these areas. An operator should not overstate or understate the current degree of compliance in the safety case outline.
In areas where there is not yet full compliance, the safety case outline should have milestone dates for when full compliance will be achieved for each item. WorkSafe will then consider compliance by that date (and thereafter) to be reasonably practicable.
The outline should be accurate and the plan achievable by the deadline. If WorkSafe is of the opinion that it would not produce a safety case compliant with the OHS Regulations, the operator may be required to make amendments.
Once the operator submits the safety case outline to WorkSafe, milestones become obligations upon the operator. To amend these milestones, the operator would need to explain to WorkSafe why a milestone cannot be reached, the implications of this to the entire process and the steps being taken to rectify the situation. However, WorkSafe recognises that it may not be possible to get the safety case outline completely right at the first attempt and that, in practice, some methods may prove unsuitable or tasks may take longer than expected.
Following submission of a safety case outline, WorkSafe will review in detail the implementation of the safety case. If an operator cannot meet the milestones stated in their safety case outline, then it is unlikely that their operations will withstand scrutiny during this review, and notices or other enforcement action may result. You must complete and submit your safety case within 24 months of when you registered with WorkSafe your intention to operate a major hazard facility.
WorkSafe will be available to assist operators during the 90 day period when the safety case outline must be prepared. Operators should also consult with employees and other groups during this period to obtain site-specific guidance on developing their safety case outline and safety case. By seeking and incorporating such guidance, operators will be better prepared for the development of the safety case.
Scope of work
The scope of the work required to develop the safety case may be determined by a gap analysis or similar process. The gap analysis should compare the requirements of the relevant regulations with current practices at the facility, as well as what is required to be consistent with the safety case philosophy.
The list of tasks resulting from that process will be an initial list for completion during the safety case. The tasks may include work on hazard identification, safety assessment, emergency planning, identification and assessment of control measures.
When reviewing the existing status of safety management and related documentation, it is important to consider the detail, and not simply the existence, of management processes and safety documentation to ensure it fully meets requirements. Management processes, operational procedures and safety studies may all need to be revised or re-done to fully satisfy the requirements of the OHS Regulations. There are varied requirements for consulting and informing others about the safety case. The process of developing the safety case requires input from stakeholders, and the nature of this involvement should be set out in the safety case outline.
The work required is likely to extend beyond assessment and documentation as described above. Deficiencies in safety management and safety engineering may be identified and require corrective action before WorkSafe can grant a licence. As the nature and detail of these deficiencies would not be fully known at the planning stage and during preparation of the outline, contingency should be allowed to complete any corrective actions.
Once the scope has been determined, the required resources can be defined. The resources would be mostly employees, and the number, skills and competencies of these should be defined at an early stage and linked to each task in which they will be involved.
Depending on the magnitude and variety of the work, it may be necessary to have a core team supplemented by specialists as required. Depending on the size of the operator's organisation, assigned personnel may be full time or part time in that core team. It will be necessary to describe the roles of any external resources that will be used during the development of the safety case. WorkSafe expects an appropriate balance between internal and external resources as this will help ensure facility ownership of the safety case.
The operator should ensure that resourcing of the safety case is robust. At a minimum, resourcing should make allowance for other duties, leave, and any other reasonably foreseeable conflicting demands on the time of the assigned personnel. As well as personnel, there may be a need for other resources, such as technical information or computer software, which need to be sourced in a timely manner.
It is important to ensure senior management understand the safety case plan and required work, the timing and resource commitment required.
Coordinated safety cases
When events on one site may create or influence risks on neighbouring or connected sites, WorkSafe may require coordinated safety cases (refer to the guidance note 'Coordination between major hazard facilities'). Operators are informed of this requirement when their facility is registered. Coordination will add complexity to the process of developing a safety case and this should be reflected in the safety case outline. Planning for a coordinated safety case requires consultation with neighbouring or connected MHFs as well as WorkSafe.
Demonstration of adequacy
In preparing their safety case outline, an operator should consider what would constitute suitable 'demonstrations' for their facility and what activities will be required to support this (for more information refer to the guidance note 'Requirements for demonstration').
'Demonstration' requires sufficient information to show that:
control measures are adequate, and that the SMS required under regulation 372 of the OHS Regulations provides a comprehensive and integrated system for managing the control measures
there are links between major incidents, hazards and control measures
Demonstration has been found to be more straightforward when decisions and assumptions made in planning are carried through to safety case development and when linkages are built up and documented over the safety case development period, rather than tied together at the end. Hence, decisions and assumptions made in the planning stages will carry through to safety case development.
Size of the safety case outline
WorkSafe expects the safety case outline to be typically between 12 and 20 pages long, not including any detailed reports used in support (eg the report from a gap analysis, the draft emergency plan).
The safety case should demonstrate that the operator has established a process for maintenance and improvement of the safety case and SMS. WorkSafe will test this 'improvement process' following submission of the safety case. Therefore, the safety case outline should describe how this process will be developed and implemented, and how it will reflect the operator's safety case philosophy.
Changes required by WorkSafe
WorkSafe may require amendments to the safety case outline if it is of the opinion that it is not fit for purpose. Amendments may include altering timeframes or inclusion of missing information. Before WorkSafe can require an amendment, they must first provide written notice to the operator informing them of the proposed amendments and consider any submissions made by the operator.
Changes requested by the operator
There are circumstances under which the operator may wish to alter the safety case outline, for example if the original approach proves ineffective or if the operator decides to alter the facility. The operator should discuss these cases with WorkSafe, and must provide WorkSafe with a copy of the amended outline as reasonably possible after the amendments are made.
Review and revision
The safety case outline does not have to be reviewed and revised before licence renewal. However, preparing a similar plan may assist MHF operators when they review and revise their safety case for licence renewal.
The following checklist lists the main requirements under the OHS Regulations relating to safety case outlines.
The operator of a registered major hazard facility must, within 90 days of the commencement of the registration of the facility, provide WorkSafe with an outline for the safety case the operator proposes to include with its major hazard facility licence application under Part 6.1 (Licences) of the OHS Regulations.
The safety case outline must include:
a detailed written program and time frame for the preparation of the safety case, with specific reference being made to each of the matters required by regulation 385 to beincluded in a safety case; and
details of the scope of consultation that will be undertaken when preparing the safety case; and
a draft of the emergency plan the operator proposes to include in the safety case
WorkSafe may require amendments to be made to the safety case outline. WorkSafe must not require the operator to make any amendments to the safety case outline unless it has:
informed the operator of the proposed amendments in writing; and
invited the operator to make written submissions within 14 days of the date of the notice; and
considered any submissions that are made
The operator must make any amendments to the safety case outline required by WorkSafe. The operator must provide WorkSafe with a safety case outline amended under this regulation, or amended by the operator on the operator's own initiative, as soon as reasonably possible after the amendments are made.
Preparation of the safety case outline also requires consideration of:
Divisions 6, 8 and 9 of Part 5.2 of the OHS Regulations
Schedules 15, 16 and 17 of the OHS Regulations
Modifying the facility while registered as an MHF
The operator of a registered MHF may wish to modify the facility before the safety case is due. Such changes may impact on the development of the safety case and changes may be required to the safety case outline.
For more information about the management of change under the MHF regulations and the DGS&H Regulations, see the guidance note 'Management of change at a major hazard facility'.
For information about the revision of existing safety cases, see the guidance note 'Revision of a safety case for a major hazard facility'.