Health and Safety

Executive
Major Hazard Regulatory Model
Safety management in major hazard sectors
Introduction
1 One of HSE’s key purposes is to ensure that major hazard risks are properly
managed. This document describes the core elements of HSE’s Major Hazard
Regulatory Model and approach to the regulation and control of risk in onshore and
offshore high hazard sectors. It provides:
■■ the underpinning principles against which HSE will direct resources to activities
that give rise to greatest risk, or are least well managed; and
■■ an overview (Annex 1) of a safety management system for major hazards.
Principles
2 The principles underpinning HSE intervention programmes and the actions of
HSE inspectors are as follows:
■■ Responsibility for managing risk rests with the dutyholder and not with HSE.
■■ Dutyholders are responsible for identifying, profiling and managing the major
hazard risks they create in a systematic way and for compliance with legal
duties in respect of those risks.
■■ Major hazard dutyholders will be subject to a level of regulatory scrutiny that is
proportionate to their risks and performance.
■■ In permissioning regimes, HSE will keep the arguments and commitments set
out in safety cases/reports under constant review and critical assessment in
light of actual dutyholder performance.
■■ The interplay between technical, organisational and management factors is
critical to effective risk control.
■■ The effectiveness of senior management leadership is an important determinant
of dutyholder success in managing major hazard risks.
■■ HSE inspectors will make regulatory decisions taking all these issues into
account and, where a gap exists, use the Enforcement Management Model
(EMM) to guide their actions.
■■ Regardless of their performance, dutyholders will be subject to a degree of
periodic inspection to provide public reassurance that major accident risks
continue to be managed appropriately.
Aims
3 The aim of HSE’s regulatory intervention programmes in the major hazard
sectors is to:
■■ Confirm, through sampling, that dutyholders have properly focused their risk
management efforts on major accident hazards.
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■■ Confirm that, where dutyholders are subject to a permissioning regime, the
basis of the demonstration remains valid and that the dutyholder can show they
are effectively controlling risks.
■■ Take proportionate action, including enforcement, to ensure that dutyholders
make improvements where there is evidence of significant shortfalls or failures in
the way they have implemented control measures.
Delivery
4 HSE will:
■■ plan intervention programmes on the basis of a common approach to risk
ranking;
■■ assign greater emphasis to higher risk activities and poor performers;
■■ use operational intelligence from multiple sources – including safety cases/
reports, previous performance and intrinsic hazard – to make best use of its
resources;
■■ intervene with dutyholders at the right organisational level, particularly with
senior managers and leaders;
■■ inspect – to common processes – by sampling key elements of a dutyholder’s
major hazard management arrangements;
■■ confirm – and react to as appropriate – any evidence of failure by a dutyholder
to demonstrate that commitments made in permissioning documents (safety
cases, safety reports, licences) remain valid;
■■ be open with dutyholders about the purpose, content and timing of inspections;
■■ hold dutyholders to account for their risk management, take appropriate action
in line with HSE’s Enforcement Policy Statement and make enforcement
decisions based on the EMM;
■■ clearly communicate with dutyholders in terms which make clear where
compliance has not been achieved, what measures are needed to achieve
compliance and to what timescale;
■■ confirm any regulatory actions with employee representatives;
■■ follow up with dutyholders to confirm that any necessary improvements have in
fact been achieved; and
■■ work with major hazard sectors to promote sustained improvement.
5 In specific areas this means the following.
Assessment
6 HSE will assess safety cases and safety reports to confirm that the dutyholder
has demonstrated that they have established a suitable safety management system
to prevent a major accident and to mitigate the consequences.
7 Under permissioning regimes, HSE will compare the findings from inspection or
investigation against the control measures and safety management system
described within the safety case or safety report or licence condition.
Inspection
8 HSE inspections in the major hazard sectors will focus on how well dutyholders
manage risk by testing and sampling dutyholder arrangements in critical areas,
including the key control measures relevant to major hazard scenarios. The core
areas for attention will be set out clearly as part of sector and delivery plan
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arrangements. Within these parameters, inspectors will focus on, and test in detail,
the most important layers of protection and accident prevention barriers and the
systems which support them. They will use their professional judgement to decide
how deeply to probe dutyholder performance and the underlying causes of failure
before they make a regulatory decision.
9 Where inspection takes place in a permissioning environment, inspectors will
further test their findings against the arguments set out by dutyholders.
10 Where an inspector identifies deficiencies which give rise to significant risk they
will:
■■ identify the underlying causes as well as immediate ones;
■■ confirm the necessary remedial action; and
■■ take appropriate enforcement action in line with the EMM.
Investigation
11 When inspectors investigate accidents and incidents they will target the key
aspects of risk control, and protective and mitigatory barriers, to identify any core
failings in the dutyholder’s safety management arrangements. Investigators will also
identify whether technical or managerial failures identified are sufficiently serious to
require enforcement.
12 At the end of any intervention, inspectors will confirm all matters requiring
attention in writing. They will confirm which matters are subject to formal
enforcement and why. If inspectors provide additional advice and guidance on good
practice and areas for continuous improvement they will make the distinction clear.
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Annex 1: How we expect
dutyholders to manage major
hazard risks
This annex gives an overview of a safety management system for major hazards. It should
help inspectors assess dutyholder arrangements for managing major hazard risks and,
specifically, to link technical, organisational and management aspects of risk control.
Safety management systems1 in a goal-setting legislative
framework
None of the current major hazard regulatory frameworks prescribes in detail what
measures the dutyholder has to take to prevent a major accident or mitigate the
consequences. Dutyholders have to determine this for themselves. They then have to
show how they have effectively implemented the appropriate barriers and protective
measures. The process may need to be set out in a safety case or safety report, or
through submission of relevant safety management information, before a consent is
granted or a licence issued.
The elements of safety management systems
Major hazard risk control has to be systematic, and as well as preventive measures,
should also confirm there are robust mitigation and emergency arrangements to limit
the impact of a serious event. In this document, safety management system describes
these arrangements. All safety management systems contain the steps: Plan, Do,
Check, Act. The actions involved in delivering effective arrangements are described in
Table 1, with a read across to process safety management.
Table 1 Summary of ‘Plan, Do, Check, Act’ and managing for health and safety
Managing for health and safety
Safety management system Process safety management
Define and communicate acceptable
PLAN Determine your policy; plan for performance and resources needed.
implementation.
Identify and assess risks; identify
controls; record and maintain process
Organise for health and safety; profile safety knowledge.
DO risks; implement your plans, including
control measures. Implement and manage control
measures.
Measure performance (monitor before
CHECK
events; investigate after events). Measure and review performance;
learn from measurements and findings
Review performance; act on lessons of investigations.
ACT
learned.
1
Known as safety and environmental management systems in offshore regimes.
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Control measures for major accident risks
HSE expects dutyholders to understand that major hazard risks have to be
managed in a multi-layered way and that the layers of protection or control
measures will address technical, managerial and procedural arrangements.
Major Hazard Control Measures (Barriers)
Preventive Barriers Mitigation Barriers
MAJOR Loss of
Outcome
HAZARD Control
Figure 1 Layers of protection
Layers of protection can be depicted as a ‘bow-tie’ to emphasise the way barriers
link in sequence in relation to each major hazard scenario.
Preventive Barriers Mitigation Barriers
MAJOR Loss of
Control
HAZARD Outcome
Figure 2 Bow-tie model of layers of protection
The dutyholder should be able to show a logical and rational flow of analysis
leading from hazard identification through to effective risk control, expressed as a
set of appropriate ‘barriers’ (or risk control systems).
Measures to control risks
Hazard Identification Risk Assessment
to ALARP
Figure 3 Sequence of analysis to determine the appropriate control and mitigation
measures for major hazards
There is not a ‘one-size-fits-all’ solution to determining the appropriate control
measures. Dutyholders should be able to show that they have properly profiled their
major hazard risks. Inspectors should be able to assess the relative importance of
the measures in place and their vulnerability to deterioration and failure when
inspection sampling at major hazard establishments.
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Measures tailored to
Hazard Identification Risk Assessment Risk Profile risk profile to control
risks to ALARP
Figure 4 Risk profile used to determine priority risk control measures
Major hazard leadership
Systems and arrangements and the supporting organisational safety culture cannot
be sustained without effective leadership. The potentially complex systems and
arrangements needed to manage major hazard risks need to be delivered and
maintained by managers with vision and determination. This cannot be left as the
sole preserve of safety specialists within an organisation.
Maintenance of control
Dutyholders have to routinely monitor and review their arrangements and act on the
findings. As well as reactive monitoring through incident investigation, dutyholders
should have programmes in place to audit their safety management system and
use leading and lagging key performance indicators to provide routine information
on performance.
Overview
These elements of a safety management system for major hazards are brought
together in an overview in Figure 5 on page 7.
Further information
Information about managing for health and safety: www.hse.gov.uk/managing/
This document is available at www.hse.gov.uk/regulating-major-hazards/index.htm
© Crown copyright If you wish to reuse this information visit
www.hse.gov.uk/copyright.htm for details. First published 02/13. Amended 12/18.
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 People Processes
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12/18

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Executive
Health and Safety
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(the big picture)

(the big picture)
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