Safety Case Handling and Assessment Manual - Aims, objectives and principles

• Introduction
• Assessment aims
• Assessment objectives
• Assessment policy
• Acceptance criteria
• Legal aspects
• Arrangements for implementation
• Quality assurance
• Guidance for assessors
• IT systems
• Training

Introduction

1 Safety cases are submitted to OSD in compliance with the Offshore Installations (Safety Case) Regulations 2005 (SCR05). This manual codifies OSD's approach to assessment of these safety cases. It provides permanent instructions that promote the quality of acceptance decisions and of the records that show how they were reached. This part describes the aims and objectives of assessment, and the policy and principles underlying the process.

Assessment aims

2 OSD's aims in carrying out safety case assessment are:

1. to contribute to OSD's overall mission of ensuring that risks to people from work activities in the upstream petroleum and diving industries are properly controlled,
2. to confirm whether or not a safety case contains sufficient particulars to enable OSD to reach an informed judgement that a satisfactory case for health and safety has been made,
3. to discharge on behalf of the Executive the responsibility for the acceptance of safety cases which provide a satisfactory case for health and safety,
4. to contribute to OSD's intervention strategy for individual installations and dutyholders (with enforcement action where appropriate);
5. to contribute to the planning of OSD's programmes of health and safety compliance, promotion and research.

Assessment objectives

3 Assessment has the following objectives:

1. to identify, clarify and prioritise matters that may affect acceptance of the case,
2. to seek to resolve these matters with the dutyholder,
3. to agree any improvement programmes,
4. to provide clear and specific reasons where acceptance cannot be given, and
5. to inform OSD's future interventions.

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Assessment policy

4 OSD shall assess each case to the extent necessary to form a competent opinion on whether it should be accepted by the Executive. Procedures are provided for:

1. targeting HSE expertise to assess the adequacy of the information and demonstrations,
2. ensuring the consistency of assessment,
3. securing effective communication with dutyholders to ensure that the implications of OSD concerns for the acceptance decision are transparent to dutyholders,
4. transmitting timely decisions on case acceptance to dutyholders and safety representatives, and
5. maintaining an auditable record of the assessment process for each safety case.

5 OSD's approach is to treat each assessment as a single, multi-disciplined evaluation activity (conducted within a specified timescale) but which is also part of a continuing process of intervention during the lifetime of the installation. OSD manages the process of making acceptance decisions with great care. Assessment has to be objective, but it is a targeted, interactive process with the dutyholder which involves the exercise of professional judgement by Inspectors within the framework provided by the guidance. There is no single 'acceptance model' against which decisions are made.

Assessment principles

6 Assessment is based on 5 principles, which define the ways of working for the process:

1. Acceptance is a legal decision informed by multi-disciplinary input.
   The decision on acceptance of a safety case flows from a system which requires individual specialist contributions in a range of topic areas, and which respects the professional integrity of all the Inspectors involved. This system must be formal and transparent to allow justification of OSD's decision.
2. Procedures and guidance seek to encourage consensus decision-making.
   They are designed to ensure, through teamwork and sound project management, that legal or technical issues that are crucial to decision making are properly identified, examined and weighed. Individual assessors are required to make competent and timely contributions to the raising and resolution of matters, and to provide assessment completion reports. This requires appropriate and early contact with the dutyholder's topic experts.
3. Assessment completion reports draw conclusions regarding the adequacy of the information and demonstrations presented, and make appropriate recommendations regarding future inspection work in the topic area.
4. The case manager makes a recommendation to the relevant operations manager on the acceptability of the case. This takes account of the views (both positive and negative) expressed by assessors, of compliance with legal requirements, and of the case made for health and safety as a whole.
   Any concerns shall be thoroughly discussed with those involved, with a view to resolving them before the case close-out report is prepared. The CM should consult OSD1.5 if there are any legal queries. Any failure to reach a resolution shall be referred to the relevant operations managers without delay.
5. Acceptance is a statutory process and shall be adequately documented before acceptance is given to, or withheld from, the dutyholder.

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Acceptance criteria

7 There is no single model of an acceptable safety case. It is not desirable in a goal-setting regime to have such a model, as absolute standards of acceptability cannot be laid down. Each case is treated on its own merits and is judged against the major accident risks to the workforce concerned. The acceptance decision must however stand up to scrutiny.

8 The operations manager will decide whether a case can be accepted using the following criteria:

1. in respect of major accident hazards, there is no prima facie evidence of non-compliance with HSWA and the relevant statutory provisions (except for trivial aspects);
2. the safety case contains all the factual information required by the regulations;
3. the demonstrations required by the regulations should not be deficient. A demonstration is deficient if any of the following apply:
   1. the relevant Assessment Principles for Offshore Safety Cases (APOSC) [PDF 158KB] are not taken account of in the safety case;
   2. the management system described is unlikely to ensure compliance with the appropriate relevant statutory provisions or satisfactory management of arrangements with contractors and sub-contractors;
   3. the audit and audit reporting arrangements described are unlikely to achieve the objectives of a safety management auditing scheme;
   4. there are inadequacies in the potential major accident hazard identification and risk assessment process which are likely to render the basis for risk management decisions invalid;
   5. it appears to HSE that the risk control measures taken, or proposed to be taken, are unlikely to ensure compliance with the relevant statutory provisions.

Explaining the reasons for non-acceptance

9 The responsibility for ensuring that a safety case satisfies all the requirements of the safety case regulations rests with the dutyholder. However, where HSE concludes that the case does not meet these requirements and cannot be accepted, HSE has a responsibility* to explain to the dutyholder what the deficiencies are and what needs to be done to remedy them.

10 An example is a case that is considered unacceptable because of inadequacies in the major accident hazard identification and risk assessment process. The assessor will need to identify and describe the inadequacies and explain how they are likely to invalidate the risk management decisions or measures. Similarly where the risk control measures do not appear to achieve compliance with the relevant statutory provisions, the assessor will need to provide reasoned arguments in support of this view.

The role of good practice

11 In reaching any conclusion, assessors are entitled to refer to authoritative sources of relevant, established good practice, as well as to HSE's own expertise. Much of HSE's interpretation of what is considered to be 'good practice' is now expressed in the new publication 'Guidance for the topic assessment of the major accident hazard aspects of safety cases [PDF 2.15MB] ' For example, assessors may have taken into consideration a technical standard, before concluding that risks have not, or will not, be reduced to the lowest level that is reasonably practicable. Account should also be taken of HSE's ALARP guidance suite in deciding what is reasonably practicable, in particular the document "Assessing Compliance with the Law in Individual Cases and the Use of Good Practice" and "Offshore Installations (Safety Case) Regulations 2005 Regulation 12 - Demonstrating compliance with the relevant statutory provisions [PDF 144KB]. Offshore Information Sheet No 2/2006"

Sufficiency of Safety Case contents

12 A sufficient case is one that contains the information specified in SCR regulation 12 and the relevant Schedule, thereby enabling OSD to decide if the document contains a satisfactory case for health and safety.

13 Arriving at this judgement does not demand ever-increasing analysis or requests for more information. Rather it requires that sufficient particulars have been provided to support the goal of the Regulations, in particular with Regulation 12(1)(d) regarding compliance with the relevant statutory provisions.

14 Assessment of a demonstration is not a mechanical exercise using a checklist to see whether items are present in a given situation. The object of the exercise is to paint a picture from the detail presented in the case. The overall effect can only be appreciated by standing back from the detailed picture and making a considered, informed, qualitative appreciation of the whole. It is a matter of evaluation of the overall effect of the detail, which may not be the same as the total of the individual details. Not all details have equal importance in any given situation, and they may vary in importance from one situation to another.

15 Assessors should also use their own knowledge in forming a view on whether the particulars are sufficient. However where a safety case is deficient because it fails to include relevant information which the assessor knows could have been included, the assessor must not give credit for this. The deficiency must be remedied by including the information in the safety case before it can be accepted.

Exercising judgement

16 The assessment process can involve forming a view on finely balanced arguments. The complexity of the issues and the technical judgement involved in evaluating major accident hazards means that demonstrations of compliance with the relevant statutory provisions may involve a degree of uncertainty. What matters is that the conclusion drawn can be shown to be reasonable, based on the information provided and the sources, expertise and knowledge referred to above, and that it involves the exercise of the assessor's best judgement. The conclusion may not be entirely free from doubt. As long as a conclusion is drawn to the assessor's best judgement, such doubt should not prevent an acceptance decision being reached by the operations manager. A formal second opinion can be requested where this may be helpful.

17 However in other cases, doubt may be more significant. Where it is so large that HSE is minded not to accept the safety case, assessors will need to be able to explain why and how the doubt involved in the dutyholder's arguments results in a failure to demonstrate compliance with the relevant statutory provisions.

Existing knowledge and further studies

18 An assessor's conclusions should only take account of information provided in the light of established technical knowledge. This includes knowledge that is newly arisen, for example information published since the previous version of the safety case. Where however this information is not yet assimilated into topic guidance, care should be taken to avoid using the assessment process to require new standards that are still to be fully debated with the industry. As a minimum, there should be an internally agreed HSE position that has been made known to the industry.

19 Assessors should also not be influenced by views on technical knowledge that might emerge from current or planned research (although a lack of research or studies may amount to a gap in the demonstration to be made).

20 There may be a need to extend current technical knowledge to see if, in the future, additional risk reduction measures could be taken. This might involve further studies by the dutyholder. The need for such studies need not prevent acceptance of the safety case in the meantime. It should be made clear to the dutyholder that the carrying out of further studies is not a condition of acceptance. Further studies should be encouraged, as they help to discharge the dutyholder's responsibilities for continuous improvement, by systematically looking for ways of reducing risks. The results may eventually need to be incorporated in a revision of the safety case. Assessors will therefore need to follow up such work as part of the intervention programme.

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Legal aspects

21 For guidance on the application and interpretation of the regulations, see the OSD Enforcement Manual.

22 Requests for exemptions from the requirements of SCR05 under Regulation 23 are handled as part of assessment activity. The arrangements are described in the OSD Enforcement Manual. The manual also describes the procedure for dealing with requests from dutyholders for approval under Regulation 7(3) to submit one safety case for more than one production installation.

23 During the assessment of a safety case, potential contraventions of HSWA or of its relevant statutory provisions may be identified, that relate to matters not relevant to the assessment decision. Any such contraventions should be addressed by intervention outside safety case assessment.

Arrangements for implementation

24 To secure compliance with OSD aims, objectives and principles, the safety case handling and assessment system has been established. It consists of SCHAM, certain elements of COIN, the planning system, the published APOSC [PDF 158KB] and GASCET [PDF 2.15MB].

25 This manual details those responsible in OSD for the management of the assessment process, the authority given to individuals and the procedures and guidance they must follow.

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Quality assurance

Quality assurance principles

26 To meet OSD's assessment principles, the safety case handling and assessment system has been designed in accordance with the quality assurance principles in the ISO 9000 series of standards.

Quality improvement arrangements

27 The operation of the safety case handling and assessment system is monitored by line management, and performance is periodically scrutinised by the Safety Case Programme Board, using data collected by the Operational Support Unit. The aim is to promote continuous improvement of each element of the system. The SCPB also have a strategic oversight of the overall process, ensuring that it meets the needs of the various stakeholders and is integrated with OSD's other intervention activities.

28 Review and update is the responsibility of the Legal and Operational Strategy Team and HID HQ Unit. The system is also subject to internal audit.

29 User input to the system is via the Safety Case Assessment System User Group, SCASUG. It provides feedback on the implementation of the System and suggests improvements. It meets at least annually.

30 The roles and responsibilities of these bodies are described in the 'roles and responsibilities' section.

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Guidance for assessors

31 Guidance for the assessment of safety cases is in the published HSE APOSC [PDF 158KB] document. This document provides an agreed framework for the consistent exercise of professional judgement by all Inspectors during the assessment process. It is backed up by detailed topic guidance provided by topic teams and GASCET [PDF 2.15MB].

IT systems

32 The COIN IT System supports the assessment process by containing a permanent record of written communications prepared by OSD, and either contains or provides cross-references to the location of written communications from the dutyholder. It also provides audit data.

Training

33 A wide range of competencies is required to ensure safety cases are handled and assessed efficiently and effectively. Technical, procedural and IT training for all of those involved will be provided as required.

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^right* This 'responsibility' derives from the HSE's Enforcement Policy Statement [PDF 88KB] and the Principles of Good Enforcement laid down in the Better Regulation Taskforce's 'Code for Enforcement Agencies' (the Enforcement Concordat).