Safety case report

The Safety Case Report - setting out the argument and evidence to support the... 

Includes all occupational safety cases reported at Al-Ain Hospital from March 2003 to April 2005... 

A Safety Assessment (or Safety Case Report) is no different a mass of evidence is generated during ... 

The fire tetrahedron indicates that if any of the elements is sufficiently reduced the propagation of the fire ceases and the full flame phase of the fire is prevented. One can envisage fire safety case reports using the fire tetrahedron as a basis, where for each operational mode of, for example, an off-shore fire management system, where the occurrence and significance of each tetrahedral element is judged to determine a level of risk priority. In turn each operational mode of a system is assessed to see if one or more of the four tetrahedral elements can be removed completely, or reduced to a level that would prevent fire propagation. 

Now the department has experience with conqtlete safety programs for projects comprising a full safety assessment process concluded with a safety case report. 

All previously performed analyses are updated with the latest available data and all safety targets and safety requirements have to be verified, whether they are met. Finally a Safety Case Report is produced. This report is a living document, which has to be kept up-to-date during the whole life-cycle of the system, especially when there are changes at the system or the environment. 

The following issues were found to be essential when performing a safety program, finished with a safety case report ... 

A phased safety case production process allows the developers and assessors to have an increasing conHdence in the final product. One of the best ways to reduce uncertainty is to reduce it over time. The staged production and delivery of safety case reports allows discussion between stakeholders about the merits of a particular argument approach. This goes some way to addressing the sufficiency issue -agreement can be reached before evidence production that the evidence set is sufficient. Common intervals for safety case report production are ... 

Parts 3 to 7 of the ISO 26262 eontain chapters requesting development activities in the context of functional safety. Each of these chapters specifies work products as input to subsequent processes of the lifecycle or for documentation purposes used for the deployment of the safety case. Reports, documenting content and relations of the EEA model, can be automatically generated and formatted out of PREEvision and thereby support the deployment of the safety case. The content of reports is based on results of predefined model query rules. 

Service SMP produced and maintained. HL actively maintained in specific tool. Client involved in regular hazard review meetings. HL and safety analyses updated regularly from variety of inputs. Single safety justification document produced (e.g. safety case report) and occasionally updated. Regular safety briefings to staff. PSE is more than half time on project. 

Regulations for ICT in the healthcare sector are presented in this section, with their impact on managing safety within the Trust s ICT department, for development and operational use. The impact is in the area of formal and evidenced management of safety the safety case report is identified as a key artefact to be planned, produced and maintained. The updates to EC directives for stand-alone software as a medical device are discussed. 

Current health software developments within the Trust are intended to comply with these NHS standards. Developments are supported with a safety case report. The strategy is to build up a set of sub-system safety cases until there is a comprehensive set covering all applicable parts of the Trust s IT. 

The safety case, safety case report and supporting activities were the key to developing a safety management strategy. When the regulations were updated, some parts of the necessary response were aheady in place within the Trust, but not all. 

Templates were produced for safety case reports and hazard analyses. It is now policy that safety case reports are to be produced at an early stage in the development of any new work. Training has been provided for key staff, to achieve this. 

The production of a safety argument and a safety case summarised in a safety case report is crucial to the implementation of the current safety standards, embodying as they do current good professional practice. A safety case is intended to be a compelling argument that an acceptable level of safety has been achieved, supported by objective evidence. 

The seope of safety management activities is not limited to just the safety of patients, but to anyone who could be affected. The scope has also been extended to inelude the infrastructure workstations, servers, network etc. This extends the formal seope of the standards into a cohesive approach which addresses the safety of all ICT activities for die Trust. Where a safety case report is issued for deployment and use of in-house developed software, tiien the requirements for a manufacture safety ease are also addressed, tiius avoiding the need for the same team to produce two reports. 

Some Safety Case reports contain an as low as reasonably practicable (ALARP) demonstration section that shows how the identified major hazards have been managed such that the associated level of risk is acceptable. The vexed topics of ALARP and acceptable risk are discussed in Chapter 1. 

Safety Cases are usually lengthy documents, supported by detailed analyses, studies, and reports. This does not mean, however, that the Safety Case report delivered to the regulator and public need to be aU that lengthy. It can provide a summary of the key results and programs, and then show where additional... 

Maintenance of a risk register and a safety case report... 

Safety case report - a summary of the safety argument, including all salient issues and any recommendations for future work. 

Later, however, QinetiQ clearly softened their tone, and in June 2004 Martin Mahy wrote to Frank Walsh to say that, Provided all the risk mitigation evidence is included in the final safety case report, I don t foresee any difficulties... in the sign-off of the baseline safety case. ... 

The System Safety Assessment (SSA) shall answer the question Does the implemented system achieve tolerable risk The system must inqilement all safety requirements and must provide the intended functionality such that the remaining risk is kept at an acceptable level. In order to assure this, test methods such as those proposed by lEC 61508 are applied. Thereby it is verified that the safety goals are achieved and that the safety requirements are considered accordingly in the design. SSAs are consequently performed in an iterative way over the remainder of the system life cycle. In this context the safety case report has to be regarded as a living document that must be kept up-to-date especially with regard to modifications of the system or the system environment. 

Inputs to the decision making activity from Ensurance, Assurance or external activities (for example safety case reports or development plans). This list of irqiuts is intended to be indicative of the minimum information which will be needed, and should not be considered exhaustive. 

COMAH An abbreviation for Control of Major Accidents and Hazards. These UK regulations under the Health and Safety at Work Act require the operator of a process plant or site that contains more than a defined amount of hazardous chemicals to provide a safety case report for the process and its operations, to demonstrate that it can be operated in a... 

The safety case is a live, virtual , document containing all of the above. It is never complete, because the hazard log should never be closed (unless the product ceases to exist) and the SMS is a living process, tailored to effect the current roleplayers. When printed, the safety case report is a reflection of the safety case at a specific point in time (i.e. a snapshot). 

In Section 9.2.1 we defined a safety case as a structured body of evidence that provides a convincing and valid argument that a system is adequately safe for a given application in a given environment. This evidence is collated and presented in a safety case report, which is a snapshot of a defined point in time. It usually provides a traceable reference to evidence in test results, detailed safety analysis reports, etc. 

The size and scope of a safety case can vary enormously and will be appropriate to the system complexity and the level of risk involved. Throughout the life of a system/facility/operation it will be necessary to abstract evidence from the safety case and present it in the form of a safety case report to support life-cycle milestones. Each safety case report will present a safety argument (a reasoned justification) that a safety claim or target has been met. 

The safety case report should be readable by non-safety experts but have sufficient detail to assist senior management to review performance and provide authority to... 

The safety case report should provide a list of recommendations and limitations needed to ensure that the required level of safety is retained. Particular issues that should be provided include ... 

---