Safety-Related Issues

Abnomnal result noticed during manual spot-checte 

For example, as an organisation learns more about a system in the course of a project it might be found that  

The processes involved in managing these issues are likely to reside in the realm of project management rather than within the SMS as many issues will not be related to safety. A strong project manager will arrange regular risk and issue review sessions ensuring that each concern has an owner and documented action plan. 

From a CRM perspective it is useful to evaluate any issues raised to determine whether they are associated with any clinical risk. What emerges is a list of open safety-related issues which should become the target of focussed investigation and risk reduction. So what is the relationship between hazards and safety-related issues Indeed, are all issues hazards and all hazards issues  

If an issue could contribute to patient harm and it is unlikely to be imminently resolved, reflecting the problem in the hazard register can pay dividends to ensure that all stakeholder are aware and that the risk is formally assessed. One should consider  

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An exercise consisting of 24 statements describing a personal experience of a safety related issue that participants have to match to other members of the group. 

Operating complexity. Complex operations may introduce the potential for overlooking safety-related issues in the design phase and may also present challenges for operators to accurately and quickly assess plant upsets and respond with appropriate action. 

This working party considers safety-related issues at the request of the CPMP and national authorities, resulting in the harmonization of the summary of produet eharae-teristics and package leaflets of marketed products. Regular videoeonferenees are held with the U.S. Food and Drug Administration (FDA) to discuss issues of mutual interest. A pilot project has been started for the electronic transmission of individual case safety reports with a restricted number of participants from national authorities and marketing authorization holders. 

Before beginning a new experiment, check the safety-related issues of the protocol as well as the chemicals involved. Take note of precautionary measures in case of accidents. Presumably all chemicals are harmful. 

The author was member of JTT4, and has similar experiences from research projects in the area of dependable systems, where it was either very difficult, under cost-pressure and funding priorities, to include certain security aspects besides the safety related issues, or, after reduction of funds,... 

Timely attention to these safety-related issues cannot, by itself, draw hydrogen into the marketplace. Left unaddressed, however, these issues will raise formidable barriers to the wide-scale use of hydrogen in the consumer economy. 

Sooner or later, every power supply designer finds out the hard way that if anything has the potential to cause a return to the drawing board at the very last moment, it is either a thermal issue, a safety related issue, or a stubborn EMI (electromagnetic interference) problem. 

DNA vaccines raise certain safety-related issues that may remain unsolved even after intensive studies. Hence, a scientifically... 

We discussed in Chap. 6 that safety-related issues are generally associated with either information which is ntisleading or information which is absent. To support the process of risk evaluation one can add a second axis to this classification, issues which are detectable aud those which are not The degree of clinical risk associated with a hazard will depend on its precise nature but, as a generalisation, the relative risk can be summarised as in (Table 14.2). 

One might argue that once a safety-related issue has been identified it is too late to consider potential controls but this is far from the case. Just because a hazardous scenario may result from the fault it is by no means a foregone conclusion that actual harm will occur. There will usually be a human operator between the system and the patient who can work around the issue or take remedial action. In some cases, the provision of practical advice to users from a system expert may alleviate much of the real world risk until the issue is hxed. Important mitigations of this nature should be documented in the issue assessment and provide one means by which the advice may be propagated. 

One has to observe that safety-related issues provide impulses for the underlying areas of knowledge. Interrelationships exist. It should be noted that the requirements on the systems and the decision of whether a certain state is to be assigned to functioning or failure depends on the required system function (totality of systems, which have to work in order to fulfil the required task). This decision may differ depending on whether full or partial load operation, shut-down or startup are to be investigated. 

A safe space now needs to be created where employees can feel comfortable about discussing and reporting safety-related issues. This employee empowerment enables management to get a realistic picture of what the safety concerns are in the workplace. Real solutions can only come from the experts in the workplace—the employees. Employees need to be listened to. Reporting systems should be anonymous. In a positive safety culture it is not who reported, but what was reported. Focusing on the what is important because that is the risk that needs to be remedied. 

Initiate formal commendation, warning, or proceedings for nonsupervisory staff for safety-related issues leading to warnings... 

In two of the case study industries, there were indications of reductions in support services that could have potential safety consequences. In particular, in the airline industry case study, there were concerns about cuts in corporate support departments such as engineering and meteorology, which could leave the airlines more dependent on other information sources (e.g., equipment vendors). Concerns about the elimination of most airline weather departments and the reliance on publicly available weather services were also raised independently by one of the airline industry interviewees. Finally, claims were also made that competition and financial pressiues had reduced the resources available for inter-airline bench-marking on safety-related issues. 

The important thing to keep in mind is that you want to keep open, two-way communication flowing between all departments of the organization. In this way, you can stay on top, and in tune with, the critical safety-related issues of the entire company. 

In your own department (Safety), make sure the drivers know who they need to talk to for safety related issues. Too many... 

How contractors and leased employees are selected and trained in safety-related issues, and how their expertise in the field of interest is ensured. This function also concerns practices to facilitate organisational learning from contractors as well as contractors own learning. ... 

Coordinate safety-related issues with the hazard control manager, safety director, and organizational safety committee. 

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