Safety Case participation

An essential part of the development of an appropriate culture is the involvement of employees through their representatives in the preparation of the safety case and the active participation of employees in the maintenance of a safe place of work. The safety case will need to clearly identify the methods used to involve employees in safety management of the facility. 

The authors would like to take this opportunity to thank Patrick Mana (EUROCONTROL) for his contribution to producing the Safety Case Development Manual (EUROCONTROL 2005), and would like to extend these thanks to those who participated in the review process, which led to current version of the Manual. 

This project has provided a convincing demonstration of the advantages of using GSN in safety case construction in an industrial setting. All of the participants in the project were impressed with how much the technique assisted in the... 

The active participation of all employees and contract workers is the key to the success of any safety program—including Safety Cases. Not only does this mean that employees are informed and trained about the Safety Case, but they also actively participate in its application and are encouraged to think of ways of improving system safety. The Safety Case becomes part of the organization s overall safety culture. 

In addition, just as employee participation is the key element of process safety management systems, worker involvement is crucial to the effective application of Safety Cases. Unfortunately, the perception among many that a Safety Case is a lengthy, highly technical document that can only be understood by specialists, mitigates effective employee participation. For example the Computational Fluid Dynamics (CFD) technique used to model explosion over-pressure uses very sophisticated mathematics. This sophistication makes communication with nonspecialists a challenge. In addition the sheer size and complexity of a Safety Case may serve as a barrier to the involvement of nontechnical personnel. 

The challenge for EFR is that it must satisfy the same level of safety as fiiture LWRs and be capable of being licensed in each of the participating countries. An important achievement has been to demonstrate the potential licensability by means of an independent review of the essential elements of the safety case by a group of prominent safety experts from France, Germany and the UK. This review allowed in-depth discussions on the general approach, the main safety functions and the proposed risk minimization measures. The outcome was as follows ... 

Safe operation of the mainline railways rests on reciprocal responsibilities of all the railway management participating in the operation of the railway network. These responsibilities are set out in railway safety cases which make visible the railway s safety arrangements, and ensure that all concerned are aware of their safety responsibilities. 

The primary objective of a Phase I trial is to assess the safety of the drug in humans. Studies are normally conducted in healthy male volunteers, although specific categories of subject may be used in certain cases. For example, to avoid the risk of low blood pressure, subjects with mild hypertension would be more appropriate for the evaluation of antihypertensive drugs, while patients are likely to be used in the case of drugs that are expected to produce significant toxic effects (e.g. anti-cancer cytotoxic drugs). Remuneration may be offered for participation in the study. The number of subjects is normally between 10 and 100 people. 

In addition to these selection criteria, the limitations of the author s contacts and the willingness of companies to participate, narrowed the search for a suitable case down to a small Dutch company (< 30 people). This company produces in batches, falls under the Dutch Seveso-II directive (BRZO, 1999) and authorized access to the relevant data. The selected company had experienced some serious accidents recently, in spite of using many technical safety systems. Thus the management was aware of the necessity to enhance both safety and the reliability of the operational process. 

First, the most recent (October, 2000) revision of the Declaration of Helsinki (World Medical Association, 2000) calls for discontinuing the use of placebo controlled trials in patients. While this is not currently binding on U.S. trials (FDA has specifically said that they will not mirror this as a requirement), and is intended to protect the health of participating patient subjects by precluding having some denied existing efficacious treatments (which would be the effect in most—but not all—cases), it will also likely cause the numbers of subjects required in a trial to increase. This will further stretch the economic aspects of limitations on the power of trials to assess potential drug safety in what will be the intended patient population. Trials are already very expensive each additional subject enrolled costs 15,000 or more in a Phase 11 or 111 trial. 

Section 4.1). For existing facilities, operating and maintenance personnel should also participate in the inherent safety review. A smaller team may be appropriate for facilities such as warehouses. In any case, the review team must include one or more individuals with the background and experience to recognize and understand the chemical reactivity hazards and how they may lead to uncontrolled chemical reactions. In this regard, outside experts may need to be consulted. 

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. 

Increased harmonization offers clear benefits for public health. It can increase the safety and quality of food produced and sold in foreign countries or food imported from other countries, as more countries participate in the international standard setting process. Harmonization benefits industry by replacing many different standards with one international standard that must be met. In the long run, harmonization will bring cost savings to industry, open markets, enhance opportunities for export, and, in some cases, lessen the time needed to bring new products to market. 

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