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Establishing Safety Objectives

While the business side of the objectives maybe stated in terms of productivity, costs, or profits, safety objectives can be stated in terms of losses, accidents, safe behaviors, [Pg.16]


As a general rule, clinical data are required as evidence to support conformity with the requirements of the Active Implantable Medical Devices (AIMD) and the Medical Device (MD) directives with regards to safety and effectiveness under the normal conditions of use, evaluation of undesirable side effects, and the acceptability of the benefit/risk ratio. Risk analysis should be used to establish key objectives that need to be addressed by clinical data, or alternatively to justify why clinical data are not required (mainly for Class I devices). The risk analysis process should help the manufacturer to identify known (or reasonably foreseeable) hazards associated with the use of the device, and decide how best to investigate and estimate the risks associated with each hazard. The clinical data should then be used to establish the safety and effectiveness of the device under the intended use conditions, and to demonstrate that any of the residual risks are acceptable, when weighed against the benefits derived from use of the device. [Pg.187]

Transitioning into an initial exploratory clinical evaluation rests upon safety and functional understanding built during preclinical evaluation. The preclinical program establishes assessment objectives related to specific product characteristics and the supporting production processes. Translational medicine study results define the extent to which preclinical information demonstrates... [Pg.807]

Plan - Identify and evaluate environmental, health, safety, security, distribution, product, and process aspects and impacts, or hazards and risks. Establish goals, objectives, and targets and programs to meet them. [Pg.110]

In recent years, from investigation on a large number of enterprises, more and more enterprises are starting to make zero accident concept as one of their safety management concepts, and establish a zero accident objective as their highest safety objective, such as DuPont, Eluor, Alcoa, Dow, Intel, Motorola, Lonza (Guangzhou), the Rainbow Group, Australian Coal Association and so on. The safety performance of these enterprises is well known, however, the relationship between achieved safety performance and zero accident concept has not been studied in depth, and this paper will carry on theoretical and empirical research on this issue. [Pg.725]

To play a safety audit in safety production of construction, you must first clear theoretical structure of safety audit. Since the entire audit objectives play a guiding role in the theoretical structure, this paper starts from the safety objectives of the audit and establishes the theoretical construct structural framework of safety audit, shown in Figure 1. [Pg.1307]

According to the realistic environment faced by the safety audit and safety audit report users determine the purpose of the safety audit objectives, only by determining the safety audit objectives at first, can we define the direction of activities. The theoretical structure of safety audit in the target is a priority position which reflects and embodies the essence of the safety audit requirements. To achieve the audit objectives, we need to clear the contents of the safety audit, scientific design of safety audit model and select the appropriate audit procedures and methods. Meanwhile, we should ultimately the formation of appropriate safety audit reports through information disclosure and accountability mechanisms in order to achieve the established safety audit functions of development services for safety audit external environment. [Pg.1307]

What safety objectives are/will be established and how is attainment monitored ... [Pg.155]

In the guidelines to be published and in training programs to be conducted, the purposes and objectives of incident investigation should be established and communicated in a language understood in the organization, particularly in relation to its established safety policies and procedures. Some such statements of purpose, taken from issued publications, follow. Choose and adopt from those that are helpful ... [Pg.220]

In System Safety Engineering and Management, 2nd edition, Harold E. Roland and Brian Moriarty ask. What is system safety In response to their own question, they give two meaningful comments and then establish the system safety objective ... [Pg.327]

Safety programming is establishing the priority and following order of the safety action steps that must be taken to reach the safety objective. If the objective is to... [Pg.42]

According to the ACSNl Study Group on Human Factors (HSC, 1993), a written corporate statement on the safety policy and organization should be a crucial element in the promotion and maintenance of a positive safety culture within the organization. Its objective should be to establish the corporate attitude to safety and the organizational framework through which the safety objectives can be assured. (Health and Safety Executive, 2001, p. 8)... [Pg.82]

Planning is the establishment of objectives and processes and actions necessary to deliver results in accordance with the safety policy leading statement. [Pg.143]

Safety Research Group translating evidence into practice model (Figure 19.1). Considerable attention is paid to established clear objectives and the associated measures, such as infection rates from central lines. The evidence and the objectives form the core, but it is also necessary to understand the reahties of the work process and its context, and the barriers to doing the j oh well. Some of this understanding comes from formal analytic methods, such as incident analysis, but much comes from simply watching and talking ... [Pg.377]

The General Nuclear Safety Objective is to protect individuals, society and the environment from harm by establishing and maintaining effective defences against radiological hazards in nuclear installations. [Pg.1]

Do 1 have established safety goals and objectives in place, and do I have a plan on how my team, drivers, and organization is going to achieve them ... [Pg.26]

This is considered a poorly written safety objective since it does not establish a timeframe for completion. It also does not provide a measure by which success or failure of meeting the objective can be ascertained. [Pg.17]

This is considered a well-constructed safety objective because it establishes a frxed shortterm focus for the safety program. The desired outcome for the goal is measurable. [Pg.17]

Establishing workplace objectives and safety recognition programs... [Pg.475]

The third step in determining the direction of your safety program is to map out your route by establishing program objectives. To do this, you first need to know where you are take a close look at the current state of your safety program and your workplace. What more is needed to protect your employees safety [2] ... [Pg.93]

The next step is to establish performance objectives for all employees with assigned safety responsibilities. These objectives must be realistic, understandable, measurable, and achievable. It is your job as a manager to clearly establish who is responsible for performing specific tasks. Evaluate your assignments of responsibility to make sure that they specify who does what and how they do it, and that they are realistic and reasonably attainable. When objectives are unclear, they can be misunderstood. In this case, it will be hard to determine whose performance is lacking— the manager or the employee [1]. [Pg.154]

Management is responsible for establishing safety and environmental objectives, goals and performance measures and should consider the following ... [Pg.150]


See other pages where Establishing Safety Objectives is mentioned: [Pg.16]    [Pg.578]    [Pg.16]    [Pg.578]    [Pg.14]    [Pg.25]    [Pg.44]    [Pg.219]    [Pg.62]    [Pg.145]    [Pg.13]    [Pg.107]    [Pg.223]    [Pg.147]    [Pg.89]    [Pg.93]    [Pg.22]    [Pg.148]    [Pg.149]    [Pg.41]    [Pg.23]    [Pg.51]    [Pg.451]    [Pg.516]    [Pg.11]    [Pg.16]    [Pg.122]    [Pg.216]    [Pg.87]   


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