Safety specification, risk

Have you read the safety-specific risk section in the job description (yes = 1 point, no = 0) ... 

Arrester Testing and Standards Regulatory and approval agencies and insurers impose acceptance testing requirements, sometimes as part of certification standards. The user may also request testing to demonstrate specific performance needs, just as the manufacturer can help develop standards. These interrelationships have resulted in several new and updated performance test procedures. Listing of an arrester by a testing laboratoiy refers only to performance under a defined set of test conditions. The flame arrester user should develop specific application requirements based on the service involved and the safety and risk criteria adopted. 

Included in this element are requirements for purchasing documents (specifications, drawings, and purchase orders), selection of suppliers, inspection and control of received material and record-keeping. For ESH/PSM, this element would focus on those aspects of the procurement process which support purchasing according to regulatory requirements, safety standards, risk management controls, etc. 

You must also do specific risk assessments for young people - you need to take account of their nexperience, lack of awareness of risks and nmatirity (see the Management of Health and Safety at Work Regulations 1999). 

POLYMERS AND BIOLOGICAL SAFETY TESTING GENERAL AND SPECIFIC RISK ASSESSMENT Baldrick P... 

FDA has also formed a Drug Safety and Risk Management Advisory Committee during this time, provided specific training for the members and has subsequently placed selected members on Advisory Committee Panels to consider various risks or to review existing risk management programs. 

The requirements for the format and content of the IND application, as well as the requirements governing the use of the IND, are provided in Title 21 of the Code of Federal Regulations (21 CFR), Section 312. Unlike an NDA, the FDA does not formally approve an IND submission. If the FDA reviewers believe that the proposed clinical trial(s) submitted in the IND are acceptable from a safety and risk versus benefit viewpoint, the IND is in effect, and the compound that is the subject of that IND may be shipped in interstate commerce for the purpose of conducting specific clinical trials. Drugs shipped under an IND have specific labeling requirements, and false or misleading statements, as well as any claims regarding safety and efficacy, are prohibited. 

In addition to specific risk assessments, most institutions will have a safety handbook, giving general details of safe working practices, together with the... 

Periodic management review is a specific risk-based process safety (RBPS) element Providing regular checkups on the health of process safety management systems—including the metrics—will identify and correct any current or incipient deficiencies before they are revealed by an audit or incident. Such management reviews also demonstrate management interest and commitment to process safety and the metrics that describe the system. 

Central venous catheters are reluctantly used as blood access for hemodialysis because of safety concerns and frequent complications, for example sepsis, thrombosis, and vessel stenosis. Nevertheless, 20% or more of all patients rely on atrial catheters for chronic dialysis because of lack of other access. Potentially fatal risks related to central venous catheters include air embolism (1), severe blood loss (2), and electric shock (3). These specific risks have been substantially eliminated by the inherent design and implantation of Dialock (Biolink Corporation, USA). Dialock is a subcutaneous device consisting of a titanium housing with two passages with integrated valves connected to two silicone catheters. The system is implanted subcutaneously below the clavicle. The tips of the catheters are placed in the right atrium. The port is accessed percutaneously with needle cannulas. 

The Eederal Eood Safety Program resides in part under the authority of the US Food and Drug Administration. The specific statutory authority is the Federal Food, Drug, and Cosmetic Act (FFDCA). The areas of responsibility include the consideration of the safety or risk of food and color additives, both direct and indirect, and food-borne contaminants, both natural and anthropogenic. The FFDCA proscribes somewhat different standards of safety/risk for intentional food additives that undergo pre-market assessment of safety, specifically, versus those dietary constituents that are found in food as contaminants because they occur naturally or because they arise from anthropogenic sources. 

Safe unit placement enhances the overall safety of a pilot plant. A containment cell or a separate building is not, however, a guarantee of safety. Other measures include Increased process monitoring of safety specific variables, limiting inventories of hazardous feedstocks and products, detailed hazard analysis and risk assessments, and good design practices. One essential element is to ensure that the pilot plant has adequate space to support its operation. This requires a careful evaluation of the required space before the unit is constructed. While a detailed layout and a careful... 

These represent a simplification over a true LCA methodology, and include also aspects related to safety and risk, and economics. They thus could be a basis, which can be adapted for specific cases, for a sustainable chemical production metric, which should be integrated with other assessment tools such as LCA, Sustainable Process Index, and Risk Analysis and evaluation. 

The a priori identification of specific risk hypotheses leads to the ability to take some of the methodology normally applied to hypothesis testing of efficacy results and apply it to safety assessment. The most important difference between these two analysis domains is that in the case of efficacy, outcomes of interest are identified a priori with great specificity, and clear statistical hypotheses are laid out in advance with complete analysis and decision rules documented in the clinical protocol. In practice, only a few efficacy variables are identified as primary, and only a few others as second-ary. Sensitivity, statistical power, and sample size are all carefully analyzed in advance to assure the trial will have a high probability of detecting differences of interest in these few critical variables. 

Phase II clinical studies usually comprise no more than several hundred subjects and are normally done as controlled studies comparing the test vaccine along with an alternative prophylactic or therapeutic treatment. Clinical evaluations are mainly addressing the vaccine s effectiveness and safety, doses, application schemes, and possibly also different target groups selected by age, specific risks, countries, or by epidemiological criteria. 

Rather than establish individual cleanup standards, CERCLA assures that remedies are based on cleanup standards established by other laws (e.g. CAA, CWA, and RCRA). In conjunction with site-specific risk factors, CERCLA requires that remedies attain any legally applicable or relevant and appropriate requirements (ARARs). ARARs are standards, criteria, or limitations under federal and state environmental laws. For example, if electrokinetic remediation involves the on-site treatment, storage, or disposal of hazardous wastes, the remediation activity must meet RCRA standards for such treatment, storage, and disposal. ARARs relative to electrokinetic remediation include (a) the CERCLA, (b) the RCRA, (c) the CAA, (d) the CWA, (e) the SDWA, and (f) Occupational Safety and Health Administration (OSHA) regulations (ERA SITE Program, 2003). These six general requirements are discussed in the sections that follow. 

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