Safety events

The roles of adenosine in these safety events have led to the term adenosine revival emphasising the important role of this nucleoside. 

Tissue cross-reactivity studies are required by FDA for monoclonal antibody products to determine if the product binds to target and/or nontarget tissues. They are also performed for nonmonoclonal biopharmaceuticals if warranted. For example, ARANESP was tested in a human tissue panel ex vivo to determine if it bound to nontarget tissues or cross-reacted with related cytokine receptors. These studies are also used to explore known or potential clinical adverse safety events (i.e., mechanism of toxicity). For example, one patient in a Raptiva study developed unilateral hearing loss. This finding was further evaluated by cross-reactivity studies with human optic chiasm, acoustic nerve, and inner ear tissues. 

In 2008 Michael Elliott and colleagues at the University of Pennsylvania Wharton Risk Center published a study ( Linking Oil and RMP Data Does Everyday Safety Prevent Catastrophic Loss ) that provided no evidence of a correlation between low Oil rates and low process safety incident rates and only marginal support for a correlation that high Oil rates might predict further high-consequence process safety events. 

Metrics on process safety events and near misses that have occurred... 

All research personnel must search for clues about safety events from many sources, such as information in clinical records at the study sites information in data collection forms (e.g. CRFs, diary cards, quality-of-life forms, psychiatric rating scales, etc.), occurrence of missed and/or unscheduled visits, dropouts and withdrawals use of any concomitant medications/devices and abnormal laboratory data. AEs may also occur simply as a result of study procedures and study participation. Information about definitions of AEs and requirements for reporting AEs must be clearly stated in the protocol and explained to the site staff, who must also be educated in the correct procedure and immediate requirement for reporting any AE suspected to be serious or unexpected as per the regulatory definitions. 

The maximum temperatures reached in this as well as other bounding safety events satisfy the design... 

All research personnel must search for clues about safety events from many sources, such as ... 

Sparnon E, Marella W. The role of the electronic health record in patient safety events. Pa Patient Saf Advis. 2012 9(4) 113-21. 

In the specific implementation of a safety audit project, safety audit project leader should be fully aware of the following circumstances, an initid assessment of the importance of this safety audit and audit risk (1) ask the audited entity related personnel and related management (2) access to the audited entity s operations manual, the internal control manual and other information (3) access to the audited entity annual production and safety plans, financial budget and other documents (4) check the safety activities or safety issues certificates and records (5) examine the audited unit production, business activities and the implementation of internal control (6) select the number of safety events to be tested. 

The assumption underpinning the incident pyramid is that the causes for all types of event are the same. In fact, this assumption is only partially correct because the root causes of minor events are different from those that lead to process safety events. Therefore, improving day-to-day safety will not necessarily reduce the number of serious incidents. Minor events are typically caused by occupational problems such as trips and falls, lack of proper PPE, and improper use of machinery. Major events, however, are more often caused by process safety problems such as incorrect instrument settings, corrosion, or mixing of incompatible chemicals. Hence a program that leads to improvements in occupational safety will not necessarily help reduce the frequency of process-related events. Indeed, improvements in the occupational safety record may induce a false sense of confidence regarding the potential for a major event. (It is probable, however, that a poor performance in occupational safety will correlate positively with a poor performance in process safety.)... 

Economic loss can either be one time (say the destruction of a piece of equipment) or ongoing, in which case the value given in Table 1.11 represents an annual loss. The cost associated with a safety event can be derived from incident data. For example, one company has reported that the cost of a serious incident is in the range 2— 10 million, whereas the cost of a lost-time incident is 150,000. 

An additional difficulty is that many process safety events (PSEs)—particularly those that are near misses—may simply not be recognized for what they are. For example, an operator and a mechanic may fix a leaking pump seal, not realizing how close they were to having a major accident. 

Senior managers are concerned primarily with long-term issues. With respect to risk, they are particularly sensitive to the potential for major environmental and safety events such as the Exxon Valdez spill, the refinery explosion at Texas City, or the Deepwater Horizon/Macondo catastrophe. 

The setting is where the action takes place. The location for process safety events is usually clearly defined and can often be associated with pictures or videos. (There are exceptions. If one of the causes of an event was a design error, then the setting is likely to be a nondescript, air-conditioned office in a suburban office park.)... 

It is unusual for a process safety event to involve conflict between people (although it was a factor in the Deepwater Horizon catastrophe). However, conflicting departmental goals are often a factor— particularly the perceived clash between safety and getting the job done. We may instill the mantra There s always time to do a job safely into people. But they do not always behave that way. 

Near-misses and process safety events (leading and lagging indicators)... 

Number of high-potential near-misses recorded Number of imperfect days recorded (day with a process safety event, near-miss, chemical release, etc.)... 

Now, back to our kaizen team. After they observe the second pass or future state work process to determine the impact of their improvements, they will be very proud of the results. What is remarkable is that they will not only recognize the safety improvements they have made, but they will also comment on and be proud of the cycle time gains that have resulted from their safety event. In two recent such safety kaizen events I facilitated, the team reduced the labor content required for the work process by 50 percent. How is that possible By making safety improvements mainly related to improving or eliminating material... 

Hosting safety events in your facility to allow those involved to showcase their efforts... 

The nrunber of adverse safety events (violations related to that BASIC or crashes) ... 

When the adverse safety events occurred (more recent events are weighted more heavily). 

Dam break is considered as the typical public safety event. Once occurred, it may cause catastrophic destroy and impact on downstream life, property, infrastructure, eco-environment and economic and social development. At present, there are altogether 98,002 reservoirs in China, ranking the first place all over the world. From the year of 1954 to 2010, 3515 dams were broken completely, some of which caused heavy casualties. But also some dam-break events had done less damage or even no damage at all. The important reason that causes such difference is to strengthen the analysis of dam-break results and forecast of dam-break... 

Two types of safety events are explored. In the first, there is a failure in the supply of cooling water to the condenser. In the second, a large surge in steam to the reboiler occurs. 

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