Safety and Human Factors Basics

The history of safety may be traced back to ancient times, but in the modem context its serious beginnings appear to be in 1868, when a patent was awarded for the first barrier safeguard [1]. In 1877 the Massachusetts legislature passed a law requiring appropriate safeguards on hazardous machinery [1,2]. In 1931 H. W. Heinrich published a book on industrial safety entitled Industrial Accident Prevention [3], and in 1970 the United States Congress passed the Occupational Safety and Health Act (OSHA) [1,2,4]. 

safety is recognized as a specialized discipline and there are a large number of publications available on the topic in the forms of books, technical reports, journal and conference proceedings articles, and standards. 

The history of human factors may be traced back to 1898, when Frederick W. Taylor conducted various studies to determine the most suitable design of shovels [5]. In 1918 the United States Department of Defense established laboratories to perform research on various aspects of human factors at the Brooks and Wright-Patterson Air Force Bases [6]. In 1924 the National Research Council (USA) initiated a study concerned with the various aspects of human factors including the effects of varying illumination, length of workday, and rest period on productivity at the Hawthorne Plant of Western Electric in the state of Illinois [7,8]. By 1945 human factors came to be recognized as a specialized discipline, and currently a vast number of publications are available on human factors. 

This chapter presents various fundamental aspects of safety and human factors considered useful for studying patient safety. 

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Chapter 3 presents introductory aspects of safety and human factors. Chapter 4 is devoted to methods considered useful to perform patient safety analysis. These methods include failure modes and effect analysis (FMEA), fault tree analysis (FTA), root cause analysis (RCA), hazard and operability analysis (HAZOP), six sigma methodology, preliminary hazard analysis (PFfA), interface safety analysis (ISA), and job safety analysis (JSA). Patient safety basics are presented in Chapter 5. This chapter covers such topics as patient safety goals, causes of patient injuries, patient safety culture, factors contributing to pahent safety culture, safe practices for better health care, and patient safety indicators and their selection. 

Source J. T. Reason, "The Basics of Human Factors," paper presented at the Salzburg Seminar on Medical Safety and Human Error, Apr. 25-May 2, 2001. 

Where loss of control could lead to severe consequences, the integrity of the basic process control system and the protective safeguards must be designed, operated and maintained to a high standard. Industry standards such as ANSI/ISA-S84.01 (1996) and IEC 61508 (2000) address the issues of how to design, operate and maintain safety instrumented systems such as high temperature interlocks to achieve the necessary level of functional safety. The scope of these standards includes hardware, software, human factors and management (HSE 2000). 

Biopharmaceuticals represent a broad but discrete class of large molecular weight therapeutic entities that are characterized by their specific pharmacological activities and distinctive pharmacokinetics. The selection of an appropriate animal model is dependent on a combination of PD and PK factors. As described in this chapter, it is essential to understand the relationship of the basic pharmacology of a biopharmaceutical (signaling, receptor presence, binding properties, etc.) and the associated PK properties to that expected in humans, in order to select animal species that will have the most predictive value in safety assessments. 

Contents indude techniques for evaluating basic process control system and safety interlock system Integrity, human factors, and safety considerations In the selection and design of basic process control systems and safety Interlock systems. 

In terms of evidence, the safety case should set out (for those key hazards where human factors are important mitigations) a clear chain of logic from the control to a workable and effective policy. At the most basic level this should consist of a formal reference to the document or traceability from a series of controls to several relevant policies. By supplementing this with a description of how the above policy characteristics were achieved, further confidence can be built to show that appropriate diligence and governance has been applied. 

It is required to manage the functional safety in entire safety lifecycle keeping the risk level of potential hazardous events at acceptable level. Thus, it is essential to modernize and improve when required the basic process control system (SCADA and DCS) and the safety-related systems including the alarm system based on experience from their operation and periodical risk assessment. In such process it is essential to consider carefully the human and organizational factors using relevant HRA methods to maintain adequate risk associated with operation of complex industrial hazardous plants. 

The International Ergonomics Association promotes a systematic approach to the ergonomic process, to incorporate human factors and human performance engineering and address problems in design of machines, environments, or systems. This can improve efficiency and safety of the human-machine relationship. The basic steps in the ergonomic process include organization of the process, identification and analyzation the problem, development of a solution, implementation of the solution, and evaluation of the result. 

In addition to the factors associated with human health and safety, and having regard to the RADWASS principles, it is also necessary to pay attention to basic requirements for protection of the... 

Utilization of technical diagnostics methods, when taking into account the reliability of results, is only one of the basic tools for effective maintenance management and elimination of undesirable conditions (hazards) as aresnlt of technical or human factors affecting the safety of the Man-Machine-Environment system. 

A full discussion of the interactions between people and their organisation, jobs and working environment, and the influence of equipment and systems design on human performance, is beyond the scope of this book. The aim of this chapter is to provide an insight into some of the basic concepts involved, and to discuss some of the solutions currently used to tackle them. A concise and readable summary of human factors in safety can be found in the excellent HSE publication Reducing error and influencing behaviour . 

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