Quality studies, incident

In three exercises, I collected a total of 905 incident investigation reports completed by supervisors for an analysis of the quality of incident investigation. With emphasis, I state that the study I made would not meet the modeling and methods requirements of scientific inquiry. Nevertheless, some interesting observations were made. 

Why a study of the quality of incident investigation There are three major elements in practice of safety preoperational (in the design process) in the operation mode (integrated within a process of continuous improvement) and post-incident (after a hazards-related incident has occurred). 

At the locations where the quality of investigations was good, it was determined that safety professionals had made much of the subject in their giving counsel, and management insisted on the job being well done. Also, as was found in previous studies, incident investigations conducted by teams produced exemplary reviews of causal data, in depth. 

Incident Investigation Studies of Quality Hazard analysis is the most important safety process. If that process fails, all other processes are likely to be ineffective. Incident investigation serves as one, vital basis for hazard analysis. Several studies of the quality of incident investigations were made by this author to provide an information base for consideration by those who undertake to improve investigation systems. Unfortunately, this author has concluded from the studies made that this vital element in operational risk management is very often done poorly. 

Why make studies of the quality of incident investigations There are four major elements in operational risk management ... 

It is a fundamental—if hazard identification and analysis do not relate to actual causal factors, the resulting corrective actions will be misdirected and ineffective. Safety professionals could profitably consider the results of the four studies made by this author of the quality of incident investigations and select from the observations made the findings that could be applicable as a base for improvement in the organization s to which they give counsel. 

To study the quality of incident investigation as actually performed, a collection was made of 537 reports completed by supervisors and investigation teams from 37 locations of 11 organizations. 

The purpose of this chapter is to show that improvements in safety, quality, and productivity are possible by applying some of the ideas and techniques described in this book. The fact that error reduction approaches have not yet been widely adopted in the CPI, together with questions of confidentiality, has meant that it has not been possible to provide examples of all the techniques described in the book. However, the examples provided in this chapter illustrate some of the most generally useful qualitative techniques. Case studies of quantitative techniques are provided separately in the quantification section (Chapter 5). The first two case studies illustrate the use of incident analysis techniques (Chapter 6). 

Consultants are equipped to monitor the quality of freshwater, estuarine and marine environments and can make field measurements of a variety of water-quality parameters in response to pollution incidents. For example, reasons for the mortality of marine shellfish and farmed freshwater fish have been determined using portable water-analysis equipment. Various items of field equipment are, of course, also employed in baseline studies and monitoring, respectively, before and after the introduction of new effluent-disposal schemes. 

In assessing animal data, careful attention must be paid to the quality of the data, the incidence of spontaneous tumors in the control population, consistency if more than one study is available, and statistical validity. If the exposure route and experimental regimen employed do not agree with the most likely mode(s) of human exposure (e.g., intramuscular injection), the data must be interpreted cautiously. Consideration should be given to data on metabolism of the compound by the animal species tested, as compared with metabolism in humans if this information is known. If only in vitro data are available, only qualitative estimates may be possible because of uncertainties regarding the association between in vitro results and human or animal effects. The availability of associated pharmacokinetic data, however, may allow development of a rough quantitative estimate. 

Not surprisingly, quality of the botanical products is a frequent review issue in our regulatory experiences. Some sponsors had not presented accurate name/identification of the botanical plants and/or description of manufacturing processes. Because of the recent incidence of diethylstilbestrol containing PC-SPES, adulteration of botanicals with active chemical drugs has become a serious concern for both the study supporter (e.g., NIH) and the regulatory agency. 

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