Evaluation of the Risk Analysis Technique in Biosafety Activities

The System Safety Engineering techniques of risk analysis were developed in order to eliminate or minimize possible occurrences and accidents in the process industries, and to give more sustainability on production process. Theses techniques allow detecting the potential risks and provide actions to prevent accidents. The risk management is of great importance regarding to damages on men and animal, and on the environment, specially in the health service process. However, there is a lack of structured procedures for risk management in this area that also consider the biosafety aspects. Any process related to health services can frequently lead to a labor accident or chronic occupational illness. Many of these accidents can cause death or diseases and could be avoided. These problems are, in many cases, associated to faults in risk management. There are a number of different types of risks that health service professionals can be subjected to such as: biological; physical; chemical; radioactive; and ergonomic risks. Based on this, it is necessary to know the existing risks of each activity involved in the production section, with the aim of minimizing and preventing exposition. This work was carried out in order to adapt, implement and evaluate an engineering structuralized technique in a new application aiming to analyze the risks present in whole blood bag processing. It is the most important process in a blood bank, as it allows transfusion medicine practices. Using risk identification and qualification, it is possible to adopt measures that are capable of reducing or eradicating hazardous conditions, assuring quality and safety in the productive processes. This work also contributes towards extending the possibilities of usage for system safety engineering techniques, presenting a novel and efficient application in the health area. The risks evaluated in the production process are directly associated to the quality and safety of the environment, the people working in the area, as well as to the procedures involved. The people directly involved in the process together with the procedures carried out were the main instruments responsible for the qualification and identification of risk. The analysis technique used to identify the risks present in biosafety activities was HAZOp (Hazard and Operability). The HAZOp process is based on the principle that a team approach to hazard analysis will identify more problems than when individuals working separately combine results. The team focuses on specific portions of the process called ?nodes?, a process parameter is identified, and then a series of guidewords is combined with the parameters to create deviations. The team then focuses on listing all the credible causes of the deviation that can result in a worst possible consequence, after any recommendations deemed appropriate. This technique was used throughout the blood bag processing stages, through team interview, important people, researcher observations and structuralized meetings. For ratification of this technique was carried through a study in health service area, specially in blood bank since in this area the most diverse risks are associates with deviations as operational procedures, equipment maintenance, ergonomic, manuscript of biological materials, imperfections human beings, wastes problems, among others. This work was based on the following methodology for the development of the risk analysis technique: mapping the health facility, development of the risk analysis technique and implementing the risk analysis technique in the case study area. In order to quantify the identified risks, the Severity Category was adapted to the Biosafety practices using the Frequency Category. The correlation between the categories was established using the Risk Matrix. The HAZOp used was adequate and the results indicated a preordination of the corrective actions for any faults in the procedures responsible for exposure to critical risks of human life and environment. The general results pointed out that 80% of the activities had critical risks associated with deviations such as ergonomic issues, lack of attention and maintenance was present with a greater probability and frequency. Implementation and application of the Safety System Engineering are highly versatile and capable of identifying, classifying and qualifying the risks existent in not only industrial process as well as other segments as demonstrated in the present paper for the health service process including beyond the activities, human resources and environments.