Characterizing and Controlling the Risk Factors in Manufacturing Dental Implants

Abstract

Background Subtractive manufacturing have been popular in dental implant production. In order to increase the survival rate of the dental implants, a comprehensive risk analysis has been performed in the technical documentation of the products. Purpose In this paper the most common risk factors categorized as implant-related, surgeon-related, patient-related, and maintenance-related risks in the manufacturing process, application, the long term usage and the so-called survival rate of dental implants are studied. Methods The importance of any of the potential risk factors which is directly or indirectly related to the product quality is assessed. In the evaluation stage, the factors are sorted based on their severity and probability of occurrence, brought to the risk criterion table. Proper measurement called as mitigations were used to standardize the risks to the acceptable criteria. The standardization could be through reducing the severity of the risk or through reducing the probability of its occurrence, or even both of them. Advancing from the hazardous situations was an expected aim for any of the risk factors. Results The equivalent risk assessment factors are compared in pre-mitigation and post-mitigation stages. The main aim was to see whether the risk level of the factors reduces to the acceptable or conditionally acceptable region. Falling in to the conditionally acceptable region makes the application of the product to be under sufficient warnings, which orders to take enough pre-cautions for the user or operator. For most of the risk factors, there was a concern that the measurements are able to only improve them in the frequency of occurrence, however, the results show that there are solutions to improve the severity as well. Conclusion Through this comprehensive study, the risk analysis file is completed however it can be even more complete, in the future, at this industry. In the further studies, discretizing the steps of severity or probability to finer steps, and ultimately converting them to a continuous form would be aimed.