Quality Risk Management In High Speed Disc Separator System

This thesis studies the application of risk management in high speed disc separator system.Nowadays in the biomedical industry,there are more and more equipment systems involved in production process,like fermenters,harvest tanks,high speed disc separators and depth filters.If any fault occurs,it will directly or indirectly affect the quality of the drug.What's more,it will cause a very bad effect on patients even the society.However,many pharmaceutical companies often overlook the importance of risk management in process systems.Moreover,the most effective way for risk management is that it should be involved from the very beginning of the project.High speed disc separator system is usually designed as a module.It seems simple and small footprint,but it contains different systems including process pipeline,operating water,computerized system,and separator.It can also be linked with the upstream fermenter and the downstream depth filter.It is why we say that the separator system is typical and representative.Therefore,it shows great significance to make the high speed disc separator system perfect introduction to quality risk management.Based on the risk management theory and its applications in the pharmaceutical industry,the thesis applies the quality risk management theory to the high speed disc separator system.Then through risk identification,risk analysis and risk control to carry out the system risk assessment form with existing risk.And then use it to guide the validation activities for the high speed disc separator system.Firstly,through the research method to compare the marketing share of different types of separators and the characteristics of the separated products within three years,it is determined that the research object is the separator system containing the high speed disc separator M.The high speed disc separator system can be divided into three major categories: equipment system,computerized system,and modification.This thesis mainly discusses the quality risk management of equipment system and computerized system.Based on the practice guideline,the high speed disc separator system can be judged as a direct impact system,and the supporting computerized system is a key system,which means that quality risk management of the high speed disc separator system is necessary.Through research and literature indexing,combined with the process characteristics and product attributes of the separator,16 key process parameter risk points were identified from the 6 quality attributes in 5 process flows;On the computerized system side,according to the classification of software system and hardware system,combined with the process characteristics,15 risk points were identified.Then the causes of these risks were analyzed one by one.Secondly,from the three aspects of risk occurrence probability,severity and detectability,the FMEA(Failure Mode and the Effect Analysis)matrix and the risk priority RPN(Risk priority number)can be defined.Therefore,the risk can be quantitative analysis.According to the RPN score,the risk level can be divided into four categories: very high risk,high risk,medium risk and low risk;by further analyzing the obtained risk level,it is considered that very high risk and high risk are unacceptable risks.Medium risk and low risk are acceptable risks.In the equipment system,the 16 identified risks are unacceptable risks;in computerized systems,there are 13 unacceptable risks and 2 acceptable risks.Based on the results of risk assessment,risk control methods are used to unacceptable risks to reduce risk levels.And risk reassessment is necessary to ensure that risk control methods can effectively reduce risks.And this is confirmed in validation phase.Only risk tracking and regular review are necessary for acceptable risks.And just performing the commissioning in the validation phase.Finally,the validation process which implements quality risk management confirms that the risk control methods taken are effective and reduce the possibility of system deviations.According to the risk points identified from system risk assessment,the user requirement specification is updated.In addition,the system risk assessment result is implemented in the design document.During the design review and design qualification,the requirement traceability matrix not only double check the design content,but also defines the commissioning and qualification activities which the design needs.After finishing the final assembling,the system is tested based on the defination in the requirement traceability matrix to ensure the function can meet the user requirement.By iterative means,quality risk management throughout the project life cycle has a guiding significance for system validation and successful acceptance.Comparing the 2 projects that one execute the quality risk management and one not,it was found that the quality risk management project can effectively reduce the over-validation activity by 24%,shorten the 10% construction period and reduce the labor cost by 12.4%.The effect is very significant.Adhering to the principle that quality based on design and the process is greater than the result,the human and material resources are used to control the risk from the beginning,and the whole cycle of quality risk management model for the high speed disc separator system is built,which ensures the system can meet the requirements from end users,contracts,regulations,etc.,and deliver successfully and soomthly.