First, the formation of HACCP system HACCP is the English "HazarD Analysis anD CriTiCal ConTrol PoinT" abbreviation, the meaning of "hazard analysis and critical control points." Currently, HACCP forms a prevention system that can control the hazards of the relevant products. The goal of this system is to identify the various hazards that may affect product safety, establish control methods, and monitor these controllable items. In many industrialized countries, medical device and equipment manufacturing industries have applied such management and control systems to provide safe and reliable medical products. Any hazard that needs to be prevented is any state that has a detrimental negative effect on the medical device, the patient, or the medical staff. This state will mean any event or potential event that will occur. All may cause the danger of equipment failure, malfunction or other harmful factors.
In fact, the HACCP system has not only been used effectively in the manufacturing of medical products, but also widely used in other sectors such as the food processing industry. The FDA (Food and Drug Administration) recognized the outstanding advantages of this system, and in 1993, it established the first regulations for the implementation of the HACCP system for the canned food processing department. The main purpose is to make such foods here. Under the regulations, aseptic packaging technology is applied to prevent the appearance of toxic bacteria. In addition, the FDA's regulations for the HACCP system for seafood products have been announced in 1996. Then, in 1998, the U.S. Department of Agriculture also promulgated regulations governing the HACCP system for meat and poultry foods. In accordance with the implementation of various food safety monitoring regulations in North America, the United States Academy of Sciences (NAS) issued an initiative as early as 1995, arguing that all food safety regulation departments should adopt the HACCP system's control method, and Enforced in the processing industry.
As a result of this initiative, the establishment of the National Food Microbiological Standards Advisory Committee (NACMCF) was initiated. The task of this committee is to standardize the regulations of the HACCP system used by the industrial and regulatory agencies. Among them, the United States' Medical Device and Radiological Health Center (CDRH) will adopt and use many of the regulations in the HACCP system. The HACCP system is a reliable protection system that can guarantee the quality of medical devices and equipment, but it is not isolated but related to other systems. In fact, the contents of the HACCP system contain the requirements of quality control regulations with effective control, and are also embodied in the newly promulgated manufacturing engineering regulations, environmental parameter control regulations and personal health monitoring regulations, and other relevant safety regulations. When inspecting the processing plants of medical devices and equipment, the regulations management department can apply the theory and methods of HACCP and concentrate on examining and evaluating every process that is most likely to affect product quality in the process of product processing.
Second, the analysis of risk factors A risk factor refers to a negative state of a certain state, whether in terms of actual performance or potential significance, this state will pose a dangerous harmful result to the safety of users or consumers and health. . Risk factors can occur when the product is used normally or in the wrong operating conditions. Scientifically and rationally designing a HACCP system can achieve the goal of controlling all factors that may pose a danger to safety. When establishing a HACCP system plan, analysis of various risk factors must be completed. The product manufacturing and processing department must have knowledge of the predictable or potential risk factors related to product quality under normal use or misuse of the product. In this way, all possible risk factors that may actually occur can be included in the project plan of the HACCP system. (To be continued)
In fact, the HACCP system has not only been used effectively in the manufacturing of medical products, but also widely used in other sectors such as the food processing industry. The FDA (Food and Drug Administration) recognized the outstanding advantages of this system, and in 1993, it established the first regulations for the implementation of the HACCP system for the canned food processing department. The main purpose is to make such foods here. Under the regulations, aseptic packaging technology is applied to prevent the appearance of toxic bacteria. In addition, the FDA's regulations for the HACCP system for seafood products have been announced in 1996. Then, in 1998, the U.S. Department of Agriculture also promulgated regulations governing the HACCP system for meat and poultry foods. In accordance with the implementation of various food safety monitoring regulations in North America, the United States Academy of Sciences (NAS) issued an initiative as early as 1995, arguing that all food safety regulation departments should adopt the HACCP system's control method, and Enforced in the processing industry.
As a result of this initiative, the establishment of the National Food Microbiological Standards Advisory Committee (NACMCF) was initiated. The task of this committee is to standardize the regulations of the HACCP system used by the industrial and regulatory agencies. Among them, the United States' Medical Device and Radiological Health Center (CDRH) will adopt and use many of the regulations in the HACCP system. The HACCP system is a reliable protection system that can guarantee the quality of medical devices and equipment, but it is not isolated but related to other systems. In fact, the contents of the HACCP system contain the requirements of quality control regulations with effective control, and are also embodied in the newly promulgated manufacturing engineering regulations, environmental parameter control regulations and personal health monitoring regulations, and other relevant safety regulations. When inspecting the processing plants of medical devices and equipment, the regulations management department can apply the theory and methods of HACCP and concentrate on examining and evaluating every process that is most likely to affect product quality in the process of product processing.
Second, the analysis of risk factors A risk factor refers to a negative state of a certain state, whether in terms of actual performance or potential significance, this state will pose a dangerous harmful result to the safety of users or consumers and health. . Risk factors can occur when the product is used normally or in the wrong operating conditions. Scientifically and rationally designing a HACCP system can achieve the goal of controlling all factors that may pose a danger to safety. When establishing a HACCP system plan, analysis of various risk factors must be completed. The product manufacturing and processing department must have knowledge of the predictable or potential risk factors related to product quality under normal use or misuse of the product. In this way, all possible risk factors that may actually occur can be included in the project plan of the HACCP system. (To be continued)
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