Hygiene management analysis support device, hygiene management analysis support system, and hygiene management analysis support method

Abstract

To easily determine whether hygiene management of an environment or an operation performed in the environment is appropriate.SOLUTION: The hygiene management analysis support device 1 includes a storage part 12 for storing environment data 121 on an environment and operation data 122 on an operation performed in the environment, a calculation part 111 for performing calculation on the hygiene management of the environment on the basis of the environment data 121 and the operation data 122, and a display part 14 for displaying the calculation result of the calculation part 111.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a hygiene management analysis support device, a hygiene management analysis support system, and a hygiene management analysis support method. [Background technology]

[0002] GxP is a concept that refers to multiple terms used in the pharmaceutical manufacturing industry, including GCP (Good Clinical Practice: standards for clinical trials of pharmaceuticals), GDP (Good Distribution Practice: standards for the transportation and distribution of pharmaceuticals), and GMP (Good Manufacturing Practice: standards for pharmaceutical manufacturing management and quality control).

[0003] Pharmaceutical manufacturing, in particular, is required to comply with GMP. Users must create an environment in which safe, high-quality pharmaceuticals are provided. Under GMP, pharmaceuticals that have a direct impact on human health and life must be controlled by strict management standards from the manufacturing stage. GMP also stipulates the standards and requirements that must be observed by law, and requires that product quality risk management be carried out.

[0004] Patent Document 1 describes an information provision system that provides a manager with information regarding the hygienic condition of an object on which a specified task related to a product is being performed, and includes: an acquisition means that acquires the number of colonies cultured in a medium containing a specimen extracted from the object at specified intervals; a determination means that judges the hygienic condition of the object based on the acquired number of colonies; an extraction means that, if the determination means judges that the hygienic condition is abnormal or tending to be abnormal, searches for work history information that indicates the work history for each object registered in a database and extracts at least one of a work attribute that indicates an attribute related to the task of the corresponding object and a work event that indicates an event related to the task as a work element; an identification means that identifies a work element that meets specified conditions as the cause of the abnormality based on the acquired number of colonies belonging to each of the extracted work elements; and a provision means that provides the manager with information regarding the identified work element as cause estimation information that indicates the cause of the abnormality. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2015-011593 Summary of the Invention [Problem to be solved by the invention]

[0006] The invention described in Patent Document 1 is effective in estimating the cause of an abnormality or tendency toward abnormality in an object and providing the estimated cause to a manager. However, the invention described in Patent Document 1 cannot determine when excessive hygiene management of the environment surrounding the object or excessive operations within that environment are occurring. Therefore, even if excessive hygiene management is occurring, it is difficult to improve hygiene management to optimal management.

[0007] Due to the regulatory framework of pharmaceutical approval schemes, all relevant documentation, including organizational structures and manufacturing processes, must be prepared before a pharmaceutical manufacturing facility is constructed. As a result, the manufacturing process is determined first, and in the early stages of facility operation, hygiene management, a means of managing the manufacturing environment, tends to be over-specified, resulting in suboptimal operations within the facility. However, analyzing data to appropriately improve hygiene management procedures or labor hours and facility operations is time-consuming, and it is difficult to determine whether the procedures or labor hours are appropriate.

[0008] Therefore, an object of the present invention is to easily determine whether the sanitation management of an environment or the operations performed within the environment are appropriate. [Means for solving the problem]

[0009] In order to solve the above-mentioned problems, the hygiene management analysis support device of the present invention is configured as follows. The hygiene management analysis support device of the present invention is characterized by comprising a memory unit that stores environmental data related to the environment and operation data related to operations performed within the environment, a calculation unit that performs calculations related to the hygiene management of the environment based on the environmental data and the operation data, and a display unit that displays the calculation results by the calculation unit.

[0010] The hygiene management analysis support system of the present invention is characterized by comprising a memory unit that stores environmental data related to an environment and operation data related to operations performed within the environment, a calculation unit that performs calculations related to hygiene management of the environment based on the environmental data and the operation data, and a display unit that displays the calculation results by the calculation unit.

[0011] The hygiene management analysis support method of the present invention is characterized by having the steps of: an input unit inputting environmental data and operation data relating to an environment; a calculation unit performing calculations relating to the hygiene management of the environment based on the environmental data and the operation data; and a display unit displaying whether the hygiene management of the environment and the operations performed within the environment are appropriate. Other means will be described in the detailed description of the invention. [Effects of the Invention]

[0012] According to the present invention, it is possible to easily determine whether the sanitation management of an environment or the operations carried out within the environment are appropriate. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a configuration diagram of a hygiene management analysis support system according to an embodiment of the present invention. [Figure 2] FIG. 10 is a diagram showing an outline of the flow of hygiene management analysis support processing. [Figure 3] 10 is a flowchart of environmental data analysis after an operation in the first embodiment. [Figure 4] 10 is a time series graph of environmental data after operation. [Figure 5] This is a graph of monitoring point analysis showing environmental data in the order of movement lines. [Figure 6] 10 is a flowchart for calculating a discrete cumulative probability distribution according to the second embodiment. [Figure 7] 1 is an example of a discrete cumulative probability distribution graph. [Figure 8] 1 is an example of a discrete cumulative probability distribution graph. [Figure 9A] 10 is a flowchart of a monitoring point analysis according to the third embodiment. [Figure 9B] 10 is a flowchart of a monitoring point analysis according to the third embodiment. [Figure 10]1 is a graph showing the average, maximum and minimum environmental data values ​​for each monitoring point. [Figure 11] 10 is a flowchart of heat map creation according to the fourth embodiment. [Figure 12] 1 is a heat map showing the relationship between operations and environmental data. DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. The hygiene management analysis support device of this embodiment collects and links human operation information and environmental data, analyzes them using a calculation unit, and then supports the optimization of hygiene management and operations based on the analysis results. The hygiene management analysis support device acquires human operation information in combination with environmental data during facility operation. Human operation information refers to information on manufacturing and operations performed for manufacturing, such as the content and duration of manufacturing work. Environmental data refers to information on particulate matter, temperature, humidity, room pressure, etc.

[0015] Sanitation management refers to the timing and frequency of cleaning, the number of monitoring points, cleaning areas, etc. Optimizing sanitation management improves sanitation management and increases the uptime that a facility can use for manufacturing depending on its usage. Operation optimization refers to improving flow lines, work methods, etc. Operation optimization reduces the risk of contaminating the manufacturing environment and improves work efficiency while limiting the impact on the manufacturing environment.

[0016] FIG. 1 is a configuration diagram of a hygiene management analysis support system 6 according to this embodiment. The hygiene management analysis support system 6 is configured by connecting a hygiene management analysis support device 1 and a terminal 5, which is operated by a user and displays calculation results, via the Internet 4. The hygiene management analysis support device 1 is, for example, a server computer installed in a data center, and is equipped with a control unit 11, a memory unit 12, an input unit 13, a display unit 14, and a communication interface 15. This hygiene management analysis support device 1 is connected to multiple sensors 2 via the communication interface 15 and the Internet 4, and is further connected to another system 3 and the terminal 5. The terminal 5 is configured to include an input unit 53 and a display unit 54, and functions as the input unit and display unit for the hygiene management analysis support device 1. The hygiene management analysis support device 1 detects environmental data 121 using a plurality of sensors 2, and exchanges data on hygiene management and operations with other systems 3.

[0017] Here, environmental data 121 refers to temperature, humidity, room pressure, microorganisms such as bioparticles, airborne bacteria, attached bacteria, and fallen bacteria, as well as harmful organisms such as insects and mice. Of these environmental data, temperature, humidity, room pressure, and bioparticles can be continuously monitored. Airborne bacteria are monitored, for example, monthly or annually, as appropriate. Attached bacteria are monitored, for example, during work or periodically, as appropriate. Falling bacteria are monitored, for example, during work or periodically, as appropriate. The data unit for these airborne bacteria, attached bacteria, and fallen bacteria is generally the number of CFU (Colony forming units) per sample, but other units indicating the amount of microorganisms may also be used. Insects and small animals may be monitored monthly, for example. The units of data for insects and small animals are generally units of individuals, but other units of data indicating the amount of pests may also be used. The environmental data 121 may be acquired by the sensor 2 or may be manually input by a human, but is not limited thereto.

[0018] The operation data 122 includes operational records such as facility events, such as manufacturing, cleaning, and material delivery, and the number of workers. The operation data 122 related to facility events includes the start and end dates and times of the event, the status of the equipment, such as during cultivation, and the type of work. This makes it possible to confirm the impact of the equipment status on the environmental data 121. The operation data 122 related to operational records includes the date and time when workers enter and exit the room, the number of people entering the room, and the work content. The operation data 122 includes data related to operations that are predefined as having the potential to affect the environment of each room that makes up the environment.

[0019] The control unit 11 includes a calculation unit 111, a planning unit 112, a document management unit 113, and a display control unit 114, and controls the hygiene management analysis support device 1. The calculation unit 111 performs calculations related to environmental hygiene management based on environmental data 121 and operation data 122 (described below), and calculates various index data. The planning unit 112 formulates a new improvement plan based on the index data calculated by the calculation unit 111. The display control unit 114 causes the display unit 14 to display whether the environmental hygiene management or the operations performed within the facilities that make up the environment are appropriate.

[0020] Specifically, when the operation data 122 is an equipment state, the calculation unit 111 may sort the related environmental data group by equipment state so that the influence of the operation data 122 on the environmental data 121 can be seen. Furthermore, when an incident occurs in the environment, the causal relationship to the environmental data 121 can be determined by referring to the equipment state.

[0021] When the operation data 122 is material delivery, the calculation unit 111 divides the related environmental data group according to the material delivery work status, so that the impact on the environmental data 121 can be seen. In addition, when an incident occurs in the environment, the causal relationship to the environmental data 121 can be determined by referring to the most recent material delivery work information.

[0022] When the operation data 122 is cleaning performance, the calculation unit 111 determines the relationship between the number of days since cleaning was performed and the environmental data 121, and visualizes the transition of the cleaning method and the environmental data 121. This allows the user to refer to the most recent cleaning performance status when an incident occurs.

[0023] During analysis, the calculation unit 111 calculates time-series changes for one measurement point of one type of environmental data 121. The display control unit 114 displays the time-series data of this environmental data 121. The calculation unit 111 also selects the target environmental data item, sorts the data into data during work and data during non-work based on the number of people information, and calculates the average value and standard deviation for each of the work and non-work periods. The display control unit 114 displays a time-series graph of the average value and standard deviation for each of the work and non-work periods.

[0024] Furthermore, the calculation unit 111 selects the target environmental data item, sorts it into work data and non-work data, calculates the cumulative probability distribution function for each data group, and finds the numerical value of each item for which the cumulative probability is 1. The display control unit 114 displays a graph of the cumulative probability distribution function, and also displays the numerical value of each item for which the cumulative probability is 1 below the graph. This enables the hygiene management analysis support device 1 to estimate the upper limit value of the environmental data 121.

[0025] The calculation unit 111 chronologically arranges each data group, such as the number of workers related to events such as material delivery and production, and calculates the standard partial regression coefficient for each item. The display control unit 114 displays the standard partial regression coefficient for each item. This allows the hygiene management analysis support device 1 to visualize the correlation between each influencing factor and the environmental data 121.

[0026] The document management unit 113 registers an improvement plan that reflects the improvement plan drawn up by the planning unit 112. The display control unit 114 causes the display unit 14 to display the improvement plan registered by the document management unit 113.

[0027] The storage unit 12 is, for example, a hard disk, a solid state drive (SSD), or a storage server installed in the cloud, and stores environmental data 121 related to the environment, operation data 122 related to operations performed in this environment, and an improvement plan database 123. The environmental data 121 is, for example, the number of bacteria present in a unit space of the manufacturing environment. The environmental data 121 is linked to time information and location information.

[0028] The operation data 122 is information indicating that an operation such as cleaning has been performed on the manufacturing environment. The operation data 122 is linked to time information and location information. The improvement plan database 123 is a database of improvement plans that reflect the improvement plans drawn up by the planning department 112.

[0029] The input unit 13 is, for example, a keyboard, a mouse, a touch panel, or the like, and inputs information to the hygiene management analysis support device 1. The display unit 14 is, for example, a liquid crystal display, and display information is output by a display control unit 114. The input unit 13 and the display unit 14 may be an integrated touch panel display.

[0030] Furthermore, the input unit 53 of the terminal 5 is, for example, a keyboard, a mouse, a touch panel, or the like, and may be, but is not limited to, anything that inputs information to the hygiene management analysis support device 1. The display unit 54 of the terminal 5 is, for example, a liquid crystal display, and may output display information via the display control unit 114 and the communication interface 15, but is also not limited to such.

[0031] The communication interface 15 is an interface for exchanging information with other systems 3 and a plurality of sensors 2.

[0032] FIG. 2 is a diagram showing an outline of the flow of the hygiene management analysis support process. First, the input unit 13 acquires or receives input of environmental data 121 and operation data 122 related to the manufacturing environment (step S10).

[0033] The calculation unit 111 performs calculations related to sanitary management of the manufacturing environment based on the environmental data 121 and the operation data 122 (step S11). Then, the display control unit 114 displays on the display unit 14 the sanitary management of the manufacturing environment and whether the manufacturing environment maintained as a result of the sanitary management is appropriate or not (step S12), and the processing of FIG. 2 ends.

[0034] First Embodiment The hygiene management analysis support device 1 of the first embodiment displays a graph of changes in environmental data for a manufacturing environment after a specified operation is performed on the manufacturing environment. Specifically, the hygiene management analysis support device 1 graphs changes in the number of bacteria in the manufacturing environment after periodic cleaning of the manufacturing environment. This makes it possible to determine whether hygiene management is being performed appropriately through operations on the manufacturing environment and whether the manufacturing environment is appropriate.

[0035] FIG. 3 is a flowchart of the post-operation environmental data analysis in the first embodiment. First, the user registers a hygiene management plan (step S20). The input unit 13 acquires or accepts input of the environment data 121 and operation data 122 (step S21).

[0036] The calculation unit 111 acquires environmental data 121 of the environmental monitoring points registered in the sanitation management plan and operation data 122, which is the cleaning performance for the target period, from the storage unit 12 (step S22). Then, the calculation unit 111 calculates the average, quartiles, maximum, and minimum values ​​for each number of days since cleaning for the target monitoring point (step S23). Then, the display control unit 114 outputs the results calculated by the calculation unit 111 to the display unit 14 as a graph (step S24). The display control unit 114 plots the latest measurement values ​​for each number of days since cleaning for the target monitoring point on the output graph (step S25). As a result, the display unit 14 displays the environmental data 121 in order of the number of days since cleaning for the environment based on the environmental data 121 and operation data 122. An example of this display is shown in FIG. 4, which will be described later.

[0037] The calculation unit 111 determines whether the latest measurement value falls within the range from the first to the third quartile (step S26). If the latest measurement value falls within the range from the first to the third quartile (YES), the process proceeds to step S27. Then, the display control unit 114 displays that cleaning is appropriate (step S27), and the process proceeds to step S30.

[0038] If the latest measurement value is not within the range of the first to third quartiles (No), the process proceeds to step S28. Then, the display control unit 114 issues an alert to consider cleaning as necessary (step S28), and proposes an improvement plan to change the cleaning frequency or chemicals (step S29), and the process proceeds to step S30. In step S30, the display control unit 114 displays the improvement plan reflecting the proposal on the display unit 14, and the processing of FIG. 3 ends.

[0039] 4 is a time series graph of the environmental data after the operation. This graph shows the environmental data for each number of days that have passed since the environment was cleaned, and is displayed on the display unit 14. The vertical axis of the graph shows the number of bacteria in the environment. The horizontal axis of the graph shows the date and time since cleaning. The origin of the graph shows the date and time when the environment was cleaned. This graph is a box plot, with the upper and lower values ​​indicating the maximum and minimum values ​​shown as vertical lines, the first and third quartiles shown as rectangles, and the second quartile shown as a dividing line within the rectangle. The most recent environmental data values ​​are plotted as hatched circles. The open circles show the average values ​​of the environmental data for the target period, and the crosses show outliers.

[0040] When the elapsed time since cleaning is 1, the most recent environmental data value is between the first and third quartiles, indicating that the cleaning was adequate. When the elapsed time since cleaning is 2, the most recent environmental data value is between the third quartile and the maximum value, indicating that an unusual event has occurred. In this case, the display control unit 114 may issue an alert. In this way, by classifying the environmental data and operation data by the number of days since cleaning, it is possible to evaluate the appropriateness of cleaning and the need for improvement, and to review operations such as cleaning, taking into account environmental heterogeneity. do.

[0041] 5 is a graph of the monitoring point analysis in which the environmental data is plotted in the order of the user's movement in the environment. This graph displays the environmental data in the order of the user's movement in the environment, and is displayed on the display unit 14. The vertical axis of the graph shows the number of bacteria in the environment. The horizontal axis of the graph shows each location in the order of the user's movement line. This graph is a box plot showing the monitoring points in the order of their movement line, with the upper and lower values ​​indicating the maximum and minimum values ​​shown as vertical lines, the first and third quartiles shown as rectangles, and the second quartile shown as a dividing line within the rectangle. The most recent environmental data values ​​are plotted as hatched circles. The average value of the environmental data for the target period is shown as a white circle, and outliers are shown as crosses.

[0042] The most recent environmental data value for the changing room location is between the first quartile and the minimum value, indicating adequate cleaning. The most recent environmental data value for production room 001 is between the second quartile and the first quartile, indicating adequate cleaning. The most recent environmental data value for production room 002 is between the maximum and first quartile, indicating an unusual event is occurring.

[0043] In this way, by classifying users along their movement lines based on the environmental data 121 and the operation data 122, the appropriateness and need for improvement of the user's movement lines or the operations performed along the movement lines can be evaluated, and the user's movement lines or the operations performed along the movement lines can be reviewed taking into account environmental heterogeneity.

[0044] Second Embodiment The hygiene management analysis support device 1 of the second embodiment classifies the presence of people, collects environmental data, and determines a likely reference value for environmental hygiene management based on a discrete cumulative probability distribution.

[0045] FIG. 6 is a flowchart for calculating a discrete cumulative probability distribution according to the second embodiment. First, the user registers a hygiene management plan (step S40). The input unit 13 acquires or accepts input of the environmental data 121 and the operation data 122 (step S41).

[0046] The calculation unit 111 acquires the environmental data 121 of the target environmental monitoring point from the storage unit 12 (step S42). Then, the calculation unit 111 calculates a discrete cumulative probability distribution of the environmental data 121 (step S43). The display control unit 114 then outputs the calculation result in a graph (step S44), and displays the environmental data value when the cumulative probability is 1.0 as an alert value for the environmental data 121 (step S45).

[0047] The calculation unit 111 calculates a reference value by multiplying the alert value by an appropriate coefficient (step S46). Then, the calculation unit 111 proposes an improvement plan that sets the calculated reference value and alert value as the reference value and alert value of the environmental monitoring point (step S47), and re-registers the plan reflecting the proposal as an improvement plan (step S48). Finally, the display control unit 114 displays the improvement plan on the display unit 14 (step S49), and the processing of FIG. 6 ends.

[0048] Figures 7 and 8 are examples of discrete cumulative probability distribution graphs. Figure 7 is a discrete cumulative probability distribution graph for work in a production room. In both graphs, the vertical axis represents cumulative probability, and the horizontal axis represents the number of bacterial colonies per unit volume.

[0049] As shown in Figure 7, during work, the cumulative probability becomes 1.0 when the number of bacterial colonies reaches Xc1. The hygiene management analysis support device can calculate an appropriate reference value for work by multiplying this Xc1 by a predetermined coefficient.

[0050] Figure 8 is a discrete cumulative probability distribution graph for non-working hours in a production room. In this graph, the vertical axis represents cumulative probability, and the horizontal axis represents the number of bacterial colonies per unit volume.

[0051] As shown in Figure 8, when no work is being performed, the cumulative probability becomes 1.0 when the number of bacterial colonies reaches Xc2. The hygiene management analysis support device can calculate an appropriate standard value for when no work is being performed by multiplying this Xc2 by a predetermined coefficient.

[0052] Third Embodiment The hygiene management analysis support device of the third embodiment determines monitoring points that suitably reflect the hygiene management state of the manufacturing environment, based on the environmental data relating to a plurality of environmental monitoring points.

[0053] 9A and 9B are flowcharts of the monitoring point analysis of the third embodiment. First, the user registers a sanitation management plan (step S60). The input unit 13 acquires or accepts input of the environment data 121 and operation data 122 (step S61).

[0054] The calculation unit 111 acquires the environmental data 121 of the target environmental monitoring points from the storage unit 12 (step S62). The calculation unit 111 then calculates the average value and standard deviation value for each monitoring point (step S63). The display control unit 114 outputs the calculation results by the calculation unit 111 as a graph (step S64).

[0055] Thereafter, the calculation unit 111 determines whether or not there is a difference between the points (step S65). If there is a difference between the points (Yes), the process proceeds to step S66. If there is no difference between the points (No), the process of FIG. 9A ends.

[0056] In step S66, the calculation unit 111 determines whether or not there is a point with the highest average value and standard deviation value. If there is a point with the highest average value and standard deviation value (Yes), the display control unit 114 displays this as a worst-case point candidate (step S67), and the process proceeds to step S68. If there is no point with the highest average value and standard deviation value (No), the process proceeds to step S68. This worst-case point candidate point appropriately reflects the hygiene management state of the manufacturing environment.

[0057] In step S68, the calculation unit 111 determines whether or not there is a point with the widest standard deviation value range. If there is a point with the widest standard deviation value range (Yes), the display control unit 114 displays it as a representative sampling point candidate for the target room (step S69), and the process proceeds to step S70. If there is no point with the widest standard deviation value range (No), the process proceeds to step S70. This representative sampling point candidate point appropriately reflects the hygiene management state of the manufacturing environment.

[0058] In step S70, the calculation unit 111 proposes an improvement plan that excludes points other than the extracted monitoring points from the monitoring targets. Then, the calculation unit 111 re-registers the plan that reflects the proposal as an improvement plan (step S72). When the display control unit 114 displays the improvement plan on the display unit (step S73), the processing in FIG. 9B ends.

[0059] Figure 10 is a graph showing the average, maximum and minimum values ​​of the environmental data at each monitoring point. The vertical axis of the graph shows the number of particles per unit volume of the production room. The horizontal axis of the measurement value graph shows each monitoring point. This graph displays the average value and standard deviation value for each monitoring point in the target production room for the target period. The horizontal line dividing the vertical lines of the monitoring points shows the average value. The horizontal line at the top of the vertical lines of the monitoring points shows the value obtained by adding the standard deviation to the standard value. The horizontal line at the bottom of the vertical lines of the monitoring points shows the value obtained by subtracting the standard deviation from the standard value.

[0060] Monitoring point AB006 is a candidate for the worst point because it has the highest value obtained by adding the standard deviation to the standard value. Monitoring point AB008 has the widest standard deviation range, making it a candidate for a representative point requiring observation. Users should remove other monitoring points from the sampling points and use the hygiene management analysis support system to observe the worst points and points requiring observation. This graph also shows that by avoiding work near the worst points, it is possible to reduce the risk of contamination of the resulting product.

[0061] Fourth Embodiment The hygiene management analysis support device of the fourth embodiment analyzes influential factors related to contamination in each of the target rooms based on environmental data related to the plurality of rooms that make up the environment.

[0062] FIG. 11 is a flowchart of the heat map creation process according to the fourth embodiment. First, the user registers a sanitation management plan (step S80). The input unit 13 acquires or accepts input of environmental data 121 and operation data 122 (step S81). The calculation unit 111 acquires the environmental data 121 of the environmental monitoring points registered in the sanitation management plan and the operation data 122 for the target period from the storage unit 12 (step S82). The calculation unit 111 then calculates the correlation coefficients between the items (step S83). The display control unit 114 outputs the results calculated by the calculation unit 111 as a heat map (step S84), and displays items with correlation coefficient values ​​equal to or greater than a certain value as factors affecting contamination of the target room (step S85).

[0063] The calculation unit 111 determines the correlation between each item (step S86). If there is a positive correlation between each item (Yes), the calculation unit 111 creates a plan that imposes restrictions so that work corresponding to the extracted items is not performed when working in the target room (step S87), and the process proceeds to step S89. If there is a negative correlation between the items (No), the calculation unit 111 creates a plan to implement the extracted items as measures when performing work that poses a risk of contamination in the target room (step S88), and the process proceeds to step S89. In step S89, the calculation unit 111 re-registers the plan reflecting the proposal as an improvement plan. Then, the display control unit 114 displays the improvement plan on the display unit 14, and the processing in FIG.

[0064] Figure 12 is a heat map showing the relationship between operations and environmental data. The vertical and horizontal axes of the heat map show the number of microorganisms in target room A, the number of workers in target room A, the number of microorganisms in target room B, and the number of workers in target room B. Each cell in the heat map is displayed with a density according to the degree of correlation, and the degree of correlation for each item is shown numerically. This makes it possible to identify the factors that have the greatest impact on contamination in the target room.

[0065] The present invention is not limited to determining whether hygiene management of a manufacturing environment or operations performed within a manufacturing environment are appropriate, but may also be applied to determining whether hygiene management of any environment or operations performed within any environment are appropriate, and is not limited thereto.

[0066] The configuration and effects of the present invention will be described below.

[0067] [1] a storage unit (12) for storing environmental data (121) relating to an environment and operation data (122) relating to operations performed within said environment; a calculation unit (111) that performs calculations related to sanitation management of the environment based on the environmental data (121) and the operation data (122); a display unit (14) that displays the calculation results of the calculation unit; A hygiene management analysis support device (1) comprising:

[0068] This makes it easy to determine whether the sanitation of the environment or the operations performed within the environment are appropriate.

[0069] [2] The environmental data (121) and the operation data (122) stored in the storage unit (12) are linked to time information and location information, respectively. 2. The hygiene management analysis support device (1) according to claim 1.

[0070] This allows the user to know about the hygiene management of this environment at the time and place.

[0071] [3] The display unit (14) displays the environmental data (121) for each date and time elapsed since cleaning of the environment based on the environmental data (121) and the operation data (122). 2. The hygiene management analysis support device (1) according to claim 1.

[0072] This allows users to know the impact their cleaning will have on the environment.

[0073] [4] the display unit (14) displays the environmental data (121) in the order of the user's movement in the environment based on the environmental data (121) and the operation data (122). 2. The hygiene management analysis support device (1) according to claim 1.

[0074] This allows the user to know the impact that the user's movement or the operations performed along the user's movement will have on the environment.

[0075] [5] The calculation unit (111) classifies the presence of people based on the operation data (122), aggregates the environmental data (121), and determines a probable standard value for sanitation management of the environment. 2. The hygiene management analysis support device (1) according to claim 1.

[0076] This allows the user to determine standard values ​​for hygiene management.

[0077] [6] the calculation unit (111) determines a monitoring point that preferably reflects the sanitation management state of the environment based on the environmental data related to the plurality of monitoring points of the environment; 3. The hygiene management analysis support device (1) according to claim 1 or 2.

[0078] This allows the user to determine a location that best reflects the hygiene management state of the environment, and to use this location as a worst-case indicator of the overall hygiene management state.

[0079] [7] The operation data (122) is data relating to predefined operations that may affect the environment of each room that constitutes the environment. 3. The hygiene management analysis support device (1) according to claim 1 or 2.

[0080] This allows the user to specify the type of operation that will affect the environment in each room.

[0081] [8] The calculation unit (111) determines whether the environmental data (121) is suitable for the environment based on a reference value. 3. The hygiene management analysis support device (1) according to claim 1 or 2.

[0082] This allows the user to determine whether the environmental data is suitable for the environment based on this reference value.

[0083] [9] a display unit for displaying whether the sanitary management of the environment or the operations performed within the environment is appropriate or not based on the environmental data (121) and the operation data (122) of the environment; A hygiene management analysis support device comprising:

[0084] This allows the user to know whether the sanitation of the environment or the operations taking place within the environment are correct or not.

[0085]

[10] a storage unit (12) for storing environmental data (121) relating to an environment and operation data (122) relating to operations performed within said environment; a calculation unit (111) that performs calculations related to sanitation management of the environment based on the environmental data (121) and the operation data (122); a display unit (14) that displays the calculation results of the calculation unit (111); A hygiene management analysis support system (6) comprising:

[0086] This makes it easy to determine whether environmental hygiene or operations are adequate.

[0087]

[11] An input unit (13) inputs environmental data (121) and operation data (122) relating to the environment; a step in which a calculation unit (111) performs calculations related to sanitation management of the environment based on the environmental data (121) and the operation data (122); a display unit (14) displaying whether the sanitation management of the environment and the operations performed within the environment are appropriate; A hygiene management analysis support method comprising:

[0088] This makes it easy to determine whether environmental hygiene or operations are adequate.

[0089] (Variation) The present invention is not limited to the above-described embodiments and includes various modifications. For example, the above-described embodiments have been described in detail to clearly explain the present invention, and are not necessarily limited to those including all of the described configurations. It is possible to replace part of the configuration of one embodiment with the configuration of another embodiment, and it is also possible to add the configuration of another embodiment to the configuration of one embodiment. Furthermore, it is also possible to add, delete, or replace part of the configuration of each embodiment with another configuration. Furthermore, the display unit may display something other than a graph as long as it provides the same information.

[0090] The above-described configurations, functions, processing units, processing means, etc. may be realized in part or in whole by hardware such as an integrated circuit. The above-described configurations, functions, etc. may be realized by software by a processor interpreting and executing a program that realizes each function. Information such as the programs, tables, and files that realize each function can be stored in a storage device such as a memory, a hard disk, or an SSD (Solid State Drive), or on a storage medium such as a flash memory card or a DVD (Digital Versatile Disk).

[0091] In each embodiment, the control lines and information lines shown are those that are considered necessary for the explanation, and not all control lines and information lines in the product are necessarily shown. In reality, it can be considered that almost all components are interconnected. [Explanation of symbols]

[0092] 1 Hygiene management analysis support device 11 Control section 111 Arithmetic section 112 Planning Department 113 Document Management Department 114 Display control unit 12 Storage section 121 Environmental Data 122 Operation Data 123 Improvement Plan Database 13 Input section 14 Display section 15 Communication Interface 2 sensors 3 Other systems 4. Internet 5. Terminal 53 Input section 54 Display section

Claims

1. a storage unit for storing environment data relating to an environment and operation data relating to operations performed within said environment; a calculation unit that performs calculations related to sanitation management of the environment based on the environmental data and the operation data; a display unit that displays the calculation results by the calculation unit; A hygiene management analysis support device comprising:

2. the environmental data and the operation data stored in the storage unit are linked to time information and location information, respectively; 2. The hygiene management analysis support device according to claim 1.

3. the display unit displays the environmental data for each date and time elapsed since the environment was cleaned based on the environmental data and the operation data.

2. The hygiene management analysis support device according to claim 1.

4. the display unit displays the environmental data in the order of a user's movement in the environment based on the environmental data and the operation data.

2. The hygiene management analysis support device according to claim 1.

5. the calculation unit classifies the presence of people based on the operation data, aggregates the environmental data, and determines a probable standard value for sanitation management of the environment; 2. The hygiene management analysis support device according to claim 1.

6. the calculation unit determines a monitoring point that preferably reflects the sanitation management state of the environment based on the environmental data related to the plurality of monitoring points of the environment; 3. The hygiene management analysis support device according to claim 1 or 2.

7. The operation data is data relating to operations that are predefined as having the potential to affect the environment of each room that constitutes the environment.

3. The hygiene management analysis support device according to claim 1 or 2.

8. The calculation unit determines whether the environmental data is suitable for the environment based on a reference value.

3. The hygiene management analysis support device according to claim 1 or 2.

9. a display unit that displays whether the sanitation management of the environment or the operations performed in the environment are appropriate or not based on the environmental data and the operation data of the environment; A hygiene management analysis support device comprising:

10. a storage unit for storing environment data relating to an environment and operation data relating to operations performed within said environment; a calculation unit that performs calculations related to sanitation management of the environment based on the environmental data and the operation data; a display unit that displays the calculation results by the calculation unit; A hygiene management analysis support system comprising:

11. an input unit inputting environmental data relating to an environment and operation data relating to an operation to be performed within the environment; a calculation unit performing a calculation related to sanitation management of the environment based on the environmental data and the operation data; a display unit displaying whether the sanitation of the environment or the operations performed within the environment is appropriate; A hygiene management analysis support method comprising:

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