Health management analysis support device, health management analysis support system, and health management analysis support method

Abstract

The objective of this invention is as follows: to easily determine whether the hygiene management of an environment or the work performed within an environment is appropriate. The solution of this invention is as follows: a hygiene management analysis support device 1 comprises: a memory unit 12, which stores environmental data 121 related to the environment and work data 122 related to the work performed within that environment; a calculation unit 111, which performs calculations related to the hygiene management of the environment based on the environmental data 121 and the work data 122; and a display unit 14, which displays the calculation results of the calculation unit 111.

Description

Technical Field

[0001] This invention relates to a health management analysis support device, a health management analysis support system, and a health management analysis support method. Prior Technology

[0002] GxP (Good "x" Practices; where "x" represents a specific area) refers to the concept of several of the following terms used in the pharmaceutical manufacturing industry: GCP (Good Clinical Practice) (benchmarks related to clinical trials of pharmaceuticals); GDP (Good Distribution Practice) (benchmarks for the transportation and distribution of pharmaceuticals); and / or GMP (Good Manufacturing Practice) (benchmarks for the manufacturing and quality management of pharmaceuticals), etc.

[0003] In particular, pharmaceutical manufacturers are obligated to comply with Good Manufacturing Practices (GMP) standards. Users are required to prepare their environments to provide safe and high-quality pharmaceutical products. Under GMP, pharmaceutical products that directly impact human health and / or life must be controlled from the manufacturing stage using stringent management standards. GMP also includes legally mandated standards and requirements for compliance, and mandates quality risk management of the products.

[0004] Patent Document 1 describes the following invention: an information providing system that provides information related to the sanitary status of a target object for which predetermined operations related to a product are to be performed to a manager; the aforementioned information providing system comprises: an acquisition unit that acquires the colony count cultured in a culture medium containing a sample, the sample being a sample extracted from the target object at predetermined times; a determination unit that determines the sanitary status of the target object based on the acquired colony count; and an extraction unit that, if the determination unit determines that the sanitary status is abnormal or has an abnormal tendency, retrieves work history information and extracts at least one of the matching work attributes and work events as work elements, the aforementioned work history information showing that it has been registered in a database. For each work history of the aforementioned target object, the aforementioned work attributes display attributes related to the work of the target object, and the aforementioned work events display events related to the work; the identification unit identifies work elements that meet predetermined conditions as the cause of anomalies based on the aforementioned colony counts obtained for each of the aforementioned extracted work elements; and the providing unit provides the aforementioned manager with information related to the identified aforementioned work elements as cause-based inference information for the aforementioned anomalies. [Previous Technical Documents] [Patent Literature]

[0005] [Patent Document 1] Japanese Patent Application Publication No. 2015-011593. Summary of the Invention

[0006] [The problem that the invention aims to solve] The invention described in Patent Document 1 is effective in situations where the object is abnormal or showing signs of abnormality, and the proposed cause is deduced and provided to the manager. However, the invention described in Patent Document 1 cannot determine situations where the hygiene management of the environment surrounding the object is excessive, or where operations performed within that environment are excessive. Therefore, even in situations where hygiene management is already excessive, it is difficult to improve to optimal hygiene management.

[0007] Before constructing a pharmaceutical manufacturing facility, it is necessary to prepare the following documents within the regulatory framework of the approval scheme: all relevant documents regarding the organizational structure and manufacturing process. The result is that, with the process already established, hygiene management—a means of managing the manufacturing environment—is prone to being over-specification in the initial stages of facility operation, leading to suboptimal operations within the facility. However, analyzing data on procedures, workloads, or operations performed within the facility to appropriately improve hygiene management is time-consuming, and determining whether procedures or workloads are appropriate is difficult.

[0008] In this regard, the present invention addresses the following issue: how to easily determine whether the hygiene management of the environment or the operations carried out in the environment are appropriate.

[0009] [Methods used to solve problems] To address the aforementioned issues, the health management analysis support device of the present invention is configured as follows. The hygiene management analysis support device of the present invention comprises: a memory unit for storing environmental data related to the environment and operational data related to operations performed in the aforementioned environment; a calculation unit for performing calculations related to hygiene management of the aforementioned environment based on the aforementioned environmental data and the aforementioned operational data; and a display unit for displaying the calculation results performed by the aforementioned calculation unit.

[0010] The hygiene management analysis support system of the present invention comprises: a memory unit for storing environmental data related to the environment and operational data related to operations performed in the aforementioned environment; a calculation unit for performing calculations related to hygiene management of the aforementioned environment based on the aforementioned environmental data and the aforementioned operational data; and a display unit for displaying the calculation results performed by the aforementioned calculation unit.

[0011] The hygiene management analysis support method of the present invention includes the following steps: a step of inputting environmental data and operational data related to the environment by an input unit; a step of performing calculations related to the hygiene management of the aforementioned environment by a calculation unit based on the aforementioned environmental data and the aforementioned operational data; and a step of displaying whether the hygiene management of the aforementioned environment and the operations performed in the aforementioned environment are appropriate by a display unit. Other methods will be described in the context of the form in which the invention is implemented.

[0012] [Invention Benefits] According to the present invention, it is possible to easily determine whether the hygiene management of the environment or the operations carried out in the environment are appropriate. Simple Explanation of the Diagram

[0013] [Figure 1] is a diagram of the structure of the health management analysis support system in this implementation. [Figure 2] is a flowchart showing the general process of health management analysis support. [Figure 3] is a flowchart of the environmental data analysis after the operation in the first implementation mode. [Figure 4] is a time-series chart of environmental data after the operation. [Figure 5] is a chart depicting the analysis of monitoring points for environmental data in the order of movement. [Figure 6] is a flowchart of the second implementation of calculating the discrete cumulative probability distribution. [Figure 7] is an example of a discrete cumulative probability distribution chart. [Figure 8] is an example of a discrete cumulative probability distribution chart. [Figure 9A] is a flowchart of the monitoring point analysis for the third implementation mode. [Figure 9B] is a flowchart of the monitoring point analysis for the third implementation mode. [Figure 10] is a chart showing the average, maximum, and minimum values ​​of environmental data for each monitoring point. [Figure 11] is a flowchart of the heat map creation process in the fourth implementation. [Figure 12] is a heatmap showing the correlation between operations and environmental data. Implementation

[0014] The following description, with reference to the figures, details the configurations used to implement the present invention. This embodiment of the hygiene management analysis support device collects and correlates human operational information with environmental data. After analysis by the calculation department, the results are used as a basis to support hygiene management and operational optimization. The hygiene management analysis support device acquires human operational information in a set with environmental data from facility operation. Human operational information refers to the content of manufacturing operations and / or the time of implementation, as well as information on manufacturing and operations performed for the purpose of manufacturing. Environmental data refers to information such as particulate matter, temperature, humidity, and room pressure.

[0015] Hygiene management refers to the timing of cleaning, the frequency of cleaning, the number of monitoring points, and / or the cleaning area. Hygiene management can be improved through optimization; therefore, depending on the usage of the facility, the operating time of the facility in manufacturing will increase. Work optimization refers to improving workflow and / or work methods. Through work optimization, work efficiency will be improved in the following ways: reducing the risk of polluting the manufacturing environment; and suppressing the impact on the manufacturing environment.

[0016] Figure 1 is a structural diagram of the health management analysis support system 6 according to this embodiment. The health management analysis support device 1 and terminal 5 are connected via the Internet 4 to form the health management analysis support system 6. The terminal 5 is operated by a user and displays the calculation results. For example, the health management analysis support device 1 is a server computer located in a data center, and includes a control unit 11, a memory unit 12, an input unit 13, a display unit 14, and a communication interface 15. The health management analysis support device 1 is connected to a plurality of sensors 2 via the communication interface 15 and the Internet 4, and further connected to other systems 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 and display units corresponding to the health management analysis support device 1. The hygiene management analysis support device 1 uses multiple sensors 2 to detect environmental data 121 and exchange data on hygiene management and operations with other systems 3.

[0017] Here, environmental data 121 refers to the following: temperature; humidity; room pressure; bioparticles; microorganisms such as planktonic bacteria, attached bacteria, and runoff bacteria; and pests such as insects and rodents. Among the above environmental data, temperature, humidity, room pressure, and bioparticles can be continuously monitored. For example, planktonic bacteria can be monitored appropriately once a month or once a year. For example, attached bacteria can be monitored appropriately during operations and / or periodically. For example, runoff bacteria can be monitored appropriately during operations and / or periodically. Although the unit for these planktonic bacteria, attached bacteria, and runoff bacteria data is generally the CFU (Colony Forming Unit) count for each sample, other units can also be used to indicate the amount of microorganisms. For example, insects and / or small animals can be monitored monthly. While the data on insects and / or small animals is generally measured in units of "individual" and "number," other units can also be used to indicate the biomass of pests. The environmental data 121 mentioned above is not limited and can be obtained through sensor 2 or input manually by humans.

[0018] Work data 122 includes work records, such as facility events including manufacturing, cleaning, and / or material handling; and the number of workers. Work data 122 concerning facility events includes: the start and end dates of the event; the condition of the equipment during cultivation; and the type of work. This allows determination of the impact of the equipment condition on environmental data 121. Work data 122 concerning work records includes: the number of days workers are in the room and the number of days workers are out; the number of workers in the room; and the content of the work. Work data 122 includes data related to pre-defined work that may affect the environment of the various rooms constituting the environment.

[0019] The control unit 11 comprises a calculation unit 111, a planning unit 112, a document management unit 113, and a display control unit 114, and comprehensively controls the hygiene management analysis support device 1. The calculation unit 111 performs calculations related to environmental hygiene management based on the environmental data 121 and operational data 122 (described later) and calculates various indicator data. The planning unit 112 creates new improvement plans based on the indicator data calculated by the calculation unit 111. The display control unit 114 displays the following information on the display unit 14: whether the environmental hygiene management or the operations performed within the facility that constitute the environment are appropriate.

[0020] Specifically, when the work data 122 is in the form of device status, the calculation unit 111 can classify the related environmental data groups according to each device status and present the impact of the work data 122 on the environmental data 121 in a visible manner. In addition, when an accident occurs in the environment, the causal relationship with the environmental data 121 can be determined by referring to the device status.

[0021] When the work data 122 pertains to material handling, the calculation unit 111 categorizes the related environmental data groups according to the material handling operation status and presents the impact on environmental data 121 in a visible manner. Furthermore, in the event of an environmental accident, the causal relationship with environmental data 121 can be determined by referring to the closest material handling operation information.

[0022] When the work data 122 is a cleaning record, the calculation unit 111 determines the relationship between the number of days elapsed since the cleaning was carried out and the environmental data 121, and visualizes the changes in the cleaning method and the environmental data 121. In this way, users can refer to the closest cleaning implementation situation when an accident occurs.

[0023] During analysis, the calculation unit 111 calculates the time-series changes for a single measurement point of a single type within the environmental data 121. The display control unit 114 displays the time-series data of the environmental data 121. Furthermore, when the calculation unit 111 selects the target environmental data item and categorizes it into working-hour data and non-working-hour data based on the number of people, it calculates the average values ​​and standard deviations for both working-hour and non-working-hour data. The display control unit 114 displays a time-series chart of the average values ​​and standard deviations for both working-hour and non-working-hour data.

[0024] Furthermore, the calculation unit 111 selects and categorizes the target environmental data items into operational and non-operational data, and calculates the cumulative probability distribution function for each data set of operational and non-operational data, obtaining the values ​​of each item whose cumulative probability is 1. The display control unit 114 displays a graph of the cumulative probability distribution function and shows the values ​​of each item whose cumulative probability is 1 below the graph. In this way, the hygiene management analysis support device 1 becomes able to estimate the upper limit of the environmental data 121.

[0025] The calculation unit 111 organizes and arranges the following data groups in chronological order and calculates the standard partial regression coefficients for each item: each data group contains the number of workers related to events such as material handling and / or manufacturing. The display and control unit 114 displays the standard partial regression coefficients for each item. In this way, the hygiene management analysis support device 1 can visualize the correlation between various influencing factors and environmental data 121.

[0026] Document Management Department 113 registers improvement plans, which reflect the improvement plans created by Planning Department 112. Display Control Department 114 displays the improvement plans registered by Document Management Department 113 on Display Department 114.

[0027] For example, memory unit 12 may be a hard disk (HD), a solid-state drive (SSD), or a storage server located in the cloud, and stores: environmental data 121 related to the environment; operational data 122 related to operations performed within that environment; and an improvement plan database 123. For example, environmental data 121 may be the number of bacteria per unit space in the manufacturing environment. Environmental data 121 is associated with time and location information.

[0028] For example, work data 122 displays information such as the cleaning of the manufacturing environment. Work data 122 is linked to time and location information. Improvement plan database 123 is a database of improvement plans that reflect the improvement plans created by the planning department 112.

[0029] For example, the input unit 13 may be a keyboard, mouse, and / or touch panel; the input unit 13 inputs information into the health management analysis support device 1. For example, the display unit 14 may be a liquid crystal display; the display unit 14 can output display information via the display control unit 114. Alternatively, the input unit 13 and the display unit 14 may be an integrated touch panel display.

[0030] Additionally, for example, the input unit 53 of terminal 5 can be a keyboard, mouse, and / or touchpad, etc.; the input unit 53 of terminal 5 is not limited, and can also be an input device used to input information into the health management analysis support device 1. For example, the display unit 54 of terminal 5 can be a liquid crystal display, etc.; the display unit 54 of terminal 5 is not limited, and can also output display information through the display control unit 114 and the communication interface 15.

[0031] Communication interface 15 is an interface for exchanging information between other systems 3 and / or multiple sensors 2.

[0032] Figure 2 is a flowchart showing a general overview of the health management analysis support process. Initially, the input unit 13 acquires environmental data 121 and operational data 122 related to the manufacturing environment or accepts input of environmental data 121 and operational data 122 related to the manufacturing environment (step S10).

[0033] The calculation unit 111 performs calculations related to the hygiene management of the manufacturing environment based on environmental data 121 and work data 122 (step S11). Then, the process in Figure 2 ends when the display control unit 114 displays the following items on the display unit 14 (step S12): displaying whether the hygiene management of the manufacturing environment is appropriate; and displaying whether the manufacturing environment is appropriate as a result of maintaining hygiene management.

[0034] [First Implementation Form] The first embodiment of the hygiene management analysis support device 1 graphically displays changes in environmental data of the manufacturing environment after predetermined operations have been performed on it. Specifically, the hygiene management analysis support device 1 graphically displays changes in the bacterial count of the manufacturing environment after regular cleaning. This allows for the determination of whether hygiene management has been appropriately implemented due to the operations performed on the manufacturing environment, and whether the manufacturing environment is adequate.

[0035] Figure 3 is a flowchart of the post-operation environmental data analysis for the first implementation mode. Initially, the user registers the hygiene management plan (step S20). The input unit 13 obtains environmental data 121 and operational data 122 or accepts the input of environmental data 121 and operational data 122 (step S21).

[0036] The calculation unit 111 retrieves environmental data 121 from the memory unit 12, which is registered in the sanitation management plan, and operational data 122 from the cleaning records for the target period (step S22). Then, the calculation unit 111 calculates the average value, quartiles, maximum value, and minimum value for each cleaning day following the target monitoring point (step S23). Next, the display control unit 114 outputs the results calculated by the calculation unit 111 to the display unit 14 in graphical form (step S24). The display control unit 114 plots the latest measurement value for each cleaning day following the target monitoring point onto the output graph (step S25). Thus, the display unit 14 displays the environmental data 121 based on the environmental data 121 and operational data 122, in order of the number of days following the environmental cleaning. This display example is shown in Figure 4, which will be explained later.

[0037] The calculation unit 111 determines whether the latest measurement value falls within the range of the first quartile to the third quartile (step S26). When the latest measurement value falls within the range of the first quartile 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 does not fall within the range of the first to third quartiles (No), the process will proceed to step S28. Then, when the display control unit 114 issues an alert indicating the need for a review of the cleaning (step S28) and proposes a plan to change the cleaning frequency and / or improve the cleaning agent (step S29), the process will proceed to step S30. In step S30, the process in Figure 3 ends when the display control unit 114 displays the improvement plan reflecting the proposal on the display unit 14.

[0039] Figure 4 is a time-series chart of environmental data after the operation. This chart displays environmental data for each day following the cleaning; the chart is displayed on display unit 14. The vertical axis of the chart displays the bacterial count in the environment. The horizontal axis displays the number of days elapsed since the cleaning. The origin of the chart indicates the number of days since the environment was cleaned. This is a box-and-whisker plot; in this plot, the values ​​above and below the maximum and minimum values ​​are displayed as vertical lines, the first and third quartiles are displayed as rectangles, and the second quartile is displayed as a line cutting into the inside of a rectangle. Then, the closest environmental data value is plotted using hooded circles. The average environmental data for the target period is displayed using white circles. Finally, deviations are indicated by crosses.

[0040] The closest environmental data value after cleaning, with a duration of 1 day, is located between the first and third quartiles, indicating that cleaning was appropriate. When the number of days since cleaning is 2, the closest environmental data value is between the third quartile and the maximum value, indicating that something different from usual has occurred. At this time, the display control unit 114 can issue an alert. In this way, based on environmental data and work data and categorized according to the number of days since cleaning, the suitability of cleaning and the necessity for improvement can be evaluated, and the cleaning work can be re-examined considering environmental inhomogeneity.

[0041] Figure 5 is a chart depicting the analysis of environmental data monitoring points in the order of user movement within the environment; this chart displays environmental data according to the user's movement sequence in the environment; this chart is displayed on display unit 14. The vertical axis of the chart displays the bacterial count in the environment. The horizontal axis displays the various locations along the user's movement path. This chart is a box plot showing the monitoring points in sequence; in this chart, the values ​​above and below the maximum and minimum values ​​are displayed as vertical lines, the first and third quartiles are displayed as rectangles, and the second quartile is displayed as a line within a rectangle. Then, the closest environmental data value is plotted using shading circles. The average environmental data for the target period is displayed using white circles. Finally, deviations are indicated by crosses.

[0042] The closest environmental data value for the changing room is between the first quartile and the minimum value, indicating that cleaning is appropriate. The closest environmental data value for manufacturing room 001 is between the second quartile and the first quartile, indicating that cleaning is appropriate. The closest environmental data value for manufacturing room 002 is between the maximum value and the third quartile, indicating that something different from usual has occurred.

[0043] In this way, the user's movement path is classified based on environmental data 121 and work data 122; thereby, the suitability of the user's movement path or the work performed on the movement path and the necessity for improvement can be evaluated, and environmental inhomogeneity can be taken into account, thereby re-examining the user's movement path or the work performed on the movement path.

[0044] [Second Implementation Form] The second implementation form of the health management analysis support device 1 classifies human presence and statistically analyzes environmental data, and determines precise benchmark values ​​related to environmental health management based on discrete cumulative probability distribution.

[0045] Figure 6 is a flowchart of the second implementation for calculating the discrete cumulative probability distribution. Initially, the user registers the hygiene management plan (step S40). The input unit 13 obtains environmental data 121 and operational data 122 or accepts the input of environmental data 121 and operational data 122 (step S41).

[0046] The calculation unit 111 retrieves the environmental data 121 of the target environmental monitoring point from the memory unit 12 (step S42). Then, the calculation unit 111 calculates the discrete cumulative probability distribution of the environmental data 121 (step S43). Then, the display control unit 114 outputs the calculation results in the form of a chart (step S44), and displays the environmental data value with a cumulative probability of 1.0 as a warning value for the environmental data 121 (step S45).

[0047] The calculation unit 111 multiplies the warning value by an appropriate coefficient to calculate the baseline value (step S46). Then, the calculation unit 111 proposes the following improvement plan: using the calculated baseline value and warning value as the baseline value and warning value of the environmental monitoring point as the improvement plan (step S47); and re-registering the plan reflecting the proposal as the improvement plan (step S48). Finally, when the display control unit 114 displays the improvement plan on the display unit 14 (step S49), the processing in Figure 6 ends.

[0048] Figures 7 and 8 are examples of discrete cumulative probability distribution charts. Figure 7 is a discrete cumulative probability distribution chart of operations in a manufacturing room. In the above charts, the vertical axis in both charts displays the cumulative probability. The horizontal axis displays the number of colonies per unit volume.

[0049] As shown in Figure 7, during operation, the cumulative probability is 1.0 when the colony count is Xc1. The hygiene management analysis support device can multiply this Xc1 by a predetermined coefficient to calculate the appropriate baseline value for operation.

[0050] Figure 8 is a discrete cumulative probability distribution chart of the manufacturing room during non-operational periods. In this chart, the vertical axis shows the cumulative probability, and the horizontal axis shows the number of colonies per unit volume.

[0051] As shown in Figure 8, during non-operational periods, the cumulative probability is 1.0 when the colony count is Xc². The hygiene management analysis support device can multiply this Xc² by a predetermined coefficient to calculate a suitable baseline value during non-operational periods.

[0052] [Third Implementation Form] The third implementation form of the hygiene management analysis support device determines the monitoring points based on the aforementioned environmental data related to multiple monitoring points in the environment, and these monitoring points appropriately reflect the hygiene management status of the manufacturing environment.

[0053] Figures 9A and 9B are flowcharts of the monitoring point analysis for the third implementation. Initially, the user registers the hygiene management plan (step S60). The input unit 13 obtains environmental data 121 and operational data 122 or accepts the input of environmental data 121 and operational data 122 (step S61).

[0054] The calculation unit 111 retrieves the environmental data 121 of the target environmental monitoring point from the memory unit 12 (step S62). Then, the calculation unit 111 calculates the average value and standard deviation value of each monitoring point (step S63). The display control unit 114 outputs the calculation results calculated by the calculation unit 111 in the form of a chart (step S64).

[0055] Next, the calculation unit 111 determines whether 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 in Figure 9A ends.

[0056] In step S66, the calculation unit 111 determines whether there exists a point with the highest average value and standard deviation. If there is a point with the highest average value and standard deviation (yes), the display control unit 114 displays this point as a candidate for the worst point (step S67), and then the process proceeds to step S68. If there is no point with the highest average value and standard deviation (no), the process proceeds to step S68. This candidate worst point appropriately reflects the hygiene management status of the manufacturing environment.

[0057] In step S68, the calculation unit 111 determines whether there is a point with the widest range of standard deviation values. If there is a point with the widest range of standard deviation values ​​(yes), the display control unit 114 displays it as a candidate representative sampling point for the target room (step S69), and then the process proceeds to step S70. If there is no point with the widest range of standard deviation values ​​(no), the process proceeds to step S70. This candidate representative sampling point appropriately reflects the hygiene management status of the manufacturing environment.

[0058] In step S70, the calculation unit 111 proposes an improvement plan to exclude points other than the extracted monitoring points from the monitoring targets. Then, the calculation unit 111 re-registers the plan reflecting the proposal as an improvement plan (step S71). When the display control unit 114 displays the improvement plan on the display unit (step S72), the processing in Figure 9B ends.

[0059] Figure 10 is a chart showing the average, maximum, and minimum values ​​of environmental data for each monitoring point. The vertical axis of the graph displays the number of microparticles per unit volume in the manufacturing chamber. The horizontal axis of the graph displays the individual monitoring points. This graph displays the average and standard deviation values ​​for each monitoring point in the target manufacturing chamber for the target period. The horizontal line at the center of the vertical line across the monitoring point displays the average value. The horizontal line above the vertical line of the monitoring point displays the value obtained by adding the standard deviation to the standard value. The horizontal line below the vertical line of the monitoring point displays the value obtained by subtracting the standard deviation from the standard value.

[0060] Since the highest value obtained by adding the standard deviation to the standard value is at monitoring point AB006, monitoring point AB006 is the candidate for the worst point. Since monitoring point AB008 has the widest standard deviation, it serves as a representative candidate point for observation. Users can exclude monitoring points other than these candidates from the sampling points and use the hygiene management analysis support device to observe the worst-case scenario and other points requiring observation. Furthermore, this chart allows users to avoid operating near the worst-case scenario, thereby reducing the risk of contamination of finished products.

[0061] [Fourth Implementation Form] The fourth implementation form of the hygiene management analysis support device is based on the analysis of environmental data related to the multiple rooms that constitute the environment and the influencing factors related to the pollution of the aforementioned rooms as targets.

[0062] Figure 11 is a flowchart of the heat map creation process for the fourth implementation. Initially, the user registers the hygiene management plan (step S80). Input unit 13 obtains environmental data 121 and operational data 122 or accepts the input of environmental data 121 and operational data 122 (step S81). Calculation unit 111 obtains environmental data 121 and operational data 122 for the target period from the memory unit 12 for the environmental monitoring points registered in the hygiene management plan (step S82). Then, calculation unit 111 calculates the correlation coefficient between the items (step S83). Display control unit 114 outputs the results calculated by calculation unit 111 in the form of a heat map (step S84), and displays items with correlation coefficient values ​​above a certain value as factors that may affect the pollution of the target room (step S85).

[0063] The calculation unit 111 determines the correlation between the various items (step S86). When there is a positive correlation between the various items (yes), the calculation unit 111 will generate a plan for setting restrictions (step S87) and advance the process to step S89; the plan for setting restrictions is to not perform operations that match the items extracted during the operation in the target room. When there is a negative correlation between the items (no), the calculation unit 111 will create a plan for the extracted items as a countermeasure when performing operations in the target room that are suspected of having a risk of contamination (step S88), and will advance the process to step S89. In step S89, the calculation unit 111 re-registers the plan reflecting the proposal as an improvement plan. Then, when the display control unit 114 displays the improvement plan on the display unit 14 (step S90), the processing in Figure 11 ends.

[0064] Figure 12 is a heatmap showing the correlation between operations and environmental data. The heatmap's vertical and horizontal axes record: 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 on the heatmap is displayed as a concentration corresponding to a correlation, and the correlation of each item is displayed numerically. This allows for the identification of the most influential factors in the contamination of the target room.

[0065] Furthermore, the present invention is not limited to determining whether the hygiene management of the manufacturing environment or the operations performed in the manufacturing environment are appropriate, but can also be applied to determining whether the hygiene management of any environment or the operations performed in any environment are appropriate, and is not limited thereto.

[0066] The following describes the structure and effects of the present invention.

[0067] [Option 1] A hygiene management analysis support device (1) comprises: a memory unit (12) for storing environmental data (121) related to the environment and operation data (122) related to the operation performed in the aforementioned environment; a calculation unit (111) for performing calculations related to hygiene management of the aforementioned environment based on the aforementioned environmental data (121) and the aforementioned operation data (122); and a display unit (14) for displaying the calculation results performed by the aforementioned calculation unit.

[0068] This makes it easy to determine whether the environmental hygiene management or the operations carried out in the environment are appropriate.

[0069] [Option 2] As described in Scheme 1, the health management analysis support device (1) stores the aforementioned environmental data (121) and the aforementioned operational data (122) in the aforementioned memory unit (12), which are respectively associated with time information and location information.

[0070] This allows users to know the location and hygiene management of the environment at any given time.

[0071] [Option 3] As described in Scheme 1, the hygiene management analysis support device (1) displays the aforementioned environmental data (121) based on the aforementioned environmental data (121) and the aforementioned work data (122) for each number of days elapsed after the cleaning of the aforementioned environment.

[0072] This allows users to understand the environmental impact of cleaning.

[0073] [Option 4] As described in Scheme 1, the hygiene management analysis support device (1) displays the aforementioned environmental data (121) based on the aforementioned environmental data (121) and the aforementioned operational data (122) and according to the user's movement sequence in the aforementioned environment.

[0074] This allows users to understand the environmental impact of their movement or the work performed along that movement.

[0075] [Option 5] As described in Scheme 1, the hygiene management analysis support device (1) is used to classify the presence of people and statistically analyze the environmental data (121) based on the aforementioned operational data (122), and determine the exact benchmark value related to the hygiene management of the aforementioned environment.

[0076] This allows users to determine baseline values ​​related to hygiene management.

[0077] [Option 6] As described in Scheme 1 or 2, the health management analysis support device (1) wherein the aforementioned calculation unit (111) determines the monitoring points based on the aforementioned environmental data related to a plurality of monitoring points in the aforementioned environment, and the aforementioned monitoring points appropriately reflect the health management status of the environment.

[0078] In this way, users can determine the location that accurately reflects the state of environmental hygiene management and set that location as the worst case as an indicator of the overall state of hygiene management.

[0079] [Option 7] As described in Scheme 1 or 2, the hygiene management analysis support device (1) contains the aforementioned operational data (122) which is data related to pre-defined operations that may affect the environment of the various rooms that constitute the aforementioned environment.

[0080] This allows users to identify the types of operations that affect the environment of each room.

[0081] [Option 8] As described in Scheme 1 or 2, the health management analysis support device (1) wherein the aforementioned calculation unit (111) judges the aforementioned environmental data (121) based on the benchmark value of whether it is suitable for the aforementioned environment.

[0082] In this way, users can determine whether environmental data is suitable for the environment based on this benchmark value.

[0083] [Option 9] A hygiene management analysis support device includes: a display unit that displays, based on environmental data (121) and operational data (122), whether the hygiene management of the environment or the operations performed in the environment are appropriate.

[0084] This allows users to know whether the environmental hygiene management or the operations carried out in the environment are appropriate.

[0085] [Option 10] A hygiene management analysis support system (6) includes: a memory unit (12) for storing environmental data (121) related to the environment and operational data (122) related to the operations performed in the aforementioned environment; a calculation unit (111) for performing calculations related to hygiene management of the aforementioned environment based on the aforementioned environmental data (121) and the aforementioned operational data (122); and a display unit (14) for displaying the calculation results performed by the aforementioned calculation unit (111).

[0086] This makes it easy to determine whether the sanitation management or operations carried out on the environment are appropriate.

[0087] [Option 11] A hygiene management analysis support method comprises the following steps: inputting environmental data (121) and operational data (122) related to the environment by an input unit (13); performing calculations related to the hygiene management of the aforementioned environment by a calculation unit (111) based on the aforementioned environmental data (121) and the aforementioned operational data (122); and displaying whether the hygiene management of the aforementioned environment and the operations performed in the aforementioned environment are appropriate by a display unit (14).

[0088] This makes it easy to determine whether the sanitation management or operations carried out on the environment are appropriate.

[0089] [Variation Example] This invention is not limited to the embodiments described above and includes various modifications. For example, the embodiments described above have been explained in detail to facilitate understanding of the invention and are not intended to limit it to having all the described components. A part of the component of one embodiment can be replaced with the component of another embodiment; or the component of one embodiment can be added to the component of another embodiment. Furthermore, it is also possible to add, delete, and / or replace a part of the component of each embodiment with another component. In addition, as long as the display provides the same information, it is acceptable to display it in a manner other than a chart.

[0090] For example, some or all of the above-described components, functions, processing units, and / or processing methods can be implemented using hardware such as integrated circuits. The above-described components and / or functions can also be implemented in software by a processor interpreting and executing the program used to implement each function. Information such as programs, tables, and / or files used to implement each function can be placed on a recording device or recording medium; the recording device is, for example, memory, hard disk, and solid-state drive; the recording medium is, for example, a flash memory card and a digital versatile disk (DVD).

[0091] In various embodiments, control lines and / or information lines are considered essential for the description, but it is not necessarily true that all control lines and / or information lines are displayed on the product. In fact, it can be considered that almost all components are interconnected.

[0092] 1: Health Management Analysis Support Device 2: Sensor 3: Other systems 4: Internet 5: Terminal 6: Health Management Analysis Support System 11: Control Department 12: Memory Department 13: Input Section 14: Display Section 15: Communication Interface 53: Input Section 54: Display Section 111: Calculation Department 112: Planning Department 113: Document Management Department 114: Display Control Unit 121: Environmental Data 122: Homework Materials 123: Improvement Plan Database S10 to S12, S20 to S30, S40 to S49, S60 to S72, S80 to S90: Steps

Claims

1. A hygiene management analysis support device comprising: a memory unit for storing environmental data related to the environment and operational data related to operations performed in the aforementioned environment; a calculation unit for performing calculations related to hygiene management of the aforementioned environment based on the aforementioned environmental data and the aforementioned operational data; and a display unit for displaying the calculation results performed by the aforementioned calculation unit; wherein the aforementioned environmental data includes airborne bacteria, attached bacteria, and fallen bacteria, and the data units for the aforementioned airborne bacteria, attached bacteria, and fallen bacteria are the number of colony-forming units for each sample.

2. The health management analysis support device described in Request 1, wherein the aforementioned environmental data and operational data stored in the aforementioned memory unit are respectively associated with time information and location information.

3. The hygiene management analysis support device as described in claim 1, wherein the aforementioned display unit displays the aforementioned environmental data based on the aforementioned environmental data and the aforementioned operational data for each number of days elapsed after the cleaning of the aforementioned environment.

4. The health management analysis support device as described in claim 1, wherein the aforementioned display unit displays the aforementioned environmental data based on the aforementioned environmental data and the aforementioned operational data and in accordance with the user's movement sequence in the aforementioned environment.

5. The hygiene management analysis support device as described in claim 1, wherein the aforementioned calculation unit classifies the presence of people and compiles the aforementioned environmental data based on the aforementioned operational data, and determines the exact benchmark value related to the hygiene management of the aforementioned environment.

6. The sanitation management analysis support device described in claim 1 or 2, wherein the aforementioned calculation unit determines the monitoring points based on the aforementioned environmental data relating to a plurality of monitoring points in the aforementioned environment, and the aforementioned monitoring points appropriately reflect the sanitation management status of the environment.

7. The hygiene management analysis support device as described in claim 1 or 2, wherein the aforementioned operational data is data relating to pre-defined operations that may affect the environment of the various rooms that constitute the aforementioned environment.

8. The health management analysis support device described in claim 1 or 2, wherein the aforementioned calculation unit determines the aforementioned environmental data based on a benchmark value for suitability to the aforementioned environment.

9. A hygiene management analysis support device, comprising: a display unit that displays, based on environmental data and operational data, whether the hygiene management of the aforementioned environment or the operations performed in the aforementioned environment are appropriate; the aforementioned environmental data includes airborne bacteria, attached bacteria, and fallen bacteria, and the data units for the aforementioned airborne bacteria, attached bacteria, and fallen bacteria are the number of colony-forming units for each sample.

10. A hygiene management analysis support system comprising: a memory unit for storing environmental data related to the environment and operational data related to operations performed in the aforementioned environment; a calculation unit for performing calculations related to hygiene management of the aforementioned environment based on the aforementioned environmental data and the aforementioned operational data; and a display unit for displaying the calculation results performed by the aforementioned calculation unit; wherein the aforementioned environmental data includes airborne bacteria, attached bacteria, and fallen bacteria, and the data units for the aforementioned airborne bacteria, attached bacteria, and fallen bacteria are the colony formation units of each sample.

11. A hygiene management analysis support method comprising the following steps: an input unit inputting environmental data related to the environment and operational data related to operations performed in the aforementioned environment; a calculation unit performing calculations related to hygiene management of the aforementioned environment based on the aforementioned environmental data and the aforementioned operational data; and a display unit displaying whether the hygiene management of the aforementioned environment or the operations performed in the aforementioned environment is appropriate; wherein the aforementioned environmental data includes airborne bacteria, attached bacteria, and fallen bacteria, and the data units for the aforementioned airborne bacteria, attached bacteria, and fallen bacteria are the colony formation units of each sample.

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