Configuration Change Management System

Abstract

This system provides a configuration change management system that can more reliably prevent problems such as the production of products of unexpected quality due to the operation of equipment before configuration changes are reflected. [Solution] The setting change management system 1 comprises an instruction information issuing unit 14f capable of issuing setting change instruction information, a touch panel capable of changing setting items in the device based on the setting change instruction information, and a change approval unit 14g capable of reflecting the changed setting items in the device by approving the changed setting items. The device is configured to be inoperable from the time the instruction information issuing unit 14f issues setting change instruction information relating to a setting change of the device until the change approval unit 14g approves the setting change of the device, while the device becomes operational once the change approval unit 14g approves the setting change of the device.

Description

Technical Field

[0001] The present invention relates to a setting change management system for managing changes in settings in a device.

Background Art

[0002] Conventionally, in manufacturing plants for pharmaceuticals, foods, etc., manufacturing, inspection, packaging, etc. are carried out using various devices having changeable setting items. For example, in a factory that manufactures and packages PTP sheets as pharmaceuticals, a device (PTP machine) for manufacturing and inspecting PTP sheets, a device (stacking machine) for stacking the manufactured PTP sheets in predetermined numbers, a device (banding machine) for binding a plurality of stacked PTP sheets with a predetermined band, a device (pillow machine) for bagging (pillow packaging) PTP sheets, a device (boxing machine) for performing box-packing processing of PTP sheets, etc. are used.

[0003] By the way, according to changes in the manufacturing product type and the quality required for the manufacturing product type, etc., the settings in the device are appropriately changed. Here, since the change in settings affects the quality of the product, it is necessary to appropriately manage the change in settings.

[0004] As a system for managing setting changes, there is one that has a touch panel for operating the device, inputs a value (setting value) related to the setting to be changed and the reason for the setting change to the touch panel, and reflects the setting change to the device by confirming the input setting value and reason reason reason that are displayed on the touch panel after these inputs (see, for example, Patent Document 1, etc.). Incidentally, in this system, it is said that changes in setting values, etc. can be made not only before the operation of the device but also during the operation of the device.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

[0006] However, in the above system, the setting change is only reflected in the device after the entered setting value has been confirmed. Therefore, there is a risk that the user (e.g., the device operator) may mistakenly believe that the setting has been changed simply by entering the setting value without confirming it. If the device is operated without the setting change being reflected, manufacturing and inspection will be carried out under inappropriate conditions (i.e., the device will not perform the intended function), which may result in problems such as the production of products of unexpected quality or a decrease in inspection accuracy.

[0007] This invention has been made in view of the above circumstances, and its purpose is to provide a setting change management system that can more reliably prevent malfunctions such as the production of products of unexpected quality due to the operation of the device without the setting changes being reflected. [Means for solving the problem]

[0008] Below, we will describe, in separate sections, each means suitable for achieving the above objectives. Furthermore, we will add notes on the effects and benefits specific to each means as needed.

[0009] Means 1. A setting change management system applicable to a device having changeable setting items, An instruction information issuing means capable of issuing instruction information indicating at least the setting item to be changed and the details of the changes in said setting item, A setting change means that can change the setting items in the device based on the setting change instruction information, An operational status switching means capable of setting the aforementioned device to an operational state or an operational state, The system includes an approval means that allows the modified setting to be reflected in the device by approving the modified setting, The operational status switching means is configured to keep the device in an operational state from the time the instruction information issuing means issues the setting change instruction information relating to the setting change of the device until the approval means approves the setting change of the device, and to make the device operational once the approval means approves the setting change of the device. Occasionally, The device is equipped with a changeability switching means that can change the setting items in the device to a state where they can be changed or a state where they cannot be changed. The changeability switching means is configured to allow the setting item in the device to be changed from the time the instruction information issuing means issues the setting change instruction information relating to the setting change of the device until the approval means approves the setting change of the device, while setting the setting item in the device to be unchangeable once the approval means approves the setting change of the device. A configuration change management system characterized by the following features.

[0010] According to the above method 1, when a setting change instruction is issued, the device becomes inoperable, and once approval is given to reflect the setting change, the device returns to an operational state. Therefore, once a setting change instruction is issued, that is, once a setting change is required, the device cannot be operated without approval, and only after approval is given and the setting change is reflected does the device become operational. This makes it possible to more reliably prevent the device from being operated before the setting change is reflected, which could lead to manufacturing or inspection being carried out under inappropriate conditions. This makes it possible to more reliably prevent problems such as the manufacture of products of unexpected quality or a decrease in inspection accuracy.

[0012] Also The setting item on the device can only be changed between the issuance of setting change instruction information and the approval of the setting change, that is, only when the device is inoperable. Therefore, accidental setting changes while the device is operating can be prevented more reliably. This further reliably prevents problems such as the manufacture of products of unexpected quality or a decrease in inspection accuracy.

[0013] Furthermore, generally speaking, products from the "same lot" are required to be manufactured in a manner that ensures homogeneity, and this requirement is particularly strict in the pharmaceutical field. In this regard, the above means 1According to this, it is possible to prevent accidental changes to settings while the device is in operation (i.e., during the manufacturing of products in the same lot), thus more reliably satisfying the requirement that manufacturing and other processes be carried out in a homogeneous manner.

[0014] means 2 A change permission control means that, based on the user's permission information, allows or denies changes to setting items using the setting change means, The system includes an issuance permission control means that, based on the aforementioned authorization information, permits or dispermits the issuance of the setting change instruction information using the instruction information issuance means, The setting change management system according to means 1, characterized in that the authority information that allows changes to setting items using the setting change means in the change permission control means and the authority information that allows the issuance of setting change instruction information using the instruction information issuance means in the issuance permission control means are set to be different.

[0015] The above means of transportation 2 According to the documentation, the authorization information that allows changes to setting items using the setting change means in the change permission control means and the authorization information that allows the issuance of setting change instruction information using the instruction information issuance means in the issuance permission control means are different. Therefore, for example, only users with authority over maintaining product quality (e.g., quality managers) can issue setting change instruction information, while only those responsible for operating the device (e.g., operators) can change the settings. This allows for checking the content of setting changes from different perspectives, making it more reliable to prevent errors in setting change instruction information.

[0016] means 3 Based on the user's authority information, an issuance permission control means is provided to permit or deny the issuance of the setting change instruction information using the instruction information issuance means. The system includes an approval / denial control means that, based on the aforementioned authority information, permits or denies approval using the aforementioned approval means, The setting change management system according to means 1, wherein the authority information that permits the issuance of the setting change instruction information using the instruction information issuance means in the issuance permission control means is set to be the same as the authority information that permits the approval using the approval means in the approval permission control means.

[0017] The above means 3 According to this, the authority information that permits the issuance of the setting change instruction information using the instruction information issuance means in the issuance permission control means and the authority information that permits the approval using the approval means in the approval permission control means are each the same. A user having the same authority information (for example, the same user) issues the setting change instruction information and approves the setting change based on this information, so that it is possible to more appropriately check the user at the time of approval, such as whether there is an error in the content of the setting change instruction information and whether the setting change has been appropriately performed. As a result, it is possible to more reliably prevent the setting change with incorrect content from being performed. In addition, it is possible to more reliably prevent the setting change that does not depend on the setting information change information from being performed.

[0018] In addition, the technical matters related to the above means may be appropriately combined. 。

Brief Description of Drawings

[0019] [Figure 1] It is a block diagram showing the schematic configuration of the setting change management system, the manufacturing equipment, and the functional configuration of the PC14. [Figure 2] It is a perspective view of the PTP sheet. [Figure 3] It is a partially enlarged cross-sectional view of the PTP sheet. [Figure 4] It is a schematic diagram showing the schematic configuration of the PTP machine. [Figure 5] It is a block diagram showing the control device and the touch panel of the PTP machine and the like. [Figure 6] It is a block diagram showing the functional configuration of the touch panel. [Figure 7]This is a table diagram showing an example of information such as user IDs stored in the account information storage unit. [Figure 8] This is a table diagram showing an example of information such as permission categories stored in the account information storage unit. [Figure 9] A table diagram showing an example of setting change instruction information. [Figure 10] This flowchart shows the login process flow on PC14. [Figure 11] This is an explanatory diagram showing the process for changing settings. [Figure 12] This is a flowchart showing the login process on a touch panel. [Modes for carrying out the invention]

[0020] An embodiment will be described below with reference to the drawings. As shown in Figure 1, the setting change management system 1 is applied to a manufacturing facility 100 that includes multiple devices and is used for manufacturing and packaging pharmaceuticals, and is for managing changes to the settings of the devices. Before describing the setting change management system 1, the manufacturing facility 100 will be described first.

[0021] The manufacturing facility 100 is equipped with multiple (e.g., 10) production lines L, each production line L having multiple devices for manufacturing PTP sheets as "medicine" and for packaging the PTP sheets. Each device has configurable settings. The PTP sheet 301 comprises a container film 303 having a pocket portion 302 in which contents 305 (e.g., tablets or capsules) are contained, and a cover film 304 attached to the container film 303 so as to close the opening of the pocket portion 302 (see Figures 2 and 3).

[0022] In this embodiment, each production line L has all or some of the following "devices": a PTP machine 101, a stacking machine 102, a banding machine 103, a pillow machine 104, and a boxing machine 105.

[0023] The PTP machine 101 is a device for manufacturing PTP sheets 301. As shown in Figure 4, a raw material roll consisting of a strip of container film 303 wound up is provided at the upstream end of the PTP machine 101, and the container film 303 fed from here is transported along a predetermined path. Along the transport path of the container film 303, the PTP machine 101 is equipped with, in order from the upstream side, a preheating device 101a, a pocket forming device 101b, a first inspection device 101c, a filling device 101d, a second inspection device 101e, a sealing device 101f, a third inspection device 101g, a slit forming device 101h, an engraving device 101j, and a sheet punching device 101k, each serving as a "component."

[0024] The preheating device 101a preheats the container film 303. The preheating temperature is a changeable setting. The pocket forming device 101b forms pockets 302 in the preheated container film 303 using a predetermined mold or the like. The pressure used when forming the pockets 302 is a changeable setting.

[0025] The first inspection device 101c determines the quality of the container film 303 before filling the pocket portion 302 with contents 305. The quality determination is performed using a threshold value (for example, an area value for quality determination) and image processing. The area value for quality determination and the setting value for image processing (for example, the binarization level used when performing binarization processing on an image) are changeable setting items.

[0026] The filling device 101d fills the pockets 302 with contents 305. The second inspection device 101e primarily determines the quality of the contents 305, for example, whether the contents 305 are reliably filled into each pocket 302, whether there are any abnormalities in the contents 305, and whether there are any foreign objects mixed into the pockets 302. The quality determination is performed using thresholds (e.g., area values ​​for quality determination) and image processing, similar to the first inspection device 101c. The area values ​​for quality determination (e.g., tablet area or chipped area) and image processing settings for the second inspection device 101e are also changeable settings.

[0027] The sealing device 101f includes a heating roll 101f1 with a heating function and a film receiving roll 101f2 that continuously conveys the container film 303. The cover film 304 is attached to the container film 303 by closing the opening of the pocket portion 302. More specifically, the strip-shaped cover film 304 is guided to the heating roll 101f1, and the two films 303 and 304 pass between the two rolls 101f1 and 101f2 in a heated and pressure-welded state, thereby attaching the cover film 304 to the container film 303. Once the cover film 304 is attached to the container film 303, a strip-shaped PTP film 306 is produced in which the contents 305 are contained in each pocket portion 302. The temperature of the heating roll 101f1 (sealing temperature) and the pressure when attaching the two films 303 and 304 are among the adjustable settings.

[0028] The third inspection device 101g performs quality control on the contents 305 and the attachment portions (sheet portions) of both films 303 and 304. Similar to inspection devices 101c and 101e, quality control is performed using thresholds (e.g., area values ​​for quality control) and image processing. The area values ​​for quality control and image processing settings for the third inspection device 101g are also adjustable settings.

[0029] The slit-forming device 101h forms separation slits at predetermined positions on the PTP film 306. The marking device 101j marks the PTP film 306 at predetermined positions (e.g., the tag portion). Note that the separation slits and markings are not shown in Figure 2.

[0030] The sheet punching device 101k has the function of punching out the outer edge of the PTP film 306 into units of PTP sheets 301, that is, separating the PTP sheets 301 from the PTP film 306. The PTP sheets 301 obtained by the sheet punching device 101k are transported by the conveyor 101m and temporarily stored in the finished product hopper 101n. However, if any of the inspection devices 101c, 101e, or 101g determine that a sheet is defective, the PTP sheet 301 related to this defect determination is not sent to the finished product hopper 101n, but is instead discharged separately by a defective sheet discharge mechanism (not shown).

[0031] Meanwhile, the scrap portion remaining after punching out the PTP film 306 is cut to predetermined dimensions by the cutting device 101p and then stored in the scrap hopper 101q.

[0032] Although details are omitted here, the filling device 101d, slitting device 101h, marking device 101j, and sheet punching device 101k also have configurable settings, similar to the preheating device 101a and sealing device 101f.

[0033] Returning to Figure 1, the stacking machine 102 is a device that stacks the manufactured PTP sheets 301 in predetermined numbers. The banding machine 103 is a device that bundles the stacked PTP sheets 301 together with predetermined bands. The pillow packaging machine 104 is a device that bags the PTP sheets 301 by performing pillow packaging. The boxing machine 105 is a device that boxes the PTP sheets 301. Details are omitted, but the stacking machine 102, banding machine 103, pillow packaging machine 104 and boxing machine 105 have changeable settings.

[0034] In each production line L, the line configuration (i.e., the equipment that makes up the production line) is appropriately set according to the final product to be obtained. For example, in a production line L that ultimately produces a product that does not require bundling or bagging of PTP sheets 301, a PTP machine 101, a stacking machine 102, and a boxing machine 105 are provided, while a banding machine 103 and a pillow machine 104 are not provided.

[0035] Furthermore, the PTP machine 101, stacking machine 102, banding machine 103, pillow machine 104, and boxing machine 105 are each equipped with a control device 201 and a touch panel 202 (see Figure 5). In this embodiment, the touch panel 202 corresponds to the "setting change means". The control device 201 and the touch panel 202 function as components of the setting change management system 1. The control device 201 and the touch panel 202 will be described later.

[0036] Next, the configuration change management system 1 will be described. As shown in Figures 1 and 5, the configuration change management system 1 includes a server 10, a number of PCs (four in this embodiment) 11, 12, 13, and 14, and control devices 201 and touch panels 202 for each device.

[0037] Server 10 is connected to PCs 11-14 and various devices (such as the PTP machine 101), and performs tasks such as sending and receiving various types of information between them and the server, as well as managing the stored information. Server 10 is composed of a computer that includes a CPU (Central Processing Unit) for executing predetermined calculations, ROM (Read Only Memory) for storing various programs and fixed value data, and storage media for storing various types of information (for example, an HDD (Hard Disk Drive) or SSD (Solid State Drive)).

[0038] Server 10 is equipped with a storage area composed of the aforementioned storage medium, which includes an account information storage unit 10a, an instruction information storage unit 10b, a line configuration information storage unit 10c, a driver / assistant driver information storage unit 10d, an assignment information storage unit 10e, and an audit trail storage unit 10f. In this embodiment, the account information storage unit 10a is located in the directory service area of ​​the storage area, and the information stored in the account information storage unit 10a is centrally managed using a directory service.

[0039] The account information storage unit 10a stores user accounts associated with a user ID and password as "authentication information" and a permission category as "permission information" for each user (see Figure 7). The account information storage unit 10a also stores permission categories and permissions in association (see Figure 8). This manages permissions for each user. Note that the permissions in Figure 8 are just an example, and the types of permissions may be changed as appropriate. For example, permissions related to device maintenance may be included.

[0040] In this embodiment, there are a total of seven authority categories: "0: Manufacturer / Distributor," "1: System Administrator," "2: Maintenance Person," "3: Quality Manager," "4: Production Manager," "5: Driver," and "6: Driver Assistant." Within each authority category, permissions are further subdivided and set. For example, the authority category "3: Quality Manager" is set to have permissions such as viewing audit trails and settings, and issuing setting change instruction information, which will be described later. Also, for example, the authority category "5: Driver" is set to have permissions such as changing and viewing user assignments to each production line L and equipment (PTP machine 101, etc.), changing and viewing various information related to drivers and driver assistants (hereinafter sometimes referred to as "drivers, etc."), changing settings of equipment (PTP machine 101, etc.), and operating the equipment.

[0041] The instruction information storage unit 10b stores setting change instruction information issued by the instruction information issuing unit 14f of the PC 14, which will be described later. The setting change instruction information indicates at least the setting item to be changed and the details of the change in that setting item, and functions as reference information when changing the settings of the device (PTP machine 101, etc.) and as information for confirming various circumstances related to the setting change.

[0042] In this embodiment, the setting change instruction information is configured by associating various pieces of information with information for identifying the information (instruction information No.) (see Figure 9). The various pieces of information include information for identifying the device and setting items subject to the setting change (line No., device, components, and setting items), information indicating the target setting value and the reason for the setting change (change value, reason for change), information for identifying the product type (product type), and information for identifying the product lot (lot No.). In addition, the various pieces of information include information for identifying the person who issued the setting change instruction information, the person who actually changed the setting, and the person who approved the setting change, respectively (issuer, changer, approver), as well as information indicating the date and time of issuance, setting change, and approval (issue date and time, change date and time, approval date and time). In the setting change instruction information shown in Figure 9, if the changer and change date and time are blank, it indicates that the setting change has not been performed, and if the approver and approval date and time are blank, it indicates that approval has not been performed.

[0043] Furthermore, when new setting change instruction information is stored in the instruction information storage unit 10b, the server 10 sends information to each device in the production line L, including the device subject to the setting change, indicating that the setting change instruction information has been issued. This notifies the outside that information that the setting change instruction information has been issued and information to identify the device subject to the setting change. In addition, once the setting change instruction information is sent, information indicating that the setting change instruction information has been issued becomes available on the touch panel 202 of at least the device subject to the setting change (such as the PTP machine 101).

[0044] The line configuration information storage unit 10c stores information about the components of each production line L, as well as the attributes of each production line L. The attributes of a production line L refer to matters that differ from a typical production line in terms of the contents 305 (tablets, capsules, etc.) handled. Examples of attributes include "hazardous chemicals" and "all-tablet management." "Hazardous chemicals" means that the production line manufactures PTP sheets using tablets that require careful handling. "All-tablet management" means that the production line requires appropriate management regarding the location of all tablets, etc.

[0045] The driver / assistant driver information storage unit 10d stores information about the driver and assistant driver who are primarily responsible for operating the equipment (such as the PTP machine 101). Unlike the assistant driver, the driver has authority over changes to assignments to the production line L and equipment, as well as changes to equipment settings.

[0046] The assignment information storage unit 10e stores information regarding the assignment of users (especially drivers and assistant drivers) to each production line L and piece of equipment.

[0047] The audit trail storage unit 10f stores information such as the operation details on PCs 11-14 and the touch panel 202, and setting changes on the control device 201, along with information to identify the user who performed the operation or setting change (user ID in this embodiment), as an audit trail. In this embodiment, when an operation is performed on PCs 11-14 or the touch panel 202, information such as the operation details and user ID is automatically sent from PCs 11-14 or the device (PTP machine 101, etc.) to the server 10, and this sent information is automatically stored in the audit trail storage unit 10f.

[0048] Furthermore, when the server 10 receives information from the touch panel 202 indicating that the setting change has been approved, it has the function to send this information to the device to which the setting change is to be made (such as the PTP machine 101). The setting change is reflected in the device only after the information indicating that the setting change has been approved is sent to the device.

[0049] PCs 11-14 are used for modifying and viewing information stored on server 10. PCs 11-14 are composed of computers with a CPU, ROM, RAM, and storage media. PCs 11-14 are also equipped with input means for inputting various types of information (e.g., keyboards) and display means for displaying various types of information (e.g., liquid crystal displays).

[0050] PC11 is a terminal that can be used by multiple users, specifically the system administrator. By logging into PC11, the system administrator can view the audit trail and modify the information stored in the account information storage unit 10a.

[0051] PC12 is a terminal that can be used exclusively by the production manager among multiple users. By logging into PC12, the production manager can view audit trails, information on drivers and driver assistants stored on server 10, and information on user assignments.

[0052] PC13 is a terminal that can only be used by maintenance personnel among multiple users. By logging into PC13, maintenance personnel can make changes to the configuration of equipment on production line L.

[0053] PC14 is a terminal that can be used only by quality managers among multiple users, and unlike the other PCs 11, 12, and 13, it has a function to issue setting change instruction information and a function to approve setting changes in devices (such as the PTP machine 101). PC14 is equipped with an audit trail viewing unit 14a, an audit trail registration unit 14b, an audit trail confirmation unit 14c, a setting viewing unit 14d, a login processing unit 14e, an instruction information issuing unit 14f, and a change approval unit 14g. In this embodiment, the instruction information issuing unit 14f corresponds to the "instruction information issuing means," and the change approval unit 14g corresponds to the "approval means."

[0054] The audit trail viewing unit 14a displays the audit trail stored in the audit trail storage unit 10f of the server 10 using the display means of the PC 14. However, the functions related to viewing, modifying, issuing, and approving information by each functional unit of the PC 14 are only available when login to the PC 14 is permitted.

[0055] The audit trail registration unit 14b sends information regarding logins and logouts to PC 14, as well as operations performed using PC 14, to the server 10 as an audit trail. In this embodiment, PCs 11, 12, and 13 are also provided with functional units similar to the audit trail viewing unit 14a and the audit trail registration unit 14b.

[0056] The audit trail verification unit 14c is a functional unit that records to the audit trail storage unit 10f of the server 10 that it has confirmed that the stored audit trail is correct.

[0057] The setting viewing unit 14d displays setting information stored in the control device 201 of the device (PTP machine 101, etc.) [production speed for each product type, temperature of the heating roll 101f1 (heater), pressure related to the formation of the pocket section 302 and the attachment of both films 303 and 304, inspection conditions (area threshold, defect threshold, binarization level, etc.)] on the display means of the PC 14.

[0058] The login processing unit 14e is responsible for the login process on PC 14. In the login process, the login processing unit 14e first determines whether the user is legitimate based on the user ID and password entered by the user into PC 14 and the user ID and password stored in the account information storage unit 10a.

[0059] More specifically, as shown in Figure 10, when the user inputs a user ID and password from the user (step S11), the login processing unit 14e sends the user ID, etc. to the server 10 and requests the server 10 to perform a determination process to determine whether the input user ID, etc. matches the user ID, etc. stored in the account information storage unit 10a, and to return the determination result. If the login processing unit 14e receives a reply indicating that the user ID, etc. matches, the login processing unit 14e determines that the user is legitimate (step S12; Yes). On the other hand, if the login processing unit 14e receives a reply indicating that the user ID, etc. does not match, the login processing unit 14e determines that the user is not legitimate (step S12; No).

[0060] Furthermore, if it is determined that the user is not legitimate, a message to that effect may be displayed. In addition, instead of requiring the input of a user ID and password, the system may read "identification information" stored on the ID card using a designated ID card information reader. Moreover, biometric information (such as iris scans or fingerprints) may be used instead of an ID and password.

[0061] Furthermore, if the login processing unit 14e determines that the user is legitimate, it will permit or deny login to the PC 14 based on the user's permission category stored in the account information storage unit 10a.

[0062] In other words, the login processing unit 14e sends the user ID of the user determined to be legitimate to the server 10 and requests the server 10 to reply with the permission category associated with the user ID. If the replied permission category is "3: Quality Administrator" (step S13; Yes), the login processing unit 14e permits login as a quality administrator (step S14). Once login to PC 14 is permitted, a menu screen for quality administrators is displayed on the display means of PC 14 (step S15). By using this menu screen, various operations can be performed on PC 14 within the scope of the quality administrator's privileges (for example, viewing audit trails, issuing setting change instruction information, approving setting changes, etc.).

[0063] On the other hand, if the returned permission category is not "3: Quality Administrator" (Step S13; No), the login processing unit 14e denies permission to log in to PC 14. Then, the login processing unit 14e displays on the display means of PC 14 that there is a mismatch between the permission category associated with the entered user ID and the permission category that PC 14 corresponds to (Step S16).

[0064] Furthermore, the login processing unit 14e includes an issuance / failure control unit 14e1 and an approval / failure control unit 14e2 (see Figure 1). In this embodiment, the issuance / failure control unit 14e1 corresponds to the "issuance / failure control means," and the approval / failure control unit 14e2 corresponds to the "approval / failure control means."

[0065] The issuance permission control unit 14e1 permits or denies the issuance of setting change instruction information using the instruction information issuance unit 14f based on the permission category (i.e., permission information) stored in the account information storage unit 10a. In this embodiment, if login to PC 14 is permitted by the login processing unit 14e, the issuance permission control unit 14e1 permits the issuance of setting change instruction information using the instruction information issuance unit 14f. This is because, if login to PC 14 is permitted, the user attempting to operate PC 14 is "3: Quality Manager" and can be said to have the appropriate authority to issue setting change instruction information. When the issuance of setting change instruction information is permitted (in this embodiment, when login to PC 14 is permitted), the quality manager's menu screen displays a button for issuing setting change instruction information, information to identify the device to be changed, and information indicating the target setting value (change value), etc., for inputting these.

[0066] On the other hand, if the login processing unit 14e denies permission to log in to PC 14, the issuance permission control unit 14e1 denies permission to issue setting change instruction information using the instruction information issuance unit 14f. This is because, if login to PC 14 is denied, the user attempting to operate PC 14 does not have the appropriate authority to issue setting change instruction information.

[0067] Furthermore, the issuance permission control unit 14e1 may have a function that prohibits the issuance of setting change instruction information related to the device while the device is in operation, but permits it while the device is stopped.

[0068] The approval / denial control unit 14e2 permits or denies approval using the change approval unit 14g based on the authority category (i.e., authority information) stored in the account information storage unit 10a. In this embodiment, if login to PC 14 is permitted by the login processing unit 14e, the approval / denial control unit 14e2 permits approval using the change approval unit 14g. This is because, when login to PC 14 is permitted, the user attempting to operate PC 14 is "3: Quality Administrator" and is considered to have the appropriate authority to approve setting changes. Furthermore, when a setting is changed (temporarily changed) by the setting change unit 202h, described later, while approval is permitted (in this embodiment, when logged into PC 14), a button to approve the setting change will be displayed on the quality administrator's menu screen.

[0069] Furthermore, in this embodiment, as described above, the authority category that allows the issuance of setting change instruction information using the instruction information issuance unit 14f in the issuance permission control unit 14e1, and the authority category that allows approval using the change approval unit 14g in the approval permission control unit 14e2, are both set to "3: Quality Manager". In other words, the authority category that allows the issuance of setting change instruction information using the instruction information issuance unit 14f in the issuance permission control unit 14e1, and the authority category that allows approval using the change approval unit 14g in the approval permission control unit 14e2 are set to be the same.

[0070] The instruction information issuing unit 14f is a functional unit for issuing setting change instruction information. In this embodiment, after logging into the PC 14, the quality manager enters the equipment to be changed and the target setting value on the menu screen displayed, and then operates the button for issuing setting change instruction information, causing the instruction information issuing unit 14f to issue the setting change instruction information. The setting change instruction information is issued when the production of a predetermined lot is completed in the production line including the equipment to be changed.

[0071] The issued configuration change instruction information is then sent to the server 10 and stored in the instruction information storage unit 10b. The configuration change instruction information includes the issuer and the date and time of issue. The PC 14 may also be equipped with a function to cancel the issued configuration change instruction information.

[0072] The change approval unit 14g is a functional unit that approves the changed setting items and reflects the changed setting items in the device (PTP machine 101, etc.). In this embodiment, when a setting item has been changed (provisionally changed) by the setting change unit 202h (described later) and login to PC 14 is permitted, the change approval unit 14g displays information on the quality manager's menu screen indicating that a setting change has been made (that it is awaiting approval), the contents of the setting change instruction information, the contents of the changed (provisionally changed) setting, and an approval button. For approval, the quality manager can compare the changed (provisionally changed) setting with the setting change instruction information by displaying the setting using the setting viewing unit 14d. When the quality manager operates the approval button and approves the setting change, the change approval unit 14g sends information that the setting change has been approved, the approver, and the approval date and time to the server 10. The approver and approval date and time sent to the server 10 are then added to the setting change instruction information and stored. Furthermore, as described above, upon approval of the configuration change, information indicating that the configuration change has been approved is sent from server 10 to the device subject to the configuration change, and the configuration change is reflected in that device.

[0073] The control device 201 stores various setting information (such as production speed for each product type and the temperature of the heating roll 101f1 (heater)) and operating programs, and controls the operation of the device (such as the PTP machine 101) based on this setting information and operating programs. When changing the settings of the device, the setting information stored in the control device 201 is changed.

[0074] Furthermore, when the instruction information issuing unit 14f issues a setting change instruction, the control device 201 notifies the outside of the device that a setting change instruction has been issued, as well as information to identify the device to which the setting change is to be made.

[0075] Furthermore, the control device 201 includes an operational / non-operational switching unit 201a (see Figure 5). In this embodiment, the operational / non-operational switching unit 201a corresponds to the "operational / non-operational switching means".

[0076] The operational status switching unit 201a switches the device (such as the PTP machine 101) to an operational or inoperable state. In this embodiment, from the time the instruction information issuing unit 14f issues setting change instruction information related to a setting change of a device (from the time the server 10 receives information that setting change instruction information has been issued) until the change approval unit 14g approves the setting change of the device, the operational status switching unit 201a of each device in the production line L including the device in question turns off the operation permission flag (see Figure 11). As a result, from the time the setting change instruction information is issued until the setting change is approved, each device in the production line L including the device subject to the setting change will be in an inoperable state. For example, when setting change instruction information related to a PTP machine 101 in a certain production line L is issued, the operational status switching unit 201a of each device constituting this production line L turns off the operation permission flag, so these devices become inoperable.

[0077] Furthermore, only the device subject to the setting change may be disabled. For example, if setting change instruction information is issued for a PTP machine 101 on a certain production line L, only that PTP machine 101 may be disabled.

[0078] On the other hand, when the change approval unit 14g approves a change in the settings of a device, the operational availability switching unit 201a of each device in the production line L, including the device in question, turns on the operational permission flag. As a result, each device in the production line L, including the device whose settings are being changed, returns to an operational state. For example, when a change in the settings of a certain PTP machine 101 is approved, the operational availability switching unit 201a of each device in the production line L, including the PTP machine 101, turns on the operational permission flag, thereby returning these devices to an operational state.

[0079] The touch panel 202 is equipped with various processing functions and functions for displaying and inputting information, and is used for operating and changing settings of a corresponding device (such as the PTP machine 101), and for checking various information. The touch panel 202 comprises a control unit having a CPU, ROM, RAM, and storage medium, and a panel unit for inputting information to the control unit and displaying information stored in the control unit. The control unit may be integrated with the control device 201.

[0080] The touch panel 202 is a terminal that can only be used by those who are authorized to operate the device (such as the PTP machine 101) among multiple users (manufacturers / distributors, maintenance personnel, production managers, drivers, and driver assistants). As shown in Figure 6, the touch panel 202 includes an audit trail registration unit 202b, an assignment viewing unit 202c, a setting viewing unit 202d, a driver information viewing unit 202e, a line configuration information viewing unit 202f, an operation unit 202g, a setting change unit 202h, an assignment change unit 202j, a driver information change unit 202k, a change eligibility switching unit 202m, and a login processing unit 202n. In this embodiment, the change eligibility switching unit 202m corresponds to the "change eligibility switching means".

[0081] The audit trail registration unit 202b functions similarly to the audit trail registration unit 14b in PC14.

[0082] The assignment viewing unit 202c displays on the touch panel 202 information regarding the assignment of users (especially drivers and assistant drivers) to each production line L and piece of equipment (such as the PTP machine 101), which is stored in the assignment information storage unit 10e of the server 10. However, each function of the touch panel 202, such as viewing and changing information, is only available when login to the touch panel 202 is permitted. In particular, changing the settings of the equipment by the setting change unit 202h is only possible when login to the touch panel 202 is permitted, and furthermore, when the user who has been granted permission to log in has a predetermined permission category (permission information) (in this embodiment, when the user is "5: Driver" or "4: Production Manager").

[0083] The settings viewing unit 202d functions similarly to the settings viewing unit 14d of the PC 14. That is, the settings viewing unit 202d displays the settings information (such as production speed for each product type) stored in the control unit 201 of the device (such as the PTP machine 101) on the touch panel 202.

[0084] The driver information viewing unit 202e displays information about the driver and driver assistant stored in the driver / driver assistant information storage unit 10d of the server 10 on the touch panel 202.

[0085] The line configuration information viewing unit 202f displays information about the components of production line L and the attributes of production line L, which are stored in the line configuration information storage unit 10c of server 10, on the touch panel 202.

[0086] The operation unit 202g is a functional unit for operating devices (such as the PTP machine 101) that correspond to the touch panel 202. However, the devices can only be operated using the touch panel 202 that corresponds to those devices.

[0087] The setting change unit 202h is a functional unit for changing the setting items (setting information stored in the control device 201) in the device. However, setting changes in the device can only be performed using the touch panel 202 corresponding to that device. For example, setting changes in PTP machine 101 can only be performed using the touch panel 202 corresponding to that PTP machine 101, and cannot be performed using the touch panel 202 corresponding to other PTP machines 101 or the integrator 102. Furthermore, as described above, setting changes in the device are only possible if the user authorized to log in to the touch panel 202 has a predetermined permission category (permission information) (in this embodiment, if the user is "5: Driver" or "4: Production Manager"). In addition, setting changes in the device are only possible if the setting item change is permitted by the change permission switching unit 202m.

[0088] In this embodiment, when setting change instruction information is issued and login to the touch panel 202 is permitted as a driver or production manager, the setting change unit 202h displays on the driver or production manager menu screen (described later) that setting change instruction information has been issued and a button to start setting changes. When the driver or production manager operates the button to start setting changes, the setting change unit 202h displays on the touch panel 202 a screen showing the contents of the setting change instruction information and a screen for setting changes side by side (for example, side by side). This allows the user (driver or production manager) to change settings on the setting change screen while referring to the setting change instruction information.

[0089] Then, after the device settings have been changed (provisionally), the user operates the designated completion button, and the person who made the change and the date and time of the change are sent to the server 10. The person who made the change and the date and time of the change sent to the server 10 are added to the setting change instruction information in the instruction information storage unit 10b. Furthermore, after the device settings have been changed (provisionally), when the completion button is operated, information that the setting change has been made (that approval of the setting change is awaited) is sent from the touch panel 202 to the PC 14 via the server 10.

[0090] The assignment change unit 202j is a functional unit for changing the user's assignment information for each production line L and piece of equipment, which is stored in the assignment information storage unit 10e of the server 10.

[0091] The driver information modification unit 202k is a functional unit for modifying information about the driver and driver assistant stored in the driver / driver assistant information storage unit 10d of the server 10.

[0092] The changeability switching unit 202m sets the device's settings to either a changeable or unchangeable state. From the time the instruction information issuing unit 14f issues setting change instruction information related to changing the device's settings (from the time the server 10 receives information that setting change instruction information has been issued) until the change approval unit 14g approves the setting change of the device, the changeability switching unit 202m of the device turns on the setting change permission flag (see Figure 11). As a result, from the time the setting change instruction information is issued until the setting change is approved, the device subject to the setting change is in a changeable state. For example, when setting change instruction information for a certain PTP machine 101 is issued, the changeability switching unit 202m of the PTP machine 101 turns on the setting change permission flag, making it possible to change the settings of the PTP machine 101.

[0093] On the other hand, when the change approval unit 14g approves a change in the device's settings, the change permission switch unit 202m of the device turns off the setting change permission flag. As a result, the device returns to a state where setting changes are not possible. For example, when a setting change for a certain PTP machine 101 is approved, the change permission switch unit 202m of the PTP machine 101 turns off the setting change permission flag, and the PTP machine 101 returns to a state where setting changes are not possible.

[0094] Furthermore, the changeability switching unit 202m may switch only the setting item that is subject to change to a changeable state or a changeable state. For example, if the setting change instruction information for a certain PTP machine 101 instructs a change in the temperature (seal temperature) of the heating roll 101f1, the changeability switching unit 202m may switch only the seal temperature to a changeable state or a changeable state.

[0095] The login processing unit 202n is responsible for the login process on the touch panel 202. In the login process, the login processing unit 202n first determines whether the user is legitimate based on the user ID and password entered by the user on the touch panel 202 and the user ID and password stored in the account information storage unit 10a.

[0096] More specifically, as shown in Figure 12, when the user inputs a user ID and password from the user (step S21), the login processing unit 202n sends the user ID, etc. to the server 10 and requests the server 10 to perform a determination process to determine whether the input user ID, etc. matches the user ID, etc. stored in the account information storage unit 10a, and to return the determination result. If the login processing unit 202n receives a reply indicating that the user ID, etc. matches, the login processing unit 202n determines that the user is legitimate (step S22; Yes). On the other hand, if the login processing unit 202n receives a reply indicating that the user ID, etc. does not match, the login processing unit 202n determines that the user is not legitimate (step S22; No).

[0097] Furthermore, if the login processing unit 202n determines that the user is legitimate, it will allow or deny login to the touch panel 202 based on the user's permission category stored in the account information storage unit 10a.

[0098] More specifically, the login processing unit 202n checks the user's permission category stored in the account information storage unit 10a (step S23), and if the permission category returned from the server 10 is "0: Manufacturer / Distributor", "2: Maintenance Person", or "6: Driver Assistant", it grants permission to log in to the touch panel 202 as a manufacturer / distributor, maintenance person, or driver assistant (step S24). Once login is permitted, the touch panel 202 displays a menu screen for manufacturers / distributors, maintenance persons, or driver assistants (step S25). This allows various operations on the touch panel 202 within the scope of the manufacturer / distributor, maintenance person, or driver assistant's permission.

[0099] Furthermore, if the authorization category returned from the server 10 is "5: Driver" or "4: Production Manager", the login processing unit 202n grants permission to log in to the touch panel 202 as a driver or production manager (step S26). Once login is permitted, a menu screen for the driver or production manager is displayed on the touch panel 202 (step S27). This allows various operations on the touch panel 202 to be performed within the authority granted to the driver or production manager. In addition, logging in as a driver or production manager enables the setting change unit 202h to change the device settings when setting change instruction information is issued.

[0100] On the other hand, if the returned authorization category is not one of "0: Manufacturer / Seller", "2: Maintenance", "4: Production Manager", "5: Driver", or "6: Driver Assistant" (Step S23; No), the login processing unit 202n denies login to the touch panel 202. Then, the login processing unit 202n displays on the touch panel 202 that there is a mismatch between the authorization category associated with the entered user ID and the authorization category that the touch panel 202 corresponds to (Step S28).

[0101] Furthermore, the login processing unit 202n includes a changeability control unit 202n1 (see Figure 6). In this embodiment, the changeability control unit 202n1 corresponds to the "changeability control means".

[0102] The change permission control unit 202n1 permits or denies changes to setting items using the setting change unit 202h based on the permission category (i.e., permission information) stored in the account information storage unit 10a. In this embodiment, if login to the touch panel is permitted by the login processing unit 202n, and the permission category of the user permitted to log in is "5: Driver" or "4: Production Manager", the change permission control unit 202n1 permits changes to setting items using the setting change unit 202h. Once changes to setting items are permitted, the change permission control unit 202n1 makes it possible to display on the menu screen for the driver or production manager that setting change instruction information has been issued and a button to start changing the setting.

[0103] On the other hand, if the login processing unit 202n denies login to the touch panel 202, or if the permission category of the user who is allowed to log in is "0: Manufacturer / Distributor", "2: Maintenance Person", or "6: Driver Assistant", the change permission control unit 202n1 denies the ability to change setting items using the setting change unit 202h. If setting item changes are denied, information indicating that setting change instruction information has been issued, as well as buttons for starting setting changes, will not be displayed on the menu screen.

[0104] In this embodiment, as described above, the authority categories that allow the change permission control unit 202n1 to change setting items using the setting change unit 202h are "5: Driver" and "4: Production Manager," while the authority category that allows the issuance of setting change instruction information using the instruction information issuance unit 14f in the issuance permission control unit 14e1 is "3: Quality Manager." In other words, the authority categories that allow the change permission control unit 202n1 to change setting items using the setting change unit 202h and the authority categories that allow the issuance of setting change instruction information using the instruction information issuance unit 14f in the issuance permission control unit 14e1 are set to be different.

[0105] The setting change process in the setting change management system 1 described above is as follows. As shown in Figure 11, first, in step S1, when each device in the production line, including the device to be changed, is stopped (when production of a predetermined lot has been completed), the quality manager who has logged into PC 14 performs a predetermined operation, and the instruction information issuing unit 14f issues setting change instruction information. As a result, the operation permission flag is switched from on to off, and the device to be changed becomes inoperable. On the other hand, the setting change permission flag is switched from off to on, and setting changes become possible on the target device. Furthermore, the setting change instruction information is stored in the server 10, and information that setting change instruction information has been issued and the contents of the setting change instruction information can be displayed on the touch panel 202 of the target device.

[0106] Next, in step S2, the operator or production manager who has logged into the touch panel 202 of the target device changes the settings (temporarily changes) of the device based on the issued setting change instruction information. As a result, the person who made the change and the date and time of the change are added to the setting change instruction information of the server 10, and information that the setting change has been made (that approval of the setting change is awaited) is sent to the PC 14.

[0107] Finally, in step S3, the quality manager logged into PC14 approves the configuration change, and the change is reflected in the device. Upon approval, the operation permission flag is switched from off to on, and the device subject to the configuration change returns to an operational state. On the other hand, the configuration change permission flag is switched from on to off, and the device returns to a state where configuration changes are not possible. Furthermore, the approver and the date and time of approval are added to the configuration change instruction information on server 10.

[0108] As detailed above, according to this embodiment, when a setting change instruction is issued, the device becomes inoperable, and once approval is given to reflect the setting change, the device returns to an operational state. Therefore, once a setting change instruction is issued, that is, once a setting change is required, the device cannot be operated without approval, and only after approval is given and the setting change is reflected does the device become operational. This makes it possible to more reliably prevent the device from being operated before the setting change is reflected, which could lead to manufacturing or inspection being carried out under inappropriate conditions. This makes it possible to more reliably prevent problems such as the manufacture of products of unexpected quality or a decrease in inspection accuracy.

[0109] Furthermore, in this embodiment, the setting item in the device can only be changed between the issuance of the setting change instruction information and the approval of the setting change, that is, only when the device is inoperable. Therefore, accidental setting changes while the device is operating can be prevented more reliably. In addition, since setting changes cannot be made when the setting change instruction information has not been issued, unnecessary setting changes can be prevented. As a result, problems such as the manufacture of products of unexpected quality or a decrease in inspection accuracy can be prevented more reliably.

[0110] In general, products from the "same lot" are required to be manufactured in a manner that ensures homogeneity, and this requirement is particularly strict in the pharmaceutical field. In this regard, this embodiment prevents accidental changes to settings while the device is in operation (i.e., while manufacturing products from the same lot), thus more reliably satisfying the requirement that products be manufactured in a manner that ensures homogeneity.

[0111] Furthermore, the authority categories that allow changes to setting items using the setting change unit 202h in the change permission control unit 202n1 and the authority categories that allow the issuance of setting change instruction information using the instruction information issuance unit 14f in the issuance permission control unit 14e1 are different. Therefore, as in this embodiment, only quality managers can issue setting change instruction information, while only operators and production managers responsible for operating the equipment can change the settings. This allows for checking the content of setting changes from different perspectives, making it possible to more reliably prevent errors in setting change instruction information.

[0112] In addition, the authorization category that allows the issuance of setting change instruction information using the instruction information issuance unit 14f in the issuance permission control unit 14e1 and the authorization category that allows approval using the change approval unit 14g in the approval permission control unit 14e2 are the same. Since a user with the same authorization category (in this embodiment, the quality manager) issues setting change instruction information and approves setting changes based on this information, the user can more effectively verify whether there are any errors in the content of the setting change instruction information and whether the setting changes have been made appropriately during the approval process. This makes it possible to more reliably prevent setting changes with incorrect content. Furthermore, it makes it possible to more reliably prevent setting changes that are not based on setting change information.

[0113] Furthermore, the embodiment is not limited to the description above, and may be implemented as follows, for example. Of course, other applications and modifications not exemplified below are also possible.

[0114] (a) In the above embodiment, a PC 12 for the production manager, a PC 13 for the maintenance staff, and a PC 14 for the quality manager are provided, but one PC may be configured to be shared by the production manager, maintenance staff, and quality manager. In this case, if the permission category of the user attempting to log in is "2: Maintenance Staff", the user may be allowed to log in to the PC as a maintenance staff member, and the maintenance staff menu screen may be displayed on the PC. Also, if the permission category of the user attempting to log in is "4: Production Manager", the user may be allowed to log in to the PC as a production manager, and the production manager menu screen may be displayed on the PC. Furthermore, if the permission category of the user attempting to log in is "3: Quality Manager", the user may be allowed to log in to the PC as a quality manager, and the quality manager menu screen may be displayed on the PC.

[0115] (b) In the above embodiment, the login process on PCs 11-14 and touch panel 202 is performed on PCs 11-14 and touch panel 202, but the login process may be performed on server 10.

[0116] (c) In the above embodiment, the manufacturing equipment 100 performs both the manufacturing and packaging of the PTP sheet 301, but it may also perform only one of the two: the manufacturing or packaging of the PTP sheet 301.

[0117] (d) The components of each production line L in the above embodiment are examples, and the components may be changed as appropriate. For example, one production line L may be equipped only with a PTP machine 101.

[0118] (e) In the above embodiment, a PTP sheet 301 is given as the medicine, but the medicine is not limited to a PTP sheet. Medicines include, for example, tablets, capsules, powders, granules, oral solutions, ointments, and containers containing these. Furthermore, the present technical concept may also be applied to equipment for manufacturing or packaging products other than medicines (e.g., food).

[0119] (f) In the above embodiment, the PTP machine 101 corresponds to the "device," but the components of the PTP machine 101 (for example, the preheating device 101a and the sealing device 101f) may each correspond to the "device." In this case, a control device 201 and a touch panel 202 may be provided for each component. [Explanation of Symbols]

[0120] 1...Setting change management system, 14e1...Issuance feasibility control unit (issuance feasibility control means), 14e2...Approval feasibility control unit (approval feasibility control means), 14f...Instruction information issuance unit (instruction information issuance means), 14g...Change approval unit (approval means), 101...PTP machine (device), 102...Stacking machine (device), 103...Banding machine (device), 104...Pillow machine (device), 105...Boxing machine (device), 201a...Operation feasibility switching unit (operation feasibility switching means), 202...Touch panel (setting change means), 202m...Change feasibility switching unit (change feasibility switching means), 202n1...Change feasibility control unit (change feasibility control means).

Claims

1. A configuration change management system applicable to a device having configurable settings, An instruction information issuing means capable of issuing instruction information indicating at least the setting item to be changed and the details of the changes in said setting item, A setting change means that can change the setting items in the device based on the setting change instruction information, An operational status switching means capable of setting the aforementioned device to an operational state or an operational state, The system includes an approval means that allows the modified setting to be reflected in the device by approving the modified setting, The operational status switching means is configured to keep the device in an inoperable state from the time the instruction information issuing means issues the setting change instruction information relating to the setting change of the device until the approval means approves the setting change of the device, and to make the device operational once the approval means approves the setting change of the device. The device is equipped with a changeability switching means that can change the setting items in the device to a state where they can be changed or a state where they cannot be changed. The setting change management system is characterized in that the changeability switching means is configured to allow the setting item in the device to be changed from the time the instruction information issuing means issues the setting change instruction information relating to the setting change of the device until the approval means approves the setting change of the device, and then, once the approval means approves the setting change of the device, it is configured to make the setting item in the device unchangeable.

2. A change permission control means that, based on the user's permission information, permits or disapproves changes to setting items using the setting change means, The system includes an issuance permission control means that, based on the aforementioned authorization information, permits or dispermits the issuance of the setting change instruction information using the instruction information issuance means, The setting change management system according to claim 1, characterized in that the authorization information that allows the setting item to be changed using the setting change means in the change permission control means and the authorization information that allows the setting change instruction information to be issued using the instruction information issuance means in the issuance permission control means are set to be different.

3. Based on the user's authority information, an issuance permission control means allows or disallows the issuance of the setting change instruction information using the instruction information issuance means, The system includes an approval / denial control means that, based on the aforementioned authority information, permits or denies approval using the aforementioned approval means, The setting change management system according to claim 1, characterized in that the authorization information that permits the issuance of the setting change instruction information using the instruction information issuance means in the issuance permission control means and the authorization information that permits approval using the approval means in the approval permission control means are set to be the same.

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