JP7394258B1 - Audit trail management system - Google Patents

Abstract

[Problem] Verify the validity of an audit trail based on the positional relationship between the location of a processing device and the location of an input device that performs an operation to advance a step in a control program in a manufacturing facility for pharmaceuticals, beverages, or foods. Provides an audit trail management system that allows [Solution] A PLC 10 is capable of advancing the step of a control program to the next step by an operation via a touch panel 20 by a worker, and an audit trail recording unit 40 is configured to display a touch panel in which an operation for proceeding to the next step is input. The validity verification unit 50 records the first position information representing the position of the tank 20 and the second position information representing the position of the processing device such as the tank 2 that was the control target in the previous step as an audit trail. If the position of the operated touch panel 20 and the position of the tank 2 are within a predetermined range from the first position information and second position information included in the trail, it is determined that the audit trail is valid. [Selection diagram] Figure 2

Description

The present invention relates to an audit trail management system that can manage the validity of audit trails in facilities that manufacture pharmaceuticals, beverages, or foods.

Facilities for manufacturing pharmaceuticals are equipped with processing devices for various processing purposes, sensors for acquiring operational data of the processing devices, and control devices for controlling the processing devices. By executing a control program, the control device operates various processing devices and manufactures the desired pharmaceutical product.

The control program consists of a plurality of steps for implementing the manufacturing process, and some of these steps are advanced to the next step by an operator's operation. For example, the control program progresses each step for realizing the raw material charging process and the stirring process as follows.
Raw material input process Step 1: Information indicating that raw materials are to be input into a tank (an example of a processing device) is displayed on an input/output device such as a touch panel.
Raw material input process Step 2: Display GUI components such as buttons to be pressed by the worker on the input/output device when the worker actually finishes inputting the raw materials.
Raw material input process Step 3: When the operator presses the button, the raw material input process is completed and the process proceeds to the next stirring process.

In facilities where such steps are performed, operational data of the processing equipment and work data representing the execution status of each step are recorded. Operation data and work data are called audit trails. The audit trail proves that there is no falsification or unauthorized manipulation of drug-related data during the manufacturing steps of the drug.

The control device and the touch panel can be connected to each other via a network. For reasons such as equipment configuration or maintenance work, the above-mentioned 2 input may be made possible not only from a touch panel placed near the processing device but also from a touch panel placed far away. In equipment that uses such control devices, touch panels, etc., if a worker performs the task of putting raw materials into a tank located on the first floor, and then performs the above-mentioned operation 2 on the touch panel located on the second floor. do. In this case, even if there is no problem with the quality of the product, it may be considered that the work deviates from the established standard work (hereinafter referred to as standard work) and that the work is not carried out appropriately.

Situations such as this, where the manufacturing process appears to be progressing normally but deviates from standard work, must be understood from the perspective of manufacturing management. Conventionally, management systems have been proposed that verify whether or not work is being performed appropriately, in other words, whether the audit trail that records the work is valid (see Patent Document 1). The validity of the audit trail was not verified in consideration of the positional relationship between the location of the processing device and the location of the touch panel where operations are performed to advance the steps of the control program.

Japanese Patent Application Publication No. 2020-194452

In view of these circumstances, the present invention is based on the positional relationship between the location of a processing device and the location of an input device where an operation for advancing the steps of a control program is performed in a manufacturing facility for pharmaceuticals, beverages, or foods. The purpose of this invention is to provide an audit trail management system that can verify the validity of an audit trail.

A mode for achieving the above object includes a processing device that manufactures medicines, drinks, or foods, a control device that controls the processing device by executing a control program consisting of multiple steps, and a control device that controls the processing device by executing a control program consisting of a plurality of steps. An audit trail management system comprising an input device capable of inputting data, an audit trail recording means for recording an audit trail, and a validity verification means for verifying the validity of the audit trail, wherein the control device The step of the control program can be advanced to the next step by a person's operation via the input device, and the audit trail recording means can advance the step to the next step by the operation after one step (hereinafter referred to as the previous step) is completed. Before executing the next step (hereinafter referred to as next step), first position information representing the position of the processing device that was the control target in the previous step and an operation for proceeding to the next step are input. second position information representing the position of the input device is recorded as an audit trail, and the validity verification means determines whether the operation The audit trail management system is characterized in that if the position of the input device and the position of the processing device are within a predetermined range, the audit trail is determined to be valid.

According to the present invention, in a pharmaceutical, beverage, or food manufacturing facility, the validity of an audit trail is determined based on the positional relationship between the location of a processing device and the location of an input device that is scanned to advance a step of a control program. An audit trail management system that can verify the audit trail is provided.

1 is a schematic configuration diagram of an audit trail management system. FIG. 2 is a block diagram showing the functions of an audit trail management system. FIG. 3 is a diagram showing an example of a control program. FIG. 2 is a diagram showing an example of an audit trail. FIG. 2 is a diagram showing an example of an audit trail.

FIG. 1 is a schematic configuration diagram of an audit trail management system 1. As shown in FIG. The management system 1 of this embodiment is aimed at equipment that manufactures pharmaceuticals. The facility consists of various processing equipment for manufacturing pharmaceuticals and a measuring device that measures operational data from the processing equipment.

The tank 2 is a device to which raw materials are supplied from the input port of the tank 2 and stores the raw materials therein. The tank 2 is provided with or connected to various devices such as a stirring device 3, a cooling device 4, a liquid feeding device 5, and a cleaning device 6. These tank 2, stirring device 3, cooling device 4, cleaning device 6, and liquid feeding device 5 are examples of processing devices, and are collectively referred to as processing devices 2 to 6.

The stirring device 3 rotates a screw disposed inside the tank 2 to stir the raw material. The stirring device 3 is given a control signal from the PLC 10, such as the rotational speed and rotation time of the screw when stirring the raw material inside the tank 2. The stirring device 3 is configured to receive the control signal and stir the raw material in the tank 2 at the set rotation speed and rotation time. Further, information from the stirring device 3, such as the actual number of rotations and the elapsed time since the start of rotation, is transmitted to the PLC 10, and the PLC 10 can read the information.

The cooling device 4 is a device for cooling the temperature of the raw material stored inside the tank 2. The cooling device 4 cools the raw material to a temperature given by the PLC.

The liquid transfer device 5 is a device for transferring the raw material stored in the tank 2 to another processing device (not shown). For example, they are a pump that supplies compressed air into the tank 2, a valve provided in a pipe through which the air flows, and the like. The pump output, the opening degree of the valve, and the like are given to the liquid feeding device 5 as control signals from the PLC 10 . The liquid feeding device 5 is configured to receive the control signal, operate the pump at a set output, and open the valve at a set opening.

The cleaning device 6 performs an operation of supplying water or cleaning liquid to the tank 2 to clean the tank 2 and various devices such as piping connected thereto. The cleaning device 6 is given control signals from the PLC 10, such as the amount of water or cleaning liquid to be supplied to the tank 2, and the cleaning time. The cleaning device 6 is configured to receive the control signal and clean the inside of the tank 2 with a set amount of water for a set cleaning time. Further, information from the cleaning device 6, such as the amount of water or cleaning liquid, and the elapsed time since the start of cleaning, is transmitted to the PLC 10, and the PLC 10 can read the information.

The temperature sensor 7 and the measuring instrument 8 are examples of measuring devices, and these are collectively referred to as measuring devices 7 and 8. The temperature sensor 7 operates to measure the temperature of the raw material stored inside the tank 2. That is, it is configured to measure the temperature of the raw material inside the tank 2 and transmit the temperature to the PLC 10. Moreover, the measuring device 8 performs an operation of measuring the raw material stored therein. That is, it is configured to measure the weight of the raw material inside the tank 2 and transmit the weight to the PLC 10.

The raw materials are mixed in the tank 2 by the operation of these processing devices 2 to 6, and the raw materials are subjected to predetermined processing in other processing devices (not particularly shown), so that pharmaceuticals are manufactured using the entire facility. It has become.

As shown in FIG. 2, the management system 1 includes a PLC 10 and a touch panel 20 as control devices for equipment equipped with such processing devices 2 to 6 and various measuring devices 7 to 8.

PLC10 is a device also called a programmable controller or a sequencer. The PLC 10 includes a CPU 11 and a memory 12, and controls the processing devices 2 to 6 by reading and executing a control program stored in the memory. The control program reads setting values for controlling the processing devices 2 to 6 from the memory and controls the processing devices 2 to 6 to operate with the set values.

The touch panel 20 is connected to the PLC 10, displays a predetermined screen, and detects an operation by an operator. Specifically, the touch panel 20 includes a CPU 21, an input/output section 22, and a memory 23. The touch panel 20 can be connected to the PLC 10 via a network.

The management system 1 of this embodiment includes two touch panels 20A and 20B. If these are not distinguished, they will be referred to as the touch panel 20. It is assumed that the touch panel 20A is placed near the tank 2, and the touch panel 20B is placed far away from the tank 2. Of course, the number of touch panels 20 is not limited to two, and the management system 1 may include two or more touch panels 20, and the arrangement of the touch panels 20 is not limited.

The touch panel 20 is capable of transmitting and receiving data to and from the PLC 10 via a network. It is possible to display a screen on each touch panel 20 from the PLC 10, and data on the operation of GUI components such as buttons, and characters and numbers generated by operating the GUI components are also transmitted from each touch panel 20 to the PLC 10. It is possible to send data such as

Specifically, the input/output unit 22 includes a display device and a detection mechanism for detecting an operation that touches the surface of the display device. As the display device, a known display device such as a liquid crystal panel or an organic EL device can be used. Further, as the detection mechanism, a known one such as a resistive film type or a capacitance type can be used.

A program for operating the touch panel 20 is stored in the memory 23, and the CPU 21 calls this program from the memory 23 and executes it. Moreover, the touch panel 20 can read and write the memory 12 of the PLC 10. Therefore, the program of the touch panel 20 can display the setting values stored in the PLC 10 on the input/output unit 22 or write new setting values changed based on the operation of the input/output unit 22 to the memory 12 of the PLC 10. is possible.

Further, in the PLC 10, a control program 30, an audit trail recording section 40, a validity verification section 50, and an audit trail 60 are stored in the memory 12.

FIG. 3 shows an example of a control program. The control program 30 is a program for operating the processing devices 2 to 6 to manufacture products. The control program 30 is written in a language such as ladder circuit. The control program 30 includes a plurality of steps and is executed sequentially, but some of the steps can be advanced to the next step by an operation performed on the touch panel 20 by an operator. The step in which the process proceeds to the next step if there is such an operation by the worker is called a confirmation step.

Steps [1] to [3] are steps for realizing one manufacturing process called "raw material input process."
Step [1]: Display information on the touch panel 20 to prompt input of raw materials. The worker looks at the information and actually puts the raw material into tank 2.

Step [2]: This is a step of confirming the weight of the raw material put into the tank 2. Specifically, the control program 30 displays on the touch panel 20 a screen on which the weight of the raw material put into the tank 2 obtained by the weighing device 8 and a button to be pressed if the weight is within the specified range are arranged. . When the button is pressed by the worker, the control program 30 proceeds to the next step [3]. Step [2] is one of the confirmation steps to proceed to the next step [3] if the operator performs an operation.

Step [3]: This is a step to confirm that the raw material input has been completed. Specifically, the control program 30 displays on the touch panel 20 a screen with buttons to be pressed once the raw material input is complete. When the button is pressed by the worker, the control program 30 proceeds to the next step [4]. Step [3] is one of the confirmation steps.

Steps [4] to [6] are steps for realizing one manufacturing process called "stirring process".

Step [4]: This is a step for confirming setting values related to stirring, such as the rotational speed (rpm) of the stirring device 3 and stirring time. Specifically, a screen is displayed on the touch panel 20 on which setting values related to stirring, buttons to be pressed if the setting values are as specified, and the like are arranged. When the button is pressed by the worker, the control program 30 proceeds to the next step [4]. Step [4] is one of the confirmation steps to proceed to the next step [5] if the operator performs an operation.

Step [5]: This is a step in which the stirring device 3 stirs the inside of the tank 2. Specifically, the stirring device 3 is operated by executing a predetermined command based on the set value.

Step [6]: This is a step to confirm that stirring is completed. Specifically, the control program 30 displays on the touch panel 20 a screen with buttons to be pressed once stirring is complete. The worker visually checks the state of the raw materials after stirring and presses the button. When the button is pressed by the worker, the control program 30 proceeds to the next step [7]. Step [6] is one of the confirmation steps.

Steps [7] to [8] are steps for realizing one manufacturing process called a "cooling process."
Step [7]: This is a step in which the cooling device 4 cools the raw material in the tank 2 to a predetermined temperature. Specifically, the cooling device 4 is operated by executing a predetermined command based on the set value.

Step [8]: This is a step to determine that cooling has been completed. Specifically, the control program 30 determines that cooling has been completed when a predetermined condition is satisfied after starting cooling. The predetermined condition is, for example, the time since the start of cooling, or whether the temperature of the raw material in the tank 2 measured by the temperature sensor 7 has reached a predetermined temperature. When cooling is completed, proceed to the next step [9]. Such a step is not a confirmation step because the process proceeds to the next step without depending on the operator's operation on the touch panel 20.

Steps [9] to [10] are steps for realizing one manufacturing process called a "transfer process."

Step [9]: This is a step of controlling the liquid feeding device 5 in order to transfer the raw material in the tank 2 to another processing device.

Step [10]: This is a step of determining that the transfer is completed. Specifically, the control program 30 determines that the transfer is completed when a predetermined condition is satisfied after the transfer is started. The predetermined condition is, for example, the time since the start of the transfer, or whether the weight of the raw material in the tank 2 as measured by the measuring device 8 has become zero. When the transfer is completed, proceed to the next step [11]. Such a step is not a confirmation step because the process proceeds to the next step without depending on the operator's operation on the touch panel 20.

Steps [11] and [12] are steps for realizing one manufacturing process called a "cleaning process."

Step [11]: This is a step of controlling the cleaning device 6 that cleans the inside of the tank 2.

Step [12]: This is a step to determine that cleaning is completed. Specifically, the control program 30 determines that the cleaning is completed when a predetermined condition is satisfied after the cleaning is started. The predetermined condition is, for example, the time since the start of cleaning. When the cleaning is completed, a series of manufacturing steps in the tank 2 are completed.

The audit trail recording unit 40 records operational data and work data in the memory 12 as an audit trail. Specifically, the audit trail recording unit 40 is a program executed by the PLC 10, which obtains operational data from the measuring devices 7 to 8, records it in the memory 12 together with the obtained time, and records the work performed by the worker. This is to record data in the memory 12.

The operational data is data obtained from the measuring devices 7 to 8. When the PLC 10 executes the above-mentioned control program, the processing devices 2 to 6 operate to manufacture pharmaceuticals. During this time, the measuring devices 7 to 8 receive operational data such as the weight and temperature of the raw materials in the tank 2. obtained as.

The work data is data representing the execution status of steps constituting the manufacturing process. Specifically, the work data includes date and time, data for specifying the processing device, and data representing executed steps. Furthermore, for steps that require operator operations, the work data also includes data identifying the worker who performed the work and data identifying the touch panel 20 that the worker operated in order to proceed to the next step. .

The data for specifying the processing device (hereinafter referred to as first specifying data) is an ID, name, etc. for specifying the processing device, and is further associated with first position information indicating the location of the processing device.

The data for specifying the touch panel 20 (hereinafter referred to as second specifying data) is an ID, a name, etc. for specifying the touch panel 20, and is further associated with second position information indicating the position of the touch panel 20. Table 1 shows an example of the association between the first specific data/second specific data and the first location information/second location information.

For example, the first specific data is the name "Tank 2" and is associated with "1st floor" as the first position information. The second specific data has the names "touch panel 20A" and "touch panel 20B", and is associated with "1st floor - in front of tank 2" and "2nd floor - control room" as second position information. Associated data such as Table 1 is recorded in the memory 12 in advance.

Although the audit trail recording unit 40 of this embodiment is executed by the PLC 10 and records the audit trail in the memory 12 of the PLC 10, the present invention is not limited to this embodiment. For example, instead of recording the audit trail in the memory 12, it may be transmitted to a general personal computer or the like via a communication means, and the audit trail may be recorded on that personal computer. In addition, the audit trail recording unit 40 is a general personal computer, and uses a communication means to obtain operational data from the measuring devices 7 to 8, obtain work data from the PLC 10, and audit them. It may also be configured to record as a trail.

Figure 4 shows an example of work data in the audit trail. Each row represents work data that is an audit trail. The audit trail on the Nth line is expressed as audit trail [N].

Audit trails [1], [5], [7] to [12] contain work data including the fact that steps 1, 5, and steps 7 to 12 were executed by the PLC 10, and the date and time when the steps were completed. This indicates that it has been recorded as an audit trail.

Audit trail [2] represents work data related to step 2. After worker A inputs the raw materials, he checks the weight of the raw materials in the tank 2, and when he performs an operation to confirm the weight on the touch panel 20A, the process proceeds from step 2 to step 3. Steps 2 and 3 correspond to "previous step" and "next step" in the claims, respectively. The audit trail recording unit 40 records the "worker A" who inputs the raw materials. "Worker A" is an example of information that identifies a worker, and is information obtained by authenticating the worker prior to operating the touch panel 20A.

Further, the audit trail recording unit 40
・“Tank 2” which was the control target in step 2 (previous step) as the first specific data
・“1st floor” which is the first location information corresponding to the first specific data
・"Touch panel 20A" where an operation (such as pressing a button displayed on touch panel 20A) to proceed to step 3 (next step) was performed as second specific data
・Second location information corresponding to the second specific data “1st floor – in front of the tank”
are recorded as an audit trail (work data).

Note that the first specific data can be obtained by previously recording in the memory 12 in association with each step and the processing device to be controlled by the step, and by referring to the record. Moreover, since the data indicating that the worker performed an operation on the touch panel 20A is sent from the touch panel 20A to the PLC 10, the PLC 10 can use the "touch panel 20A" as the transmission source as the second specific data.

In this way, the audit trail [2] shows that "Worker A" performed work on "Tank 2" (adding raw materials, checking weight) and performed an operation on "Touch panel 20A" to proceed to the next step 3. It represents what you have done. The same applies to audit trails [3], [4], and [6].

Audit trail [3] represents work data related to step 3. When the worker A performs an operation on the touch panel 20A indicating that the input of raw materials has been completed, the process proceeds from step 3 to step 4. At this time, the audit trail recording unit 40 records "Worker A" who inputted the raw materials. In addition, the audit trail recording unit 40 records "tank 2", which is the object that worker A worked on, as first specific data, and records "touch panel 20A" on which the operation of confirming the weight was performed as second specific data. Record as. In other words, the audit trail [3] shows that "Worker A" performed work on "Tank 2" (completion of raw material input) and performed an operation on "Touch panel 20A" to proceed to the next step 4. represents.

Audit trail [4] represents work data related to step 4. When the worker A performs an operation on the touch panel 20A to confirm the set value for stirring, the process proceeds from step 4 to step 5. At this time, the audit trail recording unit 40 records "Worker A" who confirmed the set value. In addition, the audit trail recording unit 40 records "tank 2", which is the object confirmed by worker A, as the first specific data, and records the "touch panel 20A" on which the operation of confirming the setting value was performed as the second specific data. Record as data. In other words, the audit trail [4] shows that "Worker A" worked on "Tank 2" (confirmed setting values) and performed an operation on "Touch panel 20A" to proceed to the next step 5. represents.

Audit trail [6] represents work data related to step 6. When the worker A performs an operation on the touch panel 20B to confirm that stirring has been completed, the process proceeds from step 6 to step 7. At this time, the audit trail recording unit 40 records "Worker A" who confirmed the completion of stirring. In addition, the audit trail recording unit 40 records "tank 2", which is the object confirmed by worker A, as first specific data, and records "touch panel 20B", which is the object confirmed by worker A, as second specific data. Record as data. In other words, the audit trail [6] shows that "Worker A" worked on "Tank 2" (confirmed the completion of stirring) and performed an operation on "Touch panel 20B" to proceed to the next step 7. represents.

The validity verification unit 50 is a program executed by the PLC 10, and reads the audit trail from the memory 12 and verifies its validity. Of course, the validity verification unit 50 of this embodiment is not limited to such an aspect. For example, the validity verification unit 50 may be a program executed on a general personal computer or the like. In this case, the validity verification unit 50 is configured to obtain an audit trail from the control device 10 using a communication means or to obtain an audit trail recorded on a personal computer and performs verification.

Specifically, the validity verification unit 50 verifies the validity of the audit trail as follows. First, the audit trail is read from the memory 12, and from the first position information and second position information included in the audit trail, it is determined that the position of the operated touch panel 20 and the position of the tank 2, which is the processing device, are within a predetermined range. If so, the audit trail is determined to be valid.

For example, for the audit trail [2] shown in Figure 4, by referring to Table 1, the first location information is "1st floor" associated with the first specific data, and the second location information is the You can get "1st floor - in front of tank 2" associated with. The predetermined range may be arbitrarily determined, but may be appropriately set within a range that allows the distance between the tank 2 to be worked on and the operated touch panel 20. Here, the predetermined range is defined as "the same floor." Audit trail [2] determines that the first location information and second location information are both "1st floor" and the same floor, so it is determined that they are within the predetermined range, and audit trail [2] is determined to be appropriate. do. In other words, from audit trail [2], a worker performs work in tank 2 (adding raw materials, checking weight), and then operates the touch panel 20A placed nearby from tank 2 to proceed to the next step. It can be determined that the work is being carried out appropriately.

On the other hand, regarding the audit trail [6] shown in Figure 4, by referring to Table 1, the first location information is "1st floor" associated with the first specific data, and the second location information is the You can get "2nd floor - control room" associated with. Since the first location information and the second location information are not on the same floor, it is determined that the audit trail [6] is not within a predetermined range, and the audit trail [6] is determined to be invalid. In other words, the audit trail [6] shows that although the worker performed work in tank 2 (confirming completion of stirring), he did not operate the touch panel 20B located far from tank 2 to proceed to the next step. Therefore, it can be determined that the work is being performed in a way that cannot be said to be appropriate.

In addition to the first location information and the second location information, the validity verification unit 50 also determines whether the audit trail is valid based on whether the time between steps (hereinafter referred to as step time) is equal to or longer than a predetermined time. You may judge.

For example, the validity of the audit trail [6] in FIG. 4 is determined as follows. First, the validity verification unit 50 calculates the step time from the time of completion of step S5 (previous step) and the time of completion of step S6 (next step) recorded as audit trail [6]. In this case, the step time is "5 minutes" from "9:45:00" to "9:50:00".

Next, if the first location information and second location information included in the audit trail [6] are outside the predetermined range and the step time is equal to or longer than the predetermined time, the validity verification unit 50 determines that the audit trail [6] is determined to be reasonable. The predetermined time can be set arbitrarily, but it is the time required to move from the location of the processing equipment (near tank 2) where the worker is assumed to be at the time of completion of the previous step to the operated touch panel 20B. It is preferable to set Here, the predetermined time is "3 minutes".

In this case, since the step time is longer than the predetermined time, the validity verification unit 50 determines that the audit trail [6] is valid. In other words, even if the tank 2 that is the target of step 6 is far away from the touch panel 20B that was scanned to proceed to the next step, it is reasonable because sufficient time has passed by the time the worker moves from the tank 2 to the touch panel 20B. It can be judged that the work is

On the other hand, if the step time for the audit trail [6] in Figure 4 is "1 minute", the time required for the worker to move from the tank 2 to the touch panel 20B will be shortened, whereas it normally takes "3 minutes". It can be determined that the work is being carried out in a way that cannot be said to be appropriate.

Further, the validity verification unit 50 may use a different predetermined range and predetermined time for each driving mode. Specifically, the equipment can be operated in a plurality of operation modes, and the control program 30 executed by the PLC 10 has a plurality of operation modes. In other words, even if the equipment including the processing devices 2 to 6 has the same device configuration, it is possible to perform different operations depending on the purpose. The operation modes include normal operation mode, cleaning mode, maintenance mode, etc. The normal operation mode is an operation mode for manufacturing pharmaceuticals, the cleaning mode is an operation mode for executing CIP/SIP on various processing devices 2 to 6, and the maintenance mode is a mode for performing maintenance for various processing devices 2 to 6. be.

In the memory 12 of the PLC 10, different predetermined ranges and predetermined times are set in advance for each operation mode. Then, the validity verification unit 50 reads out a predetermined range and a predetermined time determined for each driving mode, and performs the validity verification as described above. As a result, for example, even if the audit trail obtained in normal operation mode and the audit trail obtained in maintenance mode are the same, the predetermined range and the predetermined time that serve as the judgment criteria are different, so it is possible to determine whether they are valid or not. The judgment can be different. This makes it possible to flexibly determine validity according to the driving mode.

Furthermore, the validity verification unit 50 may use a predetermined range set according to the reason included in the audit trail. Specifically, the management system 1 includes a reason acquisition means (not shown). The reason acquisition means of this embodiment is implemented as part of a program executed on the touch panel 20. Of course, it may be implemented as part of the control program executed by the PLC 10.

The reason acquisition means causes the touch panel 20 to realize a function of displaying a reason input screen for inputting a reason indicating why the worker performed the work when executing the step. Specifically, the reason acquisition means causes the input/output unit 22 to display a screen consisting of GUI components for selecting from among a plurality of predefined reasons. Then, the reason acquisition means stores the reason selected by the operator in the memory 12. The reason stored in the memory 12 is sent to the PLC 10 when each step is executed and is stored as an audit trail (work data).

Figure 5 shows an example of an audit trail that includes reasons. Here, it is assumed that not only the raw materials in Step 1 were input, but also additional raw materials were temporarily input. It is assumed that the worker selects "temporary additional input" as the reason when performing an operation in step 3 to proceed to step 4 (next step). As a result, the audit trail [3] will include the reason.

The validity verification unit 50 normally uses "same floor" as the predetermined range, but uses a different predetermined range set in advance depending on the reason. For example, assume that the predetermined range determined in response to "temporary additional input" is "1st floor difference." This is assumed to be within a predetermined range if they are on the same floor or one floor apart. In the audit trail [3] of FIG. 5, the first location information is "1st floor" and the second location information is "2nd floor", but since they are within the predetermined range of "1st floor difference", they are determined to be valid. Even if such irregular work is performed, if there is a valid reason, it can be determined that the work is appropriate by changing the predetermined range.

As described above, the management system 1 of this embodiment not only records the audit trail of the equipment, but also determines the validity of the audit trail based on the positional relationship between the location of the processing device such as the tank 2 and the location of the touch panel 20. Verify gender. This makes it possible to verify whether or not work has been carried out appropriately based on the flow of workers.

The management system 1 of this embodiment verifies validity based on whether the step time is longer than a predetermined time in addition to the above-mentioned positional relationship. This makes it possible to more accurately capture the line of movement of workers, thereby improving the accuracy of the validity of the audit trail.

Since the management system 1 of this embodiment uses different predetermined ranges and predetermined times depending on the operation mode in equipment with multiple operation modes, it is possible to flexibly determine validity according to the operation mode.

The management system 1 of this embodiment uses a predetermined range depending on the reason when the audit trail includes the reason for the work. Therefore, even if, for example, irregular work is performed, if there is a valid reason, it can be determined that the audit trail is valid.

In addition, although each embodiment mentioned above demonstrated the management system in the equipment which manufactures a pharmaceutical product, it is not limited to this, The present invention can also be applied to the equipment which manufactures foods and drinks.

As the first location information and the second location information, names indicating locations such as "1st floor" and "in front of the tank" are used, but the information is not limited thereto. For example, the first position information and the second position information may be two-dimensional coordinates or three-dimensional coordinates when viewed in plan. The predetermined range is based on the structure of the facility, such as the same floor or one floor difference, but is not limited thereto. For example, it is possible to define data indicating whether all combinations of processing devices and touch panels are included in a predetermined range or not, and then determine whether or not they are included within a predetermined range by referring to the data. good. Further, when the first position information and the second position information are expressed by coordinates, the predetermined range may be expressed by distance.

The touch panel 20 is an example of an input device in the claims, but is not limited thereto. Any device that can be connected to the PLC 10 and capable of input may be used, and a keyboard, mouse, etc. may also be used as the input device.

1... Management system, 10... PLC (control device), 20... Touch panel, 30... Control program, 40... Audit trail recording section (audit trail recording means), 50... Validity verification section (Validity verification means)

Claims (5)

Processing equipment for producing medicines, beverages or foods;
a control device that controls the processing device by executing a control program consisting of a plurality of steps;
an input device capable of inputting data to the control device;
an audit trail recording means for recording an audit trail;
An audit trail management system comprising: a validity verification means for verifying the validity of the audit trail,
The control device is capable of advancing the step of the control program to the next step by an operation by a worker via the input device,
The audit trail recording means completes one of the steps (hereinafter referred to as "previous step") and before executing the next step (hereinafter referred to as "next step") by the operation,
first position information representing the position of the processing device that was the control target in the previous step;
second position information representing the position of the input device where an operation for proceeding to the next step is input;
be recorded as an audit trail,
The validity verification means determines, based on the first location information and the second location information included in the audit trail, if the location of the input device where the operation was performed and the location of the processing device are within a predetermined range; An audit trail management system characterized by determining that the audit trail is valid. In the audit trail management system according to claim 1,
The audit trail recording means, when the previous step is completed and the next step is executed by the operation,
recording a step time that is the time between the completion of the previous step and the time of completion of the next step as an audit trail;
The validity verification means determines from the first location information and the second location information included in the audit trail that the location of the input device where the operation was performed and the location of the processing device are outside a predetermined range, and An audit trail management system characterized by determining that the audit trail is valid if the step time is equal to or longer than a predetermined time. In the audit trail management system according to claim 1,
The control program has a plurality of operation modes,
The audit trail management system is characterized in that the validity verification means uses the predetermined range that differs depending on the driving mode. In the audit trail management system according to claim 2,
The control program has a plurality of operation modes,
The audit trail management system is characterized in that the validity verification means uses the predetermined time that differs depending on the driving mode. In the audit trail management system according to any one of claims 1 to 4,
a reason acquisition means for displaying a reason input screen on the input device for inputting a reason for executing the operation, and acquiring the reason input via the reason input screen;
The audit trail recording means records the reason acquired by the reason acquisition means when the step is completed as an audit trail,
The audit trail management system is characterized in that the validity verification means uses the predetermined range set according to the reason.

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