JP7795391B2 - Pharmaceutical Work Management System - Google Patents

Description

The present invention relates to a pharmaceutical work management system.

At product manufacturing sites, particularly pharmaceutical manufacturing sites, workers must adhere to strict work procedures that are defined for each step. However, deviations such as skipping steps or performing incorrect work procedures can occur due to various factors. The causes of such deviations can be identified after the work is completed by recording screen image data at the time of the deviation along with the system log, but if the screen image data is tampered with, it is impossible to accurately understand the circumstances at the time the deviation occurred.

Patent Document 1 discloses a work procedure management system that detects tampering with screen image data when deviations from work procedures occur during pharmaceutical manufacturing. Specifically, it discloses that the system records processing log information and hard copies of the screen along with a session ID assigned when logging in to the server, and when a deviation is determined, records the details of the deviation and information obtained by encoding part of the hard copy of the screen.

Patent No. 6474237

However, while Patent Document 1 can detect tampering with screen image data and determine work deviations after the work has been completed, it does not consider preventing work deviations before they occur.

The object of the present invention is to provide a pharmaceutical work management system that can prevent work deviations before they occur.

To achieve the above objective, the present invention provides a pharmaceutical work management system for managing work performed on pharmaceuticals, and is characterized by including a storage unit that stores model images, which are images of work procedures defined for the pharmaceuticals, captured in advance; a camera that captures actual work images, which are images of the actual work performed by workers on the pharmaceuticals; and a deviation determination unit that determines whether or not there are any deviations in the work based on the results of comparing the captured actual work images with the model images.

The present invention provides a pharmaceutical work management system that can prevent work deviations before they occur.

Overall configuration of the pharmaceutical work management system FIG. 10 is a diagram showing an example of a processing flow for capturing a sample image; An example of a work procedure manual FIG. 1 is a diagram illustrating an example of a dilution operation. Diagram explaining the dilution procedure FIG. 10 is a diagram showing an example of a process flow for determining deviations in work.

An embodiment of the pharmaceutical work management system according to the present invention will be described below with reference to the accompanying drawings. Note that in the following description and accompanying drawings, components with the same functional configuration will be assigned the same reference numerals, and redundant explanations will be omitted.

Figure 1 shows the overall configuration of the pharmaceutical work management system 100. The pharmaceutical work management system 100 is a system for managing work on pharmaceuticals, and includes a pharmaceutical work management device 101 and a camera 109. The pharmaceutical work management device 101 is configured by connecting a calculation unit 102, memory 103, storage unit 104, and interface 105 via a system bus 106 so that signals can be sent and received. Here, "signal sending and receiving enabled" refers to a state in which signals can be sent and received between each other or from one device to the other, whether electrically or optically, wired or wirelessly. A display device 107 and input device 108 may also be connected to the pharmaceutical work management device 101.

The calculation unit 102 is a device that controls the operation of each component, and specifically includes a CPU (Central Processing Unit) and an MPU (Micro Processor Unit). The calculation unit 102 loads programs stored in the storage unit 104 and data required to execute the programs into the memory 103 and executes them. The memory 103 stores the programs executed by the calculation unit 102 and the progress of calculation processing. The storage unit 104 is a device that stores the programs executed by the calculation unit 102 and data required to execute the programs, and specifically includes an HDD (Hard Disk Drive) or SSD (Solid State Drive). The interface 105 is used to connect the medical work management device 101 to the camera 109.

The display device 107 is a device that displays the processing results of the pharmaceutical work management device 101, and is specifically an LCD display. The input device 108 is an operating device with which the operator issues operational instructions to the pharmaceutical work management device 101, and is specifically a keyboard, mouse, touch panel, etc. The mouse may also be another pointing device such as a trackpad or trackball.

Camera 109 is a device that captures images of a worker using a work tool on a workbench to work on pharmaceuticals. The captured images are either still images or videos, and are stored in memory unit 104 via interface 105.

The work involved in handling pharmaceuticals is strictly defined for each work procedure, and workers are required not to deviate from the defined work. Therefore, in Example 1, a model image, which is an image of the defined work taken in advance for each work procedure, is compared with an actual work image, which is an image of the actual work being performed by the worker. Based on the results, the system determines whether or not there has been any deviation from the work, and warns the worker if there has been a deviation.

Using Figure 2, we will explain an example of the process flow for capturing a sample image, step by step.

(S201)
The calculation unit 102 acquires the work procedure manual. The work procedure manual indicates the work content for each work as shown in FIG. 3, and is stored in advance in the storage unit 104.

(S202)
The calculation unit 102 reads out the work content for each work from the work procedure manual acquired in S201. For example, the work content for the dilution work is read out from the work procedure manual of Fig. 3. The dilution work is a work performed on a specimen sampled from, for example, an incoming raw material.

Using Figure 4, we will explain the dilution work for work numbers 001-1 to 001-3 in the work procedure manual in Figure 3. First, a fixed amount of sampled sample is transferred from the 100 mL flask containing the sampled sample to 50 mL flask α using a 10 mL pipette. Since the amount of sample transferred to 50 mL flask α is 30 mL, the 10 mL pipette is used three times. Next, a fixed amount of diluent is added to 50 mL flask α, to which 30 mL of sample has been transferred, using a 20 mL pipette. Since the amount of diluent added to 50 mL flask α is 20 mL, the 20 mL pipette is used once. This completes work number 001-1. Next, for the dilution work for work number 001-2, 30 mL of sample and 20 mL of diluent are added to 50 mL flask β, and for the dilution work for work number 001-3, 30 mL of sample and 20 mL of diluent are added to 50 mL flask γ.

(S203)
The calculation unit 102 causes the camera 109 to capture the work content read out in S202 for each work procedure. For example, the work content of the dilution work for work number 001-1 in the work procedure manual of FIG. 3 is captured by the camera 109 for each work procedure.

Using Figure 5, the procedure for the dilution operation for operation number 001-1 will be explained. First, the procedure for transferring 30 mL of sample from a 100 mL flask to 50 mL flask α using a 10 mL pipette will be explained. In operation procedure (A), the 10 mL pipette approaches the 100 mL flask containing the sampled sample. In operation procedure (B), the 10 mL pipette aspirates 10 mL of sample from the 100 mL flask. In operation procedure (C), the 10 mL pipette that has aspirated the sample approaches 50 mL flask α. In operation procedure (D), the 10 mL pipette dispenses 10 mL of sample into 50 mL flask α. By repeating the above operation procedures (A) to (D) three times, 30 mL of sample is transferred to 50 mL flask α.

Next, we will explain the procedure for using a 20 mL pipette to add a fixed amount of diluent to 50 mL flask α, into which 30 mL of sample has been transferred. In procedure (E), the 20 mL pipette that has aspirated the diluent approaches 50 mL flask α. In procedure (F), the 20 mL pipette dispenses 20 mL of diluent into 50 mL flask α.

After steps (A) through (D) are repeated three times, steps (E) and (F) are performed, completing the dilution work for work number 001-1. Camera 109 captures each of steps (A) through (F) as a sample image for each step of the dilution work for work number 001-1.

(S204)
The calculation unit 102 associates the model image acquired by photographing in S203 with the work procedure and stores it in the storage unit 104. For example, a model image of a 10 mL pipette approaching a 100 mL flask is stored in association with work procedure (A) with work number 001-1.

(S205)
The calculation unit 102 determines whether there is a next task. If there is a next task, the process returns to S202, and if there is not, the process flow ends.

The processing flow described using Figure 2 associates and stores a model image for each work procedure in a predetermined work content. The model image associated with each work procedure in the work procedure manual is used to determine whether the actual work performed by the worker deviates from the specified work content.

Using Figure 6, we will explain an example of the process flow for determining work deviations, step by step.

(S601)
The calculation unit 102 acquires the work procedure manual. In the work procedure manual acquired in S601, a model image is associated with each work procedure of a predetermined work content.

(S602)
The calculation unit 102 reads out the work procedure and the model image from the work procedure manual acquired in S601. The read-out model image may be displayed on the display device 107 so that the worker can refer to it when working.

(S603)
The camera 109 captures images of actual work performed by workers. The captured images of actual work are stored in the storage unit 104 for each work procedure. Storing the images of actual work for each work procedure allows the images of actual work to be searched for using the work number and work procedure as keys, thereby reducing the amount of work required to investigate the work content. The actual work images stored for each work procedure may also be associated with the time of work and the name of the worker. Associating the actual work images for each work procedure with the time of work and the name of the worker reduces the effort required to interview the workers about the work content.

(S604)
The calculation unit 102 determines whether or not there is a deviation in the work based on the result of comparing the sample image read out in S602 with the actual work image captured in S603. If there is a deviation, the process returns to S603 via S605, and if there is no deviation, the process proceeds to S606.

The presence or absence of a deviation in work is determined, for example, based on the amount of deviation between the position of the work implement extracted from the model image and the actual work image. In other words, if the amount of deviation between the position of the work implement in the model image and the position of the work implement in the actual work image is equal to or greater than a predetermined threshold, it is determined that a deviation exists. Note that the work implements in the model image and the actual work image are extracted based on, for example, the two-dimensional barcode or color attached to the work implement. Work implements may also be extracted based on the shape of the work implement or the text attached to the work implement.

Furthermore, if the work involves dilution, the presence or absence of a deviation in the work may be determined based on the distance between the pipette and flask used as work tools. For example, the distance between the 10 mL pipette and 100 mL flask extracted from the model image of work procedure (A) and the actual work image is compared, and if the difference in distance between the two images is equal to or greater than a threshold, it is determined that a deviation has occurred. Note that if a 20 mL pipette is extracted from the actual work image of work procedure (A) instead of the 10 mL pipette, the distance between the 10 mL pipette and the 100 mL flask cannot be determined in the actual work image, and the distance cannot be compared between the two images, so it is determined that a deviation has occurred.

Furthermore, since the dilution process requires a certain amount of time to aspirate and dispense the sample, the presence or absence of a deviation in the process may be determined based on the approach time, which is the time it takes for the pipette and flask to approach each other. For example, the approach times calculated from the model image and the actual work image of work procedure (B) are compared, and if the difference in approach time between the two images is equal to or greater than a threshold, it is determined that a deviation has occurred. Whether the pipette and flask are close to each other is determined based on the distance between the pipette and flask extracted from the model image and the actual work image. In other words, if the distance between the pipette and flask is equal to or less than a threshold, it is determined that the pipette and flask are close to each other.

(S605)
The calculation unit 102 displays an alert on the display device 107 to indicate that a deviation has occurred in the work. The alert display may be text indicating that a deviation has occurred, or the entire screen or part of it may blink or change color. By displaying the alert, the worker becomes aware of the deviation and can redo the work. In other words, deviations in the work can be prevented before they occur.

(S606)
The calculation unit 102 determines whether or not there is a next work procedure. If there is a next work procedure, the process returns to S602, and if there is not, the process flow ends.

The processing flow described using Figure 6 makes it possible to determine whether there has been a deviation in the actual work performed by the worker. Furthermore, if a deviation has occurred, an alert is immediately displayed, allowing for work deviations to be prevented before they occur.

The above describes an embodiment of the present invention. However, the present invention is not limited to the above embodiment, and the components can be modified and embodied without departing from the spirit of the invention. Furthermore, multiple components disclosed in the above embodiment may be combined as appropriate. Furthermore, some components may be deleted from all of the components shown in the above embodiment.

100: Pharmaceutical work management system, 101: Pharmaceutical work management device, 102: Calculation unit, 103: Memory, 104: Storage unit, 105: Interface, 106: System bus, 107: Display device, 108: Input device, 109: Camera

Claims (8)

A pharmaceutical work management system for managing work on pharmaceuticals,
a storage unit that stores sample images that are images captured in advance for each procedure of work performed on the medicine;
a camera that captures an actual work image that is an image of an actual work performed by a worker on the medicine;
a deviation determination unit that determines whether or not there is a deviation in the work based on a result of comparing the actual work image being photographed with the model image ;
The deviation determination unit extracts the work tools used in work on the pharmaceuticals from each of the model image and the actual work image, and determines that a deviation exists if the amount of deviation in the position of the work tool between the two images is greater than or equal to a threshold value . The pharmaceutical work management system of claim 1 ,
A medical work management system characterized in that the deviation determination unit extracts the work tool based on a two-dimensional barcode attached to the work tool. The pharmaceutical work management system of claim 1 ,
The medical work management system is characterized in that the deviation determination unit extracts the work tool based on the color attached to the work tool. The pharmaceutical work management system of claim 1 ,
The medical work management system is characterized in that the deviation determination unit extracts the work tool based on the shape of the work tool. The pharmaceutical work management system of claim 1 ,
A medical work management system characterized in that the deviation determination unit extracts the work tool based on characters attached to the work tool. A pharmaceutical work management system for managing work on pharmaceuticals,
a storage unit that stores sample images that are images captured in advance for each procedure of work performed on the medicine;
a camera that captures an actual work image that is an image of an actual work performed by a worker on the medicine;
a deviation determination unit that determines whether or not there is a deviation in the work based on a result of comparing the actual work image being photographed with the model image;
The deviation determination unit, when the work on the pharmaceutical is a dilution work, compares the distance between the pipette and flask used in the dilution work between the model image and the actual work image for each work procedure, and determines that there is a deviation if the difference in distance between the two images is greater than or equal to a threshold value. The pharmaceutical work management system according to claim 6 ,
The deviation determination unit further compares the approach time, which is the time when the pipette and the flask are approaching each other, between the two images for each work procedure, and determines that a deviation has occurred if the difference in the approach time between the two images is equal to or greater than a threshold value. The pharmaceutical work management system of claim 1,
The medical work management system is characterized in that the storage unit stores the actual work image for each work procedure in association with the work time and the name of the worker.