Root cause investigation system, root cause investigation method, recording medium, and program

Abstract

To provide a cause investigation system that facilitates investigating a cause when an error occurs in analysis.SOLUTION: A processing unit (601) transmits a sample ID corresponding to a one-time analysis process for an analysis target, and acquires image information indicating the status of the analysis process from a first record database (300). The processing unit (601) also transmits a system ID corresponding to an analysis device (400) used in the analysis process, and acquires device status information indicating the state of the analysis device (400) from a second record database (500). The processing unit (601) causes a display unit (608) to display an image obtained by reproducing the image information and the device status information corresponding to the image.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to a cause investigation system, a cause investigation method, a recording medium, and a program for investigating the cause of an analysis error occurrence. [Background Art]

[0002] In sites such as production sites, the use of images captured by a camera to ascertain production performance and the like is under consideration. Japanese Patent Application Laid-open No. 2021-022232 discloses a production performance recording system capable of accurately recording setup work performed by an operator, together with the operating status of equipment as production performance in production that uses equipment. [Prior Art Document] [Patent Document]

[0003] [Patent Document 1] Japanese Patent Application Laid-open No. 2021-022232 [Summary of the Invention] [Problem to be Solved by the Invention]

[0004] When analyzing a target sample with an analyzer, it is also conceivable to use an image captured by a camera. For example, if the analysis result of the analyzer is abnormal, it is necessary to clarify the cause and take countermeasures. When clarifying the cause, if it is not clear at the initial stage whether the cause comes from the device or from a human, a comprehensive investigation of the cause must be carried out. Therefore, a great deal of time is required for the cause investigation.

[0005] The technology described in Japanese Patent Application Laid-open No. 2021-022232 (Patent Document 1) helps to accurately calculate production performance time, but cannot be directly used for cause investigation when the analysis result of an analyzer is abnormal, and there is room for improvement.

[0006] This disclosure aims to provide a cause investigation system, a cause investigation method, a recording medium, and a program that facilitate the investigation of the causes of errors when they occur in analysis. [Means for solving the problem]

[0007] A first aspect of this disclosure relates to a cause investigation system for investigating the cause of errors in analysis. The cause investigation system comprises a display unit and a processing unit. The processing unit transmits a sample ID corresponding to a single analysis process on the object to be analyzed, obtains image information indicating the status of the analysis process from a first record database, transmits a system ID corresponding to the analysis device used in the analysis process, and obtains device status information indicating the status of the analysis device from a second record database. The processing unit displays an image reproduced from the image information and the device status information corresponding to the image on the display unit. [Effects of the Invention]

[0008] The cause investigation system disclosed herein is useful for investigating the cause of errors because it facilitates the investigation of images that may provide information about human-derived causes and device status information that may provide information about device-derived causes. [Brief explanation of the drawing]

[0009] [Figure 1] This diagram shows the configuration of the cause investigation system of this embodiment. [Figure 2] This diagram shows the configuration of the survey computer 600, which acquires data from the image management server and the data management server. [Figure 3] This figure shows the external appearance of the imaging device 100. [Figure 4] This figure shows an example of the configuration of the controller for the imaging device 100. [Figure 5] This diagram shows the configuration of the image management server 300 that stores images captured by the imaging device 100. [Figure 6]This diagram shows the configuration of the data management server 500, which stores data received from the analysis device 400. [Figure 7] This diagram compares the process of identifying the cause of a problem before and after the introduction of a cause investigation system. [Figure 8] This is a flowchart illustrating the process by which the imaging device 100 records images and tags. [Figure 9] This flowchart illustrates the process by which the data management server 500 receives and records device status information from the analysis device 400. [Figure 10] This is a flowchart illustrating the process by which the survey computer 600 displays images and device status information. [Figure 11] This figure shows an example of the main screen displayed on display 608. [Figure 12] This figure shows an example of a video playback screen displayed on display 608. [Modes for carrying out the invention]

[0010] The embodiments will be described in detail below with reference to the drawings. Note that the same or corresponding parts in the drawings are denoted by the same reference numerals, and their descriptions will not be repeated.

[0011] Figure 1 shows the configuration of the cause investigation system according to this embodiment. The cause investigation system 1 is used to investigate the cause of errors in analysis. The cause investigation system 1 comprises an imaging device 100, an image management server 300, an analysis device 400, a data management server 500, and an investigation computer 600.

[0012] The imaging device 100 and the image management server 300 can communicate with each other via wired or wireless communication. The survey computer 600 and the image management server 300 can communicate with each other via wired or wireless communication.

[0013] The analysis device 400 and the data management server 500 can communicate with each other via wired communication or wireless communication. The investigation computer 600 and the data management server 500 can communicate with each other via wired communication or wireless communication.

[0014] A person in charge who performs analysis using the analysis device 400 creates a report each time an analysis is performed. The report includes a sample ID and a system ID. The sample ID is an ID for identifying each single analysis. The system ID is an ID for identifying the analysis device that performed the analysis. For example, if a company owns a plurality of liquid chromatography devices as the analysis devices 400, which of the plurality of devices was used to perform the analysis can be identified by the system ID.

[0015] The imaging device 100 is, for example, smart glasses with a continuous recording function. When a worker wears the smart glasses to perform work, a video from the worker's perspective is captured. For example, if an optical mark such as a two-dimensional barcode is arranged at the work site or on the analysis device 400, the mark can be extracted from the recorded data to identify the location. If a wireless tag or the like is arranged, a wireless transceiver may be mounted on the smart glasses. When a worker is recording, if the information of the work site or analysis device acquired by the wireless transceiver is recorded together with the recording data, it can be easily known where the recording data was recorded. The recording data and the data identifying the location or the device are stored in the image management server 300 together with information on the time when the recording data was acquired. When an investigator specifies a sample ID to the image management server 300 from the investigation computer 600, the image management server 300 transmits the information of the work site or analysis device and the recording data corresponding to the sample ID to the investigation computer 600.

[0016] On the other hand, the analysis device 400 periodically transmits device status information to the data management server 500, and the data management server 500 stores the device status information and information on the time at which the device status information was acquired. For example, when the analysis device 400 is a liquid chromatography device, column replacement time, cleaning time, and the like are automatically stored in the data management server 500. When an investigator specifies a system ID for the data management server 500 from the investigation computer 600, the data management server 500 transmits the device status information of the analysis device corresponding to the system ID to the investigation computer 600. The device status information includes, for example, measured values such as pressure and temperature detected by the analysis device 400, set values such as pressure and temperature set in the analysis device 400, replacement time for components such as columns, and cleaning time.

[0017] A cause investigation support program is installed in the investigation computer 600. When the sample ID and system ID described in a report are input, the investigation computer 600 transmits the sample ID to the image management server 300, and acquires an indexed test video corresponding to the sample ID from the image management server 300. The investigation computer 600 further transmits the system ID to the data management server 500, and acquires status information of the corresponding device from the data management server 500. Then, based on time information, the investigation computer 600 associates "recorded data and data specifying a location or a device" with "device status information".

[0018] Note that the investigation computer 600 may specify the date and time when analysis was performed from the sample ID, and acquire data from the data management server 500 by narrowing the data to a few days before and after the date and time when the analysis was performed.

[0019] Figure 2 shows the configuration of a survey computer 600 that acquires data from an image management server and a data management server. The survey computer 600 includes a processor 601, main memory 602, communication interface 603, input interface 605, input device 607, display interface 606, display 608, and storage device 620. These components are connected to each other via an internal bus 619 so as to be able to communicate with each other.

[0020] The processor 601 is comprised of, for example, at least one integrated circuit. The integrated circuit is comprised of, for example, at least one CPU (Central Processing Unit), at least one ASIC (Application Specific Integrated Circuit), at least one FPGA (Field Programmable Gate Array), or a combination thereof.

[0021] The processor 601 performs various processes by loading the program 622 stored in the storage device 620 into the main memory 602 and executing it. The main memory 602 is composed of volatile memory and functions as work memory necessary for the execution of the program by the processor 601.

[0022] The communication interface 603 communicates with the image management server 300 and the data management server 500 via the network. For example, the communication interface 603 receives work videos transmitted from the image management server 300 and device status data transmitted from the data management server 500.

[0023] The input interface 605 relays data transmission between the processor 601 and the input device 607. More specifically, the input interface 605 receives various instructions given by the operation of the input device 607.

[0024] The display interface 606 relays data transmission between the processor 601 and the display 608. Specifically, the display interface 606 outputs signals to the display 608 for displaying various types of information (e.g., work videos, device status information, etc.) according to commands from the processor 601. The display interface 606 also outputs a signal to the display 608 to indicate the end of the display, according to commands from the processor 601.

[0025] The storage device 620 is, for example, an SSD (Solid State Drive), non-volatile memory, or a hard disk. The storage device 620 stores programs 622 for implementing various processes. The storage device 620 also stores work videos transmitted from the image management server 300, along with time information indicating the time the work videos were taken, and device status data transmitted from the data management server 500, along with time information indicating the time the device status data was recorded. The various types of information stored in the storage device 620 are mainly viewed on the display 608 by the administrator who manages the work.

[0026] Program 622 may be provided not as a standalone program, but as part of any other program. In this case, the processing according to this embodiment is realized in cooperation with the other program. Even a program that does not include such a partial module does not deviate from the intent of the research computer 600 according to this embodiment. Furthermore, some or all of the functions provided by Program 622 may be implemented by dedicated hardware. Program 622 may be distributed over a network. Program 622 may also be recorded on a computer-readable recording medium and distributed.

[0027] Figure 3 shows the external appearance of the imaging device 100. In the example shown in Figure 3, the imaging device 100 is a pair of smart glasses, which is an example of a "wearable device".

[0028] The imaging device 100 comprises a main unit 10, a controller 20, and an input device 30. The main unit 10 is fitted with transparent protective glasses 11 to protect the eyes, allowing the operator to see forward while wearing the main unit 10. The main unit 10 is also equipped with a transparent display 13.

[0029] The display 13 shows an image (for example, a work video as described later). The display 13 includes a display 13a for the right eye and a display 13b for the left eye. The right eye display 13a is attached to the protective glasses 11 via a mounting part 15a on the right eye side, and the left eye display 13b is attached to the protective glasses 11 via a mounting part 15b on the left eye side. The worker can see ahead through the display 13 and can also see the image displayed on the display 13.

[0030] Furthermore, the main unit 10 is equipped with an imaging unit 14. The imaging unit 14 captures images of the worker's work while wearing the main unit 10. Specifically, the imaging unit 14 captures images of the worker's hands in their line of sight. The work video obtained by imaging with the imaging unit 14 is stored in the image management server 300 along with time information as a work log for quality assurance purposes.

[0031] The controller 20 provides overall control over the entire imaging device 100. Specifically, the controller 20 controls the imaging performed by the imaging unit 14. The controller 20 also controls the display on the display 13. Furthermore, the controller 20 transmits the work video to the image management server 300.

[0032] The operator inputs various instructions to the controller 20 into the input device 30. The input device 30 includes at least one of the following: a button, a touchpad, and a microphone. In the example shown in Figure 3, the input device 30 includes at least one button 31. Button 31 is an operation switch for inputting instructions regarding the playback of work videos on the display 13.

[0033] Figure 4 shows an example of the configuration of the controller of the imaging device 100. The controller 20 includes a processor 201, main memory 202, communication interface 203, camera interface 204, input interface 205, display interface 206, and storage device 220. These components are connected to each other via an internal bus 219 so as to be able to communicate with each other.

[0034] The processor 201 is comprised of, for example, at least one integrated circuit. The integrated circuit is comprised of, for example, at least one CPU, at least one ASIC, at least one FPGA, or a combination thereof.

[0035] The processor 201 performs various processes by loading the program 222 stored in the storage device 220 into the main memory 202 and executing it. The main memory 202 is composed of volatile memory and functions as work memory necessary for the execution of the program by the processor 201.

[0036] The communication interface 203 communicates with the image management server 300 via the network. For example, the communication interface 203 transmits the work video obtained by imaging with the imaging unit 14 and time information indicating the time the work video was taken to the image management server 300. The timing at which the work video and time information are transmitted to the image management server 300 may be, for example, while the imaging device 100 is charging, or at a timing instructed by the operator via the input device 30.

[0037] The camera interface 204 relays data transmission between the processor 201 and the imaging unit 14. Specifically, the camera interface 204 outputs a signal to the imaging unit 14 to instruct the start of imaging according to a command from the processor 201. The camera interface 204 also receives images obtained from the imaging unit 14 (for example, work videos, etc.) and outputs the received images to the processor 201. Furthermore, the camera interface 204 outputs a signal to the imaging unit 14 to instruct the end of imaging according to a command from the processor 201.

[0038] The input interface 205 relays data transmission between the processor 201 and the input device 30. More specifically, the input interface 205 receives various instructions given by the operation of the input device 30, such as instructions to start recording or playing back work videos.

[0039] The display interface 206 relays data transmission between the processor 201 and the display 13. Specifically, the display interface 206 outputs signals to the display 13 for displaying various types of information (e.g., work videos) according to commands from the processor 201. The display interface 206 also outputs a signal to the display 13 to indicate the end of the display, according to commands from the processor 201.

[0040] The storage device 220 is, for example, an SSD, non-volatile memory, or a hard disk. The storage device 220 stores programs 222 for implementing various processes. The storage device 220 also stores work videos obtained by imaging by the imaging unit 14.

[0041] Program 222 may be provided not as a standalone program, but incorporated as part of any other program. In this case, the processing according to this embodiment is realized in cooperation with the other program. Even if a program does not include such a partial module, it does not deviate from the spirit of the imaging device 100 according to this embodiment. Furthermore, some or all of the functions provided by Program 222 may be implemented by dedicated hardware. Program 222 may be distributed over a network. Program 222 may also be recorded on a computer-readable recording medium and distributed.

[0042] Figure 5 shows the configuration of the image management server 300, which stores images captured by the imaging device 100. The image management server 300 includes a processor 301, main memory 302, communication interface 303, input interface 305, display interface 306, and storage device 320. These components are connected to each other via an internal bus 319 so as to be able to communicate with each other.

[0043] The processor 301 is comprised of, for example, at least one integrated circuit. The integrated circuit is comprised of, for example, at least one CPU, at least one ASIC, at least one FPGA, or a combination thereof.

[0044] The processor 301 performs various processes by loading the program 322 stored in the storage device 320 into the main memory 302 and executing it. The main memory 302 is composed of volatile memory and functions as work memory necessary for the execution of the program by the processor 301.

[0045] The communication interface 303 communicates with the imaging device 100 via the network. For example, the communication interface 303 receives from the imaging device 100 the work video obtained by imaging by the imaging unit 14 and time information indicating the time when the work video was taken.

[0046] The input interface 305 relays data transmission between the processor 301 and the input device 307. More specifically, the input interface 305 receives various instructions given by the operation of the input device 307.

[0047] The display interface 306 relays data transmission between the processor 301 and the display 308. Specifically, the display interface 306 outputs signals to the display 308 for displaying various types of information (e.g., work videos) according to commands from the processor 301. The display interface 306 also outputs a signal to the display 308 to indicate the end of the display, according to commands from the processor 301.

[0048] The storage device 320 is, for example, an SSD, non-volatile memory, or a hard disk. The storage device 320 stores a program 322 for implementing various processes according to this embodiment. The storage device 320 also stores work videos received from the imaging device 100 and time information indicating the time when the work videos were taken. The work videos stored in the storage device 320 are mainly viewed on the display 308 by the administrator who manages the work.

[0049] Program 322 may be provided not as a standalone program, but as part of any other program. In this case, the processing according to this embodiment is realized in cooperation with the other program. Even if a program does not include such a partial module, it does not deviate from the intent of the image management server 300 according to this embodiment. Furthermore, some or all of the functions provided by Program 322 may be realized by dedicated hardware. Program 322 may be distributed over a network. Program 322 may also be recorded on a computer-readable recording medium and distributed.

[0050] Figure 6 shows the configuration of the data management server 500, which stores data received from the analysis device 400. The data management server 500 includes a processor 501, main memory 502, communication interface 503, input interface 505, display interface 506, and storage device 520. These components are connected to each other via an internal bus 519 so as to be able to communicate with each other.

[0051] The processor 501 is comprised of, for example, at least one integrated circuit. The integrated circuit is comprised of, for example, at least one CPU, at least one ASIC, at least one FPGA, or a combination thereof.

[0052] The processor 501 performs various processes by loading the program 522 stored in the storage device 520 into the main memory 502 and executing it. The main memory 502 is composed of volatile memory and functions as work memory necessary for the execution of the program by the processor 501.

[0053] The communication interface 503 communicates with the analyzer 400 via the network. For example, the communication interface 503 receives device status data transmitted from the analyzer 400 and time information indicating the time when the device status data was recorded.

[0054] The input interface 505 relays data transmission between the processor 501 and the input device 507. More specifically, the input interface 505 receives various instructions given by the operation of the input device 507.

[0055] The display interface 506 relays data transmission between the processor 501 and the display 508. Specifically, the display interface 506 outputs signals to the display 508 for displaying various information (e.g., analysis results, device status information, time information, etc.) according to commands from the processor 501. The display interface 506 also outputs a signal to the display 508 to indicate the end of the display, according to commands from the processor 501.

[0056] The storage device 520 is, for example, an SSD, non-volatile memory, or a hard disk. The storage device 520 stores programs 522 for implementing various processes. The storage device 520 also stores various information received from the analysis device 400 (analysis results, device status information, etc.). The various information stored in the storage device 520 is mainly viewed on the display 508 by the administrator who manages the operations.

[0057] Program 522 may be provided not as a standalone program, but as part of any other program. In this case, the processing according to this embodiment is realized in cooperation with the other program. Even if a program does not include such a partial module, it does not deviate from the intent of the data management server 500 according to this embodiment. Furthermore, some or all of the functions provided by Program 522 may be implemented by dedicated hardware. Program 522 may be distributed over a network. Program 522 may also be recorded on a computer-readable recording medium and distributed.

[0058] Figure 7 shows a comparison of the process of identifying the cause before and after the introduction of the cause investigation system.

[0059] For example, suppose an anomaly occurs when the components of a 1 mg tablet are analyzed using a liquid chromatography apparatus, and the peak value of the standard solution is higher than the reference value. This kind of information is recorded in a report that the analyst creates each time an analysis is performed. This report includes a sample ID associated with video data and location data, and a system ID associated with the instrument used.

[0060] S101-S106 in Figure 7 show the investigation process in the case of a general method. First, in step S101, the investigator receives a report. For example, the investigator receives a report stating that the peak value of the standard solution is greater than the reference value, indicating an anomaly.

[0061] Next, in step S102, the investigator gathers information based on the report. The investigator reviews the report and the raw data from the analytical instrument that formed the basis of the report (such as the results of liquid chromatography), and interviews the analyst about the situation at the time. However, analysts often cannot accurately describe the situation at the time the analysis was performed (when the error occurred).

[0062] Next, in step S103, the investigator estimates the cause based on the collected information and formulates several hypotheses. The analyst can formulate multiple hypotheses based on experience, such as (A) an error in the dilution ratio of the standard solution, or (B) the temperature of the solvent used during dilution being too high.

[0063] Next, the investigator or an analyst instructed by the investigator will perform follow-up tests on hypotheses (A) and (B) to confirm whether the anomalies are reproduced.

[0064] Specifically, in step S104, for hypothesis (A), the standard solution is readjusted by changing the dilution ratio and analyzed using a liquid chromatography apparatus along with the stored sample. Generally, the solution of the sample to be analyzed is not discarded until it is confirmed that there are no errors. If the same anomaly is reproduced in this analysis, the cause can be identified as hypothesis (A).

[0065] On the other hand, if the anomaly is not reproduced, a follow-up test for hypothesis (B) is performed in step S105. For hypothesis (B), the standard solution is readjusted by setting the solvent temperature higher than the standard value, and analyzed using a liquid chromatography apparatus along with the stored sample. If the same anomaly is reproduced in this analysis, the cause can be identified as hypothesis (B).

[0066] If the abnormality does not occur in process S104 but does occur in process S105, in process S106, the investigator will identify that the cause of the abnormality was that the solvent temperature rose due to being left standing for a long time.

[0067] As described above, when information is insufficient and multiple hypotheses are formulated, it becomes necessary to conduct numerous follow-up tests, which is inefficient.

[0068] Next, this embodiment will be described. S201 to S205 in Figure 7 show the investigation process when the cause investigation system of this embodiment is introduced.

[0069] First, in process S201, the investigator receives a report. For example, the investigator receives a report stating an anomaly where the peak value of the standard solution is greater than the reference value.

[0070] Next, in process S202, the investigator gathers information based on the report. The investigator reviews the report with the raw data from the analytical instrument that formed the basis of the report (such as liquid chromatography results), and interviews the analyst about the situation at the time. In addition, by using the cause investigation system, the investigator can simultaneously check the video data and location data associated with the sample ID, and the instrument status data associated with the system ID, all linked by time.

[0071] Next, in step S203, based on the collected information, the investigator estimates the cause and formulates several hypotheses. At this time, the investigator can review a video showing the work situation and also check the status information of the equipment used. The investigator can formulate several hypotheses based on experience, such as (A) an error in the dilution ratio of the standard solution, or (B) the temperature of the solvent used during dilution was too high. At this time, the video can be used to confirm whether the dilution ratio was appropriate. Therefore, for example, hypothesis (A) can be eliminated at an early stage. As a result, the follow-up test conducted in step S204 only needs to be an experiment for hypothesis (B).

[0072] If the abnormality is reproduced in process S204, the investigator in process S205 can identify that the cause of the abnormality was that the solvent temperature rose due to being left standing for a long time.

[0073] Therefore, since the hypotheses can be narrowed down through video analysis, the time required for hypothesis testing can be reduced.

[0074] Figure 8 is a flowchart illustrating the process by which the imaging device 100 records images and tags.

[0075] In step S1, the imaging unit 14 of the imaging device 100 captures an image showing the status of the analysis process. The image is expected to be a video, but it may also be a still image.

[0076] Next, in step S2, the processor 201 of the imaging device 100 determines whether a tag corresponding to the captured image exists. The tag may be a one-dimensional or two-dimensional barcode captured in the image, or it may be a wireless tag that was nearby during the capture.

[0077] If a tag exists (YES in S2), the processor 201 records the information indicated by the tag (e.g., location, name of analysis device, etc.) in the storage device 220 and proceeds to step S4. On the other hand, if a tag does not exist (NO in S2), the processor 201 proceeds to step S4 without recording the information indicated by the tag.

[0078] In step S4, the processor 201 records the image captured in step S1 and the time of capture in the storage device 220. Then, in step S5, the processor 201 determines whether or not the shooting stop condition is met. The shooting stop condition is met, for example, when the operator instructs to stop shooting from the input device 30 or when the operator moves to a different location.

[0079] If the shooting stop condition is not met (NO in S5), the processor 201 repeats the process from step S1. On the other hand, if the shooting stop condition is met (YES in S5), the image capture and recording process in this flowchart is terminated.

[0080] Figure 9 is a flowchart illustrating the process by which the data management server 500 receives and records device status information from the analysis device 400. When the analysis process using the analysis device 400 is started, the flowchart in Figure 9 is executed.

[0081] In step S11, the processor 501 of the data management server 500 acquires device status information from the analysis device 400.

[0082] Next, in step S12, the processor 501 records the device status information and the time it was recorded in the storage device 520. Then, in step S13, the processor 501 determines whether the analysis has been completed. For example, the processor 501 can know that the analysis has been completed by receiving a signal from the analysis device 400 indicating the completion of the analysis.

[0083] If the analysis is not complete (NO in S13), the processor 501 repeats the process from step S11. On the other hand, if the analysis is complete (YES in S13), in step S14, the processor 501 records the analysis results in the storage device 520, and the process of this flowchart ends.

[0084] Figure 10 is a flowchart illustrating the process by which the survey computer 600 displays images and device status information. The process shown in the flowchart of Figure 10 is executed by the survey computer 600 in conjunction with the imaging device 100 and the image management server 300.

[0085] First, in step S21, the processor 601 of the investigation computer 600 receives a video playback instruction from the input device 607 via the input interface 605 and the internal bus 619.

[0086] Next, in step S22, the processor 601 sends the sample ID to the image management server 300, and in step S23, it retrieves the video data corresponding to the sample ID from the image management server 300.

[0087] Next, in step S24, the processor 601 sends the system ID to the data management server 500, and in step S25, it obtains device status information corresponding to the system ID from the data management server 500.

[0088] Next, in step S26, the processor 601 determines whether or not there is a cueing request by tag in the playback instruction received in step S21.

[0089] If there is a request to jump to a specific point in the video using a tag (YES in S26), the processor 601 sets the playback start time to begin playback from the time indicated by the tag and proceeds to step S28. On the other hand, if there is no request to jump to a specific point in the video using a tag (NO in S26), the processor 601 leaves the playback start time as the initial video start time and proceeds to step S28.

[0090] In this way, by reading tags placed in the work area during video recording and using that information to pinpoint specific points, it becomes easier to link status information with images in the video.

[0091] In step S28, the processor 601 plays the video acquired in step S23 and simultaneously displays the playback time of the image being played and the corresponding device status information on the display 608. The image being played may provide information about human-related causes. On the other hand, the device status information may provide information about the cause of analysis errors originating from the analysis device. The image and device status information displayed simultaneously are shown on the display 608 in a state where at least their relative temporal relationship to each other can be recognized. The image and device status information may also be displayed on the display 608 with a common time axis. For example, multiple still images and multiple pieces of device status information obtained from the video may be displayed in chronological order on a common time axis so that the progress of changes between the image and the device status information can be seen. In this way, the correspondence between the still images and the device status information is easy to understand.

[0092] Then, in step S29, the processor 601 determines whether or not the playback stop condition is met. The playback stop condition is met, for example, when the investigator instructs the input device 607 to stop playback, or when the playback position of the video file reaches the end of the file.

[0093] If the playback stop condition is not met (NO in S29), the processor 601 repeats the process in step S28. On the other hand, if the playback stop condition is met (YES in S29), the process in this flowchart ends.

[0094] Figure 11 shows an example of the main screen displayed on display 608. Figure 12 shows an example of the video playback screen displayed on display 608. By using the cause investigation system, investigators can easily check the device status data on the screen shown in Figure 11. When the incident is entered into the investigation system, the system comprehensively evaluates the analysis results and device status data to infer the likely cause.

[0095] In the example shown in Figure 11, two possible causes are indicated for the event "The internal surface value of sample Std1 is lower than that of the standard solutions of other samples," which was entered in the input field. The first cause is a weighing error of the standard, and the second cause is that the entire volumetric flask was not filled with the standard.

[0096] Two video playback icon displays in the center of the screen to verify whether these causes were the actual cause. Investigators can click on the video playback icon to play the video and investigate the cause.

[0097] Below the image icon, the device status data is displayed. For example, for each component of the HPLC system—Pump A, Pump B, Autosampler, and Oven A—the part name, part number, last replacement date, and usage count are displayed in a list format. The percentage of usage that corresponds to reaching the end of its lifespan (lifespan reach rate) is displayed next to the usage count as an indicator (bar graph). The status is also indicated by A, B, and C, in order of how much time is left before the lifespan reach rate reaches 100%.

[0098] When the video playback command is initiated, the system transitions from the main screen in Figure 11 to the video playback screen in Figure 12. At the top of the screen in Figure 12, the worker's name and the work date are displayed, and below that, the video playback screen is shown. Below the video, there are buttons to switch between play and stop, and a bar indicating the progress of the video playback. At the bottom of the screen in Figure 12, the names and start times of each work process—"weighing," "sample preparation," and "sample rack"—are displayed horizontally in chronological order, and a triangular mark is displayed in the part that is suspected to be the cause. In addition, small images of representative scenes from each process are displayed side by side, which is convenient for investigators to understand the flow of work.

[0099] [Other application examples] The above description mainly shows an example where the analytical device is a liquid chromatography apparatus, but the cause investigation system of this embodiment can be applied to various types of analysis.

[0100] [Example of cause investigation 1] <Situation> In a related substance (HPLC (High Performance Liquid Chromatography): EP) test, the content result was 98.43%, outside the acceptable range of 98.5-101.5%. Alternatively, although the result was within the acceptable range, an investigation revealed an error in the preparation of the standard solution, and an investigation into the cause was conducted.

[0101] • Phase 1a investigation: No clear laboratory errors were found, so the investigation proceeded to Phase 1b.

[0102] Phase 1b investigation: The following laboratory errors were considered as possible causes. <Hypothesis / Research Test> (Hypothesis H1) Analysis of the standard solution, which was re-prepared from the standard stock solution, revealed a clear difference in area values ​​compared to the initial test, indicating that an error occurred in preparing the standard solution from the standard active pharmaceutical ingredient.

[0103] (Hypothesis H2) Analysis of the standard solution, which was diluted to a predetermined volume using a graduated cylinder with a solvent at a higher temperature, showed that the area value was larger, similar to the initial test. This confirmed that the solution was not properly diluted due to the temperature difference of the solution during preparation.

[0104] (Hypothesis H3-1) Analysis of the standard stock solution and the sample stock solution showed a correlation with the results obtained when only the standard solution was re-prepared and analyzed under Hypothesis H1, thus confirming that there were no errors in the preparation of the standard stock solution and the standard solution.

[0105] (Hypothesis H3-2) A beaker containing a small amount of solvent was placed next to a computer for one hour, and it was confirmed that the liquid temperature rose. Furthermore, the difference in area values ​​between standard solutions prepared with a warmer solvent and those prepared with a non-warmer solvent was examined, and it was found that the area (%) of the standard solution prepared with the warmer solvent increased. From this, it was inferred that the solvent used to prepare the standard solution became warmer and its volume increased, causing the make-up process to fail.

[0106] The investigation revealed that the cause of the problem was that the beaker containing the solvent was left next to the computer for one hour before the standard solution was prepared, causing the surface area of ​​the standard solution to increase. During the preparation of the standard solution, the solvent temperature rose, increasing its volume and preventing proper make-up. Therefore, the results of the re-analysis after re-preparing only the standard solution are adopted.

[0107] When conducting such a cause investigation, using the cause investigation system of this embodiment allows users to review the video footage of the work and the equipment status information after viewing the analysis report, thereby reducing the number of hypotheses and saving time.

[0108] [Cause investigation example 2] <Situation> When an elution equivalence test (pH 4.5) was performed using LC (Liquid Chromatography), 10 small peaks were detected at unspecified times in 8 analyses (standard solution and sample).

[0109] <Hypothesis / Research Test> Using the cause investigation system of this embodiment, we checked the instrument status information and found that the LC and column had not been used for approximately two weeks since the last use. The detected peaks had an unspecified retention time and a shape similar to baseline disturbance, and we concluded that the cause of the analytical anomaly was contamination of the line or column.

[0110] [Pattern] Those skilled in the art will understand that the exemplary embodiments described above are specific examples of the following embodiments.

[0111] (Section 1) A first aspect of this disclosure relates to a cause investigation system for investigating the cause of errors in analysis. The cause investigation system comprises a display unit and a processing unit. The processing unit transmits a sample ID corresponding to a single analysis process on the object to be analyzed, obtains image information indicating the status of the analysis process from a first record database, transmits a system ID corresponding to the analysis device used in the analysis process, and obtains device status information indicating the status of the analysis device from a second record database. The processing unit displays the image information and the device status information corresponding to the time specified in the image information on the display unit.

[0112] According to the cause investigation system described in Section 1, the information necessary for cause investigation (work videos and equipment status information) can be displayed together, making cause investigation easier. In addition, since the information necessary for cause investigation can be obtained immediately when an error occurs, the process and time required for cause investigation can be shortened. Status information may also be obtained from other databases by reading the barcodes on the equipment or columns.

[0113] (Article 2) In the cause investigation system described in Article 1, the cause investigation system further comprises an imaging unit that takes images showing the status of the analysis process during the time the analysis process is being performed, a first server that receives image information from the imaging unit and records it in a first record database, and a second server that receives device status information from the analysis device and records it in a second record database. The imaging unit is attached to a device worn on the body of the worker.

[0114] According to the cause investigation system described in Section 2, it becomes easy to continuously photograph the worker's hands, making it easy to record images that are useful for investigating the cause.

[0115] (Article 3) In the cause investigation system described in Article 2, the imaging unit records a video showing the surrounding conditions while the worker is working, and tag information of tags placed at the work location where the analysis processing was performed, as image information, and the processing unit executes the cueing of the video scene based on the tag information.

[0116] According to the cause investigation system described in Section 3, it becomes easier for investigators to find the scenes they want to see in the video, thus improving the efficiency of the cause investigation work.

[0117] (Article 4) In the cause investigation system described in Article 2, the device status information includes at least one of the following: measured values ​​detected by the analyzer, set values ​​set in the analyzer, replacement times of parts used in the analyzer, and cleaning times.

[0118] (Article 5) In the cause investigation system described in Article 1, the image and the device status information are displayed on the display unit in a manner that allows at least the relative temporal relationship between them to be recognized.

[0119] (Section 6) In the cause investigation system described in Section 1, the image and the device status information are displayed on the display unit with a common time axis. This makes it easy to understand the correspondence between the still image and the device status information.

[0120] (Section 7) A second aspect of the present disclosure relates to a cause investigation method for investigating the cause of an error in an analysis performed by an analytical instrument. The cause investigation method comprises the steps of: a computer transmitting a sample ID corresponding to a single analysis process on an object to be analyzed and obtaining image information indicating the status of the analysis process from a first record database; a computer transmitting a system ID corresponding to an analytical instrument and obtaining instrument status information indicating the status of the analytical instrument from a second record database; and a computer displaying an image reproduced from the image information and the instrument status information corresponding to the image.

[0121] (Section 8) A third aspect of the present disclosure relates to a computer-readable recording medium on which a program causing a computer to execute the cause investigation method described in Section 7 is recorded.

[0122] (Section 9) A fourth aspect of this disclosure relates to a program that causes a computer to execute the cause investigation method described in Section 7.

[0123] The embodiments disclosed herein should be considered in all respects to be illustrative and not restrictive. The scope of this disclosure is indicated by the claims rather than by the description of the embodiments above, and all modifications within the meaning and scope equivalent to the claims are intended to be included. [Explanation of Symbols]

[0124] 1 Cause investigation system, 10 Main unit, 11 Protective glasses, 13, 13a, 13b, 308, 508, 608 Display, 14 Imaging unit, 15a, 15b Mounting unit, 20 Controller, 30, 307, 507, 607 Input device, 31 Button, 100 Imaging device, 201, 301, 501, 601 Processor, 202, 302, 502, 602 Main memory, 203, 303, 503, 603 Communication interface, 204 Camera interface, 205, 305, 505, 605 Input interface, 206, 306, 506, 606 Display interface, 219, 319, 519, 619 Internal bus, 220, 320, 520, 620 Storage devices, 222,322,522,622 programs, 300 image management servers, 400 analytical instruments, 500 data management servers, 600 research computers.

Claims

1. A cause investigation system for investigating the cause of errors that occurred in the analysis results of a sample being analyzed, It comprises a display unit and a processing unit, The aforementioned processing unit, The system transmits a sample ID corresponding to a single analysis process on the target of analysis, and retrieves image information indicating the status of the analysis process and the time information of when the image information was taken from a first recording database that records image information received from the imaging unit. The system ID corresponding to the analytical device used in the analysis process is transmitted, and device status information indicating the state of the analytical device and the time information on which the device status information was recorded are obtained from a second record database that records device status information received from the analytical device. The processing unit displays the image reproduced from the image information and the device status information corresponding to the image on the display unit, with a common time axis, as a cause investigation system.

2. The imaging unit is configured to capture an image showing the status of the analysis process during the time the analysis process is being performed, The aforementioned cause investigation system is The imaging unit, A first server that receives the image information from the imaging unit and records it in the first recording database, The system further comprises a second server that receives the device status information from the analysis device and records it in the second record database, The cause investigation system according to claim 1, wherein the imaging unit is attached to a device worn on the body of an operator.

3. The imaging unit records a video showing the surrounding conditions while the worker is working, and tag information of tags placed in the work area where the analysis processing was performed, as image information. The cause investigation system according to claim 2, wherein the processing unit executes the cueing of the video scene based on the tag information.

4. The cause investigation system according to claim 1, wherein the device status information includes at least one of the following: a measured value detected by the analyzer, a setting value set in the analyzer, the time of replacement of a part used in the analyzer, and the time of cleaning.

5. The cause investigation system according to claim 1, wherein the image and the device status information are displayed on the display unit in a manner that allows at least their relative temporal relationship to each other to be recognized.

6. A method for investigating the cause of errors that occurred in the analysis results of a sample being analyzed using an analytical instrument, The computer transmits a sample ID corresponding to a single analysis process on the object to be analyzed, and obtains image information indicating the status of the analysis process and time information of when the image information was taken from a first recording database that records image information received from the imaging unit. The computer transmits a system ID corresponding to the analyzer, and obtains device status information indicating the state of the analyzer and time information on when the device status information was recorded from a second record database that records device status information received from the analyzer. A method for investigating the cause, comprising the step of the computer displaying an image reproduced from the image information and device status information corresponding to the image, with a common time axis.

7. A computer-readable recording medium on which a program is recorded that causes a computer to execute the cause investigation method described in claim 6.

8. A program that causes a computer to execute the cause investigation method described in claim 6.

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