JP2018036692A - Information processor for management of correction processing in clinical laboratory, method and computer program - Google Patents

Abstract

PROBLEM TO BE SOLVED: To facilitate recording performed by a user even when plural procedures are included in a proceeding related to correction processing.SOLUTION: An information processor 10 for management of correction processing to a problem which occurred in a clinical laboratory comprises: a communication part 11 which communicates with a terminal 30 which can be operated by a user; and a control part 12 for controlling display on the terminal 30 through the communication part. The proceeding related to correction processing contains plural procedures containing input of the recording by a user, and confirmation of the recording by other user other than the user who inputted the recording. The control part 12 updates information 1206 indicating a progress according to the progress of the plural procedures. The control part 12 displays a screen 100 including an entry form on which recording according to the progress indicated by the information 1206 is input for every procedure, on the terminal 30.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an information processing apparatus method and a computer program for managing corrective actions in a clinical laboratory.

  In clinical laboratories that perform hematological tests, biochemical tests, immunological tests, etc. on specimens collected from subjects, it is required to perform higher quality tests. Here, ISO15189 is known as an international standard for operating a clinical laboratory, and specific requirements regarding the quality and capability of the clinical laboratory are defined. One of the requirements for quality management in clinical laboratories defined in ISO15189 is corrective action to eliminate the cause of problems that occurred in clinical laboratories.

In ISO 15189, clinical laboratory managers are required to monitor the results of all corrective actions taken to ensure that the resolution of the problems found is successful. Specifically, for corrective actions, the laboratory should have a documented procedure for:
a. Confirmation of nonconformity b. Identification of root cause of nonconformity c. Assessment of the need for corrective action to ensure the prevention of nonconformity recurrence d. Determine and implement necessary corrective actions e. Record of the results of corrective actions taken f. Review the effectiveness of corrective actions taken

  Patent Document 1 discloses a system for managing incident data generated in a medical facility as a tool for supporting management of corrective actions in a clinical laboratory. In Patent Document 1, an incident report input by a user includes an incident occurrence status and future countermeasures. It is described that the administrator confirms the data against the incident report data input by the reporter.

JP 2007-66155 A

  However, the system of Patent Document 1 is not sufficient to perform the corrective action required in ISO15189. In the system of Patent Literature 1, an incident report including an incident occurrence state and future countermeasures is made from a reporter, and the report is only confirmed by an administrator. The corrective action procedures required in ISO 15189 require a number of procedures shown in a to f above to ensure that the found problems can be solved.

  When the number of procedures included in the procedures related to corrective actions increases, it becomes difficult for the laboratory staff to grasp the progress of these procedures. The procedure for corrective action requires a record for each procedure, but the content to be recorded for each procedure is different. For this reason, if it is not easy to grasp the progress status of the procedure included in the procedure related to the corrective action, the recording becomes complicated.

  Therefore, even if a plurality of procedures are included in the procedure regarding the corrective action, it is desirable that the user can easily record.

  One aspect of the present invention is an information processing apparatus for managing procedures related to corrective actions for problems occurring in a clinical laboratory. The clinical laboratory is a place where a specimen test is performed, and is provided in a medical facility such as a hospital or a laboratory. Corrective actions are actions that eliminate the cause of a problem that has occurred in a clinical laboratory. A problem is, for example, a non-conformity detected in a clinical laboratory or other detected undesirable situation. Nonconformity is failure to meet clinical laboratory requirements. The requirements are, for example, law, ISO, clinical laboratory rules, and arrangements with customers.

  In the embodiment, the procedure related to the corrective action includes a plurality of procedures. In an embodiment, the procedure includes recording input by a user and confirmation of the recording by a user other than the user who input the recording. Confirmation may involve actions other than confirmation. For example, the approval is an act of confirming the record and confirming the content of the record, and includes confirmation. The evaluation is an act of judging whether the content of the record is good or bad after confirming the record, and includes confirmation.

  In the embodiment, the information processing apparatus includes a communication unit that communicates with a terminal that can be operated by a user, and a control unit that controls display of the terminal via the communication unit. A control part performs the process which updates the information which shows the said progress status according to the progress status of several procedures. Thereby, management of the progress status of the procedure included in the procedure regarding the corrective action is achieved by the control unit.

  A control part performs the process which displays a screen on a terminal. The screen includes an input form for inputting a record corresponding to the progress status indicated by the information for each procedure. Since the control unit manages the progress status of the procedure included in the procedure related to the corrective action, the control unit can display a form suitable for the procedure in the current progress status on the terminal. Therefore, the user can easily input a record to be input in the current progress status on the input form.

  Another aspect of the present invention is a method for management of procedures relating to corrective actions for problems occurring in a clinical laboratory.

  Another aspect of the present invention is a computer program that causes a computer processor to execute the above method. The computer program is stored in a computer-readable recording medium.

  According to the present invention, even if a plurality of procedures are included in the procedure relating to the corrective action, recording by the user is easy.

It is a block diagram of a management system. It is a data structure figure of user setting information. 3 is a data structure diagram of a database 21. FIG. This is the terminal screen. It is a flowchart which shows the process sequence of a control part. This is the terminal screen. This is the terminal screen. It is a data structure figure of authority management information. It is a state transition diagram of status information. This is the terminal screen. It is a data structure figure of example data. This is the terminal screen. It is a data structure figure of example data. This is the terminal screen. This is the terminal screen. This is the terminal screen. This is the terminal screen. It is a data structure diagram of corrective action data This is the terminal screen. This is the terminal screen. It is a data structure figure of correction content confirmation data. This is the terminal screen. This is the terminal screen. This is the terminal screen. It is a data structure figure of effectiveness review data. This is the terminal screen. It is a data structure figure of history data. This is the terminal screen. This is the terminal screen. This is the terminal screen. This is the terminal screen.

[1. Management system]

  The management system shown in FIG. 1 includes a Web server 10, a database server 20, and a terminal 30. The Web server 10 provides an information service for clinical laboratory management to the terminal 30 via a computer network such as the Internet. The Web server 10 functions as an information processing apparatus for managing procedures related to corrective actions in a clinical laboratory. The database server 20 manages the database 21 used by the Web server 10.

  The web server 10 includes a communication unit 11 and a control unit 12. Each of the Web server 10 and the database server 20 is configured by a computer having a memory and a processor. The processor of the Web server 10 executes a computer program stored in the memory, and exhibits functions as the communication unit 11 and the control unit 12.

  The communication unit 11 communicates with one or a plurality of terminals 30 via a computer network such as the Internet. The communication unit 11 communicates with the terminal 30 using a communication protocol such as HTTP, for example. The terminal 30 is operated by a system user. The user includes personnel in the laboratory.

  The terminal 30 accesses the Web server 10 via a computer network such as the Internet. The terminal 30 is operated by a user of the system 100. The user is a person in a clinical laboratory such as a laboratory technician. Personnel in a clinical laboratory may include a physician. Hereinafter, the clinical laboratory is simply referred to as a laboratory.

  The terminal 30 includes a communication unit 31 and a web browser 32. The terminal 30 is configured by a computer having a memory and a processor. The terminal 30 is, for example, a PC, a tablet, or a smartphone. The terminal 30 is preferably a mobile computer such as a tablet. The processor of the terminal 30 executes a computer program stored in the memory and exhibits functions as the communication unit 31 and the Web browser 32. The communication unit 31 communicates with the web server 10. The terminal 30 receives information provided from the Web server 10 by the Web browser 32 and displays the received information in a display area in the Web browser 32.

  The control unit 12 of the Web server controls display of the terminal 30 via the communication unit 11. The control unit 12 executes information processing for managing procedures related to corrective actions. As will be described later, the control unit 12 causes the terminal 30 to display a dashboard referred to for laboratory management on the web browser 32 of the terminal 30.

  The control unit 12 includes an application management unit 13. The management unit 13 has a plurality of applications 13a for managing the laboratory, and manages the execution of these applications 13a. The plurality of applications 13a include one or more applications for managing procedures related to corrective actions. The application 13a has a function for supporting the operation of the laboratory according to ISO15189, in particular, the operation of the laboratory according to ISO15189 regarding the corrective action. The application 13a displays necessary information on the web browser 32 of the terminal 30 and accepts input of necessary information from the web browser in order to support the operation of the laboratory according to ISO15189 regarding corrective actions. The management unit 13 can vary the application provided to the terminal 30 according to the user.

  The management unit 13 includes authority management information 13b (see FIG. 8) for managing user operation authority. The authority management information 13b sets a user who can perform operations such as input for each of a plurality of procedures included in the corrective action. The authority management information 13b will be described later.

  The control unit 12 includes a user setting management unit 15. The management unit 15 has user setting information 15a. As shown in FIG. 2, the user setting information 15a includes information such as a department 601, job title 602, user ID 603, user name 604, proxy user 605, valid start date 606, valid end date 607 to which each user belongs. The user setting information 15a is set by a system administrator or the like.

  The department 601 indicates the type of laboratory, and the department 601 is, for example, a physiological laboratory or a bacteria laboratory. The control unit 12 can grasp the department to which the user belongs by referring to the department 601. In FIG. 2, “common to inspection section” means an inspection section having a plurality of inspection rooms. The role 602 indicates the duties assigned to each person related to the examination room. The role 602 is, for example, an inspection department manager, an engineer chief, a quality manager, each function manager, a chief, or a staff member. Here, the quality manager is a quality manager in the laboratory. In an embodiment, the quality manager is a person who has supervisory responsibility and authority regarding laboratory quality. The control unit 12 can grasp the user's job title by referring to the job title 602. As will be described later, the operation authority differs depending on the job title.

  A user ID 603 and a user name 604 indicate a user. A proxy user 605 indicates a proxy user who can perform operations such as confirmation and approval on behalf of the user. A plurality of proxy users 605 can be set. The effective start date 606 and the effective end date 607 indicate the effective period as a user.

  The control unit 12 includes a database access unit 14. The access unit 14 communicates with the database server 20 and writes and reads data to and from the database 21. The database 21 of the embodiment is a management database for corrective actions. The database 21 has management data for a plurality of corrective actions. The control unit 12 causes the eta base 21 to store a record relating to the corrective action input by the user to the terminal 30. The record stored in the database 21 is taken out in response to a request from the control unit 12 and displayed on the terminal 30.

  FIG. 3 shows the data structure of the corrective action management database. In the database 21, as shown in FIG. 3, each corrective action is, for example, management number 1200, subject 1201, case data 1202, corrective action data 1203, corrective content confirmation data 1204, effectiveness review data 1205, status information 1206, nonconformity Data items of an information source 1207, a department 1208, and history data 1209 are included.

  The management number 1200 is a number for identifying each corrective action. The management number 1200 is assigned to each corrective action by the control unit 12. The subject 1201 is a name given to each corrective action. The case data 1202 is report data of a non-conformance case that is a target of the corrective action (see FIGS. 11 and 13). The corrective action data 1203 is report data of corrective contents (see FIG. 18). The correction content confirmation data 1204 is confirmation data of the correction content by the quality manager (see FIG. 21). The effectiveness review data 1205 is report data of the effectiveness review of the corrective action performed after execution of the corrective action (see FIG. 25).

  In the embodiment, the procedure related to the corrective action includes not only the execution of the corrective action but also a plurality of other procedures. The status information 1206 indicates the progress status of a plurality of procedures included in the procedure relating to the corrective action. In the embodiment, the status information 1206 indicates not only the progress status of each procedure but also the progress status within each procedure. The control unit 12 can grasp the progress status of the procedure regarding each corrective action by referring to the status information 1206.

  The nonconformity information source 1207 indicates a classification of nonconformity (problem) that is a target of the corrective action. The nonconforming information source 1207 includes, for example, customer complaints, inspection errors, internal accuracy management, external accuracy management, purchased product management, equipment management, laboratory environment, management review, sample handling, and others. A department 1208 indicates a department in which a nonconformity that is a target of the corrective action has occurred. The department 1208 indicates, for example, a physiological examination room, a bacteria examination room, and a common examination unit.

  The history data 1209 indicates the execution results of a plurality of procedures included in the procedure relating to the corrective action (see FIG. 27).

  FIG. 4 shows a display screen 100 that the user refers to for laboratory management. The display screen 100 is generated by the control unit 12 of the Web server 10 and displayed on the display device of the terminal 30. In the embodiment, the display screen 100 is displayed by, for example, the web browser 32 of the terminal 30. The display screen 100 has, for example, a plurality of display areas 100a, 100b, and 100c.

  In the display area 100a, for example, a dashboard shown in FIG. 4 is displayed. The dashboard 100a displays one or more widgets 101. The widget 101 is an application 13a displayed on the dashboard 100a. The widget displays the application 13a as an icon. Displaying in the form of an icon means displaying a graphic that can be selected by a user operation.

  In the display area 100b, for example, the application name displayed in the area 100a "corrective action report" and information 109 indicating the user displaying the screen 100 are displayed. The display area 100b is a menu area, for example.

  The dashboard 100a shown in FIG. 1 has a plurality of titles titled “Workflow approval request”, “Correction action report submission status”, “Unread message”, “Workflow pending”, and “This week work schedule”. A widget 101 is displayed. Among these widgets 101, the widget 101 of “correction action report submission status” is an application 13a related to the corrective action.

  The “corrective action report submission status” widget 101 displays at least one piece of statistical information for managing corrective actions.

  As shown in FIG. 5, the control unit 12 accepts a user operation on the dashboard 100a in step S101. When the widget 101 corresponding to the application 13a related to the corrective action is selected by the user operation (for example, click or tap) on the dashboard 100a, in step S102, the control unit 12 displays as shown in FIG. The area 100a is switched from the dashboard to a screen generated by the corrective action report application 13a. The corrective action report application 13a supports reporting / recording of corrective actions in order to support the operation of the laboratory according to ISO15189 relating to corrective actions.

  The display area 100a in FIG. 6 includes, for example, a corrective action list 105, a search condition setting button 106, and a new creation button 107. The search condition setting button 106 is a button for displaying a screen for designating a condition (see FIG. 7) for searching for a corrective action stored in the database 21. The new creation button 107 is a button for displaying a screen for creating novelty of the nonconformity case report (see FIG. 10).

  The corrective action list 105 shows a list of incomplete and completed corrective actions registered in the database 21. The list 105 shows the management number 111, subject 112, classification 113, status 114, input deadline 115, last update date 116, department 117, applicant 118, and application destination 119 for each corrective action. Each corrective action in the list 105 can be selected by a user operation (eg, click or tap).

  The management number 111 corresponds to the management number 1200 in the database 21. The subject 112 corresponds to the subject 1201 in the database 21. The classification 113 corresponds to the nonconforming information source 1207 in the database 21 and displays the classification of the problem indicated by the nonconforming information source 1207. The status 114 corresponds to the status information 1206 in the database 21 and displays progress information indicated by the status information 1206.

  The corrective action list 105 may display all the corrective actions registered in the database 21 in a predetermined order, and displays the screen 100 among all the corrective actions registered in the database 21. It is also possible to display a corrective action that is required to be input by the user who is being made (Juro Yamada in Fig. 6). When the corrective action that requires input by the user displaying the screen 100 and the corrective action that does not require input by the user are displayed in the list 105 in a mixed manner, both corrective actions are displayed. It is preferable to display the treatment in a distinguishable manner. As shown in FIG. 6, by displaying the application destination 119 in the list 105 and displaying the screen 100, the user who displays the screen 100 (in FIG. 6, Juro Yamada) is referred to by referring to the screen 100. It is possible to grasp the corrective action (corrective action that requires input) that is the application destination. When there are a plurality of users who are application destinations, a plurality of users are displayed in the application destination 119.

  When the button 106 in the area 100a in FIG. 6 is selected in step S103 in FIG. 5, the search dialog 120 shown in FIG. 7 is displayed on the screen 100 in step S104. In the dialog 120, a subject name 121, a management number 122, a status 123, a classification 124, an input deadline 125, a last update date 126, a department 127, an updater 128, and the like can be specified as search conditions for corrective action. When the search button 129 is operated in a state where the search conditions are specified, corrective actions corresponding to the search conditions are extracted in the database 21, and a list of extracted corrective actions is displayed. The extracted corrective action list is displayed as shown in FIG.

  When the button 107 in the screen 100 of FIG. 6 is selected in step S103 of FIG. 5, a new nonconformity case report creation screen shown in FIG. 10 is displayed in the area 100a in step S105. When the user makes an input for reporting a nonconformance case in step S106, the control unit 12 registers the input content as case data 1202 or the like of the database 21, and updates the status information 1206 in step S107. The status information 1206 will be described later.

  When an operation for selecting one corrective action in the list 105 shown in FIG. 6 is performed in step S103 of FIG. 5, the control unit 12 progresses the status indicated by the status information 1206 of the selected corrective action in step S108. A screen corresponding to the above is displayed in the area 100a. The screens corresponding to the status information 1206 are shown in FIGS. 10, 12, 14, 15, 16, 16, 17, 19, 20, 22, 23, 24, and 26. These screens will be described later. In step S109, when an input (including confirmation / approval described later) is performed on these screens by a user with operation authority, the control unit 12 updates the status information 1206 in step S110.

[2. User operation authority and corrective action progress]
FIG. 8 shows authority management information 13b for managing the operation authority of the user regarding the corrective action. In the embodiment, as illustrated in FIG. 8, the user's operation authority varies depending on a procedure 702 included in the procedure related to the corrective action. In the embodiment, the procedure related to the corrective action includes five procedures of a nonconformity case report 721, a correction necessity evaluation 722a and 722b, a correction content report 723, a correction content check 724, and an effectiveness review 725. In this order. With many procedures, proper corrective action is ensured and laboratory quality is improved.

  The nonconformance case report 721 is a procedure for reporting a nonconformance case (problem case) that is a target of the corrective action. The correction necessity evaluations 722a and 722b are procedures for evaluating the necessity of corrective actions for the reported problem cases. The correction content report 723 is a procedure for reporting the content of the corrective action for the non-conformance case for which the corrective action is determined to be necessary. The report of the content of the corrective action includes, for example, a record of the execution plan and corrective action of the corrective action. The correction content confirmation 724 is a procedure in which the quality manager confirms the implementation of the corrective action after the content of the corrective action is reported. The effectiveness review is a procedure for recording the effectiveness review after confirmation by the quality manager. An effectiveness review is the result of a follow-up of corrective actions. When the effectiveness review is complete, the corrective action is complete.

  In FIG. 8, an input person 703 is included as a user related to each procedure. The input person 723 is a person who inputs a record in each procedure. In addition, in FIG. 8, there are cases where a user associated with each procedure includes a confirmer 704 and an approver 705 in addition to the input person 703. The confirmer 704 is a person who confirms the input content by the input person 703. The approver 705 is a person who approves the input content by the input person 703.

  For example, in the nonconformance case report 721, it is set that anyone can be used as the input person 703. That is, the case report 721 can be made by all users. In the correction necessity evaluation 722, the user designated as the application destination of the nonconformity case report 721 is set as the input person 703. The user designated as the application destination will be described later. When the correction necessity evaluation 722 evaluates as correction unnecessary 722b, the quality manager is set as the confirmer 704 of the correction unnecessary 722b, and the laboratory management entity is set as the approver 705. The laboratory management entity is, for example, an inspection department manager, an engineer manager, or a supervisor. The quality of the laboratory is guaranteed by the confirmation of the quality manager.

  In the correction content report 723, the user designated as the application destination of the nonconformity case report 721 is set as the input person 703. A specific user designated as the confirmer is set as the confirmer 704 of the correction content report 723. In the correction content confirmation 724, the quality manager is set as the input person 703, and the laboratory management entity is set as the approver 705. In the effectiveness review 725, the user who becomes the input person of the correction content report 723 is set as the input person 703. A quality manager is set as the confirmer 704 of the validity review 725, and a laboratory management entity is set as the approver 705. The quality of the laboratory is guaranteed by the confirmation of the quality manager. The control unit 12 grasps the user roles such as the quality manager or the inspection management subject (inspection department manager) with reference to the user setting information 15a shown in FIG.

  The control unit 12 allows a user having authority shown in FIG. 8 in each procedure to input, confirm, and approve a record in each procedure of corrective action. An unauthorized user can refer to the record in each procedure, but cannot make an input. In FIG. 8, “-” indicates that confirmation or approval is not performed in each procedure. When a proxy user 605 (see FIG. 2) is set for a user who has authority in each procedure, the proxy user 605 can perform input on behalf of the user having authority.

FIG. 8 also shows the correspondence relationship between the procedure 702 included in the procedure related to the corrective action in the embodiment and the corrective action requirement 701 required by ISO15189. As shown in FIG. 8, the corrective action requirement 701 required by ISO 15189 includes the following.
a. Confirmation of nonconformity (711)
b. Identification of root cause of nonconformity (712)
c. Assessment of the need for corrective actions to ensure the prevention of nonconformity recurrence (713)
d. Determine and implement necessary corrective actions (714)
e. Record of corrective action taken (715)
f. Review of effectiveness of corrective actions taken (716)

  The nonconformance case report 721 of the embodiment includes: a. Confirmation of nonconformity (711) and b. Corresponds to the identification of the root cause of the nonconformity (712). The correction necessity evaluation 722a, 722b of the embodiment is performed by c. Address the assessment (713) of the need for corrective action to ensure the prevention of nonconformity recurrence. The correction content report 723 of the embodiment includes d. Respond to the determination and execution (714) of the necessary corrective actions. The correction content confirmation 724 of the embodiment includes e. Corresponds to the record of the corrective action taken (715). An embodiment effectiveness review 725 includes f. Respond to review of effectiveness of corrective actions taken (716).

The control unit 12 manages the progress status of each procedure in the embodiment based on the status information 1206. As shown in FIG. 9, in the embodiment, the status information 1206 indicates the following 12 types of situations.
・ Waiting for input of nonconformity case report 721 (S10) (S11)
-Waiting for input of correction necessity assessment 722a, 722b (S20) (S21)
・ Awaiting confirmation of correction necessity evaluation (no correction required) 722b (S20) (S22)
・ Correction necessity evaluation (no correction required) 722b (S20) waiting for approval (S23)
・ Waiting for correction content report 723 (S30) (S31)
・ Waiting for confirmation of correction report 723 (S30) (S32)
・ Waiting for input of correction content confirmation 724 (S40) (S41)
・ Waiting for approval of correction content confirmation 724 (S40) (S42)
・ Waiting for input of effectiveness review 725 (S50) (S51)
・ Waiting for confirmation of effectiveness review 725 (S50) (S52)
・ Waiting for approval of effectiveness review 725 (S50) (S53)
-Corrective action completed (S60)

  The status information 1206 for each corrective action is generated when the new creation button 107 in FIG. 5 is selected, and the initial value of the status information 1206 at the time of generation is waiting for input of the nonconformance case report 721 (S10) (S11). It is. The control unit 12 updates the status information 1206 as the corrective action progresses. Then, the control unit 12 refers to the status information 206 and causes the display area 100a to display a screen corresponding to the progress status.

[3. Screen display]

[3.1 Nonconformance Case Report]

  FIG. 10 shows the screen 100 that is displayed when the status information 1206 indicates that the nonconformance case report 721 (S10) is waiting for input (S11). The display content 511 in the display area 100a of the screen 100 is an input form for inputting a record of a nonconformance case report. In FIG. 10, the user “F staff (physiology laboratory)” is the input person of the nonconformance case report. The display content 511 in FIG. 10 can also be displayed by operating the operation menu 100c (see FIG. 4). In addition, when a corrective action waiting for a case report is displayed in the list 105 of FIG. 6, it can also be displayed by selecting the displayed corrective action.

  In the non-conformance case report input form 511, input fields for a subject line 131, an application source department 133, a non-conformance information source 135, an event 136, an emergency process 137, and a root cause 138 are displayed. The subject 131 is an input field for a name given to the corrective action. The application source department 133 is an input field for the department to which the applicant belongs. The nonconformity information source 135 is a selection input field for a nonconformity classification to be a target of corrective action. The event 136 is an input field for content of nonconformity that is a target of corrective action. The emergency treatment 137 is an input field for the content of emergency treatment for nonconformity. The root cause 138 is an input field for a root cause of nonconformity.

  In the non-conformance case report input form 511, the user “F personnel (physiology laboratory)” who is the input person is automatically displayed as the applicant 132, and the input date of the form 511 is automatically displayed as the application date 134.

  The input form 511 has an application button 139a. When the application button 139a is selected, the record input in the input form 511 is registered in the database 21 as the case data 1202 shown in FIG. When the case data 1202 is registered, the status information 1206 is updated from waiting for input of the nonconforming case report 721 (S10) (S11) to waiting for input of the correction necessity evaluations 722a and 722b (S20) (S21) ( (See FIG. 9). Note that when the save button 139b is selected, the record being input is temporarily saved so that it can be input later. When the cancel button 139c is selected, the input record is cancelled.

  The input form 511 has an application destination selection field 139d for designating an application destination of the nonconformity case report 511. The application destination of the nonconformance case report 511 is designated by the user “F personnel (physiology laboratory)” who is the input person of the input form 511. In FIG. 10, the E chief of the physiology laboratory is designated as the application destination of the nonconformance case report 511. In this case, the E chief has the authority to be the input person 703 of the correction necessity evaluation 722 and the input person 703 of the correction content report 723 for the nonconformity case report 511 shown in FIG. 10 (see FIG. 8). The user designated as the application destination is notified of the necessary input.

  The input form 511 has a save button 139b. When the save button 139b is selected, a record in the middle of input input to the input form 511 is saved. After saving, additional input is possible from the screen of FIG. The input form 511 has a withdrawal button 139c. When the withdrawal button 139 is selected, the nonconformance case report is recorded as a withdrawal in the database 21. The functions of the save button and the withdrawal button are the same on the screen described later.

[3.2 Evaluation of need for correction]

  FIG. 12 is displayed when the corrective action indicating that the status information 1206 is waiting for input (S21) of the correction necessity evaluations 722a and 722b (S20) is selected in the list 105 of FIG. The screen 100 to be displayed is shown. The screen shown in FIG. 12 can also be displayed by the menu 100c (see FIG. 4), and a notification (for example, the notification 101a in FIG. 4) in the widget 101 displayed on the dashboard 100a in FIG. 4 is displayed. It can also be displayed by selecting. The same applies to other screens after FIG.

  The display content 521 in the display area 100a of the screen 100 of FIG. 12 includes a record display area 145 for displaying a record already input by the input person 703 of the nonconformance case report for the selected corrective action, and an input form 140.

  In the area 145, a record input in the procedure performed before the procedure in the progress status indicated by the status information 1206 is displayed. Specifically, in the area 145, a record including the contents of the case data 1202 (see FIG. 11) registered in the database 21 is displayed. The record displayed in area 145 is read-only and cannot be changed. The inability to change prevents tampering and improves the quality of procedures for corrective actions.

  The input form 140 corresponds to the status information 1206 indicating that the correction necessity evaluation 722a, 722b (S20) is waiting for input (S21), and the selection input field 141 for the evaluation of the necessity of the corrective action. Have The input form 140 also has a comment input field 142. Any comment can be entered in the comment input field 142.

  The screen in FIG. 12 is viewable by all users for information sharing. However, only the user who has the authority as the input person 703 of the correction necessity evaluation can input the input form 140. For other users, the input form 140 is displayed as read-only. For other users, the input form 140 may not be displayed. Here, the user who has the authority as the input person 703 of the correction necessity evaluation is the E chief selected in the application destination selection field 139d in FIG.

  The input form 140 has an application button 143a, a save button 143b, and a withdrawal button 143c. When the application button 143a is selected, a record input in the input form 140 is additionally registered in the database 21 as case data 1202, as shown in FIG. The case data 1202 in FIG. 13 is obtained by adding a record input in the input form 140 to the case data 1202 in FIG.

  When the case data 1202 (see FIG. 13) that is deemed necessary (correction required) is registered, the status information 1206 is input from the waiting for input of the correction necessity evaluations 722a and 722b (S20) (S21). It is updated to wait for input (S31) of the correction content report 723 (S30) (see FIG. 9). The control unit 12 notifies the user who becomes the input person 703 of the correction content report.

  On the other hand, when the case data 1202 that the necessity of corrective action is not required (correction is not required) is registered, the status information 1206 receives the correction necessity evaluation 722a, 722b (S20) from the input waiting (S21), and the necessity of correction is required. It is updated to wait for confirmation (S22) of the evaluation 722b (S20) (see FIG. 9). The control unit 12 notifies the user who becomes the confirmer 704 of the correction necessity evaluation.

  FIG. 14 is displayed when the corrective action indicating that the status information 1206 is waiting for confirmation (S22) of the correction necessity evaluation 722b (S20) is selected in the list 105 of FIG. 6, for example. A screen 100 is shown. The display content 522 in the display area 100a of the screen 100 is a record display area 155 for displaying records that have been input by the input person 703 of the nonconformance case report and the input person (E chief) of the correction necessity evaluation for the selected corrective action. And an input form 156.

  In the area 155, a record including the contents of the case data 1202 (see FIG. 13) registered in the database 21 is displayed. The record displayed in area 155 is read-only and cannot be changed. The input form 156 includes a confirmation button 151b corresponding to the status information 1206 indicating that the correction necessity evaluation 722b (S20) is waiting for confirmation (S22). When the confirmation button 151b is selected, the fact that it has been confirmed is registered in the database 21, and the status information 1206 receives the correction necessity evaluation 722b (S20) from the waiting for confirmation (S22) of the correction necessity evaluations 722a and 722b (S20). ) Is awaiting approval (S23) (see FIG. 9). The control unit 12 notifies the user who becomes the approver 705 of the correction necessity evaluation.

  The input form 156 has a return button 15a. When the return button 151a is selected, the status information 1206 returns from waiting for confirmation of the correction necessity evaluations 722a and 722b (S20) (S22) to waiting for input of the correction necessity evaluation 722b (S20) (S21) (FIG. 9). The control unit 12 notifies the user who becomes the input person 703 of the correction necessity evaluation to urge re-evaluation. The input form 156 also has a comment input field 156.

  The screen in FIG. 14 is viewable by all users for information sharing. However, input to the input form 156 can be performed only by a user who has the authority as the confirmer 704 of the correction necessity evaluation. For other users, the input form 156 is displayed as read-only or is not displayed. Here, the user having the authority as the confirmer 704 for the correction necessity evaluation is the C quality manager.

  FIG. 15 is displayed when the corrective action indicating that the status information 1206 is waiting for approval (S23) of the correction necessity evaluation 722b (S20) is selected in the list 105 of FIG. 6, for example. A screen 100 is shown. The display content 523 in the display area 100a of the screen 100 is a record display area 165 for displaying records that have been input by the input person 703 of the nonconformance case report and the input person (E chief) of the correction necessity evaluation for the selected corrective action. And an input form 166.

  In the area 165, a record including the contents of the case data 1202 (see FIG. 13) registered in the database 21 is displayed. The record displayed in area 165 is read-only and cannot be changed. The input form 166 has an approval button 161b corresponding to the status information 1206 indicating that the correction necessity evaluation 722b (S20) is waiting for approval (S23). When the approval button 161b is selected, the approval is registered in the database 21, and the status information 1206 is updated from the awaiting approval (S23) of the correction necessity evaluation 722b (S20) to the completion of the corrective action (S60). (See FIG. 9).

  The input form 166 also includes a return button 161a and a comment input field 166. When the return button 161a is selected, the status information 1206 returns from waiting for approval of the correction necessity evaluation 722b (S20) (S23) to waiting for confirmation of the correction necessity evaluation 722b (S20) (S31) (see FIG. 9). ). The control unit 12 notifies the user who becomes the confirmer 704 of the correction necessity evaluation to urge reconfirmation.

  The screen in FIG. 15 is viewable by all users for information sharing. However, only the user who has the authority as the approver 705 of the correction necessity evaluation can input the input form 166. For other users, the input form 166 is displayed as read-only or is not displayed. Here, the user who has the authority as the approver 705 of the correction necessity evaluation is the manager A.

[3.3 Report on corrections]

  FIG. 16 shows a screen displayed when the corrective action indicating that the status information 1206 is waiting for input of the correction content report 723 (S30) (S31) is selected in the list 105 of FIG. 6, for example. 100 is shown.

  The display content 531 in the display area 100a of the screen 100 includes a recording display area 171 for displaying a record already input by the input person 703 of the nonconformance case report for the selected corrective action, and an input form 172.

  In the area 171, a record input in the procedure performed before the procedure in the progress status indicated by the status information 1206 is displayed. Specifically, the area 171 displays a record including the contents of case data 1202 (see FIG. 13), which is data recorded for the correction necessity evaluation, which is the previous procedure. The record displayed in the area 171 is read-only and cannot be changed.

  The input form 172 has an input field 175 for inputting correction content in response to the status information 1206 indicating that the correction content report 723 (S30) is waiting for input (S31). In addition, in the correction content report input form 172, the user “D person in charge of each function (physiology laboratory)” is automatically displayed as the applicant 173, and the input date of the form 172 is automatically displayed as the application date 174. Is done. The user can easily perform input while referring to the input record displayed in the area 171.

  The screen in FIG. 16 is viewable by all users for information sharing. However, only the user who has the authority as the input person 703 of the correction content report can enter the input form 172. For other users, the input form 172 is displayed as read-only or display is omitted. Here, the user having the authority as the input person 703 of the correction content report is the person in charge of each D function. Each functional manager D is a user selected as an application destination in the nonconformity case report input form 511 displayed in the area 171 of FIG.

  The input form 172 includes an application button 143a, a save button 143b, and a withdrawal button 143c. When the application button 143a is selected, the record input in the input form 172 is registered in the database 21 as corrective action data 1203 (see FIG. 18).

  When the corrective action data 1203 is registered, the status information 1206 is updated from waiting for input of the correction content report 723 (S30) (S31) to waiting for confirmation of the correction content report 723 (S30) (S32) (FIG. 9). reference).

  The input form 172 has an application destination selection field 176 for designating an application destination of a correction content report. The application destination of the correction content report is designated by the user “D person in charge of each function (physiological examination room)” who is the input person of the input form 172. In FIG. 16, engineer B engineer is designated as the application destination for the correction content report. The engineer B engineer is, for example, the supervisor of each function manager of D. In this case, the chief engineer B has the authority to become the confirmer 704 of the correction content report (see FIG. 8). The control unit 12 notifies the user designated as the application destination to confirm the correction content report.

  The screen of FIG. 17 is displayed when the corrective action indicating that the status information 1206 is waiting for confirmation of the correction content report 723 (S30) (S32) is selected in the list 105 of FIG. 6, for example. A screen 100 is shown. The display content 531 in the display area 100a of the screen 100 includes a recording display area 171 for displaying a record already input by the input person 703 of the nonconformance case report for the selected corrective action, and an input form 172.

  In the area 171, a record including the contents of the case data 1202 (see FIG. 13) registered in the database 21 is displayed. The record displayed in the area 171 is read-only and cannot be changed. The input form 172 has an input field 175 for inputting correction content in response to the status information 1206 indicating that the correction content report 723 (S30) is waiting for input (S31).

  The input form 172 includes a return button 178a, a confirmation button 178b, and a comment input field 179. In the input form of FIG. 17, the contents of the applicant 173, the application date 174, and the correction content 175 are the same as the contents of the applicant 173, the application date 174, and the correction content 175 in FIG. In the input form of FIG. 17, the applicant 173, the application date 174, and the correction content 175 are read-only.

  The screen in FIG. 17 is viewable by all users for information sharing. However, an operation (input) to the return button 178a, the confirmation button 178b, and the comment input field 179 on the input form 172 can be performed only by a user who has the authority as the confirmer 704 of the correction content report. For other users, the return button 178a, the confirmation button 178b, and the comment input field 179 are displayed as read-only or omitted. Here, the user who has the authority as the confirmer 704 of the correction content report is the chief engineer B. The engineer B engineer is a user selected as an application destination in the application destination selection field 176 of FIG.

  When the confirmation button 178b is selected, the confirmer and the confirmation date are additionally registered in the corrective action data 1203 of the database 21, as shown in FIG.

  When the corrective action data 1203 of FIG. 18 is registered by selecting the confirmation button 178b, the status information 1206 waits for the input of the correction content confirmation 724 (S40) from the confirmation wait for the correction content report 723 (S30) (S32). (S41) is updated (see FIG. 9). The control unit 12 notifies the quality manager who has the authority as the input person of the correction content confirmation 724 (S40) to prompt the input of the correction content confirmation.

  When the return button 178a is selected, the status information 1206 returns from waiting for confirmation of the correction content report 723 (S30) (S32) to waiting for input of the correction content report 723 (S30) (S31) (see FIG. 9). The control unit 12 notifies the user who has the authority as the input person of the correction content report 723 (S30) to prompt the user to re-input the correction content report.

[3.4 Confirmation of correction details]

  FIG. 19 shows a screen displayed when the corrective action indicating that the status information 1206 is waiting for input of the correction content confirmation 724 (S40) (S41) is selected in the list 105 of FIG. 6, for example. 100 is shown.

  The display content 541 in the display area 100a of the screen 100 is a record display for displaying the records already input by the input person 703 of the nonconformity case report 721 and the input person 703 and the confirmer 704 of the correction content report 723 for the selected corrective action Regions 181 and 182 and an input form 182 are included.

  In the record display areas 181 and 182, records input in each procedure performed before the procedure in the progress status indicated by the status information 1206 are displayed. The areas 181 and 182 divide the records into “non-conformance case report” and “correction content report” which are input procedures, and display the records. The recording display areas 181 and 182 are displayed in a tab format so as to be switchable. Tabs are provided for each procedure, and the record display areas 181 and 182 include a “nonconformity case report” tab and a “correction content report” tab. When the “correction content report” tab is selected, the display area 181 of the input record including the content of the corrective action data 1203 (see FIG. 18) registered in the database 21 is switched and displayed. When the “nonconformity case report” tab is selected, the display area 182 of the input record including the contents of the case data 1202 (see FIG. 13) registered in the database 21 is switched and displayed.

  Corresponding to the status information 1206 indicating that the correction content confirmation 724 (S40) is waiting for input (S41), a correction content report that is the procedure immediately before the correction content confirmation 724 is displayed in the recording display areas 181 and 182. The display area 181 of the record including the content of the corrective action data 1203 that is the record data is displayed by default. Therefore, the input person of confirmation of correction content can easily check the correction content while referring to the correction content report. In addition, by selecting the “nonconformance case report” tab, the content of the nonconformance case report, which is the procedure before the correction content report, is switched and displayed so that it can be easily referred to. Since the input to the input form 183 can be performed while referring to the input record, the workability is improved. Further, since the recording display areas 181 and 182 are switched and displayed by tabs, it is possible to prevent the display area from becoming large.

  The input form 183 has input fields 187a and 187b for confirming the correction contents corresponding to the status information 1206 indicating that the correction information confirmation 724 (S40) is waiting for input (S41). The input fields 187a and 187b include an option button 187a for selecting “approval” and an option button 187b for selecting “recorrect”. The input form 183 also has a comment input field 189. In the input form 183, the user who is the input person “C quality manager (common to the inspection unit)” is automatically displayed as the applicant 184, and the input date of the form 182 is automatically displayed as the application date 185. The corrective action management number 186 is also automatically displayed.

  The screen in FIG. 19 is viewable by all users for information sharing. However, input to the input form 183 can be performed only by a user (quality manager) who has the authority as the input person 703 for confirming the correction content. For other users, the input form 183 is displayed as read-only or is not displayed. Here, the user having the authority as the input person 703 for checking the correction content is the C quality manager.

  The input form 172 includes an application button 190a, a save button 190b, and a withdrawal button 190c. When the application button 143a is selected after the option button 187a for selecting “approval” is selected, the record entered in the input form 183 is stored in the database as correction content confirmation data 1204 (see FIG. 21). 21 is registered.

  When the correction content confirmation data 1204 is registered, the status information 1206 is updated from waiting for input of the correction content confirmation 724 (S40) (S41) to waiting for approval of the correction content confirmation 724 (S40) (S42) (FIG. 9). The control unit 12 notifies the user who has the authority as the approver of the correction content confirmation to urge approval.

  When the application button 143a is selected and operated after selecting the option button 187b for selecting “re-correction”, the status information 1206 displays the correction content from the waiting for input of the correction content confirmation 724 (S40) (S41). The process returns to waiting for input of report 723 (S30) (S31). The control unit 12 notifies the user who has the authority as an input person of the correction content report to prompt the user to re-input the correction content report.

  The screen of FIG. 20 is displayed when the corrective action indicating that the status information 1206 is waiting for approval of the correction content confirmation 724 (S40) (S42) is selected in the list 105 of FIG. 6, for example. A screen 100 is shown. The display content 542 in the display area 100a of the screen 100 is the same as the display content 541 in FIG. 19, and includes recording display areas 181 and 182 displayed in a tab format, and an input form 182.

  The input form 182 includes a return button 191a, an approval button 191b, and a comment input field 192. In the input form of FIG. 20, the contents of the applicant 184, the application date 185, and the management number 186 are the same as the contents of the applicant 184, the application date 185, and the management number 186 in FIG. In the input form of FIG. 17, the applicant 184, the application date 185, and the management number 186 are read-only.

  The screen in FIG. 20 is viewable by all users for information sharing. However, only the user who has the authority as the approver 705 for confirming the correction contents can perform the operation (input) to the return button 191a, the approval button 191b, and the comment input field 192 in the input form 183. For other users, the return button 191a, the approval button 191b, and the comment input field 192 are displayed as read-only or omitted. Here, the user who has the authority as the approver 705 for checking the correction details is the E chief. In the embodiment, the chief is the laboratory management entity.

  When the approval button 191b is selected, the final approver and the final approval date are additionally registered in the correction content confirmation data 1204 of the database 21 as shown in FIG.

  When the correction content confirmation data 1204 of FIG. 21 is registered, the status information 1206 is updated from waiting for approval of the correction content confirmation 724 (S40) (S42) to waiting for input of the validity review 754 (S50) (S51). (See FIG. 9). The control unit 12 notifies the user having the authority as an input person of the effectiveness review 725 (S50) to prompt the input of the effectiveness review.

  When the return button 191a is selected, the status information 1206 returns from waiting for approval of the correction content confirmation 724 (S40) (S42) to waiting for input of the correction content confirmation 724 (S40) (S41) (see FIG. 9). The control unit 12 notifies the user who has the authority as the input person of the correction content confirmation 724 (S40) to prompt the user to re-input the correction content confirmation.

[3.5 Effectiveness review]

  FIG. 22 shows a screen that is displayed when the corrective action indicating that the status information 1206 is waiting for input of the validity review 725 (S50) (S51) is selected in the list 105 of FIG. 6, for example. 100 is shown.

  The display content 551 in the display area 100a of the screen 100 includes the input person 703 of the nonconformance case report 721, the input person 703 and the confirmation person 704 of the correction content report 723, and the input person of the correction content confirmation 724 for the selected corrective action. 703 and a record display area 193, 194, 195 for displaying a record already input by the approver 705, and an input form 186.

  In the record display areas 193, 194, and 195, records input in each procedure performed before the procedure in the progress status indicated by the status information 1206 are displayed. The areas 193, 194, and 195 are divided into “nonconformity case report”, “correction content report”, and “correction content confirmation” that are the input procedures, and display the records. The recording display areas 193, 194, 195 are displayed in a tab format so as to be switchable. Tabs are provided for each procedure, and the record display areas 193, 194, and 195 include a “nonconformity case report” tab, a “correction content report” tab, and a “correction content confirmation” tab. . When the “correction content confirmation” tab is selected, the display area 193 of the input record including the content of the correction content confirmation data 1204 (see FIG. 21) registered in the database 21 is switched and displayed. When the “correction content report” tab is selected, the display area 194 of the input record including the content of the corrective action data 1203 (see FIG. 18) registered in the database 21 is switched and displayed. When the “nonconformity case report” tab is selected, the display area 195 of the input record including the contents of the case data 1202 (see FIG. 13) registered in the database 21 is switched and displayed.

Corresponding to the status information 1206 indicating that the validity review 725 (S50) is waiting for input (S51), the recording display areas 193, 195, and 196 have corrections that are procedures immediately before the validity review 725. Correction content confirmation data 1204 which is record data of content confirmation
The display area 193 of the record including the contents is displayed by default. Therefore, the input person of the effectiveness review can easily input the effectiveness review while referring to the confirmation of the correction content immediately before. In addition, by selecting the “nonconformity case report” or “correction content report” tab, it is possible to easily refer to the content of the nonconformance case report or the correction content report, which is the procedure before the correction content confirmation. Since input to the input form 196 can be performed while referring to the input record, workability is improved. In addition, since the recording display areas 193, 194, and 195 are switched and displayed by tabs, the display area can be prevented from becoming large.

  The input form 196 has a comment input field 199 for validity review, corresponding to the status information 1206 indicating that the validity review 725 (S50) is waiting for input (S51). In the input form 183, the user “E chief (physiology laboratory)” who is the input person is automatically displayed as the applicant 197, and the input date of the form 196 is automatically displayed as the application date 198. The corrective action management number 198 is also automatically displayed.

  The screen in FIG. 22 is viewable by all users for information sharing. However, only the user who has the authority as the validity reviewer 703 can input the input form 196. For other users, the input form 196 is displayed as read-only or is not displayed. Here, the user who has the authority as the input person 703 of the effectiveness review is the E chief who made the correction content report 723.

  The input form 196 includes an application button 200a, a save button 200b, and a withdrawal button 200c. When the application button 200a is selected, the record input in the input form 196 is registered in the database 21 as validity review data 1205 (see FIG. 25).

  When the validity review data 1205 is registered, the status information 1206 is updated from waiting for input of the validity review 725 (S50) (S51) to waiting for confirmation of the validity review 725 (S50) (S52) (FIG. 9). The control unit 12 notifies the user who has authority as a confirmer of the effectiveness review to confirm.

  The screen in FIG. 23 is displayed when the corrective action indicating that the status information 1206 is waiting for confirmation of the effectiveness review 725 (S50) (S52) is selected in the list 105 in FIG. 6, for example. A screen 100 is shown. The display contents 552 in the display area 100a of the screen 100 are the same as the display contents 551 in FIG. 22, and include recording display areas 193, 194, 195 displayed in a tab format, and an input form 196.

  The input form 196 includes a return button 201a, a confirmation button 201b, and a comment input field 202. In the input form of FIG. 23, the contents of the applicant 197, the application date 198, and the comment 199 are the same as the contents of the applicant 197, the application date 198, and the comment 199 in FIG. In the input form of FIG. 23, the applicant 197, the application date 198, and the comment 199 are read-only.

  The screen in FIG. 23 is viewable by all users for information sharing. However, an operation (input) to the return button 201a, the confirmation button 201b, and the comment input field 202 on the input form 196 can be performed only by a user who has the authority as the validity reviewer 704. For other users, the return button 201a, the confirmation button 201b, and the comment input field 202 are displayed as read-only or omitted. Here, the user having the authority as the validity review confirmer 704 is the C quality manager.

  When the confirmation button 201b is selected, a confirmer is additionally registered in the validity review data 1205 of the database 21 (see FIG. 25).

  When a checker is additionally registered in the validity review data 1205, the status information 1206 is updated from waiting for confirmation of the validity review 725 (S50) (S52) to waiting for approval of the validity review 725 (S50) (S53). (See FIG. 9). The control unit 12 notifies the user having the authority as the approver of the effectiveness review 725 (S50) to urge the approval of the effectiveness review.

  When the return button 201a is selected, the status information 1206 returns from waiting for confirmation of the validity review 725 (S50) (S52) to waiting for input of the validity review 725 (S50) (S51) (see FIG. 9). The control unit 12 notifies the user who has the authority as the input person of the effectiveness review 725 (S50) to prompt the user to re-input the effectiveness review.

  The screen of FIG. 24 is displayed when the corrective action indicating that the status information 1206 is waiting for approval of the effectiveness review 725 (S50) (S53) is selected in the list 105 of FIG. 6, for example. A screen 100 is shown. The display contents 553 in the display area 100a of the screen 100 are the same as the display contents 551 in FIG. 22 and the display contents 552 in FIG. 23, and the recording display areas 193, 194, 195 displayed in a tab format and the input form 196. And including.

  The input form 196 includes a return button 203a, an approval button 203b, and a comment input field 204. In the input form of FIG. 24, the applicant 1197, the application date 198, and the comment 199 are read-only.

  The screen in FIG. 24 is viewable by all users for information sharing. However, an operation (input) to the return button 203a, the approval button 203b, and the comment input field 204 on the input form 196 can be performed only by a user who has the authority as the validity review approver 705. For other users, the return button 203a, the approval button 203b, and the comment input column 204 are displayed as read-only or omitted. Here, the user who has the authority as the validity review approver 705 is the department manager A.

  When the approval button 203b is selected, the approver and the approval date are additionally registered in the validity review data 1205 of the database 21 (see FIG. 25).

  When an approver or the like is additionally registered in the effectiveness review data 1205, the status information 1206 is updated from waiting for approval of the effectiveness review 725 (S50) (S53) to completion of corrective action (S60) (see FIG. 9). ).

  When the return button 203a is selected, the status information 1206 returns from waiting for approval of the validity review 725 (S50) (S53) to waiting for confirmation of the validity review 725 (S50) (S52) (see FIG. 9). The control unit 12 notifies the user who has the authority as the confirmer of the effectiveness review 725 (S50) to urge reconfirmation.

[3.6 Corrective action completed]

  The screen of FIG. 26 shows the screen 100 that is displayed when the corrective action whose status information 1206 indicates that the corrective action is completed (S60) is selected in the list 105 of FIG. 6, for example. . The display content 560 in the display area 100a of the screen 100 includes record display areas 211, 212, 213, and 214 that display records that have been input regarding the selected corrective action.

  The record display areas 211, 212, 213, and 214 are divided into “nonconformity case report”, “correction content report”, “correction content confirmation”, and “effectiveness review”, which are recorded procedures. Is displayed. The recording display areas 211, 212, 213, and 214 are displayed in a tab format so as to be switchable. Tabs are provided for each procedure, and the record display areas 211, 212, 213, and 214 include a "nonconformity case report" tab, a "correction content report" tab, a "correction content confirmation" tab, And an “Effectiveness Review” tab. When the “validity review” tab is selected, the display area 211 of the input record including the contents of the validity review data 1205 (see FIG. 24) registered in the database 21 is switched and displayed. When the “correction content confirmation” tab is selected, the display area 212 of the input record including the content of the correction content confirmation data 1204 (see FIG. 21) registered in the database 21 is switched and displayed. When the “correction content report” tab is selected, the display area 213 of the input record including the content of the corrective action data 1203 (see FIG. 18) registered in the database 21 is switched and displayed. When the “nonconformity case report” tab is selected, the display area 214 of the input record including the contents of the case data 1202 (see FIG. 13) registered in the database 21 is switched and displayed.

[3.7 Corrective action history]
As shown in FIG. 3, history data 1209 regarding procedures related to each corrective action is registered in the database 21. The history data 1209 is additionally registered every time an application, approval and confirmation in each procedure included in the procedure relating to the corrective action is performed. As shown in FIG. 27, the history data 1209 includes a management number, a user who has become a responder (input person, confirmer, approver), corrective action procedure, result of the procedure (application, confirmation, approval), comment , Including correspondence dates.

  The history data 1209 is used to display a list of procedures included in procedures related to corrective actions. FIG. 28 is a screen displaying a history of completed procedures as a list. The control unit 12 displays the screen of FIG. 28 on the terminal 30 based on the history data 1209.

  The screen of FIG. 28 is displayed in the area 100a instead of the display content 560 of FIG. 26, for example, by selecting the approval history screen 220 included in the screen of FIG. Since the screen in FIG. 26 is in the tab format, a tab switching operation is required to refer to all the information. However, in the screen in FIG. 28, the entire history is displayed as a list, so that it is displayed. Although it has a small amount of information, it is suitable for grasping the entire history.

  The history list screen as shown in FIG. 28 is displayed on other screens (FIGS. 10, 12, 14, 15, 16, 17, 17, 19, 20, 22, 23, 24). This is also displayed by selecting an approval history button 220 included in ().

[4. Search for corrective actions based on statistical information]

  29 to 31 show a modification for searching for a corrective action registered in the database 21. In the search example using the search dialog 120 shown in FIG. 7, it is necessary to input search conditions. In the example shown in FIGS. 29 to 31, a corrective action is searched without inputting search conditions or by inputting a small number of search conditions by a selection operation of a graphical user interface (GUI) displayed on the screen of the terminal 30. This improves user convenience.

  FIG. 29 shows “corrective action report submission status” which is a widget related to the corrective action among the plurality of widgets 101 displayed on the screen of FIG. A widget 101 shown in FIG. 29 displays statistical information about the progress status of a plurality of corrective actions registered in the database 21 using a GUI. The status of corrective actions can be easily grasped by displaying statistical information. The widget 101 shown in FIG. 29 includes, as statistical information, for example, a correction completion rate 801, a correction number graph 802 for each problem classification (nonconformity information source), a number of corrections required 803, a countermeasure plan waiting number 804, and a plan evaluation waiting number 805. Is displayed. The statistical information is calculated using, for example, status information 1206 of each corrective action. The statistical information may be calculated using the nonconforming information source 1207 or may be calculated using the department 1208.

  Each statistical information 801, 802, 803, and 804 can be selected by a user operation (for example, click or tap). FIG. 30 shows a screen displayed in the area 100a in place of the dashboard of FIG. 4 when the number of rectifications required 803 is selected. In the screen of FIG. 30, statistical information 811 more detailed than that in FIG. 29 is displayed regarding the corrective action to be corrected. The statistical information 811 in FIG. 30 indicates the ratio between cases requiring correction and cases not requiring correction, and is more detailed information than FIG.

  The statistical information 811 in FIG. 30 can also be selected by a user operation. When the statistical information 811 is selected, for example, the screen of FIG. 31 is displayed in the area 100a. In the screen of FIG. 31, in addition to the statistical information 811, a graph 812 of the number of corrections required for each department and a graph 813 of the number of corrections required for each nonconforming information source are displayed as statistical information. By referring to the screen of FIG. 31, the user can grasp the department where the number of cases requiring correction is large, or can grasp the number of corrections required for each information source.

  In FIG. 31, the statistical information 901, 902, and 903 included in the graph 812 and the graph 813 can also be selected by a user operation. For example, each of the statistical information 901, 902, and 903 in the graph 812 has four correction cases 901 in the bacterial laboratory, seven corrections 902 in the physiological laboratory, and corrections that are common to the inspection departments. This indicates that the number of cases 903 is three. For example, when the number of corrections 903 required in the physiology laboratory is selected by a user operation, the control unit 12 extracts seven correction actions indicated by the statistical information 902 from the database 21, and displays a list of the extracted correction processes. The corrective action list 105 as shown in FIG. 6 is displayed in the area 100a. Therefore, the user can efficiently search for corrective actions while referring to the statistical information.

  Note that a list of corrective actions indicated by the statistical information may be displayed by selecting the statistical information 801, 802, 803, 804, 805 of FIG. 29 or the statistical information 811 of FIG.

10 Web server 11 Communication unit 12 Control unit 12
30 terminal 100 screen 145 record display area 140 input form 155 record display area 156 input form 165 record display area 166 input form 171 record display area 172 input form 181 record display area 182 record display area 183 input form 191 record display area 192 record display Area 193 Record display area 196 Input form

Claims (33)

An information processing device for managing procedures related to corrective actions for problems occurring in a clinical laboratory,
A communication unit that communicates with a user-operable terminal;
A control unit that controls display of the terminal via the communication unit,
The corrective action procedure includes a plurality of procedures including a record input by a user and a confirmation of the record by a user other than the user who has input the record,
The controller is
Processing for updating information indicating the progress status according to the progress status of the plurality of procedures;
Executing a process of causing the terminal to display a screen including an input form for inputting a record corresponding to the progress indicated by the information for each procedure.
Information processing device. The plurality of procedures are:
Procedures including input of problem case reports,
A procedure that includes the input of an assessment of the need for corrective action on the problem case,
Procedures including input of corrective action content reports for problem cases;
The information processing apparatus according to claim 1, further comprising: a plurality of procedures selected from a group consisting of a procedure including an input by a quality manager regarding execution of a corrective action, and a procedure including an input of an effectiveness review of corrective actions. The information processing apparatus according to claim 1, wherein the plurality of procedures includes a procedure in which confirmation of the recording is performed by a quality manager. The information processing apparatus according to any one of claims 1 to 3, wherein the screen includes a recording display area for displaying an input record. The information processing apparatus according to claim 4, wherein the input record is a record input in a procedure performed before the progress status indicated by the information. The information processing apparatus according to claim 4, wherein the inputted record is displayed for each of the plurality of procedures and displayed in the recording display area. The information processing apparatus according to claim 6, wherein the input record that has been classified for each of the plurality of procedures is displayed so as to be switchable for each of the plurality of procedures. The information processing apparatus according to any one of claims 1 to 7, wherein the control unit performs a process of updating the information in response to a record input in the input form being registered in a database. The information processing apparatus according to any one of claims 1 to 8, wherein the input form is displayed so that a user having authority to input the input form in a progress situation indicated by the information can input a record. The control unit displays the input form as read-only when the screen is displayed on a terminal of a user who does not have authority to input the input form in the progress status indicated by the information. The information processing apparatus described. The control unit executes a process of causing the terminal to display a list of corrective actions including a display indicating the progress status of the plurality of procedures.
The process of causing the terminal to display the screen is a process of causing the terminal to display a screen including an input form for inputting a record to be input in the progress status indicated by the information about the corrective action selected from the list. The information processing apparatus according to any one of claims 1 to 10. The controller is
Processing for displaying statistical information on the progress of the plurality of procedures on the terminal;
A process of displaying the list on the terminal in response to the statistical information being selected by a user operation;
12. The information processing apparatus according to claim 11, wherein The information processing apparatus according to claim 11, wherein the list includes a classification of a problem to be removed by the corrective action. The control unit executes a process of causing the terminal to display a screen on which a search condition for searching for the corrective action can be input,
The said screen which can input the said search conditions can input the said progress and classification of the problem which should be removed by the said corrective action as said search conditions. Information processing device. The controller is
Processing to display statistical information on the progress of the procedure relating to the corrective action on the terminal;
In response to selection of the statistical information by a user operation, a process of extracting a corrective action related to the statistical information and displaying a list of the extracted corrective actions on the terminal;
The information processing apparatus according to any one of claims 1 to 14. The information processing apparatus according to claim 4, wherein the control unit displays the input record displayed in the record display area on the terminal in a read-only manner. A method for managing procedures related to corrective actions for problems occurring in a clinical laboratory,
The corrective action includes a plurality of procedures including input of a record by a user and confirmation of the record by a user other than the user who has input the record,
Updating information indicating the progress according to the progress of the plurality of procedures;
Displaying a screen including an input form for inputting a record corresponding to the progress indicated by the information for each procedure, to the user;
Including methods. The plurality of procedures are:
Procedures including input of problem case reports,
A procedure that includes the input of an assessment of the need for corrective action on the problem case,
Procedures including input of corrective action content reports for problem cases;
18. The method of claim 17, comprising a plurality of procedures selected from the group consisting of a procedure that includes input by a quality manager for performing corrective actions, and a procedure that includes input of corrective action effectiveness reviews. The method according to claim 17 or 18, wherein the plurality of procedures include a procedure in which the recording is confirmed by a quality manager. The method according to any one of claims 17 to 19, wherein the screen includes a recording display area for displaying an input record. The method according to claim 20, wherein the input record is a record input in a procedure performed before the progress indicated by the information. The method according to claim 20 or 21, wherein the inputted record is displayed for each of the plurality of procedures and displayed in the record display area. The method according to claim 22, wherein the input record that has been classified for each of the plurality of procedures is displayed so as to be switchable for each of the plurality of procedures. The method according to any one of claims 17 to 23, wherein the information is updated in response to a record entered in the input form being registered in a database. The method according to any one of claims 17 to 24, wherein the input form is displayed so that a user having authority to input the input form in a progress situation indicated by the information can input a record. The method according to claim 25, wherein the screen is displayed with the input form as read-only for a user who does not have authority to input the input form in the progress status indicated by the information. Further comprising displaying to the user a list of corrective actions including a display indicating the progress of the plurality of procedures.
27. A method according to any one of claims 17 to 26, wherein the screen includes an input form for entering a record to be entered in a progress situation indicated by the information about the corrective action selected from the list. Further displaying to the user statistical information regarding the progress of the plurality of procedures;
The method according to claim 27, wherein the list is displayed in response to the statistical information being selected by a user operation. 29. A method according to claim 27 or 28, wherein the list includes a classification of problems to be removed by the corrective action. Further including displaying to the user a screen on which a search condition for searching for the corrective action can be input,
The said screen which can input the said search conditions can input the said progress and classification of the problem which should be removed by the said corrective action as said search conditions. Method. Displaying statistical information on the progress of the procedure relating to the corrective action to the user;
In response to the statistical information being selected by a user operation, extracting corrective actions related to the statistical information and displaying a list of extracted corrective actions to the user;
The method according to any one of claims 17 to 30, comprising: The method according to any one of claims 17 to 31, wherein the input record displayed in the record display area is displayed in a read-only manner. A computer program for managing procedures related to corrective actions for problems occurring in a clinical laboratory,
The corrective action includes a plurality of procedures including input of a record by a user and confirmation of the record by a user other than the user who has input the record,
The computer program is stored in a computer,
Updating information indicating the progress according to the progress of the plurality of procedures;
Displaying a screen including an input form for inputting a record corresponding to the progress indicated by the information for each procedure, to the user;
A computer program that runs.

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