阅读说明：本技术 合格性自动判定系统 (Automatic qualification judging system ) 是由 渡辺覚 吉田刚 冈本冬树 冈部有真 安井千裕 于 2018-09-27 设计创作，主要内容包括：合格性自动判定系统包括确认文档保持部、确认文档读出部、判定试验执行部及合格性判定部。所述确认文档保持部保持合格性确认文档。所述确认文档读出部构成为,从所述确认文档保持部读出与动作合格性的判定对象的组件有关的所述合格性确认文档。所述判定试验执行部构成为,读取由所述确认文档读出部所读出的所述合格性确认文档所具有的信息,基于所述信息使动作合格性的判定对象的组件运行,由此执行所述合格性确认文档所规定的合格性判定项目的试验。所述合格性判定部构成为,基于由所述判定试验执行部所执行的所述试验的结果,判定与对应于所述试验的所述合格性判定项目有关的合格性。(The automatic qualification determination system includes a confirmation document holding unit, a confirmation document reading unit, a determination test execution unit, and a qualification determination unit. The confirmation document holding section holds a qualification confirmation document. The confirmation document reading unit is configured to read the eligibility confirmation document regarding the component to be determined as the operation eligibility from the confirmation document holding unit. The determination test execution unit is configured to read information included in the eligibility check document read by the check document reading unit, and execute a test of an eligibility determination item defined in the eligibility check document by operating a component to be determined of operation eligibility based on the information. The acceptability determining unit is configured to determine the acceptability regarding the acceptability determination item corresponding to the test based on a result of the test executed by the determination test executing unit.)

1. An automatic qualification determination system incorporated in a computer capable of communicating with an analysis system and configured to automatically determine the qualification of operations of components constituting the analysis system, the automatic qualification determination system comprising:

a confirmation document holding unit that holds a qualification confirmation document as an electronic document having information on a test for determining the operational qualification of a component constituting the analysis system;

a confirmation document reading unit configured to read the eligibility confirmation document relating to the component to be determined as the operation eligibility from the confirmation document holding unit;

a determination test execution unit configured to read information included in the eligibility check document read by the check document reading unit, and execute a test of an eligibility determination item defined in the eligibility check document by operating a component to be determined as to operational eligibility based on the information; and

and a qualification determination unit configured to determine, based on a result of the test performed by the determination test execution unit, a qualification regarding the qualification determination item corresponding to the test.

2. The automatic qualification system of claim 1 wherein,

the confirmation document holding section holds the eligibility confirmation document with respect to a plurality of kinds of components including components constituting the analysis system,

the automatic qualification determination system further includes: a module configuration detection unit configured to detect a module configuration of the analysis system,

the confirmation document reading unit is configured to read the eligibility confirmation document regarding the component constituting the analysis system from the confirmation document holding unit based on the component configuration detected by the component configuration detecting unit.

3. The automatic qualification system of claim 2 wherein,

the confirmation document reading unit is configured to display a list of the conformity confirmation documents suitable for the component configuration detected by the component configuration detecting unit, cause an operator of the conformity automatic determination system to select the conformity confirmation document to be read, and read the conformity confirmation document selected by the operator from the confirmation document holding unit.

4. The automatic qualification system of any one of claims 1-3 further comprising:

a report generation unit configured to generate a verification result report that expresses the determination result of the acceptability determination unit.

5. The automatic qualification system of claim 4 further comprising:

the rewrite prohibiting unit is configured to prohibit rewriting of the determination result expressed by the verification result report.

6. The automatic qualification system according to claim 4 or 5, wherein,

the report creation unit is configured to attach data of a test result, which is a basis of the determination result expressed by the verification result report, to the verification result report.

7. The automatic qualification system according to any one of claims 1 to 6 wherein,

the verification document holding unit is configured to be able to additionally hold the new eligibility verification document.

8. The automatic qualification system of any one of claims 1-7 further comprising:

an execution order storage unit that stores an execution order of the test of the qualification determination item together with identification information of the qualification determination item,

the identification information of the eligibility determination item to be executed is hidden in the eligibility confirmation document,

the determination test execution unit is configured to specify the eligibility determination items to be executed based on the identification information hidden in the eligibility confirmation document, and execute a test of the specified eligibility determination items based on the execution order stored in the execution order storage unit.

9. The automatic qualification system of claim 8 wherein,

in the eligibility confirmation document, a condition value required for a test of the eligibility determination item to be executed is hidden in association with the identification information,

the determination test execution unit is configured to execute a test of the eligibility determination item using the condition value hidden in the eligibility confirmation document.

10. The automatic qualification system of claim 8 or 9 wherein,

in the eligibility confirmation document, a reference value required for eligibility determination of the eligibility determination item to be executed is hidden in correspondence with the identification information,

the eligibility determination unit is configured to perform eligibility determination regarding the eligibility determination item using the reference value hidden in the eligibility check document.

Technical Field

The present invention relates to an automatic qualification determination system for automatically determining the qualification of operations of components (components) constituting an analysis system.

Background

After an analysis system is built and set up, an engineer (engineer) typically makes an action qualification determination that confirms whether the analysis system is operating properly. The order or benchmark for making the action eligibility determination is strictly defined and documented for each component comprising the analytics system. Hereinafter, a document that defines a procedure or a reference for performing the operation eligibility determination is referred to as an eligibility confirmation document.

An engineer opens a qualification confirmation document concerning a component to be determined on, for example, a notebook personal computer, operates the component while referring to the qualification confirmation document, and determines whether or not the operation of the component is qualified based on data obtained by causing the component to execute a predetermined operation, or the like.

Disclosure of Invention

[ problems to be solved by the invention ]

As described above, the determination of the operational qualification of the analysis system is generally performed by: the engineer performs a test while referring to a check document created in advance, and evaluates the data obtained thereby, etc., which causes problems such as troublesome determination work and human error. In particular, in an analysis system configured by combining a plurality of components, such as a Liquid Chromatography (LC) system, it is necessary to determine the components by operating an apparatus while checking different quality check documents for each component, and the risk of human error is increased.

For this reason, it is preferable to automate the determination of the operational acceptability of the analysis system, but the analysis system such as the LC system differs in the kind and number of components constituting the analysis system depending on the specification required by the customer. Therefore, as the software for automating the determination of the operation eligibility of the analysis system, it is necessary to prepare the software in accordance with the component configuration of the analysis system.

The present invention has been made in view of the above problems, and an object of the present invention is to automate the determination of operational acceptability of components constituting an analysis system without preparing software for automation of determination corresponding to the configuration of the analysis system.

[ means for solving problems ]

The invention provides an automatic qualification determination system incorporated in a computer capable of communicating with an analysis system, configured to automatically determine the operational qualification of a component constituting the analysis system, and including a confirmation document holding unit, a confirmation document reading unit, a determination test execution unit, and a qualification determination unit. The confirmation document holding unit holds a qualification confirmation document as an electronic document having information on a test for determining the operational qualification of the component constituting the analysis system. The confirmation document reading unit is configured to read the eligibility confirmation document regarding the component to be determined as the operation eligibility from the confirmation document holding unit. The determination test execution unit is configured to read information included in the eligibility check document read by the check document reading unit, and execute a test of an eligibility determination item defined in the eligibility check document by operating a component to be determined of operation eligibility based on the information. The acceptability determining unit is configured to determine the acceptability regarding the acceptability determination item corresponding to the test based on a result of the test executed by the determination test executing unit.

That is, the automatic qualification determination system according to the present invention is configured to create only a qualification confirmation document of a component constituting an analysis system in advance and hold the document in a confirmation document holding unit, and the automatic qualification determination system reads the qualification confirmation document and reads information included in the qualification confirmation document, automatically executes a test of a predetermined qualification determination item, and further performs qualification determination. Therefore, in order to automate the determination of the operational acceptability of the components constituting the analysis system, it is only necessary to create an acceptability confirmation document for the components. Therefore, it is not necessary to create software for determination automation corresponding to the configuration of the analysis system.

Here, the "component" is a concept that: the LC system includes all the components constituting the analysis system, and includes, for example, a system controller, a data processing device, and the like that manage the operations of the components in addition to a liquid feeding pump, an automatic sampler, a column oven, and a detector. Therefore, the determination target of the operational acceptability includes not only hardware such as a liquid sending pump, an automatic sampler, a column oven, and a detector, but also software installed in a system controller or a data processing device.

In a preferred embodiment, the verification document holding unit holds the eligibility verification document concerning a plurality of types of components including components constituting the analysis system, and the automatic eligibility determination system further includes: and a component configuration detecting unit configured to detect a component configuration of the analysis system, wherein the confirmation document reading unit is configured to read the eligibility confirmation document regarding the component constituting the analysis system from the confirmation document holding unit based on the component configuration detected by the component configuration detecting unit. In this way, if the confirmation document holding unit holds a plurality of types of components (more components than the components constituting one analysis system) in advance, reads only the conformity confirmation document corresponding to the configuration of the analysis system, and sets the document, the versatility of the conformity automatic determination system is improved.

In this case, the confirmation document reading unit may be configured to: displaying a list of the conformity confirmation documents suitable for the component configuration detected by the component configuration detecting unit, causing an operator of the conformity automatic determination system to select the conformity confirmation document to be read out, and reading out the conformity confirmation document selected by the operator from the confirmation document holding unit.

In addition, in the past, engineers may have a risk of human error in creating a report by entering the result of determination of operational acceptability in a predetermined entry field of the acceptability check document. Therefore, in the present invention, it is preferable that the verification result report generation unit generate a verification result report expressing the determination result obtained by the acceptability determination unit. With such a setting, a report for expressing the determination result can be automatically generated, and the occurrence of human errors can be prevented.

In this case, it is preferable that the verification result report further includes a rewriting prohibition unit configured to prohibit rewriting of the determination result expressed in the verification result report. With such a configuration, the contents of the verification result report created by the report creation unit cannot be rewritten, and falsification of the report can be prevented.

Further, the report making unit is preferably configured to attach data of a test result, which is a basis of a determination result expressed in the verification result report, to the verification result report. With such a configuration, data serving as proof of the determination result is automatically attached to the verification result report, and thus the reliability of the verification result report is improved.

The verification document holding unit is preferably configured to additionally hold the new eligibility verification document. With such a configuration, when a new component is present, the automatic determination of the operational acceptability of the component can be realized by merely adding the acceptability determining document for the component to the determination document holding unit, and there is no need to modify the acceptability automatic determination system itself (software).

In a preferred embodiment, the method further comprises: and an execution order storage unit that stores an execution order of a test of the eligibility determination item together with Identification information (Identification, ID) of the eligibility determination item, the Identification information of the eligibility determination item to be executed being hidden in the eligibility confirmation document, wherein the determination test execution unit is configured to specify the eligibility determination item to be executed based on the Identification information hidden in the eligibility confirmation document, and execute the test of the specified eligibility determination item based on the execution order stored in the execution order storage unit.

In a preferred embodiment, in the acceptability confirmation document, a condition value required for a test of the acceptability determination item to be executed is hidden in association with the identification information, and the determination test execution unit is configured to execute the test of the acceptability determination item using the condition value hidden in the acceptability confirmation document.

In a preferred embodiment, in the eligibility check document, a reference value required for eligibility determination of the eligibility determination item to be executed is hidden in association with the identification information, and the eligibility determination unit is configured to perform eligibility determination regarding the eligibility determination item using the reference value hidden in the eligibility check document.

[ Effect of the invention ]

The automatic qualification determination system according to the present invention is configured to automatically perform a test of a predetermined qualification determination item to determine the operation qualification by creating only a qualification confirmation document of a component constituting an analysis system in advance and holding the document in a confirmation document holding unit, and therefore, in order to automate the determination of the operation qualification of the component, it is only necessary to create the qualification confirmation document of the component, and it is not necessary to create software for the determination automation corresponding to the configuration of the analysis system.

Drawings

Fig. 1 is a block diagram schematically showing an embodiment of an automatic qualification determining system.

Fig. 2 is a flowchart showing an example of the qualification determination operation of the analysis system according to the embodiment.

Fig. 3 is a flowchart showing an example of the operation of the test for qualification determination in the above embodiment.

Detailed Description

An embodiment of the automatic qualification determining system according to the present invention will be described below with reference to the drawings.

As shown in fig. 1, the automatic qualification determining system 2 is incorporated in a Computer such as a Personal Computer (PC) that can communicate with the analyzing system 1. The analysis system 1 of the present embodiment includes a plurality of modules 1 to N. When the analysis system 1 is an LC system, a liquid feed pump, an automatic sampler, a column oven, a detector, a system controller, a computer for arithmetic processing, and the like are provided for each module. The automatic qualification determination system 2 automatically determines the operation qualification regarding whether or not any of the components 1 to N constituting the analysis system 1 is operating properly.

The automatic conformity judgment system 2 includes a confirmation document holding unit 4, an execution order storage unit 6, a component configuration detection unit 8, a confirmation document reading unit 10, a judgment test execution unit 12, a conformity judgment unit 14, a report creation unit 16, and a rewriting prohibition unit 18. The confirmation document holding unit 4 and the execution order storage unit 6 are functions realized by a part of the storage capacity of the storage device included in the computer incorporated in the automatic determination system of eligibility 2. The module configuration detecting unit 8, the confirmation document reading unit 10, the determination test executing unit 12, the conformity determining unit 14, the report creating unit 16, and the rewrite prohibiting unit 18 are functions obtained by executing programs using arithmetic elements included in a computer incorporated in the conformity automatic determination system 2.

The verification document holding unit 4 holds a qualification verification document relating to at least some of the components 1 to N of the analysis system 1. The conformity verification Document is a Document created for each component, and is an electronic Document in a Portable Document Format (PDF) Format or the like in which items of a test (conformity determination items) to be performed for determining the operation conformity of the corresponding component, an execution order of the conformity determination items, a condition value at the time of performing the test, and a reference value for determination are described.

Conventionally, an engineer operates a target component, performs a test of a predetermined acceptability determination item while referring to a acceptability determination document, compares the test result with a reference value defined in the acceptability determination document, and determines the operation acceptability.

In the present embodiment, information such as an ID, a condition value, and a reference value of the eligibility determination item is hidden in the eligibility check document as field information, and the determination test execution unit 12 and the eligibility determination unit 14, which will be described later, read the field information and automatically operate a target component, thereby automatically performing the test and determination of the operation eligibility.

The verification document holding unit 4 can hold a new conformity verification document, and can update the content of an existing conformity verification document. Further, since the component configuration of the analysis system 1, that is, what kind of components the analysis system 1 includes in combination varies depending on the specification required by the client, it is preferable that the verification document holding unit 4 holds not only the qualification verification documents relating to the components 1 to N actually constituting the analysis system 1 but also the qualification verification documents relating to the other components.

The module configuration detection unit 8 is configured to detect each of the modules 1 to N actually constituting the analysis system 1 by communicating with the analysis system 1.

The confirmed document reading unit 10 is configured to search for a qualified confirmed document corresponding to each of the components 1 to N of the analysis system 1 detected by the component configuration detection unit 8 from among the qualified confirmed documents held in the confirmed document holding unit 4, and read out a qualified confirmed document of a component to be judged as being qualified in operation.

In a preferred embodiment, the confirmation document reading unit 10 is configured to search for a conformity confirmation document corresponding to the component ID of each of the components 1 to N constituting the analysis system 1, display a list of suitable conformity confirmation documents, cause the operator of the conformity automatic determination system 2 to select a conformity confirmation document to be read (i.e., a component to be subjected to the determination of the operational conformity), and read the conformity confirmation document selected by the operator from the confirmation document holding unit 4.

The determination test execution unit 12 is configured to read the ID of the qualification determination item to be executed or the condition value of the test of each item hidden in the qualification confirmation document read by the confirmation document reading unit 10, and execute the test of the predetermined qualification determination item with respect to the target component. The execution order of the test of the eligibility determination item is stored in the execution order storage unit 6 in association with the ID of the eligibility determination item. The determination test execution unit 12 reads out the execution order for the item from the execution order storage unit 6 based on the ID of the eligibility determination item read from the eligibility confirmation document, and executes the test of the item in accordance with the order.

In addition, if the information on the execution order of the test of each of the eligibility determination items is also hidden in the eligibility confirmation document, the determination test execution unit 12 can execute the test of each of the eligibility determination items by reading the information, and thus the execution order storage unit 6 is not an essential component.

The acceptability judging unit 14 is configured to compare the test result of each acceptability judging item executed by the judgment test executing unit 12 with the reference value of the item read from the acceptability confirming document, and thereby judge whether or not the item is acceptable.

The report making unit 16 is configured to make a verification result report indicating the determination result of each of the qualification determination items obtained by the qualification determination unit 14. In the preferred embodiment, the report making unit 16 is preferably configured to attach data of test results, which are the basis of the determination results of the respective acceptability determination items, to the verification result report. The verification result report created by the report creation unit 16 may be a report in which the determination result is entered in the determination result entry field of the document for which the document is certified.

The rewrite inhibiting unit 18 is configured to inhibit rewriting of the contents described in the verification result report generated by the report generating unit 16, and for example, to set the verification result report as a read-only process.

Next, a series of flows up to the automatic conformity judgment system 2 executing the conformity judgment test will be described with reference to the flowchart of fig. 2.

When the determination of the operation eligibility is performed for the components constituting the analysis system 1, first, the component configuration detection unit 8 detects the component configuration of the analysis system 1 (step S1). In this embodiment, the detection analysis system 1 includes components 1 to N.

The verification document reading unit 10 searches for the conformity verification documents corresponding to the respective modules 1 to N detected by the module configuration detecting unit 8, displays a list of the corresponding conformity verification documents (step S2), and allows the operator of the system 2 to select the conformity verification document to be read (step S3). The confirmation document reading section 10 reads out the eligibility confirmation document selected by the operator from the confirmation document holding section 4 (step S4). After the verification document is read out by the verification document reading unit 10, the determination test execution unit 12 operates the target component using the information (for example, information hidden as domain information) of the verification document and the execution order stored in the execution order storage unit 6, and executes the test of the predetermined verification item (step S5). After the determination test execution unit 12 executes the test for each item, the qualification determination unit 14 performs qualification determination based on the result obtained by each test.

If there is another component for which the operation acceptability determination is necessary, the steps S3 to S5 are repeated, and if there is no component for which the operation acceptability determination is necessary, the process ends (step S6).

Next, a series of operations from a test for determining the operational acceptability of the component to the output of a verification result report (hereinafter referred to as a report) will be described with reference to a flowchart of fig. 3.

In step S3 of the flowchart of fig. 2, when the operator of the system 2 selects the conformity confirmation document to be read, the judgment test execution unit 12 reads the conformity judgment item ID, the condition value, and the reference value hidden in the conformity confirmation document (step S11, step S12), and executes the test in the execution order of the items stored in the execution order storage unit 6 (step S13). The acceptability determination unit 14 performs the acceptability determination of the item based on the result of the test performed by the determination test execution unit 12 (step S14). The report making unit 16 records the determination result of the item obtained by the eligibility determination unit 14 in the report (step S15).

The operations S11 to S15 are sequentially executed for all the eligibility determination items specified in the eligibility confirmation document (step S16). After the determination results regarding all the items are written in the report, the rewrite inhibiting unit 18 performs a process of inhibiting rewriting of the report (step S17). Further, the report creation unit 16 attaches data of the test results on each item to the created report (step S18), and outputs the data as a document such as a PDF file (step S19).

[ description of symbols ]

1: analysis system

2: automatic qualification judging system

4: confirmation document holding part

6: execution order storage unit

8: component structure detection unit

10: confirmed document reading unit

12: determination test execution unit

14: qualification determination unit

16: report making department

18: the rewrite inhibiting unit.