Automatic qualification determination system
By designing an automatic qualification determination system in the analysis system and automatically executing the qualified qualification determination project of the component, the problems of cumbersome and human error in the prior art are solved, and the automation and accuracy of the qualified qualification of the component are achieved. .
Patent Information
- Application Number
- CN201880096726.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2018-09-27
- Publication Date
- 2024-12-20
- Estimated Expiration
- 2038-09-27
AI Technical Summary
In the prior art, the determination of the action qualification of the analysis system relies on engineers to manually refer to confirm documents, resulting in cumbersome and prone to human errors. Especially in multi-component systems such as liquid chromatography analysis systems, the risk of error is high.
A qualified automatic determination system is designed, including a confirmation document holding unit, a confirmation document reading unit, a determination test execution unit and a qualified determination unit. By pre-made component qualification confirmation documents and automatically performing the test of the determination item, it realizes Automatic determination of component action qualifications does not require software corresponding to the analysis system structure.
It realizes automated judgment of the compliance of component actions of the analysis system, reduces the risk of human error, improves judgment efficiency and accuracy, and can be applied to analysis systems with different customer specifications and component structures.
Smart Images
Figure CN112585471B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an automatic qualification determination system for automatically determining the qualification of actions of components constituting an analysis system. Background Art
[0002] After the analysis system is built and set up, an engineer is generally required to perform an action qualification determination to confirm whether the analysis system is operating correctly. The order or benchmark for performing action qualification determination is strictly specified and documented for each component that constitutes the analysis system. Hereinafter, the document that specifies the order or benchmark for performing action qualification determination is referred to as a qualification confirmation document.
[0003] For example, an engineer opens a qualification confirmation document related to a component to be judged on a notebook personal computer, operates the component while referring to the qualification confirmation document, and judges whether the operation of the component is qualified based on data obtained by causing the component to perform specified actions. Summary of the invention
[0004] [Problems to be solved by the invention]
[0005] As described above, the determination of the operational qualification of the analysis system is generally performed by the following method: the engineer performs the test while referring to the pre-made confirmation document and evaluates the data obtained therefrom, but there are problems such as the complexity of the determination operation and the possibility of human error. In particular, for an analysis system composed of a plurality of components such as a liquid chromatography analysis system (hereinafter referred to as a liquid chromatography (LC) system), it is necessary to operate the device while confirming the qualification confirmation document different for each component to perform the determination, and the risk of human error increases.
[0006] For the above reasons, it is preferable to automate the determination of the operational eligibility of the analysis system. However, for analysis systems such as LC systems, the types and numbers of components constituting the analysis system vary depending on the specifications required by customers. Therefore, it is necessary to prepare software for automating the determination of the operational eligibility of the analysis system in accordance with the component structure of the analysis system.
[0007] The present invention has been made in view of the above-mentioned problems, and an object of the present invention is to automate the determination of the operational eligibility of components constituting an analysis system in a universal manner without preparing software for automating determination corresponding to the configuration of the analysis system.
[0008] [Technical means to solve the problem]
[0009] The present invention is an automatic qualification determination system, which is incorporated into a computer that can communicate with an analysis system, and is configured to automatically determine the action qualification of components constituting the analysis system, and 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 unit holds a qualification confirmation document as an electronic document, and the electronic document has information related to a test for determining the action qualification of components constituting the analysis system. The confirmation document reading unit is configured to read the qualification confirmation document related to the component of the action qualification determination object from the confirmation document holding unit. The determination test execution unit is configured to read the information contained in the qualification confirmation document read by the confirmation document reading unit, and operate the component of the action qualification determination object based on the information, thereby executing the test of the qualification determination item specified in the qualification confirmation document. The qualification determination unit is configured to determine the qualification related to the qualification determination item corresponding to the test based on the result of the test executed by the determination test execution unit.
[0010] That is, the automatic qualification determination system of the present invention is configured to only prepare in advance the qualification confirmation documents of the components constituting the analysis system and store them in the confirmation document storage unit, so that the automatic qualification determination system reads out the qualification confirmation documents and reads the information contained in the qualification confirmation documents, automatically performs the tests of the specified qualification determination items, and then also performs the qualification determination. Therefore, in order to realize the automation of the determination of the action qualification of the components constituting the analysis system, it is sufficient to prepare the qualification confirmation documents of the components. Therefore, it is not necessary to prepare the determination automation software corresponding to the structure of the analysis system.
[0011] Here, the so-called "component" is a concept that includes all components that constitute the analysis system. For example, in the case of an LC system, in addition to the liquid delivery pump, automatic sample injector, column oven, and detector, it also includes the system controller or data processing device that manages the operation of each component. Therefore, the object of judging the eligibility of the operation includes not only the hardware such as the liquid delivery pump, automatic sample injector, column oven, and detector, but also the software installed in the system controller or data processing device.
[0012] In a preferred embodiment, the confirmation document holding unit holds the qualification confirmation documents related to a plurality of components, the plurality of components including components constituting the analysis system, and the automatic qualification determination system further comprises: a component structure detection unit configured to detect the component structure of the analysis system, and the confirmation document reading unit configured to read the qualification confirmation documents related to the components constituting the analysis system from the confirmation document holding unit based on the component structure detected by the component structure detection unit. In this way, the confirmation document holding unit is configured to hold a plurality of components (more components than components constituting one analysis system) in advance, and only the qualification confirmation documents corresponding to the structure of the analysis system are read out. If this is set, the versatility of the automatic qualification determination system is improved.
[0013] In the case, the confirmation document reading unit may also be configured to: display an overview of the qualification confirmation documents suitable for the component structure detected by the component structure detection unit, allow the operator of the automatic qualification determination system to select the qualification confirmation document to be read, and read the qualification confirmation document selected by the operator from the confirmation document holding unit.
[0014] Furthermore, in the past, engineers recorded the results of the action qualification in the specified entry column of the qualification confirmation document to prepare a report, which also has the risk of human error. Therefore, in the present invention, it is preferred to include a report preparation unit, which is configured to prepare a verification result report that expresses the results of the qualification judgment unit. If set in this way, a report expressing the results of the judgment can be automatically prepared to prevent human errors.
[0015] In this case, it is preferable to further include a rewrite prohibition unit configured to prohibit rewriting of the determination result expressed in the verification result report. If so, the contents of the verification result report prepared by the report preparation unit cannot be rewritten, and tampering of the report can be prevented.
[0016] Furthermore, the report preparation unit is preferably configured to attach the test result data that will serve as the basis for the determination result expressed in the verification result report to the verification result report. If so, the data that will serve as evidence for the determination result will be automatically attached to the verification result report, thereby improving the reliability of the verification result report.
[0017] Furthermore, the confirmation document holding unit is preferably configured to be able to additionally hold novel qualification confirmation documents. If so configured, in the case of a novel component, the automatic qualification determination of the operation of the component can be realized by simply adding the qualification confirmation document for the component to the confirmation document holding unit, without modifying the automatic qualification determination system itself (software).
[0018] In a preferred embodiment, it also includes: an execution order storage unit, which stores the execution order of the test of the qualification judgment item together with the identification information (Identification, ID) of the qualification judgment item, and the identification information of the qualification judgment item to be executed is hidden in the qualification confirmation document. The judgment test execution unit is configured to determine the qualification judgment item to be executed based on the identification information hidden in the qualification confirmation document, and execute the test of the determined qualification judgment item based on the execution order stored in the execution order storage unit.
[0019] Moreover, in a preferred embodiment, in the qualification confirmation document, condition values required for the test of the qualification judgment item to be executed are hidden corresponding to the identification information, and the judgment test execution unit is configured to use the condition values hidden in the qualification confirmation document to execute the test of the qualification judgment item.
[0020] Moreover, in a preferred embodiment, in the qualification confirmation document, a reference value required for the qualification judgment of the qualification judgment item to be executed is hidden corresponding to the identification information, and the qualification judgment unit is configured to use the reference value hidden in the qualification confirmation document to perform the qualification judgment related to the qualification judgment item.
[0021] [Effects of the Invention]
[0022] The automatic qualification judgment system of the present invention is constructed so that only qualification confirmation documents of the components constituting the analysis system are prepared in advance and maintained in a confirmation document holding unit, and then the tests of the specified qualification judgment items are automatically executed to judge the qualification of the operation. Therefore, in order to realize the automation of the judgment of the action qualification of the component, it is only necessary to prepare the qualification confirmation document of the component, and there is no need to prepare the automatic judgment software corresponding to the structure of the analysis system. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Figure 1 The following is a block diagram schematically showing an embodiment of an automatic qualification determination system.
[0024] Figure 2 This is a flowchart showing an example of the conformity determination operation of the analysis system of the embodiment.
[0025] Figure 3 This is a flowchart showing an example of the operation of the test for determining the quality of the embodiment.
[0026] [Explanation of Symbols]
[0027] 1: Analysis system
[0028] 2: Automatic qualification determination system
[0029] 4: Confirm the document retention section
[0030] 6: Execution order storage unit
[0031] 8: Component structure detection department
[0032] 10: Confirm the document reading section
[0033] 12: Determination test execution department
[0034] 14: Qualification Assessment Department
[0035] 16: Report Preparation Department
[0036] 18: Rewrite Prohibition Department
[0037] S1~S6, S11~S19: Steps DETAILED DESCRIPTION
[0038] Hereinafter, an embodiment of the automatic conformity determination system of the present invention will be described using drawings.
[0039] like Figure 1 As shown, the automatic qualification determination system 2 is incorporated into a computer such as a personal computer (PC) that can communicate with the analysis system 1. The analysis system 1 of this embodiment includes a plurality of components 1 to N. In the case where the analysis system 1 is an LC system, a liquid delivery pump, an automatic sample injector, a column oven, a detector, a system controller, a computer for calculation processing, etc. correspond to each component. The automatic qualification determination system 2 automatically performs an action qualification determination related to whether the component is operating properly for any component among the components 1 to N constituting the analysis system 1.
[0040] The automatic qualification determination system 2 includes a confirmation document holding unit 4, an execution order storage unit 6, a component structure detection unit 8, a confirmation document reading unit 10, a determination test execution unit 12, a qualification determination unit 14, a report generation unit 16, and a rewrite 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 a storage device included in a computer incorporating the automatic qualification determination system 2. The component structure detection unit 8, the confirmation document reading unit 10, the determination test execution unit 12, the qualification determination unit 14, the report generation unit 16, and the rewrite prohibition unit 18 are functions obtained by executing a program by an operation element included in a computer incorporating the automatic qualification determination system 2.
[0041] The confirmation document storage unit 4 stores a qualification confirmation document related to at least a part of the components 1 to N of the analysis system 1. The qualification confirmation document is a document prepared for each component, and is an electronic document in a portable document format (PDF) format that records the items of the test to be performed in order to perform the qualification judgment of the operation of the corresponding component (qualification judgment items), the execution order of the qualification judgment items, the condition values when performing the test, and the reference value of the judgment.
[0042] Conventionally, engineers operated target components, performed tests on specified qualification items while referring to qualification confirmation documents, compared the test results with reference values specified in the qualification confirmation documents, and determined the operational qualification.
[0043] In this embodiment, the ID or condition value, reference value and other information of the qualification judgment item are hidden in the qualification confirmation document as domain information. The judgment test execution unit 12 and the qualification judgment unit 14 described later read the domain information and automatically operate the component that becomes the object, and automatically execute the test and judgment of the action qualification.
[0044] The confirmation document storage unit 4 can store new qualification confirmation documents and update the contents of existing qualification confirmation documents. In addition, the component structure of the analysis system 1, that is, the combination of components included in the analysis system 1, varies according to the customer's required specifications. Therefore, it is preferable that the confirmation document storage unit 4 store not only qualification confirmation documents related to the components 1 to N that actually constitute the analysis system 1, but also qualification confirmation documents related to other components.
[0045] The component configuration detection unit 8 is configured to detect the components 1 to N that actually configure the analysis system 1 by communicating with the analysis system 1 .
[0046] The confirmation document reading unit 10 is configured to retrieve the conformity confirmation documents corresponding to the components 1 to N of the analysis system 1 detected by the component structure detection unit 8 from the conformity confirmation documents retained in the confirmation document retention unit 4, and read the conformity confirmation document of the component that is the object of determining the conformity of the action.
[0047] In a preferred embodiment, the confirmation document reading unit 10 is configured to retrieve the qualification confirmation documents corresponding to the component IDs of the components 1 to N constituting the analysis system 1, display an overview of suitable qualification confirmation documents and enable the operator of the automatic qualification determination system 2 to select the qualification confirmation document to be read (i.e., the component for which the action qualification determination needs to be performed), and read the qualification confirmation document selected by the operator from the confirmation document holding unit 4.
[0048] The judgment test execution unit 12 is configured to read the ID of the qualification judgment 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 specified qualification judgment item for the target component. The execution order of the test of the qualification judgment item is stored in the execution order storage unit 6 in correspondence with the ID of the qualification judgment item. The judgment test execution unit 12 reads the execution order for this item from the execution order storage unit 6 based on the ID of the qualification judgment item read from the qualification confirmation document, and implements the test of the item in accordance with this order.
[0049] Furthermore, if the qualification confirmation document also contains information on the execution order of the tests for each qualification item, the test execution unit 12 can execute the tests for each qualification item by reading the information, and thus the execution order storage unit 6 is not an essential component.
[0050] The conformity determination unit 14 is configured to compare the test result of each conformity determination item executed by the determination test execution unit 12 with the reference value of the item read from the conformity confirmation document, thereby making a conformity determination on the item.
[0051] The report preparation unit 16 is configured to prepare a verification result report that expresses the determination results of each qualification determination item obtained by the qualification determination unit 14. In a preferred embodiment, the report preparation unit 16 is preferably configured to attach the data of the test results that serve as the basis for the determination results of each qualification determination item to the verification result report. The verification result report prepared by the report preparation unit 16 may also include the determination results recorded in the determination result recording column of the qualification confirmation document.
[0052] The rewrite prohibition unit 18 is configured to prohibit rewriting of the contents of the verification result report generated by the report generation unit 16, for example, to perform processing to make the verification result report read-only.
[0053] Next, use Figure 2 The flowchart of will explain a series of processes until the automatic conformity determination system 2 executes the conformity determination test.
[0054] When determining the operational eligibility of components constituting the analysis system 1, first, the component structure detection unit 8 detects the component structure of the analysis system 1 (step S1). In this embodiment, it is detected that the analysis system 1 includes components 1 to N.
[0055] The confirmation document reading unit 10 retrieves the qualification confirmation documents corresponding to each component 1 to N detected by the component structure detection unit 8, displays a list of the corresponding qualification confirmation documents (step S2), and allows the operator of the system 2 to select the qualification confirmation document to be read (step S3). The confirmation document reading unit 10 reads the qualification confirmation document selected by the operator from the confirmation document storage unit 4 (step S4). After the confirmation document reading unit 10 reads the qualification confirmation document, the judgment test execution unit 12 uses the information (for example, information hidden as domain information) of the qualification confirmation document and the execution order stored in the execution order storage unit 6 to operate the component that becomes the object and execute the test of the specified qualification judgment item (step S5). After the judgment test execution unit 12 executes the test related to each item, the qualification judgment unit 14 performs the qualification judgment based on the results obtained from each test.
[0056] If there is another component that needs to be judged for its operational eligibility, steps S3 to S5 are repeated. If there is no component that needs to be judged for its operational eligibility, the process ends (step S6).
[0057] Next, use Figure 3 The flowchart of the present invention describes a series of operations from the test for judging the operational qualification of the component to the output of the verification result report (hereinafter referred to as the report).
[0058] Figure 2 In step S3 of the flowchart of , after the operator of the system 2 selects the qualification confirmation document to be read, the judgment test execution unit 12 reads the qualification judgment item ID, condition value, and reference value hidden in the qualification confirmation document (steps S11 and S12), respectively, and implements the test according to the execution order related to the item stored in the execution order storage unit 6 (step S13). The qualification judgment unit 14 performs qualification judgment of the item based on the result of the test implemented by the judgment test execution unit 12 (step S14). The report preparation unit 16 records the judgment result of the item obtained by the qualification judgment unit 14 in the report (step S15).
[0059] The operations of S11 to S15 are sequentially performed for all the qualification determination items specified in the qualification confirmation document (step S16). After the determination results related to all items are recorded in the report, the rewrite prohibition unit 18 prohibits the rewrite of the report (step S17). Furthermore, the report preparation unit 16 attaches the data of the test results related to each item to the prepared report (step S18), and outputs it in the form of a document such as a PDF file (step S19).
Claims
1. An automatic qualification determination system, incorporated into a computer capable of communicating with an analysis system, and configured to automatically determine the qualification of the operation of components constituting the analysis system, wherein: include: a confirmation document holding unit that holds a conformity confirmation document as an electronic document having information related to a test for determining the operational conformity of components constituting the analysis system; a confirmation document reading unit configured to read the conformity confirmation document related to the component to be determined for the conformity of the operation from the confirmation document holding unit; a determination test execution unit configured to read information contained in the conformity confirmation document read by the confirmation document reading unit, and to operate a component of a determination target for operation conformity based on the information, thereby executing a test of conformity determination items specified in the conformity confirmation document; as well as a conformity determination unit configured to determine conformity related to the conformity determination item corresponding to the test based on the result of the test executed by the determination test execution unit, The confirmation document holding unit holds the qualification confirmation documents related to a plurality of components including components constituting the analysis system. The automatic qualification determination system further includes: a component structure detection unit configured to detect the component structure of the analysis system. The confirmation document reading unit is configured to read the conformity confirmation document related to the components constituting the analysis system from the confirmation document holding unit based on the component structure detected by the component structure detection unit.
2. The automatic qualification determination system according to claim 1, characterized in that: The confirmation document reading unit is configured to display an overview of the qualification confirmation documents suitable for the component structure detected by the component structure detection unit, so that the operator of the automatic qualification determination system can select the qualification confirmation document to be read, and read the qualification confirmation document selected by the operator from the confirmation document holding unit.
3. The automatic qualification determination system according to claim 1 or 2, characterized in that: Also includes: The report preparation unit is configured to prepare a verification result report describing a determination result of the conformity determination unit.
4. The automatic qualification determination system according to claim 3, characterized in that: Also includes: The rewrite prohibition unit is configured to prohibit rewriting of the determination result described in the verification result report.
5. The automatic qualification determination system according to claim 3, characterized in that: The report preparation unit is configured to attach test result data to the verification result report, and the test result data serves as a basis for the determination result described in the verification result report.
6. The automatic qualification determination system according to claim 1 or 2, characterized in that: The confirmation document holding unit is configured to be able to additionally hold new conformity confirmation documents.
7. The automatic qualification determination system according to claim 1 or 2, characterized in that: Also includes: an execution order storage unit for storing the execution order of the tests of the qualification items together with the identification information of the qualification items, The identification information of the qualification determination item to be executed is hidden in the qualification confirmation document. The determination test execution unit is configured to determine the qualification determination items to be executed based on the identification information hidden in the qualification confirmation document, and execute the tests of the determined qualification determination items based on the execution order stored in the execution order storage unit.
8. The automatic qualification determination system according to claim 7, characterized in that: In the qualification confirmation document, condition values required for the test of the qualification determination item to be executed are hidden corresponding to the identification information. The determination test execution unit is configured to execute the test of the compliance determination item using the condition value hidden in the compliance confirmation document.
9. The automatic qualification determination system according to claim 7, characterized in that: In the conformity confirmation document, a reference value required for conformity determination of the conformity determination item to be performed is hidden corresponding to the identification information. The conformity determination unit is configured to perform conformity determination on the conformity determination item using the reference value hidden in the conformity confirmation document.