Medical test paper production process tracing method and device
By generating detailed traceability records, covering raw materials, production processes, environmental quality and equipment calibration, the problem of lack of comprehensive traceability in the existing system is solved, and the quality and management efficiency of medical testing test strip production is improved.
Patent Information
- Application Number
- CN202510508840.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-22
- Publication Date
- 2025-07-25
AI Technical Summary
The existing medical testing test strip production management system lacks comprehensive traceability of raw materials, production processes, operators, etc., resulting in an increase in quality risks and a decrease in production efficiency, making it difficult to carry out effective quality control and compliance management.
By obtaining raw material quality information, production process information, production environment quality information, equipment calibration process information and finished product inspection process information, a detailed traceability record is generated, and a production traceability database is integrated to cover supplier review, inventory management, equipment calibration and finished product inspection and other aspects.
It has achieved a comprehensive traceability of the production process of medical testing test strips, improved product quality, compliance and production management level, ensured product quality complied with standards, and provided a deeper understanding of the production process and flexible quality control capabilities.
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Figure CN120374051A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of Internet technologies, and particularly to a method and device for tracing the production process of medical test strips. Background Art
[0002] At present, with the continuous development of medical testing technologies, medical test strips, as an important rapid testing tool, play an important role in disease prevention and control, health monitoring, etc. Some test strip production enterprises use production management systems to monitor and manage the production process. However, these systems often only focus on the operation status of the production line, lacking comprehensive traceability of multiple aspects such as raw materials, production processes, and operators, resulting in increased quality risks, decreased production efficiency, and difficulties in effective quality control and compliance management, thereby affecting product quality, reputation, and market compliance. Summary of the Invention
[0003] To solve the problem that traditional test strip production enterprises lack traceability of multi-faceted information when using production management systems, the present application provides a method and device for tracing the production process of medical test strips.
[0004] The first above-mentioned invention object of the present application is achieved through the following technical solutions: A method for tracing the production process of medical test strips, the method for tracing the production process of medical test strips includes: Obtain raw material quality information, and generate a corresponding first trace record according to the raw material quality information, where the raw material quality information includes supplier audit result information, in-warehouse inspection result information, and inventory management process information; Formulate a production process, obtain production information of each unit step in the production process, and generate a corresponding second trace record according to the production information; Obtain production environment quality information, analyze the production environment quality information, generate corresponding regulation information, and generate a corresponding third trace record according to the regulation information, where the production environment quality information includes temperature information, humidity information, and cleanliness information; Formulate an equipment calibration process, generate corresponding calibration result feedback information, generate a corresponding equipment maintenance process according to the calibration result feedback information, generate corresponding maintenance result feedback information according to the equipment maintenance process, and generate a corresponding fourth trace record according to the calibration result feedback information and the maintenance result feedback information; Formulate a finished product inspection process, generate corresponding inspection result feedback information, and generate a corresponding fifth trace record according to the inspection result feedback information; Integrate the first trace record, the second trace record, the third trace record, the fourth trace record, and the fifth trace record to generate a corresponding production trace database.
[0005] By adopting the above technical solution, by obtaining raw material quality information, production process information, production environment quality information, equipment calibration process information and finished product inspection process information, and generating corresponding traceability records at each step, the comprehensive traceability of the entire production process is realized. Compared with the traditional system that only focuses on the operation status of the production line, this method covers multiple aspects such as supplier audit, inventory management, equipment calibration, and finished product inspection, thus improving the comprehensiveness and accuracy of traceability. By integrating these traceability records, a complete production traceability database is formed, making up for the deficiencies of the traditional system in comprehensively tracing raw materials, production processes, operators, etc., and helping to improve product quality, compliance and production management level.
[0006] Preferably, in the step of obtaining raw material quality information, generating a corresponding first traceability record according to the raw material quality information, and the raw material quality information including supplier audit result information, in-stock inspection result information and inventory management process information, it includes: Obtain the qualification information, reputation information and quality management system information of the supplier, generate a corresponding trust weight value, determine the optimal supplier according to the trust weight value, and determine the supplier audit result information of the optimal supplier; Determine the in-stock raw materials supplied by the optimal supplier, obtain the appearance information and performance information of the in-stock raw materials, analyze the appearance information and performance information, and generate corresponding in-stock inspection result information; Obtain in-stock process information, out-stock process information and storage process information, and based on a preset inventory management system, compare and analyze the in-stock process information, out-stock process information and storage process information to generate a corresponding process exception status report; Judge whether the abnormal entries included in the process exception status report have been eliminated by manual intervention. If not, continuously judge whether the abnormal entries have been eliminated. If so, generate a corresponding correction report, integrate the process exception status report and the correction report, and generate corresponding inventory management process information; Generate a corresponding first traceability record according to the supplier audit result information, the in-stock inspection result information and the inventory management process information.
[0007] By adopting the above technical solution, it emphasizes the comprehensive review of raw materials and the precise monitoring of the inventory management process, helps to improve the controllability of raw material quality, reduce production risks, and ensure the traceability and quality stability of the production process of medical test strips.
[0008] Preferably, in the step of formulating a production process, obtaining production information of each unit step in the production process, and generating a corresponding second traceability record according to the production information, it includes: Formulate a production process, where the production process includes multiple unit steps; Obtain the production information of each unit step in the multiple unit steps, where the production information includes operator information, operation time information, equipment status information, and process parameter information; Extract a first associated feature field according to the production information, and generate a first traceability identifier according to the first associated feature field, where the first traceability identifier is used to trace the production information of the unit step; Generate a traceability order of the unit step according to the first traceability identifier, determine the associated steps of each unit step according to the traceability order, generate a corresponding associated traceability identifier according to the associated steps, and generate a corresponding to-be-triggered entry according to the associated traceability identifier, where the to-be-triggered entry is used to trigger the corresponding associated traceability identifier according to the user's interaction instruction when tracing the first traceability identifier; Obtain the start time point information and product information of the production process, integrate the first traceability identifier, associated traceability identifier, start time point information, and product information, and generate a corresponding second traceability identifier, where the second traceability identifier is used to trace the production information of each unit step of different batches of production processes; Record and save the production information and the second traceability identifier, and generate a corresponding second traceability record.
[0009] By adopting the above technical solution, it emphasizes the accurate traceability of the production information of each unit step in the production process, which helps to improve the traceability of the production process and the controllability of production quality.
[0010] Preferably, in the step of obtaining production environment quality information, analyzing the production environment quality information, generating corresponding regulation information, and generating a corresponding third traceability record according to the regulation information, where the production environment quality information includes temperature information, humidity information, and cleanliness information, it includes: Formulate an environmental monitoring process according to the preset process product quality requirements, and generate multiple sensor layout detection points according to the environmental monitoring process; Judge whether the sensor layout detection points have completed responding. If so, obtain the production environment quality information of the first preset period in real time, where the production environment quality information includes temperature information, humidity information, and cleanliness information; Compare the production environment quality information with a threshold, and generate and record the corresponding regulation information; Obtain the production environment quality information of the second preset period, compare the production environment quality information of the first preset period and the production environment quality information of the second preset period, generate a corresponding difference interval, compare the difference interval with the preset expected interval, generate and push a corresponding interaction window, and obtain the interaction information of the interaction window in real time; Integrate the production environment quality information, regulation information and interaction information to generate a corresponding third traceability record.
[0011] By adopting the above technical solutions, the production environment quality is comprehensively monitored, regulated and traced, improving the quality control accuracy of the production process and the flexibility of environmental regulation, which helps to ensure the quality and stability of products.
[0012] Preferably, in the step of formulating an equipment calibration process, generating corresponding calibration result feedback information, generating a corresponding equipment maintenance process according to the calibration result feedback information, generating corresponding maintenance result feedback information according to the equipment maintenance process, and generating a corresponding fourth traceability record according to the calibration result feedback information and the maintenance result feedback information, it includes: Obtain equipment characteristic information and equipment usage status information, and formulate a corresponding equipment calibration process according to the equipment characteristic information and equipment usage status information; According to the equipment calibration process, generate multiple calibration detection points, and detect in real time whether the calibration detection points have responded. If not, continue to detect. If so, obtain the position information, time information and calibration anomaly occurrence curve information of the responded calibration detection points, and integrate the position information, time information and calibration anomaly occurrence curve information of the responded calibration detection points to generate corresponding calibration result feedback information; Formulate a corresponding equipment maintenance process according to the calibration result feedback information; According to the equipment maintenance process, generate a corresponding maintenance report, and re-detect whether the responded calibration detection points corresponding to the maintenance items included in the maintenance report have been repaired. If not, continue to detect. If so, generate corresponding maintenance result feedback information; Generate a corresponding fourth traceability record according to the calibration result feedback information and the maintenance result feedback information.
[0013] By adopting the above technical solutions, the calibration and maintenance processes of the equipment are comprehensively monitored, which helps to ensure the normal operation of the equipment and improve the reliability and stability of product quality.
[0014] Preferably, in the step of formulating a finished product inspection process, generating corresponding inspection result feedback information, and generating a corresponding fifth traceability record according to the inspection result feedback information, it includes: Obtain product characteristic information and preset customer requirement information, and formulate a finished product inspection process, where the finished product inspection process at least includes a sampling planning step, an appearance inspection step, and a performance testing step; According to the preset sampling plan included in the sampling planning step, obtain the appearance imaging information and performance parameter information of the finished product sample; According to the appearance inspection standard included in the appearance inspection step, perform threshold comparison on the appearance imaging information to generate corresponding appearance inspection result information, and generate a corresponding first inspection traceability identifier according to the appearance inspection result information; According to the performance detection standard included in the performance testing step, perform threshold comparison on the performance parameter information to generate corresponding performance detection result information, and generate a corresponding second inspection traceability identifier according to the performance detection result information; According to the appearance inspection result information and the performance detection result information, establish and train a detection result algorithm model, generate corresponding product inspection result determination information according to the detection result algorithm model, normalize the product inspection result determination information, and generate a corresponding product quality interval, where the product quality interval includes a qualified interval, a first-class inferior interval, a second-class inferior interval, and a third-class inferior interval; According to the product quality interval, push corresponding comprehensive suggestion information, where the comprehensive suggestion information includes corrective suggestion information, preventive suggestion information, and scrap disposal suggestion information; Obtain the suggestion feedback information of the user, generate a corresponding processing process according to the comprehensive suggestion information and the suggestion feedback information, where the processing process includes multiple processing nodes, and obtain the node feedback information of the processing nodes in real time to generate a corresponding third inspection traceability identifier; Establish a first association relationship between the third inspection traceability identifier and the first inspection traceability identifier, and / or establish a second association relationship between the third inspection traceability identifier and the second inspection traceability identifier, and integrate the first inspection traceability identifier, the second inspection traceability identifier, the third inspection traceability identifier, the first association relationship, and the second association relationship to generate a corresponding fifth traceability record.
[0015] By adopting the above technical solutions, comprehensively inspect and trace product quality information, make the production process more controllable and traceable, and ensure that the product reaches the expected quality level.
[0016] A medical test strip production process traceability device, including: A first traceability module, configured to obtain raw material quality information, and generate a corresponding first traceability record according to the raw material quality information, where the raw material quality information includes supplier audit result information, in-stock inspection result information, and inventory management process information; The second traceability module is used to formulate a production process, obtain production information of each unit step in the production process, and generate corresponding second traceability records according to the production information; The third traceability module is used to obtain production environment quality information, analyze the production environment quality information, generate corresponding regulation information, generate corresponding regulation instructions according to the regulation information, and generate corresponding third traceability records. The production environment quality information includes temperature information, humidity information, and cleanliness information; The fourth traceability module is used to formulate an equipment calibration process, generate corresponding calibration result feedback information, generate a corresponding equipment maintenance process according to the calibration result feedback information, generate corresponding maintenance result feedback information according to the equipment maintenance process, and generate corresponding fourth traceability records according to the calibration result feedback information and the maintenance result feedback information; The fifth traceability module is used to formulate a finished product inspection process, generate corresponding inspection result feedback information, and generate corresponding fifth traceability records according to the inspection result feedback information; The integration module is used to integrate the first traceability record, the second traceability record, the third traceability record, the fourth traceability record, and the fifth traceability record to generate a corresponding production traceability database.
[0017] By adopting the above technical solutions, the comprehensiveness and accuracy of traceability are improved. By integrating these traceability records, a complete production traceability database is formed, making up for the deficiencies of traditional systems in comprehensively tracing raw materials, production processes, operators, etc., and helping to improve product quality, compliance, and production management levels.
[0018] Preferably, the second traceability module includes a test strip carrier platform, a vision system located above the test strip carrier platform, a test strip ejection mechanism located at the end of the transportation path of the test strip carrier platform, a counting mechanism electrically connected to the test strip carrier platform, and a traceability mechanism. The counting mechanism includes a counter located at the beginning of the transportation path of the test strip carrier platform and a photoelectric trigger located above the test strip carrier platform. The photoelectric trigger is used to send a test tube counting signal passing through the photoelectric trigger to the counter for counting to generate counting production information. The vision system is used to obtain visual production information of each unit step in the production process. The traceability mechanism is used to generate corresponding second traceability records according to the counting production information and the visual production information; The medical test strip production process traceability device further includes a driving element for driving the test strip carrier platform to transport forward. The driving element is located on one side of the test strip carrier platform, and the driving element is a belt drive motor.
[0019] By adopting the above technical solution, it is possible to accurately track and record every step in the production process of medical test strips. The photoelectric trigger in the counting mechanism ensures the accuracy of production information by counting the test strips, while the vision system provides real-time monitoring and data collection for each production unit step. These data are integrated through the traceability mechanism to generate a detailed second traceability record, ensuring the transparency and traceability of the production process. This design can effectively improve the management efficiency of the production process, reduce production errors, and provide strong support for subsequent quality control and fault troubleshooting; Moreover, it can ensure the smooth and continuous operation of the test strip carrier platform, thus guaranteeing the coherence and stability of the production process. The setting of the driving element reduces the need for manual intervention and the risk of production interruption or test strip damage caused by operation errors, thereby further improving the production efficiency and product consistency.
[0020] Preferably, the test strip pushing mechanism includes a cavity scraping-in unit located above the test strip carrier platform, a cavity carrier unit disposed beside the end of the test strip carrier platform and aligning the cavity opening towards the discharge port of the test strip carrier platform through a limiting effect, a cavity pushing unit located on one side of the cavity carrier unit, and a cavity rolling unit located on the other side of the cavity carrier unit. The cavity scraping-in unit is electrically connected to the counting mechanism. When the counter determines that the test tube has passed through the photoelectric trigger, the counter sends a signal to the cavity scraping-in unit to cause the cavity scraping-in unit to scrape the test strip into the cavity carrier unit. The cavity pushing unit is electrically connected to the counter. When the counter reaches the set value, the cavity filled with test strips is pushed into the cavity rolling unit to roll to the subsequent mechanism through the cavity rolling unit.
[0021] By adopting the above technical solution, it is possible to realize the automatic pushing and conveying of the test strips at the end of the production line. Through the electrical connection between the cavity scraping-in unit and the counting mechanism, when the counter confirms that the test strip has passed through the photoelectric trigger, it will send a signal to drive the cavity scraping-in unit to accurately scrape the test strip into the cavity carrier unit, ensuring the accuracy of each conveying. When the counter reaches the set quantity, the cavity pushing unit will push the cavity filled with test strips into the cavity rolling unit, thus completing the automatic blanking and conveying operation of the test strips. This automated operation not only reduces manual intervention and the possibility of operation errors, but also improves the efficiency of the entire production line and the stability of product output.
[0022] Preferably, the vision system includes a first-scale vision unit and a second-scale vision unit sequentially arranged above the test strip carrier platform, and a feature judgment unit electrically connected to both the first-scale vision unit and the second-scale vision unit. The feature judgment unit performs multi-scale feature extraction and multi-modal feature fusion on the visual information obtained by the first-scale vision unit and the second-scale vision unit to generate corresponding visual production information.
[0023] By adopting the above technical solution, it is possible to accurately extract and analyze multi-scale features in the test strip production process. Through the image information obtained by the multi-scale vision unit, the feature judgment unit can perform multi-modal feature fusion, thereby generating more comprehensive and accurate visual production information. In this way, any minor defects or deviations in the production process can be detected in a timely manner, which helps to detect potential problems early, reduce the production of defective products, and thus greatly improve the control level of production quality and the qualified rate of products.
[0024] In summary, the present application includes at least one of the following beneficial technical effects: 1. By obtaining information from multiple aspects such as raw materials, production processes, production environments, equipment calibration, and finished product inspection, the present application generates detailed traceability records to achieve comprehensive traceability of the entire production process. This helps to fill the deficiencies of traditional production management systems, which often only focus on the operation status of the production line and lack comprehensive traceability of multiple aspects such as raw materials, production processes, and operators. Through comprehensive traceability, enterprises can obtain key data at each level of the production link, identify potential problems, and take corrective measures in a timely manner. Such a comprehensive traceability system not only helps to ensure that product quality meets the expected standards, but also provides more opportunities to deeply understand the production process, promoting the overall upgrade of quality management. Based on comprehensive traceability, enterprises can more flexibly respond to changes in market demand, achieve a higher level of quality control, and provide a solid foundation for continuous improvement and innovation. BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Figure 1 is a flowchart of a method for tracing the production process of a medical test strip in an embodiment of the present application.
[0026] Figure 2 is an implementation flowchart of step S10 in a method for tracing the production process of a medical test strip in an embodiment of the present application; Figure 3 is an implementation flowchart of step S20 in a method for tracing the production process of a medical test strip in an embodiment of the present application; Figure 4 is an implementation flowchart of step S30 in a method for tracing the production process of a medical test strip in an embodiment of the present application; Figure 5 It is the implementation flowchart of step S40 in a method for tracing the production process of a medical test strip according to an embodiment of the present application; Figure 6 It is the implementation flowchart of step S50 in a method for tracing the production process of a medical test strip according to an embodiment of the present application; Figure 7 It is the three-dimensional structural schematic diagram of a device for tracing the production process of a medical test strip according to an embodiment of the present application; Figure 8 It is the partial three-dimensional structural schematic diagram of a device for tracing the production process of a medical test strip after omitting the cavity rolling unit according to an embodiment of the present application.
[0027] Explanation of reference numerals: 1. Test strip carrier platform; 2. Vision system; 21. First-scale vision unit; 22. Second-scale vision unit; 3. Test strip pushing mechanism; 31. Cavity scraping unit; 32. Cavity carrier unit; 33. Cavity pushing unit; 34. Cavity rolling unit; 4. Counting mechanism; 41. Photoelectric trigger; 42. Counter; 5. Driving element. Detailed implementation manners
[0028] The following further elaborates on the present application in conjunction with the accompanying drawings.
[0029] In one embodiment, as Figure 1 shown, the present application discloses a method for tracing the production process of a medical test strip, which specifically includes the following steps: S10. Obtain the raw material quality information, and generate a corresponding first trace record according to the raw material quality information. The raw material quality information includes supplier audit result information, in-warehouse inspection result information, and inventory management process information; in this embodiment, through the raw material quality information including supplier audit results, in-warehouse inspection results, and inventory management process information, the system can not only trace the source and quality status of each batch of raw materials, but also comprehensively record the audit results of suppliers to ensure the traceability and quality stability of raw materials; specifically, the supplier audit result information covers the evaluation of supplier qualifications, reputation, and quality management systems, while the in-warehouse inspection result information is generated by analyzing the appearance and performance information of raw materials provided by the optimal supplier to verify whether the quality of raw materials meets the expected standards. At the same time, the inventory management process information is based on a preset inventory management system. By comparing the in-warehouse, out-warehouse, and storage process information, an abnormal status report is generated to ensure the effective monitoring and management of the inventory process of medical test strips. The preset inventory management system refers to a set of predefined rules and processes for guiding and standardizing operations such as in-warehouse, out-warehouse, and storage of inventory to ensure the efficiency and accuracy of inventory management.
[0030] S20. Develop a production process, obtain the production information of each unit step in the production process, and generate corresponding second traceability records according to the production information. In this embodiment, the production information of each unit step among multiple unit steps is obtained, including detailed records in aspects such as the operator, operation time, equipment status, and process parameters. These production information are used to generate corresponding second traceability records, thus realizing the traceability of the entire production process. This comprehensive production information traceability system helps enterprises monitor each production link, promptly discover potential problems, improve production efficiency, and ensure product consistency and traceability. Specifically, the production process is the overall process plan for the production of medical test strips that includes multiple unit steps, and each unit step is an independent link in the production process. The production information in the unit step includes key data such as operator information, operation time information, equipment status information, and process parameter information. The second traceability records are generated based on these production information, recording the detailed production process of each unit step in the entire production process, and realizing the comprehensive traceability of the production process.
[0031] S30. Obtain the production environment quality information, analyze the production environment quality information, generate corresponding regulation information, and generate corresponding regulation instructions according to the regulation information, and generate corresponding third traceability records. The production environment quality information includes temperature information, humidity information, and cleanliness information. The regulation instructions are used to adjust the working parameters corresponding to the production environment quality information. In this embodiment, the detailed records of the entire process are saved in the third traceability records, ensuring the comprehensive traceability of the regulation process of the production environment. This systematic environment regulation and recording mechanism helps improve production stability, ensure that product quality meets standards, and enables the comprehensive traceability of the regulation process. Specifically, the production environment quality information includes parameters such as temperature, humidity, and cleanliness, reflecting the environmental conditions in the production process of medical test strips. The regulation information is generated by analyzing the production environment quality information, forming regulation instructions for real-time adjustment of the production environment. The third traceability records integrate the production environment quality information, regulation information, and interaction information, providing comprehensive traceability for the production process. Temperature information, humidity information, and cleanliness information are key parameters in the production environment quality information. The purpose of generating regulation instructions is to compare and analyze the real-time obtained production environment quality information, such as key parameters like temperature, humidity, and cleanliness, with the preset standards or expected values. When these parameters deviate from the preset range, the system can promptly identify and automatically adjust relevant equipment or conditions to ensure that the production environment is always in the most suitable state. This can optimize the production process, improve product quality, while reducing energy consumption and costs, ensuring the maximization of production efficiency and economic benefits.
[0032] S40. Develop an equipment calibration process, generate corresponding calibration result feedback information, generate a corresponding equipment maintenance process based on the calibration result feedback information, generate a corresponding maintenance result feedback information based on the equipment maintenance process, and generate a corresponding fourth traceability record based on the calibration result feedback information and the maintenance result feedback information; in this embodiment, by integrating the feedback information of calibration and maintenance, the system generates a fourth traceability record. This process ensures the normal operation of the equipment and the stability of product quality. By comprehensively recording the calibration and maintenance processes, problems can be analyzed and solved in a timely manner when they are discovered, ensuring that the equipment is in good condition; specifically, the equipment calibration process is a process developed based on equipment characteristics and usage status information to ensure the accuracy and reliability of the equipment in the production of medical test strips. The calibration result feedback information records the detected point information corresponding during the calibration process and provides a basis for subsequent equipment maintenance. The equipment maintenance process is developed based on the calibration result feedback information to repair equipment abnormalities and ensure its normal operation, while the maintenance result feedback information reflects the effect of maintenance. The fourth traceability record integrates the information of equipment calibration and maintenance and realizes the comprehensive traceability of the equipment status.
[0033] S50. Develop a finished product inspection process, generate corresponding inspection result feedback information, and generate a corresponding fifth traceability record based on the inspection result feedback information; in this embodiment, this process realizes the traceability and monitoring of product quality through the comprehensive record of finished product inspection. When a non-conforming product is found, the system can provide suggestions and processing procedures in a timely manner to ensure that the products produced meet the expected standards; specifically, the finished product inspection process comprehensively evaluates the quality of the finished medical test strips through steps such as sampling, appearance inspection, and performance testing. The inspection result feedback information includes the results of appearance and performance inspections, which are used to determine the quality range of the product and generate comprehensive suggestions. The fifth traceability record integrates the key information in the finished product inspection process and realizes the full-process traceability of product quality.
[0034] S60. Integrate the first traceability record, the second traceability record, the third traceability record, the fourth traceability record, and the fifth traceability record to generate a corresponding production traceability database. In this embodiment, the first traceability record (traceability of raw material quality information), the second traceability record (traceability of the production process), the third traceability record (traceability of production environment quality information and regulation), the fourth traceability record (traceability of equipment calibration and maintenance), the fifth traceability record (traceability of finished product inspection), etc. are comprehensively integrated to form a complete production traceability database. This system can comprehensively trace the entire production process of medical test strips, from the quality of raw materials, the production process, the production environment, the equipment status to the inspection results of finished products, realizing the monitoring and recording of the entire production chain; through this production traceability database, users can conveniently query and trace all relevant information of a specific production batch, including supplier audit, in-warehouse inspection, production process steps, production environment quality monitoring, equipment calibration and maintenance, finished product inspection, etc. This helps to improve the transparency and controllability of the production process, promptly discover potential problems and take corresponding measures to ensure that the quality of medical test strips meets the standard requirements. The integrated production traceability database provides a powerful management tool for enterprises, helping to improve production efficiency and product quality; more specifically, by obtaining raw material quality information, production process information, production environment quality information, equipment calibration process information, and finished product inspection process information, and generating corresponding traceability records at each step, the comprehensive traceability of the entire production process is realized. Compared with the traditional system that only focuses on the operation status of the production line, this method covers multiple aspects such as supplier audit, inventory management, equipment calibration, and finished product inspection, thus improving the comprehensiveness and accuracy of traceability. By integrating these traceability records, a complete production traceability database is formed, making up for the deficiencies of the traditional system in comprehensively tracing raw materials, production processes, operators, etc., and helping to improve product quality, compliance, and production management level.
[0035] In one embodiment, as Figure 2 shown, in step S10, it includes: S101. Obtain the qualification information, credit information, and quality management system information of the suppliers, generate corresponding trust weight values, determine the optimal supplier based on the trust weight values, and determine the supplier audit result information of the optimal supplier; In this embodiment, by obtaining the qualification information, credit information, and quality management system information of the suppliers, the system generates corresponding trust weight values. This weight value reflects the comprehensive evaluation of the suppliers in terms of qualification, credit, and quality management, helping the enterprise to objectively and comprehensively understand and judge the reliability of the suppliers. Based on the obtained trust weight values, the system can intelligently determine the optimal supplier, thereby optimizing the supply chain selection and improving the efficiency and reliability of procurement; Specifically, the setting of the trust weight values can be evaluated based on multiple aspects such as the qualification information, credit information, and quality management system information of the suppliers. By performing weighted calculations on these information, a comprehensive trust weight value is generated to measure the overall credit and quality level of the suppliers. After the optimal supplier is selected, the second step of verification is required, and the supplier audit result information is used to verify the selection of the optimal supplier. Once there is an inconsistency, a negative trust weight value is assigned to this supplier, and a new optimal supplier is re-determined.
[0036] S102. Determine the incoming raw materials supplied by the optimal supplier, obtain the appearance information and performance information of the incoming raw materials, analyze the appearance information and performance information, and generate corresponding incoming inspection result information; In this embodiment, after determining the optimal supplier, the system obtains the appearance information and performance information of the incoming raw materials based on the raw materials it supplies. By analyzing these information in detail, the system generates corresponding incoming inspection result information. This step helps to ensure that the quality of the purchased raw materials meets the expected standards and provides reliable basic data for the subsequent production process; Specifically, the analysis of the appearance information includes checking aspects such as the integrity, color, and shape of the appearance, and judging whether it meets the requirements by comparing with the preset appearance standards. The analysis of the performance information involves the detection of physical, chemical, or other relevant characteristics. Data can be obtained through measurement, testing, etc., and then these data are compared with the preset performance standards to judge whether the quality requirements are met. Finally, the inspection results of the appearance and performance are combined to comprehensively generate the incoming inspection result information to reflect whether the raw materials meet the quality standards. Among them, the preset appearance standards and preset performance standards are a set of predefined specifications and parameters used to evaluate whether the appearance integrity, color, shape, and physical, chemical, and other performance characteristics of the raw materials or products meet the established quality requirements.
[0037] S103. Obtain the inbound process information, outbound process information, and storage process information. Based on the preset inventory management system, compare and analyze the inbound process information, outbound process information, and storage process information to generate a corresponding process exception status report. In this embodiment, by obtaining the inbound, outbound, and storage process information, the system conducts a comparative analysis based on the preset inventory management system. During this process, the system can identify existing process exception statuses and generate corresponding process exception status reports. This report summarizes the abnormal situations in the inbound, outbound, and storage processes, providing timely and comprehensive information for the management of the production link. Specifically, during the comparison process, attention can be paid to whether there are mistakes by the operators during inbound, whether the outbound is executed according to regulations, and whether the storage process meets the preset standards. Once a process error or exception is found, according to the regulations in the preset inventory management system, a corresponding process exception status report can be generated, specifying the specific items of the exception, such as identifying which link and which step have problems, so as to take corrective measures in a timely manner.
[0038] Preferably, in the comparative analysis of the implementation of the inventory management process, it is first necessary to define the preset inventory management system in detail, which includes clarifying the standard operating procedures (SOPs) and key control points for the inbound, outbound, and storage processes. Then, the system will collect and record the actual inbound, outbound, and storage activity data in real time. Using this data, the system, through built-in analysis tools, compares the actual operations with the preset standards item by item. The process of comparative analysis usually includes the following steps: First, the system checks the inbound process to verify whether the operators receive and record the goods according to the specified procedures, including the accuracy of quantity, quality, and time. Second, the system examines the outbound process to ensure that all goods shipped have proper authorization and records and follow principles such as first in, first out (FIFO). Finally, the system evaluates the storage process to check whether the inventory items are stored under the specified conditions, such as temperature, humidity, and safety distance. During the comparison process, the system will mark any operations that deviate from the preset standards, such as inconsistent inbound records with the actual received goods, unapproved outbound, or storage conditions not meeting the specified requirements. Once these exceptions are found, the system will automatically generate a process exception status report, detailing the links, times, responsible persons, and possible impacts of the exceptions. The report will also propose recommended corrective measures so that managers can respond in a timely manner, take measures to prevent the problem from expanding, and optimize the inventory management process. Through this continuous monitoring and improvement, the organization can maintain efficient inventory operations, reduce errors and losses, and improve the overall quality of inventory management.
[0039] S104. Determine whether the abnormal entries included in the process exception status report have been eliminated through manual intervention. If not, continuously determine whether the abnormal entries have been eliminated. If so, generate the corresponding correction report, integrate the process exception status report and the correction report, and generate the corresponding inventory management process information. In this embodiment, when determining the abnormal entries in the process exception status report, the system will verify whether they have been eliminated through manual intervention. If the system determines that certain abnormal entries have not been eliminated, it will continue to make judgments until these abnormal entries are processed. Once the abnormal entries are eliminated, the system will generate the corresponding correction report. This correction report records the correction process of each abnormal entry, including the details of manual intervention and the specific steps to eliminate the abnormality. Finally, the system integrates the process exception status report and the correction report to generate the updated inventory management process information. Through this step, the enterprise can trace the abnormal situations and their handling processes in the inventory management process, ensure the accuracy and reliability of inventory management, and improve the operation efficiency of the entire supply chain. Specifically, for example, the inbound information is incorrect. Abnormal entry: Multiple identical inbound records are found in the inbound process. Intervention measure: Manually investigate and verify the inbound records, confirm that it is a system error, and delete the incorrect inbound records. Correction report: Records the information of the deleted inbound records, as well as the specific time and personnel of the intervention. Another example is that inventory anomalies are caused by equipment failures. Abnormal entry: Equipment failure occurs in the inventory management process, resulting in a batch of products not being normally stored in the warehouse. Intervention measure: Technicians promptly repair the equipment and re-execute the affected inventory management steps. Correction report: Details the equipment failure, the repair process, and the records of re-executing the process.
[0040] S105. Generate the corresponding first traceability record based on the supplier audit result information, inbound inspection result information, and inventory management process information. In this embodiment, this record includes the audit situation of the supplier, the results of inbound inspection, and the detailed information of the inventory management process. Integrating these information helps to establish a comprehensive traceability of the raw material quality and ensure that the raw materials used meet the quality standards. Preferably, for the generation process of the corresponding first traceability record, it is first necessary to obtain the supplier's audit result information from the supplier audit module, then extract the inbound inspection result information from the inbound inspection module, and then retrieve the inventory management process information from the inventory management module. The system automatically integrates these three parts of information. Through data matching and association technology, the supplier's audit result is associated with the corresponding inbound inspection result, and combined with the information of the inventory management process, a complete traceability record is formed. Finally, the system generates and stores this record as the first traceability record to ensure that the quality and compliance of each batch of raw materials can be traced subsequently; the automatic integration is achieved through predefined data models and rules. First, the system will match according to the key fields (such as supplier ID, batch number, etc.) in the supplier audit result information, inbound inspection result information, and inventory management process information. There is a data cleaning and conversion module in the system to ensure the unified data format from different sources; then, through association rules and logical conditions, the audit result is associated with the inspection result and inventory information. The system will perform consistency checks on this information to ensure the integrity and accuracy of the data. Finally, the data after integration processing will be summarized and the corresponding traceability record will be generated, which is automatically stored in the database for subsequent query and use.
[0041] In one embodiment, as Figure 3 shown, in step S20, it includes: S201. Formulate a production process, and the production process includes multiple unit steps; in this embodiment, the entire production process is divided into multiple independent steps, and each step is a key link in the production process. By clearly defining each unit step, the production process can be better organized and managed, making it clearer and more orderly. The production information of each unit step will be used to generate the second traceability record to achieve detailed traceability of the entire production process; S202. Obtain the production information of each unit step among the multiple unit steps. The production information includes operator information, operation time information, equipment status information, and process parameter information; in this embodiment, these data provide a comprehensive and accurate record of the detailed operations of each step. Operator information helps to track and manage the individual operation responsibilities, operation time information provides a timestamp for accurately recording the occurrence time of each step, equipment status information enables us to monitor the normal operation of the equipment, and process parameter information records the key process indicators in the production process; this series of production information will be used in the next step to generate the second traceability record to achieve accurate and comprehensive traceability of the production information of each unit step; S203. Extract the first associated feature field according to the production information. Generate a first traceability identifier based on the first associated feature field. The first traceability identifier is used to trace the production information of the unit step. In this embodiment, by analyzing the production information, the first associated feature field is extracted. This associated feature field includes key data or features related to the unit step, such as the operator, operation time, equipment status, process parameters, etc. Based on these extracted key features, a first traceability identifier is generated, which is designed to uniquely identify the production information of the unit step in the entire traceability system. Specifically, by extracting the first associated feature field, which are certain key features in the production information, such as a specific operator, a critical operation time, a specific condition of the equipment status, or an important process parameter. After extracting these feature fields, the system can generate a unique identifier, that is, the first traceability identifier, for associating and tracing the production information of the corresponding unit step. The setting of this associated identifier helps to accurately mark and record the relevant information of each step in the production process, improving the traceability and management efficiency of the production process.
[0042] S204. Generate the traceability order of the unit step according to the first traceability identifier. Determine the associated steps of each unit step according to the traceability order. Generate the corresponding associated traceability identifier according to the associated steps. And generate the corresponding entry to be triggered according to the associated traceability identifier. The entry to be triggered is used to trigger the corresponding associated traceability identifier according to the user's interaction instruction when tracing the first traceability identifier. In this embodiment, the association between each step in the traceability system is established, realizing the orderly traceability of the production process information. By generating the entry to be triggered, the user can conveniently trigger the associated traceability process according to the need, further deeply understand the detailed information of a specific unit step, and realize the comprehensive monitoring and management of the production process. Specifically, for example, through the first traceability identifier, the system generates the traceability order of the unit step, such as from A to B to C. Then, the system determines the associated steps of each unit step. For example, A is associated with B, and B is associated with C. Next, generate the associated traceability identifier. For example, the associated identifier of A is X, and the associated identifier of B is Y. Finally, generate the entry to be triggered according to these associated traceability identifiers. When the user traces the first traceability identifier, the system will trigger the corresponding associated traceability identifier according to the user's instruction. For example, when the user selects to trace A, the system triggers the associated identifier X and displays the detailed production information related to A. Such a design helps the user to flexibly view and manage the production information during the traceability process, that is, based on the mapping relationship between A and B, trigger and trace each other between the two platforms.
[0043] S205. Obtain the start time point information and product information of the production process, integrate the first traceability identifier, associated traceability identifier, start time point information and product information, and generate a corresponding second traceability identifier. The second traceability identifier is used to trace the production information of each unit step of different batches of production processes. In this embodiment, through the generation of the second traceability identifier, the system can trace the production process information of different batches more flexibly. Users can, according to their needs, obtain the production process information of a specific batch through the second traceability identifier, thereby achieving accurate traceability of the production history, which helps to timely discover and solve potential problems and ensure that the product quality meets the expected standards. Specifically, the system obtains the start time point information of a certain production process as 2024-02-18 08:00:00, and the product information is Product A. By integrating the first traceability identifier, associated traceability identifier, start time point information and product information, a second traceability identifier such as "Batch202402180800_ProductA" is generated, which is used to trace the detailed production information of each unit step of this batch of production processes.
[0044] S206. Record and save the production information and the second traceability identifier, and generate a corresponding second traceability record. In this embodiment, through the generation of the second traceability record, the system improves the recording and management system of production information, enabling users to more conveniently obtain and trace the production information of different batches. The generation of the second traceability record includes the association between the production information and the second traceability identifier, providing users with a clear and comprehensive view of the production history. This helps to accurately trace the production process of a specific batch when needed, monitor and analyze the production quality. In addition, when there are batches of raw materials with quality problems, the links, positions and responsible persons where the problems occur can be directly locked. In one embodiment, as Figure 4 shown, in step S30, it includes: S301. According to the preset process product quality requirements, formulate an environmental monitoring process, and generate multiple sensor layout detection points according to the environmental monitoring process. In this embodiment, according to this process, the system generates multiple sensor layout detection points, which cover all key positions in the production environment that need to be monitored to ensure comprehensive monitoring of the production environment. This technical effect helps to timely discover abnormal environmental changes and improves the management and control ability of the production environment. Among them, the preset process product quality requirements refer to a series of detailed quality control objectives and parameters formulated during the production process to ensure that the final product can continuously meet the established quality standards and characteristics. These requirements usually include critical quality attributes (CQA) and critical process parameters (CPP), which are the most critical factors in the formation process of product quality and need to be determined through means such as risk assessment, experimental design and process optimization, and be strictly controlled and continuously monitored during the production process. Preferably, formulating an environmental monitoring process generally follows the following steps: First, based on a deep understanding of the production environment and product quality requirements, identify and define critical quality attributes (CQAs) and critical process parameters (CPPs), which are the key factors affecting product quality. Next, through risk assessment and design of experiments, determine the control ranges of these parameters and establish the corresponding design space. Then, according to these parameters, plan and arrange the sensor network to ensure that key parameters such as temperature, humidity, and air cleanliness in the production environment can be monitored and recorded in real time. When arranging sensors, consider the accuracy, response time, and environmental adaptability of the sensors. For example, temperature and humidity sensors need to be isolated from heat sources that may affect their readings, and ensure that the installation location of the sensors can represent the conditions of the entire production environment. In addition, the electrical specifications and electrostatic discharge protection of the sensors are also factors to be considered in the design process. Once the sensors are arranged, the system will collect environmental data in real time and generate regulatory information through data analysis. These regulatory information will be used to generate regulatory instructions to ensure that various parameters of the production environment are maintained within the preset ranges, thereby ensuring product quality. At the same time, the generated regulatory instructions and environmental data will be recorded to form a traceability record for subsequent auditing and analysis. Through the above process, the environmental monitoring system can not only respond to environmental changes in a timely manner, but also provide accurate data support for the production process, helping enterprises optimize production efficiency and product quality.
[0045] S302. Determine whether the sensor layout detection points have completed the response. If so, obtain the production environment quality information of the first preset period in real time. The production environment quality information includes temperature information, humidity information, and cleanliness information. In this embodiment, once it is confirmed that the sensor points have responded, the system immediately obtains the production environment quality information of the first preset period, which includes key parameters such as temperature, humidity, and cleanliness. By monitoring these environmental parameters in real time, the system can timely grasp the state of the production environment and provide accurate basic data for subsequent quality control and instruction generation. The first preset period usually refers to the fixed time interval set in an automated monitoring or data processing system to obtain the environmental or production environment quality information. At the end of this period, the system will trigger the sensor layout detection points to collect data to ensure that the latest environmental state information is obtained. Specifically, it refers to the initial set time period after the system confirms that the sensor points have responded. During this period, the system will obtain key parameters such as temperature, humidity, and cleanliness in real time to evaluate whether the production environment meets the preset quality standards. Specifically, determining whether the sensor layout detection points have completed the response means confirming whether the corresponding sensors have been successfully installed and started collecting environmental quality information. This includes the normal startup of the sensor device, the establishment of a connection with the monitoring system, and the sensor starting to collect data. Completing the response means that the sensor is in a working state and can provide real-time production environment quality information.
[0046] S303. Compare the production environment quality information with the threshold, generate and record the corresponding control information, and generate the corresponding first control instruction according to the control information. In this embodiment, these control information reflect the actual situation of the production environment, such as whether the temperature, humidity, and cleanliness are within the appropriate range. According to these control information, the system generates the first control instruction, which includes adjusting production equipment, environmental regulation, or other control measures to ensure that the environmental quality during the production process meets the preset requirements. Preferably, the process of generating regulation information by comparing the threshold value with the production environment quality information is as follows: First, the system obtains real-time production environment quality information, including key parameters such as temperature, humidity, and pressure. Then, the system automatically compares this real-time data with a pre-set threshold range. When it detects that a certain parameter exceeds or approaches the threshold value, the system will trigger an anomaly detection mechanism to analyze the specific degree of exceeding the threshold and the possible impacts. Next, based on predefined regulation strategies and rules, the system generates corresponding regulation information, records the anomaly situation of the parameter and the recommended regulation measures to ensure that the production environment can be adjusted in time to maintain the optimal state. Finally, the system stores this regulation information to generate the corresponding first regulation instruction; The process of automatically comparing this real-time data with a pre-set threshold range first requires inputting the real-time collected production environment quality data into the analysis module of the system. The threshold ranges of various parameters are pre-stored in the system, and these thresholds are usually set by empirical data or industry standards; After the data is input, the system will compare the values of each parameter one by one, using an automatic comparison algorithm to compare the current real-time data with the upper and lower limits of the threshold range. If a certain piece of data falls outside the threshold range or is close to the upper or lower limit, the system immediately marks this data and triggers the subsequent anomaly handling and regulation information generation process to take corresponding regulation measures in time.
[0047] S304. Obtain the production environment quality information of the second preset period, compare the production environment quality information of the first preset period with that of the second preset period to generate a corresponding difference interval, compare the difference interval with the preset expected interval, generate and push a corresponding interaction window, and obtain the interaction information of the interaction window in real time; In this embodiment, the system will generate and push a corresponding interaction window to prompt relevant personnel of the change in environmental quality. According to the feedback information of the user in the interaction window, the system generates a second regulation instruction, which involves adjusting production parameters, equipment status, or other regulation means to further optimize the production environment and ensure the stability of product quality. The second preset period refers to a fixed time period set again in the monitoring or detection system after the first preset period, used to obtain the quality information of the production environment again for comparison and analysis with the data of the first period. The preset expected interval refers to a range of allowable values set to ensure that the production environment meets specific standards during environmental monitoring or quality detection, used to evaluate whether the obtained data is within an acceptable range; Specifically, for example, in the first preset period, the reading of the temperature sensor is 25 degrees Celsius, and in the second preset period, the reading is 28 degrees Celsius. By comparing the difference (3 degrees Celsius) between these two periods, the system determines that the temperature rise exceeds the expectation. The system will generate and push an interaction window to prompt the user to make a regulation. The user confirms in the interaction window that the target temperature is adjusted to 25 degrees Celsius, and the system generates a second regulation instruction accordingly, such as adjusting relevant equipment to maintain the temperature within the target range.
[0048] S305. Integrate the production environment quality information, regulation information, and interaction information to generate corresponding third traceability records. In this embodiment, this record covers the changes in the production environment quality during the production process, the regulation measures taken by the system, and the interaction feedback information with the operators. Through the third traceability records, production managers can comprehensively understand the state of the production environment, the corresponding regulation measures, and the feedback from the operators at different time points, providing strong support for the optimization of the production process and problem troubleshooting; Preferably, the process of integrating the production environment quality information, regulation information, and interaction information to generate the third traceability records first obtains the recorded production environment quality information from the system, which includes real-time parameters such as temperature and humidity. Then the system extracts the previously generated regulation information, including regulation instructions and regulation results. Next, it obtains the interaction information related to the production process from the interaction module, such as the input of the operators and the feedback of the equipment. The system sorts these three types of information respectively according to the time stamp and integrates them based on the time and event relevance. It matches and associates the production environment, regulation results, and interaction records within the same time period through preset rules and algorithms. Finally, the system generates a third traceability record containing all relevant information to ensure that all key operations and environmental changes during this time period can be traced completely.
[0049] In one embodiment, as Figure 5 shown, in step S40, it includes: S401. Obtain the equipment characteristic information and equipment usage status information, and formulate corresponding equipment calibration procedures according to the equipment characteristic information and equipment usage status information. In this embodiment, considering the characteristics and usage of the equipment comprehensively, the formulated equipment calibration procedures will help ensure the accuracy and reliability of the equipment. The technical effect of this is that through a scientific and reasonable equipment calibration process, the measurement accuracy of the equipment is improved, and the reliability and stability of the equipment used in the production process are ensured; Specifically, according to the equipment characteristic information, including parameters such as the measurement accuracy and sensitivity of the equipment, and the equipment usage status information, such as the usage time and historical calibration records, the equipment calibration procedures are formulated to ensure that the equipment can maintain a reliable working state.
[0050] S402. According to the device calibration process, generate multiple calibration detection points, and detect in real time whether the calibration detection points have responded. If not, continue the detection. If so, obtain the location information, time information, and calibration anomaly occurrence curve information of the responded calibration detection points, integrate the location information, time information, and calibration anomaly occurrence curve information of the responded calibration detection points, and generate corresponding calibration result feedback information; in this embodiment, by monitoring the response of the calibration points in real time and obtaining relevant information on calibration anomalies in a timely manner, it helps to improve the timeliness and accuracy of calibration, ensure that the device remains in a suitable calibration state, and thus improve product quality and production efficiency. Through traceability records, managers can view the detailed information of device calibration, providing a reference basis for device maintenance; specifically, integrating the location information, time information, and calibration anomaly occurrence curve information of the responded calibration detection points usually involves combining these information in a structured form. For example, a data structure or report containing these information can be created, including the coordinates of the responded calibration detection points, the calibration time, and the relevant data of the anomaly occurrence curve. Such a data structure or report can be used to generate calibration result feedback information, providing a clear overview of calibration information for subsequent analysis and maintenance decisions.
[0051] S403. According to the calibration result feedback information, formulate the corresponding device maintenance process; In this embodiment, based on the calibration result feedback information, the system will formulate the corresponding device maintenance process. This process includes identifying the devices that need maintenance and the corresponding maintenance steps. The maintenance process includes repairing or replacing the faulty components, cleaning the device, making necessary adjustments, etc.; preferably, in the process of formulating the device maintenance process, the system first receives and analyzes the calibration result feedback information. The built-in analysis module of the system will identify the devices that need maintenance according to the device status, performance deviation, and possible problems in the feedback information; then, the system will automatically generate the corresponding maintenance steps according to the device type, failure mode, and historical maintenance records, including specific suggestions for repairing or replacing components, cleaning operations, and requirements for adjusting parameters. The system will also combine the standard operating procedures (SOP) and manufacturer suggestions to further refine the maintenance process to ensure that each step is clearly described; finally, the system will integrate these steps into a complete device maintenance process and push it to the relevant maintenance personnel for execution.
[0052] S404. Generate a corresponding maintenance report according to the equipment maintenance process, and re-detect whether the calibrated detection points corresponding to the maintenance items included in the maintenance report have been repaired. If not, continue the detection. If so, generate corresponding maintenance result feedback information. In this embodiment, the comprehensiveness and timeliness of equipment maintenance are ensured, effectively reducing production interruptions and quality problems caused by equipment failures, and improving the stability and reliability of the production process. Specifically, according to the equipment maintenance process, the maintenance report contains specific maintenance items, such as equipment cleaning, component replacement, etc. During re-detection, the system checks whether the calibrated detection points corresponding to these maintenance items have been repaired. If a certain calibrated detection point has returned to normal after maintenance, the system will generate maintenance result feedback information indicating that the maintenance task has been successfully completed. If some calibrated detection points are still not repaired, the system will continue the detection until all maintenance items are effectively processed.
[0053] S405. Generate a corresponding fourth trace record according to the calibration result feedback information and the maintenance result feedback information. In this embodiment, this trace record details the entire process of equipment calibration and maintenance, including the response of calibrated detection points, calibration anomaly occurrence curve information, the execution steps of the equipment maintenance process, and the feedback information of the maintenance results. Through the fourth trace record, it is possible to trace the specific operations of each equipment calibration and maintenance, understand the execution of each step and the effect of maintenance. In one embodiment, as Figure 6 shown, in step S50, it includes: S501. Obtain product characteristic information and preset customer requirement information, and formulate a finished product inspection process. The finished product inspection process at least includes a sampling planning step, an appearance inspection step, and a performance test step. In this embodiment, the formulation of this finished product inspection process can ensure a comprehensive assessment of product quality, effectively identify and handle existing quality problems, thereby guaranteeing product quality and improving customer satisfaction. The preset customer requirement information refers to a set of standards or specifications of customer expectations and requirements predefined based on market research or customer feedback. These information are used to guide the formulation of the finished product inspection process to ensure that the final product can meet these specific expectations and requirements. S502. Obtain the appearance imaging information and performance parameter information of the finished product samples according to the preset sampling plan included in the sampling planning step. In this embodiment, according to the preset sampling plan, the system implemented a sampling operation in the sampling planning step and extracted qualified finished product samples from the production batch. This step ensures that the obtained samples are representative and can fully reflect the quality status of the entire production batch. The preset sampling plan refers to a set of detailed sampling strategies and methods, including the sampling quantity, sampling location, sampling frequency, etc., which are pre-established according to the established quality control standards and the characteristics of the production batch in the finished product inspection process, to ensure that the samples taken can accurately represent the product characteristics of the entire batch. Specifically, the appearance imaging information includes image or photo records of the sample appearance for visual inspection. The performance parameter information covers various quantitative indicators related to product functions, and through the analysis of these parameters, the product performance can be objectively evaluated whether it meets the requirements.
[0054] S503. Compare the appearance imaging information with a threshold according to the appearance inspection standard included in the appearance inspection step, generate the corresponding appearance inspection result information, and generate the corresponding first inspection traceability mark according to the appearance inspection result information. Specifically, the appearance imaging information is usually obtained by using visual sensors, cameras or other imaging devices. These devices can capture images or videos of the product appearance and convert them into digital information. When conducting the appearance inspection, the system will compare the obtained appearance imaging information with the preset appearance inspection standard for threshold comparison. The appearance inspection standard includes requirements for aspects such as the color, shape, and size of the product. By comparing the actually obtained appearance imaging information with the standard, the system can generate the appearance inspection result information indicating whether the product meets the expected appearance standard.
[0055] S504. Compare the performance parameter information with a threshold according to the performance detection standard included in the performance test step, generate the corresponding performance detection result information, and generate the corresponding second inspection traceability mark according to the performance detection result information. Specifically, in the performance test step, the system will use the preset performance detection standard to measure the performance of the product. The performance parameter information refers to the parameter data obtained by the product in the performance test, including performance parameters such as speed, power consumption, and durability. The system generates the performance detection result information by comparing the actually obtained performance parameter information with the set performance detection standard for threshold comparison.
[0056] S505. Based on the appearance inspection result information and performance test result information, establish and train a detection result algorithm model. According to the detection result algorithm model, generate corresponding product inspection result judgment information, normalize the product inspection result judgment information, and generate corresponding product quality intervals. The product quality intervals include a qualified interval, a first-class inferior interval, a second-class inferior interval, and a third-class inferior interval. In this embodiment, by comprehensively considering the results of both appearance inspection and performance test, the system establishes and trains a detection result algorithm model. This model can comprehensively judge the inspection results of products and generate corresponding product inspection result judgment information. This information is normalized and converted into product quality intervals, including levels such as a qualified interval, a first-class inferior interval, a second-class inferior interval, and a third-class inferior interval. This process fully combines the detection indicators of both product appearance and performance, providing a comprehensive and accurate basis for the judgment of product quality.
[0057] S506. According to the product quality intervals, push corresponding comprehensive suggestion information. The comprehensive suggestion information includes corrective suggestion information, preventive suggestion information, and scrapping treatment suggestion information. In this embodiment, this process enables the system to not only put forward improvement and preventive suggestions for qualified products, but also provide corrective and scrapping treatment suggestions when the product quality is poor. This comprehensive suggestion system helps manufacturing enterprises fully understand the product quality situation, take timely measures to improve the production process, prevent potential problems, and take effective scrapping treatment measures when necessary. Specifically, if a product is judged as a first-class inferior product, the system pushes comprehensive suggestion information, including corrective suggestions for the product, such as repairing defects or improving the production process; preventive suggestions, such as strengthening control measures for relevant links to prevent similar problems from occurring again; and scrapping treatment suggestions, suggesting appropriate disposal of the first-class inferior product to ensure that it does not enter the market circulation. Such suggestion information helps formulate effective quality management strategies and improvement measures.
[0058] S507. Obtain the suggestion feedback information of the user. According to the comprehensive suggestion information and the suggestion feedback information, generate the corresponding processing flow. The processing flow includes multiple processing nodes. Obtain the node feedback information of the processing nodes in real time and generate the corresponding third inspection traceability identifier. In this embodiment, this process realizes the real-time processing of the faults or problems feedback by the user and records the entire processing flow, providing more detailed and comprehensive information for production traceability. Specifically, when the user provides feedback suggestions on product quality, the system will collect and integrate these user suggestions and then generate a processing flow. The processing flow includes different processing nodes, such as the review by the quality improvement team, the adjustment of the production process, or the re-inspection of the product, etc. When implementing these processing nodes, the system will obtain the feedback information of each node in real time. These feedback information helps to track and record the execution of the entire processing flow, and finally generate the corresponding third inspection traceability identifier to achieve comprehensive traceability and quality management.
[0059] S508. Establish the first association relationship between the third inspection traceability identifier and the first inspection traceability identifier, and / or establish the second association relationship between the third inspection traceability identifier and the second inspection traceability identifier. Integrate the first inspection traceability identifier, the second inspection traceability identifier, the third inspection traceability identifier, the first association relationship, and the second association relationship to generate the corresponding fifth traceability record. In this embodiment, this traceability record details various data such as inspection information and association relationships at different stages, realizing the in-depth traceability of the entire product production process. In this way, the enterprise can more comprehensively understand the product quality status, timely discover potential problems, and improve the accuracy and efficiency of production management. Specifically, the first association relationship may refer to the connection between the third inspection traceability identifier and the first inspection traceability identifier, used to establish the correlation between the inspection information in the third stage and the inspection information in the first stage during the product production process. This association relationship includes information such as raw materials, production processes, and equipment calibration involved in which production links. By establishing such an association relationship, the system can more effectively locate and trace the root cause of the problem when a quality problem occurs, and then take corresponding corrective measures. The same applies to the second association relationship.
[0060] In one embodiment, as Figures 7 - 8 shown, a medical test strip production process traceability device is provided. This medical test strip production process traceability device corresponds one-to-one with the medical test strip production process traceability method in the above embodiment. As Figure 7As shown, it includes a test strip carrier platform 1, a vision system 2 located above the test strip carrier platform 1, a test strip ejection mechanism 3 at the end of the transport path of the test strip carrier platform 1, a counting mechanism 4 electrically connected to the test strip carrier platform 1, and a tracing mechanism. The counting mechanism 4 includes a counter 42 at the beginning of the transport path of the test strip carrier platform 1 and a photoelectric trigger 41 located above the test strip carrier platform 1. The photoelectric trigger 41 is used to send a test tube counting signal passing through the photoelectric trigger 41 to the counter 42 for counting to generate counting production information. The vision system 2 is used to obtain vision production information for each unit step in the production process. The tracing mechanism is used to generate corresponding second tracing records according to the counting production information and the vision production information. In this embodiment, the test strip carrier platform 1 is used to carry and transport the test strips on the production line and ensure their stable movement during the production process. The vision system 2 located above the test strip carrier platform 1 consists of multiple cameras or sensors, which can capture vision information in each production step in real time, including the appearance, size, and other key features of the test strips. These vision production information are transmitted to the tracing mechanism for generating detailed production records. The counting mechanism 4 includes a counter 42 installed at the beginning of the transport path and a photoelectric trigger 41 located above the carrier platform. When a test tube passes through the photoelectric trigger 41, the trigger sends a signal to the counter 42 for accurate counting and generating counting production information, ensuring the correct number and production order of each batch of test strips. Finally, the tracing mechanism generates detailed second tracing records according to the counting production information and the vision production information, providing reliable data support for subsequent quality control and tracking. Specifically, as Figure 8 shown, the medical test strip production process tracing device further includes a driving element 5 for driving the test strip carrier platform 1 to transport forward. The driving element 5 is located on one side of the test strip carrier platform 1, and the driving element 5 is a belt driving motor. In this embodiment, the stable and continuous operation of the test strip carrier platform 1 is ensured. Even when encountering certain resistance or load changes during the production process, it can maintain a constant speed and a stable transport path. The use of a belt driving motor reduces the complexity of the mechanical structure and also reduces the production interruption that may be caused by mechanical failures. In addition, the belt drive system operates smoothly and has low noise, which helps to maintain a good working environment in the production workshop.
[0061] Specifically, as Figures 7 - 8As shown, the test strip pushing mechanism 3 includes a cavity scraping-in unit 31 located above the test strip carrying platform 1, a cavity carrier unit 32 disposed beside the end of the test strip carrying platform 1 and having its cavity opening facing the discharge port of the test strip carrying platform 1 through a limiting effect, a cavity pushing unit 33 located on one side of the cavity carrier unit 32, and a cavity rolling unit 34 located on the other side of the cavity carrier unit 32. The cavity scraping-in unit 31 is electrically connected to the counting mechanism 4. When the counter 42 determines that a test tube has passed through the optoelectronic trigger 41, the counter 42 sends a signal to the cavity scraping-in unit 31 to cause the cavity scraping-in unit 31 to scrape the test strip into the cavity carrier unit 32. The cavity pushing unit 33 is electrically connected to the counter 42. When the counter 42 counts up to a set value, the cavity filled with test strips is pushed into the cavity rolling unit 34 so as to roll to a subsequent mechanism through the cavity rolling unit 34. In this embodiment, the test strip pushing mechanism 3 is composed of multiple parts, including the cavity scraping-in unit 31, the cavity carrier unit 32, the cavity pushing unit 33, and the cavity rolling unit 34 located above the test strip carrying platform 1. When the test strip reaches the end of the carrying path, the cavity scraping-in unit 31 starts to work after receiving the signal sent by the counter 42 and precisely scrapes the test strip from the carrying platform into the cavity carrier unit 32. The design of the cavity carrier unit 32 ensures that the test strip can be accurately positioned and the cavity opening faces the discharge port of the carrying platform through a limiting effect. Subsequently, when the number of test strips recorded by the counter 42 reaches the set value, the cavity pushing unit 33 pushes the cavity filled with test strips into the cavity rolling unit 34, enabling the test strips to smoothly enter the next production step. Through this automated test strip pushing mechanism 3, the entire production process not only improves efficiency but also effectively reduces the errors of manual operations.
[0062] Specifically, as Figure 7As shown, the vision system 2 includes a first-scale vision unit 21 and a second-scale vision unit 22 that are sequentially arranged above the test strip carrier platform 1, and a feature judgment unit that is electrically connected to both the first-scale vision unit 21 and the second-scale vision unit 22. The feature judgment unit performs multi-scale feature extraction and multi-modal feature fusion on the visual information obtained through the first-scale vision unit 21 and the second-scale vision unit 22 to generate corresponding visual production information. In this embodiment, the vision system 2 includes two main parts: the first-scale vision unit 21 and the second-scale vision unit 22, both of which are arranged above the test strip carrier platform 1 and are electrically connected to the feature judgment unit. The first-scale vision unit 21 is responsible for capturing the macroscopic features of the test strip, such as length, width, and shape; while the second-scale vision unit 22 focuses on the collection of microscopic features, such as fine defects on the surface of the test strip and the accuracy of patterns. The feature judgment unit receives the image data from the two vision units and deeply analyzes and processes these data through techniques of multi-scale feature extraction and multi-modal feature fusion. By integrating the visual information at different scales, the system can more comprehensively evaluate the quality of the test strip, identify potential defects or abnormalities, and thus generate more accurate and detailed visual production information. This process greatly improves the accuracy of production quality control, ensuring that each produced test strip meets the predetermined standards.
Claims
1. A method for tracing the production process of a medical test strip, characterized in that, The method for tracing the production process of a medical test strip includes: Obtain the quality information of raw materials. According to the quality information of raw materials, generate corresponding first traceability records. The quality information of raw materials includes supplier audit result information, in - warehouse inspection result information, and inventory management process information; Formulate a production process, obtain the production information of each unit step in the production process, and generate corresponding second traceability records according to the production information; Obtain the quality information of the production environment, analyze the quality information of the production environment, generate corresponding control information, and generate corresponding third traceability records according to the control information. The quality information of the production environment includes temperature information, humidity information, and cleanliness information; Formulate an equipment calibration process, generate corresponding calibration result feedback information, generate a corresponding equipment maintenance process according to the calibration result feedback information, generate corresponding maintenance result feedback information according to the equipment maintenance process, and generate corresponding fourth traceability records according to the calibration result feedback information and the maintenance result feedback information; Formulate a finished - product inspection process, generate corresponding inspection result feedback information, and generate corresponding fifth traceability records according to the inspection result feedback information; Integrate the first traceability record, the second traceability record, the third traceability record, the fourth traceability record, and the fifth traceability record to generate a corresponding production traceability database.
2. The traceability method for the production process of a medical test strip according to claim 1, characterized in that, In the step of obtaining the quality information of raw materials, generating corresponding first traceability records according to the quality information of raw materials, where the quality information of raw materials includes supplier audit result information, in - warehouse inspection result information, and inventory management process information, it includes: Obtain the qualification information, credit information, and quality management system information of the supplier, generate a corresponding trust weight value, determine the optimal supplier according to the trust weight value, and determine the supplier audit result information of the optimal supplier; Determine the in - warehouse raw materials supplied by the optimal supplier, obtain the appearance information and performance information of the in - warehouse raw materials, analyze the appearance information and performance information, and generate corresponding in - warehouse inspection result information; Obtain the in - warehouse process information, out - of - warehouse process information, and storage process information. Based on a preset inventory management system, compare and analyze the in - warehouse process information, out - of - warehouse process information, and storage process information, and generate a corresponding process exception status report; Judge whether the abnormal items included in the process exception status report have been eliminated by manual intervention. If not, continuously judge whether the abnormal items have been eliminated. If so, generate a corresponding correction report, integrate the process exception status report and the correction report, and generate corresponding inventory management process information; Generate corresponding first traceability records according to the supplier audit result information, the in - warehouse inspection result information, and the inventory management process information.
3. A method for tracing the production process of a medical test strip according to claim 1, characterized in that, In the step of formulating a production process, obtaining the production information of each unit step in the production process, and generating corresponding second traceability records according to the production information, it includes: Formulate a production process, and the production process includes multiple unit steps; Obtain the production information of each unit step in the multiple unit steps, where the production information includes operator information, operation time information, equipment status information, and process parameter information; Extract the first associated feature field according to the production information, and generate a first traceability identifier according to the first associated feature field, where the first traceability identifier is used to trace the production information of the unit step; Generate a traceability sequence for the unit step according to the first traceability identifier, determine the associated steps of each unit step according to the traceability sequence, generate corresponding associated traceability identifiers according to the associated steps, and generate corresponding trigger entries according to the associated traceability identifiers, where the trigger entries are used to trigger the corresponding associated traceability identifiers according to the user's interaction instructions when tracing the first traceability identifier; Obtain the start time point information and product information of the production process, integrate the first traceability identifier, associated traceability identifier, start time point information, and product information, and generate a corresponding second traceability identifier, where the second traceability identifier is used to trace the production information of each unit step in different batches of production processes; Record and save the production information and the second traceability identifier, and generate a corresponding second traceability record.
4. A method for tracing the production process of a medical test strip according to claim 1, characterized in that, In the step of obtaining the production environment quality information, analyzing the production environment quality information, generating corresponding regulation information, and generating a corresponding third traceability record according to the regulation information, where the production environment quality information includes temperature information, humidity information, and cleanliness information, it includes: Formulate an environmental monitoring process according to the preset process product quality requirements, and generate multiple sensor layout detection points according to the environmental monitoring process; Judge whether the sensor layout detection points have completed the response. If so, obtain the production environment quality information of the first preset period in real time, where the production environment quality information includes temperature information, humidity information, and cleanliness information; Compare the production environment quality information with the threshold, and generate and record the corresponding regulation information; Obtain the production environment quality information of the second preset period, compare the production environment quality information of the first preset period with the production environment quality information of the second preset period, generate a corresponding difference interval, compare the difference interval with the preset expected interval, generate and push a corresponding interaction window, and obtain the interaction information of the interaction window in real time; Integrate the production environment quality information, regulation information, and interaction information, and generate a corresponding third traceability record.
5. A method for tracing the production process of a medical test strip according to claim 1, characterized in that, In the step of formulating an equipment calibration process, generating corresponding calibration result feedback information, generating a corresponding equipment maintenance process according to the calibration result feedback information, generating corresponding maintenance result feedback information according to the equipment maintenance process, and generating a corresponding fourth traceability record according to the calibration result feedback information and the maintenance result feedback information, it includes: Obtain the equipment characteristic information and equipment usage status information, and formulate a corresponding equipment calibration process according to the equipment characteristic information and equipment usage status information; According to the device calibration process, multiple calibration detection points are generated, and it is detected in real time whether the calibration detection points have responded. If not, the detection continues. If so, the location information, time information, and calibration anomaly occurrence curve information of the responded calibration detection points are obtained, and the location information, time information, and calibration anomaly occurrence curve information of the responded calibration detection points are integrated to generate corresponding calibration result feedback information; According to the calibration result feedback information, a corresponding device maintenance process is formulated; According to the device maintenance process, a corresponding maintenance report is generated, and it is re-detected whether the responded calibration detection points corresponding to the maintenance items included in the maintenance report have been repaired. If not, the detection continues. If so, corresponding maintenance result feedback information is generated; According to the calibration result feedback information and the maintenance result feedback information, a corresponding fourth traceability record is generated.
6. A method for tracing the production process of a medical test strip according to claim 1, characterized in that, In the step of formulating the finished product inspection process to generate corresponding inspection result feedback information and generating a corresponding fifth traceability record according to the inspection result feedback information, it includes: Obtain product characteristic information and preset customer requirement information, and formulate a finished product inspection process. The finished product inspection process at least includes a sampling planning step, an appearance inspection step, and a performance test step; According to the preset sampling plan included in the sampling planning step, obtain the appearance imaging information and performance parameter information of the finished product sample; According to the appearance inspection standard included in the appearance inspection step, perform threshold comparison on the appearance imaging information to generate corresponding appearance inspection result information, and generate a corresponding first inspection traceability identifier according to the appearance inspection result information; According to the performance detection standard included in the performance test step, perform threshold comparison on the performance parameter information to generate corresponding performance detection result information, and generate a corresponding second inspection traceability identifier according to the performance detection result information; According to the appearance inspection result information and the performance detection result information, establish and train a detection result algorithm model, and generate corresponding product inspection result determination information according to the detection result algorithm model. Normalize the product inspection result determination information to generate a corresponding product quality interval. The product quality interval includes a qualified interval, a first-class inferior interval, a second-class inferior interval, and a third-class inferior interval; According to the product quality interval, push corresponding comprehensive suggestion information. The comprehensive suggestion information includes corrective suggestion information, preventive suggestion information, and scrap disposal suggestion information; Obtain the suggestion feedback information of the user, and generate a corresponding processing process according to the comprehensive suggestion information and the suggestion feedback information. The processing process includes multiple processing nodes, and obtain the node feedback information of the processing nodes in real time to generate a corresponding third inspection traceability identifier; Establish a first association relationship between the third inspection traceability identifier and the first inspection traceability identifier, and / or establish a second association relationship between the third inspection traceability identifier and the second inspection traceability identifier. Integrate the first inspection traceability identifier, the second inspection traceability identifier, the third inspection traceability identifier, the first association relationship, and the second association relationship to generate a corresponding fifth traceability record.
7. A device for tracing the production process of a medical test strip, characterized in that, It includes: The first traceability module is used to obtain raw material quality information, and generate corresponding first traceability records according to the raw material quality information, where the raw material quality information includes supplier audit result information, in-warehouse inspection result information, and inventory management process information; The second traceability module is used to formulate a production process, obtain production information of each unit step in the production process, and generate corresponding second traceability records according to the production information; The third traceability module is used to obtain production environment quality information, analyze the production environment quality information, generate corresponding regulation information, generate corresponding regulation instructions according to the regulation information, and generate corresponding third traceability records, where the production environment quality information includes temperature information, humidity information, and cleanliness information; The fourth traceability module is used to formulate an equipment calibration process, generate corresponding calibration result feedback information, generate a corresponding equipment maintenance process according to the calibration result feedback information, generate corresponding maintenance result feedback information according to the equipment maintenance process, and generate corresponding fourth traceability records according to the calibration result feedback information and the maintenance result feedback information; The fifth traceability module is used to formulate a finished product inspection process, generate corresponding inspection result feedback information, and generate corresponding fifth traceability records according to the inspection result feedback information; The integration module is used to integrate the first traceability record, the second traceability record, the third traceability record, the fourth traceability record, and the fifth traceability record to generate a corresponding production traceability database.
8. The traceability device for the production process of a medical test strip according to claim 7, characterized in that, The second traceability module includes a test strip carrier platform (1), a vision system (2) located above the test strip carrier platform (1), a test strip ejection mechanism (3) located at the end of the transportation path of the test strip carrier platform (1), a counting mechanism (4) electrically connected to the test strip carrier platform (1), and a traceability mechanism. The counting mechanism (4) includes a counter (42) located at the beginning of the transportation path of the test strip carrier platform (1) and a photoelectric trigger (41) located above the test strip carrier platform (1). The photoelectric trigger (41) is used to send a test tube counting signal passing through the photoelectric trigger (41) to the counter (42) for counting to generate counting production information. The vision system (2) is used to obtain visual production information of each unit step in the production process. The traceability mechanism is used to generate corresponding second traceability records according to the counting production information and the visual production information; The medical test strip production process traceability device further includes a driving element (5) for driving the test strip carrier platform (1) to transport forward. The driving element (5) is located on one side of the test strip carrier platform (1), and the driving element (5) is a belt driving motor.
9. The traceability device for the production process of a medical test strip according to claim 8, characterized in that, The test strip pushing mechanism (3) includes a cavity scraping unit (31) located above the test strip carrying platform (1), a cavity carrier unit (32) disposed beside the end of the test strip carrying platform (1) and aligning the cavity opening towards the discharge port of the test strip carrying platform (1) through a limiting effect, a cavity pushing unit (33) located on one side of the cavity carrier unit (32), and a cavity rolling unit (34) located on the other side of the cavity carrier unit (32). The cavity scraping unit (31) is electrically connected to the counting mechanism (4). When the counter (42) determines that the test tube has passed through the photoelectric trigger (41), the counter (42) sends a signal to the cavity scraping unit (31) to cause the cavity scraping unit (31) to scrape the test strip into the cavity carrier unit (32). The cavity pushing unit (33) is electrically connected to the counter (42). When the counter (42) reaches the set value, the cavity filled with test strips is pushed into the cavity rolling unit (34) to roll to the subsequent mechanism through the cavity rolling unit (34).
10. A production process traceability device for medical test strips according to claim 8, characterized in that, The vision system (2) includes a first scale vision unit (21) and a second scale vision unit (22) sequentially arranged above the test strip carrying platform (1), and a feature judgment unit electrically connected to both the first scale vision unit (21) and the second scale vision unit (22). The feature judgment unit performs multi-scale feature extraction and multi-modal feature fusion on the visual information obtained by the first scale vision unit (21) and the second scale vision unit (22) to generate corresponding visual production information.
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