A pharmaceutical industry material inspection and release control method and device and storage medium

Abstract

The application discloses a kind of medical industry material inspection release control method, device and storage medium, by monitoring to material warehousing event after through warehouse management system query the material information, according to the material information query database associated quality inspection strategy information, if quality inspection strategy information contains quality inspection release feature, then according to the material information in database query acquisition first personnel group address and send to first personnel group address inspection order prompt;According to the inspection order prompt, material information and quality inspection strategy information automatically generate the inspection order corresponding to the material;Second personnel group is according to the data generated sampling record of sampling quality inspection operation obtained by the inspection order. Solve the current pharmaceutical enterprise in the material quality inspection, there are a large number of offline paper operation links, the whole process time-consuming and labor-consuming and inefficient, while there is not real-time data, data missing error recording and so on.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of information technology, and in particular to a medicine industry material inspection and release control method, device and storage medium. BACKGROUND

[0002] When performing drug quality management, the quality assurance department of a pharmaceutical enterprise needs to strictly implement a series of quality management related procedures, such as checking relevant delivery records, quality inspection records, and production records, and then performing relevant quality determination operations on the materials. Only qualified materials in the warehouse can be used for production. Only qualified intermediates, semi-finished products, and finished products in production can enter the next process. Only qualified finished products in the warehouse can be used for commercial sales. However, when performing material quality inspection, the current pharmaceutical enterprises have a large number of offline paper operation links in the quality inspection process. The warehouse management department needs to fill out a paper inspection request form, and then the QC department takes samples offline, fills out a paper record, and issues a paper quality inspection report. The QA department performs paper verification and approval for release. There are a large number of manual operation links in the process, which is time-consuming and labor-intensive and has low efficiency. At the same time, there are risks such as non-real-time data, data omission, and quality deviation caused by data errors. Therefore, the traditional offline quality control method has great challenges in compliance. SUMMARY

[0003] The present application provides a medicine industry material inspection and release control method, which includes the following steps:

[0004] S1, after monitoring the material storage event, querying the material information through the warehouse management system, querying the associated quality inspection strategy information in the database according to the material information, the material information including one or more of material type, material quantity, storage time, supplier identifier, and batch number;

[0005] S2, if the quality inspection strategy information contains quality inspection and release characteristics, querying and obtaining the first personnel group address in the database according to the material information, and sending an inspection request reminder to the first personnel group address;

[0006] S3, automatically generating an inspection request form corresponding to the material according to the inspection request reminder, the material information, and the quality inspection strategy information, and after receiving the confirmation indication of at least one personnel in the first personnel group, filtering and obtaining the matched second personnel group address in the database according to the material information and sending the inspection request form to the second personnel group address;

[0007] S4, generating a sampling record according to the data obtained by the second personnel group performing a sampling and quality inspection operation according to the inspection request form, and sending material release information after obtaining the audit confirmation of the third personnel group on the sampling record.

[0008] Preferably, the step S3 includes:

[0009] The task progress of each quality inspector and the project information corresponding to the warehousing material are acquired, the project start time is queried in the database according to the project information, and the longest quality inspection period is acquired according to the interval between the project start time and the current time;

[0010] The time strategy feature in the quality inspection strategy information is acquired, if the time strategy feature is the least time consumption, the longest quality inspection period is queried, the longest idle period in the longest quality inspection period is queried, the personnel information in the longest idle period is selected as the second personnel group; if the time strategy feature is the least personnel, the longest idle period in the longest quality inspection period is queried, the number of quality inspectors required for the longest idle period is calculated according to the material model and the material quantity, and the personnel information in the longest idle period is selected as the second personnel group according to the number of quality inspectors.

[0011] Preferably, the step S3 further comprises:

[0012] The material information in the inspection request reminding instruction is acquired, and the inspection request template corresponding to the material is acquired by searching in the database;

[0013] The preset quality inspection strategy group associated with the material in the database is queried according to the material information; the adjustment level in the quality inspection strategy group is viewed, if there is a higher adjustment level, the historical quality inspection data of the related material class in the quality inspection history database is queried, and the related features in the quality inspection strategy group are modified according to the historical quality inspection data to obtain the adjusted quality inspection strategy group;

[0014] The information in the adjusted quality inspection strategy group is supplemented into the inspection request template to automatically generate the inspection request corresponding to the material.

[0015] Preferably, the step S2 comprises:

[0016] Whether the batch number record information exists in the database is queried according to the material batch number, if the batch number exemption information exists, the inspection request reminding is abandoned, if the batch number exemption information does not exist and the historical quality inspection record of the same batch exists, the historical qualified rate of each quality inspection record is calculated;

[0017] If the historical qualified rate is greater than the first preset value, the inspection request reminding is abandoned, otherwise, the first personnel group address is queried and acquired in the database according to the material information, and the inspection request reminding is sent to the first personnel group address.

[0018] Preferably, the step S4 specifically comprises:

[0019] The sampling record containing the inspection results of each packaging unit is generated according to the input inspection data, the sampling record includes the weight of each packaging material and the corresponding sampling weight, if the weight ratio of the sample to the packaging material is lower than the preset value of the sample weight ratio in the inspected packaging material, the packaging material re-inspection notice is issued;

[0020] If at least one material characteristic quality inspection result of the material sample in the sampling record is lower than or higher than the preset range of the material characteristic, a high or low identification is added in the corresponding record.

[0021] The application also discloses a material inspection and release control system for the pharmaceutical industry, comprising: a strategy configuration module, configured to query material information through a warehouse management system after monitoring a material warehousing event, query associated quality inspection strategy information in a database according to the material information, and the material information comprises one or more of a material model, a material quantity, a warehousing time, a supplier identifier, and a batch number; a quality inspection reminding module, configured to contain quality inspection release characteristics in the quality inspection strategy information, query a first personnel group address in the database according to the material information, and send an inspection request reminding to the first personnel group address; an inspection request submission module, configured to automatically generate an inspection request corresponding to the material according to the inspection request reminding, the material information and the quality inspection strategy information, and after receiving a confirmation indication of at least one personnel in the first personnel group, filter and obtain a matched second personnel group address in the database according to the material information, and send the inspection request to the second personnel group address; a sampling module, configured to generate a sampling record by data obtained by a sampling and quality inspection operation of the second personnel group according to the inspection request, and send material release information after obtaining an audit confirmation of the sampling record by a third personnel group.

[0022] Preferably, the inspection request submission module comprises: a quality inspection period acquisition module, configured to query and obtain project information corresponding to each quality inspection personnel task progress and the warehoused material, query a project start time in the database according to the project information, and acquire a longest quality inspection period according to an interval between the project start time and a current time; a personnel screening module, configured to acquire a time strategy characteristic in the quality inspection strategy information, if the time strategy characteristic is a minimum time consumption, query a longest idle time period of the personnel in the longest quality inspection period, and select personnel information in the time period as the second personnel group; if the time strategy characteristic is a minimum number of personnel, query a longest idle time period of the time in the longest quality inspection period, calculate and acquire a number of quality inspection personnel required in the longest idle time period according to the material model and the material quantity, and select personnel information in the time period as the second personnel group according to the number of quality inspection personnel.

[0023] Preferably, the inspection order submission module further comprises: an inspection order template acquisition module, configured to acquire material information in the inspection order prompting instruction, and search for an inspection order template corresponding to the material in a database; a strategy adjustment module, configured to query a preset quality inspection strategy group associated with the material in the database according to the material information, check an adjustment level in the quality inspection strategy group, and if the adjustment level is high, search for historical quality inspection data of a relevant material class in a quality inspection history database, modify relevant features in the quality inspection strategy group according to the historical quality inspection data, and obtain an adjusted quality inspection strategy group; and an inspection order generation module, configured to supplement information in the adjusted quality inspection strategy group into the inspection order template to automatically generate an inspection order corresponding to the material.

[0024] The application further discloses a medical industry material inspection and release control device, including a memory, a processor, and a computer program stored in the memory and executable on the processor, and the processor implements the steps of the method according to any one of the above.

[0025] The application further discloses a computer readable storage medium, which stores a computer program, and the computer program is executable on a processor to implement the steps of the method according to any one of the above.

[0026] The medical industry material inspection and release control method, device and storage medium disclosed in the above embodiments can be applied to the quality management link of materials and finished products of pharmaceutical enterprises, and provide a complete quality management process covering the links of inspection order submission, inspection order receiving, QC sampling, QC quality inspection and QA release of raw materials and finished products of pharmaceutical enterprises. After a material storage event is monitored, the material information is inquired through a warehouse management system, the quality inspection strategy information associated with the material information is inquired in the database, if the quality inspection strategy information contains quality inspection and release features, the first personnel group address is inquired and acquired in the database according to the material information, and the inspection order prompting is sent to the first personnel group address; the inspection order corresponding to the material is automatically generated according to the inspection order prompting, the material information and the quality inspection strategy information, and after at least one first personnel group confirms the indication, the matched second personnel group address is filtered and acquired in the database according to the material information, and the inspection order is sent to the second personnel group address; the data obtained by the second personnel group according to the sampling and inspection operation of the inspection order is generated into a sampling record, and the material release information is sent after the third personnel group audits and confirms the sampling record. The material quality inspection strategy can be flexibly configured, the material quality inspection is determined, the specific release mode and quality inspection process of the material are determined, the whole process of the material quality inspection from the inspection order initiation, sampling, quality inspection result submission and quality release is realized, and the online digital management is realized. The problems of offline paper operation links, time and labor consumption, low efficiency, non-real-time data, data omission and error, etc. in the material quality inspection of the pharmaceutical enterprises are solved.

[0027] Additional aspects and advantages of the present application will be given in part in the following description, become apparent from the following description, or be learned by practice of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0028] The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application. In the drawings:

[0029] Figure 1 A flowchart of a pharmaceutical industry material inspection and release control method disclosed for an embodiment.

[0030] Figure 2 A specific flowchart of step S3 disclosed for an embodiment.

[0031] Figure 3 Another specific flowchart of step S3 disclosed for an embodiment. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions of the embodiments of the present application will be described clearly and completely below with reference to the drawings of the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the described embodiments of the present application, all other embodiments obtained by those of ordinary skill in the art without any creative effort belong to the scope of protection of the present application.

[0033] In the present application, unless otherwise explicitly specified and limited, the technical terms or scientific terms used herein should be understood as the common meanings understood by those of ordinary skill in the art to which the present application belongs. The "first", "second" and similar words used in the patent application description and claims of the present application do not represent any order, quantity or importance, but are only used to distinguish different components. Similarly, "one" or "a" and similar words also do not represent a quantity limitation, but represent the existence of at least one.

[0034] This embodiment discloses a material inspection and release control method for the pharmaceutical industry. It configures corresponding quality inspection strategies for materials and then determines whether the material requires quality inspection and whether the release method is inspection-release. After the material is received into the warehouse, the system sends a quality inspection reminder message to the warehouse staff. The warehouse staff creates an inspection request form for the material and submits it to QC. After receiving the inspection request form in the system, QC, with the assistance of the warehouse staff, moves the material to the sampling room for sampling and records the sampling quantity in the system. After QC completes sampling, the laboratory conducts quality testing on the samples and issues an electronic quality inspection report. The QC then enters the material quality status as qualified / unqualified in the system and uploads the quality inspection report, submitting the inspection request form to QA. Upon receiving the inspection request form, QA makes a final judgment on the material's quality status based on the quality inspection report submitted by QC, and performs the material release operation. It clarifies whether the material is released or not; if released, the final quality status is qualified; if not released, the final quality status is unqualified. This method also provides a corresponding exception rollback process to ensure operational flexibility when data anomalies occur. QC can return problematic inspection requests to the requesting department for resubmission of the data, and QA can return problematic inspection requests to QC for adjustments to the material quality status and quality inspection documents. Details are attached. Figure 1 As shown in the figure, this embodiment discloses a material inspection and release control method for the pharmaceutical industry, which may include the following steps.

[0035] Step S1: After monitoring the material warehousing event, query the material information through the warehouse management system, and query the associated quality inspection strategy information in the database based on the material information. The material information includes one or more of the following: material model, material quantity, warehousing time, supplier identifier, and batch number.

[0036] Step S2: If the quality inspection strategy information contains quality inspection release characteristics, then query the database to obtain the address of the first personnel group based on the material information, and send an inspection request reminder to the address of the first personnel group.

[0037] Specifically, after receiving material information, the warehouse management system proactively queries the database for the associated quality inspection strategy information for that material via a program interface. This quality inspection strategy determines whether the material requires inbound quality inspection and whether the inspection method involves creating an inspection request form for release. If it is confirmed that the material requires quality inspection and release, a quality inspection reminder system message is triggered based on the batch number, prompting the corresponding first-level personnel group, i.e., the material management personnel, to submit an inspection request form.

[0038] In this embodiment, step S2 may specifically include the following:

[0039] According to the material batch number, whether the batch number record information exists in the database is queried. If the batch number exemption information exists, the inspection request reminding is abandoned. If the batch number exemption information does not exist and the same batch history quality inspection record exists, the historical qualified rate of each quality inspection record is calculated.

[0040] If the historical qualified rate is greater than the first preset value, the inspection request reminding is abandoned. Otherwise, the first personnel group address is obtained from the database according to the material information, and the inspection request reminding is sent to the first personnel group address.

[0041] In step S3, the inspection request reminding, the material information and the quality inspection strategy information are used to automatically generate the inspection request corresponding to the material. After receiving the confirmation indication of at least one person in the first personnel group, the matched second personnel group address is obtained from the database according to the material information, and the inspection request is sent to the second personnel group address. The first personnel group, i.e., the material management personnel, can jump to the inspection request submission component through the jump link of the quality inspection reminding, and enter the inspection request creation interface, as shown in FIG. 8. The inspection request of the corresponding material batch is created. The inspection request submission component is used to create the inspection request of a batch of materials. The material associated personnel can initiate the material quality inspection application based on the module. In this embodiment, as shown in FIG. 8, step S3 can include the following contents. Figure 2 Figure 2

[0042] In step S31, the task progress of each quality inspection personnel and the project information corresponding to the warehoused material are obtained. The project start time is obtained from the database according to the project information, and the longest quality inspection period is obtained according to the interval between the project start time and the current time.

[0043] In step S32, the time strategy feature in the quality inspection strategy information is obtained. If the time strategy feature is the least time consumption, the longest quality inspection period is queried. The personnel information in the longest quality inspection period is selected as the second personnel group.

[0044] In step S33, if the time strategy feature is the least personnel, the longest time idle period in the longest quality inspection period is queried. The number of quality inspection personnel required in the longest idle period is calculated according to the material model and the material quantity. The personnel information in the longest idle period is selected as the second personnel group according to the number of quality inspection personnel.

[0045] As shown in FIG. 8, step S3 further includes: Figure 3

[0046] In step S101, the material information in the inspection request reminding instruction is obtained. The inspection request template corresponding to the material is obtained from the database.

[0047] ​​​Step S102, according to the material information, the preset quality inspection strategy group associated with the material in the database is queried; the adjustment level in the quality inspection strategy group is viewed, if there is a higher adjustment level, the historical quality inspection data of the relevant material class in the quality inspection historical database is queried, and the relevant characteristics in the quality inspection strategy group are modified according to the historical quality inspection data to obtain the adjusted quality inspection strategy group.

[0048] The quality inspection strategy group includes one or more of the material name, whether to release, whether to inspect, whether to re-inspect, and adjustment level. The quality inspection strategy of each material is not fixed, and a most commonly used and most conventional quality inspection strategy corresponding to the material is preset in the database. However, with the update of relevant quality inspection information and the actual situation of each material at this time, the quality inspection strategy of part of the materials often needs to be adjusted to realize the optimization of the quality inspection work. In the existing quality inspection process, this real-time adjustment can only rely on the experience of the quality inspection personnel to temporarily adjust after obtaining the assigned quality inspection task, and at this time and after completing the assignment of the quality inspection task, the adjustment is lagging, needs to be coordinated with other personnel, and can only adjust the subsequent work, thereby limiting the adjustment timeliness and range of the quality inspection strategy. In the embodiment, by setting the adjustment level in the first quality inspection strategy group, whether the strategy group of the material needs to be adjusted and the adjustment flexibility are set. The higher the adjustment level, the more the quality inspection strategy of the material needs to be adjusted, and the quality inspection strategy of the material with a low adjustment level is relatively stable and is not affected by historical quality inspection data and other factors, and the adjustment demand is low. When the adjustment level is high, that is, the adjustment level is higher than the preset first level, the historical quality inspection data of the relevant material class in the quality inspection historical database can be queried.

[0049] In the embodiment, the quality inspection strategy associated with the relevant material in the database is the first quality inspection strategy group, and the adjusted quality inspection strategy group is the second quality inspection strategy group. If the adjustment level in the first quality inspection strategy group corresponding to the material is a high level, the relevant material class corresponding to the material is obtained, the relevant material class includes the same batch of materials as the material, the same supplier materials in a first predetermined time period, and the same model materials in a second predetermined time period. The historical quality inspection data of each material in the relevant material class corresponding to the material is respectively queried and obtained in the quality inspection historical database. The batch, supplier identifier, and material name in the material information are used to search the relevant material class in the historical database which has relevance in quality inspection information. The first predetermined time period and the second predetermined time period can be preset and set in the material information. The materials in the relevant material class have certain relevance, and the quality inspection results have a certain similarity. When the quality inspection qualified rate of the relevant material class is low, it is necessary to increase the sampling inspection proportion of the material to be inspected this time, that is, to increase the workload of the quality inspection of the material.

[0050] In the preferred embodiment, if the qualified rate of the material from the supplier is lower than the minimum qualified rate of the material in the first predetermined period, all the inspection results of the material from the supplier are called, and the first predetermined period is extended to the earliest time of the material inspection in which the qualified rate is lower than the minimum qualified rate of the material. If the qualified rate of the material of the same type is lower than the minimum qualified rate of the material in the second predetermined period, all the inspection results of the material of the same type are called, and the second predetermined period is extended to the earliest time of the material inspection in which the qualified rate is lower than the minimum qualified rate of the material. Thus, the accuracy of the inspection result of the material is improved.

[0051] In step S103, the information in the adjusted inspection strategy group is filled into the inspection request template to automatically generate the inspection request corresponding to the material.

[0052] In the embodiment, the historical qualified rate is calculated according to the historical inspection data of each material belonging to the relevant material category. If the historical qualified rate is greater than the first preset value, the inspection option in the first inspection strategy group is set to no inspection to form the second inspection strategy group. If the historical qualified rate is lower than the second preset value, the sampling inspection rate in the first inspection strategy group is increased to a predetermined value to form the second inspection strategy group. Otherwise, the first inspection strategy group is not adjusted.

[0053] In the embodiment, the step further includes: if the adjustment level in the first inspection strategy group corresponding to the material is a high level, the project information corresponding to the material is queried, and the quality control level corresponding to the project is queried in the database according to the project information.

[0054] If the material has multiple corresponding project information, the highest quality control level in each project is obtained as the quality control level of the material. If the quality control level of the material is in the first level, the inspection option information in the first inspection strategy group is checked. If the inspection option information is no inspection, the inspection option information is modified to need inspection. Otherwise, the sampling inspection rate of the material is increased to a predetermined value.

[0055] Step S4, the second personnel group generates a sampling record according to the data obtained by the sampling and inspection operation according to the inspection order, and sends material release information after obtaining the audit confirmation of the third personnel group on the sampling record. The second personnel group, i.e. the QC personnel, receives the inspection order after the inspection order is switched to the inspection state, and the system control allows only the QC personnel to receive the inspection order. The QC personnel can record the specific sampling quantity of each package according to the package number one by one to form a sampling record, realize fine sampling management function, and control the sampling precision, wherein the sampling precision can be configured in the material basic information, and the number exceeding the range is not allowed to be entered. During the sampling operation, the system queries the inspection order data of the database through the program interface, queries whether the material code and batch have an associated valid inspection order, and if there is no valid inspection order, the system control does not allow sampling. The third personnel group, i.e. the QA personnel, performs the final audit on the material inspection result and executes the corresponding quality release operation.

[0056] In the embodiment, the step S4 can specifically include the following contents.

[0057] According to the entered inspection data, a sampling record containing the inspection results of each packaging unit is generated, and the sampling record includes the weight of each packaging material and the corresponding sampling weight. If the weight ratio of the sample to the packaging material is lower than the preset value of the sample weight ratio in the inspected packaging material, a re-inspection notice of the packaging material is issued;

[0058] If at least one material characteristic inspection result of the material sample in the sampling record is lower than or higher than the preset range of the material characteristic, a high or low identification is added in the corresponding record.

[0059] In the embodiment, the system can also check the newly entered batch and item model. If there is no batch number in the quality inspection task database, an error prompt is issued and the subsequent entry of the record is aborted. Specifically, the entered data record table using each quality inspection instrument can be automatically checked. By obtaining each quality inspection instrument data and the corresponding instrument screen picture recorded in the audit verification area, the instrument information database is queried according to the instrument type in the quality inspection instrument data to obtain the corresponding screen recognition information. The instrument measurement parameters in the instrument screen picture are identified according to the position of the digital feature area in the screen, the position of the non-digital feature area in the screen, and other information. Finally, the identified information is compared with the information already entered in the electronic experiment record to find the incorrect information entered in the record, effectively ensuring the correctness of the entered data in the experiment record, and eliminating the time loss caused by manually comparing the data in the input box of the notebook with the instrument screen picture by the quality inspection personnel. Specifically, according to the received data verification instruction, the data verification instruction includes the audit verification area in the data record table; each quality inspection instrument data and the corresponding instrument screen picture recorded in the audit verification area are obtained in sequence; the instrument information database is queried according to the instrument type in the quality inspection instrument data to obtain the corresponding screen recognition information, which includes the shape of the screen area, the position of the digital feature area in the screen, and the position of the non-digital feature area in the screen. The non-digital features are character features or letter features. The instrument measurement parameters in the instrument screen picture are identified according to the position of the digital feature area in the screen and the position of the non-digital feature area in the screen; the identified instrument measurement parameters are compared with the data recorded in the quality inspection instrument data. If they are not the same, a notification of the error in the quality inspection instrument data record is issued.

[0060] In the embodiment, if the identified instrument measurement parameter is not identical with the recorded data in the quality inspection instrument data, the quality inspection instrument data error response is sent out, and the step of comparing and matching the recorded data in the quality inspection instrument data with the identified data respectively to obtain first recorded parameters and first identified parameters that cannot be matched can further include the following steps: determining whether there is a non-numeric feature region in the instrument screen picture, and if there is, obtaining a first non-numeric feature region corresponding to the first digital feature region where the first identified parameter is located, and identifying a first measurement unit in the first non-numeric feature region; and querying whether there is a unit conversion relationship group containing the first measurement unit in the instrument information database according to the first measurement unit, and if there is, obtaining a predetermined parameter unit of the first recorded parameter from the quality inspection instrument data, converting the first identified parameter into a converted parameter corresponding to the predetermined parameter unit according to the unit conversion relationship group, and comparing the converted parameter with the first recorded parameter, and if they are not identical, triggering a data error action; or if there is a unit conversion relationship group containing the first measurement unit, obtaining a predetermined parameter unit of the first recorded parameter from the quality inspection instrument data, converting the first recorded parameter into a converted parameter corresponding to the first measurement unit according to the unit conversion relationship group, and comparing the converted parameter with the first identified parameter, and if they are not identical, triggering a data error action.

[0061] In the embodiment, in the step of determining whether there is a non-numeric feature region in the instrument screen picture, and if there is, obtaining a first non-numeric feature region corresponding to the first digital feature region where the first identified parameter is located, and identifying a first measurement unit in the first non-numeric feature region, the step can further include the following steps: if there is no non-numeric feature region in the instrument screen picture, obtaining a predetermined parameter unit of the first recorded parameter from the quality inspection instrument data; querying a unit conversion relationship group containing the predetermined parameter unit in the instrument information database according to the predetermined parameter unit; obtaining conversion formulas of the predetermined parameter unit and other candidate measurement units that can be converted; sequentially converting the first recorded parameter and comparing the converted parameter with the first identified parameter, and if they are not identical, converting the next candidate measurement unit until the comparison is identical or the conversion of all candidate measurement units is completed, and if the comparison is not identical, triggering a data error action.

[0062] In the embodiment, the identified instrument measurement parameter is compared with the data recorded in the quality inspection instrument data. If they are not the same, the quality inspection instrument data error response is sent. The quality inspection instrument data error response can further include the following: the second measurement unit in the identified non-digital feature region is compared with each predetermined parameter unit of the quality inspection instrument data. If there is a same second predetermined parameter unit, the second recorded parameter corresponding to the second predetermined parameter unit in the quality inspection instrument data is obtained, and the second recorded parameter is compared with the second identified parameter in the second digital feature region corresponding to the second non-digital feature region where the second measurement unit is located. If they are not the same, the data error action is triggered. If there is no same second predetermined parameter unit, it is determined whether there is a recorded parameter in the quality inspection instrument data that has not completed the matching verification. If there is, the unit conversion relationship group containing the second measurement unit is queried in the instrument information database according to the second measurement unit. The second recorded parameter is converted into a conversion parameter of each corresponding candidate measurement unit according to the unit conversion relationship group. Each conversion parameter is compared with the recorded parameter that has not completed the matching verification in turn. If they are all not the same, the data error action is triggered.

[0063] In the embodiment, the identified instrument measurement parameter is compared with the data recorded in the quality inspection instrument data. If they are not the same, the quality inspection instrument data error response is sent. The quality inspection instrument data error response can further include the following: the second measurement unit in the identified non-digital feature region is compared with each predetermined parameter unit of the quality inspection instrument data. If there is a same second predetermined parameter unit, the second recorded parameter corresponding to the second predetermined parameter unit in the quality inspection instrument data is obtained, and the second recorded parameter is compared with the second identified parameter in the second digital feature region corresponding to the second non-digital feature region where the second measurement unit is located. If they are not the same, the data error action is triggered. If there is no same second predetermined parameter unit, it is determined whether there is a recorded parameter in the quality inspection instrument data that has not completed the matching verification. If there is, the unit conversion relationship group containing the second measurement unit is queried in the instrument information database according to the second measurement unit. The second recorded parameter is converted into a conversion parameter of each corresponding candidate measurement unit according to the unit conversion relationship group. Each conversion parameter is compared with the recorded parameter that has not completed the matching verification in turn. If they are all not the same, the data error action is triggered.

[0064] In the embodiment, the pharmaceutical industry material inspection release control method further includes a process rollback step. When data abnormity occurs, the business flexibility is flexible. QC can return the problematic inspection request to the inspection department. The inspection department can re-report the inspection data. QA can return the problematic inspection request to QC. QA adjusts the material quality state and the quality inspection file and then re-submits them. The system controls the operation of the inspection request release and return only by the QA personnel by querying the role permission data in the database.

[0065] The pharmaceutical industry material inspection release control method disclosed in the above embodiments can be applied to the quality management link of materials and finished products of pharmaceutical enterprises, and provides a complete quality management process covering the submission of inspection request forms, the reception of inspection request forms, QC sampling, QC quality inspection, and QA release of each link of raw materials and finished products of pharmaceutical enterprises. After the material storage event is monitored, the material information is queried through the warehouse management system, the associated quality inspection strategy information in the database is queried according to the material information, if the quality inspection strategy information contains quality inspection release characteristics, the first personnel group address is obtained from the database according to the material information and the inspection request form reminder is sent to the first personnel group address; the inspection request form corresponding to the material is automatically generated according to the inspection request form reminder, the material information, and the quality inspection strategy information, and after receiving the confirmation indication of at least one personnel in the first personnel group, the matched second personnel group address is obtained from the database according to the material information and the inspection request form is sent to the second personnel group; the data obtained by the second personnel group according to the sampling inspection operation of the inspection request form is generated into a sampling record, and the material release information is sent after the audit confirmation of the third personnel group on the sampling record. The material quality inspection strategy can be flexibly configured, the material quality inspection is determined, the specific release mode and quality inspection process of the material are determined, the whole process online digital management of the material quality inspection from the inspection request initiation, sampling, quality inspection result submission, and quality release is realized. The current pharmaceutical enterprises have a large number of offline paper operation links when performing material quality inspection, the whole process is time-consuming and labor-consuming and has low efficiency, and there are problems of non-real-time data, data omission, and wrong recording.

[0066] The specific functions of the above pharmaceutical industry material inspection release control system correspond one by one to the pharmaceutical industry material inspection release control method disclosed in the above embodiments, so they will not be described in detail here. For details, please refer to the above disclosed pharmaceutical industry material inspection release control method embodiments. It should be noted that the embodiments in the specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts of each embodiment can be referred to.

[0067] In some other embodiments, a pharmaceutical industry material inspection release control device is also provided, which includes a memory, a processor, and a computer program stored in the memory and executable on the processor, and the processor implements each step of the pharmaceutical industry material inspection release control method described in the above embodiments when executing the computer program.

[0068] The medicine industry material inspection and release control device can include, but is not limited to, a processor and a memory. The server can include, but is not limited to, a processor and a memory. Those skilled in the art can understand that the schematic diagram is only an example of the server and does not constitute a limitation on the server device, and can include more or fewer components than the diagram, or combine certain components, or different components, for example, the server device can also include an input / output device, a network access device, a bus, etc.

[0069] The processor can be a central processing unit (CPU), and can also be other general-purpose processors, digital signal processors (DSP), application specific integrated circuits (ASIC), field-programmable gate arrays (FPGA) or other programmable logic devices, discrete gates or transistor logic devices, discrete hardware components, etc. The general-purpose processor can be a microprocessor or any conventional processor, etc. The processor is the control center of the server device, and connects various parts of the server device through various interfaces and lines.

[0070] The memory can be used to store the computer programs and / or modules, and the processor realizes various functions of the server device by running or executing the computer programs and / or modules stored in the memory, and calling the data stored in the memory. The memory can mainly include a program storage area and a data storage area, wherein the program storage area can store an operating system, at least one application required for a function, etc. In addition, the memory can include a high-speed random access memory, and can also include a non-volatile memory, such as a hard disk, a memory, a plug-in hard disk, a smart media card (SMC), a secure digital (SD) card, a flash card, at least one disk storage device, a flash memory device, or other volatile solid-state storage devices.

[0071] If the medical industry material inspection and release control method is realized in the form of a software function unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, all or part of the processes in the above-mentioned embodiment methods can also be completed by a computer program instructing related hardware. The computer program can be stored in a computer-readable storage medium. When the processor executes the computer program, the steps of each method embodiment described above can be implemented. The computer program includes computer program code, which can be in the form of source code, object code, executable files, or some intermediate forms, etc. The computer-readable medium can include any entity or device that can carry the computer program code, recording medium, U disk, mobile hard disk, magnetic disk, optical disk, computer memory, read-only memory (ROM), random access memory (RAM), electrical carrier signal, telecommunication signal, and software distribution medium, etc. It should be noted that the content included in the computer-readable medium can be appropriately increased or decreased according to the requirements of legislation and patent practice in the jurisdiction. For example, in some jurisdictions, according to legislation and patent practice, the computer-readable medium does not include electrical carrier signals and telecommunication signals.

[0072] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacements for some technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

[0073] In summary, the above is only a preferred embodiment of the present application, and any equivalent changes and modifications made within the scope of the patent application of the present application shall be included in the scope of the present application.

Claims

1. A method for controlling the release of medical industry materials, characterized in that, The method comprises the following steps: S1, after monitoring the material storage event, querying the material information through the warehouse management system, and querying the associated quality inspection strategy information in the database according to the material information, wherein the material information comprises one or more of the material model, the material quantity, the storage time, the supplier identifier, and the batch number; S2, if the quality inspection strategy information contains quality inspection release features, the first personnel group address is obtained from the database according to the material information, and a test order reminder is sent to the first personnel group address; S3, a test order corresponding to the material is automatically generated according to the test order reminder, the material information, and the quality inspection strategy information, and after receiving the confirmation indication of at least one first personnel group, the matched second personnel group address is obtained from the database according to the material information and the test order is sent to the second personnel group; the project information corresponding to each quality inspection personnel task progress and the storage material is obtained, the project start time is obtained from the database according to the project information, and the longest quality inspection period is obtained according to the interval between the project start time and the current time; the time strategy feature in the quality inspection strategy information is obtained, if the time strategy feature is the least time-consuming, the longest quality inspection period is queried, the personnel information in the longest idle period is selected as the second personnel group; if the time strategy feature is the least personnel, the longest idle period in the longest quality inspection period is queried, the number of quality inspection personnel required in the longest idle period is calculated according to the material model and the material quantity, and the personnel information in the longest idle period is selected as the second personnel group according to the number of quality inspection personnel; The material information in the test order reminder instruction is obtained, and the test order template corresponding to the material is obtained from the database; the preset quality inspection strategy group associated with the material in the database is obtained according to the material information; the adjustment level in the quality inspection strategy group is checked, if there is a higher adjustment level, the historical quality inspection data of the related material class in the quality inspection history database is queried, and the related features in the quality inspection strategy group are modified according to the historical quality inspection data to obtain the adjusted quality inspection strategy group; The quality inspection strategy associated with the related material in the database is the first quality inspection strategy group, and the adjusted quality inspection strategy group is the second quality inspection strategy group; if the adjustment level in the first quality inspection strategy group corresponding to the material is a high level, the related material class corresponding to the material is obtained, the related material class comprises the same batch material as the material, the same supplier material in the first predetermined time period, and the same model material in the second predetermined time period; the historical quality inspection data of each material in the related material class corresponding to the material is obtained by querying the quality inspection history database respectively; the related material class having correlation with the material in the quality inspection information is searched in the historical database according to the batch, the supplier identifier, and the material name in the material information; wherein the first predetermined time period and the second predetermined time period can be preset in the material information. If the quality inspection qualified rate of the material from the supplier in the first predetermined period is lower than the minimum qualified rate of the material, all quality inspection results of the material from the supplier are called, and the first predetermined period is extended to the earliest time of quality inspection of the material whose quality inspection qualified rate is lower than the minimum qualified rate of the material; if the quality inspection qualified rate of the material of the same type in the second predetermined period is lower than the minimum qualified rate of the material, all quality inspection results of the material of the same type are called, and the second predetermined period is extended to the earliest time of quality inspection of the material whose quality inspection qualified rate is lower than the minimum qualified rate of the material; The information in the adjusted quality inspection strategy group is supplemented into the inspection order template to automatically generate an inspection order corresponding to the material; S4, the second personnel group generates a sampling record according to the data obtained by the sampling quality inspection operation of the inspection order, and sends material release information after the audit confirmation of the third personnel group to the sampling record.

2. The medical industry material inspection release control method according to claim 1, characterized by, The step S2 comprises: According to the material batch number, whether the batch number record information exists in the database is queried, if the batch number exemption information exists, the inspection order reminding is abandoned, if the batch number exemption information does not exist and the historical quality inspection record of the same batch exists, the historical qualified rate of each quality inspection record is calculated; If the historical qualified rate is greater than the first preset value, the inspection order reminding is abandoned, otherwise, the first personnel group address is obtained by querying the database according to the material information, and the inspection order reminding is sent to the first personnel group address.

3. The medical industry material inspection release control method according to claim 2, characterized by, The step S4 specifically comprises: According to the input inspection data, a sampling record containing the inspection results of each packaging unit is generated, the sampling record includes the weight of each packaging material and the corresponding sampling weight, if the weight ratio of the sample to the packaging material is lower than the preset value of the sample weight ratio in the inspected packaging material, the packaging material re-inspection notification is issued; If at least one material characteristic quality inspection result of the material sample in the sampling record is lower than or higher than the preset range of the material characteristic, a high or low identification is added in the corresponding record.

4. A medical industry material inspection release control system, characterized by, Comprise: The strategy configuration module is used for querying the material information through the warehouse management system after monitoring the material storage event, querying the associated quality inspection strategy information in the database according to the material information, and the material information includes one or more of the material type, the material quantity, the storage time, the supplier identifier, and the batch number; The quality inspection reminding module is used for containing the quality inspection release characteristics in the quality inspection strategy information, then the first personnel group address is obtained by querying the database according to the material information, and the inspection order reminding is sent to the first personnel group address; The please check module is used for automatically generating a please check sheet corresponding to the material according to the please check reminder, the material information and the quality inspection strategy information, and after receiving an indication of confirmation from at least one person in a first personnel group, screening and obtaining a matched second personnel group address in the database according to the material information and sending the please check sheet to the second personnel group; querying and obtaining the task progress of each quality inspection personnel and the project information corresponding to the warehousing material, querying the project start time in the database according to the project information, and obtaining the longest quality inspection period according to the interval between the project start time and the current time; obtaining the time strategy feature in the quality inspection strategy information, if the time strategy feature is the least time-consuming, querying the longest idle period of personnel in the longest quality inspection period, and selecting the personnel information in the period as the second personnel group; if the time strategy feature is the least personnel, querying the longest idle period of time in the longest quality inspection period, calculating the number of quality inspection personnel required in the longest idle period according to the material model and the material quantity, and selecting the personnel information in the period as the second personnel group according to the number of quality inspection personnel; obtaining the material information in the please check reminder instruction, finding and obtaining the please check sheet template corresponding to the material in the database; querying the database to obtain the preset quality inspection strategy group associated with the material according to the material information; checking the adjustment level in the quality inspection strategy group, if there is a higher adjustment level, querying the historical quality inspection data of the related material class in the quality inspection historical database, and modifying the related features in the quality inspection strategy group according to the historical quality inspection data to obtain the adjusted quality inspection strategy group; the quality inspection strategy associated with the related material in the database is the first quality inspection strategy group, and the adjusted quality inspection strategy group is the second quality inspection strategy group; if the adjustment level in the first quality inspection strategy group corresponding to the material is a high level, obtaining the related material class corresponding to the material, the related material class including the same batch material as the material, the same supplier material in a first predetermined time period, and the same model material in a second predetermined time period; querying and obtaining the historical quality inspection data of each material in the related material class corresponding to the material in the quality inspection historical database respectively; searching the related material class having correlation with the material in the quality inspection information in the historical database according to the batch, the supplier identifier and the material name in the material information; wherein the first predetermined time period and the second predetermined time period can be preset in the material information; if the quality inspection qualified rate of the same supplier material in the first predetermined time period is lower than the minimum qualified rate of the material, all quality inspection results of the same supplier material are called, the first predetermined time period is extended to the earliest material quality inspection time when the quality inspection qualified rate is lower than the minimum qualified rate of the material; if the quality inspection qualified rate of the same model material in the second predetermined time period is lower than the minimum qualified rate of the material, all quality inspection results of the same model material are called, and the second predetermined time period is extended to the earliest material quality inspection time when the quality inspection qualified rate is lower than the minimum qualified rate of the material; supplementing the information in the adjusted quality inspection strategy group into the please check sheet template to automatically generate the please check sheet corresponding to the material; A sampling module is configured to generate a sampling record based on data obtained by performing a sampling and inspection operation on the second group of personnel according to the inspection order, and send material release information after obtaining an audit confirmation of the sampling record by the third group of personnel.

5. A medical material inspection and release control device comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, characterized in that: The computer program is executed by the processor to implement the steps of the method of any one of claims 1-3.

6. A computer readable storage medium storing a computer program, characterized in that: The computer program is executed by the processor to implement the steps of the method of any one of claims 1-3.

Images