CN115619091A - Medicine industry material inspection release control method and device and storage medium - Google Patents
Medicine industry material inspection release control method and device and storage medium Download PDFInfo
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Abstract
The invention discloses a method, a device and a storage medium for controlling material inspection release in the pharmaceutical industry, wherein the material information is inquired through a storage management system after a material warehousing event is monitored, the associated quality inspection strategy information in a database is inquired according to the material information, if the quality inspection strategy information comprises a quality inspection release characteristic, a first personnel group address is inquired and obtained in the database according to the material information, and a request examination order prompt is sent to the first personnel group address; automatically generating a request-to-check list corresponding to the material according to the request-to-check list prompt, the material information and the quality inspection strategy information; and generating a sampling record by using the data obtained by performing sampling quality inspection operation on the second personnel group according to the request examination list. The problem of present pharmacy enterprise when carrying out material quality inspection, have a large amount of off-line paper operating link, whole process is consuming time and is hard and inefficiency, has simultaneously that data is not real-time, data to miss notes the mistake to remember the scheduling problem.
Description
Technical Field
The invention relates to the technical field of informatization, in particular to a method and a device for controlling material inspection and release in the pharmaceutical industry and a storage medium.
Background
When the quality assurance department of a pharmaceutical enterprise performs drug quality management, a series of related procedures related to the quality management need to be strictly executed, for example, related receiving records, quality inspection records and production records are checked, then, related quality judgment operations are executed on materials, qualified materials can be released from the stock for production, intermediates, semi-finished products and finished products in the production can enter the next procedure after being released to be qualified, and finished products in the stock can be used for commercial sale after being released to be qualified. However, when the material quality inspection is performed in the pharmaceutical enterprises at present, a large number of off-line paper operation links exist in the quality inspection process, after a material management department fills a paper request sheet, a QC department performs off-line sampling, a paper quality inspection report is issued after filling a paper record, and a QA department performs paper verification and approval release, so that a large number of manual operation links exist in the process, the process is time-consuming, labor-consuming and low in efficiency, and meanwhile, risks of quality deviation caused by data omission and misreading exist, and the like, so that the traditional off-line quality control method has great challenges in compliance.
Disclosure of Invention
The invention provides a method for controlling material inspection release in the pharmaceutical industry aiming at the defects in the prior art, which comprises the following steps:
s1, after a material warehousing event is monitored, querying material information through a warehousing management system, and querying associated quality inspection strategy information in a database according to the material information, wherein the material information comprises one or more of material model, material quantity, warehousing time, supplier identification and batch number;
s2, if the quality inspection strategy information contains quality inspection release characteristics, inquiring in a database according to the material information to obtain a first personnel group address, and sending a list asking prompt to the first personnel group address;
s3, automatically generating a request-to-check list corresponding to the material according to the request-to-check list prompt, the material information and the quality inspection strategy information, screening and acquiring a matched second personnel group address in the database according to the material information after receiving a personnel confirmation instruction in at least one first personnel group, and sending the request-to-check list to the database;
and S4, generating a sampling record by the second personnel group according to the data obtained by sampling quality inspection operation of the request and inspection list, and sending material release information after obtaining the audit confirmation of the third personnel group on the sampling record.
Preferably, the step S3 includes:
inquiring and acquiring task progress of each quality inspector and project information corresponding to warehoused materials, inquiring project starting time in a database according to the project information, and acquiring the longest quality inspection period according to the distance between the project starting time and the current time interval;
acquiring time strategy characteristics in the quality inspection strategy information, inquiring the most idle time period of personnel in the longest quality inspection period if the time strategy characteristics consume the least time, and selecting the personnel information in the time period as a second personnel group; and if the time strategy characteristic is that the number of the personnel is the minimum, inquiring the longest idle time period in the longest idle time period, calculating the number of the quality testing personnel required by the longest idle time period according to the material model and the material quantity, and selecting the personnel information in the time period as a second personnel group according to the number of the quality testing personnel.
Preferably, the step S3 further includes:
obtaining material information in the order for asking for inspection form reminding instruction, and searching and obtaining an inspection form template corresponding to the material in a database;
inquiring a preset quality inspection strategy group related to the material in a database according to the material information; checking the adjustment level in the quality inspection strategy group, inquiring historical quality inspection data of related materials in a quality inspection historical database if the adjustment level is higher, and modifying related characteristics in the quality inspection strategy group according to the historical quality inspection data to obtain an adjusted quality inspection strategy group;
and supplementing the information in the adjusted quality inspection strategy group into a test sheet template to automatically generate a test sheet corresponding to the material.
Preferably, the step S2 includes:
inquiring whether the batch number record information exists in the database or not according to the material batch number, if the batch number non-inspection information exists, giving up sending a request for inspection sheet reminding, and if the batch number non-inspection information does not exist and the same batch of historical quality inspection records exist, calculating the historical qualification rate of each quality inspection record;
and if the historical qualification rate is greater than a first preset value, giving up sending the checklist asking prompt, otherwise, inquiring in a database according to the material information to obtain a first personnel group address, and sending the checklist asking prompt to the first personnel group address.
Preferably, the step S4 specifically includes:
generating sampling records containing the inspection results of each packaging unit according to the input inspection data, wherein the sampling records comprise the weight of each packaging material and the corresponding sampling weight, and if the weight ratio of a sample to the packaging material is lower than the preset value of the weight ratio of the sample in each packaging material to be inspected, sending a packaging material additional inspection notification;
and if the quality detection result of at least one material characteristic of the material sample in the sampling record is lower than or higher than the preset range of the material characteristic, adding a higher or lower mark in the corresponding record.
The invention also discloses a medicine industry material inspection release control system, which comprises: the system comprises a strategy configuration module, a database management module and a data processing module, wherein the strategy configuration module is used for inquiring material information through a storage management system after monitoring a material warehousing event and inquiring related quality inspection strategy information in the database according to the material information, and the material information comprises one or more of material model, material quantity, warehousing time, supplier identification and batch number; the quality inspection reminding module is used for inquiring and acquiring a first personnel group address in a database according to the material information if the quality inspection strategy information contains quality inspection release characteristics, and sending a list asking for inspection to the first personnel group address; the inspection request submitting module is used for automatically generating an inspection request corresponding to the material according to the inspection request prompt, the material information and the quality inspection strategy information, screening and acquiring a matched second personnel group address in the database according to the material information after receiving a personnel confirmation instruction in at least one first personnel group, and sending the inspection request to the database; and the sampling module is used for generating a sampling record according to the data obtained by the second personnel group through sampling quality inspection operation according to the request and test list, and sending material release information after obtaining the verification confirmation of the sampling record by the third personnel group.
Preferably, the check sheet submitting module includes: the quality inspection period acquisition module is used for inquiring and acquiring the task progress of each quality inspector and the project information corresponding to the warehousing materials, inquiring the project starting time in the database according to the project information and acquiring the longest quality inspection period according to the distance between the project starting time and the current time interval; the personnel screening module is used for acquiring time strategy characteristics in the quality inspection strategy information, inquiring the most idle time period of personnel in the longest quality inspection period if the time strategy characteristics are the least time consumption, and selecting the personnel information in the time period as a second personnel group; and if the time strategy characteristic is that the number of the personnel is the minimum, inquiring the longest idle time period in the longest idle time period, calculating the number of the quality testing personnel required by the longest idle time period according to the material model and the material quantity, and selecting the personnel information in the time period as a second personnel group according to the number of the quality testing personnel.
Preferably, the request and check sheet submitting module further comprises: the system comprises a list asking and testing template acquisition module, a list asking and testing template acquisition module and a list asking and testing template processing module, wherein the list asking and testing template acquisition module is used for acquiring material information in a list asking and testing reminding instruction and searching and acquiring a list asking and testing template corresponding to the material in a database; the strategy adjusting module is used for inquiring a preset quality inspection strategy group related to the material in the database according to the material information; checking the adjustment level in the quality inspection strategy group, inquiring historical quality inspection data of related materials in a quality inspection historical database if the adjustment level is higher, and modifying related characteristics in the quality inspection strategy group according to the historical quality inspection data to obtain an adjusted quality inspection strategy group; and the test order generation module is used for supplementing the information in the adjusted quality inspection strategy group into the test order template to automatically generate a test order corresponding to the material.
The invention also discloses a material inspection and release control device in the pharmaceutical industry, which comprises a memory, a processor and a computer program stored in the memory and capable of running on the processor, wherein the processor executes the computer program to realize the steps of any one of the methods.
The invention also discloses a computer-readable storage medium, in which a computer program is stored, which, when being executed by a processor, carries out the steps of the method as set forth in any one of the above.
The method, the device and the storage medium for controlling the material inspection and release in the pharmaceutical industry disclosed by the embodiments can be applied to quality management links of materials and finished products in pharmaceutical enterprises, and provide a complete quality management flow for the pharmaceutical enterprises in each link of submitting a request-to-check list, receiving the request-to-check list, sampling QC, inspecting QC quality and releasing QA, wherein the quality management flow covers the raw materials and the finished products. Inquiring the material information through a warehousing management system after monitoring a material warehousing event, inquiring the associated quality inspection strategy information in a database according to the material information, inquiring and acquiring a first personnel group address in the database according to the material information and sending a check request prompt to the first personnel group address if the quality inspection strategy information contains a quality inspection release characteristic; automatically generating a request and test order corresponding to the material according to the request and test order reminding, the material information and the quality inspection strategy information, screening and acquiring a matched second personnel group address in a database according to the material information after receiving a personnel confirmation instruction in at least one first personnel group, and sending the request and test order to the second personnel group address; and generating a sampling record by the second personnel group according to the data obtained by sampling quality inspection operation of the request and inspection list, and sending material release information after obtaining the audit confirmation of the third personnel group on the sampling record. The method can flexibly configure a material quality inspection strategy, determine whether the material needs quality inspection or not, determine the specific release mode and quality inspection process of the material, and realize the online digital management of the whole process of material quality inspection, initiation of inspection, sampling, submission of quality inspection results and quality release. The problem of present pharmacy enterprise when carrying out material quality inspection, have a large amount of off-line paper operation links, whole process is consuming time and is laboured and inefficiency, has simultaneously that data is not real-time, data is missed to remember the misclassification etc is solved.
Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the invention and do not constitute a limitation of the invention. In the drawings:
fig. 1 is a schematic flow chart illustrating a method for controlling material inspection and release in the pharmaceutical industry according to an embodiment.
Fig. 2 is a schematic flowchart of step S3 according to an embodiment.
Fig. 3 is another specific flowchart of step S3 disclosed in an embodiment.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the drawings of the embodiments of the present invention. It is to be understood that the embodiments described are only a few embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the invention without any inventive step, are within the scope of protection of the invention.
In the present invention, unless otherwise specifically defined and limited, technical terms or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which the present invention belongs. The use of "first," "second," and similar terms in the description and claims of the present application do not denote any order, quantity, or importance, but rather the terms are used to distinguish one element from another. Also, the use of the terms "a" or "an" and the like do not denote a limitation of quantity, but rather denote the presence of at least one.
According to the method for controlling the release of the material inspection in the pharmaceutical industry, the corresponding quality inspection strategy is configured for the material, and then whether the material needs quality inspection or not and whether the release mode of the quality inspection is inspection release or not are judged. After the materials are put in storage, the system sends quality inspection reminding messages to storage management personnel, and the storage management personnel create and submit inspection request sheets to QC. And after the system receives the request and check list, the QC moves the materials to a sampling room for sampling under the assistance of the warehouse management personnel and records the sampling quantity in the system. After QC finishes sampling, laboratory tests the quality of the sample and issues an electronic quality test report, the system fills in qualified/unqualified material quality state, meanwhile, the quality test report is uploaded to submit a test order to QA, QA receives the test order, finally judges the quality state of the material based on the quality test report submitted by QC, executes the releasing operation of the material, definitely releases or does not release the quality test of the material, if the releasing operation is selected, the final quality state of the material is qualified, and if the releasing operation is not selected, the final quality state of the material is unqualified. Specifically, as shown in fig. 1, the embodiment discloses a method for controlling material inspection and release in the pharmaceutical industry, which may include the following steps.
Step S1, after a material warehousing event is monitored, querying material information through a warehousing management system, and querying associated quality inspection strategy information in a database according to the material information, wherein the material information comprises one or more of material model, material quantity, warehousing time, supplier identification and batch number.
And S2, if the quality inspection strategy information contains quality inspection release characteristics, inquiring and acquiring a first personnel group address in a database according to the material information, and sending a request and test order prompt to the first personnel group address.
Specifically, after the material warehousing information, the warehousing management system actively inquires the quality inspection strategy information related to the material in the database through a program interface, wherein the quality inspection strategy can restrict whether the material needs to be warehoused for quality inspection, and whether the quality inspection mode is that whether the quality inspection of a request inspection list needs to be created or not. And if the materials need to be subjected to quality inspection and released, triggering a quality inspection reminding system message according to the batch number to remind a corresponding first personnel group, namely material management personnel, to submit a request and check list.
In this embodiment, the step S2 may specifically include the following contents.
And inquiring whether the batch number record information exists in the database according to the material batch number, if the batch number non-inspection information exists, giving up sending an inspection request prompt, and if the batch number non-inspection information does not exist and the same batch of historical quality inspection records exist, calculating the historical qualification rate of each quality inspection record.
And if the historical qualification rate is greater than a first preset value, giving up sending the checklist asking prompt, otherwise, inquiring in a database according to the material information to obtain a first personnel group address, and sending the checklist asking prompt to the first personnel group address.
And S3, automatically generating a request and test order corresponding to the material according to the request and test order reminding, the material information and the quality inspection strategy information, and after receiving a confirmation instruction of the personnel in at least one first personnel group, screening and acquiring a matched second personnel group address in the database according to the material information and sending the request and test order to the database. The first personnel group, i.e. the material management personnel, can jump to the requisition and checklist submission component through the jump link of the quality inspection prompt, enter a requisition and checklist creation interface, as shown in fig. 2, and create a requisition and checklist of a corresponding material batch. The request-check bill submitting component is used for creating a request-check bill for a certain batch of materials, and the material correlation personnel can initiate a material quality inspection application based on the module. In this embodiment, as shown in fig. 2, the step S3 may include the following steps.
And S31, inquiring and acquiring the task progress of each quality inspector and the project information corresponding to the warehousing materials, inquiring the project starting time in the database according to the project information, and acquiring the longest quality inspection period according to the distance between the project starting time and the current time interval.
And step S32, acquiring time strategy characteristics in the quality inspection strategy information, inquiring the most idle time period of the personnel in the longest quality inspection period if the time strategy characteristics are the least time consumption, and selecting the personnel information in the time period as a second personnel group.
And S33, inquiring the longest idle time period in the longest idle time period if the time strategy characteristic is that the number of the personnel is the minimum, calculating the number of the quality inspection personnel required by the longest idle time period according to the material model and the material quantity, and selecting the personnel information in the time period as a second personnel group according to the number of the quality inspection personnel.
As shown in fig. 3, the step S3 further includes:
and S101, acquiring material information in the test order prompting instruction, and searching and acquiring a test order template corresponding to the material in a database.
Step S102, inquiring a preset quality inspection strategy group related to the material in a database according to the material information; checking the adjustment level in the quality inspection strategy group, inquiring historical quality inspection data of related materials in a quality inspection historical database if the adjustment level is higher, and modifying related characteristics 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 group comprises one or more of material name, whether to put in storage and release, whether to inspect, whether to recheck and adjustment grade. The quality inspection strategy of each material is not fixed and invariable, and a quality inspection strategy corresponding to the most common and most common conditions of the material is preset in the database. However, with the update of the relevant quality inspection information and the current actual situation of each material, the quality inspection strategy of part of the materials is often required to be adjusted so as to realize the optimization of the quality inspection work. In the existing quality inspection process, the real-time adjustment can only be temporarily adjusted by quality inspection personnel according to experience after obtaining the allocated quality inspection task, and at the moment and after the completion of the allocation of the quality inspection task, the adjustment is delayed, and the adjustment needs to be coordinated with other personnel, and only the subsequent work can be adjusted, so that the adjustment time and range of the quality inspection strategy are limited. In the embodiment, the adjustment grade is set in the first quality inspection strategy group, whether the strategy group of the material needs to be adjusted and the adjustment flexibility are preset, the quality inspection strategy of the material needs to be adjusted subsequently when the adjustment grade is higher, the quality inspection strategy of the material with a low adjustment grade is more stable, the influence of historical quality inspection data and other factors is avoided, and the adjustment requirement is lower. When the adjustment level is higher than the preset first level, the historical quality inspection data of the related materials in the quality inspection historical database can be inquired.
In this embodiment, the quality inspection strategy associated with the relevant materials in the database is a first quality inspection strategy group, and the adjusted quality inspection strategy group is a second quality inspection strategy group. And if the adjustment grade in the first quality inspection strategy group corresponding to the material is a high grade, acquiring related material classes corresponding to the material, wherein the related material classes comprise materials of the same batch as the material, materials of the same supplier in a first preset time period and materials of the same model in a second preset time period. And respectively inquiring and acquiring historical quality inspection data of each material in the related material classes corresponding to the material in a quality inspection historical database. And searching related material classes in the historical database, which have relevance on the quality inspection information with the material, according to the batches, the supplier identifications and the material names in the material information. The first preset time period and the second preset time period can be preset in the material information in advance. The materials in the related materials have certain relevance, the quality inspection results of the materials have similarity to a certain extent, and when the quality inspection qualified rate of the related materials is low, the sampling inspection proportion of the materials to be inspected at this time needs to be increased, and the like, namely the workload of the quality inspection of the materials is increased.
In a preferred embodiment, if the quality inspection yield of the material of the same supplier in the first scheduled time period is lower than the lowest material yield, all quality inspection results of the material of the same supplier are retrieved, and the first scheduled time period is prolonged to the earliest material quality inspection time when the quality inspection yield is lower than the lowest material yield. And if the quality inspection qualified rate of the materials of the same type in the second preset time period is lower than the lowest qualified rate of the materials, all quality inspection results of the materials of the same type are acquired, and the second preset time period is prolonged to the earliest material quality inspection time when the quality inspection qualified rate is lower than the lowest qualified rate of the materials. Thereby improving the accuracy of the material quality inspection result.
And S103, supplementing the information in the adjusted quality inspection strategy group into an inspection sheet template to automatically generate an inspection sheet corresponding to the material.
In this embodiment, the historical yield is calculated according to the acquired historical quality inspection data of each material belonging to the relevant material class. If the historical qualification rate is larger than a first preset value, whether the first quality inspection strategy group is inspected or not is set to be a second quality inspection strategy group after inspection is not needed; if the historical qualified rate is lower than a second preset value, the material sampling inspection proportion in the first quality inspection strategy group is increased to a preset value to form a second quality inspection strategy group; otherwise, the first quality control strategy group is not adjusted.
In this embodiment, the step further includes: and if the adjustment level in the first quality inspection strategy group corresponding to the material is a high level, inquiring the item information of the material and inquiring the quality control level corresponding to the item in a database according to the item information.
And if the material has a plurality of corresponding project information, acquiring the quality control grade with the highest quality control grade in each project as the quality control grade of the material. And if the quality control level of the material is in a first level, checking whether option information is checked in the first quality inspection strategy group, modifying the option information into information to be checked if the option information is not required to be checked, and otherwise, increasing the material sampling inspection ratio to a preset value.
And S4, generating a sampling record by the second personnel group according to the data obtained by sampling quality inspection operation of the request and test sheet, and sending material release information after obtaining the verification confirmation of the third personnel group on the sampling record. And after receiving the test order, the second personnel group, namely QC personnel, switches the test order into a quality inspection state, only the QC personnel can receive the test order under the control of the system, and other role personnel do not have the operation permission of receiving the test order. QC personnel can record each specific sample quantity of packing one by one according to the packing number, form the sample record, realize the management function of meticulous sampling to control sampling precision, wherein sampling precision can dispose in the material basic information, and definite material's measurement precision is the digit behind the decimal point, and the number that exceeds the scope does not allow to type. During sampling operation, the system inquires the data of the requisition and the test bill of the database through the program interface, inquires whether the material codes and the batches have a valid requisition and the system controls that sampling is not allowed if the requisition is not valid. And a third personnel group, namely QA personnel, performs final examination and verification on the quality inspection result of the material and executes corresponding quality release operation.
In this embodiment, the step S4 may specifically include the following contents.
Generating sampling records containing the inspection results of each packaging unit according to the input inspection data, wherein the sampling records comprise the weight of each packaging material and the corresponding sampling weight, and if the weight ratio of a sample to the packaging material is lower than the preset value of the weight ratio of the sample in each packaging material to be inspected, sending a packaging material additional inspection notification;
and if the quality inspection result of at least one material characteristic of the material sample in the sampling record is lower than or higher than the preset range of the material characteristic, adding a higher or lower mark in the corresponding record.
In this embodiment, the system may also check the newly entered batch and item model, and if there is no batch number in the quality inspection task database, send an error-reporting prompt and terminate the subsequent entry of the record. Specifically, the data recorded in the data recording table obtained by adopting various quality inspection instruments can be automatically verified. The method comprises the steps of acquiring quality inspection instrument data recorded in an audit verification area and instrument screen pictures correspondingly bound, inquiring corresponding screen identification information in an instrument information database according to instrument types in the quality inspection instrument data, respectively identifying instrument measurement parameters in the instrument screen pictures according to positions of a digital characteristic area in a screen, positions of a non-digital characteristic area in the screen and other information, and finally comparing and verifying the identified information and the information recorded in an electronic experiment record to find out the information with errors recorded in the record, so that the filling accuracy of the recorded data of the experiment record is effectively ensured, and a lot of time damage caused by manual comparison of the data in an input frame of the record and the instrument screen pictures one by quality inspectors is avoided. Specifically, according to a received data verification instruction, the data verification instruction comprises an audit verification area in a data record table; sequentially acquiring data of each quality inspection instrument recorded in an audit verification area and instrument screen pictures correspondingly bound; inquiring corresponding screen identification information in an instrument information database according to the instrument type in the quality inspection instrument data, wherein the screen identification information comprises the shape of a screen area, the position of a digital characteristic area in the screen and the position of a non-digital characteristic area in the screen, the non-digital characteristic is a character characteristic or a letter characteristic, and respectively identifying instrument measurement parameters in an instrument screen picture according to the position of the digital characteristic area in the screen and the position of the non-digital characteristic area in the screen; and comparing the identified instrument measurement parameters with the data recorded in the quality inspection instrument data, and if the instrument measurement parameters are different from the data recorded in the quality inspection instrument data, sending a notification that the quality inspection instrument data is recorded incorrectly.
In this embodiment, the step of comparing the identified instrument measurement parameter with the data recorded in the quality inspection instrument data, and if the identified instrument measurement parameter is different from the data recorded in the quality inspection instrument data, sending out the data error response of the quality inspection instrument may further specifically include the following steps: and respectively comparing and matching each recorded data in the quality inspection instrument data with the identification data to obtain a first recorded parameter and a first identification parameter which cannot be matched. And inquiring whether a non-digital characteristic region exists in the instrument screen picture, if so, acquiring a first non-digital characteristic region corresponding to a first digital characteristic region where the first identification parameter is located, and identifying a first metering unit in the first non-digital characteristic region. And inquiring whether a unit conversion relation group containing the first measurement unit exists in the instrument information database according to the first measurement unit. If a unit conversion relation group containing a first metering unit exists, acquiring a preset parameter unit of a first recording parameter from the data of the quality inspection instrument, converting the first identification parameter into a conversion parameter corresponding to the preset parameter unit according to the unit conversion relation group, comparing the conversion parameter with the first recording parameter, and if the conversion parameter is different from the first recording parameter, triggering a data error action; or if a unit conversion relation group containing the first metering unit exists, acquiring a preset parameter unit of the first recording parameter from the data of the quality inspection instrument, converting the first recording parameter into a conversion parameter corresponding to the first metering unit according to the unit conversion relation group, comparing the conversion parameter with the first identification parameter, and if the conversion parameter is different from the first identification parameter, triggering a data error action.
In this embodiment, in the step of querying whether a non-digital feature region exists in the instrument screen picture, if yes, obtaining a first non-digital feature region corresponding to a first digital feature region where the first identification parameter is located, and identifying a first measurement unit in the first non-digital feature region, the method may further include the following steps: and if the non-digital characteristic region does not exist in the instrument screen picture, acquiring a preset parameter unit of the first recording parameter from the quality inspection instrument data. And inquiring a unit conversion relation group containing the preset parameter unit in the instrument information database according to the preset parameter unit. And obtaining a conversion formula of the preset parameter unit and other convertible candidate metering units, sequentially converting the first recording parameter, comparing the converted conversion parameter with the first identification parameter, if the conversion parameters are different, converting the next candidate metering unit until the comparison is the same or the conversion comparison of all the candidate metering units is completed, and if the comparison is different, triggering a data error action.
In this embodiment, comparing the identified measurement parameter of the instrument with the data recorded in the data of the quality inspection instrument, and if the identified measurement parameter of the instrument is different from the data recorded in the data of the quality inspection instrument, sending out an error response of the data of the quality inspection instrument may further include the following contents: and comparing the second metering unit in the identified non-digital characteristic region with each preset parameter unit of the quality inspection instrument data, if the same second preset parameter unit exists, acquiring a second recording parameter corresponding to the second preset parameter unit in the quality inspection instrument data, comparing the second recording parameter with a second identification parameter in a second digital characteristic region corresponding to the second non-digital characteristic region in which the second metering unit is located, and if the second recording parameter is different from the second identification parameter, triggering a data error action. And if the same second preset parameter unit does not exist, judging whether the record parameters in the data of the quality inspection instrument are not matched and verified, and if so, inquiring a unit conversion relation group containing the second measurement unit in an instrument information database according to the second measurement unit. And converting the second recording parameters into conversion parameters of each corresponding candidate metering unit according to the unit conversion relation group, sequentially comparing each conversion parameter with the recording parameters which are not matched and verified, and triggering data error action if the conversion parameters are different.
In this embodiment, the step of comparing the identified instrument measurement parameter with the data recorded in the quality inspection instrument data, and if the identified instrument measurement parameter is different from the data recorded in the quality inspection instrument data, sending out the error response of the quality inspection instrument data may further specifically include the following steps: and respectively comparing each preset parameter unit of the quality inspection instrument data with the metering unit in the identified non-digital characteristic region, identifying and acquiring the identification parameter in the digital characteristic region corresponding to the non-digital characteristic region where the metering unit is located if the preset parameter units of the quality inspection instrument data have the same unit, and comparing, and triggering data error action if the preset parameter units of the quality inspection instrument data are different from the identification parameter in the digital characteristic region.
In this embodiment, the method for controlling the material inspection release in the pharmaceutical industry further includes a step of providing a flow rollback, when data is abnormal, the service flexibility is improved, the QC can rollback the inspection request sheet with problems to the inspection request department, the inspection request department re-fills the inspection request data, the QA can rollback the inspection request sheet with problems to the QC, and the QA re-submits the adjusted material quality status and quality inspection files. The system controls that only QA personnel have the right of operation request for release and return by inquiring the role authority data in the database.
The method for controlling the release of the material inspection in the pharmaceutical industry disclosed by each embodiment can be applied to the quality management links of materials and finished products in pharmaceutical enterprises, and provides a complete quality management flow for each link of submitting a request inspection form, receiving the request inspection form, sampling QC, inspecting QC quality and releasing QA of the materials and the finished products in the pharmaceutical enterprises. Inquiring the material information through a warehousing management system after monitoring a material warehousing event, inquiring the associated quality inspection strategy information in a database according to the material information, if the quality inspection strategy information contains quality inspection release characteristics, inquiring and acquiring a first personnel group address in the database according to the material information, and sending an inspection request prompt to the first personnel group address; automatically generating a request and test order corresponding to the material according to the request and test order reminding, the material information and the quality inspection strategy information, screening and acquiring a matched second personnel group address in a database according to the material information after receiving a personnel confirmation instruction in at least one first personnel group, and sending the request and test order to the second personnel group address; and generating a sampling record by the second personnel group according to the data obtained by sampling quality inspection operation of the request and inspection list, and sending material release information after obtaining the audit confirmation of the third personnel group on the sampling record. The method can flexibly configure a material quality inspection strategy, determine whether the material needs quality inspection, determine the specific release mode and quality inspection flow of the material, and realize the online digital management of the whole flow of material quality inspection, starting inspection, sampling, submitting quality inspection results and releasing quality. The problem of present pharmacy enterprise when carrying out material quality inspection, have a large amount of off-line paper operation links, whole process is consuming time and is laboured and inefficiency, has simultaneously that data is not real-time, data is missed to remember the misclassification etc is solved.
The specific functions of the system for controlling the release of the inspection of the materials in the pharmaceutical industry correspond to those of the method for controlling the release of the inspection of the materials in the pharmaceutical industry disclosed in the foregoing embodiments one by one, so that the detailed description is omitted here, and reference may be made to each embodiment of the method for controlling the release of the inspection of the materials in the pharmaceutical industry disclosed in the foregoing embodiments. It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments may be referred to each other.
In still other embodiments, there is provided a pharmaceutical industry material inspection release control apparatus, including a memory, a processor, and a computer program stored in the memory and executable on the processor, the processor implementing the steps of the pharmaceutical industry material inspection release control method as described in the above embodiments when executing the computer program.
The material inspection and release control device in the pharmaceutical industry may include, but is not limited to, a processor and a memory. The server may include, but is not limited to, a processor, a memory. It will be appreciated by those skilled in the art that the schematic diagram is merely an example of a server and is not intended to limit the server device, and that it may include more or less components than those shown, or some components may be combined, or different components, for example, the server device may also include input output devices, network access devices, buses, etc.
The Processor may be a Central Processing Unit (CPU), other general purpose Processor, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), an off-the-shelf Programmable Gate Array (FPGA) or other Programmable logic device, discrete Gate or transistor logic, discrete hardware components, etc. The general purpose processor may be a microprocessor or the processor may be any conventional processor or the like, the processor being the control center of the server device, the various parts of the overall server device being connected by various interfaces and lines.
The memory may be used to store the computer programs and/or modules, and the processor may implement various functions of the server device by executing or executing the computer programs and/or modules stored in the memory and invoking data stored in the memory. The memory may generally include a program storage area and a data storage area, wherein the program storage area may store an operating system, applications for at least one function, and the like, and the memory may include a high speed random access memory, and may further 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 memory Card (Flash Card), at least one magnetic disk storage device, a Flash memory device, or other volatile solid state storage device.
The medicine industry material inspection release control method can be stored in a computer readable storage medium if the method is realized in the form of a software functional unit and sold or used as an independent product. Based on such understanding, all or part of the flow of the method according to the embodiments of the present invention may also be implemented by a computer program, which may be stored in a computer-readable storage medium, and when the computer program is executed by a processor, the steps of the method embodiments may be implemented. Wherein the computer program comprises computer program code, which may be in the form of source code, object code, an executable file or some intermediate form, etc. The computer-readable medium may include: any entity or device capable of carrying the computer program code, recording medium, usb disk, removable hard disk, magnetic disk, optical disk, computer Memory, read-Only Memory (ROM), random Access Memory (RAM), electrical carrier wave signals, telecommunications signals, software distribution medium, and the like. It should be noted that the computer-readable medium may contain suitable additions or subtractions depending on the requirements of legislation and patent practice in jurisdictions, for example, in some jurisdictions, computer-readable media may not include electrical carrier signals or telecommunication signals in accordance with legislation and patent practice.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
In summary, the above-mentioned embodiments are only preferred embodiments of the present invention, and all equivalent changes and modifications made in the claims of the present invention should be covered by the claims of the present invention.
Claims (10)
1. A material inspection release control method in the pharmaceutical industry is characterized by comprising the following steps:
s1, after a material warehousing event is monitored, querying material information through a warehousing management system, and querying associated quality inspection strategy information in a database according to the material information, wherein the material information comprises one or more of material model, material quantity, warehousing time, supplier identification and batch number;
s2, if the quality inspection strategy information contains quality inspection release characteristics, inquiring in a database according to the material information to obtain a first personnel group address, and sending a list asking prompt to the first personnel group address;
s3, automatically generating a request and check list corresponding to the material according to the request and check list reminding, the material information and the quality inspection strategy information, and after receiving a person confirmation instruction in at least one first person group, screening and acquiring a matched second person group address in a database according to the material information and sending the request and check list to the database;
and S4, generating a sampling record by the second personnel group according to the data obtained by sampling quality inspection operation of the request and test sheet, and sending material release information after obtaining the verification confirmation of the third personnel group on the sampling record.
2. The pharmaceutical industry material inspection release control method according to claim 1, wherein the step S3 comprises:
inquiring and acquiring task progress of each quality inspector and project information corresponding to warehoused materials, inquiring project starting time in a database according to the project information, and acquiring the longest quality inspection period according to the distance between the project starting time and the current time interval;
acquiring time strategy characteristics in the quality inspection strategy information, inquiring the most idle time period of personnel in the longest quality inspection period if the time strategy characteristics consume the least time, and selecting the personnel information in the time period as a second personnel group; and if the time strategy characteristic is that the number of the personnel is the minimum, inquiring the longest idle time period in the longest idle time period, calculating the number of the quality testing personnel required by the longest idle time period according to the material model and the material quantity, and selecting the personnel information in the time period as a second personnel group according to the number of the quality testing personnel.
3. The pharmaceutical industry material inspection release control method according to claim 2, wherein the step S3 further comprises:
obtaining material information in the order for asking for inspection form reminding instruction, and searching and obtaining an inspection form template corresponding to the material in a database;
inquiring a preset quality inspection strategy group related to the material in a database according to the material information; checking the adjustment level in the quality inspection strategy group, inquiring historical quality inspection data of related materials in a quality inspection historical database if the adjustment level is higher, and modifying related characteristics in the quality inspection strategy group according to the historical quality inspection data to obtain an adjusted quality inspection strategy group;
and supplementing the information in the adjusted quality inspection strategy group into a test order template to automatically generate a test order corresponding to the material.
4. The pharmaceutical industry material inspection release control method according to claim 3, wherein the step S2 comprises:
inquiring whether the batch number record information exists in the database according to the material batch number, if the batch number non-inspection information exists, giving up sending an inspection request prompt, and if the batch number non-inspection information does not exist and the same batch of historical quality inspection records exist, calculating the historical qualification rate of each quality inspection record;
and if the historical qualification rate is greater than a first preset value, giving up sending the checklist asking prompt, otherwise, inquiring in a database according to the material information to obtain a first personnel group address, and sending the checklist asking prompt to the first personnel group address.
5. The pharmaceutical industry material inspection release control method according to claim 4, wherein the step S4 specifically comprises:
generating sampling records containing the inspection results of each packaging unit according to the input inspection data, wherein the sampling records comprise the weight of each packaging material and the corresponding sampling weight, and if the weight ratio of a sample to the packaging material is lower than the preset value of the weight ratio of the sample in each packaging material to be inspected, sending a packaging material additional inspection notification;
and if the quality inspection result of at least one material characteristic of the material sample in the sampling record is lower than or higher than the preset range of the material characteristic, adding a higher or lower mark in the corresponding record.
6. A pharmaceutical industry material inspection clearance control system, characterized by includes:
the system comprises a strategy configuration module, a database and a database, wherein the strategy configuration module is used for inquiring material information through a storage management system after monitoring a material warehousing event and inquiring related quality inspection strategy information in the database according to the material information, and the material information comprises one or more of material model, material quantity, warehousing time, supplier identification and batch number;
the quality inspection reminding module is used for inquiring and acquiring a first personnel group address in a database according to the material information if the quality inspection strategy information contains quality inspection release characteristics, and sending a list asking for inspection to the first personnel group address;
the inspection request submitting module is used for automatically generating an inspection request corresponding to the material according to the inspection request prompt, the material information and the quality inspection strategy information, screening and acquiring a matched second personnel group address in the database according to the material information after receiving a personnel confirmation instruction in at least one first personnel group, and sending the inspection request to the database;
and the sampling module is used for generating a sampling record according to the data obtained by the sampling quality inspection operation of the second personnel group according to the request inspection list, and sending material release information after the verification confirmation of the sampling record by the third personnel group is obtained.
7. The pharmaceutical industry material inspection release control system of claim 6, wherein the request and inspection sheet submission module comprises:
the quality inspection period acquisition module is used for inquiring and acquiring the task progress of each quality inspector and the project information corresponding to the warehousing materials, inquiring the project starting time in the database according to the project information and acquiring the longest quality inspection period according to the distance between the project starting time and the current time interval;
the personnel screening module is used for acquiring time strategy characteristics in the quality inspection strategy information, inquiring the most idle time period of personnel in the longest quality inspection period if the time strategy characteristics are the least time consumption, and selecting the personnel information in the time period as a second personnel group; and if the time strategy characteristic is that the number of the personnel is the minimum, inquiring the longest idle time period in the longest quality inspection period, calculating the number of the quality inspection personnel required by the longest idle time period according to the material model and the material number, and selecting the personnel information in the time period as a second personnel group according to the number of the quality inspection personnel.
8. The pharmaceutical industry material inspection clearance control system of claim 7, wherein the request form submission module further comprises:
the system comprises a list asking and testing template acquisition module, a list asking and testing template acquisition module and a list asking and testing template processing module, wherein the list asking and testing template acquisition module is used for acquiring material information in a list asking and testing reminding instruction and searching and acquiring a list asking and testing template corresponding to the material in a database;
the strategy adjusting module is used for inquiring a preset quality inspection strategy group related to the material in the database according to the material information; checking the adjustment level in the quality inspection strategy group, inquiring historical quality inspection data of related materials in a quality inspection historical database if the adjustment level is higher, and modifying related characteristics in the quality inspection strategy group according to the historical quality inspection data to obtain an adjusted quality inspection strategy group;
and the test sheet generation module is used for supplementing the information in the adjusted quality inspection strategy group into the test sheet template to automatically generate a test sheet corresponding to the material.
9. A pharmaceutical industry material inspection release control apparatus comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein: the processor, when executing the computer program, realizes the steps of the method according to any of claims 1-5.
10. A computer-readable storage medium storing a computer program, characterized in that: the computer program when executed by a processor implementing the steps of the method as claimed in any one of claims 1 to 5.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116452069A (en) * | 2023-06-15 | 2023-07-18 | 北京商夷数字科技有限公司 | Product quality tracking method and device and electronic equipment |
| CN117010802A (en) * | 2023-10-07 | 2023-11-07 | 武汉锐科光纤激光技术股份有限公司 | MES system-based optical device semi-finished product warehousing method and related equipment |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116452069A (en) * | 2023-06-15 | 2023-07-18 | 北京商夷数字科技有限公司 | Product quality tracking method and device and electronic equipment |
| CN116452069B (en) * | 2023-06-15 | 2023-09-29 | 北京商夷数字科技有限公司 | Product quality tracking method and device and electronic equipment |
| CN117010802A (en) * | 2023-10-07 | 2023-11-07 | 武汉锐科光纤激光技术股份有限公司 | MES system-based optical device semi-finished product warehousing method and related equipment |
| CN117010802B (en) * | 2023-10-07 | 2023-12-26 | 武汉锐科光纤激光技术股份有限公司 | MES system-based optical device semi-finished product warehousing method and related equipment |
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