Medical raw material expiration date management method and system

Abstract

The application relates to the technical field of medical raw material management, and discloses a medical raw material shelf life management method and system, which comprises the following steps: calculating the difference between the real-time residual shelf life of a to-be-allocated medical raw material batch at a current evaluation time point and the complete execution window of a current to-be-executed production order as a life coverage difference; determining the fluctuation coverage length required for a pre-set signal length threshold based on the business fluctuation upper limit value corresponding to an uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter as a boundary buffer zone; performing hierarchical labeling on the to-be-allocated medical raw material batch based on the boundary buffer zone and the life coverage difference; and generating an allocable batch sorting list for the current to-be-executed production order based on the hierarchical labeling of the to-be-allocated medical raw material batch. The life coverage difference and the boundary buffer zone are introduced to perform fine hierarchical labeling on the medical raw material, so that the accuracy of material allocation and the stability of production are improved.

Description

Technical Field

[0001] This application relates to the field of medical raw material management technology, and more specifically, to a method and system for managing the expiration date of medical raw materials. Background Technology

[0002] Current expiration date management for medical raw materials typically relies on a first-in, first-out (FIFO) allocation based on the static expiration date on the label, failing to consider the environmental exposure to temperature and humidity that raw materials undergo. This results in the book expiration date not reflecting the true remaining lifespan. Furthermore, existing solutions only use planned processing time as order requirements, neglecting to account for the complete occupancy time, including equipment preparation, batch confirmation waiting, and inter-process buffers. They also directly use inventory sorting results as allocation conclusions, without establishing an order-by-order matching mechanism between the material's true remaining lifespan and the order's complete execution window. Moreover, when the material's remaining lifespan is very close to the order execution window, the uncertainty of batch confirmation waiting time and inter-process buffer time in actual execution causes frequent jumps between allocatable and non-allocatable statuses, leading to frequent locking and releasing of materials in the warehousing system, AGV empty runs, and production line rhythm disruptions. Existing solutions often attempt to mitigate this by setting a fixed safety day, but this fixed value cannot adapt to the fluctuating characteristics of different orders. Therefore, a mechanism for handling the uncertain time parameters of the order's complete execution window is urgently needed. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this application provides a method and system for managing the expiration dates of medical raw materials. This method can solve problems such as the failure of existing methods to fully consider environmental exposure of raw materials during actual storage and transportation, incomplete order demand assessment, and unstable material allocation caused by the volatility of uncertain time parameters.

[0004] Firstly, this application provides a method for managing the expiration date of medical raw materials, including: Calculate the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the full execution window of the current production order to be executed, as the lifetime coverage difference; Based on the upper limit of business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, the fluctuation coverage duration required to cover the preset information duration threshold is determined as a boundary buffer. Based on the difference between the boundary buffer zone and the lifetime coverage, the batch of medical raw materials to be allocated is classified and labeled. The classification labeling includes at least the following: when the life coverage difference falls within the boundary buffer zone, the batch of medical raw materials to be allocated is labeled as a boundary observation batch, and a periodic review process is triggered; The periodic review process includes at least the following: calculating the changing trend of the life coverage difference and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend; Based on the classification label of the batch of medical raw materials to be allocated, a sorted list of allocable batches for the current production order to be executed is generated.

[0005] Furthermore, before calculating the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the full execution window of the current production order to be executed, as the lifetime coverage difference, the method also includes obtaining historical environmental exposure information: Obtain the label expiration date of the batch of medical raw materials to be allocated; Obtain the duration of each environmental interval, average temperature value, and average humidity value experienced by the batch of medical raw materials to be allocated from the time of entry into the warehouse to the current assessment point, and form an environmental record sequence sorted by time; The validity period of the tag is associated with the environmental record sequence and stored as historical information about environmental exposure.

[0006] Furthermore, the step of calculating the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the full execution window of the current production order to be executed, as the lifetime coverage difference, includes: Obtain the baseline decay rate of the batch of medical raw materials to be allocated under preset standard storage conditions. The baseline decay rate represents the daily shelf-life equivalent consumed by the batch of medical raw materials to be allocated under preset standard storage conditions. Traverse the environmental record sequence. For each environmental interval, find the preset environmental acceleration factor based on the average temperature and average humidity values ​​within that environmental interval. The environmental acceleration factor represents the expiration rate acceleration factor of that environmental interval relative to the preset standard storage conditions. Multiply the duration of the environmental interval by the environmental acceleration factor and then by the baseline decay rate to obtain the actual effective life consumption equivalent of the environmental interval. Calculate the real-time remaining effective period based on the consumption equivalent of the actual effective period; Obtain the planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time, and clearing time for the current production orders to be executed; The planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time and cleaning time are added together to obtain the complete execution window, which represents the total time occupied from the issuance of the material preparation instruction to the completion of the last process and the cleaning. The lifetime coverage difference is obtained by subtracting the full execution window from the real-time remaining validity period.

[0007] Furthermore, the steps for calculating the real-time remaining shelf life based on the actual shelf-life consumption equivalent include: The cumulative consumed shelf-life equivalent is obtained by summing up the actual shelf-life equivalents of all environmental periods from the time the medical raw material to be allocated was put into storage to the current assessment point. The remaining shelf life equivalent is obtained by subtracting the cumulative consumed shelf life equivalent from the total available shelf life equivalent within the label's validity period for the batch of medical raw materials to be allocated. The remaining shelf life equivalent is then divided by the baseline decay rate to obtain the real-time remaining shelf life days. The real-time remaining shelf life days are then used as the real-time remaining shelf life.

[0008] Furthermore, the step of determining the required fluctuation coverage duration to cover the preset information duration threshold, based on the upper limit of business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, as a boundary buffer zone, includes: Extract one or more of the process waiting time, inter-process buffer time, and batch confirmation waiting time from the complete execution window as indeterminate time parameters; The maximum deviation value in the historical execution duration statistics of each uncertain time parameter is used as the upper limit of business fluctuation. Based on the historical fluctuation distribution data of each uncertain time parameter, calculate the fluctuation coverage duration quantile value corresponding to each uncertain time parameter under the preset information duration threshold, and use it as the fluctuation coverage duration. For each uncertain time parameter, the larger of the upper limit of business fluctuation corresponding to the uncertain time parameter and the quantile value of fluctuation coverage duration shall be used as the fluctuation coverage requirement value of the uncertain time parameter. Add up all the fluctuation coverage demand values ​​to obtain the boundary buffer zone.

[0009] Furthermore, based on the historical fluctuation distribution data of each uncertain time parameter, the step of calculating the fluctuation coverage duration quantile value corresponding to each uncertain time parameter under the preset information duration threshold, and using this value as the fluctuation coverage duration, includes: For each uncertain time parameter, obtain the historical storage time of the same type of material corresponding to the batch of medical raw materials to be allocated, from the time it is allocated to the buffer area at the production line side to the time it is officially started to be processed, and calculate the storage time quantile value of the historical storage time under the preset information time threshold, which is used as the first fluctuation coverage time of the uncertain time parameter based on the historical fluctuation of the material. Obtain the historical cache waiting time statistics of the same type of material corresponding to the batch of medical raw materials to be allocated in the production line to which the current production order to be executed belongs; calculate the production line waiting time quantile of the historical cache waiting time statistics under the preset time threshold, and use it as the second fluctuation coverage time of the uncertain time parameter based on the historical fluctuation of the production line. The larger of the first fluctuation coverage duration and the second fluctuation coverage duration is taken as the fluctuation coverage duration corresponding to this uncertain time parameter.

[0010] Furthermore, the boundary observation batch includes boundary observation allocable batches and boundary observation restricted batches; the steps for grading and labeling the batch of medical raw materials to be allocated based on the difference between the boundary buffer zone and the lifetime coverage include: If the lifetime coverage difference is greater than or equal to the boundary buffer zone, the batch of medical raw materials to be allocated is marked as a stable and allocable batch. If the life coverage difference is greater than or equal to zero and less than the boundary buffer zone, the batch of medical raw materials to be allocated is marked as the batch that can be allocated under the boundary observation, thus triggering the periodic review process. If the life coverage difference is greater than or equal to the negative boundary buffer zone and less than zero, the batch of medical raw materials to be allocated is marked as the boundary observation restriction batch, triggering the periodic review process. If the difference in lifespan coverage is less than the negative boundary buffer zone, then when the real-time remaining shelf life is greater than the preset minimum safety threshold, the batch of medical raw materials to be allocated will be marked as a stable restricted allocation batch; when the real-time remaining shelf life is less than or equal to the preset minimum safety threshold, the batch of medical raw materials to be allocated will be marked as a prohibited allocation batch.

[0011] Furthermore, the steps of calculating the changing trend of the life coverage difference and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend include: Calculate the change in the difference between the life coverage difference of the batch of medical raw materials to be allocated at the current assessment point and the life coverage difference at the previous assessment point; If the lifetime coverage difference of the batch of medical raw materials to be allocated remains the same at the most recent preset number of assessment points and the absolute value of the change in each difference is less than the preset fluctuation limit, then the trend is determined to be stable. When the lifetime coverage difference is less than the negative boundary buffer and the real-time remaining shelf life is greater than the preset minimum safety threshold, the classification label of the batch of medical raw materials to be allocated is updated to the stable restricted allocation batch. When the lifetime coverage difference is greater than or equal to zero and less than the boundary buffer, the classification label of the batch of medical raw materials to be allocated is updated to the stable allocable batch. If the lifespan coverage difference of the batch of medical raw materials to be allocated switches between positive and negative signs at the most recent preset number of assessment points, or if the absolute value of any change in the difference exceeds the preset fluctuation limit, the trend of change is determined to be unstable, and the batch of medical raw materials to be allocated is marked as pending confirmation and frozen.

[0012] Furthermore, the step of generating a sorted list of allocable batches for the current production order to be executed, based on the graded labeling of the batch of medical raw materials to be allocated, includes: For the medical raw material batches marked as stable and allocable batches, they are arranged in ascending order of real-time remaining shelf life to form an allocable batch sorting list for the current production order to be executed. The medical raw material batch ranked first in the allocable batch sorting list is taken as the preferred batch for material preparation, and a material preparation instruction is generated and issued based on the preferred batch for material preparation. For medical raw material batches marked as being allocated under this stable restriction, remove them from the candidate pool of the current pending production orders and transfer them to the preset short-term work order candidate pool. For batches of medical raw materials to be allocated that are marked as prohibited from allocation, remove them from the candidate pool of the current pending production orders and transfer them to the preset review and warning pool; For batches of medical raw materials to be allocated that are marked as pending confirmation and frozen, remove them from the candidate pool of the current pending production orders and transfer them to the preset expiration date verification pool.

[0013] Secondly, this application also discloses a medical raw material expiration date management system, the system comprising: The lifetime coverage difference calculation module is used to calculate the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the complete execution window of the current production order to be executed, as the lifetime coverage difference; The boundary buffer zone determination module is used to determine the fluctuation coverage duration required to cover the preset information duration threshold based on the upper limit of business fluctuation corresponding to the uncertain time parameter in the full execution window and the historical fluctuation distribution data of the uncertain time parameter, and to serve as the boundary buffer zone. The grading and labeling module is used to grade and label the batch of medical raw materials to be allocated based on the difference between the boundary buffer zone and the lifetime coverage. The classification labeling includes at least the following: when the life coverage difference falls within the boundary buffer zone, the batch of medical raw materials to be allocated is labeled as a boundary observation batch, and a periodic review process is triggered; The periodic review process includes at least the following: recalculating the real-time remaining shelf life and updating the life coverage difference at subsequent assessment points, calculating the changing trend of the life coverage difference, and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend. The list generation module is used to generate a sorted list of allocable batches for the current production order to be executed, based on the grade label of the batch of medical raw materials to be allocated.

[0014] This application enables a more accurate assessment of the true remaining lifespan of medical raw materials, overcoming the limitations of traditional methods that rely solely on static expiration dates on labels, leading to inaccurate expiration date assessments. This avoids production waste or product quality risks caused by discrepancies between book expiration dates and actual expiration dates. By dynamically determining boundary buffer zones based on the upper limit of business fluctuations with uncertain time parameters and historical fluctuation distribution data, it effectively adapts to the fluctuation characteristics of different production orders and the actual environmental exposure of medical raw materials. This avoids material backlogs or insufficient risk mitigation, improving the accuracy, production efficiency, and stability of material allocation. Attached Figure Description

[0015] Figure 1 This is a flowchart illustrating a method for managing the expiration date of medical raw materials, as provided in an embodiment of this application.

[0016] Figure 2 This is a schematic diagram of a medical raw material expiration date management system provided in an embodiment of this application.

[0017] Labeling Explanation: 210, Lifetime Coverage Difference Calculation Module; 220, Boundary Buffer Zone Determination Module; 230, Hierarchical Labeling Module; 240, List Generation Module. Detailed Implementation

[0018] The technical solutions of this application will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of this application, and not all embodiments. The components of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0019] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0020] Traditional methods for managing the expiration dates of medical raw materials typically employ a first-in, first-out (FIFO) allocation strategy based on static label expiration dates. This approach fails to adequately account for the temperature and humidity exposures experienced by medical raw materials during actual storage and transportation, resulting in the on-paper expiration dates not accurately reflecting their true remaining lifespan. Therefore, in actual production, even if the on-paper expiration date indicates availability, medical raw materials may prematurely expire due to environmental factors, leading to production waste or product quality risks. Furthermore, when the true remaining lifespan of medical raw materials is very close to the complete execution window of a production order, the fluctuating nature of uncertain time parameters such as batch confirmation waiting time and inter-process buffer time causes frequent changes in the allocation status of medical raw materials between allocable and non-allocable states. This results in frequent locking and releasing operations, empty runs of automated guided vehicles, and disruptions to production line rhythm, severely impacting the continuity and stability of production.

[0021] Regarding this, firstly, see... Figure 1 This application proposes a method for managing the expiration date of medical raw materials, including: S1. Calculate the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the complete execution window of the current production order to be executed, as the lifetime coverage difference; S2. Based on the upper limit of business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, determine the fluctuation coverage duration required to cover the preset information duration threshold, and use it as a boundary buffer zone; S3. Based on the difference between the boundary buffer zone and the lifetime coverage, classify and label the batches of medical raw materials to be allocated. The grading labeling should include at least the following: when the life coverage difference falls within the boundary buffer zone, the batch of medical raw materials to be allocated should be labeled as a boundary observation batch and a periodic review process should be triggered. The periodic review process includes at least the following: calculating the changing trend of the life coverage difference and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend; S4. Based on the hierarchical labeling of the batches of medical raw materials to be allocated, generate a sorted list of allocable batches for the current production order to be executed.

[0022] In this context, "pending allocation batches of medical raw materials" refers to specific batches of medical raw materials in a warehouse awaiting allocation to production orders. Each batch typically has a unique identifier, warehousing date, label expiration date, and other information. "Current assessment point in time" refers to the specific point in time at which the expiration date assessment and allocation decision for the medical raw material batch are made. "Real-time remaining expiration date" refers to the actual usable expiration date of the medical raw material batch at the current assessment point in time, after considering the actual environmental exposure impact.

[0023] Current pending production orders refer to orders that have been issued and are awaiting allocation of medical raw materials to initiate production. The complete execution window refers to the total time occupied from the issuance of the material preparation instruction to the completion of the final process and clearing of the site. It includes all possible time consumption during the production process, not just the planned processing time. Uncertain time parameters refer to those time components within the complete execution window that are volatile and difficult to predict accurately, such as process waiting time, inter-process buffer time, batch confirmation waiting time, etc.

[0024] The lifetime coverage difference is the difference between the real-time remaining shelf life and the full execution window, used to measure whether the lifetime of a medical raw material is sufficient to cover the entire execution time of a production order.

[0025] The upper limit of business fluctuation refers to the maximum deviation of an uncertain time parameter in historical execution data, reflecting the most unfavorable situation that may occur in the business process. Historical fluctuation distribution data refers to the time distribution statistics of uncertain time parameters during past execution, such as mean, standard deviation, and quantiles.

[0026] The preset confidence threshold refers to a pre-defined confidence level, such as 95% or 99%, when calculating fluctuation coverage duration, indicating the extent to which fluctuation time is ensured to be covered. Fluctuation coverage duration refers to the additional time reserved to cover fluctuations of uncertain time parameters within the preset confidence threshold. The boundary buffer is a time interval determined based on the upper limit of business fluctuation and the fluctuation coverage duration, used to define whether the lifetime coverage difference is in a boundary observation state requiring special attention.

[0027] Tier labeling refers to the classification and marking of medical raw material batches based on the relationship between lifetime coverage difference and boundary buffer zone, such as stable and allocable, boundary observation, and stable restricted allocation. Periodic review process refers to the automatically triggered process of periodically re-evaluating and updating tier labeling when a batch is labeled as a boundary observation batch. The allocable batch sorting list is a priority list of medical raw material batches generated for the current pending production order, based on tier labeling.

[0028] The calculation of the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the complete execution window of the current production order to be executed is used as the lifetime coverage difference. In practice, various methods can be used to calculate the real-time remaining shelf life and the complete execution window. For example, the real-time remaining shelf life can be estimated by manually checking the expiration date on the batch label and combining it with experience. The complete execution window can be obtained by manually calculating various time parameters of historical production orders and then summing them up.

[0029] Specifically, the required fluctuation coverage duration to cover the preset information duration threshold is determined based on the upper limit of business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, serving as a boundary buffer. Specifically, the uncertain time parameter can be specified manually based on experience; for example, process waiting time can be specified as the uncertain time parameter. The upper limit of business fluctuation can be determined by manually recording the maximum deviation value in historical production data. Historical fluctuation distribution data can be obtained by manually collecting and organizing historical production data and then performing simple statistical analysis. The preset information duration threshold can be manually set by management based on risk preferences. The fluctuation coverage duration can be found by consulting a preset statistical table, based on historical fluctuation distribution data and the preset information duration threshold. Finally, the boundary buffer can be obtained by summing the upper limit of business fluctuation and the fluctuation coverage duration.

[0030] The process involves categorizing and labeling batches of medical raw materials to be allocated based on the difference between the boundary buffer zone and the lifetime coverage. For example, a simple rule can be set: when the absolute value of the lifetime coverage difference is less than the boundary buffer zone, the batch is labeled as a boundary observation batch. The periodic review process can be configured to manually review boundary observation batches at fixed intervals (e.g., daily or weekly). Furthermore, the periodic review process should at least include: calculating the trend of the lifetime coverage difference and updating the categorization label of the batches to be allocated based on this trend. During periodic reviews, the lifetime coverage difference at each assessment point can be manually recorded, and the trend can be determined by observing these recorded values. For example, if the lifetime coverage difference remains within the boundary buffer zone for several consecutive periods, the trend can be considered stable.

[0031] Specifically, based on the hierarchical labeling of batches of medical raw materials to be allocated, a sorted list of allocable batches for the current production order to be executed is generated. For example, all batches labeled as allocable can be filtered out and then arranged in ascending order of their remaining shelf life to form a simple sorted list of allocable batches.

[0032] This application introduces concepts such as real-time remaining shelf life, full execution window, lifetime coverage difference, uncertain time parameters, upper limit of business fluctuation, historical fluctuation distribution data, fluctuation coverage duration and boundary buffer zone, and constructs a hierarchical labeling and periodic review mechanism based on these concepts. This enables a comprehensive and accurate assessment of the true usable life of medical raw materials, dynamically adapts to the fluctuating demand of production orders, and thus significantly improves the utilization efficiency and production stability of medical raw materials.

[0033] Furthermore, before calculating the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the full execution window of the current production order to be executed, as the lifetime coverage difference, the method also includes obtaining historical environmental exposure information: Obtain the label expiration date of the batch of medical raw materials to be allocated; Obtain the duration of each environmental interval, average temperature value, and average humidity value experienced by each batch of medical raw materials to be allocated from the time of entry into the warehouse to the current assessment point, and form an environmental record sequence sorted by time; The label expiration date and environmental record sequence are associated and stored as historical environmental exposure information.

[0034] Specifically, obtaining the label validity period of a batch of medical raw materials to be allocated refers to obtaining the expected shelf life under standard storage conditions as indicated on the label of that batch of raw materials at the time of manufacture or warehousing. This label validity period is the basic data for raw material expiration management.

[0035] Furthermore, an environmental period refers to a time during which the environmental conditions, such as temperature and humidity, of raw materials remain relatively stable or undergo significant changes during storage or transportation. The duration in days indicates the length of time the raw materials remain within this specific environmental period. Average temperature and average humidity values ​​reflect the main environmental characteristics within that period. By recording this environmental data chronologically, a complete environmental exposure trajectory of the raw materials from their entry into the warehouse to the current assessment point can be constructed.

[0036] Therefore, the label expiration date and environmental record sequence are linked and stored as historical environmental exposure information. The purpose of this linked storage is to closely integrate the initial expiration date information of the raw material with the external environmental conditions it experiences during its actual use, forming a comprehensive and dynamic basis for expiration date assessment. By acquiring and utilizing historical environmental exposure information, a dynamic and refined assessment of the actual degradation of the raw material can be achieved.

[0037] Furthermore, the step of calculating the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the full execution window of the current production order to be executed, as the lifetime coverage difference, includes: Obtain the baseline decay rate of the batch of medical raw materials to be allocated under preset standard storage conditions, where the baseline decay rate represents the daily shelf-life equivalent consumed by the batch of medical raw materials to be allocated under preset standard storage conditions.

[0038] Traverse the environmental record sequence. For each environmental interval, find the preset environmental acceleration factor based on the average temperature and average humidity values ​​within that environmental interval. The environmental acceleration factor represents the expiration rate acceleration multiple of that environmental interval relative to the preset standard storage conditions. Multiply the duration of that environmental interval by the environmental acceleration factor and then by the baseline decay rate to obtain the actual expiration equivalent of that environmental interval.

[0039] Calculate the real-time remaining shelf life based on the consumption equivalent of the actual shelf life.

[0040] Obtain the planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time, and clearing time for the current production order to be executed. These time parameters together constitute the complete time chain of the production order from material preparation to completion.

[0041] The planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time, and cleaning time are added together to obtain the complete execution window. The complete execution window represents the total time occupied from the issuance of the material preparation instruction to the completion of the last process and cleaning, comprehensively considering the time consumption of various aspects of the production process.

[0042] The lifetime coverage difference is obtained by subtracting the full execution window from the real-time remaining validity period.

[0043] Among them, obtaining the baseline decay rate of the batch of medical raw materials to be allocated under preset standard storage conditions refers to obtaining the rate at which the shelf life of the material is consumed under ideal storage conditions. Specifically, this can be obtained through experimental testing, data provided by suppliers, or industry standards. For example, by conducting accelerated aging experiments on the material under constant temperature and humidity laboratory conditions and recording its shelf life decay, the daily shelf life equivalent consumed can be calculated.

[0044] The process iterates through the environmental record sequence. For each environmental interval, a preset environmental acceleration factor is found based on the average temperature and humidity values ​​within that interval. This factor determines the rate at which the material's shelf life is consumed relative to standard conditions, based on the actual temperature and humidity conditions of the material's storage environment. Specifically, a two-dimensional lookup table can be created, with temperature on the horizontal axis and humidity on the vertical axis, filled with the corresponding environmental acceleration factor. When the average temperature of a certain environmental interval is 25℃ and the average humidity is 60%RH, the lookup table yields an environmental acceleration factor of 1.5, indicating that the material's shelf life is consumed 1.5 times faster under standard conditions in this environment. The environmental acceleration factor is a dimensionless multiple.

[0045] Multiplying the duration of the environmental interval by the environmental acceleration factor and then by the baseline decay rate yields the actual shelf life consumption equivalent for that environmental interval. This means calculating the actual shelf life days consumed by the material within a specific environmental interval, quantifying the actual impact of non-standard storage conditions on the material's shelf life.

[0046] Calculating real-time remaining shelf life based on actual shelf-life consumption equivalents means determining the material's true remaining lifespan by considering the actual shelf-life consumption across all environmental periods the material has experienced from warehousing to the current assessment point. This differs from relying solely on label expiration dates, as it takes into account the actual impact of environmental exposures on shelf life. Real-time remaining shelf life can be calculated by subtracting the accumulated consumed shelf-life equivalents from the material's total usable shelf-life equivalents (e.g., label expiration date multiplied by the baseline decay rate), and then dividing by the baseline decay rate to obtain the real-time remaining shelf-life days.

[0047] Obtaining the planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time, and cleanup time for a current production order means collecting all the time elements required to complete a production order. For example, the planned processing time can be calculated using the process route and standard working hours; equipment preparation time can be determined through historical data statistics or preset values; and process waiting time, inter-process buffer time, batch confirmation waiting time, and cleanup time reflect the non-processing time in the production process.

[0048] The complete execution window is calculated by adding up the planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time, and cleanup time. This sums all time parameters to obtain the total time from the issuance of the material preparation instruction to the completion of the final cleanup step. For example, if the planned processing time is 20 hours, equipment preparation time is 2 hours, process waiting time is 3 hours, inter-process buffer time is 4 hours, batch confirmation waiting time is 1 hour, and cleanup time is 2 hours, then the complete execution window is 20 + 2 + 3 + 4 + 1 + 2 = 32 hours. This complete execution window provides a more comprehensive reflection of the order's actual demand for material shelf life than simply considering the planned processing time.

[0049] The lifetime coverage difference, calculated by subtracting the full execution window from the real-time remaining shelf life, indicates whether the material's actual remaining shelf life is sufficient to cover the entire execution time of the order. This difference is a key indicator for determining whether a material is suitable for allocation to the current order. If the real-time remaining shelf life is 50 days and the full execution window is 32 days, then the lifetime coverage difference is 50 - 32 = 18 days. A positive value indicates sufficient material shelf life, while a negative value indicates insufficient material shelf life.

[0050] Furthermore, the steps for calculating the real-time remaining shelf life based on the actual shelf-life consumption equivalent include: The cumulative consumed shelf-life equivalent is obtained by summing up the actual shelf-life equivalents of all environmental periods from the time the batch of medical raw materials to be allocated to the current assessment point. The remaining shelf life equivalent is obtained by subtracting the cumulative consumed shelf life equivalent from the total available shelf life equivalent corresponding to the batch of medical raw materials to be allocated within the label validity period. The remaining shelf life equivalent is then divided by the baseline decay rate to obtain the real-time remaining shelf life days. The real-time remaining shelf life days are used as the real-time remaining shelf life.

[0051] The cumulative consumed shelf-life equivalent (EVE) is calculated by summing the actual EVE consumption across all environmental intervals from the time the medical raw materials are received into storage to the current assessment point. This involves accumulating the EVE consumption under various environmental conditions experienced by the medical raw materials from their initial storage entry to the current assessment time. This is achieved as follows: First, the time of the medical raw materials' entry into storage is recorded. Second, the duration of the medical raw materials' stay in different storage environments (e.g., different temperature and humidity zones), as well as the average temperature and humidity of those environments, are continuously monitored and recorded. Then, for each environmental interval, the actual EVE consumption within that interval is calculated based on a preset environmental acceleration factor (reflecting the EVE consumption acceleration factor under specific temperature and humidity conditions relative to standard storage conditions) and a baseline decay rate (representing the daily EVE consumption under standard storage conditions). Finally, the actual EVE consumption of all these environmental intervals is summed to obtain the cumulative consumed shelf-life equivalent. For example, if a batch of raw materials stays in environment A (acceleration factor 1.2) for 10 days and in environment B (acceleration factor 1.5) for 5 days, with a baseline decay rate of 1 equivalent per day, then the cumulative consumed shelf-life equivalent is (10*1.2*1)+(5*1.5*1)=12+7.5=19.5 equivalents.

[0052] The remaining shelf-life equivalent (SBE) is calculated by subtracting the accumulated consumed SBE from the total available SBE of the batch of medical raw materials to be allocated within the label's expiry date. This means deducting the consumed portion from the original total SBE of the raw materials to obtain the current actual remaining SBE. Specifically, this can be achieved as follows: First, determine the total available SBE of the batch of medical raw materials within the label's expiry date. This is typically calculated by multiplying the label's expiry date in days by a baseline decay rate. For example, if the label's expiry date is 365 days and the baseline decay rate is 1 SBE / day, then the total available SBE is 365 SBE. Then, subtract the previously calculated accumulated consumed SBE from the total available SBE to obtain the remaining SBE. For example, if the total available SBE is 365 SBE and the accumulated consumed SBE is 19.5 SBE, then the remaining SBE is 365 - 19.5 = 345.5 SBE.

[0053] The real-time remaining shelf life is calculated by dividing the remaining shelf life equivalent by the baseline decay rate. Using this real-time remaining shelf life as the basis for real-time remaining shelf life means converting the abstract shelf life equivalent into a specific unit of time (days) for easier understanding and management. Specifically, this can be achieved by dividing the remaining shelf life equivalent by a preset baseline decay rate. The baseline decay rate represents the daily shelf life equivalent consumed by the medical raw material under standard storage conditions. For example, if the remaining shelf life equivalent is 345.5 equivalents and the baseline decay rate is 1 equivalent / day, then the real-time remaining shelf life in days is 345.5 / 1 = 345.5 days.

[0054] Furthermore, the step of determining the required fluctuation coverage duration to cover the preset information duration threshold, based on the upper limit of business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, as a boundary buffer zone, includes: Extract one or more of the process waiting time, inter-process buffer time, and batch confirmation waiting time from the complete execution window as indeterminate time parameters; The maximum deviation value in the historical execution duration statistics of each uncertain time parameter is used as the upper limit of business fluctuation. Based on the historical fluctuation distribution data of each uncertain time parameter, calculate the fluctuation coverage duration quantile value corresponding to each uncertain time parameter under the preset information duration threshold, and use it as the fluctuation coverage duration. For each uncertain time parameter, the larger of the upper limit of business fluctuation corresponding to the uncertain time parameter and the quantile value of fluctuation coverage duration shall be used as the fluctuation coverage requirement value of the uncertain time parameter. Add up all the fluctuation coverage demand values ​​to obtain the boundary buffer zone.

[0055] Specifically, when determining the boundary buffer zone, it is first necessary to identify and extract time parameters with significant uncertainties from the complete execution window. These uncertain time parameters may include one or more of the following: process waiting time, inter-process buffer time, and batch confirmation waiting time. These time parameters are usually affected by various factors such as production scheduling, equipment status, personnel operation, and quality inspection, and their actual occurrence time often deviates from the planned time. Therefore, they are key factors causing fluctuations in the complete execution window of production orders.

[0056] The upper limit of business fluctuation refers to the maximum deviation of various uncertain time parameters during historical execution. For example, if the planned waiting time for a certain process is 2 hours, but historical records show that it has reached a maximum of 5 hours, then the maximum deviation is 3 hours. This upper limit of business fluctuation aims to capture and quantify extreme fluctuations in history, ensuring that the boundary buffer can cover the most unfavorable business scenarios.

[0057] Furthermore, the fluctuation coverage duration quantile is a statistic calculated based on historical fluctuation distribution data for various uncertain time parameters, under a preset confidence duration threshold. Historical fluctuation distribution data can be a statistical distribution of the actual execution duration of various uncertain time parameters over a past period, such as a normal distribution, Poisson distribution, or other empirical distributions. The preset confidence duration threshold is a pre-defined confidence level, such as 95% or 99%, representing the confidence level of the fluctuation range that the boundary buffer should cover. The fluctuation coverage duration quantile represents the maximum fluctuation duration that the uncertain time parameter may reach at that confidence level. For example, if 95% of the process waiting time fluctuations do not exceed 1 hour, then its 95th percentile is 1 hour.

[0058] In practical applications, to ensure the robustness of the boundary buffer zone, for each uncertain time parameter, the larger of its corresponding upper limit of business fluctuation and the quantile value of fluctuation coverage duration is used as the fluctuation coverage requirement value for that uncertain time parameter. This strategy of taking the larger value aims to simultaneously consider both historical extreme cases (reflected by the upper limit of business fluctuation) and statistically high-confidence fluctuation ranges (reflected by the quantile value of fluctuation coverage duration), thereby avoiding insufficient or excessive buffer zone due to a single consideration.

[0059] In some preferred embodiments, suppose a batch of medical raw materials needs to be allocated to a production order, the full execution window of which contains three main uncertain time parameters: process wait time, inter-process buffer time, and batch confirmation wait time. Assume that the confidence duration threshold is set to 95%.

[0060] The maximum deviation for the process waiting time is 2 days. At a 95% confidence threshold, the fluctuation coverage quantile is 1.5 days. Therefore, the required fluctuation coverage for this process waiting time is Max(2 days, 1.5 days) = 2 days.

[0061] The maximum deviation for the inter-process buffer time is 1 day. At a 95% confidence threshold, the fluctuation coverage duration quantile is 0.8 days. Therefore, the required fluctuation coverage for this inter-process buffer time is Max(1 day, 0.8 days) = 1 day.

[0062] The maximum deviation for batch confirmation waiting time is 0.5 days. At a 95% confidence threshold, the fluctuation coverage time quantile is 0.7 days. Therefore, the required fluctuation coverage for this batch confirmation waiting time is Max(0.5 days, 0.7 days) = 0.7 days.

[0063] The fluctuations of various uncertain time parameters are added together to cover the required values, resulting in the final boundary buffer zone: 2 days + 1 day + 0.7 days = 3.7 days.

[0064] Therefore, in subsequent expiration date management, when the lifespan coverage difference of a batch of medical raw materials to be allocated falls within the buffer zone with 3.7 days as the boundary, it will be marked as a boundary observation batch and trigger a periodic review process, thereby achieving refined management of potential expiration date risks.

[0065] Furthermore, based on the historical fluctuation distribution data of each uncertain time parameter, the step of calculating the fluctuation coverage duration quantile value corresponding to each uncertain time parameter under the preset information duration threshold, and using this value as the fluctuation coverage duration, includes: For each uncertain time parameter, obtain the historical storage time of the same type of material corresponding to the batch of medical raw materials to be allocated, from the time it is allocated to the buffer area at the production line side to the time it is officially started to be processed, and calculate the storage time quantile value of the historical storage time under the preset information time threshold, which is used as the first fluctuation coverage time of the uncertain time parameter based on the historical fluctuation of the material. Obtain the historical cache waiting time statistics of the same type of material corresponding to the batch of medical raw materials to be allocated in the production line to which the current production order to be executed belongs; calculate the production line waiting time quantile of the historical cache waiting time statistics under the preset time threshold, and use it as the second fluctuation coverage time of the uncertain time parameter based on the historical fluctuation of the production line. The larger of the first fluctuation coverage duration and the second fluctuation coverage duration is taken as the fluctuation coverage duration corresponding to this uncertain time parameter.

[0066] Historical fluctuation distribution data refers to records of the actual execution duration of uncertain time parameters over a past period. This data can be used for statistical analysis, such as calculating the mean, variance, and quantiles. Specifically, this can be achieved by storing historical production data in a database and then using statistical software for analysis.

[0067] The preset confidence duration threshold refers to the level of confidence expected when determining the volatility coverage duration, such as 95% or 99%. This threshold indicates the degree to which it can be confident that actual volatility will not exceed the determined volatility coverage duration. It can be set according to actual production needs and risk appetite; for example, if the tolerance for production disruptions is low, a higher confidence duration threshold can be set.

[0068] The fluctuation coverage duration quantile refers to the duration value in historical fluctuation distribution data with uncertain time parameters, given a confidence duration threshold. For example, if the confidence duration threshold is 95%, the fluctuation coverage duration quantile indicates a 95% probability that the actual fluctuation will not exceed that duration. This can be achieved using statistical quantile calculation methods. For instance, for a set of historical data, it can be sorted, and then the data point corresponding to the percentage position of the confidence duration threshold can be found.

[0069] Similar materials refer to materials with the same or similar attributes as the batch of medical raw materials to be allocated, such as the same product model or specifications. Historical reserve duration refers to the actual waiting time of similar materials after allocation, from arrival at the production line buffer to the start of formal processing. Specifically, this can be obtained by using a Manufacturing Execution System (MES) to record the material's warehousing time, allocation time, arrival time at the buffer, and start processing time, and then calculating the time difference. Reserve duration quantiles refer to the quantile values ​​of historical reserve durations under a preset reserve duration threshold. This can be calculated using the same statistical methods as for fluctuation coverage duration quantiles.

[0070] The first fluctuation coverage duration refers to the fluctuation coverage duration determined based on the material's historical fluctuations, reflecting the uncertainty of the material's own waiting time in the production line buffer area.

[0071] The production line to which the current pending production order belongs refers to the production line corresponding to the order that needs to be produced now. Historical buffer waiting time statistics refer to the historical waiting time records for similar materials on the production line to which the current pending production order belongs, from arrival in the buffer area to the start of formal processing. Specifically, this can be achieved by using a Manufacturing Execution System (MES) to record material waiting data for the production line and performing statistical analysis. The production line waiting time quantile refers to the quantile value of the historical buffer waiting time statistics under a preset waiting time threshold. This can be calculated using the same statistical method as the fluctuation coverage time quantile.

[0072] The second fluctuation coverage duration refers to the fluctuation coverage duration determined based on the historical fluctuations of the production line, reflecting the uncertainty of the waiting time when the production line is processing materials.

[0073] The larger of the first and second fluctuation coverage durations is used as the fluctuation coverage duration corresponding to this uncertain time parameter. By taking the larger value, a more conservative and safer fluctuation coverage duration can be obtained, providing a more reliable basis for determining the subsequent boundary buffer zone. This method is consistent with the method used in the preliminary information to determine the fluctuation coverage requirement value by taking the larger of the upper limit of business fluctuation and the quantile value of fluctuation coverage duration. Both aim to adopt a more robust strategy in uncertainty management, ensuring that production needs can be met even under the worst-case scenario, thereby improving the accuracy and robustness of medical raw material expiration date management.

[0074] Furthermore, the boundary observation batch includes boundary observation allocable batches and boundary observation restricted batches; the steps for grading and labeling the batch of medical raw materials to be allocated based on the difference between the boundary buffer zone and the lifetime coverage include: If the lifetime coverage difference is greater than or equal to the boundary buffer zone, the batch of medical raw materials to be allocated is marked as a stable and allocable batch. If the life coverage difference is greater than or equal to zero and less than the boundary buffer zone, the batch of medical raw materials to be allocated is marked as the batch that can be allocated under the boundary observation, thus triggering the periodic review process. If the life coverage difference is greater than or equal to the negative boundary buffer zone and less than zero, the batch of medical raw materials to be allocated is marked as the boundary observation restriction batch, triggering the periodic review process. If the difference in lifespan coverage is less than the negative boundary buffer zone, then when the real-time remaining shelf life is greater than the preset minimum safety threshold, the batch of medical raw materials to be allocated will be marked as a stable restricted allocation batch; when the real-time remaining shelf life is less than or equal to the preset minimum safety threshold, the batch of medical raw materials to be allocated will be marked as a prohibited allocation batch.

[0075] Among them, stable and allocatable batches refer to batches whose lifetime coverage difference is greater than or equal to the boundary buffer, indicating that their shelf life is sufficient to stably cover the complete execution window of production orders and has sufficient buffer to cope with uncertainties.

[0076] Boundary observation assignable batches refer to batches with a lifetime coverage difference greater than or equal to zero but less than the boundary buffer. Although these batches can theoretically still cover production orders, their lifetime coverage difference is close to the boundary, posing a certain risk of fluctuation. Therefore, a periodic review process needs to be triggered to closely monitor their expiration status.

[0077] Boundary observation limit batches refer to batches whose lifetime coverage difference is greater than or equal to a negative boundary buffer zone but less than zero. These batches theoretically cannot fully cover the entire execution window of the production order, but their negative values ​​are still within the boundary buffer zone, meaning that their risk is still within a controllable range. They also require periodic review processes for close monitoring.

[0078] Stable-limited allocation batches refer to batches whose lifetime coverage difference is less than the negative boundary buffer zone, but whose real-time remaining shelf life is still greater than the preset minimum safety threshold. Although these batches are not suitable for the current production order, they still have a certain shelf life and can be considered for other short-term or urgent orders.

[0079] Prohibited allocation batches refer to batches with a lifetime coverage difference less than the negative boundary buffer and a real-time remaining shelf life less than or equal to a preset minimum safety threshold. These batches are explicitly prohibited from allocation because their shelf life is about to expire or has already expired, in order to avoid potential quality risks and waste.

[0080] The periodic review process refers to the regular or irregular reassessment of boundary observation batches. Specifically, when a batch is marked as a boundary observation allocable batch or a boundary observation restricted batch, the periodic review process is triggered to calculate the changing trend of the lifetime coverage difference and update the batch's classification label based on the changing trend. This is combined with the steps of calculating the difference between the real-time remaining shelf life of the medical raw material batch to be allocated at the current assessment point and the complete execution window of the current production order to be executed, as the lifetime coverage difference, and determining the fluctuation coverage duration required to cover the preset information duration threshold based on the upper limit of business fluctuations corresponding to the uncertain time parameters in the complete execution window and the historical fluctuation distribution data of the uncertain time parameters, as the boundary buffer, thus resolving the problem of unclear batch allocation status when the lifetime coverage difference is close to the boundary buffer.

[0081] Furthermore, the steps of calculating the changing trend of the life coverage difference and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend include: Calculate the change in the difference between the life coverage difference of the batch of medical raw materials to be allocated at the current assessment point and the life coverage difference at the previous assessment point; If the lifetime coverage difference of the batch of medical raw materials to be allocated remains the same at the most recent preset number of assessment points and the absolute value of the change in each difference is less than the preset fluctuation limit, then the trend is determined to be stable. When the lifetime coverage difference is less than the negative boundary buffer and the real-time remaining shelf life is greater than the preset minimum safety threshold, the classification label of the batch of medical raw materials to be allocated is updated to the stable restricted allocation batch. When the lifetime coverage difference is greater than or equal to zero and less than the boundary buffer, the classification label of the batch of medical raw materials to be allocated is updated to the stable allocable batch. If the lifespan coverage difference of the batch of medical raw materials to be allocated switches between positive and negative signs at the most recent preset number of assessment points, or if the absolute value of any change in the difference exceeds the preset fluctuation limit, the trend of change is determined to be unstable, and the batch of medical raw materials to be allocated is marked as pending confirmation and frozen.

[0082] Specifically, the change in difference refers to the numerical change in the lifetime coverage difference of a batch of medical raw materials to be allocated between two consecutive assessment points. This change can be positive, negative, or zero, reflecting the dynamic evolution of the match between the batch's expiration date and the production order execution window. For example, if the lifetime coverage difference at the current assessment point is D_current and the lifetime coverage difference at the previous assessment point is D_previous, then the change in difference can be calculated as D_current - D_previous. The preset number of assessments refers to the number of consecutive assessment points that need to be examined when judging the stability of the trend. For example, it can be set to 3, 5, or more times, the purpose of which is to avoid misjudging the trend due to accidental fluctuations in a single assessment.

[0083] The preset fluctuation limit refers to the maximum absolute change allowed in the lifetime coverage difference between consecutive assessment points. This can be set to 1 day, 0.5 days, or even less. Its purpose is to filter out insignificant, minor fluctuations, ensuring that only substantial changes are considered part of the trend. In practical applications, when the trend is determined to be stable, if the lifetime coverage difference is less than the negative boundary buffer and the real-time remaining shelf life is greater than the preset minimum safety threshold, it indicates that while the batch has some risk in terms of shelf life coverage, it still has a certain safety margin. In this case, its classification is updated to a stable, restricted allocation batch for allocation under specific conditions (such as short-time work orders). If the lifetime coverage difference is greater than or equal to zero and less than the boundary buffer, it indicates that although the batch is close to the boundary, it can still cover the entire execution window of the production order. In this case, its classification is updated to a stable, allocable batch to optimize its allocation priority. In addition, when the trend of change is determined to be unstable, such as when the life coverage difference switches back and forth between positive and negative signs, or when the absolute value of any change in the difference exceeds the preset fluctuation limit, it means that the expiration status of this batch has a large degree of uncertainty or abnormal fluctuation. At this time, it is marked as a pending confirmation frozen state. The purpose is to suspend its automatic allocation and trigger manual intervention for detailed review in order to avoid potential risks.

[0084] In a preferred embodiment, assume that a batch of medical raw materials to be allocated is marked as a boundary-observable allocable batch during the initial assessment, and its lifetime coverage difference is within the boundary buffer zone. A periodic review process will be initiated. At the first review point, the lifetime coverage difference of this batch is +2 days, compared to +3 days at the previous assessment point, with a change in difference of -1 day. At the second review point, the lifetime coverage difference of this batch is +1 day, compared to +2 days at the previous assessment point, with a change in difference of -1 day. At the third review point, the lifetime coverage difference of this batch is +0.5 days, compared to +1 day at the previous assessment point, with a change in difference of -0.5 days. Assume a preset number of reviews is 3, and a preset fluctuation limit of 1.2 days. At this point, the lifetime coverage difference of this batch at the three most recent assessment points has remained positive (+2, +1, +0.5), and the absolute value of the change in difference for each review (1 day, 1 day, 0.5 days) is less than the preset fluctuation limit of 1.2 days. Therefore, its trend is determined to be stable. Since the current lifetime coverage difference +0.5 days is still greater than or equal to zero and less than the boundary buffer zone, the classification label of this batch will be updated to a stable and allocatable batch, thus allowing it to be allocated preferentially.

[0085] In another preferred embodiment, suppose another batch exhibits the following characteristics during periodic review: At the first review point, the lifetime coverage difference is +1 day. At the second review point, the lifetime coverage difference is -0.5 days. At the third review point, the lifetime coverage difference is +0.2 days. In this case, the lifetime coverage difference of this batch switches back and forth between positive and negative signs, indicating an unstable trend. Regardless of the preset fluctuation limit, whenever a switch between positive and negative signs occurs, the batch will be marked as pending confirmation and frozen, triggering a manual review to investigate the specific reasons for the fluctuations in its expiration date.

[0086] Furthermore, the step of generating a sorted list of allocable batches for the current production order to be executed, based on the graded labeling of the batch of medical raw materials to be allocated, includes: For the medical raw material batches marked as stable and allocable batches, they are arranged in ascending order of real-time remaining shelf life to form an allocable batch sorting list for the current production order to be executed. The medical raw material batch ranked first in the allocable batch sorting list is taken as the preferred batch for material preparation, and a material preparation instruction is generated and issued based on the preferred batch for material preparation. For medical raw material batches marked as being allocated under this stable restriction, remove them from the candidate pool of the current pending production orders and transfer them to the preset short-term work order candidate pool. For batches of medical raw materials to be allocated that are marked as prohibited from allocation, remove them from the candidate pool of the current pending production orders and transfer them to the preset review and warning pool; For batches of medical raw materials to be allocated that are marked as pending confirmation and frozen, remove them from the candidate pool of the current pending production orders and transfer them to the preset expiration date verification pool.

[0087] Specifically, stable and allocable batches refer to batches with a shelf-life coverage difference greater than or equal to the boundary buffer. These batches have sufficient safety margin in terms of shelf life and can be stably allocated to current production orders. To optimize inventory turnover and reduce potential shelf-life waste, these batches are arranged in ascending order of real-time remaining shelf life. Real-time remaining shelf life refers to the actual usable shelf life of a medical raw material batch at the current assessment point, after considering the impact of actual environmental exposure. The batch ranked first, i.e., the stable and allocable batch with the shortest real-time remaining shelf life, will be designated as the preferred preparation batch, and preparation instructions will be generated and issued accordingly to ensure the effective implementation of the first-in, first-out (FIFO) principle.

[0088] Among them, stable-limited allocation batches refer to batches whose lifetime coverage difference is less than the negative boundary buffer zone, but whose real-time remaining shelf life is still greater than the preset minimum safety threshold. Although these batches are not suitable for the full execution window of the current production order, they still have a certain usable shelf life. To prevent these batches from being scrapped due to their approaching expiration date, they are removed from the candidate pool of the current production order and transferred to the preset short-term work order candidate pool. The short-term work order candidate pool is specifically used to match production orders with shorter execution windows and relatively relaxed shelf life requirements, thereby achieving efficient utilization of materials.

[0089] In practical applications, prohibited batches refer to batches with a lifetime coverage difference less than the negative boundary buffer zone and a real-time remaining shelf life less than or equal to a preset minimum safety threshold. These batches, due to their short shelf life or failure to meet safety requirements, are removed from the current production order's candidate pool and transferred to a preset review and warning pool. The purpose of the review and warning pool is to further evaluate and handle these high-risk batches, such as scrapping, special purpose assessment, or quality review, to ensure that non-conforming materials do not enter the production process.

[0090] Furthermore, batches in the pending freeze status refer to those whose lifetime coverage difference trend is deemed unstable during the periodic review process. These batches may exhibit abnormal expiration dates or uncertain assessment data. To mitigate potential risks, they are removed from the current production order candidate pool and transferred to a pre-defined expiration date review pool. The expiration date review pool is used for in-depth investigation and analysis of these batches, which may include retesting expiration dates, verifying environmental data, etc., until their status is clarified and reclassified.

[0091] Secondly, see Figure 2 This application also discloses a medical raw material expiration date management system, the system comprising: The lifetime coverage difference calculation module 210 is used to calculate the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment time and the complete execution window of the current production order to be executed, as the lifetime coverage difference. The boundary buffer zone determination module 220 is used to determine the fluctuation coverage duration required to cover the preset information duration threshold based on the upper limit value of business fluctuation corresponding to the uncertain time parameter in the full execution window and the historical fluctuation distribution data of the uncertain time parameter, and use it as the boundary buffer zone. The grading and labeling module 230 is used to grade and label batches of medical raw materials to be allocated based on the difference between the boundary buffer zone and the lifetime coverage. The grading labeling should include at least the following: when the life coverage difference falls within the boundary buffer zone, the batch of medical raw materials to be allocated should be labeled as a boundary observation batch and a periodic review process should be triggered. The periodic review process includes at least the following: recalculating the real-time remaining shelf life and updating the life coverage difference at subsequent assessment points, calculating the changing trend of the life coverage difference, and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend. The list generation module 240 is used to generate a sorted list of allocable batches for the current production order to be executed, based on the hierarchical labeling of the batches of medical raw materials to be allocated.

[0092] This technical solution automates and intelligently manages the expiration dates of medical raw materials, effectively implementing the aforementioned methods and thus improving management efficiency and accuracy.

[0093] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A method for managing the expiration date of medical raw materials, characterized in that, include: Calculate the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the full execution window of the current production order to be executed, as the lifetime coverage difference; Based on the upper limit of business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, the fluctuation coverage duration required to cover the preset information duration threshold is determined as a boundary buffer zone. Based on the difference between the boundary buffer zone and the lifetime coverage, the batches of medical raw materials to be allocated are classified and labeled. The grading labeling includes at least the following: when the life coverage difference falls within the boundary buffer zone, the batch of medical raw materials to be allocated is labeled as a boundary observation batch, and a periodic review process is triggered. The periodic review process includes at least: calculating the changing trend of the life coverage difference, and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend; Based on the classification label of the batches of medical raw materials to be allocated, a sorted list of allocable batches for the current production order to be executed is generated.

2. The method for managing the expiration date of medical raw materials according to claim 1, characterized in that, Before the step of calculating the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the full execution window of the current production order to be executed, as the lifetime coverage difference, the step of obtaining historical environmental exposure information is also included: Obtain the label expiration date of the batch of medical raw materials to be allocated; The duration of each environmental interval experienced by the batch of medical raw materials to be allocated from its entry into the warehouse to the current assessment point, the average temperature value, and the average humidity value are obtained, forming an environmental record sequence sorted by time. The tag validity period and the environmental record sequence are associated and stored as the environmental exposure history information.

3. The method for managing the expiration date of medical raw materials according to claim 2, characterized in that, The step of calculating the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the complete execution window of the current production order to be executed, as the lifetime coverage difference, includes: The baseline decay rate of the batch of medical raw materials to be allocated under preset standard storage conditions is obtained, wherein the baseline decay rate represents the daily shelf-life equivalent consumed by the batch of medical raw materials to be allocated under the preset standard storage conditions. Traverse the environmental record sequence, and for each environmental interval, find the preset environmental acceleration factor based on the average temperature and average humidity values ​​within that environmental interval. The environmental acceleration factor represents the expiration rate acceleration factor of that environmental interval relative to the preset standard storage conditions. Multiply the duration of the environmental interval by the environmental acceleration factor and then by the baseline decay rate to obtain the actual effective life consumption equivalent of the environmental interval. The real-time remaining effective period is calculated based on the actual effective period consumption equivalent. Obtain the planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time, and clearing time for the current production order to be executed; The planned processing time, equipment preparation time, process waiting time, inter-process buffer time, batch confirmation waiting time, and clearing time are added together to obtain the complete execution window, which represents the total time occupied from the issuance of the material preparation instruction to the completion of the last process and clearing. The lifetime coverage difference is obtained by subtracting the full execution window from the real-time remaining validity period.

4. The method for managing the expiration date of medical raw materials according to claim 3, characterized in that, The step of calculating the real-time remaining validity period based on the actual validity period consumption equivalent includes: The cumulative consumed shelf-life equivalent is obtained by summing up the actual shelf-life equivalents consumed in all environmental intervals from the time the batch of medical raw materials to be allocated was put into storage to the current assessment time. The remaining shelf life equivalent is obtained by subtracting the cumulative consumed shelf life equivalent from the total available shelf life equivalent of the batch of medical raw materials to be allocated within the label validity period. The remaining shelf life equivalent is then divided by the baseline decay rate to obtain the real-time remaining shelf life days. The real-time remaining shelf life days are used as the real-time remaining shelf life.

5. The method for managing the expiration date of medical raw materials according to claim 3, characterized in that, The step of determining the fluctuation coverage duration required to cover the preset information duration threshold based on the upper limit value of the business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, as a boundary buffer band, includes: Extract one or more of the process waiting time, inter-process buffer time, and batch confirmation waiting time from the complete execution window as the uncertain time parameter; The maximum deviation value in the historical execution duration statistics of each of the aforementioned uncertain time parameters is used as the upper limit value of business fluctuation. Based on the historical fluctuation distribution data of each of the uncertain time parameters, calculate the fluctuation coverage duration quantile value corresponding to each of the uncertain time parameters under the preset information duration threshold, and use it as the fluctuation coverage duration. For each of the aforementioned uncertain time parameters, the larger of the upper limit of the business fluctuation corresponding to the uncertain time parameter and the quantile value of the fluctuation coverage duration shall be used as the fluctuation coverage requirement value of the uncertain time parameter. The boundary buffer zone is obtained by summing all the fluctuation coverage requirements.

6. The method for managing the expiration date of medical raw materials according to claim 5, characterized in that, The step of calculating the fluctuation coverage duration quantile value corresponding to each of the uncertain time parameters under the preset information duration threshold, based on the historical fluctuation distribution data of each of the uncertain time parameters, and using it as the fluctuation coverage duration, includes: For each of the uncertain time parameters, the historical reserve time of the same type of material corresponding to the batch of medical raw materials to be allocated is obtained from the time it is allocated, from the time it arrives at the buffer area at the production line to the time it officially starts processing. The reserve time quantile value of the historical reserve time under the preset time threshold is calculated as the first fluctuation coverage time of the uncertain time parameter based on the historical fluctuation of the material. Obtain the historical cache waiting time statistics of the same type of material corresponding to the batch of medical raw materials to be allocated on the production line to which the current production order to be executed belongs, and calculate the production line waiting time quantile of the historical cache waiting time statistics under the preset time threshold, as the second fluctuation coverage time of the uncertain time parameter based on the historical fluctuation of the production line; The larger of the first fluctuation coverage duration and the second fluctuation coverage duration shall be taken as the fluctuation coverage duration corresponding to the uncertain time parameter mentioned in this item.

7. The method for managing the expiration date of medical raw materials according to claim 1, characterized in that, The boundary observation batch includes boundary observation allocable batches and boundary observation restricted batches; the step of classifying and labeling the batches of medical raw materials to be allocated based on the difference between the boundary buffer zone and the lifetime coverage includes: If the lifetime coverage difference is greater than or equal to the boundary buffer zone, the batch of medical raw materials to be allocated is marked as a stable and allocable batch. If the lifespan coverage difference is greater than or equal to zero and less than the boundary buffer zone, the batch of medical raw materials to be allocated is marked as the boundary observation allocateable batch, triggering the periodic review process. If the lifespan coverage difference is greater than or equal to the negative boundary buffer zone and less than zero, then the batch of medical raw materials to be allocated is marked as the boundary observation restriction batch, triggering the periodic review process. If the difference in lifespan coverage is less than the negative boundary buffer zone, then when the real-time remaining shelf life is greater than the preset minimum safety threshold, the batch of medical raw materials to be allocated is marked as a stable restricted allocation batch; when the real-time remaining shelf life is less than or equal to the preset minimum safety threshold, the batch of medical raw materials to be allocated is marked as a prohibited allocation batch.

8. The method for managing the expiration date of medical raw materials according to claim 7, characterized in that, The step of calculating the changing trend of the life coverage difference and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend includes: Calculate the change in the difference between the life coverage difference of the batch of medical raw materials to be allocated at the current assessment time and the life coverage difference at the previous assessment time; If the lifetime coverage difference of the batch of medical raw materials to be allocated remains the same at the most recent preset number of assessment points and the absolute value of the change in the difference is less than the preset fluctuation limit, then the trend is determined to be stable. When the lifetime coverage difference is less than the negative boundary buffer zone and the real-time remaining shelf life is greater than the preset minimum safety threshold, the classification label of the batch of medical raw materials to be allocated is updated to the stable restricted allocation batch. When the lifetime coverage difference is greater than or equal to zero and less than the boundary buffer zone, the classification label of the batch of medical raw materials to be allocated is updated to the stable allocable batch. If the lifespan coverage difference of the batch of medical raw materials to be allocated switches between positive and negative signs at the most recent preset number of assessment points, or if the absolute value of any change in the difference exceeds the preset fluctuation limit, then the trend of change is determined to be unstable, and the batch of medical raw materials to be allocated is marked as pending confirmation and frozen.

9. A method for managing the expiration date of medical raw materials according to claim 8, characterized in that, The step of generating an allocatable batch sorting list for the current production order to be executed based on the graded labeling of the batches of medical raw materials to be allocated includes: For the medical raw material batches marked as stable and allocable batches, they are arranged in ascending order of real-time remaining shelf life to form an allocable batch sorting list for the current production order to be executed. The medical raw material batch ranked first in the allocable batch sorting list is taken as the preferred batch for material preparation. Material preparation instructions are generated and issued based on the preferred batch for material preparation. For medical raw material batches marked as stable restricted allocation batches, remove them from the candidate pool of the current production orders to be executed and transfer them to the preset short-term work order candidate pool; For batches of medical raw materials to be allocated that are marked as prohibited batches, they are removed from the candidate pool of the current production orders to be executed and transferred to the preset review and warning pool. For batches of medical raw materials to be allocated that are marked as pending confirmation of the frozen status, they are removed from the candidate pool of the current pending production orders and transferred to the preset expiration date verification pool.

10. A medical raw material expiration date management system, used to execute the medical raw material expiration date management method as described in any one of claims 1 to 9, characterized in that, The system includes: The lifetime coverage difference calculation module is used to calculate the difference between the real-time remaining shelf life of the batch of medical raw materials to be allocated at the current assessment point and the complete execution window of the current production order to be executed, as the lifetime coverage difference; The boundary buffer zone determination module is used to determine the fluctuation coverage duration required to cover the preset information duration threshold based on the upper limit value of business fluctuation corresponding to the uncertain time parameter in the complete execution window and the historical fluctuation distribution data of the uncertain time parameter, as the boundary buffer zone; The grading and labeling module is used to grade and label the batches of medical raw materials to be allocated based on the difference between the boundary buffer zone and the lifetime coverage. The grading labeling includes at least the following: when the life coverage difference falls within the boundary buffer zone, the batch of medical raw materials to be allocated is labeled as a boundary observation batch, and a periodic review process is triggered. The periodic review process includes at least: calculating the changing trend of the life coverage difference, and updating the grading label of the batch of medical raw materials to be allocated based on the changing trend; The list generation module is used to generate a sorted list of allocable batches for the current production order to be executed, based on the graded labeling of the batches of medical raw materials to be allocated.

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