Medical material preparation and production quality analysis and evaluation method

Abstract

The invention belongs to the technical field of material production quality analysis, and particularly discloses and provides a medical material preparation and production quality analysis and evaluation method which comprises the following steps: integrating raw material detection data, production process monitoring data and finished product detection data into an initial quality inspection data list, and marking, recording the storage time and inventory environment data of the medical material corresponding to the batch to be subjected to quality inspection in the inventory period, and collecting the inspection data in the period; carrying out production quality analysis on the medical material; judging whether the production quality inspection of the medical material meets the set requirement or not, if yes, evaluating the production quality score of the medical material and feeding back, and if not, confirming the quality inspection adjustment link and the quality inspection passing rate of the medical material and feeding back. The defect that quality testing and analysis evaluation are only carried out in the production process at present is overcome.

Description

Technical Field

[0001] The present invention belongs to the technical field of material production quality analysis, and in particular, relates to a method for analyzing and evaluating the production quality of medical material preparation. Background Art

[0002] Due to the deepening of population aging and the continuous advancement of medical technology, the demand for medical materials is growing. The quality of medical materials plays an important role in the health and safety of patients, so the analysis and evaluation of their preparation and production quality is of great significance.

[0003] The production quality inspection of medical material preparation involves the quality inspection of raw materials, quality monitoring of the production process, quality inspection of finished products, and production quality analysis and evaluation based on the quality inspection data.

[0004] At present, there are still the following deficiencies in the analysis and evaluation of production quality of medical material indicators: 1. Production quality analysis has certain limitations. Currently, quality testing and analysis and evaluation are only carried out during the production process without follow-up tracking. That is, it focuses on short-term performance, but pays insufficient attention to performance changes of materials in long-term use.

[0005] 2. The evaluation is a single-item, isolated evaluation, and does not include an integrated evaluation of multiple links and multiple factors. As a result, the representativeness and reliability of the evaluation results are still lacking, and the accuracy of the evaluation results cannot be guaranteed. Summary of the invention

[0006] In view of this, in order to solve the problems raised in the above background technology, a method for analyzing and evaluating the production quality of medical material preparation is now proposed.

[0007] The purpose of the present invention can be achieved through the following technical solutions: The present invention provides a method for analyzing and evaluating the production quality of medical materials, the method comprising: S1, importing initial material data: integrating the raw material inspection data, production process monitoring data and finished product inspection data corresponding to the batch of medical materials to be inspected into an initial quality inspection data list, and marking each medical material in the batch to be inspected.

[0008] S2. Material storage data tracking: record the storage time and inventory environment data of the medical materials corresponding to the batch to be inspected during the inventory cycle, and collect the verification data during this period.

[0009] S3. Production quality indicator analysis: Use the initial quality inspection data list and inventory environment data to conduct production quality analysis on medical materials and output the analysis results.

[0010] S4. Production quality inspection judgment: Based on the analysis results of step S3, judge whether the production quality inspection of medical materials meets the established requirements. If so, evaluate the production quality score of the medical materials and provide feedback. If not, proceed to the next step.

[0011] S5. Quality inspection adjustment confirmation and feedback: Confirm the quality inspection links of medical materials and the pass rate of the quality inspection links, and provide feedback.

[0012] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) The present invention performs production quality analysis by integrating raw material detection data, production process monitoring data, finished product detection data, and tracked material storage data, thereby effectively solving the current limitations of medical material production quality analysis, avoiding the current shortcomings of only conducting quality testing and analysis and evaluation during the production process, realizing subsequent tracking analysis, and improving the comprehensiveness of medical material production quality analysis. At the same time, it also eliminates the current limitation of focusing only on short-term performance, and effectively pays attention to the performance changes of medical materials during long-term use.

[0013] (2) The present invention makes a comprehensive analysis of various information such as raw material quality inspection, production process quality inspection, finished product quality inspection, subsequent tracking quality inspection and environment, which makes up for the shortcomings of the current single-item analysis and realizes the integrated evaluation of multiple links and multiple factors, thereby improving the representativeness and reliability of the subsequent medical material production quality evaluation results, and also ensures the accuracy of the subsequent medical material production quality evaluation results.

[0014] (3) The present invention can ensure that the produced medical materials meet the predetermined quality standards by combining the compliance degree of the adjustment quality inspection link and the deviation ratio to confirm the adjustment quality inspection pass rate of the adjustment quality inspection link, thereby ensuring the safety and effectiveness of the product. At the same time, quality problems in the production process can be discovered in time, and corrective measures can be taken to prevent unqualified products from entering the market. It is also easy to identify bottlenecks and problem points in the production process, optimize the production process, improve production efficiency, and thus reduce quality problems in the subsequent use of medical materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0016] Figure 1 The present invention is a schematic flow chart of the steps for implementing the method.

[0017] Figure 2A flowchart showing the specific steps in the quality inspection process for confirming the adjustment of medical materials. DETAILED DESCRIPTION

[0018] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0019] See also Figure 1 As shown, the present invention provides a method for analyzing and evaluating the production quality of medical material preparation, the method comprising: S1, importing initial material data: integrating the raw material inspection data, production process monitoring data and finished product inspection data corresponding to the batch of medical materials to be inspected into an initial quality inspection data list, and marking each medical material in the batch to be inspected.

[0020] Among them, the raw material inspection data include the inspection values ​​of each raw material quality inspection item corresponding to each medical raw material, the production process monitoring data include the inspection values ​​of each production quality inspection item corresponding to each medical raw material, and the finished product inspection data include the inspection values ​​of each finished product quality inspection item corresponding to each medical raw material.

[0021] In a specific embodiment, the raw material quality inspection items for medical materials include density, hardness, elongation at break, purity, pH value, residual solvent content, compressive strength, flexural strength, shear strength and light transmittance, etc. The production quality inspection items involved in the production process quality inspection include the production bid temperature, pressure, time, speed, tensile strength, elongation at break, wear resistance, and scratches, cracks, burrs, etc. on the material surface; the finished product quality inspection items designed in the finished product quality inspection link include scratches, cracks, stains, bubbles on the surface of the finished product, as well as the density, hardness, elongation at break, compressive strength, flexural strength, shear strength, wear resistance, etc. of the finished product.

[0022] S2. Material storage data tracking: record the storage time and inventory environment data of the medical materials corresponding to the batch to be inspected during the inventory cycle, and collect the verification data during this period.

[0023] Specifically, the inventory environment data includes the monitoring values ​​of each environmental parameter corresponding to each inventory area on each inventory day.

[0024] It should be added that too high or too low temperature may affect the stability of medical materials. For example, some biological products need to be stored at low temperatures to prevent degradation, and too high humidity may cause the material to absorb moisture, thereby causing microbial growth or chemical reactions, reducing the performance of the material. Too low humidity may cause some materials to dry, become brittle or shrink. Therefore, in a specific embodiment, the environmental parameters may be specifically analyzed using temperature and humidity.

[0025] Specifically, the verification data includes the identification of each verification sample corresponding to each inventory area, the number of verifications of each verification sample, the date of each verification corresponding to each verification sample, and the verification value of each verification item. In a specific embodiment, the verification items may be consistent with the finished product quality inspection items designed in the finished product quality inspection link, or may be extracted from the finished product quality inspection items designed in the finished product quality inspection link. No specific limitation is made here, and it can be determined according to actual verification needs.

[0026] S3. Production quality indicator analysis: Use the initial quality inspection data list and inventory environment data to conduct production quality analysis on medical materials and output the analysis results.

[0027] S4. Production quality inspection judgment: Based on the analysis results of step S3, judge whether the production quality inspection of medical materials meets the established requirements. If so, evaluate the production quality score of the medical materials and provide feedback. If not, proceed to the next step.

[0028] S5. Quality inspection adjustment confirmation and feedback: Confirm the quality inspection links of medical materials and the pass rate of the quality inspection links, and provide feedback.

[0029] Furthermore, in step S3, production quality analysis of medical materials is performed, including: A1, locating a raw material quality inspection data list, a production process monitoring data list and a finished product inspection data list of each medical material from the initial quality data list.

[0030] A2. Based on the pre-set raw material quality inspection standards, production process monitoring standards and finished product inspection standards, a reference raw material quality inspection data list, a production process monitoring data list and a production inspection data list are constructed respectively, and the comprehensive quality inspection compliance of each medical material is counted.

[0031] It should be added that the pre-set quality inspection standards for raw materials, production process monitoring standards and finished product inspection standards are set based on the industry production standards of the target medical materials or the internal production quality standards of the enterprise, and are provided by the manufacturer of the target medical materials for the batch to be inspected.

[0032] A3. Compare the comprehensive quality inspection compliance degree of each medical material with the comprehensive quality inspection compliance degree interval corresponding to each set compliance level. If the comprehensive quality inspection compliance degree of a medical material is within the comprehensive quality inspection compliance degree interval corresponding to a certain compliance level, the medical material will be classified into the compliance level, so as to obtain the medical materials under each compliance level.

[0033] A4. Extracting the monitoring values ​​of the environmental parameters corresponding to each inventory area on each inventory day from the inventory environmental data of the target medical material, and setting the environmental interference factors of each inventory area on each inventory day.

[0034] A5. Extract from the verification data the identification of each verification sample corresponding to each inventory area, the number of verifications of each verification sample, the date of each verification of each verification sample, and the verification value of each verification item, and then calculate the quality consistency index of each verification sample corresponding to each verification in each inventory area.

[0035] A6. If the identification of a medical material at a certain compliance level is consistent with the identification of a corresponding verification sample in a certain inventory area, the inventory area shall be regarded as the associated area of ​​the compliance level, and the verification sample in the inventory area shall be regarded as the associated sample of the inventory area.

[0036] A7. Based on the quality conformity index of each associated sample in each associated area under each compliance level corresponding to each inspection and the environmental interference factor of each associated area on each inventory day, the production quality conformity index of each compliance level is calculated and used as the analysis result.

[0037] The embodiments of the present invention perform production quality analysis by integrating raw material detection data, production process monitoring data, finished product detection data, and tracked material storage data, thereby effectively solving the problem of certain limitations in the current medical material production quality analysis, avoiding the current shortcomings of only performing quality testing and analysis and evaluation during the production process, realizing subsequent tracking analysis, and improving the comprehensiveness of medical material production quality analysis. At the same time, it also removes the current limitation of focusing only on short-term performance, and effectively pays attention to the performance changes of medical materials during long-term use.

[0038] Understandably, regarding step A2, the comprehensive quality inspection compliance of each medical material is counted, including: comparing the raw material quality inspection data list of each medical material with the reference raw material quality inspection data list one by one, counting the number of raw material quality inspection items that match in the two lists, and dividing it by the number of raw material quality inspection items recorded in the raw material quality inspection data list to obtain the raw material quality inspection compliance of each medical material.

[0039] The production quality inspection standards and finished product quality inspection standards of each medical material can be calculated in the same way as the quality inspection standards of raw materials.

[0040] Set the weights for raw material quality inspection, production quality inspection and finished product quality inspection, and obtain the comprehensive quality inspection compliance of each medical material through weighted summation.

[0041] It should be added that the weights of raw material quality inspection, production quality inspection and finished product quality inspection are set to comprehensively evaluate the quality control level of medical materials throughout the entire production process. Reasonable weight setting can ensure that quality issues at different links can be effectively paid attention to and managed.

[0042] In a specific embodiment, the quality of raw materials directly affects the quality of subsequent production and final products, and reflects the quality in the early stage. Quality control in the production process is the key link to ensure the quality of the final product, and shows more quality details in the actual production process. Therefore, the weight of production quality inspection is set to the highest. The quality of the finished product reflects the final result, and the quality inspection of raw materials belongs to the initial quality inspection part and the terminal quality inspection part. Therefore, the weights of raw material quality inspection and finished product quality inspection are set to be consistent. By way of example, the weights of raw material quality inspection, production quality inspection and finished product quality inspection can be 0.3, 0.4 and 0.3 respectively.

[0043] Understandably, setting the environmental interference factors of each inventory area on each inventory day in step A4 includes: A41, comparing the monitoring values ​​of each environmental parameter corresponding to each inventory area on each inventory day with the reference value range of each environmental parameter corresponding to the target medical material.

[0044] A42. If the monitoring value corresponding to a certain environmental parameter is within its reference value interval, the environmental parameter is recorded as a deviation parameter, and the difference between the monitoring value corresponding to the deviation parameter and the reference value interval is calculated and recorded as the deviation value.

[0045] It should be added that the specific calculation method for calculating the difference between the deviation parameter and the reference value interval is as follows: if the monitored value of the deviation parameter is lower than the lower limit of the reference value interval, the difference between the lower limit of the reference value interval corresponding to the deviation parameter and the monitored value of the deviation parameter is calculated, and the calculated difference is recorded as the deviation value; if the monitored value of the deviation parameter is higher than the upper limit of its reference value interval, the difference between the monitored value of the deviation parameter and the upper limit of its reference value interval is calculated to obtain the deviation value.

[0046] In a specific embodiment, the reference value range for the target medical material corresponding to the temperature is generally exemplified as 15°C to 25°C, and the reference value range for the humidity is generally exemplified as between 45% and 65%. The example values ​​all indicate that the medical material is not particularly sensitive to temperature and humidity. When the material is more sensitive to temperature or humidity, the corresponding reference value range can be reduced and adjusted according to the specific sensitivity level. The reference value range for the temperature and the reference value range for the humidity of the medical material can usually be provided by the manufacturer of the target medical material.

[0047] It should also be added that in actual scenarios, environmental parameters can also incorporate a variety of environmental parameters such as light intensity and dust concentration. The present invention mainly considers the main influencing factors, and therefore does not provide examples of values ​​and specific analysis for other environmental parameters. In a specific embodiment, the same analysis can be performed according to the actual quality inspection requirements in accordance with the analysis method of temperature and humidity.

[0048] A43. Count the number of deviation parameters in each inventory area on each inventory day and divide it by the number of environmental parameters to obtain the deviation parameter ratio, denoted as k id , i represents the inventory area number, i=1,2,......n, d represents the inventory day number, d=1,2,......u.

[0049] A44. The deviation value of each deviation parameter in each inventory area corresponding to each inventory day is recorded as C idr , r represents the deviation parameter number, r=1,2,......y.

[0050] A45. Set the environmental interference factor η for each inventory area on each inventory day id , f0 and f1 are the deviation ratio and the corresponding coefficient of the deviation value, respectively. r ′ is the reference deviation value corresponding to the set rth deviation parameter, and e is a natural constant.

[0051] It should be added that when medical materials are stored, environmental parameters have an important impact on their quality and safety. Therefore, it is necessary to set environmental interference factors based on the monitoring values ​​of various environmental parameters corresponding to the inventory area.

[0052] It should also be added that the deviation parameter ratio reflects the extent to which environmental parameters deviate from the standard. If multiple parameters deviate at the same time, even if the deviation of each parameter is not large, it may have a significant impact on the quality of medical materials. The deviation value reflects the specific extent to which the environmental parameters deviate from the standard. If the deviation of a certain parameter is large, even if only one parameter deviates, it may have a serious impact on the quality of medical materials. For the storage of medical materials, the comprehensive interference of multiple environments often has a cross-influence, so the breadth of its impact is of great concern. For example, f0 can be specifically taken as 0.55, and f1 can be specifically taken as 0.45.

[0053] In a specific embodiment, when the deviation parameter is temperature, the reference deviation value can be 5°C, and when the deviation parameter is humidity, the reference deviation value can be 10%. It should be noted that the example values ​​given in the present invention are all reference values ​​for easy analysis and can be adjusted accordingly according to actual scenarios and specific needs.

[0054] Understandably, the statistics of the quality matching index of each inspection sample in each inventory area corresponding to each inspection in step A5 include: recording the inspection value of each inspection item when each inspection sample in each inventory area corresponds to each inspection as Z ijtg , j represents the verification sample number, j=1,2,......w, t represents the verification sequence number, t=1,2,......v, g represents the verification item number, g=1,2,......h.

[0055] Calculate the quality match index λ of each inspection sample in each inventory area corresponding to each inspection ijt , h represents the number of verification items, Z′ g and ΔZ′ g They are the reference value and allowable deviation value of the g-th verification item respectively.

[0056] It should be added that the reference value and permissible deviation value of each verification item can be provided by the manufacturer of the target medical material batch to be inspected.

[0057] It can also be understood that the calculation of the production quality conformity index of each compliance level in step A7 includes: taking two adjacent inspections as one inspection cycle and dividing each inspection into inspection cycles.

[0058] If a certain associated area corresponds to a certain inventory day and a certain associated sample in the associated area corresponds to a certain verification period, the environmental interference factor of the associated area corresponding to the inventory day will be used as the associated environmental interference factor of the associated sample in the associated area corresponding to the verification period.

[0059] The quality matching index and the associated environmental interference factor of each associated sample in each associated area under each compliance level corresponding to each verification period are calculated respectively, and the average quality matching index and the average associated environmental interference factor of the associated samples in each associated area under each compliance level are obtained, which are respectively denoted as λ b ' q and η b ' q , b represents the compliance level number, b=1,2,......B, q represents the associated area number, q=1,2,......Q.

[0060] Calculate the production quality conformity index β of each standard level b , Q is the number of associated regions.

[0061] It should be added that Q≤n.

[0062] The embodiment of the present invention makes up for the shortcomings of the current single-item analysis by conducting a comprehensive analysis of various information such as raw material quality inspection, production process quality inspection, finished product quality inspection, subsequent tracking quality inspection and environment, and realizes the integrated evaluation of multiple links and multiple factors, thereby improving the representativeness and reliability of the subsequent medical material production quality evaluation results, and also ensures the accuracy of the subsequent medical material production quality evaluation results.

[0063] Furthermore, step S4 determines whether the production quality inspection of medical materials meets the established requirements, including: comparing the production conformity index of each compliance level with the set reference production conformity index. If both are greater than or equal to the set reference production conformity index, "reached" is taken as the judgment result, otherwise "not reached" is taken as the judgment result.

[0064] Furthermore, the evaluation of the production quality score of the medical material in step S4 includes: selecting the compliance level that is less than the set reference production compliance index from the production quality compliance index as the deviation level, and counting the number of deviation levels, which is recorded as M0.

[0065] The compliance levels are sorted from low to high, and the compliance level with a sorting position in the middle is located, which is recorded as the segmentation level. From the sorting, the number of deviation levels with a sorting position after the segmentation level is counted, which is recorded as M1.

[0066] Calculate the production quality score G of medical materials, M′ is the number of qualified grades, and G′ is the set rated production quality score.

[0067] It should be added that, in a specific embodiment, the rated production quality score can be based on a ten-point system or a hundred-point system. When a ten-point system is used, G′ is 10, and when a hundred-point system is used, G′ is 100.

[0068] It should be added that the number of deviation levels after the split level in the sorting position indicates the proportion of deviations in the higher standard levels. The higher the number, the higher the standard level, and the lower the corresponding standard probability, which in turn reflects that the standard is not met. Therefore, the number of deviation levels after the split level in the sorting position and the number of deviation levels are selected as correction factors to correct the number of deviation levels, thereby improving the response authenticity of the ratio of the number of deviation levels.

[0069] For further information, see Figure 2 As shown, the adjustment quality inspection link of confirming the medical materials in step S5 includes: S51, recording the compliance level of the production quality conformity index less than the set reference production quality conformity index as the analysis level.

[0070] S52. Extract the raw material quality inspection compliance, production quality inspection compliance and finished product quality inspection compliance corresponding to each medical material in each analysis grade.

[0071] S53. Count the number of medical materials whose raw material quality inspection standards, production quality inspection standards and finished product quality inspection standards are less than the corresponding set reference values, and record them as the number of Class I medical materials, the number of Class II medical materials and the number of Class III medical materials respectively.

[0072] S54. Sum the number of medical materials within each analysis level, and use the sum result as the total number of analyzed medical materials. Divide the number of Class I medical materials, the number of Class II medical materials, and the number of Class III medical materials by the total number of analyzed medical materials, respectively, to obtain the Class I deviation ratio, Class II deviation ratio, and Class III deviation ratio.

[0073] S55. Determine whether the Class I deviation ratio, Class II deviation ratio, and Class III deviation ratio are greater than the set reference deviation ratio.

[0074] S56. If the Class I deviation ratio is greater than the set reference deviation ratio, the raw material quality inspection link shall be used as the adjustment quality inspection link. If the Class II deviation ratio is greater than the set reference deviation ratio, the production quality inspection link shall be used as the adjustment quality inspection link. If the Class III deviation ratio is greater than the set reference deviation ratio, the finished product quality inspection link shall be used as the adjustment quality inspection link.

[0075] In a specific embodiment, the specific example confirmation process of confirming the adjustment quality inspection link of medical materials is as follows: assuming that the total number of analyzed medical materials is 100, the set reference production quality conformity index is 0.9, the set reference deviation ratio is 0.3, the set raw material quality inspection reference value is 0.95, the set production quality inspection reference value is 0.95, and the set finished product quality inspection reference value is 0.95.

[0076] The raw material quality inspection compliance levels of each medical material in each analysis echelon are integrated to obtain the raw material quality inspection compliance levels of each cumulative medical material, and a raw material quality inspection compliance level set is constructed, and A is used to represent the raw material quality inspection compliance level set, where A = [0.94, 0.96, 0.93, ...], with a total of 100 values ​​in the set.

[0077] According to the construction method of the raw material quality inspection standard set, the production quality inspection standard set F and the finished product quality inspection standard set E are constructed in turn, where F = [0.95, 0.97, 0.94, ...], E = [0.96, 0.98, 0.93, ...], and there are 100 values ​​in set F and set E.

[0078] Statistics show that the number of medical materials that do not meet the standards is: 32 for Class I medical materials, 10 for Class II medical materials, and 40 for Class III medical materials.

[0079] The ratios of the numbers of each category were calculated: the ratio of category I was 0.32, the ratio of category II was 0.2, and the ratio of category III was 0.4.

[0080] The Class I number ratio, Class II number ratio and Class III number ratio were traversed. Among them, the Class I number ratio was 0.32, which was greater than the set reference deviation ratio of 0.3. The raw material quality inspection link was used as the adjustment quality inspection link. The Class II number ratio was 0.2, which was less than the set reference deviation ratio of 0.3. It was not used as the adjustment production quality inspection link. The Class III number ratio was 0.4, which was greater than the set reference deviation ratio of 0.3. The finished product quality inspection link was used as the adjustment quality inspection link, thereby confirming the adjusted quality inspection link for medical materials.

[0081] Furthermore, the adjusted quality inspection pass rate of the adjusted quality inspection link is confirmed in step S5, including: R1, statistical average raw material quality inspection compliance rate, average production quality inspection compliance rate and average finished product quality inspection compliance rate corresponding to medical materials.

[0082] It should be added that the statistical calculation of the average raw material quality inspection degree, average production quality inspection degree and average finished product quality inspection degree corresponding to medical materials includes two averaging processes, as exemplified as follows: the raw material quality inspection degree, production quality inspection degree and finished product quality inspection degree corresponding to each medical material in each analysis echelon are respectively calculated for the first time to obtain the average raw material quality inspection degree, average production quality inspection degree and average finished product quality inspection degree of the medical materials in each analysis echelon; and then the medical materials in each analysis echelon are used as the average raw material quality inspection degree, average production quality inspection degree and average finished product quality inspection degree for the average raw material quality inspection degree, average production quality inspection degree and average finished product quality inspection degree to perform the mean calculation again to obtain the average raw material quality inspection degree, average production quality inspection degree and average finished product quality inspection degree corresponding to the medical materials.

[0083] R2. If the adjusted quality inspection link is the raw material quality inspection link, the average raw material quality inspection compliance degree is taken as the first evaluation variable, recorded as x; if the adjusted quality inspection link is the production quality inspection link, the average production quality inspection compliance degree is taken as the first evaluation variable, recorded as x′; if the adjusted quality inspection link is the finished product quality inspection link, the average finished product quality inspection compliance degree is taken as the first evaluation variable, recorded as x″, so as to obtain the first evaluation variable x1 of the adjusted quality inspection link, and the value of x1 is x or x′ or x″.

[0084] R3. Take the Type I deviation ratio, Type II deviation ratio and Type III deviation ratio as the second evaluation variables corresponding to the raw material quality inspection link, production quality inspection link and finished product quality inspection link, respectively, and record them as m, m′ and m″ respectively. The second evaluation variable of the adjusted quality inspection link is recorded as m1, and the value of m1 is m or m′ or m″.

[0085] R4. The preset initial quality inspection pass rate of the adjustment quality inspection link is recorded as p0, and the adjustment quality inspection pass rate p′ of the adjustment quality inspection link is calculated. p1 is the preset quality inspection pass rate threshold, x1′ and m1′ are the set reference deviation ratio and reference quality inspection compliance degree respectively.

[0086] In a specific embodiment, the quality inspection pass rate refers to the ratio of the number of medical materials that pass the quality inspection to the total number of inspections. Therefore, the higher the quality inspection pass rate is set, the stricter the quality inspection is. By way of example, p1 can be specifically taken as 0.99, and p0 can be specifically taken as 0.95.

[0087] The embodiment of the present invention can ensure that the produced medical materials meet the predetermined quality standards by combining the compliance degree of the adjustment quality inspection link and the deviation ratio to confirm the adjustment quality inspection pass rate of the adjustment quality inspection link, thereby ensuring the safety and effectiveness of the product. At the same time, quality problems in the production process can be discovered in time, and corrective measures can be taken to prevent unqualified products from entering the market. It is also easy to identify bottlenecks and problem points in the production process, optimize the production process, improve production efficiency, and thus reduce quality problems in the subsequent use of medical materials.

[0088] The above contents are merely examples and explanations of the concept of the present invention. The technicians in this technical field may make various modifications or additions to the specific embodiments described or replace them in a similar manner. As long as they do not deviate from the concept of the invention or exceed the scope defined by the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A method for analyzing and evaluating the production quality of medical materials, characterized in that: The method includes: S1. Import of initial material data: Integrate the raw material test data, production process monitoring data and finished product test data of the medical materials in the batch to be inspected into an initial quality inspection data list, and mark each medical material in the batch to be inspected; S2. Material storage data tracking: record the storage time and inventory environment data of the medical materials corresponding to the batch to be inspected during the inventory cycle, and collect the verification data during this period; S3. Production quality index analysis: Use the initial quality inspection data list and inventory environment data to analyze the production quality of medical materials and output the analysis results; S4, production quality inspection judgment: Based on the analysis results of step S3, judge whether the production quality inspection of medical materials meets the established requirements. If so, evaluate the production quality score of the medical materials and provide feedback. If not, proceed to the next step; S5. Quality inspection adjustment confirmation and feedback: Confirm the quality inspection links of medical materials and the pass rate of the quality inspection links, and provide feedback.

2. A method for analyzing and evaluating the production quality of medical materials according to claim 1, characterized in that: The production quality analysis of medical materials includes: Locate the raw material quality inspection data list, production process monitoring data list and finished product inspection data list of each medical material from the initial quality data list; Based on the pre-set quality inspection standards for raw materials, production process monitoring standards, and finished product testing standards, a reference list of raw material quality inspection data, a list of production process monitoring data, and a list of production testing data are constructed to calculate the comprehensive quality inspection compliance of each medical material; Compare the comprehensive quality inspection compliance of each medical material with the comprehensive quality inspection compliance range corresponding to each set compliance level. If the comprehensive quality inspection compliance of a medical material is within the comprehensive quality inspection compliance range corresponding to a certain compliance level, the medical material is classified into the compliance level, thereby obtaining the medical materials under each compliance level; Extracting the monitoring values ​​of the environmental parameters corresponding to each inventory area on each inventory day from the inventory environmental data of the target medical material, and setting the environmental interference factor of each inventory area on each inventory day; Extract the identification of each inspection sample corresponding to each inventory area, the number of inspections of each inspection sample, the date of each inspection of each inspection sample, and the inspection value of each inspection item from the inspection data, and then calculate the quality matching index of each inspection sample corresponding to each inspection in each inventory area; If the identification of a medical material at a certain compliance level is consistent with the identification of a corresponding verification sample in a certain inventory area, the inventory area shall be regarded as the associated area of ​​the compliance level, and the verification sample in the inventory area shall be regarded as the associated sample of the inventory area; Based on the quality conformity index of each associated sample in each associated area under each compliance level corresponding to each inspection and the environmental interference factor of each associated area on each inventory day, the production quality conformity index of each compliance level is calculated and used as the analysis result.

3. A method for analyzing and evaluating the production quality of medical materials as claimed in claim 2, characterized in that: The statistics of comprehensive compliance of quality inspection of various medical materials include: Compare the raw material quality inspection data list of each medical material with the reference raw material quality inspection data list one by one, count the number of raw material quality inspection items that match in the two lists, and divide it by the number of raw material quality inspection items recorded in the raw material quality inspection data list to obtain the raw material quality inspection compliance of each medical material; The production quality inspection compliance and finished product quality inspection compliance of each medical material are calculated in the same way as the raw material quality inspection compliance; Set the weights for raw material quality inspection, production quality inspection and finished product quality inspection, and obtain the comprehensive quality inspection compliance of each medical material through weighted summation.

4. A method for analyzing and evaluating the production quality of medical materials as claimed in claim 2, characterized in that: The setting of the environmental interference factors of each inventory area on each inventory day includes: Compare the monitoring values ​​of each environmental parameter in each inventory area on each inventory day with the reference value range of each environmental parameter of the target medical material; If the monitoring value corresponding to a certain environmental parameter is within its reference value interval, the environmental parameter is recorded as a deviation parameter, and the difference between the monitoring value corresponding to the deviation parameter and the reference value interval is calculated and recorded as the deviation value; Count the number of deviation parameters in each inventory area on each inventory day and divide it by the number of environmental parameters to get the deviation parameter ratio, denoted as k id , i represents the inventory area number, i=1,2,......n, d represents the inventory day number, d=1,2,......u; The deviation value of each deviation parameter in each inventory area corresponding to each inventory day is recorded as C idr , r represents the deviation parameter number, r = 1, 2, ... y; Set the environmental interference factor η for each inventory area on each inventory day id , f0 and f1 are the deviation ratio and the corresponding coefficient of the deviation value, respectively. r ′ is the reference deviation value corresponding to the set rth deviation parameter, and e is a natural constant.

5. A method for analyzing and evaluating the production quality of medical materials as claimed in claim 4, characterized in that: The statistical quality matching index of each inspection sample in each inventory area corresponding to each inspection includes: The verification value of each verification item in each verification sample in each inventory area is recorded as Z ijtg , j represents the verification sample number, j=1,2,......w, t represents the verification sequence number, t=1,2,......v, g represents the verification item number, g=1,2,......h; Calculate the quality match index λ of each inspection sample in each inventory area corresponding to each inspection ijt , h represents the number of verification items, Z′ g and ΔZ′ g They are the reference value and allowable deviation value of the g-th verification item respectively.

6. A method for analyzing and evaluating the production quality of medical materials as claimed in claim 2, characterized in that: The statistical production quality conformity index of each standard level includes: Two consecutive inspections are regarded as one inspection cycle, and each inspection is divided into inspection cycles; If a certain associated area corresponds to a certain inventory day and a certain associated sample in the associated area corresponds to a certain verification period, the environmental interference factor of the associated area corresponding to the inventory day is used as the associated environmental interference factor of the associated sample in the associated area corresponding to the verification period; The quality matching index and the associated environmental interference factor of each associated sample in each associated area under each compliance level corresponding to each verification period are calculated respectively, and the average quality matching index and the average associated environmental interference factor of the associated samples in each associated area under each compliance level are obtained, which are respectively denoted as λ b ' q and η b ' q , b represents the compliance level number, b=1,2,......B, q represents the associated area number, q=1,2,......Q; Calculate the production quality conformity index β of each standard level b , Q is the number of associated regions.

7. A method for analyzing and evaluating the production quality of medical materials as claimed in claim 2, characterized in that: The determination of whether the quality inspection of medical material production meets the established requirements includes: The production match index of each compliance level is compared with the set reference production match index. If both are greater than or equal to the set reference production match index, "achieved" is taken as the judgment result; otherwise, "not achieved" is taken as the judgment result.

8. A method for analyzing and evaluating the production quality of medical materials as claimed in claim 2, characterized in that: The production quality score for evaluating medical materials includes: The qualified grades that are less than the set reference production matching index are selected from the production quality matching index and recorded as deviation grades. The number of deviation grades is counted and recorded as M0; The compliance levels are sorted from low to high, and the compliance level with the middle ranking position is located, which is recorded as the split level. From the sorting, the number of deviation levels with the ranking position after the split level is counted, which is recorded as M1; Calculate the production quality score G of medical materials, M′ is the number of qualified grades, and G′ is the set rated production quality score.

9. A method for analyzing and evaluating the production quality of medical materials as claimed in claim 3, characterized in that: The adjustment and quality inspection process for confirming medical materials includes: The level of production quality conformity index less than the set reference production quality conformity index is recorded as the analysis level; Extract the raw material quality inspection compliance, production quality inspection compliance and finished product quality inspection compliance of each medical material in each analytical grade; The number of medical materials whose raw material quality inspection compliance, production quality inspection compliance and finished product quality inspection compliance are less than the corresponding set reference values ​​are counted separately and recorded as the number of Class I medical materials, the number of Class II medical materials and the number of Class III medical materials respectively; The number of medical materials in each analysis level is summed up, and the sum result is taken as the total number of analyzed medical materials. The number of Class I medical materials, the number of Class II medical materials, and the number of Class III medical materials are divided by the total number of analyzed medical materials to obtain the Class I deviation ratio, the Class II deviation ratio, and the Class III deviation ratio; Determine whether the Class I deviation ratio, Class II deviation ratio, and Class III deviation ratio are greater than the set reference deviation ratio; If the Class I deviation ratio is greater than the set reference deviation ratio, the raw material quality inspection link will be used as the adjustment quality inspection link. If the Class II deviation ratio is greater than the set reference deviation ratio, the production quality inspection link will be used as the adjustment quality inspection link. If the Class III deviation ratio is greater than the set reference deviation ratio, the finished product quality inspection link will be used as the adjustment quality inspection link.

10. A method for analyzing and evaluating the production quality of medical materials according to claim 9, characterized in that: The adjustment quality inspection pass rate of the confirmation adjustment quality inspection link includes: Collect statistics on the average raw material quality inspection compliance, average production quality inspection compliance and average finished product quality inspection compliance of medical materials; If the quality inspection link is the raw material quality inspection link, the average raw material quality inspection compliance is taken as the first evaluation variable, recorded as x; if the quality inspection link is the production quality inspection link, the average production quality inspection compliance is taken as the first evaluation variable, recorded as x′; if the quality inspection link is the finished product quality inspection link, the average finished product quality inspection compliance is taken as the first evaluation variable, recorded as x″, so as to obtain the first evaluation variable x1 of the quality inspection link, and the value of x1 is x or x′ or x″; The type I deviation ratio, type II deviation ratio and type III deviation ratio are respectively used as the second evaluation variables corresponding to the raw material quality inspection link, the production quality inspection link and the finished product quality inspection link, and are respectively recorded as m, m′ and m″; the second evaluation variable of the adjusted quality inspection link is recorded as m1, and the value of m1 is m or m′ or m″; The preset initial quality inspection pass rate of the adjustment quality inspection link is recorded as p0, and the adjustment quality inspection pass rate p′ of the adjustment quality inspection link is calculated. p1 is the preset quality inspection pass rate threshold, x1′ and m1′ are the set reference deviation ratio and reference quality inspection compliance degree respectively.

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