Laboratory detection quality control risk assessment method

Abstract

The invention relates to the technical field of laboratory risk assessment, and discloses a laboratory detection quality control risk assessment method, which comprises the following steps: acquiring a risk identification range of laboratory chemical detection quality control, and identifying main risk factors of laboratory chemical detection quality control by adopting a preset risk identification method; constructing a target risk assessment model based on an AHP-entropy weight method, and outputting a laboratory chemical detection quality control risk level by adopting the target risk assessment model according to the main risk factors; and constructing an auxiliary risk assessment model based on a TOPSIS method to perform accurate determination and reliability verification on the target risk assessment model. According to the laboratory detection quality control risk assessment method provided by the invention, the laboratory can be helped to identify potential risks, assess risk levels and take corresponding control measures, so that the detection quality is improved, and the possibility of occurrence of quality accidents is reduced.

Description

Technical Field

[0001] This invention relates to the field of laboratory risk assessment technology, and in particular to a method for risk assessment of laboratory testing quality control. Background Technology

[0002] As a crucial technical support institution for the national inspection and quarantine of import and export commodities, customs laboratories bear the important responsibilities of safeguarding national border security, ensuring the quality of import and export goods, and protecting consumer rights. With the rapid development of global trade and the increasing complexity of the international trade environment, customs laboratories face increasingly heavy testing tasks and a constantly expanding range of testing items, placing higher demands on the accuracy, reliability, and timeliness of test results. Particularly in the field of chemical testing, due to the wide variety of chemical substances involved, complex testing procedures, and high-risk operational processes, customs laboratories face numerous quality control risks.

[0003] Quality control is a core aspect of laboratory management, directly impacting the quality of test results and the laboratory's credibility. In recent years, with the implementation of international standards, the quality management level of customs laboratories has significantly improved. However, due to various uncertainties in the chemical testing process, such as fluctuations in instrument and equipment performance, unstable reagent quality, human error, and changes in environmental conditions, deviations in test results may still occur, potentially even leading to serious quality incidents.

[0004] Therefore, given the increasingly complex domestic and international trade environment, there is an urgent need for a method to conduct risk assessments on the quality control of customs laboratory testing, in order to improve the risk management level of customs laboratories, ensure the accuracy and reliability of test results, and enhance the international competitiveness of customs laboratories. Summary of the Invention

[0005] This invention provides a laboratory testing quality control risk assessment method, which can help laboratories identify potential risks, assess risk levels, and take corresponding control measures, thereby improving testing quality and reducing the possibility of quality accidents.

[0006] This invention provides a method for risk assessment of laboratory testing quality control, comprising:

[0007] S1. Obtain the risk identification scope for laboratory chemical testing quality control, and use the preset risk identification method to identify the main risk factors for laboratory chemical testing quality control;

[0008] S2. Construct a target risk assessment model based on the AHP-entropy weight method, and output the risk level of laboratory chemical testing quality control according to the main risk factors using the target risk assessment model;

[0009] S3. Construct an auxiliary risk assessment model based on the TOPSIS method to verify the accuracy and reliability of the target risk assessment model.

[0010] Furthermore, S1 specifically includes:

[0011] S101. The object of risk identification is laboratory chemical testing quality control, including personnel, instruments and equipment, reagents and materials, methods and standards, environmental conditions and quality management;

[0012] S102. Collect information related to laboratory chemical testing quality control through literature research and expert interviews, including regulatory and standard documents, chemical property data, laboratory operation and management information, historical data and cases, environmental condition data, and personnel information;

[0013] S103. Use brainstorming, checklists, and flowcharts to identify risk factors in laboratory chemical testing quality control.

[0014] S104. Organize and classify the identified risk factors to form a systematic and comprehensive list of risk factors;

[0015] S105. The risk factor list shall be verified and improved through expert review and laboratory verification to ensure the accuracy and comprehensiveness of the risk factors.

[0016] Furthermore, S103 specifically includes:

[0017] (1) Collect physicochemical properties, toxicity data and ecotoxicity data of chemicals from literature research, obtain professional opinions through expert interviews, conduct on-site investigations to understand the use conditions and protective measures of chemicals, and collect historical data of the laboratory, including test results, equipment operation data and environmental monitoring data.

[0018] (2) Use brainstorming to organize laboratory technicians and quality management personnel to discuss risk points; use checklists to check against a list of known risk factors; use flowcharts to draw up the laboratory testing process and identify potential risk links in the process.

[0019] (3) Based on the risk points, risk factor list and potential risk links, the collected information is transformed into specific risk factors;

[0020] (4) Compile the risk factors into a preliminary list, including risk description, possible impact, and probability of occurrence.

[0021] Furthermore, S104 specifically includes:

[0022] The risk factors are classified according to preset categories; wherein, the preset categories include six major categories: personnel information, instrument and equipment information, reagent and material usage and management information, method and standard usage information, experimental environment conditions information, and quality management information.

[0023] Each category of risk factors is further subdivided into five subcategories within each category to form the risk factor list.

[0024] Furthermore, each category has five subcategories, specifically including:

[0025] The personnel information includes insufficient professional knowledge and skills, weak sense of responsibility, weak safety awareness, insufficient training, and frequent staff turnover; the instrument and equipment information includes improper equipment selection, aging equipment, inadequate maintenance, non-standard calibration and verification, and improper equipment use; the reagent and material usage and management information includes unstable reagent quality, inaccurate standard substances, consumable quality problems, chaotic reagent management, and improper reagent use; the method and standard usage information includes improper method selection, insufficient method validation, untimely standard updates, misunderstanding of methods, and non-standard use of non-standard methods; the experimental environment conditions information includes improper temperature and humidity control, failure to meet cleanliness requirements, electromagnetic interference, vibration effects, and insufficient safety protection; and the quality management information includes an incomplete quality system, inadequate quality supervision, non-standard records and reports, improper handling of non-conformities, and non-standard internal audits and management reviews.

[0026] Furthermore, S2 specifically includes:

[0027] S201. Construct a risk assessment index system for laboratory chemical testing quality control, including an objective layer, a criterion layer, and an indicator layer; the criterion layer includes personnel factors, instrument and equipment factors, reagent and material factors, method and standard factors, environmental condition factors, and quality management factors; the indicator layer includes 30 specific risk factors in the aforementioned subcategories.

[0028] S202. Based on the aforementioned risk assessment index system and the specific steps of the AHP-entropy weight method, construct a risk assessment model for laboratory chemical testing quality control.

[0029] S203. Based on the main risk factors, the target risk assessment model is used to output the risk level of laboratory chemical testing quality control.

[0030] Furthermore, S202 specifically includes:

[0031] (1) Based on the risk assessment index system, construct a hierarchical structure model for risk assessment of laboratory chemical testing quality control, including target layer, criterion layer and index layer;

[0032] (2) Invite experts in laboratory management, technology and quality control to conduct pairwise comparisons of factors at the same level using the 1-9 scale method to construct a judgment matrix; calculate the weight of each factor as the subjective weight W by solving for the largest eigenvalue of the judgment matrix and its corresponding eigenvector. j1 ;

[0033] (3) Collect relevant data on each risk factor and perform standardization processing to eliminate the influence of dimensions and orders of magnitude; the standardization formula is as follows:

[0034] For positive indicators: For negative indicators: Among them, Z ij Let X be the standardized value of the j-th indicator for the i-th sample. ij X is the original value of the j-th indicator for the i-th sample. jmax and X jmin These are the maximum and minimum values ​​of the j-th indicator, respectively;

[0035] (4) Calculate the information entropy and entropy weight of each indicator based on the standardized data; the calculation formula is as follows:

[0036] Information entropy: Among them, H j P is the information entropy of the j-th index; ij Let be the weight of the j-th indicator for the i-th sample. Z ij Let be the standardized value of the j-th indicator for the i-th sample; n is the number of samples.

[0037] Entropy weight: Among them, W j2 Let be the objective weight of the j-th indicator determined by the entropy weight method; m is the number of indicators.

[0038] (5) The subjective weight W j1 With the objective weight W j2 Perform linear weighting to obtain the comprehensive weight W. j The calculation formula is as follows:

[0039] W j =0.5W j1 +0.5W j2

[0040] Here, 0.5 and 0.5 represent the degree of importance attached to subjective weight and objective weight, respectively.

[0041] (6) Based on the comprehensive weight W j Using the standardized data, calculate the risk assessment value for each risk factor using the following formula:

[0042]

[0043] Among them, R i Let W be the risk assessment value for the i-th sample. j Z represents the comprehensive weight of the j-th indicator. ij Let be the standardized value of the j-th indicator for the i-th sample.

[0044] (7) Based on the risk assessment value, the laboratory chemical testing quality control risk is divided into four levels, including low risk, medium risk, high risk and very high risk.

[0045] Furthermore, in (7), the risk value evaluation range corresponding to each risk level is:

[0046] Low risk: [0, 0.2), the risk is low and the impact on the quality of testing is small, so it is managed in a routine manner;

[0047] Medium risk: [0.2, 0.4), medium risk, may have some impact on the quality of testing, and requires enhanced monitoring;

[0048] High risk: [0.4, 0.6), the risk is relatively high and may have a significant impact on the quality of testing, requiring key control;

[0049] Extremely high risk: [0.6, 1.0], the risk is extremely high and may have a serious impact on the quality of testing, requiring immediate rectification.

[0050] Furthermore, S3 specifically includes:

[0051] S301. Standardize the relevant data for each risk factor to eliminate the influence of dimensions and orders of magnitude; the standardization formula is as follows:

[0052]

[0053] Among them, Z ij Let X be the standardized value of the j-th indicator for the i-th sample. ij Let be the original value of the j-th indicator for the i-th sample, and n be the number of samples;

[0054] S302. Based on the standardized data matrix, determine the positive ideal solution and the negative ideal solution using the following formula:

[0055] Positive ideal solution: Negative ideal solution: in, For the j-th index, the positive ideal solution is... The negative ideal solution for the j-th index;

[0056] S303. Calculate the distance between each solution and the positive and negative ideal solutions; the calculation formula is as follows:

[0057] Distance from the ideal solution: Distance from the negative ideal solution: in, Let be the distance between the i-th sample and the positive ideal solution. Let m be the distance between the i-th sample and the negative ideal solution, and m be the number of indicators.

[0058] S304. Calculate the relative closeness of each scheme to the ideal solution, as a basis for evaluating the merits of the schemes. The calculation formula is as follows:

[0059]

[0060] Among them, C i C represents the relative proximity of the i-th sample to the positive ideal solution. i The higher the value, the lower the risk of the sample;

[0061] S305, Based on relative proximity C i The risk level of laboratory chemical testing quality control is divided into four levels: low risk, medium risk, high risk, and very high risk.

[0062] S306. Compare the risk assessment results of the target risk assessment model and the auxiliary risk assessment model, and verify the consistency between the two methods. If the assessment results of the two methods are basically consistent, it indicates that the risk assessment model has high reliability; otherwise, further adjust and improve the target risk assessment model and the auxiliary risk assessment model.

[0063] Furthermore, in S305, the risk value evaluation range corresponding to each risk level is as follows:

[0064] Low risk: [0.8, 1.0], low risk, minimal impact on testing quality, subject to routine management;

[0065] Medium risk: [0.6, 0.8), medium risk, may have some impact on the quality of testing, and requires enhanced monitoring;

[0066] High risk: [0.4, 0.6), the risk is relatively high and may have a significant impact on the quality of testing, requiring key control;

[0067] Extremely high risk: [0.0, 0.4), the risk is extremely high and may have a serious impact on the quality of testing, requiring immediate rectification.

[0068] The beneficial effects of this invention are as follows:

[0069] This invention employs a method combining theoretical analysis and empirical research. First, through literature review and expert interviews, the main risk factors for quality control in chemical testing at customs laboratories are identified. Then, an AHP-entropy weight method is used to construct a target risk assessment model, which outputs the risk level of laboratory chemical testing quality control based on the main risk factors. Finally, an auxiliary risk assessment model based on the TOPSIS method is constructed to verify the effectiveness and practicality of the target risk assessment model. This invention helps laboratories identify potential risks, assess risk levels, and take corresponding control measures, thereby improving testing quality and reducing the likelihood of quality incidents. Ultimately, it enhances the risk management level of customs laboratories, ensures the accuracy and reliability of test results, and improves the international competitiveness of customs laboratories. Attached Figure Description

[0070] Figure 1 This is a flowchart illustrating the laboratory testing quality control risk assessment method of the present invention.

[0071] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0072] It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0073] like Figure 1 As shown, the present invention provides a laboratory testing quality control risk assessment method, comprising:

[0074] S1. Obtain the risk identification scope for laboratory chemical testing quality control, and identify the main risk factors for laboratory chemical testing quality control using a pre-set risk identification method. This specifically includes the following steps:

[0075] S101. The object of risk identification is determined to be laboratory chemical testing quality control, including personnel, instruments and equipment, reagents and materials, methods and standards, environmental conditions, and quality management. Specifically,

[0076] Based on the operational characteristics of chemical testing in customs laboratories, and combined with relevant research and practical experience, the risk factors for quality control in chemical testing can be summarized into the following categories:

[0077] ① Personnel factors. Personnel are the core of laboratory testing work, and personnel factors are one of the key factors affecting testing quality. These mainly include:

[0078] a. Insufficient professional knowledge and skills: Testing personnel lack the necessary professional knowledge and skills, and are unable to correctly understand testing standards and methods, leading to operational errors.

[0079] b. Lack of responsibility: The testing personnel are not serious about their work, are careless, and do not strictly follow the standard operating procedures, resulting in inaccurate test results.

[0080] c. Weak safety awareness: Testing personnel lack sufficient understanding of the hazards of hazardous chemicals and have a weak awareness of safe operation, which can easily lead to safety accidents.

[0081] d. Insufficient training: The laboratory lacks a systematic personnel training program, and testing personnel are unable to master new testing technologies and methods in a timely manner.

[0082] e. Frequent staff turnover: Frequent staff turnover in the testing sector means that new employees need a long time to adapt to the work, affecting the continuity and stability of the testing work.

[0083] ② Instrument and equipment factors. Instruments and equipment are essential tools in chemical detection, and their performance and condition directly affect the accuracy and reliability of the test results. These mainly include:

[0084] a. Inappropriate equipment selection: The laboratory did not fully consider the testing needs when purchasing equipment, resulting in a mismatch between equipment performance and testing requirements.

[0085] b. Equipment aging: Equipment that has been used for too long will experience a decline in performance and accuracy, affecting the accuracy of test results.

[0086] c. Inadequate maintenance: Untimely or improper maintenance of equipment leads to a high failure rate and a shortened service life.

[0087] d. Non-standard calibration and verification: The equipment was not calibrated and verified regularly as required, or the calibration and verification methods were incorrect, resulting in inaccurate measurement results.

[0088] e. Improper use of equipment: If the testing personnel do not use the equipment according to the operating procedures, or overload the equipment, it may cause damage to the equipment or deviation in the measurement results.

[0089] ③ Reagent and Material Factors. Reagents and materials are the foundation of chemical testing, and their quality directly affects the accuracy and reliability of the test results. These mainly include:

[0090] a. Unstable reagent quality: Insufficient reagent purity, large batch-to-batch differences, or improper storage conditions leading to reagent deterioration, affecting test results.

[0091] b. Inaccurate reference materials: Insufficient traceability of reference materials, inaccurate value determination, or improper storage can lead to deviations in test results.

[0092] c. Consumable quality issues: The quality of experimental consumables (such as pipette tips, centrifuge tubes, filter membranes, etc.) does not meet the requirements, which may introduce contamination or affect the experimental results.

[0093] d. Disorganized reagent management: Inadequate management of reagent procurement, acceptance, storage, use and disposal may lead to reagent misuse or waste.

[0094] e. Improper use of reagents: The testing personnel did not prepare and use the reagents as required, or used expired reagents, which affected the accuracy of the test results.

[0095] ④ Method and Standard Factors. Testing methods and standards are the basis for chemical testing, and their scientific validity and applicability directly affect the accuracy and reliability of the test results. These mainly include:

[0096] a. Inappropriate method selection: The laboratory failed to select an appropriate testing method based on the test object and testing purpose, resulting in inaccurate test results or failure to meet requirements.

[0097] b. Insufficient method validation: New or modified methods have not been adequately validated before use, which fails to ensure the applicability and reliability of the methods.

[0098] c. Untimely updates to standards: The laboratory failed to keep up with and adopt the latest national or international standards in a timely manner, resulting in test results that do not meet the latest requirements.

[0099] d. Method misunderstanding: The testing personnel have a misunderstanding of the testing methods and standards, which leads to non-compliance with the requirements and affects the test results.

[0100] e. Improper use of non-standard methods: When laboratories use non-standard methods without sufficient validation and approval, it may lead to unreliable test results.

[0101] ⑤ Environmental factors. Environmental conditions are external factors in chemical detection, and their stability and suitability directly affect the accuracy and reliability of the test results. These mainly include:

[0102] a. Improper temperature and humidity control: Inaccurate or unstable temperature and humidity control in the laboratory may affect the rate of chemical reactions and the performance of instruments and equipment.

[0103] b. Cleanliness does not meet requirements: If the cleanliness of the laboratory does not meet the standards, it may lead to sample contamination and affect the test results.

[0104] c. Electromagnetic interference: Strong electromagnetic fields exist around the laboratory, which may interfere with the normal operation of instruments and equipment and affect measurement results.

[0105] d. Vibration effects: The presence of vibration sources near the laboratory may affect the stability and measurement accuracy of precision instruments.

[0106] e. Inadequate safety protection: Inadequate laboratory safety protection facilities may lead to the leakage of toxic and harmful gases or accidental leakage of hazardous chemicals, threatening personnel safety and environmental safety.

[0107] ⑥ Quality Management Factors. Quality management is the guarantee of laboratory testing work, and its effectiveness directly affects the accuracy and reliability of test results. This mainly includes:

[0108] a. Inadequate quality system: The laboratory's quality management system is incomplete, lacking effective quality control and quality assurance measures.

[0109] b. Inadequate quality supervision: The laboratory's quality supervision mechanism is imperfect, making it impossible to promptly detect and correct quality problems during the testing process.

[0110] c. Incomplete or inaccurate testing records and non-standard testing reports may result in untraceable test results or failure to meet customer requirements.

[0111] d. Improper handling of non-conformities: If the laboratory does not handle non-conformities discovered during the testing process in a timely or thorough manner, similar problems may occur repeatedly.

[0112] e. Inadequate internal audits and management reviews: Internal audits and management reviews in the laboratory are merely formalities, failing to effectively identify and resolve problems in the quality management system.

[0113] S102. Collect information related to laboratory chemical testing quality control through literature research and expert interviews, including regulatory and standard documents, chemical property data, laboratory operation and management information, historical data and cases, environmental condition data, and personnel information.

[0114] Literature review: By consulting relevant literature, standards, regulations, and case studies, potential risk factors were identified. A systematic review of literature related to quality control in chemical testing at customs laboratories identified 30 risk factors across six major categories.

[0115] Expert interviews: Interviews with laboratory managers, key technical personnel, and quality managers help identify risk factors present in actual laboratory operations. Expert interviews can supplement literature reviews and provide the latest, practical risk information.

[0116] Information related to quality control in laboratory chemical testing includes:

[0117] ①Regulations and Standards: National regulations such as the "Regulations on the Safety Management of Hazardous Chemicals" and the "Regulations on the Management of Precursor Chemicals"; standards such as the "Occupational Exposure Limits for Hazardous Factors in the Workplace" and the "Specifications for Classification and Labelling of Chemicals"; CMA and CNAS certification standards and special specifications such as HG / T20571 and GB50346; "SN / T4754-2017 Technical Requirements for Proficiency Testing of Chemicals in Import and Export Laboratories".

[0118] ② Chemical property data: information on the physicochemical properties, toxicity data, ecotoxicity, etc. of chemicals; toxicity, corrosiveness, and other properties of hazardous chemicals.

[0119] ③ Laboratory operation and management information: existing laboratory operating procedures and quality control procedures; performance, usage and maintenance records of instruments and equipment; characteristics, expiration dates and storage conditions of reagents and materials.

[0120] ④ Historical data and cases: accident cases that have occurred in the laboratory, potential accident hazards; previous testing data, quality control results and problem records; comparison results with external testing and inspection agencies.

[0121] ⑤ Environmental condition data: environmental parameters such as temperature, humidity, and ventilation conditions in the laboratory; environmental monitoring data, such as the chemical content in media such as air, water, and soil.

[0122] ⑥ Personnel Information: Qualifications, experience, and training of laboratory personnel; operating habits and level of safety awareness.

[0123] S103. Use brainstorming, checklists, and flowcharts to identify risk factors in laboratory chemical testing quality control; specifically including the following steps:

[0124] (1) Collect physicochemical properties, toxicity data, and ecotoxicity data of chemicals from literature research, and obtain professional opinions through expert interviews, such as consulting experts in chemistry, toxicology, and environmental science. Conduct on-site investigations in laboratories to understand the usage conditions and protective measures of chemicals. Collect historical laboratory data, including test results, equipment operation data, and environmental monitoring data.

[0125] (2) Use brainstorming to organize laboratory technicians and quality management personnel to discuss risk points; use checklists to check against a list of known risk factors; use flowcharts to draw up laboratory testing processes and identify potential risk links in the process.

[0126] ① Brainstorming: Organize relevant laboratory personnel for brainstorming sessions, encouraging everyone to freely express their opinions and jointly identify potential risk factors. Brainstorming can fully leverage team wisdom and improve the comprehensiveness and accuracy of risk identification.

[0127] ② Checklist Method: Based on the characteristics of the laboratory and past experience, design a risk identification checklist to check each potential risk factor. The checklist method is simple, practical, and suitable for routine risk identification.

[0128] ③ Flowchart method: Draw a flowchart of the testing process and analyze the potential risk factors at each stage. The flowchart method can visually represent the testing process and helps to systematically and comprehensively identify risks.

[0129] (3) Transform the collected information into specific potential risk factors: For example, from the information on “hazardous chemicals”, identify specific risks such as “respiratory hazards caused by the volatilization of organic solvents” and “skin corrosion caused by contact with strong acids and alkalis”; from the information on “instruments and equipment”, identify risks such as “deviation of test results caused by untimely instrument calibration” and “mechanical injury caused by improper equipment operation”; from the information on “environmental conditions”, identify risks such as “accumulation of harmful gases caused by ventilation system failure” and “affect of test results by temperature and humidity fluctuations”.

[0130] (4) Compile the identified risk factors into a preliminary list, including risk description, possible impact, probability of occurrence, etc. For example, for the risk of "volatile organic solvents", record it as "not wearing a protective mask when using organic solvents may lead to respiratory irritation or poisoning".

[0131] S104. Organize and classify the identified risk factors to form a systematic and comprehensive list of risk factors;

[0132] The risk factors are classified according to preset categories; wherein, the preset categories include six major categories: personnel information, instrument and equipment information, reagent and material usage and management information, method and standard usage information, experimental environment conditions information, and quality management information.

[0133] Each category of risk factors is further subdivided into five subcategories within each category, forming the risk factor list. The five subcategories of each category specifically include:

[0134] The personnel information includes insufficient professional knowledge and skills, weak sense of responsibility, weak safety awareness, insufficient training, and frequent staff turnover; the instrument and equipment information includes improper equipment selection, aging equipment, inadequate maintenance, non-standard calibration and verification, and improper equipment use; the reagent and material usage and management information includes unstable reagent quality, inaccurate standard substances, consumable quality problems, chaotic reagent management, and improper reagent use; the method and standard usage information includes improper method selection, insufficient method validation, untimely standard updates, misunderstanding of methods, and non-standard use of non-standard methods; the experimental environment conditions information includes improper temperature and humidity control, failure to meet cleanliness requirements, electromagnetic interference, vibration effects, and insufficient safety protection; and the quality management information includes an incomplete quality system, inadequate quality supervision, non-standard records and reports, improper handling of non-conformities, and non-standard internal audits and management reviews.

[0135] S105. The risk factor list shall be verified and improved through expert review and laboratory verification to ensure the accuracy and comprehensiveness of the risk factors.

[0136] The verification and improvement of the risk factor list should be carried out according to the following specific procedures:

[0137] Step 1: Establish a validation team. A validation team should be formed, consisting of the laboratory director, quality manager, technical experts, and safety management personnel. Team members should possess professional knowledge in laboratory testing, safety management, and quality control.

[0138] Step 2: Expert Review. Organize experts to review the risk factor list, using the Delphi method for multiple rounds of review. Experts will provide revisions and supplementary suggestions, focusing on the comprehensiveness and accuracy of the risk factors.

[0139] Step 3: Laboratory Validation. Select typical risk factors for practical validation: For example, regarding the risk of "improper reagent use," verify the impact of improper reagent use on the results through actual testing. Another example is "unstable reagent quality," where parallel testing of newly purchased and existing reagents should be conducted, and the deviation should be less than the square root of the sum of the squares of their uncertainties. Verify the existence of the risk factors through experimental data.

[0140] Step 4: On-site investigation and verification. Conduct on-site verification of the risk factors in the laboratory, observing the actual operating procedures to confirm their existence.

[0141] S2. Construct a target risk assessment model based on the AHP-entropy weight method, and output the risk level of laboratory chemical testing quality control according to the main risk factors.

[0142] The AHP-entropy weight method is a combined evaluation method that integrates the analytic hierarchy process (AHP) with the entropy weight method for multi-index decision analysis. Its basic principle is as follows: first, the AHP method is used to determine subjective weights; then, the entropy weight method is used to determine objective weights; finally, a comprehensive weight is obtained through linear weighting. The advantage of the AHP-entropy weight method is that it combines subjective judgment with objective data, improving the scientific rigor and accuracy of weight determination.

[0143] The Analytic Hierarchy Process (AHP) is a multi-criteria decision analysis method that decomposes complex problems into multiple levels, constructs a judgment matrix, calculates the weights of each factor, and then performs a comprehensive evaluation. Its basic steps are as follows:

[0144] 1. Construct a hierarchical structure model: Decompose the decision problem into layers such as the objective layer, criterion layer, and alternative layer to form a hierarchical structure model.

[0145] 2. Construct the judgment matrix: Compare each factor at the same level pairwise, determine the relative importance according to the 1-9 scale method, and construct the judgment matrix.

[0146] 3. Calculate the weight vector: Calculate the weight of each factor by solving for the largest eigenvalue of the judgment matrix and its corresponding eigenvector.

[0147] 4. Consistency Check: Calculate the consistency index and random consistency ratio, and perform a consistency check. When CR < 0.1, the judgment matrix has satisfactory consistency; otherwise, the judgment matrix needs to be adjusted.

[0148] Entropy weighting is an objective weighting method that determines the weight of an indicator by calculating its information entropy. Its basic steps are as follows:

[0149] 1. Data standardization: Standardize the raw data to eliminate the influence of dimensions and orders of magnitude.

[0150] 2. Calculate information entropy: Calculate the information entropy of each indicator based on the standardized data.

[0151] 3. Calculate entropy weights: Calculate the entropy weights of each indicator based on information entropy.

[0152] The AHP-entropy weight method obtains a comprehensive weight by linearly weighting the subjective weights determined by the AHP method with the objective weights determined by the entropy weight method. The calculation formula is as follows:

[0153] W j =αW j1 +βW j2

[0154] Among them, W j W represents the overall weight of the j-th indicator. j1 For subjective weighting, W j2Let α be the objective weight, and β be the coefficients of the subjective weight and the objective weight, respectively, and α + β = 1;

[0155] In practical applications, the values ​​of α and β can be determined based on the decision-maker's emphasis on subjective judgment and objective data. Typically, α = β = 0.5 can be chosen to indicate equal importance placed on subjective judgment and objective data.

[0156] Step S2 specifically includes the following steps:

[0157] S201. Construct a risk assessment index system for laboratory chemical testing quality control, including an objective layer, a criterion layer, and an indicator layer. The criterion layer includes personnel factors, instrument and equipment factors, reagent and material factors, method and standard factors, environmental condition factors, and quality management factors. The indicator layer includes 30 specific risk factors for each subcategory. See the table below for details:

[0158]

[0159]

[0160] The indicator system adopts a three-level hierarchical structure. The target level is "risk assessment of quality control in chemical testing in customs laboratories"; the criteria level includes six aspects: personnel factors, instrument and equipment factors, reagent and material factors, method and standard factors, environmental conditions factors, and quality management factors; and the indicator level includes 30 specific risk factors.

[0161] S202. Based on the aforementioned risk assessment index system and the specific steps of the AHP-entropy weight method, construct a laboratory chemical testing quality control risk assessment model; specifically including the following steps:

[0162] (1) Based on the risk assessment index system, construct a hierarchical structure model for risk assessment of laboratory chemical testing quality control, including target layer, criterion layer and index layer;

[0163] (2) Invite experts in laboratory management, technology and quality control to conduct pairwise comparisons of factors at the same level using the 1-9 scale method to construct a judgment matrix; calculate the weight of each factor as the subjective weight W by solving for the largest eigenvalue of the judgment matrix and its corresponding eigenvector. j1 Finally, the consistency index (CI) and random consistency ratio (CR) are calculated to perform a consistency test. When CR < 0.1, the judgment matrix has satisfactory consistency; otherwise, the judgment matrix needs to be adjusted.

[0164] (3) Collect relevant data on each risk factor and perform standardization processing to eliminate the influence of dimensions and orders of magnitude; the standardization formula is as follows:

[0165] For positive indicators:

[0166]

[0167] For negative indicators:

[0168]

[0169] Among them, Z ij Let X be the standardized value of the j-th indicator for the i-th sample. ij X is the original value of the j-th indicator for the i-th sample. jmax and X jmin These are the maximum and minimum values ​​of the j-th indicator, respectively;

[0170] (4) Calculate the information entropy and entropy weight of each indicator based on the standardized data; the calculation formula is as follows:

[0171] Information entropy:

[0172]

[0173] Among them, H j P is the information entropy of the j-th index; ij Let be the weight of the j-th indicator for the i-th sample. Z ij Let be the standardized value of the j-th indicator for the i-th sample; n is the number of samples.

[0174] Entropy weight:

[0175]

[0176] Among them, W j2 Let be the objective weight of the j-th indicator determined by the entropy weight method; m is the number of indicators.

[0177] (5) The subjective weights W determined by the AHP method j1 The objective weight W determined by the entropy weight method j2 Perform linear weighting to obtain the comprehensive weight W. j The calculation formula is as follows:

[0178] W j =0.5W j1 +0.5W j2

[0179] Here, 0.5 and 0.5 represent the degree of importance attached to subjective weight and objective weight, respectively.

[0180] (6) Based on the comprehensive weight W j Using the standardized data, calculate the risk assessment value for each risk factor using the following formula:

[0181]

[0182] Among them, R i Let W be the risk assessment value for the i-th sample. j Z represents the comprehensive weight of the j-th indicator. ij Let be the standardized value of the j-th indicator for the i-th sample.

[0183] (7) Based on the risk assessment value, the risk of laboratory chemical testing quality control is divided into four levels: low risk, medium risk, high risk, and very high risk. The risk level classification criteria are shown in the table below:

[0184]

[0185] S203. Based on the main risk factors, the target risk assessment model is used to output the risk level of laboratory chemical testing quality control.

[0186] S3. Construct an auxiliary risk assessment model based on the TOPSIS method to verify the accuracy and reliability of the target risk assessment model.

[0187] TOPSIS (Technique for Order Preference by Similarity to Ideal Solution) is a multi-attribute decision analysis method that ranks alternatives by calculating their distances to the ideal and negative ideal solutions. Its basic steps are as follows:

[0188] 1. Construct the original data matrix: Collect the indicator data of each scheme and construct the original data matrix.

[0189] 2. Data standardization: Standardize the raw data to eliminate the influence of units and orders of magnitude.

[0190] 3. Determine the positive and negative ideal solutions: Based on the standardized data matrix, determine the positive ideal solution (the optimal value of each indicator) and the negative ideal solution (the worst value of each indicator).

[0191] 4. Calculate the distance: Calculate the distance between each solution and the positive ideal solution and the negative ideal solution.

[0192] 5. Calculate the relative closeness: Calculate the relative closeness of each scheme to the ideal solution, which serves as the basis for evaluating the merits of the schemes.

[0193] 6. Ranking: Sort the solutions according to their relative proximity. The greater the relative proximity, the better the solution.

[0194] In risk assessment, the TOPSIS method can be used to calculate the distance between each risk factor and the ideal risk state (lowest risk state) and the negative ideal risk state (highest risk state), thereby determining the risk level of each risk factor.

[0195] The TOPSIS method was used as an auxiliary assessment method, and a TOPSIS risk assessment model was constructed, which includes the following steps:

[0196] S301. Standardize the relevant data for each risk factor to eliminate the influence of dimensions and orders of magnitude; the standardization formula is as follows:

[0197]

[0198] Among them, Z ij Let X be the standardized value of the j-th indicator for the i-th sample. ij Let be the original value of the j-th indicator for the i-th sample, and n be the number of samples;

[0199] S302. Based on the standardized data matrix, determine the positive ideal solution (the optimal value of each indicator) and the negative ideal solution (the worst value of each indicator). The calculation formula is as follows:

[0200] Positive ideal solution:

[0201]

[0202] Negative ideal solution:

[0203]

[0204] in, For the j-th index, the positive ideal solution is... The negative ideal solution for the j-th index;

[0205] S303. Calculate the distance between each solution and the positive and negative ideal solutions; the calculation formula is as follows:

[0206] Distance from the ideal solution:

[0207]

[0208] Distance from the negative ideal solution:

[0209]

[0210] in, Let be the distance between the i-th sample and the positive ideal solution. Let m be the distance between the i-th sample and the negative ideal solution, and m be the number of indicators.

[0211] S304. Calculate the relative closeness of each scheme to the ideal solution, as a basis for evaluating the merits of the schemes. The calculation formula is as follows:

[0212]

[0213] Among them, C i C represents the relative proximity of the i-th sample to the positive ideal solution. i The higher the value, the lower the risk of the sample;

[0214] S305, Based on relative proximity C i The risk level of laboratory chemical testing quality control is divided into four levels: low risk, medium risk, high risk, and very high risk.

[0215]

[0216] S306. Compare the risk assessment results of the target risk assessment model and the auxiliary risk assessment model, and verify the consistency between the two methods. If the assessment results of the two methods are basically consistent, it indicates that the risk assessment model has high reliability; otherwise, further adjust and improve the target risk assessment model and the auxiliary risk assessment model.

[0217] In addition, experts in customs laboratory management, technology, and quality control can be invited to evaluate and verify the risk assessment results. Based on expert opinions, the risk assessment model can be adjusted and improved to enhance its accuracy and practicality. Alternatively, one or more chemical testing items in customs laboratories can be selected, and the risk assessment model can be applied to conduct actual assessments. By comparing these assessments with actual risk scenarios, the effectiveness and practicality of the model can be verified.

[0218] The above verification methods can ensure the scientific validity, accuracy, and practicality of the risk assessment model, providing effective decision support for the quality control of chemical testing in customs laboratories.

[0219] Specific examples:

[0220] This paper analyzes a case study of chemical testing services provided by a customs laboratory. This laboratory primarily undertakes chemical testing of imported and exported chemical products, food additives, cosmetics, and other commodities. Testing items include heavy metal content, limits for hazardous substances, and nutritional analysis.

[0221] I. Data Collection

[0222] Data required for the risk assessment of chemical testing quality control in this laboratory was collected using a combination of questionnaires and on-site observation. The specific steps are as follows:

[0223] 1. Questionnaire Design: Based on the risk assessment index system, a questionnaire containing 30 risk factors was designed. Each risk factor was rated using a 5-point scale (1 indicates very low risk, and 5 indicates very high risk).

[0224] 2. Selection of survey subjects: Fifteen people, including the laboratory's management personnel, technical personnel, and quality control personnel, were selected as survey subjects to ensure that the survey results are representative.

[0225] 3. Conduct a questionnaire survey: Distribute questionnaires to the respondents and collect their evaluations of the risk level of each risk factor.

[0226] 4. On-site observation: Conduct on-site observation of the chemical testing process in the laboratory, and record the actual risk factors and risk conditions.

[0227] 5. Data processing: The collected questionnaire data and on-site observation data are processed and statistically analyzed to obtain the raw data of each risk factor.

[0228] Through the above steps, the data required for the risk assessment of chemical testing quality control in the laboratory was obtained, laying the foundation for subsequent risk assessment.

[0229] II. Risk Assessment Process of AHP-Entropy Weight Method

[0230] 1. Construct the judgment matrix and calculate the weights.

[0231] Five experts in customs laboratory management, technology, and quality control were invited to conduct pairwise comparisons of factors at both the criterion and indicator levels using a 1-9 scale, constructing a judgment matrix. Taking the criterion level as an example, the constructed judgment matrix is ​​shown in the table below:

[0232] Criterion layer C1 C2 C3 C4 C5 C6 C1 1 3 2 4 3 5 C2 1 / 3 1 1 / 2 2 1 3 C3 1 / 2 2 1 3 2 4 C4 1 / 4 1 / 2 1 / 3 1 1 / 2 2 C5 1 / 3 1 1 / 2 2 1 3 C6 1 / 5 1 / 3 1 / 4 1 / 2 1 / 3 1

[0233] By solving for the largest eigenvalue of the judgment matrix and its corresponding eigenvector, the weights of each factor in the criterion layer are calculated, and a consistency check is performed. The calculation results are shown in the table below:

[0234] Criterion layer Weight Consistency test results (CR) C1 (Personnel Factors) 0.320 0.056 C2 (Instrument and Equipment Factors) 0.120 0.056 C3 (Reagent and Material Factors) 0.180 0.056 C4 (Methodological Standard Factor) 0.080 0.056 C5 (Environmental Conditions) 0.120 0.056 C6 (Quality Management Factors) 0.180 0.056

[0235] Since CR = 0.056 < 0.1, the judgment matrix has satisfactory consistency.

[0236] Similarly, weight calculations and consistency checks are performed on each factor in the indicator layer to obtain the weights of each factor in the indicator layer relative to the criterion layer, which will not be listed here.

[0237] 2. Data standardization processing

[0238] Based on the collected questionnaire data and on-site observation data, the raw data of each risk factor were standardized to eliminate the influence of dimensions and orders of magnitude. Taking the indicator layer as an example, the standardized data is shown in the table below (partial data):

[0239]

[0240] 3. Calculate information entropy and entropy weight.

[0241] Based on the standardized data, the information entropy and entropy weight of each indicator are calculated. Taking the criterion layer as an example, the calculation results are shown in the table below:

[0242] Criterion layer Information entropy Entropy weight C1 (Personnel Factors) 0.92 0.18 C2 (Instrument and Equipment Factors) 0.95 0.12 C3 (Reagent and Material Factors) 0.93 0.16 C4 (Methodological Standard Factor) 0.96 0.10 C5 (Environmental Conditions) 0.95 0.12 C6 (Quality Management Factors) 0.93 0.16

[0243] 4. Calculate the overall weight

[0244] The subjective weights determined by the AHP method and the objective weights determined by the entropy weight method are linearly weighted to obtain the comprehensive weights. Taking the criterion layer as an example, the calculation results of the comprehensive weights are shown in the table below:

[0245] Criterion layer Subjective weight (Wj1) Objective weights (Wj2) Overall weight (Wj) C1 (Personnel Factors) 0.320 0.180 0.250 C2 (Instrument and Equipment Factors) 0.120 0.120 0.120 C3 (Reagent and Material Factors) 0.180 0.160 0.170 C4 (Methodological Standard Factor) 0.080 0.100 0.090 C5 (Environmental Conditions) 0.120 0.120 0.120 C6 (Quality Management Factors) 0.180 0.160 0.170

[0246] 5. Calculate the risk assessment value

[0247] Based on the comprehensive weights and standardized data, the risk assessment value for each risk factor is calculated. Taking the criteria layer as an example, the calculation results are shown in the table below:

[0248]

[0249]

[0250] Based on the risk assessment values ​​of each criterion level, the overall risk assessment value for the laboratory's chemical testing quality control was calculated to be 0.50.

[0251] 6. Risk Level Classification

[0252] Based on the risk assessment values, the laboratory's chemical testing quality control risks were classified into corresponding risk levels. The specific results are shown in the table below:

[0253] Criterion layer Risk assessment value Risk level C1 (Personnel Factors) 0.58 High risk C2 (Instrument and Equipment Factors) 0.43 Medium risk C3 (Reagent and Material Factors) 0.51 High risk C4 (Methodological Standard Factor) 0.38 Medium risk C5 (Environmental Conditions) 0.45 Medium risk C6 (Quality Management Factors) 0.53 High risk Overall Risk 0.50 High risk

[0254] III. Risk Assessment Process of TOPSIS Method

[0255] To verify the accuracy and reliability of the risk assessment results using the AHP-entropy weight method, the TOPSIS method was used to conduct a risk assessment on the same case.

[0256] 1. Data standardization processing

[0257] The original data was standardized to eliminate the influence of units and orders of magnitude. The standardized data is shown in the table below (partial data):

[0258]

[0259] 2. Determine the positive and negative ideal solutions.

[0260] Based on the standardized data matrix, positive ideal solutions (optimal values ​​for each indicator) and negative ideal solutions (worst values ​​for each indicator) are determined. Taking the criterion layer as an example, the positive and negative ideal solutions are shown in the table below:

[0261]

[0262]

[0263] 3. Calculate the distance

[0264] Calculate the distances between each criterion layer and the positive and negative ideal solutions. The calculation results are shown in the table below:

[0265] Criterion layer Distance from the ideal solution Distance from the negative ideal solution C1 (Personnel Factors) 0.14 0.23 C2 (Instrument and Equipment Factors) 0.18 0.19 C3 (Reagent and Material Factors) 0.15 0.22 C4 (Methodological Standard Factor) 0.18 0.17 C5 (Environmental Conditions) 0.17 0.18 C6 (Quality Management Factors) 0.16 0.20

[0266] 4. Calculate the relative proximity.

[0267] Calculate the relative proximity of each criterion layer to the positive ideal solution. The calculation results are shown in the table below:

[0268] Criterion layer Relative proximity C1 (Personnel Factors) 0.62 C2 (Instrument and Equipment Factors) 0.51 C3 (Reagent and Material Factors) 0.59 C4 (Methodological Standard Factor) 0.49 C5 (Environmental Conditions) 0.51 C6 (Quality Management Factors) 0.56

[0269] Based on the relative proximity of each criterion layer, the overall relative proximity of the laboratory's chemical testing quality control was calculated to be 0.55.

[0270] 5. Risk Level Classification

[0271] Based on relative proximity, the laboratory's chemical testing quality control risks were categorized into corresponding risk levels. The specific results are shown in the table below:

[0272] Criterion layer Relative proximity Risk level C1 (Personnel Factors) 0.62 Medium risk C2 (Instrument and Equipment Factors) 0.51 Medium risk C3 (Reagent and Material Factors) 0.59 Medium risk C4 (Methodological Standard Factor) 0.49 High risk C5 (Environmental Conditions) 0.51 Medium risk C6 (Quality Management Factors) 0.56 Medium risk Overall Risk 0.55 Medium risk

[0273] IV. Analysis and Verification of Evaluation Results

[0274] By comparing the risk assessment results of the AHP-entropy weight method and the TOPSIS method, it can be found that the assessment results of the two methods are basically consistent, but there are also some differences. The specific analysis is as follows:

[0275] 1. Comparison of overall risk assessment results: The overall risk assessment value of the AHP-entropy weight method is 0.50, corresponding to a high-risk level; the overall relative proximity assessment value of the TOPSIS method is 0.55, corresponding to a medium-risk level. Although the assessment results of the two methods differ in their level classification, both indicate that the laboratory's chemical testing quality control risk is at a medium-to-high level, requiring effective risk response measures.

[0276] 2. Comparison of Risk Assessment Results at the Criterion Level: While the two methods yielded some differences in risk assessment results at each criterion level, they were largely consistent in identifying the main risk factors. For example, both methods considered personnel factors (C1), reagent and material factors (C3), and quality management factors (C6) as the main risk factors.

[0277] 3. Analysis of the reasons for the differences: The main reason for the differences in the assessment results between the two methods lies in the different methods of determining weights and the different standards for classifying risk levels. The AHP-entropy weight method places more emphasis on the combination of subjective judgment and objective data, while the TOPSIS method places more emphasis on the objective characteristics of the data.

[0278] To verify the accuracy of the risk assessment results, five experts in customs laboratory management, technology, and quality control were invited to evaluate and verify the results. The expert evaluation results indicated that the assessment results from both methods were generally consistent with the actual situation of the laboratory. However, the AHP-entropy weight method yielded more accurate and comprehensive results, better reflecting the actual risk situation of the laboratory's chemical testing quality control.

[0279] Based on the risk assessment results, corresponding countermeasures were proposed for different risk levels:

[0280] ①Low-risk response measures

[0281] a. Routine Management: Routine management and monitoring shall be carried out in accordance with the requirements of the laboratory quality management system.

[0282] b. Regular checks: Regularly check low-risk factors to ensure that the risk level remains stable.

[0283] c. Continuous improvement: Through a continuous improvement mechanism, laboratory management and testing processes are constantly optimized to further reduce risks.

[0284] ②Medium-risk response measures

[0285] a. Strengthen monitoring: Increase the frequency and intensity of monitoring medium-risk factors to promptly identify and resolve problems.

[0286] b. Develop emergency response plans: Develop emergency response plans to address potential risk events and improve emergency response capabilities.

[0287] c. Training and Education: Strengthen training and education for relevant personnel to improve their risk awareness and response capabilities.

[0288] d. Regular assessment: Regularly assess medium-risk factors and adjust response measures based on the assessment results.

[0289] ③ High-risk response measures

[0290] a. Key Controls: High-risk factors will be the focus of laboratory management, and targeted control measures will be implemented.

[0291] b. Specialized governance: Organize special governance actions to focus on resolving high-risk issues.

[0292] c. Resource allocation: Allocate more human, material, and financial resources to high-risk areas to ensure that risks are effectively controlled.

[0293] d. Assign responsibility to individuals: Clearly define the responsible parties for high-risk factors and assign risk management responsibilities to specific individuals.

[0294] ④ Extremely high risk response measures

[0295] a. Immediate rectification: For extremely high-risk factors, immediate rectification measures should be taken to eliminate potential risks.

[0296] b. Suspend related activities: If necessary, suspend related testing activities until the risk is effectively controlled.

[0297] c. High-level intervention: Senior management personnel of the laboratory directly intervene to coordinate and resolve extremely high-risk issues.

[0298] d. Effectiveness verification: Verify the effectiveness of the rectification measures to ensure that the risks are effectively reduced.

[0299] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, apparatus, article, or method that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, apparatus, article, or method. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, apparatus, article, or method that includes that element.

[0300] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A method for risk assessment of laboratory testing quality control, characterized in that, include: S1. Obtain the risk identification scope for laboratory chemical testing quality control, and use the preset risk identification method to identify the main risk factors for laboratory chemical testing quality control; S2. Construct a target risk assessment model based on the AHP-entropy weight method, and output the risk level of laboratory chemical testing quality control according to the main risk factors using the target risk assessment model; S3. Construct an auxiliary risk assessment model based on the TOPSIS method to verify the accuracy and reliability of the target risk assessment model.

2. The laboratory testing quality control risk assessment method according to claim 1, characterized in that, S1 specifically includes: S101. The object of risk identification is the laboratory chemical testing quality control, including personnel, instruments and equipment, reagents and materials, methods and standards, environmental conditions and quality management; S102. Collect information related to laboratory chemical testing quality control through literature research and expert interviews, including regulatory and standard documents, chemical property data, laboratory operation and management information, historical data and cases, environmental condition data, and personnel information; S103. Use brainstorming, checklists, and flowcharts to identify risk factors in laboratory chemical testing quality control. S104. Organize and classify the identified risk factors to form a systematic and comprehensive list of risk factors; S105. The risk factor list shall be verified and improved through expert review and laboratory verification to ensure the accuracy and comprehensiveness of the risk factors.

3. The laboratory testing quality control risk assessment method according to claim 2, characterized in that, S103 specifically includes: (1) Collect physicochemical properties, toxicity data and ecotoxicity data of chemicals from literature research, obtain professional opinions through expert interviews, conduct on-site investigations to understand the use conditions and protective measures of chemicals, and collect historical data of the laboratory, including test results, equipment operation data and environmental monitoring data. (2) Use brainstorming to organize laboratory technicians and quality management personnel to discuss risk points; use checklists to check against a list of known risk factors; use flowcharts to draw up the laboratory testing process and identify potential risk links in the process. (3) Based on the risk points, risk factor list and potential risk links, the collected information is transformed into specific risk factors; (4) Compile the risk factors into a preliminary list, including risk description, possible impact, and probability of occurrence.

4. The laboratory testing quality control risk assessment method according to claim 3, characterized in that, S104 specifically includes: The risk factors are classified according to preset categories; wherein, the preset categories include six major categories: personnel information, instrument and equipment information, reagent and material usage and management information, method and standard usage information, experimental environment conditions information, and quality management information. Each category of risk factors is further subdivided into five subcategories within each category to form the risk factor list.

5. The laboratory testing quality control risk assessment method according to claim 4, characterized in that, Each category has five subcategories, specifically including: The personnel information includes insufficient professional knowledge and skills, weak sense of responsibility, weak safety awareness, insufficient training, and frequent staff turnover; the instrument and equipment information includes improper equipment selection, aging equipment, inadequate maintenance, non-standard calibration and verification, and improper equipment use; the reagent and material usage and management information includes unstable reagent quality, inaccurate standard substances, consumable quality problems, chaotic reagent management, and improper reagent use; the method and standard usage information includes improper method selection, insufficient method validation, untimely standard updates, misunderstanding of methods, and non-standard use of non-standard methods; the experimental environment conditions information includes improper temperature and humidity control, failure to meet cleanliness requirements, electromagnetic interference, vibration effects, and insufficient safety protection; and the quality management information includes an incomplete quality system, inadequate quality supervision, non-standard records and reports, improper handling of non-conformities, and non-standard internal audits and management reviews.

6. The laboratory testing quality control risk assessment method according to claim 5, characterized in that, S2 specifically includes: S201. Construct a risk assessment index system for laboratory chemical testing quality control, including an objective layer, a criterion layer, and an indicator layer; the criterion layer includes personnel factors, instrument and equipment factors, reagent and material factors, method and standard factors, environmental condition factors, and quality management factors; the indicator layer includes 30 specific risk factors in the aforementioned subcategories. S202. Based on the aforementioned risk assessment index system and the specific steps of the AHP-entropy weight method, construct a risk assessment model for laboratory chemical testing quality control. S203. Based on the main risk factors, the target risk assessment model is used to output the risk level of laboratory chemical testing quality control.

7. The laboratory testing quality control risk assessment method according to claim 6, characterized in that, S202 specifically includes: (1) Based on the risk assessment index system, construct a hierarchical structure model for risk assessment of laboratory chemical testing quality control, including target layer, criterion layer and index layer; (2) Invite experts in laboratory management, technology and quality control to conduct pairwise comparisons of factors at the same level using the 1-9 scale method to construct a judgment matrix; calculate the weight of each factor as the subjective weight W by solving for the largest eigenvalue of the judgment matrix and its corresponding eigenvector. j1 ; (3) Collect relevant data on each risk factor and perform standardization processing to eliminate the influence of dimensions and orders of magnitude; the standardization formula is as follows: For positive indicators: For negative indicators: Among them, Z ij Let X be the standardized value of the j-th indicator for the i-th sample. ij X is the original value of the j-th indicator for the i-th sample. jmax and X jmin These are the maximum and minimum values ​​of the j-th indicator, respectively; (4) Calculate the information entropy and entropy weight of each indicator based on the standardized data; the calculation formula is as follows: Information entropy: Among them, H j Let P be the information entropy of the j-th index; ij Let be the weight of the j-th indicator for the i-th sample. Z ij Let be the standardized value of the j-th indicator for the i-th sample; n is the number of samples. Entropy weight: Among them, W j2 Let m be the objective weight of the j-th indicator determined by the entropy weight method; m is the number of indicators. (5) The subjective weight W j1 With the objective weight W j2 Perform linear weighting to obtain the comprehensive weight W. j The calculation formula is as follows: W j =0.5W j1 +0.5W j2 Here, 0.5 and 0.5 represent the degree of importance attached to subjective weight and objective weight, respectively; (6) Based on the comprehensive weight W j Using the standardized data, calculate the risk assessment value for each risk factor using the following formula: Among them, R i Let W be the risk assessment value for the i-th sample. j Z represents the comprehensive weight of the j-th indicator. ij Let be the standardized value of the j-th indicator for the i-th sample; (7) Based on the risk assessment value, the laboratory chemical testing quality control risk is divided into four levels, including low risk, medium risk, high risk and very high risk.

8. The laboratory testing quality control risk assessment method according to claim 7, characterized in that, In (7), the risk value evaluation range corresponding to each risk level is: Low risk: [0, 0.2), the risk is low and the impact on the quality of testing is small, so it is managed in a routine manner; Medium risk: [0.2, 0.4), medium risk, may have some impact on the quality of testing, and requires enhanced monitoring; High risk: [0.4, 0.6), the risk is relatively high and may have a significant impact on the quality of testing, requiring key control; Extremely high risk: [0.6, 1.0], the risk is extremely high and may have a serious impact on the quality of testing, requiring immediate rectification.

9. The laboratory testing quality control risk assessment method according to claim 1, characterized in that, S3 specifically includes: S301. Standardize the relevant data for each risk factor to eliminate the influence of dimensions and orders of magnitude; the standardization formula is as follows: Among them, Z ij Let X be the standardized value of the j-th indicator for the i-th sample. ij Let be the original value of the j-th indicator for the i-th sample, and n be the number of samples; S302. Based on the standardized data matrix, determine the positive ideal solution and the negative ideal solution using the following formula: Positive ideal solution: Negative ideal solution: in, For the j-th index, the positive ideal solution is... The negative ideal solution for the j-th index; S303. Calculate the distance between each solution and the positive and negative ideal solutions; the calculation formula is as follows: Distance from the ideal solution: Distance from the negative ideal solution: in, Let be the distance between the i-th sample and the positive ideal solution. Let m be the distance between the i-th sample and the negative ideal solution, and m be the number of indicators. S304. Calculate the relative closeness of each scheme to the ideal solution, as a basis for evaluating the merits of the schemes. The calculation formula is as follows: Among them, C i C represents the relative proximity of the i-th sample to the positive ideal solution. i The higher the value, the lower the risk of the sample; S305, Based on relative proximity C i The risk level of laboratory chemical testing quality control is divided into four levels: low risk, medium risk, high risk, and very high risk. S306. Compare the risk assessment results of the target risk assessment model and the auxiliary risk assessment model, and verify the consistency between the two methods. If the assessment results of the two methods are basically consistent, it indicates that the risk assessment model has high reliability; otherwise, further adjust and improve the target risk assessment model and the auxiliary risk assessment model.

10. The laboratory testing quality control risk assessment method according to claim 9, characterized in that, In S305, the risk value evaluation range corresponding to each risk level is as follows: Low risk: [0.8, 1.0], low risk, minimal impact on testing quality, subject to routine management; Medium risk: [0.6, 0.8), medium risk, may have some impact on the quality of testing, and requires enhanced monitoring; High risk: [0.4, 0.6), the risk is relatively high and may have a significant impact on the quality of testing, requiring key control; Extremely high risk: [0.0, 0.4), the risk is extremely high and may have a serious impact on the quality of testing, requiring immediate rectification.

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