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How to establish a good laboratory management system: 1. Consistency within the laboratory system. Whenever a new requirement needs to be introduced into the system, it is best to clearly communicate the reasons behind it, as well as the potential benefits, with the relevant departments. Only when everyone feels as if they are on the same team will they truly accept it and go back to their own departments to advocate for carrying out this action. 2. Flexibility of the laboratory system: This requirement is directed at those who work in laboratory systems. Many of these professionals approach things in a too rigid manner; when they encounter a new requirement, they think, “This is simple; I’ll create a new document or form for them to fill out.” ” If the system really does that, it would be extremely unpopular. The biggest prerequisite for this flexibility is that those working within the system must be well-versed in the standards, and be willing to add requirements to the existing documents, striving to do so without creating too much additional workload. Let them incorporate this new requirement while using the original method; in that way, acceptance among everyone will be much higher. And it’s clear that your motivation is to truly care for them. 3. Electronicization of laboratory systems: In today’s information-driven era, the widespread use of electronic systems is a trend, and it also serves as a benchmark for improving the level of control in laboratories. Of course, this takes into account the laboratory’s funding and scale. 4. Standardization of the laboratory system: After problems are resolved, corrective and preventive measures should be documented as much as possible, so that they can serve as a written constraint and prevent situations where a new manager ignores the commitments made by the previous one. 5. The service-oriented nature of laboratory systems: Regardless of the goals for establishing a system, any laboratory system is designed to serve people and products. Therefore, it is necessary for such a system to have strong capabilities to serve others. Those of us who work on developing systems must not only consider whether these requirements are reasonable, but also assess whether they pose difficulties in terms of implementation and understanding, and whether there could be a more suitable way to meet them. At this point, the Systems Department needs to act as a customer service role, understanding everyone’s needs in order to improve the effectiveness and efficiency of the system. The daily work of those in this system is a continuous process of “finding gaps and filling them.” Both the searching and the replenishing actions are essential. One should have the openness to accept others’ opinions, encourage free discussion, and draw on the strengths of others. There is no perfect system, but we can make things better today than they were yesterday. The extent to which the system improves is the true KPI for those responsible for it. At least one day, when other departments in the laboratory no longer see the system department as unnecessary, then you will have taken the first step toward success. An excellent person in a laboratory system does not sit in an office every day issuing new standards and document requirements throughout the company; instead, they go beyond mere paperwork, delve deeply into each process, work together with the team to make improvements, and are willing to act as a \"jack of all trades\" for the company, addressing issues that arise at the intersection of different departments. Therefore, a good professional in this field, in terms of their personal qualities, is capable of handling many different tasks in the future. They have an overall perspective and are meticulous; they are good at communicating and highly intelligent; they enjoy reading and have strong skills in working with texts. So, professionals in this field shouldn’t underestimate their own abilities – since they already possess these fundamental skills. As long as they keep learning and working hard, they will surely become outstanding individuals. What aspects should a laboratory quality control lab monitor for quality control? Quality control of analytical methods, quality control of laboratory personnel, quality control of laboratory environment and conditions, quality control of laboratory instruments and equipment, quality control of reference materials, quality control of reagents, quality control of the experimental process, quality control of test reports, and inter-laboratory quality control. Let’s take a look at the quality control related to the laboratory environment, equipment, and sample handling processes in this issue. 1) Quality control of the environment: 1. The environmental conditions of the testing site should meet the requirements of testing activities. Measures should be taken to ensure that the laboratory is well-maintained, and specialized procedures should be established if necessary. Control the areas that affect the quality of analysis testing, and restrict access to or use of such areas. And determine the degree of control based on its specific circumstances. Effectively isolate adjacent areas of incompatible activities to prevent the introduction of pollution sources. 2. Areas for chemical analysis, sample preparation, and pretreatment should have good lighting, effective ventilation, and appropriate indoor temperatures. Appropriate measures should be taken to prevent cross-contamination caused by splashes or volatiles. The storage areas for samples, standards, and reagents should meet the required storage conditions; when stored in refrigerated or frozen areas, the temperature should be monitored regularly and records kept. When sampling or testing is required in locations outside the laboratory, special attention must be paid to the operating environmental conditions. The standards, methods, and procedures for making on-site records also have requirements regarding environmental conditions. Or, when environmental conditions affect the quality of the test results, those conditions should be monitored, controlled, and recorded. 3. Trace analysis and routine analysis must be conducted in separate rooms, using completely independent laboratory facilities. Avoid contamination of trace analysis by constant analysis, which can lead to false positives, false negatives, or reduced detection sensitivity. When controlling pests inside or near the laboratory, it is necessary to use agents that are considered not to affect testing. II) Quality control of equipment and instruments 1. All equipment, including auxiliary measuring equipment and instruments, that has a significant impact on the accuracy or effectiveness of testing, must be calibrated before being put into use. 2. During the periods between two calibrations of the instruments and equipment, procedures for periodic verification of such instruments should be established if necessary. In daily use, their technical specifications must be verified in accordance with these periodic verification procedures, with records kept to ensure that the instruments remain in good condition. The laboratory should consider the characteristics of the instruments and equipment. Based on the frequency of use, determine the periodic inspection cycle for instruments and equipment. 3. Containers used repeatedly must be thoroughly cleaned. If conditions permit, glass containers used for extracting standards and samples should be used separately to avoid cross-contamination ； Avoid using glass containers that have been excessively scratched or etched ； All glassware, reagents, solvents, and water should be tested through a blank experiment before use ； Check for contaminants. III) Quality control of samples 1. The packaging of laboratory samples should be sturdy, secure, and clean. Appropriate transportation methods and conditions should be used to transport laboratory samples. The condition of the laboratory samples should be as close as possible to that acceptable to consumers; otherwise, they should be considered unsuitable for testing. The person receiving the samples should carefully inspect their packaging and condition; if any abnormalities are found, a decision on how to handle them should be reached with the client who commissioned the testing. When receiving laboratory samples, full consideration must be given to the technical requirements of the testing methods for those samples. If necessary, work instructions should be prepared. Provisions are made regarding the quantity, weight, and shape of the samples, as well as the suitability and limitations of the testing methods for those samples. 2. The quantity of samples to be sent should depend on the specific requirements of the testing, and it should be no less than 3 times the amount required for testing. In case of special circumstances where the sample quantity is insufficient, this should be specified in the commission contract. 3. The laboratory samples received should be numbered and registered, and assigned unique identifiers. The design and use of these identifiers must ensure that there is no confusion regarding the samples or the associated records. Laboratory samples must have clear and durable markings to prevent confusion during different testing stages and transfer processes; attention should also be paid to any potential contamination of the samples caused by packaging materials and markings. The sample identification system should include details of the sample groups, as well as control methods for the transfer of samples within the laboratory and to external parties. 4. The received laboratory samples should be pre-treated and mixed together; thereafter, appropriate methods should be used for sampling to obtain the analysis samples. The amount of sample analyzed should generally meet the requirements for testing, retesting or confirmation, and sample retention. Samples for which an evaluation of measurement uncertainty is required. The number of samples analyzed should be increased. The preparation of the analysis samples should be carried out in a separate area. Use clean sample preparation tools and containers to prevent leakage from the containers and the introduction of contaminants into the samples to be analyzed; medicines should be stored in clean plastic bags or inert containers and sealed. Attach sample labels. Store it in a specified temperature environment. 5. During the analysis of sample preparation. The inclusion of foreign impurities should be avoided. To prevent changes in the original properties of the entire batch of goods represented by the sample due to factors such as volatilization or contamination, the preparation of the analysis sample must ensure representativeness; it should be processed in a way that maximizes the likelihood of detecting the analytes, while also preventing contamination or loss of those analytes during sample preparation. 6. Isolate the analytical portion from the prepared analytical sample. and sent to the laboratory for testing. The analysis section during the testing process should be placed properly. When not in use, the analysis section should be kept sealed and placed in a specified temperature environment; care should be taken to protect the analysis section for those parameters whose detection is unstable. 7. Samples should be kept separate from each other during transportation and storage within the laboratory. It should be isolated from other potential sources of contamination during sampling, sample transfer, storage, and analysis. Prevent external contaminants from contaminating the sample; if the analyte occurs naturally, low levels of residues can be difficult to distinguish from its natural concentration. When reporting the results, it is necessary to take into account the natural concentration of this analyte. IV) Quality control during the testing process: 1. Ensure that the original properties of the samples are preserved throughout reception, preparation, and testing, without any contamination or deterioration. 2. The following preparatory tasks should be completed before testing: ① Verify the sample labels, testing items, and corresponding testing methods ； ②Prepare the instruments and equipment as required by the testing method. Use drugs that meet the analysis requirements. Prepare the reagents according to the detection method. Standard solutions, etc ； ③Check that the testing site is clean. Environmental conditions such as temperature that may affect test quality ； ④Use standard original record forms. 3. The testing process must be carried out in accordance with the testing methods and work instructions. Any abnormalities that occur during the testing process should be recorded in detail. And take timely measures to address it. 4. When necessary, conduct blank tests, standard substance tests, and recovery rate tests for control samples along with the sample tests. 5. For the testing of routine samples, at least two experiments should be conducted. For the determination of active ingredients in samples, routine analysis, newly added testing items, as well as the testing of repeat or difficult items, double or multiple tests should be conducted; for those samples and items for which a single test is sufficient, an evaluation must be carried out first before proceeding. 6. The testers shall accurately record the testing conditions and results on the original record form, with clear handwriting and proper corrections, to ensure the authenticity, accuracy, and completeness of the records. 7. The testers must have a thorough understanding of the calculation formulas used in the testing methods, to ensure that there are no errors in the calculation and conversion of test data. The calculation results should be checked and verified. If the test results are calibrated using recovery rates, this fact should be clearly stated along with the calibration formula in the final results. 8. The number of significant figures in the test results is in accordance with the specifications specified in the testing method; one additional digit is retained for the calculated data, and rounding is carried out in accordance with GB8170. Method development 1, Preliminary research and approval 1.1 Project research This is a very important step for obtaining information. The items that need to be investigated include: 1) The name of the project ； 2) Domestic and international developments or activities in this area, as well as the requirements imposed by the situation (such as volume limits, method standards, corporate conditions, etc.) ； 3) What is the situation of this product or project in the local market? In other words, is there demand for it, and what are the economic benefits? ； 4) Whether the own laboratory meets the corresponding requirements (instrumentation and equipment, experimental conditions, staffing, etc.) ； 5) The situation of other laboratories or laboratories within the system carrying out this project. This step can be fully accomplished through searches on domestic and international websites, consultations with relevant system departments, corporate surveys, as well as social surveys; once the information is gathered, a research report is prepared. 1.2 Approval Once the aforementioned research work is completed and its feasibility has been demonstrated, a report can be prepared for submission to the responsible supervisor for approval. The supervisor can provide guidance as well as allocate the necessary resources (human resources, instruments, equipment, etc.). If approval cannot be granted due to various reasons, it is still necessary to keep the relevant documents on hand for preparing when the conditions are met in the future! 1.3 Controlled testing standards Once the project under investigation is approved, the first step is to prepare the relevant standards and literature in accordance with the requirements of the investigation (including those from abroad or provided by companies). If it is already available in the unit, it can be borrowed for direct use; if not, it needs to be purchased, and corresponding management actions must be taken in accordance with the requirements of the procedural documents (applying controlled labeling). If there are no standards in this regard, it can also be divided into two cases: if similar standards exist, deviation verification can be carried out ； In the absence of any relevant standards, it is necessary to initiate a project to develop internal laboratory methods or relevant standards through research (this situation is complex and will not be discussed for now). 2. Method validation 2.1 Method validation: After the research and approval processes are completed, if there are relevant standards, these standards shall be followed, taking into account the conditions of the own laboratory. The necessary reagents, instruments, and equipment should be prepared, and staff should be assigned to carry out the method validation or development. 2.1.1 Preparation of reagents, consumables, and instruments and equipment: In accordance with the standards, the required consumables, reagents, and standard samples shall be prepared separately (ensuring that purchased items are properly recorded, are within their valid period, and are regularly checked), and appropriate instruments shall be selected (ensuring that the instruments are in good working condition). 2.1.2 Preparation of standard solutions: In accordance with the standards, corresponding standard stock solutions and standard working solutions are prepared, and records of solution preparation must be kept (when preparing them, attention should be paid to the choice of medium, which should preferably be the same as the extraction solvent or the solvent used for volume adjustment). 2.1.3 Preliminary tests The preliminary tests mainly involve exploring the instrument conditions as well as the methods and conditions for extraction and purification. 1) The confirmation of instrument conditions should be carried out by repeating experiments under the experimental and instrument conditions specified in the standards. First, a standard sample of appropriate concentration is introduced into the instrument whose parameters have been set. The conditions under which the substance peaks are determined, and various parameters are optimized (scanning mode, injection volume, flow rate, injection method, temperature conditions, mobile phase and its proportions, selection of instrument type). This is a complex and repetitive process, yet it is a crucial step that must be carried out properly; sometimes, what works well with standards (or available data) may not work well on a particular instrument. 2) Once the instrument conditions are confirmed, it’s time to determine the methods and conditions for sample extraction and purification (it is ideal to use standard reference samples for experiments if possible; otherwise, an internal standard or substitute should be used). In this process, two tasks need to be carried out: one is the extraction or processing of the substance to be tested, and the other is the purification method and conditions for the standard samples containing the matrix or the positive samples. The extraction and processing of samples should be simplified as much as possible, while remaining efficient and free from contamination, in order to minimize losses during extraction or processing. Spectral and chromatographic samples are treated separately; spectral samples are mainly subjected to digestion or acid extraction, while chromatographic samples require extraction, which is relatively more complex than the former. There are also many methods of extraction (liquid separation, ultrasound, homogenization, rapid solvent extraction, Soxhlet extraction), but the general principle is to save time, effort, and reagents, while achieving innovative, efficient results! As for the specific method to be used, this needs to be verified through experiments. It is important to note that before deciding on the extraction method, it is best to consider the relevant properties of the substance to be extracted (including polarity, solubility and boiling point, molecular weight), as after extraction there are processes such as dissolution, concentration (rotary evaporation, nitrogen evaporation, or column chromatography), purification, and the selection of a detector, all of which can affect the detected substance.