What is the QC working standard?

1. Objective: To establish the code of conduct that quality control personnel should abide by in the laboratory, and to establish standard procedures for the analysis of raw materials, finished products and intermediates, so as to obtain reliable quality inspection data. 2. Scope of application: quality assurance and quality control 3. Responsibilities: Quality assurance inspectors and quality control chemists should strictly abide by the operating procedures, and the quality control supervisor and quality assurance supervisor are responsible for supervising the implementation of the procedures.

4. Content: 4. 1. Sampling 4. 1. 1. QA personnel prepare sampling containers according to the Inspection Delivery Note, and sample finished products, semi-finished products and raw materials as required. Fill in the sampling table after sampling. Four samples are randomly selected from each batch (the amount of each sample should be at least three times the test amount), and one sample is currently used for testing. The other three samples were used as samples and stored in the sample storage room. The label shall be filled with the name, specification, batch number, name and date of the sample. 4. 1.2.QC laboratory personnel should first check whether the items are complete, whether the inspection purpose is clear, whether the samples are in conformity with the inspection list, and whether the raw materials are sent for inspection together with the manufacturer's conformity report. After the inspection, they should sign the checklist. 4. 1.3. Sampling shall be conducted according to the sampling rules. After sampling, directly register in the sampling record book (including barrel number and appearance inspection). 4.2. Test 4.2. 1 Select the test method according to the test variety number or product name, and prepare the instruments, test solutions, standard solutions and other necessities needed for the test. If the test cycle is specified, the test will be completed within the specified time limit. 4.2.2. Operate in strict accordance with the specified test standards, and do not change the test method during the operation. If there is any problem with the test method, please inform the quality control supervisor and the manager of the quality control department so as to solve the problem. However, without the permission of the quality control supervisor or the manager of the quality control department, no changes shall be made to the test method. 4.2.3. When using precision instruments, the movements should be light, steady and skilled. After the instrument is used, fill in the use record in time. Precision instruments should be inspected and calibrated according to the corresponding standard operating procedures. Use the instrument only when it is running normally. If the instrument is abnormal, the user should report to the QC supervisor and department manager in time until the problem is solved. 4.2.4. Check our products according to various implementation standards. If the test data exceeds the error requirements specified in the method (but within the acceptable range), the QC supervisor shall be notified to find out the reasons. Decide to redo or retest according to the reason. 4.2.5. Original records should be made timely and accurately during the experiment. 4.2.6. After the test is completed, the used instruments should be cleaned up in time for the next chemist to use. All glassware should be cleaned in time after use, so as to avoid the sample being difficult to clean after drying. When handling and testing volatile substances, it should be carried out in a fume hood. Appropriate methods should be used to deal with volatile and toxic substances. 4.2.7. After the sample is tested, the chemist shall print the test report in time, and the report shall be reviewed by the QC supervisor. If the test results meet the requirements, the QC supervisor will sign the test report for approval. Chemists are responsible for errors in laboratory data and laboratory tests, and examiners are also responsible for errors in calculations. 4.2.8. Testing shall be completed in time (such as testing of intermediate products and semi-finished products to be packaged) so as not to delay production. 4.2.9. Complete sample test: including timely, complete and accurate analysis of samples and completion of test report. 4.3. The original records shall be filled in in the whole process of laboratory report sampling inspection, and the records shall be accurate, complete and timely. The specific requirements are as follows: 4.3. 1. Records shall be clear and tidy, and shall not be altered due to data or writing errors, and correction fluid shall not be used. You should draw "_ _" in the wrong place, fill in the correct data, and then sign your name and date for future reference. 4.3.2. The original records shall include the name and model (batch number) of the sample, the appearance of the sample, the amount of the sample to be weighed and sent for inspection, and the formulas for calculating the contents of intermediates and finished products; If reference substance is used, the weighing, purity, test results and phenomena, conclusions and signatures of laboratory technicians shall be indicated, and the signature of auditors shall be calculated. 4.3.3. Accuracy of various data * Effective figures of sample weighing shall be consistent with the accuracy of the balance used; * The number of milliliters consumed by standard solution should be 0.0 1 ml. * In the process of data processing, the rules of "four rounds, six rounds and fifty pairs" are adopted for rounding the figures after the significant figures. Please refer to the number rounding rules. * The significant digits of the final report test results shall be consistent with the method requirements. In the process of operation, its effective digits can be properly reserved, and then trimmed to the specified effective digits according to the trimming rules of effective digits, and then the trimmed data is compared with the limit specified by the standard to judge whether the actual indicators or parameters meet the requirements of the standard. 4.3.4. Requirements for relative error of preparation content analysis: HPLC method: ≤ 1.5%UV method: ≤ 1% titration method: ≤ 0.5% bioassay method: ≤ 2.5% Raw material content shall not exceed 50% of the relative error of the above methods. 4.3.5. Laboratory Report Laboratory technicians should issue laboratory reports and sign them in time after completing the experiment, and then submit them to QC supervisor after being reviewed and signed by examiners, who will judge, approve and sign them according to the experimental results. 4.3.6. Fill in the finished product inspection account. After sampling, QA inspectors should fill in the sampling date, product name and batch number in time, and QC supervisor should fill in all the results after inspection as required for future reference. 4.4. Distribution and filing of test reports. The original records of raw materials are kept in the laboratory. Reports are distributed to relevant departments according to specific requirements. 4.4.2. Reports and original records of intermediate products and finished products shall be included in the product files and kept together with the product files at least one year after the finished products expire, and reports of raw materials shall be kept at least one year after the last batch of finished products made of the raw materials expire. 4.4.3. If it is necessary to delete the laboratory test sheet from the document, the person who took the test sheet should sign the document management record book and write down the date of deletion and return. If a copy of the report is needed, it can only be copied after the approval of the QC supervisor and the manager of the quality control department, and the copy should be stamped with the seal of the "Quality Control Department". 4.5 When the problem feedback program finds quality problems or abnormal phenomena in the inspection process, it should give timely feedback step by step, and cooperate with the cause finding and proper handling. The parties concerned shall be responsible for the consequences caused by quality problems or inspection accidents, concealment or even fraud. QC is the abbreviation of English QUALITY CONTROL, which means quality control in Chinese. Its definition in ISO 8402: 1994 is "operation technology and activities adopted to meet quality requirements". Some organizations that implement ISO9000 will set up such a department or post to be responsible for the quality control function required by ISO9000 standard. Personnel engaged in this kind of work are called QC personnel, which are equivalent to product inspectors in general enterprises, including incoming inspectors (IQC), process inspectors (IPQC) and final inspectors (FQC).