Analytical data management
Original records is an important need to save the laboratory information, general process control analysis of the original records retained for one year, raw materials and finished products analysis of the original records retained for three years.
Requirements for the original records:
1. To use a ballpoint pen or pen in the experiment at the same time recorded in the original record of chemical testing, should not be copied after the fact on the book.
2. To exhaustive, clear and true record of measurement conditions instruments, reagents, data and operators.
3. Use legal units of measurement. Data should be recorded in accordance with the valid readings of the measuring instrument bit, found that the observation error should be noted name.
4. The method of changing the wrong data is to draw a horizontal line on the original data to indicate the elimination of the past, and write the corrected data next to it.
5. Data organization requires a clear format to express a large amount of data, must maintain the original data should be information.
Two, laboratory sampling, sample and sample room management system
I), purpose
In order to ensure the accuracy of analytical data, samples and traceability, to facilitate sampling, review, to meet the requirements of supervision and management, and to clarify the responsibility for the quality of the development of this management system.
Two, sampling management requirements
1. Sampling personnel should be strictly in accordance with the provisions of the implementation of sampling operations to ensure that the samples taken are representative and authentic.
2. Before sampling, according to the nature of the material to prepare the sampling tool and the corresponding container.
3. After the sampling is completed, do a good job on-site sampling records, affixed sample labels, labels include: sample name, source, sampling date and time, sampling, and so on.
4. Samples should be analyzed or sealed immediately to prevent oxidative deterioration and pollution.
Three), retained samples management requirements
1. Sample retention by the sample analysis and inspection position is responsible for the validity of the preservation period should be based on the retention of samples of the characteristics of the samples to be properly stored.
2. Retained samples of containers (including pockets) to be clean, sealed if necessary to prevent deterioration, retained samples should be well labeled, according to the batch or sequential order of neatly arranged in order to find.
3. Sample retention should be based on the full analysis of the sample dosage, not less than two full analysis of the amount of liquid is generally 200mL; enterprise production rules and regulations (the latest compilation) (18 doc) solid finished products or raw materials retained 300 grams. Safety production
4. Process control analysis samples are retained until the next sampling, special circumstances retained 24 hours.
5. Outsourced raw materials and samples are retained for four months.
6. Finished product samples: retain four months.
7. Samples over the retention period, according to the degree of deterioration of its quality to observe, and make a clean-up. If the retention period expires product quality has deteriorated, should be scrapped.
D), the sample room management requirements
1. Sample room should be ventilated, light, fire, explosion-proof, dedicated.
2. Sample bottles, bags to seal the mouth, clear and complete labeling.
3. Samples should be categorized, sub-species arranged in an orderly manner.
4. Keep the sample room hygiene and clean, sample room managed by the laboratory.
Three, laboratory inspection and test management system
a), purpose
In order to regulate the inspection, test order and behavior, to achieve the effectiveness of production and analysis of inspection and test activities and timeliness, and accurately provide quality data to achieve compliance with the requirements of the quality system, the development of this management system.
Scope
This management system applies to the laboratory of all inspection and testing activities throughout the process and the process of activities related to it.
Three), management requirements
1. test procedures
1.1 in accordance with the requirements of the regulations to take samples, and do a good job of registration and labeling.
1.2 sampling operations, to implement the "laboratory sampling, sample retention and sample room management system".
1.3 After sampling, carry out inspection and test according to the specified standards and test methods. Then, the retained samples are prepared and labeled as required.
1.4 The inspection process should strictly comply with the "Chemical Inspection Procedures", those factors affecting the accuracy of the test results such as dust, temperature and humidity, time, etc. to pay close attention to, and strictly control. To eliminate subjective arbitrariness, pay attention to the safety of sample handling and operational safety and instrument sensitivity and stability. When operating, do not leave the workstation without authorization.
1.5 Detection process, according to the provisions of the method of double-parallel or multi-parallel testing, the results should meet the requirements of method precision. Data processing and calculation of results should follow the rules of numerical modification, valid numbers shall not be arbitrarily discarded.
1.6 If found abnormal results or experimental deviation from the method of deviation, the inspector should not easily jump to conclusions, should be carefully check the records, check the calculation, check the operation, check the reagents, check the method, check the samples, to find out the reasons for targeted retesting.
1.7 To fill out the quality records in a timely manner. All original records must be recorded using the original record of chemical testing, neatly written, clear, true, accurate and complete. Not allowed to record with a pencil, not to be arbitrarily altered, scribbling, scribbling and folding. When a clerical error occurs, use "--" to cancel, and "--" above the correction by myself. For a small number of blank items did not occur to draw a slash, the entire item did not occur, should be written in this column in the case of the word "invalid".
1.8 difficult quality records are divided into the original records of analysis and testing, inspection report form two kinds. Laboratory involves two kinds of original records and report form.
1.9 analysis data should be instantly filled into the original records, need to calculate the results of the analysis should be filled in after confirming the correctness of the original records of analysis and testing must be filled in by the analyst himself, after confirming the correctness of the original records, reported to the person in charge of the department. The analyzer should be responsible for the authenticity of the original records, the accuracy of the test results, the formula and the accuracy of the calculation results.
1.10 department head to receive the analysis of data, after reviewing and confirming the correctness (two inspection system), immediately fill out the inspection report form, the finished product inspection form presented to the warehouse and marketing department, raw materials inspection form presented to the warehouse and raw materials department. The department head is responsible for the timeliness, accuracy and completeness of the data report, the quality of the report card is responsible.
2. Quality records should be cataloged in a book by month, well labeled, back to the file for safekeeping.
3. Strictly implement the national quality records and document management regulations, proper storage of quality records, raw materials and product analysis of the original records, analysis and test report form, sample records are kept for three years.
4. Quality records in the preservation process, should be prevented from moisture, mold, insects; lost and stolen, pay attention to fire prevention and ventilation. The use and management of quality records to comply with the provisions of the quality system program documents.
5. Non-production analysis of samples, non-sampling activities, not received by the leadership of the laboratory instructions, all can not be accepted.
4), the management of precision instruments
The room where the instrument is placed should meet the requirements of the instrument to ensure the accuracy and service life of the instrument, and do a good job of the instrument's shockproof, dustproof, anti-corrosion work shu. by the laboratory technician is responsible for the daily management.
V), chemical management
1. Laboratory reagent storage requirements
(1) corrosive reagents in plastic or enameled disk or barrel, in order to prevent accidents due to bottle rupture.
(2) pay attention to the storage period of chemicals.
(3) Both drug cabinets and reagent solutions should be kept out of direct sunlight and near heat sources such as hot air. Reagents requiring protection from light should be stored in brown bottles or wrapped in black paper or black cloth in the cabinet.
(4) The label on the reagent bottle should be affixed immediately when it is found to have fallen off or to be blurred. No label or label can not be identified reagents are to be treated as dangerous goods re-identified after careful handling of enterprise project funds management interim measures, can not be thrown, so as not to cause serious consequences.
2. Hazardous chemicals handling management
Laboratory needs to discharge of wastewater, waste gas, waste residue known as laboratory "three wastes". As a result of various types of laboratories to determine the project is different, the three wastes generated in the toxicity of the chemical substances contained in different quantities are also very different. In order to ensure the health of laboratory personnel and prevent environmental pollution, laboratory emissions of three wastes to comply with the relevant provisions of environmental protection in China.
6), the laboratory duties
1, the working principles of the laboratory: objectivity and impartiality, seeking truth from facts, rigorous and honest, and effectively put the raw material product quality.
2, responsible for the arrival of raw materials sampling, sensory inspection.
3, responsible for finished products and raw materials testing.
4, each batch of products routine laboratory items.
5, each batch of raw materials routine laboratory items in accordance with the relevant provisions of the acceptance criteria for raw materials.
6, the number of tests: in principle, the finished product at least once per shift (batch), at least two tests per batch of raw materials.
7, each batch of raw material testing and finished product testing records are contained in the file, and clearly accessible.
8, every day in a timely manner after the summary of the test results recorded in the prescribed file booklet, in principle, every day out of the production of finished products and raw materials into the warehouse must be the same day the results of the test, and report to the department manager;
9, all the laboratory records shall not be altered at will, there are a small amount of data need to be corrected, the original data should be crossed on a horizontal, and then written next to the correct number, make sure that the original data to keep clear and legible;
9, all the records shall not be changed. Data clearly identifiable;
10, in order to ensure the accuracy of the assay, all commonly used pipettes must be in accordance with the actual needs of the implementation of the special tube, shall not be arbitrarily string, and all pipettes in use should be labeled with the use of objects;
11, all the original records of the standard liquid preparation is clear, the standard liquid marking is clear;
12, the laboratory technician should be responsible for their own results, and for this reason, must be after the record of the assay. For this reason, the name of the test must be marked after the test records;
13, the laboratory technician should have a correct understanding of their own test results, if for any special reason doubt their own tests, should be reported to the department head in advance to prevent quality accidents brought about by this;
14, do a good job of raw material samples and samples of the finished product on the day of the work of the samples retained, stacked neatly in the sample cabinets;
15, observe and record the observation record of finished product samples.
16, regularly do raw material product quality monthly report.
17, keep the laboratory clean and sanitary, clean and tidy, at the end of the test, be sure to clean all the apparatus in accordance with the requirements of the regulations, the laboratory platform must be cleaned once a day, all the laboratory apparatus in an orderly manner, shall not be piled up at random.