Is the instrument qualified or used after calibration and acceptance?

File Name: Management Procedure for Measuring Instruments FileNo.: File Version: 1.0 Formulation Unit: Confidentiality Level: General Release Date: Directory 1. Purpose 42. Scope of application. Responsible unit 43. 1 quality assurance group: registration, filing, control and verification of measuring instruments and testing instruments. 43.2 User: Apply for purchasing measuring instruments and testing instruments, and be responsible for routine inspection and maintenance. 44. Definition 44. 1 Calibration: A set of operations to establish the relationship between the indicated value of a measuring instrument or measuring system (or the value represented by a physical measuring tool or reference material) and the known value of the corresponding measured object under specific conditions. 44.2 Traceability: For the characteristics of measurement results, the measurement results can be linked with appropriate standards (usually international standards or national standards) through continuous comparison chains. 45. Work content 45. 1 Application, purchase, acceptance and record of measuring instruments and testing instruments: 45.2 Management, use, spot inspection and regular maintenance of measuring instruments and testing instruments: 45.3 Timing and method of calibration: 55.4 Judgment and application of calibration results: 55.5 Disposal after calibration: 65.6 All qualified testing equipment must be labeled with qualified labels (. 65.7 Measurement quality assurance measures: In order to ensure the accuracy and precision of testing equipment, users must take the following measures. 66. Related documents 66. 1 document code table 67. Flowchart 77. 1 Flowchart 1 78. Form 78. 1 raw material identification card 78.2 semi-finished product identification card 78.3 finished product identification card 79. Attachment 7 Audit Record This document has been audited by the following personnel: company name and date 1. Objective To standardize the application, acceptance and use of testing equipment in the company. 2. Scope of application All test equipment used by the company for inspection, testing and calibration. 3. Responsible unit 3. 1 Quality Assurance Group: registration, filing, control and calibration of measuring instruments and testing instruments. 3.2 User: Apply for purchasing measuring instruments and testing instruments, and be responsible for routine inspection and maintenance. 4. Definition 4. 1 calibration: A set of operations to establish the relationship between the indicated value of a measuring instrument or measuring system (or the value represented by physical measuring tools and reference materials) and the known value of the corresponding measured object under specific conditions. 4.2 Traceability: For the characteristics of measurement results, the measurement results can be linked with appropriate standards (usually international standards or national standards) through continuous comparison chains. 5. Work content 5. 1 Application, purchase, acceptance and entry of measuring instruments and testing instruments: 5. 1. 1 When purchasing measuring instruments and testing instruments, the requisitioning unit should evaluate their specifications, accuracy and range in advance, and after knowing the product specifications, functions and quotations of each supplier, select more than three suppliers that meet the requirements to sort out relevant materials. And conduct related procurement operations according to the approval authority of the group. 5. 1.2 After purchasing the testing equipment, the user shall check and accept it together with the specialized personnel of the instrument school. During acceptance, in addition to specifications and catalogues, special attention should be paid to the integrity of accessories, operating instructions and quality guarantee. Before the newly purchased testing equipment enters the factory, the supplier may be required to do a good job of calibration if necessary, and a "verification certificate" must be provided, otherwise it will not be accepted. After acceptance, an acceptance report will be issued as one of the financial payment vouchers. 5. 1.3 Qualified measuring tools, instruments, testing instruments, etc. It must be registered in the management account of testing equipment, which includes the following items: a. Equipment & No d.brand &; Model &; Serial number B. Employer (or storage place) \ Custodian E. Verification period &; Calibration method C. Measurement application range and error allowable range F. Qualification allowable benchmark 5. 1.4 All newly purchased testing equipment must be calibrated before it can be officially used. (except without amendment). 5.2 Management, use, spot inspection and regular maintenance of measuring instruments and testing instruments: 5.2. 1 After acceptance, measuring instruments and testing instruments shall be classified into the company's property, numbered according to the Rules for Numbering of Measuring Equipment, counted regularly every year, and the resume of testing equipment shall be established. According to the regulations, each piece of equipment shall be maintained by regular users or custodians of the user unit at regular intervals, and a quality guarantee shall be provided. All purchased testing instruments are counted once a month according to the requirements of the group, and the results are reported to the relevant person in charge of the quality assurance department of the group headquarters. 5.2.2 The quality assurance group has formulated calibration standards for operation, routine inspection and maintenance of measuring instruments, stipulating that users or custodians shall operate, routine inspection and maintenance according to the methods listed in this standard book, and shall not be overloaded when using. If damage or abnormal function is found, stop using it immediately and notify the instrument proofreader to deal with it. 5.2.3 During storage and handling, the test equipment should be carefully maintained to prevent damage. When it is not used for a long time, the packaging protection and labeling should be strengthened, and it should be placed in a dry environment at normal temperature on weekdays to avoid direct sunlight. 5.2.4 Spot check of testing equipment: including surface cleaning, mechanical lubrication, loose screws and normal electrical switch circuit. Is the function check normal? 5.2.5 According to the frequency of equipment use, the period of regular maintenance can be divided into monthly maintenance, quarterly maintenance and annual maintenance. For more expensive or complex instruments, the person in charge of the quality assurance team can contact the original equipment supplier and come to the factory for maintenance and calibration when necessary. 5.3 Time and method of calibration: 5.2.6 Periodic calibration: The instrument calibrator of the quality assurance team should check the calibration period published in the Management Account of Testing Equipment. Calibration method and calibration standard book for operation, spot check and maintenance of measuring instruments, and calibrate the measuring instruments to be calibrated on time. 5.3. 1 Temporary calibration: When users find that measuring instruments are inaccurate during operation or spot check, they should check them immediately. 5.3.2 Calibration methods of testing equipment in our factory: a. External calibration B. Internal calibration C. Spot check A. External calibration: The testing equipment that needs external calibration is handed over to the instrument calibrator by the user, and then collected by the instrument calibrator and sent to the institution or laboratory recognized by the local national government for calibration. The calibration report shall indicate that it can be traced back to national standards or international standards. B. Internal calibration: the user calibrates himself or submits it to the instrument calibrator for calibration, but the standard parts used for calibration must be traced back to the calibration laboratory recognized by the state and can be in line with national standards. There is no special requirement for calibration environment. The externally calibrated standard parts are used as internal calibration standard parts, and the allowed benchmarks are listed in the account of the measuring instrument management desk. C. Spot check: The values detected by the testing equipment are for reference only, and only spot check is needed before use. 5.3.3 The instrument calibrator shall notify the user to send the overdue uncalibrated testing equipment to the school. If the instrument needs to be used beyond the time limit due to production, but the calibration period exceeds one month, the instrument calibrator shall immediately take it back and stop using it. 5.2.7 After the internal calibration is completed, the calibration record form shall be filled in, and the calibration record and data shall be submitted to the supervisor for signature and confirmation, and the instrument inspection form shall be filled in for instrument inspection. 5.2.8 For personnel sent to external schools, the contents of their certificates are accompanied by verification data &; Those who pass the certification do not need to fill in the verification record form. However, the instrument proofreader should check whether the data in the calibration record is within the allowable range specified by the company. If it is in conformity, it shall be signed on the back of the external calibration certificate record and confirmed by the person in charge of the inspection department. 5.4 Determination and application of calibration results: 5.3. 1 Acceptance criteria for calibration results of internal calibration standard parts and testing equipment shall be formulated by the person in charge of the inspection department, and the formulation principles are as follows: a. According to the required accuracy of testing equipment, the accuracy shall be 5 ~ 10% of the required accuracy. For example, what is the measurement error requirement of a scale? 100g, and its verification acceptance standard is +(5- 10g). B. The person in charge of the inspection department shall determine the reasonable and appropriate use accuracy, measuring range and calibration standard of the inspection equipment according to the company's process capability, product quality requirements and user's experience. 5.4. 1 The main purpose of calibration of testing equipment is to trace the source standard and correct the error, so the calibration result should be practical, that is, the calibration result should be placed next to the testing equipment, and the user's measurement value can correct the device difference, which is the correct reading. Such as thermometer, the results after verification are as follows: (device difference = = indicated value-standard value) standard value 020406080 100 indicated value-0.120.140.360.480.4100.2 device difference. However, the actual application is not consistent with the calibration point, so the instrument calibrator should draw a calibration curve according to the calibration results of the detection equipment, so that the subsequent users can find out the corresponding "instrument difference" by interpolation to correct it. 5.5 Disposal after calibration: 5.6 All qualified testing equipment shall be labeled with calibration qualification label (,indicating the date of this calibration, suggesting the date, identification number and calibrator of the next calibration, and recorded in the resume of testing equipment. 5. 1. 1 All unqualified testing equipment shall be labeled with the stop date, identification number and calibrator, and recorded in the resume of testing equipment. 5. 1.2 The disposal method of testing equipment with partially qualified or partially unqualified calibration results shall be proposed by the instrument proofreader, reviewed by the quality assurance team leader and the director of the inspection department, and approved by the quality assurance manager. The disposal methods are as follows: a. The user corrects the instrument error: the instrument proofreader should indicate the calibration error on the calibration label and resume, and attach the calibration curve to the equipment for the user's reference and correction. B. Limit the scope of equipment use: the calibrator shall indicate the user's scope of use on the calibration label and resume. C shorten the calibration period: one year to half a year, and half a year to three months. D. Send for repair or adjustment: send it back to the original factory for repair and adjustment, and then use it after passing the inspection. E scrapping: all testing equipment to be eliminated shall be labeled as suspended. 5. 1.3 When the calibration results show that the deviation of the testing equipment is too large, the instrument calibrator should immediately report the product warranty to the supervisor, and check whether the equipment has been used several times before calibration, and evaluate its error rate, impact on product quality or other shortcomings. In this case, the instrument proofreader should fill in the Non-Conformity Notice Processing Form (7.7) and submit it to the leader of the quality assurance team for review. After the approval of the manager of the quality assurance department, notify the affected customers or relevant departments, and jointly study the improvement measures. 5.7 Measurement quality assurance measures: In order to ensure the accuracy and precision of testing equipment, users must take the following measures. 5. 1. 1 Before use, check whether the testing equipment is normal, such as zero position, indicator light, operation and appearance. 5. 1.2 Check the calibration label to confirm that the testing equipment is within the calibration validity period. 5. 1.3 If any abnormality (such as equipment abnormality and measurement data abnormality) is found during the measurement, it shall immediately respond to the instrument calibrator. 5.8 This Law shall be implemented, revised or reissued after being approved by the General Manager, and shall be implemented in accordance with the Management Procedure for Documents and Records. Unless otherwise specified, all records arising from the implementation of this law shall be stored and preserved in accordance with the provisions of the document and record management procedures. 6. Related documents 6. 1 file code table 7. Flowchart 7. 1 Flowchart 1 8. Table 8. 1 raw material identification card 8.2 semi-finished product identification card 8.3 finished product identification card 9. accessory part