Equipment, as an important resource element, should be included in the quality management system, participate in the system operation, in order to achieve the quality policy and objectives. Therefore, the establishment of equipment management system in line with the requirements of the guidelines, the implementation of comprehensive quality management, so that the instrumentation and equipment to maintain a good working condition, to meet the needs of the testing work.
Establishment of equipment quality management system
(1) Establishment of equipment management organization
Equipment management organization consists of quality management department, technical department and support service department. According to the characteristics, scope and workload of the equipment management work, to determine the responsibilities, powers and interrelationships of managers, verifiers, operators and service personnel, so that the decomposition of the management functions to the relevant departments, relevant positions, as far as possible to achieve a clear responsibility, a clear division of labor.
(2) Develop equipment management procedures
Equipment management procedures are the way to implement equipment management in testing organizations. Through the establishment of the corresponding program documents, a clear process of equipment management activities, steps, content and all links, so that all the work can be followed.
(3) the preparation of equipment operating instructions
Equipment operating instructions is to guide the test personnel to operate the equipment normative documents. General equipment can be operated in accordance with the instructions, large, complex instruments or operators of large mobility, unstable performance of the equipment need to write operating instructions or operating procedures.
Sound equipment quality management system
(1) evaluation system
Review is the acquisition or disposal of equipment, a preliminary work, mainly from the adaptability of the equipment, reliability, economy, safety, maintenance and other aspects of a comprehensive analysis, the purpose is to rationalize the allocation of equipment resources, equipment, give full play to the best benefits. For large, valuable, sophisticated instruments need to be certified for feasibility, to achieve technically advanced, reliable performance, work needs, economically reasonable; for rental, maintenance, elimination of equipment, as well as small or auxiliary equipment, should be the necessary review.
(2) acceptance system
Acceptance is an important means to ensure the normal operation of the equipment purchased or repaired. Instruments and equipment should be unpacked in the equipment manager, operators, supply staff and other relevant personnel are present, the acceptance process, the equipment evaluation requirements, ordering contracts and packing lists, one by one inventory, and make a record. For large-scale, precision instruments and equipment, after installation and commissioning, should also be through a certain period (within the contract period) of trial operation, according to the actual operating results and indicators of the test conclusions, to confirm that there is no quality problems before acceptance. Instruments and equipment can only be accepted for handover procedures, delivery and use.
(3) the use of the system
In order to extend the service life of the equipment, to give full play to its role, we must establish a system for the use of the equipment, the personnel, the working environment, facilities and conditions, maintenance, repair and other clear requirements to do to make provisions.
(4) record system
Records are the establishment of a complete file of equipment to ensure that the normal operation of the equipment sales of a basic job, the implementation of the responsibility for equipment management, system implementation and management procedures are very important to the operation and improvement. Each piece of equipment from the plan to purchase to eliminate should maintain a complete record of the content in addition to the general equipment files, should also be the acquisition of equipment, calibration, maintenance of the plan, the demonstration of the views or reports, commissioning and acceptance report, the use of equipment and calibration records, instrumentation failures and maintenance records, operating conditions, performance changes, anomalies and corrective action, and so on.
(5) verification system
Verification is to confirm that the equipment meets the technical specifications, to avoid affecting the test results of an important initiative. Operators before and after the use of the instrument, should be in accordance with technical regulations and instructions, to take self-calibration, comparison and other methods to calibrate the main performance parameters to ensure that the accuracy and range of the instrument meets the requirements. Quality management team should regularly check the use of equipment, records, etc. For newly purchased or leased equipment, equipment used for on-site testing, equipment used frequently or with large drift, verification procedures should be formulated to keep the equipment in good working condition.
Instrument and Equipment Calibration and Verification
Calibration
(1) Definition of Calibration
Calibration refers to a group of operations to determine the relationship between the quantitative value indicated by a measuring device or a measuring system, or the quantitative value represented by a physical gauge or a reference material, and the corresponding quantitative value replicated by a standard under specified conditions.
The meaning of this definition is:
① Under the specified conditions, a reference standard can be used to assign a value to the characteristics of the measuring apparatus, including the reference material, and determine the error in its indication.
2) To trace the value indicated or represented by a measuring instrument back to the value reproduced by the standard, following the calibration chain
2) Purpose of calibration
1) To determine the error in the displayed value and to determine whether it is within the expected tolerance range;
2) To obtain a report of deviations from the nominal value to allow adjustment of the measuring instrument or correction of the displayed value;
3) To assign a value to any scale marking, including a reference material, under specified conditions, and to determine its error in displaying value. (iii) Assigning a value to any scale mark or determining the value of other characteristics, and assigning a value to the characteristics of a reference substance;
(iv) Ensuring the accuracy of the values given by the measuring instrument and achieving traceability.
(3) The basis of calibration
The basis of calibration is the calibration specification or calibration method, which may be standardized or self-developed. The results of calibration can be recorded in the calibration certificate or calibration report, and the calibration results can also be expressed in the form of calibration factors or calibration curves.
Checking
(1) definition and the object of verification
Checking refers to the process of identifying and confirming whether the measuring instrument meets the legal requirements, which includes checking, marking and/or issuing a certificate of verification (JJF1001-1998 "General Measurement Terminology and Definitions Specification Article 9.12"). Verification is an important part of the legal measurement work in the control of measuring instruments (JJF1001-1998 "General Measurement Terminology and Definitions Specification Article 9.6"), which is the object of the legal management of the scope of measuring instruments. China in 1987 by the State Bureau of Measurement issued by the Chinese People's *** and the State according to law management of measuring instruments directory *** divided into twelve categories of more than a thousand kinds of the same year the State Council issued a "Chinese People's *** and the State's mandatory calibration of the work of measuring instruments directory", that is, used for trade settlements, safety and protection, medical care and health, environmental monitoring of the work of the four aspects of the measuring instruments of the 55 items; in 1999, the State Quality and Technical Supervision under the authorization of the State Council has been added to the mandatory inspection of measuring instruments 4 6 kinds of work. Compulsory verification by the statutory metrological verification bodies or authorized metrological verification bodies to implement. China's public social measurement standards and departments and enterprises, institutions of the highest standards of measurement, but also the implementation of mandatory verification. These constitute the object of verification of measuring instruments in China.
(2) the legal requirements of measuring instruments
The legal requirements of measuring instruments are divided into metrological requirements, technical requirements and administrative requirements, the specific operation of its metrological inspection, technical and administrative inspections, these three aspects of the inspection is also referred to as the verification of the three components.
① Measurement inspection
To determine the error of measuring instruments and other measurement characteristics, such as measurement uncertainty, error of value, accuracy level; stability, repeatability and drift; reading device resolving power, index value, sensitivity to electromagnetic interference.
② Technical inspection
In order to meet the measurement requirements and must have the structure, installation requirements, visibility of readings, whether there is the possibility of deception.
③ administrative checks
including signs, nameplates, type approval, calibration marks, license marks, certificates and expiration dates, sealing, locking and other metrological safety device integrity, calibration, repair and maintenance records.
(3) the basis of the test
The basis of the test is based on the statutory procedures for approval of the published metrological verification procedures. In the test results, there must be qualified or not the conclusion, and issued a certificate or seal. Engaged in the verification of the staff must be qualified by the examination and hold the relevant measurement of the administrative departments issued by the inspector's license.
The main difference between calibration and verification
(1) calibration is not legal, is a voluntary traceability behavior; verification is legal, is a legal measurement of the scope of management of law enforcement.
(2) calibration is mainly used to determine the error in the value of the measuring instrument; verification is a comprehensive assessment of the measurement characteristics of measuring instruments and compliance with technical requirements.
(3) calibration is based on calibration specifications, calibration methods, can be made uniform provisions can also be formulated; verification must be based on verification procedures.
(4) calibration does not judge the measuring instrument qualified or not, but when needed, can determine whether a certain performance of the measuring instrument meets the expected requirements; calibration to make a qualification of the measuring instrument examined with or without the conclusion.
(5) calibration results are usually issued as a calibration certificate or calibration report; calibration results of qualified calibration certificate issued, unqualified notice of failure.
Instrumentation files and labeling management
The key to the assessment of testing organizations instrumentation in four areas:
① The required testing instruments and equipment must be fully equipped. The concept of complete is not only contain the parameters to be complete, and its range and accuracy to meet the requirements of the test standard;
② All instruments and equipment must be in normal working order;
③ measuring instruments and equipment must be traceable to the national benchmark;
④ testing instruments and equipment must be clear accounts, complete files, orderly management, instrumentation and equipment to carry out the management of the logo.
Instrumentation files
According to each set of instrumentation for filing, the file should include the following:
① Instrumentation resume, including the name of the instrument, model or specification, manufacturer, factory number, instrumentation and equipment, the unique identification number, date of purchase, date of acceptance, date of inauguration, placed in the location, the use of the main technical specifications and so on;
② Instrument purchase application, the manufacturer of the instrument, the factory number, instrumentation and equipment unique identification number, the purchase date, the acceptance date, date of inauguration, placed in the location, use of the main technical indicators;
< p> ② instrument purchase application, the original manual, product certification, warranty;③ acceptance records;
④ inspection / calibration records and calibration certificates;
⑤ calibration protocol (if necessary);
⑥ maintenance and operation inspection plan;
⑦ regular archiving of the use of records;
⑧ maintenance records )
⑨ Operation inspection records;
⑩ Damage, failure, modification or repair of the history of records.
Instrumentation identification and random information
① No. identification
All instruments and equipment should be identified, and each instrument and equipment identification must be unique.
② Status identification
According to the test/calibration, comparison or verification results of the instrument and equipment labeled with availability identification. Availability identification mark is divided into a certificate of conformity, permit and deactivation certificate.
a) Where the following conditions are met, the use of instruments and equipment, the certificate of conformity
● Measurement and verification of the conclusion of the qualified;
● Calibration in accordance with the procedures, the calibration results are within the range of the specified technical requirements;
● The above conditions can not be achieved for a variety of reasons, after the comparison of verification to prove that its technical performance in line with the specified requirements;
● Auxiliary equipment that is not required to be calibrated and has passed the inspection.
b) Where the following conditions are met, the use of instruments and equipment, the use of permitted
● multi-function detection of certain functions have been lost, but the detection of work used in the function is normal, and by the calibration / calibration qualified;
● by the detection of equipment for a range of unqualified accuracy, but the detection of work used in the range is qualified;
● measuring instruments are permitted to degrade the use of.
c) Where the following conditions of the instrument, the use of deactivation certificate
● more than the validity of the test/calibration period;
● damaged or dysfunctional;
● counted by the test/calibration does not meet the requirements.
Instrument and equipment status identification information should include the following:
● Equipment number;
● Certificate approval date;
● Expiration date;
● The name of the organization that technically confirms the status of the instrument;
● The name of the inspector responsible for confirming the status of the instrument and equipment controlled;
● The license should be approved for use;
● The license should be approved for use. For the permit should be allowed to use the scope, level or function;
● For the deactivation certificate should be the date of the beginning of deactivation and deactivation of the date of official confirmation;
● Random information
Random information, including operating procedures, a copy of the manual of the instrument, the use of the in-use records, and so on.
Control of abnormal conditions of instruments and equipments
If abnormal conditions of instruments and equipments occur, such as misuse, misoperation, overloading (overloading) or accidents, and if it is found that the detection accuracy does not meet the requirements, the displayed results are suspicious or failed by calibration/testing, the use should be stopped immediately and the operation is proved to be satisfactory by re-checking, calibrating or testing before it can be used. As a result of abnormal conditions of the instrumentation caused by the reasons for the impact on the testing work, according to the control procedures for non-compliance with the testing work to be dealt with.
Instrumentation operation check
(1) instrumentation operation check role
In order to ensure that the testing equipment in the two verification/calibration period of the operational status and performance in line with the requirements of the testing work, the need to check the inspection equipment during this period, that is, the operation of instrumentation check.
Instrumentation of the operation of the inspection of the final landing point is to verify the analysis of the data, through the data analysis of measuring equipment to determine whether the performance of the measurement meets the requirements of use. It is conducive to the testing organization to dynamically grasp the metrological performance of the testing equipment, and according to the results of the operational inspection to reasonably determine the verification/calibration intervals, in order to improve the credibility of the measurement data, but also to shorten the period of retrospective due to abnormal instrumentation and equipment function on the test data, therefore, the testing organization should be in the testing equipment between the two inspection/calibration cycle of the operational inspection.
(2) need to carry out operational checks of instruments and equipment
In the following cases of instruments and equipment need to carry out operational checks:
① Frequent use of instruments and equipment;
② Drift rate of the instruments and equipment;
③ Tested, but in the validity of the test has been a long time without the use of the instruments and equipment;
④ Use of a period of time Found that the stability is not good or detection accuracy does not meet the requirements of the instrumentation.
(3) instrumentation operation check method
① instrumentation technical indicators (precision, sensitivity, detection limit, signal-to-noise ratio, separation efficiency, spiked recovery rate, etc.) to check;
② two or more instruments of the same type / specification for the comparison of the measurement results;
③ instrumentation using the self-calibration function of the inspection;
④ the use of certificates, certificates, certificates of compliance with the requirements of the instrumentation.
(4) the implementation of the operation of the inspection points to note
① the nature of the operation of the inspection is different from the verification / calibration;
the operation of the mechanism check occurs between the two verification / calibration, it is through the verification of the stability of the measurement performance of the testing equipment in order to improve the credibility of the test data.
② Run check to use verification standards for process control
The essence of the run check is the process control, is the testing organization to use verification standards for the testing equipment measurement performance process control. The use of verification standards for operational inspection, first of all, we must choose the appropriate verification standards, the verification of instrumentation and equipment commonly used for verification; secondly, in the operational inspection of testing equipment for a certain period of time to monitor the establishment of a verification database, through the drawing of control charts of the polar control charts, mean standard deviation control charts, and other control charts to detect the measurement of the performance of the testing equipment.
③ The implementation of operational inspection of instrumentation is generally important measurement equipment or reference standards
Not all important testing equipment can be found in the appropriate verification standards, so the Review Guidelines, Article 9.6, "when appropriate" to explain. If a suitable verification standard cannot be found, the use and maintenance of the instrumentation within the validity period of the calibration recommendations is also a common means to ensure the accuracy of the instrumentation.
④ Running checks should be documented, record-keeping analysis
The implementation of running checks on instrumentation, should be developed for a variety of important instrumentation running checks of the operating instructions, specific description of the implementation of the running checks of the process, focusing on the stability of the verification standard analysis and selection, verification of the verification of the determination of the measurement point, the verification of the frequency, control charts drawn and the verification of the analysis of the data. Each verification data should be properly stored according to the record control program.