Laboratory Accreditation Review Guidelines
The accredited laboratory should be in accordance with the "Laboratory Accreditation Review Guidelines" the corresponding provisions of the requirements of the management of instrumentation to ensure that the test data issued to the test report is true, accurate, reliable, and has a third-party impartiality.
In accordance with the "Laboratory Accreditation Review Guidelines" in the technical requirements of the equipment and standard substances, the laboratory should be correctly selected and equipped with a variety of instrumentation (including sampling, sample preparation, data processing and analysis) and standard substances required for testing (including sampling, sample preparation, data processing and analysis).
And through the quality manual and program documents and the corresponding operating documents or operating instructions (collectively referred to as system documents), all instruments and equipment (including standard substances) for effective management.
The whole process of instrument and equipment management
The general management mode is to clarify the instrument and equipment of the competent leadership (generally the person in charge of technology), the competent department, the competent personnel (such as instrument and equipment manager) and the responsibilities of the relevant personnel, authority, and the corresponding level of the system documents and specific documents to be provided in the system documents and by the person responsible for the implementation of the implementation of the specific implementation of the compliance.
Take an instrument and equipment from the selection, procurement, acceptance, acceptance, establishment of files, delivery and use as an example, to describe the due process and steps.
First of all, by the responsible department of the responsible person in accordance with the needs of the laboratory business development (to carry out new projects or the establishment of the initial testing program), on the basis of research and selection, the laboratory presented to the person in charge of the application for the purchase of instrumentation and equipment purchase order, approved by the selection of the previous instrumentation and equipment suppliers or new instrumentation and equipment vendors (the qualifications of its investigation, evaluation, collection of relevant materials) procurement of the instrumentation and equipment.
Secondly, after the arrival of the instrument and equipment, it is necessary for the competent department of the laboratory or the instrument and equipment management personnel together with the personnel of the department using the instrument to conduct a comprehensive inspection and acceptance of the instrument's mainframe and accessories, fittings, etc., and make a clear conclusion. The installation, commissioning, maintenance and repair of large-scale precision and complex instruments and equipment to determine a relatively fixed service provider. At the same time in accordance with the "Laboratory Accreditation Review Guidelines" requires the establishment of the instrument's equipment files.
Then, before the installation and use of the instrument, the statutory metrological verification agency (need to confirm the qualification of the agency and the scope of authorization for verification and calibration, and collect the appropriate evidence) to test/calibrate the instrumentation in a qualified working condition or not. In the meantime, all instruments and equipment in the laboratory (including standard substances) should be clearly labeled to indicate their status. Mainly refers to the measurement test / calibration status of qualified (green), permitted (yellow), out of service (red) mark.
Finally, before use, the instrument and equipment (for important, critical, complex operation of large instruments and equipment) should be determined and authorized by the user. The user should fill in all kinds of records including the use records, environmental records, maintenance records, etc. in accordance with the requirements of the system documents.
Key Links
Traceability of Instruments and Equipment
All instruments and equipment belonging to the scope of mandatory calibration should be certified by the designated certification/calibration organization, and can only be used after passing the certification/calibration.
For easy change, drift rate, environmental requirements are more stringent or more frequent use of instruments and equipment need to consider the period of verification, through the period of verification, once found to produce deviation, to take timely measures such as repair and maintenance, in order to ensure the accuracy of the test data.
Period verification methods, generally can be utilized to assess the blind samples, standard material verification or spiked recovery methods. The data are analyzed and evaluated, and can be used when the requirements are met.
Period verification, in the middle of the two cycles of verification day and the emergence of suspicious data for period verification, in order to determine the status of the instrumentation is normal, the verifier should make a detailed record.
After the period of verification to prove that there are problems with the instrumentation must be further analyzed, such as determining its performance is not qualified, the instrument malfunctions, should be affixed to the deactivation mark, as soon as possible on the instrument for maintenance, so as to avoid delays in the normal use of the instrument.
Instrumentation labeling
Instrumentation should have a clear identification of its "verification/calibration" status, so that the status of the instrument at a glance, easy to manage. State marking is generally divided into the following categories:
1, green marking:
Indicates that the instrumentation has an official certificate of measurement and calibration of qualified reports, in a state of normal use.
2, yellow mark:
Indicates that some of the functions of the instrumentation has been lost, but the detection of the work used in the normal function, and calibrated, in use.
3, red mark:
Indicates that the instrumentation has been damaged or calibrated unqualified, in a state of deactivation.
The daily use of instruments and equipment
A, the establishment of instrumentation files
The competent department should focus on the establishment of the scope of product quality inspection instrumentation materials archiving, and set up a person responsible for the establishment of the management of product quality inspection instrumentation account.
1, detailed registration of the instrument name, model, manufacturer's name, factory number, measurement range (range), accuracy (resolution), date of purchase, purchase status, purchase cost, management number, the use of the department, operator, use, status (in use / out of service), measurement and calibration cycle, measurement and calibration unit / department, the last date of measurement and calibration, calibration results, the previous measurement and calibration records (date and results), grade (valuable, major, general), file number.
2, instrument manuals and software.
3, instrument upgrading records.
4, instrument maintenance records.
5, other materials generated during the use of instruments and equipment.
Two, classification and management of instruments and equipment
Because of the variety of instruments, different models, different purchase dates, calibration cycles and maintenance dates are also different, so the instrumentation can be divided into large, medium and small instruments, but also according to the value of the instrument for the management of the classification, and from the use of the instrument is divided into the inspection instruments, auxiliary inspection instruments.
Three, the daily use and maintenance of instruments and equipment
The daily maintenance of instruments and equipment is to ensure that the instrumentation is stable, reliable and common means.
Particularly for large instruments and equipment to pay attention to dust, moisture, mold, sun. To take appropriate and effective measures to ensure that the instrument is not affected by external factors and damage.
Some instruments and equipment for the environment temperature fluctuations have more stringent requirements, to regularly check whether the thermostat equipment is operating normally.
Timely debugging of instrument and equipment easy to wear parts, lubrication of sliding and rotating parts, easy to loose parts to check and tighten. To the application software requirements to avoid infection virus. Regularly update and upgrade the software of the instrument and equipment to improve the service life of the instrument.
1, the establishment of a sound instrumentation use, maintenance, repair procedures
2, laboratory personnel must be in accordance with the quality manual requirements, operating instruments and equipment
3, to do the licensed on the machine, the operation of standardized, carefully fill out the use of records
4, to determine the management of instrumentation status marking
5, to strengthen the maintenance of instruments and equipment, Repair, damage timely registration, repair and maintenance records, so that the instrumentation in the operation process to avoid major accidents
6, regular maintenance, so that the instrumentation is in the best operating condition
The instrumentation custody of this piece is very important, so there must be a person in charge, and to do a good job in the classification of equipment and instruments, the details of which include the following seven points:
1, to do a good job of all kinds of instrument maintenance, maintenance work, test instruments to be managed by a person.
2, the precision instruments to be classified, each instrument should be regularly calibrated and tested.
3, do a good job of all types of instruments, the use of mobile and calibration records.
4, no normal procedures for any instrument shall not be lent.
5, the instrument should be standardized storage, keep clean and tidy.
6, receive the return of the instrument to check whether the damage, found that the damage is immediately reported, and timely repair.
7, laboratory personnel are responsible for the daily custody of the instrument.
For the maintenance of instruments and equipment, mainly the following five points:
1, laboratory personnel should be familiar with the performance of the instrument before use, the principle and operating procedures, is strictly prohibited unauthorized operation.
2, non-experimental personnel shall not use the instrument.
3, in addition to overhauling the experimental personnel in accordance with the cycle, should also check the condition of the instrumentation from time to time, and found that the abnormal instrumentation should be overhauled in a timely manner.
4, non-measurement testing or maintenance personnel shall not be disassembled, adjusted to move the instrument.
5, according to the cycle of maintenance of equipment, due must be maintained or repaired in a timely manner, shall not be arbitrarily extended use.
Four, instrumentation during the verification
Period verification should be recorded and archived. During the inspection found that the equipment operation problems, should be discontinued for warranty, the operation of problematic equipment involved in the validity of the test results have an impact on the detection of the project should be re-tested.
Fifth, the use of personnel qualification management
The management of personnel involves three aspects:
1, must have participated in the organization of the unit of the detection of the use of equipment training
2, the operation of the equipment involved in all aspects of equipment, including the principles of operation, operating procedures, technical performance, etc., to have a comprehensive and detailed mastery of the
3, Knowledge and skills in the maintenance of the equipment should also be understood
Qualified means that the operator has obtained a certificate of qualification for calibration, with a certain level of operational qualifications, the only way to truly achieve the approval of the leadership of the institution to be able to take up the post, can be qualified to operate the key testing equipment.
Summary of error-prone points
Often certified laboratories are prone to errors or negligence in the management of instruments and equipment in the following cases:
1, should be sent to the test or self-calibration of the instrumentation and equipment is not in accordance with the provisions of the timely calibration calibration or self-calibration; (such as forgetfulness, negligence, or should be tested for more than one project, the actual calibration calibration project is incomplete, or the calibration and testing certificate issued by the calibration and testing certificate is not in line with the scope of measurement. The range issued by the range does not meet the standard requirements of the test specification (incomplete or some range is not enough))
2, not in a prominent position or obvious position of the instrumentation and equipment paste measurement certification logo or fill out the irregularities, incomplete;
3, not in accordance with the provisions of the program steps to manage or not leave the evidence at the time (records, purchase contracts, invoices, etc.);
4, in the provisions of the Records are not in accordance with the requirements of the system documents, by the responsible person's hand hand-signed name and date (such as name printing, no review and approval of the person's signature, only one person to sign the acceptance of the record, etc.);
5, not established instrumentation and equipment, damage, malfunction, modification or repair of the record;
6, did not fill in the date of purchase, date of inauguration, as well as instrumentation and equipment currently placed in the location;
7, only the laboratory's own number, has not been established between the factory number of instruments and equipment and laboratory number of the corresponding retrospective relationship;
8, the use of records and maintenance records are mixed into one; (use of records is in the field by the user before and after the use of instrumentation to fill in the status of its work, usually saved in the instrumentation near the table (workbench) surface or drawer. And the maintenance record is in accordance with the specified maintenance frequency by the maintainer after the maintenance by the maintainer or instrument and equipment administrator to fill in the actual occurrence of maintenance and maintenance, saved in the instrument and equipment files).
9, only the instrumentation to be measured and certified maintenance and records, the other auxiliary equipment does not maintain records or only maintenance is not recorded (that is, not all the instruments and equipment to carry out normal maintenance);
10, the confirmation of instrumentation and equipment non-testing certificate records, fill in the information is incomplete or does not explain the basis for confirmation (that is, according to which test specification standards for which the provisions of the requirements of the judgment can be confirmed)
10, the instrumentation and equipment non-test certificate, fill in the information is incomplete or does not explain the basis for confirmation (that is, according to which test specification standards require Can confirm the judgment)
Instrument and equipment management is an important part of the laboratory quality management system, is a very comprehensive work, but also very detailed and tedious work. Only seriously do every job in the management of instrumentation and equipment, in order to effectively grasp the normal operation of laboratory instrumentation and equipment. Answers from