Q
Daily use of instruments and equipment
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A
First, establish an instrument and equipment archive.
Supervisory departments should focus on establishing the scope of archiving for product quality inspection instruments and materials, and assign a dedicated person to be responsible for establishing management accounts for product quality inspection instruments. (1) Detailed registration of instrument name, model, manufacturer name, factory number, measurement range (range), accuracy (resolution), purchase date, purchase status, purchase cost, management number, using department, operator, purpose, status (in use/out of use), metrological verification cycle, metrological verification unit/department, last metrological verification date, verification results, records of all metrological verifications (date and results), grade (precious, main, general), archive number, etc. (2) Instrument instructions and software, etc. (3) Instrument upgrade and transformation records. (4) Instrument maintenance records. (5) Other materials generated during the use of instruments and equipment.
Second, classify and manage instruments and equipment.
Due to the variety of instruments, different models, different purchase dates, and different calibration and maintenance dates, instruments and equipment can be classified into large, medium, and small instruments, or managed according to the value of the instruments, and divided into inspection instruments, auxiliary inspection instruments, etc., according to the purpose of the instruments.
Third, daily use and maintenance of instruments and equipment.
Establish a complete procedure for the use, maintenance, and repair of instruments and equipment. Laboratory personnel must operate instruments and equipment in accordance with the requirements of the quality manual, obtaining certificates before operation, operating in accordance with specifications, and carefully filling out usage records; determine the management of instrument and equipment status identification; strengthen the maintenance and repair of instruments and equipment, promptly register damage, report repairs and keep repair records, to avoid major accidents during the operation of instruments and equipment, and regularly maintain and maintain them to keep the instruments and equipment in optimal operating condition.
Daily maintenance of instruments and equipment is a common method to ensure the stability and reliability of the measured values of instruments and equipment. In particular, for large-scale instruments and equipment, attention should be paid to dust prevention, moisture prevention, mildew prevention, and sun protection. Appropriate and effective measures should be taken to ensure that the instruments are not damaged by external factors. Some instruments and equipment have strict requirements for environmental temperature fluctuations. The operation of constant temperature equipment should be checked regularly. Regularly adjust the easily worn parts of the instruments and equipment, lubricate the sliding and rotating parts, check and tighten the easily loosened parts. For application software, avoid virus infection. Regularly update and upgrade the software of instruments and equipment to improve the service life of the instruments.
Q
Instrument identification
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Instruments and equipment should be clearly marked to indicate their "calibration/verification" status, making the instrument's status clear at a glance for easy management. Status indicators are generally divided into the following categories:
① Green indicator, indicating that the instrument and equipment have a formal metrological verification certificate and a calibration report, and are in normal use.
② Yellow indicator, indicating that some functions of the instrument and equipment have been lost, but the functions used for testing are normal and have been calibrated, and are in use.
③ Red indicator, indicating that the instrument and equipment are damaged or have failed calibration and are out of service.
Q
Metrological traceability of instruments and equipment
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All instruments and equipment within the mandatory inspection scope must be inspected by designated inspection/calibration institutions, and can only be used after passing the inspection/calibration.
For instruments and equipment that are easily changed, have a high drift rate, have strict environmental requirements, or are used frequently, consider conducting periodic verification. Through periodic verification, if any deviations are found, timely maintenance measures should be taken to ensure the accuracy of the test data.
The methods for periodic verification generally include using proficiency testing blind samples, standard substance verification, or standard addition recovery methods. Analyze and evaluate the data; if it meets the requirements, it can be used. The time for periodic verification is conducted between two periodic inspection dates and when suspicious data appears to determine whether the instrument and equipment are in normal condition. The verification personnel should keep detailed records. If periodic verification proves that there is a problem with the instrument and equipment, further analysis is necessary. If its performance is determined to be unqualified or the instrument malfunctions, a stop-use label should be affixed, and the instrument should be repaired as soon as possible to avoid delaying its normal use.
Q
The whole process of instrument and equipment management
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The general management model is to clarify the responsibilities and authority of the person in charge of the instrument and equipment (generally the technical leader), the competent department, the person in charge (such as the instrument and equipment administrator), and relevant personnel, and to stipulate them in the corresponding levels and specific documents of the system documents and be implemented by the person in charge.
Taking a certain instrument and equipment from selection, procurement, acceptance, file establishment, and delivery as an example, the process and steps should be described.
First, based on the needs of business expansion of the laboratory (launching new projects or establishing initial testing projects), the person in charge of the responsible department, based on the research and selection, submits an instrument and equipment purchase application to the laboratory director. After approval, the selected instrument and equipment are purchased from the previous instrument and equipment supplier or new instrument and equipment manufacturer (investigate and evaluate its qualifications, and collect relevant materials).
Second, after the instrument and equipment arrive, the competent department of the laboratory or the instrument and equipment management personnel, together with the personnel of the department using the instrument, will conduct a comprehensive acceptance of the instrument's host, attachments, accessories, etc., and draw a clear conclusion. For large, precise, and complex instruments and equipment, a relatively fixed service provider is determined for installation, commissioning, maintenance, and repair. At the same time, the instrument's equipment file is established in accordance with the requirements of the "Laboratory Accreditation Review Criteria".
Then, before the instrument is installed and used, a legally designated metrological verification institution (the qualifications and authorization scope of the institution need to be confirmed, and the corresponding evidence needs to be collected) verifies/calibrates whether the working status of the instrument and equipment is qualified. During this period, all instruments and equipment in the laboratory (including standard substances) should have clear markings to indicate their status. This mainly refers to the qualified (green), available (yellow), and out-of-service (red) signs of the metrological verification/calibration status.
Finally, before use, the users of the instrument and equipment (for important, critical, and large-scale instruments and equipment with complex operation techniques) should be determined and authorized. Users should fill in various records, including usage records, environmental records, maintenance records, etc., according to the requirements of the system documents. Several links need to be firmly grasped according to the entire process of instrument and equipment management.
Q
How does the "Laboratory Accreditation Assessment Criteria" stipulate?
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Qualified laboratories should manage their instruments and equipment in accordance with the relevant clauses of the "Laboratory Accreditation Assessment Criteria" to ensure that the testing data and inspection reports issued are true, accurate, reliable, and impartial.
In accordance with the requirements of the equipment and standard substances elements in the technical requirements section of the "Laboratory Accreditation Assessment Criteria", the laboratory should correctly select and equip various instruments and equipment (including software) and standard substances required for testing (including sampling, sample preparation, and data processing and analysis). Furthermore, through the quality manual, procedural documents, and corresponding work documents or work instructions (collectively referred to as system documents), all instruments and equipment (including standard substances) should be effectively managed.
Q
Maintaining the validity and reliability of instruments and equipment, and keeping them in good condition, is a top priority for laboratories, and it is also a difficult problem that makes laboratory personnel 'headache'.
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Laboratory instruments and equipment are directly used to provide or assist in providing test results, representing important assets and crucial testing tools for the laboratory. They play a vital role in ensuring the accuracy and reliability of test results.
Maintaining the effectiveness and reliability of instruments and equipment, ensuring they are in good working order, is particularly important during product quality testing.