1. Current status of quality supervision in calibration laboratories

GJB2725A-2001 "General Requirements for Testing Laboratories and Calibration Laboratories" 4.1.5 (g) stipulates that the laboratory "should be equipped with supervisory personnel, formulate supervision and management regulations and supervisory personnel responsibilities, and properly supervise personnel engaged in testing, calibration or verification (including personnel undergoing training). Supervisors shall be personnel who are familiar with the testing, calibration or verification methods and procedures and know how to evaluate the testing, calibration or verification results." At present, although each laboratory has established its own quality management system and equipped with quality supervisors in accordance with relevant standard requirements, in daily work, most laboratories do not pay enough attention to quality supervision, and there are problems such as insufficient professional ability of quality supervisors, lack of planning in supervision, perfunctory supervision, poor practicality and effectiveness. This article analyzes the current status of quality supervision work in calibration laboratories and the causes of existing problems from the three aspects of supervision subject, object and procedure.

1. Supervision Subject

(1) Quality supervision personnel have a weak quality awareness

Quality supervision personnel do not fully understand the importance of quality supervision work, do not have the awareness of "quality is life", neglect the preparation of supervision procedures and work documents, and lack the evaluation of the effectiveness of quality supervision. Most quality supervisors are part-time personnel in calibration positions, rather than full-time personnel appointed by laboratory managers. The independence and fairness of supervision cannot be guaranteed, and there are phenomena such as failure to truthfully record problems found during supervision. Supervision lacks planning, and daily supervision is relatively arbitrary or perfunctory. In order to cope with inspections during internal and external audits, temporary records are supplemented, resulting in problems in laboratory quality management not being discovered and solved in a timely manner, affecting the continuous improvement of the quality management system.

(2) Lack of professional skills and training for quality supervisors in metrology and testing

Because the laboratory has not made clear provisions on the qualifications of quality supervisors and has not provided relevant quality management training to supervisors before authorization, quality supervisors lack comprehensive and systematic theoretical knowledge of quality management and are unfamiliar with the significance, purpose, object, content, and process of quality supervision work, and are unable to discover quality problems or potential non-conformities in the operation of the system; there are deviations in the understanding of standards, and the scope and focus of supervision are biased, resulting in the lack of obvious daily supervision effects and failure to play the due role; the description of non-conformities in supervision records is not standardized, and the ability to deal with non-conformities is still relatively lacking. After taking up their posts, quality supervisors also lack corresponding training and assessment, and cannot ensure that the supervisors' abilities and levels continue to meet the requirements.

2. Supervision object

In terms of the supervision object, there is a problem of unclear quality supervision objects. Personnel are the first resource of the laboratory. Only by controlling personnel well can the quality of laboratory products be ensured. It can be seen from GJB2725A-2001 that the object of quality supervision is "personnel engaged in testing, calibration or verification (including personnel undergoing training)".

Therefore, the quality supervision carried out by the laboratory is the supervision of personnel capabilities. The supervision object is people rather than things. The content of quality supervision should be closely centered on "personnel capabilities", while the objects of supervision in many laboratories are the environment, equipment, methods, etc.

3. Supervision procedures

(1) The procedural documents related to quality supervision are not perfect

The management regulations or procedural documents related to quality supervision in the laboratory are not perfect and not very operational. For example, the supervisor's job responsibilities, rights, and reporting channels for important issues are not clearly defined; the objects, content, methods, and timing of quality supervision are not documented; the supervision record form is not designed reasonably, and the information is not recorded completely, which leads to insufficient basis for quality supervisors to carry out their work, unplanned supervision, single methods, and high arbitrariness, resulting in some quality problems not being discovered and solved in time.

(2) Lack of evaluation of the effectiveness of quality supervision

The laboratory does not pay enough attention to the effectiveness of quality supervision work, lacks summary of daily supervision, and there is a phenomenon that the same non-conformity occurs multiple times. The problems found in quality supervision work are not used as input for management review, and play a small role in the continuous improvement of the laboratory quality management system. 2. Main countermeasures and measures

1. Improve the ability and quality of supervisors

Quality supervision work is both technical and managerial. Equipping personnel with corresponding qualifications is the organizational guarantee to ensure the implementation of quality supervision work. The laboratory should be equipped with quality managers and quality supervisors, and their responsibilities should be clearly defined. Based on the experience of quality supervision work in recent years, the clearer and more specific the job responsibilities of the laboratory supervisors are, the more conducive it is to the implementation of this work. If the quality supervisor is concurrently held by the "job operator", it should be ensured that the part-timer has enough time and energy to perform his duties. The qualifications and main responsibilities of quality supervisors are shown in Table 1.

The laboratory should strengthen the training of quality supervisors, focus on pre-job training and job training, so that quality supervisors can receive timely and sufficient guidance. The specific training content and methods are shown in Table 2. Through regular training, the supervisors' ability to find and solve problems, as well as their sense of responsibility and work mission can be continuously improved, so as to maximize the subjective initiative of supervisors.

2. Optimize the supervision procedure

Carrying out quality supervision is a continuous work, and how to organize and implement it involves a lot of content. In order to standardize and institutionalize this work, the laboratory should compile, revise and improve the "Quality Supervision and Management Procedure" as the basis for carrying out quality supervision work. The management procedure should include the following elements:

(1) Qualifications, job responsibilities, content and time requirements for training of various quality supervision personnel.

(2) Quality supervision objects.

(3) Supervision work process.

(4) The mode and main method of supervision and inspection.

(5) The frequency of supervision.

(6) The timing of supervision.

(7) The handling and improvement of non-conformity of supervision and inspection.

(8) Filling in and keeping supervision records.

(9) Summarization and evaluation of supervision work.

3. Do a good job in effectiveness evaluation

The quality manager should organize supervisors to summarize relevant records, regularly summarize and evaluate the rationality of the quality supervision plan and the overall situation of quality supervision in the laboratory. At the end of the year, a written summary should be submitted to the management review meeting, and the results of quality supervision should be used as the input of management review so that system managers can find opportunities for continuous improvement.

(1) Contents of quality supervision effectiveness evaluation

① Whether the quality supervisor records and reflects the supervision process truthfully. ②Whether timely measures are taken to deal with non-conformities found during quality supervision, and whether the measures are appropriate and effective.

③Whether non-conformities found in the previous quality supervision occur again in subsequent supervision and system operation.

(2) Methods for evaluating the effectiveness of quality supervision

①Judgment evaluation method. The authenticity of the supervision process and records of quality supervisors can be evaluated by the judgment evaluation method; secondly, for "abnormal situations" found during the supervision process that only need to be "corrected", after the rectification and follow-up verification are completed, the judgment evaluation method can be directly used to evaluate the effectiveness of the correction behavior.

②Comparative evaluation method. For a certain type of "abnormal situation" or a certain non-conformity, after taking certain preventive or corrective measures, continue to track in subsequent work, and analyze the frequency of the non-conformity by comparing the statistical data of different quarters or years to see whether it is "reduced", "continued to occur" or "increased", so as to evaluate the effectiveness of the correction measures.

③Statistical analysis method. Statistical analysis refers to the statistical analysis of "abnormal phenomena" or "non-conformities" found in the quality supervision of the laboratory within a certain period of time. Statistics can be made according to the category or position of "non-conformities". For the same type of "non-conformities" with high frequency, the root causes of their repeated occurrence should be analyzed, and the effectiveness of the corrective measures should be evaluated. If necessary, the laboratory should be advised to organize relevant internal training, or discuss and formulate other appropriate corrective measures; for positions with more "non-conformities", the causes should be found, and suggestions should be given to the staff of the position to take measures or make improvements.