As a quality supervisor, how can one carry out work more effectively?

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As a quality supervisor involved in daily testing and inspection work in the laboratory, how can one carry out quality supervision effectively? This is a common issue that deserves the attention of all my colleagues and peers. I would like to bring it up for discussion with everyone; please feel free to offer any criticism or suggestions if there are any shortcomings. What is quality supervision? Quality supervision is aimed at ensuring compliance with various requirements (regulations and laws, standard requirements, customer requirements, contractual requirements, requirements set by regulatory authorities, requirements of accreditation/certification bodies, laboratory management requirements, etc.). It requires continuous monitoring and verification of the entity’s conditions (organizations, processes, personnel, systems, products, etc., as well as any combination of these elements), as well as analysis of records. How should we carry out and implement quality control for the work in our laboratory? First, we need to figure out what products are offered and produced by our laboratory? Here are several questions that we all should consider: “a. What products/services do we offer?” b、Who are our customers? c. What do our customers want? d. Are the requirements specific? e. Which key processes need improvement? ” How should quality supervisors carry out their work during the process of producing products in the laboratory, and what are the main aspects they need to supervise? The key points for control are first the five aspects of \"people, machinery, materials, methods, and environment\". In the ISO/IEC 17025 standard, \"Criteria for the accreditation of testing and calibration laboratories,\" \"Personnel\" is identified in the \"Technical requirements\" section as the primary factor determining the accuracy and reliability of laboratory tests. Strict requirements are placed on the personnel in testing laboratories in terms of technical competence, experience, necessary expertise, training and education, job responsibilities, and impartiality. Therefore, the human factor is the most important element: personnel qualifications and their maintenance, familiarity with operation instructions and their compliance, adherence to inspection procedures/specifications, equipment operation status, compliance of the environment and facilities, sample labeling, sample preparation as well as the availability of reagents and consumables, sampling plans and their implementation (whether the sampling plans are available on-site), verification of original records and data, data processing and interpretation, assessment of uncertainty, and the preparation of result reports. These are the main areas of supervision for the supervisors. Why is it necessary to carry out quality supervision in laboratories? Since the laboratory management is fully responsible for the quality of laboratory data and results, including bearing legal responsibilities. Moreover, quality activities are carried out by employees from various functional departments. Although each functional department has defined its responsibilities and there is a complete set of quality control methods and procedures, do they follow these procedures strictly, and are these procedures truly effective? Therefore, the laboratory management needs a group of independent personnel to carry out quality oversight on the key activities/personnel that affect product quality, so as to identify weaknesses in quality control in a timely manner, propose improvement measures, and ensure the effective implementation of quality control. The purpose of our supervision is one of the means to assess the capabilities of various personnel, ensuring continuous improvement. Therefore, quality supervisors play a crucial role in continuous improvement. Through quality supervision and continuous improvement, reliance on supervision is enhanced to boost the effectiveness and efficiency of the quality management system and processes, in order to meet the growing and evolving needs and expectations of customers and other stakeholders. Only through continuous improvement can a laboratory’s quality management system operate effectively on an ongoing basis, while also being continuously refined and improved (the ways to achieve continuous improvement include external and internal audits) ； Daily supervision, quality control, customer feedback, etc.) – only in this way can the laboratory continue to improve. Quality supervisors should be appointed by the organization and exercise their powers; it should not be a mere formality – this is precisely the problem that makes it difficult for quality supervisors in some organizations to carry out their duties. The key targets for quality oversight should be the inspection personnel (including contracted staff, additional technical personnel, and critical support staff), especially those who are under training, newly hired employees, and those on short-term contracts; effective and sufficient supervision must be applied to them. Effective supervision is necessary to ensure work quality. Quality supervisors should themselves be professional technical personnel; managers are not suitable to serve as supervisors. They should understand the purpose of testing, be familiar with the testing methods and procedures, and know how to evaluate the results. Generally, supervision should be carried out by senior technical personnel, that is, individuals at a higher level, or at least those at the same level. How can effective and sufficient supervision be achieved? I. Supervisors must have sufficient competence; they should possess adequate professional knowledge. If possible, it is best for supervisors at a higher level to oversee those at a lower level. The requirements for supervisors are: (1) familiarity with testing methods, such as \"range of application, principles, instruments, analysis steps, result calculation, and the relationships between various methods.\" ” Example: Inspector Mr. Li supervised the instruments; he found that the calibration certificate for the gas chromatograph with serial number KA-020 (certificate number XXXXXXXX) did not contain any calibration data related to the electron capture detector (ECD), yet this detector is still used for the routine detection of BHC and DDT in samples ； Conclusion: Does not meet the requirements for instrument calibration/verification. Reason for analysis: Since the ECD and FPD detectors share the same gas chromatograph, only the FPD detector was calibrated, while the calibration of the ECD was neglected. Corrective actions and implementation of improvements: The detector was sent for inspection. In the future, more detailed calibration/verification requirements need to be specified for instrument calibration. (2) Understand the purposes of testing, such as \"evaluation (including product quality assessment), supervision testing, routine monitoring, and quality control assessments, which include blind sample testing, operational demonstrations, on-site questioning, retesting of retained samples, comparison among personnel, participation in proficiency testing, quality control charts, job rotation, etc.\" ” (3) Understand the inspection procedures such as “sampling (or sample submission), sample division, sample pretreatment, inspection, verification, recheck, issuance, etc.” ” Example: Quality control for sampling of drinking water – GB/T 5750.2-2006 \"Standard test methods for drinking water – Collection and preservation of water samples.\" The purpose of quality control in water sample collection is to take measures to prevent the samples from being contaminated or deteriorating during the collection process. Quality control methods: on-site blanks, transportation blanks, on-site parallel samples, on-site spiked samples, or quality control samples; quality control must be taken into account throughout the sampling process. II. The number of supervisors must be sufficient. The ratio between the number of supervisors and those in technical professional positions is generally 1:5 to 1:10, and different types of testing tasks (such as food testing, water quality testing, environmental testing, air testing, etc.) require their own supervisors. III. The powers of supervisors must be sufficient so that they can point out issues on the spot and order immediate corrections ； When it is difficult to handle situations that do not meet the requirements for work, one can report directly to the quality supervisor or technical supervisor so that corrective actions can be taken promptly ； The test report can be withheld if necessary ； When unsatisfied with the effectiveness of the corrective actions, it is possible to put forward suggestions for improvement through communication with relevant personnel. IV. The scope of supervision must be sufficient such that, within one year (or one certification/acknowledgment cycle), supervision should cover all testing personnel in the laboratory, including contracted staff, additional technical personnel, and key support staff, especially those who are under training. V. The work positions of supervisors should facilitate supervision tasks. In special circumstances where temporary staff have not yet received the necessary training, they should work under the supervision of quality supervisors ； Sampling and testing in mobile laboratories, sampling sites, and field locations must be carried out under the effective supervision of technical control and oversight personnel. How do supervisors carry out quality supervision work? 1. During the operation of a quality management system, it is inevitable that certain activities and their outcomes deviate from the specified requirements; therefore, establishing a quality supervision network to ensure continuous and effective quality oversight is an essential aspect of the system’s operation. 2. The establishment of quality supervision points, the identification of key areas for quality oversight, and the intensity of supervision are all important factors that affect the effectiveness of quality supervision ； First, it is necessary to analyze the factors affecting the accuracy and reliability of the test results ； Factors that affect test results typically include personnel, instruments, consumables, testing methods, environmental conditions, and management systems ； Quality supervisors are assigned to these work stages, with their working methods clearly defined. 3. Continuously monitor these factors, or carry out irregular special and focused inspections; propose feasible corrective actions for any issues identified, and follow up to verify the implementation of those corrections. By continuously identifying and improving on issues in this manner, the quality management system is constantly enhanced. 　　 4. Verification of the inspection report: The inspection report represents the final result or conclusion of the entire inspection process. It not only reflects the quality and standard of the inspection work but also serves as the reward for fulfilling the responsibilities entrusted by the client. When reviewing inspection reports, it is necessary not only to check whether the reports are prepared in accordance with the quality documents, but also to conduct an analysis of the relevance of the test results in order to determine if there are any issues with the testing process. By identifying and resolving these issues, the continuous and effective operation of the system can be ensured. 5. Calibration and verification of instruments: Calibrating and verifying instruments is an important means of determining and confirming their performance, as well as ensuring the accuracy of the test results. Regularly inspecting the instruments to ensure their proper operation is a prerequisite for carrying out testing tasks. 6. Inspection and verification of consumable materials: Experimental consumable materials are important factors that affect the accuracy of test results. In addition to ensuring that these materials meet the required standards before they are used, laboratories should also continuously collect feedback from laboratory technicians and regularly verify these materials to ensure that they satisfy the necessary requirements. 7. Conduct regular supervision to ensure it is put into practice, and organize periodic intensive training for quality supervisors. Prepare a guidebook for the work methods of quality supervisors. By carrying out the tasks mentioned above and fulfilling our daily quality supervision responsibilities properly, we can ensure the quality of inspection work, thereby guaranteeing that the inspection reports (related to the products provided by the laboratory) are accurate and reliable. Appendix: Example – Daily supervision of the detection of hexavalent chromium in drinking water a. Check whether the relevant testing procedures comply with the requirements of standard methods (good observation skills). b. Correct any non-compliance immediately (accurate judgment). c. Analyze the reasons, implement corrections, specify requirements for improvement, and develop and put into effect corrective and preventive measures (significant results).  Quality supervisor Mr. Zhang conducted routine supervision of Inspector Li’s work related to testing hexavalent chromium in drinking water:  Inspector Li: Took samples to test for hexavalent chromium in the water.  Method used: Spectrophotometry.  Standard curve: The correlation coefficient R for the hexavalent chromium standard curve was 0.9983. Standard requirement: The quality control requirement for physicochemical testing of drinking water is R≥0.999.  Supervisor Engineer Zhang: The standard curve does not meet the requirements. The operator should correct it immediately.  Analyze the reasons: After the changes in the testing methods for drinking water standards, the department did not provide specialized training on GB/T 5750.3(2006), which resulted in the relevant technical staff having an insufficient understanding of the requirements regarding quality control in the physical and chemical testing of drinking water.  Formulate corrective actions and implement them.  Train relevant personnel in the department on the testing methods for drinking water quality standards as well as water quality analysis and quality control (GB/T5750.3-2006), so that they can master the requirements thoroughly and ensure the quality of tests