Answers to some typical questions in the laboratory

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Question 1: Is a quality supervisor responsible only for the specific work they oversee, or are they responsible for the entire supervised area? Answer: Requirements for a quality supervisor: 1. Understanding the purpose of testing; 2. Knowledge of testing methods and procedures; 3. Ability to interpret test results. It is true that a supervisor is responsible for the work related to a specific inspection, but they do not need to be responsible for the entire area of supervision. Just be responsible for the scope of his supervision. Question 2: Is it necessary to assess personnel’s skills in operating precision instruments and equipment, and how is such assessment carried out? Can one person be authorized to operate two different instruments? Answer: One person can be authorized to operate two different devices, and it is indeed necessary to assess personnel’s skills in operating precision instruments and equipment. The prerequisite for authorization is that the person possesses the necessary capabilities. First, it is necessary to assess whether the person can operate the instrument correctly. Second, consideration should be given to the person’s knowledge regarding the calibration of the instrument and its periodic verification, as well as their understanding of proper maintenance procedures. Third, the person’s experimental skills must be evaluated, to determine whether they are able to interpret the results produced by the instrument. For example, when conducting experiments using this instrument, assessments are made on both the process and the results, with scores assigned at various stages; these scores are then combined to determine the final assessment grade. Question 3: The laboratory stipulates that the management team consists of the director of the center, the quality officer, and the technical leader, and it also defines the responsibilities of each of them. Is it still necessary to specify the responsibilities of the management team separately? Answer: The management team is a collective composed of multiple positions. Its responsibilities are not to define individual duties, but to clarify its tasks and responsibilities: 1. The management team is fully responsible for the laboratory’s management. 2. It assumes leadership roles and must commit to impartiality. 3. It is responsible for establishing and operating the management system, ensuring that sufficient resources are allocated to it. 4. It sets policies and objectives. 5. It ensures that the management system is integrated into all laboratory activities. 6. It organizes management reviews. 7. It ensures the achievement of the laboratory’s quality objectives. 8. It ensures that the laboratory complies with legal/regulatory requirements as well as customer requirements. 9. It aims to enhance customer satisfaction. 10. It establishes a risk management system. Question 4: How does the management team exercise supervision? Is it necessary for managers to supervise one another? Answer: The purpose of supervision is to ensure experimental capabilities; if management does not take on experimental tasks, it can be involved in little or no supervision at all. Don’t think about supervision by management; focus instead on supervision by people within the management team, and assess it based on the tasks they undertake, through job analysis. There is no need for mutual supervision among managers. In a laboratory, supervisors should supervise those under their supervision, and supervisors should also supervise one another. Question 5: Which categories of personnel in inspection and testing institutions must enroll in social insurance? Answer: All laboratory staff are required to contribute to social insurance, except for those rehired after retirement. Question 6: If there is a change in the legal representative, must the appointment documents for the legal representative also be changed? Answer: The legal representative has changed, so the appointment documents need to be updated; the new legal representative must issue a new appointment. However, it is also possible for the new legal representative to fully approve the previous appointment documents issued by the old legal representative and issue a statement stating that they agree to those original appointments. Question 7: Regarding periodic reviews and the measures for control facilities, from which aspects should the review be conducted? Answer: 1. Equipment: Is there traceability? Has it been calibrated and verified? Are the results of such calibration and verification confirmed? Does the instrument have a unique identifier? Is maintenance carried out in a planned manner with proper records? Are the archives organized properly? Are the operation instructions for the equipment complete? Are there any faults with the equipment, and how are these faults handled? Are the environmental conditions in which the equipment operates satisfactory? Are the correction values/calibration factors applied? Are periodic checks of the equipment conducted on a regular basis? 2. Facilities: Generally, these have a direct impact on the results. 1) Are the facilities appropriately equipped? For example, is the illumination level of the lights adequate? 2) Are the facilities maintained regularly? 3) What environmental conditions do the facilities create? If these conditions are related to the results, they must be recorded and monitored. 3. Overall, the facilities should not have any adverse effects on the experimental results; they must ensure that the experimental conditions are met. Question 8: Can the instructor provide examples to explain how quality control and interim checks are carried out in the software industry (17020+17025)? Answer: Quality control can be carried out using comparison methods, as calibration is not possible. It can perform personnel comparison, instrument comparison, comparison between laboratories, and so on. Periodic checks can also involve comparisons; retesting of stable test subjects is carried out, with samples kept for further testing. Question 9: Can a testing agency issue a test conclusion simply by applying the judgment criteria? Is it the same as the test results issued by the testing agency? Answer: There is a big difference between inspection reports and test reports. If a testing laboratory applies for assessment criteria, those criteria can be used directly even if they do not include testing methods; no application is required in such cases. However, if testing methods are included, an application for approval is necessary. It’s not that a conclusion can be drawn just because there are criteria available; no, it depends on the agreement with the client. Question 10: What are the requirements regarding testing standards, certification/accreditation under CMA and CNAS? Answer: In the case of forensic testing, CNAS corresponds to CL08; for CMA, it is RB214 together with the forensic testing standards. If it is a test carried out by the laboratory itself, such as the identification of microorganisms, then the characteristic of such testing is qualitative judgment – either yes or no, presence or absence – which means that a descriptive report is sufficient. There is no need to consider measurement uncertainty; it is only necessary to identify the sources that affect measurement uncertainty. The other control requirements are the same; it’s just that the results differ, with qualitative outcomes being produced. Question 11: How is method validation carried out for on-site sampling and testing of flue gas and dust? Answer: 1. Verification of resources: Are the sampling devices available? Have checks been carried out before and after sampling with those devices? Are there any auxiliary facilities? Are there devices for transporting samples? If cold-chain transportation is involved, do we have what’s necessary for that? Do we have the reagents required for on-site sampling? Have the people responsible for sampling received training and do they possess the necessary qualifications? 2. Verification of technical specifications: The focus should be on the process itself. For example, in terms of personnel comparison, it is checked whether the differences in the sampling results are significant in order to determine accuracy. A real-world scenario can be simulated, and samples can be taken multiple times to determine whether there are significant differences in the sample results, thereby assessing precision. Question 12: When performing method validation, how can it be determined whether the values of precision and accuracy meet the standard requirements? Generally, the standard will specify the range of indoor and outdoor deviations measured by six laboratories; is this used as a basis for judgment? If not, how should we judge? Answer: This basis can be used to make the judgment. If the experimental standard does not provide any values for precision at all, then one can use the following method to assess precision: apply the Horwitz equation; the resulting coefficient of variation (relative standard deviation) should be less than the value predicted by the Horwitz equation. Accuracy can be determined using reference materials; it can be assessed within the range provided by those reference materials, and it is also possible to participate in proficiency testing or comparisons. Question 13: When creating quality control charts in the environmental laboratory of CMA, is it better to follow the CNAS-GL027 standard or the GB/T 4091 standard? What’s the difference between the two? Answer: GL027 primarily deals with the field of chemistry. 4091, on the other hand, is a general-purpose control chart that can be applied to many areas, such as various fields and production processes. Lecture 4091 is more detailed, and the verification is also better. It is recommended to consider GL027 and 4091 together, as both are relevant in some way. Question 14: What are the principles for formulating an internal quality control plan? Answer: The general principle is useful and effective. CL01 Clause 7.7. Question 15: If the capability verification results are suspicious, how should the laboratory handle them and what corrective actions should be taken? If laboratory tests cannot identify the cause, what should be done? If the proficiency testing results are unsatisfactory, after taking corrective actions, is it necessary to apply for proficiency testing again, or are other measures required to restore testing capabilities? Answer: Suspicious results; the Z-value is between 2 and 3. The Z-value for failed results is above 3. This result is usable; as long as it meets the requirements of this standard, it can be used, but corrective actions also need to be established. Try to analyze the reasons; don’t say that no reasons can be found. To find the cause, one should consider the following aspects: 1. Are the documents clear regarding various aspects such as the experimental process and quality control measures? 2. If the documents provide clear guidelines, then identify the reasons for non-compliance – is it a lack of resources, failure to acquire necessary items, carelessness on the part of personnel, environmental factors, issues with records, or problems with reagents? When analyzing the reasons, don’t work alone; you can consult with other lab members to pool our ideas. Consider all aspects to determine whether the corrective measures are effective, and then participate in capability assessments and measurement audits again. Note that if the proficiency testing fails, issuing reports for that item on a temporary basis should be suspended. Any issues identified in the proficiency testing must be resolved within 180 days; once resolved, the ability to issue reports for that item can be restored. Question 16: This year, our organization has arranged for some laboratories to conduct capability testing, and a plan needs to be developed. When it comes to data processing, I use both the Grubbs and Dixon methods to identify outliers; suspicious values are removed only if the results from these two methods agree. Is this approach acceptable? As for the determination of results, the Z-score method is used in most cases, but there are also the En-value method, the ζ method, and others. How should I choose? What are the criteria, and under what circumstances should each method be used? Also, how can the specified value be determined? What we do is capability verification for steel wires and ropes, using certified reference materials. Can this specified value be obtained directly? Similarly, can the σ in the denominator of the Z-score calculation also be obtained directly? Answer: For the data processing of proficiency testing, CNAS-GL002 on statistics for proficiency testing and Standard GB 28043 on statistical methods for proficiency testing can be referred to. Question 17: Teacher, what does on-site document management from a biosafety perspective refer to? How to do it? Answer: The complete set of guidelines can be found in CNAS’s documents; CL01A001 provides application instructions for the biological field. Question 18: How can risk management be effectively carried out at the laboratory site and documented? Could examples of \"risk and opportunity assessment analyses\" for laboratories be provided along with detailed document template materials? Answer: Risk management involves first identifying risks, then analyzing and assessing them, followed by implementing measures to address those risks, and finally evaluating the effectiveness of those measures. Question 19: For the RMP (Reference Material Producer) certification under CNAS, what are the requirements regarding the hardware setup, zoning, and instrument configuration in a molecular biology laboratory? Are there any reference standard documents? Answer: Currently, no reference standard documents can be found. Generally, zoning is required, with separate flow for logistics and people, etc. Question 20: Method standards usually include statements such as “It should be accurate to ***”, for example, “It should be accurate to 0.1 mm” when making measurements, and “The calculation results should be accurate to 0.1 mm”. For the same term, it is generally considered that a reading with a resolution of less than 0.1 mm meets the requirements in the former case, while in the latter case it is generally required that the value be rounded to 1 mm. Is there any basis for these statements? Answer: Don’t complicate things. If the original records state this, then it means that 0.1mm is the minimum precision; when making measurements, one decimal place can be estimated, such as 0.12mm and so on. If such a requirement is specified in the report, it usually states how many significant figures should be retained. If no such specification is given, rounding to 0.1 mm is acceptable. Question 21: How to calculate the average value of pH values? How do you read a graduated cylinder with a minimum scale interval of 0.2 ml? Answer: The average value of pH cannot be calculated directly. Instead, one must first back-calculate the hydrogen ion concentration, then take the average of those values, and finally convert it back to pH. Then it reads 0.2Xml; it could be 5.21ml, 5.62ml, and so on, but it cannot be 5.51ml, 5.12ml, etc. Question 22: The CMA evaluation does not cover all aspects and details stipulated in the CNAS accreditation requirements. If our company only undergoes CMA qualification certification, is it permissible to disregard the relevant CNAS requirements? Regarding the biosafety regulations in the field of microbial testing, is it possible to omit the requirement for a biosafety officer and a biosafety supervisor? There is also no need to develop biosafety control procedures. Answer: It is not necessary to incorporate them. First, note that the biosafety responsible person and biosafety supervisor are mentioned in CL01 A001. However, this industry still needs to appoint biological safety officers and safety supervisors, as this is essential for ensuring laboratory biological safety; alternatives can also be used in place of them, such as operational procedures or company policies. Question 23: For a triple-certified laboratory where all testing equipment is purchased by the laboratory itself, can this equipment be shared with people outside the laboratory? If possible, what are the requirements to use the instrument, and how should it be managed? Answer: According to CNAS regulations, the same device cannot be used by two laboratories simultaneously; it is possible to rent the device. First, the rental period must be long-term – CNAS requires at least two years. Second, the device must be managed in the same way as our own devices.