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1 Question: What are the differences between a technical manager and an authorized signatory in terms of qualification requirements and scope of responsibilities? Or rather, what exactly is the difference in meaning between these two positions? Can technical supervisors also serve as authorized signatories? Reference discussion: The mandatory requirements are the same; the requirements regarding work experience, length of service, and professional titles remain unchanged. However, the authorized signatory must also pass assessments conducted by relevant departments and obtain recognition from external institutions. The requirements regarding qualifications, scope of responsibilities, etc., are determined by the laboratory itself, but they can only be higher than the mandatory requirements and cannot be lower than them. The specific scope of job responsibilities should be defined by the laboratory itself. The conceptual difference is that the authorized signatory holds a purely technical position, being responsible only for the data in the report. In contrast, the technical supervisor, in addition to technical duties, may also be involved in technical management aspects, such as the management of equipment and quality control. Generally, the technical supervisor can serve as the authorized signatory; however, the authorized signatory is not necessarily the technical supervisor. 2. Question: Regarding personnel supervision in new projects, is it necessary to supervise each standard or each project? Or is it supervised for each individual? Reference discussion: To ensure that everyone applies each method correctly, if a single method involves multiple project parameters, and the operations related to these parameters are largely similar or nearly identical, it is sufficient to conduct supervision on just a representative sample of them. Question 3: From what aspects should supervisors oversee personnel involved in laboratory sampling and sample preparation? Reference discussion: There are many methods of supervision, including hands-on supervision, question-and-answer supervision, reviewing past records, observing previous work performance, and examining the records related to sampling and sample preparation this time. It is also possible to evaluate the parallelism of samples by having one person collect multiple samples, and so on. Do not forget to keep track of the storage of supervision records, as well as the evaluation and confirmation of supervision activities. Question 4: What is the minimum number of staff required for CMA and CNAS respectively? Which functions can be done part-time? Will both check employees’ social insurance? Reference discussion: There are no explicit requirements, but when applying for initial approval, an initial assessment is carried out to determine whether the applicant’s capabilities match the available resources. In a laboratory, multiple people can hold the same position, or one person can hold multiple positions. Generally, there is only one top manager, one technical supervisor, and one quality officer in a laboratory, but these roles can be held concurrently. CMA inspections are definitely carried out, and CNAS inspections are also usually conducted; the focus is on whether there are any unauthorized personnel working in the laboratory – it is required that only those who are employed by our laboratory may work there. In general, to determine whether auditors hold multiple jobs during an external audit, the best way is to check their social insurance records, as each person can be registered under only one social insurance account. 5 Question: How to distinguish between standard materials CRM and RM? Do quality control samples purchased from proficiency testing providers, such as those for peroxide value and total colony count, fall under CRM or RM? To which category do Dr.’s standards such as chloramphenicol belong? Reference discussion: Generally, it is believed that CRM is traceable while RM is not. If CRM can be used, it is recommended to give it priority over RM. CRM is a certified reference material, while RM is a reference material. The control materials provided by proficiency testing providers do not indicate whether they are CRM or RM; it is necessary to determine this oneself. Generally, capacity verification providers act merely as agents and are not necessarily the manufacturers. Our certified reference materials are usually produced by designated institutions under authorization, such as the National Institute of Metrology of China and the Ministry of Environmental Protection; the reference materials produced by these institutions are typically labeled as GBW (first-class reference materials) or GBWE (second-class reference materials), or GSB (standard samples). Additionally, reference materials produced by laboratories accredited under ISO 17034 are also traceable and fall under the CRM category. However, such manufacturers have certain limits on their scope of accreditation, allowing them to produce materials only within the boundaries of that accreditation. To determine whether it is CRM or RM, it mainly depends on whether the certificate specifies it. Dr. standard materials generally indicate on their certificates that they have passed ISO17034 accreditation, so we consider them to be CRM. If the standard purchased starts with the code BW, it is usually RM, not CRM. Try to purchase standards through official channels, as it is easier to obtain CRM in this way; for example, institutions such as metrology bureaus, the Ministry of Environmental Protection, steel research institutes, and geological and mineral research institutes. Question 6: Regarding Standard Material GL035, Clause 5.5.2 addresses the verification to be carried out during the unsealing of the standard material. For those without an established expiration date, it is necessary to determine their expected expiration date through stability tests. How are these stability tests conducted? How is the expected shelf life determined? Reference discussion: Generally, standard samples in the geology and mineralogy fields have no expiration date; as long as the environmental conditions are suitable, they are considered stable. Stability tests can be conducted several times at intervals, and then a T-test is used to determine whether there is a significant difference in the T-values obtained from the two tests. The estimation of the validity period is achieved, first, through experience, and second, through continuous experimentation or periodic verification. For the first time, you can set a date first, then check whether that date works, and make adjustments as needed. Question 7: One of the acceptance criteria for the reference material RM is the “number”; what does this number refer to? Reference discussion: The numbering is assigned by oneself; it can be the numbering of a standard substance or a numbering provided by the laboratory. In such cases, it is recommended that the laboratory establish certain requirements for filling out the form documents, providing guidance on what should be entered. You can write “Notes” below the table. 8. Question: Equipment: Must the name of the subcontracting company be indicated in the subcontracting project report? In microbial testing (such as air sediment bacteria), samples must be sent to the laboratory for cultivation within 4 hours after sampling. What should be done if the distance is too great and it’s not possible to deliver them within 4 hours? Is it possible to borrow an incubator? How should quality control of instruments and equipment be handled? Reference discussion: Generally, the names of subcontracting companies are indicated, specifying which projects were undertaken by each subcontractor. If delivery isn’t possible, it should be known at the time of accepting the order. If the standard requirements can’t be met, then it constitutes a deviation. When making the assignment, it’s necessary to clearly explain to the client whether they can accept such deviations. If the client agrees, both parties should sign off on it. It’s also important to mention these deviations in the report; if necessary, one should indicate any potential impact on the validity of the results. If there will be a deviation over the long term, it is better to use non-standard methods to handle it. It’s not allowed to borrow an incubator. Question 9: How should the accuracy of instruments verified using standard materials for equipment be evaluated? Reference discussion: The En value method is generally used in normal cases. Reference materials come with standard values and uncertainties. By using these reference materials to calibrate the instrument, an measurement value can be obtained. We can then evaluate the uncertainty of this measurement as well as the EN value; if this value is greater than 1, it is considered unsatisfactory ； If it is less than 1, then it is satisfactory. Question 10: The TTB incubation temperature for Salmonella in equipment is 42±1 degrees, while it is 41.5±1 degrees for Shigella. If only 42 degrees is calibrated, can 41.5 degrees be used for Shigella? Or can the incubation temperature for Shiga be set at 42 degrees? Or do both 42 and 41.5 have to be calibrated? Reference discussion: Shiga can be used, but it must be clearly specified in the original culture records that it was carried out at 42 degrees. It’s best to do both options. Better. 11 Question: Equipment: Should instruments be inspected or calibrated? How can one determine this? Besides checking the list of items subject to mandatory inspection, how can one distinguish them quickly? Can a calibration report be issued for instruments that require verification? Reference discussion: If the equipment to be calibrated is listed in the mandatory calibration catalog, and its intended use also meets the requirements for mandatory calibration, then it can be calibrated. Verification and calibration are determined by the laboratory. There were previous posts on the official account that you can check out. Items listed in the mandatory verification catalog must undergo mandatory verification; this service is provided free of charge, making it even more cost-effective. The rest is up to your own judgment. Generally, devices such as pH meters, balances, and pH testers do not have a fixed calibration value; in such cases, calibration can be performed. For example, incubators have a fixed operating temperature; it is advisable to calibrate them using this parameter. Of course, pH meters and balances can also be calibrated. It is possible to determine whether they meet our requirements by referring to the data on the calibration certificates. Generally, an inspection will yield a conclusion, while calibration merely provides objective calibration data. Calibration is usually carried out using actual samples, in accordance with relevant inspection procedures; however, it is not always done strictly in line with those procedures, as aspects such as repeatability and bias may not be checked. In such cases, it is necessary to communicate with the calibration agency to clarify things. Can instruments that require verification issue calibration reports? For us, **verification follows specific regulations; internationally, calibration is the standard practice. Apart from those listed in the mandatory verification catalog, we do not distinguish between instruments that must be calibrated and those that must be verified. Therefore, this issue does not arise – it depends solely on how we intend to use the instruments. Question 12: For equipment scales, does putting desiccant on them have a significant impact on the weighing results? It was kept on the side; the room temperature and humidity there are generally sufficient to meet the requirements. For reference: Mechanical balances used to require desiccants, but electronic balances these days generally don’t need them. In fact, using desiccants might affect the results, as this would result in a dry environment inside the balance while the outside is humid, which reduces stability. As long as the environmental conditions meet the balance’s requirements, that’s sufficient.