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Problems and risks associated with laboratory instruments and equipment: 1. Instruments and equipment that affect each other when placed together cause interference, leading to inaccurate data. 2. If instruments and equipment are not calibrated/verified for an extended period, their accuracy cannot be guaranteed. 3. Instrumentation and equipment are not inspected during downtime, resulting in uncontrolled performance. 4. The instrumentation and equipment lack status indicators or have confusing indicators, making it easy to use them incorrectly. 5. The instruments and equipment lack safety protection devices, posing a safety risk to the operators. 6. The gas cylinders are not stored in a classified manner, and there are no fixed or leak-proof facilities, posing a risk of explosion. 7. The gas lines of the instruments and equipment are cluttered, posing a fire hazard. 8. There are no records of the use of instruments and equipment, making it impossible to trace any abnormalities that occur. 9. Incomplete archive information on instruments and equipment poses difficulties for maintenance. 10. The instruments and equipment lack strong exhaust systems, which can be harmful to the operators. Problems and risks in laboratory environmental control: 1. There are no temperature and humidity meters in the operation rooms and instrument areas, so the conditions of the experimental environment are not known. 2. There are no facilities for collecting and treating \"three wastes,\" posing a threat to the environment. 3. The room walls are peeling, the floor is rough, there is clutter everywhere, the countertops are messy, the overall environment is unpleasant, and there is a risk of dust contamination during experiments. 4. The laboratory lacks mandatory ventilation equipment, as well as fire prevention, waterproofing, corrosion protection, and first-aid facilities, posing a risk to personal safety. 5. Waste and equipment that has been out of use for a long time have not been removed from the testing site, posing a risk of misuse. 6. There is no record of environmental conditions during testing, making it impossible to reproduce the test results. 7. The logistics and personnel flow in the microbiology laboratory are not separated, and the shifts of the first, second, and third shifts are not standardized, posing a risk of cross-contamination. 8. Pathogenic microorganism laboratories lack biosafety equipment, posing a risk of pathogen infection to operators. 9. Workspaces that affect each other are not effectively isolated, which affects the accuracy of the detection results. 10. The use of offices, testing rooms, and instrument rooms together leads to cross-contamination, posing safety risks and threats to the accuracy of results. Issues and risks related to standards and reference materials: 1. Standards lack controlled identifiers, making it impossible to track all changes made to them; there is a risk of using outdated or obsolete standards. 2. There is no novelty search for standards over a long period of time; the replacement of old standards with new ones is not properly monitored, posing a risk of misuse of outdated standards. 3. Used standards that have not been retrieved or stamped with the \"fee paid\" mark may be misused. 4. The currently valid standards do not come with official printed versions, so there is a possibility of text errors. 5. There are no records of training on the new standards, so it is not possible to ensure that all relevant personnel have a thorough understanding of them. 6. The implementation of the new standard involves no approval process or records, and the technical supervisor fails to fulfill their responsibilities. 7. Storing reference materials together with other reagents poses a risk of cross-contamination. 8. There are no records of periodic checks for reference materials; their quality cannot be controlled, which affects the test results. 9. Reference materials lack legal certificates; their standard quality cannot be guaranteed, posing a risk of inaccurate results. 10. Storing standard substances in volumetric flasks poses a risk of decreased measurement accuracy. Problems and risks related to chemical products and consumables: 1. There is no list of qualified suppliers, so the quality of consumables cannot be guaranteed. 2. There is no system of dual-person dual-locking and usage tracking and supervision for highly toxic drugs, posing a **risk** associated with such drugs. 3. The controlled drugs are not stored under a system of two-person dual-locking, posing a **risk** related to these controlled drugs. 4. There are no records of requisitioning reagents and chemicals, and the management of such reagents and chemicals is inadequate. 5. Storing reagents in the same room as the operation area is harmful to the health of inspectors. 6. The reagent bottles lack sufficient labeling information, making it impossible to keep track of when the reagents expire and become ineffective. 7. The preparation of standard reagents was not carried out under constant temperature and humidity conditions; due to the thermal expansion and contraction of measuring instruments, the standard solutions could not be accurately prepared. 8. Bulk-purchased or high-volume reagents are no longer inspected and verified; substandard reagents can result in significant losses. 9. No risk analysis and assessment of consumable quality; substandard consumable quality can result in significant losses. 10. Reagents are not stored separately, posing a risk of cross-contamination ； Reagent rooms or cabinets lack strong exhaust facilities, which is harmful to the health of operators. Problems and risks in sample management: 1. Sample numbering is chaotic; there is no unified and unique identifier, leading to confusion. 2. During sample collection, there is no description of the sample intake status nor any risk assessment, making it impossible to trace issues when abnormal results occur. 3. The samples lack transfer cards, resulting in unclear responsibility for them. 4. The samples lack status indicators for pending inspection, in inspection, inspected, or retained, which may lead to missed inspections and repeated inspections. 5. Samples and retained samples are stored and monitored without classification, posing risks of cross-contamination and mold growth. 6. The recovery and disposal of tested samples are not carried out in a standardized manner; the technical supervisor fails to fulfill their responsibilities. 7. Using the sample room as an office poses safety risks. 8. The sample processing room and testing room are used interchangeably, posing a risk of cross-contamination. 9. There are no records of environmental monitoring for sample storage, posing a risk of sample damage. 10. The samples collected lack representativeness, and the sampling records are incomplete, which affects the test results. Issues and risks related to legal awareness: 1. Changes in the name and address of certain laboratories, as well as changes in the top management or technical responsible persons, are not reported to the authorities responsible for issuing licenses for such changes; furthermore, the power of attorney for laboratories that are not independent legal entities lacks provisions specifying that the legal entity is responsible for fulfilling legal obligations. 2. No documents proving the legal status of the laboratory were provided; there were also no authorized documents for the laboratory’s test report seal and for the use of its instruments and equipment. 3. Spot checks revealed that some test reports were issued during the interim period between qualification certification periods. 4. Some reports fall outside the items and scope of restrictions approved in the qualification certification certificate. 5. Lack of documentation proving the right to use the inspection site. 6. Personnel such as quality responsible persons and inspectors also work for other organizations. 7. Subcontracting has taken place in the laboratory, and a subcontract agreement exists, but it is not clearly specified in the system documents. Issues and risks related to the supervision of honest service: 1. In some laboratories, information such as the systems for providing honest service, the laboratory’s qualifications, its approved testing capabilities, procedural guidelines, and fee structures is not made available to clients. 2. No signs or measures indicating customer feedback collection points. 3. There is a lack of records showing proactive efforts to seek customer feedback and conduct analysis and evaluation thereof. 4. A recusal system for food inspection agencies has not been established. Problems and risks related to test reports and original records: 1. The information contained in some laboratory reports does not include all the necessary details as required by the evaluation criteria; there is no description of the sample’s condition, and information on the instruments and equipment used is missing. 2. The basis for inspection is not specific or clear. 3. The standard limits for the relevant test items are not specified in the technical requirements section of the inspection report, resulting in a lack of criteria for individual assessments. 4. No end marker, no seal across the margin. 5. The original records corresponding to the inspection report lack numbering. 6. Some original inspection records do not indicate the test date, lack the signature of the sample preparation technician, and show signs of arbitrary alterations. 7. The archiving of report copies is incomplete; power of attorney, sampling forms, transfer cards, and original records with the same number are archived separately. 8. The sample number in the test report does not match the sample number in the \"Sampling and Inspection Agreement/Sampling Record\". 9. The test report was approved by an unauthorized signatory. Issues and risks related to internal audits: 1. In some laboratories, the problem is that the content of the internal audit plans is not specific; internal audits are not carried out as planned, and such audits do not cover all elements and departments of the management system, including management staff. 2. Internal auditors do not hold internal auditor certificates; the internal audit checklists lack specificity, and the descriptions of inspection findings in these checklists are overly general. There is a lack of root cause analysis for identified nonconformities, and the reported nonconformities tend to avoid addressing the core issues. In practice, nonconformities identified during internal audits are not promptly and effectively rectified. 3. In some laboratories, the inputs for management reviews are insufficient; the analysis of work performance is inadequate, the review reports are perfunctory without any conclusions, effective improvement measures cannot be developed in response to the identified issues, and the results of those measures are not verified. Issues and risks in internal oversight 1. Oversight functions have not fulfilled their proper role in certain laboratories. This is mainly manifested in the lack of appointment documents for supervisors, an insufficient number of supervisors, and the fact that the professional capabilities of supervisors do not cover all the relevant testing areas. 2. There are no requirements or procedures for supervision in the system documents; no supervision work plan has been formulated. Daily supervision is not given due attention. For problems identified during supervision, no analysis of causes is conducted to formulate corrective measures, or no verification of the effectiveness is carried out after implementing such measures. 3. Some laboratories have not established and implemented a standard renewal system for the continuous tracking and regular review of standards in use, and still employ expired or invalid standards in testing. 4. A considerable number of laboratories have failed to confirm the standard changes and have not promptly gone through the procedures for such changes with the authorities responsible for accreditation.