Common potential problems and risks in laboratories

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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 the 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 installations or leak prevention measures, 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 cause harm 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 unclear. 2. There are no facilities for collecting and treating waste, 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. Used and long-term unused equipment has 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. The laboratory for pathogenic microorganisms lacks biological safety equipment, posing a risk of germ infection to the 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 threatening the accuracy of the 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; it is not clear when old standards are replaced by new ones, which poses a risk of misusing outdated standards. 3. The obsolete standards are not retrieved or stamped with the “fee paid” mark, posing a risk of misuse. 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 verification for reference materials, and their standard quality is not under control, which affects the test results. 9. Reference materials lack official certificates; their standard quality is not guaranteed, posing a risk of distorted results. 10. Storing standard materials in volumetric flasks poses a risk of reduced 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 of their leakage. 3. The controlled drugs are not kept under a system of two-person dual-locking, posing a risk of their leakage. 4. There are no records of requisitioning reagents and chemicals, and the management of these 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. Reagents purchased in bulk or used in large quantities are no longer tested or verified; substandard reagents can result in huge 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 numbers are chaotic, lacking unified and unique identifiers, which leads to confusion. 2. There is no description of the sample intake status or risk assessment at the time of sample collection, 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 samples after inspection are not carried out in a proper manner, and the technical supervisor fails to fulfill his responsibilities. 7. Using the sample room as an office poses safety risks. 8. The sample handling room and the 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 issued 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. Some inspection reports were found to have been issued during the period of gap in the certification for qualification. 4. Some reports fall outside the items and scope limitations approved in the qualification certification. 5. Lack of documentation proving the right to use the testing site. 6. Personnel such as quality supervisors and inspectors also work at 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 regarding 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. No recusal system for food inspection agencies has been established. Problems and risks related to test reports and original records: 1. The information contained in some laboratory reports does not meet the requirements specified in the review 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 making individual judgments. 4. No end marker, no seal across the margin. 5. The original records corresponding to the inspection report are not numbered. 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 copies of the reports are not archived completely; power of attorney, sampling forms, transfer cards, and original records with the same number are filed 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 in 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 personnel. 2. The internal auditors do not hold valid auditor certificates; the internal audit checklists are not specific enough, with the descriptions of the inspection findings being too general. There is a lack of analysis regarding the reasons for the identified non-conformities, and the non-conformities noted are often treated superficially. In practice, the non-conformities identified during internal audits are not promptly and effectively addressed. 3. In some laboratories, the inputs for management reviews are insufficient; the analysis of work performance is inadequate, the review reports are perfunctory and lack concrete conclusions. Effective improvement measures cannot be formulated in response to the identified issues, and the outcomes of such 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 reflected in the lack of documents appointing supervisors, an insufficient number of supervisors, and the professional capabilities of these supervisors not covering all the testing areas involved. 2. The system documents do not specify the requirements and procedures for supervision work; no supervision work plan has been established, and daily supervision is not given due attention. For the issues identified during supervision, no efforts are made to analyze their causes and develop corrective actions, or no verification of the effectiveness of such corrective actions is carried out after they are implemented. 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 failed to conduct confirmation for standard changes and did not promptly go through the procedures for such changes with the authorities responsible for accreditation.