What are the potential risks in the laboratory CNAS and CMA certification and accreditation system?

Date：2022-12-14 15:10:36Views：444

Problems and risks of laboratory instruments and equipment

1. Instruments and equipment that affect each other are placed together, interfere with each other, and the data is inaccurate.

2. Instruments and equipment are not calibrated/verified for a long time, and the accuracy is not guaranteed.

3. The instruments and equipment are not checked during the period, and the performance is not controlled.

4. Instruments and equipment have no status identification or the identification is confused, which is easy to be misused.

5. Instruments and equipment are not equipped with safety protection equipment, which poses a safety risk to operators.

6. Cylinders are not stored by category, without fixed and leak proof facilities, and have potential explosion hazards.

7. The gas paths of instruments and equipment are crossed and disorderly, which has potential fire safety hazards.

8. The use of instruments and equipment is not recorded, and the abnormality cannot be traced.

9. Incomplete information of instrument and equipment archives has caused troubles for maintenance.

10. There is no strong exhaust device for instruments and equipment, which may cause harm to operators.

Problems and risks of laboratory environment control

1. There is no temperature and humidity meter between the operation room and the instrument room, and the experimental environmental conditions are not clear.

2. There is no "three wastes" collection and treatment device, which poses a threat to the environment.

3. The room wall falls off, the ground is not rough, the sundries are placed in disorder, the table top is messy, the environmental sense is poor, and there is a risk of dust pollution experiment.

4. The laboratory has no forced ventilation equipment, no fire prevention, waterproof, anti-corrosion and first aid facilities, and there are personal safety risks.

5. The waste and long-term disused equipment is not cleared from the testing site, which may lead to misuse.

6. There is no record of environmental conditions during testing, and the testing results cannot be reproduced.

7. The logistics of microbiology laboratory is not separated from the flow of people. The first, second and third shifts are not standardized, and there is a risk of cross contamination.

8. There is no biosafety device in the pathogenic microorganism laboratory, so there is a risk of bacterial infection to operators.

9. The workspace with mutual shadow is not effectively isolated, which affects the accuracy of detection results.

10. The office, testing room and instrument room are mixed and cross polluted, with potential safety hazards and result accuracy risks.

Problems and risks of standards and reference materials

1. There is no controlled number for the standard, and it is impossible to trace all the changes after the standard is changed, so there is a risk of misuse of obsolete standards.

2. The standards have not been checked for a long time, and the standards have not been replaced by new ones. There is a risk of misusing the old standards.

3. The waste standards are not recovered or stamped with the stamp of "operation fee", which may be misused.

4. There is no formal version of the current effective standards, which may cause text errors.

5. There is no record of publicity and implementation of the new standard, which cannot ensure that all relevant personnel can accurately master it.

6. There is no approval procedure and record for the new standard, and the technical director is not responsible.

7. The reference materials are mixed with other reagents and there is a risk of cross contamination.

8. There is no intermediate verification record for reference materials, and the standard quality is not controlled, which has an impact on the test results.

9. There is no legal certificate for the reference materials, and the quality of the standards is not guaranteed. There is a risk of distortion of the results.

10. The storage of reference materials in volumetric flasks is at risk of decreasing the accuracy of measurement.

Problems and risks of chemicals and consumables

1. There is no list of qualified suppliers, and the quality of consumables is not guaranteed.

2. The highly toxic drugs have not achieved the system of double locking for two people and tracking and monitoring the use, so there is a risk of leakage of highly toxic drugs.

3. The precursor drugs have not been locked by two people, so there is a risk that the precursor drugs will leak out.

4. There is no record of receiving and landing reagents and drugs, and the management of reagents and drugs is not in place.

5. Reagent storage and operation room are in the same room, which is harmful to the health of inspectors.

6. The reagent bottle identification information is insufficient, and the expired reagent is out of control.

7. The standard reagent was not prepared under the condition of constant temperature and humidity, the measuring tool expanded with heat and contracted with cold, and the standard solution could not be registered.

8. If the reagents purchased in batches or used in large quantities are not re inspected and verified, unqualified reagents will cause huge losses.

9. There is no risk analysis and assessment on the quality of consumables. Unqualified consumables will cause huge losses.

10. Reagents are not stored by category and there is a risk of cross contamination; There is no forced discharge facility in the reagent room or reagent cabinet, which is harmful to the health of operators.

Problems and risks of sample management

1. The sample number is confused and there is no uniform and unique number, which is easy to be confused.

2. There is no description and risk assessment of incoming sample status when receiving the sample, and the abnormal results cannot be traced.

3. There is no circulation card for the sample, and the responsibility for the sample is not clear.

4. There is no identification for the status of samples to be inspected, under inspection, inspected and reserved, and there is a possibility of missing inspection and re inspection.

5. The samples and reserved samples are not classified for storage and monitoring, and there are risks of cross contamination and mildew.

6. The recovery and disposal of the inspected samples are not standardized, and the technical director is not responsible.

7. The sample room is mixed with the office, which has security risks.

8. The sample processing room is mixed with the testing room, which has the risk of cross contamination.

9. There is no environmental monitoring record for sample storage, and there is a risk of sample damage.

10. The sample collection process is not representative, and the sampling record is ominous, which affects the test results.

Problems and Risks of Legal Awareness

1. The change of the name and address, top management and technical director of individual laboratories has not been reported to the issuing authority for handling the change formalities, and the legal person's power of attorney of the non independent legal person laboratory lacks the content that the legal person bears the legal responsibility.

2. The legal status certificate of the laboratory is not provided; The special seal of the laboratory's inspection report and the use of instruments and equipment are lack of authorization documents.

3. It is spot checked that some test reports are issued during the gap between qualification certificates.

4. Some reports are not within the scope of items and restrictions approved in the qualification certificate.

5. Lack of documents proving the right to use the inspection site.

6. The quality director, inspector and other personnel work in other units at the same time.

7. The laboratory has been subcontracted, and there is a subcontract agreement, but the provisions in the system document are not clear.

Problems and Risks in the Supervision of Honest Service

1. The integrity service system, laboratory qualification, approved inspection and detection capability, handling procedures and charging standards of individual laboratories have not been disclosed to customers.

2. No site identification and measures for customer feedback.

3. There is a lack of records for actively soliciting customers' opinions and conducting analysis and evaluation.

4. There is no withdrawal system for food inspection institutions.

Problems and risks in test reports and original records

1. The information content of some laboratory reports did not cover the due information as required by the standards and specifications of the evaluation criteria, there was no description of the sample status, and there was no information about the instruments and equipment used.

2. The inspection basis is not specific and clear.

3. The standard limit value of relevant test items is not filled in the technical requirements column of the inspection report, and there is no single judgment basis.

4. There is no end sign or perforation seal.

5. The original records corresponding to the inspection report are not numbered.

6. Some of the original inspection records did not fill in the test date, did not have the signature of the sample preparation and test personnel, and were randomly altered.

7. The report copy is incomplete, and the power of attorney, sampling form, circulation card and original record with the same number are filed separately.

8. The sample number in the test report is inconsistent with that in the "Sampling Inspection Agreement/Sampling Record".

9. The test report shall be approved by the unauthorized signatory.

Problems and risks of internal audit

1. Individual laboratories mainly showed that the contents of the internal audit plan were not specific, the internal audit was not carried out as planned, and the internal audit did not cover all elements and departments of the management system, such as the management.

2. The internal auditor did not obtain the internal auditor certificate, the internal audit checklist was not targeted, the inspection description in the checklist was too general, the causes of the nonconformities found were not analyzed, the issued nonconformities were avoided, and the nonconformities found in the internal audit were not effectively rectified in time in the actual work.

3. The management review input of individual laboratories was insufficient, the analysis of work conditions was not in place, the review report was perfunctory, and there was no review conclusion. Effective improvement measures could not be formulated for the problems found, and the results of the improvement measures were not verified.

Problems and risks of internal supervision

1. The supervision did not play its due role in some laboratories. It is mainly reflected in the lack of appointment documents of supervisors, the insufficient number of supervisors, and the professional ability of supervisors can not cover the detection fields involved.

2. There are no requirements and procedures for supervision work in the system documents, no supervision work plan has been formulated, no attention has been paid to daily supervision, no cause analysis has been made for problems found in the supervision, and no corrective measures have been developed, or no effect verification has been conducted after the implementation of the corrective measures.

3. Some laboratories have not established and implemented the standard novelty checking system for continuous tracking and regular cleaning and inspection of the standards in use, and the expired and obsolete standards are still used in the inspection.

4. A considerable number of laboratories did not make standard change confirmation and did not go through standard change procedures in time with the qualification certification management department.

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