Laboratory construction involves not only the preliminary design and decoration of the laboratory, but also the later operation, maintenance and operation. Next, we will explain the common problems and risks of laboratory decoration in detail.

VI. Problems and risks of chemicals and consumables

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

2. Highly toxic drugs have not implemented the double-double lock and use tracking supervision system, and there is a risk of leakage of highly toxic drugs.

3. Precursor drugs do not realize double locks, and there is a risk of precursor drugs leakage.

4. There is no registration record of reagent drugs, and the management of reagent drugs is not in place.

5. Reagent storage and operation room are in the same room, which is harmful to inspector's health.

6. The identification information of the reagent bottle is insufficient, and the expired reagent is not controlled.

7. The standard reagents were not prepared under constant temperature and humidity conditions, and the measuring tools expanded and contracted with heat, and the standard solution could not be registered.

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

9. The quality of consumables has no risk analysis and evaluation, and unqualified consumables will cause huge losses.

10. Reagents are not stored in separate categories, which may cause cross-contamination risks; there are no forced drainage facilities in the reagent room or reagent cabinet, which is harmful to the health of operators.

V. Problems and risks of sample management

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

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

3. The sample does not have a circulation card, and the sample responsibility is unclear.

4. There is no indication of the status of samples to be inspected, inspected, inspected and retained, and there is a possibility of missed inspection and re-inspection.

5. Samples and retained samples are stored and monitored without classification, and there is a risk of cross-contamination and mildew.

6. After the inspection, the sample recovery and disposal are not standardized, and the responsibility of the technical person in charge is not in place.

7. Mixed use of sample room and office may cause safety risks.

8. Mixed use of sample processing room and testing room may cause cross contamination risk.

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.

VI. Issues and risks of legal awareness

1. The name and address of individual laboratories, the top management, and the technical person in charge have not been reported to the issuing authority for the change procedures. The legal person authorization letter of the non-independent legal person laboratory lacks the content of the legal person's legal responsibility.

2. The laboratory’s legal status certification documents are not provided; the laboratory’s inspection report special seal and the use of equipment and equipment lack authorization documents. 3. Part of the test reports were spot-checked and issued during the gap period of the qualification certificate.

3. Part of the report is not within the scope of the items and restrictions approved by the qualification certificate.

4. Lack of certification documents for the right to use the inspection site.

5. Quality supervisors, inspectors and other personnel work in other units at the same time.

6. The laboratory has been subcontracted and there is a subcontracting agreement, but the regulations are not clear in the system documents.

The above is about the common problems and risks of laboratory decoration (2). If you have more questions about laboratory construction and design requirements, please call, and Shanghai laboratory design expert CEIDI will answer you in detail. More laboratory design expertise can be obtained by clicking "Technical Support".