Learn details of laboratory risk analysis

Problems and risks of laboratory equipment

i. Mutually influential instruments and equipment are placed together, interfere with each other, and the data are inaccurate.

ii. The instrument and equipment are not calibrated/verified for a long time, and the accuracy is not guaranteed.

iii. Instruments and equipment do not do period verification, performance does not support control.

iv. Instruments and equipment without status identification or identification confusion, easy to misuse.

v. Equipment without safety protection equipment, there is a safety risk to operators.

vi. There is no classified storage of gas cylinders, no fixed and leak-proof facilities, and deflagration risk.

vii. The air paths of instruments and equipment are crossed and disorderly, and there are fire safety hazards.

viii. There is no record of the use of instruments and equipment, and the abnormality cannot be traced back.

ix. The equipment file information is not complete, causing trouble to the maintenance.

x. There is no strong exhaust device, which is harmful to the operator.

Problems and risks of laboratory environmental control

i. There is no temperature and humidity meter between the operating room and the instrument, and the experimental environment conditions are not clear.

ii. No "three wastes" collection and treatment device, which poses a threat to the environment.  

iii. Room walls fall off, the ground is rough, clutter, mesa messy, the environment sensory is not good, there is the risk of dust pollution experiment, public number [laboratory ISO17025] remind, this kind of pollution is often difficult to find.

iv. The laboratory has no forced ventilation equipment, no fire, waterproof, anticorrosion and first aid facilities, and there is a risk of personal safety.

v. The used and long-term decommissioned equipment has not been cleared out of the testing site, and there is a risk of misuse.

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

vii. Microbiology laboratory logistics and human flow are not separated, the first shift, the second shift and the third shift are not standardized, there is a risk of cross contamination.

viii. There is no biosafety device in the pathogenic microbiology laboratory, and there is a risk of bacterial infection to the operator.

ix. There is no effective isolation of workspaces with mutual shadow, which affects the accuracy of detection results.

x. The office, testing room and instrument room are mixed and cross contaminated with each other, which may cause safety hazards and result accuracy risks.

Problems and risks of standards and reference substances

i. There is no controlled number of the standard, and all changes cannot be traced back after the standard is changed. There is a risk of misusing the old standard.

ii. Standards for a long time without novelty, standards for the new do not master, the public number [laboratory ISO17025] remind, update less than when the risk of misuse of old standards.

iii. The waste standards are not recovered or not stamped with the "cost" seal, which may be misused.

iv. The current effective standard has not purchased the formal board, there is the possibility of text error.

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

vi. The new standard has no approval procedures and records, and the responsibility of the technical director is not in place.

vii. The reference material is mixed with other reagents and there is a risk of cross contamination.

viii. There is no inspection record of the reference material during the period, and the standard quality is not controlled, which will affect the test results.

ix. The standard material can not be certified, the standard quality is not guaranteed, there is a risk of distortion of results.

x. There is a risk of loss of measurement accuracy when reference materials are stored in volumetric bottles.

Problems and risks of chemicals and consumables

i. No qualified supplier list, consumable quality is not guaranteed.

ii. There is no double-lock and use tracking supervision system for highly toxic drugs, and there is a risk of leakage of highly toxic drugs.

iii. Precursor drugs have not achieved double lock, and there is a risk of leakage of precursor drugs.

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

v. Reagents are stored in the same room as the operation room, which is harmful to the health of inspectors.

vi. Reagent bottle identification information is insufficient, reagent expiration failure control.

vii. The standard reagent was not prepared under constant temperature and humidity conditions, and the measurement was hot and cold, so the standard solution could not be registered.

viii. Batch purchase or dosage of large reagent has not been tested and verified, reagent unqualified will cause huge losses.

ix. No risk analysis and evaluation of consumables quality, consumables quality unqualified will cause huge losses.

x. The reagents are not stored in different categories, and there is a risk of cross-contamination. There is no strong discharge facility in the reagent room or cabinet, which is harmful to the health of the operator.

Sample management problems and risks

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

ii. When receiving samples, there is no sample status description and risk assessment, and abnormal results cannot be traced back.

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

iv. There is no status identification for the samples to be inspected, under inspected, inspected and retained, and there is the possibility of missed inspection and reinspection.

v. Samples and retained samples are not stored and monitored in different categories, and there are risks of cross contamination and mildew.

vi. The collection and disposal of samples after inspection are not standard, and the responsibility of the technical director is not in place.

vii. Sample room and office mixed, there is a security risk.

viii. Sample processing room and testing room are used together, there is a risk of cross contamination.

ix. Sample storage without environmental monitoring record, there is a risk of sample damage.

x. In the process of sample collection, the representative is not strong, and the sampling record is ominous, which affects the test results.

Problems and risks of legal consciousness

i. Individual laboratory name address, top management, technical responsible person change has not reported to the issuing authority for change procedures, the legal person of the non-independent legal person laboratory power of attorney lacks the legal person to bear legal responsibility content.

ii. The legal status of the laboratory is not provided; The special seal of laboratory inspection report and the use of instruments and equipment lack of authorization documents.

iii. Part of the test report is issued during the period when the qualification certification is connected.

iv. Some reports are not within the scope of the items approved by the qualification certification certificate.

v. Lack of documentation to verify the right to use the site.

vi. The person in charge of quality, inspectors and other personnel work in other units at the same time.

vii. Subcontracting has occurred in the laboratory, and there is a subcontracting agreement, but the provisions are not clear in the system document.

Problems and risks of honest service supervision

i. Individual laboratory integrity service system, laboratory qualification, approved inspection and testing capacity, procedures, charging standards are not disclosed to customers.

ii. No customer feedback site identification and measures.

iii. Lack of record of actively soliciting customer opinions and conducting analysis and evaluation.

iv. There is no avoidance system for food inspection institutions.

Problems and risks with test reports and original records

i. The information content of some laboratory reports did not cover the due information according to the requirements of the standards and specifications of the evaluation criteria, and there was no description of the sample status, and the information of the equipment used was missing.

ii. The inspection basis is not specific and clear.

iii. The standard limit value of relevant test items is not filled in the technical requirements column of the inspection report, and there is a lack of single determination basis.

iv. No end mark, no riding seal.

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

vi. Part of the original test records did not fill in the test date, there was no sample preparation test personnel signature, there was random alteration phenomenon.

vii. The copy of the report is not completely filed, and the power of attorney, sample list, circulation card and original record of the same number are filed separately.

viii. The sample number in the test report is different from that in the "Sampling Inspection Agreement/Sampling Record".

ix. The test report shall be approved by the non-authorized signatory.

Internal audit issues and risks

i. Individual laboratories are mainly reflected in the content of the internal audit plan is not specific, failed to carry out the internal audit according to the plan, the internal audit work does not cover all the elements and departments of the management system, such as the management, etc.

ii. The internal auditor did not obtain the internal auditor certificate, the internal audit checklist is lack of pertinence, the inspection description in the checklist is too general, the lack of cause analysis of the found nonconformance, the non-conformance out of the non-conformance, the actual work of the non-conformance found in the internal audit is not timely and effective rectification.

iii. The input of individual laboratory management review is not sufficient, the analysis of working conditions is not in place, the review report is perfunctory, there is no review conclusion, for the problems found can not develop effective improvement measures and the improvement measures results have not been verified.

Problems and risks of internal supervision

i. Supervision was not as effective as it should have been in individual laboratories. It is mainly manifested in the lack of appointment documents of supervisors, the insufficient number of supervisors, and the professional ability of supervisors can not cover the testing field involved.

ii. There are no requirements and procedures for the supervision work in the system documents, no supervision work plan, no attention to daily supervision, no analysis of the causes of the problems found in the supervision, and no corrective measures, or no effect verification after the implementation of corrective measures.

iii. Some laboratories have not established and implemented the standard novelty checking system of continuous tracking and periodic cleaning and inspection of the standards in use, and the expired and invalid standards are still used in the inspection.

iv. A considerable number of laboratories did not make the standard change confirmation, did not timely to the qualification certification management department for standard change procedures.