40 defects of medical equipment on-the-fly inspection

The flight inspection is an unannounced supervision and inspection carried out by the food and drug regulatory department against administrative counterparts.It has the characteristics of surprise, independence, and efficiency, and the frequency and intensity are increasing!

1.The appointment letter of the company manager representative has not been updated.
2.Idle metal cabinets are stored in the defective product area of ​​the finished product warehouse.
3.The "Procurement Control Procedures" formulated by the enterprise did not follow the requirements in the "Guidelines for Auditing Qualified Suppliers of Medical Device Manufacturers" to formulate audit points such as document review, purchase inspection, and on-site audit of suppliers.
4.The company did not perform the inspection of the extractables in accordance with the stipulated `` Incoming Inspection Rules '', but replaced it with the supplier's inspection report.
5.The product batch record provided with the batch number 19i02 is missing the record of the parameters of the packaging seal.
6.The employee's health file is incomplete, and there is no health file of the quality inspector Zheng in the file.
7.There is no buffering measure between the injection room and the intermediary intermediate warehouse, and there is no pressure difference monitoring, and the cleaning room enters through the intermediate warehouse to avoid cross-contamination.
8. There is no open door next to the air shower room. The electrical pipes in the clean room assembly workshop are cracked and unsealed.
9.For the processed products stored in the finished product warehouse area, the wall on one side of the warehouse is temporarily replaced by ground support, which cannot prevent insects and other animals from entering.
10.The ethylene oxide sterilization process confirmed by the company and the client confirms that the temperatures in the scheme and report are 50 ± 5 ℃ and 52 ± 3 ℃, respectively, and the report does not explain the factors of change; and the confirmed process epoxy The amount of ethane used is 15Kg ± 0.5Kg, but the provided sterilization process file is 7.5Kg ± 0.25Kg, which is inconsistent; the required temperature in the provided ethylene oxide sterilization batch record is 45 ~ 60 ℃, and the confirmation Inconsistent sterilization parameters.

11. There is no total water inlet in the water production system, and the conductivity monitoring records of purified water show that the actual conductivity monitoring value does not comply with the company's "conductivity ≤ 2uS / cm". 12. The inspector has no relevant learning experience and working experience in the inspection, But he served as the main inspection in the 20190903 single-use surgical kit inspection report.

13.Missing some employee health files.

14.The ethylene oxide tank scale at the sterilization workshop site is not measured; there is no ventilation facilities in the finished product warehouse and analysis room, and the finished product warehouse is not equipped with humidity control measures, and its temperature and humidity records are only recorded until August 10.

15.The unqualified product area of ​​the raw material warehouse stores irrelevant items, the recall area of ​​the finished product warehouse is not set, and the return area and the waiting area are not divided.

16.The production equipment has no obvious status identification.

17. (1) Three quality manuals were found on-site, there is no current and valid quality manual, and the invalid quality manual does not have a "discarded document" chapter in accordance with regulations; (2) Failure to comply with "Administrative Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices" Provide for updating of the adverse event management system.

18.When checking the purchase records of disposable surgical gowns, the list of purchased materials was not provided.

19. The sealing process in the batch production record does not indicate the process parameters (250 ± 5 ℃). The temperature, humidity, and vacuum values ​​of the "Ethylene Oxide Sterilization Instruction Card" do not match the standard parameters, and the effective sterilization time cannot be guaranteed for 12 hours.
20.The sterility test did not record the batch number and passage information of the positive strains of the control.

21.There is an operation table with falling wood chips in the cutting workshop.

 22.There is a directly exposed drain in the laundry room, which is not managed according to the floor drain.

23.The disinfection time regulations of the water storage system storage tanks and pipelines are not specified, and no records of disinfection are provided.

24. The disinfectants specified in the `` Standard Regulations for Cleaning and Disinfection of Class 100,000 Clean Areas '' stipulated by the company include 0.2% of Xinjieer, but its "Disinfectant Preparation and Use Regulations" does not include the preparation procedures for this concentration of disinfectants. ; And the information provided in the `` Clean Workshop Hygiene Cleaning Record '' does not include the name of the disinfectant, and some disinfectants are cross-used, and the use of disinfectants cannot be achieved.

25.The company did not clarify the frequency of initial product contamination monitoring.26.Operators did not verify their education qualifications when they entered the post.

27.The health files of some staff members are missing, some staff members' health certificates have not been reissued, and new recruits have not undergone physical examinations.

28. (1) The enterprise stipulates that the distance between the cargo space and the ground is not less than 15 cm in the raw material storage management regulations, but the actual storage environment does not meet the requirements; (2) non-woven fabrics for disposable medical surgical masks stocked in the raw material warehouse, no Identification (lot number, balance).

29.There is no obvious status mark for water making and air conditioning equipment.

30. The test results for the residual ethylene oxide in the factory inspection report of disposable medical surgical masks (batch number: 190716) did not record specific values.

31. The inspection report of the mask material (a type of non-woven fabric) with a batch number of 180302 obtained from the supplier without the inspection items of hydrostatic pressure and breaking strength does not meet the (zl-sop-16) purchase inspection specifications. Regulations.

32. Random inspection of batch production records of disposable medical surgical masks (batch number: 190526), ​​no recorder equipment number and process parameter records.

33.The number of disposable medical surgical masks in the 190526 batch of product release records that have not been released (the number of final storage, the number of retained samples).

34.The company has not kept relevant records of product recalls, such as recall evaluations and recall reports of unqualified products.

35.The enterprise has not recorded the reasons for the unqualified products (disposable medical surgical masks, disposable medical protective clothing) and the corrective and preventive measures taken.

36.Failure to provide record of preparation or use of disinfectant.

37.The purification system verification report provided did not specify the sampling requirements for dust particles and sediment bacteria in each workshop, and did not provide records of the original test results.

38.There is no stipulation on the acceptable levels of initial contamination bacteria and particulate pollution of primary packaging materials.

39.The company requires that purified water be sampled once a month, but cannot provide monthly test reports.

40.In the management regulations, the enterprise makes provisions on the observation records of the retained samples. The retained samples management regulations leave one product for each sterilized batch. A random inspection of batches of disposable medical surgical masks 090526 is required. One batch of this batch is left, which cannot meet the full performance inspection of the product. Requirements (9 are required for full performance inspection), and no sample observation records are provided.

Communicating with the inspector is not as much as possible.Some words may even have adverse effects.