Consequences of problems with the quality management system

Quote: From the website of the State Food and Drug Administration (SFDA), it was learned that on June 23rd, the SFDA issued a notice requesting three enterprises to suspend production and rectify their operations due to the deficiencies of the quality management system in the flight inspections.

01 Jiangxi Hongxin Medical Devices Group Co., Ltd. suspended production for rectification

Recently, the State Food and Drug Administration organized a flight inspection of Jiangxi Hongxin Medical Devices Group Co.

One of the main deficiencies in the quality management system of the enterprise is the following:

The quality control department of the enterprise is understaffed, and one of the three staff members is the manager's representative and manager of the quality control department, and the other two are full-time laboratory technicians, which is not in line with the "Code for the Quality Management of Medical Devices Manufacturing" and the related appendix (hereinafter referred to as "the Code").

Second, the plant and facilities

The enterprise men's first shift and the second shift between the differential pressure gauge is not zero, women's first shift and the second shift between the differential pressure gauge is damaged, the door can not be closed, the intermediate library of the material transfer window can be opened at the same time on both sides, does not comply with the "norms of" in the enterprise should be based on the quality of the production of sterile medical devices, to determine the quality in the appropriate level of clean room (area), the enterprise should have a clean room (area).

Third, equipment

(a) the enterprise particle counter (device number: C15-01), dust particle counter (device number: C28-01) of the measurement of the calibration certificate has passed the expiration date, does not comply with the "norms" in the enterprise should be equipped with appropriate measuring instruments. The range and accuracy of measuring instruments should meet the requirements of use, marked with its calibration expiration date, and save the appropriate records requirements.

(ii) the enterprise 2016 "purified water system verification report" in the total water supply port, the total water return port daily sampling for chemical testing and microbiological inspection, verification report schedule only May 30, 2016, June 6, June 13 inspection report, and did not mark the point of withdrawal of water; on-site cleaning room to open the point-of-use of purified water switch, the outflow of rust-colored water, does not meet the "norms" in the process water management should be developed.

Fourth, document management

Some non-controlled documents appeared in the scene, including paper and electronic version, does not meet the "norms" in the enterprise should establish document control procedures, systematic design, development, review, approval and issuance of quality management system documents requirements.

V. Design and development

(a) Comparison of the enterprise a two batch of product retention samples, the product of the inner packaging materials and filter traits have changed. Products to reduce the cleaning and drying process, the enterprise did not provide records of changes and risk assessment records, does not comply with the "norms" in the enterprise should be designed and developed to identify changes and maintain records. If necessary, design and development changes should be reviewed, verified and validated, and approved before implementation.

(ii) The enterprise has two ethylene oxide sterilization cabinets in use, and the 2017 Ethylene Oxide Sterilization Cabinet Verification Information shows that one was verified, and the equipment number was not recorded, which does not comply with the Code's requirement that the sterilization process (methods and parameters) and the Sterility Assurance Level (SAL) should be identified and a report on the confirmation of sterilization should be provided.

Six, production management

(a) part of the enterprise batch production records are incomplete, not standardized: such as the lack of recycled pellets crushed mixed records; extrusion post found that some of the records have been filled out the parameters of the production process, but production batch number, the source of pellets batch number column blank is not filled in; injection molding workshop on-site production records. Found that a number of records show that the first inspection has been qualified, but the personnel did not sign; temperature, pressure, operating hours and other process parameters recorded set values, not recorded the actual value, but also does not provide for the permissible range of fluctuation, does not comply with the "norms" in each batch of products should be production records, and to meet the requirements of traceability.

(b) enterprise injection molding workshop, production staff of plastic injection molding machine products for visual inspection, no qualified products, substandard products storage area, can not identify the product status; extrusion post, pulling the tube after cutting substandard products placed in a water basin, no substandard products marking; intermediate library no substandard products in and out of the storage records, does not meet the "norms" enterprises should be in the production process of marking the product The company's inspection status is not in line with the "norms" of the production process to identify the product's inspection status, to prevent the flow of unqualified intermediate products to the next process requirements.

Seven, quality control

Sampling of raw materials warehouse stored in some batches of PVC conduit material, polyethylene, ABS, no corresponding raw material inspection records and corresponding issuance, use of records, the scene found that the enterprise a batch of "one-time use of the infusion set with needle" products stored in the analysis library.

The enterprise has recognized the above defects in its quality management system. The enterprise above behavior does not meet the relevant provisions of the production quality management standard for medical devices, production quality management system has serious deficiencies, the State Food and Drug Administration instructed the Jiangxi Provincial Food and Drug Administration to order the enterprise to immediately suspend production and rectification of the violation of the "supervision and management of medical devices regulations" (State Council Decree No. 680) and related laws and regulations, according to law, and seriously dealt with. At the same time, the Jiangxi Provincial Food and Drug Administration was instructed to require the enterprise to assess the risk of product safety, which may lead to potential safety hazards, should be in accordance with the "Administrative Measures for the Recall of Medical Devices" (State Food and Drug Administration Decree No. 29), the provisions of the recall of the relevant products.

Until the enterprise to complete all the project rectification and by the location of the provincial Food and Drug Administration tracking review qualified before resuming production.

02 Tianjin Yangquan Medical Devices Co., Ltd. suspended production rectification

Recently, the State Food and Drug Administration organized a flight inspection of Tianjin Yangquan Medical Devices Co. During the inspection, it was found that the enterprise "medical device production license" on the registration of the two production address, but the enterprise medical device registration certificate is not timely for the change of registration matters, suspected of violating the "medical device registration management approach" of the relevant provisions. At the same time, the quality management system was found to have the following major deficiencies:

First, plant and facilities

The enterprise produces a large number of anhydrous ethanol per month, but the enterprise's two production addresses: one of the production address is a smaller hazardous materials warehouse, the other production address has no hazardous materials warehouse, and the two production addresses do not have a suitable dangerous goods

Second, the procurement

Check the enterprise procurement contract and procurement records, showing that a large number of resin purchased, but the enterprise ledger only a small amount of resin to receive the record, the amount of resin purchased and the amount of receipt of serious inconsistencies.

Data Ready
Data Ready is a video ready to be used as a standalone application.

Three, production management

(a) access to the production records of a batch of single-use blood perfusion device, the records of the cleaning fluid, washing fluid, chemical modification of the amount of records, the name of the material, the number of records, purification and film key processes, the absence of process parameters, the main equipment and the production environment, does not meet the "norms" of each batch of products should be the same as the "norms" of the production of the product. Specification" in each batch of products should have production records and meet the requirements of traceability.

(b) The enterprise stipulates that the finished product sterilization is carried out in the double-casement sterilization cabinet A between the 10,000-level area and the 100,000-level area, and the finished product is passed into the sterilization cabinet from the 10,000-level area, and then passed out from the 100,000-level area after sterilization. On-site inspection found that the enterprise part of the finished product sterilization in the 100,000-level area of the ` sterilization cabinet B, part of the product from the 10,000-level area passed into the 100,000-level area, in the 100,000-level area passed into the sterilization cabinet sterilization, does not comply with the "norms" should be to select the appropriate method of sterilization of products or the use of appropriate aseptic processing technology to ensure that the product is sterile, and the implementation of the requirements of the relevant regulations and standards.

Four, quality control

(a) the enterprise quality inspection room part of the inspection instruments, equipment expired, although has been entrusted to the relevant units for inspection, but has not yet obtained the relevant calibration or verification certificate, does not meet the "norms" in the enterprise should be regularly on the inspection instruments and equipment calibration or verification, and to be marked requirements.

(b) the enterprise documents provide for each production batch sampling and testing in accordance with the requirements of YZB / country 0936-2014 "single-use blood perfusion device", should meet the requirements of the 13 test items; the provisions of each raw material batch sampling and testing items, should meet the requirements of the 11 test items, did not provide evidence of non-tested reducing substances, evaporation residue of the test items, does not comply with the "norms" in the enterprise should be According to the mandatory standards and the technical requirements of the registered or filed products to develop product testing procedures, and issue the appropriate inspection report or certificate requirements.

V. Adverse event monitoring, analysis and improvement

Check the internal audit information, the enterprise regularly organized to carry out the internal audit, but the relevant audit records are not perfect, the "internal system audit checklist" "audit records" column blank, no on-site audit records.

The enterprise has recognized the above defects in its quality management system. The above behavior of the enterprise does not meet the relevant provisions of the production quality management standard for medical devices, the production quality management system has serious deficiencies, the State Food and Drug Administration has instructed the Tianjin Municipal Market and Quality Supervision and Administration Commission to order the enterprise to immediately suspend production and rectification of the violation of the "supervision and management of medical devices regulations" (State Council Decree No. 680) and related laws and regulations, according to law, and seriously dealt with. At the same time, the Tianjin Municipal Market and Quality Supervision and Administration Commission ordered the enterprise to assess the risk of product safety, which may lead to potential safety hazards, should be in accordance with the "Administrative Measures for the Recall of Medical Devices" (State Food and Drug Administration Decree No. 29), the recall of related products.

Until the enterprise to complete all the project rectification and by the location of the provincial Food and Drug Administration tracking review qualified before resuming production.

03 Zhejiang Sujia Medical Devices Co., Ltd. suspended production rectification

Recently, the State Food and Drug Administration organized a flight inspection of Zhejiang Sujia Medical Devices Co. During the inspection, it was found that the enterprise's quality management system mainly suffers from the following defects:

I. Plant and facilities

(a) The enterprise carried out reconstruction of the clean area in January 2017, and converted the original office into a 100,000-level clean area for nonwoven fabric cutting and sterilizing stick bonding, and the enterprise only provided the office to issue the approval of the The enterprise only provided the "Infrastructure Maintenance Sheet", and did not provide the "Engineering Change Application Sheet", change validation program and report issued by the Ministry of Production, the Ministry of Technology, the Ministry of Equipment, the Ministry of Quality Management and the Ministry of Regulations as required by the enterprise's "Engineering Change Management System" (No. SJ/ZD-45), which is not in line with the requirements of the "Code of Practice for the Manufacture of Medical Devices" and the relevant appendix (hereinafter referred to as the "Code") that the maintenance and Maintenance shall not affect the product quality requirements.

(b) The enterprise did not store single-use electronic analgesic pump control device parts and labeling in accordance with the specified area, does not meet the "norms" in the storage area should be in accordance with the pending inspection, qualified, unqualified, return or recall and other cases of zoning storage, to facilitate the inspection and monitoring requirements.

(c) enterprise 100,000 clean area of a workshop on the second floor and the first floor of the non-clean area between the packaging set up between the finished product chute, used to pass the finished product, but the clean area and non-clean area only a door closed. Passing finished products when the door is open, clean area directly connected to the non-clean area, the scene check the differential pressure meter shows 1 Pa, does not meet the "norms" in the air cleanliness level of different clean room (area) between the static pressure difference should be greater than 5 Pa, clean room (area) and the static pressure difference between the outdoor atmosphere should be greater than 10 Pa requirements.

(d) enterprise 100,000 clean area lighting fixtures with insects, 100,000 clean area between the men's second shift and hand-washing area of the door to the cleanliness of the direction of the low opening, does not comply with the "norms" in the production plant should be set up to prevent the dust, prevent insects and other animals from entering the facilities. Clean room (area) doors, windows and security doors should be closed, clean room (area) door should be opened to the direction of high cleanliness requirements.

Second, the equipment

(a) the enterprise provides for the use of product caps and other parts of the injection of water for fine washing, but the site check to see the injection of water at room temperature, not recycling way of storage, the other enterprise 100,000 clean area of the clean room in the injection of water and sanitary ware in the purification of the water pipeline in the presence of a dead section, does not comply with the "norms" should be determined by the process of water needed. The required process water should not be determined in accordance with the Code. When the production process using process water, should be equipped with appropriate water production equipment, and have measures to prevent contamination, when the amount is large should be piped to the clean room (area) of the water point. Process water should meet the requirements of product quality.

(b) the enterprise equipment operation record table shows that January 25, 2017 14:00 - February 3, 5:30 clean area air purification system continuous shutdown, the enterprise did not provide continuous shutdown for more than 8 days before re-opening the production of test or verification information, and did not provide the resumption of production before the environmental parameters of the clean area to test the records, can not confirm that Still can achieve the specified cleanliness level requirements, does not comply with the "norms" if the shutdown again after the opening of the air purification system, should carry out the necessary testing or verification, in order to confirm that still can achieve the specified cleanliness level requirements.

Third, document management

Sampling enterprises on January 3, 2017, 10,000 sterile testing room environmental monitoring records, including dust particle testing instrument machine playing the original record of 5.0μm detection value of 3530, exceeding the requirements of YY0033 ≤ 2,000, but the original data was altered to 1530, the conclusion is qualified, the enterprise did not comply with the "norms" if the shutdown again turn on the air cleaning system should be necessary to confirm that it still meets the requirements of the specified clean level. The conclusion of the judgment is qualified, the enterprise did not sign the name of the person who changed, the date and the reason for the change, does not comply with the "norms" in the record shall not be arbitrarily altered or destroyed, change the record should be signed name and date, and make the original information is still clear and recognizable, if necessary, should be explained to change the reason for the requirements.

Fourth, design and development

(a) in August 2016, the enterprise will be class A spare parts Ⅱ type circuit board production mode by their own patch changed to outsourcing patch, did not provide the process change review and validation records; check the enterprise spare parts purchasing list of the supplier of the memory changes, but in the bill of materials to show that the memory of the Supplier is still the original supplier unit, did not provide the supplier change related review records, does not comply with the "norms" in the enterprise should be on the design and development of changes in the identification and maintenance of records. If necessary, design and development changes should be reviewed, verified and validated, and approved before implementation.

(b) The micro-motor model specifications specified in the enterprise's bill of materials are inconsistent with the micro-motor model specifications in the enterprise's micro-motor parts and components price list, inspection record sheet and raw material supplier sample confirmation, and there are obvious differences between the two model specifications in the micro-motor specifications in terms of rated voltage, rated speed, no-load speed, starting torque, insulation resistance, axial clearance, but the enterprise did not provide the specific date of the change in model specifications, nor did it provide the change in

V. Procurement

(a) The factory test report (No. 170402) of PVC calendered film provided by the enterprise's raw material supplier does not cover the physical properties, vinyl chloride monomer and other testing items required by GB15593, and does not prove that the material complies with the national mandatory standards, and does not meet the requirements of the

(b) the list of spare parts of the enterprise A class materials micro-motor, micro pumps and infusion silicone tube suppliers in the list of qualified suppliers are included in the management of qualified suppliers for B class, does not meet the "norms" in the enterprise should establish a supplier audit system, and should be audited and evaluated by the supplier, if necessary, should be carried out on-site audits of the requirements.

(c) the enterprise micro pump and infusion silicone tube procurement quality agreement does not provide for raw material type specifications, LCD screen supplier bill of materials specified in the supplier and the procurement contract is inconsistent with the supplier, does not comply with the "norms" in the procurement should be clear procurement information, a clear statement of procurement requirements, including the type of purchased items, acceptance criteria, specifications and models, procedures, drawings and other content. . Procurement records should be established, including procurement contracts, raw material lists, supplier qualification documents, quality standards, inspection reports and acceptance criteria and other requirements.

(d) The bill of materials of the enterprise stipulates that the diameter of 2.8 infusion tubes used in the material grade for PVC lung tube material, but the enterprise did not provide the biological evaluation of the lung tube material records, does not comply with the "norms" should be purchased items should be inspected or verified, need to carry out a biological evaluation of the material, the procurement of goods should be the same as the biological evaluation of the material requirements.

Sixth, production management

Sampling enterprise a batch of electronic controller aging records, aging time is only 59-62 hours, does not meet the "electronic control analgesic pump Ⅱ controller assembly process card" (No.: SJ022-500A) in the 72-hour aging test. The above mentioned The above "electronic control analgesic pump Ⅱ controller assembly process card" shows that enterprises in the production of computer wire stripping machine to strip the insulation part of the power cord to reveal the conductive part of the (4mm long), the actual measurement of the power cord to reveal the conductive part of the only 3mm, does not comply with the "norms" in each batch (Taiwan) products should be production records, and to meet the requirements of the traceability.

VII, quality control

(a) the site found that the leakage current meter does not have a patient leakage current DC component of the detection function, the enterprise factory test report does not cover the mandatory standard GB9706 and the registered product standards require the patient leakage current DC component performance indicators. Enterprises "single-use electronically controlled analgesic pump finished product inspection procedures" (No.: SJ/GC-56) does not cover the GB9706 in the dielectric strength test requirements, finished product inspection report (No.: ZG-8.2.3-04), there is no dielectric strength test data and conclusions, does not comply with the "norms" in the enterprise should be based on mandatory standards and registered or filed products Technical requirements for the development of product testing procedures, and the issuance of appropriate inspection reports or certificates.

(b) enterprise PVC granules 5401T-A74B of the purchase records of blood transfusion (fluid) apparatus with PVC inspection certificate (Report No.: QSP-R-8.2.4-0446) without the official seal of the supplier, can not confirm the source of the inspection certificate, does not meet the "norms" in the inspection records should include incoming inspection, process inspection and finished product inspection records, inspection reports or certificates and other requirements. Report or certificate and other requirements.

(C) the enterprise did not according to the finished product sampling management system (No.: SJ / ZD-25) of the provisions of the one-time use of electronic control of analgesic pumps to focus on sampling, but also according to the system to provide sampling of the full performance of the product test report, does not meet the "norms" should be based on the characteristics of the product and the process of developing the management of sampling, sampling according to the provisions of the sampling, and to maintain sampling and observation records of the requirements.

Eight, sales and after-sales service

Sampling enterprises in May 2017, a batch of electronic control of analgesic pump sales records, records of product expiration date, does not comply with the "norms" in the sales records at least include the name of the medical device, specifications, models, quantities; production batch number, expiration date, date of sale, purchases, and so on. The unit name, address, contact information and other content requirements.

Nine, the control of nonconforming products

The enterprise did not prepare rework control documents, "electronic control of analgesic pump II controller assembly process card" (No.: SJ022-500A) in the rework requirements, re-inspection and re-verification of the content of specific provisions. Sampling enterprise a batch of electronic control analgesic pump Ⅱ controller production records (No.: SC-7.5.1-06), the number of repairs in the record and electronic controller failure report (No.: ZG-8.3-04) is inconsistent, and did not see the repair project and method, does not comply with the "norms" in the nonconforming products can be reworked, the enterprise should prepare rework control documents. Rework control documents include requirements for operating instructions, re-inspection and re-verification.

The enterprise has recognized the above defects in its quality management system. The enterprise above behavior does not meet the relevant provisions of the quality management standard for the production of medical devices, production quality management system has serious defects, the State Food and Drug Administration instructed the Zhejiang Provincial Food and Drug Administration according to law ordered the enterprise to immediately suspend production and rectification of the violation of the "supervision and management of medical devices regulations" (State Council Decree No. 680) and related laws and regulations, according to law, serious treatment. At the same time, the Zhejiang Provincial Food and Drug Administration was instructed to require the enterprise to assess the risk of product safety, which may lead to potential safety hazards, should be in accordance with the "Administrative Measures for the Recall of Medical Devices" (State Food and Drug Administration Decree No. 29), the provisions of the recall of the relevant products.

;