Consequences of problems with the quality management system

Introduction: From the website of the State Food and Drug Administration, we learned that on June 23, the State Food and Drug Administration issued a notice requiring three companies to The company stopped production for rectification because there were flaws in the company's quality management system during unannounced inspections.

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

Recently, the State Food and Drug Administration organized an unannounced inspection of Jiangxi Hongxin Medical Equipment Group Co., Ltd. During the inspection, it was found that the company's quality management system mainly had the following deficiencies:

1. Organization and personnel aspects

The company's quality control department was insufficiently staffed, and one of the three staff members was a manager. The representative of the manufacturer is also the manager of the quality management department, and the two are full-time laboratory technicians. Enterprises that do not comply with the "Good Manufacturing Practice for Medical Devices" and related appendices (hereinafter referred to as the "Specification") shall be equipped with professional and technical personnel and management personnel that are suitable for the products they produce. Personnel and operators shall have the requirements of corresponding quality inspection agencies or full-time inspection personnel.

2. Factory buildings and facilities

The pressure difference gauge between the first and second men’s watch of the company did not return to zero, the pressure difference gauge between the first and second women’s watch was damaged, and the door It cannot be sealed. Both sides of the material transfer window of the intermediate warehouse can be opened at the same time. Enterprises that do not comply with the "Specifications" should determine the production process in the corresponding level clean room (area) based on the quality requirements of the sterile medical devices produced. Requirements to avoid contamination in production.

3. Equipment aspects

(1) Measurement calibration of enterprise particle counter (equipment number: C15-01) and dust particle counter (equipment number: C28-01) The certificate has expired and does not comply with the "Specifications". Enterprises should be equipped with appropriate measuring instruments. The range and accuracy of measuring instruments should meet the requirements for use, their calibration validity period should be marked, and corresponding records should be kept.

(2) The company's 2016 "Purified Water System Verification Report" stipulates that the main water supply inlet and the main return water inlet should be sampled for chemical testing and microbial inspection every day. The appendix to the verification report is only May 30, 2016. , inspection reports on June 6 and June 13, and the water intake point was not marked; the purified water use point switch was turned on in the on-site cleaning room, and the outflowing water was rust-colored, which did not comply with the "Specifications" and a management document for process water should be formulated. Process water storage tanks and delivery pipelines should meet product requirements and be regularly cleaned and disinfected.

4. Document Management

Some uncontrolled documents appear on-site, including paper and electronic versions. Enterprises that do not comply with the "Specifications" should establish document control procedures and systems. Design, develop, review, approve and issue quality management system documents.

5. Design and development

(1) Comparing the samples of two batches of the company's products, the inner packaging materials and filter properties of the products have changed. The product reduces cleaning and drying processes, and the company does not provide change records and risk assessment records. Companies that do not comply with the "Specifications" should identify and maintain records of design and development changes. Where necessary, design and development changes should be reviewed, verified and validated, and approval requirements should be obtained before implementation.

(2) The company has two ethylene oxide sterilization cabinets in use. The 2017 "Ethylene Oxide Sterilization Cabinet Verification Data" shows that one was verified, and the equipment number was not recorded, which does not meet the requirements. The "Specifications" should clarify the sterilization process (methods and parameters) and sterility assurance level (SAL), and provide requirements for sterilization confirmation reports.

6. Production management

(1) Parts of the enterprise’s batch production records are incomplete and irregular: for example, there is a lack of crushing and mixing records for recycled pellets; it was found that some extrusion posts have been The records of production process parameters have been filled in, but the fields of production batch number and granule source batch number are left blank; in the on-site production records of the injection molding workshop, multiple records were found showing that the first inspection has passed, but the personnel did not sign; temperature, pressure, operation time, etc. The process parameters record the set values, but do not record the actual values, and do not specify the allowable floating range. Each batch of products that does not comply with the "Specifications" should have production records and meet traceability requirements.

(2) In the injection molding workshop of the enterprise, the production staff conducts visual inspection of the plastic injection molding machine products. There is no storage area for qualified products and unqualified products, and the status of the products cannot be identified; at the extrusion position, after the drawing tube is cut Unqualified products are placed in a water basin with no unqualified product markings; there are no entry, exit and storage records of unqualified products in the intermediate warehouse. Enterprises that do not comply with the "Specifications" should mark the inspection status of the products during the production process to prevent unqualified intermediate products from flowing down the road. Process requirements.

7. Quality Control

Random inspection of some batches of PVC pipe materials, polyethylene, and ABS stored in the company’s raw material warehouse found no corresponding raw material inspection records and corresponding issuance and use records. On-site It was found that a certain batch of "disposable infusion set with needle" products of the company were stored in the analysis library, but additional semi-finished products of the above batch of products were found in the ethylene oxide sterilization cabinet (equipment number A07-03), and the source cannot be traced , each batch of products that do not comply with the "Specifications" should have inspection records and meet traceability requirements.

The company has confirmed the above-mentioned defects in its quality management system. The above-mentioned behavior of the enterprise does not comply with the relevant provisions of the Medical Device Production Quality Management Standards, and the production quality management system has serious flaws. The State Food and Drug Administration instructs the Jiangxi Provincial Food and Drug Administration to order the enterprise to immediately stop production and make rectifications in accordance with the law. Regulations on the Supervision and Administration of Devices (State Council Order No. 680) and related laws and regulations will be dealt with seriously in accordance with the law. At the same time, the Jiangxi Provincial Food and Drug Administration is instructed to require the company to evaluate product safety risks. For products that may cause safety hazards, they should be recalled in accordance with the "Measures for the Management of Medical Device Recalls" (State Food and Drug Administration Order No. 29) Related products.

Production can only be resumed after the company has completed all project rectifications and passed the follow-up review by the local provincial Food and Drug Administration.

02 Tianjin Yangquan Medical Equipment Co., Ltd. stopped production for rectification

Recently, the State Food and Drug Administration organized an unannounced inspection of Tianjin Yangquan Medical Equipment Co., Ltd. During the inspection, it was found that the company's "Medical Device Production License" listed two production addresses, but the company's medical device registration certificate failed to change the registration items in a timely manner, which was suspected of violating the relevant provisions of the "Medical Device Registration Management Measures." At the same time, it was found that the quality management system mainly has the following defects:

1. Factory buildings and facilities

The company uses a large amount of anhydrous ethanol every month for production, but the company has two production addresses Medium: One of the production addresses has a small dangerous goods warehouse, the other production address does not have a dangerous goods warehouse, and the two production addresses do not have suitable dangerous goods storage areas, which does not comply with the "Good Manufacturing Practice for Medical Devices" and related appendices (hereinafter referred to as " "Specification") stipulates that factories and facilities should be reasonably designed, laid out and used according to the characteristics of the products produced, the process flow and the corresponding cleanliness level requirements.

2. Purchasing

Checking the company’s purchasing contract and purchasing records showed that a large amount of resin was purchased, but the company’s material picking ledger only had a small amount of resin receiving records. The amount of resin purchased was different from the amount of resin purchased. The amount received is seriously inconsistent. In addition, a large number of bagged resins and barreled resins with special company quality inspection seal labels were found in the warehouse next to the company's raw material warehouse without corresponding records. They did not meet the "Specifications" and the procurement records should meet the traceability requirements.

3. Production management

(1) Check the company’s production records for a certain batch of disposable hemoperfusators. The records do not include the amount of cleaning fluid, washing fluid, and chemical modification. Records, there is no record of the name and quantity of materials, and there is no record of process parameters, main equipment and production environment for key processes of purification and film. Each batch of products that do not comply with the "Specifications" should have production records and meet traceability requirements.

(2) The enterprise stipulates that the sterilization of finished products should be carried out in the double-door sterilization cabinet A between the 10,000-level area and the 100,000-level area. The finished products are introduced into the sterilization cabinet from the 10,000-level area and sterilized. The virus came from the 100,000-level area. On-site inspection found that some of the company's finished products were sterilized in sterilization cabinet B located in the 100,000-level area. Some products were transferred from the 10,000-level area to the 100,000-level area, and then transferred to the sterilization cabinet for sterilization in the 100,000-level area. If the product does not comply with the "Specifications", appropriate methods should be selected to sterilize the product or appropriate aseptic processing technology should be used to ensure the sterility of the product, and the requirements of relevant regulations and standards should be implemented.

4. Quality Control

(1) Some of the inspection instruments and equipment in the enterprise’s quality inspection room have expired. Although the relevant units have been entrusted with inspection, the relevant calibration or verification certificates have not yet been obtained. Failure to comply with the requirements in the "Specifications" that enterprises should regularly calibrate or verify inspection instruments and equipment and label them.

(2) Enterprise documents stipulate that sampling inspection of each production batch shall comply with the requirements of YZB/National 0936-2014 "Disposable Hemoperfusion Device" and shall meet the requirements of 13 testing items; stipulate sampling inspection items of each raw material batch , should meet the requirements of 11 test items, and no evidence is provided for the test items of reducing substances and evaporation residues that are not inspected. Enterprises that do not meet the "Specifications" should formulate product inspections based on mandatory standards and registered or filed product technical requirements. procedures and issue corresponding inspection reports or certificates.

5. Adverse event monitoring, analysis and improvement

Check the company’s internal audit data. The company regularly organizes internal audits, but the relevant audit records are incomplete. The "Internal System Audit and Inspection" The "Audit Record" column in the "Table" is blank, there is no on-site audit record, it is inconsistent with the requirements of the company's procedural documents, and it does not comply with the "Specifications". The company should establish internal audit procedures for the quality management system and stipulate the audit criteria, scope, frequency, participants, Methods, recording requirements, assessment of the effectiveness of corrective and preventive measures, etc., to ensure that the quality management system meets the requirements of this specification.

The company has confirmed the above-mentioned defects in its quality management system. The above-mentioned behavior of the enterprise does not comply with the relevant provisions of the medical device production quality management regulations, and the production quality management system has serious defects. The State Food and Drug Administration has instructed the Tianjin Municipal Market and Quality Supervision and Administration Commission to order the enterprise to immediately stop production and make rectifications in accordance with the law. Any violation of the " Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680) and related laws and regulations will be dealt with seriously in accordance with the law. At the same time, the Tianjin Municipal Market and Quality Supervision and Administration Commission is instructed to require the company to evaluate product safety risks. For those that may cause safety hazards, it should follow the provisions of the "Medical Device Recall Management Measures" (State Food and Drug Administration Order No. 29). Recall related products.

Production can only be resumed after the company has completed all project rectifications and passed the follow-up review by the local provincial Food and Drug Administration.

03 Zhejiang Sujia Medical Equipment Co., Ltd. suspended production for rectification

Recently, the State Food and Drug Administration organized an unannounced inspection of Zhejiang Sujia Medical Equipment Co., Ltd.

During the inspection, it was found that the company's quality management system mainly had the following deficiencies:

1. Factory buildings and facilities

(1) The company renovated the clean area in January 2017. The original office was converted into a 100,000-level clean area for non-woven fabric cutting and disinfection rod bonding. The company only provided the "Infrastructure Maintenance Order" issued and approved by the office, but did not provide the company's "Engineering Change Management System" (No. SJ /ZD-45), the "Engineering Change Application Form", change verification plan and report reviewed and issued by the Production Department, Technology Department, Equipment Department, Quality Management Department and Regulation Department do not comply with the "Medical Device Production Quality Management Specifications" and The relevant appendix (hereinafter referred to as the "Specification") requires that the maintenance and repair of factories and facilities shall not affect product quality.

(2) The enterprise fails to store and label the components of the single-use electronic analgesic pump control device in the prescribed area. If it does not comply with the "Specifications", the storage area should be classified as pending inspection, qualified, unqualified, and returned. Or recall and other situations, stored in partitions to facilitate inspection and monitoring requirements.

(3) A finished product slide is set up between the second floor of the first workshop in the 100,000-level clean area of ??the enterprise and the non-clean area packaging room on the first floor to transfer finished products, but there is only one between the clean area and the non-clean area. The door is closed. When delivering finished products, the door is opened, and the clean area is directly connected to the non-clean area. The pressure difference gauge displayed on site is 1 Pa, which does not comply with the "Specifications". The static pressure difference between clean rooms (areas) with different air cleanliness levels should be greater than 5 Pa. The static pressure difference between the clean room (area) and the outdoor atmosphere should be greater than the requirement of 10 Pa.

(4) There are insects in the lighting fixtures in the enterprise's 100,000-level clean area. The door between the men's second watch and the hand-washing area in the 100,000-level clean area opens in the direction of low cleanliness, which does not comply with the "Specifications" Production plants should be equipped with facilities to prevent dust, insects and other animals from entering. The doors, windows and safety doors of the clean room (area) should be sealed, and the door of the clean room (area) should be opened in the direction of high cleanliness.

2. Equipment aspects

(1) The company stipulates that product protective caps and other parts should be washed with injection water, but it was found on site that the water for injection is stored at room temperature without circulation. In addition, There are stagnant water sections in the water for injection and purified water pipelines in the cleaning room of the 100,000-level clean area of ??the enterprise, and the required process water should be determined in the "Specifications". When process water is used in the production process, corresponding water production equipment should be equipped and measures to prevent pollution should be taken. When the amount is large, it should be transported to the water point of the clean room (area) through pipelines. Process water should meet product quality requirements.

(2) The enterprise equipment operation record table shows that the air purification system in the clean area was shut down continuously from 14:00 on January 25, 2017 to 5:30 on February 3, 2017. The enterprise did not provide continuous shutdown for more than 8 days. Testing or verification data before restarting production, and no records of testing environmental parameters in the clean area before resuming production, cannot be confirmed to still meet the specified cleanliness level requirements. It does not comply with the "Specifications" if the air is turned on again after shutdown. Purification systems should undergo necessary testing or verification to confirm that they can still meet the specified cleanliness level requirements.

3. Document Management

Randomly check the company’s environmental monitoring records of the 10,000-level sterility testing room on January 3, 2017, including the 5.0μm detection in the original record of the dust particle testing instrument. The value is 3530, which exceeds the requirement of ≤2000 in YY0033, but the original data was changed to 1530, and the judgment was qualified. The company did not sign the name of the person who changed it, the date and the reason for the change. Records that do not comply with the "Specifications" must not be altered or destroyed at will. Changes to the record should be signed with the name and date, so that the original information is still legible. If necessary, the reasons for the change should be stated.

IV. Design and development

(1) In August 2016, the company changed the production method of type A spare parts type II circuit boards from self-mounted patching to outsourced patching. Process change review and verification records are not provided; the supplier of the memory in the company's spare parts procurement list has changed, but the supplier of the memory shown in the bill of materials is still the original supplier, and no review records related to supplier changes are provided. Enterprises that do not comply with the "Specifications" should identify and maintain records of design and development changes. Where necessary, design and development changes should be reviewed, verified and validated, and approval requirements should be obtained before implementation.

(2) The micromotor model specifications specified in the company's bill of materials are inconsistent with the micromotor specifications and models in the company's micromotor parts price list, inspection record sheet, and raw material supplier sample confirmation letter. There are obvious differences in the rated voltage, rated speed, no-load speed, starting torque, insulation resistance, and axial clearance in the micromotor specifications of the specifications and models. However, the company did not provide a specific date for changing the model specifications, nor did it evaluate the possible changes due to changes. Risks brought about by changes in materials, parts or product functions that do not comply with the "Specifications" may affect the safety and effectiveness of medical device products, the risks that may be caused by the changes should be evaluated, and measures should be taken if necessary. Risks are reduced to an acceptable level while complying with relevant regulatory requirements.

5. Procurement

(1) The PVC calendered film factory test report (No. 170402) provided by the company’s raw material supplier does not cover the physical properties required by GB15593. Testing items such as vinyl chloride monomer cannot prove that the material meets the requirements of the national mandatory standards. If it does not meet the requirements of the "Specifications", it should be ensured that the purchased items meet the specified requirements and are not lower than the relevant provisions of laws and regulations and the national mandatory standards. related requirements.

(2) Suppliers of Class A materials micromotors, micropumps and infusion silicone tubes in the enterprise's spare parts list are all listed in the list of qualified suppliers and are managed as Class B qualified suppliers. Enterprises that comply with the requirements of the "Specifications" should establish a supplier audit system and conduct audits and evaluations on suppliers. If necessary, they should conduct on-site audits.

(3) The enterprise’s purchase quality agreement for micro pumps and infusion silicone tubes does not stipulate the raw material model specifications. The supplier specified in the supplier’s bill of materials for the LCD screen is the same as the supplier in the purchase contract. Inconsistent and non-compliance with the "Specifications" When purchasing, the purchasing information should be clearly stated and the purchasing requirements should be clearly stated, including the categories of purchased items, acceptance criteria, specifications, models, procedures, drawings, etc. Procurement records should be established, including procurement contracts, raw material lists, supplier qualification documents, quality standards, inspection reports and acceptance standards, etc.

(4) The company’s bill of materials stipulates that the material grade used for the infusion tube with a diameter of 2.8 is PVC lung tube material, but the company did not provide the biological evaluation record of the lung tube material, which does not meet the requirements of the "Specifications" When purchasing items for inspection or verification, materials that require biological evaluation should meet the same requirements as materials that undergo biological evaluation.

6. Production Management

A random check of the aging records of a certain batch of electronic controllers in the company revealed that the aging time was only 59-62 hours, which did not comply with the "Type II Control of Electronic Controlled Analgesic Pumps" The provisions of the 72-hour aging test in the Device Assembly Process Card (No. SJ022-500A). The above-mentioned "Electronic Controlled Analgesic Pump Type II Controller Assembly Process Card" shows that the company uses a computer wire stripper to strip off the insulating part of the power cord to expose the conductive part (4mm long) during production. The actual conductive part of the power cord exposed on site is only 3mm, which is not Each batch (set) of products that comply with the "Specifications" must have production records and meet traceability requirements.

7. Quality Control

(1) It was found on site that the leakage current measuring instrument does not have the detection function of the DC component of patient leakage current, and the company’s factory test report does not cover mandatory standards Patient leakage current DC component performance indicators required by GB9706 and registered product standards.

The company's "Disposable Electronic Controlled Analgesic Pump Finished Product Inspection Regulations" (No.: SJ/GC-56) does not cover the dielectric strength test requirements specified in GB9706. The finished product inspection report (No.: ZG-8.2.3-04) There is also no dielectric strength test data and judgment conclusion, and it does not meet the requirements of the "Specifications" that enterprises should formulate product inspection procedures based on mandatory standards and registered or filed product technical requirements, and issue corresponding inspection reports or certificates.

(2) There is no supplier of polyvinyl chloride inspection certificate (report number: QSP-R-8.2.4-0446) for blood transfusion (liquid) equipment in the purchase record of the company's PVC granules 5401T-A74B The official seal cannot confirm the source of the inspection certificate, and does not meet the requirements of the "Specifications" that inspection records should include inspection records, inspection reports or certificates for incoming inspection, process inspection and finished product inspection.

(3) The enterprise failed to retain key samples of disposable electronically controlled analgesic pumps in accordance with the provisions of the finished product sample retention management system (No.: SJ/ZD-25), nor did it provide retention samples in accordance with the provisions of the system. The full performance test report of the sample product does not meet the requirements of the "Specifications" that sample retention management regulations should be formulated based on product and process characteristics, samples should be retained in accordance with regulations, and sample observation records should be maintained.

8. Sales and after-sales service

Randomly checked the company’s sales records of a certain batch of electronically controlled analgesic pumps in May 2017. There was no product expiration date in the records, which did not comply with the "Specifications" Sales records must include at least the name, specification, model, and quantity of the medical device; the production batch number, validity period, sales date, name, address, contact information of the purchasing unit, and other requirements.

9. Control of non-conforming products

The company has not prepared rework control documents, which is also included in the "Electronic Controlled Analgesic Pump II Controller Assembly Process Card" (No. SJ022-500A) There are no specific provisions on rework requirements, re-inspection and re-validation. A random inspection of the company's production records of a certain batch of electronically controlled analgesic pump II controllers (No.: SC-7.5.1-06) found that the number of repairs in the records was inconsistent with the electronic controller failure report (No.: ZG-8.3-04). If the repair items and methods are not found, and the unqualified products that do not meet the "Specifications" can be reworked, the enterprise should prepare rework control documents. Rework control documents include work instructions, re-inspection and re-verification requirements.

The company has confirmed the above-mentioned defects in its quality management system. The above-mentioned behavior of the enterprise does not comply with the relevant provisions of the Medical Device Production Quality Management Standards, and the production quality management system has serious flaws. The State Food and Drug Administration instructs the Zhejiang Food and Drug Administration to order the enterprise to immediately stop production and make rectifications in accordance with the law. Regulations on the Supervision and Administration of Devices (State Council Order No. 680) and related laws and regulations will be dealt with seriously in accordance with the law. At the same time, the Zhejiang Provincial Food and Drug Administration is instructed to require the company to evaluate product safety risks. For products that may cause safety hazards, they should be recalled in accordance with the "Measures for the Management of Medical Device Recalls" (State Food and Drug Administration Order No. 29) Related products. ;