CFDA issues supplier audit guidelines for medical device manufacturers

Source: CFDA 2015-1-21 Circular of the State Food and Drug Administration No.1 in 2015 on the issuance of supplier audit guidelines for medical device manufacturers In order to guide medical device manufacturers to do a good job in supplier audit and improve the quality and safety assurance level of medical devices, in accordance with the measures for the supervision and management of medical device production and the code for the management of medical device production quality, the State Food and drug administration has organized and formulated the guidelines for supplier audit of medical device manufacturers, which are hereby promulgated Notice is hereby given Annex: guidelines for supplier audit of medical device manufacturers, food and drug administration, January 19, 2015 annex, guidelines for supplier audit of medical device manufacturers The medical device manufacturer shall establish a supplier audit system in accordance with the requirements of the medical device production quality management specification, audit and evaluate the suppliers, and ensure that the purchased items meet the quality requirements of their product production 1、 Scope of application this guide is applicable to the management of medical device manufacturers on their suppliers The supplier referred to in this guide refers to the enterprise or unit that provides the products (including services) required by the medical device manufacturer 2、 Audit principle (1) classified management: the production enterprise shall take quality as the center, and classify the purchased goods and suppliers according to the impact of the purchased goods on the products The following factors shall be considered in the classification management: 1 The purchased items are standard parts or customized parts; 2 The complexity of the production process of the purchased items; 3 The impact of the purchased items on the product quality and safety; 4 The purchased items are produced by the supplier for the first time or continuously for the medical device manufacturer （2） Quality compliance: the purchased goods shall meet the quality requirements specified by the manufacturer, and shall not be lower than the national mandatory standards, and shall comply with the relevant provisions of laws and regulations 3、 Audit procedure (1) access audit The production enterprise shall, in accordance with the requirements for the purchased goods, including the categories, acceptance criteria, specifications and models, procedures, drawings, purchase quantities, etc., formulate corresponding requirements for supplier access, review and keep records of the supplier's business status, production capacity, quality management system, product quality, delivery period and other relevant contents If necessary, on-site audit shall be carried out for suppliers, or production verification and evaluation of small samples of products shall be carried out to ensure that purchased items meet the requirements （2） Process audit The production enterprise shall establish an audit procedure for the use of the purchased goods, audit and keep records of the purchase inspection, production use, finished product inspection, and disposal of unqualified products, so as to ensure that the purchased goods continue to meet the requirements in the use process （3） Assessment management The production enterprise shall establish an evaluation system The supplier shall be comprehensively evaluated on a regular basis to review and analyze the quality, technical level, delivery capacity, etc of the supplied goods, and a regular supplier audit report shall be formed as the necessary data for the annual self inspection report of the quality management system of the production enterprise If it is found that the supplier has major defects that may affect the quality of the purchased goods, the procurement shall be stopped, the risks of the used purchased goods to the products shall be analyzed in time, and the corresponding measures shall be taken In case of major changes in the production conditions, specifications, models, drawings, production processes, quality standards, inspection methods and other key factors that may affect the quality of the purchased goods, the manufacturer shall require the supplier to inform the above changes in advance, reassess the supplier, and conduct on-site audit if necessary 4、 Audit points (1) document audit 1 Supplier qualification, including business license, legal production and operation certificate, etc.; 2 Relevant documents of supplier's quality management system; 3 Description of production process of purchased goods; 4 Performance, specification and model of purchased goods, safety assessment materials, self inspection report of the enterprise or effective inspection report issued by qualified inspection agency 5 Other documents and data that can be specified in the contract （2） Purchase inspection The production enterprise shall carry out the incoming inspection in strict accordance with the specified requirements, and require the supplier to provide the effective inspection report or other quality certificate documents according to the supply batch （3） On site audit The production enterprise shall establish the key points and principles of on-site audit to audit the production environment, process flow, production process, quality management, storage and transportation conditions of suppliers and other factors that may affect the quality and safety of purchased goods Special attention shall be paid to whether the inspection capability provided by the supplier meets the requirements and whether it can ensure that the supplied goods meet the requirements continuously 5、 Audit of special purchased items (I) if the purchased items have requirements for cleanliness level, the supplier shall be required to provide the certification documents of cleanliness level of production conditions, and conduct on-site audit of relevant conditions and requirements of the supplier （2） For the suppliers of raw materials of animal origin, the relevant qualification certificates, animal quarantine certificates, animal epidemic prevention certificates, implemented quarantine standards and other data shall be reviewed, and if necessary, the feeding conditions, feed, storage and transportation, and the control of possible infectious viruses and infectious pathogens shall be extended for inspection （3） For suppliers of allogeneic raw materials, they shall review the legal certificates or confirmation documents of the ethics committee, voluntary donations, technical requirements for donor screening, donor pathogens and necessary serological test reports, etc （4） The production enterprise shall carry out on-site audit on the production process and quality control of the supplier according to the requirements and characteristics of the customized parts （5） For suppliers providing sterilization services, their qualification certificates and operation capabilities shall be reviewed, and on-site audit shall be carried out For suppliers providing metering, cleaning, transportation and other services, their qualification certificates and operation capabilities shall be reviewed, and on-site audit shall be carried out if necessary In the supply contract or agreement signed with the supplier providing services, it shall be specified that the supplier shall cooperate with the purchaser to provide corresponding records, such as sterilization time, temperature, strength records, etc If there are special requirements for storage conditions, records of storage conditions during transportation shall be provided 6、 Other (I) production enterprises shall designate departments or personnel to be responsible for the audit of suppliers, and the auditors shall be familiar with relevant laws and regulations, and have corresponding professional knowledge and work experience （2） The production enterprise shall sign a quality agreement with the main suppliers, stipulate the technical requirements, quality requirements and other contents of the purchased goods, and clarify the quality responsibilities undertaken by both parties (3) the manufacturer shall establish supplier files, including purchase contracts or agreements, list of purchased items, supplier qualification certificates, quality standards, acceptance criteria, regular supplier audit reports, etc.