Product quality management and control measures of the company

    1、 Based on the actual situation and objective conditions of the company, a product quality management system and detailed rules have been formulated.

    2、 While focusing on quality system document certification, we are also focusing on product quality management. At present, the TS16949 quality management system certification has passed the first and second stages of official audits and is about to obtain a certificate. Regularly conduct internal audits and management reviews of the quality system. Ensure the continuous improvement and effective operation of the quality management system.

    Ensure the smooth implementation of the quality management system in the production process, and strictly supervise and inspect in accordance with document requirements. Specifically, in the following aspects:

（1） Human resources training.

    Newly hired personnel shall receive training on rules and regulations, product quality awareness, etc. organized by the Administrative Human Resources Department, and can only work with a certificate after passing the assessment.

（2） Regularly carry out standardized management inspections on production facilities, equipment, and working environment to provide conditions for ensuring product quality, propose improvement measures, and order rectification within a specified period of time.

（3） Pay attention to the source and strictly control the entry inspection of raw and auxiliary materials.

    Develop quality standards for raw and auxiliary materials, stipulating that after each batch of raw and auxiliary materials arrives at the site, the first quality inspection shall be carried out by the warehouse keeper, and then the quality assurance department shall apply for sampling inspection. After passing the inspection, a qualified notice shall be issued before they can be put into storage for use. The workshop material picker receives materials based on the inspection certificate presented by the warehouse keeper.

（4） Process product control.

    1. The company has established the "Product Quality Early Planning and Control Procedure", which mainly plans the production process of new products and new customers in the form of an APOP team to ensure the product quality requirements in the subsequent production process.

    2. Establish a multi-level product quality management and supervision mechanism to ensure that product quality meets customer requirements.

    The production operator is the primary quality responsible person, and the material quality confirmation handover procedure is implemented for the front and back processes to meet the quality requirements of this process. The workshop director, process technician, etc. are the secondary quality responsible persons to supervise and inspect whether the operator processes and controls according to the product quality control procedure and process requirements; The managers of the Biotechnology Department and Quality Assurance Department are the third quality responsible persons responsible for conducting spot checks on the process control situation and records during the production process, and punishing personnel who violate regulations.

    3. Inspectors shall conduct inspections on each batch of products in accordance with product inspection specifications, strictly control the quality, supervise the quality assurance department manager, and analyze the inspection data to ensure that the products are qualified and leave the factory.

    4. Develop control procedures for non-conforming products and standardize the disposal and management of non-conforming products. Develop preventive and corrective measures for non-conforming products through cause analysis to prevent similar quality problems from recurring.