Tianjin Kager quality assurance program

Tianjin Kager quality assurance program


In order to strengthen enterprise management, improve product quality and better serve customers, the following plans are formulated:

1. Formulate quality policy

Quality and safety are the core, innovation and development are the foundation, standard management is the means, customer satisfaction is the goal.

2. Set quality goals to achieve quality policy

1) the incoming inspection/verification rate of raw and auxiliary materials reaches 99.9%.

2) the ex-factory inspection rate of products reaches 99.9%.

3) the ex-factory qualification rate of the product reaches 99.9%.

3. Strictly control all links of product production according to quality objectives

Company established a perfect quality management and product development system, the purchase of advanced production equipment and testing instruments, in accordance with the GMP requirements and workshop layout, and strictly implement GMP management system, to ensure product quality, to develop the following system:

1) develop staff training system

It is stipulated that all personnel must be trained and qualified before they can take up their posts. Regular safety and product quality training should be conducted for employees and training records should be made.

2) establish the purchase inspection system for raw and auxiliary materials

Raw material suppliers must provide the relevant documents, and to purchase raw materials inspection report shall be for the procurement of raw materials come back to factory inspection, qualified rear can put in storage, and issue the factory inspection report, fill in the receipt. Record the batch number, quantity, specification, manufacturer and purchase date of raw materials in detail.

3) formulate the warehouse management system

It is stipulated that raw materials that have not been inspected and unqualified for inspection are not allowed to be stored in the warehouse. Qualified raw materials shall be set up in the raw materials ledger, and different materials shall be stored separately to avoid confusion. For material release, the material release procedures must be fulfilled, such as the material release form and so on, according to the name, specification, quantity, model, time, limit, limited amount and so on.

4) formulate production process management procedures

It is stipulated that the production department shall make the production plan according to the market demand for the products, and the production plan shall be assigned to the production workshop to collect the materials according to the production task, and the production shall be carried out according to the operation instructions. The production technology department compiles the process flow chart and writes the operation instruction for the key process. Operators are assigned to compile and post, with clear operating instructions, after training qualified can be on the post. Operators carefully fill in the daily production log, including mixing record and production daily. In the process of production, inspectors will conduct inspection, fill in the inspection form, and timely find and solve the unqualified factors.

5) formulate production equipment management system

Set up equipment and mold ledger, and set up equipment card, whose content is: equipment name, model, service time, etc. Responsible for the production equipment and molds, set up the annual maintenance plan of the equipment, maintain the equipment according to the plan, and make records.

Inspect the equipment every day and record the working status of the equipment. The operators shall be responsible for the equipment hygiene and fill in the corresponding records.

6) formulate product inspection system and product retention sample system

According to the national pharmaceutical packaging container (material) of standard YBB00122002 product inspection, the quality department is responsible for product inspection and retention samples, product inspection qualified rear can put in storage, establishment and maintenance of the original products are inspection data record and inspection report. And set up the product ledger by the warehouse. Original test data and test report records including check the product name, specification, quantity, batch number, production date, production standards, inspection conclusion, inspection personnel, inspection time, etc. Conduct type inspection to a third party inspection institution recognized by the state every six months.

7) develop management procedures for testing equipment

Departments according to the requirements of product quality and conformance to apply for configuration testing equipment testing equipment, application content including model/specification, range and accuracy requirements (glassware must with "CMC" logo). For the national compulsory measuring instruments, the quality control department shall submit them to the inspection department of the department of surgical measurement for inspection before they pass the inspection. According to the appraisal period, the quality control department formulates the test equipment verification plan to ensure that the test equipment is in the qualified state.

8) establish control procedures for nonconforming products and corrective and preventive measures

Unqualified products shall be evaluated by the quality department. Unqualified raw materials and finished products shall not be stored in the warehouse and non-conforming products shall not be allowed to enter the market. Find out the reason of nonconformance in time and put forward corrective measures.

9) formulate product sales management system

The management department is required to communicate with customers in a timely manner and strictly follow the sales contract when selling products. Timely understand customer needs and accept customer's Suggestions and Suggestions with an open mind. Establish and maintain sales records for each batch, and record product name, specification, quantity and batch number in detail.

10) establish a consumer complaint management system and product recall system

Record the customer name and complaint content in detail for the customer complaint. After receiving the customer complaint, report it to the relevant department and handle it in time.


4. Formulate departmental assessment system

Of the various departments to examine the work of a month, by the production technology, quality control, ministers and the workshop director to examine the assessment team, the implementation of a workshop director and the relevant departments shall be responsible for the inspection. Find out the problems existing in the system and perfect the system documents.


Conclusion: our company's quality management is carried out in accordance with the PDCA cycle, and new goals are constantly proposed to improve the existing problems and improve the product quality.

This system will be implemented from May 1, 2013