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　　[Quality Control]

　　The stone of other mountains and the defects of rectification

At present, all workshops and functional departments of the company are carrying out a series of drug production quality management activities around the “2017 Jindi Kyushu Pharmaceutical Quality Management Work Implementation Plan”, which is effective for solid promotion activities, Yang Wenjun, Minister of Quality Supervision and Management Department, April On the 1st, the company's office WeChat group forwarded an article on the summary analysis of the defects found in the quality inspection of the provincial food and drug administration bureau. The title was “Analysis and Analysis of 280 Defects in 48 Enterprises”. In response to this article, the company's chief executive Zhao and Zhang made the request at the first time, asking everyone to "really study and improve." According to the leadership requirements, the supervision office carefully studied the actual supervision work in conjunction with the usual supervision work, and downloaded and bound the book into a book. After repeated reading of this article, the enlightenment and sentiment are shared with you.

First of all, clearly understand what the significance of this article is, that is, why the leader asks everyone to study hard; secondly, after learning, know how to correct the defects in our own quality management of pharmaceutical production. This is the two decisive factors for doing anything: first understand why! Then know how to do it!

First, the article is related to the situation, is the summary of the defects found by the foreign bureaus in the GMP routine inspection activities of pharmaceutical companies in March this year. Like this inspection, our company has often encountered in the past and future in the quality management of pharmaceutical production. It shows that it has accurate timeliness; the seven types of inspections cover all aspects of GMP management of pharmaceutical companies, such as: flight inspection, production inspection, daily inspection, special inspection, certification rectification inspection, tracking rectification inspection, comprehensive supervision and inspection, and 7 kinds of pharmaceutical enterprises. The inspection form, our company will also accept the GMP quality inspection in the past and in the future, which shows that it is clearly comparable; the 280 defects are summarized, compared with the actual situation of our company in the quality management of pharmaceutical production, these defects The phenomenon is obvious, and some defects are even more serious than those disclosed in the article, which proves to be highly targeted.

Second, what to do after studying the article, the two leaders of the company put forward the "control, improve" requirements in the first time. How to compare, there is a lot of attention. After studying this article, at least three question marks should be raised: 1. Is there a similar situation in our company with 280 defects? 2. Which of the 280 defects in your work is the same? 3. How to learn from others' experiences and help you correct your defects. I saw 280 defects, and I think of the actual situation I encountered in the supervision work. These kinds of defects exist in our workshops and departments, but we are commonplace, take it lightly, or turn a blind eye to it. Letting the defects continue to exist, if we accept the inspection, I am afraid that it is not just 280. Do not say anything else, such as the defects pointed out in the article, such as: the production of workplaces found in daily necessities; the ground wall is unsanitary or contaminated; the production work site is chaotic or the clearance is not thorough; the machinery and equipment are dusty; the status is not complete and many more. These defects are still evident in our workshops and departments, and are not valued by the managers. They even think that these are minor problems and are not related to quality. However, only when we seriously read this article, 280 defects, the vast majority are not caused by technical processes and machines, but the work operators are not sloppy in the details and details. Grasping quality management, there must be no mistakes of "grasping big and letting go small", pollution and cross-contamination, confusion and errors, are the four regular factors that cause product quality accidents. In the production quality management work, any subtle defects will be Contamination and errors occur, as long as these subtle defects exist, it is a blessing that no quality accidents occur, and an accident is inevitable.

Third, learn from other people's practices and help them improve their production quality management, and they have reached the requirements raised by the leaders. On the basis of careful study and comparison, how can we improve? I think we should start from two aspects. First, grasping the deep integration, combining the other people's inspection and summary analysis practices with the company's quality improvement activities; summarizing 280 defects with the company's past rectification defects; combining production quality management work arrangements with defect rectification; defects as negative teaching materials and learning training Content combination. The second is to grasp the real name of the post, and to implement it is to implement the problem into practice. All defects must be placed on the counter, specific to the post, real name to the person, a negative list, and a rectification period.

It is helpful to open the book and conceal it. His rock can attack jade. I think of the secrets of studying the college entrance examination every year. I have talked about a good practice and good habit. I will write the wrong questions in class and write them on a small book. I will do more exercises until the knowledge is solid. To improve the quality management of production, we must not be slick, and the talents of quality managers at all levels of the enterprise are how to make the 313 articles of the "Good Manufacturing Practices" become the conscious and specific actions and skilled operations of each employee. To achieve and achieve this goal, the work must be grasped, grasped, and grasped concrete. Telling us a truth based on work experience and the changing rules of things, learning from others' lessons and helping them to rectify is an effective way to quickly improve their ability to work, or a shortcut. Adopting this method is better than several times of general learning training.

When the company leaders guide us to do our work well, we often say: “Multi-communication, more understanding, and more support.” Take this case as an example, on the basis of careful study, take the specific responsibility of deep integration and real name of the post, 280 Which position is involved? Who is involved? Must be clear. This is a hard standard for measuring the responsibility of a workshop or department, communication, understanding, support, not being in place, whether it can follow the leadership requirements, and whether it has at least basic management responsibility.

　　Supervision Office: Li Zhiping

　　How to be a qualified laboratory technician

2017 is the year of drug quality improvement! As a member of the Kyushu Central Laboratory, what is currently done is how to improve quality inspection.

The role of quality inspection in product quality management.

1. For the control of raw materials and auxiliary materials entering the factory, the company must purchase the required raw materials for production and business activities. These purchased materials are part of the enterprise's products and must be controlled. Without strict quality control, it is not only difficult to guarantee the production of qualified products, but also cause a lot of financial losses, and quality inspection is needed to make this pass.

2, the control of the production process, from raw materials to finished products, process control is an important part of the product, is the key to product quality standards. If the various positions in the production workshop are deducted, one process is unqualified, which will inevitably affect the quality of the manufactured products. Quality inspection can provide data for the process in time, which is conducive to process adjustment, timely discovery of problems, and meeting qualified production conditions.

3, product inspection and control, pre-shipment inspection, is an important means to test whether the product meets customer requirements, strictly in accordance with the requirements of inspection, record, to ensure that the quality of manufactured products is qualified.

4, the control of the inspection equipment, all inspections, and ultimately the corresponding inspection methods and inspection equipment; inspection equipment needs to be corrected. Instruments that have not been calibrated are used for product quality inspection, and the credibility of the test results cannot be discussed.

How to improve quality inspection?

Quality inspection plays an important role in product quality management, and needs to be improved to improve the following content.

(1) Improve quality awareness. Our laboratory technicians should improve product quality awareness. At the same time, corporate leaders should also improve product quality awareness, actively participate in quality management activities, and directly participate in the formulation of quality policies and quality objectives, which is conducive to forming a model role and driving employees to actively care about product quality. Let all employees of the company participate in product quality management.

(2) Establish an internal quality inspection management system. The internal management system has been improved, the supervision has been guaranteed, and the product quality has been guaranteed. On the other hand, the establishment of an internal quality management system is conducive to standardizing quality inspections, so that quality inspection personnel have rules to follow.

(3) Have a quality inspection team with excellent quality. In order to do a good job in quality inspection, you need an analyst who understands product quality analysis and understands equipment operation. The training of quality inspectors is an effective way to improve quality inspectors. Through training, new knowledge and skills can be accessed; and training should have different levels of training, such as leadership training for management concepts, such as training for the backbone, technical and business, and one-to-one room quality inspection. Skills training, organize the development of laboratory technician skills competition activities.

(4) Establish an incentive mechanism. For employees who have made outstanding achievements in quality inspection work, including innovation, skill improvement, and rigorous work, employees who are good at product quality inspection should be encouraged by material and spiritual, enhance employees' initiative to care about product quality, and promote quality. The cause is moving forward.

Looking back on the past, we have hardships, setbacks, hard work and perseverance, and the continuous improvement of the company. We are constantly growing and perfecting here, and we will use our own practical actions to add to the future of Kyushu!

　　Central Laboratory: Shi Wei

　　Quality improvement starts from self

The quality of medicines is the life of our company. The quality of small-volume injection products is related to the national economy and the people's livelihood and thousands of households. Therefore, improving the quality of injection products is the consistent pursuit of our injection workshop.

Comparing the injection workshop to a machine, it is made up of thousands of different parts with different functions. The effect of one machine running normally depends on whether each part is normal and whether the function is played out. Is it accurate? From the perspective of improving product quality, workshop staff can be compared to a small component in the workshop machinery and equipment. The activities of the employees are related to the development of the entire injection workshop and the development of the enterprise. Every employee in the injection workshop now has to play the role of this component and cooperate with the operation of the surrounding gears. Therefore, for the quality construction and future development of the company, it is for our personal future development. Every employee of the company should do his or her own job and start from the little things around me. Only by doing our job well, we can be regarded as competent employees, and we can be a competent part of quality construction. If everyone in the company is working hard to do their own work, then the quality of our company is naturally perfect, then the company's "quality improvement year" activity is playing a role.

In the “Quality Improvement Year” campaign, the injection workshop advocates each employee to improve their personal quality awareness and enhance their personal quality. Quality is in my heart, product quality is in my hands, establish a quality legal concept, and improve the individual's own quality awareness. Firmly establish the correct quality values, always remember the quality first. The quality of the product depends on the perception of each employee. There is no small matter in quality and safety, and every little thing that you should do well and must be done carefully. In the spirit of the master, we will participate in the company's production management and strive to improve employees' individual learning awareness. Strengthen professional knowledge, observe more, diligently think, actively learn professional skills, and expand your professional knowledge. There is no best, only better, and improving quality is also a process of continuous learning and continuous improvement. In the work, we should constantly strengthen our understanding and practice, make a summary, and continuously improve. Only in this way can we achieve the advancement of the times and the quality of products can be guaranteed.

　　Injection workshop: Yang Shangkun

　　[Management field]

　　Two Points of Understanding and Understanding of Doing a Good Job in Enterprise Comprehensive Work

First, first understand the main duties, status and role of office work. The corporate office is responsible for the heavy work of giving up the situation, reporting the situation, foreign contacts and logistics services. It is in the position of coordinating the connection between the departments, workshops and the grassroots. It is the information center, service center, staff center and operation center of the company. Command center. It has six functions: staff, assistant, coordination, service, check and supervision. This requires office staff to have higher political acumen, more accurate predictability, and work with advanced and rich experience. Whether it is writing a document, doing business, organizing a meeting, or managing, serving, or coordinating, any problem in one link will have a great impact, and even bring a passive or loss to the work of the entire company, that is, office work How to directly restrict and influence the development of various tasks and the completion of production and operation tasks.

Second, it has the comprehensive quality of doing office work well. Working in the corporate office, especially the director of the office must participate in the discussion and decision-making of important issues, but also organize the daily trivial matters, and often experience more ups and downs in the office work. Therefore, the office staff must be strong in professionalism, work conscientiously and conscientiously, study hard and ask questions, and work hard, especially with strict organizational discipline, hard work and good quality, and resolute work style, which is a prerequisite for doing office work; office staff It also has basic text synthesis ability, can independently draft manuscripts, understand the basic situation of the company's production and operation, and be familiar with the basic processes of the company's company operations. This is a necessary condition for doing a good job in the office; the corporate office personnel must have a good mental state. The office is an integrated service department. It must not only coordinate all aspects, but also serve the upper and lower sides. It has the characteristics of overall integrity and great influence. Therefore, the office staff must have a good mental state, be loyal and reliable to the company, be clean and correct, be enthusiastic and thoughtful to the staff, be fair and impartial, and be selfless, which is the basic requirement for doing a good job in the office.

　　Comprehensive Office: Zhao Guangzhou

　　[Safe Production]

　　Safety management needs the spirit of "three irons"

In recent years, with the development of the company, the cooperation units have entered, the level of mechanization and scale has been continuously improved, which has injected a strong momentum into the company's development, but it has also brought great pressure on the company's safety work. The company leaders emphasize quality every time. Safety, environmental protection work is the top priority in all work, we must always work hard. Therefore, it is necessary for our management personnel at all levels to have the spirit of selflessness, iron fists, and iron shoes to break through in the safety management work.

Implementing the system requires selflessness. The rules and regulations are better written. If they are only hung on the wall, they will become a blank piece of paper when they are not implemented. The management personnel at all levels must grasp the safety of the iron and the surface, and truly let the safety quality standards and regulations take root in the scene. Strictly organize production according to safety quality standards and safety regulations. It is not possible to talk about relationships, disparity, change, and change standards. As a result, safety standards and measures are not implemented properly. Standard implementation is required, measures are implemented consistently, and no violations are allowed. Soil and space.

To eradicate hidden dangers, you need an iron fist to cure. The hidden dangers will not be removed, and there will never be Ningri. The safety management personnel at all levels should organize and carry out in-depth and detailed investigation of safety hazards, and carry out field-by-field, part-by-part, step-by-step, and post-checking of key areas, key parts and weakened links. Any problems and hidden dangers should be taken with categorical measures to detect hidden dangers. In addition to thorough investigation, the problem should be blocked, the loopholes should be blocked from the source, the hidden dangers should be eliminated, and the hidden dangers should be checked and rectified into a standardized, normalized and institutionalized track.

To control the scene, you need to break the iron shoes. Speaking of it is better to go to the scene, to go to the scene to check, to visit the place where you are not at ease, and to patrol the place where it is easy to become a blind spot, to grasp the implementation of safety quality standards and procedures at the scene, and to implement the situation. The base is clear, targeted, avoiding the fog, looking at the flowers, finding the problem, checking the problem, rectifying the situation, eliminating the hidden dangers in the bud, and making the exposure problem solved in the shortest time.

　　Production Department: Lian Fusheng