I. Overview of Quality Inspection Work
Quality is the life of an enterprise. Based on the market, it is a magic weapon for enterprises to survive and develop in the fierce market economy. Quality has a wide range of meanings. For the pharmaceutical industry, it is nothing more than the quality of work and the quality of products, which complement each other. Product quality is guaranteed by work quality, and work quality is reflected by product quality. Drug inspection is the main responsibility of the quality assurance department. With the strengthening and improvement of drug supervision and the further standardization of drug market, counterfeit and inferior drugs are difficult to hide. New forms such as high-tech counterfeiting, counterfeit famous products and underground channel circulation put forward higher requirements for drug inspection, and the technical support role of drug inspection is more important.
Secondly, the basic situation of quality inspection in the past 20 years is reviewed.
(1) Integrating resources and positioning our department is now under the management of Yunnan Baiyao Group Company's Chinese Herbal Pieces Branch, which is mainly responsible for the inspection of raw materials and food of Yunnan Baiyao Group and Chinese Herbal Pieces Branch. At present, our department is the Chinese herbal medicine inspection center of the group company, and all varieties of the group materials are inspected in our center. At present, there are 158 species of aggregate materials that need full inspection, and there are hundreds or even thousands of Chinese herbal medicines and Chinese herbal pieces. With the expansion of the company's business, our sample size is getting bigger and bigger, and our task is getting heavier and heavier. The 20th edition of China Pharmacopoeia was officially implemented from June to 1 October1day in 65438, which brought great difficulties to our work and increased a lot of workload. Especially when it was first implemented, the new inspection needed running-in, and it happened that the company was distributing goods, so a lot of inspection products were piled up in the inspection area. However, our QC staff took great pains, and they didn't have any complaints whether they were dragging their shifts or working overtime, so they were duty-bound to do the work well.
In this year's quality system operation, our department strictly performs the quality inspection function, gives full play to the role of quality inspection under the premise of maximizing the company's interests, and strictly inspects the company's production and operation varieties to ensure the company's product quality. Inform the production department of non-conformities in time, analyze the reasons and take corrective measures. If the product is unqualified, the quality of the product is counted regularly so that the production department can correct the unqualified items.
(2) It is a long-term and unremitting work to change ideas and ensure the quality and safety of service products. Only products with good quality can stand the test of the market. As a department serving production and products, the quality inspection department must strengthen training in time to adapt to the rapid development and changing external environment of our company, and constantly improve the overall quality to adapt to the products with increasing product diversity and complexity and ensure product quality.
(3) Strengthen training, improve the level and strengthen the operation training of employees. While doing a good job in the training of rules and regulations and codes of conduct in the whole factory, we should further put the training work on site guidance, focus on strengthening the implementation of mentoring activities, and strive to bring new workers into technicians and skilled workers, so as to provide a solid quality foundation for product quality in the production and processing process.
(4) Implementing responsibilities and highlighting key points is the first level of quality inspection in the whole company. Our inspection speed is directly related to whether our products can be delivered to customers in time, and the inspection results are also directly related to whether our product quality can pass the customs. Yunnan Baiyao is a listed company, and our products must not make any mistakes. The burden of quality inspection is particularly heavy. To this end, the quality inspectors worked tirelessly and meticulously, and faced with various difficulties, they overcame the difficulties one by one and the difficulties in product quality control.
(5) Strengthen functions and provide good services. In the work, we should pay attention to grasping the root and strive to improve the inspection level. Our department has fewer quality inspectors and a heavy workload, which requires the unity and cooperation of all employees. In the future work, no matter what kind of difficulties you encounter, you should actively cooperate with other colleagues to do a good job, and you can think with your colleagues and work hard. You never care about doing more or less, just want to finish the work successfully.
(six) strictly according to law, and constantly strengthen the construction of style. I have been strict with myself for half a year and have been putting? Endure dullness, be willing to pay and work hard? As my own criterion, I always put the focus of work style construction on rigorous, meticulous, solid, realistic, down-to-earth hard work and skillful work. In the work, consciously use the system and discipline to regulate all your words and deeds, strictly abide by the rules and regulations of the unit, respect the leadership, unite with comrades, be modest and prudent, and constantly improve the work; Insist on doing things that are not conducive to the image of the unit, and actively maintain the good image of the unit.
Third, the main work measures
This year, with the support of department leaders and colleagues, I have completed all the work, mainly in the following aspects:
1. Complete the inspection of medicinal materials and decoction pieces, and issue the inspection report in time to ensure the normal production of the production workshop and not hold the company back. 20 years1~165438+1October 25 * * Inspection of XXX batches of Chinese herbal medicines, qualified XXX batches, unqualified XXX batches, XXX reports and records issued. XXX batch of strategic varieties. Issue XXX reports and records.
2. Completed the formulation of standards for some pieces of decoction.
3. Completed the monthly monitoring and inspection of drinking water in the decoction pieces workshop and the air cleanliness inspection in the microbiology laboratory.
4. Complete the management of laboratory reagents to ensure that the reagents needed in the inspection process can be found as soon as possible.
5. Completed the inspection of packaging materials, auxiliary materials and microorganisms, and ensured the normal subpackaging and production. * * * Inspect XXX batches of packaging materials and issue XXX reports and records; * * * Inspect XXX batches of auxiliary materials, report and record XXX copies. XXX batch of food, including XXX batch of spirulina tablets and XXX batch of Yunnan olive buccal tablets. Issue XXX reports and records.
6. Completed the purchase and management of reagents.
7. Complete the purchase and management of precursor chemicals.
Four, 20 years of work ideas and arrangements
After 20 years, our department will be guided by Scientific Outlook on Development. Efficient and low consumption? For the purpose, continuously improve the quality inspection ability, and fully ensure the quality and safety of drugs in our company.
(a) actively perform the duties of quality inspection.
Combined with the characteristics of many varieties and complicated inspection in our company, the short-term and long-term objectives of quality inspection are formulated. Strictly control the inspection process, refine the inspection standards, and further standardize the inspection operation process. Focus on checking the new items in the 20th edition of Pharmacopoeia, accumulate data, and lay a solid foundation for future work.
(two) to maintain the high pressure of variety inspection.
Strengthen the inspection process and inspection report audit, implement rapid inspection methods, improve inspection efficiency and reduce inspection costs. Cooperate with relevant departments to ensure timely and accurate test results. Strengthen the importance of inspectors to the quality inspection of drug production, adopt a combination of inspection and verification, further promote the verification of inspection results, strengthen the supervision of high-risk varieties inspection, and strengthen the dynamic supervision of poisonous hemp varieties inspection.
(three) to promote the positive development of inspection skills and quality of inspectors.
It is suggested to establish and improve the reward and punishment system to promote the in-depth development of the work. Through the monthly selection of outstanding employees as a means to play the leading role of outstanding employees. Actively and regularly carry out skills training, organize inspectors to carry out skills competitions, and comprehensively improve the inspection skills of inspectors through exchange and learning, enhance their core competitiveness, improve their professional quality, and ensure the reliability of inspection results.
(four) reasonable arrangements for employees to work and vacation.
According to the relocation plan of the group company, make the plan for the relocation, installation and debugging of the instruments in the inspection room, the GMP document preparation process and division of labor. Cooperate with the company's relocation team to ensure the timely success of the relocation. Under the premise of ensuring that the quality inspection results can be provided accurately and timely, arrange the staff vacation reasonably.
Although some achievements have been made in the past year, there are still some shortcomings, mainly due to insufficient ideological emancipation, insufficient study and service, and a certain gap compared with the requirements of experienced colleagues and leaders. At the same time, there are still problems such as weak sense of innovation. In 20 years' work, I will sum up my experience, overcome my shortcomings and try my best to do better.
(1) Continue to carry forward the spirit of hard struggle. In the face of QC inspection, the inspection variety is miscellaneous, the task is heavy, not afraid of hardship, tireless, meticulous and patient. Eye diligence, mouth diligence, hand diligence and leg diligence? , actively do a good job of quality inspection. Hone your will and grow your talents in heavy work.
(2) Continue to carry forward the tireless enterprising spirit. Strengthen study, be brave in practice, learn from others' strengths and learn from others' strengths? Nutrition? ; At the same time, pay attention to learning methods, correct learning attitude, improve learning efficiency, and strive to cultivate their good habits of loving learning and practical work style. Strive to do a better job, correctly understand your own work and value, correctly handle the relationship between bitterness, gain and loss, personal interests and collective interests, adhere to professionalism, honesty and professionalism, temper and improve your theoretical and professional level, and set an example for your own work.
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