QA means "quality assurance" in Chinese, and it is defined in ISO 8402: 1994 as "all planned and systematic activities implemented in the quality management system and verified as required to provide sufficient trust to show that the entity can meet the quality requirements". The following are the articles I collected for you about qa work summary and self-evaluation. I hope I can help you. If you feel good, you can share it with more friends!
Chapter 1: The time for qa work summary and self-evaluation passed quickly. In a blink of an eye, 2008 will be over. Unexpectedly, I have been working in the company for more than a month. In these days, the leaders and colleagues of the company gave me great care and help, which made me adapt to the new working environment and post quickly. Thank you very much. This is a year of great significance to me. I have learned the relevant knowledge of pharmaceutical production, and have a practical understanding of the actual operation of production, but there are still some shortcomings. The new year is coming. I am here to sum up my work this year, sum up my experience and put forward higher requirements in order to make a greater breakthrough in 2008.
20 1X this year, my work has gone through two stages. From June to August, I was mainly engaged in the management of GMP and SOP documents. From the beginning, I was completely unfamiliar with it and successfully completed the revision of the document, which was inseparable from the patient guidance of our leaders and the enthusiastic help of our colleagues. From then on, I began to gradually realize the importance of QA responsibilities, be more strict with myself, constantly study the quality management system in depth, and work hard towards mature and qualified QA.
At the same time, the laboratory was basically completed in July, and I participated in the construction of the laboratory, and systematically studied and studied various equipment and instruments such as polarimeter, conductivity meter, high performance liquid chromatograph and microscope. In the next few months, I learned all kinds of testing methods and learned to do it myself. I have mastered the testing of various products of the company. Among them, there are still many problems in the operation of HPLC detection, which need to be consulted and studied by leaders and two colleagues of QC. Although some progress has been made in the research of experimental methods, it needs to be further developed, and sample processing and comparison are still the key. We not only studied its effect, but also compared it with HPLC and turbidimetry. At the same time, the standard curves of various methods are made and the linear range is analyzed. These determination methods of chondroitin content have their own advantages and disadvantages, and we still need to study and compare patiently and deeply before we can draw a correct conclusion. In protein detection, we discussed the conditions and limiting factors of Kjeldahl method.
In production, I followed my colleagues in the production department and the technical department and conducted several trial production operations. During the period, the process technology was adjusted many times, and colleagues in the technical department took pains to debug, and colleagues in the production department also patiently tested and stayed up all night. I admire their spirit very much. In the process of production debugging, I also look up to them. I won't stop until I finish the task. I will track the whole process from the pre-processing to the end, record the process data in detail, strictly control the sampling of clean products in equipment and sites, do a good job in QA, and work hard for the company to complete the trial production as soon as possible and achieve the expected goals. So although I worked overtime and stayed up late, I still had a full and happy life. We brainstormed with colleagues from other departments and solved many problems in the production process. Facing the challenges of the new year, we are full of confidence.
20 1X I have gained something, but at the same time I have realized many of my shortcomings:
1. Although full of enthusiasm, but lack of experience, there are shortcomings and some new problems in dealing with emergencies, which need further efforts and study.
2. We should strengthen communication with leading colleagues at work, and our immature ideas need the guidance of leaders and communication with colleagues to be more perfect.
3. The management ability of on-site GMP needs to be further strengthened, so please consult colleagues in on-site production modestly.
4. Many things are not handled properly, and I hope to make further improvement in the coming year. 2008 is a year full of expectations. For the company, the trial production of chondroitin should continue, the second phase of the project should continue to be built, and the process needs to be improved. This is a new starting point and a new challenge for me. With the continuous production, GMP verification should be carried out in depth, and all kinds of products should have perfect production guidance and inspection methods and standards. It is imperative to skillfully use what you have learned to contribute to the company. To this end, I will study hard, participate seriously, and let myself grow continuously.
annual working program
1. Strengthen study and practice and make continuous improvement. Focus on your own post, learn QA function in depth, and learn inspection and testing methods at the same time to improve your ability to solve problems.
2. Make every effort to finish the task. There are many challenging and important tasks in 2008, such as the verification of inspection methods and the implementation of GMP in the workshop, which are all challenging for me. Colleagues need to improve themselves and their knowledge in other fields when they participate in other jobs.
3. Improve your own quality. In the new year, we must unswervingly prepare for the all-round development of moral quality, and the shortcomings in interpersonal communication and society need to be improved.
Summarized by: XXX
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Chapter two: QA work summary and self-evaluation leadership:
Hello everyone!
It is a great honor to have this opportunity to write this summary report. Time flies. In a blink of an eye, I have been engaged in QA work in the quality department of * * * company for more than half a year. I have learned a lot in the past six months, and I am very grateful to the leaders for their cultivation. At the same time, I also saw some questions that I have some doubts about. Combined with my working experience in other companies before I entered * * * *, the summary report is as follows, please review and correct me:
First, the understanding of quality standards
I think people who do quality work often emphasize quality assurance and do nothing more than three things:
1. Know what is good and what is bad.
2. Know why it is good and why it is not.
3. Know how to prevent and do well.
Whether it is the final inspection of the production line or QA or OQC of the quality control department, we only verify the products that have formed quality. No matter how strict the inspection standards and sampling standards are, quality cannot be formed. However, no matter how good and strict the inspection standards are, if OQC or QA, as a process inspection, are not familiar with the standards or do not implement them, it will only be a blank sheet of paper based on subjective speculation, which will not only fail to ensure the quality, but will delay the work and seriously cause the good reputation of the enterprise. For example, the problems and customer complaints (wrong shipping label) of Tianma products made by the second line some time ago were completely caused by our OQC's carelessness during inspection. Although this is some mistakes in our own work, I think the key is to strengthen the improvement of our standard system, such as systematic training for employees, continuous confirmation of post qualifications, and improvement of performance appraisal. Forming an organic combination of employees is also a long-term policy. Now our quality control department has made a summary document of some customers' complaints and common problems in inspection, and formed a picture. The combination of sensibility and rationality has enhanced the memory of inspectors for unqualified products, which is of great help to my inspection work.
Second, the control of quality standards
As quality IPQC, QA and OQC, what I feel most is the quality dispute with the management personnel of the production department. Conventional standards cannot be unified with the standards of the production department, which is easy to cause conflicts. In fact, the attribution of responsibility for any quality problem is completely inseparable from the three departments of technology, quality control and production. Whether it is raw materials, technology, finished products, shipment. As long as it involves products, it is related to quality! And where is the root of the problem? Our inspector's position is not high, and their judgment results are easily opposed by various departments. But from another point of view, even inspectors with excellent technology and strict inspection standards and acceptance quality restrictions will only reduce the outflow of defective products, will not form product quality, and will not reduce quality costs, because this
At this time, the quality has been formed, and the subsequent inspection is only quality verification, and the company has to bear the rework cost of unqualified products.
Third, the problem of filling out forms.
How to fill in the form correctly is not a simple problem! Don't laugh, there is nothing wrong with whether the relevant items involved in the form are completely filled in, but in practice, many people have problems in filling in. For example, items that don't need to be filled in must be crossed out, and if multiple items/data need to be filled in, there will often be omissions; Leave the signature blank, etc. In particular, the delivery inspection report of our OQC, the list of quality anomalies of the production line, and whether these forms are complete and correct are also a focus of our quality control department OQC and IPQC. How to fill them out and close the case perfectly is related to many things. At this point, I think I need to study more and pay more attention in my future work, because the five or six lines are all producing small orders, scattered orders and many reports. If I make a mistake carelessly, the loss to the company will be too great.
Fourth, quality and product delivery.
Before, our company emphasized the delivery problem in the engineering management of other companies. Now, after work, let me talk about quality control. Some friends stressed that quality control workers must separate quality from delivery, only responsible for product quality, regardless of other factors! I think what is emphasized here is the single characteristic of quality, which is the inherent characteristic of the product. So are the customers satisfied with the out-of-stock products? The answer is no, if we only regard quality as a matter of quality control department and delivery as a matter of planning department and production department, I think it is definitely not comprehensive. Therefore, I think quality control workers should understand quality and give consideration to delivery. Hehe, everyone seems to be aiming at supervision from scratch. Have you ever thought that the actual situation is more complicated? It's true that many problems will be found in on-site monitoring, especially at the beginning, whether it's software, hardware or wet department, some problems can always be found from the perspective of QA, but the question is whether you can finally solve the problems while you keep discovering them. Seriously, some problems can't be solved completely. Over time, they will become normal phenomena and let them exist. Therefore, as on-site monitoring, when you find some problems, you should clearly know how much impact it has on product quality. All we can do is monitor the key points. The determination of key points needs to be determined through the process of the product and other related situations.
Although I haven't been doing QA in our company for a long time, I feel very lucky. In my daily work, I often get the support of department leaders, which makes me realize my own shortcomings and gives me room for improvement. The most important thing is to thank the leaders for their trust and give me such a platform to engage in the position I have always wanted to do. I sincerely thank the company leaders and colleagues for their support along the way. Thank you!
I am here to convey
welcome
Quality department
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