Recently, the State Food and Drug Administration announced the "Quality Management Regulations for Medical Device Production" (for trial implementation) (hereinafter referred to as "Specifications"), and will be implemented on January 1, 2011. All medical device manufacturers will face "regulations". The test of "" is ridiculously called "life and death line." How to successfully pass the “life and death line†will be the focus of medical device manufacturers in 2010. During this period, in addition to carefully studying the text of the “Regulationsâ€, enterprises should also implement production management according to requirements. Change the whole side and get the standard as soon as possible Tightening the string of risk management Spice Novelties Co.,Limited , https://www.wholesale-adult-toys.cn
Talent reserve is a top priority
extract:
Article 4 A production enterprise shall establish a corresponding organization, stipulate the duties and powers of each institution, and clarify the quality management functions. The person in charge of the production management department and the quality management department shall not concurrently serve each other.
Article 7 The person in charge of the production, technology and quality management departments shall be familiar with the relevant regulations of medical devices, have practical experience in quality management, and have the ability to make correct judgments and handling of practical problems in production and quality management.
Article 8 Personnel engaged in work affecting product quality shall undergo relevant technical training and have relevant theoretical knowledge and practical operational skills.
Interpretation:
For a long time, in the medical device industry , in addition to paying more attention to the technical requirements of product development and registration, many companies are basically in autonomous operation. Looking through the "Specifications", we will find that the requirements for the quality of the company's products have clear standards from beginning to end, and have made specific and clear regulations on the professional level of relevant quality leaders and professional and technical personnel. Therefore, around the main line of ensuring the quality of medical device production, the quality requirements of the "Specifications" can be said to be the top priority.
Therefore, in addition to the need for technical instructors in the implementation of the "Specifications", medical device manufacturers must set up specific technologies and even cutting-edge technology positions from development to product delivery. From the current medical device professional and technical talent market, in the short-term increase of multiple technical posts, and some specific positions also need to have certain professional practice skills, so the shortage of talent will inevitably become a foregone conclusion. In the case of a certain period of talent training, the demand for technical talents of medical device manufacturers will soon evolve into competition for talents. Therefore, it is a matter for enterprises to start doing their work immediately.
It can be said with certainty that enterprises, especially those above designated size, want to pass the "Regulations" and continue to grow bigger and stronger. They can't pass the talents. Only one end will be eliminated.
extract:
Article 15 A production enterprise shall establish a design control procedure and form a document to implement planning and control of the design and development process of the medical device.
Article 25 A production enterprise shall establish a procurement control procedure and form a document to ensure that the purchased product meets the specified procurement requirements.
When the purchased products have legal, administrative regulations and national mandatory standards, the requirements for purchasing products shall not be lower than the requirements of laws, administrative regulations and national mandatory standards.
Article 29 A production enterprise shall plan and implement all production processes under controlled conditions.
Interpretation:
It can be seen from the provisions of the excerpt that the "Specifications" have clear requirements and regulations for the technology, production, supply and marketing, and service processes of medical device manufacturers, aiming at strengthening the management and control of the process and further standardizing the normal operation of the enterprise. Run in sequence.
The Code imposes mandatory rules on every aspect of product quality and possible risk liability. From research and development to product sales, the "Specifications" require the establishment and improvement of relevant documents and materials, and mutual confirmation, evidence-based. Therefore, how to ensure the accuracy, accuracy, and integrity of the document records, to achieve the company's goal of passing the "norm" and adhere to the "norm", is also a difficult obstacle for medical device manufacturers to face. In order to do this, in addition to the above-mentioned technologies and management talents, relevant personnel of the enterprise should be familiar with the work processes and requirements stipulated in the "Code" as soon as possible, and quickly supplement and improve the production practices. The only way to operate. In the case of tight time, strict standards, and high degree of informatization, the standard operation cannot be achieved overnight.
Therefore, medical device manufacturers must do their utmost to shorten the gap with the "norms", through a period of period of reform, and strive to basically meet and adapt to the "norms" before the formal implementation of the "norms".
extract:
Article 24 A production enterprise shall, in the whole process of realizing products including design and development, formulate requirements for risk management and form documents to maintain relevant records.
Article 50 A production enterprise shall establish and maintain sales records, and it shall be able to trace the sales of each batch of products according to the sales records.
Article 53 When the product is found to be unqualified after the product is delivered or started to be used, the production enterprise shall take corresponding measures.
Interpretation:
Strict control and traceability of the quality risks of medical device manufacturers are clearly defined in each chapter of the Code. That is to say, enterprises that operate through the "Code" and in accordance with the "Specifications" must be well documented at all times for the quality risks of products that may exist or have been produced, and make corresponding assessments and bear the burden. Responsibility. Even if the risk is within the acceptable range of the enterprise, it will cause some economic losses to the enterprise, affecting the market sales of the product after the risk is eliminated, and will also adversely affect the reputation of the enterprise within a certain range. If the risk is enough to make the company lose its ability to withstand, the company must not only be punished by relevant regulations, but also face the claims of all parties. Such consequences are unimaginable, and the most serious ones are only bankruptcy.
Therefore, how to further strengthen the awareness of the company as the first person responsible for product quality, maximize the elimination and reduction of various risks, and enhance the ability of enterprises to withstand and deal with risks is not only the principle requirement of the "Code", but also the must for medical device manufacturers. One of the difficulties.