Medical device production processes are the main problems and solutions
2012-01-08 by seoer1
From the source to ensure the safe and effective medical products in recent years, local regulatory authorities for medical devices continue to increase supervision of production processes, increasing production and quality management standardization. But should not be overlooked is the daily medical management of production processes there are still some problems to be improved. Recently, the author of the actual area of medical device manufacturers conducted a survey of management and made suggestions for improvement and measures for the primary production enterprise and regulatory departments.
Currently, most medical device manufacturers of smaller, less product range, low quality, resulting in a lower level of management. Embodied in: increased without changing the size and scope of the product model; product brochures, packaging and labeling is not standardized; medical professionals, small, part-time quality control personnel are present, do not post, unfamiliar business, etc.; lack the necessary testing equipment or testing personnel not familiar with, not according to the standard factory inspection; production site management and health management process is not strict, the key process control in place, state identity confusion, and operation procedures are not perfect, do not strictly; free to dispose of substandard products For items not in accordance with substandard quality system documentation quality system requirements for processing; incoming inspection, production testing, factory inspection records were incomplete or no records, poor traceability of the production process; not in strict accordance with specification requirements of production activities in the purchase, acceptance, storage, marketing and other aspects are different degrees violations; quality management system has not really run, and some enterprises have not established the quality management system, daily management is very confusing.
In response to these problems, the proposed medical device manufacturers to take the following measures to improve the management level: First, strengthen the full education and training, to enable enterprises to legal persons, responsible people, quality management and all employees are familiar with both the registration and production of medical devices regulations, improve according to production and management capabilities. Second, step by step sign "commitment to quality and safety of medical devices book", and strictly implement the "Enterprise is the first responsible person" responsibility system, strengthen self-discipline, strictly abide by the "Supervision and Regulation of Medical Devices" and other regulations, product standards and quality in accordance with carefully system requirements of production. Third, strictly implement the "supervision and management of medical device manufacturers" and "the medical device manufacturer quality system assessment methods" and other regulatory requirements, and product licenses from companies, all kinds of personnel qualifications and performance of their duties in the post production storage conditions, raw material storage inspection and recording, production processes and factory inspection, the establishment and operation of quality management system standards and other aspects of daily management. Fourth, to support the independent role of quality manager, strict incoming inspection, process inspection, factory inspection and other key sectors, the real standard to do the record. Fifth, pay attention to the introduction of medical professionals and improve the existing varieties of scientific and technological content, and constantly develop new products, and gradually the company bigger and stronger, to improve the competitiveness of enterprises.
To strengthen the supervision of aspects of medical device manufacturing, primary regulatory authorities should take the following measures: First, medical device manufacturers to seriously implement the tasks of daily supervision, the production company as the regulatory focus, at least every six months to carry out an on-site supervision and inspection. Second, medical device manufacturers to carry out the operation of special inspections of the quality system, focusing on the production process of checking records and test various aspects of the timeliness and authenticity. Third, improve the credit rating system, the implementation of classification regulation. Each routine supervision and inspection must fill out the "on-site supervision and inspection of grading conclusion Form" signed and sealed by the company to confirm, at the end of the year for all enterprises comprehensive credit rating, credit rating high on the appropriate reduction in the number of checks on the credit rating is low, management is poor, there is a serious problem to increase the intensity and frequency of supervision and inspection. Fourth, improve the corporate governance standard file timely routine supervision and inspection, routine supervision and inspection rating, annual credit rating, administrative processing, production and registration for a change in corporate governance and other information recorded in the file, the implementation of dynamic regulation. Fifth, improve the professional quality, and enhance regulatory capacity, full and good use of existing needle holders regulations, avoid unfamiliar with their business caused by the absence of regulation.