Can not set up the re-inspection room as follows:
A, do not set up the re-inspection room of the reasons for the analysis
1, economic factors, re-inspection of the room need to spend a certain amount of construction and maintenance costs, including space, equipment and other aspects of investment, if the actual work needs to be not to set up a re-inspection room Room to save money.
2, the actual need, in some units or places, for the current scope of work, staffing and the nature of work, does not require the establishment of the re-inspection room, the more important thing is the quality of the personnel on the quality of the work of the seriousness, meticulousness, and assessment of the awareness of the quality of work.
3, the degree of professionalism, if the staff has a unique professional standard, experienced, with strict professional conduct and moral ethics, but also to ensure the quality of the work in question.
4, external regulation, according to the "Medical Device Quality Management Regulations", "Medical Device Manufacturing License Management Measures" and other documents, medical device manufacturers need to be subject to the supervision of the State Drug Administration, in product design, processing and manufacturing, product quality testing and use of tracking and other aspects of the State Drug Administration need to be inspected and evaluated.
Re-inspection Room
1, the difference between re-inspection and calibration: in the process of product manufacturing, it may be necessary to calibrate and re-inspect certain key indicators. The so-called calibration refers to the testing of instruments and equipment to ensure that they meet the intended requirements. And re-inspection is to have been tested after the sample again to check to ensure that the sample authenticity, accuracy and reliability.
2, the design elements of the re-inspection room: for the need to consider the establishment of the re-inspection room for the premises or units, need to pay attention to the following design elements: site selection and site planning, environmental preparedness and control, staffing and training, equipment and materials procurement, information technology construction and other aspects.
3, different areas of re-inspection room practice: according to different areas of work needs and quality requirements, there are also their specific re-inspection room practice mode. Such as medical imaging, food safety, aerospace and other fields have personalized re-inspection room practice experience.
4, the establishment of re-inspection room for some industries can better improve the quality of products or services, but for other industries can be discretionary to consider the need to establish. And whether or not to establish a re-inspection room, in any industry, should always comply with professional ethics and moral standards to ensure the quality and safety of products or services.