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Product Process Control
During the product validation process, NEST will test all performance items of the product according to internal product technical requirements to ensure that the product meets the design requirements. NEST products go through product design validation, process window validation, performance validation, small-batch trial production, and three-batch production tracking during the development stage to ensure that the products are produced stably and reliably, meeting the product design requirements.
After the product validation is completed and mass production is achieved, some of the early-stage validated product performance test items will be transformed into periodic monitoring and batch testing items to control the consistency of product quality. Periodic monitoring is conducted regularly based on different products and test items, while batch testing is conducted before each batch of product processing and release to ensure that any product quality issues are promptly identified, intercepted, and corrected during the production process.
Product Performance Validation
Product performance validation refers to a series of tests and validations to check whether the product meets the predetermined performance parameter requirements and user usage needs. The results of the validation can be used to determine whether the product can enter the next stage of development or production. These validations include, but are not limited to:
Periodic Monitoring
Periodic monitoring of products refers to regular testing and evaluation of finished products to ensure that they continue to meet quality and performance requirements during use. This type of monitoring helps identify problems with the production process or quality testing process that have a moderate level of risk and take necessary measures for repair or replacement in a timely manner. Periodic monitoring varies depending on the product type and purpose, including, but not limited to:
  • Dose Accuracy Testing
  • Resistance Testing
  • Vibration Resistance Testing
  • Stability Testing
Batch Release Test
Process inspection and batch release test are important methods for product quality management, which can control the quality of semi-finished products and pre-released finished products, ensuring stability and consistency of product quality. The advantage of batch release test is the ability to detect problems as soon as possible throughout the entire process, thereby reducing production costs and improving product quality. These testing items include, but are not limited to, the following for semi-finished and finished products:
  • Free fall test
  • Trigger force test
  • Stability test of injection dose knob
  • Appearance and packaging inspection
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