Validation Procedure
Our Product Development and Validation Procedure ( refer to ISO 9001)
  • NPD or New Product Development Request is the main document done by Customer or Development Team. NPD is comprising all project targets & requirements, competitors and annual sales volume.
  • In case of any additional requirements during the Development Process the NPD should be revises and updated according to them. OPTIONAL: List of Inputs, the document summaries requirements don’t influence for FFF (Fit Function Form). Example: development of cutters with different axial angle for best performance… Very useful form for quick and flexible project management and recording. 
  • The Combined Team (CT) is the group of leaders in Marketing, Production and Design Departments etc.
  • The CT is responsible to review NDP & priority and make decision of delivery time; make competitors and patent review.
  • CT meeting’s record, monitoring and control are required.
  • The development process of new product contents: 
    • Design of new product implementation the most critical functions: parameters, angles and dimensions.
    • Implementation of 3 independent concepts 
    • Pursuit of product family (if necessary ) according to a product range 
    • Development of measurement and technological devices 
    • List of critical points and potential sources for failure 
    • Creation of design table for test 
    • Verification (Revision) of design. During the development and manufacturing process product may have changes and modifications. A drawings and 3d model should be updated according to those modifications. Previous revisions (version) should be saved by a Designer. 
  • Outputs for product development are: 
    • 3d model of product and drawings 
    • The confirmation drawings for customer 
    • 3d model and drawings for final product
    • 3D model and tooling ( mold etc) 
    • All package for CAM and Mold drawings set 
    • Final Drawings of product and assembly 
    • Drawings of all necessary devices 
    • Design tableRecord and summary of a test results included competitors. 
  • Validation of design (before manufacturing) involves checking of critical parameters , dimensions and angles.
  • Recording of the validation process. Review and approve by team leader or all CT (if necessary).Review of number different pressing conditions and determination the best one for first production order. Validate dimensions (and special requirements) by measurement of inserts IC, M and the height; Using a special measurement prism OR (AND) additional devises (if necessary).
  • In case of product has an errors or omissions non suitable to drawings or NPD the product is coming back to re-manufacturing or redesign process. To rich the quality of product: re-manufacturing process may require new technology and equipment; Redesign of insert may require adjustment of the product to existing type of technology and may require new tooling (molds).
  • After the redesign and re-manufacturing product is require new review and validation.
    Creation design table for internal or external tests (testing conditions are depends to products type.) Make a record and summary of internal tests.
  • CT reviews test results and approve products: inserts & cutter (one by one) for external (customer) tests. In case of product line of cutters (cutters with insert) has unsatisfied performance, short tool life, damages and breakages non suitable NPD the product line OR (AND) insert are coming back to re-manufacturing or redesign process.
  • After the redesign or re-manufacturing process product line come back to external tests again.
    When the internal Tech Center tests complete and all production line has satisfied performance – CT approve product to the field (customer) tests.
  • When the external customer tests complete and production line has satisfied performance: CT completes the Validation List (requirement as NDP) and products approve to the muss production.

( Our Product Development and Validation Procedure ( refer to ISO 9001))