E Cigs Factory have breakdown the customer requirement and included the customer requirement and internal requirement into a product design requirement report.Those requirements are list out by operation mode,funtion and technical requirement.
The Project initiate report has been prepare to cover the design concept , market analysis ,cost analysis and Cross functional team for the project. E Cigs Factory have been prepare the summary and review on the project startup meeting.
a)No document number for DFMEA E Cigs ODM
b)Currently DFMEA that E Cigs Factory prepares is too simple which is not enough . Current DFMEA only has four items :Atomizer e-liquid storage ,Atomizer power supply,Atomizer charge function ,battery safety .
DFMEA included only product function failure analysis. Suggestion DEC to include more information analysis, such as indirect materials, tools and machines, package, manufacturing environment, applicable laws or regulations, etc.
E Cigs Factory showed the Prototype validation testing report during the auditor
When check E Cigs Factory validation reports for Alpha project found they had product design test plan, product design test result report, product electrical function test report and third parties certification reports, such as CE, TPT.
The Design validation test plan is available and counter check with the product requirement analysis,the testing items is align and able to trace back to product requirement.
E Cigs Manufacturers China report is Pass and All result is recorded in the DV report. For 3rd party testing result,the result show pass and is also recorded in the report.
The Design Validation Report and Plan is reviewed and approved by Engineering department head and Top management.Meeting have been called after finishing the testing . And the review result is recorded in the report.