Checked E Cigs Factory PFMEA documents

When checked E Cigs Factory PFMEA documents (including Alpha project three PFMEA: power unit, atomizer and coil and Spark project power unit ) found that E Cigs Factory did built PFMEA for Alpha and Spark project product process analysis.

But all these PFMEA didn’t have document control numbers, and they did not specify the corresponding improving responsible department or person in the documents.

Also packing process and warehouse section are not included in the documents for analysis.

In addition, analysis items (for example, fit between switch on PCBA, silicon gasket and plastic switch cover rated RPN 70) with RPN above 50 did not indicating improving measures( according to the term in the documents: >50RPN should be solved asap). These are not acceptable

According to E Cigs Factory SPC procedure , the SPC control point need to be reflected on Production process flow. But Actually there is no this information in this document.

Per customer requirement, CE/ROHS/TPD etc. test all ready conducted by 3rd party TCT when product finalized

No DOE for parameters selection for Bag heat sealing machine; E Cigs Factory need make experiment to find the optimized parameters like as Speed, Temp, and the gap bwt up&lower mold

No report, and no parameters defined on machine work instruction(E Cigs FactoryWI-PD-001)

E Cigs Factory follow cosmetic accept criteria to check the sealing effect. Machine meet the requirement

E Cigs Factory follow cosmetic accept criteria to check the sealing effect. Machine meet the requirement

E Cigs Factory has 3rd party calibration plan for instrument and testers (Sampling check calibration report for Resistance Tester E Cigs Factory-PD-005 ), but no calibration plan and label for homemade fixture & Jig

Resistance tester on E Cigs Factory production line with three behind decimal ponit,and products’ specification with resistance 1.0/1.2/1.5 ohms respectively. It meets requirement.
But need add jig to improve reliability of contact/measurement (and productivity) and need perform 2 or 4 hours’ periodic check with standard resister.

E Cigs Factory has production approval process (E Cigs Factory-QP11) to control Finance review, P.O qty loading, Material planning, Material purchasing, FG shipping etc.; but on Product Released fm NPI to Mass production Form, there is no gate criteria for FPY rate.

The Process Control Plan (QCP) procedure is avaliable.During review the procedure and process flow,found the QCP template was not in place. The IQC functional testing criteria only have Testing items but do not have testing method column.This will cause the testing method will not able to define in the current used template.

For Quality Control Plan(QCP) E Cigs Factory have 4 QCP and separate by Semi-FG and Finish goods( Atomizer core,Atomizer , Power unit and Full set Unit) . During review the QCP for Atomizer , found the sampling plan requirement reference is define follow the AQL2.5 standard for cosmetic inspection but actual sampling size frequency and quantity define is fixed at 5Pcs /Lot, not according to AQL/2.5.

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