There is a structure of Process FMEA (P-FMEA) in the company.
Class (small)
Change points considered to affect products to be delivered are clarified. Rules for changes are also clarified.
Rules setting up for quality policy/target are clarified compared with the previous year.
Top policy is conducted at the sites (workers), as the detailed improvement plans and the activity for quality policy/target are proceeded every year. Moreover, the proactive prevention contents for the occurrence of the defective parts are included in the policy/target/plan.
The status/effect/achievement rate etc. for the improvement plans are periodically/quantitatively evaluated .
The above evaluation result is reflected to the improvement measure/review of the plan.
Departments in charge of QA and responsible persons are specified, and respective roles and responsibilities are clearly indicated.
Personnel responsible for product quality are clarified, allocated to each work shift, and authorized to suspend production. - TS requirement 5.5.1.1, “Responsible for quality”
P-FMEA is created before starting of the mass-production process and the failure mode/major process on manufacturing process is clarified.
For the creation of P-FMEA, the check system of the related departments is established, and the contents is confirmed.
Based on the information of customer complaints and the quality defect information in internal process, P-FMEA is reviewed each time and utilized for the recurrence prevention/in-process confirmation
implementation