Primarily influenced by the automotive standard, our quality plan during the process of producing any new product usually includes the following key elements:
- Analysis of potential risks (FMEA)
- Creation of the operating procedure
- Inspection plan
- Partnership with suppliers
- Study of process capabilities
(Cmk, Cpk)
- Measurement System Analysis (MSA)
- Monitoring production using SPC control charts
- Preventive equipment maintenance
- Final product check performed by a qualified staff member
- PLCs working on the measuring principle using cameras or a probe; in some cases, the rate of the results can be as low as 0 ppm (zero faults per million parts)
- The 8D ("Eight Disciplines") method for handling non-conformities
The full quality plan and all the associated tests are collated to create a validation file. These documents are mandatory in the automotive and medical industries (PPAP) and must be validated by the customer before starting any series production.
