Satven team has extensive experience in creation and updating of Process FMEA.
Inputs considered for PFMEA are:-
- Process flow diagram
- Assembly instructions
- Design FMEA
- Current engineering drawings & specifications
- Data from similar processes
Process FMEA is conducted with cross functional team from Manufacturing, Product Process and Quality experts. Certain cases safety engineers, customer & supplier teams are also involved.
PFMEA is conducted for assembly, as well as individual component level manufacturing process.
Always, potential effects are identified considering target attributes such as noise, poor appearance, endangers of safety, loss of a primary function, performance etc. and their effects on next user-consequences, due to failure modes like unable to assemble, cannot tap or bore, endangers operator etc.
Similarly Potential causes are also identified with respect to equipment such as tool wear, inadequate clamping, worn locator, broken tool, gauging out of calibration etc. and operator related errors like wrong part selected, incorrect tooling, incorrect feed or speed rate, mishandling, etc.
Process Controls are suggested varying from preventive methods of operator training, SPC, inspection verification , work instructions, maintenance, error proof by design and detective methods such as functional test, visual inspection, gauging, final test, etc.
Based on customer organization standards, each parameters are classified into key, fit or function, safety critical characteristics for control methodology.
Key Process Characters (KPC) Audit
To ensure that FMEA (both DFMEA & PFMEA) is a live document and also to establish linkage between various processes & documents such as Process Flow, Control Plan, Drawing and DVP&R, Satven has supported customers with KPC Audits.
In this audit process, flow of information across various documents in the form of Key Characteristics are verified. Any inconsistencies, missing of information flow of DFMEA into drawings or PFMEA into control plan etc. are reported to rectify the documents.
This exercise has helped customers improve the quality of product and make FMEA has live document. Also, with this exercise several KPC in drawings which are not critical to current product or processes are reported (which has come as legacy from previous drawings or documents). This has helped customer to eliminate the unwanted KPCs, resulting in cost saving through reduced inspection, SPC controls etc.