According to ISO/TS 16949:2002 Clause 7.2.2.2, “The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis” During Risk analysis we need to formulate the risk associated with our nonconformity to customer specification may be time schedule or any rejection including field failure. We must find out our commercial liability in case of non-compliances.
I add further, While calculating RPN through
FMEA may be a prt of Risk Analysis BUT It is not only the solution to clause 7.2.2.2.
In FMEA we calulate risk related to product and product quality.
But we have to ensure Financial Risks, Market Risks, Environment Risk also.
I can further elaobrate on this,
During Casting of Alloy Wheel if there is metal leakage from 1000 Kg caster crucible. The temp. must be around 700 degree centrigate.Have you analyse the risk assosiated with this.