TS 16949 Clause - Risk Analysis Requirements Explaination



Risk analysis example

Dear Cove's friends,
Regarding ISO/TS 16949;2002, can you explain more about "risk analysis'? What is the general example of doing risk analysis.
If I think to show my FMEA, enough or not?

Thank you very much

Manoj Mathur

Quite Involved in Discussions
According to ISO/TS 16949:2002 Clause, “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
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.


A basic worksheet to perfrom risk analysis. It can be used in the audit process as well as for process design.


  • risk analysis.xls
    21.5 KB · Views: 2,174


Riisk Analysis

Thank you for both of your input.
As I think about FMEA becasue the requirement is likely to spot only organization manufacturing feasibility of risk.
What Manoj mentioned about molten aluminum leak is what we have included in our Safety Risk Analysis (OHSAS 18001)

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