Risk analysis - ISO/TS 16949 clause 7.2.2.2

M

michield

#1
I am new to the world of QMS and have some problems interpreting clause 7.2.2.2 of the ISO/TS 16949. I hope somebody can help me out.

Concerning the risk analysis that is asked for: is it sufficient to identify critical tools needed and make sure there is a second one available? Or preventive purchasing of spare parts?
If not, what is meant by the ?risk analysis??

Thanks for the help!
 
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L

lk2012

#3
Re: Risk analysis - TS 16949 clause 7.2.2.2

7.2.2.2 is aimed at manufacturing feasibility. Your organisation should have a process for feasibility study with responsible departments involved.

The risk assessment is done at the level of each department (when they evaluate the design) and also on top level (this would often fall to the Project / Program Manager)

One of your sure-fire risk assessment tools is your FMEA
 
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