All,

Now that we've all had some time to use the Third Edition of 61010-1, I
wonder what are the typical responses to section 17?

What I usually see are companies using their in-house FMEA/FMECA process to
satisfy the requirement of this section.  Presumably, with a view to
product safety, a formal Design FMEA/FMECA is conducted, risks identified,
Criticality & RPN calculated, corrective action plans formulated, ownership
assigned and follow-up is scheduled.  Of course, with this method, the
re-calculated Criticality & RPN should be reduced to an acceptable level
before product certification is complete.  Is this the method others are
using as well?

I see no requirement for the certifying agency to do follow-up on action
plans, so it occurs to me, what are the preferred methods for companies to
do corrective action tracking?

​Thanks a bunch, Doug




-- 

Douglas E Powell

[email protected]
http://www.linkedin.com/in/dougp01
ᐧ

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