Are the TC 176 Documents on Risk Based Thinking useful to you?

[Antonio Vieira]

...
I believe that the documents fall way short of providing practical, actionable and useful guidance for quality management system professionals to clearly understand what is needed to comply with ISO 9001:2015 in terms of RBT. Ditto for auditors.
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The document has one important thing!
It refers the 2 "Useful documents" at the end...

 

[Mark Meer]

Interesting conclusions in the document:
"- risk-based thinking is not new
- risk-based thinking is something you do already"

The bottom line appears to be:
- When making decisions you weigh risk/rewards based on your objectives
- You gather data from decisions and processes, and use it to gauge effectiveness and identify opportunities for improvement.

So what's new?
Does the document explain the concept of risk (according to this standard)? ya, I guess.
Is it informative/helpful/useful, though? ...definitely a "No" vote from me.

 

[qualprod]

It is not clear enough for me.
Is somewhat confusing, in my viewpoint , it seems that, options to cross the road, are the opportunities, and I see them as mitigation actions to lower the risks.can someone clarify this point?

 

[John Broomfield]

It is not clear enough for me.
Is somewhat confusing, in my viewpoint , it seems that, options to cross the road, are the opportunities, and I see them as mitigation actions to lower the risks.can someone clarify this point?

Another way of looking at this is to remember that our system standard mainly specifies preventive actions throughout. Very few of its clauses require inspectors or auditors to look for nonconformity after the work is done.

Having a separate clause specifying preventive action, as we had pre-2015, made no sense. It led to CAPA thinking instead of action to prevent the occurrence of failures to meet requirements.

An organization that thinks and works as a system of processes that enable its employees to get their work right the first time provides ample evidence of risk-based thinking and action. Creating FMEAs just to show auditors does not.