ISO 9001:2015 - Right method to address clause 6.1?

[Golfman25]

When the auditor asks for objective evidence - what are you going to show the auditor?

I guess my point is there are risks to purchasing/sourcing. A purchasing function is essentially there to manage those risks.

Are we required to go thru each raw material and determine the risk of single source supply for each? Is it sufficient just to hit the big one? Where does it stop?

I can just see a point where we are writing novels on risk, so we have our objective evidence, with very little added value. To me it should be about focusing on the macro level risks - probably 4-5. As opposed to every single itty bitty micro risk we deal with on a daily basis.

 

[AndyN]

I guess my point is there are risks to purchasing/sourcing. A purchasing function is essentially there to manage those risks.

Are we required to go thru each raw material and determine the risk of single source supply for each? Is it sufficient just to hit the big one? Where does it stop?

I can just see a point where we are writing novels on risk, so we have our objective evidence, with very little added value. To me it should be about focusing on the macro level risks - probably 4-5. As opposed to every single itty bitty micro risk we deal with on a daily basis.

This is a great example of mission creep where too much is being read into the requirements! (Not a comment directed at Golfman, incidentally).

I just saw, elsewhere, someone who paraphrased IATF 6.1.2.3 (which states, in part, "identify and evaluate internal and external risks to all manufacturing processes...") as " within 6.1.2.3 the organisation must identify all internal and external risks..." ( a caveat was added later).

The whole thing about risk and opportunity is becoming a monster when ISO 9001 doesn't require much more than the use of a simple tool, like a SWOT (per ISO/TS 9002 guidance) and a plan to address whatever is considered necessary, through the QMS processes. It's really not rocket science, people.

 

[Jen Kirley]

I agree it's mission creep to, as an example, go thru each raw material and determine the risk of single source supply for each. Helpfully, there are usually few such single-sourced materials.

That said, if one is looking at the risk of single-sourcing a critical raw material, what harm is there in asking if there are others?

RBT is supposed to be about value, where getting it wrong can make an organization sorry.